Oral Biologics Market Perspective by Comprehensive Analysis, Growth Prediction to 2026 With Key Players Novo Nordisk A/S, Biocon Limited, Oramed Pharmaceuticals, Rani Therapeutics, Entera Bio, Allergan, Emisphere Technologies, Enteris BioPharma

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). Biological drugs refer to therapeutic products derived from living organisms or contain components of living organisms. Biological drugs are widely used in the treatment of number of diseases including diabetes, plaque psoriasis, arthritis, Crohn’s disease, and ulcerative colitis.

Oral biologics products refer to the biological drugs taken from oral disease indication. Currently, majority of biological drugs are administrated by parental route and only guanylate cyclase-c agonist class of drug is approved oral biological in market. However, key players in the market are involved in development of orally administered glucagon-like peptide 1 (GLP-1) receptor agonist, recombinant enzyme, somatostatin analogue, and various hormone for different indications.

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Market Dynamics

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. 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.

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.

Increasing partnerships and collaborations by market players is expected to create conducive environment for global oral biologics market growth

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.

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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North America is expected to hold dominant position in the market, owing to presence of major players and frequent research by them

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.

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.

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