Plasma fractionation is the first process for large-scale protein purification, which was developed about 60 years ago by Cohn and co-workers. Currently, therapeutically important proteins are human serum albumin (HSA), immunoglobulin (IG), coagulation factor VIII, and protease inhibitors. Presently, plasma protein fractionation is, by far, the largest segment in the global therapeutic protein manufacture industry. Rising indications and therapeutic usage of plasma-derived proteins is an important factor that is expected to boost the plasma fractionation market during the forecast period. The global plasma fractionation market was valued at US$ 18,420.00 Mn in 2017 and is anticipated to reach US$ 33,763.10 Mn by 2026, expanding at a CAGR of 7.1% from 2018 to 2026. Rise in the geriatric population and the demand for plasma proteins is anticipated to drive the demand for plasma fractionation during the forecast period.
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Increase in demand for plasma proteins, rise in investment in innovation, and increase in prevalence of rare diseases across the world are key factors that are projected to propel the global plasma fractionation market. The plasma fractionation industry has been investing in research and development of new plasma proteins therapies (e.g.: Ceruloplasmin, IgA, Plasmin) leading to innovative treatments for the benefits of patients. For instance, in March 2016, Grifols announced that it would invest US$ 360 Mn to expand its production capabilities for plasma-derived therapies. The investment is expected to increase the capacity of plasma fractionation and purification of several proteins. Moreover, rise in investments in innovation leads to technological advancements in efficient and cost-effective procedures for fractionating proteins from plasma, which in turn boost the plasma fractionation market. However, rising market penetration by recombinant factors and stringent regulations and reimbursement issues are major factors restraining the global plasma fractionation market.
The global plasma fractionation market has been segmented based on product type, application, end-user and region. In terms of product type, the global plasma fractionation market has been classified into immunoglobulin, coagulation factor concentrates, albumin, protease inhibitors, and other plasma products. The immunoglobulin segment has been further sub-segmented into intravenous immunoglobulin and subcutaneous immunoglobulin. The coagulation factor concentrates segment factor VIII, factor IX, factor XIII, prothrombin complex concentrate, Von Willebrand factor, and fibrinogen concentrates. In terms of application, the global plasma fractionation market has been classified into neurology, immunology, hematology, critical care, pulmonology, and other applications. In terms of end-user, the global market has been segregated into hospitals and clinics, clinical research laboratories, and academic institutes. In terms of region, the global plasma fractionation market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.
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Based on product type, the immunoglobulin segment dominates the global plasma fractionation market. The segment dominates the market, owing to the rise prevalence of autoimmune diseases such as primary humoral immunodeficiency (PIDD), multiple sclerosis, immune thrombocytopenia purpura (ITP), autoimmune hemolytic anemia, and Kawasaki syndrome. According to the Immune Deficiency Foundation (IDF), approximately 83 people per 100,000 in the U.S. suffer from primary immunodeficiency, and there are more than 5 million undiagnosed cases in the U.S. alone each year. Hence, these factors boost the rate of adoption of immunoglobulins, which in turn boosts the market. The albumin segment is also anticipated to expand at a steady pace during the forecast period. Wide applications of human albumin as a drug formulation agent, vaccine ingredient, sealant in surgeries, and coating for medical devices and equipment are likely to propel the segment in the next few years.
Based on application, the neurology segment dominates the global plasma fractionation market. Rise in number of neurological disorders augments the segment. World Health Organization data suggest that neurological and psychiatric disorders are an important and growing cause of morbidity. The magnitude and burden of mental, neurological, and behavioral disorders is huge, affecting more than 450 million people globally per year.
Based on end-user, the hospital and clinics segment dominates the global plasma fractionation market. Hospitals are witnessing robust expansion, propelled by joint ventures, acquisitions, and provision of one-stop-shop services under one roof for various medical needs.
In terms of region, North America and Europe accounted for a combined market share of 60% in 2017. High prevalence of infectious diseases such as cholera, influenza, and syphilis in North America fuelled the demand for utilization of plasma fractionation. Likewise, Europe accounted for a prominent share, and followed North America in terms of share, of the total global market, due to the presence of a large geriatric population that is more prone to infections. Asia Pacific is regarded as an emerging market for plasma fractionation owing to the presence of large patient population, poor sanitization, and low awareness about plasma fractionation products among the people in the region.
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Major players operating in the global plasma fractionation market include CSL Limited, Shire plc, Sanquin, Biotest AG., GRIFOLS, Baxter International Inc., Kedrion, Octapharma and China Biologic Products Holdings, Inc. These players adopt organic and in-organic growth strategies in order to expand product offerings, strengthen geographical reach, increase customer base, and capture market share.