비침습적 혈당 모니터링 디바이스 시장 : 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the non-invasive glucose monitoring device market size in 2026 is estimated at USD 10.12 billion, growing from 2025 value of USD 9.34 billion with 2031 projections showing USD 15.11 billion, growing at 8.35% CAGR over 2026-2031.

This report is Segmented by Device Type (Wearable, Non-Wearable), Device Placement (Arm and Wrist, Ear Lobe, Forefinger, Thumb, Cornea, Other Alternate Sites), Patient Age Group (Adults, Geriatric, Pediatric), End User (Hospitals and Clinics, Home and Personal Use, and More), and Geography (North America, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Non-Invasive Glucose Monitoring Device Market Trends and Insights

Rising Diabetes Prevalence & Earlier Diagnosis

Diabetes cases climbed to 537 million adults in 2021 and are projected to surpass 783 million by 2045. The surge is most acute in emerging economies where lifestyle shifts converge with ageing populations. China's prevalence alone rose from 7.53% in 2005 to 13.67% in 2023, underlining the urgency for scalable, painless monitoring options . Academic evidence from the University of Tokyo shows that continuous, non-invasive glucose trends reveal pre-diabetes risk earlier than fasting blood tests, encouraging proactive lifestyle interventions. As screening shifts beyond clinics to pharmacies and workplaces, the non-invasive glucose monitoring device market gains a broader addressable base. Payers view earlier detection as a cost buffer against downstream complications, reinforcing reimbursement prospects.

Regulatory Tailwinds for Needle-Free Monitoring

The US FDA cleared Dexcom's Stelo as the first over-the-counter continuous glucose monitor in 2024, signalling a friendlier stance toward consumer-grade solutions. Parallel European CE-mark activity around optical systems such as Roche's AI-enabled Accu-Chek SmartGuide illustrates a harmonising regulatory agenda . Updated guidance on AI-enabled devices clarifies data transparency rules, lowering compliance risk for algorithms that refine optical accuracy. The integrated continuous glucose monitoring (iCGM) product code provides explicit performance targets that non-invasive vendors can benchmark. These frameworks shorten time-to-market and spur strategic alliances between diagnostics leaders and sensor start-ups.

Accuracy Gaps vs. Invasive CGMs

Leading invasive CGMs post MARD figures near 8.0%, whereas most non-invasive contenders still register between 11.1% and 18.2%. Comparative assessments place FreeStyle Libre 3 at 8.9% and Dexcom G7 at 8.0% MARD, setting a high bar for optical or radio-frequency solutions. Regulators and clinicians emphasise consensus error grid analysis over single-number MARD, yet payers remain cautious about therapy-adjustment decisions based on broader error margins. Bridging this gap requires enhanced spectral algorithms, multimodal sensing, and larger validation cohorts, all of which extend development timelines and burn rates.

Other drivers and restraints analyzed in the detailed report include:

1. Miniaturization of NIR/Raman Photonics Modules
2. Big-Tech Integration into Smart-Watch Form Factors
3. Lengthy Multi-Site Clinical-Validation Cycles

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

Segment Analysis

Non-wearable systems retained 61.45% revenue in 2025, rooted in hospital carts and clinic desktops that permit larger optics and vibration isolation. Yet wearables are racing ahead with a 9.08% CAGR, guided by smartwatch and patch designs that suit round-the-clock data capture. The non-invasive glucose monitoring device market is witnessing chipset integrations that shrink laser drivers to smartwatch motherboards without sacrificing battery life.

Samsung's and Dexcom's joint efforts epitomise convergence, while Biolinq channels its USD 100 million Series C into intradermal micro-array biosensors. Desktop platforms still claim premium pricing in endocrinology clinics, but unit growth is tilting decisively toward wrists and upper arms where consumer electronics firms wield distribution clout.

Arm and wrist deployments commanded 39.74% of the non-invasive glucose monitoring device market share in 2025, owing to prior CGM user familiarity and stable tissue characteristics. Finger-tip modalities are predicted to climb at a 9.05% CAGR, helped by rich capillary beds and seamless smartphone coupling.

Know Labs' radio-frequency dielectric sensor reached 11.1% MARD on finger measurements across 200 volunteers, indicating progress toward single-digit accuracy. Ear-lobe and thumb sensors serve niche ergonomics, while corneal and breath analyses remain exploratory due to comfort and regulatory concerns. The diversification of sites grants suppliers more design latitude to optimise accuracy, comfort, and aesthetics across user cohorts.

Complete Report Scope:

• By Device Type
  • Wearable
  • Non-Wearable
• By Device Placement
  • Arm and Wrist
  • Ear Lobe
  • Forefinger
  • Thumb
  • Cornea
  • Other Alternate Sites
• By Patient Age Group
  • Adults
  • Geriatric
  • Pediatric
• By End User
  • Hospitals and Clinics
  • Home and Personal Use
  • Ambulatory Surgical Centers
  • Others
• 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
    • Malaysia
    • Indonesia
    • Thailand
    • Philippines
    • Vietnam
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America accounted for 39.98% of 2025 revenue thanks to favourable reimbursement codes, broad commercial insurance uptake, and early FDA guidance clarity. Device makers enjoy dense clinical-trial networks that accelerate evidence generation, while venture hubs in California and Massachusetts supply scale-up capital. Europe maintains steady adoption as CE-mark frameworks harmonise AI explainability and cybersecurity clauses. National health systems in Germany, France, and the Nordics finance integrated diabetes pathways that embrace needle-free modalities, though budget ceilings temper headline volumes.

Asia-Pacific is the breakout geography, clocking a 9.45% CAGR through 2031 on the back of surging diabetes incidence and manufacturing cost advantages. China's diabetic population climbed from 92 million in 2010 to an estimated 149 million in 2024, creating a vast potential pool for consumer wearables. Local optical-component suppliers compress bill-of-materials cost structures, giving regional OEMs a pricing edge. South Korean firm i-SENS won European and Japanese approvals for its optical CGM system, exporting design credibility beyond domestic borders. Japan's depth in photonics R&D, underscored by QCL ring-resonator breakthroughs, sustains technology leadership that suppliers then industrialise in neighbouring fabrication hubs.

Middle East and Africa show early-stage adoption, led by Gulf health-authority pilots that test remote monitoring for expatriate populations with type 2 diabetes. South American growth aligns with local manufacturing incentives in Brazil and Mexico, where regulatory pathways mirror CE-mark dossiers and shorten review cycles. Across these emerging markets, smartphone penetration serves as the distribution spine for app-based visualisations, lowering entry friction for consumers and easing clinician onboarding.

1. Abbott Laboratories
2. Dexcom
3. Medtronic
4. Senseonics Holdings
5. Nemaura Medical
6. OrSense Ltd.
7. DiaMonTech GmbH
8. MediWise / Occuity Ltd.
9. Know Labs Inc.
10. Integrity Applications (GlucoTrack)
11. OptiScan Biomedical
12. CNOGA Medical
13. Biolinq Inc.
14. Movano Health
15. Verily Life Sciences
16. GlucoSense Diagnostics
17. Apple
18. Scanbo Corp.
19. DiaMonTech GmbH
20. RSP Systems

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 Diabetes Prevalence & Earlier Diagnosis
  • 4.2.2 Regulatory Tailwinds for Needle-Free Monitoring
  • 4.2.3 Miniaturization Of NIR/Raman Photonics Modules
  • 4.2.4 Big-Tech Integration into Smart-Watch Form Factors
  • 4.2.5 Continuous Metabolic-Data Monetisation Models
  • 4.2.6 VC Funding Pivot to Non-Invasive Biosensing Start-Ups
• 4.3 Market Restraints
  • 4.3.1 Accuracy Gaps Vs. Invasive CGMs
  • 4.3.2 Lengthy Multi-Site Clinical-Validation Cycles
  • 4.3.3 High Component Cost of Mid-IR Lasers
  • 4.3.4 Data-Privacy Backlash on Cloud Analytics
• 4.4 Regulatory Landscape
• 4.5 Technological Outlook
• 4.6 Porters Five Forces Analysis
  • 4.6.1 Bargaining Power of Suppliers
  • 4.6.2 Bargaining Power of Buyers
  • 4.6.3 Threat of New Entrants
  • 4.6.4 Threat of Substitute Products & Services
  • 4.6.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Device Type
  • 5.1.1 Wearable
  • 5.1.2 Non-Wearable
• 5.2 By Device Placement
  • 5.2.1 Arm and Wrist
  • 5.2.2 Ear Lobe
  • 5.2.3 Forefinger
  • 5.2.4 Thumb
  • 5.2.5 Cornea
  • 5.2.6 Other Alternate Sites
• 5.3 By Patient Age Group
  • 5.3.1 Adults
  • 5.3.2 Geriatric
  • 5.3.3 Pediatric
• 5.4 By End User
  • 5.4.1 Hospitals and Clinics
  • 5.4.2 Home and Personal Use
  • 5.4.3 Ambulatory Surgical Centers
  • 5.4.4 Others
• 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 Malaysia
    • 5.5.3.7 Indonesia
    • 5.5.3.8 Thailand
    • 5.5.3.9 Philippines
    • 5.5.3.10 Vietnam
    • 5.5.3.11 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and 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 Abbott Laboratories
  • 6.3.2 Dexcom Inc.
  • 6.3.3 Medtronic plc
  • 6.3.4 Senseonics Holdings
  • 6.3.5 Nemaura Medical
  • 6.3.6 OrSense Ltd.
  • 6.3.7 DiaMonTech GmbH
  • 6.3.8 MediWise / Occuity Ltd.
  • 6.3.9 Know Labs Inc.
  • 6.3.10 Integrity Applications (GlucoTrack)
  • 6.3.11 OptiScan Biomedical
  • 6.3.12 CNOGA Medical
  • 6.3.13 Biolinq Inc.
  • 6.3.14 Movano Health
  • 6.3.15 Verily Life Sciences
  • 6.3.16 GlucoSense Diagnostics
  • 6.3.17 Apple Inc.
  • 6.3.18 Scanbo Corp.
  • 6.3.19 DiaMonTech GmbH
  • 6.3.20 RSP Systems

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment