Outsourcing in Drug Development: The Contract CRO Market, 3rd Edition

Best Price Guarantee	Length	Publisher	Published Date	SKU
from $3,500	250 Pages	Kalorama Information	October, 2008	KLI1646604

Attention: There is an updated edition available for this report.

Best Price Guarantee
Price	from $3,500
Length	250 Pages
Publisher	Kalorama Information
Published Date	October, 2008
SKU	KLI1646604

Table of Contents
Description

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.

Executive Summary
- THE DRUG DEVELOPMENT PROCESS
- GOVERNMENT REGULATION OF CLINICAL RESEARCH
- Active Phase I, II & III Clinical Trials
  - Table Number of Active Clinical Drug Development Programs (May 11, 2007)
  - Table Total Average Number of Active Clinical Drug Development Programs, 2001-2007
- Phase IV Studies: Post Approval
- RECRUITING FOR CLINICAL TRIALS
- 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
  - Table Contract Research Market, 2002-2012
- 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
Introduction To Drug Development
- DRUG DEVELOPMENT PROCESS
- 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
  - Table Investigational New Drug Submissions, 1992-2006
- CLINICAL TRIALS
  - Table Number of Clinical Trials Initiated Annually for U.S. Submissions
- Preclinical Phase
  - Phase I
  - Phase IIa
  - Phase IIb
  - Phase III
  - Phase IIIa
  - Phase IIIb
  - Phase IV: Post Approval
- NEW DRUG APPLICATIONS
  - Table Median Total Approval Time for Standard NDAs, 1993-2006
  - Table Median Total Approval Time for Priority NDAs, 1993-2004
- New Molecular Entities and Approval Times
  - Table Median Total Approval Time for Standard NMEs, 1995-2004
  - Table Median Total Approval time for Priority NMEs, 1995-2004
  - Table U.S. NMEs 2006 Approvals: Review Times by Drug
- 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
Clinical Trials Operations
- CONDUCTING CLINICAL TRAILS
  - Table Key Clinical Trial Enrollment Statistics for NMEs Approved in 2000-2006
- 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
  - Table Number of Active Clinical Drug Development Programs (May 11, 2007)
  - Table Total Average Number of Active Clinical Drug Development Programs, 2001-2007
- PHASE IV STUDIES
- Post Approval Studies
  - Table Summary Of Postmarketing Study Commitments (Numbers as of September 30, 2007)
  - 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
  - Table Benefits and Risks of Participating 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
  - Table Guidance for Using Computerized Systems in Clinical investigations: Differences Between the Draft and the Final Guidance
  - Table Guidance for Using Computerized Systems in Clinical investigations: Key Requirements
  - Table Guidance for Using Computerized Systems in Clinical investigations: Recommendations for Implementation
- Electronic Patient Diaries
Trends in the Contract Drug Development Industry
- DRUG DEVELOPMENT COSTS
  - Table New Paradigm for R&D
  - Table Improvements in the Drug Development Process Reduce 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)
  - Table Percentage of Industry-Sponsored Clinical Trials Awarded to Academic Medical Centers Versus Private Sector Companies: 1991, 1996,2001 and 2006
  - Competing Factors
- Contract Research Organizations (CROs)
  - CRO Contracts
  - 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
Contract Drug Development Market
- Table Global Drug Development Spending, 2002-2012
- R&D SPENDING INCREASING
- Leading Pharmaceutical Developers
  - Table R&D Expenditures of Leading Pharmaceutical Developers, 2006 vs. 2005
  - Table Number of Companies with Active Product Development Projects, 1997-2006
- CLINICAL RESEARCH PRODUCTS IN DEVELOPMENT
  - Table Total Average Number of Active Phase I-III Clinical Trials Worldwide, 2001-2007
  - Table Top Ten Therapeutic Categories in R&D Worldwide, March 2007
- SHIFT IN SPENDING FOR CLINICAL RESEARCH
  - Spending for Phase I Trials Slows from Highs in 2004
- Safety Issues Drive Phase IIIb/IV Trial Spending
  - Table Clinical Trials Phase IIIb/IV Market 2004-2008 (in U.S. billions)
- CONTRACT DRUG RESEARCH MARKET
  - Table Global R&D Spending and Portion Outsourced to Contract Research, 2002-2012 (in US Billions)
  - Table Contract Drug Development Market, 2002-2012 (Outsourced to CROs, Others)
- CONTRACT RESEARCH COMPETITORS
  - Table Contract Research Market (CRO, AMC, Other) Revenue by Competitor, 2002-2012
- CROs Market Share
  - Table CRO Market Share, 2007
- CROs Broaden Services through Acquisitions
  - Table Selected Acquisitions of Leading CROs, 2006 to present
- 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
Company Profiles
Company Directory