의료 바이오센서 시장 : 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the healthcare biosensors market is expected to increase from USD 19.72 billion in 2025 to USD 21.51 billion in 2026 and reach USD 34.11 billion by 2031, growing at a CAGR of 9.67% over 2026-2031.

This report is Segmented by Product Type (Wearable Biosensors, Implantable Biosensors, and Others), Technology (Electrochemical Biosensors, and Others), Application (Clinical Diagnostics, Health and Wellness Monitoring, and Others), End-User (Hospitals and Clinics, and Others), and Geography (North America, Europe, Asia-Pacific, and Others). The Market Forecasts are Provided in Terms of Value (USD).

Global Healthcare Biosensors Market Trends and Insights

Rising Point-of-Care and At-Home Testing Demand

The healthcare biosensors market is being shaped by a lasting move away from central laboratories and toward pharmacies, clinics, and patient homes. Health systems in North America and Western Europe continue to face staffing and capacity pressure, which supports testing models that place faster diagnostic tools closer to the patient. The FDA's TEMPO pilot, launched in December 2025, supports this shift by allowing eligible digital health technologies for chronic conditions to enter the market under enforcement discretion while real-world performance data is collected.That framework lowers practical entry barriers for biosensor developers that target lower acuity cardio-metabolic use cases. As a result, the healthcare biosensors market is seeing broader room for mid-tier manufacturers that may not have the resources required for the longest and most expensive approval routes.

Growing Diabetes and Cardiometabolic Burden

The healthcare biosensors market has a strong demand base because diabetes and cardiometabolic conditions require regular monitoring over long periods. The IDF Diabetes Atlas 2025 reported that 589 million adults were living with diabetes in 2024, and more than 4 in 10 remained unaware of their condition.That large undiagnosed population supports demand for both screening and continuous management tools, especially across glucose monitoring and remote care. The WHO's 2025 monitor also kept cardiovascular disease at the center of noncommunicable disease mortality, which supports continued use of cardiac biomarker biosensors in emergency and routine care. The healthcare biosensors market is therefore likely to see a larger share of long-term volume growth come from regions where diabetes prevalence is high and monitoring infrastructure is still expanding.

High Cost of Clinical Validation and Cybersecurity Compliance

The healthcare biosensors market faces higher cost pressure as validation standards become more demanding for devices tied to therapeutic decisions and automated care pathways. The FDA's 2025 guidance on AI-enabled device software functions added lifecycle documentation expectations for AI components, which extends work beyond first approval. Implantable products face an even steeper burden because they often require long trial periods and separate evidence packages across indications and geographies. These added costs are making it harder for mid-sized companies to keep up when compared with diversified medtech groups and well-funded startups. As a result, the healthcare biosensors market is likely to see more consolidation pressure where validation, cybersecurity, and software upkeep costs keep rising together.

Other drivers and restraints analyzed in the detailed report include:

1. Miniaturization, AI, And Multi-Analyte Sensing Integration
2. Reimbursement Expansion for Remote Monitoring Use Cases
3. Fragmented Regulatory Classification Across Device and Digital Health Pathways

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

Segment Analysis

Wearable biosensors held 58.40% of the healthcare biosensors market in 2025, which made them the largest product category by revenue. Their lead reflects strong adoption in continuous glucose monitoring, cardiac rhythm surveillance, and oxygen saturation tracking, along with higher comfort for repeated daily use. The healthcare biosensors market has favored these formats because clinicians and patients both value continuous and non-intrusive data over periodic spot testing. That preference has supported steady demand for wrist-based, patch-based, and other body-worn monitoring formats across acute and chronic care settings.

Point-of-care biosensors are projected to grow at an 11.80% CAGR through 2031, making them the fastest-moving product segment in the healthcare biosensors market. Their growth is tied to primary care expansion, pharmacy diagnostics, and the continued use of rapid testing outside large hospital laboratories. Implantable biosensors are also gaining relevance as CMS added HCPCS codes G0564 and G0565 in 2025 for 365-day implantable interstitial glucose sensors. Benchtop and laboratory biosensors are growing more slowly, while home-use devices remain closely linked to payer coverage and the availability of simple monitoring workflows.

Electrochemical biosensors retained 61.70% share in 2025, which kept them at the core of the healthcare biosensors industry and the broader healthcare biosensors market. Their position rests on mature manufacturing, broad clinical evidence, and established use in glucose testing, cardiac troponin assays, and infectious disease diagnostics. Research published in 2025 showed that AI-integrated electrochemical biosensors are moving toward portable autonomous diagnostics with multiplexed capability. This extends their relevance beyond traditional analytes and supports continued volume strength across institutional and decentralized testing.

Piezoelectric biosensors are forecasted to grow at a 12.40% CAGR through 2031, making them the fastest-growing technology in the healthcare biosensors market. Their appeal comes from label-free mass-based detection, which supports pathogen detection and cancer biomarker screening without the same need for electroactive reagents. A 2025 review documented expanding medical diagnostic applications for piezoelectric chemosensors and biosensors across cancer and infectious disease testing. Optical, thermal, and nanomechanical platforms remain smaller, while compliance requirements for homecare devices continue to shape design choices across the healthcare biosensors industry.

Complete Report Scope:

• By Product Type
  • Wearable Biosensors
  • Implantable Biosensors
  • Point-of-Care Biosensors
  • Benchtop/Laboratory Biosensors
  • Home-Use Biosensors
• By Technology
  • Electrochemical Biosensors
  • Optical Biosensors
  • Piezoelectric Biosensors
  • Thermal Biosensors
  • Nanomechanical Biosensors
• By Application
  • Clinical Diagnostics
    • Glucose Monitoring
    • Infectious Disease Testing
    • Cardiac Marker Testing
    • Pregnancy and Fertility Testing
    • Other Clinical Diagnostics
  • Health and Wellness Monitoring
  • Chronic Disease Management / Therapeutic Monitoring
  • Other Applications
• By End-User
  • Hospitals and Clinics
  • Homecare Settings
  • Diagnostic Laboratories
  • Other End-Users
• 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 and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 42.50% share in 2025, which made it the largest regional contributor to the healthcare biosensors market. The region benefits from high CGM use, a developed remote patient monitoring framework, and strong private insurance support for continuous monitoring devices. The healthcare biosensors market also gains from North America's concentration of research and product development activity in major U.S. innovation centers. Canada and Mexico remain smaller, but coverage expansion and stronger health program support are widening the regional base.

Europe was the second-largest regional block in the healthcare biosensors market, but it is operating under a more complex regulatory setting. Germany and the United Kingdom remain the main revenue hubs, while Europe is also serving as an early launch market for differentiated products such as Abbott's Libre Duo and Roche's Elecsys pTau217. This means the healthcare biosensors market in Europe combines strong clinical demand with higher regulatory barriers that can favor better-prepared manufacturers.

Asia-Pacific is projected to grow at a 12.30% CAGR through 2031, which makes it the fastest-growing region in the healthcare biosensors market. China remains the largest APAC country market, and Abbott's FreeStyle Libre holds a 35% share of China's CGM segment, while Sinocare has listings in 15 provincial insurance plans. The healthcare biosensors market in Asia-Pacific is being supported by China's large diabetes management base and by India's expanding device manufacturing capacity. Japan also adds momentum through its strong healthcare technology base. The Middle East and Africa and South America remain smaller, but infrastructure spending is improving the case for affordable point-of-care and community screening products.

1. Abbott Laboratories
2. Agilent Technologies
3. Beckton Dickinson
4. Biolinq Inc.
5. Bio-Rad Laboratories
6. Biosensors International Group, Ltd.
7. Dexcom
8. Roche
9. GE HealthCare Technologies Inc.
10. Koninklijke Philips
11. LifeScan IP Holdings, LLC
12. Masimo
13. Medtronic
14. Nova Biomedical
15. Profusa Inc.
16. Mindray
17. Siemens Healthineers
18. Thermo Fisher Scientific
19. Universal Biosensors, Inc.
20. VitalConnect, Inc.
21. Wearable Devices 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 and 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 Point-of-Care and at-Home Testing Demand
  • 4.2.2 Growing Diabetes and Cardiometabolic Burden
  • 4.2.3 Miniaturization, AI, and Multi-Analyte Sensing Integration
  • 4.2.4 Reimbursement Expansion for Remote Monitoring Use Cases
  • 4.2.5 Data-Linked Service Models, Not Just Device Sales
  • 4.2.6 Clinical Validation Advantage for Non-Invasive Biosensing
• 4.3 Market Restraints
  • 4.3.1 High Cost of Clinical Validation and Cybersecurity Compliance
  • 4.3.2 Fragmented Regulatory Classification Across Device and Digital Health Pathways
  • 4.3.3 Sensor Drift, Bioreceptor Stability, and Calibration Burden
  • 4.3.4 Interoperability Gaps Between Sensors, Apps, and Payer Workflows
• 4.4 Supply/Value 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 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product Type
  • 5.1.1 Wearable Biosensors
  • 5.1.2 Implantable Biosensors
  • 5.1.3 Point-of-Care Biosensors
  • 5.1.4 Benchtop/Laboratory Biosensors
  • 5.1.5 Home-Use Biosensors
• 5.2 By Technology
  • 5.2.1 Electrochemical Biosensors
  • 5.2.2 Optical Biosensors
  • 5.2.3 Piezoelectric Biosensors
  • 5.2.4 Thermal Biosensors
  • 5.2.5 Nanomechanical Biosensors
• 5.3 By Application
  • 5.3.1 Clinical Diagnostics
    • 5.3.1.1 Glucose Monitoring
    • 5.3.1.2 Infectious Disease Testing
    • 5.3.1.3 Cardiac Marker Testing
    • 5.3.1.4 Pregnancy and Fertility Testing
    • 5.3.1.5 Other Clinical Diagnostics
  • 5.3.2 Health and Wellness Monitoring
  • 5.3.3 Chronic Disease Management / Therapeutic Monitoring
  • 5.3.4 Other Applications
• 5.4 By End-User
  • 5.4.1 Hospitals and Clinics
  • 5.4.2 Homecare Settings
  • 5.4.3 Diagnostic Laboratories
  • 5.4.4 Other End-Users
• 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 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, Recent Developments)
  • 6.3.1 Abbott Laboratories
  • 6.3.2 Agilent Technologies, Inc.
  • 6.3.3 Becton, Dickinson and Company
  • 6.3.4 Biolinq Inc.
  • 6.3.5 Bio-Rad Laboratories, Inc.
  • 6.3.6 Biosensors International Group, Ltd.
  • 6.3.7 DexCom, Inc.
  • 6.3.8 F. Hoffmann-La Roche Ltd
  • 6.3.9 GE HealthCare Technologies Inc.
  • 6.3.10 Koninklijke Philips N.V.
  • 6.3.11 LifeScan IP Holdings, LLC
  • 6.3.12 Masimo Corporation
  • 6.3.13 Medtronic plc
  • 6.3.14 Nova Biomedical Corporation
  • 6.3.15 Profusa Inc.
  • 6.3.16 Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
  • 6.3.17 Siemens Healthineers AG
  • 6.3.18 Thermo Fisher Scientific Inc.
  • 6.3.19 Universal Biosensors, Inc.
  • 6.3.20 VitalConnect, Inc.
  • 6.3.21 Wearable Devices Ltd.

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment