United States Automated Insulin Delivery Systems Market 2031 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

Automated Insulin Delivery Systems Market is expected to reach at a CAGR of 9.7% during the forecast period (2023- 2030).

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Key Development:

United States: Recent Industry Developments

✅ In December 2025, Insulet announced FDA clearance for its upgraded Omnipod 5 AID algorithm, introducing a lower 100 mg/dL glucose target to deliver tighter automated insulin control and an improved dosing experience.

✅ In November 2025, Tandem Diabetes Care received FDA clearance to expand its Control-IQ+ algorithm for adults with Type 2 diabetes, enabling broader use of automated insulin delivery beyond Type 1.

✅ In May 2025, the twiist Automated Insulin Delivery System was introduced in the U.S., combining a 1-year implantable CGM sensor with automated insulin dosing to reduce user burden and enhance long-term diabetes management.

✅ In April 2025, Medtronic submitted its MiniMed 780G system and SmartGuard algorithm for FDA review as interoperable AID components, aiming to expand hybrid closed-loop choices across CGM platforms.

Japan: Recent Industry Developments

✅ In July 2025, a national clinical-practice study confirmed strong outcomes for users of hybrid closed-loop systems such as MiniMed 770G/780G, showing stable real-world glucose control and supporting broader AID adoption across Japan.

✅ In April 2025, Kyoto University Hospital completed the first clinical transplantation of iPS-cell-derived insulin-producing cells in a patient with Type 1 diabetes a regenerative-medicine breakthrough that may reduce long-term dependence on external insulin delivery.

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Key Players:

=> Medtronic, Novo Nordisk, Insulet Corporation , Tandem Diabetes Care, Inc, Ypsomed AG, F. Hoffmann-La Roche Ltd., Becton, Dickinson and Company, Biocon, Bigfoot Biomedical, Inc. and sanofi-aventis U.S. LLC.

Key Segments:

By Device Type

Disposable insulin pens lead with 60% share, driven by convenience, growing preference for prefilled dosing, wide payer coverage in developed markets, and strong adoption in retail pharmacy channels. Reusable insulin pens account for 40%, supported by cost-efficiency for long-term users, compatibility with multiple insulin cartridges, and growing interest in sustainable reuse models in some regions.

By Insulin Pumps

External / tethered pumps dominate with 40% share, reflecting mature market adoption for intensive insulin therapy, broad clinical acceptance for type-1 diabetes management, and continued OEM investment in connectivity and sensor integration. Patch pumps hold 20%, supported by user preference for low-profile, tubeless designs and growing availability of simpler, app-driven patch systems. Closed-loop (automated) insulin pumps represent 15%, fueled by advances in CGM integration and algorithmic control for improved glycemic outcomes. Implanted insulin pumps (IIP) account for 10%, reflecting niche use, higher procedural complexity, and targeted adoption in specialized centers. Other pump types make up 15%, including hybrid designs, research-stage delivery systems, and OEM-specific variants.

By Pen Needles

Standard pen needles hold 50% share, driven by broad availability, cost-effectiveness, and continuing use across emerging and price-sensitive markets. Safety pen needles account for 35%, supported by regulatory push for sharps-injury prevention, hospital procurement policies, and growing adoption in institutional and homecare settings. Other needle formats make up 15%, including ultra-fine gauge needles, long-length needles for special patient groups, and proprietary connector systems.

By End-User

Homecare leads with 35% share, reflecting the dominant trend of self-administration, telehealth follow-up, and rising availability of user-friendly pens and wearable pumps for everyday diabetes management. Hospitals account for 30%, driven by acute care, inpatient insulin management, and procurement of safety needles and pumps for clinical use. Clinics (specialist diabetes centres, outpatient endocrinology units) hold 25%, supported by initiation/titration of pumps, structured education programs, and follow-up. Other end-users make up 10%, including long-term care facilities, correctional healthcare, and clinical research sites.

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By Region

North America - 35% Share
North America leads with 35%, propelled by high prevalence of insulin-dependent diabetes, rapid uptake of advanced pump technologies (closed-loop systems), strong reimbursement, and mature homecare markets in the U.S. and Canada.

Europe - 25% Share
Europe holds 25%, supported by structured national diabetes programs, wide clinical adoption of pumps and safety devices, and growing public procurement of safety pen needles and patch pumps across Western Europe.

Asia Pacific - 25% Share
Asia Pacific accounts for 25%, fueled by a large and growing diabetes population, expanding retail and e-commerce channels for pens and needles, and rising adoption of point-of-care and homecare devices in China, India, Japan, and Southeast Asia.

Latin America - 8% Share
Latin America holds 8%, driven by increasing insulin availability, expanding clinic networks, and greater penetration of disposable pens in urban retail channels in Brazil, Mexico, and regional hubs.

Middle East & Africa - 7% Share
The Middle East & Africa represent 7%, supported by rising healthcare investment, growing hospital procurement of safety devices, and early adoption of wearable pump solutions in GCC countries and South Africa.

FAQ

Q: What is the growth rate of the Automated Insulin Delivery Systems Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 9.7% during the forecast period from 2024 to 2031.

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