Fractional Flow Reserve Market Size, Share & Trends Analysis Report By Application (Multi-vessel CAD, Single-vessel CAD), By Product (Monitoring Systems, Guidewires), By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global fractional flow reserve market size was valued at USD 736.9 million in 2021 and is anticipated to exhibit a compound annual growth rate (CAGR) of 10.5% from 2022 to 2030. There has been an upswing in the cases of cardiovascular diseases such as coronary artery diseases and high blood pressure, which has been a key factor in the growth of the market. According to the WHO, an expected 17.9 million individuals died from cardiovascular diseases in 2019, indicating 32% of all global deaths.

HeartFlow’s non-invasive cardiac computed tomography-derived FFR technology allows virtual FFR values for the complete coronary tree of a patient using just a computed tomography scan. This information helps doctors to determine whether to send a chest pain patient to the Cath lab for revascularization or if therapeutic treatment is preferred. The outcome of diverting patients away from unnecessary invasive diagnostic angiograms can assist in lower costs and lead to faster patient discharge. This technology was integrated into the American College of Cardiology Chest Pain Guidelines of 2021. Thus, such guidelines supported the growth during the COVID-19 pandemic. As a result, it positively impacted market growth.

According to an article published by The Society for Cardiovascular Angiography and Interventions (SCAI) in May 2019, FFR provides valuable insights post angiography and can impact the treatment plans and outcomes in patients with acute coronary syndrome (ACS) stable coronary artery disease (CAD), which reinforces the importance of better patient management, which is anticipated to increase adoption of the same during the forecast period.

Furthermore, the rising geriatric population is poised to keep the demand for fractional flow reserve high. Old-aged individuals are more prone to cardiovascular diseases and chronic diseases such as diabetes. Type II diabetes can further lead to the development of fatty cells in the coronary artery, which can cause blockage, thereby causing a stroke or heart attack. The global geriatric population is expected to grow exponentially in the next few years, owing to the late baby boomers in countries such as Japan, China, and Brazil, among others. The population of individuals aged 65 years and above was estimated to be 703 million in 2019 by the United Nations, which is projected to double to 1.5 billion in 2050.

The growing incidence of coronary artery diseases and diabetes in the U.S. is working in favor of the market for Fractional Flow Reserve. Diabetes cases are on a rise due to the unhealthy eating habits of the populace in the country, which is further leading to obesity and associated diseases. For instance, in 2016, according to WHO, more than 1.9 billion adults in the U.S. were obese. In addition, the rising adoption of fractional flow systems in conjugation with OCT, for patients suffering from cardiovascular diseases, especially in the U.S., is likely to broaden the consumer base in the near future.

Product Insights

The FFR guidewires segment accounted for the dominant share of over 58.0% in 2021 owing to their extensive usage in diagnostic cardiovascular procedures. This segment is estimated to register a healthy CAGR during the projection period owing to rising usage for coronary artery disease diagnosis globally. For instance, in 2019, according to the Centers for Disease Control and Prevention (CDC), about 360,900 individuals died owing to coronary artery disease in the U.S. Additionally, aged people are more prone to cardiac disorders. Therefore, the widening base of geriatrics is benefiting the growth of the segment.

The FFR monitoring systems segment is expected to witness lucrative growth during the forecast period owing to the introduction of technologically advanced monitoring systems. For instance, in 2017, Fysicon launched the QMAPP Hemodynamic Monitoring System post the U.S. FDA approval. This device has vital patient monitoring parameters as well as 32 bipolar intra-cardiac channels in electrophysiology procedures.

Application Insights

The single-vessel Coronary Artery Disease (CAD) segment dominated the fractional flow reserve market and accounted for a share of over 50% in 2021, owing to the wide application of the device in CAD, coupled with the rise in the geriatric population. Moreover, growing partnerships among key players to increase market penetration, for instance, the collaboration of GE Healthcare and Medis in 2017, is anticipated to stimulate the growth of the overall market for Fractional Flow Reserve.

On the other hand, the multi-vessel coronary artery disease (CAD) segment is projected to post a higher CAGR during the forecast period as this disease is a matured phase of single-vessel CAD. A person suffering from single-vessel CAD is highly likely to have multi-vessel CAD in the near future if proper treatment and medications are not taken.

Regional Insights

North America dominated the market for fractional flow reserve and accounted for the largest revenue share of over 41.0% in 2021. The dominance of the region can be attributed to favorable government policies for medical device penetration and the presence of well-developed healthcare infrastructure. In addition, rising mergers and acquisitions by key players are poised to keep the level of competition high in the near future.

For instance, in July 2021, HeartFlow proclaimed it is merging with Longview Acquisition Corp. II, to become a publicly traded corporation. Upon accomplishment of the proposed transaction, the combined corporation will operate as HeartFlow Group Inc. and is anticipated to be listed on the New York Stock Exchange under the symbol HFLO.

In the Asia Pacific, the market for fractional flow reserve is expected to witness lucrative growth in the coming years due to an increase in diabetes and cardiovascular disease cases as well as rising disposable income. Additionally, the introduction of favorable laws for medical device adoption is also estimated to support the growth of the regional market. For instance, in Korea, an agreement was implemented on March 15, 2012. This agreement made medical devices duty-free, thereby increasing adoption.

Key Companies & Market Share Insights

The market for fractional flow reserve is oligopolistic in nature with few providers controlling the majority share and dynamics. The notable key players operational in this industry are OPSENS Medical, Abbott Laboratories, Koninklijke Philips N.V., Acist Medical Systems Inc., and Boston Scientific. On the other hand, players such as Medtronic plc, B. Braun Melsungen, Siemens, and Terumo Medical Corporation could be potential market entrants owing to the launch of allied products used in FFR. For e.g., Siemens Healthineers launched Sensis Vibe CTx in March 2019, which could generate data needed to do CT-based FFR. This move was in anticipation to gain more visibility in the FFR and OCT market scenario.

Furthermore, companies operating in the industry are focusing on launching novel products as well as expanding their business outreach. For instance, in March 2019, Abbott received U.S. FDA approval for the Resting Full-cycle Ratio (RFR) intravascular diagnostic test, which is a novel type of FFR physiologic assessment. This test is aimed at identifying the narrowing of the coronary arteries that determines if a stent is needed or not. Some of the prominent players in the fractional flow reserve market include:

• Opsens Medical

• Abbott Laboratories

• Boston Scientific

• ACIST Medical Systems

• Koninklijke Philips N.V.

• Opsens, Inc.

• HeartFlow, Inc.

• Siemens Healthineers

• Pie Medical Imaging

• CathWorks

• Medis Medical Imaging Systems BV

 Fractional Flow Reserve Market Report Scope

Global Fractional Flow Reserve Market Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2030. For the purpose of this study, Grand View Research has segmented the global fractional flow reserve market report on the basis of product, application, and region:

• Product Outlook (Revenue, USD Million, 2017 - 2030)

  • FFR Guidewires

  • FFR Monitoring Systems

• Application Outlook (Revenue, USD Million, 2017 - 2030)

  • Multi-vessel Coronary Artery Disease

  • Single-vessel Coronary Artery Disease

• Regional Outlook (Revenue, USD Million, 2017 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

  • Asia Pacific

    • China

    • India

    • Japan

    • Australia

    • South Korea

  • Latin America

    • Mexico

    • Brazil

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • Turkey