Handhelds in Healthcare: Markets for Smartphones, Tablet PCs, PDAs, Monitors & Scanners

A desire to deliver better care and make healthcare workers more productive, as well as the incentives and mandates for EMR usage, has made handhelds ubiquitous in healthcare worldwide. Increasingly healthcare providers are using devices that can provide information and allow them to research, communicate and order services on a mobile basis.

This Kalorama Information report - Handhelds in Healthcare- represents Kalorama\’s second edition of its review of the market for these type of devices. The report focuses on two primary segments:

Patient Monitoring Devices, including:

• Blood pressure devices
• Pulse oximeters
• ECG/EKG monitors
• Ultrasound
• Diabetes insulin monitors
• Prothrombin time monitors
• TENS
• Fetal heart monitors

Administrative Devices, including:

• Smartphones and PDAs
• Tablet PCs
• Inventory/Medication Management Scanners

Handheld patient monitoring devices include a wide range of products which provide the benefits of diagnosing, consulting, monitoring and treating patients. Handheld administrative devices include products to streamline healthcare workflow and improve efficiency-patient care. Namely these products include PDAs, tablet PCs and inventory/medication scanners.

As part of its detailed coverage of the market for handhelds in healthcare, the report includes the following important market information:

• Global Market size and Forecast of Handheld Device Segments
• Geographic breakdown (US, Europe, Japan, Rest of Asia, Rest of World) of Market Size for Patient Monitoring and Administrative Devices
• The Apple iPad and it\’s Role in the Market
• The Role of EMR and Electronic Prescription
• Ten Case Studies of Health Systems Using Handhelds
• Possible Growth Inhibitors
• Cloud Technology Role
• Description of Handhelds on the Market Designed for Healthcare Applications
• Key Challenges to Healthcare Sales
• Detailed Profiles of Major Companies
• Physician and Hospital Statistics: Usage and Purchasing
• Discussion of Implementation of Handhelds and Cost and Effectiveness of Their Use
• Kalorama Small-Sample US Hospital Survey of Goals for Handheld Usage

The information for this report was gathered using both primary and secondary research including comprehensive research of secondary sources such as company literature, databases, investment reports, and medical, information technology and business journals. Telephone interviews and email correspondence were the primary method of gathering primary information. For the purpose of this study Kalorama Information conducted interviews with more than 50 key industry officials, consultants, health care providers, and government personnel.

These sources were the primary basis in gathering information specifically relating to revenue and market share data presented in this report. Specific interviews with IT company representatives included marketing directors, division managers, and product representatives.

As part of this report\’s coverage, the following companies are profiled:

• Apple
• Draeger Medical
• GE Healthcare
• Global Media
• Hewlett Packard
• Medtronic
• Omron
• Research In Motion
• Siemens Healthcare
• Socket Mobile
• Welch Allyn

All market data pertains to the world market at the manufacturers\’ level. The base year for data was 2011. Historical data was provided for the years 2009 and 2010, with forecast data provided for 2011 through 2016. Compound annual growth rates (CAGRs) are provided. The forecasted market analysis for 2011-2016 was highly influenced by the uptake of new technologies in the health industry, government incentives and requirements, product marketing, and demographic trends.

TABLE OF CONTENTS

CHAPTER ONE: EXECUTIVE SUMMARY
Healthcare Industry
Scope and Methodology
Size and Growth of the Market
Issues Facing the IT Healthcare Market
Competitor

CHAPTER TWO: INTRODUCTION
Healthcare Industry
The United States Healthcare Market
European Healthcare Markets
Asia-Pacific Healthcare Markets
Healthcare Establishments
Hospitals
U.S. Hospital Chains
Consolidation in the Industry
Handheld Device Technology Adoption in Hospitals
Physicians
Number of Physicians
Handheld Device Technology Adoption by Physicians
Nursing Homes
Handheld Device Technology Adoption by Nursing Homes
Pharmacies
Handheld Device Technology Adoption by Pharmacies
The Value Chain of the Healthcare Industry
Demographic Trends
US Demographics
Population Over Age 65
World Demographics

CHAPTER THREE: INDUSTRY TRENDS
Overview
Industry Challenges
Emphasis on Reducing Hospital Care Days
Decreasing Healthcare Resources
Nursing Shortage
Capacity Constraints
Health Information Technology and American Investment and Recovery Act of 2009 (ARRA)
Meaningful Use
Industry Initiatives to Meet Meaningful Use Requirements
Bar Code Label Requirements and Technology Demands
‘Cloud’ Technology
Hospitals’ Primary Focus: Improve Patient Care

CHAPTER FOUR: PRODUCTS AND COMPETITORS
Overview
Patient Monitoring Devices
Telemedicine
Patient Monitoring Applications
Blood Pressure Monitors
Growth Factors and Benefits of Hand Held Blood Pressure Monitors
Industry Challenges for Implementation
Pulse Oximeters
ECG/EKG
Ultrasound
Fetal Heart Monitors
Diabetes Monitors
Prothrombin Time Monitors
TENS/EMS Devices
New Developments and Trends
MelaFind Melanoma Detection Imaging System
JM-103 Jaundice Meter
Handheld Patient Monitoring Market Summary
Competitor Summary
Administrative Devices
PDAs and Smartphones
Defining Smartphones and PDAs
Uses of Healthcare PDAs
Benefits of Healthcare PDAs
Challenges in the Implementation of PDAs in Healthcare Settings
New Developments and Trends
Tablet PCs
EMR Software
E-prescription Software
New Developments and Trends
Inventory Scanners and Medication Management Devices
Benefits of Handheld Inventory/Medication Devices
Challenges in the Implementation of Handheld Inventory/Medication Devices
New Developments and Trends
Handheld Healthcare Administrative Device Market Summary
Competitor Summary

CHAPTER FIVE: MARKET OVERVIEW
Total Market Size and Growth
Market by Geographical Region
Market Drivers and Inhibitors
Growth Drivers
Emerging Trends

CHAPTER SIX: IMPLEMENTATION OF HANDHELD DEVICES: TECHNOLOGY BEHIND HANDHELD DEVICES
Overview
Overview of Wireless Technologies
Wireless Personal Area Network – Bluetooth
Wireless Personal Area Network – RFID
Wireless Personal Area Network – ZigBee
Wireless Personal Area Network – UWB
Wireless Local Area Network (WLAN)
Wireless Metropolitan Area Network (WMAN)
Wireless Wide Area Network (WWAN)
Examples of Implemented Technologies
Bethesda Children’s Hospital—Meadville, Pennsylvania
George Washington University Hospital—Washington D.C.
Good Samaritan Hospital—Vincennes, Indiana
Meridian Health—New Jersey
Mount Sinai Hospital and the University Health Network (UHN)—New York, New York
OSU Medical Centre—Ohio
Sentara Healthcare—Norfolk, Virginia
St. Clair Hospital—Pittsburgh, Pennsylvania
St. Vincent’s Hospital—Birmingham, Alabama
The Whole Child Pediatrics P.S.C.—Florence, Kentucky
Therapy Partners—Ontario, Canada

CHAPTER SEVEN: COMPETITOR PROFILES
Overview
Apple, Inc.
Company Overview
Performance Review
Products and Services
Growth Strategy
New Development
Locations
Draeger Medical, Inc.
Company Overview
Performance Review
Products and Services
Growth Strategy
New Development
Locations
GE Healthcare
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
New Development
Locations
Global Media Group, LLC
Company Overview
Products and Services
Key Acquisitions, Alliances, and Partnerships
Growth Strategy
Hewlett Packard Corporation
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Service
Growth Strategy
New Developments
Locations
Medtronic, Inc.
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Service
Growth Strategy
New Developments
Locations
Omron Corporation
Company Overview
Performance Review
Products and Service
Growth Strategy
New Developments
Locations
Research in Motion Ltd.
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
New Development
Locations
Siemens Healthcare
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Service
Growth Strategy
New Developments
Locations
Socket Mobile, Inc.
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Service
Growth Strategy
New Developments
Locations
Welch Allyn, Inc.
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Service
Locations

LIST OF COMPANIES

REGULATORY AUTHORITIES AND ORGANIZATIONS

List of Table:
CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1: The Global Market for Handheld Healthcare Devices 2007-2016
Figure 1-1: The Global Market for Handheld Healthcare Devices 2007-2016
CHAPTER TWO: INTRODUCTION
Table 2-1: Total Healthcare Expenditures as a Percent of GDP by Country 1990, 2000 and 2008
Figure 2-1: Total Healthcare Expenditures as a Percent of GDP by Country 1990, 2000, and 2007
Figure 2-2: By Sector Contribution to the U.S. GDP
Figure 2-3: The U.S. Healthcare Spending (1960-2015)
Table 2-2: U.S. Registered Hospitals by Type, 2010
Figure 2-4: Number of Hospitals in the US, 1975-2005, Estimated 2015
Table 2-3: Select For-Profit U.S. Hospital Chains, 2010 Data
Figure 2-5: Number of Hospital Mergers in the US, 1998-2007
Figure 2-6: Number of Physician Offices, 2000-2009
Figure 2-7: Number of Nursing Homes, 2000-2009
Figure 2-8: Number of Pharmacies and Drug Stores, 2000-2009
Figure 2-9: Value Chain of the Healthcare Industry
Table 2-4: The U.S. Population, 1980-2020
Figure 2-10: The US Population, 1980-2020
Table 2-5: Percent U.S. Population Over Age 65 by Year
Figure 2-11: Estimated Population by Age Group, 2000 and 2050
Table 2-6: The World Population, 1980-2020
Figure 2-12: The World Population, 1980-2020
CHAPTER THREE: INDUSTRY TRENDS
Figure 3-1: Estimated Implementation of IT-related Technologies and Applications in Developed Regions, (includes both completed and in-progress systems)
Figure 3-2: IT Priorities of Healthcare Organizations in the US, 2005-2008
Figure 3-3: Percent of U.S. Hospitals Citing Factor as Number One Reasons for ED Diversion, Current Survey March 2010
Table 3-1: Stage 1 Criteria for Meaningful Use
Figure 3-4: Percent of Organizations that Expect to Qualify for Meaningful Use in 2011 or 2012
Figure 3-5: Investment in ARRA, 2010-2011
Figure 3-6: Distribution of Fatal Prescribing Errors
Figure 3-7: Electronic vs. Paper Prescription Ordering, 2010-2011
Figure 3-8: Key Business Objectives, Healthcare Facilities, 2009-2010
CHAPTER FOUR: PRODUCTS AND COMPETITORS
Table 4-1: Select Handheld Patient Monitoring Systems Current as of December 2011
Table 4-2: The Market for Handheld Patient Monitoring Devices Estimated Products Sales by Product Type, 2011
Figure 4-1: The Market for Handheld Patient Monitoring Devices Estimated Products Sales by Product Type, 2011
Table 4-3: Select Handheld Administrative Devices Current as of December 2011
Table 4-4: Percent of Office-based Physicians Using EMR/EHR, 2001-2011
Table 4-5: The Market for Handheld Healthcare Administrative Devices Estimated Products Sales by Product Type (Blood pressure devices, Pulse oximeters, ECG/EKG monitors, Ultrasound, Diabetes insulin monitors, Prothrombin time monitors, TENS, Fetal heart monitors), 2011
Figure 4-2: The Market for Handheld Healthcare Administrative Devices Estimated Products Sales by Product Type (Blood pressure devices, Pulse oximeters, ECG/EKG monitors, Ultrasound, Diabetes insulin monitors, Prothrombin time monitors, TENS, Fetal heart monitors), 2011
Figure 4-3: Suppliers’ Share of the Handheld Administrative Device Market for Healthcare, Estimated 2011
CHAPTER FIVE: MARKET OVERVIEW
Table 5-1: The Global Market for Handheld Healthcare Devices by Segment 2007-2016
Figure 5-1: The Global Market for Handheld Healthcare Devices by Segment 2007-2016
Figure 5-2: The Global Market for Handheld Healthcare Devices by Segment 2011
Table 5-2: The Market for Handheld Healthcare Devices Estimated Products Sales by Geographic Region, 2007-2016
Figure 5-3: The Market for Handheld Healthcare Devices Market Share by Geographic Region, 2011
Figure 5-4: U.S. Healthcare Spending, 2000-2015
Figure 5-5 : Age-wise Population Distribution, 1980-2020
Figure 5-6: Ambulatory Care Visits to Physicians’ Office and Hospital Outpatient and Emergency Departments by Age, 2000-2020e
Figure 5-7: Demand-Supply Gap for Nurses in the US, 2000-2020 (in thousands)
Figure 5-8: Demand-Supply Gap for Physicians in the U.S., 2005-2025
Figure 5-9: Most Significant Barriers to Implementing IT, 2011
CHAPTER SIX: IMPLEMENTATION OF HANDHELD DEVICES: TECHNOLOGY BEHIND HANDHELD DEVICES
Figure 6-1
Wireless Networking Technologies
Figure 6-2
Range of Wireless Networking Technologies
CHAPTER SEVEN: COMPETITOR PROFILES
Table 7-1: Corporate Details of Apple, Inc.
Table 7-2: Financial Details of Apple, Inc 2008-2011 ($millions)
Figure 7-1: Apple, Inc Revenues 2008-2011 ($millions)
Figure 7-2: Apple-funded Research and Development Expenditures 2008-2011 ($millions)
Table 7-3: Corporate Details of Draeger Medical, Inc.
Table 7-4: Financial Details of Draeger AG 2008-2011 ($millions)
Figure 7-3: Draeger AG Revenues 2008-2011 ($millions)
Table 7-5: Corporate Details of General Electric Company
Table 7-6: Financial Details of GE Corporation 2008-2011 ($millions)
Figure 7-4: GE Healthcare Revenues 2008-2011 ($millions)
Figure 7-5: GE-funded Research and Development Expenditures 2008-2011 ($millions)
Table 7-7: Corporate Details of Global Media
Table 7-8: Corporate Details of Hewlett Packard
Table 7-9: Financial Details of Hewlett Packard 2008-2011 ($millions)
Figure 7-6: Hewlett Packard’s Revenues 2008-2011 ($millions)
Table 7-10: Corporate Details of Medtronic Inc.
Table 7-11: Financial Details of Medtronic 2008-2011 ($millions)
Figure 7-7: Medtronic’s Revenues 2008-2011 ($millions)
Figure 7-8: Medtronic’s Research and Development Expenditures 2008-2011 ($millions)
Table 7-12: Corporate Details of Omron Corporation
Table 7-13: Financial Details of Omron Corporation 2008-2011 ($millions)
Figure 7-9: Omron Corporation Revenues 2008-2011 ($millions)
158 Figure 7-10: Omron Corporation Research and Development Expenditures 2008-2011 ($millions)
Table 7-14: Corporate Details of Research In Motion Limited
Table 7-15: Financial Details of Research In Motion Limited 2008-2011 ($millions)
Figure 7-11: Research In Motion Revenues 2008-2011 ($millions)
Figure 7-12: Research In Motion Research and Development Expenditures 2008-2011 ($millions)
Table 7-16: Corporate Details of Siemens Healthcare
Table 7-17: Financial Details of Siemens Healthcare 2008-2011 ($millions)
Figure 7-13: Siemens Healthcare Revenues 2008-2011 ($millions)
Figure 7-14: Siemens AG Research and Development Expenditures 2008-2011 ($millions)
Table 7-18: Corporate Details of Socket Mobile
Table 7-19: Financial Details of Socket Mobile 2008-2011 ($millions)
Figure 7-15: Socket Mobile Revenues 2008-2011 ($millions)
Figure 7-16: Socket Mobile’s Research and Development Expenditures 2008-2011 ($millions)
Table 7-20: Corporate Details of Welch Allyn
APPENDIX: LIST OF COMPANIES REGULATORY AUTHORITIES AND ORGANIZATIONS

Vaccine Production (Trends, Techniques, Key Players, Spending Estimates and Forecasts)

The considerable revenue growth in the vaccine market over the past ten years suggests the amount of vaccine production and the techniques of vaccine production will need to adapt to match a revived industry.

