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%.
* The European contract manufacturing market for OTC and nutritional products was valued at about $46.0 billion in 2010 and is projected to reach approximately $51.3 in 2011 and it will further grow to $86.5 billion by 2016, at a compound annual growth rate (CAGR) of 11%.
* The contract research market revenue for Europe in 2009 was $5.8 billion, which reached $6.3 billion in 2010. This market is expected to reach at $6.9 billion in 2011 and it will further grow to $10.5 billion by 2016, at a compound annual growth rate (CAGR) of 8.7%.

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.

Table Of Contents

CHAPTER ONE: INTRODUCTION
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 EUROPE 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 EUROPE, 2010
(%) 41
TABLE 22 (CONTINUED) 42
FIGURE 1 MARKET SHARE OF CONTRACT MANUFACTURING
COMPANIES PROVIDING BULK DRUGS/API’S, IN EUROPE, 2010
(%) 42
CONTRACT MANUFACTURERS OF SOLID DOSAGE FORMS 42
TABLE 23 MARKET SHARE OF CONTRACT MANUFACTURING
COMPANIES PROVIDING SOLID DOSAGE FORMS, IN EUROPE,
2010 (%) 43
FIGURE 2 MARKET SHARE OF CONTRACT MANUFACTURING
COMPANIES PROVIDING SOLID DOSAGE FORMS, IN EUROPE,
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 EUROPE, 2010 (%) 44
FIGURE 3 MARKET SHARE OF CONTRACT MANUFACTURING
COMPANIES PROVIDING NONSTERILE LIQUID DOSAGE FORMS,
IN EUROPE, 2010 (%) 45
STERILE 45
TABLE 25 MARKET SHARE OF CONTRACT MANUFACTURING
COMPANIES PROVIDING STERILE LIQUID DOSAGE FORMS, IN
EUROPE, 2010 (%) 46
FIGURE 4 MARKET SHARE OF CONTRACT MANUFACTURING
COMPANIES PROVIDING STERILE LIQUID DOSAGE FORMS, IN
EUROPE, 2010 (%) 46
CONTRACT MANUFACTURING OF SEMISOLID DOSAGE FORMS 47
TABLE 26 MARKET SHARE OF CONTRACT MANUFACTURING
COMPANIES PROVIDING SEMISOLID DOSAGE FORMS, IN
EUROPE, 2010 (%) 47
FIGURE 5 MARKET SHARE OF CONTRACT MANUFACTURING
COMPANIES PROVIDING SEMISOLID DOSAGE FORMS, IN
EUROPE, 2010 (%) 47
CONTRACT RESEARCH COMPANIES 48
TABLE 27 MARKET SHARE OF CONTRACT RESEARCH
COMPANIES, IN EUROPE, 2010 (%) 48
FIGURE 6 MARKET SHARE OF CONTRACT RESEARCH
COMPANIES, IN EUROPE, 2010 (%) 49
TABLE 28 MARKET SHARE OF CONTRACT PACKAGING
COMPANIES, IN EUROPE, 2010 (%) 50
FIGURE 7 MARKET SHARE OF CONTRACT PACKAGING
COMPANIES, IN EUROPE, 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 EUROPE 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
REVENUE, FOR EUROPE, THROUGH 2016 ($ BILLIONS) 64
FIGURE 8 BULK DRUG/API CONTRACT MANUFACTURING
REVENUE, FOR EUROPE, 2009-2016 ($ BILLIONS) 65
CONTRACT MANUFACTURE OF ORAL DOSAGE
FORMULATIONS 65
Solid Dosage Formulations 66
Market Overview 66
Market Revenue 67
TABLE 30 SOLID DOSAGE FORM CONTRACT MANUFACTURING,
FOR EUROPE, THROUGH 2016 ($ BILLIONS) 67
FIGURE 9 SOLID DOSAGE FORM CONTRACT MANUFACTURING,
FOR EUROPE, 2009- 2016 ($ BILLIONS) 68
Market by Formulation 68
Market Revenue 69
TABLE 31 SOLID DOSAGE FORM CONTRACT MANUFACTURING
REVENUE, BY FORMULATION, FOR EUROPE, THROUGH 2016 ($
BILLIONS) 69
FIGURE 10 SOLID DOSAGE FORM CONTRACT MANUFACTURING
REVENUE, BY FORMULATIONS, FOR EUROPE, 2009-2016 ($
BILLIONS) 70
TABLE 32 SOLID DOSAGE FORM CONTRACT MANUFACTURING
MARKET SHARES, BY FORMULATION, FOR EUROPE, 2010 (%) 70
FIGURE 11 SOLID DOSAGE FORM CONTRACT MANUFACTURING
MARKET SHARES, BY FORMULATIONS, FOR EUROPE, 2010 (%) 71
Liquid Dosage Formulation 71
Market Overview 71
Market Revenue 72
Nonsterile Formulations 72
TABLE 33 LIQUID DOSAGE FORM (NONSTERILE) CONTRACT
MANUFACTURING, FOR EUROPE, THROUGH 2016 ($ MILLIONS) 73
FIGURE 12 LIQUID DOSAGE FORM (NONSTERILE) CONTRACT
MANUFACTURING, FOR EUROPE, 2009-2016 ($ MILLIONS) 73
Sterile Formulations 73
TABLE 34 LIQUID DOSAGE FORM (STERILE) CONTRACT
MANUFACTURING, FOR EUROPE, THROUGH 2016 ($ MILLIONS) 74
FIGURE 13 LIQUID DOSAGE FORM (STERILE) CONTRACT
MANUFACTURING, FOR EUROPE, 2009-2016 ($ MILLIONS) 74
Market by Formulation 74
Nonsterile Formulations 74
TABLE 35 LIQUID DOSAGE FORM (NONSTERILE) CONTRACT
MANUFACTURING REVENUE, BY FORMULATION, FOR EUROPE,
THROUGH 2016 ($ MILLIONS) 75
FIGURE 14 LIQUID DOSAGE FORM (NONSTERILE) CONTRACT
MANUFACTURING REVENUE, BY FORMULATIONS, FOR
EUROPE, 2009-2016 ($ MILLIONS) 76
TABLE 36 LIQUID DOSAGE FORM (NONSTERILE) CONTRACT
MANUFACTURING MARKET SHARES, BY FORMULATION, FOR
EUROPE, 2010 (%) 76
FIGURE 15 LIQUID DOSAGE FORM (NONSTERILE) CONTRACT
MANUFACTURING MARKET SHARES, BY FORMULATIONS, FOR
EUROPE, 2010 (%) 77
Sterile Formulations 77
TABLE 37 LIQUID DOSAGE FORM (STERILE) CONTRACT
MANUFACTURING REVENUE, BY FORMULATION, FOR EUROPE,
THROUGH 2016 ($ MILLIONS) 78
FIGURE 16 LIQUID DOSAGE FORM (STERILE) CONTRACT
MANUFACTURING REVENUE, BY FORMULATION, FOR EUROPE,
2009-2016 ($ MILLIONS) 78
TABLE 38 LIQUID DOSAGE FORM (STERILE) CONTRACT
MANUFACTURING MARKET SHARE, BY FORMULATION, FOR
EUROPE, 2010 (%) 79
FIGURE 17 LIQUID DOSAGE FORM (STERILE) CONTRACT
MANUFACTURING MARKET SHARE, BY FORMULATIONS, FOR
EUROPE, 2010 (%) 79
CONTRACT MANUFACTURE OF SEMISOLID DOSAGE
FORMULATIONS 79
Market Overview 79
Market Revenue 80
TABLE 39 SEMISOLID DOSAGE FORM CONTRACT
MANUFACTURING, FOR EUROPE, THROUGH 2016 ($ MILLIONS) 81
FIGURE 18 SEMISOLID DOSAGE FORM CONTRACT
MANUFACTURING, FOR EUROPE, 2009-2016 ($ MILLIONS) 81
TABLE 40 SEMISOLID DOSAGE FORM CONTRACT
MANUFACTURING REVENUE, BY FORMULATION, FOR
EUROPE, THROUGH 2016 ($ MILLIONS) 82
FIGURE 19 SEMISOLID DOSAGE FORM CONTRACT
MANUFACTURING REVENUE, BY FORMULATIONS, FOR
EUROPE, 2009-2016 ($ MILLIONS) 82
TABLE 41 SEMISOLID DOSAGE FORM CONTRACT
MANUFACTURING MARKET SHARE, BY FORMULATION, FOR
EUROPE, 2010 (%) 83
FIGURE 20 SEMISOLID DOSAGE FORM CONTRACT
MANUFACTURING MARKET SHARE, BY FORMULATIONS, FOR
EUROPE, 2010 (%) 83
CONTRACT MANUFACTURE OF ADVANCED DRUG
DELIVERY PRODUCTS 83
Market Overview 84
TABLE 42 CONTRACTING COMPANIES PROVIDING DRUG
DELIVERY SYSTEMS 85
Market Revenue 85
TABLE 43 ADVANCED DRUG DELIVERY SYSTEMS REVENUE, BY
CONTRACT MANUFACTURING, FOR EUROPE, THROUGH 2016 ($
BILLIONS) 86
FIGURE 21 ADVANCED DRUG DELIVERY SYSTEMS REVENUE, BY
CONTRACT MANUFACTURING, FOR EUROPE, 2009-2016 ($
BILLIONS) 86
Market by Formulation 86
TABLE 44 ADVANCED DRUG DELIVERY SYSTEMS BY CONTRACT
MANUFACTURING REVENUE, BY FORMULATION, FOR EUROPE,
THROUGH 2016 ($ MILLIONS) 87
FIGURE 22 ADVANCED DRUG DELIVERY SYSTEMS BY CONTRACT
MANUFACTURING REVENUE, BY FORMULATIONS, FOR
EUROPE, 2009-2016 ($ MILLIONS) 88
Market Share 88
TABLE 45 ADVANCED DRUG DELIVERY SYSTEMS BY CONTRACT
MANUFACTURING MARKET SHARE, BY FORMULATION, FOR
EUROPE, 2010 (%) 89
FIGURE 23 ADVANCED DRUG DELIVERY SYSTEMS BY CONTRACT
MANUFACTURING MARKET SHARE, BY FORMULATIONS, FOR
EUROPE, 2010 (%) 89
CONTRACT MANUFACTURE OF OTC AND NUTRITIONAL
PRODUCTS 90
Market Revenue 91
TABLE 46 OTC AND NUTRITIONAL PRODUCTS REVENUE, BY
CONTRACT MANUFACTURING, FOR EUROPE, THROUGH 2016 ($
BILLIONS) 91
FIGURE 24 OTC AND NUTRITIONAL PRODUCTS REVENUE, BY
CONTRACT MANUFACTURING, FOR EUROPE, 2009-2016 ($
BILLIONS) 91
Market by Formulation 92
TABLE 47 OTC AND NUTRITIONAL PRODUCTS BY CONTRACT
MANUFACTURING REVENUE, BY FORMULATION, FOR EUROPE,
THROUGH 2016 ($ BILLIONS) 92
FIGURE 25 OTC AND NUTRITIONAL PRODUCTS BY CONTRACT
MANUFACTURING REVENUE, BY FORMULATIONS, FOR
EUROPE, 2009-2016 ($ BILLIONS) 93
Market Shares 93
TABLE 48 OTC AND NUTRITIONAL PRODUCTS BY CONTRACT
MANUFACTURING MARKET SHARE, BY FORMULATION, FOR
EUROPE, 2010 (%) 93
FIGURE 26 OTC AND NUTRITIONAL PRODUCTS BY CONTRACT
MANUFACTURING MARKET SHARE, BY FORMULATIONS, FOR
EUROPE, 2010 (%) 94
CONTRACT RESEARCH 94
MARKET OVERVIEW 94
Partnerships 94
Expansions of Facilities 95
Market Revenue 95
TABLE 49 CONTRACT RESEARCH REVENUE, FOR EUROPE,
THROUGH 2016 ($ BILLIONS) 96
FIGURE 27 CONTRACT RESEARCH REVENUE, FOR EUROPE, 2009-
2016 ($ BILLIONS) 96
Market by Discipline 96
TABLE 50 CONTRACT RESEARCH REVENUE BY DISCIPLINE, FOR
EUROPE, THROUGH 2016 ($ MILLIONS) 97
FIGURE 28 CONTRACT RESEARCH REVENUE BY DISCIPLINE, FOR
EUROPE, 2009-2016 ($ MILLIONS) 97
Market Share by Discipline 98
TABLE 51 CONTRACT RESEARCH MARKET SHARE, BY
DISCIPLINE, FOR EUROPE, 2010 (%) 98
FIGURE 29 CONTRACT RESEARCH MARKET SHARE, BY
DISCIPLINE, FOR EUROPE, 2010 (%) 98
CONTRACT PACKAGING 99
MARKET OVERVIEW 99
Market Revenue 99
TABLE 52 CONTRACT PACKAGING REVENUE, FOR EUROPE,
THROUGH 2016 ($ BILLIONS) 100
FIGURE 30 CONTRACT PACKAGING REVENUE, FOR EUROPE, 2009-
2016 ($ BILLIONS) 100
Market by Package Type 100
TABLE 53 CONTRACT PACKAGING REVENUE BY TYPE, FOR
EUROPE, THROUGH 2016 ($ MILLIONS) 101
FIGURE 31 CONTRACT RESEARCH REVENUE BY DISCIPLINE, FOR
EUROPE, 2009-2016 ($ BILLIONS) 102
Market Share by Type 102
TABLE 54 CONTRACT PACKAGING MARKET SHARE BY TYPE, FOR
EUROPE, 2010 (%) 103
FIGURE 32 CONTRACT PACKAGING MARKET SHARE BY TYPE, FOR
EUROPE, 2010 (%) 103
CHAPTER THIRTEEN: MARKET SHARE BY REGION 104
MARKET SHARE OF CONTRACT MANUFACTURED API’S 104
TABLE 55 BULK DRUG/API CONTRACT MANUFACTURING
MARKET SHARE, BY REGION, 2010 (%) 104
FIGURE 33 BULK DRUG/API CONTRACT MANUFACTURING
MARKET SHARE, BY REGION, 2010 (%) 105
MARKET SHARE OF CONTRACT MANUFACTURED SOLID
DOSAGE FORMS 105
TABLE 56 SOLID DOSAGE FORM CONTRACT MANUFACTURING
MARKET SHARE, BY REGION, 2010 (%) 105
FIGURE 34 SOLID DOSAGE FORM CONTRACT MANUFACTURING
MARKET SHARE, BY REGION, 2010 (%) 106
MARKET SHARE OF CONTRACT MANUFACTURED LIQUID
DOSAGE FORMULATIONS 106
NONSTERILE FORMULATIONS 106
