As per MRFR analysis, the US Plasma Fractionation Market Size was estimated at 4.77 (USD Billion) in 2024. The US Plasma Fractionation Market Industry is expected to grow from 5.1(USD Billion) in 2025 to 8.2 (USD Billion) by 2035. The US Plasma Fractionation Market CAGR (growth rate) is expected to be around 4.412% during the forecast period (2025 - 2035).
The US Plasma Fractionation Market is driven by several key factors that influence its growth and development. The increasing prevalence of chronic diseases and the rising demand for immunoglobulin therapies significantly shape the market landscape. The growing number of hemophilia patients and the need for clotting factor concentrates further contribute to the demand for plasma-derived products. The U.S. government supports this sector through regulatory frameworks and funding initiatives, promoting safe and efficient plasma collection and fractionation processes. As more healthcare providers recognize the benefits of plasma therapies, the market continues to gain traction.
There are also various opportunities to be explored within the US Plasma Fractionation Market. The advancement of technology in blood plasma processing and the development of new therapeutic applications offer potential avenues for expansion. Moreover, increasing awareness regarding rare diseases, which often require specific plasma-derived treatments, opens up pathways for innovative solutions. Collaborations between healthcare sectors, research institutions, and plasma collection centers could leverage shared expertise to improve treatment options. In recent times, trends such as the rise of specialty pharmacies and personalized medicine are gaining momentum.
These trends impact how plasma products are marketed and distributed, tailoring approaches to meet the needs of individual patients more effectively. The focus on patient-centered care encourages product developers to innovate and enhance existing therapies. The continuous rise in the number of plasma donation centers in the U.S. illustrates a commitment to improving access to these life-saving treatments, further reflecting the dynamic nature of the Plasma Fractionation Market in the region.
Source: Primary Research, Secondary Research, MRFR Database and Analyst Review
The US Plasma Fractionation Market Industry is witnessing a significant increase in demand for immunoglobulin products, essential for treating various healthcare conditions, including immunodeficiencies and autoimmune disorders. The National Institutes of Health reported that primary immunodeficiency diseases affect approximately 1 in 1,200 individuals in the United States, which translates to around 250,000 cases. With the rise in awareness and diagnosis of these disorders, the demand for immunoglobulin has surged, leading to an expected market growth.
Key industry competitors, which include Grifols along with CSL Behring, have been increasing their production capabilities in response to market demand, which has, in turn, benefitted the growth of the US Plasma Fractionation Market.
The expansion of plasma donation centers across the United States has significantly facilitated the availability of raw plasma for fractionation. According to the American Association of Blood Banks, there were over 900 licensed plasma collection centers in the U.S. as of recent data. This is an increase of approximately 30% in the last decade, which enhances the supply chain for the US Plasma Fractionation Market Industry, allowing manufacturers to harness more plasma for essential therapies.
Organizations like Octapharma are investing in establishing more centers, ensuring a robust supply of plasma, thus enabling continued growth in the market.
Technological advancements in plasma processing are enhancing the efficiency and yield of plasma fractionation, driving growth in the US Plasma Fractionation Market Industry. Innovations such as improved separation techniques and the development of automated systems have increased the recovery rates of therapeutic proteins from plasma. According to the U.S. Food and Drug Administration, recent technology upgrades have led to a 25% increase in yield from the plasma fractionation process.
Companies like Takeda Pharmaceutical have actively adopted these technologies, strengthening their market position and contributing to overall industry growth in the United States.
The rise in chronic conditions such as hemophilia, hepatitis, and other blood-related disorders is significantly fueling the demand for plasma-derived therapies in the US Plasma Fractionation Market Industry. The Centers for Disease Control and Prevention (CDC) estimate that approximately 15,000 people in the U.S. are affected by hemophilia, a condition that requires regular infusions of clotting factor derived from plasma. With advancements in medical treatments and an increase in patient awareness, the utilization of plasma-derived products for managing these conditions is expected to grow.
This trend is being supported by major healthcare providers, which are emphasizing comprehensive care for chronic patients.
The US Plasma Fractionation Market, particularly in the Product Type segment, encompasses a diverse range of components that are crucial for therapeutic applications. Immunoglobulin is one of the most significant fractions, widely recognized for its role in treating various immune deficiencies and other related disorders. This segment holds a dominant position in the market due to its broad spectrum of clinical applications, including autoimmune diseases and infections, reflecting a growing demand among healthcare providers.
Albumin, another vital product derived from plasma, is essential for fluid management in patients, especially those undergoing surgery or suffering from liver diseases. Its versatility and importance in critical care settings have contributed to its substantial market presence.
Coagulation factors, which are essential in managing bleeding disorders such as hemophilia, present another critical aspect of the Plasma Fractionation Market. The increasing prevalence of these disorders has driven innovation and an expanding patient population in need of effective treatments, making this segment particularly significant for ongoing market growth. Additionally, protease inhibitors, though less widespread compared to Immunoglobulin and Albumin, play an essential role in addressing viral infections and inflammatory conditions.
Their incorporation into treatment protocols has been pivotal, highlighting evolving therapeutic strategies rooted in plasma-derived products. Overall, the segmentation of the US Plasma Fractionation Market sheds light on how various product types serve specific medical needs, promoting considerable advancements in patient care and treatment efficacy across the healthcare spectrum.
This market segment continues to evolve, harnessing technological innovations and increased awareness to drive growth opportunities while also adapting to regulatory landscapes and healthcare demands. As the healthcare infrastructure in the U.S. emphasizes improved treatment outcomes and specialized therapies, each product type within this market demonstrates its unique contributions and sustained relevance in shaping the future of plasma-derived therapeutics.
Source: Primary Research, Secondary Research, MRFR Database and Analyst Review
The US Plasma Fractionation Market is a vital component of the healthcare industry, particularly in the Application segment, which encompasses various disciplines such as Neurology, Hematology, General Medicine, and Immunology. Neurology remains a crucial area due to the increasing prevalence of neurological disorders, where plasma-derived therapeutics play a significant role in treatment protocols. In Hematology, products derived from plasma fractionation are essential for managing blood-related conditions, showcasing the importance of this segment in patient care.
General Medicine integrates diverse applications of plasma products, demonstrating their versatility and wide acceptance in clinical practices. Immunology is also a key focus, as the demand for immunoglobulin therapies continues to rise, reflecting the increasing awareness and diagnosis of autoimmune diseases. The growth in these applications is fueled by advancing medical technology, increased funding for Research and Development, and a rising geriatric population, which highlights the necessity for innovative treatment solutions.
The ongoing development of new plasma-based therapies presents significant opportunities while navigating regulatory frameworks and supply chain challenges remains a key consideration within the industry landscape.
The 'End User' segment of the US Plasma Fractionation Market is diverse, comprising key entities such as Hospitals, Ambulatory Surgical Centers, Blood Banks, and Pharmaceutical Companies. Hospitals are central to plasma fractionation as they provide critical care services that depend on plasma-derived products for treating various medical conditions. Ambulatory Surgical Centers play a crucial role by enhancing patient access to specialized treatments involving plasma therapies, thereby streamlining service delivery. Blood Banks are indispensable, serving as collection, testing, and distribution hubs for plasma, with stringent regulations in place to ensure safety and efficacy in handling blood components.
Pharmaceutical Companies dominate the market by developing innovative therapies derived from plasma, thus driving advancements in treatment methodologies. The interplay of these users amid ongoing research and regulatory changes shapes the market landscape, with increasing demand for immunoglobulins and clotting factor concentrates underscoring their significance in healthcare. The ongoing improvements in processing technology and patient treatment protocols signal growth opportunities, while challenges related to supply chain management and regulatory compliance persist for these stakeholders.
The Technology segment of the US Plasma Fractionation Market plays a critical role in the effective separation and purification of plasma components, which is essential for various medical applications. Within this segment, Centrifugation stands out due to its efficiency in separating plasma proteins based on density, making it a widely used technique in laboratories. Chromatography is also significant as it provides high-resolution separation, critical for the purification of specific proteins required in therapies, reflecting increasing demand for more refined therapeutic products.
Precipitation methods offer another avenue for isolating plasma proteins, leveraging changes in solubility, and are continuously evolving to enhance efficiency and yield in clinical settings. Finally, Filtration techniques are important for their ability to maintain sterility while selectively filtering plasma components, ensuring safe and effective usage in medical treatments. The continuous advancements in these technologies foster innovation within the US Plasma Fractionation Market, contributing to improved patient outcomes and addressing the growing need for therapeutics derived from human plasma.
The integration of automation and real-time monitoring systems is also poised to enhance operational efficiency and regulatory compliance in this dynamic landscape.
The US Plasma Fractionation Market is characterized by a dynamic competitive landscape where various players strive to enhance their portfolios and market positioning through innovation and expansion. As the global demand for plasma-derived medicinal products continues to grow, companies operating within this sector are focusing on advancing their technologies, improving operational efficiency, and expanding their capacity to meet healthcare needs.
This market is influenced by factors such as regulatory frameworks, technological advancements, and the increasing prevalence of chronic diseases that necessitate the use of plasma-derived therapeutics. In addition, strategic partnerships and collaborations play a pivotal role as organizations seek to leverage collective strengths to innovate and enhance their market reach.
Cerus Corporation stands out in the US Plasma Fractionation Market with its proprietary technologies that focus on pathogen reduction and blood safety. The company has established a credible presence through its innovative Intercept Blood System, which is designed to reduce the risk of transfusion-transmitted infections. With an emphasis on safety and efficacy, Cerus Corporation has garnered a strong reputation for its commitment to enhancing blood product quality.
The company’s advancements in pathogen reduction technologies, along with a robust regulatory approval history, position it favorably among healthcare providers looking for reliable solutions. Additionally, Cerus Corporation has strategically positioned itself to expand its market share by aligning with various blood centers, thereby increasing its accessibility and operational footprint within the United States.
Octapharma is another key player in the US Plasma Fractionation Market, known for its focus on producing high-quality human protein products derived from human plasma. The company emphasizes therapeutic areas, including hematology, immunotherapy, and intensive care, delivering a range of immunoglobulins, coagulation factors, and albumins that cater to diverse patient needs.
Octapharma’s strong market presence in the U.S. is underlined by its commitment to research and development, allowing it to introduce innovative therapies adapting to evolving healthcare demands. The company has also engaged in significant mergers and acquisitions, fortifying its position within the market and expanding its product offerings. By collaborating with health organizations and maintaining a focus on quality assurance, Octapharma enhances its operational strengths, ensuring that it remains a trusted name in the plasma-derived medicinal product space.
Recent developments in the US Plasma Fractionation Market have highlighted a surge in interest and activity among key players. For instance, in August 2023, Cerus Corporation announced advancements in its INTERCEPT Blood System technology, aiming to enhance safety protocols in plasma transfusions.
In July 2023, Grifols expanded its production capacity in North Carolina to meet the rising demand for immunoglobulin therapies. Furthermore, Baxter International revealed its plans to increase operational efficiencies by automating certain plasma processing procedures earlier in September 2023.
The market is also witnessing significant growth in valuation, driven by an increasing incidence of chronic diseases and an expanded patient population requiring plasma-derived therapies. Among recent strategic activities, in June 2023, Takeda Pharmaceutical finalized the acquisition of a biologics facility from Shire, enhancing its capabilities in the plasma sector.
Moreover, CSL Behring launched new products targeting rare bleeding disorders, which contributed to a positive market outlook. The American Red Cross continues to play a vital role in plasma collection efforts, ensuring a steady supply for therapeutic needs. These activities indicate a robust and evolving market landscape in the U.S. Plasma Fractionation sector.
| Report Attribute/Metric | Details |
| Market Size 2024 | 4.77(USD Billion) |
| Market Size 2025 | 5.1(USD Billion) |
| Market Size 2035 | 8.2(USD Billion) |
| Compound Annual Growth Rate (CAGR) | 4.412% (2025 - 2035) |
| Report Coverage | Revenue Forecast, Competitive Landscape, Growth Factors, and Trends |
| Base Year | 2024 |
| Market Forecast Period | 2025 - 2035 |
| Historical Data | 2019 - 2024 |
| Market Forecast Units | USD Billion |
| Key Companies Profiled | Cerus Corporation, Octapharma, Kedrion, Grifols, Sandoz, Takeda Pharmaceutical, Baxter International, CSL Behring, Shire, Emergent BioSolutions, Thermo Fisher Scientific, Pfizer, AbbVie, American Red Cross, BioMerieux |
| Segments Covered | Product Type, Application, End User, Technology |
| Key Market Opportunities | Increasing demand for immunoglobulins, Growing prevalence of chronic diseases, Advancements in separation technologies, Expanding applications in therapeutics, Rising awareness of plasma-derived therapies |
| Key Market Dynamics | Increasing demand for immunoglobulins, Growing prevalence of bleeding disorders, Advancements in fractionation technologies, Rising number of plasma collection centers, Stringent regulatory framework |
| Countries Covered | U.S. |
US Plasma Fractionation Market Highlights:
Frequently Asked Questions (FAQ) :
The US Plasma Fractionation Market was expected to be valued at 5.1 USD Billion in 2024.
By 2035, the US Plasma Fractionation Market is anticipated to reach a value of 8.2 USD Billion.
The expected CAGR for the US Plasma Fractionation Market is 4.412 percent from 2025 to 2035.
The major product segments include Immunoglobulin, Albumin, Coagulation Factors, and Protease Inhibitors.
In 2024, the market size for Immunoglobulin was valued at 2.3 USD Billion.
The Albumin segment is projected to be valued at 2.5 USD Billion by 2035.
Major players in the market include Cerus Corporation, Octapharma, Grifols, Baxter International, and CSL Behring.
The market size for Coagulation Factors is expected to reach 1.5 USD Billion by 2035.
Key growth drivers include increasing demand for immunoglobulin therapies and advancements in medical technologies.
The Protease Inhibitors segment is anticipated to grow to 0.5 USD Billion by 2035.
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Assistant Manager He holds an experience of about 7+ years in market research and business consulting, working under the spectrum of life sciences and healthcare domains. rahul conceptualizes and implements a scalable business strategy and provides strategic leadership to the clients. his expertise lies in market estimation, competitive intelligence, pipeline analysis, customer assessment, etc. in addition to the above, his other responsibility includes strategic tracking of high growth markets & advising clients on the potential areas of focus they could direct their business initiatives
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