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) - Size, Share, Outlook, and Opportunity Analysis, 2018-2026

  • Published On : Jun 2019 |
  • Pages : 195 Pages |
  • Format : CMI Insight PPT Format CMI Insight PDF Format

Global Oral Biologics Market Insights

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.

Currently, majority of the biological products are administered through parental route of administration. However, oral biologics represent a novel category of drugs, which is gaining traction in the last few decades. Key players in the market are working for the development of oral biologics and launch them in market, however, major concern regarding oral biologics is to protect the protein from degradation and digestion in the gastrointestinal tract.

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.

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.

Such robust research and development activities by key players is expected to create a conducive environment and support global oral biologics market growth over the forecast period.  

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).

Figure 1. Global Oral Biologics Market Value (US$ Mn) Analysis and Forecast, and Y-o-Y Growth (%)

Oral Biologics  | Coherent Market Insights

Source: Coherent Market Insights Analysis (2018)

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. 

Figure 2. Global Oral Biologics Market Share (%) Analysis, By Region, 2026

Oral Biologics  | Coherent Market Insights

Source: Coherent Market Insights Analysis (2018)

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.

Key players in the market are focusing on gaining the U.S. FDA approval for their oral biologics and launch them in the market. For instance, in March 2019, Novo Nordisk A/S submitted two New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for oral semaglutide, the once-daily glucagon-like peptide-1 (GLP-1) receptor agonist in a pill.

Approval and launch of novel oral biologics in the U.S. is expected to significantly drive the North America oral biologics market growth over the forecast period.

Global Oral Biologics Market Opportunity

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.

Thus, the availability of biologics in the form of oral pills is expected to increase compliance rate and patient comfort, which can significantly improve the patients’ health by changing the course of the disease and preventing further complications. Moreover, oral biologics could also lower medication costs and improve access while improving the health of millions with chronic diseases globally.

Regulatory Scenario

The U.S. Food and Drug Administration (FDA) issues guidelines and regulates biologics including: vaccines, blood and blood products, cellular and gene therapy products tissue and tissue products, and allergenics.

The Center for Biologics Evaluation and Research (CBER) is a part of FDA that regulates biological products for human use, under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act.

CBER ensures that biological products are safe and effective and are readily available. CBER also promotes the safe and appropriate use of biological products.

CBER encourages manufacturers to use appropriate standards in the development of medical products. The use of appropriate standards can facilitate product development and provide a more efficient evaluation of regulatory submissions, including investigational new drug applications (INDs), biologics license applications (BLAs), new drug applications (NDAs), investigational device exemptions (IDEs), premarket approval applications, and premarket notifications, supplements, and amendments.

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.

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.

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.

For instance, in December 2017, Rani Therapeutics and Shire Plc. collaborated to conduct research and evaluate the application of RaniPill technology for the oral delivery of factor VIII therapy for Hemophilia A patients

In January 2017, Enteris BioPharma, Inc. and Ferring Pharmaceuticals entered into license agreement to leverage Enteris proprietary oral drug delivery platform Peptelligence, to develop an oral formulation of a peptide-based injectable therapeutic developed by Ferring.

Such strategies among key players may lead to development of novel oral biologics, which in turn is expected to drive global oral biologics market growth over the forecast period.

Key features of the study:

  • This report provides in-depth analysis of global oral biologics market and provides market size (US$ Million) and compound annual growth rate (CAGR %) for the forecast period (2018 – 2026), considering 2017, 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, regional outlook, and competitive strategy adopted by leading players
  • It profiles leading players in the global oral biologics market based on following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments, and 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., Allergan plc, Emisphere Technologies, 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 decision regarding their future product launches, technology 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 the 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
    • 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:
        • U.K.
        • Germany
        • Italy
        • France
        • 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
        • ASEAN
        • Australia
        • South Korea
        • Rest of Asia Pacific
    • 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
    • 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/Region:
        • Central Africa
        • South Africa
        • North Africa
  • Company Profiles
    • Novo Nordisk A/S*
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Key Strategies
      • Recent Developments
    • Biocon Limited
    • Oramed Pharmaceuticals, Inc.
    • Rani Therapeutics
    • Entera Bio Ltd.
    • Allergan plc.
    • Emisphere Technologies, Inc.
    • Enteris BioPharma, Inc.
    • Chiasma, Inc.
    • Allena Pharmaceuticals, Inc.

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

 

Table of Contents

  1. Research Objective and Assumption
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Purview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Drug Class
      • Market Snippet, By Disease Indication
      • Market Snippet, By Distribution Channel
      • Market Snippet, By Region
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Impact Analysis
    • Pipeline Analysis
    • PEST Analysis
    • Adherence of Patients- Injectable Biologics
    • Regulatory Scenario
    • Limitations of Injectable Biologics
    • Epidemiology
    • Mechanism of Action- Pill Technology
    • Partnership/Collaboration/Acquisition/Agreement
  4. Global Oral Biologics Market, By Drug Class, 2016 – 2026 (US$ Mn)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017–2026
      • Segment Trends
    • Glucagon-like Peptide 1 (GLP-1) Receptor Agonist
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Hormone
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Recombinant Enzyme
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Guanylate Cyclase-C Agonist
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Somatostatin Analogue
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
  5. Global Oral Biologics Market, By Disease Indication, 2016 – 2026 (US$ Mn)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017–2026
      • Segment Trends
    • Diabetes
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Hyperoxaluria
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Acromegaly
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Irritable Bowel Syndrome (IBS) & Chronic Idiopathic Constipation (CIC)
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Others (Inflammatory Bowel Disease (IBD), Hypoparathyroidism and Others)
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
  6. Global Oral Biologics Market, By Distribution Channel, 2016 – 2026 (US$ Mn)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017–2026
      • Segment Trends
    • Hospital Pharmacies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Retail Pharmacies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Online Pharmacies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
  7. Global Oral Biologics Market, By Region, 2016 – 2026 (US$ Mn)
    • Introduction
      • Market Share Analysis, By Region, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, For Regions, 2017–2026
    • North America
      • Market Size and Forecast, By Drug Class, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Disease Indication, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026 (US$ Mn)
        • U.S.
        • Canada
    • Europe
      • Market Size and Forecast, By Drug Class, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Disease Indication, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026 (US$ Mn)
        • U.K.
        • Germany
        • Italy
        • France
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast, By Drug Class, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Disease Indication, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026 (US$ Mn)
        • China
        • India
        • Japan
        • ASEAN
        • Australia
        • South Korea
        • Rest of APAC
    • Latin America
      • Market Size and Forecast, By Drug Class, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Disease Indication, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026 (US$ Mn)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Africa
      • Market Size and Forecast, By Drug Class, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Disease Indication, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Country/Region, 2016 – 2026 (US$ Mn)
        • Central Africa
        • South Africa
        • North Africa
    • Middle East
      • Market Size and Forecast, By Drug Class, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Disease Indication, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026 (US$ Mn)
        • GCC
        • Israel
        • Rest of Middle East
  8. Competitive Landscape
    • Heat Map Analysis
    • Company Profiles
      • Novo Nordisk A/S
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Biocon Limited
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Oramed Pharmaceuticals, Inc.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Rani Therapeutics
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Entera Bio Ltd.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Allergan plc
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Emisphere Technologies, Inc.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Enteris BioPharma, Inc.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Chiasma, Inc.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Allena Pharmaceuticals, Inc.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
  9. Section
    • References
    • Research Methodology
    • About us and Sales Contact

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