Inhaled Insulin Market Size, Share, Growth, Trends, Report 2025 to 2034

Inhaled Insulin Market Size and Growth 2025 to 2034

The global inhaled insulin market size was valued at USD 609 million in 2024 and is expected to be worth around USD 2,597 million by 2034, exhibiting at a compound annual growth rate (CAGR) of 15.60% over the forecast period 2025 to 2034.

The inhaled insulin market growth is primarily driven by the increasing global burden of diabetes, specifically type 2 diabetes, that is rising due to reasons like physical inactivity, overweight, and age. With the number of patients suffering from diabetes still on the rise, the demand for alternative delivery methods of insulin that enhance patient compliance and quality of life is also on the increase. Inhaled insulin is a needle-free, quick-acting option that is strongly accepted by patients with needle phobia, specifically those who need mealtime insulin but are not willing to take injections. Such an option that is so patient-friendly has a very high adoption potential, specifically for outpatient and home care.

Moreover, advancements in pulmonary drug delivery technologies, favorable regulatory actions, and increasing investments in diabetes care research are further fueling market growth. MannKind Corporation, for example, is raising awareness and expanding access to inhaled insulin therapy, such as Afrezza, which is becoming more and more acceptable as a replacement for traditional insulin injections. Moreover, healthcare professionals and patients alike are becoming more and more accepting of adopting innovative drug delivery systems that provide faster onset of action and improved post-meal glucose control, thereby fueling market growth.

What is an Inhaled Insulin?

Inhaled insulin is an inhalation formulation of rapid-acting insulin delivered through an inhaler device directly into the lungs, capable of entering the circulation via pulmonary absorption. It is primarily used to manage blood glucose in type 1 and type 2 diabetic patients, especially for mealtime. This drug delivery system offers a needle-free alternative to traditional subcutaneous injections of insulin, enhancing patient comfort, compliance, and quality of life. Inhaled insulins like Afrezza are clinically approved and are characterized by their rapid onset of action, more closely mimicking natural insulin response for meals.

Some of the Clinical Research Findings pertaining to the Inhaled insulin:

• Rapid Onset: Afrezza reaches peak insulin levels in 12–15 minutes, compared to 45–90 minutes with subcutaneous insulin.
• Comparable HbA1c Reduction: Clinical studies proved that inhaled insulin was not less efficient than injectable rapid-acting insulin in managing HbA1c.
• Less Hypoglycemia: Some studies observed fewer cases of late post-meal hypoglycemia with inhaled insulin vs. injected insulin.
• Improved Patient Satisfaction: Studies report higher treatment satisfaction and adherence due to its needle-free administration.
• Lung Function Monitoring Needed: Slight declines in FEV1 (lung function test) have been noted, though typically not clinically significant.

Inhaled Insulin Market Report Highlights

• North America has held dominant position, accounting for revenue share of 39% in 2024.
• Europe has reported revenue share of 30% in 2024.
• By indication, the type 2 diabetes segment has captured a revenue share of 57% in 2024.
• By product type, the rapid-acting inhaled insulin segment dominates the market in 2024.
• By distribution channel, the online pharmacy segment is expected to grow at the fastest CAGR during the period.

Inhaled Insulin Market Recent Trends

Expansion into Pediatric Use

• MannKind Corporation is making progress toward expanding the indication for Afrezza, its inhaled rapid-acting insulin, to pediatric patients. In March 2025, the company reported positive results from the INHALE-1 pediatric study and intends to submit a supplemental New Drug Application (sNDA) for this pediatric indication later this year. This expansion has the potential to significantly increase the patient population for inhaled insulin therapies, providing a needle-free option for children and adolescents with diabetes.

Technological Advancements in Inhaler Devices

• Technological innovations in inhaler technology are improving the efficacy and convenience of inhaled insulin delivery devices. New developments focus on creating more precise and efficient inhaler devices, enhancing drug delivery through sustained release mechanisms, optimizing formulations, and advancing device design. These technologies are expected to improve patient compliance and outcomes, thus driving market growth.

Positive Clinical Outcomes Supporting Efficacy

• Recent clinical trials have demonstrated the effectiveness of inhaled insulin in controlling blood glucose levels. For example, one trial indicated that 21% of patients on inhaled insulin showed greater improvements in HbA1c levels compared to 5% receiving standard care. Additionally, among patients with baseline HbA1c values ≥7%, 21% on inhaled insulin reached the target goal of HbA1c <7%, while none in the standard care group achieved this. These results underscore the promise of inhaled insulin as a beneficial treatment for diabetes management.

Report Scope

Inhaled Insulin Market Dynamics

Market Drivers

• Rising Prevalence of Diabetes: The growing worldwide burden of diabetes, particularly type 2 diabetes, strongly drives the inhaled insulin market. The prevalence of diabetes is increasing due to sedentary lifestyles, unhealthy diets, and aging populations, leading to a rising demand for various methods of insulin delivery that offer greater comfort and convenience for patients. Inhaled insulin presents a needle-free, non-invasive alternative that enhances patient compliance by allowing for easier administration, making it an appealing option for individuals who dislike or struggle with regular injections.
• Technological Advancements in Inhaler Devices: Recent technologies in inhaler development have made inhaled insulin more efficient, easier to use, and more precise. Newer designs simplify the controlled release of insulin, facilitating accurate dosing and minimizing the potential for errors. These advancements improve patient compliance, alleviate discomfort related to injections, and increase the acceptance of inhaled insulin, contributing to market growth.

Market Restraints

• Lung Function Concerns: Inhaled insulin is absorbed by the lungs, raising concerns about its long-term effects on lung function. Some clinical trials have shown small reductions in lung function (as measured by FEV1 - Forced Expiratory Volume), although these reductions are generally not clinically significant. Nevertheless, careful monitoring of lung function is essential for individuals using inhaled insulin, which may hinder its widespread adoption among certain patients, particularly those with pre-existing lung conditions.
• High Cost of Inhaled Insulin Therapy: Inhaled insulins, including Afrezza, tend to be more expensive than standard injectable insulin treatments. The costs of inhaler devices and the insulin itself can be obstacles for many patients, especially in low-income areas. This financial burden may deter patients from choosing inhaled insulin therapy and limit its market penetration, despite its advantages.

Market Opportunities

• Expansion into Emerging Markets: As the prevalence of diabetes grows in developing markets like Asia-Pacific, Latin America, and the Middle East, there is a significant opportunity for inhaled insulin producers to gain traction. With expanding healthcare infrastructure and an increasing use of advanced diabetes therapies, inhaled insulin offers a valuable alternative to conventional injectable treatments in these markets, where there is high demand for more convenient options.
• Pediatric and Adolescent Use: The potential to increase the use of inhaled insulin among children and adolescents represents a major growth opportunity. Most children and teenagers with diabetes are concerned about injections, and the availability of a needle-free treatment could significantly enhance compliance and overall care. Ongoing clinical trials are examining the safety and effectiveness of inhaled insulin in children, and approval for pediatric patients could create a substantial new market segment.

Market Challenges

• Limited Market Acceptance and Adoption: Despite the advantages of inhaled insulin, its adoption has been slow due to long-term safety concerns, particularly regarding lung health, as well as its limited availability compared to injectable insulin. The market has not yet achieved broad acceptance, partly due to the relatively high cost of treatment and barriers to patient education. Some patients are also uncertain about the efficacy and consistency of inhaled insulin.
• Regulatory Hurdles and Safety Concerns: Inhaled insulin undergoes intense regulatory scrutiny, especially concerning its safety profile. Any concerns that health authorities may raise about potential side effects (e.g., lung complications) or device functionality can delay the approval process or limit market access. Regulatory agencies such as the FDA require large-scale clinical trials to demonstrate the safety and efficacy of such products, which is costly and time-consuming, creating a barrier for firms looking to enter or expand in the market.

Inhaled Insulin Market Segmental Analysis

The inhaled insulin market is segmented into product type, indication, distribution channel, end user, and region. Based on product type, the market is classified into rapid-acting inhaled insulin, and long-acting inhaled insulin. Based on the indication, the market is categorised into type 1 diabetes, and type 2 diabetes. Based on distribution channel, the market is classified into hospital pharmacies, retail pharmacies, online pharmacies, and diabetes clinics & specialty centers. Based on end user, the market is classified into hospitals, homecare settings, specialty clinics, and ambulatory surgical centers (ASCs).

Product Type Analysis

Rapid-acting inhaled insulin dominates the market due to its ability to precisely replicate the human body's natural insulin response during mealtime. It acts quickly, with peak action occurring within 12–15 minutes, providing swift control of post-meal blood glucose surges. Rapid-acting forms, including Afrezza, have gained popularity as people seek quicker and more convenient insulin delivery. This segment is favored by type 1 and type 2 diabetic patients who require efficient mealtime insulin without injections, making it a strong market contender.

The long-acting inhaled insulin segment is the fastest-growing due to its potential to offer a once-daily insulin option for diabetes patients. As the market for long-acting insulins expands, patients are increasingly looking for easy, needle-free solutions that provide sustained blood glucose control. Although still in its early stages, this sector is expected to grow rapidly, particularly as clinical trials continue to show positive results regarding safety and efficacy, generating strong interest from both patients and healthcare providers.

Indication Analysis

Type 2 diabetes dominates the inhaled insulin market due to its higher prevalence compared to type 1 diabetes. The increasing global incidence of type 2 diabetes, driven by lifestyle factors such as obesity, sedentary behavior, and poor diet, has created a significant demand for alternative insulin delivery methods. Inhaled insulin offers a noninvasive solution that appeals to patients needing mealtime insulin therapy who wish to avoid traditional injections, thus driving its widespread use in managing type 2 diabetes.

The type 1 diabetes segment is the fastest-growing segment within the inhaled insulin market, primarily due to the increasing accessibility of quick-acting inhaled insulin. This provides a viable and convenient alternative to multiple daily injections for type 1 diabetes care. As further clinical research and trials validate the safety and efficacy of inhaled insulin for type 1 diabetes, demand for needle-free insulin solutions continues to rise, making this sector a critical area for expansion.

Distribution Channel Analysis

Retail pharmacies are the dominant distribution channel for inhaled insulin due to their wide accessibility and convenience for patients. Patients can easily obtain inhaled insulin products from local retail pharmacies, which are typically well-stocked with diabetes medications. This convenience is a key factor contributing to the high sales volume through this channel, making it the most prevalent distribution method for inhaled insulin.

The online pharmacy segment is the fastest-growing distribution channel for inhaled insulin. With the rise of e-commerce and the increasing trend toward online healthcare shopping, patients are opting for the convenience of purchasing insulin products from online platforms. This segment is experiencing rapid growth, driven by factors such as doorstep delivery, privacy concerns, and the increasing use of telemedicine and remote healthcare services, making it an attractive option for patients seeking easy access to medications.

End User Analysis

Hospitals are the dominant end-user segment for inhaled insulin due to their primary role in patient care, especially for individuals with complex diabetes cases or intensive treatment regimens. Hospitals provide a controlled environment for administering insulin therapies, including inhaled insulin, and have the necessary medical infrastructure and skilled professionals to monitor patient responses effectively. This establishes its leading position in the marketplace.

The homecare settings segment is the fastest-growing end-user segment for inhaled insulin. With an increasing number of diabetic patients managing their conditions at home through self-monitoring and self-administration of insulin, there is a rising demand for home-friendly insulin delivery methods. Inhaled insulin offers a more comfortable and convenient option for home use, which accounts for the rapid adoption among patients who prefer to manage their condition outside of a clinical setting. This trend is anticipated to accelerate as patients seek more flexible and accessible treatment options for managing diabetes at home.

Inhaled Insulin Market Regional Analysis

The inhaled insulin market is segmented into various regions, including North America, Europe, Asia-Pacific, and LAMEA. 

North America: Leading Market with High Adoption Rates

The North America inhaled insulin market size was valued at USD 237.51 million in 2024 and is expected to reach around USD 1,012.83 million by 2034. North America dominates the market due to its well-established healthcare infrastructure, high awareness of diabetes management, and early adoption of innovative treatments like Afrezza. The United States holds a strong position with high diabetes prevalence, favorable reimbursement rates, and widespread support for FDA-approved products. Furthermore, the presence of key pharmaceutical giants and ongoing clinical trials in the region facilitate stable growth. The trend towards non-invasive, convenient insulin delivery systems also drives demand in North America.

Asia-Pacific (APAC): Fastest Growing Market with Untapped Potential

The Asia-Pacific inhaled insulin market size was estimated at USD 152.25 million in 2024 and is projected to hit around USD 649.25 million by 2034. The Asia-Pacific region is witnessing the fastest growth, driven by a rapidly growing diabetic population, particularly in nations such as China and India. Increased healthcare spending, urbanization, and lifestyle changes are fueling a greater incidence of diabetes. Although awareness and acceptance of inhaled insulin are still emerging, increased access to healthcare services, heightened government efforts, and rising pharmaceutical investment make APAC an extremely promising market. Attempts to introduce low-cost inhaled insulin alternatives are also expected to drive expansion in this region.

Europe: Expanding Market with Regulatory Support

The Europe inhaled insulin market size was accounted for USD 182.70 million in 2024 and is predicted to surpass around USD 779.10 million by 2034. Europe represents a growing market, supported by a strong focus on innovation, regulatory clearances, and patient-oriented healthcare paradigms. Germany, the UK, and France are pursuing cutting-edge solutions for diabetes care, including inhaled insulin. While the level of market penetration is moderate compared to that in North America, heightened public awareness campaigns, positive reimbursement settings, and health system digitization are driving markets to adopt. The region's focus on enhancing the quality of life for diabetic patients favors the adoption of non-invasive insulin delivery approaches.

LAMEA (Latin America, Middle East, and Africa): Emerging Market with Growth Opportunities

The LAMEA inhaled insulin market size was valued at USD 36.54 million in 2024 and is anticipated to reach around USD 155.82 million by 2034. The LAMEA region is an emerging market, driven by improved healthcare access and a growing prevalence of diabetes. Adoption rates are low due to limited availability and costs, but healthcare reforms and foreign investments in the pharmaceutical sector are likely to enhance market conditions. Latin American countries such as Brazil and Mexico show significant potential due to rising healthcare awareness and the demand for modern diabetes care. Economic growth and urbanization in the Middle East and Africa are expected to drive gradual growth over the next few years.

Inhaled Insulin Market Top Companies

• MannKind Corporation
• Nektar Therapeutics
• Pfizer
• Aradigm Corporation
• Alkermes
• Sanofi
• Novo Nordisk
• Eli Lilly and Company

The competitive landscape of the inhaled insulin market is moderately consolidated, with a few key players dominating due to their technological expertise, regulatory approvals, and established distribution networks. MannKind Corporation, with its flagship product Afrezza, holds a significant market share and remains the frontrunner in this field. Other notable players include Dance Biopharm (now Aerami Therapeutics) and Novo Nordisk, which are investing in research and development to introduce more advanced, patient-friendly inhaled insulin formulations. Strategic collaborations, product innovations, and an expanding geographical presence are common approaches adopted by these companies to maintain competitiveness and cater to the growing global demand for non-invasive insulin therapies.

Recent Developments

• In March 2025, MannKind Corporation presented five studies on Afrezza at the 18th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD), held in Amsterdam from March 19 to 22. These presentations featured data from the INHALE-1 pediatric and INHALE-3 adult studies, demonstrating Afrezza's safety and efficacy in diabetes treatment. Interestingly, the firm revealed that it would submit a supplemental New Drug Application (sNDA) for Afrezza in the pediatric population in the latter half of 2025 to widen its therapeutic application. 
• In February 2025, the United States Food and Drug Administration (FDA) approved the first rapid-acting insulin biosimilar, insulin aspart-szjj, sold under the trade names Merilog and Merilog Solostar. The Novolog biosimilar, made by Sanofi-Aventis, marks a landmark move in making more affordable insulin available for patients.

Market Segmentation

By Product Type

• Rapid-acting Inhaled Insulin
• Long-acting Inhaled Insulin

By Indication

• Type 1 Diabetes
• Type 2 Diabetes

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies
• Diabetes Clinics & Specialty Centers

By End User

• Hospitals
• Homecare Settings
• Specialty Clinics
• Ambulatory Surgical Centers (ASCs)

By Region

• North America
• APAC
• Europe
• LAMEA