Non-Injectable Insulin Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Pills, Sprays, and Others), By Distribution Channel (Hospital Pharmacies, and Online Pharmacies, Drug Stores), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 3.69 Billion
CAGR (2026-2031)	9.78%
Fastest Growing Segment	Drug Stores
Largest Market	North America
Market Size (2031)	USD 6.46 Billion

Market Overview

The Global Non-Injectable Insulin Market will grow from USD 3.69 Billion in 2025 to USD 6.46 Billion by 2031 at a 9.78% CAGR. The Global Non-Injectable Insulin Market encompasses alternative drug delivery systems such as pulmonary inhalation and oral formulations designed to administer insulin without the use of invasive needles. The primary driver supporting this market is the escalating global prevalence of diabetes combined with the critical need to improve patient adherence among individuals suffering from needle phobia or injection fatigue. According to the International Diabetes Federation, in 2025, approximately 589 million adults globally were living with diabetes. This vast patient base creates a substantial demand for more convenient therapeutic options that address the psychological and physical barriers associated with traditional subcutaneous administration.

Despite the clear advantages regarding patient quality of life, the market faces a significant challenge concerning the lower bioavailability of non-injectable formulations compared to standard injectable insulin. This physiological limitation often necessitates higher dosage quantities to achieve the same therapeutic effect which substantially increases manufacturing costs and the final price for patients. Consequently, stringent reimbursement policies and the high economic burden of treatment remain primary obstacles that could impede widespread clinical adoption and limit market expansion in cost-sensitive regions.

Key Market Drivers

The escalating global prevalence of diabetes mellitus serves as the most critical determinant propelling the non-injectable insulin industry. As the diabetic population expands, the imperative to enhance patient adherence becomes acute, particularly for individuals struggling with the psychological and physical burdens of daily subcutaneous injections. This rising disease burden necessitates scalable, user-friendly therapeutic interventions that mitigate needle phobia. According to the International Diabetes Federation, 2025, in the 'IDF Diabetes Atlas 11th Edition', projections indicate that the total number of adults living with diabetes will surge to approximately 853 million by 2050. This trajectory underscores the urgent market need for alternative delivery methods. Furthermore, the sheer volume of patients requiring chronic care is evident in major pharmaceutical operations; according to Novo Nordisk, in 2024, the company served more than 45.2 million people living with serious chronic diseases, highlighting the immense scale of the addressable patient pool awaiting less invasive treatment options.

Simultaneously, the sector is being propelled by a surge in research and development investments for alternative insulin formulations. Pharmaceutical entities are aggressively funding innovations in oral and inhaled delivery systems to overcome historical bioavailability barriers and improve therapeutic efficacy. These financial commitments are pivotal for transitioning novel technologies from clinical trials to commercial availability. For instance, according to Oramed Pharmaceuticals, February 2025, in a corporate press release, the company announced a strategic joint venture involving a combined capital contribution of $75 million specifically designed to accelerate the development and commercialization of its oral insulin platform. Such substantial capital inflows validate the industry's focus on non-invasive solutions and are expected to drive the next wave of market expansion by making pain-free insulin administration a tangible reality.

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Key Market Challenges

The primary challenge hampering the growth of the Global Non-Injectable Insulin Market is the physiological limitation of lower bioavailability in oral and pulmonary formulations compared to standard injectables. Because these alternative delivery systems struggle to permeate biological barriers efficiently, manufacturers must formulate drugs with significantly higher quantities of active insulin to ensure the patient receives the necessary therapeutic dose. This requirement for increased active pharmaceutical ingredients directly escalates production expenses, resulting in a markedly higher final price point that limits accessibility for patients and insurers.

This cost disparity creates a substantial barrier to entry in regions where healthcare budgets are already heavily strained. Stringent reimbursement policies often favor lower-cost traditional injectables, leaving expensive non-injectable alternatives without adequate coverage. The magnitude of this economic pressure is evident in recent data regarding the overall financial toll of the disease. According to the International Diabetes Federation, in 2025, diabetes caused at least 1 trillion US dollars in global health expenditure. Such immense existing costs make payers reluctant to adopt premium-priced therapies, thereby restricting widespread clinical adoption and impeding market expansion in cost-sensitive territories.

Key Market Trends

The Focus on Ultra-Rapid Acting Inhaled Insulin is reshaping the market by prioritizing formulations that mimic the physiological insulin spike of a healthy pancreas more accurately than traditional subcutaneous methods. This trend centers on optimizing the aerodynamic particle size of dry powder formulations to ensure deep lung deposition and immediate systemic absorption, thereby reducing the risk of post-prandial hyperglycemia. Manufacturers are successfully translating this pharmacokinetic advantage into commercial viability, validating the demand for rapid-onset non-invasive options. According to MannKind Corporation, November 2024, in the 'Third Quarter 2024 Financial Results', Afrezza net revenue increased to $15.0 million, demonstrating a tangible growth trajectory for inhaled therapeutics driven by increased patient demand and improved gross-to-net adjustments.

Simultaneously, Innovation in Buccal and Sublingual Insulin Sprays is gaining momentum as researchers leverage novel peptide carriers to overcome the mucosal barrier without the degradation issues typical of gastrointestinal delivery. This trend involves developing liquid formulations administered under the tongue, where high vascularization allows for direct entry into the bloodstream, bypassing the hepatic first-pass metabolism that often neutralizes oral drugs. This technological progress is directly addressing the needs of large national patient populations seeking pain-free alternatives. According to the University of British Columbia, June 2024, in the article 'UBC-developed oral insulin drops offer relief for diabetes patients', the development of these new sublingual drops is specifically targeted to aid the 11.7 million Canadians currently living with diabetes or pre-diabetes, highlighting the extensive regional addressable market for such mucosal delivery innovations.

Segmental Insights

The Drug Stores segment represents the fastest-growing distribution channel in the Global Non-Injectable Insulin Market, primarily driven by the unparalleled accessibility of retail pharmacy networks. These establishments offer patients immediate access to regular prescription refills and vital face-to-face consultations with pharmacists, which are essential for ensuring the correct usage of novel inhalation devices. As the demand for non-invasive diabetes management solutions rises, the expanded reach of community drug stores facilitates broader market penetration. Consequently, this channel is pivotal in bridging the gap between innovative insulin therapies and widespread patient adoption.

Regional Insights

North America holds the leading position in the Global Non-Injectable Insulin Market, driven by advanced healthcare infrastructure and a rising prevalence of diabetes. This dominance is reinforced by high patient awareness and a strong demand for needle-free alternatives that enhance treatment adherence. A supportive regulatory framework further facilitates market expansion; notably, the U.S. Food and Drug Administration (FDA) has played a pivotal role in approving innovative therapies, such as inhaled insulin. Furthermore, substantial investment in research and development by key pharmaceutical companies solidifies North America’s status as the central market for non-injectable insulin solutions.

Recent Developments

• In December 2025, Cipla Limited announced the commercial launch of Afrezza, an inhaled insulin powder, across the Indian market. The company had previously secured exclusive rights to distribute and market the product in the country and received necessary approvals from the Central Drugs Standard Control Organisation. This development introduced a rapid-acting, needle-free insulin option for adults managing type 1 and type 2 diabetes in India. The launch was part of the company's broader effort to improve patient adherence and outcomes by offering non-invasive alternatives to traditional injectable insulin therapies.
• In February 2025, Oramed Pharmaceuticals announced the establishment of a joint venture, OraTech Pharmaceuticals, to accelerate the development and global commercialization of its oral insulin capsule. The company partnered with Hefei Tianhui Biotechnology, which committed to a significant financial investment and the provision of commercial-scale manufacturing capabilities. This strategic collaboration was formed to facilitate the re-initiation of a pivotal Phase 3 clinical trial in the United States, utilizing a revised protocol designed to target specific patient populations that had previously demonstrated a favorable response to the oral drug delivery platform.
• In December 2024, MannKind Corporation announced positive top-line results from its Phase 3 INHALE-1 clinical trial, which evaluated the safety and efficacy of its inhaled insulin, Afrezza, in pediatric patients with type 1 and type 2 diabetes. The study met its primary endpoint, demonstrating non-inferiority in hemoglobin A1c reduction compared to multiple daily insulin injections over a 26-week treatment period. Based on these findings, the company confirmed plans to submit a Supplemental New Drug Application to the US Food and Drug Administration in the first half of 2025 to seek approval for the use of the inhalable insulin in children and adolescents.
• In May 2024, Endo Axiom, a spin-out company from the University of Sydney, was highlighted for its development of a novel oral insulin utilizing nanotechnology. The company aims to commercialize a nano-carrier system that encapsulates insulin, protecting it from stomach acid and allowing for effective delivery to the liver. Preclinical studies in animal models, including baboons, demonstrated that this formulation could lower blood glucose levels without causing hypoglycemia. Following these successful results, the company announced its strategy to commence human clinical trials in 2025 to further evaluate the safety and efficacy of this needle-free therapeutic.

Key Market Players

• Midatech Pharma Plc
• Shreya Life Sciences Pvt. Ltd.
• Boston Therapeutics, Inc.
• Coromed, Inc.
• Diabetology Ltd.
• Emisphere Technologies, Inc.
• Oramed Pharmaceuticals, Inc.
• Diasome Pharmaceuticals, Inc.
• Generex Biotechnology Corp.
• Biodel, Inc.

By Product	By Distribution Channel	By Region
Pills Sprays and Others	Hospital Pharmacies and Online Pharmacies Drug Stores	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Non-Injectable Insulin Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Non-Injectable Insulin Market, By Product:

• Pills
• Sprays
• and Others

• Non-Injectable Insulin Market, By Distribution Channel:

• Hospital Pharmacies
• and Online Pharmacies
• Drug Stores

• Non-Injectable Insulin Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE