REPORT HIGHLIGHTS

This report provides:
An overview of the global market for contract pharmaceutical manufacturing, research, and packaging, with emphasis on the outlook of the market and a comprehensive analysis of the overall pharmaceutical and biotechnology outsourcing industry; this report will focus on contract packaging
Analyses of global market trends, with data from 2012, estimates for 2013, and projections of compound annual growth rates (CAGRs) through 2018
Discussion of the different types of contracting companies, their roles, and the shares of the market they claim
Examination of the effects on market growth of state-of-the-art packaging facilities as well as expensive research facilities and the capabilities of research organizations
Coverage of the market's need for outsourcing, the regulatory environment, and technological issues, including the latest trends and developments
Comprehensive company profiles of major players.

STUDY OBJECTIVE

BCC Research’s objective in conducting this study is to provide an overview of the current and future global pharmaceutical contract manufacturing, research and packaging markets. The study provides a global as well as a regionally specific market overview. The key objective is to present a comprehensive analysis of the current and future direction of contract manufacturing, research and packaging as an important tool for a company’s growth and financial stability and as a way to overcome various trade barriers. It also addresses the role of these organizations in reducing costs, meeting strict regulatory requirements globally, dealing with the effects of patent expiries on market share and in competing in a highly competitive and tough business environment.A detailed analysis of the industry structure of contract manufacturing, contract research and contract packaging has been conducted. Revenues are broken down by type of industry. Sales figures are estimated for the five-year period from 2013 through 2018.Applications and various formulations for which contract manufacturing, research and packaging are widely used are also discussed separately in the report. The report also takes into account various new developments and regulatory aspects in this industry. The report also covers significant patents in each category.

REASONS FOR DOING THIS STUDY

Comprehensive research in the fields of contract manufacturing, contract research and contract packaging has revealed their benefits in various industries. Contract manufacturing, research and packaging are advantageous to both parties to the contract as it provides the manufacturing company with financial stability for the duration of the contract and the hiring company the benefit of cost savings, time saved in operating and managing a production facility and research. Many industries have now begun to explore the advantages of contracting their research, production and packaging, leading to a steady market for these services.Cost control, R&D spend, new technologies, increasing competition and patent expiries resulting in markets for generics are moving this industry in a new direction. New advancements, product launches and changing technologies will drive the growth of the market in the foreseeable future. This study looks at most of the systems affected by these factors. Acquisition strategies and collaborations by companies are also covered in this report. This study also discusses the strength and weaknesses of each type of technology in light of the new technologies, growing competition and changing market needs.

CONTRIBUTIONS OF THE STUDY AND INTENDED AUDIENCE

This study contributes to the market growth of contract manufacturers, contract research and contract packaging and users. Pharmaceutical, biotechnical companies, research institutes and companies involved in the packaging of pharma and biotech products will find this study to be of interest.

SCOPE OF THE STUDY

The scope of this study encompasses contract manufacturers, contract research and contract packaging in the pharmaceutical and biotechnology markets. BCC analyzes each market and its applications, regulatory environment, technology, market projections and market shares. Technological issues include the latest trends and developments. The emerging markets for contract manufacturing research and packaging include countries such as India, China, Japan, Korea, Taiwan, Canada, Africa, Australia and New Zealand.

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 manufacturers of enzyme inhibitors and technical experts. Projections were based on estimates, including the current number of end users, potential end users, mergers and acquisitions and market trends.

INFORMATION SOURCES

Many companies were surveyed to obtain data for this study. Included were manufacturers and end users of kinase inhibitors in various therapeutic categories and disease segments. Data were gathered from various industry sources. BCC spoke with officials 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.

Table Of Contents

CHAPTER 1 INTRODUCTION 2
STUDY OBJECTIVES 2
REASONS FOR DOING THIS STUDY 2
CONTRIBUTIONS OF THE STUDY AND INTENDED AUDIENCE 3
SCOPE OF THE STUDY 3
METHODOLOGY 3
INFORMATION SOURCES 3
ABOUT THE AUTHOR 3
RELATED BCC RESEARCH REPORTS 4
BCC ONLINE SERVICES 4
DISCLAIMER 4
CHAPTER 2 SUMMARY 6
SUMMARY TABLE GLOBAL MARKET FOR PHARMACEUTICAL AND
BIOPHARMACEUTICAL CONTRACT MANUFACTURING, RESEARCH AND PACKAGING,
THROUGH 2018 ($ BILLIONS)
6
SUMMARY FIGURE GLOBAL MARKET FOR PHARMACEUTICAL AND
BIOPHARMACEUTICAL CONTRACT MANUFACTURING, RESEARCH AND PACKAGING,
2011-2018 ($ BILLIONS)
6
CHAPTER 3 OVERVIEW 10
DEFINITIONS 10
OUTSOURCING 10
CONTRACT MANUFACTURING 10
CONTRACT MANUFACTURER 10
CORE COMPETENCIES 11
VENDOR 11
CONTRACT RESEARCH ORGANIZATION (CRO) 11
REASONS FOR OUTSOURCING 12
REDUCE AND CONTROL OPERATING COSTS 12
IMPROVE FOCUS ON CORE COMPETENCIES 12
GAIN ACCESS TO WORLD-CLASS CAPABILITIES 12
SHARE RISKS WITH A PARTNER COMPANY 13
HISTORY OF OUTSOURCING 13
TABLE 1 KEY DEVELOPMENTS IN THE HISTORY OF OUTSOURCING 14
CONTRACT MANUFACTURING 16
TYPES OF CONTRACT MANUFACTURERS 16
Supply Manufacturers 16
Toll Manufacturers 17
Types of Toll Manufacturers 17
Vendors of Excess Capacity 17
Providers of Niche Services 17
Academic Institutions 17
SPECIFIC REASONS FOR OUTSOURCING 17
STRATEGIES FOR SUCCESSFUL OUTSOURCING 18
ADVANTAGES AND DISADVANTAGES OF CONTRACT MANUFACTURING 18
PHM157A - Global Markets for Contract Pharmaceutical Manufacturing, Research and Packaging -
Focus on Contract Packaging
TABLE 2 KEY ADVANTAGES OF CONTRACT MANUFACTURING 18
TABLE 3 KEY DISADVANTAGES OF CONTRACT MANUFACTURING 19
SELECTING A CONTRACT MANUFACTURER 19
TABLE 4 KEY FACTORS IN SELECTING A CONTRACT MANUFACTURER 20
IMPORTANT FACTORS IN WORKING WITH A CONTRACT MANUFACTURER 21
Product Quality 21
Cost Competitiveness 21
Delivery Schedule 21
Client-CMO Relationship 21
CONTRACT RESEARCH 22
RESPONSIBILITIES OF CONTRACT RESEARCH ORGANIZATIONS 23
CRO-SPONSOR RELATIONSHIP: KEY TO SUCCESS 23
SERVICES OFFERED BY CONTRACT RESEARCH ORGANIZATIONS 24
TABLE 5 SERVICES OFFERED BY CONTRACT RESEARCH ORGANIZATIONS 24
SELECTION CRITERIA 25
TABLE 6 KEY FACTORS IN SELECTING A CONTRACT RESEARCH ORGANIZATION 25
RESEARCH PROVIDED BY CONTRACT RESEARCH ORGANIZATIONS 26
TABLE 7 TYPES OF SERVICES PROVIDED BY CONTRACT RESEARCH
ORGANIZATIONS 26
CONTRACT PACKAGING 27
NEED FOR CONTRACT PACKAGERS 27
TABLE 8 REASONS COMPANIES HIRE CONTRACT PACKAGERS 28
ETHICAL STANDARDS FOR CONTRACT PACKAGERS 28
CHAPTER 4 REGULATORY ASPECTS 31
WARNING LETTERS 31
TABLE 9 WARNING LETTERS ISSUED TO PHARMACEUTICAL CONTRACT
MANUFACTURERS, 2012 32
TABLE 10 WARNING LETTERS ISSUED TO PHARMACEUTICAL CONTRACT
MANUFACTURERS, 2011 33
TABLE 11 WARNING LETTERS ISSUED TO PHARMACEUTICAL CONTRACT
MANUFACTURERS, 2010 33
REGULATORY APPROVALS 33
TABLE 12 REGULATORY APPROVALS OF PHARMACEUTICAL CONTRACT
MANUFACTURER ACTIVITIES AND FACILITIES, JAN. AND FEB. 2013 34
TABLE 13 REGULATORY APPROVALS OF PHARMACEUTICAL CONTRACT
MANUFACTURER ACTIVITIES AND FACILITIES, 2012 35
TABLE 14 REGULATORY APPROVALS OF PHARMACEUTICAL CONTRACT
MANUFACTURER ACTIVITIES AND FACILITIES, 2011 35
TABLE 15 REGULATORY APPROVALS OF CONTRACT MANUFACTURER ACTIVITIES
AND FACILITIES, 2010 36
CHAPTER 5 NEW DEVELOPMENTS 38
LONZA 38
BRISTOL-MYERS SQUIBB 39
ABBOTT 39
ALBANY MOLECULAR RESEARCH INC. (AMRI) 40
EVOTEC AG 40
HOSPIRA 41
PHM157A - Global Markets for Contract Pharmaceutical Manufacturing, Research and Packaging -
Focus on Contract Packaging
COVIDIEN 41
DR. REDDY'S LABORATORIES 42
OTHER 42
CHAPTER 6 GLOBAL MARKETS FOR CONTRACT MANUFACTURING, RESEARCH AND
PACKAGING 47
MARKETS BY TYPE 47
CONTRACT MANUFACTURE OF VARIOUS DOSAGE FORMS AND BULK
DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS 48
Market Overview 49
Market Revenue 49
TABLE 16 GLOBAL MARKET FOR CONTRACT MANUFACTURING OF BULK
DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS AND VARIOUS DOSAGE FORMS,
THROUGH 2018 ($ BILLIONS)
50
FIGURE 1 GLOBAL MARKET FOR CONTRACT MANUFACTURING OF BULK
DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS AND VARIOUS DOSAGE FORMS,
2011-2018 ($ BILLIONS)
50
Market Shares 50
TABLE 17 MARKET SHARES OF CONTRACT MANUFACTURING OF BULK
DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS AND VARIOUS DOSAGE FORMS,
2012 (%)
51
FIGURE 2 MARKET SHARES OF CONTRACT MANUFACTURING OF BULK
DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS AND VARIOUS DOSAGE FORMS,
2012 (%)
51
MARKET FOR CONTRACT MANUFACTURING OF OTC DRUGS AND
NUTRITIONALS 51
Market Overview 52
Market Revenues 52
TABLE 18 GLOBAL MARKET FOR CONTRACT MANUFACTURING OF OTC DRUGS AND
NUTRITIONAL PRODUCTS BY FORMULATION, THROUGH 2018 ($ BILLIONS) 53
FIGURE 3 GLOBAL MARKET FOR CONTRACT MANUFACTURING OF OTC DRUGS AND
NUTRITIONAL PRODUCTS BY FORMULATION, 2011-2018 ($ BILLIONS) 53
Market Share 53
TABLE 19 MARKET SHARES OF CONTRACT MANUFACTURING OF OTC DRUGS AND
NUTRITIONAL PRODUCTS BY FORMULATION, 2012 (%) 54
FIGURE 4 MARKET SHARES OF CONTRACT MANUFACTURING OF OTC DRUGS AND
NUTRITIONAL PRODUCTS BY FORMULATION, 2012 (%) 54
MARKET FOR VARIOUS DOSAGE FORMS, BULK DRUGS/ACTIVE
PHARMACEUTICAL INGREDIENTS AND OTC DRUGS/NUTRITIONALS 54
Market Revenue 54
TABLE 20 GLOBAL MARKET FOR CONTRACT MANUFACTURING OF BULK
DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS, VARIOUS DOSAGE FORMS AND
OTC DRUGS/NUTRITIONAL PRODUCTS, THROUGH 2018 ($ BILLIONS)
55
FIGURE 5 GLOBAL MARKET FOR CONTRACT MANUFACTURING OF BULK
DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS, VARIOUS DOSAGE FORMS AND
OTC DRUGS/NUTRITIONAL PRODUCTS, 2011-2018 ($ BILLIONS)
55
Market Share 56
TABLE 21 MARKET SHARES OF CONTRACT MANUFACTURING OF BULK
DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS, VARIOUS DOSAGE FORMS AND
OTC DRUGS/NUTRITIONAL PRODUCTS, 2012 (%)
56
PHM157A - Global Markets for Contract Pharmaceutical Manufacturing, Research and Packaging -
Focus on Contract Packaging
FIGURE 6 MARKET SHARES OF CONTRACT MANUFACTURING OF BULK
DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS, VARIOUS DOSAGE FORMS AND
OTC DRUGS/NUTRITIONAL PRODUCTS, 2012 (%)
56
CONTRACT RESEARCH MARKET 57
Market Overview 57
Market Revenue 57
TABLE 22 GLOBAL MARKET FOR CONTRACT RESEARCH BY SEGMENT, THROUGH
2018 ($ BILLIONS) 57
FIGURE 7 GLOBAL MARKET FOR CONTRACT RESEARCH BY SEGMENT, 2011-2018 ($
BILLIONS) 58
Market Shares 58
TABLE 23 CONTRACT RESEARCH MARKET SHARES BY SEGMENT, 2012 (%) 59
FIGURE 8 CONTRACT RESEARCH MARKET SHARES BY SEGMENT, 2012 (%) 59
CONTRACT PACKAGING MARKET 59
Market Overview 60
Market Revenue 61
TABLE 24 GLOBAL MARKET FOR CONTRACT PACKAGING BY TYPE, THROUGH 2018
($ BILLIONS) 61
FIGURE 9 GLOBAL MARKET FOR CONTRACT PACKAGING BY TYPE, 2011-2018 ($
BILLIONS) 61
Market Share 62
TABLE 25 MARKET SHARES OF CONTRACT PACKAGING BY TYPE, 2012 (%) 62
FIGURE 10 MARKET SHARES OF CONTRACT PACKAGING BY TYPE, 2012 (%) 62
MARKET BY REGION 62
MARKET FOR CONTRACT MANUFACTURE OF VARIOUS DOSAGE FORMS,
BULK DRUGS AND ACTIVE PHARMACEUTICAL INGREDIENTS 63
Market Overview 64
Market Revenue 66
TABLE 26 GLOBAL MARKET FOR CONTRACT MANUFACTURING OF VARIOUS
DOSAGE FORMS AND BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS BY
REGION, THROUGH 2018 ($ BILLIONS)
66
FIGURE 11 GLOBAL MARKET FOR CONTRACT MANUFACTURING OF VARIOUS
DOSAGE FORMS AND BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS BY
REGION, 2011-2018 ($ BILLIONS)
67
Market Share 67
TABLE 27 REGIONAL MARKETS SHARES OF CONTRACT MANUFACTURING OF
VARIOUS DOSAGE FORMS AND BULK DRUGS/ACTIVE PHARMACEUTICAL
INGREDIENTS, 2012 (%)
68
FIGURE 12 REGIONAL MARKETS SHARES OF CONTRACT MANUFACTURING OF
VARIOUS DOSAGE FORMS AND BULK DRUGS/ACTIVE PHARMACEUTICAL
INGREDIENTS, 2012 (%)
68
MARKET FOR CONTRACT MANUFACTURING, RESEARCH AND PACKAGING 68
Market Overview 69
Market Revenue 72
TABLE 28 GLOBAL MARKET FOR CONTRACT MANUFACTURING, RESEARCH AND
PACKAGING BY REGION, THROUGH 2018 ($ BILLIONS) 73
FIGURE 13 GLOBAL MARKET FOR CONTRACT MANUFACTURING, RESEARCH AND
PACKAGING BY REGION, 2011-2018 ($ BILLIONS) 73
Market Share 73
TABLE 29 REGIONAL MARKET SHARES OF CONTRACT MANUFACTURING,
RESEARCH AND PACKAGING, 2012 (%) 74
PHM157A - Global Markets for Contract Pharmaceutical Manufacturing, Research and Packaging -
Focus on Contract Packaging
FIGURE 14 REGIONAL MARKET SHARES OF CONTRACT MANUFACTURING,
RESEARCH AND PACKAGING, 2012 (%) 74
MARKET BY THERAPEUTIC USE 74
CARDIOVASCULAR DRUGS 75
ONCOLOGY 75
ANTIBIOTICS 75
ANALGESICS 76
ANTIVIRALS 76
REPRODUCTIVE DRUG PRODUCTS 77
INFLAMMATION AND IMMUNOLOGY 78
NEUROSCIENCE 78
VACCINES 78
OTHERS 79
MARKET REVENUE 79
TABLE 30 GLOBAL MARKET FOR CONTRACT MANUFACTURING AND RESEARCH OF
DRUGS BY THERAPEUTIC AREA, THROUGH 2018 ($ MILLIONS) 80
FIGURE 15 GLOBAL MARKET FOR CONTRACT MANUFACTURING AND RESEARCH OF
DRUGS BY THERAPEUTIC AREA, 2011-2018 ($ MILLIONS) 80
MARKET SHARES 81
TABLE 31 CONTRACT MANUFACTURING AND RESEARCH MARKET SHARES BY
THERAPEUTIC AREA, 2012 (%) 81
FIGURE 16 CONTRACT MANUFACTURING AND RESEARCH MARKET SHARES BY
THERAPEUTIC AREA, 2012 (%) 82
CHAPTER 7 CONTRACT PACKAGING MARKETS 84
MARKET BY TYPE 84
MARKET OVERVIEW 85
MARKET REVENUE 85
TABLE 32 GLOBAL MARKET FOR CONTRACT PACKAGING BY TYPE, THROUGH 2018
($ MILLIONS) 86
FIGURE 17 GLOBAL MARKET FOR CONTRACT PACKAGING BY TYPE, 2011-2018 ($
MILLIONS) 86
TABLE 33 GLOBAL MARKET FOR PRIMARY PACKAGING, THROUGH 2018 ($
MILLIONS) 87
FIGURE 18 GLOBAL MARKET FOR PRIMARY PACKAGING, 2011-2018 ($ MILLIONS) 87
MARKET SHARE 87
TABLE 34 MARKET SHARES OF CONTRACT PACKAGING BY TYPE, 2012 (%) 88
FIGURE 19 MARKET SHARES OF CONTRACT PACKAGING BY TYPE, 2012 (%) 88
MARKET BY REGION 88
MARKET OVERVIEW 89
MARKET REVENUE 90
TABLE 35 GLOBAL MARKET FOR CONTRACT PACKAGING BY REGION, THROUGH
2018 ($ MILLIONS) 90
FIGURE 20 GLOBAL MARKET FOR CONTRACT PACKAGING BY REGION, 2011-2018
($ MILLIONS) 90
MARKET SHARE 91
TABLE 36 MARKET SHARES OF CONTRACT PACKAGING BY REGION, 2012 (%) 91
FIGURE 21 MARKET SHARES OF CONTRACT PACKAGING BY REGION, 2012 (%) 91
Primary Packaging by Region 92
PHM157A - Global Markets for Contract Pharmaceutical Manufacturing, Research and Packaging -
Focus on Contract Packaging
TABLE 37 GLOBAL MARKET FOR PRIMARY PACKAGING BY REGION, THROUGH 2018
($ MILLIONS) 92
FIGURE 22 GLOBAL MARKET FOR PRIMARY PACKAGING BY REGION, 2011-2018 ($
MILLIONS) 92
Secondary Packaging by Region 93
TABLE 38 GLOBAL MARKET FOR SECONDARY PACKAGING BY REGION, THROUGH
2018 ($ MILLIONS) 94
FIGURE 23 GLOBAL MARKET FOR SECONDARY PACKAGING BY REGION, 2011-2018
($ MILLIONS) 94
Other Types of Packaging by Region 94
TABLE 39 GLOBAL MARKET FOR OTHER PACKAGING BY REGION, THROUGH 2018
($ MILLIONS) 95
FIGURE 24 GLOBAL MARKET FOR OTHER PACKAGING BY REGION, 2011-2018 ($
MILLIONS) 95
INDUSTRY STRUCTURE 95
MARKET LEADERS 95
TABLE 40 SERVICES PROVIDED BY CONTRACT PACKAGING FIRMS BY PACKAGING
TYPE, 2012 96
MARKET SHARE 97
TABLE 41 MARKET SHARES OF CONTRACT PACKAGING COMPANIES, 2012 (%) 97
FIGURE 25 MARKET SHARES OF CONTRACT PACKAGING COMPANIES, 2012 (%) 97
CHAPTER 8 PATENT ANALYSIS 100
PATENTS BY YEAR 100
TABLE 42 SIGNIFICANT U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING,
RESEARCH AND PACKAGING COMPANIES BY YEAR, 2010-FEB. 2013 (NO.) 100
FIGURE 26 SIGNIFICANT U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING,
RESEARCH AND PACKAGING COMPANIES BY YEAR, 2010-FEB. 2013 (NO.) 100
PATENTS BY EMPHASIS 101
TABLE 43 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING COMPANIES BY EMPHASIS, 2010-FEB. 2013 (NO.) 101
FIGURE 27 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING COMPANIES BY EMPHASIS, 2010-FEB. 2013 (NO.) 101
PATENTS BY COMPANY 102
TABLE 44 MARKET SHARES OF CONTRACT PACKAGING COMPANIES, 2012 (%) 103
PATENTS BY THE PATENT HOLDER'S COUNTRY 104
TABLE 45 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING COMPANIES BY THE PATENT HOLDER’S COUNTRY, 2010-FEB.
2013 (NO.)
105
FIGURE 28 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING COMPANIES BY PATENT HOLDER'S COUNTRY, 2010-FEB. 2013
(NO.)
106
TABLE 46 SHARES OF U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING,
RESEARCH AND PACKAGING COMPANIES BY PATENT HOLDER’S COUNTRY,
2010-FEB. 2013 (%)
106
FIGURE 29 SHARES OF U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING,
RESEARCH AND PACKAGING COMPANIES BY PATENT HOLDER'S COUNTRY,
2010-FEB. 2013 (%)
107
PATENTS BY PATENT HOLDER TYPE 107
TABLE 47 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING COMPANIES BY TYPE OF PATENT HOLDER, 2010-FEB. 2013 (NO.) 108
PHM157A - Global Markets for Contract Pharmaceutical Manufacturing, Research and Packaging -
Focus on Contract Packaging
FIGURE 30 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING COMPANIES BY TYPE OF PATENT HOLDER, 2010-FEB. 2013 (NO.) 108
CHAPTER 9 CURRENT MARKET ENVIRONMENT 110
FACTORS AFFECTING THE OUTSOURCING MARKET 110
COST SAVINGS 110
STRINGENT REGULATIONS 110
PATENT EXPIRIES 111
DECREASING RESEARCH AND DEVELOPMENT SUCCESS RATES 111
INCREASING DEMAND FOR BIOSIMILARS 111
PHARMACEUTICAL OUTSOURCING TRENDS 112
CHAPTER 10 COMPANY PROFILES 115
3M CO. 115
AAI PHARMA INC. 115
ABBOTT LABORATORIES 116
AEROGEN LTD. 117
ALBANY MOLECULAR RESEARCH INC. (AMRI) 117
ALKERMES PLC 118
ALTHEA TECHNOLOGIES 118
AMCOR 119
AMERISOURCEBERGEN CORP. 119
AMPAC FINE CHEMICALS 120
A.P. PHARMA INC. 120
APTIV SOLUTIONS 121
APTUIT INC. 121
ARADIGM CORP. 122
BASF SE 122
BAXTER HEALTHCARE 123
BCM/BOOTS MANUFACTURING 124
BOEHRINGER INGELHEIM 124
CAMBREX CORP. 125
CANGENE BIOPHARMA INC. 126
CATALENT PHARMA SOLUTIONS 126
CEDARBURG HAUSER PHARMACEUTICALS INC. 126
CENEXI 127
CHARLES RIVER LABORATORIES 127
CHEMBRIDGE CORP. 128
CONFAB LABORATORIES 128
COVANCE INC. 129
COVIDIEN 130
CONTRACT PHARMACEUTICALS LTD. 130
CORDENPHARMA SWITZERLAND LLC 131
DECODE GENETICS 132
DISHMAN PHARMACEUTICALS AND CHEMICALS LTD. 132
DOW PHARMACEUTICAL SCIENCES 133
DPT LABORATORIES INC. 133
DR. REDDY'S LABORATORIES 134
PHM157A - Global Markets for Contract Pharmaceutical Manufacturing, Research and Packaging -
Focus on Contract Packaging
DSM PHARMACEUTICAL PRODUCTS 134
FUJIFILM DIOSYNTH BIOTECHNOLOGY 135
ELAN DRUG TECHNOLOGIES 135
EVOTEC AG 136
GIRINDUS AG 136
GLAXOSMITHKLINE 137
GRIFOLS INTERNATIONAL SA 138
HOSPIRA 138
HAUPT PHARMA AG 139
HOVIONE SA 140
ICON PLC 140
INC RESEARCH LLC 141
JUBILANT LIFESCIENCES 141
KENDLE INTERNATIONAL INC. 142
KP PHARMACEUTICAL TECHNOLOGIES INC. 142
LIGAND PHARMACEUTICALS INC. 143
LONZA GROUP 143
LYNE LABORATORIES 144
MEADWESTVACO CORP. 145
MIKART INC. 145
NEXTPHARMA TECHNOLOGIES 146
NORWICH PHARMACEUTICALS 146
NOVAVAX INC. 147
PAREXEL INTERNATIONAL CORP. 148
PATHEON INC. 148
PERRIGO CO. 149
PFIZER CENTRESOURCE 149
PIRAMAL HEALTHCARE LTD. 150
PPD 151
PRA INTERNATIONAL 151
QUINTILES 152
RANBAXY LABORATORIES LTD. 152
RECIPHARM AB 153
REGIS TECHNOLOGIES INC. 154
SCHOTT PHARMACEUTICAL PACKAGING 154
SKYEPHARMA PLC 155
TAKEDA PHARMACEUTICALS 155
THEOREM CLINICAL RESEARCH 156
VETTER PHARMA INTERNATIONAL GMBH 156
WOCKHARDT LTD. 157
WUXI APP TEC 157
XCELLEREX LLC 158
ZACH SYSTEM SPA 158
CHAPTER 11 APPENDIX: ACRONYMS 160
PHM157A - Global Markets for Contract Pharmaceutical Manufacturing, Research and Packaging -
Focus on Contract Packaging

