December 9, 2023

Plasma Fractionation Market Report: Trends, Growth, and Share Analysis 2030

Plasma-derived medicinal products (PDMPs) have a rich history spanning over 75 years in clinical therapy for a multitude of diseases. Today, more than 30 commercial plasma-derived medicines are available, playing a vital role in treating various medical conditions. However, challenges such as cost and accessibility persist, leaving some in short supply. Several plasma protein concentrates have gained recognition as essential medicines by the World Health Organization (WHO), addressing critical needs, including clotting factor concentrates for haemophilia and gamma globulin preparations for immunodeficiency. The global plasma fractionation market is poised for robust growth in the coming years, as an increasing array of complex medical conditions emerge.

Addressing Unmet Needs: Conserving Recovered Blood Plasma

WHO estimates that a staggering 21.6 million liters of plasma can be recovered annually from total blood collection. Of this volume, only approximately 4.2 million liters are transfused, with another 8.1 million liters sent for fractionation. Astonishingly, a significant 9.3 million liters are disposed of.

Despite this, epidemiological data reveals a significant gap in the availability of essential plasma products for diagnosed and treated patients. Shockingly, only 30% of patients with hemophilia A or B have been diagnosed, and a mere 25% receive treatment, according to the World Federation of Hemophilia. Moreover, fewer than 10% of patients with primary immune deficiency are diagnosed, with just 6% receiving immunoglobulin treatment. As new treatments emerge and protein deficiencies necessitating plasma protein therapy are identified annually, the demand for plasma-derived products continues to surge.

Global Initiatives: Elevating Standards for Blood Establishments

WHO is spearheading efforts to implement Good Manufacturing Practices (GMP) in blood establishments through the WHO Expert Committee on Biological Standardization. To further bolster regulatory frameworks, WHO has established a Blood Regulators Network (BRN) to support organizations in enhancing National Regulatory Authorities (NRAs) in the blood sector. These initiatives are pivotal in ensuring the quality and safety of plasma-derived medicinal products.

Impact of COVID-19: A Shifting Landscape

In the wake of the COVID-19 pandemic, the healthcare community has rallied to develop treatments targeting the virus. Convalescent plasma (CP) therapy has shown promise in increasing the survival rate of COVID-19 patients, as evidenced by multiple clinical trials. While not yet FDA-approved for general use, CP therapy is authorized for the treatment of hospitalized patients with COVID-19 under emergency use. The true impact of COVID-19 on the plasma fractionation market hinges on ongoing clinical trial outcomes.

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Immunoglobulin Adoption on the Rise

Immunoglobulins, recognized for their ability to combat infection, emerged as the largest product segment in 2019. Their widespread use in treating various medical conditions, including primary immune deficiencies and autoimmune diseases, has been on the upswing. The rising rate of immunology disease diagnoses and increased investigational research in immunodeficiency are set to drive future demand for immunoglobulins.

Innovations and Growth Drivers

The protease inhibitors segment is expected to witness significant growth, driven by their efficacy against viral infections. As viral outbreaks become more frequent, the demand for protease inhibitors is likely to soar.

In the field of neurology, plasma proteins like coagulation factors and immunoglobulin play a critical role in treatments. There are ongoing developments of plasma proteins for both immunology and neurology, further propelling market growth.

Global Reach: Expanding Facilities in Asia Pacific

While North America held the largest market share in 2019, Asia Pacific is witnessing increasing interest in establishing modern plasma fractionation facilities. China, in particular, has become a key player in manufacturing plasma-derived medicinal products, collecting around 7 million liters of plasma annually.

Rise of Recombinant Alternatives

In recent years, recombinant alternatives for various plasma-derived products have gained traction, offering clinical benefits such as less-frequent administration. These alternatives are posing competition to traditional plasma products, reshaping the industry landscape.

Investments in Plasma Production Facilities

Leading market players are investing in advanced, dedicated plasma production facilities. For example, Israeli biotech company Alishech is establishing Russia’s largest blood plasma fractionation plant, with a substantial investment of US$170 million. Kedrion Biopharma recently received FDA approval to establish a plasma proteins production facility in Melville, New York.

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Prominent industry players include CSL, Grifols, Shire, Octapharma, Kedrion, LFB, Biotest, Sanquin, China Biologic Products, Bio Products Laboratory, Japan Blood Products Organization, Green Cross Corporation, Shanghai RAAS Blood Products, Emergent BioSolutions, Intas Biopharmaceuticals, Bharat Serums and Vaccines Limited, SK Plasma, Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd., KabaFusion, and Centurion Pharma.

As the plasma fractionation market continues to evolve and expand, it remains a vital pillar of modern healthcare, addressing unmet medical needs and driving innovation in the field.

Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2023-2030 – By Product, Technology, Grade, Application, End-user, Region: (North America, Europe, Asia Pacific, Latin America and Middle East and Africa)

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This press release first seen on Brilad