发布时间：2008.7

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摘要

The global clinical trials business is worth an estimated $50bn in 2008, with a growth of rate of 10%. The market will show considerable growth in the future, as this visiongain report, Global Clinical Trial Business 2008-2018, explains in detail. In recent years, the nature of clinical trials has changed considerably. An increased emphasis has been placed on cost-effectiveness of pharmaceutical R&D, as well as increased productivity to maintain the high output of recent years. Consequently, the pharmaceutical industry has witnessed rapid expansion of outsourced clinical services in both the West and in developing nations, most notably India and China. Importantly, pharmaceutical and biotechnological companies are increasingly delegating the responsibility of clinical trials to contract research organisations (CROs).

This visiongain report investigates the global market for such services, providing forecasts for revenues and expenditure there, as well as a comprehensive examination of principles driving and restraining the clinical trials market worldwide. Neither pharmaceutical companies nor CROs can afford to ignore this research, which relies heavily upon interviews with experts in the relevant sectors, as well as providing comprehensive revenue forecasts for the next 10 years.

The majority of the revenues generated by the clinical trials industry are due to large pharmaceutical companies outsourcing clinical research, the most crucial and expensive stage of drug development, to companies specialising in that work. The major challenge for the pharmaceutical companies in the next five years will be to maintain high growth rates. The branded pharmaceuticals market is under substantial pressure due to:

* Existing generic competition
* Impending loss of major patents
* Relatively thin pipeline.

Because of the nature of the clinical trials industry it will, in turn, experience increasing pressures to deliver a cost-effective service. The demand among drugs companies for a more cost-efficient pipeline has therefore intensified in recent years. The strategy that pharmaceutical companies now seem to be applying to clinical trials mirrors the latest trends in the drug discovery section of development.

Contract research organisations (CROs) are playing increasingly vital roles on behalf of manufacturers in the global drug development process, from conducting Phase I trials to post-marketing studies. It is often difficult for pharmaceutical and biotech companies to decide which CRO to offer a contract to. However, the market is due to undergo rapid change over the coming years, with different companies approaching the challenges in different ways. The CRO market, however, continues to grow steadily at an average 10% yearly growth rate. Visiongain predicts that there remains a sufficient growth opportunity for both mainstream and other CROs.

Why You Should Buy This Report:
In Global Clinical Trial Business 2008-2018 you will receive the following essential information for understanding the clinical trial business:

* The value of the clinical trial business market and its principal market segments from 2008 to 2018
* Which current or future therapies that will drive the market for clinical trial business from 2008 to 2018
* Market drivers and restraints, including a comprehensive SWOT analysis
* Comprehensive views of key opinion leaders on clinical trial business
* The companies involved in clinical trial business and their business strategy
* Forecasts for revenue in each of the phases of clinical trial business
* The present state of clinical trial business and future trends there
* What contract research opportunities exist for market entrants, both established companies and newcomers
* The main concerns for outsourcing clinical trials to CROs
* Ways to improve cost-effectiveness of clinical trial business
* Changes in clinical trial regulations
* Focus on drug safety issues.

Clinical trials are now performed in many regions of the world, with increasing numbers of major pharmaceutical and biotechnology companies performing or outsourcing clinical trials in rapidly developing nations such as India and China.

Visiongain's Global Clinical Trial Business 2008-2018 report also covers the following issues:
* Electronic data capture (EDC) systems have existed for approx. 20 years and pharma companies are beginning to recognise the value of those processes in clinical research.
* Adaptive clinical trials are a concept in development: adaptive trial designs have the potential to benefit drug development programmes, changing current processes
* Biomarkers can increase efficiency of clinical trials by identifying potential failures early, saving time and money potentially, facilitating drug development and paving the way to more-personalised medicine with better safety and efficacy profiles, especially in defined populations.

This Report is essential to the Following Professionals, Amongst Others:
* Investors in clinical trial business
* Business managers of multinational companies in both the developed and  developing countries
* Business managers of domestic companies in the emerging economies
* Business managers of pharmaceutical industry related to outsourcing
* Researchers, analysts and academics interested in clinical trial business
* Senior staff in healthcare authorities relevant to clinical trial business.

