Table of Contents

1 Table of Contents
1.1 List of Tables
1.2 List of Figures

2 Biomarkers in Drug Discovery – Facilitating a Quick Turnaround Time: Overview
2.1 Introduction
2.2 GBI Research Report Guidance
2.3 History of Biomarkers
2.4 Biomarker Discovery and the Validation Process
2.4.1 Product Development Process from Discovery to Launch
2.5 General Application of Biomarkers
2.5.1 Biomarkers in Drug Discovery and Drug Development
2.5.2 Role of Biomarkers in the Drug Discovery Process
2.5.3 Application of Biomarkers in Disease Diagnosis and Prognosis
2.5.4 Potential Impact of Biomarkers on Disease States
2.5.5 Population Genetics Study
2.5.6 Environmental Health and Risk Assessment
2.5.7 Role of Biomarkers in Environmental Health and Risk Assessment
2.5.8 Toxicology Studies in Dietary Items or Nutraceuticals
2.6 Application of Biomarkers in Drug Discovery
2.6.1 Lead Identification & Optimization
2.6.2 Potential Role of Biomarkers in Lead Identification and Optimization
2.6.3 Target Validation
2.6.4 Toxicological Assay (Preclinical & Clinical)
2.6.5 Mechanism of Action
2.6.6 Monitor Therapy and Dose Response
2.6.7 Stratify Patient Population
2.6.8 Filing and Post Marketing Surveillance

3 Biomarkers in Drug Discovery – Case Studies
3.1 Vermillion’s Hepcidin Biomarker for Ovarian Oancer
3.1.1 Definition
3.1.2 Hepcidin Biomarker
3.1.3 About Ovarian Cancer
3.1.4 Company Profile
3.1.5 Technology Used
3.1.6 Market Information
3.1.7 Advantages
3.1.8 Future Prospect
3.2 Epigenomic’s Septin 9 Biomarker for Colorectal Cancer
3.2.1 DNA Methylation
3.2.2 Septin 9
3.2.3 Septin Biomarker
3.2.4 About Colorectal Cancer
3.2.5 Advantages
3.2.6 Future Perspective
3.2.7 Clinical Study
3.2.8 Company Profile
3.2.9 Technology Overview
3.2.10 Market Information
3.3 BiPar Science’s PARP 1 Gene Biomarker for Multiple Cancer Types
3.3.1 PARP 1 Gene
3.3.2 PARP 1 Inhibitors
3.3.3 BSI-201
3.3.4 TNBC (Triple Negative Breast Cancer)
3.3.5 Technology
3.3.6 Advantage
3.3.7 Company Profile
3.3.8 Market Information
3.3.9 Clinical Study

4 Biomarkers in Drug Discovery – Market Characterization
4.1 Market Overview
4.2 Market Size and Forecasts
4.2.1 Driver and Restraints
4.2.2 Drivers for the Global Biomarkers Market
4.2.3 Barriers for the Global Biomarkers Market
4.3 Unmet Needs – Biomarkers Fulfilling the Unmet Needs of Drug Discovery
4.3.1 High Attrition Rates
4.3.2 High Drug Discovery Cost
4.3.3 Time consuming
4.3.4 Safety and Efficacy
4.3.5 Invasiveness, Selectivity and Sensitivity

5 Trends Analysis
5.1 Regulatory Landscape (Current and Future)
5.1.1 Investigative/ Exploratory Biomarker
5.1.2 Probable Valid Biomarker
5.1.3 Known Valid Biomarker
5.1.4 Regulatory Biomarker
5.2 Validated Biomarker
5.2.1 Validated Biomarkers Applied by Top Pharmaceuticals Players in their FDA Approved Drugs
5.3 Regulatory Acceptance of Valid Biomarkers
5.4 Regulatory Guidance from the FDA, EMEA, and MHLW (Japan)

6 Technology Adoptions
6.1 Unmet Need – Drug Discovery
6.1.1 Biomarkers Technology Exists to Fulfill Unmet Drug Discovery Needs
6.2 Increased Awareness Among Pharmaceutical and Research Sector
6.3 Increasing Adoption Due to Wide Application
6.4 Biomarkers’ Future – Drug Discovery Unmet Needs Fulfilled

7 Global Biomarkers Market- Competitive Landscape
7.1 Key Biomarkers Players
7.1.1 Quest Diagnostics
7.1.2 Applied Biosystems
7.1.3 Vermillion
7.1.4 BGMedical
7.1.5 Menarini
7.1.6 Abbott
7.1.7 Roche
7.1.8 Genentech
7.1.9 Affymetrix
7.1.10 Amgen
7.2 Global Biomarkers Market – Geographic Landscape

8 Biomarkers in Drug Discovery – Pipeline Analysis
8.1 Pipeline Analysis
8.1.1 Pipeline analysis by Phase
8.1.2 Pipeline Analysis – Therapeutic class
8.1.3 Pipeline Analysis by Geography

9 Global Biomarkers market – Strategic Consolidations
9.1 Mergers and Acquisitions
9.1.1 Thermo Fisher Scientific Inc. Merges with B.R.A.H.M.S. AG
9.1.2 Clinical Data Inc to Acquire Avlon Pharmaceuticals
9.1.3 OSI Pharmaceuticals and AVEO Enter Collaborative Alliance
9.1.4 PEP Products Inc. and Interleukin Genetics Inc. Enter Collaborative Alliance
9.1.5 Pfizer Canada signs Alliance Deal with the Centre of Excellence For The Prevention of Organ Failure (Proof)
9.1.6 Millipore Corporation Acquires Guava Technologies
9.1.7 SuperGen Inc. Acquires Montigen Pharmaceuticals, Inc.
9.1.8 National Institute of Allergy and Infectious Diseases (NIAID) Enters Collaborative Alliance with Caprion Proteomics Inc.
9.1.9 Entelos Inc Acquires Iconix Biosciences
9.1.10 Vermillion Inc Acquires Ciphergen Biosystems
9.1.11 Cleveland Biolabs, Inc. Enters Collaborative Alliance with CBMS-MITS JPMO
9.2 Mergers and Acquisition Analysis by Deal Type
9.3 Mergers and Acquisition by Year of Consolidations
9.4 Mergers and Acquisitions by Geography
9.5 Mergers and Acquisitions by Deal value

10 Appendix
10.1 Abbreviations
10.2 Research Methodology
10.2.1 Coverage
10.2.2 Secondary Research
10.2.3 Primary Research
10.2.4 Expert Panel Validation
10.3 Contact Us
10.4 Disclaimer

List of Table:
Table 1: Biomarkers in Drug Discovery, Historical Revenue, Global Biomarkers Market,
($bn, 2000-2008) 33
Table 2: Biomarkers in Drug Discovery, Historical Revenue, Global Biomarkers Market,
($bn, 2008-2015) 34
Table 3: Biomarkers in Drug Discovery, Historical Revenue, Biomarkers Drug Discovery Market Revenue ($bn), 2000-2008 34
Table 4: Biomarkers in Drug Discovery, Historical Revenue, Global Biomarkers Drug Discovery Market Revenue ($bn), 2008-2015 34
Table 5: Biomarkers in Drug Discovery, Historical Revenues, Biomarkers Molecular Diagnostics Market Revenue ($bn), 2000-2008 35
Table 6: Biomarkers in Drug Discovery, Historical Revenue, Biomarkers Molecular Diagnostics Market Revenue ($bn), 2008-2015 35
Table 7: Biomarkers in Drug Discovery, Historical Revenue, Others Market Revenue ($bn), 2000-2008 36
Table 8: Biomarkers in Drug Discovery, Historical Revenue, Others Market Revenue ($bn), 2008-2015 36
Table 9: Biomarkers in Drug Discovery, Global, Regulatory Filings for Biomarkers, 2009 43
Table 10: Biomarkers in Drug Discovery, Global, Validated Biomarkers Applied in FDA Approved Drugs, 2009 44
Table 11: Biomarkers in Drug Discovery, Global,Biomarkers in Discovery Phase, 2009 62
Table 12: Biomarkers in Drug Discovery, Global, Biomarkers in Preclinical Phase, 2009 64
Table 13: Biomarkers in Drug Discovery, Global, Biomarkers in Phase I, 2009 65
Table 14: Biomarkers in Drug Discovery, Global, Biomarkers in Phase II, 2009 65
Table 15: Biomarkers in Drug Discovery, Global, Biomarkers in Phase III, 2009 65
Table 16: Biomarkers in Drug Discovery, Global, Merger and Acquisitions, 2009 68

List of Charts:
Figure 1: Biomarkers in Drug Discovery, Global, History of Biomarkers, 2009 10
Figure 2: Biomarkers in Drug Discovery, Global, Biomarker Discovery and Validation Process, 2009 11
Figure 3: Biomarkers in Drug Discovery, Global, General Application of Biomarkers, 2010 12
Figure 4: Biomarkers in Drug Discovery, Global, Application of Biomarkers in Diagnosis, 2009 14
Figure 5: Biomarkers in Drug Discovery, Global, Potential Impact of Biomarkers on Disease States, 2009 15
Figure 6: Biomarkers in Drug Discovery, Global, Application of Biomarkers in Population Genetic Studies, 2009 16
Figure 7: Biomarkers in Drug Discovery, Global, Role of Biomarkers in Risk Assessment, 2009 17
Figure 8: Biomarkers in Drug Discovery, Global, Biomarkers Accelerate the Drug Discovery Process, 2009 19
Figure 9: Biomarkers in Drug Discovery, Global, Adoption of Biomarkers by Top Companies in Drug Discovery, 2009 21
Figure 10: Biomarkers in Drug Discovery, Global, Case Studies, 2009 23
Figure 11: Biomarkers in Drug Discovery, Global, Hepicidine Biomarker Case Study, 2009 24
Figure 12: Biomarkers in Drug Discovery, Global, Septin 9 Biomarker Case Study, 2009 26
Figure 13: Biomarkers in Drug Discovery, Global, PARP1 Gene Biomarker Case Study, 2009 30
Figure 14: Biomarkers in Drug Discovery, Global, Global Biomarkers Market Revenues ($bn), 2000-2015 33
Figure 15: Biomarkers in Drug Discovery, Global, Biomarkers Drug Discovery Market Revenues ($bn), 2000-2015 34
Figure 16: Biomarkers in Drug Discovery, Historical Revenue, Biomarkers Molecular Diagnostics Market Revenue ($bn), 2000-2008 35
Figure 17: Biomarkers in Drug Discovery, Global, Others Market Revenues ($bn), 2000-2015 36
Figure 18: Biomarkers in Drug Discovery, Global, Global Biomarkers Market Segmentation, 2009 37
Figure 19: Biomarkers in Drug Discovery, Global, Market Drivers and Restrains, 2009 37
Figure 20:Biomarkers in Drug Discovery, Global, Integration of Omics Drive Global Biomarker Market, 2009 39
Figure 21: Biomarkers in Drug Discovery, Global, Biomarkers Fulfill Unmet Needs of Conventional Drug Discovery Methods, 2009 41
Figure 22: Biomarkers in Drug Discovery, Global, Validated Biomarkers Applied by Pharmaceutical Companies in Drug Discovery, 2009 45
Figure 23: Biomarkers in Drug Discovery, Global, Biomarkers Technology Adoption Framework, 2009 47
Figure 24: Biomarkers in Drug Discovery, Global, Company Profile – Quest Diagnostics, 2009 50
Figure 25: Biomarkers in Drug Discovery, Global, Company Profile – Applied Biosystems, 2009 51
Figure 26: Biomarkers in Drug Discovery, Global, Company Profile – Vermillion, 2009 52
Figure 27: Biomarkers in Drug Discovery, Global, Company Profile- BGMedical, 2009 53
Figure 28: Biomarkers in Drug Discovery, Global, Company Profile – Menarini, 2009 54
Figure 29: Biomarkers in Drug Discovery, Global, Company Profile- Abbott, 2009 55
Figure 30: Biomarkers in Drug Discovery, Global, Company Profile-Roche, 2009 56
Figure 31: Biomarkers in Drug Discovery, Global, Company Profile-Genentech, 2009 57
Figure 32: Biomarkers in Drug Discovery, Global, Company Profile- Affymetrix, 2009 58
Figure 33: Biomarkers in Drug Discovery, Global, Company Profile- Amgen, 2009 59
Figure 34: Biomarkers in Drug Discovery, Global, Geographic Landscape-Global Biomarkers Market, 2009 60
Figure 35: Biomarkers in Drug Discovery, Global, Pipeline Analysis by Phase, 2009 65
Figure 36: Biomarkers in Drug Discovery, Global, Pipeline Analysis by Therapeutic Class, 2009 66
Figure 37: Biomarkers in Drug Discovery, Global, Pipeline Analysis by Geography, 2009 67
Figure 38: Biomarkers in Drug Discovery, Global, Global Biomarkers Market Deal Analysis, 2009 70
Figure 39: Biomarkers in Drug Discovery, Global, Mergers and Acquisition by Year of Consolidation, 2009 71
Figure 40: Biomarkers in Drug Discovery, Global, Mergers and Acquisitions Geographical Distribution, 2009 72
Figure 41: Biomarkers in Drug Discovery, Global, Mergers and Acquisitions Deal Value ($m), 2009 72
Figure 42: GBI Research Methodology 75

Biomarkers in Drug Discovery – Earlier Usage of Biomarkers in Optimization Stage to Reduce Drug Attrition Rate Significantly