SPI Infoamtion

Table of Contents

Executive summary

Market dynamics
Biomarker activity at leading pharma companies
Applications of biomarkers in clinical trials
Biomarker market for late stage clinical trials by tools and services
Company profiles

Chapter1 Market dynamics

Summary
Introduction
Factors influencing biomarker adoption in clinical trials
Investment scenario for late stage clinical trials
Cost of clinical trials: early stage vs. late stage
Impact of drug failure in last stage clinical trials

Case 1: Vicriviroc - Merck
Case 2: Flurizon - Myriad Pharmaceutical

Technologies influencing drug success ratio

Genomics
Proteomics
Pharmacogenomics
Nanotechnology

Emerging technology integration (biomarker and bioinformatics)
Impact of omics and increasing adoption of biomarkers in clinical trials
Key market drivers & restraints

Increasing presence of CROs
Biomarkers in oncology clinical trials
Genomics and proteomics developments
Cost and reliability issues

Patent analysis
Competitive landscape
Regulatory environment

Introduction
Role of FDA
European Medicines Agency
Regulatory impact on drug safety

Chapter2 Biomarker activity at leading pharma companies

Summary
Trends in the biomarker market for late stage clinical trials
Ongoing biomarker late stage clinical trials

Abbott
Astra Zeneca
Bristol-Myers Squibb
Eli Lilly

GlaxoSmithKline

Merck & Co., Inc.
Novartis
Pfizer
Roche
Sanofi-Aventis

Overview of pharmaceutical sector and biomarker use
Overview of contract research organizations and biomarker use
Overview of biomarker industry and biomarker use

Chapter3 Applications of biomarkers in clinical trials

Summary
Early stage clinical trials

Toxicity determination
Dosage level
Drug efficacy

Late stage clinical trials

Phase III
Phase IV

Competitive landscape for late stage clinical trials
Application by therapy area

Oncology
Cardiovascular
Neurological disorders
Autoimmune diseases

Selected applications

Synta - Elesclomol
HGS - Benlysta
Roche - Herceptin
Eli Lilly - Alzheimer's Phase III trial

Chapter4 Biomarker market for late stage clinical trials by tools and services

Summary
Service
Technology

Immunoassay
Biochip/microarray
GC/MS and LC/MS
Flow cytometry
Imaging
PCR (Polymerase Chain Reaction)

Chapter5 Company profiles

Summary
Pharmaceutical companies

Abbott Laboratories Inc
Astellas Pharma Inc.
AstraZeneca Ltd
Bayer Schering Pharma AG
Boehringer Ingelheim GmbH
Bristol-Myers Squibb Co
Daiichi Sankyo Company, Ltd
Eisai Co. Ltd.
Eli Lilly and Company
GlaxoSmithKline Ltd
Johnson & Johnson Ltd
Merck & Co., Inc.
Novartis AG
Pfizer Inc
Roche Ltd
Sanofi-Aventis
Takeda Pharmaceuticals Ltd
Teva Pharmaceutical Industries Ltd.

Contract Research Organizations

Charles River Laboratories International, Inc.
Clininvent Research Pvt. Ltd.
Covance Inc.
ICON plc
Kendle International
MDS Pharma Services Inc
Parexel International Corp
PharmaNet Development Group, Inc.
PPD, Inc.
Pharsight Corp
PRA International Inc
Quintiles Inc
ReSearch Pharmaceutical Services, Inc.

Biomarker companies

Affymetrix, Inc.
Banyan Biomarkers, Inc.
BG Medicine, Inc.
Biophysical Corp
BioSystems International Inc
Caprion Proteomics Inc
Clinical Data, Inc
Correlogic Systems, Inc.
Epigenomics AG
Genedata AG
GeneGo, Inc.
GeneNews Ltd

Appendix

List of Figures
Figure 1.1: Biomarker applications in clinical stages
Figure 1.2: Disease specific biomarkers as surrogate end points
Figure 1.3: Role of biomarkers in cost saving
Figure 1.4: Average cost of clinical trials (per patient basis)
Figure 1.5: Approximation of time taken for clinical trial phases
Figure 1.6: Important elements in new biomarker discovery and role of bioinformatics
Figure 1.7: Functions of omics in the drug development process
Figure 1.8: Patent analysis by geography 2006 vs. 2008
Figure 1.9: Patent analysis by competitors 2008
Figure 1.10: Therapy areas focus of major market players (2007-2009)
Figure 7.11: Biomarker classification by FDA
Figure 2.12: Biomarker late stage clinical trials by disease
Figure 2.13: Biomarker late stage clinical trials by phase
Figure 2.14: Abbott's biomarker-based late stage clinical trials
Figure 2.15: Astra Zeneca's biomarker-based late stage clinical trials
Figure 2.16: Bristol-Myers Squibb's biomarker-based late stage clinical trials
Figure 2.17: Eli Lilly biomarker-based late stage clinical trials
Figure 2.18: GSK's biomarker-based late stage clinical trials
Figure 2.19: Merck & Co. biomarker-based late stage clinical trials
Figure 2.20: Novartis' biomarker-based late stage clinical trials
Figure 2.21: Pfizer's late stage clinical trials
Figure 2.22: Roche's biomarker-based late stage clinical trials
Figure 2.23: Sanofi-Aventis' biomarker-based late stage clinical trials
Figure 3.24: Biomarker types for toxicity
Figure 3.25: Major focus areas for the late stage clinical trials by pharmaceutical companies (2008-2009)
Figure 3.26: Applications of biomarkers in late stage clinical trials

