United States Fractional Flow Reserve Market 2031 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

The Global Fractional Flow Reserve Market reached US$ 881.35 million in 2023 and is expected to reach US$ 2,047.68 million by 2031, growing at a CAGR of 11.27% during the forecast period 2024-2031.

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Key Development:

United States: Recent Industry Developments

✅ In December 2025, Royal Philips agreed to acquire SpectraWAVE Inc., integrating the X1-FFR AI-enabled coronary physiology platform into its cardiovascular portfolio. The acquisition strengthens Philips' intravascular imaging and FFR-related capabilities. It enhances AI-driven decision support in coronary interventions.

Japan: Recent Industry Developments

✅ In October 2025, Japan's Ministry of Health, Labour and Welfare enabled national reimbursement for MedHub-AI's AutocathFFRTM system, allowing automated AI-based FFR assessment during routine coronary angiography. The decision supports faster clinical adoption across Japanese hospitals. It improves access to physiology-guided coronary care.

✅ In October 2025, MedHub-AI expanded deployment of its AutocathFFRTM platform through strategic collaboration with Terumo Corporation, accelerating hospital-level integration across Japan. The partnership focuses on scaling AI-driven coronary physiology analysis. It strengthens Japan's digital cardiology ecosystem.

Key Players:

=> Boston Scientific Corporation, Abbott Laboratories, Koninklijke Philips N.V., CathWorks Ltd., Opsens Inc (Haemonetics), HeartFlow Inc., Siemens Healthineers AG, Pie Medical Imaging B.V., Acist Medical Systems, Medis Imaging among others.

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Key Segments:

By Device Type

Pressure Guidewire - ~45% share, dominant segment due to widespread use in invasive fractional flow reserve (FFR) procedures during coronary angiography.
Monitoring Systems - ~35% share, driven by adoption of integrated FFR consoles and real-time hemodynamic monitoring platforms.
Non-Invasive Scanning Systems - ~20% share, fastest-growing segment supported by advancements in CT-FFR and AI-based imaging analytics.

By Measurement Method

Invasive FFR - ~60% share, considered the clinical gold standard for assessing coronary artery disease severity.
Non-Invasive FFR - ~40% share, rapidly growing due to reduced procedural risk, lower cost, and increasing use of CT-based diagnostics.

By Application

Single-Vessel CAD Evaluation - ~40% share, high utilization in routine diagnostic assessments.
Multi-Vessel CAD Evaluation - ~30% share, growing demand driven by complex coronary artery disease cases.
CABG Assessment - ~15% share, used to evaluate graft patency and procedural outcomes.
Others - ~15% share, includes post-PCI assessment and research applications.

By End User

Hospitals - ~45% share, primary adopters due to advanced cardiac care infrastructure and high procedural volumes.
Cardiac Catheterization Labs - ~30% share, specialized centers focused on interventional cardiology procedures.
Ambulatory Surgical Centers (ASCs) - ~15% share, growing adoption for minimally invasive diagnostic procedures.
Others - ~10% share, includes specialty clinics and research centers.

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By Region

North America - ~35% Share
Largest market supported by high prevalence of coronary artery disease, advanced reimbursement systems, and early adoption of non-invasive FFR technologies.

Europe - ~25% Share
Growth driven by strong clinical adoption, guideline support, and increasing use of CT-FFR in diagnostic workflows.

Asia Pacific - ~30% Share
Fastest-growing region due to rising cardiovascular disease burden, expanding catheterization labs, and healthcare infrastructure development.

South America - ~5% Share
Gradual growth supported by improving access to advanced cardiac diagnostics.

Middle East & Africa - ~5% Share
Emerging market driven by increasing investment in cardiac care facilities and diagnostic modernization.

FAQ

What is the current size of the Fractional Flow Reserve Market?

A: In 2023, the Fractional Flow Reserve Market was valued at US$ 881.35 million , reflecting its strong industry presence.

Q2: How large is the Fractional Flow Reserve Market expected to be by 2031?

A: By 2031, industry forecasts suggest the Fractional Flow Reserve Market will grow to around US$ 2,047.68 million, demonstrating significant expansion.

Q3: What is the growth rate of the Fractional Flow Reserve Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 11.27% during the forecast period from 2024 to 2031.

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