A biopharmaceutical is a medicinal product that is derived from biological sources such as animals, humans, and microorganisms using biotechnology. They are manufactured using stem cells, mammalian cells, etc., through tissue culture methods.
Tissue culture methods rely on cell culture medium, which contains a number of essential components such as carbohydrates, amino acids, vitamins, minerals, and a pH buffer system that keep the cell culture healthy and supply nutrition for the production of therapeutic recombinant molecules or biopharmaceuticals.
One such component of cell culture is recombinant human albumin. Recombinant human albumin (rHu) has applications in cell culture media and stem cell therapy. It is particularly a nutrient supplement and stabilizer in the cell culture medium. Moreover, it plays a role in cryopreservation for stem cell therapies.
Market Dynamics
Market players are focusing on various strategies such as distribution agreements which is expected to drive market growth over the forecast period. In April 2021, Albumedix, a science-driven, biotechnology Company, announced that they had entered into a distribution agreement with established and well recognized reagent supplier Fujifilm Wako Pure Chemical Corporation in Japan and China including Hong Kong.
Research and/or academic institutes are focused on research and development activities related to rHu albumin, which is expected to drive growth of the global rHu albumin market over the forecast period. For instance, in June 2019, The First Hospital of Jilin University, a leading national research university located in Changchun, China, initiated a phase I, single-center, randomized, double-blind, placebo-controlled single dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of recombinant human albumin injection in healthy volunteers for treatment of ascites.
Increasing research and development activities of rHu albumin in the region is expected to drive growth of the global rHu albumin market. For instance, according to a study published in clinicaltrials.gov, a trial, which started on April 8, 2021, is being conducted by Protgen Ltd, a research and development-oriented high-tech enterprise, based in Beijing, China. The trial is aimed at adopting a single-center, randomized, double-blind, dose-escalation, placebo-controlled design to evaluate the safety, tolerability, pharmacokinetics, and efficacy of a single administration of recombinant human serum albumin in healthy subjects. The study is estimated to be completed by December 31, 2022.
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