REPORT HIGHLIGHTS
* The global pharmaceutical contract manufacturing and contract research organizations revenue reached at $196.5 billion in 2010, it will further grow to $217.9 billion in 2011 and is projected to reach at $360.6 billion by 2016, increasing at a compound annual growth rate (CAGR) of 10.6%.
* North American markets’ revenue for bulk drugs in contract manufacturing in 2009 was about $8.8 billion and increased to about $9.7 billion in 2010. It is projected to reach $16.6 billion by 2016, for a 5-year CAGR of 9.4%.
* The total market for solid dosage form contract manufacturing in 2010 was valued at about $9.1 billion. This is expected to reach $10 billion by 2011 and forecasted to cross $16.1 billion by the end of 2016 at a CAGR of 10% for the five year period.
INTRODUCTION
STUDY OBJECTIVE
The objective of BCC Research in conducting this study is to provide an overview of the current situation and future capabilities of the global pharmaceutical contract manufacturing, research, and packaging markets. The study provides a global as well as a regionally specific market overview. The report emphasizes the current and future outlook of the pharmaceutical contract manufacturing market, with a comprehensive analysis of the overall pharmaceutical and biotechnology outsourcing industry.
The current report discusses and outlines the current capabilities as well as the needs of the pharmaceutical contract manufacturing, research, and packaging markets. In addition, it discusses company and market strategies to further enhance the market. The report includes the different types of contract manufacturing and, more specifically, the services offered by global contract manufacturers, researchers, and packagers. The report also discusses the methods best used to identify an effective contract manufacturer as well as the advantages of contract manufacturing and outsourcing. The REPORT HIGHLIGHTS the need for project management, provides market forecasts for different aspects of contract manufacturing specific to each region, and examines the role of market leaders in the industry. Regulatory requirements and new developments in the market are also discussed in the report.
The report encompasses the revenues gained from contract manufacturing in each specific market and in each specific region. Sales analysis was performed on specific categories of drugs and dosage forms including API/bulk drugs and solid, liquid, and semisolid dosage forms. Sales analyses were also performed on revenues gained from contract packaging and contract research. The sales figures discussed are for the examined period of 2009 to 2011. Sales figures were also forecast for the following 5-year period from 2011 through 2016.
Over-the-counter (OTC) drugs, nutritional drugs, and drug delivery products are discussed in a separate section of this report.
REASONS FOR DOING THIS STUDY
The majority of pharmaceutical companies are now using contract manufacturing, research, and packaging services. To save costs and product development time while simultaneously being effective, efficient, and productive, pharmaceutical companies are relying on contract manufacturers to fulfill many basic as well as specialized competencies. This study discusses the different types of contracting companies, their roles, and the share of the market they claim. New developments and new technologies warrant the issuing of this report, which is an important resource for anyone analyzing the discussed markets.
Trends in outsourcing and new emerging markets for outsourcing are providing a new look to the market and greater options to pharmaceutical companies. The industry is seeing an increase in outsourcing as contract manufacturers, researchers, and packagers provide cheaper options as well as region-specific suppliers. The new state-of-the-art packaging facilities as well as expensive research facilities and capabilities of research organizations are enhancing the overall growth of the contract manufacturing industry. Contract manufacturers are providing pharmaceutical companies with expertise in all forms that the companies do not have available in-house.
INTENDED AUDIENCE
This study examines the areas of market growth in pharmaceuticals contract manufacturing, research, and packaging from the point of view of manufacturers and users. Strategic decision makers at biochemical and biotechnology companies, physicians, pharmaceuticals and biopharmaceuticals companies, and related research companies will find value in this study.
SCOPE OF THE STUDY
The scope of this study encompasses the contract manufacturing, research, and packaging markets. BCC analyzes each market and its applications for contract manufacturing by its need for outsourcing, regulatory environment, technology involved, market projections, and market share. Technological issues include the latest trends and developments.
METHODOLOGY
Both primary and secondary research methodologies were used in preparing this study. 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. Market sizing estimates and 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 and research. Data were gathered from various industry sources. BCC spoke with officials and physicians within the industry, and 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.
Global Packaging Industry
CHAPTER ONE: INTRODUCTION 1
STUDY OBJECTIVE 1
REASONS FOR DOING THIS STUDY 1
INTENDED AUDIENCE 2
SCOPE OF THE STUDY 2
METHODOLOGY 2
INFORMATION SOURCES 3
ABOUT THE AUTHOR 3
RELATED BCC RESEARCH REPORTS 3
BCC ONLINE SERVICES 4
DISCLAIMER 4
CHAPTER TWO: SUMMARY 5
SUMMARY 5
SUMMARY (CONTINUED) 6
SUMMARY TABLE GLOBAL PHARMACEUTICAL CONTRACT
MANUFACTURING AND CONTRACT RESEARCH
ORGANIZATIONS REVENUE, THROUGH 2016 ($ BILLIONS) 7
SUMMARY FIGURE GLOBAL PHARMACEUTICAL CONTRACT
MANUFACTURING AND CONTRACT RESEARCH
ORGANIZATIONS REVENUE, 2009-2016 ($ BILLIONS) 7
CHAPTER THREE: OVERVIEW 8
DEFINITIONS 8
DEFINITIONS (CONTINUED) 9
HISTORY OF OUTSOURCING 10
TABLE 1 KEY DEVELOPMENTS IN THE HISTORY OF
OUTSOURCING 10
TABLE 1 (CONTINUED) 11
CHAPTER FOUR: OVERVIEW OF CONTRACT MANUFACTURING 12
TYPES OF CONTRACT MANUFACTURERS 12
CONTRACT MANUFACTURING TRAITS 12
REQUIREMENT 12
ABILITY TO BE FLEXIBLE 13
CAPABILITIES WITHOUT COST 13
ADVANTAGES AND DISADVANTAGES OF CONTRACT
MANUFACTURING 13
TABLE 2 KEY ADVANTAGES OF CONTRACT MANUFACTURING 14
TABLE 3 KEY DISADVANTAGES OF CONTRACT MANUFACTURING 14
SELECTING A CONTRACT MANUFACTURER 14
TABLE 4 KEY FACTORS IN SELECTING A CONTRACT
MANUFACTURER 15
TABLE 4 (CONTINUED) 16
ADDITIONAL FACTS ABOUT CONTRACT MANUFACTURING 16
LOCATION AND PROXIMITY 16
AFTER-SALES SUPPORT 16
CHAPTER FIVE: OVERVIEW OF CONTRACT RESEARCH 17
OVERVIEW OF CONTRACT RESEARCH 17
SERVICES OFFERED BY CONTRACT RESEARCH
ORGANIZATIONS 18
TABLE 5 SERVICES OF CONTRACT RESEARCH ORGANIZATIONS 18
TABLE 5 (CONTINUED) 19
SELECTING A CONTRACT RESEARCH ORGANIZATION 19
TABLE 6 KEY CHARACTERISITCS IN SELECTING A CONTRACT
RESEARCH ORGANIZATION 19
TABLE 6 (CONTINUED) 20
RESEARCH PROVIDED BY CONTRACT RESEARCH
ORGNIZATIONS 20
TABLE 7 TYPES OF RESEARCH PROVIDED BY CONTRACT
RESEARCH ORGANIZATIONS 20
TABLE 7 (CONTINUED) 21
CHAPTER SIX: OVERVIEW OF CONTRACT PACKAGING 22
NEEDING A CONTRACT PACKAGER 22
TABLE 8 REASONS BEHIND NEEDING A CONTRACT PACKAGER 22
TABLE 8 (CONTINUED) 23
SELECTING A CONTRACT PACKAGER 23
TABLE 9 KEY CHARACTERISTICS IN SELECTING A CONTRACT
PACKAGER 24
HIRING A CONTRACT PACKAGER 24
TABLE 10 KEY STEPS IN HIRING A CONTRACT PACKAGER 25
TYPES OF PACKAGING 25
TYPES OF PACKAGING (CONTINUED) 26
CHAPTER SEVEN: PROJECT MANAGEMENT 27
SPECIFICATIONS OF PROJECT MANAGEMENT 27
TABLE 11 STEPS OF PROJECT MANAGEMENT 27
TABLE 11 (CONTINUED) 28
PROCESSES OF PROJECT MANAGEMENT 28
TABLE 12 PROCESSES OF PROJECT MANAGEMENT 28
TABLE 12 (CONTINUED) 29
FACTORS INVOLVED 29
ROLE OF THE PROJECT MANAGER 29
TABLE 13 KEY RESPONSIBILITIES OF PROJECT MANAGERS 30
TECHNOLOGY TRANSFER 30
TABLE 14 TECHNOLOGY TRANSFER STEPS 31
CHAPTER EIGHT: REGULATORY ASPECTS 32
REGULATORY ASPECTS 32
TABLE 15 REGULATED FACTORS OF CMO’S AND CRO’S 33
TABLE 16 TITLE 21 CFR RULES ASSOCIATED WITH CONTRACT
MANUFACTURING 33
TABLE 16 (CONTINUED) 34
TABLE 16 (CONTINUED) 35
WARNING LETTERS 36
TABLE 17 WARNING LETTERS ISSUED TO CONTRACT
MANUFACTURERS, 2010 36
TABLE 18 WARNING LETTERS ISSUED TO CONTRACT
MANUFACTURERS, 2009 37
REGULATORY APPROVALS 37
TABLE 19 REGULATORY APPROVALS OF CONTRACT
MANUFACTURERS AND FACILITIES, JANUARY THROUGH
MARCH, 2011 38
TABLE 20 REGULATORY APPROVALS OF CONTRACT
MANUFACTURERS AND FACILITIES, 2010 38
TABLE 20 (CONTINUED) 39
TABLE 21 REGULATORY APPROVALS OF CONTRACT
MANUFACTURERS AND FACILITIES, 2009 39
TABLE 21 (CONTINUED) 40
CHAPTER NINE: INDUSTRY STRUCTURE FOR NORTH AMERICA 41
MARKET SHARE OF INDUSTRY LEADERS 41
CONTRACT MANUFACTURERS OF BULK DRUGS AND API’S 41
TABLE 22 MARKET SHARE OF CONTRACT MANUFACTURING
COMPANIES PROVIDING BULK DRUGS/API’S, IN NORTH
AMERICA, 2010 (%) 41
TABLE 22 (CONTINUED) 42
FIGURE 1 MARKET SHARE OF CONTRACT MANUFACTURING
COMPANIES PROVIDING BULK DRUGS/API’S, IN NORTH
AMERICA, 2010 (%) 42
CONTRACT MANUFACTURERS OF SOLID-DOSAGE FORMS 42
TABLE 23 MARKET SHARE OF CONTRACT MANUFACTURING
COMPANIES PROVIDING SOLID DOSAGE FORMS, IN NORTH
AMERICA, 2010 (%) 43
FIGURE 2 MARKET SHARE OF CONTRACT MANUFACTURING
COMPANIES PROVIDING SOLID DOSAGE FORMS, IN NORTH
AMERICA, 2010 (%) 43
CONTRACT MANUFACTURERS OF LIQUID DOSAGE FORMS 44
NONSTERILE 44
TABLE 24 MARKET SHARE OF CONTRACT MANUFACTURING
COMPANIES PROVIDING NONSTERILE LIQUID DOSAGE FORMS,
IN NORTH AMERICA, 2010 (%) 44
FIGURE 3 MARKET SHARE OF CONTRACT MANUFACTURING
COMPANIES PROVIDING NONSTERILE LIQUID DOSAGE FORMS,
IN NORTH AMERICA, 2010 (%) 45
STERILE 45
TABLE 25 MARKET SHARE OF CONTRACT MANUFACTURING
COMPANIES PROVIDING STERILE LIQUID DOSAGE FORMS, IN
NORTH AMERICA, 2010 (%) 46
FIGURE 4 MARKET SHARE OF CONTRACT MANUFACTURING
COMPANIES PROVIDING STERILE LIQUID DOSAGE FORMS, IN
NORTH AMERICA, 2010 (%) 46
CONTRACT MANUFACTURERS OF SEMISOLID DOSAGE FORMS 46
TABLE 26 MARKET SHARE OF CONTRACT MANUFACTURING
COMPANIES PROVIDING SEMISOLID DOSAGE FORMS, IN
NORTH AMERICA, 2010 (%) 47
FIGURE 5 MARKET SHARE OF CONTRACT MANUFACTURING
COMPANIES PROVIDING SEMISOLID DOSAGE FORMS, IN
NORTH AMERICA, 2010 (%) 47
CONTRACT RESEARCH COMPANIES 48
TABLE 27 MARKET SHARE OF CONTRACT RESEARCH
COMPANIES, IN NORTH AMERICA, 2010 (%) 48
FIGURE 6 MARKET SHARE OF CONTRACT RESEARCH
COMPANIES, IN NORTH AMERICA, 2010 (%) 49
CONTRACT PACKAGING COMPANIES 49
TABLE 28 MARKET SHARE OF CONTRACT PACKAGING
COMPANIES, IN NORTH AMERICA 2010 (%) 50
FIGURE 7 MARKET SHARE OF CONTRACT PACKAGING
COMPANIES, IN NORTH AMERICA, 2010 (%) 50
CHAPTER TEN: TECHNOLOGY TRANSFER 51
REASONS FOR TECHNOLOGY TRANSFER 51
CHALLENGING PROBLEMS DURING TECHNOLOGY TRANSFER 52
TECHNOLOGY TRANSFER 53
STEPS FOR SUCCESSFUL TECHNOLOGY TRANSFER 53
TYPES OF CONTRACTUAL AGREEMENTS USED IN
TECHNOLOGY TRANSFER 54
CONFIDENTIAL DISCLOSURE AGREEMENT (CDA) 55
MATERIAL TRANSFER AGREEMENT (MTA) 55
ASSIGNMENT DEED 55
LICENSE AGREEMENT 56
CO-DEVELOPMENT AND CO-MARKETING AGREEMENTS 56
CHARACTERISTICS OF A SUCCESSFUL PROJECT 56
CHARACTERISTICS OF A SUCCESSFUL … (CONTINUED) 57
CHAPTER ELEVEN: NEW DEVELOPMENTS 58
LONZA 58
ABBOTT 59
HOSPIRA 60
COVIDIEN 60
OTHER 61
OTHER (CONTINUED) 62
CHAPTER TWELVE: MARKET ANALYSIS FOR NORTH AMERICA 63
CONTRACT MANUFACTURING 63
CONTRACT MANUFACTURE OF BULK DRUGS/API’S 63
Market Overview 63
Market Revenue 64
TABLE 29 BULK DRUG/API CONTRACT MANUFACTURING, FOR
NORTH AMERICA, THROUGH 2016 ($ BILLIONS) 65
FIGURE 8 BULK DRUG/API CONTRACT MANUFACTURING, FOR
NORTH AMERICA, 2009-2016 ($ BILLIONS) 65
CONTRACT MANUFACTURE OF DOSAGE FORMULATIONS 65
Solid Dosage Formulations 66
Market Overview 66
Market Revenue 67
TABLE 30 SOLID DOSAGE FORM CONTRACT MANUFACTURING,
FOR NORTH AMERICA, THROUGH 2016 ($ BILLIONS) 68
FIGURE 9 SOLID DOSAGE FORM CONTRACT MANUFACTURING,
FOR NORTH AMERICA, 2009-2016 ($ BILLIONS) 68
Market by Formulation 68
Market Revenue 69
TABLE 31 SOLID DOSAGE FORM CONTRACT MANUFACTURING
REVENUE, BY FORMULATION, FOR NORTH AMERICA,
THROUGH 2016 ($ BILLIONS) 69
FIGURE 10 SOLID DOSAGE FORM CONTRACT MANUFACTURING
REVENUE, BY FORMULATIONS, FOR NORTH AMERICA, 2009-
2016 ($ BILLIONS) 70
TABLE 32 SOLID DOSAGE FORM CONTRACT MANUFACTURING
MARKET SHARES, BY FORMULATION, FOR NORTH AMERICA,
2010 (%) 70
FIGURE 11 SOLID DOSAGE FORM CONTRACT MANUFACTURING
MARKET SHARES, BY FORMULATIONS, FOR NORTH AMERICA,
2010 (%) 71
Liquid Dosage Formulation 71
Market Overview 71
Market Revenue 72
Nonsterile Formulations 72
TABLE 33 LIQUID DOSAGE FORM (NONSTERILE) CONTRACT
MANUFACTURING, FOR NORTH AMERICA, THROUGH 2016 ($
MILLIONS) 73
FIGURE 12 LIQUID DOSAGE FORM (NONSTERILE) CONTRACT
MANUFACTURING, FOR NORTH AMERICA, 2009-2016 ($
MILLIONS) 73
Sterile Formulations 73
TABLE 34 LIQUID DOSAGE FORM (STERILE) CONTRACT
MANUFACTURING, FOR NORTH AMERICA, THROUGH 2016 ($
MILLIONS) 74
FIGURE 13 LIQUID DOSAGE FORM (STERILE) CONTRACT
MANUFACTURING, FOR NORTH AMERICA, THROUGH 2016 ($
MILLIONS) 74
Market by Formulation 74
Nonsterile Formulations 74
TABLE 35 LIQUID DOSAGE FORM (NONSTERILE) CONTRACT
MANUFACTURING REVENUE, BY FORMULATION, FOR NORTH
AMERICA, THROUGH 2016 ($ MILLIONS) 75
FIGURE 14 LIQUID DOSAGE FORM (NON STERILE) CONTRACT
MANUFACTURING REVENUE, BY FORMULATION, FOR NORTH
AMERICA, 2009-2016 ($ MILLIONS) 76
TABLE 36 LIQUID DOSAGE FORM (NONSTERILE) CONTRACT
MANUFACTURING MARKET SHARES BY FORMULATION, FOR
NORTH AMERICA, 2010 (%) 76
FIGURE 15 LIQUID DOSAGE FORM (NONSTERILE) CONTRACT
MANUFACTURING MARKET SHARES, BY FORMULATION, FOR
NORTH AMERICA, 2010 (%) 77
Sterile Formulations 77
TABLE 37 LIQUID DOSAGE FORM (STERILE) CONTRACT
MANUFACTURING REVENUE, BY FORMULATION, FOR NORTH
AMERICA, THROUGH 2016 ($ MILLIONS) 78
FIGURE 16 LIQUID DOSAGE FORM (STERILE) CONTRACT
MANUFACTURING REVENUE, BY FORMULATION, FOR NORTH
AMERICA, 2009-2016 ($ MILLIONS) 78
TABLE 38 LIQUID DOSAGE FORM (STERILE) CONTRACT
MANUFACTURING MARKET SHARE, BY FORMULATION, FOR
NORTH AMERICA, 2010 (%) 79
FIGURE 17 LIQUID DOSAGE FORM (STERILE) CONTRACT
MANUFACTURING MARKET SHARE, BY FORMULATION, FOR
NORTH AMERICA, 2010 (%) 79
CONTRACT MANUFACTURE OF SEMISOLID DOSAGE
FORMULATIONS 79
Market Overview 79
Market Revenue 80
TABLE 39 SEMISOLID DOSAGE FORM CONTRACT
MANUFACTURING, FOR NORTH AMERICA, THROUGH 2016 ($
MILLIONS) 80
FIGURE 18 SEMISOLID DOSAGE FORM CONTRACT
MANUFACTURING, FOR NORTH AMERICA, 2009-2016 ($
MILLIONS) 81
TABLE 40 SEMISOLID DOSAGE FORM CONTRACT
MANUFACTURING REVENUE, BY FORMULATION, FOR NORTH
AMERICA, THROUGH 2016 ($ MILLIONS) 82
FIGURE 19 SEMISOLID DOSAGE FORM CONTRACT
MANUFACTURING REVENUE, BY FORMULATION, FOR NORTH
AMERICA, 2009-2016 ($ MILLIONS) 82
TABLE 41 SEMISOLID DOSAGE FORM CONTRACT
MANUFACTURING MARKET SHARE, BY FORMULATION, FOR
NORTH AMERICA, 2010 (%) 83
FIGURE 20 SEMISOLID DOSAGE FORM CONTRACT
MANUFACTURING MARKET SHARE, BY FORMULATION, FOR
NORTH AMERICA, 2010 (%) 83
CONTRACT MANUFACTURE OF ADVANCED DRUG
DELIVERY PRODUCTS 83
Market Overview 84
TABLE 42 CONTRACTING COMPANIES PROVIDING DRUGDELIVERY
SYSTEMS 85
Market Revenue 86
TABLE 43 ADVANCED DRUG DELIVERY SYSTEMS REVENUE BY
CONTRACT MANUFACTURING, FOR NORTH AMERICA,
THROUGH 2016 ($ BILLIONS) 86
FIGURE 21 ADVANCED DRUG DELIVERY SYSTEMS REVENUE BY
CONTRACT MANUFACTURING, FOR NORTH AMERICA,
THROUGH 2016 ($ BILLIONS) 86
Market by Formulation 87
TABLE 44 ADVANCED DRUG DELIVERY SYSTEMS FOR NORTH
AMERICA, BY CONTRACT MANUFACTURING REVENUE, BY
FORMULATION, THROUGH 2016 ($ MILLIONS) 88
FIGURE 22 ADVANCED DRUG DELIVERY SYSTEMS FOR NORTH
AMERICA, BY CONTRACT MANUFACTURING REVENUE, BY
FORMULATIONS, 2009-2016 ($ MILLIONS) 88
Market Share 89
TABLE 45 ADVANCED DRUG DELIVERY SYSTEMS FOR NORTH
AMERICA, BY CONTRACT MANUFACTURING MARKET SHARE,
BY FORMULATION, 2010 (%) 89
FIGURE 23 ADVANCED DRUG DELIVERY SYSTEMS FOR NORTH
AMERICA, BY CONTRACT MANUFACTURING MARKET SHARE,
BY FORMULATIONS, 2010 (%) 90
CONTRACT MANUFACTURE OF OTC AND NUTRITIONAL
PRODUCTS 90
Market Overview 91
Market Revenue 92
TABLE 46 OTC AND NUTRITIONAL PRODUCT REVENUE FOR
NORTH AMERICA BY CONTRACT MANUFACTURING, THROUGH
2016 ($ BILLIONS) 92
FIGURE 24 OTC AND NUTRITIONAL PRODUCT REVENUE FOR
NORTH AMERICA BY CONTRACT MANUFACTURING, 2009-2016
($ BILLIONS) 92
Market by Formulation 93
TABLE 47 OTC AND NUTRITIONAL PRODUCTS BY CONTRACT
MANUFACTURING REVENUE BY FORMULATION FOR NORTH
AMERICA, THROUGH 2016 ($ BILLIONS) 93
FIGURE 25 OTC AND NUTRITIONAL PRODUCTS BY CONTRACT
MANUFACTURING REVENUE, BY FORMULATION, FOR NORTH
AMERICA, 2009-2016 ($ BILLIONS) 94
Market Shares 94
TABLE 48 OTC AND NUTRITIONAL PRODUCTS BY CONTRACT
MANUFACTURING MARKET SHARE, BY FORMULATION, FOR
NORTH AMERICA, 2010 (%) 94
FIGURE 26 OTC AND NUTRITIONAL PRODUCTS BY CONTRACT
MANUFACTURING MARKET SHARE, BY FORMULATIONS, FOR
NORTH AMERICA, 2010 (%) 95
CONTRACT RESEARCH 95
MARKET OVERVIEW 95
Partnerships 96
Expansions of Facilities 96
MARKET REVENUE 96
TABLE 49 CONTRACT RESEARCH REVENUE FOR NORTH
AMERICA, THROUGH 2016 ($ BILLIONS) 97
FIGURE 27 CONTRACT RESEARCH REVENUE, FOR NORTH
AMERICA, 2009-2016 ($ BILLIONS) 97
Market by Discipline 97
TABLE 50 CONTRACT RESEARCH REVENUE BY DISCIPLINE, FOR
NORTH AMERICA, THROUGH 2016 ($ BILLIONS) 98
FIGURE 28 CONTRACT RESEARCH REVENUE BY DISCIPLINE, FOR
NORTH AMERICA, 2009-2016 ($ BILLIONS) 98
Market Shares by Discipline 99
TABLE 51 CONTRACT RESEARCH MARKET SHARE, BY
DISCIPLINE, FOR NORTH AMERICA, 2010 (%) 99
FIGURE 29 CONTRACT RESEARCH MARKET SHARE, BY
DISCIPLINE, FOR NORTH AMERICA, 2010 (%) 99
CONTRACT PACKAGING 100
MARKET OVERVIEW 100
Market Revenue 100
TABLE 52 CONTRACT PACKAGING REVENUE, FOR NORTH
AMERICA, THROUGH 2016 ($ BILLIONS) 101
FIGURE 30 CONTRACT PACKAGING REVENUE, FOR NORTH
AMERICA, 2009-2016 ($ BILLIONS) 101
Market by Package Type 102
TABLE 53 CONTRACT PACKAGING REVENUE BY TYPE, FOR
NORTH AMERICA, THROUGH 2016 ($ MILLIONS) 103
FIGURE 45 CONTRACT RESEARCH REVENUE BY DISCIPLINE, FOR
NORTH AMERICA, 2009-2016 ($ MILLIONS) 103
Market Share by Type 104
TABLE 54 CONTRACT PACKAGING MARKET SHARE, BY TYPE, FOR
NORTH AMERICA, 2010 (%) 104
FIGURE 31 CONTRACT PACKAGING MARKET SHARE, BY TYPE,
FOR NORTH AMERICA, 2010 (%) 104
CHAPTER THIRTEEN: MARKET SHARE BY REGION 105
MARKET SHARE OF CONTRACT MANUFACTURED API’S 105
TABLE 55 BULK DRUG/API CONTRACT MANUFACTURING
MARKET SHARE, BY REGION, 2010 (%) 105
FIGURE 32 BULK DRUG/API CONTRACT MANUFACTURING
MARKET SHARE, BY REGION, 2010 (%) 106
MARKET SHARE OF CONTRACT MANUFACTURED SOLID
DOSAGE FORMS 106
TABLE 56 SOLID DOSAGE FORM CONTRACT MANUFACTURING
MARKET SHARE, BY REGION, 2010 (%) 106
FIGURE 33 SOLID DOSAGE FORM CONTRACT MANUFACTURING
MARKET SHARE, BY REGION, 2010 (%) 107
MARKET SHARE OF CONTRACT MANUFACTURED LIQUID
DOSAGE FORMULATIONS 107
NONSTERILE FORMULATIONS 107
TABLE 57 LIQUID DOSAGE FORM (NONSTERILE) CONTRACT
MANUFACTURING MARKET SHARE, BY REGION, 2010 (%) 107
FIGURE 34 LIQUID DOSAGE FORM (NONSTERILE) CONTRACT
MANUFACTURING MARKET SHARE, BY REGION, 2010 (%) 108
STERILE FORMULATIONS 108
TABLE 58 LIQUID DOSAGE FORM (STERILE) CONTRACT
MANUFACTURING MARKET SHARE, BY REGION, 2010 (%) 108
FIGURE 35 LIQUID DOSAGE FORM (STERILE) CONTRACT
MANUFACTURING MARKET SHARE, BY REGION, 2010 (%) 109
MARKET SHARE OF CONTRACT MANUFACTURED SEMISOLID
DOSAGE FORMULATIONS 109
TABLE 59 SEMISOLID DOSAGE FORM CONTRACT
MANUFACTURING MARKET SHARES, BY REGION, 2010 (%) 109
FIGURE 36 SEMISOLID DOSAGE FORM CONTRACT
MANUFACTURING MARKET SHARE, BY REGION, 2010 (%) 110
MARKET SHARE OF CONTRACT MANUFACTURED ADVANCED
DRUG DELIVERY PRODUCTS 110
TABLE 60 DRUG DELIVERY CONTRACT MANUFACTURING
MARKET SHARE, BY REGION, 2010 (%) 110
FIGURE 37 DRUG DELIVERY CONTRACT MANUFACTURING
MARKET SHARE, BY REGION, 2010 (%) 111
MARKET SHARE OF CONTRACT MANUFACTURED OTC AND
NUTRITIONAL PRODUCTS 111
TABLE 61 OTC AND NUTRITIONAL PRODUCTS CONTRACT
MANUFACTURING MARKET SHARE, BY REGION, 2010 (%) 111
FIGURE 38 OTC AND NUTRITIONAL PRODUCT CONTRACT
MANUFACTURING MARKET SHARE, BY REGION, 2010 (%) 112
MARKET SHARE OF CONTRACT RESEARCH 112
TABLE 62 CONTRACT RESEARCH MARKET SHARE, BY REGION,
2010 (%) 112
FIGURE 39 CONTRACT RESEARCH MARKET SHARE, BY REGION,
2010 (%) 113
MARKET SHARE OF CONTRACT PACKAGING 113
TABLE 63 CONTRACT PACKAGING MARKET SHARE, BY REGION,
2010 (%) 113
FIGURE 40 CONTRACT PACKAGING MARKET SHARE, BY REGION,
2010 (%) 114
CHAPTER FOURTEEN: CONTRACT MANUFACTURING APPLICATIONS
FOR NORTH AMERICAN MARKETS 115
CARDIOVASCULAR DRUGS 115
MARKET REVENUE 116
TABLE 64 REVENUE FROM CONTRACT MANUFACTURERS OF
CARDIOVASCULAR DRUGS, IN NORTH AMERICA, THROUGH
2016 ($ MILLIONS) 117
FIGURE 41 REVENUE FROM CONTRACT MANUFACTURERS OF
CARDIOVASCULAR DRUGS, IN NORTH AMERICA, 2009-2016 ($
MILLIONS) 117
REPRODUCTIVE DRUG MARKET 117
REPRODUCTIVE DRUG MARKET (CONTINUED) 118
MARKET REVENUE 119
TABLE 65 REVENUE FROM CONTRACT MANUFACTURERS OF
REPRODUCTIVE DRUGS, IN NORTH AMERICA, THROUGH 2016
($ MILLIONS) 119
FIGURE 42 REVENUE FROM CONTRACT MANUFACTURERS OF
REPRODUCTIVE DRUGS, IN NORTH AMERICA, 2009-2016 ($
MILLIONS) 119
ONCOLOGY DRUG MARKET 120
MARKET REVENUE 121
TABLE 66 REVENUE FROM CONTRACT MANUFACTURERS OF
ONCOLOGY DRUGS, IN NORTH AMERICA, THROUGH 2016 ($
MILLIONS) 121
FIGURE 43 REVENUE FROM CONTRACT MANUFACTURERS OF
ONCOLOGY DRUGS, IN NORTH AMERICA, 2009-2016 ($
MILLIONS) 122
ANALGESICS MARKET 122
MARKET REVENUE 123
TABLE 67 REVENUE FROM CONTRACT MANUFACTURERS OF
ANALGESICS, IN NORTH AMERICA, THROUGH 2016 ($
MILLIONS) 123
FIGURE 44 REVENUE FROM CONTRACT MANUFACTURERS OF
ANALGESICS, IN NORTH AMERICA, 2009-2016 ($ MILLIONS) 124
MARKET REVENUE 125
TABLE 68 REVENUE FROM CONTRACT MANUFACTURERS OF
ANTIVIRALS, IN NORTH AMERICA, THROUGH 2016 ($
MILLIONS) 125
FIGURE 45 REVENUE FROM CONTRACT MANUFACTURERS OF
ANTIVIRALS, IN NORTH AMERICA, 2009-2016 ($ MILLIONS) 126
ANTIBIOTICS MARKET 126
MARKET REVENUE 127
TABLE 69 REVENUE FROM CONTRACT MANUFACTURERS OF
ANTIBIOTICS, IN NORTH AMERICA, THROUGH 2016 ($
MILLIONS) 127
FIGURE 46 REVENUE FROM CONTRACT MANUFACTURERS OF
ANTIBIOTICS, IN NORTH AMERICA, 2009-2016 ($ MILLIONS) 128
MARKETS FOR OTHER DRUGS 128
MARKET REVENUE 129
TABLE 70 REVENUE FROM CONTRACT MANUFACTURERS OF
OTHER DRUGS, IN NORTH AMERICA, THROUGH 2016 ($
BILLIONS) 129
FIGURE 47 REVENUE FROM CONTRACT MANUFACTURERS OF
OTHER DRUGS, IN NORTH AMERICA, 2009-2016 ($ BILLIONS) 130
CHAPTER FIFTEEN: PATENT ANALYSIS 131
PATENTS BY YEAR 131
TABLE 71 NUMBER OF SIGNIFICANT PATENTS, BY YEAR, 2009-
2011 131
FIGURE 62 NUMBER OF PATENTS, BY YEAR, 2009-MAY 31, 2011 131
FIGURE 63 NUMBER OF PATENTS, BY YEAR, 2009-MAY 31, 2011 (%) 132
PATENTS BY COMPANY 132
TABLE 72 NUMBER OF US PATENTS, BY COMPANY, 2009-2011 133
FIGURE 64 NUMBER OF US PATENTS, BY COMPANY, 2009-2011 134
PATENTS BY COUNTRY 135
TABLE 73 NUMBER OF US PATENTS, BY COUNTRY, 1/1/2009 TO
5/31/2011 135
FIGURE 65 NUMBER OF US PATENTS, BY COUNTRY, 1/1/2009 TO
5/31/2011 136
TABLE 74 PATENT SHARES, BY COUNTRY, 1/1/2009 TO 5/31/2011
(%) 136
FIGURE 66 PATENT SHARES, BY COUNTRY, 1/1/2009 TO
