| D&MD’s Expanding Opportunities in Contract Research and Contract Manufacture of Biotherapeutics/ Biologics market analysis report is a comprehensive compilation of CROs, CMOs and their numerous secondary interconnections. This report traces the funding of the CRO network and highlights failure points along the chain of the biologic’s production including the realization that pharmaceutical productivity decline is most imminent in Phase II failure rates.
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- 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.2-12
- 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
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