셀프 케어 의료기기 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the self care medical devices market size is expected to grow from USD 21.47 billion in 2025 to USD 22.83 billion in 2026 and is forecast to reach USD 31.03 billion by 2031 at 6.32% CAGR over 2026-2031.

This report is Segmented by Type (Blood Glucose Monitors, Blood Pressure Monitors, Body Temperature Monitors, Nebulizers, Pedometers, Pregnancy/Fertility Test Kits, and Others), and Geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The Market Provides the Value (in USD Million) for the Above-Mentioned Segments.

Global Self Care Medical Devices Market Trends and Insights

Chronic-Disease & Geriatric Burden

Population aging and the rising incidence of long-term conditions are steering care from episodic interventions to continuous, home-based monitoring. More than 11 million insulin-dependent individuals worldwide depend on automated glucose monitors that cut clinic visits while safeguarding glycemic control . Similar momentum is unfolding in cardiology, where battery-efficient implantable monitors such as Abbott's Assert-IQ deliver six-year rhythm surveillance and improve early detection of arrhythmia. Payers value these tools because they avert emergency admissions, a dynamic that keeps the self care medical devices market on a widening trajectory.

Home-Based Care Preference

Public-health emergencies accelerated comfort with tele-monitoring, but the behavior has become entrenched. The FDA formally acknowledged domestic settings as integral to care delivery via its "Home as a Health Care Hub" framework in 2024, encouraging manufacturers to tailor usability, infection-control features, and training materials for laypersons. CMS now requires remotely monitored devices to transmit at least 16 data points every 30 days, effectively setting a performance floor that propels technology refinement. Women's health illustrates the trend: at-home hormone-monitoring pads validated by the agency allow discreet, routine testing and broaden engagement for underserved groups.

High Device Cost & Cheaper Alternatives

Premium connected devices often carry multi-year ownership costs that exceed budgets in low- to middle-income economies, hampering penetration. Semiconductor tariffs under discussion in several major jurisdictions threaten additional price rises given that more than half of medical devices require advanced chips, potentially lifting component costs across production lines. Manufacturers are countering with tiered portfolios that strip non-essential features for emerging markets, though the approach risks narrowing margins.

Other drivers and restraints analyzed in the detailed report include:

1. Device Miniaturization & Wireless Tech
2. Healthcare-Cost Pressure on Payers & Patients
3. Data-Privacy Adoption Barriers

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

Segment Analysis

The segment for blood-glucose monitors generated 35.78% of 2025 revenue, making it the cornerstone of the self care medical devices market. Reimbursement stability and clinical guidelines requiring continuous glucose data sustain predictable demand. At the same time, microneedle-based smart patches are forecast to rise 7.78% annually as they move beyond sensing to on-demand drug delivery, evidenced by an FDA-cleared smartphone-controlled patch able to dispense multiple medications. Blood-pressure monitors show mid-single-digit growth driven by hypertension screening programs, whereas wearable temperature sensors gain relevance in pediatric remote-fever management.

Proliferating respiratory solutions such as the FDA-cleared SIMEOX 200 airway clearance system leverage pulse-pressure wave technology to assist mucus evacuation in chronic obstructive pulmonary disease cohorts. Commodity pedometers and fitness trackers face value erosion, but advanced models integrating ECG and oxygen saturation data retain pricing power through clinical validation. Fertility and pregnancy kits now employ quantitative hormone analytics rather than colorimetric strips, appealing to women seeking data-rich insights. Emerging acoustic-therapy devices targeting nasal congestion and sleep apnea broaden non-pharmaceutical respiratory care, illustrating continuous product-pipeline diversification across the self care medical devices market.

Applications linked to diabetes management captured 41.92% of 2025 revenue and anchor recurring consumable demand for sensors and infusion sets. Insulin dosing algorithms embedded in closed-loop systems reduce hypoglycemia risk and create ecosystem stickiness, enlarging the self care medical devices market size for diabetes by 6% through value-added software subscriptions. Women's health constitutes the most dynamic frontier, expanding at a projected 6.87% CAGR as regulatory agencies green-light home tests for sexually transmitted infections and hormone panels that previously required clinic visits. Cardiovascular monitoring benefits from the roll-out of extended-life implantables and AI arrhythmia detection that improves post-discharge outcomes.

Respiratory-care use cases are shifting from episodic nebulization to smart inhalers equipped with flow sensors that guide technique and adherence. Integrated wellness platforms converge multiple biomarkers-glucose, blood pressure, heart rate variability-into one dashboard, cutting the number of individual devices a consumer needs. Predictive-analytics engines embedded within applications convert historical biometrics into individualized risk scores, positioning the self care medical devices industry for a future where preventive alerts precede symptom onset.

