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 Automated Insulin Delivery System Developments

✅ In November 2025, the FDA cleared Tandem Diabetes Care's Control‐IQ+ algorithm for adults with type 2 diabetes, expanding its automated insulin delivery system use beyond type 1 and broadening access to AID tech for a larger patient population.

✅ In October 2025, the FDA granted 510(k) clearance to Insulet's enhanced Omnipod 5 Automated Insulin Delivery System with a new lower glucose target and algorithm improvements enabling more customizable automation and fewer interruptions in automated mode.

✅ In May 2025, Sequel Med Tech's twiist AID system debuted in the U.S. with integration of a 1‐year implantable CGM sensor, marking the first automated delivery setup designed to pair with ultra‐long sensor life for reduced user burden.

✅ In April 2025, Medtronic submitted 510(k) applications to the FDA for its MiniMed 780G pump and SmartGuard algorithm as interoperable AID components that could work across multiple CGM platforms a key step toward broader hybrid closed‐loop options.

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Japan: Recent Automated Insulin Delivery System Developments

✅ In December 2025, There is a growing demand for artificial pancreas systems (automated insulin delivery + CGM combos) in Japan as advanced AID adoption begins to rise with awareness and clinical interest increasing nationwide.

✅ In September 2025, Japan's insulin delivery device landscape saw continued interest in CGM‐integrated automated insulin solutions as the artificial pancreas market expanded in planning and early adoption signaling stronger local healthcare focus on AID tech.

✅ In July 2025, broader clinical support for hybrid closed‐loop systems in Japan was backed by real‐world outcomes from closed‐loop users (e.g., Medtronic systems), strengthening the foundation for future automated insulin delivery uptake.

✅ In April 2025, Kyoto University Hospital completed a first clinical islet cell transplant for Type 1 diabetes a regenerative therapy advancement that may, over time, impact insulin‐delivery needs and spur integrated AID‐supportive care developments.

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.

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Key Segments:

By Device Type

Reusable Insulin Pens - 40% share, widely used for patient convenience and long-term use.
Disposable Insulin Pens - 60% share, preferred for hygiene, ease-of-use, and reducing infection risks.

By Insulin Pumps

External/Tethered Pumps - 35% share, conventional pumps connected via tubing for continuous insulin delivery.
Implanted Insulin Pump (IIP) - 5% share, niche adoption due to surgical implantation requirements.
Patch Pumps - 20% share, compact and wearable solutions for improved patient compliance.
Closed-Loop Insulin Pump - 15% share, automated insulin delivery systems integrating CGM for real-time glucose control.
Others - 25% share, including hybrid or emerging insulin pump technologies.

By Pen Needles

Standard Pen Needles - 50% share, commonly used across patient populations.
Safety Pen Needles - 40% share, growing adoption due to needlestick injury prevention.
Others - ~10% share, including specialized and pediatric needle options.

By End-User

Hospitals - 30% share, primary adopters for inpatient insulin therapy.
Clinics - 20% share, used for outpatient diabetes management.
Homecare - 40% share, rising due to self-administration and telemedicine integration.
Others - 10% share, including research facilities and specialized care centers.

By Region

North America - 40% Share
High adoption of advanced insulin delivery devices and strong diabetes management programs.

Europe - 25% Share
Growing use of insulin pumps and safety needles supported by healthcare policies.

Asia Pacific - 20% Share
Rapidly expanding diabetes population and increasing patient awareness driving market growth.

Latin America - 10% Share
Selective adoption in urban hospitals and clinics; growing awareness campaigns.

Middle East & Africa - 5% Share
Emerging market, gradual adoption driven by private healthcare facilities and urban populations.

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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