发布时间：2008.10

摘要

Driven by mounting market pressures, companies are increasingly implementing outsourcing strategies to increase revenues through faster drug development. By decreasing their in-house facilities and staff, and outsourcing more of their R&D functions, pharmaceutical and biotechnology companies are reshaping the drug development services industry.

Kalorama Information's Outsourcing in Drug Development is the third edition of this study of the drivers for outsourcing drug development, the companies involved in this market and the opportunity for revenues. Part of the CMO Market Series, this volume joins Outsourcing in Drug Discovery, published earlier this year.

As part of its comprehensive coverage of this market, this report contains:

• A Detailed Introduction to the Clinical Trial Process
• Statistics of Drugs in Development by Phase
• Markets and Forecasts for Outsourcing In Drug Development (broken down by AMC, CMO and other)
• Main Drivers for Outsourcing in Drug Development
• Discussion of Industry and Regulatory Trends
• CMO Market Share
• Detailed Profiles of CMOs, Contract Laboratories, Clinical Trial Labs and EDC Solution Companies

As part of Kalorama Information's research process, information for this report is gathered from sources including trade press, company reports and government databases. Kalorama Information's analyst also interviewed dozens of experts in the industry to discover new trends and confirm assumptions.

目录及图表

CHAPTER ONE: EXECUTIVE SUMMARY

• The Drug Development Process
• Government Regulation of Clinical Researc
• Active Phase I, II & III Clinical Trial
• Phase IV Studies: Post Approval
• Recruiting for Clinical Trial
• The Complexity and Costs Of Clinical Trials Are Increasing
• Clinical Trials Worldwide
• The Contract Drug Development Industry
• R&D Outsourced to Contract Drug Development
• Contract Drug Development Market
• Trends Affecting Growth of Contract Drug Development Industry
  • Globalization of Drug Development
  • Rapid Technological Change Increasing Data
  • Biotechnology Industry Growth
  • Increased Regulatory Scrutiny
  • Need for Fast, Efficient, and Cost-Effective Drug Development
  • Drug Development Process

CHAPTER TWO: INTRODUCTION

• Government Regulation of Clinical Research
• Center for Biological Evaluation and Review
• Center for Drug Evaluation and Research
• Investigational Review Board
• Preclinical Research
• In Vitro and In Vivo Testing Process
• Investigational New Drug Application
• Clinical Trials
• Preclinical Phase
• Phase I
• Phase IIa
• Phase IIb
• Phase III
• Phase IIIa
• Phase IIIb
• Phase IV: Post Approval
• New Drug Applications
• New Molecular Entities and Approval Times
• Accelerated Approval
• Has FDA’s PDUFA ACT Weakened Safety Standards?
• Government Initiatives to Improve Research and the Review Process
• FDA’s Critical Path Report
• Exploratory IND Studies—An Approach to Complying with CGMP
• INDs—Approaches to Complying with CGMP During Phase 1
• Biotechnology Industry Endorses FDA’s Critical Path
• Globalization Trends in Drug Development
• Clinical Trials Worldwide
• China is Ranked First
• India's Growing Market
• Russia Dominates Eastern Europe

CHAPTER THREE: CLINICAL TRIAL OPERATIONS

• Conducting Clinical Trails
• Government Sponsored Clinical Trials
• Organizations Contracted to Conduct Clinical Trials
• Contract Research Organizations (CROs)
• Managed Site Networks
• Major Elements of Clinical Trials
• Protocol
• Eligibility Criteria
• Endpoints
• Randomization
• Stratification
• Blinding
• Data Collection and Management Tools
• Statistical Interpretation
• Data Collection and Management Tools
• Statistical Interpretation
• Phase IV Studies Post Approval Studies
• Sentinel Initiative
• Recruiting for clinical Trials
• Clinical Trials Recruitment Promotion
• Internet-Enabled Recruitment
• Recruiting Principal Investigators
• Physician as Principal Investigator
• Recruiting Patients
• Use of Homecare Services
• Patient Recruitment Outside the U.S.
• Delays in Patient Recruiting Increases Project Costs
• Factors Influencing Participation in Clinical Trials
• Increasing Complexity of Clinical Trials
• Informed Consent Process
• Demographics and Clinical Trials
• Ethnicity and Gender in Clinical Trials
• Electronic Data Management
• Traditional Paper-based Case Report Forms
• Advantages of EDC
• Current Assessment of EDC Adoption
• Need for an EDC Standard
• FDA Releases Guidance for Using Computerized Systems in
• Clinical investigations
• Electronic Patient Diaries

CHAPTER FOUR: TRENDS

• Drug Development Costs
• Outsourcing Drug Development
• A Brief History of Contract Research Outsourcing
• Focus Shifts in Outsourced Clinical Research Operations from Phase II-III to Phase I to IIIb/IV
• Major Factors Driving Contract Research Outsourcing Strategy
• Outsourcing as a Cost Reduction Strategy
• Number of New Chemical Entities (NCEs) in Pipeline Increasing
• Growing Complexity of Regulatory Requirements
• Outsourcing to Gain Rapid Access to Patient Recruiting
• Contract Research Competitors
• Academic Medical Centers (AMCs)
  • Competing Factors
• Contract Research Organizations (CROs)
  • CRO Contract
• Competing Factors Managed Site Networks
• Competing Factors
• Clinical Trial Laboratories
  • Competing Factors
• Clinical Trials as a Business Opportunity
• Community Physicians
• Electronic Technology Solutions
• Internet Patient/Investigator Recruiting
• Clinical Trials Packaging
• Effective Packaging Promotes Patient Compliance

CHAPTER FIVE: MARKETS

• R&D Spending Increasing
• Leading Pharmaceutical Developers
• Clinical Research Products in Development
• Shift in Spending for Clinical Research
• Spending for Phase I Trials Slows from Highs in 2004
• Safety Issues Drive Phase IIIb/IV Trial Spending
• Contract Drug Research Market
• Contract Research Competitors
• CROs Market Share
• CROs Broaden Services through Acquisitions
• CROs Expanding Laboratory Services
• AMC Market Share
• AMCs Reassess Role in Industry-funded Clinical Research
• Academic Clinical Reseach Organizations Expanding
• Niche Competitors’ Market Share
• Clinical Trial Laboratory Services
• EDC Services Gaining Market Share
• Managed Site Networks
• Trends Affecting Growth in Contract Drug Development Industry
• Globalization of Drug Development
• Rapid Technological Change Increasing Data
• Biotechnology Industry Growth
• Increased Regulatory Scrutiny
• Need for Fast, Efficient, and Cost-Effective Drug Development

  CHAPTER SIX: COMPANY PROFILES

• Charles River Laboratories International, Inc.
• Covance, Inc.
• Encorium Group, Inc.
• Icon, Plc
• Kendle International, Inc.
• MDS Pharma Services
• Omnicare Clinical Research
• Paraxel International Corporation
• Pharmanet Development Inc.
• Pharmaceutical Product Development, Inc.
• Radiant Development
• Clinical Trial Laboratories
• Bioanalytical Research Corporation
• Calvert Laboratories, Inc.
• Kronos Science Laboratories, Inc.
• Medtox Scientific Inc.
• Pacific Biometric, Inc.
• PRL Central Laboratory Services
• Quest Diagnostics, inc.
• TGA Sciences, Inc.
• CNS Clinical Trials
• DaVita Clinical Research
• -USA, Inc.
• Synarc, Inc.
• Advanced Clinical Software
• eTrials Worldwide, Inc.
• Interactive Clinical Technologies, Inc.
• Medidata Solutions Worldwide
• Pharsight Corporation

APPENDIX: COMPANY DIRECTORY

TABLE OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

• Exhibit 1-1: The U.S. Drug Discovery, Development, and Approval Process

• Exhibit 1-2: Number of Active Clinical Drug Development Programs (May 11, 2007)

• Exhibit 1-3: Total Average Number of Active Clinical Drug Development Programs, 2001-2007

• Exhibit 1-4: Change in Protocol Eligibility Criteria, Comparison of 1999-2000 and 2003-2006

• Exhibit 1-5: Worldwide Clinical Trial Sites, by Region and Percent, as of 7/12/2008

• Exhibit 1-6: Portion of Global R&D Expenditures Outsourced: 2003-2008 by percent

• Exhibit 1-7: Contract Drug Development Market Share, Percent by Competitor Type (AMC, CRO’s Others), 2007

• Exhibit 1-8: Contract Research Market, Revenue by Competitor, 2002-2012

CHAPTER TWO: INTRODUCTION

• Exhibit 2-1: Investigational New Drug Submissions, 1992-2006

• Exhibit 2-3: Number of Clinical Trials Initiated Annually for U.S. Submissions

• Exhibit 2-4: Median Total Approval Time for Standard NDAs, 1993-2006

• Exhibit 2-5: Median Total Approval Time for Priority NDAs, 1993-2004

• Exhibit 2-6: Median Total Approval Time for Standard NMEs, 1995-2004

• Exhibit 2-7: Median Total Approval time for Priority NMEs, 1995-2004

• Exhibit 2-8: U.S. NMEs 2006 Approvals: Review Times by Drug

• Exhibit 2-10: Median Approval times for Safety vs All Drugs, By Decade

• Exhibit 2-11: Number and Location of Clinical Trial Sites Worldwide, as of 7/12/2008

• Exhibit 2-12: Worldwide Clinical Trial Sites, by Region and Percent, as of 7/12/2008

CHAPTER THREE: CLINICAL TRIAL OPERATIONS

• Exhibit 3-1: Key Clinical Trial Enrollment Statistics for: NMEs Approved in 2000-2006

• Exhibit 3-2: Number of Active Clinical Drug Development Programs (May 11, 2007)

• Exhibit 3-3: Total Average Number of Active Clinical Drug Development Programs, 2001-2007

• Exhibit 3-4: Summary Of Postmarketing Study Commitments (Numbers as of September 30, 2007)

• Exhibit 3-5: Benefits and Risks of Participating in Clinical Trials

• Exhibit 3-6: Change in Protocol Eligibility Criteria, Comparison of 1999-2000 and 2003-2006

• Exhibit 3-7: Aggregate Enrollment Data for All Extramural and Intramural Research Protocols Funded in FY2005 and Reported in FY2006, by Percent and Gender

CHAPTER FOUR: TRENDS

• Exhibit 4-1: New Paradigm for R&D

• Exhibit 4-2: Improvements in the Drug Development Process Reduce Development Costs

• Exhibit 4-3: Portion of Global R&D Expenditures Outsourced: 2003-2008 by percent

• Exhibit 4-4: Percentage of Industry-Sponsored Clinical Trials Awarded to Academic Medical Centers Versus Private Sector Companies: 1991, 1996,2001 and 2006

CHAPTER FIVE: MARKETS

• Table 5-2: Global Drug Development Spending, 2002-2012

• Table 5-2: Global Drug Development Spending, 2002-2012

• Exhibit 5-3: R&D Expenditures of Leading Pharmaceutical Developers, 2006 vs. 2005

• Exhibit 5-4: Number of Companies with Active Product Development Projects, 1997-2006

• Exhibit 5-5: Total Average Number of Active Phase I-III Clinical Trials Worldwide, 2001-2007

• Exhibit 5-6: Top Ten Therapeutic Categories in R&D Worldwide, March 2007

• Exhibit 5-7: A Comparison of Spending Rates in Phase I and Phase II/III Trials, 2004-2008

• Exhibit 5-8: Clinical Trials Phase IIIb/IV Market 2004-2008 (in U.S. billions)

• Exhibit 5-9: Global R&D Spending and Portion Outsourced to Contract Research, 2002-2012 (in US Billions)

• Exhibit 5-10: Contract Drug Development Market, 2002-2012 (Outsourced to CROs, Others)

• Exhibit 5-11: Contract Research Market (CRO, AMC, Other) 127

• Exhibit 5-12: CRO Market Share, 2007

• Exhibit 5-13: Selected Acquisitions of Leading CROs, 2006 to present

TABLE OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

• Table 1-1: The U.S. Drug Discovery, Development, and Approval Process

• Exhibit 1-2: Number of Active Clinical Drug Development Programs (May 11, 2007)

• Exhibit 1-3: Total Average Number of Active Clinical Drug Development Programs, 2001-2007

• Exhibit 1-4: Change in Protocol Eligibility Criteria, Comparison of 1999-2000 and 2003-2006

• Exhibit 1-5: Worldwide Clinical Trial Sites, by Region and Percent, as of 7/12/2008

• Exhibit 1-6: Portion of Global R&D Expenditures Outsourced: 2003-2008 by percent

• Exhibit 1-7: Contract Drug Development Market Share, Percent by Competitor Type (AMC, CRO’s Others), 2007

• Exhibit 1-8: Contract Research Market, Revenue by Competitor, 2002-2012

CHAPTER TWO: INTRODUCTION

• Exhibit 2-1: Investigational New Drug Submissions, 1992-2006

• Exhibit 2-3: Number of Clinical Trials Initiated Annually for U.S. Submissions

• Exhibit 2-4: Median Total Approval Time for Standard NDAs, 1993-2006

• Exhibit 2-5: Median Total Approval Time for Priority NDAs, 1993-2004

• Exhibit 2-6: Median Total Approval Time for Standard NMEs, 1995-2004

• Exhibit 2-7: Median Total Approval time for Priority NMEs, 1995-2004

• Exhibit 2-8: U.S. NMEs 2006 Approvals: Review Times by Drug

• Exhibit 2-10: Median Approval times for Safety vs All Drugs, By Decade

• Exhibit 2-11: Number and Location of Clinical Trial Sites Worldwide, as of 7/12/2008

• Exhibit 2-12: Worldwide Clinical Trial Sites, by Region and Percent, as of 7/12/2008

CHAPTER THREE: CLINICAL TRIAL OPERATIONS

• Exhibit 3-1: Key Clinical Trial Enrollment Statistics for: NMEs Approved in 2000-2006

• Exhibit 3-2: Number of Active Clinical Drug Development Programs (May 11, 2007)

• Exhibit 3-3: Total Average Number of Active Clinical Drug Development Programs, 2001-2007

• Exhibit 3-4: Summary Of Postmarketing Study Commitments (Numbers as of September 30, 2007)

• Exhibit 3-5: Benefits and Risks of Participating in Clinical Trials

• Exhibit 3-6: Change in Protocol Eligibility Criteria, Comparison of 1999-2000 and 2003-2006

• Exhibit 3-7: Aggregate Enrollment Data for All Extramural and Intramural Research Protocols Funded in FY2005 and Reported in FY2006, by Percent and Gender

CHAPTER FOUR: TRENDS

• Exhibit 4-1: New Paradigm for R&D

• Exhibit 4-2: Improvements in the Drug Development Process Reduce Development Costs

• Exhibit 4-3: Portion of Global R&D Expenditures Outsourced: 2003-2008 by percent

• Exhibit 4-4: Percentage of Industry-Sponsored Clinical Trials Awarded to Academic Medical Centers Versus Private Sector Companies: 1991, 1996,2001 and 2006

CHAPTER FIVE: MARKETS

• Table 5-2: Global Drug Development Spending, 2002-2012

• Table 5-2: Global Drug Development Spending, 2002-2012

• Exhibit 5-3: R&D Expenditures of Leading Pharmaceutical Developers, 2006 vs. 2005

• Exhibit 5-4: Number of Companies with Active Product Development Projects, 1997-2006

• Exhibit 5-5: Total Average Number of Active Phase I-III Clinical Trials Worldwide, 2001-2007

• Exhibit 5-6: Top Ten Therapeutic Categories in R&D Worldwide, March 2007

• Exhibit 5-7: A Comparison of Spending Rates in Phase I and Phase II/III Trials, 2004-2008

• Exhibit 5-8: Clinical Trials Phase IIIb/IV Market 2004-2008 (in U.S. billions)

• Exhibit 5-9: Global R&D Spending and Portion Outsourced to Contract Research, 2002-2012 (in US Billions)

• Exhibit 5-10: Contract Drug Development Market, 2002-2012 (Outsourced to CROs, Others)

• Exhibit 5-11: Contract Research Market (CRO, AMC, Other)

• Exhibit 5-12: CRO Market Share, 2007

• Exhibit 5-13: Selected Acquisitions of Leading CROs, 2006 to present