Plasma Fractionation Market Analysis, Size, and Forecast 2025-2029: North America (US and Canada), Europe (France, Germany, Italy, Spain, and UK), APAC (China, India, and Japan), and Rest of World (ROW)

Plasma Fractionation Market Size 2025-2029

The plasma fractionation market size is forecast to increase by USD 15.69 billion, at a CAGR of 7.3% between 2024 and 2029.

• The market is witnessing significant growth, driven by the increasing prevalence of plasma products in the treatment of respiratory diseases and Alpha-1 Antitrypsin Deficiency (AATD). The demand for plasma fractionation is further fueled by the growing elderly population and the associated disorders. However, stringent government regulations regarding the safety of plasma-derived products pose a significant challenge to market growth. These regulations necessitate rigorous testing and adherence to stringent quality standards, increasing production costs and potentially limiting market entry for new players. Precision medicine and personalized immunotherapies are emerging trends in the field, focusing on the genetic composition of each patient to optimize treatment outcomes.
• Additionally, strategic partnerships and collaborations can help companies navigate the complex regulatory landscape and expand their market reach. Overall, the market holds immense potential for growth, with opportunities in the respiratory disorders and AATD segments, and a growing elderly population driving demand for plasma-derived products. However, companies must navigate the regulatory challenges to effectively capitalize on these opportunities and maintain a strong market position. Hematologists rely on their diagnostic skills to navigate the intricacies of the medical diagnosis process and provide patient-centric approaches to treatment.

What will be the Size of the Plasma Fractionation Market during the forecast period?

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• The market continues to evolve, driven by advancements in automation and technology. Neurological disorders, such as Alzheimer's and Parkinson's diseases, are among the therapeutic areas that significantly benefit from plasma-derived factors like alpha-1-antitrypsin. Baxter, a leading player, recently announced a 15% increase in sales of its neurology portfolio, including products like prothrombin complex and subcutaneous immunoglobulin (SCIG). The market's scale of operation varies, with mid-sized companies focusing on specific plasma-derived therapies, while large companies cater to a broader range of applications. The market's growth is also driven by the increasing use of targeted therapies, including tyrosine kinase inhibitors and Janus kinase inhibitors, and the development of personalized medicine and precision medicine approaches.
• Regulatory authorities, such as the World Health Organization (WHO) and the European Medicines Agency (EMA), play a crucial role in setting guidelines for plasma collection and diagnostics techniques, ensuring safety and efficacy. The plasma industry's growth is expected to reach double digits, with a significant portion attributed to the increasing demand for plasma fractionation technologies in critical care, rare diseases, and clinical research laboratories. For example, rheumatology and hematology applications, such as hemophilia and hematological disorders, are expected to witness substantial growth. Plasma fractionation companies are investing in R&D institutes and collaborating with biopharmaceutical manufacturers to develop recombinant factors, protease inhibitors, and other plasma-derived therapies.

How is this Plasma Fractionation Industry segmented?

The plasma fractionation industry research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD million" for the period 2025-2029, as well as historical data from 2019-2023 for the following segments.

• Product
  • Immunoglobulins
  • Albumin
  • Coagulation factor concentrates
  • Protease inhibitors
  • Others
• Application
  • Immunology
  • Neurology
  • Hematology
  • Critical care
  • Others
• Technology
  • Chromatography
  • Filtration
  • Precipitation
• Geography
  • North America
    • US
    • Canada
  • Europe
    • France
    • Germany
    • Italy
    • Spain
    • UK
  • APAC
    • China
    • India
    • Japan
  • Rest of World (ROW)

By Product Insights

The Immunoglobulins segment is estimated to witness significant growth during the forecast period. Immunoglobulins, also known as antibodies, play a significant role in the immune system to body defense against infections and diseases in the global plasma fractionation market. Plasma fractionation is the process of separating plasma into its various components, including immunoglobulins, albumin, clotting factors, and other proteins. The market encompasses the production and utilization of immunoglobulins, derived from plasma fractionation. This process separates plasma into components, including immunoglobulins, albumin, clotting factors, and proteins. Immunoglobulins, specifically intravenous immunoglobulin (IVIG) and subcutaneous immunoglobulin (SCIG), are crucial therapeutic products in the healthcare sector. Currently, the market for these immunoglobulins experiences significant demand, with a 21.7% share attributed to IVIG and 7.8% to SCIG in 2020.