5/31/2011 (%) 137
PATENTS BY EMPHASIS 137
TABLE 75 PATENTS, BY EMPHASIS, 1/1/2009 TO 5/31/2011 138
FIGURE 67 NUMBER OF US PATENTS, BY EMPHASIS, 1/1/2009 TO
5/31/2011 138
CHAPTER SIXTEEN: CURRENT ENVIRONMENT 139
SITUATION OF THE NORTH AMERICAN CONTRACTING
MARKETS 139
CONTRACT MANUFACTURING OF API AND DOSAGE
FORMS 139
CONTRACT MANUFACTURING OF OTC AND
NUTRACEUTICALS 139
CONTRACT RESEARCH 140
CONTRACT PACKAGING 140
SITUATION OF THE EUROPEAN CONTRACTING MARKET 140
CONTRACT MANUFACTURING OF API AND DOSAGE
FORMS 140
CONTRACT MANUFACTURING OF OTC AND
NUTRACEUTICALS 140
CONTRACT RESEARCH 141
CONTRACT PACKAGING 141
SITUATION OF THE ROW CONTRACTING MARKET 141
CONTRACT MANUFACTURING OF API AND DOSAGE
FORMS 141
CONTRACT MANUFACTURING OF OTC AND
NUTRACEUTICALS 141
CONTRACT RESEARCH 142
CONTRACT PACKAGING 142
OPPORTUNITIES AND CHALLENGES OF THE CURRENT
CONTRACT MANUFACTURING INDUSTRY 142
OPPORTUNITIES AND CHALLENGES…(CONTINUED) 143
OPPORTUNITIES AND CHALLENGES…(CONTINUED) 144
CHAPTER SEVENTEEN: COMPANY PROFILES 145
AAI PHARMA, INC 145
ABBOTT LABORATORIES 145
AEROGEN LTD 146
ALKERMES 146
ALTHEA TECHNOLOGIES 147
AMCOR 148
AMERISOURCE BERGEN CORPORATION 148
AMPAC FINE CHEMICALS 149
ALBANY MOLECULAR RESEARCH INC (AMRI) 149
AP PHARMA INC 150
APTUIT INC 150
ARADIGM CORPORATION 151
BASF SE 152
BAXTER HEALTHCARE 152
BCM/BOOTS MANUFACTURING 153
BOEHRINGER INGELHEIM 154
BRISTOL-MYERS SQUIBB 154
CAMBREX CORPORATION 155
CANGENE CORPORATION 156
CATALENT PHARMA SOLUTIONS 156
CEDARBURG HAUSER PHARMACEUTICALS INC 157
CENEXI 157
CHARLES RIVER LABORATORIES 158
CHEMBRIDGE CORP 158
CLEARSTONE CENTRAL LABORATORIES 159
CONFAB LABORATORIES 159
COVANCE INC 160
COVIDIEN 160
CONTRACT PHARMACEUTICALS LIMITED 161
CORDEN PHARMA SWITZERLAND LLC 161
DAVOS PHARMA 162
DECODE GENETICS 162
DISHMAN PHARMACEUTICALS AND CHEMICALS LTD 163
DOW CHEMICAL 164
DPT LABORATORIES INC 164
DR REDDY’S LABORATORIES 165
DSM PHARMACEUTICAL PRODUCTS 165
FUJIFILM DIOSYNTH BIOTECHNOLOGY 166
ELAN DRUG TECHNOLOGIES 166
EVOTEC AG 167
FULCRUM PHARMA PLC 167
GIRINDUS AG 168
GLAXOSMITHKLINE 168
HOSPIRA 169
HAUPT PHARMA AG 170
HOVIONE SA 170
ICON PLC 171
INC RESEARCH, INC 171
JUBILANT LIFESCIENCES 172
KENDLE INTERNATIONAL INC 172
KP PHARMACEUTICAL TECHNOLOGIES INC 173
KV PHARMACEUTICAL CO 173
LIGAND PHARMACEUTICALS, INC 174
LONZA GROUP 174
LYNE LABORATORIES 175
MERCK / MSD BIOMANUFACTURING NETWORK 176
MIKART INC 176
NEXTPHARMA TECHNOLOGIES 177
NORWICH PHARMACEUTICALS 177
NOVAVAX, INC 178
OMNICARE CLINICAL RESEARCH 178
PAREXEL INTERNATIONAL CORPORATION 179
PATHEON INC 179
PERRIGO COMPANY 180
PFIZER (KING PHARMACEUTICALS 181
PIRAMAL HEALTHCARE LIMITED 181
PPD 182
PRA INTERNATIONAL 182
QUINTILES 183
RANBAXY 183
REGIS TECHNOLOGIES, INC 184
SKYEPHARMA 184
TALECRIS BIOTHERAPEUTICS INC 185
VETTER PHARMA INTERNATIONAL GMBH 185
WOCKHARDT LIMITED 186
WUXI APP TEC 187
XCELLEREX LLC 187
ZACH SYSTEM SPA 188
APPENDIX I: ABBREVIATIONS 189
