인슐린 주입 펌프 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the insulin infusion pumps market size was valued at USD 4.08 billion in 2025 and estimated to grow from USD 4.3 billion in 2026 to reach USD 5.59 billion by 2031, at a CAGR of 5.38% during the forecast period (2026-2031).

This report Segments the Industry Into by Component (Insulin Pump Devices, Infusion Sets, Reservoirs), Pump Type (Tethered Pumps, Patch Pumps, Implantable Pumps), Patient Type (Type-1 Diabetes, Type-2 Diabetes), End User (Hospitals & Clinics, and More), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Insulin Infusion Pumps Market Trends and Insights

Rapid Adoption of Closed-Loop "Artificial Pancreas" Systems

FDA approval of Medtronic's MiniMed 780G in April 2025 underscored the value of automated meal detection and five-minute insulin adjustments, pushing time-in-range figures above 70% among large user cohorts. Tandem's Control-IQ platform shows comparable benefits, highlighting a technology race that rewards algorithm accuracy and sensor reliability. Artificial intelligence enables dose personalization that mimics physiologic insulin patterns, positioning closed-loop platforms as the future standard of care. Growing clinical proof amplifies payer confidence and broadens eligibility criteria. As marketing emphasizes lifestyle simplicity instead of device mechanics, patient receptivity rises, driving incremental units and recurring consumable sales.

Rising Prevalence of Type 1 Diabetes in Youth

Incidence rates among children now exceed 3.5 per 1,000 in the United States, with similar uptrends in Europe and parts of Asia. Pediatric societies recommend pump therapy as first-line treatment, citing superior glycemic control and reduced nocturnal hypoglycemia. FDA clearance of automated insulin delivery for ages two and above widens the pediatric addressable pool. Regional registries reveal adoption gaps, suggesting unmet demand where clinical support lags. Manufacturers respond with smaller reservoirs, simplified user interfaces, and colorful patch adhesives that resonate with younger users and caregivers.

Cybersecurity Risks in Connected Devices

In 2024 the FDA flagged vulnerabilities in certain wireless pumps that could allow unauthorized access and unintended insulin delivery, prompting multiple Class I recalls. Academic analyses have since documented potential exploit pathways via unsecured Bluetooth channels, underscoring the need for end-to-end encryption and tamper-proof firmware. New FDA premarket guidance requires threat-mitigation plans and postmarket monitoring, adding development cost and elongating approval timelines. Hospitals now press suppliers for detailed cybersecurity certifications before procurement. Although no catastrophic patient harm has been reported publicly, lingering risk perception may slow adoption among risk-averse payers.

Other drivers and restraints analyzed in the detailed report include:

1. Reimbursement Expansion for Tubeless Pumps
2. Rising Adoption of DIY Looping Systems
3. High Out-of-Pocket Costs in Emerging Markets

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Insulin pump devices retained 65.12% of 2025 revenue, underscoring their premium pricing and embedded software complexity. Consumable reservoirs, however, expanded faster at an 7.62% CAGR as hybrid closed-loop algorithms modulated insulin micro-boluses more frequently. Integration of smart sensors inside reservoirs to detect occlusions and air bubbles heightens patient safety and gives vendors cross-selling leverage. Strategic partnerships, such as Medtronic pairing its pumps with Abbott glucose sensors, exemplify an ecosystem approach that influences procurement.

Consumable dynamics also strengthen recurring revenue visibility. Manufacturers introduce extended-wear infusion sets aimed at seven-day site usage, reducing insertion trauma and driving brand loyalty. Competitive differentiation now hinges on frictionless cartridge loading, lower residual insulin waste, and antimicrobial linings that curb infection risk. These incremental innovations stabilize unit volume outlook, even when device replacement cycles lengthen in mature markets.

Patch pumps captured 52.05% share in 2025 and are on track for an 8.28% CAGR, validating patient preference for tubeless, discreet wearables. Sleek industrial design, waterproof housing, and automated cannula insertion raise user comfort and minimize social stigma. Tethered pumps, while declining, still serve high-dose users who need large reservoirs or dual-hormone research protocols. Implantable systems remain experimental due to surgical hurdles.

Competition within the patch segment intensifies as Tandem's Mobi challenges Insulet's incumbency with a thinner profile and smartphone-only interface. Emerging entrants position low-cost patch alternatives for Asia-Pacific, bundling simplified feature sets with subscription pricing. Firmware upgrades delivered over the air enhance functionality without physical replacements, reinforcing user stickiness.

