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, 2020-2030F

Market Overview

Global Non-Injectable Insulin Market has valued at USD 3.14 Billion in 2024 and is expected to reach USD 5.45 Billion by 2030 with a CAGR of 9.63% during the forecast period. The non-injectable insulin market comprises various insulin formulations designed for administration without injections. These alternatives offer options for individuals with diabetes who face challenges with conventional injection techniques or have allergies to injections. Non-injectable options include oral, inhalable, patches, and other emerging delivery methods.

The non-injectable insulin market faces uncertainty due to a high failure rate in clinical trials. For example, Oramed Pharmaceuticals Inc. recently reported that its oral insulin candidate, ORMD-0801, failed to meet its primary endpoint, though the company has yet to finalize the trial's closure. Similarly, Biocon discontinued its Phase 1 trial of oral Insulin Tregopil for Type 1 diabetes mellitus in June 2022, while continuing its Phase 3 trials for Type 2 diabetes mellitus, as per company officials.

Key Market Drivers

Improved Glycemic Control

Improved glycemic control can have a significant influence on the growth of the global non-injectable insulin market. Non-injectable insulin refers to insulin delivery methods that do not involve traditional needle injections, such as inhalable insulin, oral insulin, and transdermal insulin delivery systems. One of the main challenges in diabetes management is maintaining consistent glycemic control. Injectable insulin may lead to discomfort, pain, and needle anxiety, which can deter some patients from adhering to their prescribed insulin regimen. Non-injectable insulin methods offer more convenient and less invasive options, potentially increasing patient compliance. When patients can manage their diabetes more effectively, it leads to improved glycemic control, reducing the risk of complications and hospitalizations. Non-injectable insulin methods, especially those that are easier to administer and less intimidating, can encourage earlier intervention in diabetes management. By starting insulin therapy earlier in the disease progression, patients can achieve better glycemic control and slow down the progression of the disease. This can lead to better long-term outcomes and reduced healthcare costs associated with diabetes-related complications. Improved glycemic control with non-injectable insulin methods offers a wider range of treatment options for individuals with diabetes. This is especially important for patients who may have a fear of needles or struggle with injections due to physical limitations. By offering multiple routes of administration, healthcare providers can tailor treatment plans to individual patient needs, potentially leading to better glycemic control. Improved glycemic control achieved through non-injectable insulin methods can attract new patient populations, including those who may have been hesitant to start insulin therapy due to the fear of injections. This expansion of the patient base can contribute to market growth.

Growing Diabetic Population

The growing diabetic population has a substantial influence on the growth of the global non-injectable insulin market. Diabetes is a chronic condition characterized by high blood sugar levels, and its prevalence has been increasing globally. This rise in the number of people with diabetes directly impacts the demand for effective and convenient treatment options, such as non-injectable insulin. As the diabetic population continues to grow, the demand for various diabetes management solutions, including insulin therapies, also increases. Non-injectable insulin methods provide alternative options for those who may be reluctant or unable to use traditional injectable insulin. This increased demand for more convenient and patient-friendly treatment options contributes to the growth of the non-injectable insulin market. Non-injectable insulin methods can cater to a broader range of patients, including those who are hesitant to use needles or have difficulty with injections. The growing diabetic population includes individuals from diverse backgrounds and age groups. Non-injectable insulin products, such as inhalable insulin or oral insulin, provide options that are more acceptable to different segments of the population, thus expanding the potential patient base. Adherence to diabetes treatment plans is essential for achieving good glycemic control and preventing complications. However, many diabetic patients struggle with adhering to injectable insulin regimens due to factors like fear of needles or inconvenience.

Non-injectable insulin methods offer improved convenience and ease of use, potentially leading to better treatment adherence and outcomes. With a larger diabetic population, there is a greater emphasis on early intervention and preventive measures. Non-injectable insulin options can encourage individuals to start insulin therapy earlier in their disease progression, leading to better glycemic control. Early intervention can potentially delay or prevent the onset of diabetes-related complications, reducing healthcare costs and improving patients' quality of life. The increasing prevalence of diabetes has led to a significant market opportunity for innovative diabetes management products. Manufacturers and researchers are motivated to develop new and improved non-injectable insulin technologies to meet the diverse needs of the growing diabetic population. This drives investment in research, development, and commercialization of these products, thereby fostering market growth.

According to WHO, The number of people living with diabetes rose from 200 million in 1990 to 830 million in 2022. Prevalence has been rising more rapidly in low- and middle-income countries than in high-income countries. In 2021, diabetes and kidney disease due to diabetes caused over 2 million deaths. In addition, around 11% of cardiovascular deaths were caused by high blood glucose. A healthy diet, regular physical activity, maintaining a normal body weight and avoiding tobacco use are ways to prevent or delay the onset of type 2 diabetes.

Pharmaceutical Industry Investment

Pharmaceutical industry investments play a significant role in influencing the growth of the global non-injectable insulin market. These investments encompass research and development (R&D), clinical trials, manufacturing, marketing, and distribution efforts related to non-injectable insulin products. Pharmaceutical companies allocate substantial resources to R&D for developing innovative non-injectable insulin delivery methods. According to IBEF, Indian pharmaceutical sector supplies over 50% of global demand for various vaccines, 40% of generic demand in the US and 25% of all medicine in the UK. The domestic pharmaceutical industry includes a network of 3,000 drug companies and ~10,500 manufacturing units. These investments go into exploring new technologies, formulations, and administration routes that make insulin therapy more convenient and patient-friendly. Advancements resulting from these investments contribute to the expansion of the market by introducing novel and effective treatment options. Pharmaceutical industry investments drive innovation in the non-injectable insulin sector. Companies aim to create products with improved efficacy, safety, and patient experience. Innovations could include more accurate dosing mechanisms, longer-lasting formulations, and optimized delivery systems. Such advancements attract healthcare professionals and patients, boosting market adoption and growth. Rigorous clinical trials are a crucial part of bringing new pharmaceutical products to market. Industry investments in these trials validate the safety and efficacy of non-injectable insulin methods, providing the data needed for regulatory approvals. Positive trial results build confidence in the medical community and encourage wider adoption of these products, driving market growth. Industry investments often extend to educational initiatives aimed at informing healthcare professionals and patients about non-injectable insulin methods. Educational programs help healthcare providers make informed treatment decisions and empower patients to choose suitable options. Improved awareness leads to higher adoption rates, positively impacting market growth.

According to a recent FICCI report, there has been a growing consensus over providing new innovative therapies to patients. Indian pharmaceutical market is estimated to touch US$ 130 billion in value by the end of 2030. Meanwhile, the global market size of pharmaceutical products was estimated to cross over the US$ 1 trillion mark in 2023.

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Key Market Challenges

Efficacy and Safety Concerns

Efficacy and safety concerns can indeed hinder the growth of the global non-injectable insulin market. While non-injectable insulin methods offer convenient and patient-friendly alternatives to traditional injections, addressing these concerns is essential to gain the trust of healthcare professionals, regulators, and patients. Efficacy concerns arise when there is insufficient clinical evidence to demonstrate that non-injectable insulin methods provide consistent and reliable blood sugar control comparable to injectable insulin. Healthcare professionals and patients may be hesitant to switch to non-injectable options without clear evidence of their effectiveness. If non-injectable insulin products result in inconsistent or unpredictable blood sugar levels, patients and healthcare providers may view them as less reliable than injectable insulin. This can lead to skepticism about their long-term effectiveness in managing diabetes, inhibiting market growth. Safety concerns related to non-injectable insulin methods encompass issues such as adverse reactions, side effects, and potential interactions with other medications. Ensuring the safety of these products is critical to gaining regulatory approvals and building trust among patients and healthcare professionals. The long-term effects of non-injectable insulin methods may not be fully understood, especially for novel delivery technologies. Healthcare providers and patients may worry about potential complications that could arise after extended use, impacting the willingness to adopt these methods.

Cost and Affordability

Cost and affordability are significant factors that can hinder the growth of the global non-injectable insulin market. While non-injectable insulin methods offer advantages in terms of convenience and patient-friendliness, they can sometimes come with higher costs compared to traditional injectable insulin. Non-injectable insulin methods often involve more complex technology, research, and development, which can lead to higher production costs. As a result, the initial purchase price of non-injectable insulin products can be higher than that of injectable insulin. This cost difference may discourage patients and healthcare providers from choosing non-injectable options. Insurance coverage and reimbursement policies may not fully cover the costs of non-injectable insulin methods. Patients may face out-of-pocket expenses that they find challenging to afford. This lack of coverage can be a significant barrier, preventing patients from accessing these options and inhibiting market growth. Individuals with diabetes often have ongoing healthcare expenses related to medications, monitoring equipment, doctor visits, and more. Adding the cost of non-injectable insulin methods to these expenses can create a significant financial burden for patients, leading them to opt for more affordable alternatives. Non-injectable insulin products, especially the more advanced ones, may not be accessible or affordable in low-income countries with limited healthcare resources. This can result in health disparities and hinder the global expansion of the market. The competitive landscape includes established injectable insulin products that have been on the market for a long time. New non-injectable options may need to compete on pricing to gain market share, which could be challenging if production costs are higher.

Key Market Trends

Personalized Treatment Approaches

Personalized approaches enable healthcare providers to choose the most suitable non-injectable insulin method based on a patient's medical history, lifestyle, and preferences. This tailored approach increases the likelihood of treatment adherence and successful outcomes, driving the adoption of non-injectable methods. When patients have a say in their treatment plans and can choose options that align with their preferences, they are more likely to be satisfied with their care. Non-injectable insulin methods that offer convenience and patient-friendliness contribute to higher patient satisfaction and the growth of the market. Patients may have concerns about traditional injections, such as needle anxiety or fear of pain. Personalized treatment approaches can address these concerns by offering non-injectable insulin alternatives, which can lead to greater patient comfort and acceptance. Different age groups have varying preferences and needs. For example, elderly individuals may struggle with injections due to reduced dexterity, and young children may have difficulties with traditional insulin injections. Non-injectable insulin methods can be tailored to these age-specific challenges, expanding the market's reach. Personalized approaches consider patients' lifestyles, such as their daily routines, work schedules, and dietary habits. Non-injectable insulin options that align with patients' lifestyles are more likely to be adopted, leading to market growth. Diabetes management is crucial to prevent complications. Personalized treatment plans can target specific risk factors, ensuring that patients receive the most effective treatment to prevent complications associated with poor glycemic control. This approach encourages the adoption of non-injectable insulin methods that suit the patient's needs.

Regulatory and Reimbursement Advancements

Regulatory agencies play a crucial role in ensuring the safety and efficacy of medical products, including non-injectable insulin. Advancements in regulatory pathways that specifically address innovative delivery methods can expedite the approval process. A faster regulatory pathway encourages manufacturers to invest in non-injectable insulin research and development, leading to quicker market entry. Clear and supportive regulatory guidelines for non-injectable insulin methods provide manufacturers with a roadmap for product development and clinical trials. These guidelines ensure that developers meet specific standards while bringing innovative products to market, fostering innovation and growth. Regulatory agencies adopting risk-based oversight can tailor their evaluation processes to the unique characteristics of non-injectable insulin methods. This approach ensures that rigorous safety standards are met while accommodating the specific benefits and challenges of these delivery systems. Regulatory advancements that allow for expanded indications for non-injectable insulin methods increase their potential patient populations. For example, gaining approval for different types of diabetes or specific patient groups can significantly broaden the market reach. Reimbursement advancements that offer better coverage for non-injectable insulin methods encourage healthcare providers to prescribe these options. Improved reimbursement policies reduce financial barriers for patients, making non-injectable insulin more accessible and encouraging adoption. Collaboration between pharmaceutical companies and payers (insurance providers, government healthcare programs) can lead to mutually beneficial agreements. Negotiating pricing and reimbursement terms for non-injectable insulin products ensures that they are affordable for patients, driving adoption and market expansion. International alignment of regulatory and reimbursement policies can facilitate simultaneous market access in multiple regions. This harmonization reduces barriers and accelerates the global expansion of non-injectable insulin products.

Segmental Insights

Type Insights

Based on the type, the pills segment held the largest market share and it is anticipated to witness substantial market growth throughout the forecast period. This growth can be attributed to multiple factors, such as Many individuals with diabetes have an aversion to needles or injections. Oral insulin pills offer a more comfortable and familiar form of medication delivery, reducing the psychological barrier to insulin therapy. This increased patient acceptance can lead to higher adoption rates and market growth. The convenience of taking an insulin pill compared to an injection can enhance treatment adherence. Patients may be more likely to follow their prescribed treatment plan consistently when it involves a simple and easy-to-take pill. Improved adherence contributes to better glycemic control and overall patient outcomes. Oral insulin pills can encourage early intervention in diabetes management. Individuals who are hesitant to start injectable insulin therapy might be more open to trying oral pills. Early intervention can lead to better blood sugar control and prevention of complications, driving market growth. Oral insulin pills can attract a wider patient base, including those who were previously resistant to insulin therapy due to injection-related fears or concerns. This expansion of the patient population can contribute to market growth. Pills empower patients to take charge of their diabetes management independently. Patients can easily carry and administer their medication without the need for medical personnel or specialized equipment, leading to greater patient empowerment and engagement.

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Regional Insights

Based on the region, North America, specifically the Non-Injectable Insulin Market, dominated the market in 2024, primarily due to North America, particularly the United States and Canada, boasts advanced healthcare systems, research institutions, and pharmaceutical industries. This infrastructure supports the development, clinical testing, and commercialization of innovative medical products like non-injectable insulin. The region is a hub for technological innovation, which includes advancements in drug delivery systems. Non-injectable insulin methods require sophisticated technology, and North America's innovation ecosystem facilitates the development of these technologies. The pharmaceutical industry in North America is robust, with many companies investing in research and development. These companies have the resources to develop and market non-injectable insulin products, driving growth. North America is often a preferred location for conducting clinical trials due to its diverse population, well-established regulatory framework, and skilled medical professionals. Clinical trials are crucial for demonstrating the safety and efficacy of new medical products. Public awareness campaigns and healthcare initiatives help educate patients about various treatment options. As patients become more aware of non-injectable insulin methods, they are likely to express interest, driving demand. Patient preferences for non-injectable insulin options align with the convenience and ease of use offered by these methods. Meeting patient preferences drives adoption and market growth.

Recent Developments

• In December 2024, Cipla Limited announced that it has obtained regulatory approval from Central Drugs Standard Control Organisation (CDSCO) for the exclusive distribution and marketing of Afrezza (insulin human) Inhalation Powder in India.
• In May 2024, Eli Lilly and Company announced positive topline results from the QWINT-2 and QWINT-4 phase 3 clinical trials evaluating once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes using insulin for the first time (insulin naïve) and those who require multiple daily insulin injections. In the treat-to-target clinical trials, efsitora showed non-inferior A1C reduction compared to the most commonly used daily basal insulins globally.
• In November 2023, NiedlFree Technologies introduced Ozulin, an oral insulin spray designed for patients with Type 1 and Type 2 diabetes. The product is expected to be available in India and globally by 2025 or 2026.
• In August 2023, Oramed Pharmaceuticals partnered with Hefei Tianhui Biotech (HTIT) to establish a joint venture aimed at advancing oral drug products. Leveraging Oramed’s oral insulin and protein delivery pipeline, the venture seeks to expand the global reach of Oramed’s oral drug delivery technology.
• In January 2023, researchers at UiT Norway's Arctic University published a study in Nature Nanotechnology, highlighting a breakthrough in insulin delivery. According to their findings, out of the 425 million people worldwide living with diabetes, nearly 75 million rely on insulin injections. However, this could soon change with the development of a novel smart insulin delivery method, allowing patients to consume insulin in the form of a capsule or infused into food items, including chocolates.
• In November 2022, The U.S. Food and Drug Administration approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type-1 diabetics and pediatric patients 8 years of age and older who were stage 2 type-1 diabetics.
• In May 2022, The FDA approved Lilly’s new medication Mounjaro (also known as tirzepatide) for type-2 diabetes management in addition to diet and exercise. This first-in-class medication showed improvement in glucose levels and also dramatically improved weight in clinical trials.

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.

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:

o   Pills

o   Sprays

o   Others

• Non-Injectable Insulin Market, By Distribution Channel:

o   Hospital Pharmacies

o   Online Pharmacies

o   Drug Stores

• Non-Injectable Insulin Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia-Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Non-Injectable Insulin Market.

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Global Non-Injectable Insulin market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

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