Human serum albumin (HSA) is responsible for a number of biological functions including binding and delivering molecules and substances to the cell. It also plays an important role as antioxidant and transporter of ligands.
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HSA is widely used in hospitals and clinics to treat a number of diseases such as hemorrhagic shock, hypoproteinemia, serious burn injuries, fetal erythroblastosis, and cirrhotic ascites. In spite of its widespread utility, high safety risks due to limited human donors, persistent supply shortages, and risk associated with the transmission of blood borne contaminants such as viruses, prions, and mycoplasma have led to development of recombinant technology to manufacture HSA from different animal and plant sources.
Increase in shift toward usage of recombinant albumin for a number of applications such as drug formulation, drug delivery, vaccine production, and cell culture media is the major driver of the global recombinant human serum albumin market. HSA has been successfully used as an excipient in the manufacture of vaccines and drugs; however, there still remains risk of transmission of known and new infectious agents such as HIV and hepatitis due to the use of plasma- and blood-derived products.
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This inherent risk has prompted regulatory authorities across the globe to create a myriad of regulations limiting the use of plasma-derived products and necessitating the need to develop substitute products for human serum albumin in order to minimize the risk of transmission of adventitious agents. In order to overcome these challenges, recombinant albumin has emerged as a suitable alternative to human serum albumin for use as an excipient in the manufacture of biotherapeutics. Apart from avoiding the spread of serum-derived disease agents, it offers advantages such as improved batch-to-batch consistency. These factors are expected to shift demand from traditional human serum albumin to recombinant albumin in the next few years.
Grant of approvals by national regulatory agencies for new recombinant albumin products developed by pharmaceutical and biotechnology companies is another factor contributing to the growth of the global recombinant human serum albumin market. In May 2017, China’s Food and Drug Administration approved the clinical trials of human blood albumin developed from transgenic rice seeds. Wuhan Healthgen Biotechnology Corp. for Human Health, a privately held Chinese firm that develops and commercializes novel animal-free products for pharmaceutical use, invested nearly US$ 29 Mn to support the research. The company expects to launch the product within four to five years and is eyeing extensive quantities of human serum albumin from rice in order to address the significant shortage of human serum albumin in China.
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In February 2013, MAQUET Cardiopulmonary was granted regulatory approval in Japan for a medical device that uses Recombumin Alpha, a recombinant albumin produced by Albumedix A/S (formerly Novozymes Biopharma) in combination with MAQUET’s Bioline coating. Bioline coating helps to enhance biocompatibility of the extracorporeal circulation system devices such as centrifugal pumps, oxygenators, and filters to reduce the negative effects on blood when it comes into contact with foreign surfaces.
The global recombinant human serum albumin market can be segmented based on source of origin, application, and region. In terms of source of origin, the recombinant human serum albumin market can be divided into plant derived, microbes, and others. Based on application, the global recombinant human serum albumin market can be classified into drug development & drug delivery, vaccine production, component of cell culture media, and others. In terms of application, the recombinant human serum albumin market can be categorized into pharmaceutical & biotechnology industries, research institutes, and others.
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In terms of region, the global recombinant human serum albumin market can be segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominates the global recombinant human serum albumin market due to increase in focus of major players to launch new recombinant albumin-based products in the region. In March 2016, CSL Behring announced that it received approval from the U.S. Food and Drug Administration (FDA) for its IDELVION, a novel albumin fusion protein linking recombinant albumin with recombinant coagulation factor IX, to be used in hemophilia B treatment.
Prominent players operating in the global recombinant human serum albumin market are Albumedix A/S (Novozyme A/S), Sigma-Aldrich Co. LLC (Merck KGaA), Medxbio Pte. Ltd., Prospec-Tany TechnoGene Ltd., Albumin Therapeutics, LLC, Wuhan Healthgen Biotechnology Corp., Mitsubishi Tanabe Pharma Corporation, and Thermo Fisher Scientific, Inc.
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