Global Artificial Pancreas Device System (APDS) Market, By Type (Threshold Suspended Device System, CTR System, CTT System), By Application, and By Region - Trends and Forecast Analysis, 2021-2035

Global Artificial Pancreas Device System (APDS) Market Size is expected to reach USD 12.25 Billion by 2035 from USD 2.68 Billion in 2024, with a CAGR of around 14.79% between 2024 and 2035. ​The global Artificial Pancreas Device System (APDS) market is being propelled by two primary drivers: the increasing prevalence of diabetes and technological advancements in diabetes management. The rising number of diabetes cases worldwide has heightened the demand for effective glucose control solutions. Technological innovations, such as continuous glucose monitoring (CGM) and automated insulin delivery systems, have enhanced the efficacy of APDS, making them more appealing to both patients and healthcare providers. For instance, the NHS in England has initiated the distribution of artificial pancreas devices to thousands of individuals with type 1 diabetes, aiming to eliminate the need for daily insulin injections. ​

However, the high cost associated with APDS remains a significant restraint, limiting accessibility for many patients. Despite this, opportunities exist in the integration of advanced technologies and expanding market penetration in emerging economies. The incorporation of artificial intelligence and machine learning into APDS can further enhance their functionality, offering personalized diabetes management solutions. Additionally, emerging markets present significant growth prospects due to increasing healthcare awareness and infrastructure development. For example, the FDA's approval of the CamAPS FX artificial pancreas system for use during pregnancy marks a significant advancement in personalized diabetes care.

Driver: Rising Diabetes Cases Fuel Demand

A steady increase in diabetes cases has significantly driven the global demand for Artificial Pancreas Device Systems. This trend has been noticed especially in urban populations where sedentary lifestyles and poor dietary habits are more common. With more people being diagnosed at a younger age, long-term glucose management has become a top priority. Artificial pancreas systems, designed to automate insulin delivery, have been adopted to reduce manual intervention and improve health outcomes. In many developed countries, patients have shifted from traditional insulin injections to closed-loop systems that mimic natural pancreatic function. For example, a 16-year-old athlete in California was able to maintain stable glucose levels during high-intensity training after switching to an artificial pancreas. In India, a working professional struggling with erratic sugar spikes found relief using a hybrid closed-loop system. Parents of children with type 1 diabetes have increasingly turned to these systems for peace of mind, especially overnight when glucose monitoring becomes more difficult. The rising awareness about early diabetes control and the growing preference for automated devices have boosted acceptance. As the burden of diabetes grows globally, this driver will continue to shape the adoption of advanced and intelligent diabetes management technologies.

Key Insights:

• The adoption rate of artificial pancreas device systems among U.S. Type 1 diabetes patients is estimated at about 15% in 2024.

• In Germany, approximately 9% of adults with diabetes are potential candidates for APDS, reflecting growing penetration in Europe.

• The U.S. Medicare and Medicaid programs now reimburse APDS for eligible patients, increasing accessibility and adoption.

• Major companies have invested over $500 million in R&D for APDS technology development and clinical trials in the past five years.

• In 2025, threshold suspend device systems are projected to account for 72.5% of the global APDS product segment.

• The number of APDS units sold globally surpassed 100,000 in 2024, with rapid growth in North America and Europe.

• The penetration rate of APDS in U.S. hospitals and diabetes clinics is estimated at 22% as of 2024.

Segment Analysis:

The Artificial Pancreas Device System (APDS) market is segmented by type into Threshold Suspended Device Systems, Control-to-Range (CTR) Systems, and Control-to-Target (CTT) Systems, each offering different levels of glucose regulation. Threshold Suspended Device Systems are designed to stop insulin delivery when glucose levels fall too low, reducing the risk of hypoglycemia. These systems are often used in children or elderly patients who are prone to sudden glucose drops. CTR Systems aim to maintain glucose within a safe range by adjusting insulin levels periodically, and are widely used by active adults managing fluctuating sugar levels due to inconsistent routines. CTT Systems, being the most advanced, automatically aim for and maintain a specific glucose target. These are preferred by patients with type 1 diabetes seeking tighter control and fewer interventions. In terms of application, hospitals primarily use these systems for inpatient diabetes management, especially during surgeries or post-operative recovery. For instance, patients recovering from cardiac procedures are monitored using CTR systems to avoid glycemic complications. Clinics use APDS for long-term outpatient care, helping patients transition from manual insulin injections to automated solutions. A diabetic schoolteacher in France recently adopted a CTT system through her local clinic and reported improved glucose stability and reduced stress during work hours.

Regional Analysis:

The global Artificial Pancreas Device System (APDS) market has seen varied growth across regions, shaped by healthcare infrastructure, awareness, and regulatory support. In North America, adoption has been widespread due to strong insurance coverage and patient education. A college student in Canada with type 1 diabetes recently benefited from a government-supported program that provided access to a hybrid closed-loop system, improving his quality of life during exams. In Europe, innovation and public health initiatives have driven usage. A retiree in Sweden, previously relying on manual insulin doses, now manages his condition with a Control-to-Target device, experiencing fewer hypoglycemic episodes. Asia-Pacific has witnessed rising demand, mainly due to growing urban populations and increasing diabetes cases. A working mother in Japan now uses a threshold suspend system provided through a corporate wellness plan, allowing her to better manage her condition while juggling work and childcare. In Latin America, access remains limited but improving, with clinics in Brazil recently introducing APDS technology through pilot programs. In the Middle East and Africa, growth has been slower, but interest is growing. A teenager in the UAE recently became one of the first in her community to start APDS therapy through a private hospital, showing promising early results.

Competitive Scenario:

The Artificial Pancreas Device System (APDS) market has been rapidly advancing, with key companies driving innovation and accessibility through recent developments. Medtronic continues refining its hybrid closed-loop systems, focusing on improved user experience for both children and adults. Bigfoot Biomedical has shifted its strategy by licensing insulin pump patents to Insulet, allowing it to focus more on smart injection technologies like the Bigfoot Unity system. Johnson & Johnson, though quieter in recent years, has contributed to the foundational technology behind automated insulin delivery. Tandem Diabetes Care has expanded its partnerships, integrating the Dexcom G7 CGM into its insulin pumps, aiming for tighter glucose control with seamless interoperability. Pancreum Inc. remains in the development phase with its modular AP system, intended to offer users customizable insulin therapy. TypeZero Technologies, known for its algorithms, is collaborating with Tandem to accelerate the rollout of more responsive closed-loop systems. Beta Bionics has made a major leap with its iLet Bionic Pancreas receiving regulatory clearance; the device determines all insulin doses autonomously based only on body weight. These companies are reshaping diabetes care through automation, convenience, and precision, offering patients—from school-aged children to working adults—better glycemic control and reduced burden in daily disease management.

Artificial Pancreas Device System (APDS) Market Report Scope

The Global Artificial Pancreas Device System (APDS) Market report is segmented as follows:

By Type,

• Threshold Suspended Device System
• CTR System
• CTT System

By Application,

• Hospitals
• Clinics

By Region,

• North America
• U.S.
• Canada
• Mexico
• Europe
• UK
• Germany
• France
• Spain
• Italy
• Russia
• Rest of Europe
• Asia Pacific
• China
• Japan
• India
• South Korea
• Australia
• Southeast Asia
• Rest of Asia Pacific
• Latin America
• Brazil
• Argentina
• Rest of Latin America
• Middle East & Africa
• Saudi Arabia
• UAE
• South Africa
• Rest of Middle East and Africa

Key Market Players,

• Medtronic
• Bigfoot Biomedical
• Johnson & Johnson
• Tandem Diabetes Care Inc
• Pancreum Inc
• TypeZero Technologies, LLC
• Beta Bionics

Research Objectives

• Proliferation and maturation of trade in the global Artificial Pancreas Device System (APDS) Market.
• The market share of the global Artificial Pancreas Device System (APDS) Market, supply and demand ratio, growth revenue, supply chain analysis, and business overview.
• Current and future market trends that are influencing the growth opportunities and growth rate of the global Artificial Pancreas Device System (APDS) Market.
• Feasibility study, new market insights, company profiles, investment return, market size of the global Artificial Pancreas Device System (APDS) Market.