심부전 POC 및 LOC 디바이스 시장 : 검사 유형, 디바이스 유형, 기술, 최종사용자별 - 세계 예측(2025-2032년)

The Heart Failure POC & LOC Devices Market is projected to grow by USD 744.92 million at a CAGR of 13.67% by 2032.

An integrated overview of technological, clinical, and operational trends redefining heart failure point-of-care and line-of-care diagnostics in modern healthcare

The convergence of technological advances, shifting care delivery models, and increasingly granular biological insights has placed point-of-care and line-of-care devices at the forefront of heart failure management. This executive summary synthesizes the most consequential developments affecting stakeholders across clinical, commercial, regulatory, and supply chain domains. It articulates how emerging diagnostic modalities, device form factors, and payer expectations are reshaping where, when, and how heart failure is detected and monitored, and it frames implications for manufacturers, health systems, and investors.

Across care settings, clinicians demand faster, more actionable data to support treatment adjustments, triage decisions, and remote monitoring. Concurrently, device makers are moving from single-analyte tests toward multiplexed platforms and integrating biosensor and imaging capabilities into wearable and bench devices. As a result, product development cycles increasingly emphasize interoperability, data security, and user-centered design to meet the needs of both acute care and community-based practitioners. The following sections unpack transformative shifts, tariff-driven supply chain effects, and segmentation- and region-specific insights, concluding with pragmatic recommendations and a transparent description of analytical methods used to derive the findings.

How converging advances in biomarker science, sensor miniaturization, and decentralized care delivery are reshaping diagnostics and monitoring for heart failure patients

Heart failure care is undergoing transformative shifts driven by the interplay of novel biological testing, device miniaturization, and new models of care that prioritize early intervention and longitudinal monitoring. Innovations in genomic, proteomic, and metabolomic testing are expanding the range of biomarkers available to clinicians, enabling more nuanced phenotyping of heart failure syndromes and identifying therapeutic targets previously obscured by clinical heterogeneity. In parallel, biosensor-based systems and imaging-enhanced platforms are permitting continuous or near-real-time physiologic assessment outside traditional hospital settings.

These technological shifts are complemented by evolving clinical pathways that move diagnostic intelligence closer to the patient. Wearable devices and ambulatory diagnostic devices now provide sustained physiologic signals that, when integrated with lab-based assays, create hybrid diagnostic profiles that inform personalized titration of therapies. As interoperability and cloud-native analytics mature, care teams can synthesize longitudinal signals with discrete test results to detect decompensation earlier and reduce avoidable admissions. Regulatory frameworks and reimbursement mechanisms are adapting incrementally, incentivizing outcomes-driven deployments while emphasizing data integrity, clinical validation, and patient safety. Taken together, these developments herald a new era in which diagnostic precision, care decentralization, and digital enablement converge to improve heart failure management.

Assessing how recent United States tariff dynamics are shaping supply chain resilience, sourcing choices, and product design decisions for heart failure diagnostic and monitoring devices

Recent tariff adjustments and trade policy shifts in the United States create complex downstream effects on the supply chains and commercial strategies of manufacturers and distributors serving heart failure point-of-care and line-of-care markets. Tariff-driven increases in component costs can disproportionately affect device makers that rely on specialized sensors, imaging modules, and imported assay reagents. As a result, procurement teams face pressure to seek alternative sourcing, negotiate longer-term supplier agreements, or accelerate vertical integration to preserve margin and ensure continuity of supply.

Beyond direct cost implications, tariffs influence strategic choices such as regional manufacturing footprints, inventory policy, and product design decisions that favor modularity and component standardization. Companies are responding by diversifying suppliers across geographies, qualifying secondary manufacturing sites, and redesigning devices to minimize reliance on tariff-sensitive inputs. For clinical partners and health systems, these changes may alter device availability timelines and necessitate adaptive purchasing strategies that prioritize validated alternatives and accelerate clinical validation of locally sourced technologies. Importantly, regulatory compliance and quality assurance remain non-negotiable during supply chain shifts, and stakeholders must balance speed with rigorous clinical and safety oversight to maintain patient trust and system resilience.

Insights informed by layered segmentation of test modalities, device form factors, enabling technologies, and care settings to prioritize clinical validation and commercialization pathways

Segmentation-driven insight reveals how different modalities and use cases are steering research and commercialization priorities within the heart failure diagnostic landscape. Based on test type, the market is studied across genomic testing, metabolomic testing, and proteomic testing, each offering distinct advantages: genomic approaches help stratify inherited risk and therapy response, metabolomic profiling captures dynamic metabolic derangements linked to congestion and perfusion, and proteomic assays illuminate protein biomarkers that correlate with myocardial stress and remodeling. Together, these test types support a layered diagnostic architecture in which molecular signatures complement physiologic monitoring to refine diagnosis and prognostication.

Based on device type, the market is studied across diagnostic devices and wearable devices. Diagnostic devices are further studied across cardiac biomarker analyzers, cardiac imaging devices, and electrocardiogram (ECG) systems. Cardiac biomarker analyzers enable point-of-care quantification of peptides and enzymes critical for acute assessment, while compact imaging and impedance platforms extend structural and hemodynamic evaluation to non-traditional settings. Electrocardiogram systems remain foundational for rhythm and conduction assessment and are increasingly integrated into multimodal diagnostic suites. Wearable devices are further studied across external defibrillators and heart rate monitors, reflecting a spectrum that ranges from life-saving emergency interventions to continuous physiologic surveillance that supports early intervention.

Based on technology, the market is studied across biosensor-based systems, imaging & impedance-based platforms, immunoassays, and nucleic acid-based platforms. Biosensor-based systems drive continuous, minimally invasive monitoring; imaging and impedance technologies add structural and fluid status context; immunoassays provide rapid protein-based quantification; and nucleic acid platforms facilitate precision-level molecular diagnostics. Based on end user, the market is studied across assisted living healthcare, home care facilities, hospitals & clinics, and laboratory settings, each with unique operational constraints, staffing models, and data integration requirements. When considered together, these segmentation layers reveal where investment and clinical validation should concentrate to create interoperable, clinically actionable diagnostic pathways across care environments.

Regional adoption patterns and regulatory heterogeneity across the Americas, Europe, Middle East & Africa, and Asia-Pacific that influence commercialization strategies and clinical deployment

Regional dynamics materially influence device adoption patterns, regulatory approaches, and partnership models across the Americas, Europe, Middle East & Africa, and Asia-Pacific. In the Americas, health systems increasingly emphasize outpatient management and value-based initiatives that create demand for rapid, actionable diagnostics and remote monitoring solutions. This environment favors devices and platforms that integrate with electronic medical records and support care-coordination workflows, as well as those that demonstrate impact on readmissions and resource utilization.

Across Europe, Middle East & Africa, diverse regulatory landscapes and reimbursement models shape adoption heterogeneously. High-income European markets often prioritize clinical validation and interoperability standards, while resource-constrained settings focus on cost-effectiveness and robustness. As a result, manufacturers must tailor market-entry strategies to local regulatory requirements and demonstrate pragmatic benefits in both tertiary centers and community settings. In the Asia-Pacific region, rapid adoption of digital health, large population cohorts, and growing local manufacturing capacity generate opportunities for scalable deployments of biosensor-enabled wearables and compact diagnostic devices. Strategic partnerships with regional distributors and clinical networks accelerate validation and uptake, while localization efforts in design and service support enhance user adoption. Across all regions, data governance, privacy compliance, and supply chain stability remain critical considerations for successful commercialization.

Analyzing competitive forces where incumbent manufacturers, diagnostics innovators, and tech-enabled entrants converge to form partnerships and differentiate through clinical evidence and service models

Competitive dynamics in the heart failure point-of-care and line-of-care space reflect a mix of established medical device firms, specialized diagnostics developers, and technology-focused entrants that blend hardware, assays, and analytics. Established device manufacturers leverage legacy relationships with health systems and supply chain scale to distribute diagnostic devices and integrated platforms, while smaller innovators focus on niche biologic assays, novel biosensors, and software-enabled monitoring solutions that prioritize user experience and connectivity.

Collaborations between device makers and clinical research networks are increasingly common because co-development helps accelerate real-world validation and payer engagement. Strategic alliances, licensing arrangements, and OEM partnerships enable rapid scaling while preserving clinical credibility. Additionally, the integration of analytics and cloud services creates new value propositions around predictive maintenance, population health management, and remote patient management. As a result, companies that can demonstrate clinical utility, regulatory compliance, and secure data interoperability gain a competitive advantage. Supply chain adaptability, modular product architectures, and the ability to offer bundled hardware-plus-service models further distinguish market leaders from niche players. Ultimately, the competitive landscape rewards organizations that align rigorous clinical evidence generation with nimble commercial execution and robust post-market support.

Practical strategic actions for manufacturers and health system leaders to accelerate adoption, strengthen supply resilience, and align evidence generation with payer priorities

Industry leaders should prioritize a set of actionable measures that accelerate clinical adoption and safeguard commercial resilience. First, align product development with clinically meaningful endpoints and pragmatic trial designs that reflect real-world workflows and demonstrate outcomes that matter to payers and providers. This focus reduces time-to-adoption friction and strengthens reimbursement discussions. Second, invest in supply chain diversification and component standardization to reduce exposure to tariff shocks and geopolitical disruption. Dual-sourcing critical components and qualifying alternate manufacturing sites will enhance continuity and enable more predictable delivery schedules.

Third, design devices and software with interoperability and cybersecurity by default, ensuring seamless integration with electronic health records and remote monitoring platforms while protecting patient data. Fourth, pursue strategic partnerships with care networks and home health providers to validate care models that leverage diagnostic and wearable combinations, enabling smoother commercialization pathways. Fifth, adopt flexible commercial models that combine device sales with subscription-based analytics and service agreements to create recurring revenue and deeper system integration. Finally, maintain an active engagement with regulators and payers to shape pragmatic evidence requirements and to accelerate pathways for reimbursement that reflect real-world value.

Transparent description of the research approach integrating primary interviews, literature synthesis, and scenario analysis to derive actionable insights without relying on numerical market forecasts

This analysis synthesizes primary interviews with clinical leaders, device manufacturers, supply chain experts, and regulatory advisors, complemented by a systematic review of peer-reviewed literature and public regulatory guidance relevant to heart failure diagnostics and monitoring. Primary qualitative input focused on clinical workflows, device usability, sourcing strategies, and commercialization hurdles. Secondary sources provided technical context on biosensor technologies, assay performance characteristics, and recent policy shifts influencing trade and reimbursement. The methodology prioritized triangulation to validate emergent themes across multiple data sources and to surface actionable insights rather than raw market estimates.

Analytical steps included mapping the diagnostic and device ecosystem by test type, device form factor, enabling technology, and end-user environment to reveal where clinical need and technical feasibility align. Scenario analysis explored supply chain responses to tariff and trade policy changes, emphasizing operational strategies that preserve quality and continuity. Evidence synthesis highlighted recurring barriers to adoption-such as integration burden, clinical validation gaps, and reimbursement uncertainty-and identified levers for acceleration including strategic partnerships, localized manufacturing, and flexible commercial models. Wherever applicable, findings were cross-validated with domain experts to ensure relevance and practical applicability for decision-makers.

Synthesis of how innovation, clinical validation, and resilient commercialization strategies must converge to turn diagnostic and monitoring advances into tangible improvements in heart failure care

The landscape of heart failure point-of-care and line-of-care devices is marked by rapid technical innovation, evolving care models, and heightened sensitivity to supply chain and policy dynamics. New molecular tests and biosensor-enabled monitoring are expanding diagnostic possibilities, while modular device architectures and data-driven services are redefining commercial value. Concurrent pressures from trade policy and tariff changes underscore the need for resilient sourcing and adaptive manufacturing strategies that do not compromise clinical quality or regulatory compliance.

Looking ahead, stakeholders who integrate rigorous clinical validation with pragmatic commercialization approaches and robust supply chain planning will be best positioned to capture clinical trust and operational scale. Cross-sector collaboration among manufacturers, care providers, payers, and regulators remains essential to translate technological promise into sustained improvements in patient outcomes. By focusing on interoperability, evidence generation tied to meaningful clinical endpoints, and flexible deployment models suited to regional contexts, organizations can accelerate the adoption of diagnostic and wearable solutions that meaningfully improve heart failure management across care settings.

Table of Contents

1. Preface

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

2. Research Methodology

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Adoption of AI-driven algorithms in point-of-care heart failure diagnostics for predictive risk stratification
• 5.2. Development of microfluidic lab-on-chip platforms enabling multiplexed biomarker detection for heart failure monitoring
• 5.3. Integration of wearable sensor data with point-of-care devices to facilitate remote heart failure patient management
• 5.4. Advancements in nanomaterial-based biosensors for increasing sensitivity of heart failure marker detection in LOC systems
• 5.5. Regulatory pathways accelerating the approval of innovative heart failure point-of-care diagnostic technologies in emerging markets
• 5.6. Collaborative ecosystem between device manufacturers and telehealth providers enhancing connectivity for heart failure management
• 5.7. Commercialization challenges and cost-effectiveness analyses influencing adoption of point-of-care and lab-on-chip devices in heart failure care
• 5.8. Emergence of smartphone-integrated lab-on-chip devices offering portable heart failure biomarker quantification at-home use

6. Cumulative Impact of United States Tariffs 2025

7. Cumulative Impact of Artificial Intelligence 2025

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

• 8.1. Genomic Testing
• 8.2. Metabolomic Testing
• 8.3. Proteomic Testing

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

• 9.1. Diagnostic Devices
  • 9.1.1. Cardiac Biomarker Analyzers
  • 9.1.2. Cardiac Imaging Devices
  • 9.1.3. Electrocardiogram (ECG)
• 9.2. Wearable Devices
  • 9.2.1. External Defibrillator
  • 9.2.2. Heart Rate Monitors

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

• 10.1. Biosensor-based systems
• 10.2. Imaging & impedance-based platforms
• 10.3. Immunoassays
• 10.4. Nucleic acid-based platforms

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

• 11.1. Assisted Living Healthcare
• 11.2. Home Care Facilities
• 11.3. Hospitals & Clinics
• 11.4. Laboratory

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

• 12.1. Americas
  • 12.1.1. North America
  • 12.1.2. Latin America
• 12.2. Europe, Middle East & Africa
  • 12.2.1. Europe
  • 12.2.2. Middle East
  • 12.2.3. Africa
• 12.3. Asia-Pacific

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

• 13.1. ASEAN
• 13.2. GCC
• 13.3. European Union
• 13.4. BRICS
• 13.5. G7
• 13.6. NATO

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

• 14.1. United States
• 14.2. Canada
• 14.3. Mexico
• 14.4. Brazil
• 14.5. United Kingdom
• 14.6. Germany
• 14.7. France
• 14.8. Russia
• 14.9. Italy
• 14.10. Spain
• 14.11. China
• 14.12. India
• 14.13. Japan
• 14.14. Australia
• 14.15. South Korea

15. Competitive Landscape

• 15.1. Market Share Analysis, 2024
• 15.2. FPNV Positioning Matrix, 2024
• 15.3. Competitive Analysis
  • 15.3.1. Abbott Laboratories
  • 15.3.2. ACON Laboratories Inc.
  • 15.3.3. Becton, Dickinson and Company
  • 15.3.4. Bio-Rad Laboratories, Inc.
  • 15.3.5. bioMerieux S.A.
  • 15.3.6. Boston Scientific Corporation
  • 15.3.7. Cipla Limited
  • 15.3.8. Danaher Corporation
  • 15.3.9. F. Hoffmann-La Roche Ltd.
  • 15.3.10. Fukuda Denshi Co., Ltd.
  • 15.3.11. Jant Pharmacal Corporation
  • 15.3.12. Johari Digital India Limited by Syrma SGS
  • 15.3.13. Koninklijke Philips N.V.
  • 15.3.14. LifeSign LLC
  • 15.3.15. LifeSync
  • 15.3.16. Luminex Corporation by DiaSorin S.p.A.
  • 15.3.17. Mitsubishi Chemical Group Corporation
  • 15.3.18. Nexus Dx, Inc
  • 15.3.19. Nihon Kohden Corporation
  • 15.3.20. Quidel Corporation
  • 15.3.21. Schiller AG
  • 15.3.22. Shenzhen EDAN Instrument Co., Ltd.
  • 15.3.23. Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
  • 15.3.24. Siemens Healthineers AG
  • 15.3.25. Spectral Diagnostics Inc.
  • 15.3.26. Trinity Biotech PLC