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report thumbnailU.S. Plasma Fractionation Market

U.S. Plasma Fractionation Market 2025-2033 Overview: Trends, Competitor Dynamics, and Opportunities

U.S. Plasma Fractionation Market by Product (Albumin, Immunoglobulin [Intravenous Immunoglobulin {IVIG}, Subcutaneous Immunoglobulin {SCIG}], Coagulation Factors [Factor IX, Factor VIII, Prothrombin Complex Concentrates, Fibrinogen Concentrates, Others], Protease Inhibitors, Others), by Application (Immunology & Neurology, Hematology, Critical Care, Pulmonology, Others), by End-user (Hospitals & Clinics, Clinical Research Laboratories, Others), by Forecast 2025-2033

Jun 21 2025

Base Year: 2024

150 Pages

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U.S. Plasma Fractionation Market 2025-2033 Overview: Trends, Competitor Dynamics, and Opportunities

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U.S. Plasma Fractionation Market 2025-2033 Overview: Trends, Competitor Dynamics, and Opportunities




Key Insights

The U.S. Plasma Fractionation Market size was valued at USD 15.64 USD Billion in 2023 and is projected to reach USD 25.95 USD Billion by 2032, exhibiting a CAGR of 7.5 % during the forecast period. Plasma fractionation is defined as the process of dividing or separating the plasma into its major elements for medicinal use. Common methods include cryoprecipitation, column chromatography, and precipitation with ethanol or other organic solvents. Some of the properties include: the ability to separate specific proteins such as albumin, immunoglobulins, and clotting factors, this helps in the purification of the protein to its highest point thus ensuring its effectiveness. Some of the example application areas include treatments for immune deficiency hemophilia and other blood disorders. In the US the market is shaped by technological innovation and a growing demand for plasma-derived products – the key market players focus on R&D investments to increase the yield and safety of plasma-derived therapies – this also indicates toward a robust growth trajectory.

U.S. Plasma Fractionation Market Research Report - Market Size, Growth & Forecast

U.S. Plasma Fractionation Trends

  • Surge in demand for treatment of neurological and immunological disorders
  • Increasing prevalence of chronic conditions requiring immunoglobulin therapy
  • Technological advancements in plasma fractionation techniques
  • Rising awareness about blood plasma products and their applications

Driving Forces: What's Propelling the U.S. Plasma Fractionation Market

  • Escalating incidence of autoimmune disorders, such as rheumatoid arthritis, lupus, and Crohn's disease
  • Surging healthcare spending on chronic disease management
  • Breakthroughs in plasma separation and purification techniques, improving product yield and quality
  • Aging population with a higher susceptibility to chronic conditions and reliance on plasma-derived therapies
  • Increased awareness of plasma donation and its therapeutic benefits
  • Growing demand for plasma-derived vaccines and immunoglobulins for infectious disease prevention and treatment
  • Government initiatives and regulations supporting the collection, processing, and distribution of plasma

Challenges and Restraints in the U.S. Plasma Fractionation Market

  • Stringent regulatory requirements for plasma collection and processing
  • High costs associated with plasma fractionation and manufacturing processes
  • Limited availability of qualified plasma donors
  • Potential for product contamination and safety concerns

Emerging Trends in U.S. Plasma Fractionation

  • Precision plasma fractionation for customized therapies
  • Artificial intelligence (AI) and machine learning (ML) in plasma analysis
  • Development of new coagulation factor concentrates
  • Emerging applications in regenerative medicine

Growth Catalysts in the U.S. Plasma Fractionation Industry

U.S. Plasma Fractionation Market Growth
  • Government support for plasma collection and research
  • Partnerships between plasma fractionators and biotech companies
  • Innovations in plasma collection techniques, such as automated plasmapheresis
  • Expansion into emerging markets with high unmet medical needs

Market Segmentation: U.S. Plasma Fractionation Analysis

Product:

  • Albumin
  • Immunoglobulin
  • Coagulation Factors
  • Protease Inhibitors
  • Others

Application:

  • Immunology & Neurology
  • Hematology
  • Critical Care
  • Pulmonology
  • Others

End-user:

  • Hospitals & Clinics
  • Clinical Research Laboratories
  • Others

Leading Players in the U.S. Plasma Fractionation Market

  • CSL Behring 
  • Grifols, S.A. 
  • Takeda Pharmaceutical Company Limited
  • Kedrion S.p.A 
  • Octapharma AG
  • Bio Products Laboratory Ltd. 

Significant Developments in the U.S. Plasma Fractionation Sector

April 2023:

  • CSL Behring received U.S. FDA clearance for a prefilled syringe, Hizentra, for treating Primary Immunodeficiency and Chronic Inflammatory Demyelinating Polyneuropathy.

April 2023:

  • Takeda Pharmaceutical Company Limited received U.S. FDA approval for extended use of Hyqvia for treating children aged 2-16 years with Primary Immunodeficiency.

August 2021:

  • Octapharma USA received seven years of market exclusivity for Octagam 10% from the U.S. FDA’s Office of Orphan Products Development.

Comprehensive Coverage U.S. Plasma Fractionation Market Report

This comprehensive report offers an in-depth analysis of the U.S. plasma fractionation market, providing critical insights for stakeholders across the industry. The report goes beyond a simple overview, delivering actionable intelligence to inform strategic decision-making.

Our analysis encompasses:

  • Market Overview and Dynamics: A detailed examination of the current market size, growth rate, and key drivers influencing the U.S. plasma fractionation market. This includes an assessment of macroeconomic factors, regulatory changes, and technological advancements impacting market performance.
  • Detailed Market Segmentation: A granular breakdown of the market by product type (e.g., albumin, immunoglobulins, coagulation factors), application (e.g., therapeutic treatment, prophylactic treatment), and end-user (e.g., hospitals, clinics, blood banks). This allows for a precise understanding of segment-specific growth trajectories and market opportunities.
  • Competitive Landscape Analysis: A thorough evaluation of the major players operating in the U.S. plasma fractionation market, including their market share, competitive strategies, and recent activities (mergers, acquisitions, product launches). This analysis also includes a SWOT assessment of key competitors.
  • Key Industry Trends and Developments: An in-depth exploration of emerging trends shaping the future of the market, such as technological innovations in plasma fractionation processes, increasing demand for plasma-derived therapies, and the evolving regulatory landscape. This includes discussion of potential disruptive technologies and their market impact.
  • Growth Opportunities and Challenges: Identification of key growth opportunities and potential challenges hindering market expansion. This section provides a realistic assessment of the market's future prospects, including an analysis of potential risks and mitigation strategies.
  • Forecasts and Projections: Accurate and reliable market forecasts and projections for the coming years, considering various growth scenarios and market dynamics. This allows stakeholders to anticipate future market trends and develop proactive strategies.

This report is an invaluable resource for industry professionals, investors, and researchers seeking a comprehensive understanding of the U.S. plasma fractionation market.

DROCT

  • Drivers: Growing demand for plasma-derived products
  • Restraints: Stringent regulatory requirements
  • Opportunities: Technological advancements and emerging applications
  • Challenges: Plasma donor shortage and product contamination concerns
  • Trends: Precision plasma fractionation and AI integration

Pricing Analysis

  • Factors influencing pricing
  • Competitive pricing strategies
  • Impact of technology and scale on pricing

Import And Export Analysis

  • Major importing and exporting countries
  • Impact of trade policies and regulations
  • Trends in global plasma trade

Segmentation

  • Product-wise segmentation
  • Application-wise segmentation
  • End-user-wise segmentation

Patent/Trademark Analysis

  • Key patents and trademarks in the U.S. plasma fractionation market
  • Analysis of the intellectual property landscape
  • Impact of patents and trademarks on market dynamics


U.S. Plasma Fractionation Market REPORT HIGHLIGHTS

AspectsDetails
Study Period 2019-2033
Base Year 2024
Estimated Year 2025
Forecast Period2025-2033
Historical Period2019-2024
Growth RateCAGR of 7.5% from 2019-2033
Segmentation
    • By Product
      • Albumin
      • Immunoglobulin [Intravenous Immunoglobulin {IVIG}
      • Subcutaneous Immunoglobulin {SCIG}]
      • Coagulation Factors [Factor IX
      • Factor VIII
      • Prothrombin Complex Concentrates
      • Fibrinogen Concentrates
      • Others]
      • Protease Inhibitors
      • Others
    • By Application
      • Immunology & Neurology
      • Hematology
      • Critical Care
      • Pulmonology
      • Others
    • By End-user
      • Hospitals & Clinics
      • Clinical Research Laboratories
      • Others
  • By Geography


Table of Contents

  1. 1. Introduction
    • 1.1. Research Scope
    • 1.2. Market Segmentation
    • 1.3. Research Methodology
    • 1.4. Definitions and Assumptions
  2. 2. Executive Summary
    • 2.1. Introduction
  3. 3. Market Dynamics
    • 3.1. Introduction
      • 3.2. Market Drivers
        • 3.2.1. Rising Occurrence of Chronic Disorders to Propel the Market Growth
      • 3.3. Market Restrains
        • 3.3.1. Availability of Recombinant Therapies to Limit the Adoption of Plasma-Derived Therapies
      • 3.4. Market Trends
        • 3.4.1. Increasing Number of Hospitals and ASCs Identified as Significant Market Trend
  4. 4. Market Factor Analysis
    • 4.1. Porters Five Forces
    • 4.2. Supply/Value Chain
    • 4.3. PESTEL analysis
    • 4.4. Market Entropy
    • 4.5. Patent/Trademark Analysis
  5. 5. U.S. Plasma Fractionation Market Analysis, Insights and Forecast, 2019-2031
    • 5.1. Market Analysis, Insights and Forecast - by Product
      • 5.1.1. Albumin
      • 5.1.2. Immunoglobulin [Intravenous Immunoglobulin {IVIG}
      • 5.1.3. Subcutaneous Immunoglobulin {SCIG}]
      • 5.1.4. Coagulation Factors [Factor IX
      • 5.1.5. Factor VIII
      • 5.1.6. Prothrombin Complex Concentrates
      • 5.1.7. Fibrinogen Concentrates
      • 5.1.8. Others]
      • 5.1.9. Protease Inhibitors
      • 5.1.10. Others
    • 5.2. Market Analysis, Insights and Forecast - by Application
      • 5.2.1. Immunology & Neurology
      • 5.2.2. Hematology
      • 5.2.3. Critical Care
      • 5.2.4. Pulmonology
      • 5.2.5. Others
    • 5.3. Market Analysis, Insights and Forecast - by End-user
      • 5.3.1. Hospitals & Clinics
      • 5.3.2. Clinical Research Laboratories
      • 5.3.3. Others
    • 5.4. Market Analysis, Insights and Forecast - by Region
      • 5.4.1.
  6. 6. Northeast U.S. Plasma Fractionation Market Analysis, Insights and Forecast, 2019-2031
    • 7. Southeast U.S. Plasma Fractionation Market Analysis, Insights and Forecast, 2019-2031
      • 8. Midwest U.S. Plasma Fractionation Market Analysis, Insights and Forecast, 2019-2031
        • 9. Southwest U.S. Plasma Fractionation Market Analysis, Insights and Forecast, 2019-2031
          • 10. West U.S. Plasma Fractionation Market Analysis, Insights and Forecast, 2019-2031
            • 11. Competitive Analysis
              • 11.1. Market Share Analysis 2024
                • 11.2. Company Profiles
                  • 11.2.1 CSL (Australia)
                    • 11.2.1.1. Overview
                    • 11.2.1.2. Products
                    • 11.2.1.3. SWOT Analysis
                    • 11.2.1.4. Recent Developments
                    • 11.2.1.5. Financials (Based on Availability)
                  • 11.2.2 Grifols S.A. (Spain)
                    • 11.2.2.1. Overview
                    • 11.2.2.2. Products
                    • 11.2.2.3. SWOT Analysis
                    • 11.2.2.4. Recent Developments
                    • 11.2.2.5. Financials (Based on Availability)
                  • 11.2.3 Takeda Pharmaceutical Company Limited (Japan)
                    • 11.2.3.1. Overview
                    • 11.2.3.2. Products
                    • 11.2.3.3. SWOT Analysis
                    • 11.2.3.4. Recent Developments
                    • 11.2.3.5. Financials (Based on Availability)
                  • 11.2.4 Kedrion S.p.A (Italy)
                    • 11.2.4.1. Overview
                    • 11.2.4.2. Products
                    • 11.2.4.3. SWOT Analysis
                    • 11.2.4.4. Recent Developments
                    • 11.2.4.5. Financials (Based on Availability)
                  • 11.2.5 Octapharma AG (Switzerland)
                    • 11.2.5.1. Overview
                    • 11.2.5.2. Products
                    • 11.2.5.3. SWOT Analysis
                    • 11.2.5.4. Recent Developments
                    • 11.2.5.5. Financials (Based on Availability)
                  • 11.2.6 Bio Products Laboratory Ltd. (U.K.)
                    • 11.2.6.1. Overview
                    • 11.2.6.2. Products
                    • 11.2.6.3. SWOT Analysis
                    • 11.2.6.4. Recent Developments
                    • 11.2.6.5. Financials (Based on Availability)
                  • 11.2.7 LFB (France)
                    • 11.2.7.1. Overview
                    • 11.2.7.2. Products
                    • 11.2.7.3. SWOT Analysis
                    • 11.2.7.4. Recent Developments
                    • 11.2.7.5. Financials (Based on Availability)

            List of Figures

            1. Figure 1: U.S. Plasma Fractionation Market Revenue Breakdown (USD Billion, %) by Product 2024 & 2032
            2. Figure 2: U.S. Plasma Fractionation Market Share (%) by Company 2024

            List of Tables

            1. Table 1: U.S. Plasma Fractionation Market Revenue USD Billion Forecast, by Region 2019 & 2032
            2. Table 2: U.S. Plasma Fractionation Market Revenue USD Billion Forecast, by Product 2019 & 2032
            3. Table 3: U.S. Plasma Fractionation Market Revenue USD Billion Forecast, by Application 2019 & 2032
            4. Table 4: U.S. Plasma Fractionation Market Revenue USD Billion Forecast, by End-user 2019 & 2032
            5. Table 5: U.S. Plasma Fractionation Market Revenue USD Billion Forecast, by Region 2019 & 2032
            6. Table 6: U.S. Plasma Fractionation Market Revenue USD Billion Forecast, by Country 2019 & 2032
            7. Table 7: Northeast U.S. Plasma Fractionation Market Revenue (USD Billion) Forecast, by Application 2019 & 2032
            8. Table 8: Southeast U.S. Plasma Fractionation Market Revenue (USD Billion) Forecast, by Application 2019 & 2032
            9. Table 9: Midwest U.S. Plasma Fractionation Market Revenue (USD Billion) Forecast, by Application 2019 & 2032
            10. Table 10: Southwest U.S. Plasma Fractionation Market Revenue (USD Billion) Forecast, by Application 2019 & 2032
            11. Table 11: West U.S. Plasma Fractionation Market Revenue (USD Billion) Forecast, by Application 2019 & 2032
            12. Table 12: U.S. Plasma Fractionation Market Revenue USD Billion Forecast, by Product 2019 & 2032
            13. Table 13: U.S. Plasma Fractionation Market Revenue USD Billion Forecast, by Application 2019 & 2032
            14. Table 14: U.S. Plasma Fractionation Market Revenue USD Billion Forecast, by End-user 2019 & 2032
            15. Table 15: U.S. Plasma Fractionation Market Revenue USD Billion Forecast, by Country 2019 & 2032


            Methodology

            Step 1 - Identification of Relevant Samples Size from Population Database

            Step Chart
            Bar Chart
            Method Chart

            Step 2 - Approaches for Defining Global Market Size (Value, Volume* & Price*)

            Approach Chart
            Top-down and bottom-up approaches are used to validate the global market size and estimate the market size for manufactures, regional segments, product, and application.

