유럽의 당뇨병 관리 기기 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the Europe diabetes care devices market size is expected to grow from USD 8.53 billion in 2025 to USD 9.03 billion in 2026 and is forecast to reach USD 11.99 billion by 2031 at 5.85% CAGR over 2026-2031.

This report is Segmented by Device Type (Monitoring Devices, Management Devices), Patient Type (Type-1 Diabetes, Type-2 Diabetes, Gestational & Others), End-User (Hospitals & Clinics, Home-Care Settings, and More), Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and More), and Geography. Market Forecasts are Provided in Terms of Value (USD).

Europe Diabetes Care Devices Market Trends and Insights

National Reimbursement Reforms Boosting CGM Uptake in Germany & Nordics

Statutory insurance in Germany broadened CGM coverage to all insulin-dependent patients at the start of 2024, instantly eliminating the primary cost barrier. Denmark, Sweden, and Norway mirrored the move, creating a unified northern cluster where reimbursement now favors sensor-based monitoring over test strips. The resulting surge in prescriptions is encouraging suppliers to localize sensor assembly to secure tender points and shorten lead times. Healthcare providers are revising clinical pathways so that CGM initiation happens within four weeks of insulin therapy commencement, tightening links between primary care and diabetology clinics. Manufacturers expect device utilization rates to climb steadily over the next three years as physician familiarity increases and patient self-management apps integrate national e-health records. Reimbursement certainty is therefore translating into higher volumes, more predictable revenue, and stronger negotiating power for compliant suppliers

EU MDR Fast-Track for Class IIb "Smart Pens" Accelerating Product Launches

The 2024 introduction of a twelve-to-fifteen-month fast-track review for connected insulin pens under the EU Medical Device Regulation slashed average time-to-market by roughly one-third. Leading developers rapidly submitted Bluetooth-enabled pens that capture dose data, flag omissions, and transmit information to physicians' dashboards. Early approvals have prompted a queue of follow-on filings, signaling that the regulatory bottleneck is unlikely to return soon. Marketing teams are capitalizing on the compressed timeline by aligning European launches with global brand campaigns, thereby maximizing initial uptake. National formularies that previously hesitated to reimburse premium pens are reassessing cost-benefit models because real-world adherence gains are now easier to quantify. Collectively, these factors make Europe the launchpad for next-generation insulin-delivery hardware. .

Divergent VAT Rates on Devices vs. Consumables Distorting SMBG Economics

Reduced VAT on glucose meters but full VAT on test strips in several EU states inflates lifetime costs for self-monitoring of blood glucose. Patients may defer testing or stretch strip use, undermining glycemic control. Manufacturers are lobbying for harmonized medical-device VAT schemes, yet legislative progress remains slow. In the interim, low-priced strip bundles and subscription models aim to preserve testing frequency. Until tax parity is achieved, the economics of strip-based monitoring will limit growth potential for the segment inside the Europe diabetes care devices market.

Other drivers and restraints analyzed in the detailed report include:

1. Tender-Driven Consolidation of Test-Strip Pricing in Southern Europe
2. Hospital-at-Home Pilots in the UK & France Driving Remote Monitoring Kits
3. Data-Residency Rules Limiting Cloud CGM Platforms in the DACH Region

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

Segment Analysis

The monitoring segment captured 53.40% of the Europe diabetes care devices market in 2025, reflecting the primacy of accurate glucose data in day-to-day therapy. CGM systems now account for a majority of monitoring revenue because they deliver painless, continuous readings and integrate seamlessly with smartphones and hospital dashboards. CGM penetration accelerated once reimbursement expanded beyond type-1 to all insulin-treated patients. Suppliers are differentiating through sensor wear time, calibration-free operation, and direct-to-watch connectivity, signalling a gradual fade-out of fingerstick meters for regular measurement.

Management devices represent a smaller revenue pool but are forecast to progress at a 6.85% CAGR to 2031. Automated insulin delivery systems that combine CGM input with closed-loop algorithms epitomize this momentum. The result is a tighter convergence of traditionally separate hardware categories into unified ecosystems capable of autonomous glucose control. As algorithm accuracy improves, payers increasingly view advanced pump-sensor systems as an investment that offsets future complication costs. Consequently, management devices will narrow the gap with monitoring tools and may even surpass them in value toward the end of the decade, reshaping the competitive centre of gravity within the Europe diabetes care devices market.

Type-2 diabetes patients accounted for 80.62% of the Europe diabetes care devices market size in 2025, underscoring a paradigm shift from type-1-centric engineering to broader metabolic-health use cases. Simplicity, discreet form factors, and low training overhead guide product roadmaps aimed at this cohort. Connected sensors that pair with diet-tracking apps appeal to type-2 users keen on lifestyle feedback rather than intensive insulin titration. As national guidelines now encourage CGM even for basal-insulin regimens, device makers are rolling out value-priced sensors that maintain core accuracy while omitting premium bells and whistles.

Type-1 diabetes retains outsized influence on breakthrough innovation. Hybrid closed-loop systems were perfected in the paediatric type-1 population before scaling to adult users and, more recently, to select type-2 subgroups. Meanwhile, gestational diabetes is beginning to attract tailored solutions that emphasise rapid onboarding and per-trimester subscription models. Collectively, patient-type diversification broadens the Europe diabetes care devices market and mitigates reliance on any single therapy pathway.

Complete Report Scope:

• By Device Type
  • Monitoring Devices
    • Self-Monitoring Blood Glucose
      • Glucometer Devices
      • Test Strips
      • Lancets
    • Continuous Glucose Monitoring
      • Sensors
      • Durables
  • Management Devices
    • Insulin Pumps
      • Insulin Pump Device
      • Insulin Pump Reservoir
      • Infusion Set
    • Insulin Syringes
    • Insulin Pens
    • Jet Injectors
• By Patient Type
  • Type-1 Diabetes
  • Type-2 Diabetes
  • Gestational & Others
• By End-user
  • Hospitals & Clinics
  • Home-care Settings
  • Ambulatory Surgical Centres
  • Pharmacies & Retail Chains
• By Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
  • Direct-to-Consumer E-commerce
• By Country
  • Germany
  • United Kingdom
  • France
  • Spain
  • Italy
  • Rest of Europe

List of Companies Covered in this Report:

1. Abbott Laboratories
2. Medtronic
3. Roche
4. Dexcom
5. Ascensia Diabetes Care Holdings AG
6. Novo Nordisk
7. Sanofi
8. Insulet
9. Tandem Diabetes Care
10. Ypsomed
11. Senseonics
12. Beckton Dickinson
13. Terumo
14. Eli Lilly and Company
15. B. Braun
16. Owen Mumford
17. Nipro
18. Menarini Diagnostics Srl
19. AgaMatrix Holdings LLC
20. Sooil Development Co. Ltd.

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 National Reimbursement Reforms Boosting CGM Uptake in Germany & Nordics
  • 4.2.2 EU MDR Fast-Track for Class IIb "Smart Pens" Accelerating Product Launches
  • 4.2.3 Tender-Driven Consolidation of Test-Strip Pricing in Southern Europe
  • 4.2.4 Pediatric T1D Prevalence Surge in CEE Fueling Patch-Pump Demand
  • 4.2.5 Hospital-at-Home Pilots in UK & France Driving Remote Monitoring Kits
  • 4.2.6 AI-based Decision Support Mandates in Spain Increasing Smart Pen Sales
• 4.3 Market Restraints
  • 4.3.1 Divergent VAT Rates on Devices vs. Consumables Distorting SMBG Economics
  • 4.3.2 Data-Residency Rules Limiting Cloud CGM Platforms in DACH Region
  • 4.3.3 Fragmented HTA Processes Delaying Insulin Pump Funding in Italy & Spain
  • 4.3.4 Sensor Waste-Disposal Regulations Raising Cost of Ownership in Benelux
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Outlook
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces
  • 4.7.1 Bargaining Power of Suppliers
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Threat of New Entrants
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value)

• 5.1 By Device Type
  • 5.1.1 Monitoring Devices
    • 5.1.1.1 Self-Monitoring Blood Glucose
      • 5.1.1.1.1 Glucometer Devices
      • 5.1.1.1.2 Test Strips
      • 5.1.1.1.3 Lancets
    • 5.1.1.2 Continuous Glucose Monitoring
      • 5.1.1.2.1 Sensors
      • 5.1.1.2.2 Durables
  • 5.1.2 Management Devices
    • 5.1.2.1 Insulin Pumps
      • 5.1.2.1.1 Insulin Pump Device
      • 5.1.2.1.2 Insulin Pump Reservoir
      • 5.1.2.1.3 Infusion Set
    • 5.1.2.2 Insulin Syringes
    • 5.1.2.3 Insulin Pens
    • 5.1.2.4 Jet Injectors
• 5.2 By Patient Type
  • 5.2.1 Type-1 Diabetes
  • 5.2.2 Type-2 Diabetes
  • 5.2.3 Gestational & Others
• 5.3 By End-user
  • 5.3.1 Hospitals & Clinics
  • 5.3.2 Home-care Settings
  • 5.3.3 Ambulatory Surgical Centres
  • 5.3.4 Pharmacies & Retail Chains
• 5.4 By Distribution Channel
  • 5.4.1 Hospital Pharmacies
  • 5.4.2 Retail Pharmacies
  • 5.4.3 Online Pharmacies
  • 5.4.4 Direct-to-Consumer E-commerce
• 5.5 By Country
  • 5.5.1 Germany
  • 5.5.2 United Kingdom
  • 5.5.3 France
  • 5.5.4 Spain
  • 5.5.5 Italy
  • 5.5.6 Rest of Europe

6 Competitive Landscape

• 6.1 Strategic Moves
• 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, Products & Services, Recent Developments)
  • 6.3.1 Abbott Laboratories
  • 6.3.2 Medtronic PLC
  • 6.3.3 F. Hoffmann-La Roche AG
  • 6.3.4 Dexcom Inc.
  • 6.3.5 Ascensia Diabetes Care Holdings AG
  • 6.3.6 Novo Nordisk A/S
  • 6.3.7 Sanofi S.A.
  • 6.3.8 Insulet Corporation
  • 6.3.9 Tandem Diabetes Care Inc.
  • 6.3.10 Ypsomed AG
  • 6.3.11 Senseonics Holdings Inc.
  • 6.3.12 Becton, Dickinson and Company (BD)
  • 6.3.13 Terumo Corporation
  • 6.3.14 Eli Lilly and Company
  • 6.3.15 B. Braun Melsungen AG
  • 6.3.16 Owen Mumford Ltd.
  • 6.3.17 Nipro Corporation
  • 6.3.18 Menarini Diagnostics Srl
  • 6.3.19 AgaMatrix Holdings LLC
  • 6.3.20 Sooil Development Co. Ltd.

7 Market Opportunities & Future Outlook

• 7.1 White-Space & Unmet-Need Assessment