Smart Insulin Management Devices Market - 2025-2033
Description
Smart Insulin Management Devices Market Size
Smart Insulin Management Devices Market Size reached US$ 12.93 Billion in 2024 and is expected to reach US$ 27.07 Billion by 2033, growing at a CAGR of 8.6% during the forecast period 2025-2033.
Smart Insulin Management Devices Market The smart insulin management devices market is experiencing rapid growth, driven by the global rise in diabetes, increasing adoption of connected health technologies, and the demand for improved glycemic control. Key innovations include smart insulin pens, patch pumps, and automated insulin delivery (AID) systems integrated with CGMs and AI-based dosing algorithms. North America leads the market, while Asia-Pacific emerges as the fastest-growing region. Challenges such as high device costs and integration issues persist, but growing reimbursement support and advancements in digital therapeutics are expected to accelerate adoption globally.
Smart Insulin Management Devices Market Dynamics: Drivers & Restraints
The rising prevalence of diabetes is significantly driving the smart insulin management devices market growth
According to the International Diabetes Federation, by 2050, IDF projections show that 1 in 8 adults, approximately 853 million, will be living with diabetes, an increase of 46%. This surge necessitates scalable, automated management tools, fueling demand for smart insulin pens and pumps that improve adherence and reduce complications. Smart devices like the NovoPen 6 and Medtronic MiniMed 780G help patients manage dosing accurately, track data, and prevent hypoglycemia/hyperglycemia, critical in populations with long-term diabetes.
Traditional insulin methods often lead to poor adherence and suboptimal control. Smart devices like Medtronic’s MiniMed 780G and Insulet’s Omnipod 5 automate insulin delivery based on real-time CGM data, helping patients maintain target glucose levels more consistently. With Type 1 diabetes increasing among children and adolescents, user-friendly and discreet smart insulin pens are becoming more popular, supporting long-term management without complex procedures.
As diabetes-related complications lead to increased hospital visits and costs, smart insulin devices help reduce emergency cases through proactive monitoring and data-driven dosing adjustments. Overall, as diabetes cases rise globally, the demand for smarter, more integrated insulin management solutions grows in parallel, making these technologies critical to both individual patient outcomes and broader public health strategies.
Complications associated with the devices are hampering the smart insulin management devices market's growth
Technical failures can lead to incorrect insulin dosing, which may cause hypoglycemia or hyperglycemia. For instance, Medtronic recalled over 300,000 MiniMed insulin pumps due to a faulty retainer ring that could lead to under- or overdosing, raising safety concerns and affecting brand reputation. Devices like patch pumps and CGMs often require adhesive contact with the skin. Many users report skin irritation, infections, or allergic reactions at the site of application, discouraging long-term use, especially in sensitive populations such as children and elderly patients.
Smart insulin systems often involve a steep learning curve. Elderly patients or those with limited tech literacy may find it difficult to operate apps, interpret CGM data, or troubleshoot devices, reducing overall adoption rates. Not all devices are compatible across platforms. For instance, a Dexcom CGM may not seamlessly integrate with certain insulin pumps or digital health apps, leading to fragmented care experiences. This lack of interoperability complicates device management and discourages multi-device usage.
Smart Insulin Management Devices Market Segment Analysis
The global smart insulin management devices market is segmented based on product type, application, end-user, and region.
The insulin pumps from the product type segment are expected to hold 39.37% of the market share in 2024 in the smart insulin management devices market
Insulin pumps, especially hybrid closed-loop systems, deliver insulin continuously and adjust doses based on real-time glucose data. Devices like the Medtronic MiniMed 780G and Insulet Omnipod 5 have revolutionized diabetes care by minimizing user input and reducing hypo-/hyperglycemia events. Pumps paired with CGMs (e.g., Dexcom G6) allow for automated dose adjustments. This interoperability has led to significant clinical benefits, such as improved HbA1c levels and time-in-range metrics, making pumps more attractive to both patients and clinicians.
Newer models like software in insulin pumps eliminate complications, further driving user preference for convenience and comfort. For instance, in March 2025, Tandem Diabetes Care, Inc. launched Control-IQ+ technology, the latest generation of the company’s advanced hybrid closed-loop algorithm. Control-IQ+, compatible with both the t:slim X2 insulin pump and Tandem Mobi System, is available for people with type 1 diabetes ages 2 years and older and adults with type 2 diabetes. Pumps pre-loaded with the updated software are shipping to new customers, and all eligible, in-warranty Tandem customers will have access to the new features via remote software update free of charge. With these continuous innovations, insulin pumps remain the leading segment within the smart insulin management devices market.
Smart Insulin Management Devices Market Geographical Analysis
North America is expected to dominate the global smart insulin management devices market with a 43.18% share in 2024
North America is a leader in adopting advanced insulin devices. Major manufacturers like Medtronic, Insulet, Dexcom, and Tandem Diabetes Care are headquartered in North America, particularly in the United States and Canada, contributing to faster innovation cycles, FDA approvals, and local market penetration.
For instance, in April 2025, Insulet Corporation, the global leader in tubeless insulin pump technology with its Omnipod brand of products, announced that Omnipod 5 is now commercially available in Canada. Omnipod 5 is the first tubeless, waterproof Automated Insulin Delivery (AID) System approved for use in Canada for people with type 1 diabetes aged two years and above.
The region is at the forefront of integrating diabetes devices with telehealth and smartphone platforms. Apps like Dexcom Clarity and Tandem’s t:connect allow remote monitoring, which became especially critical during the COVID-19 pandemic. For instance, in November 2024, the US Food and Drug Administration (FDA) granted clearance to Medtronic’s new InPen app, setting the stage for the launch of the company’s Smart MDI system integrated with the Simplera continuous glucose monitor (CGM). The InPen app, a smart insulin pen companion, can improve type 1 diabetes care by increasing insulin dosing accuracy and providing real-time data.
Smart Insulin Management Devices Market Top Companies
Top companies in the smart insulin management devices market include Abbott, Medtronic, Tandem Diabetes Care, Inc., Insulet Corporation, Eli Lilly and Company, F. Hoffmann-La Roche Ltd, Novo Nordisk A/S, Ypsomed AG, i-SENS, Inc., and Diabeloop SA, among others.
The global smart insulin management devices market report delivers a detailed analysis with 62 key tables, more than 55 visually impactful figures, and 157 pages of expert insights, providing a complete view of the market landscape.
Smart Insulin Management Devices Market Size reached US$ 12.93 Billion in 2024 and is expected to reach US$ 27.07 Billion by 2033, growing at a CAGR of 8.6% during the forecast period 2025-2033.
Smart Insulin Management Devices Market The smart insulin management devices market is experiencing rapid growth, driven by the global rise in diabetes, increasing adoption of connected health technologies, and the demand for improved glycemic control. Key innovations include smart insulin pens, patch pumps, and automated insulin delivery (AID) systems integrated with CGMs and AI-based dosing algorithms. North America leads the market, while Asia-Pacific emerges as the fastest-growing region. Challenges such as high device costs and integration issues persist, but growing reimbursement support and advancements in digital therapeutics are expected to accelerate adoption globally.
Smart Insulin Management Devices Market Dynamics: Drivers & Restraints
The rising prevalence of diabetes is significantly driving the smart insulin management devices market growth
According to the International Diabetes Federation, by 2050, IDF projections show that 1 in 8 adults, approximately 853 million, will be living with diabetes, an increase of 46%. This surge necessitates scalable, automated management tools, fueling demand for smart insulin pens and pumps that improve adherence and reduce complications. Smart devices like the NovoPen 6 and Medtronic MiniMed 780G help patients manage dosing accurately, track data, and prevent hypoglycemia/hyperglycemia, critical in populations with long-term diabetes.
Traditional insulin methods often lead to poor adherence and suboptimal control. Smart devices like Medtronic’s MiniMed 780G and Insulet’s Omnipod 5 automate insulin delivery based on real-time CGM data, helping patients maintain target glucose levels more consistently. With Type 1 diabetes increasing among children and adolescents, user-friendly and discreet smart insulin pens are becoming more popular, supporting long-term management without complex procedures.
As diabetes-related complications lead to increased hospital visits and costs, smart insulin devices help reduce emergency cases through proactive monitoring and data-driven dosing adjustments. Overall, as diabetes cases rise globally, the demand for smarter, more integrated insulin management solutions grows in parallel, making these technologies critical to both individual patient outcomes and broader public health strategies.
Complications associated with the devices are hampering the smart insulin management devices market's growth
Technical failures can lead to incorrect insulin dosing, which may cause hypoglycemia or hyperglycemia. For instance, Medtronic recalled over 300,000 MiniMed insulin pumps due to a faulty retainer ring that could lead to under- or overdosing, raising safety concerns and affecting brand reputation. Devices like patch pumps and CGMs often require adhesive contact with the skin. Many users report skin irritation, infections, or allergic reactions at the site of application, discouraging long-term use, especially in sensitive populations such as children and elderly patients.
Smart insulin systems often involve a steep learning curve. Elderly patients or those with limited tech literacy may find it difficult to operate apps, interpret CGM data, or troubleshoot devices, reducing overall adoption rates. Not all devices are compatible across platforms. For instance, a Dexcom CGM may not seamlessly integrate with certain insulin pumps or digital health apps, leading to fragmented care experiences. This lack of interoperability complicates device management and discourages multi-device usage.
Smart Insulin Management Devices Market Segment Analysis
The global smart insulin management devices market is segmented based on product type, application, end-user, and region.
The insulin pumps from the product type segment are expected to hold 39.37% of the market share in 2024 in the smart insulin management devices market
Insulin pumps, especially hybrid closed-loop systems, deliver insulin continuously and adjust doses based on real-time glucose data. Devices like the Medtronic MiniMed 780G and Insulet Omnipod 5 have revolutionized diabetes care by minimizing user input and reducing hypo-/hyperglycemia events. Pumps paired with CGMs (e.g., Dexcom G6) allow for automated dose adjustments. This interoperability has led to significant clinical benefits, such as improved HbA1c levels and time-in-range metrics, making pumps more attractive to both patients and clinicians.
Newer models like software in insulin pumps eliminate complications, further driving user preference for convenience and comfort. For instance, in March 2025, Tandem Diabetes Care, Inc. launched Control-IQ+ technology, the latest generation of the company’s advanced hybrid closed-loop algorithm. Control-IQ+, compatible with both the t:slim X2 insulin pump and Tandem Mobi System, is available for people with type 1 diabetes ages 2 years and older and adults with type 2 diabetes. Pumps pre-loaded with the updated software are shipping to new customers, and all eligible, in-warranty Tandem customers will have access to the new features via remote software update free of charge. With these continuous innovations, insulin pumps remain the leading segment within the smart insulin management devices market.
Smart Insulin Management Devices Market Geographical Analysis
North America is expected to dominate the global smart insulin management devices market with a 43.18% share in 2024
North America is a leader in adopting advanced insulin devices. Major manufacturers like Medtronic, Insulet, Dexcom, and Tandem Diabetes Care are headquartered in North America, particularly in the United States and Canada, contributing to faster innovation cycles, FDA approvals, and local market penetration.
For instance, in April 2025, Insulet Corporation, the global leader in tubeless insulin pump technology with its Omnipod brand of products, announced that Omnipod 5 is now commercially available in Canada. Omnipod 5 is the first tubeless, waterproof Automated Insulin Delivery (AID) System approved for use in Canada for people with type 1 diabetes aged two years and above.
The region is at the forefront of integrating diabetes devices with telehealth and smartphone platforms. Apps like Dexcom Clarity and Tandem’s t:connect allow remote monitoring, which became especially critical during the COVID-19 pandemic. For instance, in November 2024, the US Food and Drug Administration (FDA) granted clearance to Medtronic’s new InPen app, setting the stage for the launch of the company’s Smart MDI system integrated with the Simplera continuous glucose monitor (CGM). The InPen app, a smart insulin pen companion, can improve type 1 diabetes care by increasing insulin dosing accuracy and providing real-time data.
Smart Insulin Management Devices Market Top Companies
Top companies in the smart insulin management devices market include Abbott, Medtronic, Tandem Diabetes Care, Inc., Insulet Corporation, Eli Lilly and Company, F. Hoffmann-La Roche Ltd, Novo Nordisk A/S, Ypsomed AG, i-SENS, Inc., and Diabeloop SA, among others.
The global smart insulin management devices market report delivers a detailed analysis with 62 key tables, more than 55 visually impactful figures, and 157 pages of expert insights, providing a complete view of the market landscape.
Table of Contents
180 Pages
- 1. Market Introduction and Scope
- 1.1. Objectives of the Report
- 1.2. Report Coverage & Definitions
- 1.3. Report Scope
- 2. Executive Insights and Key Takeaways
- 3. Market Highlights and Strategic Takeaways
- 3.1. Key Trends and Future Projections
- 4. Snippet by Product Type
- 4.1. Snippet by Application
- 4.2. Snippet by End-User
- 4.3. Snippet by Region
- 5. Dynamics
- 5.1. Impacting Factors
- 5.1.1. Drivers
- 5.1.1.1. Rising Prevalence of Diabetes
- 5.1.1.2. Increasing Strategic Developments by the Companies
- 5.1.1.3. XX
- 5.1.2. Restraints
- 5.1.2.1. Complications Associated with the Devices
- 5.1.2.2. High Cost of Smart Insulin Management Devices
- 5.1.2.3. XX
- 5.1.3. Opportunity
- 5.1.3.1. Technological Advancements in Smart Insulin Management Devices
- 5.1.3.2. XX
- 5.1.4. Impact Analysis
- 6. Strategic Insights and Industry Outlook
- 6.1. Market Leaders and Pioneers
- 6.1.1. Emerging Pioneers and Prominent Players
- 6.1.2. Established Leaders with the Largest Marketing Brand
- 6.1.3. Market Leaders with Established Products
- 6.2. Latest Developments and Breakthroughs
- 6.3. Regulatory and Reimbursement Landscape
- 6.3.1. North America
- 6.3.2. Europe
- 6.3.3. Asia Pacific
- 6.3.4. South America
- 6.3.5. Middle East & Africa
- 6.4. Porter’s Five Forces Analysis
- 6.5. Supply Chain Analysis
- 6.6. Patent Analysis
- 6.7. SWOT Analysis
- 6.8. Unmet Needs and Gaps
- 6.9. Recommended Strategies for Market Entry and Expansion
- 6.10. Pricing Analysis and Price Dynamics
- 7. Smart Insulin Management Devices Market, By Product Type
- 8. Introduction
- 8.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 8.1.1. Market Attractiveness Index, By Product Type
- 8.2. Insulin Pen Injectors*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
- 8.3. Insulin Jet Injectors
- 8.4. Insulin Pumps
- 8.4.1. External Insulin Pumps
- 8.4.2. Implantable Pumps
- 8.5. Insulin Patches
- 8.6. Others
- 9. Smart Insulin Management Devices Market, By Application
- 9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 9.1.2. Market Attractiveness Index, By Application
- 9.2. Type I Diabetes*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
- 9.3. Type II Diabetes
- 9.4. Gestational Diabetes
- 10. Smart Insulin Management Devices Market, By End-User
- 10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.1.2. Market Attractiveness Index, By End-User
- 10.2. Hospitals*
- 10.2.1. Introduction
- 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
- 10.3. Home Care settings
- 10.4. Specialty Clinics
- 10.5. Others
- 11. Smart Insulin Management Devices Market, By Regional Market Analysis and Growth Opportunities
- 12. Introduction
- 12.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 12.1.1. Market Attractiveness Index, By Region
- 12.2. North America
- 12.2.1. Introduction
- 12.2.2. Key Region-Specific Dynamics
- 12.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 12.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 12.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 12.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 12.2.6.1. U.S.
- 12.2.6.2. Canada
- 12.2.6.3. Mexico
- 12.3. Europe
- 12.3.1. Introduction
- 12.3.2. Key Region-Specific Dynamics
- 12.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 12.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 12.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 12.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 12.3.6.1. Germany
- 12.3.6.2. UK
- 12.3.6.3. France
- 12.3.6.4. Spain
- 12.3.6.5. Italy
- 12.3.6.6. Rest of Europe
- 12.4. Asia-Pacific
- 12.4.1. Introduction
- 12.4.2. Key Region-Specific Dynamics
- 12.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 12.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 12.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 12.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 12.4.6.1. China
- 12.4.6.2. India
- 12.4.6.3. Japan
- 12.4.6.4. South Korea
- 12.4.6.5. Rest of Asia-Pacific
- 12.5. South America
- 12.5.1. Introduction
- 12.5.2. Key Region-Specific Dynamics
- 12.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 12.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 12.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 12.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 12.5.6.1. Brazil
- 12.5.6.2. Argentina
- 12.5.6.3. Rest of South America
- 12.6. Middle East and Africa
- 12.6.1. Introduction
- 12.6.2. Key Region-Specific Dynamics
- 12.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 12.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 12.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 13. Competitive Landscape and Market Positioning
- 14. Competitive Overview and Key Market Players
- 14.1. Market Share Analysis and Positioning Matrix
- 14.2. Strategic Partnerships, Mergers & Acquisitions
- 14.3. Key Developments in Product Portfolios and Innovations
- 14.4. Company Benchmarking
- 15. Company Profiles
- 15.1. Abbott*
- 15.1.1. Company Overview
- 15.1.2. Product Portfolio
- 15.1.2.1. Product Description
- 15.1.2.2. Product Key Performance Indicators (KPIs)
- 16. Financial Overview
- 16.1. Company Revenue
- 16.1.1. Geographical Revenue Shares
- 16.1.1.1. Revenue Forecasts
- 16.1.2. Key Developments
- 16.1.2.1. Mergers & Acquisitions
- 16.1.2.2. Key Product Development Activities
- 16.1.2.3. Regulatory Approvals, etc.
- 16.1.3. SWOT Analysis
- 16.2. Medtronic
- 16.3. Tandem Diabetes Care, Inc.
- 16.4. Insulet Corporation
- 16.5. Eli Lilly and Company
- 16.6. F. Hoffmann-La Roche Ltd
- 16.7. Novo Nordisk A/S
- 16.8. Ypsomed AG
- 16.9. i-SENS, Inc.
- 16.10. Diabeloop SALIST NOT EXHAUSTIVE
- 17. Assumption and Research Methodology
- 17.1. Data Collection Methods
- 17.2. Data Triangulation
- 17.3. Forecasting Techniques
- 17.4. Data Verification and Validation
- 18. Appendix
- 18.1. About Us and Services
- 18.2. Contact Us
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