Plasma Fractionation Market By Product Type (Immunoglobulins, Albumin, Coagulation Factors, Protease Inhibitors, Others); By Application (Neurology, Immunology, Hematology, Critical Care, Infectious Diseases, Others); By End User (Hospitals, Plasma Collection Centers, Research Laboratories, Academic Institutions, Others); By Geography, Segment Revenue Estimation, Forecast, 2024–2030.

1. Introduction and Strategic Context

The Global Plasma Fractionation Market will witness a robust CAGR of 7.1% , valued at approximately $28.9 billion in 2024 , and is expected to appreciate and reach $43.61 billion by 2030 , confirms Strategic Market Research.

Plasma fractionation is the process of separating various therapeutic components—such as immunoglobulins, clotting factors, and albumin—from human plasma. It is a cornerstone technology within biopharmaceutical manufacturing, especially for chronic, rare, and life-threatening conditions like primary immunodeficiencies, hemophilia , and liver disease. As of 2024, plasma-derived therapies represent an indispensable segment of global healthcare, offering irreplaceable treatments where synthetic alternatives are still under development or unavailable.

Strategically, the market aligns with several macro-level forces. These include the rising global prevalence of immune and bleeding disorders , growth in aging populations , and regulatory support for plasma therapy infrastructure , particularly in North America, Europe, and parts of Asia-Pacific. Moreover, innovation in cold chain logistics, plasmapheresis technology, and AI-led plasma screening are expected to accelerate collection and fractionation efficiency.

The COVID-19 pandemic further spotlighted the sector, as convalescent plasma therapy gained experimental traction, reviving both public and private investment in plasma processing infrastructure.

Key stakeholders in this market include:

• Plasma collection organizations (e.g., blood banks, commercial collection centers )
• Biopharmaceutical manufacturers specializing in plasma derivatives
• Government health bodies and regulatory agencies
• Hospital procurement departments and clinical laboratories
• Investors and private equity firms focused on healthcare innovation

Expert insight: “With autoimmune and neuroimmune diseases increasingly being linked to immune protein deficiencies, the demand for highly purified immunoglobulins is set to reshape the landscape of biologics by 2030.”

2. Market Segmentation and Forecast Scope

To provide a holistic view, the plasma fractionation market can be segmented across four strategic dimensions: By Product Type , By Application , By End User , and By Region . These segments reflect the market’s underlying drivers—from therapeutic demand to manufacturing capabilities—and help identify key growth opportunities across stakeholder groups.

By Product Type

This dimension focuses on the core plasma-derived components generated through fractionation. The primary categories include:

• Immunoglobulins (Intravenous [IVIG] and Subcutaneous [SCIG])
• Albumin
• Coagulation Factor Concentrates (Factor VIII, Factor IX, von Willebrand factor, fibrinogen, etc.)
• Protease Inhibitors
• Others (alpha-1 antitrypsin, C1 esterase inhibitors)

In 2024 , immunoglobulins accounted for approximately 42% of the total market share , driven by increasing diagnoses of primary immunodeficiency diseases (PIDs), autoimmune conditions, and off-label neurological use (e.g., for CIDP and MMN).

Albumin , while used less frequently in chronic disease settings, is experiencing growing demand due to its role in liver disease and sepsis management—particularly in Asia-Pacific markets.

By Application

Applications reflect the therapeutic areas and disease conditions addressed by plasma-derived products:

• Neurology (Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy)
• Immunology (Primary and secondary immunodeficiency diseases)
• Hematology ( Hemophilia A & B, von Willebrand Disease)
• Critical Care (Shock, trauma, burns)
• Infectious Diseases
• Others (organ transplant, hepatic conditions)

The neurology and immunology segments are witnessing the fastest growth, driven by increased awareness, earlier diagnosis, and expanded clinical recommendations for IVIG usage.

By End User

• Hospitals and Clinics
• Research Laboratories
• Academic Institutions
• Plasma Collection Centers
• Others (Military, Mobile Units)

Hospitals remain the dominant end-user, owing to their role in acute and chronic therapy delivery. However, plasma collection centers are witnessing rapid expansion due to rising demand for raw plasma in both regulated and emerging markets.

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa

North America remains the global leader in plasma fractionation, supported by its vast donor base, favorable reimbursement models, and strong biopharmaceutical ecosystem. However, Asia Pacific is expected to register the highest CAGR through 2030, owing to rising healthcare investments, growing patient awareness, and expanding plasma donation infrastructure in countries like China, South Korea, and India.

Strategic Note: “With China’s National Plasma Plan and India’s public-private biopharma accelerators, Asia is poised to become a strategic reservoir for raw plasma collection and regional fractionation hubs.”

3. Market Trends and Innovation Landscape

The plasma fractionation market is undergoing a wave of innovation driven by biotechnology advancements, automation, and strategic collaborations. The sector is no longer confined to traditional protein separation but is evolving into a high-precision, tech-integrated therapeutic ecosystem.

A. Technological Advancements in Fractionation and Collection

The shift from ethanol-based cold fractionation to chromatography and advanced filtration techniques is allowing manufacturers to improve yield, reduce impurities, and optimize processing time. Innovations like continuous flow centrifugation and closed-loop fractionation systems are helping reduce cross-contamination risks and enhance protein recovery.

Plasma collection, the front end of this value chain, is being modernized through AI-powered donor screening , digital vein visualization , and plasma protein profiling tools . These tools help in matching specific plasma characteristics to disease-specific product outputs—improving product efficacy.

Expert insight: “Next-generation fractionation lines are designed for modular scalability, enabling producers to adapt to regional surges in demand without complete infrastructure overhauls.”

B. Innovation in Formulation and Delivery

While intravenous immunoglobulins (IVIG) remain standard, subcutaneous formulations (SCIG) are gaining traction for at-home administration. These offer improved patient compliance and reduce hospital burden.

Emerging areas include:

• Nanoparticle-enhanced albumin formulations
• Lyophilized clotting factors for better shelf life
• Recombinant plasma substitutes as adjunct or backup therapies

The push for low-volume, high-potency formulations is opening new delivery mechanisms such as pen-injectors and on-body infusion pumps, especially for neuromuscular conditions requiring long-term immunoglobulin therapy.

C. Strategic M&A, Partnerships, and Capacity Expansion

Global leaders are investing in both vertical integration and geographic diversification. For example:

• Major biopharma firms have announced multi-billion-dollar expansion projects in North America and Japan to scale up fractionation capacity.
• Tech partnerships are emerging between AI health startups and plasma centers to accelerate donor analytics and plasma quality scoring .
• Mergers are increasingly focused on access to regional donor pools , allowing companies to localize supply chains and bypass raw material bottlenecks.

D. Clinical Research and Pipeline Evolution

The pipeline for plasma-derived therapies is expanding to target neurodegenerative disorders , post-viral syndromes , and rare complement deficiencies . Several studies are evaluating hyperimmune globulin applications in long COVID and sepsis-associated immune dysfunction .

Moreover, the integration of real-world evidence (RWE) into product life-cycle planning is becoming standard practice. This ensures faster market adaptation and more personalized use of plasma therapies.

Strategic Commentary: “The fusion of biologics, AI, and decentralized logistics is quietly revolutionizing plasma fractionation—transforming it from a batch-intensive process to a predictive, precision-driven platform.”

4. Competitive Intelligence and Benchmarking

The plasma fractionation market is characterized by a combination of global biopharmaceutical giants , regionally dominant players , and emerging specialists leveraging localized donor networks and innovative fractionation technologies. The competitive landscape is shaped by access to raw plasma, fractionation capacity, regulatory certifications, and clinical trial pipelines.

Here are six key companies and their strategic positioning:

1. CSL Behring

A global frontrunner, CSL Behring operates one of the world’s largest plasma collection networks through CSL Plasma , with over 300 centers worldwide. The company maintains a vertically integrated model—spanning donor recruitment to end-product delivery.

Strategy: Heavy investment in new fractionation plants in Australia and Germany, expansion of SCIG product lines , and acquisitions such as Vifor Pharma to strengthen its nephrology and rare disease focus.

2. Grifols

Grifols , headquartered in Spain, controls a significant portion of the U.S. plasma collection ecosystem via Biomat USA and other centers . It operates multiple manufacturing facilities across Europe and North America.

Strategy: Focused on automated fractionation processes and AI-led donor management systems , along with strategic partnerships for hyperimmune globulin development. Grifols is also exploring plasma-derived therapies for neurodegenerative diseases through its Alzheimer’s treatment trials.

3. Takeda Pharmaceutical Company

Takeda , after acquiring Shire, emerged as a top-tier player in the plasma-derived therapy space. It leads in immunoglobulin therapy and hereditary angioedema solutions.

Strategy: Strengthening presence in Asia-Pacific through localized manufacturing and government alliances. R&D is centered on differentiated plasma proteins , especially for underserved conditions such as CIDP and rare bleeding disorders.

4. Octapharma

Octapharma , based in Switzerland, has a diverse portfolio that spans immunotherapy, hematology , and critical care . It operates fractionation facilities in Austria, Sweden, and Germany.

Strategy: Strong emphasis on research-led differentiation , including virus-inactivated IVIGs and personalized dosing regimens. The company is also expanding its clinical trial footprint in Latin America and Eastern Europe to address unmet medical needs.

5. Kedrion Biopharma

Italian-based Kedrion focuses on the development of plasma-derived medicines for both common and rare conditions. It recently merged with Bio Products Laboratory (BPL), enhancing its fractionation footprint in the UK and U.S.

Strategy: Focused on synergistic product development and strengthening its donor base across the U.S. and Europe. Kedrion is also positioning itself as a mid-market innovator for niche indications like Rh incompatibility .

6. Bio Products Laboratory (BPL)

Now operating under a joint framework with Kedrion , BPL is known for its emphasis on safety-led innovation and high-purity proteins. The company also operates a growing plasma collection arm in the United States.

Strategy: Investment in next-gen purification platforms and expanding critical care product lines for military and emergency medicine markets.

Benchmark Insight: “While large players dominate infrastructure and donor access, the next battleground is innovation in rare disease treatment and biologic formulation. Those who adapt fastest to patient-centric therapies will define the next growth cycle.”

5. Regional Landscape and Adoption Outlook

The plasma fractionation market demonstrates pronounced geographic variations in donor availability, infrastructure readiness, regulatory alignment, and disease prevalence. While North America and Europe currently dominate the landscape, Asia-Pacific and Latin America are emerging as high-growth frontiers due to policy shifts and capacity-building initiatives.

North America

The United States leads the global market by a significant margin, contributing over 40% of total plasma collected globally . This is supported by a well-established plasma donation culture , favorable reimbursement systems, and mature biomanufacturing infrastructure.

• Strengths: Robust FDA oversight, vertically integrated fractionation plants, high public awareness
• Challenges: Rising donor compensation costs, stringent quality standards that delay international entry

Canada , while more restrictive in plasma collection compensation, is exploring public-private partnerships to reduce its dependency on imported plasma products.

Europe

Europe holds a strong position due to nationalized healthcare systems and government-affiliated fractionation agencies in countries like France (LFB) and Germany ( Octapharma , CSL Behring facilities) .

• Western Europe : Advanced fractionation facilities and ethical donor policies (mostly non-compensated)
• Eastern Europe : Rising investments in plasma centers , especially in Poland and Hungary, where donor growth is robust

The EU Plasma Master Plan promotes regional self-sufficiency, pushing member states to build local reserves of immunoglobulins and clotting factors.

Expert insight: “The European plasma model is pivoting from ethical sufficiency to therapeutic urgency—expect state-funded fractionation expansion over the next five years.”

Asia Pacific

Asia-Pacific is poised to be the fastest-growing regional market , with a projected CAGR exceeding 9% through 2030. This growth is underpinned by healthcare infrastructure upgrades , expanding plasma donation programs, and domestic biopharma champions .

• China : Under its Plasma Collection Regulation Act, the country is significantly expanding its donor pool through regional collection centers . Domestic players like China Biologic Products are receiving R&D incentives.
• Japan : A mature market with strong adoption of immunoglobulin therapy in neurology
• India : Fragmented infrastructure, but growing interest from public-private joint ventures and academic institutions in building national fractionation capabilities

Latin America

Latin America presents a mix of opportunity and underutilization . While countries like Brazil and Mexico have robust public health institutions, plasma donation rates remain low.

• Opportunities : Increasing prevalence of liver disease, trauma-related conditions, and hemophilia
• Barriers : Weak supply chains and limited local fractionation plants

Government efforts in Brazil aim to ramp up self-sufficiency by supporting domestic biotech companies and building public plasma banks .

Middle East & Africa (MEA)

This region is currently underserved but offers white-space opportunities, particularly in GCC countries with rising demand for immunoglobulins and albumin.

• UAE and Saudi Arabia are exploring in-region fractionation capabilities as part of their biotech localization goals.
• Sub-Saharan Africa faces the largest gap, with almost complete reliance on imported plasma products and limited diagnostic capabilities for rare diseases.

Regional Forecast: “Asia-Pacific’s rise is inevitable, but Africa’s need is urgent. Strategic partnerships in diagnostics, donor engagement, and localized training could unlock billions in untapped value.”

6. End-User Dynamics and Use Case

End-user demand in the plasma fractionation market is shaped by clinical urgency, procedural volume, and infrastructure readiness. Each category of end user plays a unique role in the supply chain and therapeutic application of plasma-derived products, influencing not only the scale of adoption but also product specifications and regulatory engagement.

Primary End Users

1. Hospitals and Clinics Hospitals—particularly tertiary care and specialty clinics—remain the largest end users , primarily due to their role in administering immunoglobulins, clotting factors, and albumin in high-acuity settings. They serve patients with chronic immunodeficiency, trauma, burns, and post-operative bleeding disorders. Many institutions also run their own plasma therapy protocols, especially for neurological and oncological patients .

2. Plasma Collection Centers These centers are vital nodes in the upstream supply chain. Organizations like CSL Plasma , Grifols Biomat , and Octapharma Plasma operate dedicated collection facilities with donor screening, plasma storage, and cold-chain logistics. In emerging economies, mobile collection units and university-affiliated plasma donation campaigns are becoming more common.

3. Research and Academic Institutions These users contribute to preclinical and clinical research in biologics, investigating plasma fractions for newer indications like sepsis-related immunosuppression, long COVID, and Alzheimer’s disease. Academic hospitals often pilot novel protocols before broader clinical adoption.

4. Military and Emergency Services In specific geographies (e.g., the U.S., Israel), military hospitals use freeze-dried plasma and albumin in battlefield trauma and emergency response situations, valuing portability and extended shelf life.

Illustrative Use Case: Hospital-Based IVIG Therapy for Autoimmune Neuropathy

A tertiary hospital in South Korea launched a structured outpatient program for patients diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Using subcutaneous immunoglobulin (SCIG) sourced from local suppliers, the hospital implemented a biweekly home-administered therapy protocol.

Results showed a 25% reduction in hospital readmissions and a 40% improvement in patient-reported mobility scores over 9 months. Additionally, pharmacy waste dropped by 18% due to more accurate dose matching through plasma protein analytics.

This use case underscores the efficiency and patient-centric potential of evolving plasma therapies when combined with tech-supported protocols and decentralized administration.

Expert insight: “The shift from hospital-exclusive delivery to hybrid and home-based models will redefine how plasma-derived therapies are valued—not just by volume, but by outcomes.”

7. Recent Developments + Opportunities & Restraints

(Short Section)

🆕 Recent Developments (Past 2 Years)

• CSL Behring announced a $1.5 billion expansion of its Marburg, Germany fractionation plant in 2023, aiming to increase its capacity by 70% to meet the rising global demand for immunoglobulins.
• Grifols and the Egyptian government signed a public-private partnership in 2022 to develop Egypt’s first large-scale plasma collection and fractionation infrastructure.
• Takeda launched new SCIG formulations for immunodeficiency therapy in key European and Asian markets, enhancing patient flexibility and reducing hospital dependency.
• Octapharma received EMA approval for its new immunoglobulin formulation designed for neurological disorders, including CIDP and MMN.
• BPL and Kedrion completed their merger in early 2023 , forming a combined entity focused on rare plasma protein therapies and expanded global donor access.

🔁 Opportunities

1. Asia-Pacific Expansion Governments in China, India, and Indonesia are pushing for local plasma collection and fractionation capacities, reducing dependency on imports and creating fertile ground for regional market entry.

2. At-Home Immunoglobulin Therapy The rapid adoption of SCIG and wearable infusion systems supports decentralization, lowering hospital burden and opening new segments in home healthcare.

3. AI and Predictive Analytics in Donor Management Digital transformation in plasma centers —using AI to optimize donor selection, screening, and plasma matching—can improve safety, yields, and cost-efficiency.

🚧 Restraints

1. Regulatory Fragmentation and Delays Differences in plasma-related laws (especially around donor compensation and cross-border plasma movement) limit scalability and slow down market penetration in new regions.

2. High Infrastructure and Operational Costs Setting up fractionation facilities involves massive capital investment, specialized talent, and high biosafety protocols—posing a barrier for new entrants and emerging market facilities.