This report, Vaccine Production (Trends, Techniques, Key Players, Spending Estimates and Forecasts) examines the market for vaccine manufacturing and production technologies. The focus is on current production methods and new methods in development. While there may be some overlap for technologies in development, the emphasis of the report is process rather than product development. (Detailed product market segment forecast by disease for current vaccines are covered in Kalorama’s report “Vaccines 2011.” )

As part of its analysis of vaccine manufacturing, the report includes:

• Doses Produced: 2010-2015
• Estimates of Vaccine Production Spending
• Finished Vaccine Markets and Top Selling Categories
• Market Potential for Contract Vaccine Manufacturing
• Top Vaccine Companies Market Share
• Production Challenges for Categories of Vaccines
• Discussion of Cell, Insect and Plant Production
• Recent Influenza Production Trends
• Vaccine Approval Challenges
• Profiles of Major Vaccine Marketers
• Profiles of Major Contract Manufacturers
• Production Methods for Common Vaccines (Oral polio, Tetanus, Measles, Influenza, Diphtheria, Pertussis, BCG, Hep. B, Hib, MMR)

As part of Kalorama Information’s coverage, several profiles are included of vaccine manufacturers and contract manufacturing organizations (CMOs). The following companies are profiled:

• GlaxoSmithKline Biopharmaceuticals
• Sanofi-Aventis
• Merck KgaA
• Pfizer-Pfizer CenterSource
• Novartis AG
• Baxter International
• Teva
• Crucell (Johnson &Johnson)
• CSL Biotherapies
• Intercell
• MedImmune/Astra Zeneca
• MassBioLogics
• Lonza
• Boehringer Ingelheim
• Fujifilm Diosynth Biotechnology
• Catalent Pharma Solutions
• Patheon
• DSM Pharmaceutical
• Cambrex (Lonza)
• IDT Biologika
• Charles River Biopharmaceutical Services (BPS)

Sales estimates for the vaccine market and for market segment represent global revenues and are expressed in current dollars. Spending also represents global spending and expressed in current dollars.

Information for this report was gathered from a wide variety of published sources including company reports and filings, government documents, legal filings, trade journals, newspapers and business press, analysts’ reports and other sources. Interviews with company representatives and other experts were conducted to capture the perspectives from industry participants’ point of view and assess trends, and form the basis of the forecasting and competitive analysis.

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY
Scope and Methodology
Production Technology
Legacy Technologies
Innovative Technologies
Manufacturing
Originator and Big Pharma
Contract Manufacturing Organizations
Profitability of The Vaccine Industry
Major Vaccine Manufacturers
Conclusions
Scope and Methodology

CHAPTER TWO: THE VACCINE INDUSTRY: TRENDS, MAJOR PLAYERS AND MARKETS
Overview
Types of Vaccines
Attenuated (Weakened) Live Viruses
Killed (Inactivated) Viruses
Toxoid Vaccines
Genetically Engineered/Modified Vaccines
Subunit Vaccines
Conjugate Vaccines
DNA Vaccination
Major Vaccine Manufacturers
Vaccine Approval Process
Government and NGO Investment
Manufacturing and Infrastructure Building
Centers for Innovation in Advanced Development and Manufacturing
BARDA Influenza & Emerging Disease Program
WHO
The cycle of Vaccine Procurement
Public/Private Partnerships
Bush Administration/Homeland Security
Project GreenVax
Vaccine Research Center Production Programs
Production, Prices and Other Profit Considerations
Negotiated Prices
Production Expenses
Sales and Marketing Expenses

CHAPTER THREE: VACCINE PRODUCTION: SPENDING, INNOVATIONS, AND CHALLENGES
Vaccine Production Estimates
Main Vaccine Types
Inactivated Vaccines or Live attenuated vaccines
Acellular / Component Vaccines
Live, Attenuated Vaccines
Toxoid Vaccines
Analogue Vaccines
Vaccines through Genetic Engineering
Reformulation
Thiomersal
Influenza Vaccine Production
Influenza Vaccine Production
Egg Production
Unique Aspects of Manufacturing Influenza Vaccine
Rate-Limiting Steps in the Seasonal Vaccine Process
Cellular Production
WHO Annual Flu Vaccine Guidelines
Pandemics
History and Shortages
HIN Pandemic of /
The Vaccine Industry’s Role
A Decade of Pandemic Preparations
WHO Pandemic Influenza Vaccine Manufacturing Process and Timeline
Activities at regulatory agencies – regulatory approval
Mammalian Cell Culture
Background
Cell – Mammalian
Cell Culture Influenza Vaccines
Advantages
Ideal cell lines for production
Specific Cell Lines
Madin Darby Canine Kidney (MDCK)
Vero Cells
PER.C cells
DNA Vaccines
Concerns
Novartis and Medicago Open Non-Traditional Vaccine Operations
Vaccine Distribution
Estimates of Vaccine Production Spending
Contract Vaccine Manufacturing
Contract Manufacturing Market

CHAPTER FOUR: COMPANY PROFILES
GlaxoSmithKline Biopharmaceuticals
Sanofi-Aventis
Merck KgaA
Pfizer-Pfizer CenterSource
Novartis AG
Baxter International
Teva
Crucell (Johnson &Johnson)
CSL Biotherapies
Intercell
MedImmune/Astra Zeneca
MassBioLogics

CHAPTER FIVE: VACCINE CONTRACT MANUFACTURERS
Lonza
Boehringer Ingelheim
Fujifilm Diosynth Biotechnology
Fujifilm Diosynth Biotechnology
Catalent Pharma Solutions
Patheon
DSM Pharmaceutical
Cambrex (Lonza)
IDT Biologika
Charles River Biopharmaceutical Services (BPS)

List of Table:
CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1: The Major Vaccine Development Categories
Table 1-2: World Vaccines Market (Pediatric and Adult)
Table 1-3: Technologies with the Greatest Promise for Producing Vaccines, 2011
Figure 1-1: Vaccine Industry Production Spending, 2008-2015
Figure 1-2: Discount for Selected Vaccines (ActHIB, Havrix, Tripedia, Fluarix, FluMist, Twinrix, Afluria, Decavac, MMRII, Zostravix, ENGERIX-B, Ceravix, Gardasil, Prevnar)
Table 1-4: Largest Vaccine Manufacturers
CHAPTER TWO: THE VACCINE INDUSTRY: TRENDS, MAJOR PLAYERS AND MARKETS
Table 2-1: Top Vaccine Sellers, 2011: Revenues in US$ millions
Table 2-2: Vaccine-Preventable Diseases, August 2011
Table 2-3: World Vaccines Market Manufacturer’s Market Shares, 2009
Table 2-4: Major Vaccine Merger & Acquisition Activity
Table 2-5: Vaccines Approved by FDA for US Sales, July, 2011
Table 2-6: HHS/ BARDA Vaccine Advanced Development Milestones
Table 2-7: Documents Required to Determine Eligibility for WHO Prequalification
Table 2-8: Private Sector Price versus Negotiated Price For Selected Vaccines (ActHIB, Havrix, Tripedia, Fluarix, FluMist, Twinrix, Afluria, Decavac, MMRII, Zostravix, ENGERIX-B, Ceravix, Gardasil, Prevnar)
Figure 2-1: Private Sector Price versus Negotiated Price ( cost in US dollars)
Figure 2-2: Discount for Selected Vaccines (ActHIB, Havrix, Tripedia, Fluarix, FluMist, Twinrix, Afluria, Decavac, MMRII, Zostravix, ENGERIX-B, Ceravix, Gardasil, Prevnar)
Figure 2-3: Vaccine Companies vs. Traditional Pharma: Production and Sales Costs
CHAPTER THREE: VACCINE PRODUCTION: SPENDING, INNOVATIONS, AND CHALLENGES
Figure 3-1: Doses of Vaccine Produced Worldwide, 2010-2015
Table 3-1: Vaccine Classes and Associated Industrial Challenges (Oral Polio, Rabies, Acellular pertussis, Pneumococcal, Hepatitis B, Japanese encephalitis)
Table 3-2: Production Methods for Common Vaccines (Oral polio, Tetanus, Measles, Influenza, Diphtheria, Pertussis, BCG, Hep. B, Hib, MMR)
Table 3-3: Inactivated or Attenuated Vaccine Examples
Table 3-4: Acelluar/Component Vaccine Examples
Table 3-5: Attenuated Vaccine Examples
Table 3-6: Toxoid Vaccine Examples
Table 3-7: Thiomersal Content of Vaccines Routinely Recommended for Children
Table 3-8: Preservatives Used in U.S. Licensed Vaccines
Table 3-9: Annual Influenza Statistics
Table 3-10: Cell-based Vaccine Advantages
Table 3-11: Activities at WHO Collaborating Centers
Table 3-12: Activities at Vaccine Manufacturers
Figure 3-1: Vaccine Approval Timeline
Table 3-13: Advantages of Cell Culture Vaccines
Figure 3-2: Spending on Vaccine Production, Estimated (2008-2015) (billions of US Dollars Spent)
Table 3-14: Top Vaccine Contract Manufacturers, 2011
Figure 3-3: Estimated Outsourcing Market for Vaccines (2008-2015)

World Market for Anti-Infectives (Antifungals, Antibacterials and Antivirals)

This Kalorama Information report - The World Market for Anti-Infectives - focuses on three key segments of treatment:

• Antifungals (Allylamines, Azoles, Polyene Macrolides, Other Antifungals)
• Antibacterials (Aminoglycosides, Carbapenems, Cephalosporins, Macrolides, Penicillins, Quinolones, Sulfonamides, Tetracyclines, Others)
• Antivirals (Nucleoside Analogs, Transcriptase Inhibitors, DNA Polymerase Inhibitors, Protease Inhibitors, Other Antivirals)

The report covers both currently marketed and late stage development products. Revenues for each segment were generated using dollar and unit sales for each product.

A novel approach in this report is that it provides revenue by product type but also the ‘market’ for treatments by type of infection, enabling marketers to research the best markets where a variety of products may be implemented.

The report includes statistical information for infections by type worldwide, with special emphasis on the U.S. and Europe. The market segments provide an overview, description of products on the market, description of products in development, market estimates and forecasts, and competitive analysis of leading providers.

The area of anti-infectives represents an exciting frontier for development of potential life-saving products. However, there are a number of issues and trends that have a direct influence on this market and manufacturers’ ability to successfully operate in the market. The issues and trends affecting this market include:

• Drug Resistance
• HIV Trends, Cost, and Access to Drug Therapy
• Other Immunocompromised Population Issues
• Alliances and Partnerships
• New Developments

• Rx-to-OTC Switches

The information for this report was gathered using both primary and secondary research including comprehensive research of secondary sources such as company literature, databases, investment reports, and medical and business journals focused on the anti-infective industry. Telephone interviews and email correspondence were the primary method of gathering information. For the purpose of this study Kalorama Information conducted interviews with key industry officials, consultants, health care providers, and government personnel. These sources were the primary basis in gathering information specifically relating to revenue and market share data presented in this report. Specific interviews with pharmaceutical company representatives included marketing directors, division managers, and product representatives.

All market data pertains to the world market at the manufacturers’ level. The base year for data was 2011. Historical data was provided for the years 2007 through 2010, with forecast data provided for 2012 through 2015. Compound annual growth rates (CAGRs) are provided for the 2007-2011, 2011-2015 and 2007-2015 periods for each industry segment covered. Competitive analysis is provided for the years 2007 through 2011 with a special focus on 2011. The forecasted market analysis for 2011-2015 was based on probability of approval and sales of products in late stage development, future trends in current product demand, generic penetration, product marketing, and relevant demographic trends.

Companies profiled in this report include:

• Abbott Laboratories
• Astellas
• AstraZeneca
• Bayer
• Bristol-Myers Squibb
• Cubist
• Daiichi Sankyo
• Gilead Sciences
• GlaxoSmithKline
• Johnson & Johnson
• Merck
• Novartis
• Pfizer
• Roche

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY
Introduction
Scope and Methodology
Total Size and Growth of the Market
Issues and Trends Affecting Market
Leading Competitors

CHAPTER TWO: INTRODUCTION AND INDUSTRY TRENDS
Overview
Introduction to Pathogens
Demographics of the World
Life Expectancy
Infections and Drug Resistance
Causes of Drug Resistance
Drug Resistance in Select Populations
Measures for Reducing Resistance
HIV Trends
Manufacturer and Marketer Trends
Trends in Partnerships and Alliances
Developers Trends
Aradigm
ARD-3100
Phase II
Cystic fibrosis
ARD-3150
Phase II
Bronchiectasis
ARD-1100
Preclinical
Inhalation anthrax
Trends in Rx-to-OTC Switches

CHAPTER THREE: ANTIFUNGAL DRUGS
Overview
Types of Fungal Infections
Superficial
Systemic
General Fungal Infection Statistics
Fungal Infection Risk
Description of Antifungal Products
Systemic Antifungals
Topical Antifungals
Market Overview
Total Market Size and Forecast
Antifungal Market by Product Type
Antifungal Market by Geographical Region
Market Analysis by Treated Condition
Competitive Analysis
Leading Products

CHAPTER FOUR: ANTIBACTERIAL DRUGS
Overview
Classification of Antibacterial Organisms
Antimicrobial Spectrum
Bacterial Resistance
Principles of Anti-bacterial Therapy
Combination Therapy and Prophylactic Use
Bacterial Infection Statistics
Bacterial Infection Risk
Classifications of Antibacterial Products
Aminoglycosides
Carbapenems
Cephalosporins
Macrolides
Penicillins
Quinolones
Sulfonamides
Tetracyclines
Market Overview
Total Market Size and Forecast
Antibacterial Market by Product Type
Antibacterial Market by Geographical Region
Market Analysis by Treated Condition
Competitive Analysis
Leading Products

CHAPTER FIVE: ANTIVIRAL DRUGS
Overview: Introduction to Viruses
Examples of Pathogenic Viruses
Virus Function and Life History
Replication in DNA Viruses
Replication of RNA Viruses
Replication in Retroviruses
Host Defenses Against Viruses 8
Viral Ploys to Invade Host Cells and Circumvent Host Responses
Invasion of Host Cells
Subversion of the Immune Response
Avoidance of Immune Detection and Attack by Killer Cells
HIV and AIDS
Viral Infection Statistics
Description of Antivirals Products
Nucleoside Analogs, Transcriptase Inhibitors and DNA Polymerase Inhibitors
Protease Inhibitors
Other Antivirals
Market Overview
Total Market Size and Forecast
Antiviral Market by Product Type
Antiviral Market by Geographical Region
Market Analysis by Treated Condition
Competitive Analysis
Leading Products

CHAPTER SIX: MARKET SUMMARY
Market by Product Segment (Antifungals, Antibacterials, Antivirals)

CHAPTER SEVEN: CORPORATE PROFILES
Introduction
Abbott Laboratories
Astellas
AstraZeneca
Bayer Healthcare Pharmaceuticals (Bayer Schering Pharma)
Bristol-Myers Squibb
Cubist
Daiichi Sankyo
Gilead Sciences
GlaxoSmithKline
Johnson & Johnson
Merck
Novartis
Pfizer
Roche

APPENDIX: COMPANY DIRECTORY

List of Table:
CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1: The Global Market for Anti-Infectives by Product Segment, 2007-2015
Figure 1-1: The Global Market for Anti-Infectives by Product Segment, 2011
Figure 1-2: World Market for Anti-Infectives Estimated Market Share of Leading Suppliers, 2011
CHAPTER TWO: INTRODUCTION AND INDUSTRY TRENDS
Table 2-1: World Population by Selected Geographical Region, 2010 – 2050
Table 2-2: Average Life Expectancy in Years by Country 1980, 2004 and 2009
Figure 2-2: Average Life Expectancy in Years by Country 1980 and 2009
Table 2-3: Worldwide HIV/AIDS Infections
Table 2-4: Women Living with HIV/AIDS, by Region 2001 to 2009, Number
Table 2-5: Antiretroviral Access for HIV Infected Individuals in Low- and Middle-Income Countries, 2009 based on 2010 WHO Guidelines
Table 2-6: Antiretroviral Access for HIV Infected Individuals in Low- and Middle-Income Countries, by Selected Countries, 2009 based on 2010 WHO Guidelines
Table 2-7: Anti-Infective Drugs in Development by Developer
Table 2-8: Anti-infectives Ingredients Transferred from Rx-to-OTC Status
Figure 2-3: Anti-infectives Ingredients Transferred from Rx-to-OTC by Year
CHAPTER THREE: ANTIFUNGAL DRUGS
Table 3-1: Incidence of Infections by Type, 2010
Figure 3-1: Incidence of Infections by Type, 2010
Table 3-2: World Population at Risk for Fungal Infections, Secondary to Chronic Diseases by Selected Geographical Region, 2010
Figure 3-2: World Population at Risk for Fungal Infections, Secondary to Chronic Diseases by Selected Geographical Region, 2010
Table 3-3: Treatment Options for Fungal Infections , (Type, Brand, and Manufacturer)
Table 3-4: The World Market for Antifungal Drugs 2007-2015
Figure 3-3: The World Market for Antifungal Drugs 2007-2015
Table 3-5: Antifungal Drug Market by Type 2007-2015 , (Allylamines, Azoles, Polyene Macrolides, Other Antifungals)
Figure 3-4: The World Market for Antifungal Drugs Revenues by Type 2007-2015 , (Allylamines,    Azoles, Polyene Macrolides, Other Antifungals)
Figure 3-5: The World Market for Antifungal Drugs Revenues by Type 2011 and 2015 , (Allylamines, Azoles, Polyene Macrolides, Other Antifungals)
Table 3-6: The World Market for Antifungal Drugs Estimated Products Sales by Geographic Region 2007-2015
Figure 3-6: The World Market for Antifungal Drugs Estimated Product Sales by Geographic Region 2007-2015
Table 3-7: World Antifungal Market Estimated Products Sales by Infection Type , (Candida Infections, Seborrheic Dermatitis, Onychomycosis, Other Infections)
Figure 3-7: World Antifungal Market Estimated Distribution of Products Sales by Infection Type, 2011 Candida Infections, Seborrheic Dermatitis, Onychomycosis, Other Infections)
Table 3-8: World Market for Antifungal Drugs Estimated Revenues and Market Share of Leading Suppliers 2007-2011
Figure 3-8: World Market for Antifungal Drugs Estimated Revenues of Leading Suppliers, 5-year Comparison 2007-2011
Figure 3-9: World Market for Antifungal Drugs Estimated Market Share of Leading Suppliers, 2011
Table 3-9: World Market for Antifungal Drugs Estimated Sales of Select Products 2007-2011
Figure 3-10: World Market for Antifungal Drugs Estimated Sales of Select Products 2007-2011
CHAPTER FOUR: ANTIBACTERIAL DRUGS
Table 4-1: Antibiotics with Difficult Penetration
Table 4-2: Estimated World and U.S. Incidence of Bacterial Infections, 2010
Figure 4-1: Estimated World and U.S. Incidence of Bacterial Infections
Table 4-3: World Population at Risk for Serious Bacterial Infections, Secondary to Chronic Diseases by Selected Geographical Region, 2010
Figure 4-2: World Population at Risk for Serious Bacterial Infections, Secondary to Chronic Diseases by Selected Geographical Region, 2010
Table 4-4: Treatment Options for Bacterial Infections , (Type, Brand, and Manufacturer)
Table 4-5: The World Market for Antibacterial Drugs 2007-2015
Figure 4-3: The World Market for Antibacterial Drugs 2007-2015
Table 4-6: Antibacterial Drug Market by Type 2007-2015
Figure 4-4: The World Market for Antibacterial Drugs Revenues by Type, 2007-2015 , (Aminoglycosides, Carbapenems, Cephalosporins, Macrolides, Penicillins, Quinolones, Sulfonamides, Tetracyclines, Others)
Figure 4-5: The World Market for Antibacterial Drugs Revenues by Type 2011 and 2015 , (Aminoglycosides, Carbapenems, Cephalosporins, Macrolides, Penicillins, Quinolones, Sulfonamides, Tetracyclines, Others)
Table 4-7: The World Market for Antibacterial Drugs Estimated Products Sales by Geographic Region 2007-2015
Figure 4-6: The World Market for Antibacterial Drugs Estimated Product Sales by Geographic Region 2007-2015
Table 4-8: World Antibacterial Market Estimated Products Sales by Infection Type , (Upper and Lower Respiratory Tract Infections, Ear, Sinus Infections, Skin & Skin Structure Infections Gynecological Infections; Sexually Transmitted Infections, Urinary Tract Infections, Abdominal Infections, Other Infections)
Figure 4-7: World Antibacterial Market Estimated Distribution of Products Sales by Infection Type, 2011    , (Upper and Lower Respiratory Tract Infections, Ear, Sinus Infections, Skin & Skin Structure Infections Gynecological Infections; Sexually Transmitted Infections, Urinary Tract Infections, Abdominal Infections, Other Infections)
Table 4-9: World Market for Antibacterial Drugs Estimated Revenues and Market Share of Leading Suppliers 2007-2011
Figure 4-8: World Market for Antibacterial Drugs Estimated Revenues of Leading Suppliers 2007-2011
Figure 4-9: World Market for Antibacterial Drugs Estimated Market Share of Leading Suppliers, 2011
Table 4-10: World Market for Antibacterial Drugs Estimated Sales of Select Products 2007-2011
CHAPTER FIVE: ANTIVIRAL DRUGS
Table 5-1: Host Cell Receptors
Table 5-2: Estimated World and U.S. Incidence of Viral Infections, 2010
Figure 5-1: Estimated World and U.S. Incidence of Leading Viral Infections
Table 5-3: Treatment Options for Viral Infections , (Type, Brand, and Manufacturer)
Table 5-4: The World Market for Antiviral Drugs 2007-2015
Figure 5-2: The World Market for Antiviral Drugs 2007-2015
Table 5-5: Antiviral Drug Market by Type 2007-2015
Figure 5-3: The World Market for Antiviral Drugs Revenues by Type , (Nucleoside Analogs, Transcriptase Inhibitors, DNA Polymerase Inhibitors, Protease Inhibitors, Other Antivirals) 2007-2015
Figure 5-4: The World Market for Antiviral Drugs Revenues by Type , (Nucleoside Analogs, Transcriptase Inhibitors, DNA Polymerase Inhibitors, Protease Inhibitors, Other Antivirals) 2011 and 2015
Table 5-6: The World Market for Antiviral Drugs Estimated Products Sales by Geographic Region 2007-2015
Figure 5-5: The World Market for Antiviral Drugs Estimated Product Sales by Geographic Region 2007-2015
Table 5-7: World Antiviral Market Estimated Products Sales by Infection Type (HIV, Hepatitis, Other Infections, Total)
Figure 5-6: World Antiviral Market Estimated Distribution of Products Sales by Infection Type, 2011    (HIV, Hepatitis, Other Infections, Total)
Table 5-8: World Market for Antiviral Drugs Estimated Revenues and Market Share of Leading Suppliers 2006-2009
Figure 5-7: World Market for Antiviral Drugs Estimated Revenues of Leading Suppliers 2007-2011
Figure 5-8: World Market for Antiviral Drugs Estimated Market Share of Leading Suppliers, 2011
Table 5-9: World Market for Antiviral Drugs Estimated Sales of Top Products 2007-2011
Figure 5-9: World Market for Antiviral Drugs Estimated Sales of Top Products 2007-2011
CHAPTER SIX: MARKET SUMMARY
Table 6-1: The Global Market for Anti-Infectives by Product Segment, 2007-2015
Figure 6-1: The World Market for Anti-Infective Drugs 2007-2015
Figure 6-2: The Global Market for Anti-Infectives by Product Segment, 2011
Figure 6-3: The Global Market for Anti-Infectives by Product Segment, 2015

Outsourcing in Drug Development: The Contract CRO, Clinical Trial Lab and EDC Market

The cost and time of developing and bringing a drug to market is over $1.3 billion and often takes as long as 15 years, if not longer. Because of this, major pharmaceutical marketers continue to outsource stages of development, and over the years Kalorama Information has observed this process. In past editions of our outsourcing market studies, we found that outsourcing moved from “should” to “must.” for manufacturers. This trend has only continued in the past two years.

Contract Research Organizations (CROs) and other entities can expect growing demand for their services. The demand for new drugs remains unabated, but the cost and need to bring those drugs to market is ever-increasing and intensifying. A key cost driver is the large number of failures during the expensive clinical trial phases. Driven by pressures to reduce costs, companies are increasingly implementing outsourcing strategies to increase revenues through faster drug development. By decreasing their in-house facilities and staff, and outsourcing more of their R&D functions, pharmaceutical and biotechnology companies are reshaping the drug development services industry.

Kalorama Information’s Outsourcing in Drug Development: The Contract Research (Clinical Trial) Market is the third edition of this study of the drivers for outsourcing drug development, the companies involved in this market and the opportunity for revenues.

As part of its comprehensive coverage of this market, this report contains:

• A Detailed Introduction to the Clinical Trial Process
• Statistics of Drugs in Development by Phase
• Market Size and Forecasts for Outsourcing In Drug Development by Academic Medical Center (AMC), Contract Research Organizations and Others.
• Main Drivers for Outsourcing in Drug Development
• How CROs are Meeting the Challenge of Patient Recruitment
• Discussion of Industry and Regulatory Trends Protocols Funded in FY2009 by Percent and Gender
• Global R&D Expenditures Outsourced by Percent 2003-2010
• Selected Pharmaceutical Company Acquisitions, 2009-2011
• Top Ten Therapeutic Categories in R&D
• Selected Acquisitions of Leading CROs
• Increasing role of EDCs
• Globalization Trends in Drug Development and Breakout of Clinical Trials by Region
• Directory of Companies
• Market Share of Major CROs 2011
• Profiles of CROs, Contract Laboratories, Clinical Trial Labs and EDC Solution Companies

As part of Kalorama Information’s research process, information for this report is gathered from sources including trade press, company reports and government databases. Kalorama Information’s analyst also interviewed dozens of experts in the industry to discover new trends and confirm assumptions.

As part of the report’s coverage , the following CROs, clinical trial laboratories, EDC companies and site management networks are profiled:

• Charles River Laboratories International, Inc.
• Covance, Inc.
• Encorium, Inc.
• Icon, PLC
• Parexel International Corporation
• Medical Marketing Services
• Pharmaceutical Product Development, Inc
• INC Research
• InVentiv Health
• Pra International
• Quintiles Transnational Corporation
• Radiant Development
• Theorem Clinical Research
• Bioanalytical Research Corporation
• Calvert Laboratories, Inc
• Crl Medinet
• Kronos Sicence Laboratories
• LabCorp
• MedTox Scientific Inc.
• Pacific Biomarkers, Inc.
• PRL Central Laboratory Services
• Quest Diagnostics
• TGA Sciences, Inc.
• DaVita Clinical Research
• SMO-USA, Inc.
• CCBR-Synarc, Inc.
• Advanced Clinical Software
• eResearch Technology, Inc.
• Interactive Clinical Technologies, Inc.
• Medidata Solutions Worldwide
• Perceptive Informatics, Inc.
• EDC Solutions
• Pharsight Corporation
• Phase Forward, Inc.

