Plasma Fractionation Market Size, Share, Opportunities, And Trends By Application (Neurology, Immunology, Hematology, Pulmonology), By End-User (Hospitals and Clinics, Academic & Research Institutes), And By Geography - Forecasts From 2025 To 2030

Description

Plasma Fractionation Market Size:

Plasma Fractionation Market is projected to grow at a CAGR of 6.13% between 2025 to 2030.

The Plasma Fractionation Market operates at the critical intersection of specialized biotechnology and human biology, producing essential, life-saving therapies from human blood plasma. This complex process involves isolating and purifying specific therapeutic proteins, such as Immunoglobulins, Albumin, and Coagulation Factors, which are indispensable for treating a range of rare and chronic conditions across immunology, hematology, and neurology. The market's structural imperative is the delicate balance between a perpetually increasing clinical demand, driven by broadening therapeutic indications and rising diagnosis rates, and the inherent supply constraints associated with sourcing the raw material: human plasma. This dependency places established market leaders that control expansive collection networks at a significant competitive advantage, shaping the overall market dynamics and investment decisions around manufacturing capacity and process technologies.

Plasma Fractionation Market Analysis

• Growth Drivers

The primary force propelling market expansion is the Rising Diagnosis and Treatment of Primary and Secondary Immunodeficiencies. As global disease awareness and healthcare access improve, particularly in emerging economies, the pool of patients requiring regular, life-long immunoglobulin treatment expands, directly increasing demand for the fractionation output. Concurrently, the Expansion of Therapeutic Indications for plasma derivatives into chronic neurological disorders, notably Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), introduces a high-volume, continuous patient base. This dual-pronged clinical growth creates an urgent, inelastic demand for the finite supply of plasma-derived products, necessitating capacity augmentation by fractionators like Octapharma and Grifols.

• Challenges and Opportunities

A critical challenge is the inherent Supply Chain Vulnerability, rooted in the dependence on human plasma donation, which experienced instability during periods like the COVID-19 pandemic, restricting the primary raw material supply. This vulnerability creates pricing pressure and limits output, directly constraining market volume. This constraint concurrently generates a significant opportunity: the pursuit of Technological Advancements in Chromatography. Implementing next-generation chromatography and automated purification systems allows fractionators to significantly improve the yield of target proteins per liter of processed plasma. This enhancement increases the effective output of existing plasma supply, addressing the core supply constraint without requiring an equivalent increase in the raw material collected, thereby offering a strategic pathway to meet accelerating demand.

• Raw Material and Pricing Analysis

The sole raw material for the Plasma Fractionation Market is source plasma, making the market fundamentally supply-constrained. Plasma pricing is determined by the variable costs associated with donor compensation, regulatory compliance, and operating extensive collection center networks. The geographic concentration of paid plasma donation centers, particularly in the United States, grants that region disproportionate influence over global raw material availability and cost. Fractionators with vertically integrated operations, such as CSL and Grifols, gain significant cost control and supply assurance advantages over those reliant on third-party plasma sourcing. The high cost of specialized collection and stringent quality control processes translate directly into the high manufacturing cost and premium pricing of finished plasma-derived medicinal products.

• Supply Chain Analysis

The Plasma Fractionation supply chain is exceptionally complex, highly regulated, and vertically integrated. It begins with the collection of source plasma at dedicated centers, predominantly in the US and Europe. Major production hubs are concentrated in established pharmaceutical manufacturing regions (e.g., the US, Spain, Germany, and Austria), where companies like Takeda and CSL operate advanced fractionation facilities. Key logistical complexities include maintaining the ultra-cold chain for plasma storage and transport, and navigating stringent cross-border regulatory clearances for both raw plasma and finished products. The entire chain is critically dependent on a stable, high-volume flow of donor plasma, with global supply heavily reliant on US-sourced donations, creating a geopolitical dependency for end-product manufacturing.

Plasma Fractionation Market Government Regulations

Plasma Fractionation Market Segment Analysis

• By Application: Immunology

The Immunology segment, dominated by the use of Immunoglobulin (Ig) therapies, drives the largest portion of the Plasma Fractionation Market. The necessity is intrinsically linked to the Increasing Prevalence and Improved Diagnosis of Primary and Secondary Immunodeficiency Disorders (PID/SID). PID patients require regular, life-long infusions of Ig to restore protective antibody levels, creating a predictable and non-discretionary revenue stream. The critical driver is the expanding use of Ig for off-label or secondary indications, particularly Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), which consumes significant volumes of product. As clinical guidelines evolve and real-world evidence of efficacy in these chronic neurological conditions mounts, the established patient cohort for Ig expands, translating directly into a sustained, double-digit growth in demand that major fractionators must satisfy through continuous plasma supply expansion.

• By End-User: Hospitals & Clinics

The Hospitals & Clinics segment is the dominant end-user for plasma-derived medicinal products, primarily due to the established administration routes for key therapies. The core growth driver is the requirement for Intravenous Immunoglobulin (IVIg) Administration, which typically necessitates inpatient or specialized outpatient clinic settings due to the volume, infusion rate, and monitoring requirements. Hospitals also consume large volumes of Albumin for critical care, trauma, and liver disease management, applications that are nearly exclusive to the hospital environment. While the market is trending toward home-based care (SCIg), the complex dosing and initial supervision required for a majority of plasma-derived products, coupled with the critical nature of conditions treated, ensure that hospitals and clinics remain the major purchasing entities and points of care, sustaining high institutional demand.

Plasma Fractionation Market Geographical Analysis

• US Market Analysis (North America)

The US market is distinguished by its Dominance in Plasma Sourcing and Premium Reimbursement Environment. The US houses the majority of the world's commercial plasma collection centers, providing the essential raw material that dictates global supply. Favorable and robust reimbursement policies, particularly for high-cost therapies like IVIg and subcutaneous immunoglobulin (SCIg), drive high per-patient utilization. This combination of secured supply and strong purchasing power results in the US being the largest single market, with demand highly sensitive to FDA approvals for new indications and innovations in plasma collection technology that can improve donor yield.

• Brazil Market Analysis (South America)

Brazil represents the most significant market opportunity in South America, driven by Expanding Universal Healthcare Access and Increasing Awareness of Rare Diseases. The public health system (SUS) is the primary purchaser of plasma-derived medicines, with demand directly tied to government tendering processes. While the domestic plasma collection is limited, growing awareness of conditions like hemophilia and primary immunodeficiency translates into steady, mandated demand for imported coagulation factors and immunoglobulins. Market growth is constrained by fluctuating currency and dependency on international fractionation capacity but fueled by demographic shifts.

• Germany Market Analysis (Europe)

Germany is a key European market, characterized by its Strong Public-Private Partnership in Plasma Supply and High Regulatory Standards. Germany possesses a robust infrastructure for both commercial and non-remunerated plasma collection, contributing significantly to Europe's total supply. The local factor impacting demand is the high level of medical sophistication and the established patient pathways for complex treatments. This results in strong, stable demand for high-quality Albumin and specialized Immunoglobulins, reinforced by the country's reliable reimbursement system and the presence of major fractionators like Biotest and Octapharma.

• Saudi Arabia Market Analysis (Middle East & Africa)

The Saudi Arabian market is experiencing accelerated growth, driven by Significant Government Investment in Specialized Healthcare Infrastructure. National initiatives to improve treatment for chronic diseases and a rapidly modernizing hospital system fuel this demand. Due to a near-total reliance on imports, demand is determined by long-term government procurement contracts and tenders for plasma products, particularly IVIg for immunodeficiency and neurological indications. The market prioritizes product quality, requiring international certifications (e.g., EMA/FDA approval), which favors the established global fractionators.

• Japan Market Analysis (Asia-Pacific)

Japan is a critical, mature market in Asia-Pacific, defined by its Commitment to Domestic Plasma Self-Sufficiency and Strict Quality Control. The government actively encourages domestic plasma collection to reduce reliance on imports, although demand still exceeds local supply. The local factor influencing demand is the Aging Population and the subsequent rise in age-related chronic conditions, including neurological disorders, which require immunoglobulin therapy. This demographic trend sustains high, consistent demand for premium plasma-derived products, with regulatory processes emphasizing long-term safety and stability.

Plasma Fractionation Market Competitive Environment and Analysis

The Plasma Fractionation Market exhibits a high degree of concentration, functioning as an oligopoly dominated by three globally integrated fractionators, such as CSL, Grifols, and Takeda, who collectively manage the majority of the world's plasma supply and processing capacity. Competition is driven by securing the raw material (plasma), maximizing fractionation yield through proprietary technology, and expanding therapeutic indications through clinical trials. Strategic expansion focuses on vertical integration, ensuring control over the entire value chain from donor arm to patient administration.

• Grifols SA

Grifols SA is strategically positioned as a fully integrated global leader with a massive network of plasma collection centers, primarily in North America. Its strategy centers on Securing and Expanding Raw Material Supply, directly investing substantial capital into building new donation centers. A key development in 2025 was the announced investment of EUR 160 million in a new facility in Spain to double its European plasma fractionation capacity, directly addressing the rising regional demand for immunoglobulins. The company’s product portfolio is broad, focusing on high-volume Immunoglobulins and Albumin, complemented by specialized products like Alpha-1 Antitrypsin for Pulmonology applications.

• CSL Ltd.

CSL Ltd., operating through CSL Behring and CSL Plasma, leverages its global scale and deep R&D pipeline to maintain market leadership. The company’s strategy prioritizes Technological Innovation to Enhance Yield and Patient Convenience. Key products include Hizentra (Subcutaneous Immunoglobulin - SCIg), which capitalizes on the trend toward home-based therapy, and a leading portfolio of Albumin and coagulation factors. CSL is continuously optimizing its plasma collection process, such as deploying the RIKA Plasma Donation System, to improve donor throughput and efficiency, which directly translates into a more secure and higher-yielding raw material supply.

• Takeda Pharmaceutical Company

Takeda Pharmaceutical Company became a major player through the acquisition of Shire, consolidating a significant plasma-derived therapy portfolio, especially in the Hereditary Angioedema (HAE) and Immunology spaces. Takeda's strategic position emphasizes Portfolio Rationalization and Manufacturing Optimization. In 2025, the company reaffirmed its commitment to expand manufacturing capacity for plasma-derived therapies in Juso, Osaka, signaling long-term commitment to the segment despite market headwinds. The focus is on leveraging its global pharmaceutical expertise to develop advanced, high-purity formulations for both intravenous and subcutaneous administration to serve the global Immunology market.

Plasma Fractionation Market Developments

• July 2025: Grifols announced a EUR 160 million investment in Lliçà de Vall (Barcelona), Spain, to construct a new facility, effectively doubling its European plasma fractionation capacity. This capacity addition reinforces its commitment to meet increasing European demand for immunoglobulins and other plasma-derived medicines.
• April 2025: Canadian Blood Services (CBS) opened a new dedicated plasma donor center in Thunder Bay. This capacity addition is part of a national strategy to increase domestic plasma collection and improve the country's self-sufficiency in plasma-derived products, easing reliance on international sources.
• June 2024: Biotest, now controlled by Grifols, received FDA approval for Yimmugo (Human Immunoglobulin G, Intravenous 10%), a new high-concentration IVIg product. This product launch expands the treatment options for primary humoral immunodeficiency (PI) patients, enhancing the Grifols/Biotest offering in the critical Immunology segment.

Plasma Fractionation Market Segmentation

• By Application
  • Neurology
  • Immunology
  • Hematology
  • Pulmonology
• By End-User
  • Hospitals & Clinics
  • Academic & Research Institutes
• By Geography
  • North America
    • USA
    • Canada
    • Mexico
  • South America
    • Brazil
    • Argentina
    • Others
  • Europe
    • UK
    • Germany
    • France
    • Spain
    • Others
  • Middle East and Africa
    • Saudi Arabia
    • UAE
    • Israel
    • Others
  • Asia Pacific
    • Japan
    • China
    • India
    • South Korea
    • Thailand
    • Taiwan
    • Indonesia
    • Others

Table Of Contents

1. Introduction
1.1. Market Overview
1.2. Scope of the Study
1.3. Market Definition
1.4. Market Segmentation
2. Research Methodology
2.1. Research Data
2.2. Assumptions
3. Executive Summary
3.1. Research Highlights
4. Market Dynamics
4.1. Market Drivers
4.2. Market Restraints
4.3. Porter's Five Forces Analysis
4.3.1. Bargaining Power of Suppliers
4.3.2. Bargaining Power of Buyers
4.3.3. Threat of New Entrants
4.3.4. Threat of Substitutes
4.3.5. Competitive Rivalry in the Industry
4.4. Industry Value Chain Analysis
5. Plasma Fractionation Market Analysis, By Application 
5.1. Introduction
5.2. Neurology
5.3. Immunology
5.4. Hematology
5.5. Pulmonology
6. Plasma Fractionation Market Analysis, By End User 
6.1. Introduction
6.2. Hospitals & Clinics
6.3. Academic & Research Institutes
7. Plasma Fractionation Market Analysis, By Geography 
7.1.  Introduction
7.2.  North America
7.2.1. United States
7.2.2. Canada
7.2.3. Mexico
7.3. South America
7.3.1. Brazil
7.3.2. Argentina
7.3.3. Others
7.4. Europe
7.4.1. UK
7.4.2. France
7.4.3. Germany
7.4.4. Spain
7.4.5. Others
7.5. Middle East and Africa
7.5.1. Saudi Arabia
7.5.2. UAE
7.5.3. Israel
7.5.4. Others
7.6. Asia Pacific
7.6.1. Japan
7.6.2. China
7.6.3. India
7.6.4. South Korea
7.6.5. Thailand
7.6.6. Taiwan
7.6.7. Indonesia
7.6.8. Others
8.  Competitive Environment and Analysis
8.1. Major Players and Strategy Analysis
8.2.  Emerging Players and Market Lucrativeness
8.3.  Mergers, Acquisitions, Agreements, and Collaborations
8.4.  Vendor Competitiveness Matrix
9. Company Profiles
9.1. Octapharma AG
9.2. GE Healthcare
9.3. Merck KGaA
9.4. Grifols SA
9.5. CSL Ltd.
9.6. Biotest
9.7. Sanquin
9.8. Takeda Pharmaceutical Company
9.9. Kedrion
9.10. Bio Products Laboratory

Companies Profiled

Octapharma AG

GE Healthcare

Merck KGaA

Grifols SA

CSL Ltd.

Biotest

Sanquin

Takeda Pharmaceutical Company

Kedrion

Bio Products Laboratory

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