세계의 이식형 인슐린 펌프 시장(2025-2033년)

The global implantable insulin pumps market reached US$ 3.2 billion in 2024 and is expected to reach US$ 6.9 billion by 2033, growing at a CAGR of 9.0% during the forecast period 2025-2033.

An implantable insulin pump is a medical device designed for the continuous delivery of insulin to individuals with diabetes. Unlike external insulin pumps that are worn on the body, an implantable insulin pump is surgically placed under the skin, typically in the abdominal area and functions as a long-term solution for insulin therapy. The primary function of an implantable insulin pump is to deliver insulin in precise doses, mimicking the function of a healthy pancreas. The device uses a small catheter or reservoir to administer insulin into the bloodstream over a specified period, ensuring blood sugar levels remain stable.

The implantable insulin pumps market is experiencing significant growth, driven by technological advancements, increasing diabetes prevalence and a shift towards personalized medicine. For instance, according to the American Action Forum, about 8.3 million of the United States increasing diabetic population depend on insulin to control their blood sugar levels, and by 2030, it's predicted that insulin use will rise by 20% globally. This rising insulin use boosts the demand for implantable insulin pumps.

Market Dynamics: Drivers & Restraints

Rising prevalence of diabetes

The rising prevalence of diabetes is significantly driving the growth of the implantable insulin pumps market and is expected to drive the market over the forecast period. According to the International Diabetes Federation, In 2021, 1 in 10 adults (536.6 million) between the ages of 20 and 79 have diabetes. By 2030, this figure is expected to increase to 642.8 million, and by 2045, it will reach 783.7 million. More than three out of four diabetic individuals reside in low- and middle-income nations. In 2021, diabetes will be the cause of 6.7 million fatalities or one every five seconds. Impaired Glucose Tolerance (IGT) puts 541 million persons at high risk of developing type 2 diabetes. This growing diabetic population is a major driver for insulin delivery devices.

Type 1 diabetes, which requires constant insulin administration, is seeing a rise in diagnoses, particularly in children and adolescents. This population is more likely to benefit from advanced insulin delivery solutions like implantable pumps, which provide a more consistent and automated form of treatment compared to traditional injections. For instance, according to the Centers for Disease Control and Prevention (CDC), type 1 diabetes and insulin use were reported by 1.7 million persons aged 20 years or older, or 5.7% of all adults with diabetes in the United States.

Implantable insulin pumps offer continuous and precise insulin delivery, which helps manage blood glucose levels more effectively. As more people with diabetes seek to reduce the burden of managing their condition with multiple daily injections, the demand for more sophisticated devices like implantable pumps increases.

Many individuals with diabetes, particularly those with Type 1 diabetes, require frequent insulin injections. Implantable insulin pumps, by providing consistent, 24/7 insulin delivery, offer these patients the opportunity for improved blood sugar control, reduced hypoglycemia, and better overall diabetes management.

Limited clinical data

The limited clinical data surrounding implantable insulin pumps is a significant barrier to the growth of the market. Although these devices offer advanced diabetes management solutions, the lack of comprehensive, long-term clinical evidence presents challenges in terms of adoption, regulatory approval and market confidence.

While implantable insulin pumps show promise, there is limited clinical data on their long-term effectiveness and safety compared to external pumps. Regulatory bodies like the FDA require extensive data from long-term clinical trials to ensure these devices are safe for sustained use. The absence of such data increases skepticism among healthcare providers and patients, limiting adoption.

For instance, implantable insulin pumps require rigorous clinical trials to prove their efficacy and safety. These trials are lengthy and expensive, and the results can take years to accumulate. This delay in obtaining clinical data slows down the approval process and market entry for new devices.

There are concerns about infections, device malfunctions or complications arising from the implantation of insulin pumps. For instance, while external pumps are known for their ease of replacement and maintenance, implantable pumps require surgery for both implantation and removal. This raises concerns over potential risks like surgical infections, device failures, and the need for re-implantation, all of which need to be substantiated through clinical data.

Segment Analysis

The global implantable insulin pumps market is segmented based on type, disease, end-user and region.

Type:

The closed-loop insulin pumps segment is expected to dominate the implantable insulin pumps market share

The closed-loop insulin pumps segment is emerging as a dominant force in the implantable insulin pumps market due to its advanced technology, superior control over blood glucose levels, and patient-centric benefits. Closed-loop insulin pumps, also known as artificial pancreas systems, offer the ability to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) data. This functionality makes them a highly attractive solution for people with diabetes, driving their growing demand.

For instance, in May 2024, Arecor Therapeutics plc announced a research collaboration with Medtronic plc to develop a novel, high-concentration, thermostable insulin for use by Medtronic's Diabetes business in a next-generation implantable pump. The collaboration adds to Arecor's broad program of diabetes-focused activities, led by its two lead proprietary clinical development programs AT278 and AT247, two ultra-rapid acting insulin candidates that offer the potential to simplify and improve blood glucose control for people living with diabetes and could enable the development of next-generation miniaturized insulin delivery systems and a fully closed loop artificial pancreas system.

Closed-loop insulin pumps are integrated with CGM systems that measure blood glucose levels continuously. These pumps use real-time glucose data to automatically adjust insulin delivery, optimizing blood sugar levels without requiring manual intervention from the patient. This automated insulin delivery significantly reduces the risk of both hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar).

Geographical Analysis

North America is expected to hold a significant position in the implantable insulin pumps market share

North America, particularly the United States, has one of the highest rates of diabetes worldwide. According to the Centers for Disease Control and Prevention (CDC), over 38 million Americans are living with diabetes i.e., 1 in 10 people, with nearly 90-95% of them having Type 2 diabetes. The rising prevalence of diabetes fuels the demand for advanced insulin delivery solutions, such as implantable insulin pumps.

In addition to Type 2 diabetes, the number of people with Type 1 diabetes is also significant. Type 1 diabetes requires constant insulin delivery, which is a key driver for the adoption of insulin pumps. According to the National Institute of Health (NIH), more than 5 million Americans are predicted to have Type 1 diabetes by 2050, with an estimated 1.6 million now living with the disease and an additional 64,000 being diagnosed annually, which is a major target market for implantable insulin pumps.

North America leads in adopting and integrating advanced medical technologies such as closed-loop systems, continuous glucose monitoring (CGM) and insulin pumps. The region is home to major players like Medtronic and other emerging players, which are leading the development of implantable insulin pumps and related technologies.

For instance, in April 2024, Senseonics Holdings, Inc. announced that Eversense was granted an integrated CGM (iCGM) designation by the US Food and Drug Administration (FDA). As the first fully implantable device in the category, Eversense is authorized to be marketed as an iCGM through the FDA's De Novo pathway, by establishing the special controls that will serve as a predicate device for 510(k) submissions in the future for devices of the same type.

Asia-Pacific is growing at the fastest pace in the implantable insulin pumps market

The Asia Pacific region is witnessing a dramatic increase in the number of diabetes cases, particularly in countries like China, India, and Japan. According to the International Diabetes Federation (IDF), approximately 160 million people in the Asia-Pacific region were living with diabetes in 2021, a figure expected to rise to 225 million by 2045. This escalating prevalence of diabetes directly contributes to the rising demand for advanced insulin delivery systems like implantable insulin pumps.

Countries in the Asia-Pacific region, especially in East Asia and Southeast Asia, have made significant strides in improving their healthcare systems, especially in urban areas. Increased healthcare investments are making advanced diabetes care, including implantable insulin pumps, more accessible to patients.

For instance, according to the National Institute of Health (NIH), India holds the dubious title of "Diabetes Capital of the World" due to having the greatest number of diabetes patients worldwide. A number of recent articles have provided extensive documentation of the issue. Diabetes prevention and treatment account for 5% to 10% of the country's health expenditure.

Several healthcare organizations, including the International Diabetes Federation (IDF) and local diabetes associations in APAC countries, have been running educational campaigns to raise awareness about the benefits of insulin pumps over traditional insulin therapy. These initiatives are helping patients in the region understand the advantages of insulin pumps, contributing to the segment's growth.

Competitive Landscape

The major global players in the implantable insulin pumps market include Medtronic plc, Senseonics Holdings, Inc. Arecor Therapeutics plc and among others.

Why Purchase the Report?

• Pipeline & 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 Implantable Insulin Pumps market report delivers a detailed analysis with 41 key tables, more than 43 visually impactful figures, and 125 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.
• Technology & 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.

