Summary

North America blood plasma & plasma derived medicinal Products market is expected to reach USD 31.93 billion by 2032 from USD 17.70 thousand in 2024, growing at a CAGR of 7.70% during the forecast period of 2025 to 2032.

Market Segmentation:
North America Blood Plasma & Plasma Derived Medicinal Products Market, By Product (Immunoglobulins, Coagulation Factors (For Bleeding Disorders), Albumin (Plasma Volume Expander), Protease Inhibitors (For Genetic Deficiencies), Monoclonal Antibodies (Derived From Plasma Cells), and Other Plasma Derived Proteins), Application (Immunology, Hematology, Critical Care, Neurology, Pulmonology, Haemato-Oncology, Rheumatology, and Other Applications), Processing Technology (Ion Exchange Chromatography, Affinity Chromatography, Cryoprecipitation, Ultrafiltration, and Microfiltration), Mode (Modern and Traditional Plasma Fractionation), End-User (Hospitals & Clinics, Research Labs, Academic Institutes, and Others), Distribution Channel (Direct Tender, Third Party Distributors, and Others), Country (U.S., Canada, Mexico, Germany, France, U.K., Italy, Spain, Russia, Turkey, Netherlands, Switzerland, Poland, Denmark, Sweden, Belgium, Ireland, Norway, Finland, Rest of Europe, China, Japan, South Korea, Australia, India, Malaysia, Thailand, Singapore, Philippines, Indonesia, New Zealand, Vietnam, Taiwan, Rest of Asia-Pacific, Brazil, Argentina, Columbia, Chile, Peru, Rest of South America, South Africa, Saudi Arabia, U.A.E., Israel, Egypt, Bahrain, Kuwait, Oman, Qatar, and Rest of Middle East and Africa) - Industry Trends and Forecast to 2032
Overview of the North America Blood Plasma & Plasma Derived Medicinal Market Dynamics:
Drivers
• Rising prevalence of rare and chronic diseases
• Expanding geriatric population
Restraints
• High cost and complex manufacturing process
• Lack of plasma supply and donor
Opportunities
• Advancements in plasma processing technologies to enhance yield and reduce costs
• Reimbursement frameworks and increased governmental focus on rare disease treatment
Market Players:
The key players operating in the North America blood plasma & plasma derived medicinal products market are:
• CSL
• Takeda Pharmaceutical Company Limited
• Grifols, S.A.
• Octapharma AG
• Kedrion
• ADMA Biologics, Inc
• Biotest AG
• Fresenius Kabi AG
• GC Biopharma corporate
• Intas Pharmaceuticals Ltd.
• Kamada Pharmaceuticals
• KM Biologics
• LFB
• Proliant Health & Biologicals
• Promea
• Reliance Life Sciences
• SK Plasma
• Synthaverse S. A.

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Table of Contents

TABLE OF CONTENTS
1 INTRODUCTION 88
1.1 OBJECTIVES OF THE STUDY 88
1.2 MARKET DEFINITION 88
1.3 OVERVIEW OF THE NORTH AMERICA BLOOD PLASMA & PLASMA DERIVED MEDICINAL PRODUCTS MARKET 88
1.4 LIMITATIONS 90
1.5 MARKETS COVERED 91
2 MARKET SEGMENTATION 94
2.1 MARKETS COVERED 94
2.2 GEOGRAPHICAL SCOPE 95
2.3 YEARS CONSIDERED FOR THE STUDY 96
2.4 CURRENCY AND PRICING 96
2.5 DBMR TRIPOD DATA VALIDATION MODEL 97
2.6 MULTIVARIATE MODELLING 100
2.7 PRODUCT LIFELINE CURVE 100
2.8 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS 101
2.9 DBMR MARKET POSITION GRID 102
2.10 MARKET END USER COVERAGE GRID 103
2.11 VENDOR SHARE ANALYSIS 104
2.12 SECONDARY SOURCES 105
2.13 ASSUMPTIONS 105
3 EXECUTIVE SUMMARY 106
4 PREMIUM INSIGHTS 111
4.1 PESTLE ANALYSIS 112
4.1.1 POLITICAL FACTORS 112
4.1.2 ECONOMIC FACTORS 112
4.1.3 SOCIAL FACTORS 112
4.1.4 TECHNOLOGICAL FACTORS 113
4.1.5 ENVIRONMENTAL FACTORS 113
4.1.6 LEGAL FACTORS 113
4.2 PORTER’S FIVE FORCES 114
4.2.1 THREAT OF NEW ENTRANTS 114
4.2.2 BARGAINING POWER OF SUPPLIERS 114
4.2.3 BARGAINING POWER OF BUYERS 115
4.2.4 THREAT OF SUBSTITUTES 115
4.2.5 INDUSTRY RIVALRY 115
4.3 SUPPLY CHAIN IMPACT ON THE NORTH AMERICA BLOOD PLASMA & PLASMA DERIVED MEDICINAL PRODUCTS MARKET 116
4.3.1 OVERVIEW 116
4.3.2 RAW MATERIAL AVAILABILITY 116
4.3.3 MANUFACTURING CAPACITY 116
4.3.4 LOGISTICS AND LAST-MILE HURDLES 116
4.3.5 PRICING MODELS AND MARKET POSITIONING 117
4.4 INNOVATION STRATEGIES 118
4.4.1 KEY INNOVATION STRATEGIES 118
4.4.2 EMERGING DELIVERY TECHNIQUES 119
4.4.3 STRATEGIC IMPLICATIONS 119
4.4.4 CONCLUSION 119
4.5 RISK AND MITIGATION 120
4.6 VENDOR SELECTION DYNAMICS 122
4.6.1 PRODUCT QUALITY AND REGULATORY COMPLIANCE 122
4.6.2 SUPPLY CHAIN CAPABILITIES AND RELIABILITY 122
4.6.3 CLINICAL EFFICACY AND INNOVATION 122
4.6.4 COST COMPETITIVENESS AND REIMBURSEMENT COMPATIBILITY 122
4.6.5 LOCAL MARKET PRESENCE AND SUPPORT INFRASTRUCTURE 122
4.6.6 ETHICAL SOURCING, ESG COMPLIANCE, AND TRANSPARENCY 123
4.6.7 CONCLUSION 123
4.7 TARIFFS AND THEIR IMPACT ON MARKET 124
4.7.1 CURRENT TARIFF RATES IN TOP-5 COUNTRY MARKETS 124
4.7.2 OUTLOOK: LOCAL PRODUCTION V/S IMPORT RELIANCE 124
4.7.3 VENDOR SELECTION CRITERIA DYNAMICS 124
4.7.4 IMPACT ON SUPPLY CHAIN 125
4.7.5 IMPACT ON PRICES 125
4.7.6 REGULATORY INCLINATION 125
4.7.6.1 GCC TRADE ALIGNMENT & FTAS 125
4.7.6.2 SPECIAL ZONES AND RE-EXPORT MODELS 125
4.7.6.3 LOCAL SUBSIDY & POLICY RESPONSE 125
4.7.6.4 DOMESTIC COURSE OF CORRECTION 125
5 REGULATION COVERAGE 127
6 MARKET OVERVIEW 130
6.1 DRIVERS 132
6.1.1 RISING PREVALENCE OF RARE AND CHRONIC DISEASES 132
6.1.2 EXPANDING GERIATRIC POPULATION 132
6.1.3 TECHNOLOGICAL ADVANCEMENTS IN PLASMA FRACTIONATION 133
6.1.4 GOVERNMENT AND INSTITUTIONAL SUPPORT 134
6.2 RESTRAINTS 135
6.2.1 HIGH COST AND COMPLEX MANUFACTURING PROCESS 135
6.2.2 LACK OF PLASMA SUPPLY AND DONOR 135
6.3 OPPORTUNITIES 136
6.3.1 ADVANCEMENTS IN PLASMA PROCESSING TECHNOLOGIES TO ENHANCE YIELD AND REDUCE COSTS 136
