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.

ABOUT THE AUTHOR

A team of professionals in the biotechnology industry carried out this study. The project manager is Shalini S. Dewan, who holds a master’s degree in pharmaceutical chemistry and has more than 14 years of industry experience. Among the research topics she has covered are studies on compounds of potential pharmaceutical interest such as ibuprofen and 2-naphthyl acetic acid. Shalini was awarded a Gold Medal by the Prime Minister of India for her work and has worked with top companies in India and the U.S. Some of her other reports with BCC are: Reagents for Chromatography; Spectroscopy: An Enduring Market; Advanced Drug Delivery Systems: Technologies and Global Markets; Orthopedic Drugs, Implants and Devices; Medical Imaging Reagents and Analysis Equipment; Pharmaceutical Regulatory Industry; The Dynamic Media, Sera and Reagent Market in Biotechnology; Contract Pharmaceutical Manufacturing, Research and Packaging: Global Markets; Chiral Technology: Global Markets; Autacoids and Related Drugs: Technologies and Global Markets; Contraceptives: Technologies and Global Markets; Liver Disease Treatments: The Global Market; Hormone Replacement Therapies and Other Hormone Therapies: Global Markets; Cardiovascular Medicine: Diagnostics, Drugs and Devices; and Cancer Therapies: Technologies and Global Markets.

The lead consultant for this project was Dr. Kapil A. Setia, who holds a doctoral degree in the life sciences. She has a number of research publications to her credit, including her thesis, which was given an award of excellence.

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 Research
• 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.

Table Of Contents

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
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
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
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
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 RESEARCH MARKET 84

MARKET BY DISCIPLINE 84
MARKET OVERVIEW 84
MARKET REVENUE 85
TABLE 32 GLOBAL MARKET FOR CONTRACT RESEARCH BY DISCIPLINE, THROUGH
2018 ($ BILLIONS) 86
FIGURE 17 GLOBAL MARKET FOR CONTRACT RESEARCH BY DISCIPLINE, 2011-2018
($ BILLIONS) 86
MARKET SHARES 86
TABLE 33 MARKET SHARES OF CONTRACT RESEARCH BY DISCIPLINE, 2012 (%) 87
FIGURE 18 MARKET SHARES OF CONTRACT RESEARCH BY DISCIPLINE, 2012 (%) 87
MARKET BY REGION 87
MARKET OVERVIEW 88
MARKET REVENUE 88
TABLE 34 GLOBAL MARKET FOR CONTRACT RESEARCH BY REGION, THROUGH
2018 ($ BILLIONS) 89
FIGURE 19 GLOBAL MARKET FOR CONTRACT RESEARCH BY REGION, 2011-2018 ($
BILLIONS) 89
MARKET SHARES 90
TABLE 35 CONTRACT RESEARCH MARKET SHARES BY REGION, 2012 (%) 90
FIGURE 20 CONTRACT RESEARCH MARKET SHARES BY REGION, 2012 (%) 90
Contract Clinical Research Market by Region 90
TABLE 36 GLOBAL MARKET FOR CONTRACT CLINICAL RESEARCH BY REGION,
THROUGH 2018 ($ MILLIONS) 91
FIGURE 21 GLOBAL MARKET FOR CONTRACT CLINICAL RESEARCH BY REGION,
2011-2018 ($ MILLIONS) 91
Contract Drug Discovery Market by Region 92
TABLE 37 GLOBAL MARKET FOR CONTRACT DRUG DISCOVERY BY REGION,
THROUGH 2018 ($ MILLIONS) 92
FIGURE 22 GLOBAL MARKET FOR CONTRACT DRUG DISCOVERY BY REGION,
2011-2018 ($ MILLIONS) 92
Contract Analytical Research Market by Region 93
TABLE 38 GLOBAL MARKET FOR CONTRACT ANALYTICAL RESEARCH BY REGION,
THROUGH 2018 ($ MILLIONS) 94
FIGURE 23 GLOBAL MARKET FOR CONTRACT ANALYTICAL RESEARCH BY REGION,
2011-2018 ($ MILLIONS) 94
Other Contract Research Activities Market by Region 94
TABLE 39 GLOBAL MARKET FOR OTHER CONTRACT RESEARCH SERVICES BY
REGION, THROUGH 2018 ($ MILLIONS) 95
FIGURE 24 GLOBAL MARKET FOR OTHER CONTRACT RESEARCH SERVICES BY
REGION, 2011-2018 ($ MILLIONS) 95
MARKET BY THERAPEUTIC AREA 95
CARDIOLOGY 96
ONCOLOGY 96
INFLAMMATION AND IMMUNOLOGY 96
NEUROSCIENCE 97
VACCINES 97
OTHERS 98
MARKET REVENUE 99
TABLE 40 GLOBAL MARKET FOR CONTRACT RESEARCH BY THERAPEUTIC AREA,
THROUGH 2018 ($ MILLIONS) 99
FIGURE 25 GLOBAL MARKET FOR CONTRACT RESEARCH BY THERAPEUTIC AREA,
2011-2018 ($ MILLIONS) 99
MARKET SHARE 100
TABLE 41 MARKET SHARES OF CONTRACT RESEARCH BY THERAPEUTIC AREA,
2012 (%) 100
FIGURE 26 MARKET SHARES OF CONTRACT RESEARCH BY THERAPEUTIC AREA,
2012 (%) 101
INDUSTRY STRUCTURE 101
MARKET LEADERS 101
TABLE 42 SERVICES PROVIDED BY RESEARCH FIRMS 101
MARKET SHARES 102
TABLE 43 MARKET SHARES OF CONTRACT RESEARCH COMPANIES, 2012 (%) 103
FIGURE 27 MARKET SHARES OF CONTRACT RESEARCH COMPANIES, 2012 (%) 103

CHAPTER 8 PATENT ANALYSIS 105

PATENTS BY YEAR 105
TABLE 44 SIGNIFICANT U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING,
RESEARCH AND PACKAGING COMPANIES BY YEAR, 2010-FEB. 2013 (NO.) 105
FIGURE 28 SIGNIFICANT U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING,
RESEARCH AND PACKAGING COMPANIES BY YEAR, 2010-FEB. 2013 (NO.) 105
PATENTS BY EMPHASIS 106
TABLE 45 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING COMPANIES BY EMPHASIS, 2010-FEB. 2013 (NO.) 106
FIGURE 29 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING COMPANIES BY EMPHASIS, 2010-FEB. 2013 (NO.) 106




PATENTS BY COMPANY 107
TABLE 46 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING COMPANIES, 2010-FEB. 2013 (NO.) 108
PATENTS BY THE PATENT HOLDER'S COUNTRY 109
TABLE 47 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING COMPANIES BY THE PATENT HOLDER’S COUNTRY, 2010-FEB.
2013 (NO.)
110
FIGURE 30 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING COMPANIES BY PATENT HOLDER'S COUNTRY, 2010-FEB. 2013
(NO.)
111
TABLE 48 SHARES OF U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING,
RESEARCH AND PACKAGING COMPANIES BY PATENT HOLDER’S COUNTRY,
2010-FEB. 2013 (%)
111
FIGURE 31 SHARES OF U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING,
RESEARCH AND PACKAGING COMPANIES BY PATENT HOLDER'S COUNTRY,
2010-FEB. 2013 (%)
112
PATENTS BY PATENT HOLDER TYPE 112
TABLE 49 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING COMPANIES BY TYPE OF PATENT HOLDER, 2010-FEB. 2013 (NO.) 113
FIGURE 32 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING COMPANIES BY TYPE OF PATENT HOLDER, 2010-FEB. 2013 (NO.) 113

CHAPTER 9 CURRENT MARKET ENVIRONMENT 115

FACTORS AFFECTING THE OUTSOURCING MARKET 115
COST SAVINGS 115
STRINGENT REGULATIONS 115
PATENT EXPIRIES 116
DECREASING RESEARCH AND DEVELOPMENT SUCCESS RATES 116
INCREASING DEMAND FOR BIOSIMILARS 116
PHARMACEUTICAL OUTSOURCING TRENDS 117

CHAPTER 10 COMPANY PROFILES 120

3M CO. 120
AAI PHARMA INC. 120
ABBOTT LABORATORIES 121
AEROGEN LTD. 122
ALBANY MOLECULAR RESEARCH INC. (AMRI) 122
ALKERMES PLC 123
ALTHEA TECHNOLOGIES 123
AMCOR 124
AMERISOURCEBERGEN CORP. 124
AMPAC FINE CHEMICALS 125
A.P. PHARMA INC. 125
APTIV SOLUTIONS 126
APTUIT INC. 126
ARADIGM CORP. 127
BASF SE 127
BAXTER HEALTHCARE 128
BCM/BOOTS MANUFACTURING 129
BOEHRINGER INGELHEIM 129
CAMBREX CORP. 130
CANGENE BIOPHARMA INC. 131
CATALENT PHARMA SOLUTIONS 131
CEDARBURG HAUSER PHARMACEUTICALS INC. 131
CENEXI 132
CHARLES RIVER LABORATORIES 132
CHEMBRIDGE CORP. 133
CONFAB LABORATORIES 133
COVANCE INC. 134
COVIDIEN 135
CONTRACT PHARMACEUTICALS LTD. 135
CORDENPHARMA SWITZERLAND LLC 136
DECODE GENETICS 137
DISHMAN PHARMACEUTICALS AND CHEMICALS LTD. 137
DOW PHARMACEUTICAL SCIENCES 138
DPT LABORATORIES INC. 138
DR. REDDY'S LABORATORIES 139
DSM PHARMACEUTICAL PRODUCTS 139
FUJIFILM DIOSYNTH BIOTECHNOLOGY 140
ELAN DRUG TECHNOLOGIES 140
EVOTEC AG 141
GIRINDUS AG 141
GLAXOSMITHKLINE 142
GRIFOLS INTERNATIONAL SA 143
HOSPIRA 143
HAUPT PHARMA AG 144
HOVIONE SA 145
ICON PLC 145
INC RESEARCH LLC 146
JUBILANT LIFESCIENCES 146
KENDLE INTERNATIONAL INC. 147
KP PHARMACEUTICAL TECHNOLOGIES INC. 147
LIGAND PHARMACEUTICALS INC. 148
LONZA GROUP 148
LYNE LABORATORIES 149
MEADWESTVACO CORP. 150
MIKART INC. 150
NEXTPHARMA TECHNOLOGIES 151
NORWICH PHARMACEUTICALS 151
NOVAVAX INC. 152
PAREXEL INTERNATIONAL CORP. 153
PATHEON INC. 153
PERRIGO CO. 154
PFIZER CENTRESOURCE 154
PIRAMAL HEALTHCARE LTD. 155
PPD 156
PRA INTERNATIONAL 156
QUINTILES 157
RANBAXY LABORATORIES LTD. 157
RECIPHARM AB 158
REGIS TECHNOLOGIES INC. 159
SCHOTT PHARMACEUTICAL PACKAGING 159
SKYEPHARMA PLC 160
TAKEDA PHARMACEUTICALS 160
THEOREM CLINICAL RESEARCH 161
VETTER PHARMA INTERNATIONAL GMBH 161
WOCKHARDT LTD. 162
WUXI APP TEC 162
XCELLEREX LLC 163
ZACH SYSTEM SPA 163

CHAPTER 11 APPENDIX: ACRONYMS 165



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
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 RESEARCH BY DISCIPLINE, THROUGH
2018 ($ BILLIONS) 86
TABLE 33 MARKET SHARES OF CONTRACT RESEARCH BY DISCIPLINE, 2012 (%) 87
TABLE 34 GLOBAL MARKET FOR CONTRACT RESEARCH BY REGION, THROUGH 2018
($ BILLIONS) 89
TABLE 35 CONTRACT RESEARCH MARKET SHARES BY REGION, 2012 (%) 90
TABLE 36 GLOBAL MARKET FOR CONTRACT CLINICAL RESEARCH BY REGION,
THROUGH 2018 ($ MILLIONS) 91
TABLE 37 GLOBAL MARKET FOR CONTRACT DRUG DISCOVERY BY REGION,
THROUGH 2018 ($ MILLIONS) 92
TABLE 38 GLOBAL MARKET FOR CONTRACT ANALYTICAL RESEARCH BY REGION,
THROUGH 2018 ($ MILLIONS) 94
TABLE 39 GLOBAL MARKET FOR OTHER CONTRACT RESEARCH SERVICES BY REGION,
THROUGH 2018 ($ MILLIONS) 95
TABLE 40 GLOBAL MARKET FOR CONTRACT RESEARCH BY THERAPEUTIC AREA,
THROUGH 2018 ($ MILLIONS) 99
TABLE 41 MARKET SHARES OF CONTRACT RESEARCH BY THERAPEUTIC AREA, 2012
(%) 100
TABLE 42 SERVICES PROVIDED BY RESEARCH FIRMS 101
TABLE 43 MARKET SHARES OF CONTRACT RESEARCH COMPANIES, 2012 (%) 103
TABLE 44 SIGNIFICANT U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING,
RESEARCH AND PACKAGING COMPANIES BY YEAR, 2010-FEB. 2013 (NO.) 105
TABLE 45 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND
PACKAGING COMPANIES BY EMPHASIS, 2010-FEB. 2013 (NO.) 106
TABLE 46 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND
PACKAGING COMPANIES, 2010-FEB. 2013 (NO.) 108
TABLE 47 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND
PACKAGING COMPANIES BY THE PATENT HOLDER’S COUNTRY, 2010-FEB. 2013
(NO.)
110
TABLE 48 SHARES OF U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING,
RESEARCH AND PACKAGING COMPANIES BY PATENT HOLDER’S COUNTRY,
2010-FEB. 2013 (%)
111
TABLE 49 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND
PACKAGING COMPANIES BY TYPE OF PATENT HOLDER, 2010-FEB. 2013 (NO.) 113



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 RESEARCH BY DISCIPLINE, 2011-2018
($ BILLIONS) 86
FIGURE 18 MARKET SHARES OF CONTRACT RESEARCH BY DISCIPLINE, 2012 (%) 87
FIGURE 19 GLOBAL MARKET FOR CONTRACT RESEARCH BY REGION, 2011-2018 ($
BILLIONS) 89
FIGURE 20 CONTRACT RESEARCH MARKET SHARES BY REGION, 2012 (%) 90
FIGURE 21 GLOBAL MARKET FOR CONTRACT CLINICAL RESEARCH BY REGION,
2011-2018 ($ MILLIONS) 91
FIGURE 22 GLOBAL MARKET FOR CONTRACT DRUG DISCOVERY BY REGION,
2011-2018 ($ MILLIONS) 92
FIGURE 23 GLOBAL MARKET FOR CONTRACT ANALYTICAL RESEARCH BY REGION,
2011-2018 ($ MILLIONS) 94
FIGURE 24 GLOBAL MARKET FOR OTHER CONTRACT RESEARCH SERVICES BY
REGION, 2011-2018 ($ MILLIONS) 95
FIGURE 25 GLOBAL MARKET FOR CONTRACT RESEARCH BY THERAPEUTIC AREA,
2011-2018 ($ MILLIONS) 99
FIGURE 26 MARKET SHARES OF CONTRACT RESEARCH BY THERAPEUTIC AREA, 2012
(%) 101
FIGURE 27 MARKET SHARES OF CONTRACT RESEARCH COMPANIES, 2012 (%) 103
FIGURE 28 SIGNIFICANT U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING,
RESEARCH AND PACKAGING COMPANIES BY YEAR, 2010-FEB. 2013 (NO.) 105
FIGURE 29 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING COMPANIES BY EMPHASIS, 2010-FEB. 2013 (NO.) 106
FIGURE 30 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING COMPANIES BY PATENT HOLDER'S COUNTRY, 2010-FEB. 2013
(NO.)
111
FIGURE 31 SHARES OF U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING,
RESEARCH AND PACKAGING COMPANIES BY PATENT HOLDER'S COUNTRY, 2010-FEB.
2013 (%)
112
FIGURE 32 U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH
AND PACKAGING COMPANIES BY TYPE OF PATENT HOLDER, 2010-FEB. 2013 (NO.) 113

View This Report »

Find all the market research you need - instantly, in one place.

+1.2 Million Research Documents & Statistics +200,000 Trusted Public Sources 350 Industries With Global Coverage

24/7 Customer Support

Talk to Amrita

+1 718 303 2019

Purchase Reports From Reputable Market Research Publishers

PharmaPoint: Asthma - Global Drug Forecast and Market Analysis to 2023

PharmaPoint: Asthma - Global Drug Forecast and Market Analysis to 2023

  • $ 10 995
  • Industry report
  • August 2014
  • by Global Data

PharmaPoint: Asthma - Global Drug Forecast and Market Analysis to 2023 Summary Asthma accounts for approximately 250,000 deaths around the world annually, deaths that otherwise could be easily prevented ...

PharmaPoint: Ulcerative Colitis - Global Drug Forecast and Market Analysis to 2022 - Event-Driven Update

PharmaPoint: Ulcerative Colitis - Global Drug Forecast and Market Analysis to 2022 - Event-Driven Update

  • $ 10 995
  • Industry report
  • September 2014
  • by Global Data

PharmaPoint: Ulcerative Colitis - Global Drug Forecast and Market Analysis to 2022 - Event-Driven Update Summary During the forecast period from 2012-2022, the growth of the UC market will be driven largely ...

Cancer Vaccines: Technologies and Global Markets

Cancer Vaccines: Technologies and Global Markets

  • $ 6 650
  • Industry report
  • Dec 2014
  • by BCC Research

REPORT HIGHLIGHTS The global market for cancer vaccines was about $4.5 billion in 2013. This market reached about $4.0 billion in 2014 and is expected to reach $4.3 billion in 2019, registering a compound ...


ReportLinker is an award-winning market research solution that finds, filters and organizes the latest industry data so you get all the market research you need - quickly, in one place.