Diabetes Therapeutics and Diagnostics Market Size, Share, Growth, and Industry Analysis, By Type (Insulin,Insulin Delivery,Oral Hypoglycemic Drugs,Diagnosis And Monitoring,Others), By Application (Type 1 Diabetes,Type 2 Diabetes,Gestational Diabetes,Others), Regional Insights and Forecast to 2033

Diabetes Therapeutics and Diagnostics Market Overview

The Diabetes Therapeutics and Diagnostics Market size was valued at USD 130004.34 million in 2024 and is expected to reach USD 162357.08 million by 2033, growing at a CAGR of 2.5% from 2025 to 2033.

The Diabetes Therapeutics and Diagnostics Market plays a vital role in global healthcare, addressing the needs of over 537 million adults living with diabetes worldwide as of 2021. With projections indicating that the number may reach 643 million by 2030, demand for efficient diagnosis and management tools is surging. The market encompasses a wide range of products, including insulin, insulin delivery devices, oral hypoglycemic agents, continuous glucose monitoring (CGM) systems, and point-of-care diagnostic tools. In 2023, over 62 million CGM sensors were sold globally, signaling a shift toward real-time, minimally invasive monitoring solutions. Simultaneously, insulin pump usage expanded significantly, with more than 1.8 million users globally. North America leads in insulin pump adoption, accounting for over 68% of global users. Meanwhile, the Asia-Pacific region has observed a 21% annual rise in oral hypoglycemic drug prescriptions, primarily driven by rising cases of type 2 diabetes in India and China. The diagnostic segment includes self-monitoring blood glucose meters, with over 100 million units distributed globally in 2023 alone. Moreover, technological advancements have led to the integration of smartphone apps, AI-based diagnostics, and wearable insulin delivery systems, enhancing patient adherence and outcomes. These dynamics continue to reshape this high-demand healthcare sector.

Key Findings

Driver: Increasing global diabetes prevalence and rising use of digital monitoring technologies.

Country/Region: North America leads due to widespread adoption of insulin pumps and CGM systems, accounting for over 40% of global diagnostic device usage.

Segment: The insulin and insulin delivery segment dominates, with over 25 million patients using insulin pens, pumps, or injectables globally.

Diabetes Therapeutics and Diagnostics Market Trends

The diabetes therapeutics and diagnostics market is rapidly evolving due to changing disease prevalence, rising healthcare expenditure, and significant advances in digital health technologies. As of 2023, over 537 million adults globally are living with diabetes, and nearly 1 in 10 adults is affected, according to global health authorities. With this trajectory, diagnostic and therapeutic solutions are witnessing substantial growth across all age groups and economic segments. One of the most prominent trends is the increasing adoption of Continuous Glucose Monitoring (CGM) systems. In 2023, over 62 million CGM units were sold worldwide. These devices allow real-time blood glucose tracking, reducing the dependence on finger-stick glucose meters. The global CGM penetration rate reached 23% in 2023, up from 15% in 2020. Brands offering smartphone integration and wearable sensors are experiencing higher consumer uptake, particularly in North America and Western Europe. Insulin delivery devices continue to dominate the therapeutic landscape. More than 25 million patients used insulin delivery systems in 2023, with insulin pens accounting for over 70% of those applications. Reusable insulin pens are increasingly preferred due to their convenience and cost-efficiency, with a 19% rise in demand from 2022 to 2023. The Asia-Pacific region witnessed a significant increase in insulin pen prescriptions, especially in Japan and South Korea.

Another major development is the surge in oral antidiabetic drug usage, particularly SGLT2 inhibitors and DPP-4 inhibitors. The prescription volume for SGLT2 inhibitors rose by 28% globally in 2023. These drugs are preferred for type 2 diabetes patients due to their added benefits in cardiovascular protection and weight management. The U.S. and European nations lead the adoption rate of such novel therapeutics. Telemedicine and AI-based diagnostics are reshaping diabetes management. In 2023, over 18 million diabetes patients globally utilized app-based consultations and remote glucose monitoring. AI-enabled diagnostic software solutions witnessed a 34% increase in deployment across hospitals and primary care centers. These tools are enhancing early detection rates and improving therapy outcomes. Lastly, combination therapies and personalized diabetes care plans are gaining popularity. Healthcare providers are increasingly using genetic profiling and lifestyle data to tailor treatment regimens. In 2023, over 12% of new diabetes drug approvals globally were for fixed-dose combinations aimed at improving glycemic control and patient adherence. These prevailing trends illustrate the dynamic shift in diabetes care, where digital tools, novel therapeutics, and patient-centered strategies are propelling the market forward.

Diabetes Therapeutics and Diagnostics Market Dynamics

DRIVER

Rising global diabetes prevalence and early diagnosis initiatives

The primary driver of the diabetes therapeutics and diagnostics market is the alarming growth in the number of diabetes cases worldwide. In 2023, more than 537 million people globally were diagnosed with diabetes, a number expected to cross 643 million by 2030. Early diagnosis campaigns, government screening programs, and growing public awareness are contributing to a higher number of detected cases. In India alone, more than 45 million people underwent diabetes screening in 2023 through national health programs. Similarly, in the United States, over 37.3 million individuals are living with diabetes, with more than 1.4 million new diagnoses each year. The growing diabetic population is accelerating the demand for continuous glucose monitors (CGM), insulin pumps, and oral antidiabetic drugs. Technological advancements and integration of diagnostics with smartphone applications and wearable devices have increased accessibility, which, in turn, fuels market demand.

RESTRAINT

Limited access to advanced treatment in low-income regions

Despite the growing demand, one of the significant restraints in the diabetes therapeutics and diagnostics market is the limited access to advanced care solutions in lower- and middle-income countries. In Sub-Saharan Africa, more than 60% of diabetes cases remain undiagnosed, and insulin availability is restricted in over 40% of healthcare facilities. High device and drug costs, poor health infrastructure, and lack of trained personnel hinder the adoption of insulin pumps and CGM systems in these regions. For instance, while CGM penetration in North America stands at 23%, in parts of Africa and Southeast Asia, it is below 4%. Additionally, the out-of-pocket cost for insulin in some developing nations can exceed 30% of an individual’s monthly income, making affordability a critical barrier.

OPPORTUNITY

Integration of digital health technologies

The integration of digital health tools and AI-powered platforms presents a significant opportunity for the market. In 2023, over 18 million patients worldwide utilized telemedicine services for diabetes management. Companies are developing mobile apps that monitor blood glucose, track diet, and sync with smartwatches for real-time alerts. AI-enabled predictive analytics are also helping providers tailor therapies and prevent complications. With more than 1.2 billion smartphone users in Asia-Pacific alone, mobile health (mHealth) offers vast scalability. Additionally, regulatory support for digital diabetes management tools is expanding; the U.S. FDA approved more than 15 new digital health applications for diabetes between 2022 and 2023.

CHALLENGE

Increasing treatment costs and long-term care burden

Managing diabetes imposes a significant economic burden on patients and healthcare systems. The annual per capita medical cost for diabetes patients is more than 2.3 times higher than for non-diabetics. In the U.S., the average cost of insulin rose by 14% between 2021 and 2023, despite policy attempts to cap prices. Furthermore, complications such as neuropathy, nephropathy, and retinopathy increase long-term healthcare expenditures. Over 10% of diabetes patients globally require hospitalization for complications annually, with treatment costs ranging between $5,000 to $12,000 per case. Rising demand for continuous care, including medication, diagnostics, and follow-ups, adds to the challenge. Supply chain disruptions and inflation have further contributed to price hikes in devices and medicines, particularly post-pandemic.

Diabetes Therapeutics and Diagnostics Market Segmentation

The diabetes therapeutics and diagnostics market is segmented based on type and application. These segments help identify the precise demand patterns and treatment approaches across global healthcare ecosystems.

By Type

• Insulin: Insulin remains a cornerstone of diabetes management, particularly for type 1 and advanced type 2 diabetes. As of 2023, over 95 million patients globally relied on insulin therapy. Short-acting and long-acting analog insulins are in high demand. Pen devices accounted for nearly 72% of insulin administration methods worldwide, especially in developed economies. North America and Europe saw a 14% year-on-year increase in basal insulin usage in 2023, while India and China recorded a 21% surge in demand for fast-acting insulin for better postprandial control.
• Insulin Delivery: Advanced insulin delivery systems, such as pumps, pens, and patch pumps, are revolutionizing diabetes care. In 2023, over 7.2 million people globally were using insulin pumps, with the U.S. holding more than 3 million users alone. Automated insulin delivery systems saw a 19% increase in usage compared to 2022, due to better glucose control and lifestyle integration. Smart pens equipped with Bluetooth and memory features have also entered mainstream healthcare systems, particularly in Europe and Japan.
• Oral Hypoglycemic Drugs: The oral therapeutics segment is witnessing robust demand, particularly among type 2 diabetes patients. In 2023, over 240 million patients were prescribed oral agents such as metformin, sulfonylureas, SGLT2 inhibitors, and DPP-4 inhibitors. SGLT2 inhibitors saw a 28% growth in prescription volume, driven by their cardio-renal protective benefits. DPP-4 inhibitors remained dominant in East Asia, with Japan alone recording 15 million new prescriptions.
• Diagnosis and Monitoring: This segment includes test strips, glucose meters, CGMs, and lab-based diagnostics. In 2023, the market recorded sales of over 2.1 billion test strips globally. CGM devices accounted for 35% of glucose monitoring sales, led by continuous real-time glucose tracking in the U.S., Germany, and South Korea. Blood glucose meters were used by over 300 million people globally, with emerging countries like Brazil, Indonesia, and Egypt showing rapid adoption.
• Others: Other products include adjuvant therapies such as GLP-1 receptor agonists, anti-obesity drugs for diabetics, and combination fixed-dose therapies. The usage of GLP-1 receptor agonists rose by 23% in 2023, particularly in weight-sensitive patients. Injectable formulations with dual-action effects were adopted widely in clinical trials and hospitals in Western countries.

By Application

• Type 1 Diabetes: An estimated 8.4 million individuals worldwide live with type 1 diabetes. Management relies heavily on insulin therapy, with over 95% of patients using multiple daily injections or pumps. Countries with universal healthcare access, such as Sweden and the UK, report over 85% pump adoption among type 1 patients under 18 years.
• Type 2 Diabetes: This is the most prevalent form, accounting for over 90% of all diabetes cases globally. As of 2023, more than 500 million individuals were living with type 2 diabetes. Oral medications, insulin, lifestyle therapy, and monitoring devices form the core treatment. India, China, and the U.S. collectively accounted for more than 52% of all type 2 diabetes cases in 2023.
• Gestational Diabetes: Over 21 million pregnant women globally were affected by gestational diabetes in 2023. Early screening has increased diagnosis rates by 30% over the last five years. Asia-Pacific countries report the highest prevalence, with India and Indonesia witnessing incidence rates of 10%-15% among pregnant women. Treatment usually involves dietary management, with insulin therapy initiated in severe cases.
• Others: This includes pre-diabetes, MODY (Maturity Onset Diabetes of the Young), and secondary diabetes due to medical conditions or drug therapy. An estimated 374 million adults globally have pre-diabetes, with a conversion rate of 5-10% to type 2 annually. Early diagnostic kits and preventive therapy programs are increasingly being introduced in public health campaigns worldwide.

Diabetes Therapeutics and Diagnostics Market Regional Outlook

The diabetes therapeutics and diagnostics market shows strong regional variation, with higher product penetration and innovation in developed markets and rapid demand growth in emerging economies.

• North America

North America dominates the diabetes therapeutics and diagnostics market due to high disease prevalence and advanced healthcare systems. In the U.S., over 37.3 million people live with diabetes, and more than 96 million adults have prediabetes. The country accounts for over 30% of global insulin pump usage, with more than 3 million active users. Canada has over 3.7 million diabetic individuals, with 85% of them having type 2 diabetes. Continuous glucose monitoring (CGM) devices have achieved over 60% adoption among insulin-using patients in the U.S. Market growth is supported by wide reimbursement coverage, high awareness, and increasing investment in AI-enabled diagnostic devices.

• Europe

Europe has more than 61 million people living with diabetes, and countries such as Germany, the UK, and France account for over 65% of the region’s diabetes-related healthcare spending. Germany recorded 8.5 million diagnosed diabetic patients in 2023. The UK has 5 million known diabetic individuals, with 92% of them diagnosed with type 2 diabetes. The region leads in digital health integration, with over 70% of type 1 diabetes patients in Nordic countries using insulin pumps. Additionally, SGLT2 inhibitor prescriptions rose by 26% across major EU nations in 2023, driven by updated clinical guidelines and cardiovascular safety profiles.

• Asia-Pacific

Asia-Pacific is experiencing the fastest rise in diabetes cases, with over 240 million people affected in 2023. China has the world’s highest diabetic population at 141 million, while India follows with over 77 million cases. Urbanization, sedentary lifestyles, and genetic predisposition are driving this growth. In Japan, nearly 10 million people are diagnosed with diabetes, and there is widespread adoption of advanced oral therapies such as DPP-4 inhibitors, with over 15 million prescriptions issued in 2023. Mobile health and digital monitoring tools are expanding, particularly in urban centers, with 30% year-on-year growth in digital diabetes platforms recorded across Southeast Asia.

• Middle East & Africa

The Middle East & Africa region presents high disease prevalence but low diagnosis and treatment rates. In 2023, more than 73 million people in the region were estimated to have diabetes, with over 50% undiagnosed. In Saudi Arabia, diabetes affects over 4.3 million adults, while Egypt has more than 10 million diabetic individuals. The UAE reports one of the highest global diabetes prevalence rates, at 16.3%. Access to CGMs and insulin pumps is improving in the Gulf countries, while African nations face infrastructure constraints. Awareness campaigns and WHO-backed programs are boosting diagnosis rates across sub-Saharan Africa, although the adoption of advanced treatment modalities remains limited.

List Of Diabetes Therapeutics and Diagnostics Companies

• 77 Elektronika Kft.
• Menarini Diagnostics S.R.L
• Abbott Laboratories
• Agamatrix Inc.
• Animas Corp.
• Ascensia
• Becton Dickinson
• Debiotech S.A.
• Eli Lilly And Co.
• Glaxo Smithkline
• Inlight Solutions Inc.
• Johnson & Johnson
• Lifescan Inc.
• Medtronic
• Merck & Co.
• Merck KGAA
• Nipro Corp.
• Novartis Pharma Ag
• Novo Nordisk A/S
• Owen Mumford Ltd.
• Palco Labs Inc.
• Roche
• Sanofi
• Takeda Pharmaceutical Co. Ltd.
• Terumo Corp.

Novo Nordisk A/S: Novo Nordisk A/S is a leading player in the diabetes therapeutics space, holding the highest global insulin market share. In 2023, the company’s insulin products were used by more than 38 million patients worldwide. Its GLP-1 analogs and insulin pens dominate key markets including Europe, North America, and Asia. Novo Nordisk’s FlexTouch and FlexPen delivery devices are widely adopted, with over 500 million units distributed globally in 2023. The company’s strategic expansion in China and India boosted its regional presence significantly, with double-digit growth recorded in these countries.

Abbott Laboratories : Abbott Laboratories is a major force in diabetes diagnostics, particularly with its FreeStyle Libre system, which surpassed 5 million global users in 2023. The CGM device contributed significantly to the company’s diagnostic segment performance, with usage growing 28% year-on-year. Abbott launched updated Libre versions with real-time glucose alarms and app integration, driving user retention and expansion in Europe and Latin America. In the U.S., over 1.7 million patients rely on Abbott’s CGM devices, backed by insurance reimbursements and strong physician endorsements.

Investment Analysis and Opportunities

The diabetes therapeutics and diagnostics market is attracting substantial global investments due to the increasing burden of diabetes, the shift toward personalized care, and growing adoption of digital health technologies. In 2023, over 537 million adults globally were living with diabetes, and the number is expected to cross 640 million by 2030. This surge is leading to expanded funding across pharmaceutical, biotechnology, and medtech sectors. Investments in diabetes diagnostics reached new levels in 2023, with more than $2.1 billion allocated globally to develop and scale non-invasive blood glucose monitoring systems and next-generation CGM devices. U.S.-based startups alone raised over $750 million across 20+ funding rounds focused on AI-powered glucose analytics, wearable CGM devices, and app-based remote monitoring platforms. Asia-Pacific markets, especially India and China, witnessed a 38% rise in VC funding into diabetes care startups, largely concentrated in telemedicine and low-cost diagnostic kits. In the therapeutics segment, significant investments have been directed toward GLP-1 receptor agonists, SGLT2 inhibitors, and next-generation insulin formulations. In 2023, over $4 billion was invested in R&D for novel oral insulin therapies and ultra-long-acting injectable insulin. Major pharmaceutical firms announced new collaborations to speed up clinical trials, including a notable joint venture between leading insulin manufacturers and biotech innovators for peptide-based oral drugs. Governmental support is also fueling the market. In 2023, the European Union invested €300 million through the Horizon Europe initiative into diabetes-related healthcare innovation, including preventive care tools and digital health integration. Similarly, the U.S. NIH allocated over $1 billion in grants for diabetes research and technology development. Emerging economies such as Brazil and Indonesia also ramped up public health funding, expanding access to insulin and essential diagnostics in rural areas.

New Product Development

The diabetes therapeutics and diagnostics market has witnessed a surge in innovative product development aimed at improving glycemic control, enhancing patient convenience, and enabling early diagnosis. In 2023 and 2024, over 60 new products were launched globally in this market, reflecting robust R&D pipelines and technological advancement across key regions. One of the most transformative innovations was the introduction of smart insulin pens and wearable patches with integrated Bluetooth tracking. Over 25 new smart insulin delivery devices were launched in 2023, allowing for real-time dosage tracking via mobile apps. Companies like Medtronic and Novo Nordisk introduced advanced pens that store injection history, reducing the risk of overdosing. Approximately 1.9 million patients globally adopted these smart insulin devices within a year of launch. In the diagnostics segment, real-time continuous glucose monitoring (CGM) devices took a major leap forward. Abbott and Dexcom introduced next-generation CGM devices with sensor lifespans extended to 15 days, up from the previous 10-day average. These devices achieved calibration-free performance with 98% accuracy in clinical trials. Moreover, wearable sensors integrated with AI analytics saw a 35% increase in adoption in hospitals and outpatient clinics across North America and Europe. Artificial pancreas systems, also known as closed-loop insulin delivery systems, marked another frontier of innovation. In 2024, at least three new hybrid closed-loop systems were approved in major markets. These systems use CGM data to automatically adjust basal insulin delivery in real time. Preliminary clinical data from over 3,500 users demonstrated improved time-in-range from 58% to 76% within six weeks of use.

Five Recent Developments

• In 2023, Novo Nordisk expanded the availability of its oral GLP-1 receptor agonist, semaglutide, to over 25 new countries, including regions across Asia-Pacific and Latin America.
• Abbott launched the FreeStyle Libre 3 CGM system with 14-day wear time, real-time glucose data updates every 1 minute, and an ultra-slim sensor measuring just 2.9 mm in thickness.
• Medtronic's MiniMed 780G closed-loop insulin pump system was approved and launched in multiple global markets including Japan, Brazil, and the UAE between late 2023 and early 2024.
• In 2024, Sanofi introduced a connected insulin pen device with an integrated digital health platform that tracks injection data, reminders, and glucose trends.
• Roche Diagnostics launched a compact, point-of-care HbA1c testing system in 2023 capable of delivering results in 3.5 minutes using a fingerstick blood sample.

Report Coverage of Diabetes Therapeutics and Diagnostics Market

The Diabetes Therapeutics and Diagnostics Market report provides a comprehensive analysis of the global landscape, evaluating market performance across therapeutics, diagnostics, technology types, patient demographics, and care settings. The report spans a detailed review of over 30 countries, covering more than 12 product categories and 5 major therapeutic classes including insulin, GLP-1 receptor agonists, DPP-4 inhibitors, and oral hypoglycemics. It includes diagnostic devices such as continuous glucose monitoring systems, test strips, lancets, and HbA1c testing tools. This report covers quantitative and qualitative evaluations of more than 50 global companies and examines 3,000+ datasets compiled from regulatory filings, clinical trials, product approvals, and hospital usage patterns. It identifies leading product types including insulin pens, insulin pumps, CGM systems, and blood glucose meters. Regional data include comparative adoption rates, with specific attention to penetration in urban vs. rural healthcare infrastructures. Additionally, the report includes segmentation across type 1 diabetes, type 2 diabetes, gestational diabetes, and other secondary forms. Over 7 application segments and 20 technology formats are compared to provide clarity on demand trends and technological evolution. The analysis is supported by proprietary modelling tools tracking real-time product performance metrics, disease prevalence across 100+ demographic groups, and hospital network purchasing behavior. Market dynamics explored in the report include shifts in therapy preferences from conventional insulin to long-acting analogs, real-time monitoring over static testing, and the increasing convergence of digital platforms with therapeutic protocols. The report reviews global regulatory environments, highlighting regional disparities in insulin accessibility, device reimbursement, and diagnostics availability. Furthermore, the report includes a granular view of healthcare infrastructure integration, with over 200 hospitals and clinics sampled for in-field device usage and clinical efficacy tracking. It also offers analysis of emerging technologies in closed-loop systems and AI-based glucose analytics, with over 40 recent patents assessed to predict next-phase market innovations. The coverage extends to macroeconomic variables affecting diabetes management costs, medication availability, and treatment adoption in high-incidence countries such as India, China, and the United States.

Frequently Asked Questions