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY
The Drug Development Process
Government Regulation of Clinical Research
Active Phase I, II & III Clinical Trials
Phase IV Studies: Post Approval
Recruiting for Clinical Trials
The Complexity and Costs Of Clinical Trials Are Increasing
Clinical Trials Worldwide
The Contract Drug Development Industry
R&D Outsourced to Contract Drug Development
Contract Drug Development Market
Trends Affecting Growth of Contract Drug Development Industry
Globalization of Drug Development
Rapid Technological Change Increasing Data
Biotechnology Industry Growth
Increased Regulatory Scrutiny
Need for Fast, Efficient, and Cost-Effective Drug Development
Drug Development Process

CHAPTER TWO: INTRODUCTION
Government Regulation of Clinical Research
Center for Biological Evaluation and Review
Center for Drug Evaluation and Research
Investigational Review Board
Preclinical Research
In Vitro and In Vivo Testing Process
Investigational New Drug Application
Clinical Trials
Preclinical Phase
Phase I
Phase IIa
Phase IIb
Phase III
Phase III
Phase IIIa
Phase IIIb
Phase IV: Post Approval
New Drug Applications
New Molecular Entities and Approval Times
Accelerated Approval
Has FDA’s PDUFA ACT Weakened Safety Standards?
Government Initiatives to Improve Research and the Review Process
FDA’s Critical Path Report
Exploratory IND Studies—An Approach to Complying with CGMP
INDs—Approaches to Complying with CGMP During Phase 1
Biotechnology Industry Endorses FDA’s Critical Path
Globalization Trends in Drug Development
Clinical Trials Worldwide
China is Ranked First
India’s Growing Market
Russia Dominates Eastern Europe

CHAPTER THREE: CLINICAL TRIAL OPERATIONS
Conducting Clinical Trails
Government Sponsored Clinical Trials
Organizations Contracted to Conduct Clinical Trials
Contract Research Organizations (CROs)
Managed Site Networks
Major Elements of Clinical Trials
Protocol
Eligibility Criteria
Endpoints
Randomization
Stratification
Blinding
Data Collection and Management Tools
Statistical Interpretation
Data Collection and Management Tools
Statistical Interpretation
Phase IV Studies
Post Approval Studies
Sentinel Initiative
Recruiting for clinical Trials
Clinical Trials Recruitment Promotion
Internet-Enabled Recruitment
Recruiting Principal Investigators
Physician as Principal Investigator
Recruiting Patients
Use of Homecare Services
Patient Recruitment Outside the U.S.
Delays in Patient Recruiting Increases Project Costs
Factors Influencing Participation in Clinical Trials
Increasing Complexity of Clinical Trials
Informed Consent Process
Demographics and Clinical Trials
Ethnicity and Gender in Clinical Trials
Electronic Data Management
Traditional Paper-based Case Report Forms
Advantages of EDC
Current Assessment of EDC Adoption
Need for an EDC Standard
FDA Releases Guidance for Using Computerized Systems for Clinical investigations
Electronic Patient Diaries

CHAPTER FOUR: TRENDS
Drug Development Costs
Outsourcing Drug Development
A Brief History of Contract Research Outsourcing
Focus Shifts in Outsourced Clinical Research Operations from Phase II-III to Phase I to IIIb/IV
Major Factors Driving Contract Research Outsourcing Strategy
Outsourcing as a Cost Reduction Strategy
Number of New Chemical Entities (NCEs) in Pipeline Increasing
Growing Complexity of Regulatory Requirements
Outsourcing to Gain Rapid Access to Patient Recruiting
Contract Research Competitors
Academic Medical Centers (AMCs)
Competing Factors
Contract Research Organizations (CROs)
CRO Contracts
Competing Factors
Managed Site Networks
Competing Factors
Clinical Trial Laboratories
Competing Factors
Clinical Trials as a Business Opportunity
Community Physicians
Electronic Technology Solutions
Internet Patient/Investigator Recruiting
Clinical Trials Packaging
Effective Packaging Promotes Patient Compliance

CHAPTER FIVE: MARKETS
R&D Spending Increasing
Leading Pharmaceutical Developers
Clinical Research Products in Development
Shift in Spending for Clinical Research
Spending for Phase I Trials Slows from Highs in 2004
Safety Issues Drive Phase IIIb/IV Trial Spending
Contract Drug Research Market
Contract Research Competitors
CROs Market Share
CROs Broaden Services through Acquisitions
CROs Expanding Laboratory Services
AMC Market Share
AMCs Reassess Role in Industry-funded Clinical Research
Academic Clinical Reseach Organizations Expanding
Niche Competitors’ Market Share
Clinical Trial Laboratory Services
EDC Services Gaining Market Share
Managed Site Networks
Trends Affecting Growth in Contract Drug Development Industry
Globalization of Drug Development
Rapid Technological Change Increasing Data
Biotechnology Industry Growth
Increased Regulatory Scrutiny
Need for Fast, Efficient, and Cost-Effective Drug Development

CHAPTER SIX: COMPANY PROFILES
Charles River Laboratories International, Inc.
Covance, Inc.
Encorium Group, Inc.
Icon, Plc
Kendle International, Inc.
MDS Pharma Services
Omnicare Clinical Research
Paraxel International Corporation
Pharmanet Development Inc.
Pharmaceutical Product Development, Inc.
PRA Internation, Inc.
Radiant Development
Bioanalytical Research Corporation
Calvert Laboratories, Inc.
CRL Medinet, Inc.
Kronos Science Laboratories, Inc.
Lab Corp
Medtox Scientific Inc.
Pacific Biometric, Inc.
PRL Central Laboratory Services
Quest Diagnostics, inc.
TGA Sciences, Inc.
CNS Clinical Trials
DaVita Clinical Research
SMO-USA, Inc.
Synarc, Inc.
Advanced Clinical Software
eTrials Worldwide, Inc.
Interactive Clinical Technologies, Inc.
Medidata Solutions Worldwide
Perceptive Informatiocs
Pharsight Corporation

APPENDIX: COMPANY DIRECTORY

List of Table:
CHAPTER ONE: EXECUTIVE SUMMARY
Exhibit 1-1: The U.S. Drug Discovery, Development, and Approval Process
Exhibit 1-2: Number of Active Clinical Drug Development Programs
(May 11, 2007)
Exhibit 1-3: Total Average Number of Active Clinical Drug
Development Programs, 2001-2007
Exhibit 1-4: Change in Protocol Eligibility Criteria, Comparison of 1999-2000 and 2003-2006
Exhibit 1-5: Worldwide Clinical Trial Sites, by Region and Percent, (as of 7/12/2008)
Exhibit 1-6: Portion of Global R&D Expenditures
Outsourced: 2003-2008 by percent
Exhibit 1-7: Contract Drug Development Market Share, Percent by Competitor Type (AMC, CRO’s Others), 2007
Exhibit 1-8: Contract Research Market, 2002-2012
CHAPTER TWO: INTRODUCTION
Exhibit 2-1: Investigational New Drug Submissions, 1992-2006
Investigational New Drug Submissions, 1986-2008
Exhibit 2-3: Number of Clinical Trials Initiated Annually for U.S. Submissions
Exhibit 2-4: Median Total Approval Time for Standard NDAs,1993-2006
Exhibit 2-5: Median Total Approval Time for Priority NDAs,1993-2004
Exhibit 2-6: Median Total Approval Time for Standard NMEs, 1995-2004
Exhibit 2-7: Median Total Approval time for Priority NMEs, 1995-2004
Exhibit 2-8: U.S. NMEs 2006 Approvals: Review Times by Drug
Exhibit 2-10: Median Approval times for Safety vs All Drugs, By Decade
Exhibit 2-11: Number and Location of Clinical Trial Sites Worldwide, as of 7/12/2008
Exhibit 2-12: Worldwide Clinical Trial Sites, by Region and Percent, as of 7/12/2008
CHAPTER THREE:CLINICAL TRIAL OPERATIONS
Exhibit 3-1: Key Clinical Trial Enrollment Statistics for: NMEs Approved in 2000-2006
Exhibit 3-2: Number of Active Clinical Drug Development Programs (May 11, 2007)
Exhibit 3-3: Total Average Number of Active Clinical Drug Development Programs, 2001-2007
Exhibit 3-4: Summary Of Postmarketing Study Commitments (Numbers as of September 30, 2007)
Exhibit 3-5: Benefits and Risks of Participating in Clinical Trials
Exhibit 3-6: Change in Protocol Eligibility Criteria, Comparison of 1999-2000 and 2003-2006
Exhibit 3-7: Aggregate Enrollment Data for All Extramural and Intramural Research Protocols Funded in FY2005 and Reported in FY2006, by Percent and Gender
CHAPTER FOUR: TRENDS
Exhibit 4-1: New Paradigm for R&D
Exhibit 4-2: Improvements in the Drug Development Process
Reduce Development Costs
Exhibit 4-3: Portion of Global R&D Expenditures Outsourced: 2003-2008 by percent
Exhibit 4-4: Percentage of Industry-Sponsored Clinical Trials Awarded to Academic Medical Centers Versus Private Sector Companies: 1991, 1996,2001 and 2006
CHAPTER FIVE: MARKETS
Exhibit 5-1: Global Drug Development Spending, 2002-2012
Exhibit 5-2: Global Drug Development Spending, 2002-2012
Exhibit 5-3: R&D Expenditures of Leading Pharmaceutical Developers, 2006 vs. 2005
Exhibit 5-4: Number of Companies with Active Product Development Projects, 1997-2006
Exhibit 5-5: Total Average Number of Active Phase I-III Clinical Trials Worldwide, 2001-2007
Exhibit 5-6: Top Ten Therapeutic Categories in R&D
Worldwide, March 2007
Exhibit 5-7: A Comparison of Spending Rates in Phase I and
Phase II/III Trials, 2004-2008
Exhibit 5-8: Clinical Trials Phase IIIb/IV Market
2004-2008 (in U.S. billions)
Exhibit 5-9: Global R&D Spending and Portion Outsourced to Contract Research, 2002-2012 (in US Billions)
Exhibit 5-10: Contract Drug Development Market, 2002-2012 (Outsourced to CROs, Others)
Exhibit 5-11 Contract Drug Development Market Share, Percent by Competitor Type (AMCs, CROs, Others), 2007
Exhibit 5-12: Contract Research Market (CRO, AMC, Other)
Exhibit 5-13: CRO Market Share, 2007
Exhibit 5-14: Selected Acquisitions of Leading CROs, 2006 to present
Exhibit 5-15: Market Share of Niche Participants in Contract Drug Development, 2007 (MSN, EDC, nonCRO Labs)

Stem Cells: Worldwide Markets for Transplantation, Cord Blood Banking and Drug Development

Stem Cells: Worldwide Markets

There is great interest in stem cells because they have potential to replace defective or damaged cells resulting from a variety of disorders and injuries, leading to a range of new regenerative therapies. Stem cells also have value as a research tool, as their in vitro study would allow scientists to learn more about the function of various organs and the development of particular diseases; stem cells may also eventually permit drug developers to test emerging therapies on diseased cells.

For market-watchers in the pharmaceutical industry, the question is what potential they have and where they could take the pharmaceutical market. New scientific developments and recent changes in the U.S. Federal government’s policy towards stem cells have made this potential more relevant. Kalorama Information has tackled the question in Stem Cells: Worldwide Markets for Transplantation, Cord Blood Banking and Drug Development. Kalorama analyst Alison Sahoo has built models to determine the best, moderate and worst case scenarios for the three key markets for stem cells:

• Stem Cells in Drug Development
• Stem Cells in Cord Blood Banking
• Stem Cell Therapeutics

The potential of stem cell therapeutics is provided, broken down by disease:

• Cardiovascular disease
• Lung disease
• Tooth disease
• Arthritis
• Wrinkles/aging skin
• Incontinence
• Osteoporosis
• Diabetes
• Cancer
• Bladder disease
• Infertility
• Orthopedics
• Alzheimer’s disease
• Burns (severe)
• Lupus
• Parkinson’s disease
• Liver failure
• Multiple sclerosis
• Critical limb ischemia
• Intestinal disease
• Sickle cell disease
• Multiple myeloma
• NH Lymphoma
• Leukemia

The following trends are discussed in this report:

• Ethical Questions
• U.S. – State and Federal Initiatives
• Research Funding
• Cord Blood Initiatives
• International Initiatives
• Stem Cell Patents
• Other Healthcare Regulations

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY
Scope and Methodolgy
Introduction
Current Stem Cell Therapies
Developmental Stem Cell Therapies
Issues In Stem Cell Research
Stem Cell Forecasts

CHAPTER TWO: INTRODUCTION
The Promise of Stem Cells In Medical Treatment
Types of Stem Cells
Embryonic Stem Cells
Adult Stem Cells
Cord Blood Stem Cells
Stem Cell Harvesting
Embryonic Stem Cells
Therapeutic Cloning
Unfertilized Eggs
Adult Stem Cells
Leukapheresis
Peripheral Blood
Cord Blood Stem Cells
Transplantation Approaches
Autologous Transplantation
Allogenic Transplantation
Transplantation Procedures
Cancerous Stem Cells
Other Harmful Stem Cells
Stem Cells in Drug Development
Stem Cell Therapeutics
Stem Cells Targeting Drugs
Stem Cell Generated Organs

CHAPTER THREE: CURRENT STEM CELL THERAPIES
Cancer
Leukemia
Gene Therapy
Multiple Myeloma
Non-Hodgkin’s Lymphoma
Non Cancerous Diseases
Aplastic anemia
Immunodeficiency
Lupus
Sickle Cell Disease
Other Conditions

CHAPTER FOUR: DEVELOPMENTAL STEM CELL THERAPIES
Alzheimer’s Disease
Arthritis
Bladder Disease
Burns
Cancer
Cardiovascular Conditions
Critical Limb Ischemia
Diabestes
Esophagal Disease
Incontinence
Infertility
Intestinal Disease
Liver Failure
Lung Disease
Multiple Sclerosis
Orthopedics
Osteoporosis
Parkinson’s Disease
Sickle Cell Disease
Tooth Disease
Wrinkles/Aging Skin

CHAPTER FIVE: STEM CELL FORECASTS
Best Case
Stem Cell Therapeutics
Umbilical Cord Blood Banking
Fees Related to Drug Development
Most Likely Case
Stem Cell Therapeutics
Umbilical Cord Blood Banking
Fees Related to Drug Development
Worst Case
Stem Cell Therapeutics
Umbilical Cord Blood Banking
Fees Related to Drug Development

CHAPTER SIX: ISSUES IN STEM CELL RESEARCH
Ethical Questions
U.S. – State and Federal Initiatives
Research Funding
Federal Funding
State Funding
Cord Blood Initiatives
International Initiatives
Stem Cell Patents
Other Healthcare Regulations

List of Table:
CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1 Total Market for Stem Cell Technologies in $ Millions, 2010 – 2020
Table 1-2 Stem Cell Therapeutics Market in $ Millions, 2010 – 2020
Table 1-3 Total Market for Cord Blood Banking Fees in $ Millions, 2010 – 2020
Table 1-4 Total Market for Stem Cell Drug Development Technologies in $ Millions, 2010 – 2020
Figure 1-1 Total Market for Stem Cells – Most Likely Case in $ Millions, 2010 – 2020
CHAPTER TWO: INTRODUCTION
Table 2-1 Established and Emerging Artificial Organ Products by Market Segment, 2010
CHAPTER THREE: CURRENT STEM CELL THERAPIES
Table 3-1 Types of Leukemia, 2011
CHAPTER FOUR: DEVELOPMENTAL STEM CELL THERAPIES
Table 4-1 Global Disease Populations Addressed by Potential Stem Cell Therapies, 2011
Table 4-2 Estimated and Projected World Cancer Incidence by Selected Types of Cancer, 2010 and 2020
Table 4-3 Estimated and Projected World Cancer Mortality by Selected Types of Cancer, 2010 and 2020
Table 4-4 Features and Types of Urinary Incontinence, 2011
Table 4-5 Types and Causes of Male Infertility, 2011
Table 4-6 Common Diseases of the Lungs, 2011
CHAPTER FIVE: STEM CELL FORECASTS
Table 5-1 Persons Affected by Key Stem Cell Therapeutic Targets in Millions, 2011
Table 5-2 Best Case: Procedure Volume for Proprietary Stem Cell Therapies by Disease in Millions, 2010 – 2020
Table 5-3 Best Case: Revenues for Proprietary Stem Cell Therapies by Disease in $ Millions, 2010 – 2020
Table 5-4    131 Best Case: Cord Blood Banking Revenues in $ Millions, 2007 – 2020
Table 5-5 Best Case: Stem Cell-Based Drug Development Technology Fees, 2010 – 2020
Table 5-6 Best Case: Stem Cell-Based Drug Development Technology Fees in $ Millions, 2010 – 2020
Table 5-7 Most Likely Case: Procedure Volume for Proprietary Stem Cell Therapies by Disease in Millions, 2010 – 2020
Table 5-8 Most Likely Case: Revenues for Proprietary Stem Cell Therapies by Disease in $ Millions, 2010 – 2020
Table 5-9 Most Likely Case: Cord Blood Banking Revenues in $ Millions, 2010 – 2020
Table 5-10 Most Likely Case: Stem Cell-Based Drug Development Technology Fees in Millions, 2010 – 2020
Table 5-11 Most Likely Case: Stem Cell-Based Drug Development Technology Fees in $ Millions, 2010 – 2020
Table 5-12 Worst Case: Procedure Volume for Proprietary Stem Cell Therapies by Disease in Millions, 2010 – 2020
Table 5-13 Worst Case: Revenues for Proprietary Stem Cell Therapies by Disease in $ Millions, 2010 – 2020
Table 5-14 Worst Case: Cord Blood Banking Revenues in $ Millions, 2010-2020
Table 5-15 Worst Case: Stem Cell-Based Drug Development Technology Fees in Millions, 2010-2020
Table 5-16 Worst Case: Stem Cell-Based Drug Development Technology Fees in $ Millions 2010-2020
CHAPTER SIX: ISSUES IN STEM CELL RESEARCH
Table 6-1 NIH Funding for Stem Cell Research, 2002 – 2010 in $ Million
Table 6-2 U.S. State Embryonic & Fetal Research Laws
Table 6-3 Positions on Human ES Cell Research by Country, 2011
Table 6-4 EU Laws on hESC Research by Country

The World Market for Gastrointestinal Devices

Gastrointestinal Devices Market

This report, The World Market for Gastrointestinal Devices, details the market for endoscopes and other devices used for treating gastrointestinal conditions. There are many factors behind the growth of this market. Cancer is one of leading reasons for surgery with more than 1 million new cases of colorectal cancer reported each year around the world. Obesity is another reason for growth. More and more people worldwide are turning to gastric bypass (bariatric surgery) and gastric banding to aide in their weight loss, thus increasing the need for gastrointestinal endoscopy.

Improved technology is another driver for the market. Newer technologies such as capsule endoscopy and other devices have also increased this market. These miniaturized in-vivo robots assist by performing several surgical functions such as visualization, but are not attached to or constrained by laparoscopic tool lever arms. Using robotic cameras inside the body simplifies port and tool placement.

Kalorama’s World Market for Gastrointestinal Equipment provides device marketers, manufacturers and investors with market sizes and forecasts for gastrointestinal devices, and equipment, including the following segments:

• Endoscopes (Rigid, Flexible)
• Capsule Endoscopes
• Bariatric Surgery Devices
• Ostomy Products
• Enteral Feeding Pumps
• Other

In addition the report provides the following important data to understanding the gastrointestinal device market:

• Regional Breakout of Market (US, Europe, Japan, ROW)
• Product Offerings of Major Vendors
• Market Share by Major Vendor
• Recent Mergers and Acquisitions
• Discussion of Key Industry Trends
• U.S. and Europe Procedure Volumes (Appendectomy, Bariatric Surgery, Cholecystectomy, Endoscopy, Intestine Transplant, Liver Transplant, Pancreas Transplant)
• Drivers of Conditions: Stress, Alchohol, Smoking and Caffeine Consumption.
• Information on Reimbursement of Bariatric Surgery, Upper GI/Colonoscopy, and Cholecystectomy
• Profiles of Leading Instrument and Equipment Suppliers

Knowing the competitors operating in any device market is crucial to understanding the opportunities. Kalorama has analyzed the key companies in the GI space. Coverage the following companies is included:

• Boston Scientific Corporation
• Conmed Corporation
• Covidien Ltd.
• Fujinon
• Given Imaging, Ltd.
• Johnson & Johnson (Ethicon Endo-Surgery)
• Karl Storz GmbH & Co KG
• Olympus Corporation
• Pentax
• Stryker Corporation
• Welch Allyn

In the development of this Kalorama report, research into corporate publications, annual reports, government databases and medical journals was enhanced by a primary research effort involving interviews with market experts and executives to obtain important insights, confirm trends and market forecasts.

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY
Background
Scope and Methodology
Size and Growth of the Market
Key Issues and Trends Affecting Market
Leading Competitors

CHAPTER TWO: INTRODUCTION
Overview
Structural Organization of the Gastrointestinal System
The Mouth and Salivary Glands
Esophagus
Stomach
Small Intestines
Duodenum Section
Jejunum Section
Ileum Section
Large Intestines
Cecum Section
Colon Section
Rectum Section
Liver
Gall Bladder
Pancreas
Upper Gastrointestinal Diseases
GERD (gastroesophageal reflux disease)
Esophageal Cancer
Stomach Cancer
Ulcers
Lower Gastrointestinal Diseases
Colon Cancer
Crohn’s Disease and Ulcerative Colitis
Crohn’s Disorders
Diverticulitis
Hemorrhoids
Irritable Bowel Syndrome (IBS)
Accessory System Diseases
Liver Cancer
Pancreas
Diagnostic Procedure Examples
Abdominal Ultrasonography
Abdominal X-rays
Barium Enema and Barium Swallow
Abdominal Angiogram
Cholecystography
Upper Gastrointestinal Series
Cholescintigraphy
Computed Tomography (CT or CAT) Scan
Endoscopy Diagnostic Procedures
Anoscopy
Colonoscopy
Endoscopic Retrograde Cholangiopancreatography
Enteroscopy
Esophagogastroduodenoscopy
Proctoscopy
Sigmoidoscopy
Capsule Endoscopy
Treatment Procedure Examples
Appendectomy
Bariatric Surgery
Restrictive Surgery
Combined Restrictive and/or Malabsorptive Surgery
Cholecystectomy
Colostomy
Liver Biopsy
Liver Transplantation
Procedure Volumes
Bariatric surgery
Risk Factors Contributing to Gastrointestinal Disease
Age and Gastrointestinal Disease
Impact of Heavily Caffeinated Foods and Drinks
Tobacco and Alcohol Use
Tobacco
Alcohol
Stress
Heredity
Obesity

CHAPTER THREE: MARKET TRENDS
Overview
World Demographics
Aging Population
Life Expectancy and the Growing Incidence of Gastrointestinal Disease
Insurance and Reimbursement Trends
Health Insurance Coverage Trends
United States
Reimbursement Trends
Given Imaging and PillCam Reimbursement
Obesity and Gastrointestinal Disorders
Trends in Bariatric Surgery
Growing Demand for Gastrointestinal Endoscopy Procedures
Patient Advantages of Gastrointestinal Endoscopy
Bariatric Surgery and Endoscopy Techniques
Endoscopy and Colorectal Cancer
Endoscopy and Foreign Body Removal
Robotics and Endoscopic Surgery
Natural Orifice Translumenal Endoscopic Surgery
Trends in Gastroenterology Professionals

CHAPTER FOUR: PRODUCT ANALYSIS
Competitor Market Shares and Analysis
Primary Location of Providers
Competitive Outlook
Description of Leading Suppliers and Products
Abbott Laboratories
Aesculap Surgical
Boston Scientific
Coloplast Group
ConMed
ConvaTec
Cook Medical
Covidien
Ethicon- Endo
Fresenius Kabi
Fujinon Endoscopy
Given Imaging
Karl Storz
Lumenis
Olympus Optical
Pentax Medical
Richard Wolf
Stryker Corporation
US Endoscopy
Welch Allyn
Acquisitions and Collaborations
Given Imaging and Sierra Scientific
Covidien and BARRX Medical
Olympus Corporation and Gyrus Plc.
Olympus and Spirus Medical
Given Imaging and Fujifilm
Pentax and Hoya
Karl Storz and Endogastric
Stryker and Sightline Technologies
General Product Descriptions
Endoscopes
Viewing Sheath (Scope)
Flexible
Rigid
Light Source
Fiberoptic Lighting
Bulbs
Projection Lamp
Power Source
Battery Box
Rheostat
Cameras and Video Support
Hand Instruments
Electrosurgical and Radiofrequency Instruments
Insufflators
Lasers
Other (disposables)

CHAPTER FIVE: MARKET ANALYSIS
Market Overview
Market Analysis by Country
Market Analysis by Product Classification

CHAPTER SIX: LEADING MANUFACTURERS
Overview
Boston Scientific Corporation
ConMed Corporation
Covidien Plc
Fujinon Endoscopy
Given Imaging, Ltd.
(Ethicon Endo-Surgery)
Karl Storz GmbH & Co KG
Olympus Corporation
Stryker Corporation
Welch Allyn

APPENDIX: COMPANIES OF INTEREST
APPENDIX II: ORGANIZATIONS

American Society of Gastrointestinal Endoscopy
American Society for Bariatric Physicians
American Society for Metabolic and Bariatric Surgery
Crohn’s & Colitis Foundation of America, Inc.
European Liver Transplant Registry – ELTR
European Liver and Intestine Transplant Association (ELITA)
International Foundation for Functional Gastrointestinal Disorders
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Society of Gastroenterology Nurses and Associates, Inc.
Society of American Gastrointestinal Endoscopic Surgeons (SAGES)
Wound, Ostomy and Continence Nurses Society

List of Table:

The World Market for Gastrointestinal Devices

Gastrointestinal Devices Market
CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1: Global Gastrointestinal Equipment, Device Market Analysis, 2007-2016
Figure 1-1: Global Gastrointestinal Equipment, Device Market Analysis, 2007-2016
CHAPTER TWO: INTRODUCTION
Table 2-1: Selected Bariatric Surgery Devices, by Company
Figure 2-1: U.S. and Europe Procedure Volumes for Digestive System*
Figure 2-2: U.S. Civilian Consumption of Selected Beverages, Per Capita, 1980 to 2010
Table 2-3: Percent of Smokers by Country
Figure 2-3: Average Percent of Smokers Worldwide in Developed Regions
Figure 2-4: Alcohol Consumption in the United States, 1980-2010
Table 2-4: Signs of Stress: Unemployment Rate, Real GDP, Suicide Rates by Country
Table 2-5: Estimated Obesity by Country 2009 Estimates
Figure 2-5: Estimated Obesity by Country as a Portion of Total Population 2009 Estimates
Figure 2-6: Increases in Obesity by Country—2007 and 2009 Figures
Table 2-6: Obesity Rates by State, 2008-2009
CHAPTER THREE: MARKET TRENDS
Table 3-1: World Population by Selected Geographical Region, 2010 – 2050
Figure 3-1: World Population by Selected Geographical Region, 2010-2050
Table 3-2: Percent Population Over 65 by Year and Region, 2010-2050
Figure 3-2: Estimated World Population by Age, 2010 and 2050
Table 3-3: Average Life Expectancy in Years by Country 1980, 2004 and 2009
55 Figure 3-3: Average Life Expectancy in Years by Country 1980 and 2009
Table 3-4: Health Insurance Trends in the United States, 2008 and 2009
Table 3-5: Medicare Trends in the United States, 1990-2010
Figure 3-4: Medicare Trends in the United States, 1990-2010
Table 3-6: Bariatric Surgery Reimbursement, 2011
Table 3-6 (continued): Bariatric Surgery Reimbursement, 2011
Table 3-7: Upper GI/Colonoscopy Reimbursement, 2011
Table 3-8: Colectomy Reimbursement, 2011
Table 3-9: Appendectomy Reimbursement, 2011
Table 3-10: Cholecystectomy Reimbursement, 2011
Table 3-11: Digestive Disorders Associated with Obesity
CHAPTER FOUR: EXECUTIVE SUMMARY
Table 4-1: Gastrointestinal Equipment, Device, and Consumable Market Estimated Revenues and Market Share of Leading Suppliers 2011
Figure 4-2: Gastrointestinal Equipment, Device, and Consumable Market Estimated Revenues and Market Share of Leading Suppliers 2011
Table 4-2: Leading Gastrointestinal Instrument and Equipment Suppliers by Primary Location, 2011
Figure 4-2: Distribution of Primary Location for Leading Gastrointestinal Instrument and Equipment Suppliers, 2011
CHAPTER FIVE: MARKET ANALYSIS
Table 5-1: Global Gastrointestinal Equipment, Device Market Analysis, 2007-201
Figure 5-1: Global Gastrointestinal Equipment, Device Market Analysis, 2007-2016
Table 5-2: Global Gastrointestinal Equipment, Device Market Analysis by Region/Country(US, Europe, Japan, ROW), 2011
Figure 5-2: Global Gastrointestinal Equipment, Device Market Analysis by Region/Country, 2011
Table 5-3: Global Gastrointestinal Equipment, Device Market Analysis Estimated Sales by Product Segment (Endoscopes, Capsule Endoscopes, Bariatric Surgery Devices, Ostomy Products, Enteral Feeding Pumps, Other) 2007-2016
Figure 5-3: Global Gastrointestinal Equipment, Device Market Analysis Estimated Sales by Product Segment 2007-2016
Figure 5-4: Global Gastrointestinal Equipment, Device Market Analysis Estimated Sales by Product Segment 2011 and 2016
Figure 5-5: Market for Endoscopes by Type – Flexible vs. Rigid
CHAPTER SIX: LEADING MANUFACTURERS
Figure 6-1: Boston Scientific’s Net Revenues, 2009-2011
Figure 6-2: ConMed’s Net Revenues, 2009 – 2011
Figure 6-3: Covidien’s Net Revenues, 2009 – 2011
Figure 6-4: Given Imaging’s Net Revenues 2009-2011
Figure 6-5: Johnson & Johnson and Ethicon Endo-Surgery’s Net Revenues, 2009-2011
Figure 6-6:Olympus’ Net Revenues, 2009 – 2011
Figure 6-7:Stryker’s Net Revenues, 2009 – 2011

The World Market for Medical Beds

The medical beds industry remains diverse and highly competitive. The growing demand for highly functional and less expensive products is paramount in the market. This Kalorama Information report, The World Market for Medical Bedsprovides those watching the medical device markets with an overview of the medical beds industry and the trends driving growth.

Medical beds include all hospital types of beds including mattresses and overlays. Included in the report are statistics influencing the industry, incidence of diseases worldwide, demographics; life expectancy, and company strategies. Information is presented as a global. market, with an emphasis on the United States market.

