Outsourcing in Drug Development: The Contract CRO Market, 3rd Edition
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.
TABLE OF CONTENTS
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)
- Contract Research Organizations (CROs)
- Competing Factors Managed Site Networks
- Competing Factors
- Clinical Trial Laboratories
- 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
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
