혈장 분획 시장 규모, 점유율, 성장 - 업계 분석, 지역별 동향 및 예측(2026-2034년)

Growth Factors of plasma fractionation Market

The global plasma fractionation market size was valued at USD 40.27 billion in 2025. The market is projected to grow from USD 43.55 billion in 2026 to USD 87.23 billion by 2034, exhibiting a CAGR of 9.1% during 2026-2034. North America dominated the global market with a 56.22% share in 2025, supported by strong plasma collection infrastructure, high use of immunoglobulin therapies, and well-established treatment access for rare and immune disorders.

Plasma fractionation separates human plasma into therapeutic proteins such as immunoglobulins, albumin, coagulation factors, and protease inhibitors. These products are essential for treating immune deficiencies, neurological disorders, bleeding conditions, metabolic deficiencies, and critical-care needs. Rising diagnosis rates and increasing demand for long-term plasma-derived therapies are supporting market growth.

Plasma Fractionation Market Trends

A major market trend is the growing focus on national plasma self-sufficiency. Governments and healthcare systems are working to reduce dependence on imported plasma-derived medicines by strengthening domestic collection and fractionation capabilities.

In June 2024, Takeda announced a USD 230 million investment to expand plasma-derived therapy production capacity at its Los Angeles manufacturing site, supporting greater availability of treatments for rare, chronic, and genetic diseases.

Market Drivers

The major market driver is the rising prevalence of immune deficiencies, autoimmune disorders, neurological conditions, and rare diseases. Many patients require recurring or lifelong treatment with immunoglobulins or other plasma-derived medicines.

In June 2025, Takeda received U.S. FDA approval for GAMMAGARD LIQUID ERC for patients aged two years and older with primary immunodeficiency. Such approvals are widening treatment access and strengthening demand for plasma-derived products.

Market Restraints and Challenges

Limited plasma availability and strong dependence on human donors remain major restraints. Plasma-derived medicines require a continuous donor supply, while processing, purification, testing, viral inactivation, and regulatory release can take several months.

Manufacturing complexity is another challenge. According to data cited in the report, plasma-derived medicines can require 7-12 months to produce, making it difficult to respond quickly to sudden increases in clinical demand.

Market Opportunities

The expansion of plasma collection centers and fractionation capacity offers significant opportunities. Larger collection networks can improve supply security and reduce shortages of immunoglobulins, albumin, and coagulation factors.

In 2024, Grifols invested USD 180.6 million in a new manufacturing facility in Llica de Vall, Spain, designed to double its plasma fractionation capacity in Europe.

Segmentation Analysis

By product, the immunoglobulin segment dominated the market, supported by extensive use in primary immunodeficiency, secondary immunodeficiency, autoimmune disorders, and neurological diseases. The albumin segment is projected to grow at a 7.8% CAGR.

By application, immunology held the leading share, driven by recurring immunoglobulin replacement therapies. The hematology segment is expected to grow at a 9.1% CAGR.

By end user, hospitals & clinics dominated in 2025, as many plasma-derived therapies require physician supervision, infusion support, and clinical monitoring. Homecare settings are projected to record the fastest 10.2% CAGR.

Regional Outlook

North America dominated with a market value of USD 22.64 billion in 2025. The U.S. market is estimated to reach approximately USD 22.66 billion in 2026.

Europe is projected to reach USD 9.11 billion in 2026, with Germany at approximately USD 1.90 billion and the U.K. at USD 1.46 billion.

Asia Pacific is estimated to reach USD 8.48 billion in 2026. China is projected at USD 3.72 billion, Japan at USD 2.29 billion, and India at USD 1.03 billion.

Latin America is projected to reach USD 0.98 billion in 2026, while the GCC market is estimated at USD 0.21 billion.

Competitive Landscape

Major companies include CSL, Grifols, Takeda Pharmaceutical, Octapharma, Kedrion, LFB Group, ADMA Biologics, GC Biopharma, Beijing Tiantan Biological Products, and Shanghai RAAS Blood Products. Competition centers on plasma collection expansion, new product approvals, manufacturing capacity, portfolio diversification, and regional supply partnerships.

Key Industry Developments

In December 2025, Grifols received U.S. FDA approval for FESILTY for congenital fibrinogen deficiency. In November 2025, Baiyang Pharmaceutical collaborated with CSL Behring for promotion and distribution of selected plasma-derived products in China. In July 2024, Kedrion partnered with Portugal's IPST to fractionate locally donated plasma.

Conclusion

The plasma fractionation market is expected to grow from USD 40.27 billion in 2025 to USD 43.55 billion in 2026 and USD 87.23 billion by 2034, at a CAGR of 9.1% during 2026-2034. Growth will be driven by rising immunoglobulin demand, increasing diagnosis of rare and immune disorders, plasma self-sufficiency initiatives, and expansion of collection and manufacturing capacity. However, donor dependency, limited plasma availability, and lengthy production timelines may constrain supply. North America is expected to retain its leading position, while Europe and Asia Pacific continue expanding plasma collection and treatment access.

Segmentation By Product, Application, End User, and Region

By Product

• Albumin
• Immunoglobulin
  • Intravenous Immunoglobulin
  • Subcutaneous Immunoglobulin
• Coagulation Factors
  • Factor IX
  • Factor VIII
  • Prothrombin Complex Concentrates
  • Fibrinogen Concentrates
  • von Willebrand Factor
  • Antithrombin
  • Others
• Protease Inhibitors
  • Alpha-1 Antitrypsin
  • C1 Esterase Inhibitor
  • Others
• Others

By Application

• Immunology
• Neurology
• Hematology
• Critical Care
• Pulmonology
• Infectious Disease
• Others

By End User

• Hospitals & Clinics
• Specialty Clinics & Infusion Centers
• Homecare Settings
• Others

By Region

• North America (By Product, Application, End User, and Country)
  • U.S. (Product)
  • Canada (Product)
• Europe (By Product, Application, End User, and Country/Sub-region)
  • Germany (Product)
  • U.K. (Product)
  • France (Product)
  • Spain (Product)
  • Italy (Product)
  • Scandinavia (Product)
  • Rest of Europe (Product)
• Asia Pacific (By Product, Application, End User, and Country/Sub-region)
  • China (Product)
  • Japan (Product)
  • India (Product)
  • Australia (Product)
  • Southeast Asia (Product)
  • Rest of Asia Pacific (Product)
• Latin America (By Product, Application, End User, and Country/Sub-region)
  • Brazil (Product)
  • Mexico (Product)
  • Rest of Latin America (Product)
• Middle East & Africa (By Product, Application, End User, and Country/Sub-region)
  • GCC (Product)
  • South Africa (Product)
  • Rest of Middle East & Africa (Product)

Table of Content

1. Introduction

• 1.1. Research Scope
• 1.2. Market Segmentation
• 1.3. Research Methodology
• 1.4. Definitions and Assumptions

2. Executive Summary

3. Market Dynamics

• 3.1. Market Drivers
• 3.2. Market Restraints
• 3.3. Market Opportunities
• 3.4. Market Challenges
• 3.5. Market Trends

4. Key Insights

• 4.1. Plasma Fractionation Capacity, By Key Players
• 4.2. Number of Plasma Collection Centers, By Key Countries
• 4.3. Cost Breakdown of Plasma Fractionation, By Key Countries
• 4.4. Regional Distribution of Plasma Fractionation Throughput
• 4.5. Prevalence of Chronic Diseases (Key Indications), By Key Countries
• 4.6. Pricing Analysis, Plasma Fractionated Products, By Key Countries
• 4.7. Regulatory Scenario, By Key Countries
• 4.8. Overview : Plasma Collection Technologies
• 4.9. Pipeline Analysis, By Key Companies
• 4.10. Key Industry Developments (Mergers, Acquisitions, Partnerships, etc.)
• 4.11. Porter's Five Forces Analysis
• 4.12. PESTEL Analysis
• 4.13. Value Chain Analysis
• 4.14. Price Trend Analysis

5. Global Plasma Fractionation Market Analysis, Insights and Forecast, 2021-2034

• 5.1. Market Analysis, Insights and Forecast - By Product
  • 5.1.1. Albumin
  • 5.1.2. Immunoglobulin
    • 5.1.2.1. Intravenous Immunoglobulin
    • 5.1.2.2. Subcutaneous Immunoglobulin
  • 5.1.3. Coagulation Factors
    • 5.1.3.1. Factor IX
    • 5.1.3.2. Factor VIII
    • 5.1.3.3. Prothrombin Complex Concentrates
    • 5.1.3.4. Fibrinogen Concentrates
    • 5.1.3.5. von Willebrand Factor
    • 5.1.3.6. Antithrombin
    • 5.1.3.7. Others
  • 5.1.4. Protease Inhibitors
    • 5.1.4.1. Alpha-1 Antitrypsin
    • 5.1.4.2. C1 Esterase Inhibitor
    • 5.1.4.3. Others
  • 5.1.5. Others
• 5.2. Market Analysis, Insights and Forecast - By Application
  • 5.2.1. Immunology
  • 5.2.2. Neurology
  • 5.2.3. Hematology
  • 5.2.4. Critical Care
  • 5.2.5. Pulmonology
  • 5.2.6. Infectious Disease
  • 5.2.7. Others
• 5.3. Market Analysis, Insights and Forecast - By End-user
  • 5.3.1. Hospitals & Clinics
  • 5.3.2. Specialty Clinics & Infusion Centers
  • 5.3.3. Homecare Settings
  • 5.3.4. Others
• 5.4. Market Analysis, Insights and Forecast - By Region
  • 5.4.1. North America
  • 5.4.2. Europe
  • 5.4.3. Asia Pacific
  • 5.4.4. Latin America
  • 5.4.5. Middle East & Africa

6. North America Plasma Fractionation Market Analysis, Insights and Forecast, 2021-2034

• 6.1. Market Analysis, Insights and Forecast - By Product
  • 6.1.1. Albumin
  • 6.1.2. Immunoglobulin
    • 6.1.2.1. Intravenous Immunoglobulin
    • 6.1.2.2. Subcutaneous Immunoglobulin
  • 6.1.3. Coagulation Factors
    • 6.1.3.1. Factor IX
    • 6.1.3.2. Factor VIII
    • 6.1.3.3. Prothrombin Complex Concentrates
    • 6.1.3.4. Fibrinogen Concentrates
    • 6.1.3.5. von Willebrand Factor
    • 6.1.3.6. Antithrombin
    • 6.1.3.7. Others
  • 6.1.4. Protease Inhibitors
    • 6.1.4.1. Alpha-1 Antitrypsin
    • 6.1.4.2. C1 Esterase Inhibitor
    • 6.1.4.3. Others
  • 6.1.5. Others
• 6.2. Market Analysis, Insights and Forecast - By Application
  • 6.2.1. Immunology
  • 6.2.2. Neurology
  • 6.2.3. Hematology
  • 6.2.4. Critical Care
  • 6.2.5. Pulmonology
  • 6.2.6. Infectious Disease
  • 6.2.7. Others
• 6.3. Market Analysis, Insights and Forecast - By End-user
  • 6.3.1. Hospitals & Clinics
  • 6.3.2. Specialty Clinics & Infusion Centers
  • 6.3.3. Homecare Settings
  • 6.3.4. Others
• 6.4. Market Analysis, Insights and Forecast - By Country
  • 6.4.1. U.S.
    • 6.4.1.1. By Product
  • 6.4.2. Canada
    • 6.4.2.1. By Product

7. Europe Plasma Fractionation Market Analysis, Insights and Forecast, 2021-2034

• 7.1. Market Analysis, Insights and Forecast - By Product
  • 7.1.1. Albumin
  • 7.1.2. Immunoglobulin
    • 7.1.2.1. Intravenous Immunoglobulin
    • 7.1.2.2. Subcutaneous Immunoglobulin
  • 7.1.3. Coagulation Factors
    • 7.1.3.1. Factor IX
    • 7.1.3.2. Factor VIII
    • 7.1.3.3. Prothrombin Complex Concentrates
    • 7.1.3.4. Fibrinogen Concentrates
    • 7.1.3.5. von Willebrand Factor
    • 7.1.3.6. Antithrombin
    • 7.1.3.7. Others
  • 7.1.4. Protease Inhibitors
    • 7.1.4.1. Alpha-1 Antitrypsin
    • 7.1.4.2. C1 Esterase Inhibitor
    • 7.1.4.3. Others
  • 7.1.5. Others
• 7.2. Market Analysis, Insights and Forecast - By Application
  • 7.2.1. Immunology
  • 7.2.2. Neurology
  • 7.2.3. Hematology
  • 7.2.4. Critical Care
  • 7.2.5. Pulmonology
  • 7.2.6. Infectious Disease
  • 7.2.7. Others
• 7.3. Market Analysis, Insights and Forecast - By End-user
  • 7.3.1. Hospitals & Clinics
  • 7.3.2. Specialty Clinics & Infusion Centers
  • 7.3.3. Homecare Settings
  • 7.3.4. Others
• 7.4. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 7.4.1. U.K.
    • 7.4.1.1. By Product
  • 7.4.2. Germany
    • 7.4.2.1. By Product
  • 7.4.3. France
    • 7.4.3.1. By Product
  • 7.4.4. Spain
    • 7.4.4.1. By Product
  • 7.4.5. Italy
    • 7.4.5.1. By Product
  • 7.4.6. Scandinavia
    • 7.4.6.1. By Product
  • 7.4.7. Rest of Europe
    • 7.4.7.1. By Product

8. Asia Pacific Plasma Fractionation Market Analysis, Insights and Forecast, 2021-2034

• 8.1. Market Analysis, Insights and Forecast - By Product
  • 8.1.1. Albumin
  • 8.1.2. Immunoglobulin
    • 8.1.2.1. Intravenous Immunoglobulin
    • 8.1.2.2. Subcutaneous Immunoglobulin
  • 8.1.3. Coagulation Factors
    • 8.1.3.1. Factor IX
    • 8.1.3.2. Factor VIII
    • 8.1.3.3. Prothrombin Complex Concentrates
    • 8.1.3.4. Fibrinogen Concentrates
    • 8.1.3.5. von Willebrand Factor
    • 8.1.3.6. Antithrombin
    • 8.1.3.7. Others
  • 8.1.4. Protease Inhibitors
    • 8.1.4.1. Alpha-1 Antitrypsin
    • 8.1.4.2. C1 Esterase Inhibitor
    • 8.1.4.3. Others
  • 8.1.5. Others
• 8.2. Market Analysis, Insights and Forecast - By Application
  • 8.2.1. Immunology
  • 8.2.2. Neurology
  • 8.2.3. Hematology
  • 8.2.4. Critical Care
  • 8.2.5. Pulmonology
  • 8.2.6. Infectious Disease
  • 8.2.7. Others
• 8.3. Market Analysis, Insights and Forecast - By End-user
  • 8.3.1. Hospitals & Clinics
  • 8.3.2. Specialty Clinics & Infusion Centers
  • 8.3.3. Homecare Settings
  • 8.3.4. Others
• 8.4. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 8.4.1. Japan
    • 8.4.1.1. By Product
  • 8.4.2. China
    • 8.4.2.1. By Product
  • 8.4.3. India
    • 8.4.3.1. By Product
  • 8.4.4. Australia
    • 8.4.4.1. By Product
  • 8.4.5. Southeast Asia
    • 8.4.5.1. By Product
  • 8.4.6. Rest of Asia Pacific
    • 8.4.6.1. By Product

9. Latin America Plasma Fractionation Market Analysis, Insights and Forecast, 2021-2034

• 9.1. Market Analysis, Insights and Forecast - By Product
  • 9.1.1. Albumin
  • 9.1.2. Immunoglobulin
    • 9.1.2.1. Intravenous Immunoglobulin
    • 9.1.2.2. Subcutaneous Immunoglobulin
  • 9.1.3. Coagulation Factors
    • 9.1.3.1. Factor IX
    • 9.1.3.2. Factor VIII
    • 9.1.3.3. Prothrombin Complex Concentrates
    • 9.1.3.4. Fibrinogen Concentrates
    • 9.1.3.5. von Willebrand Factor
    • 9.1.3.6. Antithrombin
    • 9.1.3.7. Others
  • 9.1.4. Protease Inhibitors
    • 9.1.4.1. Alpha-1 Antitrypsin
    • 9.1.4.2. C1 Esterase Inhibitor
    • 9.1.4.3. Others
  • 9.1.5. Others
• 9.2. Market Analysis, Insights and Forecast - By Application
  • 9.2.1. Immunology
  • 9.2.2. Neurology
  • 9.2.3. Hematology
  • 9.2.4. Critical Care
  • 9.2.5. Pulmonology
  • 9.2.6. Infectious Disease
  • 9.2.7. Others
• 9.3. Market Analysis, Insights and Forecast - By End-user
  • 9.3.1. Hospitals & Clinics
  • 9.3.2. Specialty Clinics & Infusion Centers
  • 9.3.3. Homecare Settings
  • 9.3.4. Others
• 9.4. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 9.4.1. Brazil
    • 9.4.1.1. By Product
  • 9.4.2. Mexico
    • 9.4.2.1. By Product
  • 9.4.3. Rest of Latin America
    • 9.4.3.1. By Product

10. Middle East & Africa Plasma Fractionation Market Analysis, Insights and Forecast, 2021-2034

• 10.1. Market Analysis, Insights and Forecast - By Product
  • 10.1.1. Albumin
  • 10.1.2. Immunoglobulin
    • 10.1.2.1. Intravenous Immunoglobulin
    • 10.1.2.2. Subcutaneous Immunoglobulin
  • 10.1.3. Coagulation Factors
    • 10.1.3.1. Factor IX
    • 10.1.3.2. Factor VIII
    • 10.1.3.3. Prothrombin Complex Concentrates
    • 10.1.3.4. Fibrinogen Concentrates
    • 10.1.3.5. von Willebrand Factor
    • 10.1.3.6. Antithrombin
    • 10.1.3.7. Others
  • 10.1.4. Protease Inhibitors
    • 10.1.4.1. Alpha-1 Antitrypsin
    • 10.1.4.2. C1 Esterase Inhibitor
    • 10.1.4.3. Others
  • 10.1.5. Others
• 10.2. Market Analysis, Insights and Forecast - By Application
  • 10.2.1. Immunology
  • 10.2.2. Neurology
  • 10.2.3. Hematology
  • 10.2.4. Critical Care
  • 10.2.5. Pulmonology
  • 10.2.6. Infectious Disease
  • 10.2.7. Others
• 10.3. Market Analysis, Insights and Forecast - By End-user
  • 10.3.1. Hospitals & Clinics
  • 10.3.2. Specialty Clinics & Infusion Centers
  • 10.3.3. Homecare Settings
  • 10.3.4. Others
• 10.4. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 10.4.1. GCC
    • 10.4.1.1. By Product
  • 10.4.2. South Africa
    • 10.4.2.1. By Product
  • 10.4.3. Rest of Middle East & Africa
    • 10.4.3.1. By Product

11. Competitive Analysis

• 11.1. Global Market Share Analysis (2024)
• 11.2. Company Profiles
  • 11.2.1. CSL
  • 11.2.2. Grifols, S.A.
  • 11.2.3. Takeda Pharmaceutical Company Limited
  • 11.2.4. Octapharma AG
  • 11.2.5. Kedrion S.p.A.
  • 11.2.6. LFB Group
  • 11.2.7. ADMA Biologics, Inc.
  • 11.2.8. GC Biopharma corporate
  • 11.2.9. Beijing Tiantan Biological Products Co., Ltd.
  • 11.2.10. Shanghai RAAS Blood Products Co., Ltd.