臨床試験におけるバイオマーカー利用に関する戦略的分析

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)

Frost & Sullivan

• Healthcare Team
• Our Capabilities