Immunoglobulins, particularly intravenous immunoglobulin (IVIG) and subcutaneous immunoglobulin (SCIG), have been essential therapeutic products derived from plasma fractionation. Furthermore, immunoglobulins are used to treat primary immunodeficiency disorders such as Human Immunodeficiency Virus (HIV), autoimmune disease, and cancers, where the immune system is unable to produce sufficient antibodies. IVIG and SCIG provide patients with a regular supply of immunoglobulins to help fight infections. Immunoglobulins are also used in the treatment of various autoimmune disorders, such as autoimmune hemolytic anemia, immune thrombocytopenia, and Guillain-Barre syndrome. Autoimmune diseases, such as Chron's disease, inflammatory bowel disease, and arthritis, frequently necessitate their use. Immunosuppressants function by preventing a hyper-immune response in patients, shielding transplanted organs from destruction and safeguarding other body components.

Immunoglobulins are integral to treating various conditions, such as primary immunodeficiency disorders, HIV, autoimmune diseases, and cancers, where the immune system fails to produce adequate antibodies. These therapeutics provide patients with a vital source of immunoglobulins to combat infections. Plasma fractionation technologies have been instrumental in addressing various therapeutic areas, including hemato-oncology, rheumatology, neurology, immunology, rare hematology, critical care, and pulmonology.

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The Immunoglobulins segment was valued at USD 15.36 billion in 2019 and showed a gradual increase during the forecast period.

Immunoglobulins are also used in the treatment of various autoimmune disorders, such as autoimmune hemolytic anemia, immune thrombocytopenia, and Guillain-Barre syndrome. In June 2024, Grifols announced that its subsidiary, Biotest, received FDA approval for its intravenous immunoglobulin therapeutic, Yimmugo, for treating primary immunodeficiencies. Moreover, the rising prevalence of immunodeficiency and autoimmune disorders globally has contributed to an increased demand for immunoglobulin products. This growing patient pool has driven the production and market growth of immunoglobulins. Plasma therapeutics, a segment of the healthcare industry, is experiencing significant growth due to the increasing demand for plasma-derived proteins, particularly human immunoglobulin (HIg).

The Plasma Fractionation Market plays a vital role in the production of life-saving therapies for a range of conditions including Hepatic diseases, Bleeding disorders, and Immunological disorders. Advanced Diagnostic techniques such as CT scanning assist in the early detection of Hepatic disorders and guide appropriate treatment. Specialized products like Kovaltry are essential for managing Von Willebrand (VWD) Disease and Factor IX deficiencies, aligning with WHO guidelines for patient care. Key stakeholders include Academic institutes, In-house manufacturers, Contract service providers, and Small companies, all contributing to the evolving Plasma fractionation market landscape. Therapeutic areas extend to Hemato-oncology and Pulmonology, supported by innovations in Plasma derived therapies. The availability of Blood plasma through regulated Plasma donations is crucial for maintaining a steady Raw material supply.

Regional Analysis

North America is estimated to contribute 35% to the growth of the global market during the forecast period.Technavio's analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.

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The market in North America is experiencing moderate growth, with significant contributions from the US, Canada, and Mexico. This growth is attributed to the rise in surgical procedures, increasing number of blood donors, and the prevalence of various types of cancer. The market's expansion is further fueled by increasing demand from end-users, including governments and NGOs. According to industry reports, the market is projected to grow by 15% by 2025. The established plasma collection centers and a culture of voluntary plasma donation in these countries ensure a consistent and sufficient supply for fractionation. Plasma fractionators operate within specialized Plasma therapy manufacturing facility setups, ensuring quality and compliance. The market relies on a combination of large and niche players to meet global demand. Facilities dedicated to Plasma therapy manufacturing facility production are strategically positioned to handle diverse patient needs.

Plasma collection centers and hospitals & clinics are essential partners in the plasma industry's value chain, ensuring a steady supply of raw materials. Ethanol fractionation and plasmapheresis are the primary plasma fractionation technologies used to extract various plasma components, including albumins, fibrinogen, factor VIII, and anticoagulant factors. Despite the challenges, such as blood-borne pathogens and regulatory compliance, the plasma industry's future looks promising, with CDMOs and raw material suppliers playing a pivotal role in ensuring a consistent supply of high-quality raw materials and services. Plasma facilities are being established in various regions to cater to the increasing demand for plasma-derived therapies, including those for lung diseases like emphysema and respiratory diseases. Immunotherapy, including cancer immunotherapy, has emerged as a significant area of focus in the market.

Market Dynamics

Our researchers analyzed the data with 2024 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage. The Plasma Fractionation Market is experiencing significant growth due to rising demand for therapeutic proteins, advanced plasma protein fractionation methods, and innovations in blood fractionation technology. The core of the industry relies on the cryoprecipitation process for extracting key plasma components, followed by albumin purification, immunoglobulin separation, and coagulation factor isolation. Advanced chromatographic techniques such as affinity chromatography, ion-exchange chromatography, and size exclusion chromatography are widely adopted to improve selectivity, while robust viral inactivation methods ensure product safety.

The sector is central to biopharmaceutical production, emphasizing protein stability analysis, process efficiency improvement, and cost reduction strategies. In parallel, waste minimization strategies and enhanced plasma derivative safety ensure sustainable growth. Companies invest in purification process validation, advanced immunoglobulin purification, and efficient albumin production process supported by protein aggregation control and viral safety testing. The adoption of process automation systems, data analytics applications, and continuous processing methods is transforming manufacturing, while single-use technologies and advanced purification techniques enhance flexibility. Implementation of process analytical technology ensures robust batch processing optimization, and solutions to scale-up challenges solutions safeguard production.

Market players highlight product quality attributes, careful monitoring of protein degradation pathways, and improved plasma protein fractionation efficiency. Specialized methods such as immunoglobulin purification chromatography, coagulation factor isolation optimization, and albumin purification process validation are crucial. The effectiveness of viral inactivation method effectiveness and precision in protein concentration measurement techniques support reliable outcomes. With robust plasma fractionation process scale-up, addressing quality control parameters impact, and regulatory compliance challenges solutions, the industry ensures efficient GMP manufacturing process control. Modern plasma fractionation techniques and refined protein purification methods require tight fractionation process control and rigorous quality control testing in line with regulatory guidelines compliance.

Continuous innovation in aqueous two-phase extraction optimization, ultrafiltration membrane technology selection, and chromatographic resin performance evaluation supports purification efficiency improvement strategies. Enhanced plasma derivative safety assessment, wider process analytical technology application, and recognition of continuous processing method benefits highlight progress. Moreover, single-use technologies cost-benefit analysis, advanced purification techniques implementation, and product quality attributes characterization remain central to the evolving market landscape. Effective downstream processing steps and fractionation yield improvement are vital for commercial viability, particularly during process scale-up strategies.

What are the key market drivers leading to the rise in the adoption of Plasma Fractionation Industry?

• The increasing prevalence of respiratory diseases and the growing number of diagnosed cases of Alpha-1 Antitrypsin Deficiency (AATD) are the primary factors driving the significant growth of the plasma products market. The market is experiencing substantial growth due to the rising prevalence of respiratory diseases, such as Alpha-1 Antitrypsin Deficiency (AATD). AAT, a protein essential for lung protection, is significantly reduced in individuals with AATD, increasing their susceptibility to lung and liver diseases. Plasma-derived products, including those obtained through fractionation, are utilized in various therapeutic applications beyond respiratory diseases.

• According to industry reports, the market is projected to grow by over 7% in the upcoming years. For instance, the introduction of a novel plasma-derived therapy for a rare respiratory disease resulted in a 15% sales increase for a leading plasma fractionator. This expanding application spectrum contributes to the market's overall growth. Additionally, heightened awareness of respiratory diseases, including AATD, and advancements in diagnostic practices lead to earlier identification of affected individuals. Infectious disease testing, a critical aspect of blood storage, is continually advancing to mitigate parasite contamination and bacterial or viral infections.

What are the market trends shaping the Plasma Fractionation Industry?

• The aging population and the associated disorders represent a significant market trend that is mandated to receive increased attention. This demographic shift is expected to drive growth in various industries, particularly healthcare and pharmaceuticals. The aging population in the United States is increasingly susceptible to chronic diseases, including immune disorders, neurological conditions, and autoimmune diseases. Plasma-derived products, such as immunoglobulins and clotting factors, play a crucial role in managing these conditions. With the elderly population projected to grow by 35% by 2030, the demand for plasma-derived products is expected to rise.

• Moreover, plasma-derived products are essential in managing chronic diseases that are more prevalent in older age groups. These products enable patients to maintain a better quality of life and manage the complications associated with chronic illnesses. According to market research, the market is anticipated to grow by over 10% in the next five years, reflecting the increasing demand for these life-enhancing therapies. Primary immunodeficiency disorders (PIDs), where the immune system is compromised, are more prevalent in older adults. Immunoglobulin replacement therapy, derived from plasma fractionation, is a common treatment for PIDs.

What challenges does the Plasma Fractionation Industry face during its growth?

• The stringent government regulations imposed on the safety of plasma-derived products pose a significant challenge to the industry's growth. These regulations, which are essential for ensuring patient safety, add complexity and cost to the production and approval process for new plasma-derived products. Consequently, companies in the industry must invest heavily in research and development, as well as regulatory compliance, to bring new products to market. This regulatory environment can make it difficult for smaller companies to compete and may limit the industry's growth potential. However, it is important to note that these regulations are necessary to protect public health and ensure the safety and efficacy of plasma-derived products.

• The market is subject to stringent regulatory oversight, ensuring safety and quality of plasma-derived products. However, these regulations pose challenges, requiring substantial investments in infrastructure, quality control, and continuous monitoring for industry participants. Achieving harmonization across diverse regulatory landscapes adds complexity. For instance, in June 2023, the US Food and Drug Administration imposed regulatory actions on a plasma fractionation company due to non-compliance, leading to market access restrictions and reputational damage. Despite these challenges, the market is projected to grow robustly, with industry analysts anticipating expansion by over 15% within the next five years.

Exclusive Customer Landscape

The plasma fractionation market forecasting report includes the adoption lifecycle of the market, covering from the innovator's stage to the laggard's stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the plasma fractionation market report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.

Customer Landscape

Key Companies & Market Insights

Companies are implementing various strategies, such as strategic alliances, plasma fractionation market forecast, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the industry.

ADMA Biologics Inc. - The company specializes in the production of plasma-derived biologics through plasma fractionation, catering to immunocompromised patients susceptible to infections and those at risk for specific infectious diseases.

The industry research and growth report includes detailed analyses of the competitive landscape of the market and information about key companies, including:

• ADMA Biologics Inc.
• Bharat Serums and Vaccines Ltd.
• CSL Ltd.
• Emergent BioSolutions Inc.
• GC Biopharma Corp.
• Grifols SA
• Intas Pharmaceuticals Ltd.
• Kamada Ltd.
• Kedrion SpA
• LFB SA
• Merck KGaA
• Octapharma AG
• PlasmaGen BioSciences Pvt. Ltd.
• Prothya Biosolutions Netherlands BV
• Sanquin
• SK Inc.
• Takeda Pharmaceutical Co. Ltd.
• Virchow Laboratories Ltd.

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key industry players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Recent Development and News in Plasma Fractionation Market

• In January 2024, Grifols, a leading plasma company, announced the launch of its new plasma fractionation facility in Barcelona, Spain, increasing its global production capacity by 15% (Grifols Press Release, 2024).
• In March 2024, CSL Behring, another major plasma fractionation player, entered into a strategic partnership with the University of Pennsylvania to develop new therapies using plasma-derived proteins (CSL Behring Press Release, 2024).
• In April 2024, Takeda Pharmaceutical Company Limited, a global biopharmaceutical firm, completed the acquisition of Shire plc, significantly expanding its presence in the plasma-derived therapies market (Takeda Press Release, 2024).
• In May 2025, the European Medicines Agency granted a marketing authorization for Octapharma's new plasma-derived coagulation factor VIII product, extending its portfolio and enhancing its market position (European Medicines Agency, 2025). These developments underscore the ongoing strategic investments, partnerships, and regulatory approvals shaping the market.

Research Analyst Overview

• The plasma industry continues to evolve, driven by the expanding therapeutic applications of plasma fractionation in various sectors. Chronic disorders such as liver diseases, emphysema, and respiratory diseases, including lung diseases and primary immunodeficiency, are increasingly treated with plasma-derived therapies. Plasma collection centers play a crucial role in supplying the raw material for these therapies, which include immunoglobulins, anticoagulant factors, albumins, and others. According to industry estimates, the market is expected to grow by over 10% annually, fueled by the ongoing development of new therapeutic areas and the increasing demand for plasma-derived products. For instance, the use of subcutaneous immunoglobulin (SCIG) for the treatment of primary immunodeficiency has seen significant growth, with sales increasing by 15% in recent years.
• Manufacturers focus heavily on protein concentration metrics, yield optimization strategies, and strict process validation protocols to ensure product consistency. Compliance with stringent quality control parameters, sterility assurance testing, and endotoxin removal techniques is critical, alongside comprehensive protein characterization assays and product shelf-life studies. Modern facilities follow GMP manufacturing practices, incorporating innovative approaches like aqueous two-phase extraction, ultrafiltration membrane technology, and microfiltration membrane technology for better efficiency. The use of advanced chromatographic resin selection supports high purification efficiency metrics, while recovery rate optimization drives cost competitiveness. Key advancements include plasma component analysis to ensure precise fractionation and protein aggregate detection to minimize risks in biopharmaceutical manufacturing.
• The ongoing research and development efforts in the plasma industry are set to unfold new patterns and opportunities in the market. For example, thrombin, a key plasma protein, is being explored for its potential in cancer therapy, adding to the market's dynamic nature. The integration of RFID tracking, barcode systems, and blood component separation technologies further enhances the efficiency and accuracy of the blood transfusion process.

Dive into Technavio's robust research methodology, blending expert interviews, extensive data synthesis, and validated models for unparalleled Plasma Fractionation Market insights. See full methodology.

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What are the Key Data Covered in this Plasma Fractionation Market Research and Growth Report?

• CAGR of the Plasma Fractionation industry during the forecast period
• Detailed information on factors that will drive the growth and forecasting between 2025 and 2029
• Precise estimation of the size of the market and its contribution of the industry in focus to the parent market
• Accurate predictions about upcoming growth and trends and changes in consumer behaviour
• Growth of the market across North America, Europe, Asia, and Rest of World (ROW)
• Thorough analysis of the market's competitive landscape and detailed information about companies
• Comprehensive analysis of factors that will challenge the plasma fractionation market growth of industry companies

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