Plasma Fractionation Market to Hit $57 Billion by 2032

Introduction

The Plasma Fractionation Market is experiencing robust growth, driven by several key factors including regulatory oversight, technological advancements, and market dynamics. Regulatory bodies enforce stringent standards for the collection, processing, and storage of plasma, ensuring product safety and quality. Regular audits of collection centers uphold these standards, essential for maintaining the integrity of fractionated products. Meanwhile, technological progress in plasma fractionation techniques, such as cryoprecipitation and ethanol fractionation, continues to improve efficiency and yield, crucial for therapeutic applications.

The demand for plasma-derived products is escalating globally, influenced by an increase in plasma volume and collection efficiency. Innovations in plasmapheresis and optimized collection protocols enable more frequent and voluminous donations. These advancements meet the growing clinical needs for plasma-derived therapeutics, such as immunoglobulins and clotting factors, especially significant given the aging population and rising prevalence of chronic diseases. These conditions often necessitate long-term management and treatment with plasma products.

Economic considerations also significantly impact the plasma fractionation industry. The cost of plasma collection and fractionation processes affects the affordability and accessibility of these vital products. Efficient resource allocation in plasma separation from whole blood donations is crucial for maximizing production while managing costs. This economic aspect, coupled with the increasing clinical demand, underscores the importance of strategic market and resource planning within the sector.

Recent developments further illustrate the sector’s growth trajectory. In April 2022, Grifols acquired Biotest AG, gaining significant market share and enhancing its global plasma capacity. This strategic move, valued at approximately EUR 1,600 million in equity and EUR 2,000 million in enterprise value, aims to expand Grifols’ product portfolio and increase the availability of plasma therapies worldwide. Additionally, in August 2022, Taibang Biologic Group secured $300 million in equity funding to expand plasma stations and develop new products, bolstering its market presence in China.

Moreover, in November 2023, Intas Pharmaceuticals entered a significant licensing agreement with Syna Therapeutics to commercialize LB-0702 globally. This deal not only broadens Intas’ biosimilar program but also aligns with its strategy to enhance global access to affordable biosimilar drugs, addressing large-scale healthcare needs. These strategic moves by leading companies highlight the ongoing commitment to innovation and market expansion in the plasma fractionation industry, reflecting its critical role in modern healthcare.

Key Takeaways

• The market is projected to hit USD 57.0 billion by 2032, expanding at a 7.3% CAGR.
• Immunoglobulins dominate the product segment, with coagulation factors and albumin following.
• Centrifugation leads in methods used, ahead of chromatography and depth filtration.
• Neurology tops application segments, with hematology and oncology trailing.
• Hospitals and clinics represent the largest end-user segment, followed by academic institutes and clinical research laboratories.
• Growth is driven by rising immunodeficiency disorders and increased use of plasma-derived products.
• The main restraint is the growing preference for recombinant therapies over plasma-derived medicines.

Plasma Fractionation Statistics

• Blood composition includes approximately 55% plasma and 44% red blood cells, with less than 1% comprising white blood cells and platelets.
• The U.S. leads as the primary global supplier of plasma and plasma-derived products.
• India operates around 3,840 licensed blood banks.
• Annually, blood banks globally collect 11-12 million units of blood.
• Theoretically, this collection could yield 1.6-1.7 million liters of plasma annually.
• Due to various losses, only about 1.2-1.3 million liters of plasma are available for clinical uses each year.
• Germany, Austria, Hungary, and the Czech Republic together contribute to 40% of Europe’s plasma collection efforts.
• Plasma donations decreased by 20% during 2020 and 2021, exacerbating the global plasma shortage.
• ChromaCon’s technology potentially increases product yields up to 80% while maintaining target purity.
• This technology could also reduce the overall cost of affinity resins by up to 60% and buffer consumption by as much as 80%.
• Expected improvements in overall yield could exceed 90%.
• Potential capital expenditure reductions are estimated at 30%.
• In Germany, 56.8% of plasma donors are male, compared to 62% in the U.S.
• First-time plasma donors in Germany average 29.8 years of age, with repeat donors averaging 43.2 years. In the U.S., these averages are 30 years and 36 years, respectively.
• German plasma donors typically make 14.2 donations per year.
• In the Netherlands, 76-79% of plasma donors are employed, and 74-86% live with a partner and children.
• A higher educational attainment is noted among Dutch plasma donors, with 34-36% having completed higher education, above the general population’s average.
• A significant portion of donors, 47.2%, cease donating due to lack of time, job changes, or relocation.
• Approximately 23% of donors stop donating due to lengthy donation processes or job-related conflicts.
• Travel difficulties and compensation issues lead 21% and 22% of donors, respectively, to stop donating.
• Around 23-56% of paid donors in Germany and Austria would consider continuing their contributions even without financial incentives.
• Only 0.16–2.3% of plasma donations result in adverse events.
• Adverse events are more common in females, being 2.6 times more likely than in males.
• New donors experience adverse events 11 times more frequently than repeat donors, with 7.96% of first-time donors reporting issues compared to 1.01% of repeat donors.
• The majority of adverse events (about 90%) are related to hypotensive/vasovagal reactions and issues at the needle insertion site.
• Adverse events affect 0.49% of whole blood donations and 0.16–1.2% of plasma donations.

Emerging Trends

• Increased Use of Subcutaneous Immunoglobulin (SCIG): The trend towards subcutaneous administration of immunoglobulins, rather than intravenous methods, is growing rapidly. This method is favored due to its convenience and the lower risk of adverse reactions it presents. SCIG can be administered in the comfort of one’s home, making it more accessible to patients. This shift is expected to increase the demand for SCIG, potentially surpassing the need for traditional IVIG formulations. This trend reflects a significant evolution in how patients receive and manage their immunoglobulin treatments.
• Development of Convalescent Plasma and Hyperimmune Globulin (H-Ig): The recent global health crisis highlighted the potential of convalescent plasma and Hyperimmune Globulin (H-Ig) in the treatment of emerging infectious diseases. Although their effectiveness in treating COVID-19 was variable, these therapies show promise for future health challenges. The plasma fractionation industry has witnessed considerable collaborative efforts to enhance the development and application of these treatments. This trend is expected to continue, shaping future therapeutic strategies in the sector.
• Addressing Plasma Shortages: The plasma fractionation sector faces ongoing challenges due to a shortage of plasma, a situation worsened by the COVID-19 pandemic which saw a decrease in donations. In response, significant efforts are being made to enhance the efficiency of plasma collection and expand the capacity of collection facilities worldwide. These initiatives aim to meet the increasing global demand for plasma-derived therapies, ensuring a steadier supply chain and availability of essential treatments.
• Promoting Regional Self-Sufficiency: There is a growing trend towards regional self-sufficiency in plasma supply. Countries are actively working to lessen their reliance on imported plasma products by improving local collection and fractionation capacities. This includes revising regulatory frameworks and investing in infrastructure to bolster domestic plasma industries. Such moves aim to secure a more stable plasma supply chain and cater to the healthcare needs of local populations more effectively.

Use Cases

• Treatment of Chronic Diseases: Plasma fractionation is essential in managing chronic illnesses such as immunodeficiency disorders, autoimmune diseases, and hemophilia. This process isolates specific proteins from plasma, allowing for customized treatments that enhance patient outcomes significantly. By targeting precise components within plasma, therapies can be tailored to the unique needs of individual patients, promoting better management of complex conditions and improving quality of life.
• Support for Medical Research and Clinical Trials: In the realm of medical research, plasma fractionation is indispensable. High-quality plasma derivatives are crucial for clinical research laboratories and academic institutions. They rely on these components for conducting experiments and clinical trials. This support is pivotal in advancing medical science, developing new treatments, and refining therapeutic approaches. As research progresses, plasma fractionation continues to facilitate breakthroughs in understanding and treating various health conditions.
• Emergency Medical Responses: Plasma fractionation plays a critical role in emergency medical responses, especially during outbreaks of infectious diseases. Plasma products are vital for treating individuals affected by such outbreaks and are integral in developing rapid-response therapies. By isolating specific antibodies from convalescent plasma, medical professionals can quickly create targeted treatments to combat emerging health threats, showcasing the adaptability and importance of plasma fractionation in crisis situations.
• Global Health Initiatives: The process of plasma fractionation is key to global health efforts. It enables the production and distribution of vital biological medications worldwide, particularly to areas with scarce healthcare resources. This not only helps in managing global health crises but also ensures broader access to life-saving treatments. Plasma fractionation’s role in global health initiatives demonstrates its profound impact on improving healthcare accessibility and equity across diverse populations.

Conclusion

In conclusion, the Plasma Fractionation Market is poised for substantial growth, driven by advancements in technology and robust regulatory frameworks. This sector is critical in meeting the escalating demand for plasma-derived therapeutics, vital for managing chronic diseases and supporting medical research. With strategic acquisitions and investments enhancing global capacity, the market is set to expand significantly. Moreover, the trend toward regional self-sufficiency and increased use of subcutaneous immunoglobulin introduces new opportunities for innovation and market development. These dynamics underscore the integral role of plasma fractionation in advancing healthcare and improving patient outcomes globally, signaling a promising future for this essential industry.

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