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Report
North America Self-injections Market
Market Report I 2024-09-01 I 302 Pages I Data Bridge Market Research
North America self-injection market is expected to reach USD 41.75 billion by 2031 from USD 19.52 billion in 2023, growing with a CAGR of 10.2% in the forecast period of 2024 to 2031.
Market Segmentation:
North America Self-injections Market, By Product Type (Self-Injection Devices and Self-Injection Formulation), Dosage Form (Single Dose and Multi-Dose), Route of Administration (Subcutaneous, Intra muscular, and Others), Application (Autoimmune Diseases, Pain Management, Emergency Drugs, Oncology, Hormonal Disorders, and Others), Age Group (Adult, Geriatric, and Pediatric), Gender (Male and Female), Distribution Channel (Direct Tender, Hospital Pharmacy, Online Pharmacy, and Others), Country (U.S., Canada, and Mexico) - Industry Trends and Forecast to 2031
Overview of North America Self-Injections Market Dynamics:
Driver
- Rising prevalence of chronic disease
Restraint
- High cost of self injectors
Opportunity
- Government initiatives to self-injections
Market Players:
The key market players operating in the North America self-injection market are listed below:
- Novo Nordisk A/S
- Johnson & Johnson Services, Inc.
- Biogen
- Amgen Inc.
- Sanofi
- AbbVie Inc.
- YPSOMED
- BD
- AstraZeneca
- AptarGroup, Inc.
- Bayer AG
- Bausch Health Companies Inc.
- Boehringer Ingelheim International GmBH
- Credence Medsystems, Inc.
- Enable Injections
- F. Hoffmann-La Roche Ltd
- GSK plc
- Gerresheimer AG
- Haselmeier
- Ipsen Biopharmaceuticals, Inc.
- Lilly
- Midas Pharma GmBH
- Merck & Co., Inc.
- Novartis AG
- Nemera
- OVAL MEDICAL TECHNOLOGIES LTD. (SMC LIMITED)
- Owen Mumford
- Pfizer Inc.
- Philips-Medisize
- PharmaJet
- PenJet
- Recipharm AB
- SCHOTT PHARMA
- SHL Medical AG
- Societe Industrielle de Sonceboz SA
- Terumo Corporation
- Takeda Pharmaceutical Company Limited
- Teva Pharmaceuticals Industries Ltd.
- UCB Pharma
- West Pharmaceutical Service
1 INTRODUCTION 52
1.1 OBJECTIVES OF THE STUDY 52
1.2 MARKET DEFINITION 52
1.3 OVERVIEW OF NORTH AMERICA SELF-INJECTIONS MARKET 52
1.4 MARKETS COVERED 55
2 MARKET SEGMENTATION 58
2.1 MARKETS COVERED 58
2.2 GEOGRAPHICAL SCOPE 59
2.3 YEARS CONSIDERED FOR THE STUDY 60
2.4 CURRENCY AND PRICING 60
2.5 DBMR TRIPOD DATA VALIDATION MODEL 61
2.6 MULTIVARIATE MODELLING 64
2.7 THERAPEUTICS LIFELINE CURVE 64
2.8 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS 65
2.9 DBMR MARKET POSITION GRID 66
2.10 VENDOR SHARE ANALYSIS 67
2.11 MARKET APPLICATION COVERAGE GRID 68
2.12 SECONDARY SOURCES 69
2.13 ASSUMPTIONS 69
3 EXECUTIVE SUMMARY 70
4 PREMIUM INSIGHT 76
4.1 PORTER'S FIVE FORCES 77
4.2 PESTEL ANALYSIS 78
4.3 CUSTOMIZATIONS 79
5 NORTH AMERICA SELF-INJECTIONS MARKET: REGULATIONS 84
5.1 REGULATORY AUTHORITIES IN THE ASIA-PACIFIC REGION 84
5.1.1 AUSTRALIA 84
5.1.2 CHINA 86
5.1.3 INDIA 88
5.2 REGULATORY SUBMISSIONS 89
5.2.1 PRE-SUBMISSION ACTIVITIES 89
5.2.2 DEVELOPMENT OF TECHNICAL DOCUMENTATION 90
5.3 CLINICAL EVALUATION 90
5.4 REGULATORY SUBMISSION PREPARATION 90
5.5 SUBMISSION TO REGULATORY AUTHORITY 90
5.6 REVIEW AND EVALUATION BY REGULATORY AUTHORITY 90
5.7 APPROVAL AND MARKET AUTHORIZATION 91
5.8 POST-MARKET SURVEILLANCE 91
5.9 RENEWAL AND COMPLIANCE 91
5.10 ASEAN MEDICAL DEVICE DIRECTIVE (AMDD) 91
5.11 ADOPTION OF NORTH AMERICA STANDARDS (ISO AND IEC) 92
5.12 COLLABORATION VIA APEC REGULATORY HARMONIZATION STEERING COMMITTEE 92
5.13 CLINICAL DATA HARMONIZATION 92
5.14 COMMON TECHNICAL DOCUMENT (CTD) FORMAT 92
5.15 POST-MARKET SURVEILLANCE AND REPORTING HARMONIZATION 92
5.16 MUTUAL RECOGNITION AGREEMENTS (MRAS) 92
5.17 TRAINING AND CAPACITY BUILDING INITIATIVES 93
5.18 NORTH AMERICA REGULATORY SCENARIO 93
5.19 MEDICAL DEVICE CLASSIFICATION 95
5.20 REGULATORY SUBMISSIONS 98
5.21 EUROPE REGULATORY SCENARIO 100
5.22 REGULATORY SUBMISSIONS 102
5.23 MIDDLE EAST AND AFRICA REGULATORY SCENARIO 104
5.24 SOUTH AMERICA REGULATORY SCENARIO 111
5.25 INTERNATIONAL HARMONIZATION 115
6 MARKET OVERVIEW 119
6.1 DRIVERS 121
6.1.1 RISING PREVALENCE OF CHRONIC DISEASE 121
6.1.2 TECHNOLOGICAL ADVANCEMENT IN SELF INJECTIONS 121
6.1.3 INCREASE IN PATIENT AUTONOMY 122
6.1.4 RISE IN MOBILE HEALTH APPLICATIONS 122
6.2 RESTRAINTS 124
6.2.1 HIGH COST OF SELF INJECTORS 124
6.2.2 REGULATORY HURDLES AND NEED FOR PROPER TRAINING FOR SELF-INJECTION DEVICES 125
6.3 OPPORTUNITIES 126
6.3.1 GOVERNMENT INITIATIVES TO SELF-INJECTIONS 126
6.3.2 INCREASED RESEARCH AND DEVELOPMENT FOR SELF-INJECTION 127
6.3.3 GROWING DEMAND FOR BIOLOGICS AND PERSONALIZED MEDICINE 128
6.4 CHALLENGES 129
6.4.1 PATIENT RELUCTANCE TOWARDS NEEDLES 129
6.4.2 ENVIRONMENTAL CONCERNS WITH SELF-INJECTIONS 129
7 NORTH AMERICA SELF-INJECTIONS MARKET, BY PRODUCT TYPE 131
7.1 OVERVIEW 132
7.2 SELF-INJECTION DEVICES 135
7.3 SELF-INJECTION FORMULATION 137
8 NORTH AMERICA SELF-INJECTIONS MARKET, BY DOSAGE FORM 138
8.1 OVERVIEW 139
8.2 SINGLE DOSE 142
8.3 MULTI-DOSE 142
9 NORTH AMERICA SELF-INJECTIONS MARKET, BY ROUTE OF ADMINISTRATION 143
9.1 OVERVIEW 144
9.2 SUBCUTANEOUS 147
9.3 INTRA MUSCULAR 147
9.4 OTHERS 148
10 NORTH AMERICA SELF-INJECTIONS MARKET, BY APPLICATION 149
10.1 OVERVIEW 150
10.2 AUTOIMMUNE DISEASES 153
10.3 PAIN MANAGEMENT 154
10.4 EMERGENCY DRUGS 154
10.5 ONCOLOGY 155
10.6 HORMONAL DISORDERS 155
10.7 OTHERS 156
11 NORTH AMERICA SELF-INJECTIONS MARKET, BY AGE GROUP 157
11.1 OVERVIEW 158
11.2 ADULT 161
11.3 GERIATRIC 161
11.4 PEDIATRIC 162
12 NORTH AMERICA SELF-INJECTIONS MARKET, BY GENDER 163
12.1 OVERVIEW 164
12.2 MALE 167
12.3 FEMALE 167
13 NORTH AMERICA SELF-INJECTIONS MARKET, BY DISTRIBUTION CHANNEL 168
13.1 OVERVIEW 169
13.2 DIRECT TENDER 172
13.3 HOSPITAL PHARMACY 172
13.4 ONLINE PHARMACY 173
13.5 OTHERS 173
14 NORTH AMERICA SELF-INJECTIONS MARKET, BY REGION 174
14.1 NORTH AMERICA 177
15 NORTH AMERICA SELF-INJECTIONS MARKET: COMPANY LANDSCAPE 201
15.1 COMPANY SHARE ANALYSIS: NORTH AMERICA 201
16 SWOT ANALYSIS 202
17 COMPANY PROFILES 203
17.1 NOVO NORDISK 203
17.1.1 COMPANY SNAPSHOT 203
17.1.2 REVENUE 204
17.1.3 COMPANY SHARE ANALYSIS 204
17.1.4 PRODUCT PORTFOLIO 205
17.1.5 RECENT DEVELOPMENT 206
17.2 JOHNSON & JOHNSON SERVICES, INC. 207
17.2.1 COMPANY SNAPSHOT 207
17.2.2 REVENUE ANALYSIS 207
17.2.3 COMPANY SHARE ANALYSIS 208
17.2.4 PRODUCT PORTFOLIO 208
17.2.5 RECENT DEVELOPMENT 208
17.3 BIOGEN 210
17.3.1 COMPANY SNAPSHOT 210
17.3.2 REVENUE ANALYSIS 210
17.3.3 PRODUCT PORTFOLIO 211
17.3.4 RECENT DEVELOPMENT 212
17.4 AMGEN INC. 213
17.4.1 COMPANY SNAPSHOT 213
17.4.2 REVENUE ANALYSIS 213
17.4.3 COMPANY SHARE ANALYSIS 214
17.4.4 PRODUCT PORTFOLIO 214
17.4.5 RECENT DEVELOPMENT 214
17.5 SANOFI 215
17.5.1 COMPANY SNAPSHOT 215
17.5.2 REVENUE ANALYSIS 215
17.5.3 COMPANY SHARE ANALYSIS 216
17.5.4 PRODUCT PORTFOLIO 216
17.5.5 RECENT DEVELOPMENT 217
17.6 ABBVIE INC. 218
17.6.1 COMPANY SNAPSHOT 218
17.6.2 REVENUE ANALYSIS 218
17.6.3 COMPANY SHARE ANALYSIS 219
17.6.4 PRODUCT PORTFOLIO 219
17.6.5 RECENT DEVELOPMENT 219
17.7 YPSOMED 220
17.7.1 COMPANY SNAPSHOT 220
17.7.2 REVENUE ANALYSIS 220
17.7.3 PRODUCT PORTFOLIO 221
17.7.4 RECENT DEVELOPMENT 221
17.8 BD 222
17.8.1 COMPANY SNAPSHOT 222
17.8.2 REVENUE ANALYSIS 222
17.8.3 PRODUCT PORTFOLIO 223
17.8.4 RECENT DEVELOPMENT 223
17.9 ASTRAZENECA 224
17.9.1 COMPANY SNAPSHOT 224
17.9.2 REVENUE ANALYSIS 224
17.9.3 PRODUCT PORTFOLIO 225
17.9.4 RECENT DEVELOPMENTS 225
17.10 APTARGROUP, INC. 226
17.10.1 COMPANY SNAPSHOT 226
17.10.2 REVENUE ANALYSIS 226
17.10.3 PRODUCT PORTFOLIO 227
17.10.4 RECENT DEVELOPMENTS 227
17.11 BAYER 228
17.11.1 COMPANY SNAPSHOT 228
17.11.2 REVENUE 228
17.11.3 PRODUCT PORTFOLIO 229
17.11.4 RECENT DEVELOPMENT 229
17.12 BAUSCH HEALTH COMPANIES INC. 230
17.12.1 COMPANY SNAPSHOT 230
17.12.2 REVENUE ANALYSIS 230
17.12.3 PRODUCT PORTFOLIO 231
17.13 BOEHRINGER INGELHEIM INTERNATIONAL GMBH 232
17.13.1 COMPANY SNAPSHOT 232
17.13.2 REVENUE ANALYSIS 233
17.13.3 PRODUCT PORTFOLIO 233
17.13.4 RECENT DEVELOPMENTS 234
17.14 CREDENCE MEDSYSTEMS, INC. 235
17.14.1 COMPANY SNAPSHOT 235
17.14.2 PRODUCT PORTFOLIO 235
17.14.3 RECENT DEVELOPMENT 237
17.15 DALI MEDICAL DEVICES 238
17.15.1 COMPANY SN.APSHOT 238
17.15.2 PRODUCT PORTFOLIO 238
17.15.3 RECENT DEVELOPMENT 241
17.16 ENABLE INJECTIONS 242
17.16.1 COMPANY SNAPSHOT 242
17.16.2 PRODUCT PORTFOLIO 242
17.16.3 RECENT DEVELOPMENTS 243
17.17 E3D ELCAM DRUG DELIVERY DEVICES 245
17.17.1 COMPANY SNAPSHOT 245
17.17.2 PRODUCT PORTFOLIO 245
17.17.3 RECENT DEVELOPMENT 247
17.18 F. HOFFMANN-LA ROCHE LTD 248
17.18.1 COMPANY SNAPSHOT 248
17.18.2 REVENUE ANALYSIS 248
17.18.3 PRODUCT PORTFOLIO 249
17.18.4 RECENT DEVELOPMENT 249
17.19 GSK PLC 250
17.19.1 COMPANY SNAPSHOT 250
17.19.2 REVENUE ANALYSIS 250
17.19.3 PRODUCT PORTFOLIO 251
17.19.4 RECENT DEVELOPMENTS 251
17.20 GERRESHEIMER AG 252
17.20.1 COMPANY SNAPSHOT 252
17.20.2 REVENUE ANALYSIS 252
17.20.3 PRODUCT PORTFOLIO 253
17.20.4 RECENT DEVELOPMENTS 254
17.21 HASELMEIER 255
17.21.1 COMPANY SNAPSHOT 255
17.21.2 PRODUCT PORTFOLIO 255
17.21.3 RECENT DEVELOPMENT 257
17.22 IPSEN BIOPHARMACEUTICALS, INC. 258
17.22.1 COMPANY SNAPSHOT 258
17.22.2 REVENUE ANALYSIS 259
17.22.3 PRODUCT PORTFOLIO 259
17.22.4 RECENT DEVELOPMENT 259
17.23 LILLY 260
17.23.1 COMPANY SNAPSHOT 260
17.23.2 REVENUE ANALYSIS 260
17.23.3 PRODUCT PORTFOLIO 261
17.23.4 RECENT DEVELOPMENT 261
17.24 MIDAS PHARMA GMBH 262
17.24.1 COMPANY SNAPSHOT 262
17.24.2 PRODUCT PORTFOLIO 262
17.24.3 RECENT DEVELOPMENT 262
17.25 MERCK & CO., INC., 263
17.25.1 COMPANY SNAPSHOT 263
17.25.2 REVENUE ANALYSIS 263
17.25.3 PRODUCT PORTFOLIO 264
17.25.4 RECENT DEVELOPMENT 264
17.26 NOVARTIS AG 265
17.26.1 COMPANY SNAPSHOT 265
17.26.2 REVENUE ANALYSIS 266
17.26.3 PRODUCT PORTFOLIO 266
17.26.4 RECENT DEVELOPMENTS 266
17.27 NEMERA 268
17.27.1 COMPANY SNAPSHOT 268
17.27.2 PRODUCT PORTFOLIO 268
17.27.3 RECENT DEVELOPMENT 270
17.28 OVAL MEDICAL TECHNOLOGIES LTD. (SMC LIMITED) 271
17.28.1 COMPANY SNAPSHOT 271
17.28.2 PRODUCT PORTFOLIO 271
17.28.3 RECENT DEVELOPMENT 272
17.29 OWEN MUMFORD 273
17.29.1 COMPANY SNAPSHOT 273
17.29.2 PRODUCT PORTFOLIO 273
17.29.3 RECENT DEVELOPMENT 273
17.30 PFIZER INC. 274
17.30.1 COMPANY SNAPSHOT 274
17.30.2 REVENUE ANALYSIS 274
17.30.3 PRODUCT PORTFOLIO 275
17.30.4 RECENT DEVELOPMENT 275
17.30.5 RECENT DEVELOPMENT 275
17.31 PHILIP MEDSIZE 276
17.31.1 COMPANY SNAPSHOT 276
17.31.2 PRODUCT PORTFOLIO 276
17.31.3 RECENT DEVELOPMENTS 277
17.32 PHARMAJET. 278
17.32.1 COMPANY SNAPSHOT 278
17.32.2 PRODUCT PORTFOLIO 278
17.32.3 RECENT DEVELOPMENT 278
17.33 PENJET 279
17.33.1 COMPANY SNAPSHOT 279
17.33.2 1.1.4 PRODUCT PORTFOLIO 279
17.33.3 RECENT DEVELOPMENT 279
17.34 RECIPHARM AB 280
17.34.1 COMPANY SNAPSHOT 280
17.34.2 PRODUCT PORTFOLIO 280
17.34.3 RECENT DEVELOPMENTS 281
17.35 SCHOTT PHARMA 282
17.35.1 COMPANY SNAPSHOT 282
17.35.2 PRODUCT PORTFOLIO 282
17.35.3 RECENT DEVELOPMENTS 283
17.36 SHL MEDICAL AG 284
17.36.1 COMPANY SNAPSHOT 284
17.36.2 PRODUCT PORTFOLIO 284
17.36.3 RECENT DEVELOPMENT 285
17.37 SOCIETE INDUSTRIELLE DE SONCEBOZ SA 286
17.37.1 COMPANY SNAPSHOT 286
17.37.2 PRODUCT PORTFOLIO 286
17.37.3 RECENT DEVELOPMENT 286
17.38 TERUMO CORPORATION 287
17.38.1 COMPANY SNAPSHOT 287
17.38.2 REVENUE ANALYSIS 287
17.38.3 PRODUCT PORTFOLIO 288
17.38.4 RECENT DEVELOPMENT 288
17.39 TAKEDA PHARMACEUTICAL COMPANY LIMITED 290
17.39.1 COMPANY SNAPSHOT 290
17.39.2 REVENUE ANALYSIS 291
17.39.3 PRODUCT PORTFOLIO 291
17.39.4 RECENT DEVELOPMENT 291
17.40 TEVA PHARMACEUTICALS 292
17.40.1 COMPANY SNAPSHOT 292
17.40.2 REVENUE 292
17.40.3 PRODUCT PORTFOLIO 293
17.40.4 RECENT DEVELOPMENT 293
17.41 UCB PHARMA 294
17.41.1 COMPANY SNAPSHOT 294
17.41.2 REVENUE 294
17.41.3 PRODUCT PORTFOLIO 295
17.41.4 RECENT DEVELOPMENT 295
17.42 WEST PHARMACEUTICAL SERVICES 296
17.42.1 COMPANY SNAPSHOT 296
17.42.2 REVENUE ANALYSIS 296
17.42.3 PRODUCT PORTFOLIO 297
17.42.4 RECENT DEVELOPMENTS 298
18 QUESTIONNAIRE 299
19 RELATED REPORTS 302
17.30.1 COMPANY SNAPSHOT 274
17.30.2 REVENUE ANALYSIS 274
17.30.3 PRODUCT PORTFOLIO 275
17.30.4 RECENT DEVELOPMENT 275
17.30.5 RECENT DEVELOPMENT 275
17.31 PHILIP MEDSIZE 276
17.31.1 COMPANY SNAPSHOT 276
17.31.2 PRODUCT PORTFOLIO 276
17.31.3 RECENT DEVELOPMENTS 277
17.32 PHARMAJET. 278
17.32.1 COMPANY SNAPSHOT 278
17.32.2 PRODUCT PORTFOLIO 278
17.32.3 RECENT DEVELOPMENT 278
17.33 PENJET 279
17.33.1 COMPANY SNAPSHOT 279
17.33.2 1.1.4 PRODUCT PORTFOLIO 279
17.33.3 RECENT DEVELOPMENT 279
17.34 RECIPHARM AB 280
17.34.1 COMPANY SNAPSHOT 280
17.34.2 PRODUCT PORTFOLIO 280
17.34.3 RECENT DEVELOPMENTS 281
17.35 SCHOTT PHARMA 282
17.35.1 COMPANY SNAPSHOT 282
17.35.2 PRODUCT PORTFOLIO 282
17.35.3 RECENT DEVELOPMENTS 283
17.36 SHL MEDICAL AG 284
17.36.1 COMPANY SNAPSHOT 284
17.36.2 PRODUCT PORTFOLIO 284
17.36.3 RECENT DEVELOPMENT 285
17.37 SOCIETE INDUSTRIELLE DE SONCEBOZ SA 286
17.37.1 COMPANY SNAPSHOT 286
17.37.2 PRODUCT PORTFOLIO 286
17.37.3 RECENT DEVELOPMENT 286
17.38 TERUMO CORPORATION 287
17.38.1 COMPANY SNAPSHOT 287
17.38.2 REVENUE ANALYSIS 287
17.38.3 PRODUCT PORTFOLIO 288
17.38.4 RECENT DEVELOPMENT 288
17.39 TAKEDA PHARMACEUTICAL COMPANY LIMITED 290
17.39.1 COMPANY SNAPSHOT 290
17.39.2 REVENUE ANALYSIS 291
17.39.3 PRODUCT PORTFOLIO 291
17.39.4 RECENT DEVELOPMENT 291
17.40 TEVA PHARMACEUTICALS 292
17.40.1 COMPANY SNAPSHOT 292
17.40.2 REVENUE 292
17.40.3 PRODUCT PORTFOLIO 293
17.40.4 RECENT DEVELOPMENT 293
17.41 UCB PHARMA 294
17.41.1 COMPANY SNAPSHOT 294
17.41.2 REVENUE 294
17.41.3 PRODUCT PORTFOLIO 295
17.41.4 RECENT DEVELOPMENT 295
17.42 WEST PHARMACEUTICAL SERVICES 296
17.42.1 COMPANY SNAPSHOT 296
17.42.2 REVENUE ANALYSIS 296
17.42.3 PRODUCT PORTFOLIO 297
17.42.4 RECENT DEVELOPMENTS 298
18 QUESTIONNAIRE 299
19 RELATED REPORTS 302
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