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Global Fractional Flow Reserve (FFR) Market - Outlook and Forecast 2022-2027
The global fractional flow reserve market achieved a valuation of USD 734.9 million in 2021 and is projected to reach USD 1.4 billion by 2027, registering a compound annual growth rate (CAGR) of 12% during the forecast period. Fractional flow reserve (FFR) serves as the gold standard for assessing coronary artery disease (CAD) in invasive coronary angiography. The demand for FFR is on the rise due to its expanding applications, which contribute to improved patient outcomes, reduced stent insertions, and cost-effective treatment. Despite the numerous advantages offered by FFR, its utilization remains limited in the market, with it commonly being employed to determine the need for revascularization.
The adoption of non-invasive fractional flow reserve systems is increasing thanks to innovative approaches in healthcare systems. As part of the standard diagnostic procedure for CAD, multiple non-invasive tests are conducted on patients who present with stable chest pain and have a low or intermediate probability of CAD. In fact, chest pain stands as the second most common reason for adult emergency visits in the United States.
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USD 1477.5 Mn incremental growth between 2021 and 2026
The market is segmented based on various factors, including Technology, Application, End-Use, and Geography
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The growing target population will play a significant role in driving the usage of fractional flow reserve systems. Cardiovascular diseases account for one-third of global deaths, with ischemic heart disease (IHD) being one of the leading conditions. The incidence of IHD is expected to rise due to factors such as increased obesity rates, prevalence of metabolic syndrome and diabetes, as well as an aging population. Over the past two decades, there has been a substantial increase in the elderly population. According to the United Nations, by 2050, one in every eleven people will be over 65 years old, up from one in every eleven in 2019. Additionally, factors such as reduced physical activity, rapid urbanization, and globalization activities in low- and middle-income countries (LMICs) have contributed to the uptick in cardiovascular diseases, including IHD. In countries like the United States, the cost of IHD approaches 1%-1.5% of the gross domestic product (GDP), while in LMICs, it constitutes 10% of total per capita healthcare expenditure. The expanding global target population will be a driving force behind the growth of the global fractional flow reserve market.
The fractional flow reserve market is witnessing significant technological advancements, particularly in non-invasive methods. This trend boosts the demand for and adoption of next-generation FFR products among healthcare providers and end-users. Key vendors like Boston Scientific, Philips, and ACIST Medical Systems have introduced next-generation products to the market. Artificial intelligence (AI) and machine learning also play vital roles in providing realistic patient experiences with FFR products. AI technology enables end-users to analyze a large volume of cases efficiently, ensuring equal quality treatment for all patients, regardless of the number being diagnosed simultaneously. Image-based techniques such as FFR-CT and FFRangio are increasingly favored by end-users due to their ability to non-invasively assess coronary lesions.
The market is segmented based on various factors, including technology, application, end-use, and geography.
Segmentation by Technology
Segmentation by Applications
Segmentation by End-Users
Hospitals & Specialty Cardiac Centers
Diagnostic Imaging Centers
Segmentation by Geography
North America – US, Canada
Europe – Germany, France, UK, Italy, Spain
APAC – China, Japan, India, South Korea, Australia
Latin America – Brazil, Mexico, Argentina
Middle East & Africa – South Africa, Saudi Arabia, Turkey
In the field of medical diagnostics, invasive fractional flow reserve (FFR) systems are widely recognized as the standard technique for assessing lesion-specific ischemic in patients with 50% to 90% stenosis. However, advancements in the invasive segment have been limited. For example, in 2020, Philips introduced the first solid core pressure guidewire for coronary interventional procedures.
The number of patients admitted to cardiac catheterization laboratories (CATH labs) is decreasing in developed countries due to improvements in the diagnostic capabilities for coronary artery disease. Non-invasive methods are revolutionizing the cardiac diagnostic segment. FFR-CT, a non-invasive technique, has helped reduce the number of patients unnecessarily referred for catheterization. In situations where invasive FFR is ineffective in diagnosing a patient’s condition or when there is insufficient data to recommend stents or other procedures, FFR-CT has proven to be superior to invasive methods. It is seen as a gatekeeper for CATH labs in the market.
One of the primary reasons for the slower adoption of non-invasive FFR systems is that many clinicians still believe that angiography provides better results and is sufficient for determining the treatment pathway for patients. The choice of diagnostic steps also depends on local practitioners, with many preferring CT scans, nuclear tests, and invasive angiography.