            Note*: In applicable scenarios

            Step 3 - Data Sources

            Primary Research

            • Web Analytics
            • Survey Reports
            • Research Institute
            • Latest Research Reports
            • Opinion Leaders

            Secondary Research

            • Annual Reports
            • White Paper
            • Latest Press Release
            • Industry Association
            • Paid Database
            • Investor Presentations
            Analyst Chart

            Step 4 - Data Triangulation

            Involves using different sources of information in order to increase the validity of a study

            These sources are likely to be stakeholders in a program - participants, other researchers, program staff, other community members, and so on.

            Then we put all data in single framework & apply various statistical tools to find out the dynamic on the market.

            During the analysis stage, feedback from the stakeholder groups would be compared to determine areas of agreement as well as areas of divergence

            Additionally, after gathering mixed and scattered data from a wide range of sources, data is triangulated and correlated to come up with estimated figures which are further validated through primary mediums or industry experts, opinion leaders.

            Frequently Asked Questions

            1. What is the projected Compound Annual Growth Rate (CAGR) of the U.S. Plasma Fractionation Market?

            The projected CAGR is approximately 7.5%.

            2. Which companies are prominent players in the U.S. Plasma Fractionation Market?

            Key companies in the market include CSL (Australia), Grifols, S.A. (Spain), Takeda Pharmaceutical Company Limited (Japan), Kedrion S.p.A (Italy), Octapharma AG (Switzerland), Bio Products Laboratory Ltd. (U.K.), LFB (France).

            3. What are the main segments of the U.S. Plasma Fractionation Market?

            The market segments include Product, Application, End-user.

            4. Can you provide details about the market size?

            The market size is estimated to be USD 15.64 USD Billion as of 2022.

            5. What are some drivers contributing to market growth?

            Rising Occurrence of Chronic Disorders to Propel the Market Growth.

            6. What are the notable trends driving market growth?

            Increasing Number of Hospitals and ASCs Identified as Significant Market Trend.

            7. Are there any restraints impacting market growth?

            Availability of Recombinant Therapies to Limit the Adoption of Plasma-Derived Therapies.

            8. Can you provide examples of recent developments in the market?

            April 2023- CSL Behring received the U.S. FDA clearance for a prefilled syringe, Hizentra, a subcutaneous immunoglobulin (Human) intended for treating people suffering from Primary Immunodeficiency (PI) or Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

            9. What pricing options are available for accessing the report?

            Pricing options include single-user, multi-user, and enterprise licenses priced at USD 2850, USD 3850, and USD 4850 respectively.

            10. Is the market size provided in terms of value or volume?

            The market size is provided in terms of value, measured in USD Billion.

            11. Are there any specific market keywords associated with the report?

            Yes, the market keyword associated with the report is "U.S. Plasma Fractionation Market," which aids in identifying and referencing the specific market segment covered.

            12. How do I determine which pricing option suits my needs best?

            The pricing options vary based on user requirements and access needs. Individual users may opt for single-user licenses, while businesses requiring broader access may choose multi-user or enterprise licenses for cost-effective access to the report.

            13. Are there any additional resources or data provided in the U.S. Plasma Fractionation Market report?

            While the report offers comprehensive insights, it's advisable to review the specific contents or supplementary materials provided to ascertain if additional resources or data are available.

            14. How can I stay updated on further developments or reports in the U.S. Plasma Fractionation Market?

            To stay informed about further developments, trends, and reports in the U.S. Plasma Fractionation Market, consider subscribing to industry newsletters, following relevant companies and organizations, or regularly checking reputable industry news sources and publications.

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