Plasma-derived medicinal products (PDMPs) have a history of more than 75 years in clinical therapy of multiple diseases. There are over 30 commercial plasma-derived medicines; many are expensive, and few are in short supply. Number of these plasma protein concentrates have been recognized as essential medicines by the World Health Organization (WHO) such as clotting factor concentrates to treat haemophilia and gamma globulin preparations to treat immunodeficiency. The global market for plasma fractionation is expected to thrive in the coming years as the world is expected to see a range of complicated medical conditions.
Conserving Recovered Blood Plasma: Essential Step in Addressing Unmet Needs
WHO estimates that 21.6 million litres of plasma can be recovered from total blood collection, annually. Of this volume, an estimated 4.2 million litres are transfused and an estimated 8.1 million litres are sent for fractionation, leaving 9.3 million litres for disposal.
On the other hand, epidemiological data indicates a demand and supply gap in essential plasma product treatment for diagnosed and treated patients. As per the World Federation of Hemophilia, only 30% of the patients with hemophilia A or B have been diagnosed and only 25% receive treatment.
Furthermore, only less than 10% of patients with primary immune deficiency are diagnosed and hardly 6% receive treatment with immunoglobulin. To add to this, new treatments like transplant and protein deficiencies requiring plasma protein therapy are being identified every year.
WHO is pressing for implementation of GMP in blood establishments via WHO Expert Committee on Biological Standardization and has established a Blood Regulators Network (BRN) to support the organization in enhancing NRAs in the blood sector.
Thus, plasma derived product demand in the world is raging. However, availability of plasma protein therapeutics especially in developing countries is currently inadequate and the plasma generated is of such low quality as to make it unusable for fractionation and production of biological medicines.
Impact of COVID-19 Pandemic on the Plasma Fractionation Market
Post outbreak of novel Coronavirus, many pharmaceutical giants, healthcare providers, and start-ups stepped forward to develop treatments that target the infection. Although no specific drugs are in sight, convalescent plasma (CP) therapy has shown positive signs in multiple clinical trials to increase the survival rate of COVID-19 patients. Nodal agencies worldwide are taking initiatives to offer this therapy to patients while clinical investigations for its safety and effectiveness remain underway.
Convalescent plasma for the treatment of COVID-19 has not yet been approved for use by FDA. However, it is regulated as an investigational product under emergency use, authorized for the treatment of hospitalized patients with COVID-19. Therefore, real impact of COVID-19 on the plasma fractionation market would largely rely on ongoing clinical trials outcome.
Immunoglobulin Adoption on the Rise in Plasma Fractionation Market
Immunoglobulins was the largest product segment in 2019. Immunoglobulin is widely accepted as a treatment for a variety of medical conditions due to its ability to fight infection.
Immunoglobulins are used in primary therapy for various neurologic and autoimmune conditions. They is commonly used to treat primary immune deficiencies and chronic inflammatory demyelinating polyradiculoneuropathy. In recent years, immunology disease diagnostic rate has increased significantly. In addition, there is rise in investigational research over immunodeficiency. Therefore, increase in number of diagnosed patients will boost the need for immunoglobulins in future.
The protease inhibitors segment is to witness highest growth during the forecast period as an antiviral agent. Increasing viral outbreaks are going to bolster demand of protease inhibitors due to their efficacy against viral infections.
Neurology and Immunology Segments to Drive Plasma Fractionation Market Growth
In 2019, the neurology segment was leading the plasma fractionation market. Intravenous immunoglobulins have shown superiority in terms of response time as compared to steroids or oral immunosuppressant.
There is extensive use of plasma proteins like coagulation factors and immunoglobulin in neurology disease treatments. There are many plasma proteins that are under development for immunology and neurology.
Asia Pacific to Continue Adding up Modern Plasma Fractionation Facilities
In 2019, North America held largest market share of the plasma fractionation market, followed by Europe and Asia Pacific. High usage of immunoglobulins coupled with growing geriatric population are driving growth in western countries.
In Asia Pacific, continued interest in the establishment of new modern plasma fractionation facilities is likely to continue. China has become one of the largest manufacturers of plasma derived medicinal products. Around 7 million litres of plasma gets collected in China annually.
Strong Emergence of Recombinant Substitutes
In recent times, there is upsurge in recombinant alternatives for different plasma-derived products like factor VIII, factor IX, and protease inhibitors. Recombinant factors VIII and IX are being used as an alternative to plasma-derived factors VIII and IX for haemorrhage.
These recombinant products would provide significant clinical benefits over plasma derived products like less-frequent administration in prophylactic use. The greater use of recombinant factors is a detriment to the adoption of plasma products.
Manufacturers Are Setting Up Dedicated Plasma Proteins Production Facilities
Leading market players are focusing on establishing advanced dedicated plasma production facilities. Israeli biotech company Alishech is setting up Russia’s largest blood plasma fractionation plant with investment worth US$170 Mn. The plant will be manufacturing more than 25 drugs and dried plasma. Kedrion Biopharma recently received FDA approval to set up plasma proteins production facility in Melville, Ney York.
Few other prominent players in the field are: CSL (Australia), Grifols (Spain), Shire (Ireland), Octapharma (Switzerland), Kedrion (Italy), LFB (France), Biotest (Germany), Sanquin (Netherlands), China Biologic Products (UK), Bio Products Laboratory (UK), Japan Blood Products Organization (Japan), Green Cross Corporation (South Korea), Shanghai RAAS Blood Products (China), Emergent BioSolutions (US), Intas Biopharmaceuticals (India), Bharat Serums and Vaccines Limited (India), SK Plasma (Republic of Korea), Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd. (China), KabaFusion (US), and Centurion Pharma (Turkey).
Key Elements Included In The Study: Global Plasma Fractionation Market
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