TABLE 57 LIQUID DOSAGE FORM (NONSTERILE) CONTRACT
MANUFACTURING MARKET SHARE, BY REGION, 2010 (%) 106
FIGURE 35 LIQUID DOSAGE FORM (NONSTERILE) CONTRACT
MANUFACTURING MARKET SHARE, BY REGION, 2010 (%) 107
STERILE FORMULATIONS 107
TABLE 58 LIQUID DOSAGE FORM (STERILE) CONTRACT
MANUFACTURING MARKET SHARE, BY REGION, 2010 (%) 107
FIGURE 36 LIQUID DOSAGE FORM (STERILE) CONTRACT
MANUFACTURING MARKET SHARE, BY REGION, 2010 (%) 108
MARKET SHARE OF CONTRACT MANUFACTURED SEMISOLID
DOSAGE FORMULATIONS 108
TABLE 59 SEMISOLID DOSAGE FORM CONTRACT
MANUFACTURING MARKET SHARES, BY REGION, 2010 (%) 108
FIGURE 37 SEMISOLID DOSAGE FORM CONTRACT
MANUFACTURING MARKET SHARE, BY REGION, 2010 (%) 109
MARKET SHARE OF CONTRACT MANUFACTURED ADVANCED
DRUG DELIVERY PRODUCTS 109
TABLE 60 DRUG DELIVERY CONTRACT MANUFACTURING
MARKET SHARE, BY REGION, 2010 (%) 109
FIGURE 38 DRUG DELIVERY CONTRACT MANUFACTURING
MARKET SHARE, BY REGION, 2010 (%) 110
MARKET SHARE OF CONTRACT MANUFACTURED OTC AND
NUTRITIONAL PRODUCTS 110
TABLE 61 OTC AND NUTRITIONAL PRODUCTS CONTRACT
MANUFACTURING MARKET SHARE, BY REGION, 2010 (%) 110
FIGURE 39 OTC AND NUTRITIONAL PRODUCT CONTRACT
MANUFACTURING MARKET SHARE, BY REGION, 2010 (%) 111
MARKET SHARE OF CONTRACT RESEARCH 111
TABLE 62 CONTRACT RESEARCH MARKET SHARE, BY REGION,
2010 (%) 111
FIGURE 40 CONTRACT RESEARCH MARKET SHARE, BY REGION,
2010 (%) 112
MARKET SHARE OF CONTRACT PACKAGING 112
TABLE 63 CONTRACT PACKAGING MARKET SHARE, BY REGION,
2010 (%) 112
FIGURE 41 CONTRACT PACKAGING MARKET SHARE, BY REGION,
2010 (%) 113
CHAPTER FOURTEEN: CONTRACT MANUFACTURING APPLICATIONS
FOR EUROPEAN MARKETS 114
CARDIOVASCULAR DRUGS 114
MARKET REVENUE 115
TABLE 64 REVENUE FROM CONTRACT MANUFACTURERS OF
CARDIOVASCULAR DRUGS, IN EUROPE, THROUGH 2016 ($
MILLIONS) 115
FIGURE 42 REVENUE FROM CONTRACT MANUFACTURERS OF
CARDIOVASCULAR DRUGS, IN EUROPE, 2009-2016 ($ MILLIONS) 116
REPRODUCTIVE DRUG MARKET 116
MARKET REVENUE 117
TABLE 65 REVENUE FROM CONTRACT MANUFACTURERS OF
REPRODUCTIVE DRUGS, IN EUROPE, THROUGH 2016 ($
MILLIONS) 118
FIGURE 43 REVENUE FROM CONTRACT MANUFACTURERS OF
REPRODUCTIVE DRUGS, IN EUROPE, 2009-2016 ($ MILLIONS) 118
ONCOLOGY DRUG MARKET 118
MARKET REVENUE 119
TABLE 66 REVENUE FROM CONTRACT MANUFACTURERS OF
ONCOLOGY DRUGS, IN EUROPE, THROUGH 2016 ($ MILLIONS) 120
FIGURE 44 REVENUE FROM CONTRACT MANUFACTURERS OF
ONCOLOGY DRUGS, IN EUROPE, 2009-2016 ($ MILLIONS) 120
ANALGESICS MARKET 120
MARKET REVENUE 121
TABLE 67 REVENUE FROM CONTRACT MANUFACTURERS OF
ANALGESICS, IN EUROPE, THROUGH 2016 ($ MILLIONS) 121
FIGURE 45 REVENUE FROM CONTRACT MANUFACTURERS OF
ANALGESICS, IN EUROPE, 2009-2016 ($ MILLIONS) 122
ANTIVIRAL DRUG MARKET 122
MARKET REVENUE 123
TABLE 68 REVENUE FROM CONTRACT MANUFACTURERS OF
ANTIVIRALS, IN EUROPE, THROUGH 2016 ($ MILLIONS) 123
FIGURE 46 REVENUE FROM CONTRACT MANUFACTURERS OF
ANTIVIRALS, IN EUROPE, 2009-2016 ($ MILLIONS) 124
ANTIBIOTICS MARKET 124
MARKET REVENUE 125
TABLE 69 REVENUE FROM CONTRACT MANUFACTURERS OF
ANTIBIOTICS, IN EUROPE, THROUGH 2016 ($ MILLIONS) 125
FIGURE 47 REVENUE FROM CONTRACT MANUFACTURERS OF
ANTIBIOTICS, IN EUROPE, 2009-2016 ($ MILLIONS) 125
MARKETS FOR OTHER DRUGS 126
MARKET REVENUE 126
TABLE 70 REVENUE FROM CONTRACT MANUFACTURERS OF
OTHER DRUGS, IN EUROPE, THROUGH 2016 ($ BILLIONS) 126
FIGURE 48 REVENUE FROM CONTRACT MANUFACTURERS OF
OTHER DRUGS, IN EUROPE, 2009-2016 ($ BILLIONS) 127
CHAPTER FIFTEEN: PATENT ANALYSIS 128
PATENTS BY YEAR 128
TABLE 71 NUMBER OF SIGNIFICANT PATENTS, BY YEAR, 2009-
2011 128
FIGURE 49 NUMBER OF PATENTS, BY YEAR, 2009-MAY 31, 2011 128
FIGURE 50 NUMBER OF PATENTS, BY YEAR, 2009-MAY 31, 2011 (%) 129
PATENTS BY COMPANY 129
TABLE 72 NUMBER OF US PATENTS, BY COMPANY, 2009-2011 130
FIGURE 51 NUMBER OF US PATENTS, BY COMPANY, 2009-2011 131
PATENTS BY COUNTRY 132
TABLE 73 NUMBER OF US PATENTS, BY COUNTRY, 1/1/2009 TO
5/31/2011 132
FIGURE 52 NUMBER OF US PATENTS, BY COUNTRY, 1/1/2009 TO
5/31/2011 133
TABLE 74 PATENT SHARES, BY COUNTRY, 1/1/2009 TO 5/31/2011
(%) 133
FIGURE 53 PATENT SHARES, BY COUNTRY, 1/1/2009 TO
5/31/2011 (%) 134
PATENTS BY EMPHASIS 134
TABLE 75 PATENTS, BY EMPHASIS, 1/1/2009 TO 5/31/2011 135
FIGURE 54 NUMBER OF US PATENTS, BY EMPHASIS, 1/1/2009 TO
5/31/2011 135
CHAPTER SIXTEEN: CURRENT ENVIRONMENT 136
SITUATION OF THE NORTH AMERICAN CONTRACTING
MARKETS 136
CONTRACT MANUFACTURING OF API AND DOSAGE
FORMS 136
CONTRACT MANUFACTURING OF OTC AND
NUTRACEUTICALS 136
CONTRACT RESEARCH 137
CONTRACT PACKAGING 137
SITUATION OF THE EUROPEAN CONTRACTING MARKET 137
CONTRACT MANUFACTURING OF API AND DOSAGE
FORMS 137
CONTRACT MANUFACTURING OF OTC AND
NUTRACEUTICALS 137
CONTRACT RESEARCH 138
CONTRACT PACKAGING 138
SITUATION OF THE ROW CONTRACTING MARKET 138
CONTRACT MANUFACTURING OF API AND DOSAGE
FORMS 138
CONTRACT MANUFACTURING OF OTC AND
NUTRACEUTICALS 138
CONTRACT RESEARCH 139
CONTRACT PACKAGING 139
OPPORTUNITIES AND CHALLENGES OF THE CURRENT
CONTRACT MANUFACTURING INDUSTRY 139
OPPORTUNITIES AND CHALLENGES…(CONTINUED) 140
OPPORTUNITIES AND CHALLENGES…(CONTINUED) 141
CHAPTER SEVENTEEN: COMPANY PROFILES 142
AAI PHARMA, INC 142
ABBOTT LABORATORIES 142
AEROGEN LTD 143
ALKERMES 143
ALTHEA TECHNOLOGIES 144
AMCOR 145
AMERISOURCE BERGEN CORPORATION 145
AMPAC FINE CHEMICALS 146
ALBANY MOLECULAR RESEARCH INC (AMRI) 146
AP PHARMA INC 147
APTUIT INC 147
ARADIGM CORPORATION 148
BASF SE 149
BAXTER HEALTHCARE 149
BCM/BOOTS MANUFACTURING 150
BOEHRINGER INGELHEIM 151
BRISTOL-MYERS SQUIBB 151
CAMBREX CORPORATION 152
CANGENE CORPORATION 153
CATALENT PHARMA SOLUTIONS 153
CEDARBURG HAUSER PHARMACEUTICALS INC 154
CENEXI 154
CHARLES RIVER LABORATORIES 155
CHEMBRIDGE CORP 155
CLEARSTONE CENTRAL LABORATORIES 156
CONFAB LABORATORIES 156
COVANCE INC 157
COVIDIEN 157
CONTRACT PHARMACEUTICALS LIMITED 158
CORDEN PHARMA SWITZERLAND LLC 158
DAVOS PHARMA 159
DECODE GENETICS 159
DISHMAN PHARMACEUTICALS AND CHEMICALS LTD 160
DOW CHEMICAL 161
DPT LABORATORIES INC 161
DR REDDY’S LABORATORIES 162
DSM PHARMACEUTICAL PRODUCTS 162
FUJIFILM DIOSYNTH BIOTECHNOLOGY 163
ELAN DRUG TECHNOLOGIES 163
EVOTEC AG 164
FULCRUM PHARMA PLC 164
GIRINDUS AG 165
GLAXOSMITHKLINE 165
HOSPIRA 166
HAUPT PHARMA AG 167
HOVIONE SA 167
ICON PLC 168
INC RESEARCH, INC 168
JUBILANT LIFESCIENCES 169
KENDLE INTERNATIONAL INC 169
KP PHARMACEUTICAL TECHNOLOGIES INC 170
KV PHARMACEUTICAL CO 170
LIGAND PHARMACEUTICALS, INC 171
LONZA GROUP 171
LYNE LABORATORIES 172
MERCK / MSD BIOMANUFACTURING NETWORK 173
MIKART INC 173
NEXTPHARMA TECHNOLOGIES 174
NORWICH PHARMACEUTICALS 174
NOVAVAX, INC 175
OMNICARE CLINICAL RESEARCH 175
PAREXEL INTERNATIONAL CORPORATION 176
PATHEON INC 176
PERRIGO COMPANY 177
PFIZER (KING PHARMACEUTICALS 178
PIRAMAL HEALTHCARE LIMITED 178
PPD 179
PRA INTERNATIONAL 179
QUINTILES 180
RANBAXY 180
REGIS TECHNOLOGIES, INC 181
SKYEPHARMA 181
TALECRIS BIOTHERAPEUTICS INC 182
VETTER PHARMA INTERNATIONAL GMBH 182
WOCKHARDT LIMITED 183
WUXI APP TEC 184
XCELLEREX LLC 184
ZACH SYSTEM SPA 185
APPENDIX I: ABBREVIATIONS 186

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