Aarkstore Enterprise -Biomarkers in Late Stage Clinical Trials-Aarkstore Enterprise Market Research
Biomarkers in Late Stage Clinical Trials: Applications, opportunities and activities of leading players
Table of Contents :
Biomarkers in Late Stage Clinical Trials
Executive summary 12
Market dynamics 12
Biomarker activity at leading pharma companies 13
Applications of biomarkers in clinical trials 13
Biomarker market for late stage clinical trials by tools and services 14
Company profiles 15
Chapter 1 Market dynamics 18
Summary 18
Introduction 19
Factors influencing biomarker adoption in clinical trials 22
Investment scenario for late stage clinical trials 22
Cost of clinical trials: early stage vs. late stage 23
Impact of drug failure in last stage clinical trials 24
Case 1: Vicriviroc - Merck 25
Case 2: Flurizon – Myriad Pharmaceutical 26
Technologies influencing drug success ratio 26
Genomics 26
Proteomics 26
Pharmacogenomics 27
Nanotechnology 27
Emerging technology integration (biomarker and bioinformatics) 27
Impact of omics and increasing adoption of biomarkers in clinical trials 28
Key market drivers & restraints 29
Increasing presence of CROs 29
Biomarkers in oncology clinical trials 30
Genomics and proteomics developments 30
Cost and reliability issues 30
Patent analysis 30
Competitive landscape 32
Regulatory environment 35
Introduction 35
Role of FDA 35
European Medicines Agency 37
Regulatory impact on drug safety 38
Chapter 2 Biomarker activity at leading pharma companies 40
Summary 40
Trends in the biomarker market for late stage clinical trials 41
Ongoing biomarker late stage clinical trials 43
Abbott 43
Astra Zeneca 45
Bristol-Myers Squibb 47
Eli Lilly 48
GlaxoSmithKline 49
Merck & Co., Inc. 51
Novartis 52
Pfizer 53
Roche 54
Sanofi-Aventis 55
Overview of pharmaceutical sector and biomarker use 57
Overview of contract research organizations and biomarker use 58
Overview of biomarker industry and biomarker use 59
Chapter 3 Applications of biomarkers in clinical trials 62
Summary 62
Early stage clinical trials 63
Toxicity determination 63
Dosage level 66
Drug efficacy 68
Late stage clinical trials 68
Phase III 68
Phase IV 69
Competitive landscape for late stage clinical trials 69
Application by therapy area 72
Oncology 72
Cardiovascular 73
Neurological disorders 74
Autoimmune diseases 75
Selected applications 76
Synta - Elesclomol 76
HGS – Benlysta 77
Roche – Herceptin 77
Eli Lilly - Alzheimer's Phase III trial 77
Chapter 4 Biomarker market for late stage clinical trials by tools and services 80
Summary 80
Service 82
Technology 83
Immunoassay 85
Biochip/microarray 85
GC/MS and LC/MS 86
Flow cytometry 87
Imaging 88
PCR (Polymerase Chain Reaction) 89
Chapter 5 Company profiles 92
Summary 92
Pharmaceutical companies 93
Abbott Laboratories Inc 93
Astellas Pharma Inc. 94
AstraZeneca Ltd 95
Bayer Schering Pharma AG 96
Boehringer Ingelheim GmbH 98
Bristol-Myers Squibb Co 99
Daiichi Sankyo Company, Ltd 100
Eisai Co. Ltd. 102
Eli Lilly and Company 103
GlaxoSmithKline Ltd 104
Johnson & Johnson Ltd 106
Merck & Co., Inc. 107
Novartis AG 109
Pfizer Inc 110
Roche Ltd 111
Sanofi-Aventis 112
Takeda Pharmaceuticals Ltd 114
Teva Pharmaceutical Industries Ltd. 115
Contract Research Organizations 117
Charles River Laboratories International, Inc. 117
Clininvent Research Pvt. Ltd. 118
Covance Inc. 120
ICON plc 121
Kendle International 122
MDS Pharma Services Inc 123
Parexel International Corp 124
PharmaNet Development Group, Inc. 125
PPD, Inc. 126
Pharsight Corp 127
PRA International Inc 129
Quintiles Inc 130
ReSearch Pharmaceutical Services, Inc. 132
Biomarker companies 133
Affymetrix, Inc. 133
Banyan Biomarkers, Inc. 134
BG Medicine, Inc. 135
Biophysical Corp 136
BioSystems International Inc 137
Caprion Proteomics Inc 138
Clinical Data, Inc 139
Correlogic Systems, Inc. 140
Epigenomics AG 141
Genedata AG 143
GeneGo, Inc. 144
GeneNews Ltd 145
Appendix 147
List of Figures
Figure 1.1: Biomarker applications in clinical stages 20
Figure 1.2: Disease specific biomarkers as surrogate end points 21
Figure 1.3: Role of biomarkers in cost saving 23
Figure 1.4: Average cost of clinical trials (per patient basis) 24
Figure 1.5: Approximation of time taken for clinical trial phases 25
Figure 1.6: Important elements in new biomarker discovery and role of bioinformatics 28
Figure 1.7: Functions of omics in the drug development process 29
Figure 1.8: Patent analysis by geography 2006 vs. 2008 31
Figure 1.9: Patent analysis by competitors 2008 32
Figure 1.10: Therapy areas focus of major market players (2007-2009) 33
Figure 7.11: Biomarker classification by FDA 37
Figure 2.12: Biomarker late stage clinical trials by disease 41
Figure 2.13: Biomarker late stage clinical trials by phase 42
Figure 2.14: Abbott's biomarker-based late stage clinical trials 44
Figure 2.15: Astra Zeneca's biomarker-based late stage clinical trials 46
Figure 2.16: Bristol-Myers Squibb's biomarker-based late stage clinical trials 47
Figure 2.17: Eli Lilly biomarker-based late stage clinical trials 48
Figure 2.18: GSK's biomarker-based late stage clinical trials 50
Figure 2.19: Merck & Co. biomarker-based late stage clinical trials 51
Figure 2.20: Novartis' biomarker-based late stage clinical trials 52
Figure 2.21: Pfizer's late stage clinical trials 53
Figure 2.22: Roche's biomarker-based late stage clinical trials 54
Figure 2.23: Sanofi-Aventis' biomarker-based late stage clinical trials 56
Figure 3.24: Biomarker types for toxicity 64
Figure 3.25: Major focus areas for the late stage clinical trials by pharmaceutical companies (2008- 2009) 70
Figure 3.26: Applications of biomarkers in late stage clinical trials 71
List of Tables
Table 1.1: Agreements & Collaborations (2007 – 2009) 34
Table 1.2: New product launches (2007 – 2009) 35
Table 2.3: Late stage clinical trial scenario by top players 43
Table 2.4: Key late stage clinical trials - Abbott 45
Table 2.5: Key late stage clinical trials – Astra Zeneca 46
Table 2.6: Key late stage clinical trials – Bristol-Myers Squibb 48
Table 2.7: Key late stage clinical trials – Eli Lilly's 49
Table 2.8: Key late stage clinical trials – GlaxoSmithKline 50
Table 2.9: Key late stage clinical trials – Merck & Co. 51
Table 2.10: Key late stage clinical trials – Novartis 52
Table 2.11: Key late stage clinical trials – Pfizer 53
Table 2.12: Key late stage clinical trials – Roche 55
Table 2.13: Key late stage clinical trials – Sanofi-Aventis 56
Table 2.14: Developments by pharmaceutical companies for biomarker applications 57
Table 2.15: Developments by contract research organizations for biomarker applications 58
Table 2.16: Developments by biomarker companies for biomarker applications 59
Table 3.17: Clinical trials for biomarker toxicity 65
Table 3.18: Clinical trials for biomarker dose range 67
Table 3.19: Clinical trials for biomarker validation 68
Table 3.20: Global biomarker late stage clinical trials applications market, by diseases 2007-2014f ($m) 72
Table 3.21: Ongoing biomarker late stage clinical trials in oncology 73
Table 3.22: Ongoing biomarker late stage clinical trials in cardiovascular diseases 74
Table 3.23: Ongoing biomarker late stage clinical trials in neurological diseases 75
Table 3.24: Ongoing biomarker late stage clinical trials in autoimmune diseases 76
Table 4.25: Global biomarker market in late stage clinical trials, by services and technologies
2007-2014f ($m) 81
Table 4.26: Global biomarker market in late stage clinical trials, by geography 2007-2014f ($m) 82
Table 4.27: Global biomarker services market in late stage clinical trials, by geography 2007-2014f ($m) 83
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