인슐린 투여 기기 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the insulin delivery devices market size is expected to increase from USD 31.92 billion in 2025 to USD 33.79 billion in 2026 and reach USD 49.23 billion by 2031, growing at a CAGR of 7.82% over 2026-2031.

This report is Segmented by Product Type (Insulin Pens [Reusable Pens and More], Insulin Pumps, Insulin Syringes [Tethered Pumps and More], and More), Technology/Connectivity (Connected, Non-Connected), Patient Age Group (Pediatrics, and More), Distribution Channel (Hospital Pharmacies, and More), End User (Homecare, and More), and Geography. Market Forecasts are Provided in Terms of Value (USD).

Global Insulin Delivery Devices Market Trends and Insights

Rising Prevalence of Diabetes and Earlier Diagnosis

Global diabetes prevalence continues to climb, yet the more telling shift is the shorter interval between symptom onset and confirmed diagnosis. The United States now recommends HbA1c screening for every adult over 35, enlarging the pool for basal-bolus regimens that need purpose-built devices. China mandated workplace screening for employees over 40 in January 2025, identifying millions of previously undiagnosed adults and boosting first-time device purchases. Europe recorded a 3.4% rise in pediatric type 1 incidence during 2024, lifting demand for simplified pumps with smaller reservoirs. Manufacturers are answering with color-coded pen caps and pre-set basal profiles that reduce the learning curve for new users. Earlier diagnosis therefore widens the installed base and pushes patients toward connected tools that guide dose titration.

Rapid Uptake of Connected "Smart" Pens and Add-On Caps

Smart pens that log dose data through Bluetooth or near-field communication are displacing conventional pens faster than forecast two years ago. Companion Medical's InPen counted 180,000 active U.S. users in December 2025, up from 95,000 a year earlier. The Centers for Medicare & Medicaid Services reclassified smart pens as durable medical equipment in January 2025, cutting out-of-pocket spending for Medicare Part B users. Novo Nordisk shipped 1.2 million NovoPen 6 and Echo Plus units worldwide in 2025, securing 18% of reusable-pen sales. Bigfoot Biomedical began shipping its Unity smart cap in March 2025, creating a lower-cost entry point for patients hesitant to adopt pumps. Updated IEEE 11073 standards, released in June 2025, now require end-to-end encryption, easing privacy concerns among hospital IT teams.

Cybersecurity and Data-Privacy Risks in Connected Pumps

Connected pumps move dose data over Bluetooth Low Energy and cellular links, creating entry points for malicious actors. The U.S. Food and Drug Administration warned in April 2024 that certain MiniMed pumps could be accessed wirelessly if older firmware remained unpatched. Insulet fixed a man-in-the-middle vulnerability in Omnipod 5 within 72 hours of discovery in June 2025, underscoring strong incident response but highlighting ongoing exposure. The European Union Medical Device Regulation now mandates a full cybersecurity risk file in conformity assessments, adding up to nine months to approval timelines. Hospitals demand ISO 27001 compliance before including connected pumps on formularies, a hurdle for smaller entrants without dedicated security teams. Persistent headline risk can slow adoption among risk-averse clinics and older patients.

Other drivers and restraints analyzed in the detailed report include:

1. Reimbursement Expansion for Pen Cartridges and Patch Pumps
2. Surge in GLP-1 / Insulin Co-Formulations Requiring Device Redesign
3. Global Supply-Chain Pressure on Medical-Grade Plastics and Cannulas

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

Segment Analysis

Insulin pens commanded 52.44% of 2025 revenue, yet pumps are set to grow faster, with an 11.33% CAGR through 2031 as payers reward automated dosing that lowers hypoglycemia rates. Reusable pens represented 60% of pen sales, favored in regions with cartridge recycling mandates, while disposable pens held the remaining 40% thanks to convenience in markets with limited cold-chain capacity. Within pumps, tethered models still delivered 55% of 2025 pump turnover, but patch designs are advancing quickly because they avoid tubing snags and support discreet wear. Insulet shipped 1.8 million Omnipod 5 pods in 2025, up 38% year-on-year. Automated hybrid closed-loop pumps accounted for 22% of 2025 revenue share and are projected to reach 45% by 2031. Syringes continue to decline at 3% per year and now sit mainly in hospital wards and low-income regions. Needle-free jet injectors remain niche, under 2% of 2025 revenue, limited by high start-up cost and unfamiliar operation. Tandem's Mobi pump, 50% smaller than the t:slim X2, entered the market in late-2024 and targets discretion-minded adolescents.

