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Production / Manufacturing |
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Pharmaceutical Contract Manufacturing and Research
Publication Date May 2005
Publisher Business Communications Company
Product Type Report
Pages 145
ISBN Number not applicable
Product Code BCC002
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Summary
Large pharmaceutical companies increasingly turn to contract manufacturing organizations (CMOs) solely to achieve efficiencies in cost, capacity and time-to-market, or to obtain a specific expertise not available in-house. Today, these factors still play a role, but now the most dynamic driver behind the use of CMOs in the pharmaceutical industry rapidly is becoming the unique, innovative, and state-of-the-art process and production technology they offer. More and more pharma companies are leaning towards outsourcing to concentrate on marketing their products, without spending time in drug discovery and process of manufacturing. This applies to those virtual companies that exist by the simple fact they can rely on contract manufacturers and researchers.
This BCC study looks at almost all types of contracting models and contracting companies. The rapid development of technologies and major changes in market behavior justify focusing on this segment. The report provides an overview of contract manufacturing and research in the pharmaceutical and examines contracting models and the history of and need for outsourcing. The contract companies manufacturing and researching pharmaceuticals and biopharmaceuticals are brought to the forefront and described in terms of industry structure and where they are placed in the present scenario.
Scope Of Study
The report contains:
- An overview of the contract in the pharmaceutical industry
- Analysis of the quality assurance required, the regulatory environment and technology transfer aspects
- An overview of technological issues and trends
- Examination of the market's size by specific drug with forecasts through 2009
- Revenue analysis by bulk drugs and dosage forms like solids, liquids and semisolids, and separately for OTC and nutritional products
- Analysis of the contract research market, with forecasts through 2009
- Company profiles and market shares, where available.
Report Highlights
- Worldwide revenue for contract manufacturing and research for the pharmaceutical industry was estimated at $100 billion in 2004 and is expected to rise at an average annual growth rate (AAGR) of 10.8% to $168 billion in 2009.
- Contract manufacturing of prescription drugs for 2004 was estimated at $26.2 billion, and is expected to rise to $43.9 billion by end of 2009.
- Contract manufacturing of OTC and nutritional products is the largest and fastest growing segment, expected to rise at an AAGR of 11.3% to $102 billion by 2009.
- The contract research market is expected to reach $21.9 billion by 2009, rising at an AAGR of 8.6% from $ 14.5 billion in 2004.
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Content
- Introduction
- Study Objectives
- Reasons For Doing This Study
- Contributions Of The Study And For Whom
- Scope Of The Study
- Methodology
- Information Sources
- About The Author
- Abbreviations Used
- Related BCC Reports
- BCC Online Services
- Disclaimer
- Summary
- Summary Table: Worldwide Revenue Of Pharmaceutical Contract Manufacturing And Contract Research Organizations, Through 2009 ($ Billions)
- Summary Figure: Worldwide Revenue Of Pharmaceutical Contract Manufacturing And Contract Research Organizations, 2002-2009 ($ Billions)
- Overview
- Background
- Need For Contract Manufacturing
- Capacity
- Risk
- Capital
- Flexibility
- Need For Contract Research
- Requirements For Contract Manufacturing Or Research
- Personnel And Other Requirements For Contract Organizations
- Basis Of Selection Of The Contract Organizations
- The Pros And Cons Of Contract Manufacturing
- Advantages Of Outsourcing
- Disadvantages Of Outsourcing
- Contracting Models
- Vendor Competitor Model
- Pre-Qualified Vendor Selection Model
- Partnership Model
- Principal Vendor Model
- Project Manager Model
- Quality And Performance Metrics
- History Of Outsourcing
- Regulatory Aspects
- Regulatory Aspects
- Regulatory Issues Which Could Arise In Contract Manufacturing And Research
- Regulations Governing The Manufacture Of Bulk Drugs
- Technology Transfer
- Technology Transfer &Quot;Definition&Quot;
- Factors Affecting Successful Technology Transfer Between Client And Contract Manufacturing Organization
- Process Definition
- Process Robustness
- Process Fit
- Process Changes
- Alignment Of Expectations
- Project Implementation And Management
- Working Relationship/Communication
- Establishing And Managing The Relationship
- Technical Transfer Process
- Role Of Project Teams
- Change Management
- Communications
- Industry Structure
- Market Shares
- Contract Manufacturers Of Bulk Drugs And Apis
- Contract Manufacturers Of Dosage Forms
- Market Share Of Contract Research Companies
- Types Of Contract Manufacturing And Research Firms
- Market By Products
- Contract Manufacturing
- Bulk Drugs Or Api
- India
- China
- Role Of Contract Bulk/Api Manufacturer In Product Development
- Future Role
- Government Contracts
- Market Leaders
- Market Size
- Oral Dosage Formulations
- Solid Dosage Formulations
- Market Leaders
- Market Outlook
- Regional Markets
- Market By Formulation
- Liquid Dosage Formulations
- Regional Markets
- Nonsterile Formulations
- Sterile Formulations
- Market Leaders
- Market By Formulation
- Nonsterile Formulations
- Sterile Formulations
- Semi-Solid Dosage Formulations
- Market Leaders
- Regional Markets
- Market By Formulation
- Contract Manufacturing Of Advanced Drug Delivery Products
- Background
- Overview
- Industry Structure
- Outsourcing
- Partnerships
- Market Leaders
- Market Outlook
- Otc And Nutritional Market
- Market Leaders
- Otc And Nutritional Market By Formulation
- Contract Research
- Market Leaders
- Market Outlook
- Applications Of Contract Manufacturing
- Cardiovascular Drug Market
- Reproductive Drug Market
- Oncology Drug And Diagnostics Market
- Analgesic Market
- Antiviral Drugs Market
- Antibiotics Market
- Market For Other Drugs
- Patent Analysis
- Patents By Year
- Patents By Company
- Patents By Country
- Outsourcing Perspectives
- Common Problems With Outsourcing/Contracting
- Philosophical Differences
- Ambiguous Scope
- How To Decrease The Chance Of Being Unhappy
- Conclusion
- Company Profiles
- Aai Development Services
- Albany Molecular Research, Inc.
- Alpharma Uspd, Inc.
- Alkermes
- Alza Corp. (J&J Company)
- Apptec Laboratories
- Advanced Polymer Pharma, Inc. (A.P. Pharma)
- Atrix Laboratories (QLT)
- Aerogen, Inc.
- Aradigm Corp.
- Aster Cephac
- Baxter Pharmaceutical Solutions
- Ben Venue Laboratories (Company Of Boehringer Ingelheim)
- Bioreliance Corp. (Invitrogen Bioservices)
- Cambrex Biopharmaceuticals
- Cangene
- Carbogen Laboratories Ag
- Cardinal Health
- Cedarburg Pharmaceuticals, Ltd.
- Chembridge Corp.
- Confab Laboratories
- Davos Chemical Corp.
- Decode Genetics
- Diosynth
- Discovery Partners International, Inc.
- Dowpharma
- Dpt Laboratories, Ltd.
- Dr Reddy's Laboratories
- Dsm Pharmaceuticals
- Evotec Oai
- Fulcrum Pharma Developments, Ltd.
- Genzyme Pharmaceuticals
- Gilead
- Glatt Contract Manufacturing
- Glaxosmithkline Bio Pharmaceuticals
- Girindus
- Hovione Sa
- Icos Corp.
- Lonza Group
- Lyne Laboratories
- 3m Drug Delivery Systems (3m Pharmaceuticals)
- Mallinckrodt Pharmaceuticals (OUTSOURCING)
- Mds Pharma Services
- Medarex, Inc.
- Mikart
- Mova Pharmaceutical Corp.
- Ortec Inc.
- Osg Norwich Pharmaceuticals
- Patheon
- Pharmacopeia Drug Discovery, Inc.
- Precision Pharma Services
- Quintiles, Inc.
- Regis Technologies, Inc.
- Ranbaxy Research Labs
- Schwarz Pharma
- Skyepharma
- Tetrionics, Inc.
- Xcellerex, Llc
- List Of Figures
- Summary Table: Worldwide Revenue Of Pharmaceutical Contract Manufacturing And Contract Research Organizations, Through 2009 ($ Billions)
- Table 1 Contracting Models
- Table 2 Metrics Used To Measure Contract Manufacturer Performance
- Table 3 Worldwide Market Share Of Contract Manufacturing Companies Providing Bulk Drug/Api, 2003
- Table 4 Worldwide Market Share Of Contract Manufacturing Companies Providing Solid Dosage Forms, 2003
- Table 5 Worldwide Market Share Of Contract Manufacturing Companies Providing Liquid Dosage Forms, 2003 (%)
- Table 6 Worldwide Market Share Of Contract Research Companies, 2003 (%)
- Table 7 Services Provided By Contract Manufacturing And Research Firms
- Table 8 Worldwide Revenue Of Bulk Drug/Api Contract Manufacturing By Region, Through 2009 ($ Billions)
- Table 9 Worldwide Share Of Bulk Drug/ Api Contract Manufacturing, Market Share By Region, 2004 (%)
- Table 10 Worldwide Revenue Of Solid Dosage Form Contract Manufacturing By Region, Through 2009 ($ Billions)
- Table 11 Worldwide Share Of Solid Dosage Form Contract Manufacturing, Market Share By Region, 2004
- Table 12 Worldwide Revenue Of Solid Dosage Form Contract Manufacturing By Formulation, Through 2009 ($ Billions)
- Table 13 Worldwide Share Of Solid Dosage Form Contract Manufacturing Market Share By Formulation, 2004 (%)
- Table 14 Worldwide Revenue Of Liquid Dosage Form (NONSTERILE) Contract Manufacturing By Region, Through 2009 ($ Millions)
- Table 15 Worldwide Share Of Liquid Dosage Form (NONSTERILE) Contract Manufacturing, Market Share By Region, 2004 (%)
- Table 16 Worldwide Revenue Of Liquid Dosage Form (STERILE) Contract Manufacturing By Region, Through 2009 ($ Millions)
- Table 17 Worldwide Share Of Liquid Dosage Form (STERILE) Contract Manufacturing, Market Share By Region, 2004 (%)
- Table 18 Worldwide Revenue Of Liquid Dosage Form (NONSTERILE) Contract Manufacturing By Formulation, Through 2009 ($ Millions)
- Table 19 Worldwide Share Of Liquid Dosage Form (NONSTERILE) Contract Manufacturing, Market Share By Formulation, 2004 (%)
- Table 20 Worldwide Revenue Of Liquid Dosage Form (STERILE) Contract Manufacturing By Formulation, Through 2009 ($ Millions)
- Table 21 Worldwide Share Of Liquid Dosage Form (STERILE) Contract Manufacturing, Market Share By Formulation, 2004 (%)
- Table 22 Worldwide Revenue Of Semi-Solid Dosage Form Contract Manufacturing By Region, Through 2009 ($ Millions)
- Table 23 Worldwide Share Of Semi-Solid Dosage Form Contract Manufacturing, Market Share By Region, 2004 (%)
- Table 24 Worldwide Revenue Of Semi-Solid Dosage Form Contract Manufacturing By Formulation, Through 2009 ($ Millions)
- Table 25 Worldwide Share Of Semi-Solid Dosage Form Contract Manufacturing, Market Share By Formulation, 2004 (%)
- Table 26 Contracting Companies Providing Drug Delivery Systems
- Table 27 Worldwide Revenue Of Advanced Drug Delivery System Contract Manufacturing By Type, Through 2009 ($ Billions)
- Table 28 Worldwide Share Of Advanced Drug Delivery System Contract Manufacturing, 2004 (%)
- Table 29 Worldwide Revenue Of Otc And Nutritional Product Contract Manufacturing By Region, Through 2009 ($ Billions)
- Table 30 Worldwide Share Of Otc And Nutritional Products Contract Manufacturing, Market Share By Region, 2004 (%)
- Table 31 Worldwide Revenue Of Otc And Nutritional Product Contract Manufacturing By Dosage Form, Through 2009 ($ Billions)
- Table 32 Worldwide Share Of Otc And Nutritional Product Contract Manufacturing, Market Share By Dosage Form, 2004 (%)
- Table 33 Worldwide Market For Contract Pharmaceutical Research By Region, Through 2009 ($ Billions)
- Table 34 Worldwide Share Of Otc And Nutritional Product Contract Research, Market Share By Region, 2004 (%)
- Table 35 Worldwide Revenue Of Contract Research By Discipline, Through 2009 ($ Billions)
- Table 36 Worldwide Share Of Contract Research Market Share By Discipline, 2004 (%)
- Table 37 Worldwide Revenue Of Cardiovascular Drugs Contract Manufacturing By Region, Through 2009 ($ Millions)
- Table 38 Worldwide Revenue Of Reproductive Drug Contract Manufacturing By Region, Through 2009 ($ Millions)
- Table 39 Worldwide Revenue Of Oncology Drug And Diagnostic Contract Manufacturing By Region, Through 2009 ($ Millions)
- Table 40 Worldwide Revenue Of Analgesic Contract Manufacturing By Region, Through 2009 ($ Millions)
- Table 41 Worldwide Revenue Of Antiviral Drug Contract Manufacturing By Region, Through 2009 ($ Millions)
- Table 42 Worldwide Revenue Of Antibiotic Contract Manufacturing By Region, Through 2009 ($ Millions)
- Table 43 Worldwide Revenue Of Other Drug Contract Manufacturing By Region, Through 2009 ($ Billions)
- Table 44 Number Of Patents, 2000-2004
- Table 45 Number Of U.S. Patents By Company, 2000-2004
- Table 46 Number Of U.S. Patents By Country, 2000-2004
- Table 47 Share Of Patents, By Country, 2004-2000 (%)
- List Of Figures
- Summary Figure: Worldwide Revenue Of Pharmaceutical Contract Manufacturing And Contract Research Organizations, 2002-2009 ($ Billions)
- Figure 1 Worldwide Market Share Of Contract Manufacturing Companies Providing Bulk Drug/Api, 2003 (%)
- Figure 2 Worldwide Market Share Of Contract Manufacturing Companies Providing Solid Dosage Forms, 2003 (%)
- Figure 3 Worldwide Market Share Of Contract Manufacturing Companies Providing Liquid Dosage Forms, 2003 (%)
- Figure 4 Worldwide Market Share Of Contract Research Companies, 2003 (%)
- Figure 5 Worldwide Revenue Of Bulk Drug/Api Contract Manufacturing By Region, 2002-2009 ($ Billions)
- Figure 6 Worldwide Share Of Bulk Drug/Api Contract Manufacturing, Market Share By Region, 2004 (%)
- Figure 7 Worldwide Revenue Of Solid Dosage Form Contract Manufacturing By Region, 2002-2009 ($ Billions)
- Figure 8 Worldwide Share Of Solid Dosage Form Contract Manufacturing, Market Share By Region, 2004 (%)
- Figure 9 Worldwide Revenue Of Solid Dosage Form Contract Manufacturing By Formulation, 2002-2009 ($ Billions)
- Figure 10 Worldwide Share Of Solid Dosage Form Contract Manufacturing, Market Share By Formulation, 2004 (%)
- Figure 11 Worldwide Revenue Of Liquid Dosage Form (NONSTERILE) Contract Manufacturing By Region, 2002-2009 ($ Millions)
- Figure 12 Worldwide Share Of Liquid Dosage Form (NONSTERILE) Contract Manufacturing, Market Share By Region, 2004 (%)
- Figure 13 Worldwide Revenue Of Liquid Dosage Form (STERILE) Contract Manufacturing By Region, 2002-2009 ($ Millions)
- Figure 14 Worldwide Revenue Of Liquid Dosage Form (STERILE) Contract Manufacturing, Market Share By Region, 2004 (%)
- Figure 15 Worldwide Revenue Of Liquid Dosage Form (Non-Sterile) Contract Manufacturing By Formulation, 2002-2009 ($ Millions)
- Figure 16 Worldwide Share Of Liquid Dosage Form (NONSTERILE) Contract Manufacturing, Market Share By Formulation, 2004 (%)
- Figure 17 Worldwide Revenue Of Liquid Dosage Form (STERILE) Contract Manufacturing By Formulation, 2002-2009 ($ Millions)
- Figure 18 Worldwide Share Of Liquid Dosage Form (STERILE) Contract Manufacturing, Market Share By Formulation, 2004 (%)
- Figure 19 World-Wide Revenue Of Semi-Solid Dosage Form Contract Manufacturing By Region, 2002-2009 ($ Millions)
- Figure 20 Worldwide Share Of Semi-Solid Dosage Form Contract Manufacturing, Market Share By Region, 2004 (%)
- Figure 21 Worldwide Revenue Of Solid Dosage Form Contract Manufacturing By Formulation, 2002-2009 ($ Millions)
- Figure 22 Worldwide Share Of Semi-Solid Dosage Form Contract Manufacturing, Market Share By Formulation, 2004 (%)
- Figure 23 Worldwide Revenue Of Advanced Drug Delivery System Contract Manufacturing By Type, 2002-2009 ($ Billions)
- Figure 24 Worldwide Share Of Advanced Drug Delivery System Contract Manufacturing, 2004 (%)
- Figure 25 Worldwide Revenue Of Otc And Nutritional Products By Contract Manufacturing By Region, 2002-2009 ($ Billions)
- Figure 26 Worldwide Share Of Otc And Nutritional Product Contract Manufacturing, Market Share By Region, 2004 (%)
- Figure 27 Worldwide Revenue Of Otc And Nutritional Product Contract Manufacturing By Dosage Form, 2002-2009 ($ Billions)
- Figure 28 Worldwide Share Of Otc And Nutritional Product Contract Manufacturing, Market Share By Dosage Form, 2004 (%)
- Figure 29 Worldwide Market For Contract Pharmaceutical Research By Region, 2002-2009 ($ Billions)
- Figure 30 Worldwide Share Of Otc And Nutritional Product Contract Research, Market Share By Region, 2004 (%)
- Figure 31 Worldwide Revenue Of Contract Research By Discipline, 2002-2009 ($ Billions)
- Figure 32 Worldwide Share Of Contract Research Market Share By Discipline, 2004 (%)
- Figure 33 Worldwide Revenue Of Cardiovascular Drug Contract Manufacturing By Region, 2002-2009 ($ Millions)
- Figure 34 Worldwide Revenue Of Reproductive Drugs Contract Manufacturing By Region, 2002-2009 ($ Millions)
- Figure 35 Worldwide Revenue Of Oncology Drug And Diagnostic Contract Manufacturing By Region, 2002-2009 ($ Millions)
- Figure 36 Worldwide Revenue Of Analgesic Contract Manufacturing By Region, 2002-2009 ($ Millions)
- Figure 37 Worldwide Revenue Of Antiviral Drug Contract Manufacturing By Region, 2002-2009 ($ Millions)
- Figure 38 Worldwide Revenue Of Antibiotic Contract Manufacturing By Region, 2002-2009 ($ Millions)
- Figure 39 Worldwide Revenue Of Other Drug Contract Manufacturing By Region, 2002-2009 ($ Billions)
- Figure 40 Number Of Patents, 2000-2004
- Figure 41 Number Of Patents, Share By Year, 2000-2004 (%)
- Figure 42 Number Of U.S. Patents By Company, 2000-2004
- Figure 43 Number Of U.S. Patents By Country, 2000-2004
- Figure 44 Number Of Patents Issued By Country, 2000-2004
- Figure 45 Share Of Patents Issued, By Country, 2000-2004 (%)
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