Fractional Flow Reserve (FFR) Market

Market Overview

The global fractional flow reserve (FFR) market size was valued at USD 824.12 million in 2022. It is estimated to reach USD 2,311.18 million by 2031, growing at a CAGR of 12.14% during the forecast period (2023–2031). 

Fractional Flow Reserve (FFR) is an invasive guide wire-based procedure used to measure blood pressure and flow through a specific coronary artery segment. In coronary catheterization, it is utilized to determine the pressure disparities across coronary artery stenosis. Pressure after (distal to) stenosis in comparison to pressure before stenosis is the definition of fractional flow reserve.

The prevalence of CAD has increased significantly over the last few years across the globe, creating opportunities in the market. The market is also surging due to increased awareness among people with cardiovascular diseases and other risk factors.

Its application aids in determining the possibility that the stenosis obstructs the heart's ability to receive oxygen by contrasting the maximum blood flow theoretically achievable in a diseased coronary artery with the maximum flow in a normal coronary artery. It has tiny guidewires that can efficiently traverse arteries and assist surgeons in assessing whether additional procedures, such as stenting or angioplasty, are necessary. Medical professionals widely recommend it because it helps patients avoid extra procedures, such as a stent or bypass surgery, while saving money.

Market Dynamics

Global Fractional Flow Reserve (FFR) Market Drivers

Rising Patient Population of CVDs

Cardiovascular disease (CVD) is the world's foremost cause of death, with an estimated death of 17.9 million people annually. The prevalence of several CVDs like CAD (coronary artery disease) is rising due to changes in lifestyle patterns and an increase in diabetes, hypertension, and obesity/overweight in young and older groups. Generally, people with a history of diabetes, high cholesterol, high blood pressure, smoking, and overweight/obesity have an increased risk of developing CAD.

According to WHO, the worldwide burden of CAD is set to reach 47 million disability-adjusted life years (years lost due to disability, ill health, and death) by 2020. Given the high burden of CAD, it is important to adopt innovative diagnostic platforms such as FFR that can improve procedural outcomes, minimize unnecessary use of stents, and disease management. Thus, the surging patient population is expected to drive market growth.

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, 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

Lower Penetration of FFR

The adoption of FFR is low, and various reasons among end-users limit the use of FFR in the market. Many operators do not consider FFR as they think angiography is good enough. The adoption and use of FFR continue to lag the guidelines and recommendations worldwide. One of the major reasons was that lab operators were more confident that angiography would give them better information for the revascularization process. Lack of reimbursement, adenosine cost, and other side effects are the major reasons limiting the use of FFR in the market.

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 high. 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 fractional flow reserve (FFR) market is bifurcated into North America, Asia-Pacific, Europe, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global fractional flow reserve (FFR) market shareholder and is estimated to exhibit a CAGR of 11.88% during the forecast period. North American region is growing phenomenally compared with other regions due to favorable patient demographics and the availability of the developed infrastructure. The overall economic burden of CVDs continues to grow in this region. Millions of patients experience symptoms potentially associated with coronary artery disease every year. In addition, more than 7 million people in America go to EDs with chest pain complaints annually. The uptake of stent surgeries is also growing, indicating a huge opportunity for FFR diagnostics. For instance, in the US, around 1 in every 13 Americans aged 18 years and above has coronary artery disease.

Additionally, North America accounts for a major share mainly due to the growing volume of SR endovascular surgeries such as PCI for treating several CVDs. The surge in the volume of surgeries is because of the constant technological innovations, availability of advanced healthcare infrastructure, and growing acceptance of advanced technology. The growing prevalence of arterial diseases is also the primary factor behind the market growth.

Europe is expected to exhibit a CAGR of 12.52% 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 facilities performing these and other diagnostic procedures are 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.

Asia-Pacific's fractional flow reserve market is growing faster than in other regions. Japan is a major revenue contributor to the Asia-Pacific FFR market. Some factors contributing to this region's expansion are a large patient population, improvement in the healthcare infrastructure, and rising healthcare expenditure. Likewise, favorable government policies and vendor initiatives in spreading awareness of stents and the incidence of CVDs due to changes in living patterns also contribute to the market growth of the FFR market in the region. For instance, CVDs are India's leading cause of mortality, with over one-fourth of deaths attributed to the illness. According to the Global Burden of Disease (GBD) 2015 study, the lack rate due to CVDs in the country stood at 272 per 100,000 population.

The Latin American market is growing at a moderate rate. One of the major factors driving the market is the increasing target population with ischemic heart disease. Among all the CVDs, ischemic heart disease is the predominant form, with an adjusted mortality rate of 66.4 per 100,000 people in Latin America. The major reason is the increased adoption of Western lifestyles and the soaring prevalence of obesity. However, resistance to shifting toward new technology and lack of awareness among diagnostic technicians and healthcare professionals limit the adoption of advanced methods such as FFR-CT in Latin American countries. Most treatment costs are out-of-pocket expenditures, which further adds challenges to adopting 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 and is projected to grow at a CAGR of 12.93% 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.

Invasive FFR is the most accurate technique for stenosis diagnosis. It is a pressure wire-based technique that measures the stenosis's proximal (Pa) and distal pressure (Pd) (upstream and downstream) using a small sensor on the tip of the wire. The issue with invasive FFR is that it requires an expensive pressure wire, adds procedure time, and necessitates the injection of vasodilator drugs to induce pharmacologic stress (hyperemia), usually with the drug adenosine. This adds cost and time, while adenosine adds to the discomfort of patients. These factors have limited the widespread use of technology.

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 and is predicted to exhibit a CAGR of 11.19% 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.

Multi-vessels coronary artery disease (CAD) is a stage in which at least two or three epicardial coronary arteries are involved with atherosclerosis of significant severity. The treatment of multi-vessel disease aims to reduce angina and heart failure symptoms. In addition, FFR resulting from computed tomography (FFR-CT) is a non-invasive method that distinguishes lesion-specific ischemia. FFR-CT has been shown to have good diagnostic performance in patients with multi-vessel disease with invasive pressure-wire assessment as a reference.

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 hospitals and specialty cardiac centers segment is the largest contributor and is projected to exhibit a CAGR of 11.14% 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.

Specialty cardiology centers (SCCs) provide exclusive healthcare services to patients suspected or diagnosed with CVDs. These centers are dedicated to treating patients with various CVDS, such as vascular stenosis, heart failure, and other cardiac ailments, offering quality care. The specialty cardiology center segment is growing at a healthy rate. This is because of the availability of sophisticated infrastructure for diagnosing and treating CVDs in standalone cardiology centers.

A shift from hospital-based imaging services to outpatient or diagnostic centers-based imaging services has become unavoidable because of the high demand for diagnostic imaging fueled by the rise in chronic conditions and diseases. This includes cardiac diagnostic procedures, such as FFR-CT. Overheads and fixed costs are also greater in hospitals, making outpatient diagnostic centers more financially and operationally efficient. This made people prefer standalone diagnostic imaging centers for the treatment.

Recent Developments

• June 2022- Medix Biochemica acquired all of Bioresource Technology's (BRT) shares to expand its base matrix capabilities and strengthen its local presence in the US market. Due to this acquisition, Medix Biochemica will offer its customers a comprehensive selection of raw materials for its IVD quality control products.
• July 2023- Biosynth, a provider of essential raw materials to the life science industry, announced that it acquired Celares, a leader in the development and manufacturing of conjugate vaccines and bioconjugate pharmaceuticals, activated PEGs, and polymer-based drug delivery excipients.