Biologics drugs can be defined as molecules derived from living cells such as microorganism, or plant, or animal cells and used for the treatment, diagnosis, or prevention of various diseases. Biologic therapeutics has proven to be a highly effective treatment for various chronic ailments, such as diabetes, plaque psoriasis, arthritis, Crohn’s disease, and ulcerative colitis.
Strategic collaborations undertaken by local players in the respective regions is expected to augment the market growth
For instance, in 2021, Amgen inc, biopharmaceutical company and Entera Bio Ltd., an Israel-based company, entered into a research collaboration and license agreement to develop orally administered formulations of biologic drugs. Under the agreement, Entera will use its proprietary drug delivery platform to develop oral formulations for Amgen’s preclinical large molecule.
The Global Oral Biologics Market is estimated to be valued at US$ 1,437.4 million in 2021 and is expected to exhibit a CAGR of 35.3% over the forecast period (2021-2028).
Figure 1. Global Oral Biologics Market Share (%) in Terms of Value, By Region, 2021
Increasing research and development activities is expected to drive the market growth over the forecast period
For instance, in December 2020, Entera Bio Ltd. announced that the U.S. Food Drug and Administration had revived the company’s Investigational New Drug (IND) application for EB613, orally delivered human parathyroid hormone (1-34) or PTH, for the treatment of osteoporosis patients.
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 study 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.
Oramed Pharmaceuticals a pharmaceutical company, based in Jerusalem, Israel, developed an innovative oral insulin capsule transforming injectable treatments into oral therapies. In October 2018, enrolled the first patient in an exploratory clinical study of its oral insulin capsule, ORMD-0801, for treating non-alcoholic steatohepatitis (NASH).
Thus, the availability of oral biologics for treating various chronic diseases is expected to drive the global oral biologics market as biologic treatments have exhibited positive outcomes in treatment of diseases such as diabetes, inflammatory bowel diseases, and others.
Oral Biologics Market Report Coverage
||Market Size in 2021:
||US$ 1,437.4 Mn
|Historical Data for:
||2017 to 2020
||2020 to 2027
|Forecast Period 2021 to 2028 CAGR:
||2028 Value Projection:
||US$ 11,907.2 Mn
- North America: U.S. and Canada
- Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
- Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
- Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
- Middle East: GCC Countries, Israel, and Rest of Middle East
- Africa: South Africa, North Africa, and Central Africa
- By Drug Class: Glucagon-like Peptide 1 (GLP-1) Receptor Agonist, Hormone, Recombinant Enzyme, Guanylate Cyclase-C Agonist, Somatostatin Analogue, Others
- By Disease Indication: Diabetes, Hyperoxaluria, Acromegaly, Irritable Bowel Syndrome (IBS) & Chronic Idiopathic Constipation (CIC), Others (Inflammatory Bowel Disease (IBD), Hypoparathyroidism and Others)
- By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies
Novo Nordisk A/S, Biocon Limited, Oramed Pharmaceuticals, Inc., Rani Therapeutics, Entera Bio Ltd., AbbVie Inc., Enteris BioPharma, Inc., Chiasma, Inc. and Allena Pharmaceuticals, Inc.
- Increasing partnerships, collaborations, mergers, and acquisitions by market players
- Increasing research and development activities
|Restraints & Challenges:
Figure 2. Global Oral Biologics Market Share (%), by Drug Class, 2021
High prevalence of diabetes and frequent research and development activities by key players for development of oral biologics is expected to drive the market growth over the forecast period
According to the International Diabetes Federation 2015, the total number of population suffering from diabetes accounted for 415 million in 2015 and was estimated to reach to 642 million by 2040 globally
For instance, Biocon Limited a biopharmaceutical company is developing Insulin Tregopil, a first in class Oral, Prandial Insulin, that is currently undergoing phase II/III clinical trial for treatment of patients with type 2 diabetes.
Global Oral Biologics Market – Impact of Coronavirus (Covid-19) Pandemic
The coronavirus (COVID-19) pandemic and lockdowns in various countries across the globe have impacted the financial status of businesses across all sectors. The private healthcare sector is one of the sectors, which has been majorly impacted by the COVID 19 pandemic.
The lockdown in various countries due to the COVID-19 pandemic has created an economic burden on the private healthcare sectors. Healthcare providers were facing challenges with regards to manpower, equipment, consumables, and other resources to ensure safety in treatment of patients with other diseases, and declining outpatients’ visits, etc.
Moreover, the coronavirus pandemic has negatively impacted the development, production, and supply of oral biologics and affected the growth of the oral biologics businesses of various companies across the globe, as the COVID 19 pandemic has led to nationwide lockdowns in several countries. This has led to closure of industrial establishments, except manufacturing of essential commodities and disruption in supply chain of products.
Thus, COVID-19 pandemic has affected the economy in three main ways: 1) by directly affecting the production and demand; 2) by creating disruptions in distribution channels; and 3) through its financial impact on companies and financial markets
Supply chain and manufacturing activities in India, China, and the U.S. have been disrupted due to the global lockdowns, while countries such as Saudi Arabia, UAE, Egypt, and others are facing problems with regards to transportation of oral biologics
Thus, impact of the coronavirus (COVID-19) pandemic is expected to limit growth of the global oral biologics market during the forecast period
Global Oral Biologics Market Restraint
The lack of successful commercialization of oral delivery of biologics is a major challenge with overcoming physiological barriers of gastrointestinal tract for successful drug delivery, despite higher number of research activities undertaken by players. For instance, in 2016, Novo Nordisk discontinued the oral insulin development programme, owing to long-standing difficulties associated with its development.
As per the article published by PMGroup Worldwide Ltd. in 2016, the production of oral biologics poses a challenge, as large molecule drugs such as proteins and peptides have low bioavailability (around 0-2%) when administered orally. As a result, several research and development projects for oral delivery of peptides and proteins end in failure, despite adopting various strategies to enhance drug bioavailability, and enzymatic degradation.
Major players operating in the global oral biologics market include Novo Nordisk A/S, Biocon Limited, Oramed Pharmaceuticals, Inc., Rani Therapeutics, Entera Bio Ltd., AbbVie Inc., Enteris BioPharma, Inc., Chiasma, Inc., and Allena Pharmaceuticals, Inc.