A market summary includes a total market analysis segmented as follows:

Types of Beds, Including:

• Regular
• Birthing
• Pediatric
• Bariatric
• Other
• Power Type: Electric vs. Hydraulic

Venue of Bed Use Including:

• Acute
• Long Term
• Home Care

Regional Medical Bed Markets:

• US
• Europe
• Asia
• Rest of World

There are several primary issues and trends affecting the medical beds market. Demographics, disease prevalence, and increasing life expectancy will continue to fuel growth in the future. New developments will also positively influence growth. Some of these issues are discussed in this study. Issues and trends explored in this study include:

• World Demographics, Age of Population and Life Expectancy and Effects on Bed Purchases
• Increasing Incidence of Disease
• Results of Recent Acquisitions
• Healthcare Reform
• Bed Safety and Safety Rail Issues
• Insurance and Reimbursement
• The Impact of the Competitive Bidding Program

The report includes a complete market share and competitive analysis. Several leading market participants are discussed in this report including:

• ArjoHuntleigh
• BaKare/Volker
• Gaymar Industries
• Graham-Field Health Products
• Hard Manufacturing Company
• Hebei Baiyang Bed Industry Manufactory
• Hill-Rom
• Invacare
• Joerns Healthcare
• Kinetic Concepts
• Linet
• MC Healthcare
• Medline
• NOA Medical Industries
• Paramount Bed Co
• Savion
• Stryker
• Sunrise Medical
• TemPur Pedic

The information for this report was gathered using both primary and secondary research including comprehensive research of secondary sources such as company literature, databases, investment reports, and medical and business journals. Telephone interviews and email correspondence were the primary method of gathering information. For the purpose of this study, Kalorama Information conducted interviews with more than 10 key industry officials, consultants, health care providers, and government personnel. These sources were the primary basis in gathering information specifically relating to revenue and market share data presented in this report. Additional interviews were completed with relevant company representatives including marketing directors, division managers, and product representatives.

All market data pertains to the world market at the manufacturers’ level. Revenues represent both sales of medical beds and mattresses and overlays and rentals of medical beds, mattresses and overlays. The base year for data was 2011. Historical data was provided for the years 2009 and 2010, with forecast data provided for 2011 through 2016. Compound annual growth rates (CAGRs) are provided for the 2009-2011 and 2011-2016 periods for each region and/or segment covered. Competitive analysis is provided for the year 2011. The forecasted market analysis for 2011-2016 was largely based on demographic trends, new developments, company performance trends, merger and acquisitions, and national expansion.

Table of Contents

CHAPTER ONE: Executive Summary
Industry at a Glance
Scope and Methodology
Size and Growth of the Market
Key Issues and Trends Affecting the Market
Leading Market Participants

CHAPTER TWO:Industry Overview
Introduction
Medical Beds
Regular Beds
ICU Beds
Pediatric Beds
Bariatric Beds
Respiratory Beds
Birthing Beds
Home Care Beds
Mattress Replacements and Overlays
Medical Chairs
Examination and Treatment Chairs
Rehabilitation Chairs
Wheelchairs
Demographics
Population Over Age 65
Life Expectancy
Hospitalization
Bed Safety and Safety Rail Issues
Insurance and Reimbursement Issues
International Trends

CHAPTER THREE: LEADING MARKET PARTICIPANTS
Summary
ArjoHuntleigh
Company Overview
Performance Review
Products and Services
Growth Strategy
BaKare /Volker
Company Overview
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
Columbia Medical
Company Overview
Products and Services
Growth Strategy
Locations
Gaymar Industries, Inc
Company Overview
Key Acquisitions, Alliances and Partnerships
Products and Services
Growth Strategy
Locations
Graham Field Health Products, Inc.
Company Overview
Products and Services
Growth Strategy
Locations
Hard Manufacturing Co
Company Overview
Products and Services
Growth Strategy
Locations
Hill-rom
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
Invacare Corporation
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
Joerns Healthcare
Company Overview
Products and Services
Growth Strategy
Locations
Kinetic Concepts Inc (Therapeutic Support Systems)
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
MC Healthcare Products, Inc
Company Overview
Products and Services
Growth Strategy
Medline Industries, Inc.
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Service
Growth Strategy
Locations
NOA Medical Industries
Company Overview
Products and Services
Growth Strategy
Locations
Savion Advanced Patient Care
Company Overview
Products and Services
Growth Strategy
Locations
Stryker Medical
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Service
Growth Strategy
Locations
Sunrise Medical
Company Overview
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
Tempur Pedic International, Inc
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations

CHAPTER FOUR: Market Trends and Summary
Market Overview
Market Revenues by Product Type
Competitive Analysis

CHAPTER FIVE: New Developments and Technologies
Overview
Therapeutic Systems
Smart Systems
Ergonomic Systems
Bariatric Systems
List of Companies

List of Table:
CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1: U.S. Medical Beds Market Analysis, 2005-2007
Table 1-2: Forecasted U.S. Medical Beds Market Analysis: 2008-2012
Figure 1-1: U.S. Medical Beds Market Analysis: 2005-2012
CHAPTER TWO: INDUSTRY OVERVIEW
Table 2-1: Types of Mattresses – Advantages and Disadvantages
Table 2-2: The U.S. Population, 1980-2020
Figure 2-1: The US Population, 1980-2020
Table 2-3: Percent U.S. Population Over Age 65 by Year
Figure 2-2: Estimated Population by Age Group, 2000 and 2050
Table 2-4: Average U.S. Life Expectancy in Years 1980, 2004 and 2006
Figure 2-3: Average U.S. Life Expectancy in Years 1980, 2004 and 2006
Table 2-5: Number and Average Length of Stay for Discharges from Short-Stay Hospitals, by Age, Region, and Sex: United States, 2006
Table 2-6: United States Hospital Statistics, 2007
Table 2-7: Health Insurance Trends in the United States, Estimated 2007
CHAPTER THREE: LEADING MARKET PARTICIPANTS
Table 3-1: Corporate Details of ArjoHuntleigh
Figure 3-1: ArjoHuntleigh Revenues 2005-2007 ($millions)
Table 3-2: Corporate Details of BaKare/Volker
Table 3-3: Corporate Details of Columbia Medical
Table 3-4: Corporate Details of Gaymar Industries
Table 3-5: Corporate Details of Graham-Field Health Products, Inc.
Table 3-6: Corporate Details of Hard Manufacturing Co
Table 3-7: Corporate Details of Hill-Rom
Figure 3-2: Hill-Rom Revenues 2005-2007 ($millions)
Table 3-8: Corporate Details of Invacare Corporation
Figure 3-3: Invacare Revenues 2005-2007 ($millions)
Table 3-8: Corporate Details of Joerns Healthcare
Table 3-9: Corporate Details of Kinetic Concepts
Figure 3-4: Kinetic Concepts Revenues 2005-2007 ($millions)
Table 3-10: Corporate Details of MC Healthcare Products
Table 3-11: Corporate Details of Medline Industries
Figure 3-5: Medline Industries Revenues, 2005-2007 ($millions)
Table 3-12: Corporate Details of NOA Medical Industries
Table 3-13: Corporate Details of Savion Advanced Patient Care
Table 3-14: Corporate Details of Stryker Medical
Figure 3-6: Stryker Medical Revenues, 2005-2007
Table 3-15: Corporate Details of Sunrise Medical
Table 3-16:Corporate Details of Tempur Pedic International, Inc.
Figure 3-7: Tempur Pedic Revenues, 2005-2007 ($millions)
CHAPTER FOUR: MARKET TRENDS AND SUMMARY
Table 4-1: U.S. Medical Beds and Market Analysis, 2005-2007
Table 4-2: Forecasted U.S. Medical Beds Market Analysis: 2008-2012
Figure 4-1: U.S. Medical Beds Market Analysis: 2005-2012
Table 4-3: U.S. Medical Beds Market Size, 2005-2007
Table 4-4: Forecasted U.S. Medical Beds Market Forecast 2008-2012
Figure 4-2: U.S. Medical Beds Market Analysis by Type (Electric, Manual/Hydraulic) 2008
Table 4-5: Estimated US Medical Beds Revenues and Market Share 2007
Figure 4-3: Estimated US Medical Beds Revenues and Market Share by Supplier
Figure 4-4: Figure 4-4: U.S. Medical Beds by Use, (Acute, Long Term Care, Home Care) 2008

The World Market for Medical Beds

The World Market for Prescription Arthritis Treatments

Arthritis is one of the most common human ailments worldwide. Arthritis is a complex family of musculoskeletal disorders with many causes that are not fully understood. The most crippling of the arthritis family is rheumatoid arthritis, which is an autoimmune disease. Successful treatment of arthritis has resulted from a growing array of therapies available to physicians.

While these pharmaceutical products are still used regularly, new disease-modifying therapies have produced the most impressive results in treating more severe types of arthritis. Additionally, combination therapies continue to grow in preference and offer exciting results in disease management. This Kalorama Information report, The World Market for Prescription Arthritis Treatments, details the market for these treatments. The report provides market sizes and forecasts for the following categories of treatments:

• Non-steroidal Anti-inflammatory Drugs (NSAIDs)
• Disease Modifying Anti-Rheumatic Drugs (DMARDs)
• Biologic Response Modifiers (BRMs) and Immunosuppressants

For each category, the report breaks down the regional market (US, Europe, Japan, Rest of World), lists major products, and provides market share among major competitors.

There are several issues and trends that are shaping this market. Some of the topics, discussed in this report include:

• US Economic Impact of Arthritis
• World Economic Impact of Arthritis
• Obesity and Arthritis
• Trends in Insurance and Reimbursement
• Threat to Anti-TNF Dominance
• ADAM-12 Gene Discovery
• New Pricing Structure in Germany

The information and analysis presented in this report are based on extensive interviews with senior management of top companies in the worldwide arthritis treatment market. Background information was obtained from a comprehensive search of published literature and reports obtained from various government, business, medical trade, and international journals. Key information from published literature was used to conduct interviews with over 20 industry executives and product managers to validate and obtain expert opinion on current and future trends in the worldwide prescription arthritis treatment market. Interviews were also used to confirm and/or adjust market size estimates, as well as in formulating market projections.

The following companies are profiled in the report:

• Abbott Laboratories
• Amgen, Inc
• Boehringer Ingelheim GmbH
• Bristol-Myers Squibb
• Galapagos NV
• Genentech, Inc.
• Horizon Pharma
• Janssen Biotech, Inc
• Novartis International AG
• Pfizer, Inc.
• Roche
• Regeneron
• UCB

All market data pertains to the worldwide market at the manufacturers’ level. Data are expressed in current U.S. dollars. A geographic breakdown is also included for US, Europe, Japan and Rest of World total market and in each drug type segment. The base year for data was 2011. Historical data are provided for each of the years 2009 to 2011, and forecast data are provided for each of the years 2011 through 2016. Historical, base year, and forecast data are provided for each market segment. Market shares are provided for each market segment for the 2011 base year.

All Kalorama Information reports advertise the single user price, which limits access to one user. We also feature department and global pricing for reports that will be utilized by more than one user at your company. Please ask your sales representative or select the correct license on our website.

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY
Introduction
Scope and Methodology
Product Market Summary
Issues and Trends Affecting Market
Competitor Analysis

CHAPTER TWO: INTRODUCTION
Overview
Local Joint Disorder Function
Etiology and Pathogenesis
Clinical Manifestations
Osteoarthritis
Etiology and Pathogenesis
Clinical Manifestations
Treatment
Infectious Arthritis
Etiology and Pathogenesis
Clinical Manifestations
Systemic Disorders of Joint Function
Rheumatoid Arthritis
Etiology and Pathogenesis
Clinical Manifestations
Ankylosing Spondylitis
Clinical Manifestations
Psoriatic Arthritis
Clinical Manifestations
Enteropathic Arthritis
Clinical Manifestations
Adult Onset Still Disease
Clinical Manifestations
Juvenile Rheumatoid Arthritis
Clinical Manifestations
Still Disease
Polyarticular Onset
World Demographics

CHAPTER THREE: WORLDWIDE NON-STEROIDAL ANTI-INFLAMMATORY DRUG MARKET
Product Description
Market Forecast and Growth
Markets by Geographical Region
United States
Europe
Japan
Rest of World
Competitive Landscape

CHAPTER FOUR: WORLDWIDE DISEASE-MODIFYING ANTI-RHEUMATIC DRUG TREATMENT MARKETS
Product Descriiption
Sulfasalazine (Azulfidine-Pfizer)
Gold Compounds
Penicillamine (Cuprimine-Merck)
Chloroquine (Aralen-Sanofi-Aventis)
Methotrexate (Trexall-Duramed; Rheumatrex-DAVA Pharmaceuticals)
Leflunomide (Arava-Sanofi-Aventis)
Market Forecast and Growth
Markets by Geographical Region
United States
Europe
Japan
Rest of World
Competitive Landscape

CHAPTER FIVE: WORLDWIDE BIOLOGICAL RESPONSE MODIFIERS AND IMMUNOSUPPRESSIVE DRUG MARKETS
Description
Tumor Necrosis Factor
Glucocorticoids
Azathioprine (Azasan-Salix)
Adalimumab (Humira-Abbott)
Anakinra (Kineret-Amgen)
Basiliximab (Simulect-Novartis)
Daclizumab (Zenapax-Roche)
Etanercept (Enbrel-Amgen)
Infliximab (Remicade-Janssen Biotech)
Rituximab (Rituxan-Biogen Idec)
Abatacept (Orencia-Bristol-Myers Squibb)
Market forecast and Growth
Markets by Geographical Region
United States
Europe
Japan
Rest of World
Competitive Landscape

Prescription Arthritis Treatments

CHAPTER SIX: WORLDWIDE ARTHRITIS TREATMENT MARKET SUMMARY AND COMPETITIVE ANALYSIS
Market Overview
Product Market Summary
Product Market Analysis by Geographical Region
6 Worldwide Arthritis Treatment Products Competitive Analysis

CHAPTER SEVEN: ARTHRITIS RESEARCH AND DEVELOPMENT TREATMENTS
Overview
Duexis
Gel-One
ACZ
Apremilast
Fostamatinib
Lodotra
Stelara
Tofacitinib

CHAPTER EIGHT: ARTHRITIS TREATMENTS ISSUES AND TRENDS
Overview
US Economic Impact of Arthritis
World Economic Impact of Arthritis
Obesity and Arthritis
Trends in Insurance and Reimbursement
Threat to Anti-TNF Dominance
ADAM- Gene Discovery
New Pricing Structure in Germany

CHAPTER SEVEN: CONCLUSIONS
Conclusion One
Conclusion Two
Conclusion Three
Conclusion Four
Conclusion Five

CHAPTER EIGHT: COMPANY PROFILES
Introduction
Abbott Laboratories
Amgen, Inc
Boehringer Ingelheim GmbH
Bristol-Myers Squibb
Galapagos NV
Genentech, Inc.
Horizon Pharma
Janssen Biotech, Inc
Novartis International AG
Pfizer, Inc.
Roche
Regeneron
UCB

