Fractional Flow Reserve (FFR) Market Size, Share & Trends Analysis Report By Technology (Invasive, Non-Invasive), By Applications (Single-Vessel, Multi-Vessel), By End-Users (Hospitals and Specialty Cardiac Centers, Office-Based Labs, Diagnostic Imaging Centers, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2024-2032

Market Overview

The global fractional flow reserve (FFR) market size was valued at USD 920.24 million in 2023. It is estimated to reach USD 2580.75 million by 2032, growing at a CAGR of 12.14% during the forecast period (2024–2032). In the past few years, with the adoption of unhealthy and sluggish lifestyles worldwide, the prevalence of cardiovascular diseases has risen globally, thereby driving the global fractional flow reserve (FFR) market. Furthermore, advancements in the fractional flow reserve (FFR) technology are estimated to enhance its efficiency and, in turn, create opportunities for global market expansion.

Highlights

• Non-invasive dominates the technology segment.
• Single-vessel dominates the application segment.
• Hospitals and specialties dominate the end-user segment.
• North America is the highest shareholder in the global market.

Market Overview

Fractional Flow Reserve (FFR) is a medical term that describes the ratio of blood flow through a narrowed or blocked coronary artery to the maximum possible blood flow through that artery. It assesses the functional significance of coronary stenosis, which is a narrowing or obstruction of the coronary arteries that supply blood to the heart muscle. FFR is calculated by dividing the blood flow through the narrowed or blocked artery by the maximum blood flow through that artery, which is typically measured during a cardiac catheterization procedure. The resulting value is expressed as a percentage, with a higher value indicating a more severe stenosis.

FFR is used to determine the severity of coronary artery disease and to inform treatment decisions. It is especially useful for determining whether a patient with coronary artery disease needs angioplasty or bypass surgery. A low FFR value indicates that the narrowed or blocked artery is not significantly reducing blood flow to the heart muscle, and thus, intervention may not be necessary. A high FFR value, on the other hand, indicates that a narrowed or blocked artery is significantly reducing blood flow to the heart muscle, necessitating intervention to improve blood flow and lower the risk of a heart attack or other complications.

Market Dynamics

Global Fractional Flow Reserve (FFR) Market Drivers

Increasing Prevalence of Cardiovascular Diseases

The rising incidence of cardiovascular diseases (CVDs) is a significant driver for the Fractional Flow Reserve (FFR) market. According to the World Health Organization (WHO), CVDs are the leading cause of death globally, accounting for an estimated 17.9 million deaths annually. This surge in cardiovascular conditions has heightened the demand for accurate diagnostic methods to assess the severity of coronary artery disease (CAD), thereby boosting the adoption of FFR.

FFR, an index used during coronary angiography, provides precise measurements of blood pressure and flow through a specific part of the coronary artery, helping in the identification of significant blockages that may require intervention. The American Heart Association (AHA) emphasizes the importance of FFR in guiding percutaneous coronary intervention (PCI), which is pivotal for patient outcomes. As the global burden of CVDs continues to rise, the need for advanced diagnostic tools like FFR is expected to grow, driven by the aim to reduce mortality rates and improve the quality of life for patients with coronary artery disease.

Increasing Number of CATH Labs

The FFR and FFR CT procedures are largely performed in CATH Labs. These procedures take around 30 minutes and provide a 3D model of the coronary arteries, helping doctors determine the next treatment plan. More than 3.5 million procedures are carried out in European catheterization labs every year, and the number is constantly increasing in the market. The FFR is one of the important procedures in CATH labs.

In cardiac CATH labs, FFR use has gone high. One of the major benefits of undergoing FFR in the CATH lab is cost savings. The cost of FFR procedures is approximately USD 700, less than the cardiac nuclear scan of approximately USD 1,000. FFR has increasingly provided enhanced patient convenience, mitigating the need for superfluous stent treatments. Such factors are estimated to expand the market size.

Global Fractional Flow Reserve (FFR) Market Restraint

High Cost of FFR Procedures and Devices

Despite its clinical benefits, the high cost of FFR procedures and devices acts as a significant restraint to market growth. The cost associated with FFR measurements includes the price of the pressure wire, the hyperemic agents, and the additional time required in the catheterization laboratory. This can make FFR-guided PCI procedures substantially more expensive compared to conventional angiography-guided interventions. According to a study published in the Journal of the American College of Cardiology, the incremental cost of using FFR can be a barrier, especially in healthcare systems with limited budgets or in regions where patients bear a significant portion of the treatment costs.

Furthermore, the adoption of FFR is limited in low- and middle-income countries due to economic constraints and lack of reimbursement policies. In these regions, the healthcare infrastructure often prioritizes more cost-effective diagnostic and therapeutic options. The financial burden associated with FFR can deter healthcare providers from adopting this technology, thereby limiting its widespread implementation. To overcome this barrier, there is a need for cost-effective solutions and favorable reimbursement policies that can make FFR procedures more accessible to a broader patient population.

Global Fractional Flow Reserve (FFR) Market Opportunities

Artificial Intelligence and Machine Learning Revolutionizing FFR-CT

The healthcare imaging industry is undergoing a significant transformation due to the advancements in Artificial Intelligence and Machine Learning technology. Many medical academic institutes are involved in research based on AI and ML. This will enhance the application of FFR-CT in various other applications and increase the accuracy of treatment, reducing the mortality rate in emergency care, especially among patients admitted with chest pain. In addition, the adoption of these technologies has also gone up.

For instance, to combat coronary heart disease (CHD), the main cause of death in the UK, the National Health Service England (NHSE) and NHS Improvement have mandated that English hospitals employ the AI-powered HeartFlow FFRCT Analysis starting in 2021. Similarly, there are other advances in the market. For instance, in 2018, ML-based FFR was performed and provided better results to end-users. It was observed that CT FFR on ML improved the performance of Coronary computed tomographic angiography by correctly reclassifying hemodynamically nonsignificant stenosis and performed equally well as CFD-based CT-FF. Such advancements are expected to create opportunities for market growth.

Regional Analysis

Based on region, the global market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. 

North America Dominates the Global Market

The North American region stands as the leading market for Fractional Flow Reserve (FFR) diagnostics and is anticipated to experience significant growth during the forecast period. This expansion is driven by several key factors, including favorable patient demographics and a robust healthcare infrastructure. Cardiovascular diseases (CVDs) present a growing economic burden in North America, with millions of patients annually exhibiting symptoms of coronary artery disease. Over 7 million individuals in the U.S. visit emergency departments each year due to chest pain, underscoring a high demand for diagnostic interventions such as FFR.

The increasing prevalence of arterial diseases and a rising number of stent surgeries highlight substantial opportunities for FFR diagnostics. Approximately 1 in 13 Americans aged 18 and older are affected by coronary artery disease, reflecting a large patient base. Furthermore, the region's dominance is attributed to the surge in endovascular procedures like percutaneous coronary interventions (PCI), driven by continuous technological advancements and the adoption of cutting-edge healthcare solutions. North America's significant market share is also supported by its advanced medical infrastructure and high acceptance of innovative technologies in cardiovascular care.

Europe is expected to exhibit significant growth over the forecast period. This region is rising steadily due to the favorable patient demographic and the high awareness of various advanced treatment options and technologically advanced non-invasive cardiovascular treatments. The prevalence of cardiovascular diseases is increasing drastically across Europe due to various risk factors such as decreased physical work, increased age population, and obese population. Interventional cardiology in Europe is ever-expanding. The number of facilities performing these and other diagnostic procedures is increasing in the region.

In addition, the number of stenting procedures performed in Europe is increasing due to various favorable conditions such as reimbursement and faster adoption of healthcare technologies among physicians. Office labs are also decreasing in European countries due to the lack of proper reimbursement. However, CATH labs are slowly increasing, driving the use of FFR procedures.

Segmental Analysis

The global fractional flow reserve (FFR) market is bifurcated into technology, application, and end-users.

Based on technology, the global fractional flow reserve (FFR) market is divided into invasive and non-invasive FFR.

The non-invasive FFR segment is the highest contributor to the market throughout the forecast period. New technologies may replace the traditional pressure wires and adenosine to assess FFR. This includes image-derived FFR tests that can be done while the patient is on the exam table in the CATH lab, such as non-invasive computed tomography imaging-derived FFR (FFR-CT) and X-ray angiography-derived FFR (FFR-angio). The non-invasive FFR system could be a breakthrough technology that transforms how catheterization laboratories work to improve patients. Due to the benefits of non-invasive methods, the adoption of this method among physicians is increasing, and many independent laboratories and CATH labs are also investing in non-invasive technologies.

Based on application, the global fractional flow reserve (FFR) market is bifurcated into single-vessel and multi-vessel.

The single-vessel segment dominates the global market during the forecast period. FFR was initially used only to treat single-vessel coronary stenosis. Post technological advances, the use of FFR has expanded its applications in emergency rooms' first line of treatment for chest pains, myocardial infarctions, and other cardiovascular emergencies. This adds up the applications and increases the use of FFR. The rise in the target population base is one of the major driving factors for using FFR.

Based on end-users, the global fractional flow reserve (FFR) market is bifurcated into hospitals and specialty cardiac centers, office-based labs, diagnostic imaging centers, and others.

The hospital and specialty cardiac center segment has been the largest contributor over the forecast period. For decades, hospitals have been the primary options for the basic diagnosis of various cardiovascular diseases as they are the traditional healthcare providers. As a result, most patients prefer undergoing advanced treatment in hospitals than any other healthcare center because of their convenient locations and easy access. The aging population and advances in FFR devices are the major aspects driving the market growth of the hospital segment.

Recent Developments

• February 2024- Cleerly, a company that is revolutionizing the diagnosis of heart disease, has announced that their Cleerly ISCHEMIA software device, which has been recently cleared by the U.S. Food and Drug Administration (FDA), can now be billed using the new Category I CPT code 75580 when applied to a non-invasive coronary CT angiogram (CCTA). According to the American Medical Association (AMA), this service is described as a supplemental tool that uses advanced intelligence to provide noninvasive estimations of fractional flow reserve (FFR).