Blood Plasma Fractionation Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Albumin, Immunoglobulins, Coagulation Factors, Protease Inhibitors and Others), By Method (Centrifugation, Depth Filtration, Chromatography, and Others), By Application (Neurology, Haematology, Oncology, Immunology, Pulmonology, and Others), By End Use (Hospitals & Clinics, Clinical Research, and Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 37.11 Billion
CAGR (2026-2031)	8.59%
Fastest Growing Segment	Immunoglobulins
Largest Market	North America
Market Size (2031)	USD 60.85 Billion

Market Overview

The Global Blood Plasma Fractionation Market will grow from USD 37.11 Billion in 2025 to USD 60.85 Billion by 2031 at a 8.59% CAGR. The Global Blood Plasma Fractionation Market centers on the industrial process of separating human blood plasma into its constituent therapeutic proteins, such as immunoglobulins, albumin, and coagulation factors. This sector is primarily propelled by the rising global prevalence of immunodeficiency disorders and an aging population requiring critical care therapies. Furthermore, advancements in diagnostic technologies have led to higher identification rates of rare diseases, thereby increasing the clinical necessity for plasma-derived medicinal products beyond traditional usage.

Despite this robust demand, the market faces significant hurdles related to the complex logistics and high costs associated with sourcing raw material. A primary challenge is the heavy reliance on a limited number of regions for plasma collection, which creates supply chain vulnerabilities. For instance, according to the Plasma Protein Therapeutics Association, in 2025, North American donors provided over 63% of the global plasma supply used for manufacturing. This geographic concentration highlights the difficulty in diversifying collection sources to ensure a stable and sufficient global inventory of fractionation substrates.

Key Market Drivers

Surging demand for immunoglobulins in neurology and immunology applications is acting as a primary catalyst for the market, driven by the expanding clinical utility of these therapies for conditions such as Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Primary Immunodeficiency (PID). As diagnosis rates improve and off-label usage gains traction, manufacturers are witnessing substantial revenue upticks in their immunology portfolios, necessitating increased production to satisfy sustained patient needs. This robust consumption pattern is directly influencing corporate performance metrics and reinforcing the focus on plasma-derived medicinal products. According to CSL Limited, August 2024, in the 'Annual Report 2024', immunoglobulin product sales increased by 20% to reach $5.66 billion, highlighting the dominant contribution of this therapeutic class to market growth.

To support this trajectory, the rapid expansion of plasma collection and fractionation infrastructure has become a decisive driving factor, with key players aggressively increasing donor center capacity and enhancing purification yields. This strategic broadening of the collection network is essential to mitigate supply chain vulnerabilities and lower the cost per liter of source plasma. Consequently, improved collection volumes are stabilizing the global supply chain and enabling manufacturers to meet rising orders. For instance, according to Grifols, May 2024, in the 'First Quarter 2024 Results', plasma supply increased by 8%, reflecting the effectiveness of these operational initiatives. Broader market resilience is also evident in sector revenues; according to Grifols, in 2024, total revenue for the first half of the year reached EUR 3,444 million.

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Key Market Challenges

The heavy reliance on a limited number of regions for plasma collection creates a logistical bottleneck that severely hampers the growth of the Global Blood Plasma Fractionation Market. This geographic imbalance forces the industry to maintain expensive and complex transcontinental supply chains to move biological raw materials from donor-rich nations to fractionation facilities worldwide. Consequently, manufacturers frequently face feedstock limitations that prevent them from scaling production volumes to match the escalating clinical requirements for immunoglobulin and coagulation therapies.

This supply chain vulnerability directly results in market stagnation in import-dependent regions, where the inability to secure sufficient fractionation substrates leads to critical therapy shortages. This restriction on availability effectively caps revenue potential and stalls market penetration in underserved areas. According to the European Blood Alliance, in 2024, persistent supply constraints and import dependencies led the European Medicines Agency to anticipate shortages of essential plasma-derived medicinal products in 14 European countries. These disruptions illustrate how the difficulty in diversifying collection sources directly constrains the industry's ability to capitalize on growing global demand.

Key Market Trends

The increasing adoption of subcutaneous immunoglobulin (SCIg) administration is fundamentally reshaping the market, driven by a growing patient preference for home-based therapies that minimize clinical dependence. This delivery method allows for self-administration and maintains stable serum antibody levels, effectively mitigating the systemic side effects often associated with intravenous cycles. Manufacturers are responding by launching high-concentration formulations and user-friendly devices specifically designed to facilitate this autonomous treatment model. This rapid transition is substantiated by corporate performance; according to Grifols, July 2024, in the 'First Half 2024 Results', sales of the subcutaneous product Xembify surged by 60% at constant currency, reflecting the strong commercial momentum of this therapeutic modality.

Simultaneously, the localization of fractionation facilities is emerging as a critical strategy for nations striving to achieve self-sufficiency and insulate their healthcare systems from global supply volatility. Import-dependent regions are moving beyond simple procurement models to establish domestic processing infrastructure, enabling the conversion of locally sourced plasma into finished medicinal products within national borders. This structural evolution aims to secure a sovereign supply of essential proteins while reducing exposure to cross-border logistics risks. Illustrating this development, according to the Indonesia Investment Authority, November 2024, in a joint venture announcement, the organization confirmed the construction of a domestic fractionation plant with an annual processing capacity of 600,000 liters to meet national demand.

Segmental Insights

Immunoglobulins constitute the fastest-growing segment in the Global Blood Plasma Fractionation Market, primarily driven by the increasing prevalence of primary and acquired immunodeficiencies. This demand is further amplified by a rising geriatric population, which is highly susceptible to autoimmune and neurological disorders requiring plasma-derived therapies. Furthermore, regulatory bodies such as the U.S. Food and Drug Administration continue to approve these therapies for new clinical indications, significantly expanding the eligible patient base. Consequently, the widespread adoption of immunoglobulins for diverse medical conditions serves as a primary catalyst for this sector’s rapid expansion.

Regional Insights

North America holds a leading position in the Global Blood Plasma Fractionation Market, supported by a well-established healthcare system and a high density of plasma collection facilities. The region sees consistent demand for immunoglobulin and coagulation factors to treat chronic conditions such as immunodeficiency disorders. This market position is strengthened by the concentration of major manufacturers and clear regulatory guidelines from the U.S. Food and Drug Administration. These factors ensure a steady supply chain and efficient approval processes, effectively maintaining North America’s dominance in the global landscape.

Recent Developments

• In November 2025, CSL announced a plan to invest $1.5 billion to expand its manufacturing operations in the United States, aiming to strengthen the production of plasma-derived therapies. This strategic capital injection was directed toward increasing the capacity for collecting and fractionating blood plasma, which is essential for creating life-saving treatments for bleeding disorders and immune deficiencies. The initiative was intended to enhance the company's domestic supply chain resilience and mitigate potential risks associated with international shipping or tariffs. The investment underscored the organization's long-term commitment to meeting the growing clinical need for immunoglobulin and other plasma products.
• In June 2024, Grifols solidified a strategic alliance with Haier Group, a global leader in innovation, to capitalize on the growing plasma market in China. As part of this collaboration, the company finalized the sale of a 20% equity stake in Shanghai RAAS to its partner for RMB 12.5 billion. This partnership was designed to leverage the respective capabilities of both organizations, enhancing the distribution and accessibility of plasma-derived medicines within the region. The deal also extended an exclusive albumin distribution agreement, ensuring long-term supply continuity while allowing the organization to focus on reducing its secured debt obligations.
• In June 2024, Takeda announced a significant capital investment of $230 million to expand the production capacity of its plasma-derived therapies at its manufacturing site in Los Angeles, California. This facility, recognized as one of the company's largest fractionation sites globally, was upgraded to process an additional capacity of up to 2 million liters of plasma annually. The expansion was undertaken to address the increasing global demand for essential treatments for patients with rare and chronic diseases, such as immunodeficiencies. The project also aimed to enhance supply chain resilience and foster sustainable growth within the local community.
• In January 2024, Octapharma USA announced the commercial launch of Balfaxar, a human prothrombin complex concentrate, in the United States market. This new therapy was introduced for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy in adult patients necessitating urgent surgery or invasive procedures. The product release followed approval from the U.S. Food and Drug Administration and provided healthcare professionals with a critical treatment option to restore blood coagulation by replenishing deficient clotting factors. The company emphasized its commitment to ensuring a consistent supply of this life-saving medication to hospitals and medical providers.

Key Market Players

• Grifols, S.A.
• CSL Limited
• Takeda Pharmaceutical Company Limited
• Octapharma AG
• Kedrion S.p.A
• Biotest AG
• Bio Products Laboratory Ltd.
• Intas Pharmaceuticals Ltd.
• ADMA Biologics, Inc.
• Meiji Holdings Co., Ltd.

By Product	By Method	By Application	By End Use	By Region
Albumin Immunoglobulins Coagulation Factors Protease Inhibitors and Others	Centrifugation Depth Filtration Chromatography Others	Neurology Haematology Oncology Immunology Pulmonology Others	Hospitals & Clinics Clinical Research Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Blood Plasma Fractionation Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Blood Plasma Fractionation Market, By Product:

• Albumin
• Immunoglobulins
• Coagulation Factors
• Protease Inhibitors and Others

• Blood Plasma Fractionation Market, By Method:

• Centrifugation
• Depth Filtration
• Chromatography
• Others

• Blood Plasma Fractionation Market, By Application:

• Neurology
• Haematology
• Oncology
• Immunology
• Pulmonology
• Others

• Blood Plasma Fractionation Market, By End Use:

• Hospitals & Clinics
• Clinical Research
• Others

• Blood Plasma Fractionation Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE