Oral Biologics Market to Surpass US$ 8,087.5 Mn Threshold by 2026: Novo Nordisk A/S, Biocon Limited, Oramed Pharmaceuticals, Inc., Rani Therapeutics, Entera Bio Ltd., Allergan plc

increasing research and development activities and frequent strategic partnership between key players for development of novel oral biologics are expected to support the global oral biologics market growth. Increasing research and development by key players for development of novel oral biologics is expected to drive global oral biologics market growth over the forecast period. For instance, Oramed Pharmaceuticals, based in Jerusalem, Israel, developed an innovative oral insulin capsule, transforming injectable treatments into oral therapies.

In October 2018, they enrolled the first patient in an exploratory clinical study of its oral insulin capsule, ORMD-0801, for treating nonalcoholic steatohepatitis (NASH). Frequent partnership and collaboration activities by key players for the development of novel oral biologics is expected to form a conducive environment and significantly support global oral biologics market growth over the forecast period. For instance, in 2018, Amgen Inc. entered into a deal with Entera Bio Ltd., to develop oral formulations of biologics. As per the deal, Amgen gained access to Entera's technology to develop an oral formulation of a large molecule, as well as an option to develop two other (oral) large molecules.

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Browse 30 Market Data Tables and 32 Figures spread through 195 Pages and in-depth TOC on Global Oral Biologics Market by Drug Class (Glucagon-like Peptide 1 (GLP-1) Receptor Agonist, Hormone, Recombinant Enzyme, Guanylate Cyclase-C Agonist, Somatostatin Analogue, and Others), by Disease Indication (Diabetes, Hyperoxaluria, Acromegaly, Irritable Bowel Syndrome (IBS) & Chronic Idiopathic Constipation (CIC), and Others (Inflammatory Bowel Disease (IBD), Hypoparathyroidism, and Others)), by Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), and Region (North America, Latin America, Europe, Asia Pacific, the Middle East, and Africa) - Global Forecast to 2026.

Oral biologics are also in clinical trial for rare conditions such as Hyperoxaluria and Acromegaly. In Acromegaly, oral drug would be injectable, however, there are no approved drugs for Hyperoxaluria. This high unmet need in Hyperoxaluria presents a significant market opportunity for oral enzyme i.e. Reloxaliase (ALLN-177). The drug is in Phase 3 and is expected to be filed with U.S. FDA in 2020. Furthermore, oral delivery of biologics has witnessed some major setbacks. For instance, in 2016, Novo Nordisk A/S discontinued the trials for oral insulin due to unsatisfactory result in clinical trials, and same year Bristol-Myers Squibb discontinued the collaboration with Biocon for the development of oral insulin.

These two events suggest that development of oral biologics would not be an easy path for other companies, as well. Significantly, large molecules such as monoclonal antibodies, fusion proteins, and others are difficult to administer orally. However, few companies have taken this challenge and are working in this direction. For instance, Protalix Biotherapeutics' OPRX-106, a fusion protein is in Phase 2 for the treatment of inflammatory bowel disease (IBD). VHsquared Ltd. and Applied Molecular Transport, LLC are few other companies working in this domain.

Key Takeaways of the Global Oral Biologics Market:

The global oral biologics market is expected to exhibit a CAGR of 8% during the forecast period (2018 - 2026), owing to frequent product launches and approvals, and robust pipeline of novel oral biologics

Patients suffering from chronic diseases such as diabetes (advanced stage) need to inject insulin multiple times a day for a long period of time. However, inconvenient mode of delivery i.e. injection has resulted in lower adherence rate. Insulin in oral dosage form is expected to significantly improve the adherence rate and oral insulin is expected to drive market growth.
GLP-1 receptor agonists segment has witnessed multiple changes in the recent years.

For instance, shifting of significant percentage of patients from Victoza (Liraglutide) to Trulicity (Dulaglutide). This shift was mainly attributed to administration pattern. Trulicity is administered once in a week, however, Victoza needs to be administered daily.

As per CMI analysis, there would be much higher shift from injectable to oral GLP-1 receptor agonists post-the launch of oral version. This shift would mainly be due to more convenient mode of delivery i.e. oral. Furthermore, oral drug would be available to attract additional patients who are afraid to take injectables.

Major 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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Detailed Segmentation:

Global Oral Biologics Market, By Drug Class:
Glucagon-like Peptide 1 (GLP-1) Receptor Agonist
Hormone
Recombinant Enzyme
Guanylate Cyclase-C Agonist
Somatostatin Analogue
Others
Global Oral Biologics Market, By Disease Indication:
Diabetes
Hyperoxaluria
Acromegaly
Irritable Bowel Syndrome (IBS) & Chronic Idiopathic Constipation (CIC)
Others (Inflammatory Bowel Disease (IBD), Hypoparathyroidism and Others)
Global Oral Biologics Market, By Distribution Channel:
Hospital Pharmacies
Retail Pharmacies
Online Pharmacies

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