Biomarkers In Late Stage Clinical Trials: Applications, Opportunities And Activities Of Leading Players

The pharmaceuticals and biotechnology sectorsincreased significantly over the last few years.
are currently facing increasing time and cost• Late stage failures are much more
issues related to clinical trials in drug discovery.expensive than early ones.
The cost of developing a new drug can reach $2• The rising demand for better safety data
billion; clinical trials, regulatory approval andhas put a considerable amount of regulatory and
subsequent launch may take up to a decade.economic pressure on pharmaceutical companies.
Biomarkers reduce the attrition rate of late stage• The current average approval rate of cancer
clinical trials by assessing drug potential in terms ofdrugs is as low as 5%, while the development
efficacy and toxicity at the early stages of theperiod can reach 15 years.
clinical development. Thus, biomarkers significantly• More than 50% of clinical trials fail in Phase III
increase productivity, lower the cost and durationdue to a host of reasons, greater disease
of the clinical trial, and help researchers completecomplexity, stiffer clinical endpoints, and the
drug development process at a faster pace.inability of the data to prove drug effectiveness.
This report reviews various biomarkerKey findings from this report
technologies and therapy area applications. Market• The biomarkers in late stage clinical trials
drivers and restraints are viewed in the contextmarket is largest in North American and European
of biomarker activity of leading innovatorregion, with Europe having the second largest
companies as well as contract researchmarket.
organizations.• North America constitutes the major market
Key features of this reportshare with the immunoassay, flow cytometry and
• The report analyzes revenues of late stageGC/MS and LC/MS having high market growth.
biomarker technology and services in North• Caprion proteomics, Applied BioSystems, BG
America, Europe, Asia and rest of the world.Medicine, Covance, Eli Lilly, Pfizer and Astra
• Provides key market drivers and restraintsZeneca are some of the major companies
of the biomarker market.engaged in collaborative partnerships in the past
• Covers microarrays, immunoassay, LC/MSthree years.
and GC/MS, flow cytometry, imaging, PCR and• A number of market players have formed
servicesstrategic alliances for the development and sharing
• Provides patent analysis with respect toof technology for biomarker applications in the
competitors and geography.late stage clinical trials.
Scope of this report• Pharmaceutical companies are focusing
• Understand and evaluate the growthmainly on cancer biomarkers for use in late stage
potential of emerging technologies.(Phase III and IV) clinical trials.
• Understand biomarker activity in clinical trialsKey questions answered
of leading market players.• How is the biomarker late stage clinical trials
• Gain knowledge about the relativemarket segmented and what will growth be to
importance of the biomarker late stage clinical2014?
trials technologies in the next five years for• What are the major technologies that have
investment opportunities.emerged such as microarrays, PCR, LC/MS and
• Learn which therapy areas leading marketGC/MS?
players in the late stage biomarker clinical trials• In which areas are the companies focusing
market.while forming strategic alliances with other
• Determine the collaborations and partnershipsindustrial players?
of the major market players.• What is the competitive landscape and what
Key Market Issuesis the strategic focus of innovator companies,
• The pharmaceutical and biotech sectors areCROs and biomarker specialists?
currently facing increasing duration and cost issues• What applications are pharmaceutical
related to clinical trials in drug discovery.companies focusing on while conducting late stage
• Funding from government sources such asbiomarker clinical trials?
the National Institutes of Health (NIH) has not