심부전용 POC 및 LOC 디바이스 시장 : 검사 유형별, 디바이스 유형별, 기술, 최종 사용자별 예측(2026-2032년)

The Heart Failure POC & LOC Devices Market is projected to grow by USD 744.92 million at a CAGR of 13.77% by 2032.

Heart failure point-of-care (POC) and lab-on-chip (LOC) devices are moving from adjunct diagnostics to essential tools for faster triage, risk stratification, and longitudinal disease management. Global heart failure prevalence is commonly reported at more than 64 million people, while the CDC reports that approximately 6.7 million U.S. adults aged 20 and older live with heart failure, underscoring the need for rapid, decentralized testing.

The field is anchored by natriuretic peptide testing, including BNP and NT-proBNP, which is supported by major clinical guidelines for diagnosis, exclusion, and risk assessment in suspected heart failure. Adoption is expanding as emergency departments, primary care clinics, home care programs, ambulatory settings, and community-based care teams seek faster decisions, fewer avoidable admissions, and improved monitoring of high-risk patients.

Transformative Shifts in the Heart Failure Diagnostics Landscape

The heart failure diagnostics landscape is shifting toward decentralized, connected, and miniaturized testing. Microfluidics, biosensors, immunoassay miniaturization, and smartphone-enabled readers are improving turnaround time and reducing dependence on centralized laboratories, especially where urgent dyspnea evaluation, congestion assessment, and therapy optimization require fast results.

Healthcare systems are also prioritizing value-based care, hospital-at-home models, and remote patient monitoring. These shifts support integrated heart failure pathways where POC and LOC devices work alongside echocardiography, ECG, wearable sensors, electronic health records, and guideline-directed medical therapy to reduce diagnostic delays and support timely escalation or de-escalation of care.

Cumulative Impact of Artificial Intelligence

Artificial intelligence is strengthening heart failure POC and LOC devices by improving signal processing, assay interpretation, risk scoring, and workflow prioritization. AI-enabled analytics can combine biomarker values with vital signs, ECG patterns, comorbidities, medications, renal function indicators, and prior utilization data to support earlier identification of decompensation and higher-risk presentations.

The cumulative impact is most valuable when algorithms are clinically validated, explainable, bias-assessed, and integrated into physician-supervised workflows. Regulatory expectations from guidance on software as a medical device, good machine learning practice, cybersecurity, data governance, and post-market monitoring are shaping responsible deployment across connected heart failure diagnostics.

Key Regional Insights Across Global Markets

North America remains a leading adoption region due to mature emergency care networks, high heart failure burden, established reimbursement pathways, and strong digital health infrastructure. Europe is driven by guideline-based natriuretic peptide testing, aging populations, laboratory quality standards, and national programs focused on integrated chronic disease care across hospital and community settings.

Asia-Pacific is expanding as China, India, Japan, South Korea, and Australia invest in diagnostics access, connected care, local manufacturing, and chronic cardiovascular disease management. Latin America shows demand for cost-effective POC testing in urban hospitals, public health systems, and underserved areas, while the Middle East is advancing premium hospital infrastructure, digital transformation, and specialist cardiovascular services. Africa presents long-term opportunity where portable diagnostics can improve access to heart failure assessment despite workforce shortages, fragmented referral systems, and limited centralized laboratory capacity.

Key Group Insights for Strategic Market Prioritization

The European Union benefits from harmonized medical device regulation, large aging populations, structured clinical pathways, and strong guideline adoption, making it an important environment for validated POC and LOC heart failure diagnostics. G7 countries lead in reimbursement maturity, clinical research intensity, quality standards, and adoption of connected care models for chronic cardiovascular disease.

BRICS markets are important for scalable access, local production, and affordable testing models suited to large and diverse patient populations. ASEAN countries are prioritizing diagnostics access, mobile health integration, and primary care strengthening, while GCC systems are investing in advanced hospital networks, digital transformation, and chronic disease programs. NATO member markets add relevance through procurement resilience, cybersecurity expectations, interoperability, and secure medical infrastructure for connected diagnostic platforms.

Key Country Insights Across Major Heart Failure Markets

The United States leads in clinical adoption due to strong emergency medicine use cases, CDC-recognized disease burden, established biomarker testing practices, and growing remote monitoring programs. Canada emphasizes equitable access and chronic disease management, while Mexico and Brazil show rising need for affordable decentralized diagnostics as cardiovascular disease burdens expand and health systems seek faster triage outside centralized laboratories.

In Europe, the United Kingdom, Germany, France, Italy, and Spain support evidence-based natriuretic peptide testing through guideline-led care pathways, aging populations, and established hospital networks, while Russia faces a need for scalable diagnostics across dispersed populations and variable regional access. China and India are priority growth environments due to population size, urban hospital expansion, and improving diagnostics access; Japan, South Korea, and Australia are advanced adopters shaped by aging demographics, sophisticated hospitals, quality-focused regulation, and digital health readiness.

Actionable Recommendations for Industry Leaders

Industry leaders should prioritize clinically validated assays, fast turnaround time, interoperability with electronic health records, and usability across emergency, outpatient, rural, and home-based settings. Devices that combine biomarker accuracy with connectivity, embedded quality controls, cybersecurity, and clear clinical decision support will be better positioned for guideline-aligned adoption.

Organizations should build evidence packages demonstrating diagnostic performance, workflow impact, reduced time to treatment, readmission-related outcomes, and health economic value. Partnerships with hospitals, payers, home care providers, emergency networks, and public health systems can accelerate procurement, while localized pricing, service support, training, and manufacturing strategies can improve access in emerging markets.

Research Methodology for Evidence-Based Market Analysis

The research methodology should combine primary interviews with cardiologists, emergency physicians, laboratory directors, device developers, payers, procurement leaders, home care providers, and digital health stakeholders. Secondary validation should include peer-reviewed cardiology literature, clinical guideline statements from major societies, regulatory databases, hospital utilization data, reimbursement policies, and public health sources such as WHO and CDC.

Market interpretation should triangulate clinical demand, installed care pathways, reimbursement readiness, diagnostic accuracy requirements, technology maturity, regional access gaps, regulatory expectations, and competitive positioning. This approach supports defensible, evidence-based insights without relying on unsupported projections and helps identify where POC and LOC devices can create measurable clinical and operational value.

Conclusion and Strategic Outlook

Heart failure POC and LOC devices are becoming central to faster diagnosis, targeted triage, and continuous management of a high-burden chronic condition. Their value is strongest when rapid biomarker testing is paired with connected workflows, validated AI, quality assurance, and integrated care models that support timely clinical decisions.

The strategic outlook is supported by aging populations, rising cardiovascular disease prevalence, emergency department pressure, and health system efforts to reduce avoidable admissions. Organizations that deliver accurate, affordable, interoperable, secure, and clinically trusted solutions will be well positioned to shape the next phase of decentralized heart failure care.

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Definition
• 1.3. Market Segmentation & Coverage
• 1.4. Years Considered for the Study
• 1.5. Currency Considered for the Study
• 1.6. Language Considered for the Study
• 1.7. Key Stakeholders

2. Research Methodology

• 2.1. Introduction
• 2.2. Research Design
  • 2.2.1. Primary Research
  • 2.2.2. Secondary Research
• 2.3. Research Framework
  • 2.3.1. Qualitative Analysis
  • 2.3.2. Quantitative Analysis
• 2.4. Market Size Estimation
  • 2.4.1. Top-Down Approach
  • 2.4.2. Bottom-Up Approach
• 2.5. Data Triangulation
• 2.6. Research Outcomes
• 2.7. Research Assumptions
• 2.8. Research Limitations

3. Executive Summary

• 3.1. Introduction
• 3.2. CXO Perspective
• 3.3. Market Size & Growth Trends
• 3.4. Market Share Analysis, 2025
• 3.5. FPNV Positioning Matrix, 2025
• 3.6. New Revenue Opportunities
• 3.7. Next-Generation Business Models
• 3.8. Industry Roadmap

4. Market Overview

• 4.1. Introduction
• 4.2. Industry Ecosystem & Value Chain Analysis
  • 4.2.1. Supply-Side Analysis
  • 4.2.2. Demand-Side Analysis
  • 4.2.3. Stakeholder Analysis
• 4.3. Market Dynamics
  • 4.3.1. Key Drivers
  • 4.3.2. Key Restraints
  • 4.3.3. Key Opportunities
  • 4.3.4. Key Challenges
• 4.4. Porter's Five Forces Analysis
• 4.5. PESTLE Analysis
• 4.6. Market Outlook
  • 4.6.1. Near-Term Market Outlook (0-2 Years)
  • 4.6.2. Medium-Term Market Outlook (3-5 Years)
  • 4.6.3. Long-Term Market Outlook (5-10 Years)
• 4.7. Go-to-Market Strategy

5. Market Insights

• 5.1. Consumer Insights & End-User Perspective
• 5.2. Consumer Experience Benchmarking
• 5.3. Opportunity Mapping
• 5.4. Distribution Channel Analysis
• 5.5. Pricing Trend Analysis
• 5.6. Regulatory Compliance & Standards Framework
• 5.7. ESG & Sustainability Analysis
• 5.8. Disruption & Risk Scenarios
• 5.9. Return on Investment & Cost-Benefit Analysis

6. Cumulative Impact of Artificial Intelligence 2026

7. Heart Failure POC & LOC Devices Market, by Test Type

• 7.1. Genomic Testing
• 7.2. Metabolomic Testing
• 7.3. Proteomic Testing

8. Heart Failure POC & LOC Devices Market, by Device Type

• 8.1. Diagnostic Devices
  • 8.1.1. Cardiac Biomarker Analyzers
  • 8.1.2. Cardiac Imaging Devices
  • 8.1.3. Electrocardiogram (ECG)
• 8.2. Wearable Devices
  • 8.2.1. External Defibrillator
  • 8.2.2. Heart Rate Monitors

9. Heart Failure POC & LOC Devices Market, by Technology

• 9.1. Biosensor-based systems
• 9.2. Imaging & impedance-based platforms
• 9.3. Immunoassays
• 9.4. Nucleic acid-based platforms

10. Heart Failure POC & LOC Devices Market, by End User

• 10.1. Assisted Living Healthcare
• 10.2. Home Care Facilities
• 10.3. Hospitals & Clinics
• 10.4. Laboratory

11. Heart Failure POC & LOC Devices Market, by Region

• 11.1. Asia-Pacific
• 11.2. North America
• 11.3. Latin America
• 11.4. Europe
• 11.5. Middle East
• 11.6. Africa

12. Heart Failure POC & LOC Devices Market, by Group

• 12.1. ASEAN
• 12.2. GCC
• 12.3. European Union
• 12.4. BRICS
• 12.5. G7
• 12.6. NATO

13. Heart Failure POC & LOC Devices Market, by Country

• 13.1. United States
• 13.2. Canada
• 13.3. Mexico
• 13.4. Brazil
• 13.5. United Kingdom
• 13.6. Germany
• 13.7. France
• 13.8. Russia
• 13.9. Italy
• 13.10. Spain
• 13.11. China
• 13.12. India
• 13.13. Japan
• 13.14. Australia
• 13.15. South Korea

14. Competitive Landscape

• 14.1. Market Concentration Analysis, 2025
  • 14.1.1. Concentration Ratio (CR)
  • 14.1.2. Herfindahl Hirschman Index (HHI)
• 14.2. Recent Developments & Impact Analysis, 2025
• 14.3. Product Portfolio Analysis, 2025
• 14.4. Benchmarking Analysis, 2025

15. Company Profiles

• 15.1. Abbott Laboratories
• 15.2. ACON Laboratories Inc.
• 15.3. Becton, Dickinson and Company
• 15.4. Bio-Rad Laboratories, Inc.
• 15.5. bioMerieux S.A.
• 15.6. Boston Scientific Corporation
• 15.7. Cipla Limited
• 15.8. Danaher Corporation
• 15.9. F. Hoffmann-La Roche Ltd.
• 15.10. Fukuda Denshi Co., Ltd.
• 15.11. Jant Pharmacal Corporation
• 15.12. Johari Digital India Limited by Syrma SGS
• 15.13. Koninklijke Philips N.V.
• 15.14. LifeSign LLC
• 15.15. LifeSync
• 15.16. Luminex Corporation by DiaSorin S.p.A.
• 15.17. Mitsubishi Chemical Group Corporation
• 15.18. Nexus Dx, Inc
• 15.19. Nihon Kohden Corporation
• 15.20. Quidel Corporation
• 15.21. Schiller AG
• 15.22. Shenzhen EDAN Instrument Co., Ltd.
• 15.23. Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• 15.24. Siemens Healthineers AG
• 15.25. Spectral Diagnostics Inc.
• 15.26. Trinity Biotech PLC