Summary

Image based FFR Diagnosis Market Size
The global image based FFR diagnosis market size was valued at $1.33 billion in 2025 and is projected to reach $2.49 billion by 2031, growing at a CAGR of 11.0% during the forecast period.

Image based FFR Diagnosis Market Overview
Image-based fractional flow reserve (FFR) diagnosis represents a significant advancement in the assessment of coronary artery disease, utilizing non-invasive imaging techniques to estimate the hemodynamic significance of coronary lesions. This approach leverages computational fluid dynamics and coronary imaging data, such as from computed tomographic angiography (CTA) or traditional angiography, to derive FFR values without the need for invasive pressure wire measurements or the administration of vasodilators. For example, technologies like FFRangio and QFR have been developed to provide rapid assessments directly in the catheterization lab, significantly reducing procedural time and complications associated with traditional methods.
Companies can benefit from this innovation by enhancing their product offerings, improving patient outcomes, and streamlining clinical workflows. The adoption of image-based FFR can lead to cost savings in healthcare by minimizing the need for invasive procedures and associated hospital stays, thus appealing to healthcare providers and payers. Additionally, regulatory approvals, such as those received by Medis for its QAngio XA 3D technology, highlight the growing acceptance and potential market for these non-invasive diagnostic tools, creating opportunities for companies to capture a larger share of the cardiology market while improving the standard of care for patients with coronary artery disease.

Image based FFR Diagnosis Market Dynamics
The image based FFR diagnosis market is expected to witness significant growth in the future due to the increasing prevalence of cardiovascular diseases (CVD) globally, advancements in imaging technologies enhancing the accuracy and efficiency of FFR diagnosis, and growing geriatric population. However, the high costs associated with advanced imaging technologies and FFR procedures, limited availability of trained professionals, and competition from alternative diagnostic methods are restraining the growth of the market.

Furthermore, expansion of healthcare infrastructure in emerging markets, increasing access to advanced diagnostic tools, development of non-invasive FFR techniques, and growing partnerships between technology companies and healthcare providers are the key trends propelling the image based ffr diagnosis market.

Increasing Prevalence of Cardiovascular Diseases (CVD) Globallyis Driving the Image based FFR Diagnosis Market
The increasing prevalence of cardiovascular diseases (CVD) globally is significantly impacting the image based FFR diagnosis market, for several reasons. With the growing incidence of coronary artery diseases (CADs), there is a heightened demand for advanced diagnostic tools like FFR devices. CVDs are responsible for approximately 17.9 million deaths worldwide annually, with the incidence of unstable angina reaching about 60 out of 100,000 individuals in industrialized countries. The favorable reimbursement scenario for FFR procedures, along with advancements in non-invasive technologies like HeartFlow's cardiac computed tomography-derived FFR technology, further supports the growth of the global FFR devices market. R&D focus on the development of image-based non-invasive FFR technologies such as FFR derived from computed tomography angiography (FFRCT), FFR derived from angiography (FFRQCA), and frequency-domain OCT (FD-OCT) is increasing. These technologies have significant superiority over traditionally invasive FFR procedures and can be a potential diagnostic tool for lesion-specific ischemia.
• For instance, in April 2019, the Indian government launched the Faster Adoption and Manufacturing of Hybrid and Electric Vehicles (FAME) initiative with a budget of $1 billion to boost the adoption of hybrid and electric vehicles.
• Similarly, in October 2022, the wholesale volume of new energy vehicle (NEV) passenger cars in China reached 676,000 units, reflecting an 85.8% year-on-year increase.
These factors, coupled with the aging population and the rising prevalence of risk factors such as high blood pressure, smoking, diabetes, and obesity, are contributing to the growth of the image-based FFR diagnosis market worldwide.

By Application, the Hospital Segment is projected to be the Largest Segment in the Image based FFR Diagnosis Market
Hospital is the largest segment in the image based FFR diagnosis market, driven by rising prevalence of cardiovascular diseases (CVDs) and the need for advanced diagnostic technologies. CVDs are responsible for approximately 17.9 million deaths globally each year, prompting healthcare providers to seek effective diagnostic solutions that can accurately assess coronary artery disease (CAD) and improve patient outcomes. Hospitals are increasingly adopting non-invasive imaging techniques, such as computed tomography-derived FFR (CT-FFR), which provide detailed insights into coronary blood flow without the need for invasive procedures.
• For instance, HeartFlow, a leading company in this space, has developed a CT-FFR technology that has gained traction in hospitals, allowing for better clinical decision-making and reducing the need for unnecessary invasive tests.
Additionally, government initiatives, such as the implementation of favorable reimbursement policies for FFR procedures, have further incentivized hospitals to invest in these advanced diagnostic tools.
Overall, the convergence of rising CVD prevalence, technological advancements, and supportive healthcare policies is creating a robust demand for image-based FFR diagnosis in hospitals.

By Geography, North America Holds the Largest Share in the Market Revenue
North America holds the largest share of the image based FFR diagnosis market, driven by rising prevalence of cardiovascular diseases, advancements in imaging technologies, and increasing adoption of minimally invasive procedures. The United States and Canada are the major contributors to the growth of this market in the region. In the United States, the government has been actively promoting the integration of artificial intelligence (AI) into healthcare, particularly in medical imaging.
• In September 2022, the National Institutes of Health (NIH) announced plans to allocate $130 million over four years to accelerate the adoption of AI in biomedical and behavioral research through the Bridge2AI initiative. This funding aims to support the development of specialized AI tools, resources, and datasets to facilitate broader adoption of AI technology in the healthcare sector.
Furthermore, the U.S. Food and Drug Administration (FDA) is working on developing a regulatory framework for software modifications driven by AI and machine learning (ML) to ensure the safety and efficacy of these technologies. These government initiatives are expected to drive the growth of the Image-based FFR Diagnosis market in the United States.In Canada, the increasing adoption of advanced imaging technologies and the rising awareness about the benefits of minimally invasive procedures are contributing to the growth of the Image-based FFR Diagnosis market.
• Companies like HeartFlow, Medis QFR, and Beijing Heart Century are actively involved in the development and commercialization of image-based FFR diagnosis solutions in the North American region.
The emergence of industry-specific AI and IoT technologies is also creating opportunities for growth in the Image-based FFR Diagnosis market.
• For example, Rayscape CXR, an AI-powered solution, can distinguish between regular X-rays and those presenting abnormalities, streamlining patient treatment and facilitating prompt physician assessment. The ability of this technology to identify more than 147 pathologies provides a rapid and effective means for doctors to prioritize and manage patient requirements.

Key Target Audience:
• Healthcare Providers and Hospitals
• Interventional Cardiologists and Medical Professionals
• Medical Device Manufacturers and Suppliers
• Regulatory Agencies and Health Authorities
• Research Institutions and Academic Organizations

List of the Key Players Profiled in the Report Includes:
• HeartFlow
• Medis QFR
• Beijing Heart Century
• RainMed
• AITROX
• Keya Medical
• Beijing GuanShengYun
• ShengShi
• Shenzhen Escope Tech
• Pulse Medical Imaging
• Shukun
• Raysight
• Cathworks

Recent Developments:
• In May 2024, GE HealthCare and Medis Medical Imaging announced a collaboration to further develop and commercialize the Medis Quantitative Flow Ratio (Medis QFR), a non-invasive approach to assessing coronary physiology.
• In June 2024, Raysight, a leading AI and IoT technology provider for the medical imaging industry, announced the launch of Rayscape CXR, an AI-powered solution that can distinguish between regular chest X-rays and those presenting abnormalities.Rayscape CXR is capable of identifying more than 147 pathologies, providing a rapid and effective means for doctors to prioritize and manage patient requirements
• In September 2024, HeartFlow, a leader in revolutionizing precision heart care, announced that it has received FDA clearance for its next-generation FFRct Analysis. The new technology incorporates advanced algorithms and machine learning to provide physicians with rapid, highly accurate, and personalized insights into the functional severity of coronary artery disease.

Market Segmentation:
The research report includes in-depth coverage of the industry analysis with size, share, and forecast for the below segments:

Market by, Type:
• CT-FFR (Computed Tomography Fractional Flow Reserve)
• QFR (Quantitative Flow Reserve)
• OFR (Optical Flow Reserve)

Market by, Application:
• Hospital
• Imaging Center

Market by, Geography:
The image based FFR diagnosis market report also analyzes the major geographic regions and countries of the market. The regions and countries covered in the study include:
• North America (The United States, Canada, Mexico), Market Estimates, Forecast & Opportunity Analysis
• Europe (Germany, France, UK, Italy, Spain, Rest of Europe), Market Estimates, Forecast & Opportunity Analysis
• Asia Pacific (China, Japan, India, South Korea, Australia, New Zealand, Rest of Asia Pacific), Market Estimates, Forecast & Opportunity Analysis
• South America (Brazil, Argentina, Chile, Rest of South America), Market Estimates, Forecast & Opportunity Analysis
• Middle East & Africa (UAE, Saudi Arabia, Qatar, Iran, South Africa, Rest of Middle East & Africa), Market Estimates, Forecast & Opportunity Analysis

The report offers insights into the following aspects:
• Analysis of major market trends, factors driving, restraining, threatening, and providing opportunities for the market.
• Analysis of the market structure by identifying various segments and sub-segments of the market.
• Understand the revenue forecast of the market for North America, Europe, Asia-Pacific, South America, and Middle East & Africa.
• Analysis of opportunities by identification of high-growth segments/revenue pockets in the market.
• Understand major player profiles in the market and analyze their business strategies.
• Understand competitive developments such as joint ventures, alliances, mergers and acquisitions, and new product launches in the market.

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Table of Contents

1 Market Introduction
1.1 Market Definition
1.2 Research Scope and Segmentation
1.3 Stakeholders
1.4 List of Abbreviations

2 Executive Summary

3 Research Methodology
3.1 Identification of Data
3.2 Data Analysis
3.3 Verification
3.4 Data Sources
3.5 Assumptions

4 Market Dynamics
4.1 Market Drivers
4.2 Market Restraints
4.3 Market Opportunities
4.4 Market Challenges

5 Porter's Five Force Analysis
5.1 Bargaining Power of Suppliers
5.2 Bargaining Power of Buyers
5.3 Threat of New Entrants
5.4 Threat of Substitutes
5.5 Competitive Rivalry in the Market

6 Global Image based FFR Diagnosis Market by, Type
6.1 Overview
6.2 CT-FFR (Computed Tomography Fractional Flow Reserve)
6.3 QFR (Quantitative Flow Reserve)
6.4 OFR (Optical Flow Reserve)

7 Global Image based FFR Diagnosis Market by, Application
7.1 Overview
7.2 Hospital
7.3 Imaging Center

8 Global Image based FFR Diagnosis Market by, Geography
8.1 Overview
8.2 North America
8.2.1 US
8.2.2 Canada
8.2.3 Mexico
8.3 Europe
8.3.1 Germany
8.3.2 France
8.3.3 UK
8.3.4 Italy
8.3.5 Spain
8.3.6 Rest of Europe
8.4 Asia Pacific
8.4.1 China
8.4.2 Japan
8.4.3 India
8.4.4 South Korea
8.4.5 Australia
8.4.6 New Zealand
8.4.7 Rest of Asia Pacific
8.5 South America
8.5.1 Brazil
8.5.2 Argentina
8.5.3 Chile
8.5.4 Rest of South America
8.6 Middle East & Africa
8.6.1 UAE
8.6.2 Saudi Arabia
8.6.3 Qatar
8.6.4 Iran
8.6.5 South Africa
8.6.6 Rest of Middle East & Africa

9 Key Developments

10 Company Profiling
10.1 HeartFlow
10.1.1 Business Overview
10.1.2 Product/Service Offering
10.1.3 Financial Overview
10.1.4 SWOT Analysis
10.1.5 Key Activities
10.2 Medis QFR
10.3 Beijing Heart Century
10.4 RainMed
10.5 AITROX
10.6 Keya Medical
10.7 Beijing GuanShengYun
10.8 ShengShi
10.9 Shenzhen Escope Tech
10.10 Pulse Medical Imaging
10.11 Shukun
10.12 Raysight
10.13 Cathworks