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?

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

Chapter 2 Biomarker activity at leading pharma companies 40

Chapter 3 Applications of biomarkers in clinical trials 62

Chapter 4 Biomarker market for late stage clinical trials by tools and services 80

Appendix 147