Oral Biologics Market is expected to witness a CAGR of 32.8% to Surpass US$ 8,087.5 Mn Threshold By 2026

Biologics drugs can be defined as molecules derived from living cells such as microorganism or plant or animal cells and used for the treatment, diagnosis, or prevention of various diseases. Biologic therapeutics has proven to be a highly effective treatment for various chronic ailments, such as diabetes, plaque psoriasis, arthritis, Crohn's disease, and ulcerative colitis.

Currently, majority of the biological products are administered through parental route of administration. However, oral biologics represent a novel category of drugs, which is gaining traction in the last few decades. Key players in the market are working for the development of oral biologics and launch them in market, however, major concern regarding oral biologics is to protect the protein from degradation and digestion in the gastrointestinal tract.

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Robust research and development activities for development of novel oral biologics is expected fuel the market growth

Key players are involved in extensive research and development of novel oral biologics for various conditions

In February 2019, researchers at Massachusetts Institute of Technology (MIT) developed a drug capsule with the potential to deliver an oral insulin named SOMA capsule, thereby replacing (or eliminating) the need to administer insulin via injections multiple times a day for patients with type 1 diabetes. The researchers stated that the drugs is currently under preclinical studies and is expected to enter clinical trials by 2022.

The research was funded by Novo Nordisk, the National Institutes of Health, a National Science Foundation Graduate Research Fellowship, Brigham and Women's Hospital, a Viking Olaf Bjork Research Scholarship, and the MIT Undergraduate Research Opportunities Program.

Such robust research and development activities by key players is expected to create a conducive environment and support global oral biologics market growth over the forecast period.

The global oral biologics market size was valued at US$ 834.3 Mn in 2018, and is expected to witness a CAGR of 32.8% during the forecast period (2018 - 2026).

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The U.S. Food and Drug Administration (FDA) issues guidelines and regulates biologics including: vaccines, blood and blood products, cellular and gene therapy products tissue and tissue products, and allergenics.

The Center for Biologics Evaluation and Research (CBER) is a part of FDA that regulates biological products for human use, under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act.

CBER ensures that biological products are safe and effective and are readily available. CBER also promotes the safe and appropriate use of biological products.

CBER encourages manufacturers to use appropriate standards in the development of medical products. The use of appropriate standards can facilitate product development and provide a more efficient evaluation of regulatory submissions, including investigational new drug applications (INDs), biologics license applications (BLAs), new drug applications (NDAs), investigational device exemptions (IDEs), premarket approval applications, and premarket notifications, supplements, and amendments.

Key players operating in the global oral biologics market include Novo Nordisk A/S, Biocon Limited, Oramed Pharmaceuticals, Inc., Rani Therapeutics, Entera Bio Ltd., Allergan plc, Emisphere Technologies, Inc., Enteris BioPharma, Inc., Chiasma, Inc., and Allena Pharmaceuticals, Inc.

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