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The Clinical Trials Market 2006

Table of Contents

Chapter 1: Executive Summary

• 1.1 Aims and Scope of The Clinical Trials Market 2006 Report   

Chapter 2: Introduction

• 2.1 Brief History of Clinical Trials
  • 2.1.1 The Nuremberg Code and The Declaration of Helsinki
  • 2.1.2 Establishing Standards for Good Clinical Practice and the International Conference on Harmonisation   
• 2.2 Different Stages of Clinical Trials
  • 2.2.1 Phase I Trials
  • 2.2.2 Phase II Trials
  • 2.2.3 Phase III Trials
  • 2.2.4 Phase IV Trials (post-marketing surveillance)
  • 2.2.5 Further Division of Trials
• 2.3 Basics Principles in the Design of Clinical Trials
  • 2.3.1 The Placebo Effect
  • 2.3.2 Inclusion Criteria and Exclusion Criteria
  • 2.3.3 Randomisation of Subjects and Blinded Trials
  • 2.3.4 Endpoints
• 2.4 The World Branded Pharmaceutical Market
  • 2.4.1 Summary of the Global Pharmaceutical Market    
  • 2.4.2 Leading Branded Drugs and Pharmaceutical Companies   
• 2.5  The Branded Pharmaceutical Industry Will Struggle to Maintain Considerable Growth

Chapter 3: Outsourcing Clinical Trials to Developing Countries

3.1 A SWOT Analysis of Outsourcing Clinical Trials

• 3.2 Many Factors are Considered When Deciding Clinical Trial Location but Quality of Data Should Be Paramount    
• 3.3 India as a Model for Rapid Growth in the Clinical Trials Industry
  • 3.3.1 Expanding Pharmaceutical Investment in India is Led by Clinical Trials   
  • 3.3.2 Changes to the Law Have Caused Rapid Growth of Clinical Research    
  • 3.3.3 Rapid Recruitment is Driven by a Large Willing Patient Population and an Organised Healthcare System 3.3.4 Ethical Considerations
  • 3.3.5 What is India Doing to Promote Clinical Research?    
  • 3.3.6 Forecast: What is the Future of Indian Clinical Research?   
• 3.4 China Faces Real Challenges to Establish Itself in the Clinical Trials Market  
  • 3.4.1 China's Large Treatment-Naïve Population is Attracting Investment but Healthcare Infrastructure Needs to be Improved       
  • 3.4.2 Rapid Growth of the Pharmaceutical Market Will Drive Clinical Research in China   
  • 3.4.3 Enforcement of Intellectual Property Law is the Most Pressing Issue for China 
  • 3.4.4 Lack of Clinical Trial Standardisation Will Also Inhibit Growth   
  • 3.4.5  It Will Take Time for China to Fulfil its Potential
• 3.5  Central and Eastern Europe: Location and Quality Are Key Issues 

Chapter 4: How Regulatory Bodies Will Reform the Governance of Clinical Trials

• 4.1 The FDA - Gatekeepers to the Largest Pharmaceutical Market in the World 
  • 4.1.1 The FDA is Under Pressure to Tighten Up Drug Approval Procedures   
• 4.2 Europe: The European Medicines Agency (EMEA)   
  • 4.2.1 The EU Clinical Trials Directive
• 4.3 Japan Has a High Level of Regulation
  • 4.3.1 Re-examination and Re-evaluation - Concepts that Could Establish Themselves Globally
• 4.4 Safety and Speed are Now Pressing Issues for Regulatory Authorities  
• 4.5 The Use of Phase IV Clinical Trials is Set to Soar   
• 4.6 Phase IV Studies are Growing Due to Safety Concerns   
• 4.7 Self-Monitoring of Patients Will Become More Established
  • 4.7.1 The Yellow Card System is a Well Established Example of Post-approval Monitoring
• 4.8 Stringent Assessment of Risk will Require More Patients and Better Indicators of Risk
• 4.9 Education is a Key Issue
• 4.10 Summary: Changes in the Way Drugs are Regulated Will Change the Nature of Clinical Trials   

Chapter 5: Patient Recruitment

• 5.1 Patient Recruitment is Key to Cost and Quality
• 5.2 Patient Attitude to Trials Inhibits Recruitment
  • 5.2.1 Education and Communication Can Help Both Patient Recruitment and Retention  
  • 5.2.2 Advertising Must Provide Value for Money
  • 5.2.3 Safety Is Now a Major Issue for Recruitment
• 5.3 The Physician Also Has a Vital Role to Play in Patient Recruitment

Chapter 6: The Top Ten Global CROs

• 6.1 An Example of a Global CRO - Quintiles Reflects the Changes in the Clinical Trials Market  
  • 6.1.1 A Global Company is Required for Global Trials: Quintiles Fulfils that Role
  • 6.1.2 Sale of Business Units Indicates a Strong Emphasis on Late Phase Trials
• 6.2 Covance Successfully Combines Pre-Clinical Research with Late Phase Organisation
• 6.3 PPD: The Third-Largest CRO
• 6.4 MDS Pharma Services Expands Early-Phase Development   
• 6.5 PAREXEL Has Recovered From a Period of Low Growth  
• 6.6 SFBC International Will Continue to Have High Growth  
• 6.7 Icon's Growth Rates Have Stalled
• 6.8  PRA Has the Second-Lowest Growth Rates of all CROs in the Top Ten  
• 6.9 Kendle International Returns to Growth After Reorganisation Slump  
• 6.10  Omnicare Clinical Research
• 6.11  Summary: The Top Ten CROs Take 50% of the Global Clinical Trials Market

Chapter 7: Technological Advances and Clinical Trial Design

• 7.1 Electronic Data Capture (EDC)
  • 7.1.1 EDC Promises to Streamline Clinical Trials
  • 7.1.2 Training and Security are Barriers to EDC Conversion
  • 7.1.3 The Clinical Trials Industry Must Take the Initiative on EDC Standards  
• 7.2 Pharmacogenomics and Molecular Profiling
  • 7.2.1 Pharmacogenomics has the Potential to Revolutionise the Pharmaceutical Industry  
  • 7.2.2 The Progress of Pharmacogenomics Has Been Slow
  • 7.2.3 Identification of Expression Profiles in Pre-Clinical Models   
  • 7.2.4 Phase I and II Clinical Trials Will Incorporate More Complex Screening Techniques  

Chapter 8: Clinical Trials Market Forecast

• 8.1 Market Forecast 2005-2011
  • 8.1.1 The Global Clinical Trials Market Will Display Strong Growth   
  • 8.1.2 The US and Europe Will Lose Market Share to Asia
  • 8.1.3 Increased Costs and Numbers of Clinical Trials Will Drive the Market
• 8.2  Summary

Chapter 9: Conclusion: The Clinical Trials Market Will Experience Substantial Growth and Change

• 9.1 The Clinical Trials Market in Asia Will Expand - India and China Will Lead the Way  
• 9.2 Safety Concerns and Development Pressures Will Change the Structure of Clinical Trials   

List of Tables

Table 2.1, Key Stages in the History of Clinical Trials

Table 2.2, World Pharmaceutical Market ($bn), 2000-2004

Table 2.3, World Pharmaceutical Market ($bn) by Region, 2004   

Table 2.4, Top Ten Countries by Pharmaceutical Revenue, 2004   

Table 2.5, Top Ten Drugs by Revenue ($m), 2004

Table 2.6, Top Ten Pharmaceutical Companies by Revenue, 2004   

Table 2.7, Top Ten Drug Categories by Revenue ($m), 2004   

Table 2.8, Drugs in Development Pipeline by Therapeutic Area    

Table 3.1, SWOT Analysis of Outsourcing to Developing Countries, 2006  

Table 3.2, Estimated Cost ($m) of Clinical Trials in the US and India, 2006   

Table 3.3, Comparison of Disease Prevalence (m) in the US and India    

Table 3.4, Disease Prevalence (m) in China, 2006

Table 4.1, Drug Approvals Agencies Within the EU, 2006   

Table 5.1, Reasons Given for Non-Participation in Clinical Trials, 2006   

Table 6.1, Leading CROs by Total Revenue ($m), 2004-2005   

Table 6.2, Leading CROs by Clinical Trial Revenue Only ($m), 2004-2005  

Table 6.3, Growth of Covance Revenues ($m) for Early and Late Development, 2002-2005

Table 6.4, Revenues ($m) for PPD, 2002-2005

Table 6.5, Revenues ($m) for MDS Pharma, 2002-2005

Table 6.6, Revenues ($m) for PAREXEL, 2002-2005

Table 6.7, Revenues ($m) for SFBC International, 2002-2005   

Table 6.8, Revenues ($m) for Icon, 2002-2005

Table 6.9, Revenues ($m) for PRA, 2002-2005

Table 6.10, PRA Clinical Trial Revenues ($m) by Country, 2004

Table 6.11, Revenues ($m) for Kendle International, 2002-2005

Table 6.12, Kendle International Clinical Trial Revenues ($m) by Country, 2004

Table 6.13, Revenues ($m) for Omnicare CR, 2002-2005

Table 7.1, Assessment of EDC Solutions, 2006

Table 8.1, Clinical Trials Revenue ($m), 2004-2011

Table 8.2, Market Shares and CAGR for the Clinical Trials Market by Country/Region, 2004-2011

Table 9.1, The Clinical Trials Industry by Revenue ($m) and Country Region, 2011

List of Figures

Figure 3.1, Factors Affecting Clinical Trial Location

Figure 3.2, Clinical Trial Revenues ($m) in India, 2005-2011   

Figure 3.3, Clinical Trial Growth Rates (%) in India, 2005-2011   

Figure 3.4, Profile of the Chinese Pharmaceutical Market, 2000   

Figure 3.5, Profile of the Chinese Pharmaceutical Market, 2010   

Figure 5.1, Delay Observed in Clinical Trials, 2006

Figure 5.2, Clinical Trials Recruitment Spending ($m), 1998-2002   

Figure 5.3, Attitude of the Public to Volunteering for  Clinical Trials, 2005  

Figure 6.1, Global Top Ten CROs by Revenue ($m), 2005

Figure 6.2, Top Ten CROs by Market Share (%), 2005

Figure 6.3, Revenues ($m) from Quintiles Developmental Services Group, 2002-2005  

Figure 6.4, Growth Rate (%) for Quintiles Clinical Services Revenues, 2003-2005   

Figure 6.5,Revenues ($m) for Covance, 2002-2005

Figure 6.6, Revenues ($m) for PPD, 2002-2005

Figure 6.7, Clinical Service Revenues ($m) for MDS Pharma Services, 2002-2005  

Figure 6.8, Clinical Service Revenues ($m) for PAREXEL, 2002-2005   

Figure 6.9, Total Revenues ($m) SFBC International, 2002-2005   

Figure 6.10, Total Revenues ($m) Icon, 2002-2005

Figure 6.11, PRA Clinical Trials Revenues ($m), 2002-2005   

Figure 6.12, PRA Clinical Trial Revenues ($m) by Country, 2004   

Figure 6.13, Kendle International Clinical Trials Revenues ($m), 2002-2005   

Figure 6.14, Kendle International Clinical Trial Revenues ($m) by Country, 2004   

Figure 6.15, Omnicare CR Clinical Trials Revenues ($m), 2004-2005   

Figure 8.1, Total Clinical Trials Revenue ($m), 2004- 2011  

Figure 8.2, Clinical Trial Market Share (%) by Region, 2004   

Figure 8.3, Clinical Trial Market Share ($%) by Region, 2011   

Figure 8.4, Revenues ($m) of the Clinical Trials Industry by Region, 2004-2011   

Figure 8.5, Growth Rates (%) for the Clinical Trials Market by Region, 2005-2011   

Figure 8.6, Median Cost per Patient by Therapeutic Area (US), 2003  

Figure 8.7, Number of Clinical Trials Worldwide, 2000-2003

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