List of Tables
Table 1.1: Agreements & Collaborations (2007 - 2009)
Table 1.2: New product launches (2007 - 2009)
Table 2.3: Late stage clinical trial scenario by top players
Table 2.4: Key late stage clinical trials - Abbott
Table 2.5: Key late stage clinical trials - Astra Zeneca
Table 2.6: Key late stage clinical trials - Bristol-Myers Squibb
Table 2.7: Key late stage clinical trials - Eli Lilly's
Table 2.8: Key late stage clinical trials - GlaxoSmithKline
Table 2.9: Key late stage clinical trials - Merck & Co.
Table 2.10: Key late stage clinical trials - Novartis
Table 2.11: Key late stage clinical trials - Pfizer
Table 2.12: Key late stage clinical trials - Roche
Table 2.13: Key late stage clinical trials - Sanofi-Aventis
Table 2.14: Developments by pharmaceutical companies for biomarker applications
Table 2.15: Developments by contract research organizations for biomarker applications
Table 2.16: Developments by biomarker companies for biomarker applications
Table 3.17: Clinical trials for biomarker toxicity
Table 3.18: Clinical trials for biomarker dose range
Table 3.19: Clinical trials for biomarker validation
Table 3.20: Global biomarker late stage clinical trials applications market, by diseases 2007-2014f($m)
Table 3.21: Ongoing biomarker late stage clinical trials in oncology
Table 3.22: Ongoing biomarker late stage clinical trials in cardiovascular diseases
Table 3.23: Ongoing biomarker late stage clinical trials in neurological diseases
Table 3.24: Ongoing biomarker late stage clinical trials in autoimmune diseases
Table 4.25: Global biomarker market in late stage clinical trials, by services and technologies 2007-2014f ($m)
Table 4.26: Global biomarker market in late stage clinical trials, by geography 2007-2014f ($m)
Table 4.27: Global biomarker services market in late stage clinical trials, by geography 2007-2014f($m)
Table 4.28: Global biomarker technology market in late stage clinical trials, by products 2007-2014f ($m)
Table 4.29: Global biomarker technology market in late stage clinical trials, by products 2007-2014f ($m)
Table 4.30: Global immunoassay market, by geography 2007-2014f ($m)
Table 4.31: Global Biochip/microarray market, by geography 2007-2014f ($m)
Table 4.32: Global Biochip/Microarray market, by geography 2007-2014f ($m)
Table 4.33: Global flow cytometry market by geography 2007-2014f ($m)
Table 4.34: Global imaging market by geography 2007-2014f ($m)
Table 4.35: Global PCR market by geography 2007-2014f ($m)
Table 6.36: US patents
Table 6.37: US patents (Contd.)
Table 6.38: US patents (Contd.)
Table 6.39: US patents (Contd.)
Table 6.40: US patents (Contd.)
Table 6.41: US patents (Contd.)
Table 6.42: US patents (Contd.)
Table 6.43: US patents (Contd.)
Table 6.44: US patents (Contd.)
Table 6.45: US patents (Contd.)
Table 6.46: US patents (Contd.)
Table 6.47: US patents (Contd.)
Table 6.48: US patents (Contd.)
Table 6.49: US patents (Contd.)
Table 6.50: US patents (Contd.)
Table 6.51: European patents
Table 6.52: European patents (Contd)
Table 6.53: European patents (Contd)
Table 6.54: European patents (Contd)
Table 6.55: European patents (Contd)
Table 6.56: European patents (Contd)
Table 6.57: European patents (Contd)
Table 6.58: European patents (Contd)
Table 6.59: European patents (Contd)
Table 6.60: Japan patents
Table 6.61: Japan patents (Contd)
Table 6.62: Japan patents (Contd)
Table 6.63: Japan patents (Contd)
Table 6.64: Japan patents (Contd)
Table 6.65: Japan patents (Contd)
Table 6.66: Japan patents (Contd)
Table 6.67: FDA Guidelines