Therapeutic proteins are engineered in the laboratory for pharmaceutical use, including non-covalent binders. These proteins are highly effective and serve as modernized treatment for rare as well as chronic diseases. Protein therapeutics offer custom-made treatment approach by supporting a specifically targeted therapeutic process by compensating the deficiency of an essential protein. Recombinant proteins have gained significant traction for therapeutic applications and the number of proteins either launched or approved into clinical trials has continually increased over the past two decades. According to the National Center for Biotechnology Information (NCBI) data of 2017, the U.S. Food and Drug Administration (FDA) approved over 140 recombinant therapeutic proteins for human use and several hundred are currently in development. Majority of these proteins are recombinant monoclonal antibodies.

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The global recombinant therapeutic antibodies and proteins market size was valued at US$ 91.2 billion in 2017, and is expected to witness a robust CAGR of 12.2% over the forecast period (2018 – 2026).

Market Dynamics

Recombinant therapeutic proteins and antibodies have gained high traction in clinical applications. Due to development of antibody-based therapeutics, mammalian expression systems have experienced a major boost and microbial expression systems continue to be widely used in industries, which in turn will fuel growth of the market. However, variations in production methods of therapeutic antibodies can lead to differences in their structure, based on the selection of recombinant procedure. Most protein therapeutics available in the market are recombinant and majority of them are in clinical trials for therapy of immune disorders, cancers, infections, and other diseases. Various engineered proteins, including multi-specific fusion proteins, bi-specific monoclonal antibodies (mAbs) and mAbs conjugated small molecule drugs, and proteins with optimized pharmacokinetics are under development.

Advancements in recombinant therapeutic drugs are expected to bolster the recombinant therapeutic antibodies and proteins market growth

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.

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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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