Plasma Fractionation Market | USD 80.44 Billion by 2034
The plasma fractionation market size was exhibited at USD 35.25 billion in 2024 and is projected to hit around USD 80.44 billion by 2034, growing at a CAGR of 8.6% during the forecast period 2024 to 2034.
The plasma fractionation market has emerged as a cornerstone of the modern biopharmaceutical industry, offering life-saving therapeutic products derived from human plasma. Plasma, the liquid component of blood, contains a plethora of proteins that are crucial for maintaining bodily functions such as immune responses, blood coagulation, and regulation of oncotic pressure. The process of plasma fractionation involves separating and purifying these valuable components namely albumin, immunoglobulins, coagulation factors, and others for therapeutic use.
Globally, the demand for plasma-derived therapies is soaring, particularly in the treatment of chronic and genetic disorders like hemophilia, primary immunodeficiency diseases (PIDs), and alpha-1 antitrypsin deficiency. An aging population, increased prevalence of rare diseases, and a surge in demand for immunoglobulin therapies are catalyzing market growth. Furthermore, the ongoing development in plasma collection technologies, enhanced safety standards, and strategic collaborations among key players are reshaping the plasma industry.
While North America currently leads in terms of market share, emerging economies in Asia-Pacific are registering the fastest growth due to increasing healthcare expenditures, supportive regulatory reforms, and infrastructural advancements in blood and plasma collection facilities.
Rising demand for immunoglobulins for chronic disease management
Growing incidences of autoimmune and immune-deficiency disorders are driving demand for intravenous and subcutaneous immunoglobulin therapies.
Technological advancements in plasma separation techniques
Modern methods such as affinity chromatography and membrane filtration are enhancing yield and safety profiles of plasma products.
Expansion of plasma donation centers globally
Companies like Grifols and CSL Behring are heavily investing in expanding donation centers, especially in North America and Europe.
Biopharmaceutical partnerships and acquisitions
Strategic alliances between pharma companies and plasma processors are increasing the reach and availability of therapeutic products.
Growing use of albumin in non-therapeutic applications
The utility of albumin in drug formulation, cell culture media, and vaccine production is expanding its market presence.
Increased regulatory support in emerging economies
Nations like China and India are strengthening regulatory pathways to enhance local production of plasma-derived products.
| Report Coverage | Details |
| Market Size in 2025 | USD 38.28 Billion |
| Market Size by 2034 | USD 80.44 Billion |
| Growth Rate From 2024 to 2034 | CAGR of 8.6% |
| Base Year | 2024 |
| Forecast Period | 2024-2034 |
| Segments Covered | Product, Method, Application, End-use, Region |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Regional Covered | North America, Europe, Asia Pacific, Latin America, MEA |
| Key Companies Profiled | Grifols S.A.; CSL Limited; Takeda Pharmaceutical Company Limited; Octapharma AG; Kedrion S.p.A; LFB S.A.; Biotest AG; Sanquin; Bio Products Laboratory Ltd.; Intas Pharmaceuticals Ltd. |
One of the foremost drivers in the plasma fractionation market is the rising prevalence of immunodeficiency and rare bleeding disorders worldwide. Immunoglobulins particularly IVIG (Intravenous Immunoglobulin) have become crucial in the treatment of diseases such as primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy (CIDP), and Guillain-Barré syndrome. In parallel, coagulation factors like Factor VIII and Factor IX remain indispensable in managing hemophilia A and B, respectively.
For instance, according to the World Federation of Hemophilia, over 210,000 individuals worldwide suffer from hemophilia, with many cases still underdiagnosed, especially in developing regions. The increasing awareness, coupled with diagnostic capabilities and treatment accessibility, has significantly enhanced demand for plasma-derived therapies. This expanding patient base forms the bedrock for robust growth in the plasma fractionation market.
Despite promising growth, the market is hindered by the high cost of plasma-derived products and logistical challenges associated with plasma collection and storage. The fractionation process is capital-intensive, requiring stringent quality control, cold chain logistics, and extended manufacturing timelines. Additionally, human plasma, unlike synthetic drugs, is sourced only from donors, creating supply vulnerabilities.
There is also a geographical imbalance in plasma collection over 60% of the global plasma is sourced from the U.S., raising concerns about supply security for other nations. Regulatory compliance, including donor screening, viral inactivation procedures, and pathogen testing, adds further cost and complexity. These barriers particularly impact access in low- and middle-income countries, limiting the full potential of the market.
Emerging economies, especially in Asia Pacific and Latin America, represent a vast untapped opportunity. These regions are witnessing rapid healthcare infrastructure development, an increasing burden of rare diseases, and government efforts to establish domestic plasma collection and fractionation facilities. For example, India has taken significant steps to regulate and promote plasma donation, while China has increased local production to reduce dependency on imports.
Additionally, the increasing focus on self-sufficiency in biologics, coupled with the entrance of domestic players and public-private partnerships, is set to create a robust foundation for market expansion. International companies establishing manufacturing or R&D units in these regions can gain early-mover advantages and cater to a rising demand for plasma therapies.
Immunoglobulins, particularly intravenous immunoglobulins (IVIG), held the largest share in the plasma fractionation market in 2024. Their widespread application in autoimmune diseases, primary immunodeficiency disorders, and neurological conditions makes them indispensable. IVIG therapies are frequently administered in hospital and outpatient settings and have gained favor due to their rapid action and wide-spectrum immunomodulatory effects. With rising approvals and increasing off-label usage in inflammatory conditions, this segment continues to expand. For example, Octapharma's IVIG products are being evaluated for newer indications, enhancing demand potential.
Coagulation factors, especially Factor VIII and Factor IX, are projected to grow at the fastest CAGR during the forecast period. These factors are crucial in managing inherited bleeding disorders such as hemophilia A and B. Continuous advancements in recombinant and plasma-derived factor concentrates are improving treatment efficacy and patient outcomes. Moreover, prophylactic treatment regimens, patient awareness, and newborn screening programs are driving earlier diagnosis and long-term management strategies. The growth in hemophilia care centers and global non-profit initiatives, like those of the World Federation of Hemophilia, further bolster this segment.
Chromatography emerged as the dominant method used in plasma fractionation due to its high specificity and yield. Techniques like affinity and ion-exchange chromatography enable the precise separation of proteins with minimal denaturation. This method is widely adopted by manufacturers due to its scalability, reproducibility, and ability to maintain product integrity. It is particularly useful in purifying high-value proteins such as immunoglobulins and coagulation factors. Chromatography also plays a central role in process validation and quality assurance, making it the gold standard across many facilities.
Depth filtration is expected to exhibit the highest growth rate during the forecast period. Its adoption is increasing in early-stage plasma clarification processes, especially due to its cost-effectiveness and compatibility with single-use systems. Depth filtration effectively removes cellular debris and aggregates before fine purification, reducing downstream processing burden. With the rise in modular and continuous manufacturing setups, this method is becoming a vital part of efficient and flexible production workflows, especially in facilities catering to medium-scale plasma volumes.
Immunology remained the dominant application segment in 2024, owing to the extensive use of immunoglobulins in managing immunodeficiency disorders. IVIG and subcutaneous IG therapies are routinely prescribed to boost immune function in patients with compromised immunity due to genetic or acquired conditions. The broad therapeutic scope in immunology—ranging from primary immune deficiencies to secondary immune responses in cancer or HIV patients—has entrenched this application as a leading revenue generator.
Neurology is projected to grow at the highest CAGR, driven by increased recognition of plasma therapies in treating conditions like chronic inflammatory demyelinating polyneuropathy (CIDP), myasthenia gravis, and Guillain-Barré syndrome. IVIG has become a frontline therapy in these conditions due to its immunomodulatory effects and ability to mitigate disease progression. Expanding research on the neurological benefits of immunoglobulin treatments, coupled with increasing clinical trials, is likely to drive robust growth in this segment over the next decade.
Hospitals and clinics accounted for the largest share of the plasma fractionation market. These settings administer the majority of immunoglobulin and coagulation factor therapies, especially for acute management of bleeding disorders, immune deficiencies, and neurological diseases. The availability of trained staff, infusion facilities, and emergency care capabilities makes hospitals the most suitable locations for complex plasma therapies.
Clinical research is the fastest-growing end-use segment, fueled by the surge in investigational studies surrounding plasma-derived products. Biopharmaceutical companies and research institutions are actively exploring novel indications and next-generation purification techniques, leading to increased demand for high-purity plasma fractions in lab environments. Additionally, ongoing COVID-19-related research and broader interest in hyperimmune globulin have accelerated this segment's growth.
North America, particularly the United States, leads the plasma fractionation market, accounting for the highest revenue share. The region’s dominance can be attributed to an advanced healthcare infrastructure, favorable reimbursement policies, and a large base of plasma donation centers. The U.S. alone accounts for the majority of the world’s plasma collection, with companies like Grifols, CSL Plasma, and BioLife (a Takeda subsidiary) operating hundreds of donation centers. Moreover, strong regulatory oversight by agencies like the FDA ensures product safety and accelerates innovation. The growing geriatric population and high prevalence of chronic conditions requiring plasma-based treatments further consolidate the region’s leading position.
Asia Pacific is the Fastest Growing Market
Asia Pacific is poised to register the fastest CAGR over the forecast period. Countries like China, India, and South Korea are making significant investments in healthcare infrastructure, including plasma collection and biomanufacturing. The rising burden of immunological and genetic diseases, coupled with government support and foreign investments, is driving local plasma product production. For instance, in 2023, China's National Medical Products Administration (NMPA) approved several new plasma-derived therapies, reflecting the country's intent to localize supply. Additionally, increasing medical tourism and cost-effective manufacturing make Asia Pacific a strategic growth hub for both regional and global players.
Grifols opened a new plasma donation center in Texas, USA, in March 2025, further expanding its U.S. network of over 400 centers and ensuring continuous plasma supply to meet rising therapeutic demands.
In January 2025, CSL Behring announced an expansion of its manufacturing facility in Marburg, Germany, aimed at increasing output capacity for immunoglobulins and albumin to cater to global markets.
Takeda Pharmaceutical launched a Phase III trial in December 2024 for a new subcutaneous immunoglobulin therapy to treat multifocal motor neuropathy (MMN), reflecting a growing pipeline in neuro-immunological disorders.
Octapharma reported positive Phase II trial results in February 2025 for its new fibrinogen concentrate targeting postpartum hemorrhage—an area of growing clinical interest in women's health.
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2034. For this study, Nova one advisor, Inc. has segmented the plasma fractionation market
Product
Method
Application
End-use
Regional
Cross-segment Market Size and Analysis for Mentioned Segments
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Country/Region-specific Report
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