1. Executive Summary
1.1 Pharmaceutical Clinical Trial Services Market Review
1.2 Chapter Breakdown
1.3 Research and Analysis Methods
2. Clinical Trials and Clinical Trial Services: An Introduction
2.1 A Brief History of Clinical Trials
2.1.1 The Nuremburg Code and the Declaration of Helsinki
2.1.2 Council for International Organizations of Medical Sciences (CIOMS)
2.1.3 Good Clinical Practice
2.2 Phases of Clinical Trials
2.2.1 Phase I Trials: First-in-Human Studies
2.2.2 Efficacy Analysis in Phase II Trials
2.2.3 Phase III Trials
2.2.4 Phase IV Trials: Post-Marketing Surveillance
2.3 Key Elements of Clinical Trial Design
2.4 Clinical Research Outsourcing
3. The Pharmaceutical Clinical Trial Services Market 2011-2021
3.1 The Pharmaceutical Clinical Trial Services Market in 2010
3.1.1 Market Value by Sponsor Type 2010
3.1.2 A New Pharma R&D Model?
3.1.2.1 Advantages in Outsourcing to CROs
3.2 Pharma Clinical Trial Services Market Forecast 2011-2021
3.2.1 Slow Market Growth 2010-2011
3.2.2 Clinical Trial Services Market 2010-2016
3.2.3 Clinical Trial Services Market 2017-2021
3.3 Early Stage Services Market 2011-2021
3.4 Late Stage Services Market 2011-2021
4. Key Therapeutic Areas in the Clinical Trial Services Market 2011-2021
4.1 Selected Niche CROs Operating in the Market 2011
4.1.1 Specialist Oncology CROs
4.1.1.1 Medelis
4.1.1.2 Nexus Oncology: Experience in Over 350 Trials
4.1.1.3 Theradex: Partner to the National Cancer Institute
4.1.2 Selected CNS CROs
4.1.2.1 Cogtest: Data Capture and Cognitive Assessment
4.1.2.2 Comprehensive NeuroScience (CNS)
4.1.2.3 Neuroimage: CNS Imaging Specialist
4.1.3 Niche Infectious Disease CROs
4.1.3.1 TransPharm Preclinical Solutions
4.1.4 Cardiovascular and Metabolic Disease Specialist Service Providers
4.1.4.1 Global Research Services
4.1.4.2 Integrium
4.1.4.3 Java Clinical Research
4.2 Oncology Clinical Trial Services: Market Trends 2011-2021
4.2.1 Cancer Biomarkers in Diagnosis, Treatment and Clinical Trials
4.2.2 Patient Recruitment and Cancer Clinical Trials
4.3 CNS Clinical Trial Services: Market Trends 2011-2021
4.3.1 Improving CNS Trial Design
4.3.2 Neuroimaging in CNS Drug Development
4.4 Infectious Disease Clinical Trials Services: Market Trends 2011-2021
4.4.1 Infectious Diseases and Seasonality
4.4.2 Non-Inferiority Clinical Trials
4.5 Cardiovascular Disease Clinical Trials Services: Market Trends 2011-2021
4.5.1 Cardiovascular Diseases and Imaging
4.6 Metabolic Disease Clinical Trial Services: Market Trends 2011-2021
4.6.1 Avandia (Rosiglitazone) and Cardiovascular Safety in Diabetes
5. Market-Leading CROs 2011-2021
5.1 Quintiles: The World's Leading CRO
5.1.1 Quintile's Risk Sharing and Strategic Alliances
5.1.2 Theranostics, Biomarkers and Quintile's Other Future Strategies
5.2 Covance
5.2.1 Revenue Analysis 2008-2010
5.2.2 Refocusing Early-Stage Efforts
5.2.3 Strategic Alliance Experience
5.3 PPD
5.3.1 Revenue Analysis 2009-2010
5.3.2 Strategic Alliances
5.3.3 Expansion in Asia
5.3.4 PPD's Other Growth Targets
5.4 Charles River Laboratories
5.4.1 Revenue Analysis 2006-2010
5.4.2 Early Stage Restructuring
5.4.3 Expanding Model Distribution
5.5 Parexel International
5.5.1 Revenue Analysis 2009-2010
5.5.2 Recent Developments and Future Directions
5.6 ICON
5.6.1 Revenue Analysis 2008-2010
5.6.2 ICON in China
5.6.3 ICON and Proteome Sciences: Increased Biomarker Services
5.7 Kendle
5.7.1 Revenue Analysis 2009-2010
5.7.2 Asian Expansion and Other Recent Developments
5.8 WuXi PharmaTech
5.8.1 Revenue Analysis 2006-2010
5.8.2 WuXi's Strategic Partnerships and Other Recent Developments
5.8.3 Failed Acquisition by Charles River Laboratories
5.9 CMIC
5.9.1 Revenue Analysis 2009-2010
5.9.2 CMIC in China
5.10 INC Research
5.10.1 INC's Global Expansion
5.10.2 INC Acquires Kendle
5.11 PRA International
5.11.1 PRA in the CEE, the Middle East and Latin America
5.12 Chiltern International
5.12.1 Chiltern Expands into Brazil and Asia
5.13 InVentiv Health: From Medium to Large CRO in Two Acquisitions
5.13.1 InVentiv Acquires i3 Research
5.13.2 InVentiv Acquires PharmaNet Development Group
5.14 ReSearch Pharmaceutical Services
5.14.1 Private Equity Investment in the CRO Market
5.15 Omnicare Clinical Research
5.16 Clinipace Worldwide
5.17 Veeda Clinical Research
5.18 Aptiv Solutions
6. Pharmaceutical Clinical Trial Services Market: Trends 2011-2021
6.1 SWOT Analysis of the Market 2011-2021
6.1.1 New Trial Demands and Designs
6.1.1.1 Slow but Rising Use of Adaptive Trial Designs
6.1.1.2 Comparative Effectiveness Research
6.1.2 Increased Demand for Biosimilars
6.1.2.1 The Patient Protection and Affordable Care Act 2010
6.1.2.2 Biosimilars and CROs
6.1.3 Increased CRO Consolidation and Niche CROs
6.1.4 Clinical Trial Globalisation
6.2 STEP Analysis of the Market 2011-2021
6.2.1 Social Factors
6.2.1.1 Patient Recruitment and Retention
6.2.1.2 Ethical Concerns in Off-Shoring Clinical Trials
6.2.2 Technological Developments
6.2.2.1 Biomarkers as a Tool for Drug Development
6.2.2.2 Electronic Data Capture, Storage and Sharing
6.2.3 Economic Pressures
6.2.3.1 Cutting Back Pharma R&D
6.2.3.2 The Growth in Strategic Partnering
6.2.4 Political Issues
6.2.4.1 Increasing Pharmacovigilance Demands
6.2.4.2 Clearer Clinical Trial Regulatory Procedures
7. Pharmaceutical Clinical Trial Services: Leading National Markets 2011-2021
7.1 Regional Market Breakdown, 2010
7.2 The US Market 2011-2021
7.3 Leading Western European Markets
7.3.1 Trial Costs Are High in Germany
7.3.2 The UK
7.3.3 France: Fast Trial Approvals
7.3.4 Italy
7.3.5 Spain
7.4 Japan: The Drug Lag and CROs
7.4.1 The Japanese Market 2011-2021
7.5 BRIC Nations and Other Emerging Markets 2011-2021
7.5.1 The Brazilian Market 2011-2021
7.5.2 The Russian Market 2011-2021
7.5.3 India
7.5.3.1 The Indian Market 2011-2021
7.5.4 China
7.5.4.1 Novartis Bucks the Trend in Chinese R&D
7.5.4.2 Benefits and Challenges to Conducting Trials in China
7.5.4.3 The Chinese Market 2011-2021
7.5.5 CEE as an Alternative to Western Europe
7.6 Changing Regional Market Shares 2011-2021
8. Opinions from Our Research Interviews
8.1 Dr Jörg Täubel, Co-Founder and Managing Director, Richmond Pharmacology
8.1.1 Richmond Pharmacology
8.1.2 The Challenge of Patient Recruitment
8.1.3 The Advantages of Niche CROs
8.1.4 Increased Use of Bridging Studies
8.1.5 Technological Advances in Early Phase Clinical Trials
8.2 Dr Amir Kalali, Vice President, Medical and Scientific Services and Global Therapeutic Group Leader, CNS at Quintiles
8.2.1 Challenges in Neuroimaging Biomarkers
8.2.2 Placebo Problems in CNS Clinical Trials
8.2.3 CROs and CNS Clinical Trials
8.2.4 The Myth Surrounding Failure Rate in CNS R&D
8.2.5 Big Pharma and CNS R&D
8.2.6 Clinical Trial Globalisation
8.2.7 Challenges in CNS Clinical Trials
8.3 Dr Fabio Thiers, Director, Global Clinical Trials Research Program, MIT
8.3.1 The Future of Clinical Trial Outsourcing
8.3.2 Outsourcing Opportunities by Phase of Development
8.3.3 Outsourcing Opportunities by Therapeutic Area
8.3.4 CRO Market Consolidation
9. Conclusions
9.1 There Will Be Greater Demand for Clinical Trial Outsourcing
9.2 Off-Shoring Clinical Trials Will Become Increasingly Popular
9.3 Oncology and CNS: Key Indications for Research
9.4 The Drive Towards Faster and More-Proactive Clinical Trials
9.5 Strategic Partnering as a Business Model for the CRO Industry
9.5.1 Niche CROs Will Survive
List of Tables
Table 1.1 Currency Exchange Rates, 2010
Table 2.1 Members of the ICH, 2011
Table 3.1 Pharmaceutical Clinical Trial Services: Market by Sector, 2010
Table 3.2 Pharmaceutical Clinical Trial Services: Market by Sponsor, 2010
Table 3.3 Strategic Partnerships: CRO-Sponsor, 2007-2010
Table 3.4 Pharmaceutical Clinical Trial Services: Market Drivers and Restraints, 2011-2021
Table 3.5 Pharmaceutical Clinical Trial Services: World Market Forecast, 2010-2021
Table 4.1 Clinical Trials by Indication and Phase, 2011
Table 4.2 Pharmaceutical Clinical Trial Services: Market by Indication, 2010
Table 4.3 CNS Specialist CROs Not Discussed in This Report, 2011
Table 4.4 Oncology Clinical Trials: Opportunities and Threats, 2011-2021
Table 4.5 Indexed Clinical Trial Costs by Therapeutic Area, 2011
Table 4.6 Infectious Disease Clinical Trials: Opportunities and Threats, 2011-2021
Table 4.7 Cardiovascular Disease Clinical Trials: Opportunities and Threats, 2011-2021
Table 5.1 Staff and Number of Countries Served by Leading CROs, 2011
Table 5.2 Pharmaceutical Clinical Trial Services: Market by Company, 2010
Table 5.3 Backlog for Leading CROs, 2009-2010
Table 5.4 Selected PI3K Inhibitors Under Investigation, 2011
Table 5.5 Covance: Revenue by Segment, 2009-2010
Table 5.6 Covance: Revenue by Service, 2008-2010
Table 5.7 PPD: Revenue by Sector, 2009-2010
Table 5.8 PPD: Revenue by Client, 2009-2010
Table 5.9 Leading Monoclonal Antibody Sales, 2010
Table 5.10 Charles River Laboratories: Revenue by Business Segment, 2009-2010
Table 5.11 Charles River Laboratories: Revenue, 2006-2010
Table 5.12 Parexel: Revenue by Business Segment, 2009-2010
Table 5.13 Parexel: Revenue by Region, 2010