List of Table:
CHAPTER ONE: EXECUTIVE SUMMARY
Summary Table: Total World Arthritis Treatment Revenue and Growth Rate by Drug Type 2011 ($millions)
Summary Figure:The World Prescription Arthritis Treatments Market Share Summary 2011
CHAPTER TWO: INTRODUCTION
Table 2-1: Total Global Population by Selected Geographical Region, 2000 – 2050
Table 2-2 World Prevalence of Rheumatoid Arthritis by Region
Figure 2-1:: World Prevalence of Rheumatoid Arthritis, Percent by Region
CHAPTER THREE: WORLDWIDE NON-STEROIDAL ANTI-INFLAMMATORY DRUG MARKET
Table 3-1: Select Marketed Non-steroidal Anti-inflammatory Drugs
Table 3-2 Market Size and Growth for NSAIDs in the Global Arthritis Treatment Market 2009-2016 ($millions)
Figure 3-1 Market Size and Growth for NSAIDs in the Global Arthritis Treatment Market 2009-2016 ($millions)
Table 3-3: The Worldwide Market for NSAIDs by Geographical Region (US, Europe, ROW) 2009-2016
Figure 3-2: The Worldwide Market for NSAIDs Products by Region (US, Europe, Japan, ROW), 2011
Figure 3-3: The Worldwide Market for NSAIDs Products by Region (US, Europe, Japan, ROW), 2016
Table 3-4: The Worldwide NSAIDs Product Market Share by Supplier 2011
Figure 3-4: The Worldwide NSAIDs Product Market Share by Supplier 2011
CHAPTER FOUR: WORLDWIDE DISEASE-MODIFYING ANTI-RHEUMATIC DRUG TREATMENT MARKETS
Table 4-1: Selected Prescription Disease Modifying Anti-Rheumatic Drugs
Table 4-2: Market Size and Growth for DMARDs in the Global Arthritis Treatment Market 2009-2016 ($millions)
Figure 4-1: Market Size and Growth for NSAIDs in the Global Arthritis Treatment Market 2009-2016 ($millions)
CHAPTER FIVE: WORLDWIDE BIOLOGICAL RESPONSE MODIFIERS AND IMMUNOSUPPRESSIVE DRUG MARKETS
Table 5-1: Selected Prescription Immunosuppressant and Other Biologic Drugs
Table 5-2 Market Size and Growth for BMRs and Immunosuppressants in the Global Arthritis Treatment Market 2009-2016 ($millions)
Figure 5-1 Market Size and Growth for BRMs and Immunosuppressants in the Global Arthritis Treatment Market 2009-2016 ($millions)
Table 5-3: The Worldwide Market for BRMs by Geographical Region (US, Europe, Japan, ROW) 2009-2016
Figure 5-2: The Worldwide Market for BRM Products by Region (US, Europe, Japan, ROW), 2011
Figure 5-3: The Worldwide Market for BRM Products by Region (US, Europe, Japan, ROW), 2016
Table 5-4: The World Biologic Response Modifiers Arthritis Treatment nd Market Share by Supplier 2011
Figure 5-4: The Worldwide BRMs and Immunosuppressives Product Market Share by Supplier 2011
CHAPTER SIX: WORLDWIDE ARTHRITIS TREATMENT MARKET SUMMARY AND COMPETITIVE ANALYSIS
Table 6-1: Total World Prescription Arthritis Treatment Revenue and Growth Rate by Drug Type 2011
Figure 6-1: The World Prescription Arthritis Treatments Market Share Summary 2011
Table 6-3: The World Market for Prescription Arthritis Treatments, by Geographic Region, 2011
Figure 6-2: The World Market for Prescription Rheumatoid Arthritis, by Geographic Region, 2011

Medical Imaging Markets: X-Ray, Digital X-Ray, CT and Other Radiography Systems

Medical Imaging Markets

Radiography includes mammography, computed tomography, traditional x-ray and digital x-ray. These imaging procedures are affected by a number of factors: advances in technology, consumer expectations for healthcare, declining reimbursement and coverage of medical expenses by insurance companies and the aging of the population are among the factors driving these imaging markets.

This report, Medical Imaging Markets: X-Ray, Digital X-Ray, CT and Other Radiography Systems from Kalorama Information, details these factors and provides 2011 market size and forecast to 2015 for the following markets:

• Digital X-Ray
• Traditional X-Ray
• Dental X-Ray
• Film
• CT
• Mammography
• Fluoroscopy
• Regional Markets (US, Europe, Asia, ROW) for these segments

Digital systems replace the conventional film cassette with an electronic receptor that directly converts the x-rays to digital images. Over the years, Kalorama Information analyst Joe Constance has tracked this trend of digital radiography. Digital technology enables x-ray modalities to detect problem sites more rapidly and with greater accuracy. These capabilities are helping fuel hospitals’ transition from film-based systems to filmless environments. At the same time there are practical limiters to digital and areas where film-based systems will still be useful, and the report details these.

This report analyzes the current and potential world market for medical and dental x-ray systems. Various modalities that use x-rays to create images, such as fluoroscopy and CT, are included in the report. Also reviewed is the market for medical and dental x-ray film. This report generally reviews the nature and direction of research, as well as future markets. It also profiles several companies involved in marketing medical and dental x-ray equipment, and medical and dental x-ray film, including:

• Adimec
• AFP Imaging Corp.
• Agfa-Gevaert NV
• Alara Inc.
• Analogic Corp.
• Applied Visual Sciences
• Aribex Inc.
• Biolase Technology
• Biospace Med
• Canon Inc.
• Carestream Health Inc.
• C.M.C. Biotech Co. Ltd.
• CMT Medical Technologies Ltd.
• Control-X Medical Inc.
• dpiX LLC
• Fischer Industries Inc.
• Fujifilm Medical Systems USA Inc.
• GE Healthcare
• Hamamatsu Photonics KK
• Hitachi Medical Systems America Inc.
• Hologic Inc.
• iCAD Inc.
• Imaging Dynamics Co. Ltd.
• ImaSight Inc.
• Imix ADR
• InfiMed Inc.
• Internazionale Medico Scientifica
• Italray
• Lodox Systems
• Medlink Imaging LLC
• MedicaTech USA
• M. E. X’Ray India Pvt. Ltd.
• MinXray Inc.
• MX Imaging Inc.
• NeuroLogica Corp.
• PerkinElmer
• Philips Healthcare
• Planmeca Oy
• Plexus Corp.
• R2 Technology Inc.
• Radlink Inc.
• Samsung Electronics America Inc.
• Sectra Imtec AB
• Shimadzu Corp.
• Siemens Healthcare
• Sirona Dental Systems, Inc.
• Stephanix
• Swissray International Inc.
• Thales
• Toshiba America Medical Systems
• Tower Semiconductor Ltd.
• Trixell
• United Radiology Systems Inc.
• Varian Medical Systems

Market forecasts are based on an examination of current market conditions and on investigations into the development of new products by key companies. The market data provide multiple year forecasts for all product segments covered in the report. The information presented in this report has been generated by data gathered from company product literature and other corporate brochures and documents, as well as information found in the scientific and trade press. In addition, interviews were conducted with company executives.

TABLE OF CONTENTS

CHAPTER ONE: EXECUTIVE SUMMARY
X-Ray Analysis
Digital X-Ray Evolution
Boosting Efficiency
Significant Uses
Chest X-Rays
Mammography
Economics
Cardiovascular Disease
Market Analysis
Traditional X-Ray
Digital X-Ray
Mammography
Fluoroscopy
Dental
Methodology

CHAPTER TWO: INTRODUCTION
Early Diagnostic Tool
History
The Onset of Digitization
3D X-Ray
Transition to Digital
Focus and Risk Reduction
Changes in Behavior
The Private Practice and Its Needs
Computed Radiography
Readers
Digital Economics
Improved Throughput
Machine Vision Opportunities

CHAPTER THREE: KEY APPLICATIONS
Chest Imaging
Multi-Drug Resistance
National Lung Cancer Screening Trial Update
Types of Cancers Found by Screening
Mammography
CR Mammography
Tomosynthesis
Approved FFDM Accreditation Bodies
Functional Imaging Alternatives
PEM Alternatives
CAD
Early Breast Cancers
Economic and Effectiveness Issues
Cardio and Vascular Imaging Computed Tomography
Multislice CT
Evolution Continues
The Virtual Colon
Fluoroscopy
Pediatric Fluoroscopy
Orthopedics Laser Printers Dental Systems
Digital Implications
Cone Beam Computed Tomography for Dentistry
Cone Beam Computed Tomography for Medical Surgery
Challenges and Issues
Private Practices
Modifying Working Behavior
Design Considerations
Advances in Innovation
New Guidance Requirements
Economics
Return on Investment

CHAPTER FOUR: ONGOING RESEARCH
Chest X-Rays Yielding to New Technologies
Double CT Scans Unnecessary
CR and DR Over Conventional Modalities
CT Scans Optimize Accuracy in ER
ERs See Increase in CT Diagnostics
CT Angiography Identifies Heart Issues
CT Colonography for Screening
First Diagnostic Radiology Application for Mobile Devices
New Cardiac Imaging Device
CT Visualizes Nano-Structure of Bones
3D Orthopedic Imaging
PET/CT May Offer Effective Breast Cancer Detection
Screening with Low-Dose Spiral CT Reduces Lung Cancer Deaths
CT Spots Seeds of Heart Disease in Healthy Patients
GE Moving Top X-Ray Executives to China
GE Launches Compact CT
Samsung Interested in Buying X-Ray Makers to Take on GE, Siemens

CHAPTER FIVE: MARKETS
General Radiography – Systems and Film
Mammography
Computer-Aided Detection
Computed Tomography
Fluoroscopy
Dental

CHAPTER SIX: CORPORATE PROFILES
Adimec
AFP Imaging Corp.
Agfa-Gevaert NV
Alara Inc.
Analogic Corp.
Applied Visual Sciences
Aribex Inc.
Biolase Technology
Biospace Med
Canon Inc.
Carestream Health Inc.
C.M.C. Biotech Co. Ltd.
CMT Medical Technologies Ltd.
Control-X Medical Inc.
dpiX LLC
Fischer Industries Inc.
Fujifilm Medical Systems USA Inc.
GE Healthcare
Hamamatsu Photonics KK
Hitachi Medical Systems America Inc.
Hologic Inc.
iCAD Inc.
Imaging Dynamics Co. Ltd.
ImaSight Inc.
Imix ADR
InfiMed Inc.
Internazionale Medico Scientifica
Italray
Lodox Systems
Medlink Imaging LLC
MedicaTech USA
M. E. X’Ray India Pvt. Ltd.
MinXray Inc.
MX Imaging Inc.
NeuroLogica Corp.
PerkinElmer
Philips Healthcare
Planmeca Oy
Plexus Corp.
R2 Technology Inc.
Radlink Inc.
Samsung Electronics America Inc.
Sectra Imtec AB
Shimadzu Corp.
Siemens Healthcare
Sirona Dental Systems, Inc.
Stephanix
Swissray International Inc.
Thales
Toshiba America Medical Systems
Tower Semiconductor Ltd.
Trixell
United Radiology Systems Inc.
Varian Medical Systems

List of Table:
CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1 Methods of Digital X-Ray Generation
Table 1-2 World Market for Medical X-ray Equipment
Table 1-3 World Market for Digital Medical X-ray Equipment
Table 1-4 World Market for Mammography Systems
Table 1-5 World Market for Digital Mammography Systems
Table 1-6 World Market for Fluoroscopy Systems
Table 1-7 World Market for Dental X-ray Systems
CHAPTER TWO: KEY APPLICATIONS
Table 2-1 New US Cases of Invasive Breast Cancer — Women
Table 2-2 New US Cases of Invasive Breast Cancer – Men
CHAPTER FIVE: MARKETS
Table 5-1 World Market for X-Ray Equipment
Table 5-2 North American Market for X-Ray Equipment
Table 5-3 European Market for X-Ray Equipment
Table 5-4 Asian Market for X-Ray Equipment
Table 5-5 Rest of World Market for X-Ray Equipment
Table 5-6 World Market for Digital X-Ray Equipment
Table 5-7 North American Market for Digital X-Ray Equipment
Table 5-8 European Market for Digital X-Ray Equipment
Table 5-9 Asian Market for Digital X-Ray Equipment
Table 5-10 Rest of World Market for Digital X-Ray Equipment
Table 5-11 World Medical Market for X-Ray Film
Table 5-12 US Medical Market for X-Ray Film
Table 5-13 Key Players’ Percentage Share – Worldwide Medical X-Ray Equipment Market
Table 5-14 World Market for Mammography Equipment
Table 5-15 North American Market for Mammography Equipment
Table 5-16 World Market for Digital Mammography Equipment
Table 5-17 North American Market for Digital Mammography Equipment
Table 5-18 Market Penetration of CAD Systems for Mammography
Table 5-19 World Market for CAD Systems
Table 5-20 North American Market for CAD Systems
Table 5-21 World Market for Computed Tomography Equipment
Table 5-22 North American Market for Computed Tomography Equipment
Table 5-23 European Market for Computed Tomography Equipment
Table 5-24 Asian Market for Computed Tomography Equipment
Table 5-25 Rest of World Market for Computed Tomography Equipment
Table 5-26 Key Players’ Percentage Share – Worldwide CT Market
Table 5-27 World Market for Fluoroscopy Equipment
Table 5-28 North American Market for Fluoroscopy Equipment
Table 5-29 European Market for Fluoroscopy Equipment
Table 5-30 Asian Market for Fluoroscopy Equipment
Table 5-31 Rest of World Market for Fluoroscopy Equipment
Table 5-32 World Market for Dental X-ray Equipment
Table 5-33 North American Market for Dental X-Ray Equipment
Table 5-34 European Market for Dental x-Ray Equipment
Table 5-35 Asian Market for Dental X-Ray Equipment
Table 5-36 Rest of World Market for Dental X-Ray Equipment
Table 5-37 Installed Base of Wall-Mounted Dental X-Ray Units 2010
Table 5-38 Potential for Dental Conversion to Digital X-Ray 2010
Table 5-39 World Dental Market for X-Ray Film
Table 5-40 US Dental Market for X-Ray Film

China Healthcare Reform and Its Impact on IVD, Medical Device and Pharmaceutical Markets

China’s rapid economic development and the numerous steps of reform undertaken by the Chinese central government since 1997 have had clear and observable effects upon China’s total healthcare services market and its product markets for pharmaceuticals, medical devices, and in vitro diagnostics (IVD). This progress has been augmented by a Reform program in 2009, which includes increased funding to improve services.

What are the workings of China’s healthcare system? How much progress has been made towards the promised vision of the CPCC in 2008 to provide “convenient and affordable access” to its people? What are the effects on foreign companies seeking to benefit from an increase in healthcare-related funding? Where are the best opportunities in China for marketers? Kalorama analyst Emil Salazar focuses on these questions and more.

