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Home > Market Research > Prescription Medicines > Contract Pharmaceutical Manufacturing, Research, and Packaging
REPORT HIGHLIGHTS Worldwide revenue for contract manufacture of prescription drugs (dosage forms) for 2004 was $11.1 billion, which is projected to increase at a compound annual growth rate (CAGR) of 9.4%, reaching $22.5 billion by the end of 2011. Contract manufacture of over-the-counter and nutritional products worldwide is projected to reach $108.8 billion by 2011 increasing at a CAGR of 8.1%. Contract research revenues are projected to reach $24.3 billion by 2011, increasing from $17.3 billion in 2006 at a CAGR of 7.0%. Contract manufacturing in the bulk drug market had worldwide revenue of about $13.5 billion in 2004
INTRODUCTION BCC's goal in conducting this study is to provide an overview of the current and future characteristics of the global market for contract manufacturing, research, and packaging in the pharmaceutical business. The key objective is to present a comprehensive analysis of the current market and its future direction in the pharmaceutical outsourcing industry with the emphasis on contract manufacturing. This report explores present and future strategies within the contract manufacturing, research, and packaging pharmaceutical industry. Definitions, needs, requirements, and the advantages and disadvantages of outsourcing are discussed. The study also includes market forecasts and a discussion of the market leaders in the industry. Risks involved, regulatory requirements, and technologies involved are crucial components of this market outlook. Influential market scenarios such as the need for contract manufacturing, research, selection of contractors, etc. have been included, along with a detailed analysis of the pharmaceutical/biopharmaceutical contract manufacturing, research, and packaging industry structure. Revenues are broken down by the bulk as well as by dosage forms of solid, liquid, and semisolid. Sales figures are estimated for the 5-year period from 2006 through 2011. Over-the-counter (OTC), nutritional, and drug delivery products are discussed separately in this report. Contract research and contract packaging are also discussed separately SCOPE OF STUDY This report contains: The current market status for contract manufacturing, research, and packaging and forecasts for growth through 2011 Discussion of the advantages and disadvantages of outsourcing Technological issues including the latest trends and developments Descriptions of each market's need for outsourcing, risks and regulatory environment. A break down of revenues by the bulk as well as by the dosage forms of solid, liquid and semisolid. METHODOLOGY BCC conducted a comprehensive literature search, which included technical newsletters and journals, and many other sources. Data were collected through interviews and correspondence with various analytical/chemical/pharmaceutical and contracting experts. Projections were based on estimates such as the current number of end users, potential end users, mergers and acquisitions, and market trends. INFORMATION SOURCES Many companies within the industry were surveyed to obtain data for this study. Included were manufacturers and end users of pharmaceuticals through contract manufacturing/research. Data were gathered from various industry sources. BCC spoke with officials and physicians within the industry, consulted newsletters, company literature, product literature, and a host of technical articles, journals, indexes, and abstracts. Exhaustive investigations of databases by key terminology were completed. In addition, data were compiled from current financial, trade, and government sources.
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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 RELATED BCC RESEARCH REPORTS BCC ONLINE SERVICES DISCLAIMER EXECUTIVE SUMMARY SUMMARY TABLE GLOBAL PHARMACEUTICAL CONTRACT MANUFACTURING AND CONTRACT RESEARCH ORGANIZATIONS REVENUE FORECAST, THROUGH 2011 ($ BILLIONS) SUMMARY FIGURE WORLDWIDE PHARMACEUTICAL CONTRACT MANUFACTURING AND CONTRACT RESEARCH ORGANIZATIONS REVENUE, 2004-2011 (BILLIONS) OVERVIEW DEFINITIONS CONTRACT MANUFACTURING CONTRACT RESEARCH CONTRACT PACKAGING PACKAGING SERVICE SELECTION CRITERIA ADVANTAGES OF CONTRACT PACKAGING NEED FOR OUTSOURCING NEED FOR CONTRACT MANUFACTURING Flexibility Capacity and Capital Risks NEED FOR CONTRACT RESEARCH NEED FOR CONTRACT PACKAGING CAPABILITIES AND QUALITIES OF CONTRACT COMPANIES PROS AND CONS OF OUTSOURCING ADVANTAGES OF OUTSOURCING DISADVANTAGES OF OUTSOURCING CONTRACT REQUIREMENTS BASIC RISKS IN OUTSOURCING PARTNERSHIPS KEYS TO REDUCING RISKS KEYS TO CONTRACT ORGANIZATIONS MEETING CHALLENGES IN QUALITY AND REGULATORY REQUIREMENTS TECHNOLOGY INTRODUCTION SELECTION OF AN OUTSOURCING PROVIDER CONTRACT MANUFACTURING ORGANIZATION REQUIREMENTS Term Sheet Manufacturing Agreement between the Parties Quality Agreement Technology Transfer Information Exchange Process Design and Process Logistics Process Description Production Requirements Plan Reviewing Production Details Perform Transfer Runs Implementation of the Production Requirements Plan Training Keys to a Good Relationship Client Involvement in Technology Transfer Team Meetings Management’s Involvement Contract Manufacturing Agreement Role of the Project Manager Role of the Project Manager (Continued) REGULATORY ASPECTS REGULATORY COMPLIANCE REQUIREMENTS AGREEMENT BETWEEN CONTRACTOR AND CLIENT TO MEET REGULATIONS REGULATORY ISSUES IN CONTRACT MANUFACTURING USE OF CONSULTING FIRMS REGULATION OF API/BULK DRUG MANUFACTURING INDUSTRY STRUCTURE MARKET SHARES OF INDUSTRY LEADERS CONTRACT MANUFACTURERS OF BULK DRUGS AND APIS TABLE 1 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING BULK DRUGS/API, 2006 (%) TABLE 1 (CONTINUED) FIGURE 1 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING BULK DRUGS/API, 2006 (%) CONTRACT MANUFACTURERS OF SOLID DOSAGE FORMS TABLE 2 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING SOLID DOSAGE FORMS, 2006 (%) FIGURE 2 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING SOLID DOSAGE FORMS, 2006 (%) CONTRACT MANUFACTURERS OF LIQUID DOSAGE FORMS TABLE 3 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING LIQUID DOSAGE FORMS, 2006 (%) FIGURE 3 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING LIQUID DOSAGE FORMS, 2006 (%) CONTRACT MANUFACTURERS OF SEMISOLID DOSAGE FORMS TABLE 4 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING SEMISOLID DOSAGE FORMS, 2006 (%) FIGURE 4 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING SEMISOLID DOSAGE FORMS, 2006 (%) CONTRACT RESEARCH COMPANIES TABLE 5 WORLDWIDE MARKET SHARES OF CONTRACT RESEARCH COMPANIES, 2006 (%) FIGURE 5 WORLDWIDE MARKET SHARES OF CONTRACT RESEARCH COMPANIES, 2006 (%) CONTRACT PACKAGING COMPANIES TABLE 6 WORLDWIDE MARKET SHARES OF CONTRACT PACKAGING COMPANIES, 2006 (%) FIGURE 6 WORLDWIDE MARKET SHARES OF CONTRACT PACKAGING COMPANIES, 2006 (%) TYPES OF CONTRACT MANUFACTURING AND RESEARCH FIRMS TABLE 7 SERVICES PROVIDED BY CONTRACT MANUFACTURING AND RESEARCH FIRMS TABLE 7 (CONTINUED) TABLE 7 (CONTINUED) TABLE 7 (CONTINUED) TABLE 7 (CONTINUED) TABLE 7 (CONTINUED) TABLE 7 (CONTINUED) TABLE 8 SERVICES PROVIDED BY CONTRACT PACKAGING FIRMS BY PACKAGING TYPE SUPPLY AND DEMAND STRATEGIC TOOLS TIME TO MARKET CHALLENGES IN OUTSOURCING IDENTIFICATION OF OUTSOURCING PARTNERS FINANCIAL CONSIDERATIONS PREFERRED PROVIDERS INNOVATIVE PARTNERS SUITABLE ALTERNATIVES NEW DEVELOPMENTS ABBOTT LABORATORIES ALBANY MOLECULAR RESEARCH (AMRI) ASTELLAS PHARMA CAMBREX CARDINAL HEALTH CHEMBRIDGE GLAXOSMITHKLINE (GSK) MALLINCKRODT, INC. PATHEON SCHWARZ PHARMA MARKETS BACKGROUND CONTRACT MANUFACTURING CONTRACT MANUFACTURE OF BULK DRUGS/APIS Contract Manufacture of ? (Continued) Role of APIs in the Success of Generic Firms Role of Contract Manufacturer in API Product Development Market Leaders Market Revenue TABLE 9 GLOBAL BULK DRUG/API CONTRACT MANUFACTURING REVENUE FORECAST BY REGION THROUGH 2011 ($ BILLIONS) FIGURE 7 GLOBAL BULK DRUG/API CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004-2011 ($ BILLIONS) Market Shares TABLE 10 GLOBAL BULK DRUG/API CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) FIGURE 8 GLOBAL BULK DRUG/API CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) CONTRACT MANUFACTURE OF ORAL DOSAGE FORMULATIONS Solid Dosage Formulations Market Leaders Market Revenue TABLE 11 GLOBAL SOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, THROUGH 2011 ($ BILLIONS) FIGURE 9 GLOBAL SOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004-2011 (BILLIONS) Market Shares TABLE 12 GLOBAL SOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) FIGURE 10 GLOBAL SOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) Market by Formulation Market Revenue TABLE 13 GLOBAL SOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE FORECAST BY FORMULATION, THROUGH 2011 ($ BILLIONS) FIGURE 11 GLOBAL SOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE FORECAST BY FORMULATION, 2004-2011 ($ BILLIONS) TABLE 14 GLOBAL SOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2006 (%) FIGURE 12 GLOBAL SOLID DOSAGE FORM CONTRACT MANUFACTURING, MARKET SHARES BY FORMULATION, 2006 (%) CONTRACT MANUFACTURE OF LIQUID DOSAGE FORMULATIONS Non-sterile Formulations Market Revenue TABLE 15 GLOBAL LIQUID DOSAGE FORM (NON-STERILE) CONTRACT MANUFACTURING REVENUE BY REGION, THROUGH 2011 ($ MILLIONS) FIGURE 13 GLOBAL LIQUID DOSAGE FORM (NON-STERILE) CONTRACT MANUFACTURING REVENUE BY REGION, 2004-2011 ($ MILLIONS) Market Shares TABLE 16 GLOBAL LIQUID DOSAGE FORM (NON-STERILE) CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) FIGURE 14 GLOBAL LIQUID DOSAGE FORM (NON-STERILE) CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) Sterile Formulations Market Leaders Market Revenue TABLE 17 GLOBAL LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING REVENUE FORECAST, BY REGION, THROUGH 2011 ($ MILLIONS) FIGURE 15 GLOBAL LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING REVENUE FORECAST, BY REGION, THROUGH 2011 ($ MILLIONS) Market Shares TABLE 18 GLOBAL LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) FIGURE 16 GLOBAL LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) Market by Formulation Non-sterile Formulations TABLE 19 GLOBAL LIQUID DOSAGE FORM (NON-STERILE) CONTRACT MANUFACTURING REVENUE FORECAST, BY FORMULATION, THROUGH 2011 ($ MILLIONS) FIGURE 17 GLOBAL LIQUID DOSAGE FORM (NON-STERILE) CONTRACT MANUFACTURING REVENUE BY FORMULATION, 2004-2011 ($ MILLIONS) TABLE 20 GLOBAL LIQUID DOSAGE FORM (NON-STERILE) CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2006 (%) FIGURE 18 GLOBAL LIQUID DOSAGE FORM (NON-STERILE) CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2006 (%) Sterile Formulations TABLE 21 GLOBAL LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING REVENUE FORECAST BY FORMULATION, THROUGH 2011 ($ MILLIONS) FIGURE 19 GLOBAL LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING REVENUE FORECAST BY FORMULATION, 2004-2011 ($ MILLIONS) TABLE 22 GLOBAL LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2006 (%) FIGURE 20 GLOBAL LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2006 (%) CONTRACT MANUFACTURE OF SEMISOLID DOSAGE FORMULATIONS Market Leaders Market Revenue TABLE 23 GLOBAL SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, THROUGH 2011 ($ MILLIONS) FIGURE 21 GLOBAL SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004-2011 ($ MILLIONS) Market Shares TABLE 24 GLOBAL SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) FIGURE 22 GLOBAL SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) Market by Formulation TABLE 25 GLOBAL SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE FORECAST BY FORMULATION, THROUGH 2011 ($ MILLIONS) FIGURE 23 GLOBAL SOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE FORECAST BY FORMULATION, 2004-2011 ($ MILLIONS) TABLE 26 GLOBAL SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2006 (%) FIGURE 24 GLOBAL SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2006 (%) CONTRACT MANUFACTURE OF ADVANCED DRUG DELIVERY PRODUCTS Contract Manufacture of?(Continued) Partnerships Market Leaders TABLE 27 CONTRACTING COMPANIES PROVIDING DRUG DELIVERY SYSTEMS Market Outlook Market Revenue TABLE 28 GLOBAL CONTRACTING COMPANIES PROVIDING ADVANCED DRUG DELIVERY SYSTEMS REVENUE FORECAST BY TYPE, THROUGH 2011 ($ BILLIONS) FIGURE 25 GLOBAL ADVANCED DRUG DELIVERY SYSTEM CONTRACT MANUFACTURING REVENUE FORECAST BY TYPE, 2004-2011 ($ BILLIONS) Market Shares TABLE 29 GLOBAL ADVANCED DRUG DELIVERY SYSTEM CONTRACT MANUFACTURING SHARE BY TYPE, 2006 (%) FIGURE 26 GLOBAL ADVANCED DRUG DELIVERY SYSTEM CONTRACT MANUFACTURING REVENUE BY TYPE, 2006 (%) CONTRACT MANUFACTURE OF OTC AND NUTRITIONAL PRODUCTS Market Leaders Market Revenue TABLE 30 GLOBAL OTC AND NUTRITIONAL PRODUCT CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, THROUGH 2011 ($ BILLIONS) FIGURE 27 GLOBAL OTC AND NUTRITIONAL PRODUCTS CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004-2011 ($ BILLIONS) Market Shares TABLE 31 GLOBAL OTC AND NUTRITIONAL PRODUCTS CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) FIGURE 28 GLOBAL OTC AND NUTRITIONAL PRODUCT CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) Market by Formulation TABLE 32 GLOBAL OTC AND NUTRITIONAL PRODUCT CONTRACT MANUFACTURING REVENUE FORECAST BY DOSAGE FORM, THROUGH 2011 ($ BILLIONS) FIGURE 29 GLOBAL OTC AND NUTRITIONAL PRODUCT CONTRACT MANUFACTURING REVENUE FORECAST BY DOSAGE FORM, 2004-2011 ($ BILLIONS) TABLE 33 GLOBAL OTC AND NUTRITIONAL PRODUCT CONTRACT MANUFACTURING MARKET SHARES BY DOSAGE FORM, 2006 (%) FIGURE 30 GLOBAL OTC AND NUTRITIONAL PRODUCT CONTRACT MANUFACTURING MARKET SHARES BY DOSAGE FORM, 2006 (%) CONTRACT RESEARCH MARKET LEADERS MARKET OUTLOOK MARKET REVENUE TABLE 34 GLOBAL CONTRACT PHARMACEUTICAL RESEARCH MARKET FORECAST BY REGION, THROUGH 2011 ($ BILLIONS) FIGURE 31 GLOBAL CONTRACT PHARMACEUTICAL RESEARCH MARKET FORECAST BY REGION, 2004-2011 ($ BILLIONS) MARKET SHARES TABLE 35 GLOBAL CONTRACT RESEARCH MARKET SHARES BY REGION, 2006 (%) FIGURE 32 GLOBAL CONTRACT RESEARCH MARKET SHARES BY REGION, 2006 (%) MARKET BY DISCIPLINE TABLE 36 GLOBAL CONTRACT RESEARCH REVENUE FORECAST BY DISCIPLINE, THROUGH 2011 ($ BILLIONS) FIGURE 33 GLOBAL CONTRACT RESEARCH REVENUE FORECAST BY DISCIPLINE, 2004-2011 ($ BILLIONS) MARKET SHARES BY DISCIPLINE TABLE 37 GLOBAL CONTRACT RESEARCH MARKET SHARES BY DISCIPLINE, 2006 (%) FIGURE 34 GLOBAL CONTRACT RESEARCH MARKET SHARES BY DISCIPLINE, 2006 (%) CONTRACT PACKAGING MARKET LEADERS MARKET REVENUE TABLE 38 GLOBAL CONTRACT PACKAGING MARKET FORECAST BY REGION, THROUGH 2011 ($ BILLIONS) FIGURE 35 GLOBAL CONTRACT PACKAGING MARKET FORECAST BY REGION, 2004-2011 ($ BILLIONS) MARKET SHARES TABLE 39 GLOBAL CONTRACT PACKAGING MARKET SHARES