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  • Published On : May 2021
  • Code : CMI989
  • Industry : Biotechnology
  • Pages : 197
  • Formats :

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

Oral Biologics  | Coherent Market Insights

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.

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Oral Biologics Market Report Coverage

Report Coverage Details
Base Year: 2020 Market Size in 2021: US$ 1,437.4 Mn
Historical Data for: 2017 to 2020 Forecast Period: 2020 to 2027
Forecast Period 2021 to 2028 CAGR: 35.3% 2028 Value Projection: US$ 11,907.2 Mn
Geographies covered:
  • 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
Segments covered:
  • 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
Companies covered:

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.

Growth Drivers:
  • Increasing partnerships, collaborations, mergers, and acquisitions by market players
  • Increasing research and development activities
Restraints & Challenges:
  • High technical hurdles

Figure 2. Global Oral Biologics Market Share (%), by Drug Class, 2021

Oral Biologics  | Coherent Market Insights

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.

Key Players

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.

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 parenteral route and only guanylate cyclase-c agonist class of drug is approved oral biologics 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.

Market Dynamics

Increasing number of inorganic strategies such as collaborations, partnerships, mergers, and acquisition by key players is a major factor driving growth of the market. For instance, in February 2021, Biocon Limited announced merger with International Diabetes Federation (IDF), an insulin biosimilar company, and the merger focuses on the research and development of Biocon’s biologics segment and promote the affordable access of insulin products manufactured by Biocon to the diabetes patients globally.

Key features of the study:

  • This report provides in-depth analysis of the global oral biologics market, and provides market size (US$ Mn) and compound annual growth rate (CAGR%) for the forecast period (2021–2028), considering 2020 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends,  regional outlook, and competitive strategies adopted by key players
  • It profiles key players in the global oral biologics market based on the following parameters – company overview, financial performance, product portfolio, market presence, distribution strategies, key developments, strategies, and future plans
  • Key companies covered as a part of this study 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.
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
  • The global oral biologics market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global oral biologics market

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
  • Global Oral Biologics Market, By Region:
    • North America
      • 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
      • By Country
        • U.S.
        • Canada
    • Latin America
      • 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
      • By Country
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • 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
      • By Country
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • 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
      • By Country
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • 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
      • By Country
        • GCC
        • Israel
        • Rest of Middle East
    • 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
      • By Country
        • South Africa
        • Central Africa
        • North Africa
  • Company Profiles
    • Novo Nordisk A/S *
      • Company Overview
      • Product Portfolio
      • Financial Overview
      • Key Highlights
      • Market Strategies
    • Biocon Limited
    • Oramed Pharmaceuticals, Inc.
    • Rani Therapeutics
    • Entera Bio Ltd.
    • AbbVie Inc.
    • Enteris BioPharma, Inc.
    • Chiasma, Inc.
    • Allena Pharmaceuticals, Inc.

“*” marked represents similar segmentation in other categories in the respective section.

Frequently Asked Questions

The global oral biologics market size is estimated to be valued at US$ 1,437.4 million in 2021 and is expected to exhibit a CAGR of 35.3% between 2021 and 2028.
Increasing partnerships, collaborations, mergers, and acquisitions by market players and research and development activities are expected to drive the market growth over the forecast period
Glucagon-like Peptide 1 (GLP-1) Receptor Agonist segment is expected to hold the major market share, owing to increasing product approvals and launches during the forecast period.
North America holds the largest market share in the market.
Major factors hampering growth of the market include high technical hurdles such as lack of successful commercialization of oral delivery of biologics.
Major players operating in the 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.

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