目录及图表

1 Executive Summary: Global Clinical Trial Business 2008-2018
1.1 Aims of the Global Clinical Trial Business 2008-2018 Report
1.2 Scope of the Global Clinical Trial Business 2008-2018 Report

2 Background Information on Clinical Trials
2.1 Brief History of Code of Conduct for Clinical Trial
2.1.1 The Nuremberg Code
2.1.2 The Declaration of Helsinki
2.1.3 Establishing Standards for Good Clinical Practice
2.1.4 FDA's New Rules for Incorporating Foreign Clinical Studies
2.2 Pre-Clinical Studies
2.2.1 Pre-Clinical Studies on Animal Models
2.2.2 Phase 0 is a Recent Designation
2.3 Different Stages 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 Basics Principles in Clinical Trial Design
2.4.1 The Placebo Effect
2.4.2 Inclusion Criteria and Exclusion Criteria
2.4.3 Randomisation of Subjects and Blinded Trials
2.4.4 Endpoints
2.5 The World Branded Pharmaceutical Market
2.5.1 Summary of the Global Pharmaceutical Market
2.5.2 Leading Branded Drugs and Pharmaceutical Companies
2.5.3 Leading Drug Categories
2.6 Technological and Scientific Models for Clinical Trial
2.6.1 Usefulness of Electronic Data Capture Use
2.6.1.1 Clinical Data Management System
2.6.1.2 Electronic Data Capture
2.6.1.3 Hurdles Faced by Investigators in the Process of Implementation of EDC
2.6.1.4 Clinical Data Interchange Standards Consortium
2.6.2 Adaptive Clinical Trial Designs
2.6.3 Biomarkers and Adaptive Designs
2.6.4 Identification of Expression Profiles in Pre-Clinical Models
2.7 Demands for Cost-Efficient Pipeline
2.8 Clinical Trial for Biopharmaceuticals
2.8.1 Pioneering Personalized Medicine
2.8.2 The Progress of Pharmacogenomics Has Been Slow
2.8.3 RNAi Therapeutics Perform Clinical Trials
2.8.4 Clinical Trials for Evaluation of Immunogenicity of Biosimilars

3 Market Analyses for Clinical Trial Business
3.1 Global Clinical Trial Business
3.2 US Clinical Trial Business
3.3 European Clinical Trial Business
3.4 Increased Demand for Phase IIIb and IV Studies
3.5 Demand for Phase II and IIIa Studies Grows
3.6 Outsourcing Clinical Trial Business to CROs
3.7 Major CROs Take Half of the Market Share
3.8 Reasons for Outsourcing Clinical Trials
3.9 Clinical Trial Outsourcing to Countries in the Developing World
3.10 Summary of the Chapter

4 Outsourcing Clinical Research to CROs
4.1 SWOT Analysis for Outsourcing Clinical Trial
4.2 Growth of CRO Industry
4.3 Growth Rate of Major CROs
4.4 CRO Forming Alliances for Improving Market Share
4.4.1 Parexel Increases its Presence in China's CRO Market
4.4.2 PRA International Expands Clinical Trial to Russia
4.4.3 Kendle Acquires Charles River
4.4.4 Covance Successfully Combines Pre-clinical Research with Late Phase-Organisation
4.5 Quintiles Allies with Thermo Fisher
4.6 CROs to Maintain High Quality
4.7 CROs in India
4.7.1 Progressive Life Sciences
4.7.2 Wellquest is a CRO from India Compliant with International Regulatory Norms
4.7.3 Vimta is an Emerging Company
4.8 Quintiles Central Laboratory Facility to Facilitate Clinical Trials in Asia
4.9 MDS Pharma Services Expands Early-Phase Development
4.10 The Use of CROs in Drug Discovery and Development is Increasing as Big Pharma Changes
4.10.1 Contract Research for Drug Discovery at Suven Life Sciences
4.11 Clininvent is a CRO with Standardised Data Management Skills

5 Outsourcing Clinical Trials to Developing Countries
5.1 Selection of Developing Countries is for Cost-Savings
5.2 China Receives Renewed Attention
5.3 India Receives Renewed Attention
5.4 Drivers for Outsourcing Clinical Research Services from China and India
5.5 Restrains for Outsourcing Clinical Research Services from China and India
5.6 Factors for Patient Recruitment in China
5.7 Patient Recruitment is Quicker in Latin America
5.8 Outsourcing Clinical Data Management
5.8.1 GlaxoSmithKline to Outsource Data Management

6 Firsthand Interviews with Industry Opinion Leaders
6.1 Interview with Dr Tom Parke, Tessella
6.1.1 Cost Saving with Adaptive Designs
6.2 Interview with Dr Goran Gannedahl, NMCT
6.2.1 Scandinavia Opens Up its Business to Emerging Economies
6.3 Interview with Dr Arun Bhatt, Clininvent
6.3.1Small and Medium Sized Companies Opt For CROs
6.3.2 EDC Makes Clinical Trials More Cost-Effective
6.3.3 Adaptive Clinical Trial as a Creative Statistical Strategy
6.3.4 EDC Helpful for Adaptive Clinical Trial
6.3.5 Biomarkers for Decision Making Process
6.3.6 Pros and Cons of Contract Research Services from India
6.3.7 Patients Benefit form Clinical Trials in India
6.3.8 India's Own Innovative Products
6.3.9 Differences between India and China for Undertaking Trials
6.3.10 Types of Trials Undertaken In India
6.3.11 Cost Ratio for Each Stage of Drug Development
6.4 Interview with Dr Ernst Johannes, Quintiles
6.4.1 Reasons for Outsourcing Clinical Research
6.4.2 Electronic Data Capture for Greater Efficiency
6.4.3 Software for Adaptive Clinical Trial
6.4.4 Biomarkers as Surrogate Indicators
6.4.5 Asian Nations with Proven Efficacy to Undertake Clinical Trials
6.5 Interview with Dr Louis Christian Clauss, Baxter
6.5.1 CRO Industry Shows Potential for Growth
6.5.2 Electronic Data Capture Market
6.5.3 Adaptive Clinical Trials Market
6.5.4 CROs to Undertake Clinical Trials Increasingly in Europe
6.5.5 EU Clinical Trial Directive for Pan-European Market
6.6 Interview with Dr Venkat Jasti
6.6.1 CROs Providing Link
6.6.2 Web-Based Systems Implemented In India for EDC
6.6.3 Clinical Trial Simulations (CTS) as a Cost-Effective Measure
6.6.4 Biomarkers Can Reduce the Duration of Clinical Trials
6.6.5 Pros and Cons of Contract Research Services from India
6.7 Interview with Dr Valery Novikov, PRA International
6.7.1 International CROs are Growing Industry in Russia
6.7.2 Electronic Data Capture Use Increases in Russia
6.7.3 Pros and Cons of Outsourcing Clinical Research to Russia
6.8 Interview with Jay McTaggart
6.8.1 CROs as an Inherent Part in Clinical Research Business
6.8.2 EDC Expansion Inevitable
6.8.3 Biomarkers for Pre-Clinical Studies
6.9 Interview with Patricia Moenaert, Progenitor International Research
6.9.1 Expansion of CRO Industry Globally
6.9.2 Challenges of Undertaking Clinical Trials Globally
6.9.3 Reasons behind Choosing Emerging Economies
6.9.4 Official Action Indicated (OAI) Rate for Asia and Latin America
6.10 Presentation at Clinical Trials 2008 Congress by Vinka Ljubimir, GlaxoSmithKline    
6.10.1 Reasons for Undertaking Global Trials
6.10.2 Challenges in a Global Team
6.11 Interview with David Eaton, Institute of Cancer Research and NHS
6.11.1 CROs are Selected by Sponsors
6.11.2 Increased Trend in the Use of EDC
6.11.3 Preference for Web-Based Data Capture
6.11.4 Interactive Voice Response for Data Capture
6.11.5 Implementation of EDC Requires Skilled Manpower
6.11.6 Electronic Patient Record Complementary to EDC Systems
6.11.7 Advantages for Implementation of EDC Systems
6.11.8 EDC Provides Sponsors Instant Access to Patient Records
6.11.9 EDC Implementation Increases at Investigator's Sites
6.12 Interview with Dr Laura Brown, Cardiff University
6.12.1 EDC Use Has Increased Significantly in Last Ten Years
6.13 Interview with Anne Maria Ylisaari, Orion
6.13.1 Criteria for CRO/SMO Selection
6.14 Interview with Carmen Salazar, Cellerix
6.14.1 Essentials of Clinical Trial Supply Management
6.14.2 Management Skills for Ensuring Good Clinical Trial Supply
6.15 Interview with Manish Badonia, Cadila
6.15.1 Clinical Trial Outsourcing to Asia will Grow due to Cost Competitiveness
6.15.2 One-Stop Shop (CRO and CMO)

7 Patient Recruitment as a Factor for Successful Clinical Trial Business
7.1 Advertising to Provide Value

8 Drug Safety Issue in Clinical Trial
8.1 Safety Concerns and Development Pressures Will Change the Structure of Clinical Trials
8.2 Phase I and II Clinical Trials Will Incorporate More Complex Screening Techniques
8.3 Presentation at Clinical Trials 2008 Congress by Francis Ruiz, NICE
8.3.1 NICE's Role in Technology Appraisal Guidance
8.3.2 How NICE Fits in with the Regulators
8.3.3 Manufacturers and Sponsors to Consider Collecting Evidence of Cost Effectiveness at Drug Development Stage
8.3.4 Evidence Required For an Appraisal of Cost-Effectiveness
8.4 Presentation at Clinical Trials 2008 Congress by Dr Peter Feldschreiber, MHRA
8.4.1 Recommended Regulations in Europe
8.4.2 EU Directive Revised
8.5 Presentation at Clinical Trial Congress 2008 by Alison McAdams, Davies Arnold Cooper
8.5.1 Safety Issues for Clinical Trials Have Received Unprecedented Attention Since 2006
8.6 GlaxoSmithKline's Clinical Trial Data Suggests Increased Suicide Risks among Subjects

9 Conclusions
9.1 The Contract Research Market is Dominated by a Few Companies
9.2 The Clinical Trial Market Outsourcing Will Increase in Revenue from 2008-2018
9.3 Prospects for Clinical Trial Business
9.3.1 Clinical Trial Phases
9.3.2 Technology Developments

List of Tables
Table 1.1 World Clinical Trial Revenue ($bn) Forecasts, 2006-2018
Table 2.1 Key Stages in the History of Clinical Trials
Table 2.2 World Pharmaceutical Market ($bn), 2000-2007
Table 2.3 Top Ten Countries by Pharmaceutical Revenue ($m), 2007
Table 2.4 Top Twenty Drugs by Revenue ($m), 2007
Table 2.5 Top Twenty-Five Pharmaceutical Companies by Revenue, 2007
Table 2.6 Top Ten Drug Categories by Revenue ($m), 2004
Table 2.7 Top Fifteen Treatment Areas by Revenue ($m), 2007
Table 2.8 Drugs in Development Pipeline by Therapeutic Area, 2006
Table 3.1 World Clinical Trial Revenue ($bn) Forecasts, 2006-2018
Table 3.2 US Clinical Trial Revenue ($bn) Forecasts, 2006-2018
Table 3.3 European Clinical Trial Revenue ($bn) Forecasts, 2006-2018
Table 3.4 World Clinical Trial Revenue ($bn) Forecasts for Phase IIIB-IV, 2006-2018
Table 3.5 World Clinical Trial Revenue ($bn) Forecasts for Phase II-IIIA, 2006-2018
Table 3.6 World CRO Clinical Trial Revenue ($bn) Forecasts, 2006-2018
Table 3.7 US CRO Clinical Trial Revenue ($bn) Forecasts, 2006-2018
Table 3.8 European CRO Clinical Trial Revenue ($bn) Forecasts, 2006-2018
Table 3.9 Ten Largest CROs by Revenues ($m), 2006
Table 3.10 Total Clinical Trial Revenue ($bn) for Top Ten CROs Forecasts, 2006-2018
Table 3.11 Forecasts for Clinical Trial Revenue ($m) for Outsourcing Services from India, 2007-2018
Table 3.12 Forecasts for Clinical Trial Revenue ($m) for Outsourcing Services from China, 2006-2018
Table 4.1 SWOT Analysis of Outsourcing to CROs
Table 4.2 Growth of Covance Revenues ($m) for Early and Late Development 2002-2005
Table 4.3 Clinical Services Revenue ($m) for MDS Pharma, 2002-2005
Table 5.1 Drug development Cost in India, 2007
Table 5.2 SWOT Analysis for Outsourcing Services from Developing Countries
Table 6.1 Population Size in Countries of Central and Eastern Europe (CEE), 2007
Table 6.2 Regulatory Time-Line for Countries in Asia, Latin America and CEE
Table 7.1 Reasons Given for Participation

List of Figures
Figure 1.1 World Clinical Trial Revenue Forecasts, 2006-2018
Figure 3.1 World Clinical Trial Revenue Forecasts, 2006-2018
Figure 3.2 US Clinical Trial Revenue Forecasts, 2006-2018
Figure 3.3 European Clinical Trial Revenue Forecasts, 2006-2018
Figure 3.4 Market Share (%) for Different Clinical Trial Phases, 2006
Figure 3.5 World Clinical Trial Revenue Forecasts for Phase IIIB-IV, 2006-2018
Figure 3.6 World Clinical Trial Revenue Forecasts for Phase II-IIIA, 2006-2018
Figure 3.7 World CRO Clinical Trial Revenue Forecasts, 2006-2018
Figure 3.8 US CRO Clinical Trial Revenue Forecasts, 2006-2018
Figure 3.9 European CRO Clinical Trial Revenue Forecasts, 2006-2018
Figure 3.10 CROs by Market Share (%), 2006
Figure 3.11 Top Ten CROs Clinical Trial Revenue Forecasts, 2006-2018
Figure 3.12 Forecasts for Clinical Trial Revenue for Outsourcing Services from India, 2006-2018
Figure 4.1 Growth Rate from 2005 for leading CROs, 2006
Figure 4.2 Growth Rate from 2006 for Leading CROs, 2007
Figure 4.3 Therapeutic Areas (%) of Clinical Trial Outsourcing, 2007
Figure 4.4 Revenues ($m) for Covance, 2002-2005
Figure 4.5 Clinical Services Revenue ($m) for MDS Pharma Services, 2002-2005
Figure 6.1 World Distribution of Proportion of Clinical Trial Business, 2007