1 Table of Contents 3
1.1 List of Tables 6
1.2 List of Figures 7
2 Biomarkers in Drug Discovery - Facilitating a Quick Turnaround Time: Overview 8
2.1 Introduction 8
2.2 GBI Research Report Guidance 8
2.3 History of Biomarkers 9
2.4 Biomarker Discovery and the Validation Process 10
2.4.1 Product Development Process from Discovery to Launch 11
2.5 General Application of Biomarkers 12
2.5.1 Biomarkers in Drug Discovery and Drug Development 13
2.5.2 Role of Biomarkers in the Drug Discovery Process 13
2.5.3 Application of Biomarkers in Disease Diagnosis and Prognosis 13
2.5.4 Potential Impact of Biomarkers on Disease States 15
2.5.5 Population Genetics Study 15
2.5.6 Environmental Health and Risk Assessment 17
2.5.7 Role of Biomarkers in Environmental Health and Risk Assessment 17
2.5.8 Toxicology Studies in Dietary Items or Nutraceuticals 18
2.6 Application of Biomarkers in Drug Discovery 18
2.6.1 Lead Identification & Optimization 19
2.6.2 Potential Role of Biomarkers in Lead Identification and Optimization 19
2.6.3 Target Validation 20
2.6.4 Toxicological Assay (Preclinical & Clinical) 20
2.6.5 Mechanism of Action 20
2.6.6 Monitor Therapy and Dose Response 21
2.6.7 Stratify Patient Population 21
2.6.8 Filing and Post Marketing Surveillance 21
3 Biomarkers in Drug Discovery - Case Studies 23
3.1 Vermillion’s Hepcidin Biomarker for Ovarian Oancer 23
3.1.1 Definition 23
3.1.2 Hepcidin Biomarker 23
3.1.3 About Ovarian Cancer 23
3.1.4 Company Profile 24
3.1.5 Technology Used 25
3.1.6 Market Information 25
3.1.7 Advantages 25
3.1.8 Future Prospect 26
3.2 Epigenomic’s Septin 9 Biomarker for Colorectal Cancer 26
3.2.1 DNA Methylation 26
3.2.2 Septin 9 27
3.2.3 Septin Biomarker 27
3.2.4 About Colorectal Cancer 27
3.2.5 Advantages 27
3.2.6 Future Perspective 28
3.2.7 Clinical Study 28
3.2.8 Company Profile 28
3.2.9 Technology Overview 29
3.2.10 Market Information 29
3.3 BiPar Science’s PARP 1 Gene Biomarker for Multiple Cancer Types 29
3.3.1 PARP 1 Gene 29
3.3.2 PARP 1 Inhibitors 30
3.3.3 BSI-201 30
3.3.4 TNBC (Triple Negative Breast Cancer) 31
3.3.5 Technology 31
3.3.6 Advantage 31
3.3.7 Company Profile 31
3.3.8 Market Information 31
3.3.9 Clinical Study 31
4 Biomarkers in Drug Discovery – Market Characterization 33
4.1 Market Overview 33
4.2 Market Size and Forecasts 33
4.2.1 Driver and Restraints 37
4.2.2 Drivers for the Global Biomarkers Market 38
4.2.3 Barriers for the Global Biomarkers Market 40
4.3 Unmet Needs - Biomarkers Fulfilling the Unmet Needs of Drug Discovery 40
4.3.1 High Attrition Rates 41
4.3.2 High Drug Discovery Cost 41
4.3.3 Time consuming 42
4.3.4 Safety and Efficacy 42
4.3.5 Invasiveness, Selectivity and Sensitivity 42
5 Trends Analysis 43
5.1 Regulatory Landscape (Current and Future) 43
5.1.1 Investigative/ Exploratory Biomarker 43
5.1.2 Probable Valid Biomarker 43
5.1.3 Known Valid Biomarker 43
5.1.4 Regulatory Biomarker 43
5.2 Validated Biomarker 43
5.2.1 Validated Biomarkers Applied by Top Pharmaceuticals Players in their FDA Approved Drugs 44
5.3 Regulatory Acceptance of Valid Biomarkers 45
5.4 Regulatory Guidance from the FDA, EMEA, and MHLW (Japan) 46
6 Technology Adoptions 47
6.1 Unmet Need - Drug Discovery 47
6.1.1 Biomarkers Technology Exists to Fulfill Unmet Drug Discovery Needs 47
6.2 Increased Awareness Among Pharmaceutical and Research Sector 48
6.3 Increasing Adoption Due to Wide Application 48
6.4 Biomarkers’ Future - Drug Discovery Unmet Needs Fulfilled 48
7 Global Biomarkers Market– Competitive Landscape 49
7.1 Key Biomarkers Players 49
7.1.1 Quest Diagnostics 50
7.1.2 Applied Biosystems 51
7.1.3 Vermillion 52
7.1.4 BGMedical 53
7.1.5 Menarini 54
7.1.6 Abbott 55
7.1.7 Roche 56
7.1.8 Genentech 57
7.1.9 Affymetrix 58
7.1.10 Amgen 59
7.2 Global Biomarkers Market – Geographic Landscape 60
8 Biomarkers in Drug Discovery – Pipeline Analysis 62
8.1 Pipeline Analysis 62
8.1.1 Pipeline analysis by Phase 65
8.1.2 Pipeline Analysis – Therapeutic class 66
8.1.3 Pipeline Analysis by Geography 67
9 Global Biomarkers market – Strategic Consolidations 68
9.1 Mergers and Acquisitions 68
9.1.1 Thermo Fisher Scientific Inc. Merges with B.R.A.H.M.S. AG 68
9.1.2 Clinical Data Inc to Acquire Avlon Pharmaceuticals 68
9.1.3 OSI Pharmaceuticals and AVEO Enter Collaborative Alliance 68
9.1.4 PEP Products Inc. And Interleukin Genetics Inc. Enter Collaborative Alliance 69
9.1.5 Pfizer Canada signs Alliance Deal with the Centre of Excellence For The Prevention of Organ Failure (Proof) 69
9.1.6 Millipore Corporation Acquires Guava Technologies 69
9.1.7 SuperGen Inc. Acquires Montigen Pharmaceuticals, Inc. 69
9.1.8 National Institute of Allergy and Infectious Diseases (NIAID) Enters Collaborative Alliance with Caprion Proteomics Inc. 69
9.1.9 Entelos Inc Acquires Iconix Biosciences 69
9.1.10 Vermillion Inc Acquires Ciphergen Biosystems 69
9.1.11 Cleveland Biolabs, Inc. Enters Collaborative Alliance with CBMS-MITS JPMO 69
9.2 Mergers and Acquisition Analysis by Deal Type 70
9.3 Mergers and Acquisition by Year of Consolidations 71
9.4 Mergers and Acquisitions by Geography 72
9.5 Mergers and Acquisitions by Deal value 72
10 Appendix 74
10.1 Abbreviations 74
10.2 Research Methodology 74
10.2.1 Coverage 75
10.2.2 Secondary Research 75
10.2.3 Primary Research 76
10.2.4 Expert Panel Validation 76
10.3 Contact Us 76
10.4 Disclaimer 76" "1.1 List of Tables
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, Biomarker’s 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, Biomarker’s 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" "1.2 List of Figures
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 ($bn), 2000-2015 33
Figure 15: Biomarkers in Drug Discovery, Global, Biomarker’s Drug Discovery Market Revenues ($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