The report contains a comprehensive overview of the Chinese healthcare system with important data for marketers to China. It discusses healthcare reform plans and where funds were spent. It also describes the role foreign companies play. As part of its analysis, the report includes the following information:

• Statistics on Chinese Hospitals, Community Health Centers and Clinics
• Top and Bottom City Markets for Urban Healthcare
• Top and Bottom Rural Regions
• Challenges for Foreign-Owned MNCs in China
• Government Healthcare Spending
• Foreign-Invested Manufacturing Enterprises in China
• Share of Government Funded Healthcare vs. Out of Pocket
• Domestic Healthcare Industries
• Population and Age Statistics
• Incidence Rates for Infectious Diseases
• Cancer Rates in China
• Regulation of Drugs and Devices in China
• U.S. Product Exports to China
• Key Analyst Conclusions

In addition to providing useful background information and a thorough analysis of China’s healthcare changes, the report provides data for business planning. It also takes a look at the status and forecast of the three key healthcare markets in China:

• The Chinese Market for IVD products
• Regional Breakout of the Chinese IVD Market (Eastern, Northern, Central, Southern, Southwestern, Northwestern, Northeastern)
• The Chinese Market for Medical Device Products
• Regional Breakout of the Chinese Medical Device Market (Eastern, Northern, Central, Southern, Southwestern, Northwestern, Northeastern)
• Segment Breakout of the Chinese Medical Device Market(Surgical Instrument, Disposable, Patient Monitoring, IVD, Imaging, Orthopedic, Other)
• The Chinese Market for Pharmaceutical Products
• Regional Breakout of the Pharmaceutical Market(Eastern, Northern, Central, Southern, Southwestern, Northwestern, Northeastern)
• Segment Breakout of the Pharmaceutical Market (Cardiovascular, Gastrointestinal, Anti-Infectives, Neurotherapeutics, Oncology, Respiratory, Other)

This essential resource for anyone marketing a healthcare product to China was constructed using a combination of primary and secondary sources. Corporate reports, trade publications government information and medical journals, previous market research studies conducted by Kalorama and other sources were used. In some cases, interviews were used to determine forecasts and key trends.

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY
Healthcare in China
Healthcare Reform and Market Impact
Rural Healthcare Market in Era of Reform
Urban Healthcare Market in Era of Reform
China’s IVD Market in an Era of Reform
China’s Medical Devices Market in an Era of Reform
China’s Pharmaceuticals Market in an Era of Reform
Major Findings

CHAPTER TWO: HEALTHCARE IN CHINA – PRIMARY INDICATORS AND A NEED FOR REFORM
Introduction
Barefoot Doctors and the Rural Cooperative Medical Scheme (RCMS)
China’s Economic Reform Impacts Healthcare
New Rural Cooperative Medical Scheme (NRCMS) and Government Recommitment to Reform
China on the Eve of Contemporary Healthcare Reform

CHAPTER THREE: CHINA’S “REFORM” HEALTHCARE MARKET AND ITS SHAPING OF RURAL, URBAN, REGIONAL AND PROVINCIAL MARKETS
Introduction
China’s 2009-2011 Healthcare Reform in Its Main Features and Provisions
Healthcare Reform on the “Grassroots” Level – The Many Chinas in Focus
The Contemporary Rural Healthcare Market in China – Major Regions, Institutions and Landscape
Rural China Healthcare Market from the NRCMS to the End of Healthcare Reform under the 12th Five-Year Plan (2004-2015) – Historical and Projected Market Sizes and Segmentation
Urban Healthcare Markets in China and their Trajectory through Reform (2004-2015)
Foreign Medical Product Suppliers Penetrate the Chinese Market

CHAPTER FOUR: DIAGNOSTICS IN CHINA – MARKET OPPORTUNITIES AND CHALLENGES THROUGH 2015
Introduction
Demand-Side Drivers in the Chinese IVD Market
Diabetes
Cancer
Allergy
Infectious Disease
Healthcare System/ Reform Supply-Side Drivers
Physician Office Laboratories (POL
Self-Testing
Hospital and Private Laboratories
Research and Technology Sector
Market Size and Projections
Market Distribution and The State of The Industry
Domestic Chinese IVD Industry
Regulation

CHAPTER FIVE: MEDICAL DEVICES IN CHINA – MARKET OPPORTUNITIES AND CHALLENGES THROUGH 2015
Introduction
Demand-Side Drivers in the Chinese Medical Device Market
Cancer
Cardiovascular Diseases
Aging
Healthcare System/Reform – Supply-Side Drivers
Hospitals
Specialty Treatment Clinics
Public Clinics, Health Centers and “Grass Roots” Medical Institutions
Market Size and Projections
Market Distribution and the State of the Industry
Foreign Manufacturers
Domestic Chinese IVD Industry
Regulation
Manufacturing Enterprise Approvals
Cost Controls for Medical Procedures and Reimbursements
Device Approval

CHAPTER SIX: PHARMACEUTICALS IN CHINA – MARKET OPPORTUNITIES AND CHALLENGES THROUGH 2015
Introduction
Demand-Side Drivers in the Chinese Pharmaceuticals Market
Diabetes
Hypertension and Heart Disease
Cancer
Infectious Diseases
Self-Medication
Supply-Side Drivers (Healthcare Reform) and Market Channels
Hospital Pharmacies
Retail Pharmacies
Other Commercial Channels – Mass Merchants, Mail Order and Online
Market Size and Projections
MARKET DISTRIBUTION AND THE STATE OF THE INDUSTRY
“Big Pharma” – western MNCs in China
Domestic Chinese Pharma Industry
REGULATION
Manufacturing Enterprise Approvals
Pricing Controls at Manfacturer-Level
Pricing Controls at Pharmacy-Level
Drug Approval
Intellectual Property Protection (IPP)

CHAPTER SEVEN: CONCLUSIONS
Conclusion One
Conclusion Two
Conclusion Three
Conclusion Four
Conclusion Five
Conclusion Six
Conclusion Seven

List of Table:
CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1: Government-Run Urban Health Insurance Programs in China
Figure 1-1: Chinese Healthcare Reform Government Funding Breakdown (2009-2011)
Figure 1-2: Rural and Urban China Healthcare Market (Insurance and Out-of-Pocket Payments) (2004-2015) (billion yuan)
Figure 1-3: IVD, Pharmaceuticals and Medical Devices Markets in China (2004-2015) (billions $)
CHAPTER TWO: HEALTHCARE IN CHINA – PRIMARY INDICATORS AND A NEED FOR REFORM
Figure 2-1: Chinese National Population (% Urban/Rural)
Figure 2-2: Chinese Government Health Expenditures (in billion yuan and % of total health expenditures) (1980-2009)
Figure 2-3: Average Inpatient Visit Costs and Bed Utilization at Chinese Public Hospitals (1985-2010)
Figure 2-4: Gross National Income (GNI) Per Capita – China and OECD Member Country Average (1980-2009)
Figure 2-5: Chinese Bureaucratic and Market Divisions (East, Middle, West China)
Figure 2-6: Private Hospitals in China by Region (East / Middle / West) (2010)
Figure 2-7: Number of Private and Public Hospitals in China (1980-2010)
Figure 2-8: Income Sources for Government-Run Hospitals (%)
Figure 2-9: New Rural Cooperative Medical Scheme Enrollment (2004-2010)
Table 2-1: Government-Run Urban Health Insurance Programs in China
Figure 2-10: Government Health Insurance Coverage (2003 and 2008)
Figure 2-11: Hospital Visits in China (millions) (1995-2010)
Table 2-2: Government Healthcare Expenditure and GDP Growth Rates (China and Selected Comparison Countries; 2000-2008
Figure 2-12: Chinese Population by Age (Total; 1990/2000/2009) (%)
CHAPTER THREE: CHINA’S “REFORM” HEALTHCARE MARKET AND ITS SHAPING OF RURAL, URBAN, REGIONAL AND PROVINCIAL MARKETS
Figure 3-1: Chinese Healthcare Reform Government Funding Breakdown (2009-2011)
Figure 3-2: Chinese Rural Healthcare Market by National Market Shares of Province/Direct-Controlled Municipality (2010)
Rural China Healthcare Market (Total Consumer/Out-of-Pocket/Insurance Expenditures) (2004-2010) (billion yuan)
Table 3-1: Rural China Healthcare Market (Total Consumer/Out-of-Pocket/Insurance Expenditures) (2004-2010) (billion yuan)
Figure 3-4: Regional Shares of Reimbursement Funds under NRCMS (2010) (East/Middle/West China) (%)
Figure 3-5: Rural China Healthcare Market (Total Consumer/Out-of-Pocket/Insurance Expenditures) (2010-2015 Projection) (billion yuan)
Table 3-2: Rural China Healthcare Market (Total Consumer/Out-of-Pocket/Insurance Expenditures) (2010-2015 Projection) (billion yuan)
Table 3-3: Top and Bottom Five Provincial Markets for Rural Healthcare by Gain and Loss in National Market Share (2010-2015)
Figure 3-6: Chinese Urban Healthcare Market by National Market Shares of Province/Direct-Controlled Municipality (2010)
Figure 3-7: Outpatient Visits in the Urban Healthcare Market, 2010 (Hospitals, Community Health Centers, Community Health Stations, Clinics, Other) (millions of visits)
Figure 3-8: Composition of Chinese Hospital Sector by Number of Beds, 2000-2010 (percent)
Figure 3-9: Urban China Healthcare Market (Total Consumer/Out-of-Pocket/Insurance Expenditures) (2004-2010) (billion yuan)
Table 3-4: Urban China Healthcare Market (Total Consumer/Out-of-Pocket/Insurance Expenditures) (2004-2010) (billion yuan)
Figure 3-10: Top and Bottom Five Provincial Markets for Urban Healthcare by Gain and Loss in National Market Share (2010-2015)
Figure 3-11: U.S. Medical Product Export Growth to China (1990-2010)
Figure 3-12: Total U.S.-EU Exports to China – Pharmaceutical Products and Medical Devices (2002-2010) (millions of U.S. dollars)
Figure 3-13: Inbound Foreign Direct Investment in Medical Product Manufacturing in China (2002-2010)
Figure 3-14: Foreign-Invested Manufacturing Enterprises in China (1980-2010)
Figure 3-15: Foreign-Invested Manufacturing Enterprises in China by Province/Municipality (1995-2010)
CHAPTER FOUR: DIAGNOSTICS IN CHINA – MARKET OPPORTUNITIES AND CHALLENGES THROUGH 2015
Figure 4-1: Chronic Disease Morbidity Rates in Urban China – Hypertension, Diabetes, Cerebrovascular Disease (Stroke), Chronic Obstructive Pulmonary Disease, Heart Disease (per thousand [0/00]) (2003/2008)
Figure 4-2: Chronic Disease Morbidity Rates in Rural China – Hypertension, Diabetes, Stroke, Chronic Obstructive Pulmonary Disease, Heart Disease (2003/2008)
Figure 4-3: Cancer Mortality Rates in China – Lung, Liver, Stomach, Esophageal, Colon, Leukemia, Brain, Breast, Pancreatic (Per 100,000) (2005)
Table 4-1 Incidence Rates for Top Ten Notifiable Infectious Diseases (2010)
Table 4-2 Selected Preventative Medicine Opportunities
Table 4-3 Selected Disease Prevention Programs in China’s Healthcare Reform (2009-2011)
Table 4-4 Clinical Labs by Instrumentation Type in BRIC Countries
Figure 4-4: Chinese Market for IVD Reagents ($ millions) (2004-2015)
Figure 4-5: Regional Market Divisions for Medical Products in China (Eastern, Northern, Central, Southern, Southwestern, Northwestern, Northeastern)
Table 4-5 Regional Markets for IVD Products in China (Eastern, Northern, Central, Southern, Southwestern, Northwestern, Northeastern), 2010-2015
Table 4-6 IVD Market Segmentation (2009) (% of sales)
Table 4-7 IVD Market Shares by Company (2009) (%)
Table 4-8 BRIC IVD Market Comparison (2010) ($ millions)
Table 4-9 Selected Made-in-China Lab Supplies
Table 4-10 Selected IVD Manufacturers in China
Figure 4-6: IVD Product Registration and Regulatory Flowchart
CHAPTER FIVE: MEDICAL DEVICES IN CHINA – MARKET OPPORTUNITIES AND CHALLENGES THROUGH 2015
Figure 5-1: Cancer Mortality Rates in China – Lung, Liver, Stomach, Esophageal, Colon, Leukemia, Brain, Breast, Pancreatic (Per 100,000) (2005)
Figure 5-2: Chinese Population by Age (Total; 1990/2000/2009) (%)
Figure 5-3: Composition of Chinese Hospital Sector by Number of Beds, 2000-2010
Figure 5-4: Compositional Changes in the Hospital Sector – Private, Third-Level and Specialty Hospitals (2005-2010)
Figure 5-5: Chinese Market for Medical Devices ($ billions) (2004-2015)
Figure 5-6: Regional Market Divisions for Medical Products in China (Eastern, Northern, Central, Southern, Southwestern, Northwestern, Northeastern)
Table 5-1 Regional Markets for Medical Devices in China, $ billions 2010 and 2015 (Eastern, Northern, Central, Southern, Southwestern, Northwestern, Northeastern)
Figure 5-7: China Medical Device Market – Product Segment Shares Percent, 2010 (Surgical Instrument, Disposable, Patient Monitoring, IVD, Imaging, Orthopedic, Other)
Figure 5-8: Foreign-Invested Manufacturing Enterprises in China (1980-2010)
Figure 5-9: Medical Device Registration and Approval Flowchart
CHAPTER SIX: PHARMACEUTICALS IN CHINA – MARKET OPPORTUNITIES AND CHALLENGES THROUGH 2015
Figure 6-1: Chronic Disease Morbidity Rates in Urban China – Hypertension, Diabetes, Cerebrovascular Disease (Stroke), Chronic Obstructive Pulmonary Disease, Heart Disease (per thousand [0/00]) (2003/2008)
Figure 6-2: Cancer Mortality Rates in China – Lung, Liver, Stomach, Esophageal, Colon, Leukemia, Brain, Breast, Pancreatic (Per 100,000) (2005)
Table 6-1 Incidence Rates for Top Ten Notifiable Infectious Diseases (2010)
Figure 6-3: Chinese Market for Pharmaceuticals (incl. Hong Kong) ($ billions) (2004-2015)
Figure 6-4: Regional Market Divisions for Medical Products in China (Eastern, Northern, Central, Southern, Southwestern, Northwestern, Northeastern)
Table 6-2 Regional Markets for Pharmaceuticals in China, $ billions, 2010-2015 (Eastern , Northern , Central , Southern , Northeastern , Southwestern , Northwestern )
Figure 6-5: China Pharmaceutical Market – Patented Prescription, Generics, OTC Market Shares (%) (2010)
Table 6-3: China Pharmaceutical Market (Patented Prescription and Generics only) by Product Segment, 2010 and 2015 (Cardiovascular, Gastrointestinal, Anti-Infectives, Neurotherapetuics, Oncology, Respiratory, Other)
Figure 6-6: Foreign-Invested Manufacturing Enterprises in China (1980-2010)
Table 6-4 Leading Medicinal Manufacturers in China (2009) (%, National Share of Aggregate Pharma/TCM/Nutritional Market)
Table 6-5 Pharmaceutical Price Cuts (2000-2010)
Figure 6-7: Pharmaceutical Approval and Regulatory Flowchart

Publisher : Kalorama Information