TABLE OF CONTENTS
1 INTRODUCTION 42
1.1 OBJECTIVES OF THE STUDY 42
1.2 MARKET DEFINITION 42
1.3 OVERVIEW OF THE NORTH AMERICA CONTRACT MANUFACTURING MARKET 42
1.4 CURRENCY AND PRICING 44
1.5 LIMITATIONS 44
1.6 MARKETS COVERED 44
2 MARKET SEGMENTATION 47
2.1 MARKETS COVERED 47
2.2 GEOGRAPHICAL SCOPE 48
2.3 YEARS CONSIDERED FOR THE STUDY 49
2.4 DBMR TRIPOD DATA VALIDATION MODEL 50
2.5 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS 53
2.6 MULTIVARIATE MODELLING 54
2.7 PRODUCT SEGMENT LIFELINE CURVE 54
2.8 MARKET END USER COVERAGE GRID 55
2.9 DBMR MARKET POSITION GRID 56
2.10 VENDOR SHARE ANALYSIS 57
2.11 SECONDARY SOURCES 58
2.12 ASSUMPTIONS 58
3 EXECUTIVE SUMMARY 59
4 PREMIUM INSIGHTS 61
4.1 PESTEL ANALYSIS 62
4.2 PORTER'S FIVE FORCES 63
4.3 STRATEGIC INITIATIVES: 64
5 REGULATORY FRAMEWORK 65
5.1 REGULATORY SCENARIO BY FDA 65
5.2 REGULATORY SCENARIO IN AUSTRALIA 66
5.3 REGULATORY SCENARIO IN EUROPE FOR MEDICINES 67
6 MARKET OVERVIEW 68
6.1 DRIVERS 70
6.1.1 COST-EFFECTIVENESS FOR THE MANUFACTURING COMPANIES 70
6.1.2 RISE OF TECHNOLOGICAL ADVANCEMENTS IN CONTRACT MANUFACTURING 70
6.1.3 NORTH AMERICA PRESENCE AND CONNECTED NETWORK 71
6.2 RESTRAINTS 71
6.2.1 STRINGENT REGULATIONS AMONG VARIOUS JURISDICTIONS 71
6.2.2 RISK OF CONFIDENTIAL INFORMATION 72
6.3 OPPORTUNITIES 72
6.3.1 PATENT EXPIRY AND INCREASING DEMAND FOR GENERIC DRUGS 72
6.3.2 GROWING EXPENSES ON THE DEVELOPMENT OF HEALTHCARE INFRASTRUCTURE 73
6.3.3 INCREASE IN NUMBER OF STRATEGIC INITIATIVES BY KEY MARKET PLAYERS 73
6.4 CHALLENGES 74
6.4.1 INTELLECTUAL PROPERTY RISKS 74
6.4.2 INCREASE IN NUMBER OF PHARMACEUTICAL COMPANIES TO SET UP THEIR MANUFACTURING SITES 74
7 NORTH AMERICA CONTRACT MANUFACTURING MARKET, BY PRODUCT 75
7.1 OVERVIEW 76
7.2 PHARMACEUTICAL PRODUCTS MANUFACTURING 79
7.2.1 TYPES OF PRODUCTS 80
7.2.1.1 TABLETS 80
7.2.1.2 CAPSULES 80
7.2.1.3 BIOLOGICS 81
7.2.1.4 SMALL MOLECULE 81
7.2.1.5 CELL & GENES MANUFACTURING 81
7.2.1.6 NUTRACEUTICALS 81
7.2.1.7 OTHERS 81
7.2.2 TYPE OF SERVICES 81
7.2.2.1 DRUG DEVELOPMENT SERVICES 82
7.2.2.2 TABLET MANUFACTURING SERVICES 82
7.2.2.3 BIOLOGICS API MANUFACTURING 82
7.2.2.4 BIOLOGICS FDF MANUFACTURING SERVICES 82
7.2.2.5 OTHERS 82
7.2.3 BY DOSAGE FORM 82
7.2.3.1 SOLID FORMULATIONS 83
7.2.3.2 LIQUID FORMULATIONS 83
7.2.3.2.1 INJECTABLE 83
7.2.3.2.2 SYRUPS 83
7.2.3.3 SEMI-SOLID FORMULATIONS 83
7.2.3.4 TOPICAL DRUG FORMULATIONS 83
7.2.3.5 OTHERS 83
7.3 MEDICAL DEVICE MANUFACTURING 84
7.3.1 TYPE OF DEVICES 85
7.3.1.1 SYRINGES AND NEEDLES 86
7.3.1.2 INFUSION DEVICES & ADMINISTRATION SETS 86
7.3.1.3 MEDICAL ACCESSORIES, COMPONENTS & CONSUMABLES 86
7.3.1.4 DISPOSABLES 86
7.3.1.5 IVD DEVICES 87
7.3.1.6 CARDIOVASCULAR DEVICES 87
7.3.1.7 DIABETES CARE DEVICES 87
7.3.1.8 GENERAL SURGERY DEVICES 87
7.3.1.9 ORTHOPEDIC DEVICES 87
7.3.1.10 RESPIRATORY DEVICES 87
7.3.1.11 OPHTHALMIC DEVICES 87
7.3.1.12 DENTAL DEVICES 87
7.3.1.13 GYNECOLOGY/UROLOGY DEVICES 87
7.3.1.14 LABORATORY EQUIPMENT 87
7.3.2 TYPE OF SERVICES 88
7.3.2.1 MEDICAL DEVICE DESIGN AND DEVELOPMENT 88
7.3.2.2 DEVICE ASSEMBLY 88
7.3.2.3 REGULATORY ASSISTANCE 88
7.3.2.4 PACKAGING & LABELLING 88
7.3.2.5 STERILIZATION SERVICES 89
7.3.2.6 TRAINING AND VALIDATION 89
7.3.2.7 QUALITY ASSURANCE 89
7.3.2.8 OTHERS 89
7.3.3 BY DEVICE CLASS 89
7.3.3.1 CLASS I MEDICAL DEVICES 90
7.3.3.2 CLASS IIA MEDICAL DEVICES 90
7.3.3.3 CLASS IIB MEDICAL DEVICES 90
7.3.3.4 CLASS III MEDICAL DEVICES 90
8 NORTH AMERICA CONTRACT MANUFACTURING MARKET, BY END USER 91
8.1 OVERVIEW 92
8.2 PHARMACEUTICAL COMPANIES 95
8.3 BIOTECHNOLOGY COMPANIES 95
8.4 BIOPHARMA COMPANIES 96
8.5 MEDICAL DEVICES COMPANIES 97
8.6 ORIGINAL EQUIPMENT MANUFACTURER 97
8.7 RESEARCH INSTITUTES 98
9 NORTH AMERICA CONTRACT MANUFACTURING MARKET, BY DISTRIBUTION CHANNEL 99
9.1 OVERVIEW 100
9.2 RETAIL SALES 103
9.3 DIRECT TENDER 104
9.4 OTHERS 105
10 NORTH AMERICA CONTRACT MANUFACTURING MARKET, BY REGION 106
10.1 NORTH AMERICA 107
10.1.1 U.S. 118
10.1.2 CANADA 125
10.1.3 MEXICO 132
11 NORTH AMERICA CONTRACT MANUFACTURING MARKET: COMPANY LANDSCAPE 139
11.1 COMPANY SHARE ANALYSIS: NORTH AMERICA 139
12 SWOT ANALYSIS 140
13 COMPANY PROFILE 141
13.1 AENOVA GROUP 141
13.1.1 COMPANY SNAPSHOT 141
13.1.2 COMPANY SHARE ANALYSIS 141
13.1.3 PRODUCT PORTFOLIO 142
13.1.4 RECENT DEVELOPMENTS 142
13.2 THERMO FISHER SCIENTIFIC INC. 143
13.2.1 COMPANY SNAPSHOT 143
13.2.2 REVENUE ANALYSIS 144
13.2.3 COMPANY SHARE ANALYSIS 144
13.2.4 PRODUCT PORTFOLIO 145
13.2.5 RECENT DEVELOPMENTS 145
13.3 EVONIK INDUSTRIES AG 146
13.3.1 COMPANY SNAPSHOT 146
13.3.2 REVENUE ANALYSIS 146
13.3.3 COMPANY SHARE ANALYSIS 147
13.3.4 PRODUCT PORTFOLIO 147
13.3.5 RECENT DEVELOPMENTS 147
13.4 LONZA 148
13.4.1 COMPANY SNAPSHOT 148
13.4.2 REVENUE ANALYSIS 148
13.4.3 COMPANY SHARE ANALYSIS 149
13.4.4 PRODUCT PORTFOLIO 149
13.4.5 RECENT DEVELOPMENTS 150
13.5 BOEHRINGER INGELHEIM INTERNATIONAL GMBH. 151
13.5.1 COMPANY SNAPSHOT 151
13.5.2 REVENUE ANALYSIS 151
13.5.3 COMPANY SHARE ANALYSIS 152
13.5.4 PRODUCT PORTFOLIO 152
13.5.5 RECENT DEVELOPMENTS 152
13.6 ABBVIE INC. 153
13.6.1 COMPANY SNAPSHOT 153
13.6.2 REVENUE ANALYSIS 153
13.6.3 PRODUCT PORTFOLIO 154
13.6.4 RECENT DEVELOPMENT 154
13.7 ALMAC GROUP 155
13.7.1 COMPANY SNAPSHOT 155
13.7.2 PRODUCT PORTFOLIO 155
13.7.3 RECENT DEVELOPMENTS 155
13.8 AVID BIOSERVICES, INC. 156
13.8.1 COMPANY SNAPSHOT 156
13.8.2 REVENUE ANALYSIS 156
13.8.3 PRODUCT PORTFOLIO 157
13.8.4 RECENT DEVELOPMENT 157
13.9 BAXTER 158
13.9.1 COMPANY SNAPSHOT 158
13.9.2 REVENUE ANALYSIS 158
13.9.3 PRODUCT PORTFOLIO 159
13.9.4 RECENT DEVELOPMENTS 160
13.10 CATALENT, INC 161
13.10.1 COMPANY SNAPSHOT 161
13.10.2 REVENUE ANALYSIS 161
13.10.3 PRODUCT PORTFOLIO 162
13.10.4 RECENT DEVELOPMENT 162
13.11 FAMAR HEALTH CARE SERVICES 163
13.11.1 COMPANY SNAPSHOT 163
13.11.2 PRODUCT PORTFOLIO 163
13.11.3 RECENT DEVELOPMENTS 163
13.12 JUBILANT PHARMA LIMITED 164
13.12.1 COMPANY SNAPSHOT 164
13.12.2 REVENUE ANALYSIS 164
13.12.3 PRODUCT PORTFOLIO 165
13.12.4 RECENT DEVELOPMENT 165
13.13 KIMBALL INTERNATIONAL 166
13.13.1 COMPANY SNAPSHOT 166
13.13.2 REVENUE ANALYSIS 166
13.13.3 PRODUCT PORTFOLIO 167
13.13.4 RECENT DEVELOPMENT 167
13.14 MERCK KGAA 168
13.14.1 COMPANY SNAPSHOT 168
13.14.2 REVENUE ANALYSIS 168
13.14.3 PRODUCT PORTFOLIO 169
13.14.4 RECENT DEVELOPMENTS 169
13.15 NIPR0 170
13.15.1 COMPANY SNAPSHOT 170
13.15.2 REVENUE ANALYSIS 170
13.15.3 PRODUCT PORTFOLIO 171
13.15.4 RECENT DEVELOPMENT 171
13.16 PFIZER INC 172
13.16.1 COMPANY SNAPSHOT 172
13.16.2 REVENUE ANALYSIS 172
13.16.3 PRODUCT PORTFOLIO 173
13.16.4 RECENT DEVELOPMENT 173
13.17 RECIPHARM AB. 174
13.17.1 COMPANY SNAPSHOT 174
13.17.2 REVENUE ANALYSIS 174
13.17.3 PRODUCT PORTFOLIO 175
13.17.4 RECENT DEVELOPMENT 175
13.18 SIEGFRIED HOLDING AG 176
13.18.1 COMPANY SNAPSHOT 176
13.18.2 REVENUE ANALYSIS 176
13.18.3 PRODUCT PORTFOLIO 177
13.18.4 RECENT DEVELOPMENTS 177
13.19 SUN PHARMACEUTICAL INDUSTRIES LTD 178
13.19.1 COMPANY SNAPSHOT 178
13.19.2 REVENUE ANALYSIS 178
13.19.3 PRODUCT PORTFOLIO 179
13.19.4 RECENT DEVELOPMENT 179
13.20 TE CONNECTIVITY 180
13.20.1 COMPANY SNAPSHOT 180
13.20.2 REVENUE ANALYSIS 180
13.20.3 PRODUCT PORTFOLIO 181
13.20.4 RECENT DEVELOPMENT 181
13.21 VETTER PHARMA-FERTIGUNG GMBH & CO. KG 182
13.21.1 COMPANY SNAPSHOT 182
13.21.2 PRODUCT PORTFOLIO 182
13.21.3 RECENT DEVELOPMENTS 182
14 QUESTIONNAIRE 183
15 RELATED REPORTS 186

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