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PUBLISHER: DataM Intelligence | PRODUCT CODE: 1696289

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PUBLISHER: DataM Intelligence | PRODUCT CODE: 1696289

Global Artificial Pancreas System Market - 2025-2033

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The global artificial pancreas system market reached US$ 456.97 million in 2024 and is expected to reach US$ 6304.70 million by 2033, growing at a CAGR of 30.0% during the forecast period 2025-2033.

Artificial pancreas system is a medical device that automates blood glucose control in type 1 diabetes patients. It includes a continuous glucose monitor, insulin pump, and advanced control algorithm. This system mimics the function of a healthy pancreas, ensuring optimal blood sugar levels and reducing the risk of hyperglycemia and hypoglycemia. It improves diabetes management and patient convenience and minimizes the need for manual insulin administration.

Market Dynamics: Drivers & Restraints

Rising Prevalence of Diabetes

The global diabetes prevalence, particularly type 1, is driving the artificial pancreas system market. Many diabetes patients need continuous blood glucose management, leading to a demand for automated solutions. Advancements in sensor technology improved insulin delivery, and AI-driven algorithms are contributing to market growth by offering efficient, personalized diabetes management solutions.

For instance, according to International Diabetes Foundation by 2045, IDF projections indicate a 46% increase in diabetes prevalence, with over 90% of individuals having type 2 diabetes. Factors contributing to this increase include urbanization, an aging population, decreased physical activity, and an increase in overweight and obesity, which are exacerbated by socio-economic, demographic, environmental, and genetic factors.

Hence, an increase in the prevalence of diabetes will drive demand for artificial pancreas device systems. This demand, coupled with urbanization and lifestyle-related risk factors, necessitates advanced glucose management solutions, leading to market expansion for automated insulin delivery.

High Cost of Artificial Pancreas Systems

Artificial pancreas systems, despite their potential benefits in diabetes management, face significant barriers to market expansion, particularly in low- and middle-income countries. The high cost of advanced components, limited reimbursement policies, and high maintenance costs further restrict adoption, limiting their widespread use. For instance, The Tandem t:slim X2 pump with Control-IQ costs around $4,000, with insurance typically covering 80% of the cost. Additional costs for Dexcom G6 CGM supplies, such as a transmitter and sensors, can be significant.

Segment Analysis

The global artificial pancreas system market is segmented based on device type, end-user, and region.

Device Type:

The threshold suspend device systems from the device type segment is expected to dominate the artificial pancreas system market with the highest market share

The threshold suspend and predictive suspend systems are tools that temporarily suspend insulin delivery when blood glucose levels drop below a pre-set level. These systems calculate blood glucose levels and stop delivering insulin before they reach too low. They do not automatically increase insulin doses. Storing insulin at the right moment can help prevent low blood sugar, or hypoglycemia, in individuals with type 1 diabetes. These systems may also assist those who develop hypoglycemia overnight, especially children.

The rise in diabetes, particularly type 1, is driving the adoption of Threshold Suspend Device Systems. This is driven by increased awareness of hypoglycemia risks and the need for automated insulin delivery systems. Technological advancements, regulatory approvals, healthcare expenditure, and expanded reimbursement policies in developed regions contribute to the adoption of these life-saving devices.

Geographical Analysis

North America is expected to hold a significant position in the artificial pancreas system market with the highest market share

North America dominates the threshold suspend device systems market due to advanced healthcare infrastructure, high diabetes management technologies, and key market players. The region's large type 1 diabetes population drives demand for automated insulin delivery solutions. Benefits from reimbursement policies, continuous glucose monitoring awareness, and technological advancements in insulin pumps drive market growth. Government initiatives, increased healthcare expenditure, and personalized medicine focus contribute to the growing adoption of Threshold Suspend Device Systems in North America.

Moreover, FDA approvals are also a significant factor that helps the region to grow during the forecast period. For instance, in May 2024, The U.S. Food and Drug Administration (FDA) approved an artificial pancreas developed by University of Cambridge researchers for use by individuals with type 1 diabetes, including during pregnancy, marking the first time the FDA has authorized the use of this life-changing app during pregnancy.

Moreover, in May 2023, the FDA approved the iLet Insulin-Only Bionic Pancreas System for individuals aged 6 and above with type 1 diabetes, an artificial pancreas system that autonomously determines and delivers insulin doses.

Competitive Landscape

The major global players in the artificial pancreas system market include Medtronic Plc, Tandem Diabetes Care, Inc., Beta Bionics, Insulet Corporation, Diabeloop, Inreda Diabetic B.V., and Nikkiso Co., Ltd among others.

Key Developments

  • In April 2024, the NHS launched a world-first initiative for tens of thousands of children and adults with type 1 diabetes in England, which will use an 'artificial pancreas' to monitor blood glucose levels and automatically adjust insulin dosage.

Why Purchase the Report?

  • Technological Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
  • Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
  • Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
  • Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
  • Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
  • Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
  • Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
  • Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
  • Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
  • Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
  • Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
  • Post-market Surveillance: Uses post-market data to enhance product safety and access.
  • Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global artificial pancreas system market report delivers a detailed analysis with 45key tables, more than 40 visually impactful figures and 165 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

  • Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
  • Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
  • Application & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
  • Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
  • Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
  • Supply Chain: Distribution and Supply Chain Managers.
  • Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
  • Academic & Research: Academic Institutions.
Product Code: MD9415

Table of Contents

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
  • 3.2. Snippet by Device Type
  • 3.3. Snippet by End-User
  • 3.4. Snippet by Region

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Rising Prevalence of Diabetes
      • 4.1.1.2. Growing Adoption of Wearable and AI-driven Healthcare Devices
    • 4.1.2. Restraints
      • 4.1.2.1. High Cost of Artificial Pancreas Systems
      • 4.1.2.2. Stringent Regulatory Requirements and Approval Delays
    • 4.1.3. Opportunity
      • 4.1.3.1. Integration of AI and Machine Learning for Personalized Diabetes Management
    • 4.1.4. Impact Analysis

5. Strategic Insights and Industry Outlook

  • 5.1. Market Leaders and Pioneers
    • 5.1.1. Emerging Pioneers and Prominent Players
    • 5.1.2. Established leaders with largest selling Brand
    • 5.1.3. Market leaders with established Product
  • 5.2. CXO Perspectives
  • 5.3. Latest Developments and Breakthroughs
  • 5.4. Case Studies/Ongoing Research
  • 5.5. Regulatory and Reimbursement Landscape
    • 5.5.1. North America
    • 5.5.2. Europe
    • 5.5.3. Asia Pacific
    • 5.5.4. Latin America
    • 5.5.5. Middle East & Africa
  • 5.6. Porter's Five Force Analysis
  • 5.7. Supply Chain Analysis
  • 5.8. Patent Analysis
  • 5.9. SWOT Analysis
  • 5.10. Unmet Needs and Gaps
  • 5.11. Recommended Strategies for Market Entry and Expansion
  • 5.12. Scenario Analysis: Best-Case, Base-Case, and Worst-Case Forecasts
  • 5.13. Pricing Analysis and Price Dynamics
  • 5.14. Key Opinion Leaders

6. By Device Type

  • 6.1. Introduction
    • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
    • 6.1.2. Market Attractiveness Index, By Device Type
  • 6.2. Threshold Suspend Device Systems*
    • 6.2.1. Introduction
    • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 6.3. Insulin-only Systems
  • 6.4. Dual Hormone Systems

7. By End-User

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 7.1.2. Market Attractiveness Index, By End-User
  • 7.2. Hospitals*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Clinics
  • 7.4. Homecare Settings
  • 7.5. Ambulatory Surgical Centers

8. Regional Market Analysis and Growth Opportunities

9. Introduction

  • 9.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 9.1.1. Market Attractiveness Index, By Region
  • 9.2. North America
    • 9.2.1. Introduction
    • 9.2.2. Key Region-Specific Dynamics
    • 9.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
    • 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.2.5.1. U.S.
      • 9.2.5.2. Canada
  • 9.3. Europe
    • 9.3.1. Introduction
    • 9.3.2. Key Region-Specific Dynamics
    • 9.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
    • 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.3.5.1. Germany
      • 9.3.5.2. U.K.
      • 9.3.5.3. France
      • 9.3.5.4. Spain
      • 9.3.5.5. Italy
      • 9.3.5.6. Rest of Europe
  • 9.4. Latin America
    • 9.4.1. Introduction
    • 9.4.2. Key Region-Specific Dynamics
    • 9.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
    • 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.4.5.1. Mexico
      • 9.4.5.2. Brazil
      • 9.4.5.3. Argentina
      • 9.4.5.4. Rest of Latin America
  • 9.5. Asia-Pacific
    • 9.5.1. Introduction
    • 9.5.2. Key Region-Specific Dynamics
    • 9.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
    • 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.5.5.1. China
      • 9.5.5.2. India
      • 9.5.5.3. Japan
      • 9.5.5.4. South Korea
      • 9.5.5.5. Rest of Asia-Pacific
  • 9.6. Middle East and Africa
    • 9.6.1. Introduction
    • 9.6.2. Key Region-Specific Dynamics
    • 9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
    • 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

10. Competitive Landscape and Market Positioning

  • 10.1. Competitive Overview and Key Market Players
    • 10.1.1. Market Share Analysis and Positioning Matrix
    • 10.1.2. Strategic Partnerships, Mergers & Acquisitions
    • 10.1.3. Key Developments in Product Portfolios and Innovations
    • 10.1.4. Company Benchmarking

11. Company Profiles

  • 11.1. Medtronic Plc*
    • 11.1.1. Company Overview
    • 11.1.2. Product Portfolio
      • 11.1.2.1. Product Description
      • 11.1.2.2. Product Key Performance Indicators (KPIs)
      • 11.1.2.3. Historic and Forecasted Product Sales
      • 11.1.2.4. Product Sales Volume
    • 11.1.3. Financial Overview
      • 11.1.3.1. Company Revenue's
      • 11.1.3.1.1. Geographical Revenue Shares
      • 11.1.3.1.1.1. Revenue Forecasts
      • 11.1.3.1.2. Key Developments
      • 11.1.3.1.2.1. Mergers & Acquisitions
      • 11.1.3.1.2.2. Key Product Development Activities
      • 11.1.3.1.2.3. Regulatory Approvals, etc.
      • 11.1.3.1.3. SWOT Analysis
  • 11.2. Tandem Diabetes Care, Inc
  • 11.3. Beta Bionics
  • 11.4. Insulet Corporation
  • 11.5. Diabeloop
  • 11.6. Inreda Diabetic B.V
  • 11.7. Nikkiso Co., Ltd(LIST NOT EXHAUSTIVE)

12. Assumption and Research Methodology

  • 12.1. Data Collection Methods
  • 12.2. Data Triangulation
  • 12.3. Forecasting Techniques
  • 12.4. Data Verification and Validation

13. Appendix

  • 13.1. About Us and Services
  • 13.2. Contact Us
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