Technological advancements in the market have enabled clinicians to diagnose patients with multivessel diseases, which pose complex challenges for invasive methods. Non-invasive techniques provide the 3D structure of the heart along with FFR values, identifying possible stenosis locations. This represents a major breakthrough in treating patients with multivessel diseases, a condition that is becoming increasingly common in both developing and developed countries.
Hospitals and specialty cardiac centers are typically the first point of contact for patients, particularly in emergency situations such as chest pain. As a result, the number of people seeking treatment at hospitals is increasing, prompting these institutions to invest in the latest technologies to attract patients. Most elective surgeries and complex cardiac procedures are performed in specialty cardiac centers.
Office-based labs represent a new trend in laboratory spaces. The desire for better attention, safer treatments, and quicker access to care has led to a shift of both patients and doctors away from traditional hospitals towards these types of labs.
Diagnostic imaging centers primarily invest in advanced products to attract customers, often partnering with clinics and hospitals to indirectly provide their services. These centers are expected to experience faster growth during the forecast period.
In many developed countries, such as the United States, there is a shift from volume-based to value-based approaches in healthcare systems. This trend favors the adoption of advanced products like FFR-CT. Some European countries also prefer value-based products to enhance treatment quality. However, developing countries like India, China, Brazil, Mexico, and Turkey still mainly rely on volume-based treatments, considering them more cost-effective and providing satisfactory outcomes.
In terms of market dominance, the United States currently leads the global fractional flow reserve market. Factors contributing to this include the rapid adoption of value-based products in the US healthcare system, increased awareness among clinicians, and the growing use of FFR-CT.
In Europe, healthcare providers adopt a combination of value-based and volume-based approaches. Value-based treatment providers tend to adopt advanced technologies more quickly. However, some developing economies in Europe have low adoption rates for advanced technologies. The proliferation of CATH labs and office-based labs is driving the usage of advanced products and promoting growth in the non-invasive fractional flow reserve market.
In the Asia-Pacific (APAC) region, the adoption of advanced products like FFR remains limited. Despite an increasing number of cardiovascular disease patients and a rise in diagnostic tests performed, there is still a high demand for invasive methods compared to non-invasive techniques. Nonetheless, due to its significant market potential, the APAC region is expected to experience the highest growth during the forecast period.
Latin American countries are becoming popular destinations for various medical treatments. Urban hospitals in Latin America show high adoption rates for advanced technologies to attract medical tourists. However, due to limited reimbursement options, local patients prefer more affordable tests. Additionally, a shortage of skilled lab technicians restricts the use of conventional methods in the market.
The Middle East and Africa region exhibit lower compound annual growth rates (CAGR) compared to other regions. While the region has a substantial population of over 1.1 billion people, only 20 countries have CATH labs. The potential demand for FFR-based products is high in this market due to the larger target population. As more economical products become available, the fractional flow reserve market will continue to grow in this region.
Key players in the global fractional flow reserve market include Abbott, ACIST Medical Systems, Boston Scientific, CathWorks, General Electric Company, Koninklijke Philips, Opsens, and Siemens Healthineers.
Companies such as HeartFlow are implementing advanced methodologies to introduce improved products. Their technology utilizes computational fluid dynamics models and precise coronary segmentation to identify areas of interest and generate interactive images with FFR values, enabling doctors to make accurate decisions. Additionally, one of the significant advantages of their FFR-CT technology is its ability to provide superior results without the need for invasive angiograms. To enhance results and diagnostic accuracy, they also employ AI technology.
In 2018, CathWorks received approval from the US Food and Drug Administration (FDA) for FFRangio. Furthermore, in 2021, the CathWorks System will obtain National Reimbursement Approval in Japan.
Key Questions Answered
What is the estimated value of the global fractional flow reserve market?
The global fractional flow reserve market was valued at USD 734.9 million in 2021 and is projected to reach USD 1.4 billion by 2027.
What is the growth rate of the global fractional flow reserve market?
The global fractional flow reserve market is expected to grow at a compound annual growth rate (CAGR) of 12% during the period of 2022-2027.
Which region has the highest growth rate in the fractional flow reserve market?
The Asia-Pacific region is expected to witness the highest growth rate in the fractional flow reserve market during the period of 2022-2027.
Which region has the largest market share of fractional flow reserve globally?
North America holds the largest market share of fractional flow reserve globally, with the United States dominating the market.
Who are the key players in the fractional flow reserve market?
The key players in the global fractional flow reserve market include Abbott, ACIST Medical Systems, Boston Scientific, CathWorks, General Electric Company, Koninklijke Philips, Opsens, and Siemens Healthineers.