심부전 POC 및 LOC 장치 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the heart failure pOC and lOC devices market size is expected to grow from USD 185.45 million in 2025 to USD 206.15 million in 2026 and is forecast to reach USD 374.92 million by 2031 at 12.71% CAGR over 2026-2031.

This report is Segmented by Device Type (Point-Of-Care (POC) Devices, and More), Test Type (Proteomic, Metabolomic, Genomic), Platform (Immunofluorescence Readers, and More), End User (Hospitals & IDNs, Primary Care & GP Clinics, and More), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, South America). Market Forecasts are Provided in Terms of Value (USD).

Global Heart Failure POC And LOC Devices Market Trends and Insights

Guideline-Backed Natriuretic Peptide Testing Adoption in ED and Primary Care

Diagnostic societies now require BNP or NT-proBNP results within 1 hour of patient arrival, which central laboratories rarely achieve during peak periods . U.S. cardiology bodies echoed this stance in 2025, effectively doubling the pool of patients eligible for testing in emergency departments. Primary-care uptake is accelerating following the United Kingdom guidance instructing general practitioners to rule out heart failure with NT-proBNP before making referrals. These policies require hospitals to relocate assays from the core lab to triage bays and encourage office-based clinicians to install handheld readers. Vendors that can certify devices to ISO 15189 and EU IVDR standards are enjoying faster market clearance and wider tender eligibility.

APAC Health-System Investments in POCT Infrastructure

Asia-Pacific governments view decentralized diagnostics as a cost-effective way to shorten referral pathways and address uneven laboratory capacity. China earmarked CNY 12 billion (USD 1.7 billion) in 2025 to outfit county hospitals with cardiac biomarker analyzers. India's Ayushman Bharat program favors connected devices that upload results to the national health records system. Japan raised the NT-proBNP reimbursement ceiling to JPY 1,800 (USD 12) per test in 2025, halving payback periods for hospitals. South Korea matched central-lab fees for POC BNP in 2025, eliminating historical cost penalties. These incentives accelerate the distributor's focus on APAC, where device penetration still trails that of the West.

BNP vs NT-proBNP Assay Variability and Drug Interference Risks

Sacubitril-valsartan suppresses BNP but not NT-proBNP, generating discordant readings that can misclassify patients. Cardiology societies now favor NT-proBNP for treated patients, yet many low-cost POC platforms offer only BNP because of simpler reagent chemistry. The American Heart Association advises clinicians to record ARNI use and adjust BNP cutoffs, adding complexity that erodes time savings. Cross-platform variability of up to 20% persists despite early harmonization work by the IFCC. Manufacturers must recalibrate assays to emerging universal standards, a process that could stretch into 2028.

Other drivers and restraints analyzed in the detailed report include:

1. Microfluidic/Digital LOC NT-proBNP Assays Enabling Finger-Stick Workflows
2. Operational Gains from Rapid NP Testing
3. Competition from Point-of-Care Ultrasound and Integrated Care Pathways

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

Segment Analysis

Proteomic assays captured a 51.4% Heart Failure POC and LOC Devices market share in 2025, largely due to entrenched use of BNP and NT-proBNP across triage algorithms. Metabolomic panels are climbing at a 13.67% CAGR because ceramide and acylcarnitine signatures reclassify 22% of patients into higher-risk strata, prompting earlier device therapy initiation . Proteomic testing still benefits from widespread reimbursement and physician familiarity, but clinicians at specialty heart-failure centers are beginning to order metabolomic panels for prognostic fine-tuning. Manufacturers are racing to combine both analyte classes on single cartridges, which could unify guideline compliance with incremental prognostic power. Genomic assays remain in pilot use because payers frequently deem them investigational, yet successful trial outcomes could unlock coverage by 2028.

Metabolomic expansion is also reshaping supplier dynamics. Startups with lipidomics expertise partner with established platform owners to secure analyzer shelf space, while hospital labs benchmark metabolomic cost per quality-adjusted life-year against implantable hemodynamics monitors. If reimbursement parity emerges, metabolomic cartridges could displace single-marker assays in advanced-care pathways. Until then, the Heart Failure POC and LOC Devices market size for proteomic testing will continue to dwarf newer segments, though its growth will trail the metabolomic curve.

Microfluidic digital immunoassay systems accounted for 46.40% of platform revenue in 2025, demonstrating superior analytical sensitivity at low sample volumes. Hospitals deploy them to achieve sub-15-minute turnaround while minimizing nurse handling steps. Immunofluorescence readers, however, are expanding at a 13.32% CAGR because they cost less to acquire and can run a broader menu of infectious-disease tests. The Heart Failure POC and LOC Devices market size for microfluidic platforms is forecast to rise steadily but will concede share to fluorescence systems in community clinics that prioritize upfront affordability over ultralow limits of detection.

Vendor road maps reveal convergence. Siemens launched a chemiluminescence benchtop analyzer that combines 30-test hourly throughput with automatic QC. Quanterix obtained CE-IVD for a handheld reader using single-molecule arrays, pushing microfluidics into price points once reserved for fluorescence. As capital budgets tighten, platform leases bundled with cartridge minimums are replacing outright purchases, generating recurring revenue for suppliers and lower initial outlays for buyers. Integration with cloud analytics will further differentiate offers, as administrators seek dashboards that track reagent burn rates and clinical key performance indicators.

Geography Analysis

North America accounted for 46.25% of global revenue in 2025, supported by Medicare reimbursement rising to USD 24 per test and the elimination of prior authorizations for Medicare Advantage plans. U.S. physician-office laboratories expanded BNP testing after multiple devices earned CLIA-waived status in 2024-2025. Canada pilots POC programs in rural emergency departments, though budget variability among provinces slows full rollout. Mexico's private hospitals adopt analyzers to differentiate premium emergency services, but public-sector uptake lags because central-lab infrastructure is concentrated in urban hubs.

Asia-Pacific is the fastest-growing region and will post a 13.48% CAGR through 2031. China's county-hospital stimulus spurs volume orders for combined cardiac and metabolic analyzers. India's procurement rules favor cloud-connected readers that feed data into the Ayushman Bharat Digital Health network. Japan's reimbursement hike to USD 12 per NT-proBNP test halves payback periods and unlocks capital budgets in mid-size hospitals. South Korea, Australia, and Southeast Asia replicate the pattern, emphasizing decentralized diagnostics to alleviate physician shortages and reduce patient travel distances.

Europe holds a mature but slower-growing position. ESC guidelines require BNP or NT-proBNP within 60 minutes of ED arrival, anchoring steady cartridge demand. However, compliance with the EU IVDR raises validation costs and delays launches, stretching vendor regulatory timelines. Germany leads per-capita analyzer density, while the United Kingdom aligns adoption with NHS funding cycles. Middle East & Africa and South America remain early-stage, with flagship private hospitals in the Gulf and Brazil pioneering placements, but large public tenders are scarce.

1. Abaxis, Inc.
2. Abbott Laboratories
3. Acon Laboratories
4. Beckton Dickinson
5. bioMerieux S.A.
6. Bio-Rad Laboratories
7. BioTelemetry
8. Boston Scientific
9. Danaher
10. Roche
11. GE Healthcare
12. Instrumentation Laboratory
13. Koninklijke Philips
14. Masimo
15. Medtronic
16. Nexus Dx, Inc.
17. QuidelOrtho
18. Shenzhen EDAN Instrument Co., Ltd.
19. Siemens Healthineers
20. Trinity Biotech

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 Guideline-Backed Natriuretic Peptide Testing Adoption In ED And Primary Care (HF Triage and Rule-Out)
  • 4.2.2 Operational Gains from Rapid NP Testing (Shorter ED LOS, Lower Costs, Faster Disposition)
  • 4.2.3 CLIA-Waived BNP Availability Enabling Decentralized US Testing (Urgent Care, Physician Office)
  • 4.2.4 APAC Health-System Investments in POCT Infrastructure Accelerating Adoption
  • 4.2.5 Microfluidic/Digital LOC NT-Probnp Assays Enabling Fingerstick, Near-Patient Workflows
  • 4.2.6 Rise of Prognostic Markers (Sst2) And Multi-Marker HF Panels in POC Pathways
• 4.3 Market Restraints
  • 4.3.1 Mixed/Neutral RCT Evidence on Triage Outcomes for Routine NP POCT In Prehospital/ED Settings
  • 4.3.2 Moderate-Complexity Status of Many NT-proBNP POC Assays Limits Decentralization and Staffing Flexibility
  • 4.3.3 BNP vs NT-proBNP Assay Variability and Drug (ARNI) Interference Risks Complicate Interpretation
  • 4.3.4 Competition From Point-Of-Care Ultrasound (POCUS) And Integrated Care Pathways Reduces Incremental Value in Some ED Cohorts
• 4.4 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 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 Point-of-Care (POC) Devices
  • 5.1.2 Lab-on-Chip (LOC) Devices
• 5.2 By Test Type
  • 5.2.1 Proteomic testing
  • 5.2.2 Metabolomic testing
  • 5.2.3 Genomic testing
• 5.3 By Platform
  • 5.3.1 Immunofluorescence readers
  • 5.3.2 Benchtop chemiluminescence POC
  • 5.3.3 Microfluidic digital immunoassay
• 5.4 By End User
  • 5.4.1 Hospitals & IDNs
  • 5.4.2 Primary Care & GP Clinics
  • 5.4.3 Diagnostic Centers
  • 5.4.4 EMS Providers
  • 5.4.5 Retail Clinics
• 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 India
    • 5.5.3.3 Japan
    • 5.5.3.4 South Korea
    • 5.5.3.5 Australia
    • 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, and Recent Developments)}
  • 6.3.1 Abaxis, Inc.
  • 6.3.2 Abbott Laboratories
  • 6.3.3 ACON Laboratories, Inc.
  • 6.3.4 Becton, Dickinson and Company
  • 6.3.5 bioMerieux S.A.
  • 6.3.6 Bio-Rad Laboratories, Inc.
  • 6.3.7 BioTelemetry, Inc.
  • 6.3.8 Boston Scientific Corporation
  • 6.3.9 Danaher Corporation
  • 6.3.10 F. Hoffmann-La Roche Ltd
  • 6.3.11 GE HealthCare
  • 6.3.12 Instrumentation Laboratory
  • 6.3.13 Koninklijke Philips N.V.
  • 6.3.14 Masimo Corporation
  • 6.3.15 Medtronic plc
  • 6.3.16 Nexus Dx, Inc.
  • 6.3.17 QuidelOrtho Corporation
  • 6.3.18 Shenzhen EDAN Instrument Co., Ltd.
  • 6.3.19 Siemens Healthineers AG
  • 6.3.20 Trinity Biotech PLC

7 Market Opportunities & Future Outlook

• 7.1 White-space & unmet-need assessment