The Nature of Pharmaceutical Contract Manufacturing
Scope and Methodology
State of the Marketplace
Size of the Market
2. Introduction and Overview
The Need for Outsourcing
Structured Processes Along the Chain of Development
Product Scalability and Quality Issues
Managing Several Products Simultaneously
Reasons Not to Contract Out
Types of Contract Organizations
3. Drivers and Trends
Drivers of Market Growth
A Changing Environment
Division of Knowledge and Time to Market
Growing Number of New Pharmaceuticals
The Virtual Company in the Market Place
Challenges and Obstacles
Multi-Product and Technology Challenges
Determining Manufacturing Requirements
Outsourcing Trends in Research and Development
Impact of Genomics
Protein Manufacturing Capacity Issues
Monoclonal Antibody Production Stretched
Demand Outstripping Supply
Smaller CMOs May Benefit
The European Picture
Trends in the Overall Size of the Contract Manufacturing-Outsourcing Market
Abbott One 2 One
Albany Molecular Research Inc.
Alpharma USPD Inc. Contract Manufacturing
Aurobindo Pharma Ltd.
Ben Venue Laboratories Inc.
BioSpecialties Australia Pty Ltd.
Burron OEM Division
Cardinal Health Inc.
ChemFirst Fine Chemicals Inc.
Chesapeake Biological Laboratories Inc.
Cook Pharmaceutical Solutions (Baxter Healthcare Corp.)
CP Pharmaceuticals Ltd.
DPT Laboratories Ltd.
Matrix Contract Services (Matrix Pharmaceutical Inc.)
MDS Pharma Services
Mova Pharmaceutical Corp.
Pharm-Eco Laboratories Inc.
Rhodia ChiRex Inc.
SP Pharmaceuticals LLC
West Pharmaceutical Services
Appendix: Company Directory
List of exhibits
Table 2-1: Reasons for Outsourcing Activity
Table 2-2: Research Outsourcing Expenditures, 1997-2000
Table 2-3: Issues Facing Contract Manufacturers
Table 2-4: Reasons for Not Using Contract Manufacturing Services
Table 2-5: Important Manufacturing Issues for Contractors
Table 2-6: Types of Industry Suppliers
Table 2-7: Services Offered by Contract Manufacturers
Table 2-8: GMP Issues for Contract Manufacturing
Table 3-1: Average Number of Units Required for Clinical Trials by Phase
Table 3-2: Biomanufacturing Capacity Relationship to Value of Product Produced
Table 3-3: Capacity Required for Biomanufacturing Market
Table 3-4: Issues Facing Transgenics Contract Manufacturing
Table 3-5: Potential Strong Growth Areas for Contract Manufacturers
Table 4-1: World Market for Pharmaceutical Outsourcing, 2001-2005
Table 4-2: U.S. Market for Pharmaceutical Outsourcing, 2001-2005
Table 4-3: European Market for Pharmaceutical Outsourcing, 2001-2005
Table 4-4: Japan-Asia Market for Pharmaceutical Outsourcing, 2001-2005
Table 4-5: World Market for Biopharmaceutical Outsourcing, 2001-2005
Table 4-6: World Demand for Lyophilization, 2001-2005
Table 4-7: Leading Pharmaceutical Contract Organizations
Figure 4-1: World Market for Pharmaceutical Outsourcing, 2001-2005
Figure 4-2: U.S. Market for Pharmaceutical Outsourcing, 2001-2005
Figure 4-3: European Market for Pharmaceutical Outsourcing, 2001-2005
Figure 4-4: Japan-Asia Market for Pharmaceutical Outsourcing, 2001-2005
The Pharmaceutical Contract Manufacturing Marketplace Description
Outsourcing pharmaceutical production is not new, and the benefits to big pharma companies are well documented. However, rapid changes in the kinds of drugs, the delivery technologies they will require, the expertise to scale-up new biopharmaceuticals, and even changes in capacity demand are all on the horizon for the contract manufacturing marketplace. One thing is for certain, contract manufacturing organizations (CMOs) will need to adapt to the changing needs of the pharma industry in the new age of drug discovery.
This research study on the status and outlook for pharmaceutical outsourcing is looking into such pressing issues as:
current and future capacity and demand
delivery and production technologies that CMOs will need to master
the state of "manufacturing R&D"—the research into effective scale-up
the demands of government and industry partners in the QC realm
the effects of industry trends, such as consolidation and specialization
Kalorama has conducted scores of interviews with executives and engineers at pharmaceutical companies and at CMOs to validate projections and to assess expectations and on both sides of this large and important marketplace.
Scope and Methodology
This report analyzes the state of the manufacturing segment of the pharmaceutical outsourcing business, reporting figures on the three key markets of North America, Europe, and Japan. The report profiles several companies involved in marketing their manufacturing services to the pharmaceutical companies, including Quintiles, Cammbrex, Genzyme, and others. The report generally reviews the nature and direction of where the pharmaceutical contract industry, specifically contract manufacturing, is headed and the challenges it faces. Discussions of contract research work, while not the focus of this report, are included in some areas because they represent a more mature model of outsourcing in the pharmaceutical industry as a whole and can be instructive.
Market forecasts are based on an examination of current market conditions and on investigations into the development of new products by key suppliers. This information also is weighted with projected timing and the probability of receiving FDA approval to market products. The information is the result of data gathered from company product literature and other corporate brochures and documents, as well as information found in the scientific and trade press. In addition, multiple interviews were conducted with key company executives and industry analysts. Research was conducted from June 2001 to November 2001.
New York, January 7, 2002 /PR Newswire — Contract manufacturing in the pharmaceutical industry will experience double-digit growth for the foreseeable future, according to a new study released today from Kalorama Information and available at MarketResearch.com, and a coming scarcity in manufacturing capacity will be a major factor in the upsurge in global outsourcing activity.
According to the new study, The Pharmaceutical Contract Manufacturing Marketplace, the global pharmaceutical outsourcing market stands at approximately $8 billion. However, the tsunami of new chemical entities in the pipeline, especially the huge number of biopharmaceuticals in development, will help to push the size of the market well past the $10 billion mark in less than three years as traditional manufacturers realize that capacity and specialized expertise are in short supply.
“Biomanufacturing capacity is definitely on everyone’s mind,” notes Steven Heffner, Acquisitions Editor for Kalorama Information. “But our research doesn’t necessarily indicate the dire shortfalls in capacity that some analysts have been predicting. We believe there are too many variables in the late-stage development process to assume the worst.”
In addition to the overall growth in outsourcing dollar volume, the number of pharmaceutical contract manufacturing organizations worldwide also continues to grow, according to the study. And the spectrum of services offered and the geographic spread of contract organizations also continues to widen as virtual pharmaceutical companies with more manufacturing needs become more common. The report examines these and other market trends, especially the importance of long-term strategic partnerships as the outsourcing industry matures.