Oral Insulin Therapies Market By Drug Class (Fast-acting, Intermediate-acting, Others) By Application (Type 1 and Type 2 diabetes) Regional Analysis & Forecast to 2026

  • OI-82
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  • Published date: Mar, 2019
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  • Metabolic Diseases
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  • Pages

In type 1 diabetes people, the pancreas does not make insulin -- a hormone that helps glucose to get into your cells and give them energy -- which is why they take insulin. In Type 2 diabetes people, the body does not make or use insulin well, and so insulin therapy may be needed. Daily insulin shots for the management of diabetes could become a thing of the past, and insulin pills now are another option for diabetes patients. Insulin is a peptide hormone, which is produced by the pancreas and is central to regulating carbohydrate and fat metabolism in the body. Insulin therapy is used for the treatment of people with type 1 diabetes in order to avoid complications arising from hyperglycemia. Insulin is administered mainly through subcutaneous insulin injections such as vials and syringes, insulin pens, and insulin pumps. In addition to this, various other physiological minimally invasive or noninvasive ways for delivering insulin are oral, buccal, nasal, peritoneal and transdermal.

Market Overview

The oral insulin therapies market is expected to grow at a CAGR of x% during the period 2018-2026. Diabetes ranks among the fast-growing chronic diseases in the United States.  The prevailing cases of diabetes are mainly due to the rise in obesity levels, which is mainly because of their sedentary lifestyles, physical inactivities, unhealthy eating habits, and an increasingly aging population. Several companies across the globe are working for creating effective oral insulin delivery systems, and many major pharmaceutical companies are at the lead of the research and development stage. It is one of a holy grail of medical innovation. An oral form of insulin is going to make insulin therapy less complicated, and surely increases the rate at which insulin users abide with the insulin therapy schedule.

Postliminary 90 years of research on oral insulin, their commercial availability seems to be still distant. The obstacles present in the production of oral insulin in 1922-1923 has not been overcome completely still now. Oral insulin is designed explicitly for enteral absorption and is totally different from conventional insulin that uses the intravenous or subcutaneous route. Hence, oral insulin will take the route that would be of non-invasive nature but is still being investigated. Oral insulin development in 2014 is challenging due to the fact that 6 out of a total of 13 companies are claiming for the clinical development of oral insulin. Currently, they are passing through novel clinical trials.

Oramed had made a capsule that uses Protein Oral Delivery (POD) technology. Oramed formulation, ORMID-0801 has passed through testing till 2010 October. In 2013 Oramed has passed two more phases of II phase in both type 1 and 2 diabetes. There was a set final trial of phase II by the FDA in late 2017. After the trials success now there will be final trials of Oramed oral insulin in 2019-2020, ahead of registration that will bring the oral treatment in the market. Sotagliflozin is also currently in phase 3 trials for type 2 diabetes, and if sotagliflozin is approved, it would be the first oral insulin treatment to treat type 1 diabetes on the market.

The market growth is propelled by increasing incidences of diabetes, the rise in geriatric population, growing the obese population, propagation of Diabetes management awareness and government impetus. Better accessibility to treatment therapies and the presence of favorable reimbursement programs will result in the high turnout of patients opting for diabetes treatment. This will, in turn, fuel the growth of the insulin market size during the next few years.

Key Developments

  • Oramed on September 2018 announced that there glucagon-like peptide (GLP) analog capsule ORMID 0901 has cleared their investigation done by FDA.

  • In 2019, Sotagliflozin is found currently in phase 3 trials for type 2 diabetes and could receive a PDUFA for that indication later this year.


The market presents a detailed segmentation of the oral insulin market by drug class, by the application.

By drug class: Fast-acting, Intermediate-acting, and Long-acting drugs.

By the application: Type 1 and Type 2 diabetes. Type 2 diabetes is the largest segment of the oral insulin market in terms of application.

Based on regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America stands as the largest region in the oral insulin therapies market in 2018, followed by Asia Pacific, Western Europe, and other regions.

Based on gender: Presently females are accounting for the majority of the diabetes patients.

In terms of age groups: The age group of 40-59 currently accounts for the majority of the total diabetes patients followed by the age group 60-79 and 20-39.

Some of the few key players involved in oral insulin therapies market include Abbott Laboratories, GlySens Incorporated, Echo Therapeutics Inc., Sanofi, Medtronic Plc, Novo Nordisk, Hoffmann-La Roche Ltd., MannKind Corporation, Dexcom Inc., and Senseonics Holding Inc.

Report Description: The report covers in-depth analysis on Oral Insulin Therapies Market. The report assesses the market products pipeline by stage of development (early development, pre-clinical, clinical and in approval), by application (Type 1 diabetes and Type 2 diabetes). In addition, the report includes key insights on other development activities, including (but not limited to) – licensing (In and Out), collaborations, acquisitions, reimbursement, patent, and regulatory designations.

The report includes in-depth company profiles of key players in Oral Insulin Therapies Market. The company profile includes key information on overview, financial highlights, product portfolio, business strategies, and key recent developments.

The report highlights information on emerging companies with potentially disruptive technologies and new market entrants.


  • Provides detailed analysis of the market structure along with forecast of the various segments and sub-segments of the Oral Insulin Therapies Market.

  • Provides a comparative analysis of key marketed products and pipeline market products.

  • Provides key information on players involved on the Oral Insulin Therapies Market.

  • Provides a complete overview of market segments and the regional outlook of Oral Insulin Therapies Market.

  • Provides in-depth coverage of key news related to Oral Insulin Therapies Market, including major mergers and acquisitions and product development updates such as clinical trial progression updates and regulatory updates

Our research works on a holistic 360° approach to deliver high quality, validated and reliable information in our market reports. The Market estimation and forecasting involve the following steps:

  • Data Collation (Primary & Secondary)

  • In-house Estimation (Based on proprietary databases and Models)

  • Market Triangulation

  • Forecasting

  • Market-related information is assembled from both primary and secondary sources. 

  • Primary sources involved participants from all global stakeholders such as experts from several related industries and suppliers that have been interviewed to obtain and verify critical information as well as to assess prospects of the market. The participants included are CXOs, VPs, and managers. Plus, our in-house industry experts having decades of industry experience contribute their consulting and advisory services. 

  • Secondary sources include public sources such as regulatory frameworks, government IT spending, government demographic indicators, industry association statistics, and company publications annual reports press releases along with paid sources such as Factiva, OneSource, Bloomberg among others. 

  • Top-down and bottom-up approaches: The overall market size was used in the top-down approach to estimate the sizes of other individual submarkets (mentioned in the market segmentation by product, type of manufacturing, and disease) through percentage splits from secondary and primary research. The bottom-up approach was also implemented (wherever applicable) for data extracted from secondary research to validate the market segment revenues obtained. 



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