Human Plasma Products and Derivatives Market Size, Share, Growth, and Industry Analysis, By Types (Coagulation Factor, Immune Globulin, Albumin, Others), Applications (Hospital, Retail Pharmacy, Others) and Regional Forecast to 2033

HUMAN PLASMA PRODUCTS AND DERIVATIVES MARKET

Global Human Plasma Products and Derivatives Market size was USD 30330 million in 2024 and is projected to touch USD 68027.61 million in 2025 to USD 32635.08 million by 2033, exhibiting a 7.6% during the forecast period [2025-2033].

The U.S. Human Plasma Products and Derivatives Market dominates globally, driven by advanced healthcare infrastructure, rising prevalence of immune deficiencies, and strong investments in plasma therapy research and development for innovative treatment solutions.

The human plasma products and derivatives market is an essential segment of the healthcare industry, focusing on life-saving therapies derived from human plasma. These products, including immunoglobulins, clotting factors, and albumin, address critical medical conditions like immune deficiencies, hemophilia, and liver diseases. Advancements in plasma fractionation technology and the rise in therapeutic applications for rare disorders have fueled market growth. Additionally, increasing awareness regarding plasma donation and the establishment of collection centers globally play a vital role in meeting the rising demand. The market's growth is supported by stringent quality standards, ensuring the safety and efficacy of plasma-based treatments.

HUMAN PLASMA PRODUCTS AND DERIVATIVES MARKET TRENDS

The human plasma products and derivatives market is witnessing significant advancements, driven by a rise in chronic diseases, increased awareness about plasma donation, and technological progress in plasma fractionation processes. For example, the global prevalence of hemophilia is estimated to affect over 400,000 people, leading to a surge in demand for clotting factor concentrates.

Immunoglobulins, which play a critical role in treating immune disorders, are increasingly sought after, with autoimmune diseases affecting 4%–5% of the global population. Moreover, albumin, used extensively in treating liver conditions and surgical procedures, has seen steady growth in demand, especially in emerging markets.

Another notable trend is the rise of advanced donor-screening technologies, ensuring the safety of plasma products. North America and Europe dominate the plasma collection and production landscape, while Asia-Pacific is rapidly expanding due to investments in healthcare infrastructure and rising patient awareness. Companies are also focusing on collaborations to enhance production capacity and strengthen supply chains. The growing emphasis on personalized medicine and rare disease treatments is further boosting the adoption of plasma-derived therapies.

HUMAN PLASMA PRODUCTS AND DERIVATIVES MARKET DYNAMICS

The human plasma products and derivatives market is shaped by various dynamic factors that influence its growth and challenges. The rising prevalence of rare and chronic disorders, such as hemophilia and primary immunodeficiencies, has increased the demand for plasma-based treatments. Innovations in plasma fractionation technology have improved the yield and efficiency of product development, further propelling the market. However, stringent regulatory frameworks, coupled with the high cost and complexity of plasma collection and processing, pose significant challenges. Despite this, the increasing adoption of these products in emerging markets and expanding applications in critical care underscore the market's potential.

Drivers of Market Growth

"Rising prevalence of chronic diseases and immune disorders"

The growing global burden of diseases such as hemophilia, autoimmune disorders, and liver diseases is a major driver for the human plasma products market. Hemophilia alone affects over 400,000 people globally, necessitating clotting factor therapies. Similarly, immunoglobulin products are in high demand, particularly as autoimmune disorders impact approximately 5% of the global population. Additionally, government initiatives promoting plasma donation, coupled with public awareness campaigns, have contributed to increasing plasma collection volumes. Emerging markets like India and China are also witnessing a surge in demand due to improving healthcare infrastructure and increased focus on treating rare disorders.

