Clinical Trials: World Market 2009-2024

Content

• 1 Executive Summary
  • 1.1 This Report Provides Crucial, Hard-to-Find Clinical Trials Data
  • 1.2 Summary Points of This Report
  • 1.3 Aims, Scope and Format of This Report
    • 1.3.1 Market Growth or Rising Costs?
    • 1.3.2 Chapter Outline
  • 1.4 Research Methods
• 2 Introduction
  • 2.1 Costs of Clinical Trials
  • 2.2 A Brief History of Clinical Trials
    • 2.2.1 The Nuremberg Code
    • 2.2.2 The Declaration of Helsinki
    • 2.2.3 Council for International Organizations of Medical Sciences(CIOMS)
    • 2.2.4 Establishing International Standards for Good Clinical Practice
    • 2.2.5 The FDA's New Rules for Acceptable Foreign Clinical Studies
  • 2.3 Pre-Clinical Drug Studies
    • 2.3.1 Animal Models
    • 2.3.2 The FDA's Phase 0
  • 2.4 Standard Clinical Phases: Phase I-III Trials
    • 2.4.1 Phase I Trials
    • 2.4.2 Phase II Trials
    • 2.4.3 Phase III Trials
    • 2.4.4 Phase IV Trials: Post-Marketing Surveillance
  • 2.5 Basic Principles in Clinical Trials Design
    • 2.5.1 The Placebo Effect
    • 2.5.2 Inclusion Criteria and Exclusion Criteria
    • 2.5.3 Randomisation of Subjects
    • 2.5.4 Blinded Trials
    • 2.5.5 Endpoints
  • 2.6 Adaptive Clinical Trial Designs
    • 2.6.1 Adaptive Trials and Staging
    • 2.6.2 Adaptive Trials and Blending Phases
    • 2.6.3 Adaptive Trials, the FDA and the EMEA
    • 2.6.4 Academia Setting the Standard?
  • 2.7 Clinical Trials and Genetic Tests
    • 2.7.1 Genetics and Micro-Arrays
    • 2.7.2 Toxicity Libraries
  • 2.8 Clinical Data Management Systems
    • 2.8.1 Clinical Trials Data Management Systems: Electronic Data Capture
    • 2.8.2 Hurdles Faced by Investigators in Implementing EDC
    • 2.8.3 Clinical Data Interchange Standards Consortium
• 3 Clinical Trials Market
  • 3.1 World Market for Clinical Trials
  • 3.2 Changing Market Share Percentages
  • 3.3 US and Canada: Growing in Revenues but Losing Market Share by 2024
    • 3.3.1 North America Market Share Through to 2024
  • 3.4 Western Europe Revenue Trends
    • 3.4.1 Western Europe Market Share Through to 2024
  • 3.5 Central and Eastern Europe (CEE) and Russia Revenue Trends
    • 3.5.1 CEE and Russia Market Share Rising Significantly Through to 2019
    • 3.5.2 Russia
  • 3.6 India: The Fastest-Growing Outsourcing Destination?
    • 3.6.1 India's Market Share Growing Rapidly
  • 3.7 China: Promising but Challenging Market
    • 3.7.1 China's Market Share Growing Through to 2024
• 4 The Trend Towards Outsourcing and Off-Shoring
  • 4.1 More International Investigation Sites Registering for FDA Approval
  • 4.2 How Countries Invite More Trials
  • 4.3 How Foreign Clinical Trials Help Host Countries
  • 4.4 Ongoing Challenges for Emerging Outsourcing Markets
  • 4.5 Questions about Genetic / Ethnic Differences and Relevance
    • 4.5.1 New Discoveries Possible Through International Trials and Genetic
      • Variation
  • 4.6 Questions About Ethics in Outsourced Trials
  • 4.7 Institute of Clinical Research (India)
    • 4.7.1 Institute of Clinical Research (India) (ICRI): Assuring Ethics
    • 4.7.2 Pfizer's Ethics Accreditation
  • 4.8 India as Case-Study
    • 4.8.1 Benefits and Concerns of India as an Outsource Location
    • 4.8.2 India Needs More Research Personnel
    • 4.8.3 Short- and Long-Term Personnel Goals
  • 4.9 Interview with Dr Arun Bhatt, President, Clininvent Research
    • 4.9.1 Dr Bhatt on the Benefits and Complexities of Clinical Trials in
      • India
    • 4.9.2 Tested Drugs Marketed in India?
    • 4.9.3 Marketing and the Need for Harmonisation
• 5 Contract / Clinical Research Organisations (CROs)
  • 5.1 CROs Gaining Market Share Through to 2024
  • 5.2 Value of CROs Rising Threefold by 2024
  • 5.3 Year-Over-Year Growth Percentages for CROs: Average over 16%
  • 5.4 Quintiles
    • 5.4.1 Quintiles Highest-Rated in Industry Standards Research Survey
    • 5.4.2 Quintiles Opening Phase I Facility in India
    • 5.4.3 Quintiles and SAS: New Certification
  • 5.5 Pharmaceutical Product Development, Inc. (PPD)
  • 5.6 Covance
    • 5.6.1 Covance and Eli Lilly
  • 5.7 Pharsight Corporation: Crucial Software and Modelling Techniques
    • 5.7.1 Fiscal Year 2009, Quarter 1: Financial Results Up from 2008
    • 5.7.2 Pharsight's Products Used by the FDA
    • 5.7.3 Pharsight in China: Agreement with InforSense
  • 5.8 Amarex
  • 5.9 Kendle
    • 5.9.1 Kendle and DecisionLine
  • 5.10 MDS Pharma Services
    • 5.10.1 MDS Pharma Expanding in Taiwan
    • 5.10.2 MDS and Compendia Biosciences, Inc.: Facilitating Cancer
      • Therapies
  • 5.11 Clininvent / TCG Lifesciences
  • 5.12 Parexel
  • 5.13 PharmaNet Development Group (formerly SFBC International Inc.)
    • 5.13.1 PharmaNet Purchased by JLL Partners in February 2009
  • 5.14 ReSearch Pharmaceutical Services (RPS)
    • 5.14.1 RPS Acquires 4 CROs in 4 Months
  • 5.15 ICON Plc
    • 5.15.1 ICON Partners with Eli Lilly
    • 5.15.2 ICON Acquires New Phase I Facility
  • 5.16 PRA International
  • 5.17 Omnicare Clinical Research
  • 5.18 The Clinical Trial Company (TCTC)
  • 5.19 Chiltern International, Ltd.
    • 5.19.1 Chiltern Acquires Vigiun
  • 5.20 Averion International Corp.
    • 5.20.1 Averion Doubled Workforce by Acquiring Hesperion
  • 5.21 Veeda Clinical Research
  • 5.22 Synexus
• 6 Interviews with Experts
  • 6.1 Interview with Dr Nathaniel Katz, MD., MS., Founder of Analgesic
    • Research (Interview conducted 18 June 2009)
    • 6.1.1 On the Emphasis on Biomarkers
    • 6.1.2 On the Inadequacies of Some Objective Endpoints
    • 6.1.3 On the Need for Root-Cause Analysis of Clinical Trials
      • Inefficiencies
    • 6.1.4 On Reducing Sample Size
    • 6.1.5 On Sample Size and Reliable Measures
    • 6.1.6 On Measures of Reporting: Reliability and Validity
    • 6.1.7 On Improving Efficiency by Improving Research Methods Themselves
    • 6.1.8 On the Fundamental Problems of Current Patient Recruiting
      • Paradigms
    • 6.1.9 On the New Recruitment Paradigm: Engaging Patients and Pre-Trial
      • Recruitment
    • 6.1.10 On Assessing Patient Motivations
    • 6.1.11 On Proof-of-Concept Studies as Major Efficiency Bottlenecks
    • 6.1.12 On Adaptive Trials and Combining Phases
    • 6.1.13 On Experimental Models and Their Limitations
    • 6.1.14 On the Over-Emphasis on Technology
    • 6.1.15 On the Need for Pharmaceutical Companies to Invest in New
      • Recruitment Paradigms
    • 6.1.16 On Using Patients Efficiently and as Experts
    • 6.1.17 On the Benefits of Early-Stage Focus Groups for Later-Stage
      • Trials, for Development and for Marketing
  • 6.2 Interview with Dr Kevin Dykstra, PhD. Senior Vice President,
    • Worldwide Strategic Consulting Services for Pharsight (Interview
    • Conducted 9 June 2009)
    • 6.2.1 On the Promises and Problems of Adaptive Trials
    • 6.2.2 On the Limits of Trials Adaptation
    • 6.2.3 On The Selection of Efficacy Endpoints
    • 6.2.4 On Signal Discovery Times and Biomarkers
    • 6.2.5 On Trial Adjustments and Endpoints
    • 6.2.6 On Pharsight's "Clinical Utility" Approach to Development
      • Strategies
    • 6.2.7 On Software Innovations and Trials Efficiency
    • 6.2.8 On Phased Development Becoming or Not Becoming Obsolete
    • 6.2.9 On Combining Phase II and III Trials
    • 6.2.10 On the Future and Usefulness of Placebo Models and Datasharing
    • 6.2.11 On Databases of Drugs' Mechanisms
• 7 SWOT Analysis of the Global Clinical Trials Market
  • 7.1 Overall Strengths and Weaknesses in 2009
  • 7.2 Overall Opportunities and Threats Through to 2024
    • 7.2.1 The Impact of Thin Pipelines
    • 7.2.2 Outsourcing Drug Discovery
    • 7.2.3 The Impact of Specialised Medicines
    • 7.2.4 The Decline of the Blockbuster Model
  • 7.3 Different Perspectives on Costs / Threats: Pharmaceutical Companies
    • and CROs
    • 7.3.1 Increasing Competition: Potential Threat to CROs
  • 7.4 Different Perspectives on Benefits / Gains: Pharmaceutical Companies
    • and CROs
• 8 Conclusions
  • 8.1 The Demand for Late- versus Early-Stage Trials
  • 8.2 The Growth of CROs
    • 8.2.1 Increasing Competition Among CROs
    • 8.2.2 Increased Regional Competition
  • 8.3 The Short-Term Future
  • 8.4 The Long-Term Future
• List of Tables
  • Table 2.1 Key Stages in the History of Clinical Trials
  • Table 3.1 Total Market Forecasts ($m), 2009-2024, Showing Regiona Forecasts
  • Table 3.2 US and Canada Market Forecast ($m), 2009-2024
  • Table 3.3 Costs and Benefits of Conducting Clinical Trials in North America
  • Table 3.4 Western Europe Market Forecast ($m), 2009-2024
  • Table 3.5 Costs and Benefits of Conducting Clinical Trials in CEE Countries
  • Table 3.6 CEE and Russia Market Forecast ($m), 2009-2024
  • Table 3.7 India Market Forecast ($m), 2009-2024
  • Table 3.8 China Market Forecast ($m), 2009-2024
  • Table 3.9 Costs and Benefits of Conducting Clinical Trials in China
  • Table 4.1 Some Countries Actively Funding Drug Development Infrastructure
  • Table 4.2 Benefits and Challenges to Outsource Host Countries
  • Table 4.3 Benefits and Concerns with Running Clinical Trials in India
  • Table 5.1 CROs and Direct Industry Funding Market Forecast ($bn),2009-2024
  • Table 5.2 Year-Over-Year Growth (%) for Selected CROs, 2007-2008
  • Table 7.1 Strengths and Weaknesses in Clinical Trials Market, 2009
  • Table 7.2 Opportunities and Threats for the Future Clinical Trials Market, 2009-2024
  • Table 7.3 Pharmaceutical Companies' and CROs' Perspectives on Costs and Threats
  • Table 7.4 Pharmaceutical Companies' and CROs' Perspectives on Benefits and Gains
  • Table 8.1 Trials Breakdown Forecast in 5-Year Increments (by Phase), 2009-2024
• List of Figures
  • Figure 2.1 Drug Development Progression
  • Figure 3.1 Market Forecast ($bn) for Top 3 Regions, 2009-2024
  • Figure 3.2 Market Forecast ($m) for Lower 3 Regions, 2009-2024