Table 5.14 ICON: Revenue by Business Segment, 2008-2010
Table 5.15 ICON: Revenue by Region, 2008-2010
Table 5.16 Kendle: Gross and Net Revenue, 2009-2010
Table 5.17 Kendle: Net Revenue by Region, 2009-2010
Table 5.18 WuXi PharmaTech: Revenue, 2006-2010
Table 5.19 CMIC: CRO Revenue and Operating Income, 2009-2010
Table 5.20 Chiltern International: Clinical Trials by Therapeutic Area, 2011
Table 5.21 InVentiv Health: Revenue, 2007-2009
Table 5.22 Clinipace Worldwide: Clinical Trials by Therapeutic Area, 2011
Table 6.1 SWOT Analysis of the Pharmaceutical Clinical Trial Services Market, 2011-2021
Table 6.2 Selected CRO M&A Activity, 2009-2011
Table 6.3 NIH Biomarker Definitions, 2011
Table 6.4 CRO Top Five Customer Revenue Shares, 2010
Table 7.1 Pharmaceutical Clinical Trial Services: Market by Region, 2010
Table 7.2 Global Clinical Trials by Phase and Region, 2010
Table 7.3 National Clinical Trial Cost Index, 2011
Table 7.4 US Pharmaceutical Clinical Trial Services: Market Drivers and Restraints, 2011-2021
Table 7.5 Pharmaceutical Clinical Trial Services: Market Forecast by Region, 2010-2021
Table 7.6 Western European Pharmaceutical Clinical Trial Services: Market by Country, 2010
Table 7.7 Western European Clinical Trials by Phase and Country, 2010
Table 7.8 Western European Pharmaceutical Clinical Trial Services: Market Drivers and Restraints, 2011-2021
Table 7.9 Western European Pharmaceutical Clinical Trial Services: Market Forecast, 2010-2021
Table 7.10 Standard and Priority Review Times in Developed Markets, 2011
Table 7.11 Japanese Pharmaceutical Clinical Trial Services: Market Drivers and Restraints, 2011-2021
Table 7.12 Brazilian Pharmaceutical Clinical Trial Services: Market Drivers and Restraints, 2011-2021
Table 7.13 Russian Pharmaceutical Clinical Trial Services: Market Drivers and Restraints, 2011-2021
Table 7.14 Indian Pharmaceutical Clinical Trial Services: Market Drivers and Restraints, 2011-2021
Table 7.15 Chinese Pharmaceutical Clinical Trial Services: Market Drivers and Restraints, 2011-2021
Table 7.16 EU Membership Status of CEE Countries, 2010
Table 9.1 Pharmaceutical Clinical Trial Services: Market by Sector, 2010, 2016 and 2021
Table 9.2 Pharmaceutical Clinical Trial Services: Market by Region, 2010, 2016 and 2021
List of Figures
Figure 2.1 A Brief History of Clinical Trials, 1940-2011
Figure 2.2 The Drug Development Process, 2011
Figure 3.1 Pharmaceutical Clinical Trial Services: Market by Sector, 2010
Figure 3.2 Pharmaceutical Clinical Trial Services: Market by Sponsor, 2010
Figure 3.3 Pharmaceutical Clinical Trial Services: World Market Forecast, 2010-2021
Figure 3.4 Early Stage Services: World Market Forecast, 2010-2021
Figure 3.5 Pharmaceutical Clinical Trial Services: World Market, 2010, 2016 and 2021
Figure 3.6 Late Stage Services: World Market Forecast, 2010-2021
Figure 4.1 Clinical Trials by Indication and Phase, 2010
Figure 4.2 Pharmaceutical Clinical Trial Services: Market by Indication, 2010
Figure 4.3 Indexed Clinical Trial Costs by Therapeutic Area, 2011
