Plasma Fractionation Market Set for Strong Growth to Reach USD 42.6 Bn by 2031, Driven by Rising Prevalence of Rare Diseases and Expanding Plasma Collection Infrastructure

The global Plasma Fractionation Market, valued at US$ 24.1 Bn in 2022, is projected to grow at a CAGR of 6.7% from 2023 to 2031, reaching an estimated US$ 42.6 Bn by 2031. The industry is experiencing substantial momentum due to increasing diagnosis and treatment of rare chronic diseases, rising demand for plasma-derived therapies, and expanding plasma collection networks worldwide.

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As genetic testing becomes more accessible and aging populations increase vulnerability to chronic illnesses, plasma-derived products including immunoglobulins, albumin, and coagulation factors continue to see unprecedented demand. Governments, regulatory bodies, and private organizations are investing heavily in bolstering plasma collection centers and improving plasma fractionation technologies to meet global therapeutic needs.

This press release provides a comprehensive overview of market growth, key drivers, competitive landscape, recent developments, opportunities, challenges, and strategic recommendations for investors and stakeholders.

Market Overview
Plasma fractionation involves separating and purifying valuable proteins and biomolecules from blood plasma, including immunoglobulins, coagulation factors, albumin, and protease inhibitors. These plasma-derived therapies play a critical role in managing conditions such as:

Hemophilia

Primary immunodeficiency

Hereditary angioedema

Autoimmune disorders

Liver disease

Shock and burns

Over the past decade, plasma fractionation has transitioned from a conventional biological process to a highly advanced and regulated manufacturing operation. Quality assurance, sterility, and safety protocols have become more stringent, while technological advancements have enabled high-yield extraction and improved pathogen inactivation.

Industry trends shaping market dynamics include:

Growing use of plasma-derived immunoglobulins in neurology and immunology.

Rising government involvement in plasma collection infrastructure.

Increasing reliance on plasma-based therapies in developing countries.

Shift toward recombinant substitutes-but plasma-derived products remain essential.

Enhanced focus on storage, cold chain management, and donor safety.

North America leads the global market, supported by sophisticated healthcare systems, a large number of plasma collection centers, and strong regulatory frameworks. Europe follows closely, driven by increasing investments in precision medicine and continued support for rare disease treatment initiatives. Asia Pacific is emerging as one of the fastest-growing regions due to rapidly improving healthcare access and increasing domestic plasma fractionation capacities.

Key Market Growth Drivers
1. Rising Prevalence of Rare Chronic and Genetic Disorders
More than 400 million people globally suffer from rare genetic disorders, as per Global Genes. Rare diseases often require long-term plasma-derived therapy, making plasma fractionation indispensable.

Examples of conditions heavily dependent on plasma-derived therapies include:

Hemophilia A & B

Hereditary angioedema

von Willebrand disease

Primary immune deficiency disorders

Alpha-1 antitrypsin deficiency

With increased awareness and improved diagnostic testing, especially genetic and molecular diagnostics, the number of identified rare conditions has surged. This has driven strong demand for immunoglobulins, Factor VIII, Factor IX, albumin, and other plasma-derived products.

2. Growing Demand for Plasma Proteins
The global aging population is more susceptible to chronic diseases such as:

Liver disorders

Neurological conditions

Immune system deficiencies

Plasma proteins play an important therapeutic role in managing age-related conditions, making them highly sought after.

According to the Plasma Protein Therapeutics Association (PPTA):

The EU collected 8.4 million liters of plasma in 2021 for therapeutic production.

The U.S. has approximately 740 plasma collection centers.

Europe has 111+ centers, and expansion is ongoing.

Such robust infrastructure highlights the increasing reliance on plasma-based medicines.

3. Expansion of Plasma Collection Centers Globally
To meet growing demand, many countries are strengthening their plasma collection networks. For instance:

Indonesia is developing Southeast Asia's largest plasma fractionation facility.

The U.S. continues to dominate the plasma collection landscape.

India and Brazil are emerging as major markets due to rising awareness and investment.

This expansion significantly enhances supply chain stability and reduces dependence on imported plasma.

4. Technological Advancements in Fractionation
Innovations in biotechnology and high-yield purification processes have enabled:

Higher recovery rates

Shorter processing cycles

Improved virus inactivation

Enhanced product quality and safety

This aligns with the global push toward precision medicine and personalized therapeutic solutions.

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Analysis of Key Players and Their Strategic Moves

The plasma fractionation industry is moderately consolidated, with global leaders controlling a significant share of the market. These key players include:

CSL Limited

Takeda Pharmaceutical Company

Grifols

Biotest AG

Octapharma AG

Baxter International Inc.

Sanquin

Kedrion Biopharma

Taibang Biological Group Co., Ltd

Key Strategic Approaches

1. Capacity Expansion
Leading manufacturers are expanding plasma collection centers and fractionation facilities to meet soaring global demand.
Examples include:

GC Biopharma's new 400,000-liter annual capacity facility in Indonesia.

Expanded donor centers by CSL Plasma and Grifols across the U.S. and Europe.

2. Diversification of Product Portfolio
Companies are adding new plasma-derived therapeutic solutions for rare diseases, including:

Novel immunoglobulin therapies

Specialized coagulation factor concentrates

Enhanced albumin-grade products

3. Vertical Integration
Major companies are controlling entire value chains-from plasma collection to manufacturing-to ensure quality, safety, and availability.

4. Geographic Expansion
Emerging markets such as India, Brazil, and Southeast Asia are becoming lucrative regions for investment due to unmet therapeutic needs.

5. R&D Intensification
Players are investing in:

Recombinant alternatives

High-purity coagulation factor technologies

Virus inactivation and removal technologies

Market Challenges & Opportunities

Challenges

1. High Manufacturing Costs
Plasma fractionation is capital-intensive, requiring:

Highly regulated collection processes

Sophisticated cold chain logistics

State-of-the-art purification technologies

Expenses for infrastructure and donor compensation remain high.

2. Stringent Regulations
The plasma industry is regulated more strictly than many pharmaceutical sectors.
Compliance must meet standards from:

FDA (U.S.)

EMA (Europe)

WHO guidelines

This can delay product approvals and facility certifications.

3. Limited Plasma Availability
Despite rising demand, plasma collection rates may not always synchronize globally, especially in:

Emerging economies

Regions with low donor participation

4. Competition from Recombinant Products
Although plasma-derived products remain essential, recombinant substitutes (e.g., rFVIII) pose partial competition in specific therapeutic areas.

Opportunities

1. Growing Demand in Emerging Markets
Countries such as India, China, Brazil, and Indonesia present massive opportunities due to:

Large patient populations

Improving diagnostic capabilities

Government support for domestic plasma fractionation

2. Technological Advancements
High-yield purification technologies, next-gen virus inactivation, and cell-based analytics open new avenues for improved therapies.

3. Increasing Use in Regenerative Medicine
Albumin and other plasma proteins are now being integrated into:

Regenerative treatments

Stem cell therapies

Advanced wound care

4. Rising Investment in Rare Disease Programs
Governments and global health organizations are increasing funding for rare disease research, boosting demand for plasma-derived drugs.

Recent Developments in the Plasma Fractionation Industry

1. GC Biopharma (December 2023)
Announced investment in Indonesia's largest plasma fractionation facility with 400,000-liter annual capacity, expected to begin production by 2027.

2. PlasmaGen Biosciences (December 2023)
Raised US$ 27 Mn (₹225 Cr) to expand plasma-derived product manufacturing for India and emerging countries.

3. Expansion of U.S. Donor Centers
Major companies including CSL and Grifols have established new donor centers to counter plasma shortages.

4. Increasing Focus on Domestic Production
Countries such as India and China are rapidly developing domestic fractionation plants to reduce import dependency.

Investment Landscape & ROI Outlook

The plasma fractionation industry offers a stable and attractive investment environment characterized by:

1. High Entry Barriers
Extensive regulatory approvals, capital requirements, and technological expertise protect market incumbents and stabilize competition.

2. Strong Long-Term Demand
Rare disease therapies and immunoglobulin therapies exhibit recession-proof demand, ensuring predictable revenue streams.

3. Consistent CAGR
With a steady 6.7% CAGR, investors can expect consistent growth in:

Plasma collection infrastructure

Product manufacturing

Export opportunities

4. Attractive Returns in Emerging Markets
Regions like Asia Pacific and Latin America offer:

Lower operating costs

Large patient pools

Growing insurance penetration

5. R&D Incentives
Governments across Europe, the U.S., and Asia are offering incentives for rare disease research, promoting investment in plasma-derived therapeutics.

Market Segmentation

By Product Type

Immunoglobulin

Intravenous

Subcutaneous

Coagulation Factor Concentrates

Factor VIII

Factor IX

Factor XIII

Prothrombin Complex Concentrates

Von Willebrand Factor

Fibrinogen

Albumin

Protease Inhibitors

Other Plasma Products

By Application

Neurology

Immunology

Hematology

Pulmonology

Critical Care

Others

By End-user

Hospitals & Clinics

Clinical Research Laboratories

Academic Institutes

By Region

North America (U.S., Canada)

Europe (Germany, France, UK, Italy, Spain, Rest of Europe)

Asia Pacific (Japan, China, India, Southeast Asia)

Latin America (Brazil, Mexico, Rest of LATAM)

Middle East & Africa (GCC, South Africa, Others)

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Provides detailed insights into market size, share, and forecasts through 2031.

Offers in-depth analysis of drivers, restraints, opportunities, and competitive dynamics.

Includes segmentation by product type, application, end-user, and region.

Covers key strategic initiatives and developments by major market players.

Supports business planning, investment decision-making, and portfolio expansion.

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Provides SWOT, Porter's Five Forces, value chain analysis, and supplier analysis.

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FAQs

1. What is the projected size of the plasma fractionation market by 2031?
The market is expected to reach US$ 42.6 Bn by 2031, growing at a CAGR of 6.7%.

2. Which product segment dominates the market?
Immunoglobulins remain the largest segment due to high demand for immune deficiency and autoimmune therapy.

3. Which region leads the global market?
North America leads due to strong healthcare infrastructure, high awareness, and extensive plasma collection networks.

4. What factors are driving market growth?
Key drivers include the rise in rare chronic diseases, aging population, increasing plasma donation centers, and advanced purification technologies.

5. Who are the key players in the plasma fractionation market?
Leading players include CSL Limited, Takeda, Grifols, Baxter, Octapharma, Biotest, Kedrion, Sanquin, and Taibang Biological Group.

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