Impact Analysis of Covid-19
The complete version of the Report will include the impact of the COVID-19, and anticipated change on the future outlook of the industry, by taking into the account the political, economic, social, and technological parameters.
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 by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) was valued at US$ 834.3 Mn in 2018 and is projected to exhibit a CAGR of 32.8% during the forecast period (2018–2026).
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Factors such as increasing research and development activities and strategic partnerships 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, has developed an innovative oral insulin capsule, transforming injectable treatments for 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 among key players for the development of novel oral biologics is expected to create a conducive environment for market growth. For instance, in 2018, Amgen Inc. entered into a partnership with Entera Bio Ltd. to develop oral formulations of biologics. As per the partnership agreement, Amgen was provided 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.
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.
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Oral biologics are also undergoing clinical trials for rare conditions such as Hyperoxaluria and Acromegaly. In Acromegaly, oral drugs would be injectable, however, there are no approved drugs for Hyperoxaluria. This high unmet need in Hyperoxaluria presents a significant market opportunity for oral enzymes 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.
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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 injectables to oral GLP-1 receptor agonists post the launch of oral versions. This shift would mainly be due to more convenient mode of delivery.
- Major players operating in the global oral biologics market are 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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