Integration of novel approaches and strategies to modify protein drug products is an important aspect. Advancements in recombinant protein technologies have allowed drug manufacturers and developers to adjust required functional characteristics of proteins of interest while maintaining product efficacy and safety.
Various recombinant technologies are currently in use to increase the half-life, functionality, and targeting of novel therapeutic protein drugs and increase product purity and volume. For instance, protein conjugation and derivatization methods, including albumin-fusion15, PEGylation and Fc-fusion are currently being used to extend a drug's circulating half-life.
Moreover, increasing number of rare diseases significantly impacting public health is expected to drive growth of the recombinant therapeutic antibodies and proteins market size. According to National institute of Health (NIH) 2018 report, an estimated 7,000 different disorders collectively affect about 10% of the U.S. population, mainly young children and many lack effective treatments. In order to encourage the development of drugs that specifically address unmet medical needs, in 2013, an orphan designation was given for drugs used for the treatment of less than 200,000 patients in the U.S.
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Monoclonal antibodies (mAbs) are most commonly used recombinant therapeutic products. The production of most monoclonal antibody products is easily amenable to effective platform-based approaches as antibodies are highly specific and the risk of unexpected safety issues in human clinical trials of mAb products is less as compared to other types of therapeutic products. The constant evaluation of monoclonal antibody drugs in new and expanded clinical indications results in constant demand for products in clinical studies ensuing increased sales in newly approved indications.
However, government regulations are stringent for production and approval of recombinant therapeutic drugs in order to ensure that these products are effective and safe.
Major players operating in the global recombinant therapeutic antibodies and proteins market include Abbott, Amgen Inc., Biogen Inc., Eli Lilly and Company, F. Hoffmann-La Roche, Johnson and Johnson, Merck & Co., Novo Nordisk, Pfizer Inc., and Sanofi S.A.
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