Plasma Fractionation Market Expansion To US$ 57 Billion By 2032

Introduction

Global Plasma Fractionation Market Size is expected to be worth around USD 57.0 Billion by 2032 from USD 30.8 Billion in 2023, growing at a CAGR of 7.3% during the forecast period from 2023 to 2032. In 2023, North America held over 53.5% market share, reaching a revenue total of USD 15.33 Billion.

The Plasma Fractionation Market is experiencing substantial growth due to factors like stringent regulatory oversight, technological advancements, and evolving market dynamics. Regulatory bodies maintain high standards for plasma collection, processing, and storage to ensure safety and quality, with regular audits at collection centers to uphold these standards. Technological improvements in fractionation techniques, such as cryoprecipitation and ethanol fractionation, are enhancing efficiency and yields, vital for therapeutic uses.

Globally, the demand for plasma-derived products is rising, fueled by better plasmapheresis techniques and optimized collection protocols that allow for more frequent and larger donations. This meets the increasing need for plasma therapeutics like immunoglobulins and clotting factors, driven by an aging population and the prevalence of chronic diseases requiring ongoing treatment with these products.

Economically, the cost of plasma collection and fractionation processes directly influences the affordability and availability of these crucial products. Efficient resource management in plasma separation from whole blood donations is key to maximizing production while controlling costs, highlighting the need for strategic market and resource planning in the industry.

Recent industry developments include Grifols’ acquisition of Biotest AG in April 2022, enhancing its global plasma capacity and market share with a deal worth approximately EUR 1,600 million in equity and EUR 2,000 million in enterprise value. In August 2022, Taibang Biologic Group secured $300 million in equity funding to expand plasma stations and develop new products, strengthening its market position in China.

Additionally, in November 2023, Intas Pharmaceuticals entered into a licensing agreement with Syna Therapeutics to globally commercialize LB-0702, expanding its biosimilar program and enhancing global access to affordable biosimilar drugs.

Key Takeaways

• Market size: Expected to reach USD 57.0 Bn by 2032, growing at a CAGR of 7.3%.
• Key products: Immunoglobulins are the largest segment, followed by coagulation factors and albumin.
• Key methods: Centrifugation is the most widely used method, followed by chromatography and depth filtration.
• Key applications: Neurology is the largest segment, followed by hematology and oncology.
• Key end-users: Hospitals and clinics are the largest segment, followed by academic institutes and clinical research laboratories.
• Growth drivers: Rising incidences of immunodeficiency disorders, increased use of plasma-derived products in various medical fields, and growing demand for plasma-derived products for the treatment of complex conditions.
• Restraints: Emergence of recombinant therapies as an alternative to plasma-derived medicines.

Plasma Fractionation Statistics

• Blood Composition and Plasma Collection
  • Blood typically consists of about 55% plasma and 44% red blood cells, with the remainder being white blood cells and platelets.
  • The U.S. is a leading supplier of plasma and plasma-derived products worldwide.
• Global Blood Banks and Plasma Collection
  • India has approximately 3,840 licensed blood banks.
  • Globally, blood banks collect around 11-12 million units of blood each year, potentially yielding 1.6-1.7 million liters of plasma. However, due to various losses, only about 1.2-1.3 million liters are available for clinical uses annually.
  • Germany, Austria, Hungary, and the Czech Republic account for 40% of Europe’s plasma collection efforts.
• Impact of the Pandemic on Plasma Donations
  • Plasma donations saw a 20% reduction during 2020 and 2021, intensifying the global plasma shortage.
• Advancements in Plasma Fractionation
  • ChromaCon’s technology could increase product yields by up to 80% while maintaining target purity, potentially reducing the cost of affinity resins by 60% and buffer consumption by 80%. Expected improvements in overall yield could exceed 90%, with potential capital expenditure reductions estimated at 30%.
• Demographics and Behaviors of Plasma Donors
  • In Germany, 56.8% of plasma donors are male, with first-time donors averaging 29.8 years old and repeat donors 43.2 years old. German donors typically donate 14.2 times per year.
  • In the U.S., the average age of first-time and repeat plasma donors is 30 years and 36 years, respectively, with 62% being male.
  • In the Netherlands, 76-79% of plasma donors are employed, and 74-86% live with a partner and children. A higher educational attainment is observed among Dutch donors, with 34-36% having completed higher education.
• Donor Retention Challenges
  • A significant portion of donors (47.2%) cease donating due to time constraints, job changes, or relocation.
  • About 23% stop donating because of the lengthy donation process or job-related conflicts, while travel difficulties and compensation issues deter 21% and 22% of donors, respectively.
  • Approximately 23-56% of paid donors in Germany and Austria would consider continuing to donate even without financial incentives.
• Adverse Events in Plasma Donation
  • Only 0.16–2.3% of plasma donations result in adverse events, with adverse events being 2.6 times more likely in females than in males.
  • New donors experience adverse events 11 times more frequently than repeat donors. The majority of adverse events are related to hypotensive/vasovagal reactions and issues at the needle insertion site.
  • Adverse events affect 0.49% of whole blood donations and 0.16–1.2% of plasma donations.

Plasma Fractionation Product Type Analysis

• Albumin: Albumin is a key plasma-derived product regulated by the FDA. It is produced from human plasma and is essential for various medical uses, including volume expansion and maintenance of blood pressure. Albumin solutions are sterile, nonpyrogenic, and available in different concentrations, commonly used intravenously for therapeutic purposes. The production process ensures that albumin is safe, with a high purity level of not less than 96% of the total protein being albumin. Despite rigorous safety measures, like screening and testing for viruses, there remains a theoretical risk of transmitting infectious diseases, although no cases have been reported. This product is critical in managing conditions related to blood volume and protein levels, particularly in emergency and surgical settings.
• Immunoglobulins: Immunoglobulins are antibodies derived from plasma that play a crucial role in the immune response. They are used to treat a variety of immune deficiencies and autoimmune diseases. The fractionation process allows for the concentration and purification of specific immunoglobulins, which are then used therapeutically to boost the patient’s immune system or modulate it in cases of autoimmune disorders.
• Coagulation Factors: Coagulation factors are another vital product of plasma fractionation. They are essential for blood clotting and are primarily used to treat and manage diseases such as hemophilia, where the blood does not clot properly. Patients with these conditions rely on regular infusions of clotting factors to prevent bleeding episodes and manage the symptoms of their disease.
• Protease Inhibitors: Protease inhibitors are used in the treatment of conditions where protease activity needs to be controlled, such as in hereditary angioedema, which causes severe swelling. They work by inhibiting the activity of specific proteases, thereby controlling inflammation and other symptoms associated with excess protease activity.

Emerging Trends

• Increased Use of Subcutaneous Immunoglobulin (SCIG): There is a noticeable shift towards the subcutaneous administration of immunoglobulins over intravenous methods. This preference stems from the convenience and reduced risk of adverse reactions offered by SCIG, allowing for home administration. This shift is expected to drive higher demand for SCIG, potentially surpassing traditional IVIG formulations. This evolution marks a significant change in patient treatment modalities for immunoglobulin therapies.
• Development of Convalescent Plasma and Hyperimmune Globulin (H-Ig): The recent global health emergencies have underscored the potential of convalescent plasma and Hyperimmune Globulin (H-Ig) in managing emerging infectious diseases. Despite mixed results in their effectiveness, particularly against COVID-19, these therapies are seen as promising for future medical challenges. The plasma fractionation industry has seen extensive collaborative efforts to advance the development and application of these treatments, a trend likely to persist and shape future therapeutic strategies.
• Addressing Plasma Shortages: The plasma fractionation sector continues to navigate challenges associated with plasma shortages, exacerbated by the COVID-19 pandemic’s impact on donations. In response, there is a strong push to improve the efficiency of plasma collection and to expand the capacity of facilities globally. These efforts aim to satisfy the growing worldwide demand for plasma-derived therapies and ensure a more reliable supply chain.
• Promoting Regional Self-Sufficiency: A growing movement towards regional self-sufficiency in plasma supply is emerging. Countries are striving to reduce dependence on imported plasma products by enhancing local collection and fractionation capabilities. This involves updating regulatory frameworks and investing in infrastructure to strengthen domestic plasma industries, aiming to ensure a stable supply chain and better meet local healthcare needs.

Use Cases

• Treatment of Chronic Diseases: Plasma fractionation is a pivotal process in managing chronic conditions such as immunodeficiency disorders, autoimmune diseases, and hemophilia. This technique isolates specific proteins from plasma, enabling tailored treatments that significantly improve patient outcomes. By focusing on precise plasma components, treatments can be customized to meet the individual needs of patients, enhancing the management of complex diseases and boosting quality of life.
• Support for Medical Research and Clinical Trials: Plasma fractionation is vital in the field of medical research. High-quality plasma derivatives are essential for clinical research laboratories and academic institutions, facilitating experiments and clinical trials. This support is crucial for advancing medical science, developing new treatments, and refining therapeutic approaches. As research evolves, plasma fractionation continues to be instrumental in driving medical breakthroughs and enhancing our understanding of various health conditions.
• Emergency Medical Responses: In emergency medical situations, especially during infectious disease outbreaks, plasma fractionation is critical. Plasma products are essential for treating affected individuals and are key in developing rapid-response therapies. By isolating specific antibodies from convalescent plasma, medical professionals can swiftly develop targeted treatments to combat emerging health threats, highlighting the versatility and importance of plasma fractionation in crisis management.
• Global Health Initiatives: Plasma fractionation plays a significant role in global health efforts, enabling the production and distribution of crucial biological medications worldwide. This is particularly important in regions with limited healthcare resources, helping manage global health crises and ensuring wider access to life-saving treatments. The role of plasma fractionation in global health initiatives underscores its substantial impact on enhancing healthcare accessibility and equity across different populations.

Conclusion

The plasma fractionation market is poised for sustained growth, driven by advancements in collection and fractionation technologies, rising global demand for plasma-derived products, and stringent regulatory standards ensuring safety and quality. The market’s expansion is bolstered by significant investments and strategic initiatives within the industry, aiming to enhance global capacity and improve the efficiency of plasma processing. These factors collectively support the increasing use of plasma-derived therapeutics across various medical applications, addressing both chronic conditions and emergent health needs, ultimately fostering better patient outcomes and broader healthcare accessibility.

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