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

Global Fractional Flow Reserve Devices Market Forecast 2023-2027

The Global Fractional Flow Reserve Devices Market is forecast to increase by USD 718.07 million at a CAGR of 15.56% between 2022 and 2027. The market experiences growth driven by pivotal factors. With the rising prevalence of coronary artery diseases (CADs), there's a heightened demand for advanced diagnostic tools like FFR devices. Moreover, continuous technological advancements in FFR technology enhance diagnostic accuracy and efficacy, driving market expansion. Additionally, the increasing number of percutaneous coronary intervention (PCI) procedures further boosts the adoption of FFR devices, as they play a crucial role in guiding treatment decisions for patients with CADs. This market research and growth report 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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Market Segmentation

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. The 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 Companies 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 technology used by clinical practices.

The market segment FFR guidewires recorded the largest contribution in market share of USD 215.07 million and continues to grow.

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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 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 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 these devices, which is driven by an increase in the global demand for the Fractional Flow Reserve Devices Industry. 

Key Regions 

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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. In 2017, in terms of market size, North America dominated the market with a share of USD 157.90 million. Additionally, the US was the largest contributor of market share with USD 125.32 million.

North America holds a major share of the market. The US and Canada hold major shares of the regional market. Key Companies such as Abbott, Boston Scientific, and Koninklijke Philips generate significant revenues from North America. The US is the highest revenue contributor to themarket in North America. This is due to the high prevalence of CADs, high awareness of advanced FFR products, and the increased number of 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 these procedures to assess angiographically intermediate coronary stenoses and to guide revascularization in patients with stable ischemic heart disease.

Market Dynamics and Customer Landscape

The market experiences growth due to the cost benefits of FFR and the rising geriatric population, with healthcare experts, including cardiologists relying on Centers for Disease Control and Prevention (CDC) data to address heart-related diseases such as single-cell coronary artery disease (CAD) and coronary artery diseases, with emphasis on diagnosis and treatment strategies incorporating traditional angiography and HeartFlow's non-invasive cardiac computed tomography-derived FFR technology for acute coronary syndrome (ACS) and stable coronary artery disease (CAD), amidst the prevalence of cardiovascular diseases and favorable reimbursement scenarios, tackling conditions like stenosis and inducible ischemia linked to lifestyle factors like smoking, hypertension, and high blood cholesterol. 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 Market Driver

The increasing prevalence of CVDs is a key factor driving the global fractional flow reserve devices market growth, due to the increasing prevalence of cardiovascular diseases (CVDs), including stable angina, unstable angina, and sudden cardiac deaths. CVDs are responsible for approximately 17.9 million deaths worldwide annually. In the US alone, nearly one million hospitalized patients are diagnosed with unstable angina each year. Risk factors such as high blood pressure, smoking, diabetes, and obesity are contributing to the rise in coronary artery diseases (CADs), with the incidence of unstable angina reaching about 60 out of 100,000 individuals in industrialized countries.

Furthermore, the aging population is a significant factor driving the demand for FFR procedures, with the number of people aged 60 and above expected to double by 2050. Additionally, the number of individuals aged 80 or older is projected to triple during the same period, indicating a positive outlook for the market. The favorable reimbursement scenario for FFR procedures, along with advancements in non-invasive technologies like HeartFlow's cardiac computed tomography-derived FFR technology, further supports the growth of the global FFR devices market. This data underscores the importance of FFR in diagnosis and treatment strategies for CADs, providing cost benefits and improved outcomes for patients.

Significant Market Trends

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 state-of-the-art OCT and angiography co-registration with the 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 market during the forecast period.

Major 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 market during the forecast period.

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 Market Companies? 

Companies 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 SE & Co KG - 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 Companies, 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 Companies 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 Companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize Companies as dominant, leading, strong, tentative, and weak. 

Market Analyst Overview

The market is witnessing significant growth owing to the rising prevalence of cardiovascular diseases (CVD) and associated mortality rates. Healthcare experts are adopting advanced diagnosis and treatment strategies such as HeartFlow's non-invasive cardiac computed tomography-derived FFR technology, which offers alternatives to traditional angiography. FFR devices are particularly crucial in managing conditions like Acute coronary syndrome (ACS) and Stable coronary artery disease (CAD), providing valuable insights into inducible ischemia. The market benefits from a favorable reimbursement scenario and the cost advantages of FFR over other techniques like angioplasty. With the increasing geriatric population and lifestyle-related factors such as hypertension and high blood cholesterol, the demand for FFR devices is poised for continuous growth.

The market addresses critical needs in managing cardiovascular conditions like Type II diabetes, stroke, and heart attack, which are exacerbated by factors such as high blood cholesterol levels, physical inactivity, and high BMI. With the support of advanced technologies like CT Fractional Flow Reserve (CT-FFR), healthcare providers can accurately diagnose conditions like single-vessel CAD and multi-vessel coronary artery disease CAD. Despite the cost benefits and favorable reimbursement scenario for FFR, challenges remain, including the reluctance of interventional cardiologists to adopt FFR and the technical limitations of invasive FFR. Overcoming these hurdles requires addressing issues related to diagnostic and treatment procedures and optimizing FFR measurements for optimal performance and interpretation.

The market is also influenced by various factors, including the prevalence of conditions such as myocardial ischemia and the rising incidence of obesity, as highlighted by organizations like the World Obesity Federation. The market benefits from the cost advantages associated with FFR technology, aiding in the management of conditions like epicardial coronary artery disease in an increasingly geriatric population. However, challenges persist, such as accurately assessing the severity of stenosis through visual assessment and ensuring optimal performance and interpretation of FFR measurements, particularly in cases of left main stenoses and serial stenosis. Additionally, considerations for aortocoronary bypass grafts and addressing issues related to device support, drift, and connectivity are vital for advancing the efficacy of FFR-systems.

Segment Overview

Our market analysis and 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 
  • FFR-guidewires
  • FFR-monitoring systems 

• Application Outlook 
  • Single-vessel diseases
  • Multi-vessel diseases

• Region Outlook 
  • 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

Fractional Flow Reserve Devices Market Scope
Report Coverage	Details
Page number	160
Base year	2022
Historical year	2017-2021
Forecast period	2023-2027
Growth momentum & CAGR	Accelerate at a CAGR of 15.56%
Market growth 2023-2027	USD 718.07 million
Market structure	Fragmented
YoY growth (%)	15.2
Regional analysis	North America, Europe, Asia, and the Rest of the World (ROW)
Performing market contribution	North America at 46%
Key consumer countries	US, Canada, Germany, UK, and Japan
Competitive landscape	Leading companies, Competitive Strategies, Consumer engagement scope
Key companies profiled	Abbott Laboratories, Asahi Intecc Co. Ltd., B. Braun SE, BIOTRONIK SE & Co KG, 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., and Siemens AG
Market dynamics	Market growth and trends, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, and Market trends and analysis for the forecast period.
Customization purview	If our market report has not included the data that you are looking for, you can reach out to our analysts and get segments customized.

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What are the Key Data Covered in this Market Research Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the market growth and forecasting between 2023 and 2027
• Precise estimation of the size of the market size and its contribution to the parent market.
• Accurate predictions about  upcoming trends and changes in consumer behavior
• Market growth analysis 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 companies
• Market forecasting of factors that will challenge the growth of the key companies

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