PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1916510
PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1916510
The global plasma fractionation market is a vital component of the biopharmaceutical industry, enabling the separation of human plasma into therapeutic proteins such as immunoglobulins, albumin, coagulation factors, and protease inhibitors. These plasma-derived products are essential for treating immunodeficiency disorders, bleeding disorders, metabolic diseases, neurological conditions, and critical care complications. Continuous growth in chronic and rare disease prevalence, along with expansion of plasma collection infrastructure, is strengthening market demand worldwide.
Plasma Fractionation Market Size and Market Value
According to the 2025 market report, the global plasma fractionation market size was valued at USD 40.27 billion in 2025. The market is projected to grow to USD 43.55 billion in 2026, supported by increasing plasma donation volumes, growing demand for immunoglobulin therapies, and expansion of fractionation capacity by major manufacturers. Over the long-term forecast period, the market is expected to reach a market value of USD 87.20 billion by 2034, reflecting strong demand for plasma-derived medicinal products across multiple therapeutic areas. The market is projected to grow at a CAGR of 9.10% from 2026 to 2034, driven by rising healthcare spending and increasing regulatory approvals of plasma-based biologics.
Market Drivers Supporting Growth
A major growth driver is the increasing prevalence of immunodeficiency disorders, autoimmune diseases, and rare genetic bleeding disorders such as hemophilia A, hemophilia B, and von Willebrand disease. Plasma-derived therapies remain the primary treatment option for many of these conditions, supporting consistent demand for fractionated products. Rising numbers of patients with HIV, primary immunodeficiency disorders, and chronic liver disease are also contributing to higher immunoglobulin and albumin consumption.
Government support for plasma-derived medicinal product manufacturing is further strengthening market growth. Several regulatory bodies recognize plasma therapies as essential medicines, encouraging national plasma self-sufficiency programs and investment in domestic fractionation capacity. Increasing funding for blood services, regulatory relaxation for plasma usage, and public-private partnerships are improving plasma availability and strengthening production pipelines.
Market Trends and Technology Advancements
Technological advancements in plasma fractionation are improving production efficiency, yield, and protein purity. Automation, improved chromatography systems, and optimized separation techniques are enabling manufacturers to maximize output from each liter of collected plasma. Next-generation donor collection systems are also improving donor safety and reducing plasma collection time, enhancing supply stability.
Another emerging trend is the development of biological products and biosimilars derived from plasma proteins. Manufacturers are expanding clinical research programs to explore new therapeutic indications for immunoglobulins and albumin in neurology, liver disease, and inflammatory disorders. Strategic collaborations between biopharmaceutical companies and protein technology providers are accelerating biologics development using plasma proteins as critical raw materials.
Market Restraints and Challenges
Despite strong demand, the plasma fractionation market faces challenges related to high production costs, strict regulatory compliance, and plasma supply dependency. Fractionation facilities require highly specialized equipment, validated purification processes, and strict viral inactivation protocols, which increase operational expenses. Regulatory approvals for plasma-derived products often involve lengthy clinical and manufacturing evaluations, delaying market entry.
The increasing adoption of recombinant therapies presents competitive pressure. Recombinant clotting factors and biologics offer reduced infection risk and longer half-life, leading to increased use in prophylactic treatment regimens. These alternatives are gradually reducing dependence on plasma-derived coagulation factors in certain patient groups.
Plasma supply chain stability also remains a challenge, as plasma is sourced exclusively from human donors. Any disruption in donor recruitment, logistics, or regulatory policies can directly impact manufacturing capacity and product availability.
Segmentation Analysis by Product
By product, the market includes immunoglobulins, albumin, coagulation factors, protease inhibitors, and others. The immunoglobulin segment dominated the market with a 53.76% share in 2026, driven by rising use in primary and secondary immunodeficiency disorders and autoimmune diseases. Increasing regulatory approvals for both IVIG and SCIG formulations are strengthening clinical adoption.
The albumin segment held the second-largest share, supported by growing use in liver diseases, critical care, sepsis, and hypoalbuminemia. Coagulation factors are witnessing strong growth due to the continued prevalence of bleeding disorders, particularly in emerging markets where access to recombinant alternatives remains limited. Protease inhibitors are gaining moderate traction in infectious disease and inflammatory disorder treatments.
Segmentation by Application and End User
By application, immunology and neurology accounted for the largest market share, estimated at 70.50% in 2026, driven by expanding indications for immunoglobulin therapies in autoimmune neuropathies and immune disorders. Hematology represents the second-largest segment, supported by hemophilia management programs and clotting factor demand. Critical care applications are rising due to increasing trauma cases and surgical interventions.
By end user, hospitals and clinics dominated the market with an estimated 86.67% share in 2026, supported by high inpatient use of plasma therapies and centralized treatment protocols. Clinical research laboratories are growing steadily due to expanding plasma-based drug development programs.
North America dominated the plasma fractionation market with a market size of USD 24.50 billion in 2025 and USD 26.57 billion in 2026, supported by extensive plasma collection networks, strong reimbursement systems, and high therapeutic adoption. Europe held the second-largest share in 2026, driven by increasing plasma self-sufficiency initiatives and expansion of fractionation facilities.
Asia Pacific is emerging as a high-growth region due to expanding healthcare infrastructure, rising chronic disease prevalence, and increasing domestic plasma manufacturing investments in China, Japan, and India. Latin America and the Middle East & Africa are witnessing gradual growth supported by government healthcare investments and rising demand for immunoglobulin therapies.
Competitive Landscape
The plasma fractionation market is highly consolidated, with major players including CSL Behring, Grifols, Takeda Pharmaceutical Company Limited, Octapharma, Kedrion, ADMA Biologics, Sartorius AG, and LFB. Companies are actively expanding plasma collection centers, investing in fractionation capacity, and launching new plasma-derived products. Strategic acquisitions, long-term plasma supply agreements, and facility expansions remain central to competitive strategies across global markets.
Conclusion
The global plasma fractionation market is positioned for strong and sustained expansion, supported by rising prevalence of immunodeficiency, autoimmune, and bleeding disorders, along with continuous growth in demand for immunoglobulins, albumin, and coagulation factors. With the market valued at USD 40.27 billion in 2025, projected to reach USD 43.55 billion in 2026 and further expand to USD 87.20 billion by 2034, the industry reflects robust long-term growth potential. Ongoing investments in plasma collection networks, expansion of fractionation capacity, technological advancements in purification and automation, and increasing regulatory approvals for plasma-derived therapies are strengthening market penetration across hospitals and specialty treatment centers. Although challenges such as high production costs, regulatory complexity, and competition from recombinant therapies persist, rising healthcare spending, government support for plasma self-sufficiency programs, and expanding clinical applications of plasma-derived products are expected to continue driving market momentum globally.
Segmentation By Product
By Application
By End-user
By Region