Chapter- 1: INTRODUCTION -- Complimentary
STUDY OBJECTIVES 1
REASONS FOR DOING THIS STUDY 1
INTENDED AUDIENCE 2
SCOPE OF THE STUDY 2
METHODOLOGY 2
INFORMATION SOURCES 2
ABOUT THE AUTHOR 3
RELATED BCC RESEARCH REPORTS 3
BCC ONLINE SERVICES 3
DISCLAIMER 4
Chapter-2: SUMMARY
SUMMARY 5
SUMMARY TABLE WORLDWIDE PHARMACEUTICAL CONTRACT MANUFACTURING AND CONTRACT RESEARCH ORGANIZATIONS REVENUE, THROUGH 2014 ($ BILLIONS) 6
SUMMARY FIGURE WORLDWIDE PHARMACEUTICAL CONTRACT MANUFACTURING AND CONTRACT RESEARCH ORGANIZATIONS REVENUE, 2007-2014 ($ BILLIONS) 7
Chapter-3: OVERVIEW
DEFINITIONS 8
CONTRACT MANUFACTURING 8
CONTRACT MANUFACTURER 8
TYPES OF CONTRACT MANUFACTURERS 9
CORE COMPETENCIES 9
VENDOR 9
CONTRACT RESEARCH ORGANIZATION (CRO) 9
HISTORY OF OUTSOURCING 9
HISTORY OF OUTSOURCING (CONTINUED) 10
HISTORY OF OUTSOURCING (CONTINUED) 11
Chapter-4: CONTRACT MANUFACTURING
NEED FOR CONTRACT MANUFACTURING 12
FLEXIBILITY 12
CAPACITY AND CAPITAL 12
RISK 12
ADVANTAGES OF CONTRACT MANUFACTURING 13
TABLE 1 KEY ADVANTAGES OF CONTRACT MANUFACTURING 13
TABLE 1 (CONTINUED) 14
SELECTION OF CONTRACT MANUFACTURER 14
MISCONCEPTIONS REGARDING CONTRACT MANUFACTURERS 15
Chapter-5: CONTRACT RESEARCH
INCLUDED IN RESEARCH 16
DRUG DISCOVERY AND DEVELOPMENT 16
CLINICAL RESEARCH 17
ANALYTICAL RESEARCH 17
NEED FOR CONTRACT RESEARCH 17
SERVICES OFFERED BY CONTRACT RESEARCH ORGANIZATION 18
SELECTION AND MANAGEMENT OF CRO 18
Chapter-6: CONTRACT PACKAGING
CONTRACT PACKAGING 19
THE NEED FOR CONTRACT PACKAGING 20
CRITERIA FOR THE SELECTION OF A PACKAGING SERVICE 20
LOCATION 21
EXPERIENCE 21
PERSONALITY 21
FINANCIAL STRENGTH 21
ADVANTAGES OF CONTRACT PACKAGING 21
ADVANTAGES OF CONTRACT PACKAGING (CONTINUED) 22
Chapter-7: THE NEED FOR PROJECT MANAGEMENT
PROJECT EVALUATION AND SET UP 23
PLANNING AND EXECUTION 24
QUALITY MANAGEMENT 24
MANAGEMENT OF QUALITY COMPONENTS FROM CLIENT’S PERSPECTIVE 25
MANAGEMENT OF QUALITY COMPONENTS FROM THE CMO PERSPECTIVE 25
Management of Quality Components … (Continued) 26
Chapter-8: REGULATORY ASPECTS
SHORT SUPPLY ARRANGEMENTS 27
DIVIDED MANUFACTURING ARRANGEMENTS 28
SHARED MANUFACTURING ARRANGEMENTS 29
RESPONSIBILITIES OF EACH PARTICIPATING MANUFACTURER 29
CONTRACT MANUFACTURING ARRANGEMENTS 30
RESPONSIBILITIES OF LICENSED MANUFACTURER 30
TABLE 2 RESPONSIBILITIES OF LICENSED MANUFACTURER UNDER FDA ACTS 31
RESPONSIBILITIES OF THE CONTRACT MANUFACTURER 31
WARNING LETTERS 32
WARNING LETTERS ISSUED TO CONTRACT MANUFACTURERS 32
Warning Letters Issued to … (Continued) 33
APPROVALS OF MANUFACTURING FACILITIES 34
Chapter-9: INDUSTRY STRUCTURE
MARKET SHARES OF INDUSTRY LEADERS 35
CONTRACT MANUFACTURERS OF BULK DRUGS AND APIS 35
TABLE 3 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING BULK DRUGS/API, 2009 (%) 35
FIGURE 1 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING BULK DRUGS/API, 2009 (%) 36
CONTRACT MANUFACTURERS OF SOLID DOSAGE FORMS 36
TABLE 4 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING SOLID DOSAGE FORMS, 2009 (%) 36
TABLE 4 (CONTINUED) 37
FIGURE 2 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING SOLID DOSAGE FORMS, 2009 (%) 37
CONTRACT MANUFACTURERS OF LIQUID DOSAGE FORMS 38
NONSTERILE 38
TABLE 5 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING NON-STERILE LIQUID DOSAGE FORMS, 2009 (%) 38
FIGURE 3 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING NON-STERILE LIQUID DOSAGE FORMS, 2009 (%) 39
STERILE 39
TABLE 6 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING STERILE LIQUID DOSAGE FORMS, 2009 (%) 39
TABLE 6 (CONTINUED) 40
FIGURE 4 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING STERILE LIQUID DOSAGE FORMS, 2009 (%) 40
CONTRACT MANUFACTURERS OF SEMISOLID DOSAGE FORMS 40
TABLE 7 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING SEMISOLID DOSAGE FORMS, 2009 (%) 41
FIGURE 5 WORLDWIDE MARKET SHARES OF CONTRACT MANUFACTURING COMPANIES PROVIDING SEMISOLID DOSAGE FORMS, 2009 (%) 41
CONTRACT RESEARCH COMPANIES 41
TABLE 8 WORLDWIDE MARKET SHARES OF CONTRACT RESEARCH COMPANIES, 2009 (%) 42
FIGURE 6 WORLDWIDE MARKET SHARES OF CONTRACT RESEARCH COMPANIES, 2009 (%) 42
CONTRACT PACKAGING COMPANIES 43
TABLE 9 WORLDWIDE MARKET SHARES OF CONTRACT PACKAGING COMPANIES, 2009 (%) 43
FIGURE 7 WORLDWIDE MARKET SHARES OF CONTRACT PACKAGING COMPANIES, 2009 (%) 44
TYPES OF CONTRACT MANUFACTURING AND RESEARCH FIRMS 44
TABLE 10 SERVICES PROVIDED BY CONTRACT MANUFACTURING AND RESEARCH FIRMS 45
TABLE 10 (CONTINUED) 46
TABLE 10 (CONTINUED) 47
TABLE 10 (CONTINUED) 48
TABLE 10 (CONTINUED) 49
TABLE 10 (CONTINUED) 50
TABLE 10 (CONTINUED) 51
TABLE 10 (CONTINUED) 52
TABLE 11 SERVICES PROVIDED BY CONTRACT PACKAGING FIRMS BY PACKAGING TYPE 53
Chapter-10: TECHNOLOGY TRANSFER
REASONS FOR TECHNOLOGY TRANSFER 54
CHALLENGING PROBLEMS DURING TECHNOLOGY TRANSFER 55
PRELIMINARY STEPS TOWARD TECHNOLOGY TRANSFER 56
STEPS FOR SUCCESSFUL TECHNOLOGY TRANSFER 56
TYPES OF CONTRACTUAL AGREEMENTS USED IN TECHNOLOGY TRANSFER 57
CONFIDENTIAL DISCLOSURE AGREEMENT (CDA) 57
MATERIAL TRANSFER AGREEMENT (MTA) 58
ASSIGNMENT DEED 58
LICENSE AGREEMENT 58
CO-DEVELOPMENT AND CO-MARKETING AGREEMENTS 58
FACTORS FOR A SUCCESSFUL PROJECT 59
FACTORS FOR A SUCCESSFUL PROJECT (CONTINUED) 60
Chapter-11: NEW DEVELOPMENTS
QUINTILES INC. 61
COVANCE 62
CHARLES RIVER LABORATORIES 63
OTHERS 63
OTHERS (CONTINUED) 64
OTHERS (CONTINUED) 65
Chapter-12: MARKETS
CONTRACT MANUFACTURING 66
CONTRACT MANUFACTURE OF BULK DRUGS/APIS 66
Market Overview 66
Market Overview (Continued) 67
Market Revenue 68
TABLE 12 WORLDWIDE BULK DRUG/API CONTRACT MANUFACTURING REVENUE BY REGION, THROUGH 2014 ($ BILLIONS) 68
FIGURE 8 WORLDWIDE BULK DRUG/API CONTRACT MANUFACTURING REVENUE BY REGION, 2007-2014 ($ BILLIONS) 69
Market Shares 69
TABLE 13 WORLDWIDE BULK DRUG/API CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2009 (%) 70
FIGURE 9 WORLDWIDE BULK DRUG/API CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2009 (%) 70
CONTRACT MANUFACTURE OF ORAL DOSAGE FORMULATIONS 70
Solid Dosage Formulations 71
Market Overview 71
Market Revenue 72
TABLE 14 WORLDWIDE SOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE BY REGION, THROUGH 2014 ($ BILLIONS) 73
FIGURE 10 WORLDWIDE SOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE BY REGION, 2007-2014 ($ BILLIONS) 73
Market Shares 73
TABLE 15 WORLDWIDE SOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2009 (%) 74
FIGURE 11 WORLDWIDE SOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2009 (%) 74
Market by Formulation 75
Market Revenue 75
TABLE 16 WORLDWIDE SOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE BY FORMULATION, THROUGH 2014 ($ BILLIONS) 76
FIGURE 12 WORLDWIDE SOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE BY FORMULATION, 2007-2014 ($ BILLIONS) 76
TABLE 17 WORLDWIDE SOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2009 (%) 77
FIGURE 13 WORLDWIDE SOLID DOSAGE FORM CONTRACT MANUFACTURING, MARKET SHARES BY FORMULATION, 2009 (%) 77
Liquid Dosage Formulations 77
Market Overview 77
Market Overview (Continued) 78
Market Overview (Continued) 79
Non-sterile Formulations 80
Market Revenue 80
TABLE 18 WORLDWIDE LIQUID DOSAGE FORM (NON-STERILE) CONTRACT MANUFACTURING REVENUE BY REGION, THROUGH 2014 ($ MILLIONS) 80
FIGURE 14 WORLDWIDE LIQUID DOSAGE FORM (NON-STERILE) CONTRACT MANUFACTURING REVENUE BY REGION, 2007-2014 ($ MILLIONS) 81
Market Shares 81
TABLE 19 WORLDWIDE LIQUID DOSAGE FORM (NON-STERILE) CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2006 (%) 81
FIGURE 15 WORLDWIDE LIQUID DOSAGE FORM (NON-STERILE) CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2009 (%) 82
Sterile Formulations 82
Market Revenue 82
TABLE 20 WORLDWIDE LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING REVENUE BY REGION, THROUGH 2014 ($ MILLIONS) 82
FIGURE 16 WORLDWIDE LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING REVENUE BY REGION, 2007-2014 ($ MILLIONS) 83
Market Shares 83
TABLE 21 WORLDWIDE LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2009 (%) 83
FIGURE 17 WORLDWIDE LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2009 (%) 84
Market by Formulation 84
Non-sterile Formulations 84
TABLE 22 WORLDWIDE LIQUID DOSAGE FORM (NON-STERILE) CONTRACT MANUFACTURING REVENUE BY FORMULATION, THROUGH 2014 ($ MILLIONS) 85
FIGURE 18 WORLDWIDE LIQUID DOSAGE FORM (NON-STERILE) CONTRACT MANUFACTURING REVENUE BY FORMULATION, 2007-2014 ($ MILLIONS) 85
TABLE 23 WORLDWIDE LIQUID DOSAGE FORM (NON-STERILE) CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2009 (%) 86
FIGURE 19 WORLDWIDE LIQUID DOSAGE FORM (NON-STERILE) CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2009 (%) 86
Sterile Formulations 86
TABLE 24 WORLDWIDE LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING REVENUE BY FORMULATION, THROUGH 2014 ($ MILLIONS) 87
FIGURE 20 WORLDWIDE LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING REVENUE BY FORMULATION, 2007-2014 ($ MILLIONS) 87
TABLE 25 WORLDWIDE LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2009 (%) 88
FIGURE 21 WORLDWIDE LIQUID DOSAGE FORM (STERILE) CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2009 (%) 88
CONTRACT MANUFACTURE OF SEMISOLID DOSAGE FORMULATIONS 88
Market Overview 88
Market Overview (Continued) 89
Market Revenue 90
TABLE 26 WORLDWIDE SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE BY REGION, THROUGH 2014 ($ MILLIONS) 90
FIGURE 22 WORLDWIDE SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE BY REGION, 2007-2014 ($ MILLIONS) 91
Market Shares 91
TABLE 27 WORLDWIDE SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2009 (%) 91
FIGURE 23 WORLDWIDE SEMI-SOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2009 (%) 92
Market by Formulation 92
TABLE 28 WORLDWIDE SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE BY FORMULATION, THROUGH 2014 ($ MILLIONS) 93
FIGURE 24 WORLDWIDE SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING REVENUE BY FORMULATION, THROUGH 2014 ($ MILLIONS) 93
TABLE 29 WORLDWIDE SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2009 (%) 94
FIGURE 25 WORLDWIDE SEMISOLID DOSAGE FORM CONTRACT MANUFACTURING MARKET SHARES BY FORMULATION, 2009 (%) 94
CONTRACT MANUFACTURE OF ADVANCED DRUG DELIVERY PRODUCTS 94
Contract Manufacture …(Continued) 95
Market Overview 96
TABLE 30 CONTRACTING COMPANIES PROVIDING DRUG DELIVERY SYSTEMS 97
TABLE 30 (CONTINUED) 98
Market Revenue 98
TABLE 31 WORLDWIDE CONTRACTING COMPANIES PROVIDING ADVANCED DRUG DELIVERY SYSTEMS REVENUE BY REGION, THROUGH 2014 ($ BILLIONS) 98
FIGURE 26 WORLDWIDE ADVANCED DRUG DELIVERY SYSTEM CONTRACT MANUFACTURING REVENUE BY REGION, 2007-2014 ($ BILLIONS) 99
Market Shares 99
TABLE 32 WORLDWIDE DRUG DELIVERY CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2009 (%) 99
FIGURE 27 WORLDWIDE DRUG DELIVERY CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2009 (%) 100
Market by Formulation 100
TABLE 33 WORLDWIDE CONTRACTING COMPANIES PROVIDING ADVANCED DRUG DELIVERY SYSTEMS REVENUE BY TYPE, THROUGH 2014 ($ BILLIONS) 101
FIGURE 28 WORLDWIDE ADVANCED DRUG DELIVERY SYSTEM CONTRACT MANUFACTURING REVENUE BY TYPE, 2007-2014 ($ BILLIONS) 101
Market Shares 102
TABLE 34 WORLDWIDE ADVANCED DRUG DELIVERY SYSTEM CONTRACT MANUFACTURING SHARE BY TYPE, 2009 (%) 102
FIGURE 29 WORLDWIDE ADVANCED DRUG DELIVERY SYSTEM CONTRACT MANUFACTURING REVENUE BY TYPE, 2009 (%) 103
CONTRACT MANUFACTURE OF OTC AND NUTRITIONAL PRODUCTS 103
Market Overview 104
Market Revenue 105
TABLE 35 WORLDWIDE OTC AND NUTRITIONAL PRODUCT CONTRACT MANUFACTURING REVENUE BY REGION, THROUGH 2014 ($ BILLIONS) 106
FIGURE 30 WORLDWIDE OTC AND NUTRITIONAL PRODUCTS CONTRACT MANUFACTURING REVENUE BY REGION, 2007-2014 ($ BILLIONS) 106
Market Shares 107
TABLE 36 WORLDWIDE OTC AND NUTRITIONAL PRODUCTS CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2009 (%) 107
FIGURE 31 WORLDWIDE OTC AND NUTRITIONAL PRODUCT CONTRACT MANUFACTURING MARKET SHARES BY REGION, 2009 (%) 107
Market by Formulation 108
TABLE 37 WORLDWIDE OTC AND NUTRITIONAL PRODUCT CONTRACT MANUFACTURING REVENUE BY DOSAGE FORM, THROUGH 2014 ($ BILLIONS) 108
FIGURE 32 WORLDWIDE OTC AND NUTRITIONAL PRODUCT CONTRACT MANUFACTURING REVENUE BY DOSAGE FORM, 2007-2014 ($ BILLIONS) 109
TABLE 38 WORLDWIDE OTC AND NUTRITIONAL PRODUCT CONTRACT MANUFACTURING MARKET SHARES BY DOSAGE FORM, 2009 (%) 109
FIGURE 33 WORLDWIDE OTC AND NUTRITIONAL PRODUCT CONTRACT MANUFACTURING MARKET SHARES BY DOSAGE FORM, 2009 (%) 110
CONTRACT RESEARCH 110
MARKET OVERVIEW 110
Partnerships 110
Partnerships (Continued) 111
Expansions of Facilities 112
MARKET REVENUE 113
TABLE 39 WORLDWIDE CONTRACT PHARMACEUTICAL RESEARCH MARKET BY REGION, THROUGH 2014 ($ BILLIONS) 114
FIGURE 34 WORLDWIDE CONTRACT PHARMACEUTICAL RESEARCH MARKET BY REGION, 2007-2014 ($ BILLIONS) 114
MARKET SHARES 115
TABLE 40 WORLDWIDE CONTRACT RESEARCH MARKET SHARES BY REGION, 2009 (%) 115
FIGURE 35 WORLDWIDE CONTRACT RESEARCH MARKET SHARES BY REGION, 2009 (%) 115
MARKET BY DISCIPLINE 116
TABLE 41 WORLDWIDE CONTRACT RESEARCH REVENUE BY DISCIPLINE, THROUGH 2014 ($ BILLIONS) 116
FIGURE 36 WORLDWIDE CONTRACT RESEARCH REVENUE BY DISCIPLINE, 2007-2014 ($ BILLIONS) 117
MARKET SHARES BY DISCIPLINE 117
TABLE 42 WORLDWIDE CONTRACT RESEARCH MARKET SHARES BY DISCIPLINE, 2009 (%) 117
FIGURE 37 WORLDWIDE CONTRACT RESEARCH MARKET SHARES BY DISCIPLINE, 2009 (%) 118
CONTRACT PACKAGING 118
MARKET OVERVIEW 118
Market Overview (Continued) 119
MARKET REVENUE 119
TABLE 43 WORLDWIDE CONTRACT PACKAGING MARKET BY REGION, THROUGH 2014 ($ BILLIONS) 120
FIGURE 38 WORLDWIDE CONTRACT PACKAGING MARKET BY REGION, 2007-2014 ($ BILLIONS) 120
MARKET SHARES 121
TABLE 44 WORLDWIDE CONTRACT PACKAGING MARKET SHARES BY REGION, 2009 (%) 121
FIGURE 39 WORLDWIDE CONTRACT PACKAGING MARKET SHARES BY REGION, 2009 (%) 121
MARKET BY PACKAGE TYPE 122
MARKET REVENUE 122
TABLE 45 WORLDWIDE CONTRACT PACKAGING MARKET BY PACKAGE TYPE, THROUGH 2014 ($ BILLIONS) 123
FIGURE 40 WORLDWIDE CONTRACT PACKAGING MARKET BY PACKAGE TYPE, 2007-2014 ($ BILLIONS) 123
MARKET SHARES 123
TABLE 46 WORLDWIDE CONTRACT PACKAGING MARKET SHARES BY PACKAGE TYPE, 2009 (%) 124
FIGURE 41 WORLDWIDE CONTRACT PACKAGING MARKET SHARES BY PACKAGE TYPE, 2009 (%) 124
Chapter-13: CONTRACT MANUFACTURING APPLICATIONS
CARDIOVASCULAR DRUG MARKET 125
MARKET REVENUE 126
TABLE 47 WORLDWIDE REVENUE FROM CONTRACT MANUFACTURE OF CARDIOVASCULAR DRUGS BY REGION, THROUGH 2014 ($ MILLIONS) 126
FIGURE 42 WORLDWIDE CARDIOVASCULAR DRUG CONTRACT MANUFACTURING REVENUE BY REGION, 2007-2014 ($ MILLIONS) 127
REPRODUCTIVE DRUG MARKET 127
MARKET REVENUE 128
TABLE 48 WORLDWIDE REPRODUCTIVE DRUG CONTRACT MANUFACTURING REVENUE BY REGION, THROUGH 2014 ($ MILLIONS) 128
FIGURE 43 WORLDWIDE REPRODUCTIVE DRUG CONTRACT MANUFACTURING REVENUE BY REGION, 2007-2014 ($ MILLIONS) 129
ONCOLOGY DRUG MARKET 129
MARKET REVENUE 130
TABLE 49 WORLDWIDE ONCOLOGY DRUG AND DIAGNOSTIC CONTRACT MANUFACTURING REVENUE BY REGION, THROUGH 2014 ($ MILLIONS) 131
FIGURE 44 WORLDWIDE ONCOLOGY DRUG AND DIAGNOSTIC CONTRACT MANUFACTURING REVENUE BY REGION, 2007-2014 ($ MILLIONS) 131
ANALGESIC MARKET 132
MARKET REVENUE 132
TABLE 50 WORLDWIDE ANALGESIC CONTRACT MANUFACTURING REVENUE BY REGION, THROUGH 2014 ($ MILLIONS) 133
FIGURE 45 WORLDWIDE ANALGESIC CONTRACT MANUFACTURING REVENUE BY REGION, 2007-2014 ($ MILLIONS) 133
ANTIVIRAL DRUGS MARKET 133
MARKET REVENUE 134
TABLE 51 WORLDWIDE ANTIVIRAL DRUG CONTRACT MANUFACTURING REVENUE BY REGION, THROUGH 2014 ($ MILLIONS) 135
FIGURE 46 WORLDWIDE ANTIVIRAL DRUG CONTRACT MANUFACTURING REVENUE BY REGION, 2007-2014 ($ MILLIONS) 135
ANTIBIOTICS MARKET 136
MARKET REVENUE 136
TABLE 52 WORLDWIDE ANTIBIOTIC CONTRACT MANUFACTURING REVENUE BY REGION, THROUGH 2014 ($ MILLIONS) 137
FIGURE 47 WORLDWIDE ANTIBIOTIC CONTRACT MANUFACTURING REVENUE BY REGION, 2007-2014 ($ MILLIONS) 137
MARKETS FOR OTHER DRUGS 138
MARKET REVENUE 138
TABLE 53 WORLDWIDE OTHER DRUG CONTRACT MANUFACTURING REVENUE BY REGION, THROUGH 2014 ($ BILLIONS) 139
FIGURE 48 WORLDWIDE OTHER DRUG CONTRACT MANUFACTURING REVENUE BY REGION, 2007-2014 ($ BILLIONS) 139
Chapter-14: PATENT ANALYSIS
PATENTS BY YEAR 140
TABLE 54 NUMBER OF SIGNIFICANT PATENTS BY YEAR, 2005-2009 140
FIGURE 49 NUMBER OF PATENTS BY YEAR, 2005-2009 140
FIGURE 50 NUMBER OF PATENTS BY YEAR, 2005–2009 (%) 141
PATENTS BY COMPANY 141
