Global Fractional Flow Reserve Devices Market by Product, Application, and Geography - Forecast and Analysis 2023-2027

The fractional flow reserve devices market is estimated to grow at a CAGR of 15.56% and the size of the market is forecast to increase by USD 718.07 million between 2022 and 2027. The growth of the market depends on several factors, including the increasing prevalence of CADs, technological advances, and the increasing number of PCI procedures. 

This report extensively covers market segmentation by product (FFR guidewires and FFR monitoring systems), application (single-vessel diseases and multi-vessel diseases), and geography (North America, Europe, Asia, and Rest of World (ROW)). It also includes an in-depth analysis of drivers, trends, and challenges. Furthermore, the report includes historic market data from 2017 to 2021. 

 What will the Size of the Fractional Flow Reserve Devices Market be During the Forecast Period?

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In 2017, in terms of market size, North Amercia dominated the market with a share of USD 157.90 million. Additionally, US was the largest contributor of market share USD 125.32 million. The market segment FFR guidewires recorded the largest contribution in market share of USD 215.07 million and continues to grow.

Parent Market Analysis

Technavio categorizes the global FFR devices market as a part of the Healthcare Equipment & within the global Healthcare industry. The parent, global healthcare equipment market covers products and companies engaged in research and development (R&D) of a variety of product categories, including capital equipment, instruments, implants, accessories, and consumables that are used for the diagnosis, monitoring, and treatment of various diseases. Our research report has extensively covered external factors influencing the parent market growth during the forecast period.

Fractional Flow Reserve Devices Market: Key Drivers, Trends, Challenges, and Customer Landscape

The innovative features and user interfaces are notably driving the fractional flow reserve (FFR) devices market growth, although factors such as the low adoption of the FFR technique may impede the market growth. Our researchers analyzed the data with 2022 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.

Key Fractional Flow Reserve Devices Market Driver

The increasing prevalence of CVDs is a key factor driving the global fractional flow reserve devices market growth. The prevalence of CVDs (cardiovascular diseases), such as stable angina, unstable angina, and sudden cardiac deaths, is increasing worldwide. CVDs are responsible for approximately 17.9 million deaths every year globally. Every year, nearly one million patients who are hospitalized in the US have a primary diagnosis of unstable angina. In industrialized countries, the annual incidence of unstable angina is about 60 out of 100,000 individuals in the general population.

The risk factors associated with CADs, such as high blood pressure, smoking, diabetes, and obesity, are on the rise. The risk of CADs significantly increases with age. There are 1.4 billion people above 60 years currently, up from 1 billion in 2020. By 2050, there will be twice as many people worldwide who are 60 years of age or older. The number of people aged 80 or older is expected to treble between 2020 and 2050, reaching 426 million. This data indicates a positive outlook for the demand for FFR procedures, which will drive the growth of the global FFR devices market during the forecast period.

Key Fractional Flow Reserve Devices Market Trend

The increasing focus on non-invasive FFR will fuel the global fractional flow reserve (FFR) devices market growth. R and 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 a significant superiority over traditionally invasive FFR procedures and can be a potential diagnostic tool for lesion-specific ischemia and help in making optimal clinical decisions. 

A growing interest in the R&D of non-invasive calculation of FD-OCT is also being witnessed. For Instance, St. Jude Medical (acquired by Abbott) offers its OPTIS Mobile System in Japan and Europe. The system combines the state-of-the-art OCT and angiography co-registration with the FFR technology into one portable system for hospitals with multiple catheterization labs. Studies such as ILUMIEN I and ILUMIEN II have shown that OCT imaging technology can influence pre and post-PCI decision-making, stent sizing, and deployment. As there are no clear guidelines for managing multiple lesions with a positive FFR in the distal segment, FD-OCT is increasingly gaining importance as it can identify noncritical MLA in the proximal stenosis, which can help in the selective intervention of distal stenosis and optimization of the stent deployment procedure. Thus, an increasing focus on non-invasive FFR will contribute to the growth of the global FFR devices market during the forecast period.

Key Fractional Flow Reserve Devices Market Challenge

The low adoption of the FFR technique is a major challenge to the global fractional flow reserve devices market growth. Despite all the clinical and economic evidence and revascularization guidelines recommending the use of FFR, the technique is still in its early stages of adoption in several developing and developed countries. The frequency of FFR use in cardiac catheterization laboratories in several countries, such as Mexico, Canada, Brazil, China, and India, is less than 6%. Even in developed countries, such as the US, many physicians continue to rely on angiography alone, despite it being found to be less effective in several classes of patients.

For instance, approximately 800,000-100,000 PCI procedures are performed annually in the US. However, only around 20% of these procedures are performed using FFR guidance. The reasons for this are multifactorial, including the lack of complete reimbursement, inconvenience associated with vasodilator administration, and lack of easy access to vasodilator drugs. Furthermore, the high cost of adenosine and its side effects are also limiting the widespread adoption of FFR procedures. The average cost of intravenous adenosine solution (3 mg/mL) for a supply of 20 milliliters is USD 60. These factors are impeding the widespread adoption of FFR, which will inhibit the growth of the global FFR devices market during the forecast period.

Key Fractional Flow Reserve Devices Market Customer Landscape

The report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates?in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their growth strategies.

Global Fractional Flow Reserve Devices Market Customer Landscape

Who are the Major Fractional Flow Reserve Devices Market Vendors?                                     

Vendors are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market 

biotronik.com - The company offers fractional flow reserve devices such as cardiac resynchronization and bradycardia. Also, under this segment, the company develops, produces, and markets devices for cardiac rhythm management and vascular intervention solutions, including diagnostic tools, pacemakers, implantable defibrillators, leads, and more.

We also have detailed analyses of the market’s competitive landscape and offer information on 20 market vendors, including :

• Abbott Laboratories
• Asahi Intecc Co. Ltd.
• B. Braun SE
• Bluesail Medical Co. Ltd.
• Boston Scientific Corp.
• Bracco Spa
• CathWorks Inc.
• Esaote Spa
• General Electric Co.
• HeartFlow Inc.
• Koninklijke Philips NV
• Medis Medical Imaging Systems BV
• Medtronic Plc
• Mennen Medical Group
• Opsens Inc.
• Siemens AG

Qualitative and quantitative analysis of vendors has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize vendors as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize vendors as dominant, leading, strong, tentative, and weak. 

What is the Fastest-Growing Segment in the Fractional Flow Reserve Devices Market?

Based on product, the market is segmented into FFR guidewires and FFR monitoring systems. The market share growth by the FFR guidewires segment will be significant during the forecast period. FFR measurement requires threading a 0.014-inch wire with a pressure sensor (pressure wire) to measure the pressure distal to a stenosis, across an intermediate stenotic lesion, with the support of a guiding catheter in the target artery. All pressure wires offered by the leading vendors in the market can also serve as guidewires. Guidewire technologies available in the market can be broadly classified into three types, namely pressure wire technology (piezoelectric wires), microcatheter technology (optical fiber catheters), and optical fiber technology (optical fiber wires). Pressure wire technology involves a specially fabricated 0.014-inch wire with a distal pressure sensor incorporated into the distal end at the junction of the radiopaque and radiolucent sections. This is the most common FFR technology used by clinical practices.

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Pressure wires have several special features, including fast response, ruggedness, high stiffness, an extended range, and the ability to measure quasi-static pressures. The pressure wires offered by Abbott and Koninklijke Philips are extensively used in clinical practice due to their various unique advantages. For instance, Abbott's PressureWire X guidewire is the only pressure guidewire for FFR measurement that can transmit measurements wirelessly to an FFR system. Koninklijke Philips's FloWire Doppler guidewire is the only Doppler guidewire available in the market, which provides direct measurements of intracoronary flow. Despite several unique features and benefits of use, pressure wires are associated with various challenges, including wire kinking or the lack of support when advancing or removing balloons and stents and the need for multiple pull-backs and rewiring for tandem lesions. These challenges contribute to long procedural times, especially for patients with multivessel CADs, thus necessitating the use of durable wires. However, the FFR guidewires segment has a major share in the global FFR devices market in 2022 and is expected to dominate during the forecast period. Furthermore, our report provides a brief analysis of the historical and forecast market share and their segment along with their reasons for growth from 2017 to 2027.

The growth of this segment is primarily attributed to the increasing adoption of FFR devices, which is driven by an increase in the global demand for the Fractional Flow Reserve Devices Industry. 

Which are the Key Regions for the Fractional Flow Reserve Devices Market?

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North America is projected to contribute 46% by 2027. Technavio’s analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.

North America holds a major share of the global FFR devices market. The US and Canada hold major shares of the regional market. Key vendors such as Abbott, Boston Scientific, and Koninklijke Philips generate significant revenues from North America. The US is the highest revenue contributor to the FFR devices market in North America. This is due to the high prevalence of CADs, high awareness of advanced FFR products, and the increased number of FFR procedures performed in the country. Every year, approximately 180,000 FFR procedures are performed in the US. Major medical society guidelines such as those of the American Association for Thoracic Surgery (AATS) and the American Society of Echocardiography (ASE) recommend using FFR procedures to assess angiographically intermediate coronary stenoses and to guide revascularization in patients with stable ischemic heart disease.

This report forecasts the contribution of all the segments to the growth of the market. In addition, we have included the COVID-19 impact and the recovery strategies for each segment. The outbreak of the COVID-19 pandemic led to a decline in the demand for FFR devices in North America. In 2020, North America was one of the regions worst affected by the COVID-19 pandemic, with a high number of COVID-19 patients in the US, Canada, and Mexico. Hospitals and medical staff prioritized the diagnosis, procedures, and treatment of COVID-19 patients over other patients. The shortage of healthcare personnel in the region also led to low or no treatment for non-COVID-19 patients. Thus, the pandemic had a negative impact on the FFR devices market in the region in 2020. From 2021 onwards, economic activities in the region resumed and started regaining their momentum due to the substantial investments made by governments in developing healthcare infrastructure, besides allowing the healthcare industry to work with the full workforce to cater to the surging demand for several healthcare-related issues. Furthermore, the high prevalence of CADs and an increase in the number of FFR procedures performed are expected to propel the sales of FFR devices. Hence, the market in the region is expected to grow moderately during the forecast period.

Segment Overview

Our report forecasts revenue growth at global, regional & country levels and provides an analysis of the latest trends and growth opportunities from 2017 to 2027. The market has been segmented by product, application, and region.

• Product Outlook (USD Million, 2017 - 2027)
  • FFR guidewires
  • FFR monitoring systems 

• Application Outlook (USD Million, 2017 - 2027)
  • Single-vessel diseases
  • Multi-vessel diseases

• Region Outlook (USD Million, 2017 - 2027)
  • North America
    • The U.S.
    • Canada
  • Europe
    • The U.K.
    • Germany
    • France
    • Rest of Europe
  • Asia
    • China
    • India
  • ROW
    • Argentina
    • Australia
    • Rest of the world

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What are the Key Data Covered in this Fractional Flow Reserve Devices Market Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the growth of the fractional flow reserve devices market between 2023 and 2027
• Precise estimation of the size of the fractional flow reserve devices market size and its contribution to the parent market.
• Accurate predictions about  upcoming trends and changes in consumer behaviour
• Growth of the fractional flow reserve devices market industry across North America, Europe, Asia, and the Rest of the World (ROW)
• A thorough analysis of the market’s competitive landscape and detailed information about vendors
• Comprehensive analysis of factors that will challenge the growth of fractional flow reserve devices vendors

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