  • Figure 3.3 Regional Market Share (%) 2009
  • Figure 3.4 Regional Market Share (%) 2014
  • Figure 3.5 Regional Market Share (%) 2019
  • Figure 3.6 Regional Market Share (%) 2024
  • Figure 3.7 US and Canada Market Forecast ($bn), 2009-2024
  • Figure 3.8 US and Canada Market Share Forecast (%), 2009-2024
  • Figure 3.9 Western Europe Market Forecast ($bn), 2009-2024
  • Figure 3.10 Western Europe Market Share Forecast (%), 2009-2024
  • Figure 3.11 CEE and Russia Market Forecast ($bn), 2009-2024
  • Figure 3.12 CEE and Russia Market Share Forecast (%), 2009-2024
  • Figure 3.13 India Market Forecast ($m), 2009-2024
  • Figure 3.14 India Market Share Forecast (%), 2009-2024
  • Figure 3.15 China Market Forecast ($m), 2009-2024
  • Figure 3.16 China Market Share Forecast (%), 2009-2024
  • Figure 5.1 CROs Market Share Forecast (%), 2009-2024
  • Figure 5.2 CROs Value Forecast ($bn), 2009-2024
  • Figure 5.3 Year-Over-Year Growth (%) for Selected CROs, 2007-2008
• Companies Listed
  • Amarex
  • Anapharm Clinics
  • Anapharm Europe
  • Anapharm Laboratories
  • Apollo Hospitals Group
  • Association for the Accreditation of Human Research Protection Programs
  • (AAHRPP)
  • AstraZeneca
  • Averion International Corp.
  • Cenduit
  • Center for Drug Evaluation and Research (subsidiary of the FDA)
  • Certara
  • Chembiotek
  • Chiltern International Limited
  • Clinical Data Interchange Standards Consortium (CDISC)
  • Clininvent
  • Committee for Medicinal Products for Human Use (CHMP)
  • Compendia Bioscience, Inc.
  • Council for International Organizations of Medical Sciences (CIOMS)
  • Covance
  • DecisionLine Clinical Research Corporation
  • Eli Lilly
  • European Commission
  • European Medicines Agency (EMEA)
  • Food and Drug Administration (FDA)
  • Genentech
  • Genstar Capital, LLC
  • Genzyme
  • GlaxoSmithKline
  • Hesperion
  • ICON PLC
  • Industry Standards Research (ISR)
  • Infociencia S.L.
  • InforSense Ltd.
  • Institute for Medical Research Management and Biometrics (IMEREM)
  • Institute of Clinical Research (India) (ICRI)
  • International Conference on Harmonisation (ICH)
  • JLL Partners
  • Johnson & Johnson
  • Kendle
  • LabVantage
  • MDS Inc.
  • MDS Pharma
  • Myriad
  • National Institutes of Health (NIH)
  • Novartis
  • Novo Nordisk
  • Omnicare Clinical Research
  • Omnicare Inc.
  • Paramax International (Beijing) Inc.
  • Parexel
  • Pfizer
  • Pharmaceutical Product Development, Inc. (PPD)
  • PharmaNet Development Group
  • Pharmstandard (Russia)
  • Pharsight Corporation
  • Qualia Clinical Services, Inc.
  • Quintiles
  • ReSearch Pharmaceutical Services (RPS)
  • SAS Institute Inc.
  • Servier
  • SFBC International, Inc.
  • Standard & Poor's
  • Synexus
  • Takeda
  • Taylor Technology
  • TCG Lifesciences (TCGLS)
  • The Clinical Trial Company (TCTC)
  • The Clinical Trials Company Group
  • Therapharm Recherches
  • Thermo Fisher Scientific
  • Tripos International
  • Tufts Center for the Study of Drug Development (Tufts CSDD)
  • United Nations Educational, Scientific and Cultural Organization
  • (UNESCO)
  • Veeda Clinical Research
  • Vigiun
  • World Health Organization (WHO)
  • World Medical Assembly