TABLE 55 NUMBER OF U.S. PATENTS BY COMPANY, 2005-2009 142
PATENTS BY COUNTRY 142
TABLE 56 NUMBER OF U.S. PATENTS BY COUNTRY, 2005-2009 143
TABLE 57 PATENT SHARES BY COUNTRY, 2005-2009 (%) 143
FIGURE 51 PATENT SHARES BY COUNTRY, 2005-2009 (%) 144
PATENTS BY EMPHASIS 144
TABLE 58 PATENTS BY EMPHASIS, 2005-2009 145
Chapter-15: CURRENT ENVIRONMENT
OVERALL SITUATION OF THE CONTRACTING MARKET 146
CONTRACT MANUFACTURING OF API AND DOSAGE FORMS 146
CONTRACT MANUFACTURING OF OTC AND NUTRACEUTICALS 146
CONTRACT RESEARCH 147
CONTRACT PACKAGING 147
SUCCESS FACTORS FOR CMOS 147
PRESENT SCENARIO OF THE CONTRACT MANUFACTURING MARKET 148
FROM THE PHARMACEUTICAL COMPANIES’ PERSPECTIVE 148
FROM CONTRACT MANUFACTURING ORGANIZATION’S PERSPECTIVE 149
FACTORS AFFECTING THE OUTSOURCING MARKET 149
COST CONTAINMENT 150
GLOBALIZATION 150
MERGERS AND ACQUISITIONS 150
REGULATORY REQUIREMENTS 151
NEED FOR SPECIALIZED SERVICES 151
COMPETITION WITHIN THE PHARMACEUTICAL INDUSTRY 151
INTRODUCTION OF NEW BIOTHERAPEUTICS 151
Chapter-16: COMPANY PROFILES
AAI PHARMA, INC. 152
ABBOTT LABORATORIES 152
AEROGEN, INC. 153
ALBANY MOLECULAR RESEARCH, INC. 153
ALCAN PACKAGING 154
ALKERMES, INC. 154
AMERISOURCE BERGEN 155
A. P. PHARMA, INC. 155
ARADIGM CORPORATION 156
BAXTER HEALTHCARE 157
BEN VENUE LABORATORIES INC. 157
BIOVAIL CORP. 158
BOEHRINGER INGELHEIM 158
BOOTS MANUFACTURING 159
CAMBREX CORP. 159
CANGENE 160
CATALENT PHARMA SOLUTIONS 160
CEDARBURG HAUSER PHARMACEUTICAL LTD. 161
CENEXI 161
CHARLES RIVER LABORATORIES 162
CHEMBRIDGE CORP. 162
CONFAB LABORATORIES 163
COVANCE INC. 163
DAVOS PHARMA 164
DECODE GENETICS 164
DIOSYNTH BIOTECHNOLOGY 165
DISHMAN PHARMACEUTICALS AND CHEMICALS LTD. 165
DOW CHEMICAL COMPANY 166
DPT LABORATORIES INC. 166
DR REDDY’S LABORATORIES 167
DSM PHARMACEUTICAL PRODUCTS 167
ELAN DRUG TECHNOLOGIES 168
EVOTEC AG 168
FULCRUM PHARMA PLC 169
GENZYME PHARMACEUTICALS 169
GIRINDUS AG 170
GLAXOSMITHKLINE BIOPHARMACEUTICALS 170
HOVIONE S.A. 171
JUBILANT ORGANOSYS 171
KENDLE INTERNATIONAL INC. 172
KING PHARMACEUTICALS 172
KP PHARMACEUTICAL TECHNOLOGIES INC 173
K.V. PHARMACEUTICAL CO. 173
LIGAND PHARMACEUTICALS 174
LONZA GROUP 174
LYNE LABORATORIES 175
MALLINCKRODT 175
MDS PHARMA SERVICES 176
MEDAREX INC. 176
MIKART INC 177
NORWICH PHARMACEUTICALS 177
NOVAVAX, INC. 177
OMNICARE CLINICAL RESEARCH 178
PAREXEL INTERNATIONAL CORPORATION 178
PATHEON INC. 179
PERRIGO COMPANY 179
PHARMACEUTICAL PRODUCT DEVELOPMENT INC. 180
PIRAMAL HEALTHCARE 180
PRA INTERNATIONAL 181
QUINTILES 181
RANBAXY RESEARCH LABS 182
REGIS TECHNOLOGIES, INC. 182
SCHWARZ PHARMA AG 183
SKYEPHARMA 183
TALECRIS BIOTHERAPEUTICS INC. 184
WUXI APP TEC 184
XCELLEREX, LLC 185
APPENDIX : ABBREVIATIONS 186
APPENDIX 186
APPENDIX (CONTINUED) 187