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

• 2.1. Market Highlights and Strategic Takeaways
• 2.2. Key Trends and Future Projections
• 2.3. Snippet by Type
• 2.4. Snippet by Disease
• 2.5. Snippet by End-User
• 2.6. Snippet by Region

3. Dynamics

• 3.1. Impacting Factors
  • 3.1.1. Drivers
    • 3.1.1.1. Rising Prevalence of Diabetes
  • 3.1.2. Restraints
    • 3.1.2.1. Limited Clinical Data
  • 3.1.3. Opportunity
  • 3.1.4. Impact Analysis

4. Strategic Insights and Industry Outlook

• 4.1. Market Leaders and Pioneers
  • 4.1.1. Emerging Pioneers and Prominent Players
  • 4.1.2. Established leaders with largest selling Brand
  • 4.1.3. Market leaders with established Product
• 4.2. Emerging Startups and Key Innovators
• 4.3. CXO Perspectives
• 4.4. Latest Developments and Breakthroughs
• 4.5. Case Studies/Ongoing Research
• 4.6. Regulatory and Reimbursement Landscape
  • 4.6.1. North America
  • 4.6.2. Europe
  • 4.6.3. Asia Pacific
  • 4.6.4. Latin America
  • 4.6.5. Middle East & Africa
• 4.7. Porter's Five Force Analysis
• 4.8. Supply Chain Analysis
• 4.9. Patent Analysis
• 4.10. SWOT Analysis
• 4.11. Unmet Needs and Gaps
• 4.12. Recommended Strategies for Market Entry and Expansion
• 4.13. Scenario Analysis: Best-Case, Base-Case, and Worst-Case Forecasts
• 4.14. Pricing Analysis and Price Dynamics

5. Implantable Insulin Pumps Market, By Type

• 5.1. Introduction
  • 5.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 5.1.2. Market Attractiveness Index, By Type
• 5.2. Closed-Loop Insulin Pumps*
  • 5.2.1. Introduction
  • 5.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 5.3. Open-Loop Insulin Pumps

6. Implantable Insulin Pumps Market, By Disease

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease
  • 6.1.2. Market Attractiveness Index, By Disease
• 6.2. Type-1 Diabetes*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Type-2 Diabetes

7. Implantable Insulin Pumps Market, 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. Specialty Clinics
• 7.4. Homecare Settings

8. Implantable Insulin Pumps Market, By Regional Market Analysis and Growth Opportunities

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 8.1.2. Market Attractiveness Index, By Region
• 8.2. North America
  • 8.2.1. Introduction
  • 8.2.2. Key Region-Specific Dynamics
  • 8.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 8.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease
  • 8.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 8.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 8.2.6.1. U.S.
    • 8.2.6.2. Canada
    • 8.2.6.3. Mexico
• 8.3. Europe
  • 8.3.1. Introduction
  • 8.3.2. Key Region-Specific Dynamics
  • 8.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 8.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease
  • 8.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 8.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 8.3.6.1. Germany
    • 8.3.6.2. U.K.
    • 8.3.6.3. France
    • 8.3.6.4. Spain
    • 8.3.6.5. Italy
    • 8.3.6.6. Rest of Europe
• 8.4. South America
  • 8.4.1. Introduction
  • 8.4.2. Key Region-Specific Dynamics
  • 8.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 8.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease
  • 8.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 8.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 8.4.6.1. Brazil
    • 8.4.6.2. Argentina
    • 8.4.6.3. Rest of South America
• 8.5. Asia-Pacific
  • 8.5.1. Introduction
  • 8.5.2. Key Region-Specific Dynamics
  • 8.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 8.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease
  • 8.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 8.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 8.5.6.1. China
    • 8.5.6.2. India
    • 8.5.6.3. Japan
    • 8.5.6.4. South Korea
    • 8.5.6.5. Rest of Asia-Pacific
• 8.6. Middle East and Africa
  • 8.6.1. Introduction
  • 8.6.2. Key Region-Specific Dynamics
  • 8.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 8.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease
  • 8.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

9. Competitive Landscape and Market Positioning

• 9.1. Competitive Overview and Key Market Players
• 9.2. Market Share Analysis and Positioning Matrix
• 9.3. Strategic Partnerships, Mergers & Acquisitions
• 9.4. Key Developments in Product Portfolios and Innovations
• 9.5. Company Benchmarking

10. Company Profiles

• 10.1. Medtronic plc*
  • 10.1.1. Company Overview
  • 10.1.2. Product Portfolio and Description
  • 10.1.3. Financial Overview
  • 10.1.4. Key Developments
  • 10.1.5. SWOT Analysis
• 10.2. Senseonics Holdings, Inc.
• 10.3. Arecor Therapeutics plc

LIST NOT EXHAUSTIVE

11. Assumption and Research Methodology

• 11.1. Data Collection Methods
• 11.2. Data Triangulation
• 11.3. Forecasting Techniques
• 11.4. Data Verification and Validation

12. Appendix

• 12.1. About Us and Services
• 12.2. Contact Us