Expanding Opportunities in Contract Research and Contract Manufacture of Biotherapeutics/Biologics

Table of Contents

Chapter 1: Executive Summary

Chapter 2: Economics of Outsourcing BioPharmaceuticals/Biologics

• 2.1 Funding of Biomedical Research by the Pharmaceutical Industry and Federal Government in US
  • 2.1.1 Government Funding
    • 2.1.1.1 Industry Support
    • 2.1.1.2 Distribution of Funds between Basic and Clinical Research
  • 2.1.2 R&D Funding for Drug Development in 2006
  • 2.1.3 Regulatory Environment
  • 2.1.4 Funding for Discovery and Preclinical Innovation of Drugs
  • 2.1.5 Failure Analysis of Pharmaceutical Productivity
  • 2.1.6 Small/Mid Tier Pharmaceutical Companies
• 2.2 CROs Contribution to Drug Discovery, Development, Manufacture and Sale of BioPharmaceuticals
  • 2.2.1 Meta Analysis of the CRO Markets
  • 2.2.2 CRO Segment Growth Rates
• 2.3 Outsourcing BioPharmaceutical to Contract Research Organizations
  • 2.3.1 Reasons for Outsourcing Clinical Trials to CROs
    • 2.3.1.1 Drivers of Outsourcing
    • 2.3.1.2 Downward Cost Pressures
    • 2.3.1.3 Upward Cost Pressures

Chapter 3: An FDA Approved Drug Takes 15 Years and Costs Over $1 Billion

• 3.1 CROs-Integral to the Drug Discovery and Development of Biologics
• 3.2 An Overview of Biologics Manufacturing
  • 3.2.1 The Drug Discovery and Development (Preclinical) to Clinical FDA Approval Process
  • 3.2.2 Phases of Drug Development in the US
• 3.3 Making a Reliable Estimate of Drug Productivity
  • 3.3.1 Current Costs to Develop a New Drug
• 3.4 Clinical Trials (Phases I to III) Leading to NDA Submissions, Phase IV and FDA Approval
  • 3.4.1 Tactical, Project, and Strategic Clinical Trial Outsourcing Models
  • 3.4.2 Preclinical Market in 2006
    • 3.4.2.1 Phase I Clinical Study Market
    • 3.4.2.2 Phase II/IIIB Clinical Study Market
    • 3.4.2.3 Phase IIIb/IV Clinical Study Market Projection
  • 3.4.3 Central Laboratory/Clinical Trial Laboratory Service Market
  • 3.4.4 Electronic Data Capture (EDC) and Electronic Health Record (EHR)
    • 3.4.4.1 Electronic Data Capture (EDC)
    • 3.4.4.2 Electronic Health Records (EHR)
  • 3.4.5 Medical Devices Worldwide and US Revenues
• 3.5 Market Drivers for CROs
  • 3.5.1 CRO Usage by Sponsor Companies
  • 3.5.2 Drivers of CRO Growth
• 3.6 Estimating Clinical Success and Evaluating Clinical Phase Related Attrition Rates
  • 3.6.1 CMOs Can Speed Up Time to Market by 30%

Chapter 4: Large Scale Contract Manufacture in Phase IV

• 4.1 CMOs-A Gateway to Clinical Trials f0r Growing Biotech Companies
  • 4.1.1 Case Study of Wyeth' s Over- and Under- Production of BioPharmaceuticals
• 4.2 Biologics Growth Drives the CMO Market
  • 4.2.2 Demand for Biotech Products on the Rise
  • 4.2.3 The Growth of Pharmaceutical/Biotech Company-based Gross Sales Revenues
• 4.3 Large Number of Branded Drugs Going Off-Patent Likely to Boost Demand for Manufacturing
• 4.4 CMOs Provide Biotech Follow ups for Smaller and Mid Size Biotech and Pharmaceutical Agencies
  • 4.4.1 CMOs Provide the Means to Entry at a Later Stage of the Development Process
  • 4.4.2 CMOs Add Value by Increasing the Rate of Manufacturing
  • 4.4.3 Self Manufacture Versus Outsourcing to a CMO
• 4.5 Capacity Sharing: Symbiotic Relationships between Bio/Pharmaceutical Companies and Contract Manufacturers of Therapeutic Antibodies
  • 4.5.1 Summary of Market Drivers for CMOs

Chapter 5: Globalized CRO Outsourcing in Asia

• 5.1 India is the Number One Preferred Offshoring Site for CROs
  • 5.1.1 CROs are Boosting the Indian Biotech Market and Vice Versa
    • 5.1.1.1 Conclusion
• 5.2 China, Singapore, Malaysia, and South Korea
  • 5.2.1 Production Issues in China in 2007 in a Rapidly Growing Generics Market
    • 5.2.1.1 Infrastructure and Local Regulations -the Growing Generics Industry
    • 5.2.1.2 Major Biotech Advances in Taiwan
    • 5.2.1.3 Singapore' s Strategic Imperative
    • 5.2.1.4 South Korea
  • 5.2.2 CROs Market Analysis

Chapter 6: Company Profiles

• AAI Pharmaceutical
• Averion International
• Bioanalytical Systems
• Bio-Imaging Technologies
• Catalyst Pharmaceutical Group
• Charles River Laboratories
• Clinigene (Biocon)
• ClinPro
• Commonwealth Biotechnologies
• Constella Group
• Covalent Group (Encorium Group)
• Covance
• Eurofins Scientific
• ICON Clinical
• Kendle Research
• Lab International & LAB Research (Aleka Pharma)
• Life Science Research
• MDS Pharmaceutical
• Medpace
• Novum Pharmaceutical
• Omnicare CRO Services
• Paragon Biomedical
• Parexel
• Patheon
• PPD
• PRA International (Genstar Capital)
• Pracs Institute
• Quest
• Quintiles Transnational
• SFBC (PharmaNet)
• SIRO Clinpharm (3i Group)

TABLE OF EXHIBITS

• Exhibit 2.1 Pharmaceutical/BioPharmaceutical and NIH Funding 2004 - 2006
• Exhibit 2.2 Domestic Spending for R&D in Biomedical Sector
• Exhibit 2.3 2006 Budget for R&D Funding for Drug Development
• Exhibit 2.4 Current Legislative Acts Initiated in 2007
• Exhibit 2.5 Industry versus Non-Industry Distribution of Funding
• Exhibit 2.6 NME Output Normalized for 2004 $s
• Exhibit 2.7 Division of NMEs Attributed to Small/Mid-Tier Pharmaceutical Companies versus Large Pharmaceutical Companies 2001-2006
• Exhibit 2.8 Current Deal Term by Stage of Development
• Exhibit 2.9 Meta Analyses of Financial Projections for the CRO Market
• Exhibit 2.10 Projected CRO Market Revenues Derived from Global Pharmaceutical Sales
• Exhibit 2.11 Contract Clinical Service Represented as a Fraction of Developmental Budget
• Exhibit 2.12 Shifting Share of Clinical Projects from AMC to Independent Community Based CRO Related Sponsors
• Exhibit 2.13 Annual Increase in the Percent of Outsourced R&D Expenditure
• Exhibit 2.14 Pharmaceutical R&D Spending Growth is Outpaced by the Outsourced R&D Growth
• Exhibit 2.15 Double Digit Growth of CAGR of Developmental Phases
• Exhibit 2.16 Activities Across the Development Process
• Exhibit 2.17 2006 Services Offered by CROs
• Exhibit 3.1 Pharmaceutical Firm Spending by R&D Phase
• Exhibit 3.2 Increasing Numbers of Investigators and Clinical Trial studies
• Exhibit 3.3 Clinical Trial Spending on Various Drug Development Phases
• Exhibit 3.4 Increase in Number of NMEs in Phase II
• Exhibit 3.5 Total 2005 Revenue from Companies with Central Laboratory Services
• Exhibit 3.6 Clinical Trial Laboratory Services Estimated Revenues
• Exhibit 3.7 Clinical Trials Service Providers Market Share
• Exhibit 3.8 Estimated Market Size of EDC Solutions
• Exhibit 3.9 Estimated EHR Market Growth
• Exhibit 3.10 Global and Domestic Medical Device Market to 2009
• Exhibit 3.11 Relating Cost and Speed
• Exhibit 3.12 Overall Costs and Times in the Drug Development Process
• Exhibit 4.1 Companies Having $400 Million Cash Reserve
• Exhibit 4.2 CMO Related Manufacturing Capacity
• Exhibit 4.3 Top 20 Blockbuster Biologic Products (Global) in 2006
• Exhibit 4.4 Worldwide 2006 Sale of Bio/Pharmaceutical Biologics
• Exhibit 4.5 Number of Biotech Drugs in Pipeline
• Exhibit 4.6 Implied Demand For Manufacturing Capacity of Monoclonal Antibodies
• Exhibit 4.7 US Pharmaceutical Sales Under Generic Competition Threat
• Exhibit 4.8 Top 10 Generic Companies 2005 US Revenues
• Exhibit 4.9 Generic Pharmaceutical Market
• Exhibit 4.10 Current Blockbusters that are Expected to be Targeted as Generics
• Exhibit 4.11 Number of Biotechnology Derived Marketed Drugs
• Exhibit 4.12 Number of Biotechnology Derived Marketed Drugs
• Exhibit 4.13 Assumptions Made in an Economical Model
• Exhibit 4.14 Comparison of the CRO Manufacturing versus Self Manufacturing Advantages
• Exhibit 4.15 Cell Culture Manufacturing Capacity of CMOs
• Exhibit 5.1 2003 Survey Conducted Across Six Offshoring Operations
• Exhibit 5.2 Global Clinical Investigation Spread as Demonstrated by Increase in 1572 Filings
• Exhibit 5.3 Clinical Studies Cost Comparison by Country
• Exhibit 5.4 2004 Leading Pharmaceutical Companies in India
• Exhibit 5.5 India' s Biotech Firms
• Exhibit 5.6 Revenue Forecasts for China' s CRO Activities
• Exhibit 5.7 Major Generics being Manufactured in Taiwan
• Exhibit 5.8 Top 5 CROs Increasing Market Share
• Exhibit 5.9 Public CRO Revenues in 2006
• Exhibit 5.10 CAGR Relating to Revenues of Public Traded CROs
• Exhibit 5.11 CRO Sector Metrics