6.3.2 REIMBURSEMENT FRAMEWORKS AND INCREASED GOVERNMENTAL FOCUS ON RARE DISEASE TREATMENT 137
6.3.3 STRATEGIC ALLIANCES, MERGERS, AND ACQUISITIONS TO STRENGTHEN NORTH AMERICA MARKET PENETRATION 138
6.4 CHALLENGES 139
6.4.1 COMPETITIVE PRESSURE FROM RECOMBINANT AND ALTERNATIVE BIOLOGICAL THERAPIES 139
6.4.2 INFRASTRUCTURE LIMITATIONS IN COLD CHAIN LOGISTICS IMPACTING PRODUCT DISTRIBUTION 139
7 NORTH AMERICA BLOOD PLASMA & PLASMA DERIVED MEDICINAL PRODUCTS MARKET, BY PRODUCT 141
7.1 OVERVIEW 142
7.2 IMMUNOGLOBULINS 145
7.3 COAGULATION FACTORS (FOR BLEEDING DISORDERS) 147
7.4 ALBUMIN (PLASMA VOLUME EXPANDER) 152
7.5 PROTEASE INHIBITORS (FOR GENETIC DEFICIENCIES) 153
7.6 MONOCLONAL ANTIBODIES (DERIVED FROM PLASMA CELLS) 155
7.7 OTHER PLASMA DERIVED PROTEINS 156
8 NORTH AMERICA BLOOD PLASMA & PLASMA DERIVED MEDICINAL PRODUCTS MARKET, BY APPLICATION 158
8.1 OVERVIEW 159
8.2 IMMUNOLOGY 162
8.3 HEMATOLOGY 162
8.4 CRITICAL CARE 163
8.5 NEUROLOGY 163
8.6 PULMONOLOGY 164
8.7 HAEMATO-ONCOLOGY 164
8.8 RHEUMATOLOGY 165
8.9 OTHER APPLICATIONS 165
9 NORTH AMERICA BLOOD PLASMA & PLASMA DERIVED MEDICINAL PRODUCTS MARKET, BY TECHNOLOGY 166
9.1 OVERVIEW 167
9.2 ION EXCHANGE CHROMATOGRAPHY 170
9.3 AFFINITY CHROMATOGRAPHY 170
9.4 CRYOPRECIPITATION 171
9.5 ULTRAFILTRATION 171
9.6 MICROFILTRATION 172
10 NORTH AMERICA BLOOD PLASMA & PLASMA DERIVED MEDICINAL PRODUCTS MARKET, BY MODE 173
10.1 OVERVIEW 174
10.2 MODERN 177
10.3 TRADITIONAL PLASMA FRACTIONATION 177
11 NORTH AMERICA BLOOD PLASMA & PLASMA DERIVED MEDICINAL PRODUCTS MARKET, BY END USER 178
11.1 OVERVIEW 179
11.2 HOSPITALS & CLINICS 182
11.3 RESEARCH LABS 182
11.4 ACADEMIC INSTITUTES 183
11.5 OTHERS 183
12 NORTH AMERICA BLOOD PLASMA & PLASMA DERIVED MEDICINAL PRODUCTS MARKET, BY DISTRIBUTION CHANNEL 184
12.1 OVERVIEW 185
12.2 DIRECT TENDERS 188
12.3 THIRD PARTY DISTRIBUTORS 188
12.4 OTHERS 189
13 NORTH AMERICA BLOOD PLASMA & PLASMA DERIVED MEDICINAL PRODUCTS MARKET, BY REGION 190
13.1 NORTH AMERICA 192
13.1.1 U.S 202
13.1.2 CANADA 212
13.1.3 MEXICO 222
14 NORTH AMERICA BLOOD PLASMA & PLASMA DERIVED MEDICINAL PRODUCTS MARKET, COMPANY LANDSCAPE 232
14.1 COMPANY SHARE ANALYSIS: NORTH AMERICA 232
15 SWOT ANALYSIS 233
16 COMPANY PROFILE 234
16.1 CSL 234
16.1.1 COMPANY SNAPSHOT 234
16.1.2 REVENUE ANALYSIS 234
16.1.3 COMPANY SHARE ANALYSIS 235
16.1.4 PRODUCT PORTFOLIO 235
16.1.5 RECENT DEVELOPMENTS 236
16.2 TAKEDA PHARMACEUTICAL COMPANY LIMITED 237
16.2.1 COMPANY SNAPSHOT 237
16.2.2 REVENUE ANALYSIS 238
16.2.3 COMPANY SHARE ANALYSIS 238
16.2.4 PRODUCT PORTFOLIO 239
16.2.5 RECENT DEVELOPMENTS 239
16.3 GRIFOLS, S.A. 240
16.3.1 COMPANY SNAPSHOT 240
16.3.2 REVENUE ANALYSIS 240
16.3.3 COMPANY SHARE ANALYSIS 241
16.3.4 PRODUCT PORTFOLIO 241
16.3.5 RECENT DEVELOPMENTS 243
16.4 OCTAPHARMA AG 244
16.4.1 COMPANY SNAPSHOT 244
16.4.2 COMPANY SHARE ANALYSIS 244
16.4.3 PRODUCT PORTFOLIO 245
16.4.4 RECENT DEVELOPMENTS 247
16.5 KEDRION 248
16.5.1 COMPANY SNAPSHOT 248
16.5.2 COMPANY SHARE ANALYSIS 248
16.5.3 PRODUCT PORTFOLIO 249
16.5.4 RECENT DEVELOPMENT 249
16.6 ADMA BIOLOGICS, INC 250
16.6.1 COMPANY SNAPSHOT 250
16.6.2 REVENUE ANALYSIS 250
16.6.3 PRODUCT PORTFOLIO 251
16.6.4 RECENT DEVELOPMENT 251
16.7 AEGROS 252
16.7.1 COMPANY SNAPSHOT 252
16.7.2 PRODUCT PORTFOLIO 252
16.7.3 RECENT DEVELOPMENT 252
16.8 BHARAT SERUMS 253
16.8.1 COMPANY SNAPSHOT 253
16.8.2 PRODUCT PORTFOLIO 253
16.8.3 RECENT DEVELOPMENT 253
16.9 BIOTEST AG. 254
16.9.1 COMPANY SNAPSHOT 254
16.9.2 REVENUE ANALYSIS 254
16.9.3 PRODUCT PORTFOLIO 255
16.9.4 RECENT DEVELOPMENTS 257
16.10 FRESENIUS KABI AG 258
16.10.1 COMPANY SNAPSHOT 258
16.10.2 PRODUCT PORTFOLIO 258
16.10.3 RECENT DEVELOPMENT 258
16.11 GC BIOPHARMA CORPORATE 259
16.11.1 COMPANY SNAPSHOT 259
16.11.2 REVENUE ANALYSIS 259
16.11.3 PRODUCT PORTFOLIO 260
16.11.4 RECENT DEVELOPMENT 261
16.12 ICHOR 262
16.12.1 COMPANY SNAPSHOT 262
16.12.2 PRODUCT PORTFOLIO 262
16.12.3 RECENT DEVELOPMENT 266
16.13 INTAS PHARMACEUTICALS LTD. 267
16.13.1 COMPANY SNAPSHOT 267
16.13.2 PRODUCT PORTFOLIO 267
16.13.3 RECENT DEVELOPMENT 267
16.14 KAMADA PHARMACEUTICALS 268
16.14.1 COMPANY SNAPSHOT 268
16.14.2 REVENUE ANALYSIS 268
16.14.3 PRODUCT PORTFOLIO 269
16.14.4 RECENT DEVELOPMENT 270
16.15 KM BIOLOGICS 271
16.15.1 COMPANY SNAPSHOT 271
16.15.2 PRODUCT PORTFOLIO 271
16.15.3 RECENT DEVELOPMENT 271
16.16 LFB 272
16.16.1 COMPANY SNAPSHOT 272
16.16.2 PRODUCT PORTFOLIO 272
16.16.3 RECENT DEVELOPMENT 274
16.17 PLASMAGEN BIOSCIENCES PVT. LTD. 275
16.17.1 COMPANY SNAPSHOT 275
16.17.2 PRODUCT PORTFOLIO 275
16.17.3 RECENT DEVELOPMENTS 277
16.18 PROLIANT HEALTH & BIOLOGICALS 278
16.18.1 COMPANY SNAPSHOT 278
16.18.2 PRODUCT PORTFOLIO 278
16.18.3 RECENT DEVELOPMENT 278
16.19 PROMEA 279
16.19.1 COMPANY SNAPSHOT 279
16.19.2 PRODUCT PORTFOLIO 279
16.19.3 RECENT DEVELOPMENT 280
16.20 RELIANCE LIFE SCIENCES 281
16.20.1 COMPANY SNAPSHOT 281
16.20.2 BUSINESS PORTFOLIO 281
16.20.3 RECENT DEVELOPMENT 282
16.21 SICHUAN YUANDA SHYUANG PHARMACEUTICAL CO., LTD. 283
16.21.1 COMPANY SNAPSHOT 283
16.21.2 PRODUCT PORTFOLIO 283
16.21.3 RECENT DEVELOPMENT 284
16.22 SK PLASMA 285
16.22.1 COMPANY SNAPSHOT 285
16.22.2 PRODUCT PORTFOLIO 285
16.22.3 RECENT DEVELOPMENT 286
16.23 SYNTHAVERSE S. A. 287
16.23.1 COMPANY SNAPSHOT 287
16.23.2 REVENUE ANALYSIS 288
16.23.3 PRODUCT PORTFOLIO 288
16.23.4 RECENT DEVELOPMENTS 289
16.24 TAIBANG BIO GROUP CO., LTD 290
16.24.1 COMPANY SNAPSHOT 290
16.24.2 PRODUCT PORTFOLIO 290
16.24.3 RECENT DEVELOPMENT 290
16.25 VIRCHOW BIOTECH 291
16.25.1 COMPANY SNAPSHOT 291
16.25.2 PRODUCT PORTFOLIO 291
16.25.3 RECENT DEVELOPMENT 293
17 QUESTIONNAIRE 294
18 RELATED REPORTS 297