Strategic Analysis of Biomarkers in Clinical Trials

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