Complete Report Scope:

• By Component
  • Insulin Pump Devices
  • Infusion Sets
  • Reservoirs
• By Pump Type
  • Tethered Pumps
  • Patch Pumps
  • Implantable Pumps
• By Patient Type
  • Type-1 Diabetes
  • Type-2 Diabetes
• By End User
  • Hospitals & Clinics
  • Homecare Settings
  • Ambulatory Surgical Centers
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America remained the largest market in 2025 with a 36.95% share, underpinned by widespread insurance coverage, advanced supply chains, and early demand from both Type 1 and Type 2 populations. The region's mature infrastructure supports swift adoption of closed-loop upgrades and interoperable component ecosystems, though unit growth now mirrors replacement cycles more than net new users. Cybersecurity regulations also originate here, influencing global design standards.

Europe contributes steady volumes thanks to universal healthcare and robust clinical registries that benchmark outcomes. Reimbursement frameworks vary but generally favor technology proven to cut hospitalization costs. Rapid CE-mark pathways for integrated pumps and continuous glucose monitors promote competitive diversity. The Middle East and Africa lag in penetration, yet investment initiatives in Saudi Arabia and the UAE spark pilot programs that introduce patch pumps into public diabetes centers. Asia-Pacific posts the fastest 6.72% CAGR through 2031 due to rising diabetes prevalence, urbanization, and expanding middle-class insurance pools. China's tiered hospital system now reimburses select patch pumps for pediatric Type 1 users, while India experiments with low-cost subscription bundles for Type 2 adults. Latin America sits between growth extremes, with Brazil and Mexico leading regional adoption as private insurers pilot value-based diabetes programs. Market entrants target localized language support, hotter-climate adhesive formulations, and flexible financing to fit each region's socioeconomic profile.

1. Medtronic
2. Insulet
3. Tandem Diabetes Care
4. Roche
5. Ypsomed
6. SOOIL Development
7. EOFlow
8. Beta Bionics
9. CeQur
10. Debiotech
11. Medtrum Technologies
12. MicroPort
13. Terumo
14. Beckton Dickinson
15. Bigfoot Biomedical
16. ViCentra
17. Cambridge Medical Robotics
18. Valeritas
19. Smiths Group
20. Delta Life

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rapid Adoption of Closed-Loop "Artificial Pancreas" Systems
  • 4.2.2 Rising Prevalence of Type 1 Diabetes in Youth
  • 4.2.3 Reimbursement Expansion for Tubeless Pumps
  • 4.2.4 Growth of the DIY Looping Community
  • 4.2.5 Bluetooth-Enabled Analytics and Mobile Integration
  • 4.2.6 Inclusion in Corporate Wellness Programs
• 4.3 Market Restraints
  • 4.3.1 Cybersecurity Risks in Connected Devices
  • 4.3.2 High Out-of-Pocket Costs in Emerging Markets
  • 4.3.3 Supply Chain Disruptions for Sterile Tubing and Components
  • 4.3.4 Regulatory Delays for Next-Gen Devices
• 4.4 Market Indicators
  • 4.4.1 Type-1 Diabetes Population Analysis
  • 4.4.2 Type-2 Diabetes Population Analysis
• 4.5 Porter's Five Forces Analysis
  • 4.5.1 Bargaining Power of Suppliers
  • 4.5.2 Bargaining Power of Buyers
  • 4.5.3 Threat of New Entrants
  • 4.5.4 Threat of Substitutes
  • 4.5.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value in USD)

• 5.1 By Component
  • 5.1.1 Insulin Pump Devices
  • 5.1.2 Infusion Sets
  • 5.1.3 Reservoirs
• 5.2 By Pump Type
  • 5.2.1 Tethered Pumps
  • 5.2.2 Patch Pumps
  • 5.2.3 Implantable Pumps
• 5.3 By Patient Type
  • 5.3.1 Type-1 Diabetes
  • 5.3.2 Type-2 Diabetes
• 5.4 By End User
  • 5.4.1 Hospitals & Clinics
  • 5.4.2 Homecare Settings
  • 5.4.3 Ambulatory Surgical Centers
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East & Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East & Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.3.1 Medtronic
  • 6.3.2 Insulet
  • 6.3.3 Tandem Diabetes Care
  • 6.3.4 Roche Diabetes Care
  • 6.3.5 Ypsomed
  • 6.3.6 SOOIL Development
  • 6.3.7 EOFlow
  • 6.3.8 Beta Bionics
  • 6.3.9 CeQur
  • 6.3.10 Debiotech
  • 6.3.11 Medtrum Technologies
  • 6.3.12 MicroPort
  • 6.3.13 Terumo
  • 6.3.14 Becton, Dickinson & Co.
  • 6.3.15 Bigfoot Biomedical
  • 6.3.16 ViCentra
  • 6.3.17 Cambridge Medical Robotics
  • 6.3.18 Valeritas
  • 6.3.19 Smiths Medical
  • 6.3.20 Delta Life

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment