1. Executive Summary
1.1 Overview of Findings
1.2 Chapter Breakdown
1.3 Research Methods
1.4 Format of the Report
1.4.1 Market Growth or Rising Costs?
2. CNS Clinical Trials: An Introduction
2.1 Central Nervous System Disorders
2.1.1 The Central Nervous System (CNS)
2.1.2 Common CNS Disorders
2.1.3 Causes of CNS Disorders
2.1.4 The CNS Drug Market 2009
2.2 Clinical Trials
2.2.1 A Brief History of Clinical Trials
2.2.1.1 The Nuremburg Code and the Declaration of Helsinki
2.2.1.2 Council for International Organizations of Medical Sciences (CIOMS)
2.2.1.3 Good Clinical Practice
2.3 Phases of Clinical Trials
2.3.1 Phase I Trials
2.3.2 Phase II Trials
2.3.3 Phase III Trials
2.3.4 Phase IV Trials: Post-Marketing Surveillance
2.4 Clinical Research Outsourcing
3. Global CNS Clinical Trials Market 2010-2026
3.1 The Global CNS Clinical Trials Market in 2010
3.1.1 CNS Clinical Trials in 2010, by Phase
3.1.2 Value of the CNS Clinical Trials Market in 2010
3.2 Leading Sponsors of CNS Clinical Trials in 2010
3.2.1 GSK
3.2.2 Pfizer
3.2.3 Novartis
3.2.4 AstraZeneca
3.2.5 J&J
3.3 CNS Clinical Trials: Market Forecast 2011-2026
3.3.1 Significant Unmet Needs to Drive Growth
3.3.2 Increasing Emphasis on Late-Stage Trials
3.3.3 CNS Clinical Trials Market: 2011-2016
3.3.4 CNS Clinical Trials Market: 2016-2021
3.3.5 CNS Clinical Trials Market: 2021-2026
3.4 In-house vs. CROs
3.4.1 Clinical Research Outsourcing
3.4.2 CNS CRO Market to Grow from 2011
4. Leading National Market Forecasts 2011-2026
4.1 Regional CNS Clinical Trials Markets 2010
4.2 Regional CNS Clinical Trials Markets: Forecast 2011-2026
4.3 US and Canada
4.4 Europe
4.4.1 Europe: Half Emerging, Half Established
4.4.2 Western Europe
4.4.2.1 Market Forecast 2011-2026
4.5 BRIC Nations
4.6 Brazil
4.6.1 CNS Clinical Trials in Latin America
4.7 Russia
4.8 India
4.9 China
4.9.1 Chinese Interest in CNS Disorders Set to Increase
4.10 Other Emerging Markets
4.10.1 CEE
4.10.2 South East Asia
5. Leading Companies Providing CRO Services for CNS Clinical Trials
5.1 Quintiles
5.1.1 Expertise in CNS Clinical Trials
5.1.2 Recent Developments and Growth Strategies
5.2 Covance
5.2.1 Financial Performance 2009
5.2.2 Covance CNS Experience
5.2.3 Industry Partnerships
5.3 Pharmaceutical Product Development (PPD)
5.3.1 Financial Performance 2009
5.3.2 CNS: Over 330 Trials in Five Years
5.3.3 Expanding in Eastern Europe
5.3.4 Vaccines and Biologics
5.4 Charles River Laboratories
5.4.1 Financial Performance 2009
5.4.2 Interest in CNS Development
5.5 Parexel
5.5.1 Financial Performance 2009
5.5.2 Experts in CNS Clinical Trials
5.6 ICON
5.6.1 Financial Performance 2009
5.6.2 Ten Years of CNS Experience
5.6.3 Expanding into Biomarkers and Imaging
5.7 Kendle
5.7.1 Financial Performance 2009
5.7.2 CNS Clinical Trial Capabilities
5.8 PRA International
5.8.1 CNS Clinical Trial Experience
5.9 PharmaNet Development Group
5.9.1 PharmaNet Neuroscience
5.9.2 Emerging Market Expansion
5.10 CNS Specialists
5.11 CROs Specialising in Pre-clinical CNS Services
5.11.1 Biotrofix
5.11.2 CNS-CRO
5.12 CNS Patient Recruitment Services
5.12.1 QCTR
5.12.2 Alliance Research Group
5.13 Early-stage CNS CROs
5.13.1 CNS Network
5.13.2 Forenap
5.13.3 Lifetree Clinical Research
5.14 Some Companies Specialise in All Development Phases
5.14.1 Tangent Data
5.14.2 Comprehensive NeuroScience (CNS)
5.15 Imaging and Testing for CNS Trials
5.15.1 Neuroimage
5.15.2 Miicro
5.15.3 Cogtest
6. Industry Trends from 2011
6.1 SWOT Chart for CNS Trial Sponsors: 2010-2026
6.1.1 High Cost, Low Success
6.1.2 Money-Saving Opportunities
6.1.3 High Placebo Response Rates
6.2 SWOT Chart for CROs in the CNS Sector: 2010-2026
6.2.1 More-efficient Trials
6.2.2 Big Pharma M&A to Boost CRO Growth
6.2.2.1 Strategic Partnering
6.2.3 Patient Recruitment and Enrolment
6.3 Suicidality
6.3.1 The Columbia Suicide Severity Rating Scale (C-SSRS)
6.3.2 Man vs. Machine
6.4 Alternative Trial Design
6.4.1 Delayed-Start Trials
6.4.2 Challenges with Delayed-start Trials
6.4.3 Case Study: The ADAGIO Trial
6.4.4 Adaptive Clinical Trials
6.5 Neuroimaging
6.5.1 Neuroimaging Biomarkers
6.5.2 Neuroimaging and Future Drug Development
6.5.3 Alzheimer's Disease
6.5.4 Alzheimer's Disease Neuroimaging Initiative
6.6 CNS Target Compounds Are Changing
6.6.1 Neuroprotective Drugs
6.6.2 Biologics & Biosimilars
6.7 Benefits and Challenges to Outsourcing CNS Trials
6.7.1 Large Patient Populations
6.7.2 Genetic Variations
6.8 Challenges Faced by Large Pharma Companies in CNS R&D
6.9 Animal Models Must Be Improved Upon
7. Expert Opinion
7.1 Professor Alan Palmer, Chief Scientific Officer and Co-founder, MS Therapeutics
7.1.1 Neuroimaging and CNS Drug Development
7.1.2 Delayed-start Trials for CNS Diseases
7.1.3 Patient Recruitment in CNS Clinical Trials
7.1.4 Changing Priorities in CNS Drug Development
7.1.5 Therapeutic Areas That Will See Increased Investment
7.1.6 Threats to CNS Drug Development and Clinical Trials
7.2 Dr Amir Kalali, Vice President, Medical and Scientific Services and Global Therapeutic Group Leader, CNS at Quintiles
7.2.1 Challenges in Neuroimaging Biomarkers
7.2.2 Placebo Problems in CNS Clinical Trials
7.2.3 CROs in the CNS Clinical Trials Market
7.2.4 Failure Rate in CNS R&D
7.2.5 Big Pharma and CNS R&D
7.2.6 Globalisation
7.2.7 Challenges in CNS Clinical Trials
8. Conclusions
8.1 There Will Be Growth Throughout the Period
8.1.1 Unmet Needs to Drive Growth
8.2 CROs Will Play a Larger Role in the Market
8.3 Increasing Use of Neuroimaging
8.4 Emerging Markets to Drive Growth
8.4.1 India and China
List of Tables
Table 2.1 World CNS Disease Drug Market, 2009
Table 2.2 Members of the ICH, 2010
Table 3.1 CNS Clinical Trials by Phase, 2010
Table 3.2 CNS Clinical Trials Market, 2010
Table 3.3 Top 25 Big Pharma Sponsors of CNS Clinical Trials, 2010
Table 3.4 GSK's Neuroscience Pipeline, February 2010
Table 3.5 Pfizer's Neuroscience Pipeline, September 2010
Table 3.6 Novartis CNS Clinical Trials Enrolling in November 2010
Table 3.7 AstraZeneca's Neuroscience Pipeline, 2010
Table 3.8 Janssen-Sponsored Clinical Trials, 2010
Table 3.9 World CNS Clinical Trials Market Forecast, 2010-2018
Table 3.10 World CNS Clinical Trials Market Forecast, 2018-2026
Table 3.11 CNS Clinical Trials Drivers and Restraints, 2011-2026
Table 3.12 CRO and In-house Market Shares, 2010-2026
Table 3.13 CNS CRO Market Drivers and Restraints, 2011-2026
Table 4.1 CNS Clinical Trials Market by Region, 2010
Table 4.2 CNS Clinical Trials Market: National Forecasts, 2010-2018
Table 4.3 CNS Clinical Trials Market: National Forecasts, 2018-2026
Table 4.4 CNS Clinical Trials Market Regional Shares, 2010-2026
Table 4.5 CNS Clinical Trials Registered in US and Canada by Phase, 2010
Table 4.6 US and Canadian Market Drivers and Restraints, 2011-2026
Table 4.7 European CNS Clinical Trials by Phase, 2010
Table 4.8 EU Membership Status of CEE Countries, 2010
Table 4.9 CNS Clinical Trials in Selected Western European Countries by Phase, 2010
Table 4.10 Western Europe Market Drivers and Restraints, 2011-2026
Table 4.11 Relative Cost of Conducting Clinical Trials in Western Europe, 2010
Table 4.12 CNS Clinical Trials in BRIC Nations, 2010
Table 4.13 Latin American Market Benefits and Challenges, 2011-2026
Table 4.14 Russian Market Drivers and Restraints, 2011-2026
Table 4.15 Indian Market Benefits and Challenges, 2011-2026
Table 4.16 Chinese Market Benefits and Challenges, 2011-2026
Table 4.17 CNS Disorder Prevalence in South East Asia, 2010
Table 5.1 Number of CNS Clinical Trials Performed by Company, 1990-2010
Table 5.2 CROs Offering CNS Services Not Discussed in This Report, 2010
Table 5.3 Covance Sales by Market Segment, 2009
Table 5.4 PPD Sales by Market Segment, 2009
Table 5.5 Parexel Sales by Market Segment, 2009
Table 5.6 ICON Sales by Region, 2009
Table 5.7 Kendle Sales by Market Segment, 2009
Table 5.8 Kendle Sales by Region, 2009
Table 5.9 CNS Specialist CROs Not Discussed in This Report, 2010
Table 6.1 SWOT Chart for CNS Clinical Trial Sponsors, 2011-2026
Table 6.2 SWOT Chart for CROs Conducting CNS Clinical Trials, 2011-2026
Table 6.3 C-CASA Levels of Suicidality, 2010
Table 6.4 Some Companies Offering Neuroimaging Services for CNS Clinical Trials, 2010
Table 6.5 Levels of Biomarker, 2010
Table 6.6 Selected Treatments Targeting Amyloid-?, 2010
Table 8.1 CNS Clinical Trials Market Forecast, 2010-2026
Table 8.2 CNS Clinical Trials Market by Region, 2010-2026
List of Figures
Figure 2.1 World CNS Diseases Drug Market, 2009
Figure 2.2 The Drug Development Process, 2010
Figure 3.1 CNS Clinical Trials by Phase, 2010
Figure 3.2 CNS Clinical Trials Market, 2010
Figure 3.3 Top 25 Big Pharma Sponsors of CNS Clinical Trials, 2010
Figure 3.4 GSK's Neuroscience Pipeline, February 2010
Figure 3.5 Pfizer's Neuroscience Pipeline, September 2010
Figure 3.6 AstraZeneca's Neuroscience Pipeline, 2010
Figure 3.7 World CNS Clinical Trials Market, 2010-2026
Figure 3.8 World CNS Clinical Trials Market, 2016
Figure 3.9 World CNS Clinical Trials Market, 2021
Figure 3.10 World CNS Clinical Trials Market, 2026
Figure 4.1 CNS Clinical Trials Market by Region, 2010
Figure 4.2 CNS Clinical Trials Market by Region, 2016
Figure 4.3 CNS Clinical Trials Market by Region, 2021
Figure 4.4 CNS Clinical Trials Market by Region, 2026
Figure 4.5 US and Canada CNS Trials Split by Country, 2010
Figure 4.6 US and Canada CNS Trials by Phase, 2010
Figure 4.7 US and Canada: CNS Clinical Trials Market, 2010-2026
Figure 4.8 European CNS Trials by Phase, 2010
Figure 4.9 CNS Clinical Trials in Selected Western European Countries, 2010
Figure 4.10 CNS Clinical Trials in Selected Western European Countries by Phase, 2010
Figure 4.11 Selected Western European Countries: CNS Clinical Trials Market, 2010-2026
Figure 4.12 CNS Clinical Trials in BRIC Countries, 2010
Figure 4.13 CNS Clinical Trials in BRIC Countries by Phase, 2010
Figure 4.14 BRIC National CNS Clinical Trials Markets, 2010-2026
Figure 4.15 CNS Clinical Trials in Brazil by Phase, 2010
Figure 4.16 CNS Clinical Trials in Russia by Phase, 2010
Figure 4.17 CNS Clinical Trials in India by Phase, 2010
Figure 4.18 CNS Clinical Trials in China by Phase, 2010
Figure 4.19 Other CNS Clinical Trials Markets, 2010-2026
Figure 4.20 CNS Disorder Prevalence in South East Asia, 2010
Figure 5.1 Number of CNS Clinical Trials Performed by Company, 1990-2010
Figure 5.2 Covance Sales by Market Segment, 2009
Figure 5.3 Covance Sales by Region, 2009
Figure 5.4 PPD Sales by Market Segment, 2009
Figure 5.5 Charles River Laboratories Sales by Market Segment, 2009
Figure 5.6 Parexel Sales by Market Segment, 2009
Figure 5.7 ICON Sales by Region, 2009
Figure 5.8 Kendle Sales by Market Segment, 2009
Figure 5.9 Kendle Sales by Region, 2009
Figure 6.1 Suicidality and the FDA, 2003-2008
Figure 6.2 The Delayed-start Trial Design