Abstract
Biomarkers to Play a Key Role in Tackling Failure Rates in Clinical Trials
Biomarkers are emerging as an essential tool to boost efficiency in the field
of drug discovery. Around 90 per cent of new compounds fail during the clinical
trials, predominantly related to absorption, distribution, metabolism, excretion
(ADME) and toxicology issues. Biomarkers increase productivity by identifying
potential drug failures at an early stage thereby saving costs and time in the
long term. Better patient stratification integration with drug development and
pre-clinical testing processes and the advent of biomarker pattern profiling
rather than reliance on a single target are set to improve results in the
future.
This strategic analysis service from Frost & Sullivan evaluates the key
drivers and challenges facing the uptake of biomarkers in clinical trials. It
also examines important market and research trends to give an idea of future
opportunities and developments. Strategic proposals are identified which
overcome the major barriers to increased industry productivity.
High Costs and Duration of Clinical Trials Drives Biomarker Research
There is growing concern in the field of drug discovery regarding cost and
duration of clinical trials that are reaching magnified proportions. A new drug
is estimated to cost anywhere between $800 million and $1,700 million and is
expected to take anywhere between 7 and 12 years to be approved and launched.
Biomarkers have the potential to be used in clinical trials as validated
surrogate endpoints to indicate drug efficacy or toxicity, or to make a
go-no-go decision. "Although biomarkers initially increase the cost of
clinical development, as a larger biomarker portfolio is developed and other
drug discovery technologies are integrated, the cost and duration of clinical
development are expected to drop," explains the analyst.
Growth in Biomarkers Market Governed by Regulatory Affairs
Despite being aware of the benefits of biomarkers in clinical trials,
regulatory authorities are unwilling to compromise drug safety and efficacy and
are therefore cautious in implementing new regulations. "However, the
anticipated shift in the regulatory climate towards the use of biomarkers as
surrogate endpoints is likely to reduce the time to market and ultimately
increase overall revenues," says the analyst.
The increased prevalence of terminal diseases among the ageing baby boomer
generation also requires an accelerated drug pipeline. Regulatory authorities
have recognised this need and are proving to be more supportive of biomarkers
and their capabilities in making drug approval quicker and cheaper.
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Table of Contents
1 STRATEGIC ANALYSIS OF BIOMARKERS IN CLINICAL TRIALS
Overview Research Scope & Methodology Introduction & Background
Market Dynamics
- Major Challenges for Biomarkers in Clinical Trials
- Key Market Trends
- Market Drivers
- Market Restraints
- Key Market Engineering Measurements
- Total Market Revenue Forecast
Regulatory Climate
- Drug Failure in Clinical Development
- Decrease in FDA Submissions
- Decrease in EMEA Submissions
- Current FDA Policy
Research Trends
- Assumptions
- World Biomarker Research Direction
- World Investment in Research and Development
- World Biomarker IP Portfolios
- Competitive Profiles
- Other Key Industry Participants
Major Challenges and Strategic Proposals
- Biomarker Misdiagnosis Issues
- Investment in Biomarkers
- Clinical Development Productivity Improvement
- Biomarker Regulatory Issues
- Late Stage Clinical Failure
- Summary of Strategic Proposals
Corporate Strategy
- Corporate Strategy--Strategic Anticipation
- Corporate Strategy--Market Maturation Process
- Corporate Strategy--Competitive Framework
- Corporate Strategy--Potential Threats
- Corporate Strategy--Meeting the Challenge
Frost & Sullivan Awards
- Frost & Sullivan Awards Description
- Growth Strategy Leadership Award
- Technology Leadership Award
- Entrepreneurial Company Award
- Market Leadership Award
- Competitive Strategy Leadership Award
Decision Support Databases
- New Drugs Approved by the FDA (2000-2004)
- New Drugs Approved by the EMEA (2000-2004)
- Number of Biotechnology Companies--Western Europe and North America
(1999-2006)
- Major Pharmaceutical Companies in Europe (2003)
- Biotechnology European Patents Filed (1996-2000)
- Governmental Biotechnology Investment (1999-2006)
- Pharmaceutical Research and Development Expenditure (1999-2006)
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