Oral Biologics Market Aims to Expand at Double-Digit Growth Rate

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.

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Increasing number of strategic moves such as collaborations and innovations by key players is an important factor driving global oral biologics market growth in near future.

For instance, in 2016, Rani Therapeutics announced collaboration with Medimmune, a research and development subsidiary of AstraZeneca, to evaluate Rani Therapeutics’ novel oral drug delivering platform. This collaboration is expected to facilitate feasibility studies of drugs and test biologic molecules in the area of metabolic disease, to evaluate oral delivery of molecules. The objective of this collaboration is to deliver biologics orally, in order to increase compliance and improve patients’ lives globally.

The U.S. is expected to be most lucrative market for oral biologics in North America, as it is the biggest pharmaceutical market with high presence of major players. Furthermore, high healthcare expenditure, healthcare awareness, and high adoption rate of novel drugs make the U.S. most prominent market for oral biologics.

Key players in the market are focusing on gaining the U.S. FDA approval for their oral biologics and launch them in the market. For instance, in March 2019, Novo Nordisk A/S submitted two New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for oral semaglutide, the once-daily glucagon-like peptide-1 (GLP-1) receptor agonist in a pill.

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Approval and launch of novel oral biologics in the U.S. is expected to significantly drive the North America oral biologics market growth over the forecast period.

According to Labiotech.eu, 2018, around half of the top 100 drug sales will be biologics by 2022. Moreover, an estimated 2,700 biologics are currently in development, which means they can create a conducive biologics market post approval. However, the biological drugs are administered parentally, which can result in high treatment costs and lower adherence rates.

According to the research conducted by Rani Therapeutics in 2018, around 62% patients and 86% physicians reported that patients either skip their injection or consistently fail to inject the drug as prescribed. The research further stated that around 70% rheumatologists and 92% gastroenterologists believe that availability of pills would significantly increase patient compliance rates.

Thus, the availability of biologics in the form of oral pills is expected to increase compliance rate and patient comfort, which can significantly improve the patients’ health by changing the course of the disease and preventing further complications. Moreover, oral biologics could also lower medication costs and improve access while improving the health of millions with chronic diseases globally.

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.

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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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