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The Global Fractional Flow Reserve Devices Market is forecast to increase by USD 1.17 billion at a CAGR of 20.08% between 2023 and 2028. 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 fractional flow reserve devices technology enhance diagnostic accuracy and efficacy, driving market expansion. Additionally, the increasing number of percutaneous coronary intervention (PCI) procedures further boosts the adoption of fractional flow reserve devices technology 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 2018 to 2022.
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Based on product, the market is segmented into guidewires and monitoring systems. The market share growth by the fractional flow reserve devices technology 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 share growth by the FFR guidewires segment is significant during the forecast period. 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 system. Koninklijke Philips's FloWire Doppler guidewire is the only Doppler guidewire available in the market, which provides direct measurements of intracoronary flow.
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The FFR guidewires segment was the largest segment and valued at USD 247 million in 2018. 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 devices market in 2022 and is expected to dominate during the forecast period.
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North America is projected to contribute 45% by 2028. 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 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 products, and the increased number of procedures performed in the country. Every year, approximately 180,000 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. Hence, such factors are driving the market in North America during the forecast period.
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 2023 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.
The increasing prevalence of CVDs is a key factor driving the global 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. Hence, such factors are driving the market during the forecast period.
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.
The low adoption of the FFR technique is a major challenge to the global 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.
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.
Market Customer Landscape
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 :
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.
The market research report provides comprehensive data (region wise segment analysis), with forecasts and estimates in "USD Million" for the period 2024 to 2028, as well as historical data from 2018 to 2023 for the following segments
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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 for Fractional Flow Reserve (FFR) systems in the cardiology domain is significantly influenced by several factors. These include the growing prevalence of conditions such as myocardial ischemia and the rising incidence of obesity, as underscored by organizations like the World Obesity Federation. The market experiences substantial benefits from the cost advantages linked to FFR technology, which plays a crucial role in managing conditions like epicardial coronary artery disease in an aging population. However, challenges remain, such as precisely evaluating the extent of stenosis via visual assessment and ensuring optimal FFR measurement performance and interpretation, particularly in instances of left main stenoses and serial stenosis. Furthermore, considerations for aortocoronary bypass grafts and addressing issues related to device support, drift, and connectivity are essential for enhancing the effectiveness of FFR-systems. Thoracic catheters, a vital component of FFR assessment, enable the accurate measurement of blood flow in the coronary arteries, contributing significantly to the diagnostic process and informed decision-making in interventional procedures.
Market Scope |
|
Report Coverage |
Details |
Page number |
167 |
Base year |
2023 |
Forecast period |
2024-2028 |
Growth momentum & CAGR |
Accelerate at a CAGR of 20.08% |
Market growth 2024-2028 |
USD 1.17 billion |
Market structure |
Fragmented |
YoY growth 2023-2024(%) |
16.47 |
Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
Performing market contribution |
North America at 45% |
Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
Key companies profiled |
Abbott Laboratories, Asahi Intecc Co. Ltd., B.Braun SE, BIOTRONIK SE and Co. KG, Bluesail Medical Co. Ltd., Boston Scientific Corp., Bracco Spa, CathWorks Inc., Esaote Spa, General Electric Co., HeartFlow Inc., Koninklijke Philips N.V., Medis Medical Imaging Systems BV, Medtronic Plc, Mennen Medical Group, Opsens Inc., and Siemens AG |
Market dynamics |
Parent market analysis, market trends and analysis, market report, market growth and trends, market forecast, market analysis and report Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, Market growth and Forecasting, COVID 19 impact and recovery analysis and future consumer dynamics, Market condition analysis for forecast period |
Customization purview |
If our 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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1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Product
7 Market Segmentation by Application
8 Customer Landscape
9 Geographic Landscape
10 Drivers, Challenges, and Opportunity/Restraints
11 Competitive Landscape
12 Competitive Analysis
13 Appendix
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