Complete Report Scope:

• By Device Type
  • Blood Glucose Monitors
  • Blood Pressure Monitors
  • Body Temperature Monitors
  • Nebulizers
  • Pedometers & Activity Trackers
  • Pregnancy/Fertility Test Kits
  • Smart Wearable Patches
  • Others
• By Application
  • Diabetes Management
  • Cardiovascular Health
  • Respiratory Care
  • Women's Health & Fertility
  • Fitness & Wellness
• By Connectivity
  • Connected / IoT-enabled Devices
  • Non-connected Devices
• By Distribution Channel
  • Pharmacies & Drug Stores
  • Online Retail
  • Hospital Outpatient & Clinics
  • Mass-merchandisers & Others
• By End-user
  • Home-care Users
  • Ambulatory Care Centres
  • Long-term Care Facilities
• 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 secured 42.19% of 2025 self care medical devices market revenue by combining robust reimbursement, tech-sector innovation, and supportive regulation. Updated CMS codes for Advanced Primary Care Management reimburse device-generated data reviews, improving financial justification for remote-monitoring dashboards. The FDA's harmonization of Quality System Regulation with ISO 13485 expedites dual market access and lowers redundant auditing costs. Venture investment channeled into Silicon Valley and Boston med-tech clusters fuels sensor miniaturization, clinical-grade firmware, and edge-processing breakthroughs. Potential semiconductor tariffs loom as a cost headwind, yet strategic on-shoring of chip fabrication is underway to secure supply.

Asia-Pacific is the fastest-growing region, tracking an 8.31% CAGR through 2031. Governments are enlarging public-insurance coverage for digital-health tools, and local manufacturing scale keeps price points attractive. China's updated medical-device law enhances transparency on post-market surveillance and label requirements, simplifying pathways for foreign entrants. Japan, valued at USD 40 billion, leans on self-monitoring as part of its Healthy Life Extension vision, with large payers subsidizing continuous glucose monitors for older adults . Australia's adoption of mutual-recognition schemes for CE-marked devices trims review cycles, further boosting regional competitiveness.

Europe delivers steady mid-single-digit expansion underpinned by aging populations and universal-coverage systems willing to reimburse evidence-based wearables. The European Health Data Space proposal, expected to enter force during 2026, will standardize health-data interoperability while mandating high encryption standards that favor companies with strong security credentials. Sustainability requirements drive interest in biodegradable sensor substrates such as nanocellulose ECG patches developed with Finnish research funding. Meanwhile, emergent Gulf and Latin American markets broaden addressable demand as infrastructure investment and regulatory overhauls attract multinationals looking for growth adjacencies.

1. Abbott Laboratories
2. Medtronic
3. Roche
4. Koninklijke Philips
5. Dexcom
6. OMRON
7. Resmed
8. Johnson & Johnson (Lifescan)
9. Bayer
10. Insulet
11. GE Healthcare
12. Orasure Technologies
13. B. Braun
14. Garmin
15. Fitbit (Google)
16. iHealth Labs
17. Beurer
18. Microlife Corp
19. Withings SA
20. Nipro

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 Chronic-Disease & Geriatric Burden
  • 4.2.2 Home-Based Care Preference
  • 4.2.3 Device Miniaturisation & Wireless Tech
  • 4.2.4 Healthcare-Cost Pressure on Payers & Patients
  • 4.2.5 AI-Driven Personalised Self-Monitoring
  • 4.2.6 Reimbursement-Linnked Remote Monitoring Codes
• 4.3 Market Restraints
  • 4.3.1 High Device Cost & Cheaper Alternatives
  • 4.3.2 Adverse Events From Implantables
  • 4.3.3 Data-Privacy Adoption Barriers
  • 4.3.4 Chip-Supply Volatility & Price Spikes
• 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 Buyers
  • 4.7.3 Bargaining Power of Suppliers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD Million)

• 5.1 By Device Type
  • 5.1.1 Blood Glucose Monitors
  • 5.1.2 Blood Pressure Monitors
  • 5.1.3 Body Temperature Monitors
  • 5.1.4 Nebulizers
  • 5.1.5 Pedometers & Activity Trackers
  • 5.1.6 Pregnancy/Fertility Test Kits
  • 5.1.7 Smart Wearable Patches
  • 5.1.8 Others
• 5.2 By Application
  • 5.2.1 Diabetes Management
  • 5.2.2 Cardiovascular Health
  • 5.2.3 Respiratory Care
  • 5.2.4 Women's Health & Fertility
  • 5.2.5 Fitness & Wellness
• 5.3 By Connectivity
  • 5.3.1 Connected / IoT-enabled Devices
  • 5.3.2 Non-connected Devices
• 5.4 By Distribution Channel
  • 5.4.1 Pharmacies & Drug Stores
  • 5.4.2 Online Retail
  • 5.4.3 Hospital Outpatient & Clinics
  • 5.4.4 Mass-merchandisers & Others
• 5.5 By End-user
  • 5.5.1 Home-care Users
  • 5.5.2 Ambulatory Care Centres
  • 5.5.3 Long-term Care Facilities
• 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 United Kingdom
    • 5.6.2.3 France
    • 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 Australia
    • 5.6.3.5 South Korea
    • 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, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 Abbott
  • 6.3.2 Medtronic
  • 6.3.3 F. Hoffmann-La Roche
  • 6.3.4 Koninklijke Philips
  • 6.3.5 Dexcom
  • 6.3.6 Omron Healthcare
  • 6.3.7 ResMed
  • 6.3.8 Johnson & Johnson (Lifescan)
  • 6.3.9 Bayer
  • 6.3.10 Insulet Corporation
  • 6.3.11 GE HealthCare
  • 6.3.12 OraSure Technologies
  • 6.3.13 B. Braun Melsungen
  • 6.3.14 Garmin Ltd
  • 6.3.15 Fitbit (Google)
  • 6.3.16 iHealth Labs
  • 6.3.17 Beurer GmbH
  • 6.3.18 Microlife Corp
  • 6.3.19 Withings SA
  • 6.3.20 Nipro Corporation

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment