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

According to Mordor Intelligence, the cholesterol management devices market is projected to be USD 2.51 billion in 2025, USD 2.68 billion in 2026, and reach USD 3.97 billion by 2031, growing at a CAGR of 8.16% from 2026 to 2031.

This report is Segmented by Device Type (Cholesterol Monitors, Lipid Test Kits, and More), Technology (Digital Devices, Analog Devices), End-User (Hospitals and Clinics, and More), Distribution Channel (Hospital Pharmacies, and More), and Geography (North America, Europe, Asia-Pacific, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Cholesterol Management Devices Market Trends and Insights

Rising Cardiovascular Risk Screening Across Primary Care and Pharmacies

The epidemiological pressure behind the cholesterol management devices market extends beyond headline mortality counts and now shapes routine screening policy in many care settings. The Global Burden of Disease 2023 study found that modifiable metabolic risk factors, including high LDL cholesterol, accounted for 67.3% of global cardiovascular disease related disability adjusted life years, which keeps cholesterol testing high on national prevention agendas HEALTHDATA.ORG. The 2026 ACC and AHA guideline also moves cardiovascular risk assessment earlier in life, reflecting the view that atherosclerotic risk builds over decades rather than appearing suddenly in older age JACC.ORG. As screening broadens across physician offices, community pharmacies, and preventive care programs, the cholesterol management devices market gains from a larger installed base requirement for analyzers, monitors, and recurring test supplies.

Growth of Point-of-Care Lipid Testing in Outpatient and Home Settings

Point of care lipid testing is moving beyond cardiology offices and has become more relevant in primary care, urgent care, and retail health settings. The main shift is that lipid panel delivery is becoming less dependent on central phlebotomy infrastructure, which allows more same day decision making during a patient visit. Faster result turnaround supports immediate medication adjustment, referral decisions, and follow-up planning, which improves the practical value of these systems for routine care. This makes the cholesterol management devices market more responsive to workflow needs in outpatient care, where speed and convenience often determine whether a test is used regularly. The same trend also supports home use in the cholesterol management devices market, especially where chronic disease management is moving away from episodic clinical visits toward ongoing monitoring between appointments.

Reimbursement Friction for Non-Laboratory Cholesterol Testing

The reimbursement model for non-laboratory cholesterol testing remains a practical barrier, especially in the United States. UnitedHealthcare issued a September 2025 commercial reimbursement policy update that became effective on December 1, 2025 and tightened the conditions around routine laboratory testing across office, outpatient, and independent laboratory settings. In the cholesterol management devices market, this slows adoption of office based and point of care products because smaller manufacturers often lack the payer contracting strength that large laboratory service providers already have. It also limits how quickly testing can move from centralized laboratories into clinics, pharmacies, and home centered care pathways within the cholesterol management devices market.

Other drivers and restraints analyzed in the detailed report include:

1. Expansion of Digital and Connected Cholesterol Monitoring Ecosystems
2. Higher Adoption of Preventive Cardiometabolic Checkups in Aging Populations
3. Regulatory Validation Burden Across Multiparameter and Connected Devices

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

Segment Analysis

Cholesterol monitors held 57.26% of device type revenue in 2025, which reflects how hypertension and dyslipidemia are often managed together in real clinical practice. Lipid test kits are expected to record the fastest growth at an 8.8% CAGR through 2031, supported by broader lipid testing recommendations and stronger demand for compact fingerstick based systems. Lipid test kits still are becoming more useful in pharmacy, retail health, and recurring home testing models.

Companies in the cholesterol management devices industry are therefore balancing capital device placement with repeat strip and reagent sales to improve lifetime customer value. Product lines that fit multi-analyte cardiometabolic workflows should remain better positioned, because cholesterol testing is increasingly ordered alongside glucose, HbA1c, and other risk markers rather than as an isolated measurement.

Digital devices accounted for 51.24% of technology revenue in 2025, which made digital hardware the main commercial standard across hospital, laboratory, and home care settings. That position reflects the wider availability of app connectivity, cloud transfer, and smartphone linked interfaces that help users store and review measurements. Analog devices are projected to expand at a 9.21% CAGR through 2031, which makes them the fastest growing part of the cholesterol management devices market within the technology split.

Even so, analog devices still matter in cost sensitive settings and in locations where digital connectivity remains less reliable. The cholesterol management devices market will likely see gradual share erosion for analog formats rather than an abrupt exit, because affordability and operational simplicity still matter in many use cases.