The U.S. Food and Drug Administration cleared the iLet Bionic Pancreas in May 2024, signaling confidence in algorithms that require minimal user input. Medtronic's MiniMed 780G, approved in August 2024, adjusts basal rates up to 288 times per day and removes much of the carb-count burden. Chinese suppliers such as Medtrum now price starter kits at half Western levels, broadening access in middle-income economies. Reusable pens benefit from NFC-based dose logging, while disposable pens remain the default for basal-only regimens in type 2 patients who value simplicity over sustainability. Jet injectors appeal to needle-phobic adults but need stronger payer support to scale.

Conventional hardware still held 71.45% of 2025 revenue, yet connected devices will grow at a 12.77% CAGR to 2031, bolstered by payer policy that classifies smart pens as durable equipment. InPen almost doubled its active user base within a year, confirming demand for dose-memory that links to CGM trends. Tandem's t:slim X2 and Insulet's Omnipod 5 send basal and bolus data to cloud dashboards, enabling remote care and expanding pediatric adoption. After IEEE 11073 added encryption mandates in June 2025, hospital IT teams warmed to connected pumps.

Cost-sensitive markets still favor non-connected pens, yet add-on caps such as Bigfoot Unity provide a bridge at lower price points. Novo Nordisk's connected pens recorded 1.2 million global shipments in 2025, equal to 18% of reusable-pen volume. As smartphone penetration widens among seniors, connected uptake should further erode the gap. However, privacy concerns and the need to update firmware will keep a role for conventional devices through the decade.

Complete Report Scope:

• By Product Type
  • Insulin Pens
    • Reusable Pens
    • Disposable Pens
  • Insulin Pumps
    • Tethered Pumps
    • Patch / Wearable Pumps
    • Automated Hybrid Closed-Loop Systems
  • Insulin Syringes
  • Needle-Free Injectors
  • Jet Injectors
  • Others
• By Technology / Connectivity
  • Connected (Bluetooth / NFC)
  • Non-Connected / Conventional
• By Patient Age Group
  • Pediatrics (Less Than 18 yrs)
  • Adults (Equal to, More Than 18 yrs)
  • Geriatrics (>=65 years+)
• By Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
  • Diabetes Clinics & Centers
• By End User
  • Homecare Settings
  • Hospitals & Specialty Clinics
  • Ambulatory Surgical Centers
  • Others
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • France
    • United Kingdom
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • 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 is expected to record the highest regional growth at a 9.05% CAGR through 2031 on the back of high pump penetration and broad reimbursement. Medicare's 2024 decision to cover tubeless pumps removed historic delays in the 65-plus cohort. Canada added connected pens to provincial formularies in 2025, lifting smart-pen prescriptions by 52%. Mexico's social-security system started funding patch pumps in February 2025, though supply constraints limited early uptake. U.S. pump penetration in type 1 diabetes reached 63% in 2025; growth now leans on type 2 patients.

Europe held roughly 28% of 2025 turnover. Germany funded connected pens at EUR 120 per unit starting January 2025. France reimburses smart pens when paired with CGM, lowering hypoglycemia events by 28%. The United Kingdom signed a GBP 180 million framework with Medtronic and Insulet in June 2024 to deploy 100,000 hybrid closed-loop pumps by 2026. Southern Europe trails due to mixed reimbursement, while Eastern Europe still favors disposable pens. Ypsomed's alliance with Biocon is beginning to change that dynamic.

Asia-Pacific accounted for 38.55% of 2025 revenue, supported by expanding reimbursement and rapid uptake of lower-cost patch pumps. China now reimburses up to 70% of pump cost for urban employees, driving 200,000 Medtrum shipments in 2025. India's Ayushman Bharat pilot covers pumps in five states but faces clinician shortages. Japan approved Terumo's dose-memory pen in April 2024 to serve 11 million diabetics who mainly use pens. South Korea added hybrid closed-loop systems to its insurance catalog in August 2024, spurring 41% pump growth. Southeast Asia remains syringe-heavy, yet online pharmacies are improving pen access in urban areas.

Middle East and Africa plus South America combined for about 10% of 2025 turnover. Gulf states now fund patch pumps for citizens, with Saudi Arabia approving reimbursement in March 2025. South Africa's private plans cover pumps, but public patients rely on syringes. Brazil began a pen pilot in two major cities in mid-2025 that could reach 16 million users by 2028. Argentina's currency devaluation lifted import prices, forcing many patients back to syringes. Sub-Saharan Africa faces cold-chain gaps that restrict cartridge distribution.

1. Beckton Dickinson
2. Bigfoot Biomedical
3. Biocon
4. CeQur Corporation
5. Debiotech SA
6. Eli Lilly and Company
7. Roche
8. Insulet
9. Jiangsu Delfu Medical Device Co., Ltd.
10. Medtronic
11. Medtrum Technologies Inc.
12. Nipro
13. Novo Nordisk
14. Owen Mumford
15. Sanofi
16. Sooil Development Co., Ltd.
17. Tandem Diabetes Care
18. Terumo
19. Valeritas Holdings, Inc.
20. Ypsomed

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 Rising Prevalence of Diabetes and Earlier Diagnosis
  • 4.2.2 Shift Toward Convenient, Minimally Invasive Self-Administration Modalities
  • 4.2.3 Reimbursement Expansion for Pen Cartridges & Patch Pumps
  • 4.2.4 Rapid Uptake of Connected "Smart" Insulin Pens & Add-On Caps
  • 4.2.5 Surge In GLP-1/Insulin Co-Formulations That Require Device Redesign
  • 4.2.6 Emergence Of Low-Cost Chinese Patch Pumps Targeting Middle-Income Markets
• 4.3 Market Restraints
  • 4.3.1 High Device ASPs Vs. MDI in Emerging Countries
  • 4.3.2 Needle-Phobia & User-Error Concerns
  • 4.3.3 Cyber-Security & Data-Privacy Vulnerabilities in Connected Pumps
  • 4.3.4 Global Supply-Chain Pressure on Medical-Grade Plastics & Cannulas
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value in USD)

• 5.1 By Product Type
  • 5.1.1 Insulin Pens
    • 5.1.1.1 Reusable Pens
    • 5.1.1.2 Disposable Pens
  • 5.1.2 Insulin Pumps
    • 5.1.2.1 Tethered Pumps
    • 5.1.2.2 Patch / Wearable Pumps
    • 5.1.2.3 Automated Hybrid Closed-Loop Systems
  • 5.1.3 Insulin Syringes
  • 5.1.4 Needle-Free Injectors
  • 5.1.5 Jet Injectors
  • 5.1.6 Others
• 5.2 By Technology / Connectivity
  • 5.2.1 Connected (Bluetooth / NFC)
  • 5.2.2 Non-Connected / Conventional
• 5.3 By Patient Age Group
  • 5.3.1 Pediatrics (Less Than 18 yrs)
  • 5.3.2 Adults (Equal to, More Than 18 yrs)
  • 5.3.3 Geriatrics (>=65 years+)
• 5.4 By Distribution Channel
  • 5.4.1 Hospital Pharmacies
  • 5.4.2 Retail Pharmacies
  • 5.4.3 Online Pharmacies
  • 5.4.4 Diabetes Clinics & Centers
• 5.5 By End User
  • 5.5.1 Homecare Settings
  • 5.5.2 Hospitals & Specialty Clinics
  • 5.5.3 Ambulatory Surgical Centers
  • 5.5.4 Others
• 5.6 By Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 France
    • 5.6.2.3 United Kingdom
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 South Korea
    • 5.6.3.5 Australia
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East & Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East & Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 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 and Services, and Recent Developments)
  • 6.3.1 Becton, Dickinson and Company
  • 6.3.2 Bigfoot Biomedical
  • 6.3.3 Biocon Ltd.
  • 6.3.4 CeQur Corporation
  • 6.3.5 Debiotech SA
  • 6.3.6 Eli Lilly and Company
  • 6.3.7 F. Hoffmann-La Roche Ltd
  • 6.3.8 Insulet Corporation
  • 6.3.9 Jiangsu Delfu Medical Device Co., Ltd.
  • 6.3.10 Medtronic plc
  • 6.3.11 Medtrum Technologies Inc.
  • 6.3.12 Nipro Corporation
  • 6.3.13 Novo Nordisk A/S
  • 6.3.14 Owen Mumford Ltd.
  • 6.3.15 Sanofi S.A.
  • 6.3.16 Sooil Development Co., Ltd.
  • 6.3.17 Tandem Diabetes Care, Inc.
  • 6.3.18 Terumo Corporation
  • 6.3.19 Valeritas Holdings, Inc.
  • 6.3.20 Ypsomed AG

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment