AARKSTORE ENTERPRISE -BIOMARKERS IN LATE STAGE CLINICAL TRIALS-AARKSTORE ENTERPRISE MARKET RESEARCH
Biomarkers in Late Stage Clinical Trials: Applications, opportunities as well as activities of heading players
Table of Contents :
Biomarkers in Late Stage Clinical Trials
Executive outline 12
Market dynamics 12
Biomarker wake up during heading pharma companies 13
Applications of biomarkers in clinical trials 13
Biomarker marketplace for late theatre clinical trials by collection as well as services 14
Company profiles 15
Chapter 1 Market dynamics 18
Summary 18
Introduction 19
Factors conversion biomarker embracing a cause in clinical trials 22
Investment unfolding for late theatre clinical trials 22
Cost of clinical trials: early theatre vs. late theatre 23
Impact of drug disaster in final theatre clinical trials 24
Case 1: Vicriviroc – Merck 25
Case 2: Flurizon – Myriad Pharmaceutical 26
Technologies conversion drug success comparative measure 26
Genomics 26
Proteomics 26
Pharmacogenomics 27
Nanotechnology 27
Emerging record formation (biomarker as well as bioinformatics) 27
Impact of omics as well as augmenting embracing a cause of biomarkers in clinical trials 28
Key marketplace drivers & restraints 29
Increasing participation of CROs 29
Biomarkers in oncology clinical trials 30
Genomics as well as proteomics developments 30
Cost as well as trustworthiness issues 30
Patent investigate 30
Competitive landscape 32
Regulatory sourroundings 35
Introduction 35
Role of FDA 35
European Medicines Agency 37
Regulatory stroke upon drug reserve 38
Chapter 2 Biomarker wake up during heading pharma companies 40
Summary 40
Trends in a biomarker marketplace for late theatre clinical trials 41
Ongoing biomarker late theatre 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 curative zone as well as biomarker make make make use of of of 57
Overview of stipulate investigate organizations as well as biomarker make make make use of of of 58
Overview of biomarker attention as well as biomarker make make make use of of of 59
Chapter 3 Applications of biomarkers in clinical trials 62
Summary 62
Early theatre clinical trials 63
Toxicity integrity 63
Dosage turn 66
Drug efficiency 68
Late theatre clinical trials 68
Phase III 68
Phase IV 69
Competitive landscape for late theatre clinical trials 69
Application by care 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 hearing 77
Chapter 4 Biomarker marketplace for late theatre clinical trials by collection as well as services 80
Summary 80
Service 82
Technology 83
Immunoassay 85
Biochip/microarray 85
GC/MS as well as 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 as well as 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 broker finish points 21
Figure 1.3: Role of biomarkers in price saving 23
Figure 1.4: Average price of clinical trials (per studious basis) 24
Figure 1.5: Approximation of time taken for clinical hearing phases 25
Figure 1.6: Important elements in brand new biomarker find as well as purpose of bioinformatics 28
Figure 1.7: Functions of omics in a drug growth routine 29
Figure 1.8: Patent investigate by embankment 2006 vs. 2008 31
Figure 1.9: Patent investigate by competitors 2008 32
Figure 1.10: Therapy areas concentration of vital marketplace players (2007-2009) 33
Figure 7.11: Biomarker sequence by FDA 37
Figure 2.12: Biomarker late theatre clinical trials by mildew 41
Figure 2.13: Biomarker late theatre clinical trials by proviso 42
Figure 2.14: Abbott’s biomarker-based late theatre clinical trials 44
Figure 2.15: Astra Zeneca’s biomarker-based late theatre clinical trials 46
Figure 2.16: Bristol-Myers Squibb’s biomarker-based late theatre clinical trials 47
Figure 2.17: Eli Lilly biomarker-based late theatre clinical trials 48
Figure 2.18: GSK’s biomarker-based late theatre clinical trials 50
Figure 2.19: Merck & Co. biomarker-based late theatre clinical trials 51
Figure 2.20: Novartis’ biomarker-based late theatre clinical trials 52
Figure 2.21: Pfizer’s late theatre clinical trials 53
Figure 2.22: Roche’s biomarker-based late theatre clinical trials 54
Figure 2.23: Sanofi-Aventis’ biomarker-based late theatre clinical trials 56
Figure 3.24: Biomarker sorts for toxicity 64
Figure 3.25: Major concentration areas for a late theatre clinical trials by curative companies (2008- 2009) 70
Figure 3.26: Applications of biomarkers in late theatre 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 theatre clinical hearing unfolding by tip players 43
Table 2.4: Key late theatre clinical trials – Abbott 45
Table 2.5: Key late theatre clinical trials – Astra Zeneca 46
Table 2.6: Key late theatre clinical trials – Bristol-Myers Squibb 48
Table 2.7: Key late theatre clinical trials – Eli Lilly’s 49
Table 2.8: Key late theatre clinical trials – GlaxoSmithKline 50
Table 2.9: Key late theatre clinical trials – Merck & Co. 51
Table 2.10: Key late theatre clinical trials – Novartis 52
Table 2.11: Key late theatre clinical trials – Pfizer 53
Table 2.12: Key late theatre clinical trials – Roche 55
Table 2.13: Key late theatre clinical trials – Sanofi-Aventis 56
Table 2.14: Developments by curative companies for biomarker applications 57
Table 2.15: Developments by stipulate investigate 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 sip operation 67
Table 3.19: Clinical trials for biomarker validation 68
Table 3.20: Global biomarker late theatre clinical trials applications market, by diseases 2007-2014f ($m) 72
Table 3.21: Ongoing biomarker late theatre clinical trials in oncology 73
Table 3.22: Ongoing biomarker late theatre clinical trials in cardiovascular diseases 74
Table 3.23: Ongoing biomarker late theatre clinical trials in neurological diseases 75
Table 3.24: Ongoing biomarker late theatre clinical trials in autoimmune diseases 76
Table 4.25: Global biomarker marketplace in late theatre clinical trials, by services as well as technologies
2007-2014f ($m) 81
Table 4.26: Global biomarker marketplace in late theatre clinical trials, by embankment 2007-2014f ($m) 82
Table 4.27: Global biomarker services marketplace in late theatre clinical trials, by embankment 2007-2014f ($m) 83
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