Complete Report Scope:

• By Device Type
  • Cholesterol Monitors
  • Lipid Test Kits
  • Other Device Types
• By Technology
  • Digital Devices
  • Analog Devices
• By End-User
  • Hospitals and Clinics
  • Diagnostic Laboratories
  • Home Healthcare Settings
• By Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Retail and E-Commerce
• 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 46.51% of the cholesterol management devices market share in 2025, supported by mature healthcare infrastructure, high testing intensity, and broad access to diagnostic pathways. The 2026 ACC and AHA dyslipidemia guideline is a meaningful near-term catalyst in the United States because it makes Lp(a) testing a once in adulthood recommendation and expands the role of ApoB in risk assessment. Canada and Mexico contribute a smaller share, but urban cardiovascular programs continue to support broader diagnostic investment across the region.

Europe remained the second largest regional segment in the cholesterol management devices market, with Germany, the United Kingdom, and France forming the main country level demand centers. The region still leans more heavily toward centralized laboratory medicine than decentralized point of care testing, which shapes product adoption patterns across hospitals and outpatient settings. IVDR related compliance demands are pushing manufacturers to spend more on evidence generation and portfolio prioritization, especially when they want wide European coverage. The European Commission's December 2025 amendment proposal could simplify parts of that process by 2027, which would help the entry path for next generation connected cholesterol monitoring systems.

Asia-Pacific is projected to grow at a 10.43% CAGR through 2031, which makes it the fastest growing regional block in the cholesterol management devices market. India is described as the fastest growing country market in the region, supported by rising urban cardiovascular burden and expanding diagnostic capacity. Japan provides a stable base for routine lipid testing through established health check structures, while other Asian markets continue to build institutional and consumer testing capacity. South America and the Middle East and Africa remain earlier stage opportunities in the cholesterol management devices market, where urban demand is rising but affordability limits and infrastructure gaps still moderate adoption.

1. Abbott Laboratories
2. Acon Laboratories
3. Arkray
4. Bayer
5. Beckton Dickinson
6. Bioptik Technology
7. Cardinal Health
8. Danaher
9. EKF Diagnostics
10. Johnson & Johnson
11. Koninklijke Philips
12. Medtronic
13. Nova Biomedical
14. PTS Diagnostics
15. Quest Diagnostics
16. Randox Laboratories
17. Roche
18. Siemens Healthineers
19. Sinocare
20. Thermo Fisher Scientific

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 Cardiovascular Risk Screening Across Primary Care and Pharmacies
  • 4.2.2 Growth of Point-of-Care Lipid Testing in Outpatient and Home Settings
  • 4.2.3 Expansion of Digital and Connected Cholesterol Monitoring Ecosystems
  • 4.2.4 Higher Adoption of Preventive Cardiometabolic Checkups in Aging Populations
  • 4.2.5 Expansion of at-Home Self-Testing Through Subscription and Employer Health Programs
  • 4.2.6 Demand for Multi-Analyte Cardiometabolic Panels that Bundle Cholesterol with HbA1c and Glucose
• 4.3 Market Restraints
  • 4.3.1 Reimbursement Friction for Non-Laboratory Cholesterol Testing
  • 4.3.2 Regulatory Validation Burden Across Multiparameter and Connected Devices
  • 4.3.3 Consumables Dependency and Pricing Pressure on Test Strips and Reagents
  • 4.3.4 Clinical Preference for Centralized Laboratory Reference Testing in Higher-Acuity Settings
• 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 Device Type
  • 5.1.1 Cholesterol Monitors
  • 5.1.2 Lipid Test Kits
  • 5.1.3 Other Device Types
• 5.2 By Technology
  • 5.2.1 Digital Devices
  • 5.2.2 Analog Devices
• 5.3 By End-User
  • 5.3.1 Hospitals and Clinics
  • 5.3.2 Diagnostic Laboratories
  • 5.3.3 Home Healthcare Settings
• 5.4 By Distribution Channel
  • 5.4.1 Hospital Pharmacies
  • 5.4.2 Retail Pharmacies
  • 5.4.3 Online Retail and E-Commerce
• 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
  • 6.3.2 ACON Laboratories
  • 6.3.3 ARKRAY
  • 6.3.4 Bayer
  • 6.3.5 Beckman Coulter
  • 6.3.6 Bioptik Technology
  • 6.3.7 Cardinal Health
  • 6.3.8 Danaher
  • 6.3.9 EKF Diagnostics
  • 6.3.10 Johnson and Johnson
  • 6.3.11 Koninklijke Philips N.V.
  • 6.3.12 Medtronic
  • 6.3.13 Nova Biomedical
  • 6.3.14 PTS Diagnostics
  • 6.3.15 Quest Diagnostics
  • 6.3.16 Randox Laboratories
  • 6.3.17 Roche Diagnostics
  • 6.3.18 Siemens Healthineers
  • 6.3.19 Sinocare
  • 6.3.20 Thermo Fisher Scientific, Inc.

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment