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.

Introduction and Strategic Context

The Global Plasma Fractionation Market is projected to grow at a strong CAGR of 7.1%, increasing from $28.9 billion in 2024 to $43.61 billion by 2030, fueled by expanding plasma collection infrastructure, surging immune disorder treatment, rising rare disease therapeutics, advancements in fractionation technologies, growth in biologics market, and demand for IVIG therapy, according to 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.”

 

Comprehensive Market Snapshot

The Global Plasma Fractionation Market is projected to grow at a strong CAGR of 7.1%, increasing from USD 28.9 billion in 2024 to USD 43.61 billion by 2030, fueled by expanding plasma collection infrastructure, surging immune disorder treatment demand, rising rare disease therapeutics, advancements in fractionation technologies, growth in the biologics landscape, and accelerating IVIG therapy adoption, according to Strategic Market Research.

Regional Market Share

• USA Plasma Fractionation Market accounted for 63.0% of the global market in 2024 and is estimated at USD 18.21 billion, projected to reach approximately USD 25.83 billion by 2030 at a 6.0% CAGR, supported by its extensive plasma collection network, strong reimbursement systems, and leadership in biologics manufacturing.

• Europe Plasma Fractionation Market represented 19.0% of the global market in 2024 and is valued at USD 5.49 billion, expected to reach around USD 7.33 billion by 2030 at a 4.9% CAGR, driven by established fractionation infrastructure and stable demand across immunology and hematology applications.

• APAC Plasma Fractionation Market held 5.8% of the global market in 2024 and is estimated at USD 1.68 billion, projected to grow to approximately USD 2.91 billion by 2030 at a 9.6% CAGR, fueled by increasing plasma infrastructure investments, rising healthcare access, and expanding rare disease awareness.

 

Regional Insights

• USA accounted for the largest market share of 63.0% in 2024, supported by its extensive plasma collection network, strong reimbursement systems, and leadership in biologics manufacturing.

• Asia Pacific (APAC) is expected to expand at the fastest CAGR of 9.6% during 2024–2030, driven by increasing plasma infrastructure investments, rising healthcare access, and expanding rare disease awareness.

 

By Product Type

• Immunoglobulins dominated the product landscape with a 42.0% share in 2024, valued at approximately USD 12.14 billion, reflecting strong IVIG and SCIG demand across neurology and immunology applications.

• Albumin accounted for 23.0% of the global market in 2024, estimated at around USD 6.65 billion, supported by its widespread use in critical care, liver disease management, and surgical procedures.

• Coagulation Factors represented 18.0% of the market in 2024, valued at nearly USD 5.20 billion, and are projected to grow at a notable CAGR through 2030 due to rising hemophilia diagnosis rates and recombinant–plasma hybrid therapy adoption.

• Protease Inhibitors contributed 9.0% of the market in 2024, estimated at approximately USD 2.60 billion, driven by their use in hereditary angioedema and rare disease treatments.

• Others (Product Segment) held 8.0% of the global market in 2024, valued at about USD 2.31 billion, covering niche plasma-derived therapies and specialty biologics.

 

By Application

• Immunology led the application segment with a 34.0% share in 2024, estimated at roughly USD 9.83 billion, owing to the increasing prevalence of primary and secondary immunodeficiency disorders.

• Neurology accounted for 24.0% of the market in 2024, valued at around USD 6.94 billion, and is expected to expand at a strong CAGR through 2030 driven by expanded IVIG clinical indications such as CIDP and Guillain-Barré syndrome.

• Hematology represented 18.0% of the market in 2024, estimated at nearly USD 5.20 billion, supported by growing demand for coagulation factor therapies and bleeding disorder management.

• Critical Care captured 12.0% of the market in 2024, valued at approximately USD 3.47 billion, reflecting albumin use in trauma, burns, and intensive care management.

• Infectious Diseases accounted for 7.0% of the global market in 2024, estimated at about USD 2.02 billion, driven by immunoglobulin therapies in infection-related complications.

• Others (Application Segment) contributed 5.0% of the market in 2024, valued at roughly USD 1.45 billion, covering emerging and specialty indications.

 

By End User

• Hospitals & Clinics dominated the end-user segment with a 55.0% share in 2024, estimated at approximately USD 15.90 billion, reflecting their leadership in acute IVIG administration and chronic hematology therapy delivery.

• Plasma Collection Centers represented 22.0% of the market in 2024, valued at around USD 6.36 billion, and are anticipated to expand at a robust CAGR through 2030 supported by increasing plasma demand and regulatory expansion of collection capacity.

• Research Laboratories accounted for 10.0% of the market in 2024, estimated at nearly USD 2.89 billion, driven by ongoing biologics development and clinical research activities.

• Academic Institutions held 7.0% of the market in 2024, valued at approximately USD 2.02 billion, supported by translational research and plasma-derived therapy studies.

• Others (End User Segment) contributed 6.0% of the market in 2024, estimated at about USD 1.73 billion, encompassing specialty treatment centers and contract research organizations.

 

Strategic Questions Driving the Next Phase of the Global Plasma Fractionation Market

1. What plasma-derived products (e.g., immunoglobulins, albumin, coagulation factors, protease inhibitors) are explicitly included within the Global Plasma Fractionation Market, and which blood components or recombinant alternatives are out of scope?

2. How does the Plasma Fractionation Market structurally differ from adjacent biologics, recombinant factor therapies, gene therapies, and synthetic plasma substitute markets?

3. What is the current and projected size of the Global Plasma Fractionation Market, and how is value distributed across major product categories?

4. How is revenue allocated between immunoglobulins (IVIG/SCIG), albumin, coagulation factors, and specialty plasma proteins, and how is this mix expected to evolve over the forecast period?

5. Which therapeutic areas (immunology, neurology, hematology, critical care, infectious diseases) account for the largest and fastest-growing revenue pools?

6. Which plasma-derived product segments generate disproportionately higher margins relative to treatment volume?

7. How does demand differ between acute care, chronic therapy, and prophylactic treatment populations, and how does this impact product utilization patterns?

8. How are first-line, maintenance, and advanced plasma-derived therapies evolving within treatment guidelines for immunodeficiency, hemophilia, and autoimmune neurological disorders?

9. What role do treatment duration, dosing frequency, patient switching (IVIG to SCIG), and long-term persistence play in revenue growth?

10. How are plasma donation rates, collection infrastructure capacity, and fractionation yield efficiency influencing global supply-demand balance?

11. What regulatory, safety, or donor-screening constraints limit expansion in specific geographic markets?

12. How do reimbursement policies, pricing controls, and tender-based procurement systems impact revenue realization across developed and emerging markets?

13. How strong is the mid-term pipeline for new plasma-derived indications and fractionation technologies, and which innovations could create new revenue segments?

14. To what extent will recombinant and gene therapies for hemophilia and rare diseases displace plasma-derived products versus expand overall treated populations?

15. How are advances in purification technologies, pathogen reduction systems, and high-yield fractionation processes improving cost efficiency and product safety?

16. How will consolidation among plasma collectors and fractionators reshape competitive intensity and bargaining power across the value chain?

17. What role will biosimilars, alternative biologics, and regional manufacturing expansion play in segment-level price dynamics?

18. How are leading companies aligning their plasma collection networks, product portfolios, and geographic expansion strategies to secure long-term supply leadership?

19. Which geographic regions are expected to outperform global growth, and which product categories are driving this outperformance?

20. How should manufacturers and investors prioritize capacity expansion, product mix optimization, and regional partnerships to maximize long-term value creation in the Plasma Fractionation Market?

 

Segment-Level Insights and Market Structure

Global Plasma Fractionation Market

The Global Plasma Fractionation Market is organized around differentiated product categories and end-use delivery structures that reflect therapeutic purpose, clinical complexity, and supply-chain intensity. Each segment contributes uniquely to revenue generation, margin structure, capital requirements, and long-term strategic positioning. Market dynamics are shaped not only by disease burden and treatment guidelines, but also by plasma availability, fractionation capacity, regulatory oversight, and global distribution networks.

 

Product Type Insights

Immunoglobulins (IVIG and SCIG)

Immunoglobulins represent the most commercially significant segment within plasma fractionation. These products are widely used in primary and secondary immunodeficiency disorders, autoimmune diseases, and neurological conditions. Their importance is driven by chronic, repeat-dosing regimens and expanding clinical indications.

From a structural standpoint, immunoglobulins require highly controlled purification processes and significant plasma input, which reinforces supply sensitivity. Demand growth is closely linked to earlier diagnosis, broader guideline recommendations, and improved access to infusion and home-based subcutaneous therapies. Over time, the mix between intravenous (IVIG) and subcutaneous (SCIG) formats is evolving, with SCIG gaining traction due to improved convenience and patient autonomy.

Immunoglobulins anchor overall market value and typically command strong margins due to their therapeutic breadth and limited substitution alternatives.

Albumin

Albumin occupies a more volume-driven but price-sensitive position within the market. It is used extensively in critical care settings, liver disease management, burn treatment, and surgical support. Unlike immunoglobulins, albumin usage is often episodic rather than chronic.

Commercially, albumin benefits from high clinical familiarity and broad institutional demand, particularly in emerging healthcare systems. However, it faces more pronounced pricing pressure and tender-based procurement in several regions. Growth in this segment is influenced by hospital capacity expansion and increasing incidence of hepatic and critical illnesses.

While albumin contributes meaningfully to global fractionation output utilization, it typically reflects lower per-unit margins compared to specialty plasma proteins.

Coagulation Factor Concentrates

Coagulation factors, including Factor VIII, Factor IX, von Willebrand factor, fibrinogen, and related proteins, are essential for treating bleeding disorders such as hemophilia and rare clotting deficiencies.

This segment operates at the intersection of plasma-derived and recombinant competition. In some regions, recombinant factors dominate early-line therapy, while plasma-derived alternatives retain relevance in cost-sensitive markets and specific patient populations.

From a strategic standpoint, coagulation factors represent a specialized, high-value segment with targeted patient populations. Demand patterns are influenced by prophylactic treatment protocols, national hemophilia programs, and access to advanced therapies. The competitive landscape is evolving due to gene therapy advancements and extended half-life products, which may alter long-term utilization patterns.

Protease Inhibitors

Protease inhibitors derived from plasma, including therapies for hereditary angioedema and alpha-1 antitrypsin deficiency, represent niche but clinically critical segments.

These products typically address rare diseases with high unmet need, leading to concentrated but premium-priced markets. Their commercial dynamics differ from broader segments, as patient volumes are limited but long-term therapy duration supports sustained revenue streams.

Innovation in this category often focuses on improved dosing frequency, safety profiles, and expansion into additional rare indications.

Other Plasma-Derived Proteins

This category includes specialized proteins such as C1 esterase inhibitors and other low-volume fractionation outputs. These therapies serve defined patient populations and contribute to maximizing plasma utilization efficiency.

Although individually smaller in scale, collectively they enhance the economic yield of fractionation processes and diversify portfolio exposure across rare disease treatment segments.

 

Application Insights

Immunology

Immunology constitutes a core therapeutic application for plasma-derived products, particularly immunoglobulins. Demand is driven by primary immunodeficiency disorders, secondary immune suppression, and autoimmune diseases requiring immune modulation.

Chronic treatment duration and rising awareness of immune disorders reinforce consistent product utilization. Improvements in diagnostic rates and expanded clinical indications continue to shape long-term demand growth in this segment.

Neurology

Neurological conditions such as chronic inflammatory demyelinating polyneuropathy (CIDP) and Guillain-Barré syndrome represent high-value use cases for immunoglobulin therapies.

Growth in neurology is influenced by earlier diagnosis, expanding treatment guidelines, and improved long-term disease management strategies. As evidence accumulates for off-label and extended uses, neurology is becoming an increasingly important contributor to overall immunoglobulin demand.

Hematology

Hematology applications center on bleeding disorders and coagulation deficiencies. Market performance in this segment is closely tied to national screening programs, prophylaxis adoption, and access to specialty care.

While gene therapy and recombinant factors introduce competitive pressure, plasma-derived options remain relevant in several healthcare systems, particularly where cost constraints shape therapeutic choice.

Critical Care

Critical care usage includes shock management, trauma care, burns, and severe liver disease. Albumin is especially prominent in this setting.

Demand in this segment fluctuates based on hospital infrastructure capacity, public health emergencies, and surgical volumes. Though often episodic, critical care contributes meaningfully to baseline product consumption.

Infectious Diseases and Other Applications

Certain plasma-derived therapies are utilized in infectious disease management and specialized transplant settings. These applications tend to be more selective but may expand as clinical evidence evolves.

 

End User Insights

Hospitals and Clinics

Hospitals represent the primary setting for plasma-derived therapy administration, especially for IVIG infusions, coagulation factors, and acute albumin use.

Their central role in specialist care, infusion infrastructure, and complex case management positions hospitals as the dominant end-user segment. Institutional procurement and reimbursement negotiations significantly influence product pricing and volume dynamics.

Plasma Collection Centers

Plasma collection centers are foundational to the supply side of the market. While not end users in a therapeutic sense, their expansion directly determines raw material availability.

Growth in this segment reflects strategic investments in donor networks, regulatory compliance, and geographic diversification to secure long-term supply resilience.

Research Laboratories and Academic Institutions

Research institutions contribute to innovation in fractionation technologies, rare disease research, and clinical trials. Although smaller in direct revenue contribution, this segment plays a key role in pipeline development and new indication expansion.

Other Institutional Users

This category includes military healthcare systems, mobile medical units, and specialty care facilities. While representing a modest share of demand, these users contribute to diversified distribution channels.

 

Segment Evolution Perspective

The Plasma Fractionation Market is gradually shifting from primarily hospital-centered acute care use toward a broader chronic disease management model anchored by immunoglobulin therapies.

At the same time, competitive pressure from recombinant and gene-based treatments is influencing specific product categories, particularly within hematology. Supply-side factors—such as plasma collection capacity, donor recruitment trends, and fractionation efficiency—remain critical structural determinants of growth.

Looking ahead, value distribution across segments will increasingly depend on:

• Expansion of chronic immune and neurological indications

• Technological advancements in purification and yield optimization

• Geographic expansion of plasma collection infrastructure

• Shifts toward home-based therapy delivery models

• Competitive dynamics from non-plasma biologic alternatives

Together, these forces will define how revenue, margins, and strategic investment priorities evolve across product, application, and distribution segments in the Global Plasma Fractionation Market.

 

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.”

 

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.”

 

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.”

 

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.”

 

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.”

 

Recent Developments + Opportunities & Restraints

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

• 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.

• 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.

• 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

• 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.

• 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.

 

7.1 Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 28.9 Billion
Revenue Forecast in 2030	USD 43.61 Billion
Overall Growth Rate	CAGR of 7.1% (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Product Type, By Application, By End User, By Geography
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 Region	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Country Scope	U.S., UK, Germany, China, India, Japan, Brazil, etc.
Market Drivers	Rising prevalence of immunological and neurological disorders; Growth in plasma donation infrastructure; Innovations in SCIG and fractionation tech
Customization Option	Available upon request