BY REGION, 2006 (%) FIGURE 36 GLOBAL CONTRACT PACKAGING MARKET SHARES BY REGION, 2006 (%) MARKET BY PACKAGE TYPE MARKET REVENUE TABLE 40 GLOBAL CONTRACT PACKAGING MARKET FORECAST BY PACKAGE TYPE, THROUGH 2011 ($ BILLIONS) FIGURE 37 GLOBAL CONTRACT PACKAGING MARKET FORECAST BY PACKAGE TYPE, 2004-2011 ($ BILLIONS) MARKET SHARES TABLE 41 GLOBAL CONTRACT PACKAGING MARKET SHARES BY PACKAGE TYPE, 2006 (%) FIGURE 38 GLOBAL CONTRACT PACKAGING MARKET SHARES BY PACKAGE TYPE, 2006 (%) CONTRACT MANUFACTURING APPLICATIONS CARDIOVASCULAR DRUG MARKET MARKET REVENUE TABLE 42 GLOBAL CONTRACT MANUFACTURE OF CARDIOVASCULAR DRUGS REVENUE FORECAST BY REGION, THROUGH 2011 ($ MILLIONS) FIGURE 39 GLOBAL CARDIOVASCULAR DRUG CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004 2011 ($ MILLIONS) REPRODUCTIVE DRUG MARKET MARKET REVENUE TABLE 43 GLOBAL REPRODUCTIVE DRUG CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, THROUGH 2011 ($ MILLIONS) FIGURE 40 GLOBAL REPRODUCTIVE DRUG CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004-2011 ($ MILLIONS) ONCOLOGY DRUG AND DIAGNOSTICS MARKET MARKET REVENUE TABLE 44 GLOBAL ONCOLOGY DRUG AND DIAGNOSTIC CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, THROUGH 2011 ($ MILLIONS) FIGURE 41 GLOBAL ONCOLOGY DRUG AND DIAGNOSTIC CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004-2011 ($ MILLIONS) ANALGESIC MARKET MARKET REVENUE TABLE 45 GLOBAL ANALGESIC CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, THROUGH 2011 ($ MILLIONS) FIGURE 42 GLOBAL ANALGESIC CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004-2011 ($ MILLIONS) ANTIVIRAL DRUGS MARKET MARKET REVENUE TABLE 46 GLOBAL ANTIVIRAL DRUG CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, THROUGH 2011 ($ MILLIONS) FIGURE 43 GLOBAL ANTIVIRAL DRUG CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004 2011 ($ MILLIONS) ANTIBIOTICS MARKET MARKET REVENUE TABLE 47 GLOBAL ANTIBIOTIC CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, THROUGH 2011 ($ MILLIONS) FIGURE 44 GLOBAL ANTIBIOTIC CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004-2011 ($ MILLIONS) MARKET FOR OTHER DRUGS MARKET REVENUE TABLE 48 GLOBAL OTHER DRUG CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, THROUGH 2011 ($ BILLIONS) FIGURE 45 GLOBAL OTHER DRUG CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004-2011 ($ BILLIONS) PATENT ANALYSIS PATENTS BY YEAR TABLE 49 NUMBER OF PATENTS BY YEAR, 2005-2007 FIGURE 46 NUMBER OF PATENTS BY YEAR, 2005-2007 FIGURE 47 NUMBER OF PATENTS BY YEAR, 2005-2007 (%) PATENTS BY COMPANY TABLE 50 NUMBER OF U.S. PATENTS BY COMPANY, 2005-2007 FIGURE 48 NUMBER OF U.S. PATENTS BY COMPANY, 2005-2007 PATENTS BY COUNTRY TABLE 51 NUMBER OF U.S. PATENTS BY COUNTRY, 2005-2007 FIGURE 49 NUMBER OF U.S. PATENTS BY COUNTRY, 2005-2007 TABLE 52 PATENT SHARES BY COUNTRY, 2005-2007 (%) FIGURE 50 PATENT SHARES BY COUNTRY, 2005-2007 (%) PATENTS BY EMPHASIS TABLE 53 PATENTS BY EMPHASIS, 2005-2007 FIGURE 51 NUMBER OF U.S. PATENTS BY COUNTRY, 2005-2007 SIGNIFICANT PATENTS OF 2006 TABLE 54 SIGNIFICANT PATENTS IN RESEARCH AND DEVELOPMENT, 2006 TABLE 54 (CONTINUED) TABLE 55 SIGNIFICANT PATENTS IN DRUG DELIVERY, 2006 TABLE 55 (CONTINUED) CURRENT ENVIRONMENT CURRENT ENVIRONMENT THE NEED HOW MUCH AND WITH WHOM OPEN OPTIONS GLOBALIZATION FROM WEST TO EAST CURRENT EUROPEAN CONTRACT MANUFACTURING ENVIRONMENT OUTSOURCING CHALLENGES FOR VIRTUAL PHARMACEUTICAL COMPANIES LEGAL CONTRACT-BID WORK VENDOR SELECTION COMMON MISTAKES MADE BY VIRTUAL COMPANIES IN VENDOR SELECTION PROJECT MANAGEMENT COMPANY PROFILES AAIPHARMA, INC. ADVANCED POLYMER PHARMA, INC. (A.P. PHARMA) AEROGEN, INC ALBANY MOLECULAR RESEARCH, INC. ALCAN PACKAGING ALKERMES ALMAC ALPHARMA USPD, INC ALZA CORP. (J&J CO.) AMCOR LIMITED APPTEC LABORATORIES APTUIT ARADIGM CORP ASTER-CEPHAC ATRIX LABORATORIES (QLT) BAXTER PHARMACEUTICAL SOLUTIONS BEN VENUE LABORATORIES (SUBSIDIARY OF BOEHRINGER INGELHEIM) BIORELIANCE CORP. (AVISTA CAPITAL PARTNERS) CAMBREX CORP. CANGENE CARBOGEN AMCIS AG CARDINAL HEALTH CEDARBURG PHARMACEUTICALS, LTD CHEMBRIDGE CORP CONFAB LABORATORIES DAVOS CHEMICAL CORP DECODE GENETICS DIOSYNTH RTP DOWPHARMA DPT LABORATORIES, LTD DR. REDDY’S LABORATORIES DSM PHARMACEUTICALS EVOTEC AG FULCRUM PHARMA, PLC GENZYME PHARMACEUTICALS GILEAD GIRINDUS GLAXOSMITHKLINE BIOPHARMACEUTICALS HOVIONE S.A ICOS CORP. KV PHARMACEUTICAL CO LYNE LABORATORIES MALLINCKRODT PHARMACEUTICALS (OUTSOURCING) MDS PHARMA SERVICES MEDAREX, INC. MIKART MOVA PHARMACEUTICAL CORP NICHOLAS PIRAMAL INDIA, LTD. NOVAVAX, INC ORTEC, INC OSG NORWICH PHARMACEUTICALS PATHEON PHARMACOPEIA DRUG DISCOVERY, INC PRECISION PHARMA SERVICES QUINTILES, INC. RANBAXY RESEARCH LABS REGIS TECHNOLOGIES, INC. SCHWARZ PHARMA SKYEPHARMA TETRIONICS, INC. XCELLEREX, LLC APPENDIX I. ABBREVIATIONS LIST OF TABLES SUMMARY TABLE GLOBAL PHARMACEUTICAL CONTRACT MANUFACTURING AND CONTRACT RESEARCH ORGANIZATIONS REVENUE FORECAST, THROUGH 2011 ($ BILLIONS) TABLE 1 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING BULK DRUGS/API, 2006 (%) TABLE 1 (CONTINUED) TABLE 2 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING SOLID DOSAGE FORMS, 2006 (%) TABLE 3 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING LIQUID DOSAGE FORMS, 2006 (%) TABLE 4 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING SEMISOLID DOSAGE FORMS, 2006 (%) TABLE 5 WORLDWIDE MARKET SHARES OF CONTRACT RESEARCH COMPANIES, 2006 (%) TABLE 6 WORLDWIDE MARKET SHARES OF CONTRACT PACKAGING COMPANIES, 2006 (%) TABLE 7 SERVICES PROVIDED BY CONTRACT MANUFACTURING AND RESEARCH FIRMS TABLE 8 SERVICES PROVIDED BY CONTRACT PACKAGING FIRMS BY PACKAGING TYPE TABLE 9 GLOBAL BULK DRUG/API CONTRACT MANUFACTURING REVENUE FORECAST BY REGION THROUGH 2011 ($ BILLIONS) TABLE 10 GLOBAL BULK DRUG/API CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) TABLE 11 GLOBAL SOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, THROUGH 2011 ($ BILLIONS) TABLE 12 GLOBAL SOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) TABLE 13 GLOBAL SOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE FORECAST BY FORMULATION, THROUGH 2011 ($ BILLIONS) TABLE 14 GLOBAL SOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2006 (%) TABLE 15 GLOBAL LIQUID DOSAGE FORM (NONSTERILE) CONTRACT MANUFACTURING REVENUE BY REGION, THROUGH 2011 ($ MILLIONS) TABLE 16 GLOBAL LIQUID DOSAGE FORM (NONSTERILE) CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) TABLE 17 GLOBAL LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING REVENUE FORECAST, BY REGION, THROUGH 2011 ($ MILLIONS) TABLE 18 GLOBAL LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) TABLE 19 GLOBAL LIQUID DOSAGE FORM (NONSTERILE) CONTRACT MANUFACTURING REVENUE FORECAST, BY FORMULATION, THROUGH 2011 ($ MILLIONS) TABLE 20 GLOBAL LIQUID DOSAGE FORM (NONSTERILE) CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2006 (%) TABLE 21 GLOBAL LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING REVENUE FORECAST BY FORMULATION, THROUGH 2011 ($ MILLIONS) TABLE 22 GLOBAL LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2006 (%) TABLE 23 GLOBAL SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, THROUGH 2011 ($ MILLIONS) TABLE 24 GLOBAL SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) TABLE 25 GLOBAL SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE FORECAST BY FORMULATION, THROUGH 2011 ($ MILLIONS) TABLE 26 GLOBAL SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2006 (%) TABLE 27 CONTRACTING COMPANIES PROVIDING DRUG DELIVERY SYSTEMS TABLE 28 GLOBAL CONTRACTING COMPANIES PROVIDING ADVANCED DRUG DELIVERY SYSTEMS REVENUE FORECAST BY TYPE, THROUGH 2011 ($ BILLIONS) TABLE 29 GLOBAL ADVANCED DRUG DELIVERY SYSTEM CONTRACT MANUFACTURING SHARE BY TYPE, 2006 (%) TABLE 30 GLOBAL OTC AND NUTRITIONAL PRODUCT CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, THROUGH 2011 ($ BILLIONS) TABLE 31 GLOBAL OTC AND NUTRITIONAL PRODUCTS CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) TABLE 32 GLOBAL OTC AND NUTRITIONAL PRODUCT CONTRACT MANUFACTURING REVENUE FORECAST BY DOSAGE FORM, THROUGH 2011 ($ BILLIONS) TABLE 33 GLOBAL OTC AND NUTRITIONAL PRODUCT CONTRACT MANUFACTURING MARKET SHARES BY DOSAGE FORM, 2006 (%) TABLE 34 GLOBAL CONTRACT PHARMACEUTICAL RESEARCH MARKET FORECAST BY REGION, THROUGH 2011 ($ BILLIONS) TABLE 35 GLOBAL CONTRACT RESEARCH MARKET SHARES BY REGION, 2006 (%) TABLE 36 GLOBAL CONTRACT RESEARCH REVENUE FORECAST BY DISCIPLINE, THROUGH 2011 ($ BILLIONS) TABLE 37 GLOBAL CONTRACT RESEARCH MARKET SHARES BY DISCIPLINE, 2006 (%) TABLE 38 GLOBAL CONTRACT PACKAGING MARKET FORECAST BY REGION, THROUGH 2011 ($ BILLIONS) TABLE 39 GLOBAL CONTRACT PACKAGING MARKET SHARES BY REGION, 2006 (%) TABLE 40 GLOBAL CONTRACT PACKAGING MARKET FORECAST BY PACKAGE TYPE, THROUGH 2011 ($ BILLIONS) TABLE 41 GLOBAL CONTRACT PACKAGING MARKET SHARES BY PACKAGE TYPE, 2006 (%) TABLE 42 GLOBAL CONTRACT MANUFACTURE OF CARDIOVASCULAR DRUGS REVENUE FORECAST BY REGION, THROUGH 2011 ($ MILLIONS) TABLE 43 GLOBAL REPRODUCTIVE DRUG CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, THROUGH 2011 ($ MILLIONS) TABLE 44 GLOBAL ONCOLOGY DRUG AND DIAGNOSTIC CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, THROUGH 2011 ($ MILLIONS) TABLE 45 GLOBAL ANALGESIC CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, THROUGH 2011 ($ MILLIONS) TABLE 46 GLOBAL ANTIVIRAL DRUG CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, THROUGH 2011 ($ MILLIONS) TABLE 47 GLOBAL ANTIBIOTIC CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, THROUGH 2011 ($ MILLIONS) TABLE 48 GLOBAL OTHER DRUG CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, THROUGH 2011 ($ BILLIONS) TABLE 49 NUMBER OF PATENTS BY YEAR, 2005-2007 TABLE 50 NUMBER OF U.S. PATENTS BY COMPANY, 2005-2007 TABLE 51 NUMBER OF U.S. PATENTS BY COUNTRY, 2005-2007 TABLE 52 PATENT SHARES BY COUNTRY, 2005-2007 (%) TABLE 53 PATENTS BY EMPHASIS, 2005-2007 TABLE 54 SIGNIFICANT PATENTS IN RESEARCH AND DEVELOPMENT, 2006 TABLE 55 SIGNIFICANT PATENTS IN DRUG DELIVERY, 2006 LIST OF FIGURES SUMMARY FIGURE WORLDWIDE PHARMACEUTICAL CONTRACT MANUFACTURING AND CONTRACT RESEARCH ORGANIZATIONS REVENUE, 2004-2011 (BILLIONS) FIGURE 1 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING BULK DRUGS/API, 2006 (%) FIGURE 2 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING SOLID DOSAGE FORMS, 2006 (%) FIGURE 3 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING LIQUID DOSAGE FORMS, 2006 (%) FIGURE 4 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING SEMISOLID DOSAGE FORMS, 2006 (%) FIGURE 5 WORLDWIDE MARKET SHARES OF CONTRACT RESEARCH COMPANIES, 2006 (%) FIGURE 6 WORLDWIDE MARKET SHARES OF CONTRACT PACKAGING COMPANIES, 2006 (%) FIGURE 7 GLOBAL BULK DRUG/API CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004-2011 ($ BILLIONS) FIGURE 8 GLOBAL BULK DRUG/API CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) FIGURE 9 GLOBAL SOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004-2011 (BILLIONS) FIGURE 10 GLOBAL SOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) FIGURE 11 GLOBAL SOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE FORECAST BY FORMULATION, 2004-2011 ($ BILLIONS) FIGURE 12 GLOBAL SOLID DOSAGE FORM CONTRACT MANUFACTURING, MARKET SHARES BY FORMULATION, 2006 (%) FIGURE 13 GLOBAL LIQUID DOSAGE FORM (NONSTERILE) CONTRACT MANUFACTURING REVENUE BY REGION, 2004-2011 ($ MILLIONS) FIGURE 14 GLOBAL LIQUID DOSAGE FORM (NONSTERILE) CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) FIGURE 15 GLOBAL LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING REVENUE FORECAST, BY REGION, THROUGH 2011 ($ MILLIONS) FIGURE 16 GLOBAL LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) FIGURE 17 GLOBAL LIQUID DOSAGE FORM (NONSTERILE) CONTRACT MANUFACTURING REVENUE BY FORMULATION, 2004-2011 ($ MILLIONS) FIGURE 18 GLOBAL LIQUID DOSAGE FORM (NONSTERILE) CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2006 (%) FIGURE 19 GLOBAL LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING REVENUE FORECAST BY FORMULATION, 2004-2011 ($ MILLIONS) FIGURE 20 GLOBAL LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2006 (%) FIGURE 21 GLOBAL SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004-2011 ($ MILLIONS) FIGURE 22 GLOBAL SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) FIGURE 23 GLOBAL SOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE FORECAST BY FORMULATION, 2004-2011 ($ MILLIONS) FIGURE 24 GLOBAL SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2006 (%) FIGURE 25 GLOBAL ADVANCED DRUG DELIVERY SYSTEM CONTRACT MANUFACTURING REVENUE FORECAST BY TYPE, 2004-2011 ($ BILLIONS) FIGURE 26 GLOBAL ADVANCED DRUG DELIVERY SYSTEM CONTRACT MANUFACTURING REVENUE BY TYPE, 2006 (%) FIGURE 27 GLOBAL OTC AND NUTRITIONAL PRODUCTS CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004-2011 ($ BILLIONS) FIGURE 28 GLOBAL OTC AND NUTRITIONAL PRODUCT CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) FIGURE 29 GLOBAL OTC AND NUTRITIONAL PRODUCT CONTRACT MANUFACTURING REVENUE FORECAST BY DOSAGE FORM, 2004-2011 ($ BILLIONS) FIGURE 30 GLOBAL OTC AND NUTRITIONAL PRODUCT CONTRACT MANUFACTURING MARKET SHARES BY DOSAGE FORM, 2006 (%) FIGURE 31 GLOBAL CONTRACT PHARMACEUTICAL RESEARCH MARKET FORECAST BY REGION, 2004-2011 ($ BILLIONS) FIGURE 32 GLOBAL CONTRACT RESEARCH MARKET SHARES BY REGION, 2006 (%) FIGURE 33 GLOBAL CONTRACT RESEARCH REVENUE FORECAST BY DISCIPLINE, 2004-2011 ($ BILLIONS) FIGURE 34 GLOBAL CONTRACT RESEARCH MARKET SHARES BY DISCIPLINE, 2006 (%) FIGURE 35 GLOBAL CONTRACT PACKAGING MARKET FORECAST BY REGION, 2004-2011 ($ BILLIONS) FIGURE 36 GLOBAL CONTRACT PACKAGING MARKET SHARES BY REGION, 2006 (%) FIGURE 37 GLOBAL CONTRACT PACKAGING MARKET FORECAST BY PACKAGE TYPE, 2004-2011 ($ BILLIONS) FIGURE 38 GLOBAL CONTRACT PACKAGING MARKET SHARES BY PACKAGE TYPE, 2006 (%) FIGURE 39 GLOBAL CARDIOVASCULAR DRUG CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004 2011 ($ MILLIONS) FIGURE 40 GLOBAL REPRODUCTIVE DRUG CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004-2011 ($ MILLIONS) FIGURE 41 GLOBAL ONCOLOGY DRUG AND DIAGNOSTIC CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004-2011 ($ MILLIONS) FIGURE 42 GLOBAL ANALGESIC CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004-2011 ($ MILLIONS) FIGURE 43 GLOBAL ANTIVIRAL DRUG CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004 2011 ($ MILLIONS) FIGURE 44 GLOBAL ANTIBIOTIC CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004-2011 ($ MILLIONS) FIGURE 45 GLOBAL OTHER DRUG CONTRACT MANUFACTURING REVENUE FORECAST BY REGION, 2004-2011 ($ BILLIONS) FIGURE 46 NUMBER OF PATENTS BY YEAR, 2005-2007 FIGURE 47 NUMBER OF PATENTS BY YEAR, 2005-2007 (%) FIGURE 48 NUMBER OF U.S. PATENTS BY COMPANY, 2005-2007 FIGURE 49 NUMBER OF U.S. PATENTS BY COUNTRY, 2005-2007 FIGURE 50 PATENT SHARES BY COUNTRY, 2005-2007 (%) FIGURE 51 NUMBER OF U.S. PATENTS BY COUNTRY, 2005-2007
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