Figure 4.4 Delayed-Start Trial Design, 2011
Figure 4.5 Non-Inferiority Trials and Biocreep: A Worst Case Scenario
Figure 4.6 Avandia Approval and Withdrawal Timeline, 1999-2011
Figure 5.1 Staff and Number of Countries Served by Leading CROs, 2011
Figure 5.2 Pharmaceutical Clinical Trial Services: Market by Company, 2010
Figure 5.3 Backlog for Leading CROs, 2009-2010
Figure 5.4 Covance: Revenue by Segment, 2009-2010
Figure 5.5 Covance: Revenue by Service, 2008-2010
Figure 5.6 PPD: Revenue by Sector, 2010
Figure 5.7 PPD: Revenue by Client, 2010
Figure 5.8 Charles River Laboratories: Revenue by Business Segment, 2010
Figure 5.9 Charles River Laboratories: Revenue, 2006-2010
Figure 5.10 Parexel: Revenue by Business Segment, 2009-2010
Figure 5.11 Parexel: Revenue by Region, 2010
Figure 5.12 ICON: Revenue by Business Segment, 2010
Figure 5.13 ICON: Revenue by Region, 2008-2010
Figure 5.14 Kendle: Net Revenue, 2009-2010
Figure 5.15 Kendle: Net Revenue by Region, 2010
Figure 5.16 WuXi PharmaTech: Revenue, 2006-2010
Figure 5.17 CMIC: CRO Revenue and Operating Income, 2009-2010
Figure 5.18 Chiltern International: Clinical Trials by Therapeutic Area, 2011
Figure 5.19 InVentiv Health: Revenue, 2007-2009
Figure 5.20 Clinipace Worldwide: Clinical Trials by Therapeutic Area, 2011
Figure 6.1 Some Pharma Company R&D Site Closures, 2009-2010
Figure 6.2 CRO Top Five Customer Revenue Shares, 2010
Figure 7.1 Pharmaceutical Clinical Trial Services: Market by Region, 2010
Figure 7.2 Global Clinical Trials by Phase and Region, 2010
Figure 7.3 US Pharmaceutical Clinical Trial Services: Market Forecast, 2010-2021
Figure 7.4 Western European Pharmaceutical Clinical Trial Services: Market by Country, 2010
Figure 7.5 Western European Clinical Trials by Phase and Country, 2010
Figure 7.6 Western European Pharmaceutical Clinical Trial Services: Market Forecast, 2010-2021
Figure 7.7 German Pharmaceutical Clinical Trial Services: Market Forecast, 2010-2021
Figure 7.8 UK Pharmaceutical Clinical Trial Services: Market Forecast, 2010-2021
Figure 7.9 French Pharmaceutical Clinical Trial Services: Market Forecast, 2010-2021
Figure 7.10 Italian Pharmaceutical Clinical Trial Services: Market Forecast, 2010-2021
Figure 7.11 Spanish Pharmaceutical Clinical Trial Services: Market Forecast, 2010-2021
Figure 7.12 Japanese Pharmaceutical Clinical Trial Services: Market Forecast, 2010-2021
Figure 7.13 Brazilian Pharmaceutical Clinical Trial Services: Market Forecast, 2010-2021
Figure 7.14 Russian Pharmaceutical Clinical Trial Services: Market Forecast, 2010-2021
Figure 7.15 Indian Pharmaceutical Clinical Trial Services: Market Forecast, 2010-2021
Figure 7.16 Chinese Pharmaceutical Clinical Trial Services: Market Forecast, 2010-2021
Figure 7.17 Regional Breakdown of the Pharmaceutical Clinical Trial Services Market, 2016
Figure 7.18 Regional Breakdown of the Pharmaceutical Clinical Trial Services Market, 2021
Figure 9.1 Pharmaceutical Clinical Trial Services: Market by Region, 2010, 2016 and 2021