Biomarkers in Late Stage Clinical Trials: Applications, opportunities and activities of leading players

Date: April 22, 2010
Pages: 178
Price:
US$ 3,835.00
Publisher: Business Insights
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: B19B325ED30EN
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Biomarkers in Late Stage Clinical Trials: Applications, opportunities and activities of leading players
The pharmaceuticals and biotechnology sectors are currently facing increasing time and cost issues related to clinical trials in drug discovery. The cost of developing a new drug can reach $2 billion; clinical trials, regulatory approval and subsequent launch may take up to a decade.

Biomarkers reduce the attrition rate of late stage clinical trials by assessing drug potential in terms of efficacy and toxicity at the early stages of the clinical development. Thus, biomarkers significantly increase productivity, lower the cost and duration of the clinical trial, and help researchers complete drug development process at a faster pace.

This report reviews various biomarker technologies and therapy area applications. Market drivers and restraints are viewed in the context of biomarker activity of leading innovator companies as well as contract research organizations.

Key features of this report
  • The report analyzes revenues of late stage biomarker technology and services in North America, Europe, Asia and rest of the world.
  • Provides key market drivers and restraints of the biomarker market.
  • Covers microarrays, immunoassay, LC/MS and GC/MS, flow cytometry, imaging, PCR and services
  • Provides patent analysis with respect to competitors and geography.
Scope of this report
  • Understand and evaluate the growth potential of emerging technologies.
  • Understand biomarker activity in clinical trials of leading market players.
  • Gain knowledge about the relative importance of the biomarker late stage clinical trials technologies in the next five years for investment opportunities.
  • Learn which therapy areas leading market players in the late stage biomarker clinical trials market.
  • Determine the collaborations and partnerships of the major market players.
Key Market Issues
  • The pharmaceutical and biotech sectors are currently facing increasing duration and cost issues related to clinical trials in drug discovery.
  • Funding from government sources such as the National Institutes of Health (NIH) has not increased significantly over the last few years.
  • Late stage failures are much more expensive than early ones.
  • The rising demand for better safety data has put a considerable amount of regulatory and economic pressure on pharmaceutical companies.
  • The current average approval rate of cancer drugs is as low as 5%, while the development period can reach 15 years.
  • More than 50% of clinical trials fail in Phase III due to a host of reasons, greater disease complexity, stiffer clinical endpoints, and the inability of the data to prove drug effectiveness.
Key findings from this report
  • The biomarkers in late stage clinical trials market is largest in North American and European region, with Europe having the second largest market.
  • North America constitutes the major market share with the immunoassay, flow cytometry and GC/MS and LC/MS having high market growth.
  • Caprion proteomics, Applied BioSystems, BG Medicine, Covance, Eli Lilly, Pfizer and Astra Zeneca are some of the major companies engaged in collaborative partnerships in the past three years.
  • A number of market players have formed strategic alliances for the development and sharing of technology for biomarker applications in the late stage clinical trials.
  • Pharmaceutical companies are focusing mainly on cancer biomarkers for use in late stage (Phase III and IV) clinical trials.
Key questions answered
  • How is the biomarker late stage clinical trials market segmented and what will growth be to 2014?
  • What are the major technologies that have emerged such as microarrays, PCR, LC/MS and GC/MS?
  • In which areas are the companies focusing while forming strategic alliances with other industrial players?
  • What is the competitive landscape and what is the strategic focus of innovator companies, CROs and biomarker specialists?
  • What applications are pharmaceutical companies focusing on while conducting late stage biomarker clinical trials?

Biomarkers in Late Stage Clinical Trials
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

CHAPTER 1 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

CHAPTER 2 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

CHAPTER 3 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

CHAPTER 4 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)

CHAPTER 5 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

COMPANIES MENTIONED

Abbott , Astra Zeneca , Bayer Schering Pharma , Boehringer Ingelheim , Bristol-Myers Squibb , Covance , Eisai Co. Ltd , Eli Lilly , GSK , ICON plc , Merck and Co. Inc. , Novartis , Pfizer , Roche , Sanofi-Aventis , Takeda Pharmaceuticals
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