Oral Insulin Therapy Devices & Technologies (By Definition)
Oral insulin refers to insulin formulations designed to be taken by mouth, offering a non-invasive alternative to injectable insulin therapies for diabetes management. Unlike traditional insulin injections, oral insulin formulations aim to mimic the natural pathway of insulin by being absorbed through the gastrointestinal (GI) tract and transported directly to the liver, much like endogenous insulin. These therapies are particularly significant for improving patient compliance, reducing injection-related anxiety, and enhancing quality of life in people with Type 1 and Type 2 diabetes.
Use: Oral insulin therapies are being developed to improve glycemic control in diabetic patients by offering a more physiological insulin delivery route. For individuals with Type 1 Diabetes, oral insulin has the potential to complement or, in the future, even partially replace subcutaneous injections, thereby enhancing therapy adherence. For Type 2 Diabetes, oral insulin could be used in early stages to delay progression or as part of combination therapy in insulin-resistant individuals. Additionally, it reduces systemic hyperinsulinemia and may lower the risk of weight gain and hypoglycemia compared to conventional insulin delivery.
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Types of Oral Insulin – By Product Type:
- Capsules:
These oral insulin formulations are typically enteric-coated to protect insulin from degradation in the gastrointestinal tract. They are engineered to release insulin in the stomach or intestine, where absorption can occur efficiently.
- Liquid Formulations:
Liquid oral insulin solutions or suspensions often utilize advanced technologies like nanoparticles or enzyme inhibitors to preserve insulin integrity and enhance absorption across the intestinal lining.
- Film Strips:
Thin, dissolvable strips administered via the buccal or sublingual route offer a needle-free alternative. These films allow insulin to be absorbed directly through the mucosal membranes, bypassing the digestive system entirely.
- Others (Hydrogel, Microspheres, Tablets):
This category includes innovative delivery systems like hydrogels and microspheres for controlled release, and buccal/sublingual tablets designed for direct mucosal absorption, improving bioavailability and extending insulin action.
Market Developments
- In April, Endo Axiom's spin-off company focused on developing oral insulin has received commercial backing in Australia. This funding supports the advancement of their innovative oral insulin formulation, aiming to provide a more convenient, non-invasive insulin delivery solution, enhancing patient compliance and improving diabetes management.
- In November 2022, Oramed Pharmaceuticals announced positive results from its Phase 2 clinical trials of ORMD-0801, its lead oral insulin candidate, showing significant reduction in fasting and post-prandial blood glucose levels in Type 2 diabetes patients.
Future Opportunities -
Advancements in oral insulin delivery technologies: Advancements in insulin drug formulation, including nanoparticle carriers, mucoadhesive agents, and pH-sensitive coatings, have significantly improved the bioavailability of oral insulin, making it a viable alternative to traditional injections. Innovations such as insulin analogs and smart drug delivery systems enhance absorption and enable real-time glucose monitoring. These breakthroughs address patient adherence, particularly in emerging markets with increasing diabetes prevalence, creating significant growth opportunities for the oral insulin market
Revolutionizing diabetes management with needle-free oral insulin: Needle-free oral insulin is transforming diabetes management by providing a convenient alternative to traditional insulin injections. This approach eliminates the discomfort associated with needles, improving patient adherence, especially among children and individuals with needle phobia. By leveraging advanced formulations that protect insulin from digestive degradation, oral insulin mimics natural insulin absorption, offering more accessible and effective treatment. This innovation holds significant promise for improving diabetes care globally, particularly in underserved regions where traditional delivery methods may be challenging or inaccessible
Increasing pharmaceutical investments and strategic collaborations: The growing focus on research and development in diabetes care is driving significant advancements, particularly in oral insulin and needle-free delivery systems. By addressing challenges such as patient compliance and access to treatment, strategic collaborations between biotech and pharmaceutical companies are enhancing product development. This synergy expands market reach, improves treatment options, and accelerates global healthcare access, paving the way for better diabetes management worldwide.
Key Market Players.
Oramed Pharmaceuticals
Oramed is at the forefront of the oral insulin revolution with its ORMD-0801 product. The company is pioneering Protein Oral Delivery (POD) technology and has received regulatory attention from both the U.S. FDA and EMA.
Biocon
India-based Biocon is actively developing oral insulin formulations leveraging proprietary delivery technologies and has a strong presence in emerging and developed markets.
Related Reports-
- Global Insulin Market for Type 1 And Type 2 Diabetes
- Global Insulin Storage Device Market
- Europe Human Insulin Drugs & Delivery Devices Market
- Global Insulin Glargine Market