LIST OF TABLES

SUMMARY TABLE GLOBAL MARKET FOR PHARMACEUTICAL AND
BIOPHARMACEUTICAL CONTRACT MANUFACTURING, RESEARCH AND PACKAGING,
THROUGH 2018 ($ BILLIONS)
6
TABLE 1 KEY DEVELOPMENTS IN THE HISTORY OF OUTSOURCING 14
TABLE 2 KEY ADVANTAGES OF CONTRACT MANUFACTURING 18
TABLE 3 KEY DISADVANTAGES OF CONTRACT MANUFACTURING 19
TABLE 4 KEY FACTORS IN SELECTING A CONTRACT MANUFACTURER 20
TABLE 5 SERVICES OFFERED BY CONTRACT RESEARCH ORGANIZATIONS 24
TABLE 6 KEY FACTORS IN SELECTING A CONTRACT RESEARCH ORGANIZATION 25
TABLE 7 TYPES OF SERVICES PROVIDED BY CONTRACT RESEARCH ORGANIZATIONS 26
TABLE 8 REASONS COMPANIES HIRE CONTRACT PACKAGERS 28
TABLE 9 WARNING LETTERS ISSUED TO PHARMACEUTICAL CONTRACT
MANUFACTURERS, 2012 32
TABLE 10 WARNING LETTERS ISSUED TO PHARMACEUTICAL CONTRACT
MANUFACTURERS, 2011 33
TABLE 11 WARNING LETTERS ISSUED TO PHARMACEUTICAL CONTRACT
MANUFACTURERS, 2010 33
TABLE 12 REGULATORY APPROVALS OF PHARMACEUTICAL CONTRACT
MANUFACTURER ACTIVITIES AND FACILITIES, JAN. AND FEB. 2013 34
TABLE 13 REGULATORY APPROVALS OF PHARMACEUTICAL CONTRACT
MANUFACTURER ACTIVITIES AND FACILITIES, 2012 35
TABLE 14 REGULATORY APPROVALS OF PHARMACEUTICAL CONTRACT
MANUFACTURER ACTIVITIES AND FACILITIES, 2011 35
TABLE 15 REGULATORY APPROVALS OF CONTRACT MANUFACTURER ACTIVITIES
AND FACILITIES, 2010 36
TABLE 16 GLOBAL MARKET FOR CONTRACT MANUFACTURING OF BULK
DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS AND VARIOUS DOSAGE FORMS,
THROUGH 2018 ($ BILLIONS)
50
TABLE 17 MARKET SHARES OF CONTRACT MANUFACTURING OF BULK
DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS AND VARIOUS DOSAGE FORMS,
2012 (%)
51
TABLE 18 GLOBAL MARKET FOR CONTRACT MANUFACTURING OF OTC DRUGS AND
NUTRITIONAL PRODUCTS BY FORMULATION, THROUGH 2018 ($ BILLIONS) 53
TABLE 19 MARKET SHARES OF CONTRACT MANUFACTURING OF OTC DRUGS AND
NUTRITIONAL PRODUCTS BY FORMULATION, 2012 (%) 54
TABLE 20 GLOBAL MARKET FOR CONTRACT MANUFACTURING OF BULK
DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS, VARIOUS DOSAGE FORMS AND
OTC DRUGS/NUTRITIONAL PRODUCTS, THROUGH 2018 ($ BILLIONS)
55
TABLE 21 MARKET SHARES OF CONTRACT MANUFACTURING OF BULK
DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS, VARIOUS DOSAGE FORMS AND
OTC DRUGS/NUTRITIONAL PRODUCTS, 2012 (%)
56
TABLE 22 GLOBAL MARKET FOR CONTRACT RESEARCH BY SEGMENT, THROUGH
2018 ($ BILLIONS) 57
TABLE 23 CONTRACT RESEARCH MARKET SHARES BY SEGMENT, 2012 (%) 59
TABLE 24 GLOBAL MARKET FOR CONTRACT PACKAGING BY TYPE, THROUGH 2018 ($
BILLIONS) 61
TABLE 25 MARKET SHARES OF CONTRACT PACKAGING BY TYPE, 2012 (%) 62
TABLE 26 GLOBAL MARKET FOR CONTRACT MANUFACTURING OF VARIOUS DOSAGE
FORMS AND BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS BY REGION,
THROUGH 2018 ($ BILLIONS)
66
PHM157A - Global Markets for Contract Pharmaceutical Manufacturing, Research and Packaging -
Focus on Contract Packaging
TABLE 27 REGIONAL MARKETS SHARES OF CONTRACT MANUFACTURING OF
VARIOUS DOSAGE FORMS AND BULK DRUGS/ACTIVE PHARMACEUTICAL
INGREDIENTS, 2012 (%)
68
TABLE 28 GLOBAL MARKET FOR CONTRACT MANUFACTURING, RESEARCH AND
PACKAGING BY REGION, THROUGH 2018 ($ BILLIONS) 73
TABLE 29 REGIONAL MARKET SHARES OF CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING, 2012 (%) 74
TABLE 30 GLOBAL MARKET FOR CONTRACT MANUFACTURING AND RESEARCH OF
DRUGS BY THERAPEUTIC AREA, THROUGH 2018 ($ MILLIONS) 80
TABLE 31 CONTRACT MANUFACTURING AND RESEARCH MARKET SHARES BY
THERAPEUTIC AREA, 2012 (%) 81
TABLE 32 GLOBAL MARKET FOR CONTRACT PACKAGING BY TYPE, THROUGH 2018 ($
MILLIONS) 86
TABLE 33 GLOBAL MARKET FOR PRIMARY PACKAGING, THROUGH 2018 ($ MILLIONS) 87
TABLE 34 MARKET SHARES OF CONTRACT PACKAGING BY TYPE, 2012 (%) 88
TABLE 35 GLOBAL MARKET FOR CONTRACT PACKAGING BY REGION, THROUGH
2018 ($ MILLIONS) 90
TABLE 36 MARKET SHARES OF CONTRACT PACKAGING BY REGION, 2012 (%) 91
TABLE 37 GLOBAL MARKET FOR PRIMARY PACKAGING BY REGION, THROUGH 2018
($ MILLIONS) 92
TABLE 38 GLOBAL MARKET FOR SECONDARY PACKAGING BY REGION, THROUGH
2018 ($ MILLIONS) 94
TABLE 39 GLOBAL MARKET FOR OTHER PACKAGING BY REGION, THROUGH 2018 ($
MILLIONS) 95
TABLE 40 SERVICES PROVIDED BY CONTRACT PACKAGING FIRMS BY PACKAGING
TYPE, 2012 96
TABLE 41 MARKET SHARES OF CONTRACT PACKAGING COMPANIES, 2012 (%) 97
TABLE 42 SIGNIFICANT U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING,
RESEARCH AND PACKAGING COMPANIES BY YEAR, 2010-FEB. 2013 (NO.) 100
TABLE 43 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND
PACKAGING COMPANIES BY EMPHASIS, 2010-FEB. 2013 (NO.) 101
TABLE 44 MARKET SHARES OF CONTRACT PACKAGING COMPANIES, 2012 (%) 103
TABLE 45 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND
PACKAGING COMPANIES BY THE PATENT HOLDER’S COUNTRY, 2010-FEB. 2013
(NO.)
105
TABLE 46 SHARES OF U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING,
RESEARCH AND PACKAGING COMPANIES BY PATENT HOLDER’S COUNTRY,
2010-FEB. 2013 (%)
106
TABLE 47 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND
PACKAGING COMPANIES BY TYPE OF PATENT HOLDER, 2010-FEB. 2013 (NO.) 108
PHM157A - Global Markets for Contract Pharmaceutical Manufacturing, Research and Packaging -
Focus on Contract Packaging

LIST OF FIGURES

SUMMARY FIGURE GLOBAL MARKET FOR PHARMACEUTICAL AND
BIOPHARMACEUTICAL CONTRACT MANUFACTURING, RESEARCH AND PACKAGING,
2011-2018 ($ BILLIONS)
6
FIGURE 1 GLOBAL MARKET FOR CONTRACT MANUFACTURING OF BULK
DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS AND VARIOUS DOSAGE FORMS,
2011-2018 ($ BILLIONS)
50
FIGURE 2 MARKET SHARES OF CONTRACT MANUFACTURING OF BULK
DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS AND VARIOUS DOSAGE FORMS,
2012 (%)
51
FIGURE 3 GLOBAL MARKET FOR CONTRACT MANUFACTURING OF OTC DRUGS AND
NUTRITIONAL PRODUCTS BY FORMULATION, 2011-2018 ($ BILLIONS) 53
FIGURE 4 MARKET SHARES OF CONTRACT MANUFACTURING OF OTC DRUGS AND
NUTRITIONAL PRODUCTS BY FORMULATION, 2012 (%) 54
FIGURE 5 GLOBAL MARKET FOR CONTRACT MANUFACTURING OF BULK
DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS, VARIOUS DOSAGE FORMS AND
OTC DRUGS/NUTRITIONAL PRODUCTS, 2011-2018 ($ BILLIONS)
55
FIGURE 6 MARKET SHARES OF CONTRACT MANUFACTURING OF BULK
DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS, VARIOUS DOSAGE FORMS AND
OTC DRUGS/NUTRITIONAL PRODUCTS, 2012 (%)
56
FIGURE 7 GLOBAL MARKET FOR CONTRACT RESEARCH BY SEGMENT, 2011-2018 ($
BILLIONS) 58
FIGURE 8 CONTRACT RESEARCH MARKET SHARES BY SEGMENT, 2012 (%) 59
FIGURE 9 GLOBAL MARKET FOR CONTRACT PACKAGING BY TYPE, 2011-2018 ($
BILLIONS) 61
FIGURE 10 MARKET SHARES OF CONTRACT PACKAGING BY TYPE, 2012 (%) 62
FIGURE 11 GLOBAL MARKET FOR CONTRACT MANUFACTURING OF VARIOUS
DOSAGE FORMS AND BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS BY
REGION, 2011-2018 ($ BILLIONS)
67
FIGURE 12 REGIONAL MARKETS SHARES OF CONTRACT MANUFACTURING OF
VARIOUS DOSAGE FORMS AND BULK DRUGS/ACTIVE PHARMACEUTICAL
INGREDIENTS, 2012 (%)
68
FIGURE 13 GLOBAL MARKET FOR CONTRACT MANUFACTURING, RESEARCH AND
PACKAGING BY REGION, 2011-2018 ($ BILLIONS) 73
FIGURE 14 REGIONAL MARKET SHARES OF CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING, 2012 (%) 74
FIGURE 15 GLOBAL MARKET FOR CONTRACT MANUFACTURING AND RESEARCH OF
DRUGS BY THERAPEUTIC AREA, 2011-2018 ($ MILLIONS) 80
FIGURE 16 CONTRACT MANUFACTURING AND RESEARCH MARKET SHARES BY
THERAPEUTIC AREA, 2012 (%) 82
FIGURE 17 GLOBAL MARKET FOR CONTRACT PACKAGING BY TYPE, 2011-2018 ($
MILLIONS) 86
FIGURE 18 GLOBAL MARKET FOR PRIMARY PACKAGING, 2011-2018 ($ MILLIONS) 87
FIGURE 19 MARKET SHARES OF CONTRACT PACKAGING BY TYPE, 2012 (%) 88
FIGURE 20 GLOBAL MARKET FOR CONTRACT PACKAGING BY REGION, 2011-2018 ($
MILLIONS) 90
FIGURE 21 MARKET SHARES OF CONTRACT PACKAGING BY REGION, 2012 (%) 91
FIGURE 22 GLOBAL MARKET FOR PRIMARY PACKAGING BY REGION, 2011-2018 ($
MILLIONS) 92
FIGURE 23 GLOBAL MARKET FOR SECONDARY PACKAGING BY REGION, 2011-2018
($ MILLIONS) 94
FIGURE 24 GLOBAL MARKET FOR OTHER PACKAGING BY REGION, 2011-2018 ($
MILLIONS) 95
PHM157A - Global Markets for Contract Pharmaceutical Manufacturing, Research and Packaging -
Focus on Contract Packaging
FIGURE 25 MARKET SHARES OF CONTRACT PACKAGING COMPANIES, 2012 (%) 97
FIGURE 26 SIGNIFICANT U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING,
RESEARCH AND PACKAGING COMPANIES BY YEAR, 2010-FEB. 2013 (NO.) 100
FIGURE 27 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING COMPANIES BY EMPHASIS, 2010-FEB. 2013 (NO.) 101
FIGURE 28 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING COMPANIES BY PATENT HOLDER'S COUNTRY, 2010-FEB. 2013
(NO.)
106
FIGURE 29 SHARES OF U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING,
RESEARCH AND PACKAGING COMPANIES BY PATENT HOLDER'S COUNTRY, 2010-FEB.
2013 (%)
107
FIGURE 30 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING COMPANIES BY TYPE OF PATENT HOLDER, 2010-FEB. 2013 (NO.) 108

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