Plasma Fractionation Market

The plasma fractionation market was approximated at US$27.32 Bn as of 2024 and is anticipated to ascend to US$42.6 Bn by 2031-end. This growth reflects a projected CAGR of 6.7% from 2024 to 2031.

Market Overview

The plasma fractionation market refers to the industry involved in the separation of plasma into its individual components for therapeutic use. These components include albumin, immunoglobulins, clotting factors, and others. The market is driven by the rising prevalence of immune deficiency disorders, autoimmune diseases, and hemophilia, coupled with the increasing use of plasma-derived therapies.

Additionally, advancements in plasma fractionation technologies and the expansion of plasma collection centres contribute to market growth. Moreover, the aging population and the growing demand for plasma-derived products in emerging economies further boost market expansion.

However, stringent regulatory requirements and the high cost associated with plasma fractionation processes may hinder market growth to some extent. Nonetheless, ongoing research and development activities aimed at improving the efficacy and safety of plasma-derived products offer promising opportunities for market players.

Key Report Findings

• The plasma fractionation market size is projected to expand at a rate of more than 1.5x between the years of forecast.
• The market growth will be driven by increasing prevalence of immune deficiency disorders, autoimmune diseases, and haemophilia.
• Lucrative market opportunities include expansion into emerging markets, research and development innovations, and strategic collaborations and partnerships.
• Key challenges include regulatory hurdles, supply chain vulnerability, and pricing pressures due to high production costs and stringent regulatory requirements.
• Major players in the market include CSL Limited, Takeda Pharmaceutical Company, GRIFOLS, and Baxter International Inc.
• Plasmagen Biosciences recently secured INR 225 crore in equity financing, aiming to fuel expansion initiatives such as scaling up manufacturing capacities and investing in research and development efforts.

Market Drivers

Stringent Regulatory Requirements

The plasma fractionation industry is subject to strict regulatory oversight to ensure the safety and efficacy of plasma-derived products. Compliance with these regulations entails significant investment in research, development, and manufacturing processes, which can be a restraint for smaller market players.

High Cost of Plasma Fractionation

The complex and resource-intensive nature of plasma fractionation processes results in high production costs. This can lead to elevated prices for plasma-derived therapies, limiting their accessibility to certain patient populations and posing a challenge for market growth.

Limited Plasma Supply

The availability of plasma for fractionation is limited by factors such as donor eligibility criteria, collection infrastructure, and geographical disparities. Insufficient plasma supply can constrain the production capacity of plasma fractionation facilities, thereby impeding market growth.

Market Opportunities

Expansion Opportunity Across Developing Markets

There is a significant opportunity for market expansion in emerging economies where there is a growing demand for plasma-derived therapies due to increasing healthcare expenditure, improving healthcare infrastructure, and rising awareness about these treatments. By investing in establishing presence and distribution channels in these regions, companies can tap into a previously untapped market and drive substantial growth.

R&D Innovations

Continued investment in research and development can lead to the development of novel plasma fractionation technologies and products with improved efficacy, safety, and cost-effectiveness. Innovations such as novel fractionation processes, enhanced purification techniques, and the development of new therapeutic proteins can create opportunities for market differentiation and expansion into new therapeutic areas.

Strategic Collaborations, and Partnerships

Collaborations between plasma fractionation companies, pharmaceutical firms, research institutions, and healthcare organisations can foster innovation, accelerate product development, and expand market reach. Strategic partnerships can facilitate access to new technologies, expertise, and resources, enabling companies to strengthen their product portfolios, enter new markets, and capitalise on synergies to drive growth.

Market Challenges

Regulatory Hurdles

The plasma fractionation industry is subject to stringent regulatory requirements to ensure the safety, efficacy, and quality of plasma-derived products. Compliance with evolving regulatory standards and requirements across different regions poses a significant challenge for market players.

Supply Chain Vulnerability

The plasma fractionation process relies heavily on a stable and sufficient supply of human plasma, which is sourced from voluntary donors. Factors such as fluctuations in donor availability, disruptions in plasma collection due to pandemics or natural disasters, and logistical challenges in transporting plasma to fractionation facilities can result in supply chain disruptions.

Pricing Pressures

The high cost of plasma fractionation processes, coupled with pricing pressures from healthcare payers and regulatory authorities, presents a significant challenge for market players. Payers, including government healthcare programs and insurance companies, may impose price controls or negotiate lower reimbursement rates for plasma-derived therapies, squeezing profit margins for manufacturers.

Competitive Analysis

• CSL Limited
• Takeda Pharmaceutical Company
• Sanquin
• Biotest AG
• GRIFOLS
• Baxter International Inc.
• Kedrion
• Octapharma AG
• Taibang Biological Group Co., Ltd

Significant Industry Developments

Plasmagen Biosciences has concluded a successful equity financing round, securing INR 225 crore to fuel its expansion endeavors. The funding aims to drive growth initiatives, including scaling up manufacturing capacities, expanding market reach, and investing in research and development efforts. Plasmagen Biosciences specialises in plasma fractionation, producing essential plasma-derived therapies to address various medical conditions.

The infusion of funds reflects investor confidence in the company's strategic vision and underscores its commitment to advancing healthcare solutions. This financial boost positions Plasmagen Biosciences to capitalise on emerging opportunities in the plasma fractionation market and strengthen its competitive position.

The plasma fractionation market is projected to attain a value of US$61.6 Bn by 2032, driven by advancements in medical technology. The market's growth is attributed to the increasing prevalence of chronic diseases requiring plasma-derived therapies, coupled with ongoing innovations in plasma fractionation techniques.

Factors such as rising healthcare expenditure and expanding healthcare infrastructure also contribute to market expansion. The demand for plasma-derived products is expected to surge further, supported by the aging population and growing awareness about these therapies. Overall, the market shows promising growth prospects, driven by medical advancements and evolving healthcare needs.

Market Segmentation

The Global Plasma Fractionation Market is Segmented as Below:

By Product

• Immunoglobulins
• Intravenous Immunoglobulins
• Subcutaneous Immunoglobulins
• Other Immunoglobulins
• Coagulation Factor Concentrates
• Factor VIII
• Factor IX
• Von Willebrand Factor
• Prothrombin Complex Concentrate
• Fibrinogen Concentrates
• Factor XIII
• Other Coagulation Factor Concentrates
• Albumin
• Protease Inhibitors
• Other Plasma Products

By Application

• Neurology
• Immunology
• Haematology
• Critical care
• Pulmonology
• Haemato-Oncology
• Rheumatology
• Other Applications

By End User

• Hospitals and Clinics
• Clinical Research Laboratories
• Academic institutes

By Region

• North America
• Europe
• Asia Pacific (APAC)
• Latin America
• Middle East and Africa (MEA)