Our New Report Shows You How this Sector Will Expand its Revenues and Influence, Highlighting the Opportunities from 2009 Onwards

The market for clinical trials has been expanding rapidly in recent years, with impressive revenue growth and important trends. One regional market expanded by 65% in 2008. From the perspectives of various pharma stakeholders, the expanding clinical research market represents opportunities for revenue growth and cost savings. Our latest report - Clinical Trials: World Market 2009-2024 - considers perspectives of pharma companies and CROs in particular. We comprehensively analyse the market’s strengths, weaknesses and revenue trends from 2009 to 2024.

This report provides hard-to-find data on the current and future value of clinical trials markets, both worldwide and regionally. Importantly, this report covers emerging markets, highlighting salient trends there. Our report addresses regional questions. For example, how will India’s market share change between now and 2024? Will the Central and Eastern European market expand more quickly than the market in China? We also address global questions, such as: what proportion of the sector will be controlled by contract research organisations in the future? CROs are playing increasingly important roles in drug development worldwide, from conducting phase I trials to post-marketing studies.

Clinical Trials: World Market 2009-2024 is now in its third edition. This 2009 edition is re-written, with all-new analyses. It takes into account the changed economic environment, as well as developments in policy, technology and the market.

Comprehensive analysis of the clinical trials market

Clinical Trials: World Market 2009-2024 examines that sector critically, through a comprehensive review of information sources, both primary and secondary. This report provides detailed sales forecasts, discussions of pipeline developments and analyses of commercial drivers and restraints, including a SWOT analysis. There are many tables and figures and two full interviews with experts in the sector. The result is a comprehensive market- and industry-centred report, with detailed analyses and informed opinion to benefit your work.

Why you should buy Clinical Trials: World Market 2009-2024

Our new report provides you with the following benefits:
• Instant access to hard-to-find revenue forecasts for the clinical trials market from 2009 to 2024
• An analysis of regional developments and how revenues and market shares will change from 2009 to 2024
• Comprehensive quantitative and qualitative analyses of how the clinical trials market will develop from 2009, and why
• A comprehensive assessment of the worldwide market for CROs
• An easily-accessible review of clinical trials regulations, procedures and essential market information
• Insight into market drivers and restraints for the global clinical trials market in the shorter and longer term, including SWOT analysis
• Analytical reviews of important CROs and services they offer
• Full transcripts of original interviews with Dr Nathaniel Katz of Analgesic Research, discussing patient recruitment, and with Dr Kevin Dykstra of Pharsight, discussing the future of adaptive trials
• All the information you need to assess the market’s potential from the present onwards. 

You can stay ahead by obtaining this report today

Clinical Trials: World Market 2009-2024 will provide you with the information that you need to understand this dynamic and rapidly-expanding sector. How will this market change in the future, and in what ways will it remain the same? What will be the main revenue trends? Which regions will show the highest growth? This report answers those vital questions and many more besides. Do you want to know more about this important market area? You can stay ahead by ordering this report today.

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