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

Published by: Drug and Market Development Publishing

Published: Nov. 1, 2007 - 162 Pages

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.2-12

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

Abstract

About MarketResearch.com
MarketResearch.com is an online aggregator selling over 160,000 market research reports, company profiles and country profiles from over 600 research firms. Our reports will provide you with the critical business and competitive intelligence you need for strategic planning and marketing research. Coverage includes the US, UK, Europe, Asia and global markets.