Oral Biologics Market Robust research and development are Novo Nordisk A/S, Biocon Limited, Oramed Pharmaceuticals, Inc., Rani Therapeutics, Entera Bio Ltd., Allergan plc

Frequent research and development activities by key players for the development of novel oral biologics products and launch them in market is expected to boost global oral biologics market growth over the forecast period.

For instance, Allena Pharmaceuticals, Inc., a U.S.-based biopharmaceutical company, is involved in development of Reloxaliase, a non-absorbed, orally-administered enzyme for treatment of hyperoxaluria. Currently (June 2019), Reloxaliase is in Phase 2 clinical trial.

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Furthermore, key players in the market are involved in strategic partnership and mergers for development of novel oral biologics products and gain its approval. Such strategic partnerships are expected to drive global oral biologics market growth.

For instance, in December 2017, Rani Therapeutics and Shire Plc. collaborated to conduct research and evaluate the application of RaniPill technology for the oral delivery of factor VIII therapy for Hemophilia A patients

In January 2017, Enteris BioPharma, Inc. and Ferring Pharmaceuticals entered into license agreement to leverage Enteris proprietary oral drug delivery platform Peptelligence, to develop an oral formulation of a peptide-based injectable therapeutic developed by Ferring.

Such strategies among key players may lead to development of novel oral biologics, which in turn is expected to drive global oral biologics market growth over the forecast period.

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.

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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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