Market Restraints

"High production costs and stringent regulatory requirements"

The production of plasma-derived products is a complex, time-intensive process involving meticulous donor screening, plasma collection, and fractionation. This results in high costs, limiting affordability, especially in low-income regions. Stringent regulatory frameworks worldwide, such as the FDA and EMA guidelines, mandate rigorous testing for product safety and efficacy, further increasing operational expenses for manufacturers. Moreover, plasma donation relies heavily on voluntary participation, leading to potential shortages in supply. For example, in regions like Africa, limited plasma collection infrastructure restricts access to these life-saving therapies. Such challenges hinder the market's expansion despite its significant potential.

Market Opportunities

"Rising demand in emerging markets and expanding therapeutic applications"

Emerging markets such as India, China, and Brazil present untapped opportunities for the human plasma products and derivatives market. Improved healthcare infrastructure and increased government support for plasma donation are driving growth in these regions. For instance, plasma collection in China has risen significantly in recent years due to initiatives promoting voluntary plasma donation. Additionally, expanding therapeutic applications, including the use of immunoglobulins for neurological and autoimmune disorders, offer new avenues. An increasing geriatric population, which is more susceptible to chronic diseases, further boosts the demand for plasma-based treatments globally.

Market Challenges

"Limited plasma supply and donor dependency"

The market faces a critical challenge in ensuring an adequate and consistent supply of plasma, as it relies heavily on voluntary plasma donors. Plasma donation is time-intensive, with a single donation taking over an hour and requiring specific health conditions for donors. Regions such as Africa and parts of Southeast Asia suffer from underdeveloped plasma collection systems, leading to supply shortages. Additionally, the COVID-19 pandemic exacerbated the challenge by causing a temporary halt in donation drives globally. Addressing this issue will require significant investment in collection infrastructure and campaigns to encourage donor participation.

Immunoglobulins hold a significant share in the market due to their extensive use in treating immune deficiencies and autoimmune conditions, while albumin is widely utilized for restoring blood volume in critical care and managing hypovolemia. Clotting factors, particularly Factor VIII and Factor IX, are crucial for hemophilia treatment and bleeding disorder management. Hospitals dominate the application segment as primary end-users, driven by the frequent use of plasma-derived therapies in surgeries, critical care, and emergency treatments. Additionally, specialty clinics and research institutions contribute notably, supported by growing investments in rare disease treatment, clinical trials, and personalized medicine advancements.

SEGMENTATION ANALYSIS

The Human Plasma Products and Derivatives market is segmented into various types and applications, each serving specific therapeutic needs. Key product types include immunoglobulins (IVIg), albumin, clotting factors, and fibrinogen. Immunoglobulins hold the largest market share due to their crucial role in treating immune system disorders. Albumin, known for its ability to regulate blood volume, is widely used in treating burns and shock. Clotting factors, particularly factor VIII and factor IX, are essential in hemophilia treatments. The market is also segmented based on application, including immunology, hematology, neurology, and critical care. Immunology is the leading application segment, driven by the demand for IVIg in autoimmune diseases. Hematology follows closely, with plasma-derived clotting factors used to manage bleeding disorders. Neurology and critical care applications are also gaining momentum, with plasma products supporting recovery from neurological disorders and trauma.

By Type

• Coagulation Factor: Coagulation factors, such as Factor VIII and Factor IX, are critical for managing bleeding disorders like hemophilia A and B. Over 400,000 individuals globally suffer from hemophilia, driving the demand for these life-saving products. Recent advancements in recombinant technology have improved the safety and efficacy of coagulation factors, further enhancing their adoption.

• Immune Globulin: Immune globulins account for a significant portion of the market due to their effectiveness in treating immunodeficiency disorders, such as primary immune deficiencies and autoimmune conditions. The increasing prevalence of neurological diseases, including chronic inflammatory demyelinating polyneuropathy (CIDP), has boosted the demand for intravenous immune globulin (IVIG) therapies, particularly in North America and Europe.

• Albumin: Albumin, widely used for volume replacement in critical care settings, plays a vital role in managing conditions like liver cirrhosis and shock. The rising number of surgeries and trauma cases globally has driven albumin consumption. For instance, China accounts for a large share of albumin usage, contributing to the segment's growth in the Asia-Pacific region.

• Others: Other plasma-derived products, including hyperimmune globulins and fibrin sealants, cater to niche applications such as specific infectious diseases and surgical procedures. The increasing focus on developing targeted therapies has led to steady growth in this segment.

By Application

• Hospital: Hospitals dominate the market as the primary end-users of plasma products, especially for critical care and surgical procedures. For example, the World Federation of Hemophilia reports that a significant percentage of plasma-based therapies, such as coagulation factors, are utilized in hospital settings to manage bleeding disorders effectively.

• Retail Pharmacy: Retail pharmacies are emerging as a key distribution channel for plasma products, particularly immune globulins for outpatient care. This shift has been facilitated by increasing patient preference for at-home treatment options, especially for chronic conditions like immune deficiencies.

• Others: Other applications include specialty clinics and research institutions. Specialty clinics play a significant role in providing advanced plasma-derived treatments, while research institutions drive innovation by leveraging plasma products for clinical trials and the development of new therapies.

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REGIONAL OUTLOOK

The global Human Plasma Products and Derivatives market exhibits significant regional variations driven by healthcare infrastructure, patient demographics, and regulatory frameworks. North America leads the market due to high adoption rates and advanced healthcare systems. Europe closely follows, benefiting from a rising geriatric population and government initiatives to support plasma therapies. Asia-Pacific is experiencing robust growth, fueled by increasing healthcare investments and awareness about plasma-derived treatments. Meanwhile, the Middle East & Africa, although in the nascent stage, holds potential due to the rising prevalence of chronic diseases and improving healthcare access.

North America

North America dominates the Human Plasma Products and Derivatives market, supported by extensive R&D initiatives and a well-established healthcare infrastructure. According to reports, the U.S. is a major consumer of immune globulins, with increasing demand for intravenous and subcutaneous formulations to treat autoimmune and neurological disorders. Additionally, the region has the highest number of plasma donation centers, with over 850 centers in the U.S. alone, ensuring a steady supply of raw plasma for processing.

Europe

Europe is a key market due to its large aging population and high prevalence of chronic diseases. Countries like Germany, France, and the U.K. are leading consumers of albumin and coagulation factors. For instance, hemophilia management programs in these countries have significantly boosted the use of Factor VIII and Factor IX products. Moreover, regulatory bodies like the European Medicines Agency (EMA) are actively supporting plasma product innovations, further strengthening the market.

Asia-Pacific

Asia-Pacific is the fastest-growing region in the Human Plasma Products and Derivatives market. Countries like China, Japan, and India are driving demand due to increasing healthcare expenditure and rising awareness about plasma therapies. For example, China is a major contributor to albumin consumption, accounting for nearly half of the global demand. Government initiatives to establish plasma collection centers are also accelerating market growth.

Middle East & Africa

The Middle East & Africa market is gradually expanding, driven by the rising prevalence of chronic diseases such as liver cirrhosis and immune deficiencies. Countries like Saudi Arabia and South Africa are witnessing improved access to plasma-derived treatments due to growing healthcare investments. Additionally, efforts to increase plasma donation and awareness campaigns by non-profit organizations are contributing to the market's steady growth in this region.

KEY HUMAN PLASMA PRODUCTS AND DERIVATIVES MARKET COMPANIES PROFILED

• Takeda
• CSL
• Grifols
• Octapharma
• Kedrion
• LFB Group
• Biotest
• BPL (Bio Products Laboratory)
• RAAS (China Resources Biopharmaceutical)
• CBPO (China Biologic Products Holdings)
• Hualan Bio
• Tiantan Bio
• Shuanglin Bio
• Boya Bio
• Yuanda Shuyang
• Weiguang Bio
• Nanyue Bio
• KM Biologics

Top Companies:

• CSL - Holds approximately 23% of the global Human Plasma Products and Derivatives market share due to its strong portfolio in immune globulin and albumin products.
• Grifols - Accounts for around 21% of the global market share, driven by its advanced plasma collection network and diversified product offerings.

INVESTMENT ANALYSIS AND OPPORTUNITIES

The Human Plasma Products and Derivatives market is witnessing growing investment opportunities, particularly in research and development for advanced plasma therapies and manufacturing technologies. Governments across key regions are allocating substantial funds for improving plasma collection infrastructure, especially in Asia-Pacific and North America. For instance, in 2023, Japan launched a public-private partnership to expand its plasma donation network, aiming to address the growing demand for albumin and coagulation factors.

Additionally, the entry of innovative startups in emerging markets is spurring competition. These companies are focusing on developing cost-effective solutions for plasma fractionation, which presents an untapped growth potential. For example, China-based companies like Hualan Bio are investing heavily in expanding their plasma collection capacity to cater to rising regional demand.

Collaborative ventures between pharmaceutical giants and research institutes are also fostering advancements in recombinant alternatives to plasma-derived products, opening new avenues for investment. The global focus on treating rare and orphan diseases using plasma-derived therapies is expected to create a surge in funding, particularly in the immune globulin and Factor VIII segments.

NEW PRODUCT DEVELOPMENT

The Human Plasma Products and Derivatives market is witnessing significant advancements in product development, aimed at meeting increasing global demand for advanced therapeutic solutions. In 2023, CSL launched a next-generation intravenous immunoglobulin (IVIG) product tailored for enhanced bioavailability, offering a higher safety profile for patients with primary immunodeficiency. Similarly, Grifols introduced a novel plasma-derived fibrinogen concentrate in 2024, targeting surgical and trauma care, providing faster recovery outcomes in patients with bleeding disorders.

Innovations in recombinant protein technologies are shaping the market, with manufacturers like Takeda introducing recombinant Factor VIII products to address hemophilia A, reducing the dependency on human plasma. These developments aim to improve patient outcomes and safety by eliminating risks associated with plasma-derived pathogen transmission.

Companies in emerging economies, such as Hualan Bio and RAAS, are also focusing on low-cost alternatives for albumin and coagulation factors. For instance, Hualan Bio developed an albumin solution in 2023 for emergency and critical care applications, ensuring greater affordability. These advancements are expected to increase accessibility to life-saving plasma products in developing countries, further fueling market growth.

FIVE RECENT DEVELOPMENTS BY MANUFACTURERS

• CSL (2024): Expanded its plasma collection network by adding 30 new centers in North America, increasing supply for IVIG production.

• Grifols (2023): Unveiled a fibrinogen concentrate in Europe for rapid blood coagulation in trauma patients.

• Octapharma (2023): Launched a new immunoglobulin product approved for chronic inflammatory demyelinating polyneuropathy (CIDP).

• Kedrion (2024): Partnered with a biotech startup to develop a hybrid plasma-recombinant Factor IX product for hemophilia B.

• Hualan Bio (2023): Introduced a cost-effective albumin solution aimed at enhancing accessibility in rural healthcare centers across China.

REPORT COVERAGE OF HUMAN PLASMA PRODUCTS AND DERIVATIVES MARKET

The comprehensive analysis of the Human Plasma Products and Derivatives Market includes critical insights into product segments such as immune globulins, coagulation factors, and albumin, alongside their applications in hospitals and retail pharmacies. The report evaluates key market dynamics, including drivers like the rising prevalence of hemophilia and immunodeficiency disorders, coupled with growing plasma donation networks worldwide.

Regional analysis highlights North America's dominance due to advanced plasma collection technologies and strong R&D initiatives. Europe follows, supported by government healthcare investments, while Asia-Pacific exhibits significant growth potential driven by expanding healthcare infrastructure and increasing plasma demand. The report also profiles key players, such as CSL and Grifols, detailing their market shares, product launches, and strategic expansions.

Additionally, the report examines challenges, such as stringent regulatory frameworks and high production costs, while identifying opportunities for innovation in recombinant alternatives and plasma fractionation methods. With data on emerging trends, competitive landscapes, and regional outlooks, the report serves as a valuable resource for stakeholders seeking to navigate and capitalize on the evolving market dynamics.