Plasma Fractionation Market
Plasma fractionation involves the process of separation, extraction, and purification of plasma. Human plasma contains the large variety of proteins, yet, only a few of these proteins are help in producing therapeutic plasma products. Plasma is used in prevention and treatment of various life-threatening diseases caused by trauma, immunologic disorders, and infections. Plasma fractionation process is majorly used in treating protein deficiency condition in healthcare applications.
The proteins extracted from the plasma are categorized into three main classes: Immunoglobulins which are useful in treatment of autoimmune disorders and increasing the immune response of the body, clotting factors which are help in treatment of blood disorders such as Hemophilia, and the albumins which are useful in conditions of decreased albumin levels or during fluid loss. Plasma fractionation process is carried by different methods such as solubility of the products, and their physical and chemical conditions such as ionic strengths, pH levels, and temperature, etc. The removal or inactivation of viruses and prions is an important function of plasma fractionation, and it can be carried by various mechanical and physical treatments for virus inactivation such as Nanofiltration, detergent/solvent treatment, heat treatment, chromatography, centrifugation, ultrafiltration, and sterile filtration in order to achieve homogeneity of plasma, and reduce the risks of viral transmissions.
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Plasma fractionation market expected to grow at a significant rate due to rise in the incidence of immune and bleeding disorders, increase in the use of alpha-1 antitrypsin and immunoglobulin, a rise in prevalence of Alpha-1 Antitrypsin Deficiency (AATD), emphysema, and Hemophilia. In addition, the development of plasma techniques and plasma utilization are the key factors expected to grow the plasma fractionation market. However, high cost for the plasma products, adverse effects associated with the plasma fractionation products, lack of reimbursement policies, stringent regulatory policies and increase in the recombinant coagulation factors might hamper the growth of plasma fractionation market.
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Global plasma fractionation market segmented based on the product type, application, and end users.
1. Product type
• Albumin
• Immunoglobulin
o Intravenous immunoglobulin
o Subcutaneous immunoglobulin
o Others
• Coagulation Factor Concentrates
o Factor viii
o Factor ix
o Factor xiii
o Prothrombin complex concentrates
o Von Willebrand factor (VWF)
• Protease Inhibitors
• Other Plasma Fractionation Products
2. Applications
• Neurology
• Hematology
• Immunology
• Rheumatology
• Hemato-oncology
• Critical Care
• Pulmonology
• Others
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3. End-users
Hospitals, clinics, academic institutes and clinical research laboratories.
And geographically, global plasma fractionation market has been divided into following regions- North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa. North America dominates the global plasma fractionation market followed by Europe and Asia-Pacific. North-America holds the largest share in global plasma fractionation market is due to increasing use of immunoglobulins in neurological diseases and increasing use of prophylaxis treatments for chronic diseases in this region. According to Centers of Disease Control (CDC), in 2012, chronic diseases were one of the leading causes of death and disability in the U.S., with an estimated 117 million adults suffering from some form of chronic diseases. Europe is the second largest region for global plasma fractionation market due to the rise in aging population and increase in the prevalence of chronic diseases. However, Asia-Pacific is expected to grow owing to the increasing aging population, growing albumin and immunoglobulin usage, and an increasing focus on better diagnosis, prophylactic treatments, medical research, and organ transplantations. Some of the key players in plasma fractionation market are Grifols S.A (Spain), CSL Ltd. (Australia), Shire (Ireland), Octapharma AG (Switzerland), China Biologic Products, Inc. (China), Biotest AG (OGEL GmbH) (Germany), LFB S.A (France), and Sanquin (Netherlands) to name a few. In 2017, Grifols opens new lines of research with the acquisition of a 44% stake in GigaGen for 35 million USD. In 2015, Baxalta receives CHMP positive opinion for Sanquin to begin production, purification and enhancing the global supply of plasma-based therapies.
Several international players are actively involved in the development of global plasma fractionation products. In 2015, immunoglobulins headed for the largest share of the global plasma fractionation market due to rise in prevalence and high incidence autoimmune disorders. However, the protease inhibitors market is expected to grow, due to increasing use of proteases for respiratory diseases and growing applications in various diseases. Partnerships, collaborations, acquisitions and mergers, agreements, new products launch and joint ventures are being actively adopted by various key players in the global plasma fractionation market. For e.g. in 2003, Probitas Pharma obtained Alpha Therapeutic from Mitsubishi Pharma, similarly, Octapharma acquired Mexican fractionator Probifasa S.A. de C.V. for developing the plasma products.
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