Pulsed Field Ablation (PFA) System Market: Current Analysis and Forecast (2023-2030)

Report Description

The pulsed field ablation (PFA) system market was valued at USD 100 Million in 2022 and is expected to grow a CAGR of 25.1% during the forecast period (2023-2030). The pulsed field ablation (PFA) system is a pioneering medical technology revolutionizing the treatment landscape for various cardiac arrhythmias and other medical conditions. PFA specializes in delivering controlled bursts of pulsed electric fields to achieve tissue ablation and minimize the risk of collateral damage to neighboring tissues. Pulsed field ablation (PFA) system services mainly gained prominence due to the rising number of cardiovascular disease cases. For instance, according to the U.S. Department of Health & Human Services in 2021, about 1 in 20 adults aged 20 and older had cardiovascular disorder (about 5%).  There has been a significant rise in the market due to this driving factor. In addition to this, investments in healthcare departments and government awareness programs regarding chronic diseases have increased significantly in recent years, which are the key factors creating opportunities for the market.

Boston Scientific Corporation; Kardium; Abbott; Galvanize Therapeutics, Inc.; MIRAI MEDICAL; Pulse Biosciences, Inc.; AccuPulse Medical; Acutus Medical, Inc.; CathRx Ltd.; AccuPulse Medical are some of the key players in the market. Several M&As along with partnerships have been undertaken by these players to facilitate customers with hi-tech and innovative products/technologies.

Insights Presented in the Report

“Amongst therapeutic area, oncological disorders category to witness higher CAGR during the forecast period”

Based on therapeutic areas, the market is segmented into cardiovascular disorders, oncological disorders, respiratory disorders, and others. The oncological disorders segment is expected to grow with a high CAGR during the forecast period because of the rising liver cancer cases. For instance, according to the American Cancer Society, more than 800,000 people are diagnosed with liver cancer each year throughout the world. PFA is a relatively new technology that offers promising results in terms of efficacy and safety compared to traditional ablation methods. Thus, oncological disorders are expected to witness a higher CAGR during the forecast period.

“Amongst product components, catheters held a significant share in the market in 2022”

Based on product components, the market is bifurcated into catheters and generators. The catheters segment is dominating the market owing to the advanced features like easier pulmonary vein isolation performed by the catheters. Catheters are a critical component of PFA systems, as they deliver the pulsed electric fields to target tissues during the ablation procedure. Advancements in catheter technology, such as enhanced tissue contact, and better mapping capabilities, have contributed to the increasing adoption of PFA systems. For instance, in January 2024, Boston Scientific Corporation received U.S. Food and Drug Administration (FDA) approval for the FARAPULSE™ Pulsed Field Ablation (PFA) System which has an advanced catheter named FARAWAVE™ PFA Catheter which is designed to treat a range of pulmonary vein anatomies using an over-the-wire catheter with variable distal shapes (basket and flower). Furthermore, the growing demand for minimally invasive treatment options has fueled the expansion of the catheter segment within the PFA system market. Thus, catheters held a significant share in the market in 2022.

“Amongst application area, ablation & mapping category to witness higher CAGR during the forecast period”

Based on application area, the market is bifurcated into ablation and ablation & mapping. The ablation & mapping segment is expected to grow with a high CAGR during the forecast period because of the advanced features offered by the device. Features such as continually recording and displaying the electrical activity of the atrium expanded the scope of applications and have contributed to the growth of the ablation and mapping segment. There has been a corresponding rise in the adoption of these systems for ablation and mapping procedures. The ablation and mapping segment in the PFA system market is expected to continue growing as technological advancements drive improvements in treatment outcomes and expand the scope of applications. For instance, in December 2023, Medtronic received FDA approval for its novel PulseSelect™ Pulsed Field Ablation System to treat atrial fibrillation. It is a cardiac ablation system that enables both mapping and precise lesion delivery using biphasic waveform optimization. Thus, ablation & mapping are expected to witness a higher CAGR during the forecast period.

“Amongst regions, North America held a significant share in the market in 2022”

North America is dominating the market in the current scenario of 2022 due to the rising number of investments in developing effective pulsed field ablation (PFA) systems. Government organizations are initiating cardiac disorder awareness programs to provide efficient care to patients. Continuous innovations including improvements in catheter design, generator capabilities, and mapping techniques, have enhanced the efficacy and safety of ablation procedures, driving increased adoption in North America. North America has a relatively high prevalence of cardiac arrhythmias such as atrial fibrillation. For instance, according to the U.S. Department of Health & Human Services, it is estimated that 12.1 million people in the U.S. will have atrial fibrillation in 2030. As the population ages and risk factors such as obesity and hypertension become more prevalent, the demand for effective treatment options like PFA systems has potentially risen. The well-established healthcare infrastructure in North America, including advanced hospitals and medical centers, supports the adoption and utilization of innovative medical technologies. Thus, amongst regions, North America held a significant share of the market in 2022.

Reasons to buy this report:

• The study includes market sizing and forecasting analysis validated by authenticated key industry experts.
• The report presents a quick review of overall industry performance at one glance.
• The report covers an in-depth analysis of prominent industry peers with a primary focus on key business financials, product portfolio, expansion strategies, and recent developments.
• Detailed examination of drivers, restraints, key trends, and opportunities prevailing in the industry.
• The study comprehensively covers the market across different segments.
• Deep dive regional level analysis of the industry.

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Frequently Asked Questions (FAQ)

Research Methodology

Research Methodology for the Pulsed Field Ablation (PFA) Systems Market Analysis (2023-2030)

Analyzing the historical market, estimating the current market, and forecasting the future market of the global pulsed field ablation (PFA) systems market were the three major steps undertaken to create and analyze the adoption of pulsed field ablation (PFA) systems in major regions globally. Exhaustive secondary research was conducted to collect the historical market numbers and estimate the current market size. Secondly, to validate these insights, numerous findings and assumptions were taken into consideration. Moreover, exhaustive primary interviews were also conducted, with industry experts across the value chain of the global pulsed field ablation (PFA) systems market. Post assumption and validation of market numbers through primary interviews, we employed a top-down/bottom-up approach to forecasting the complete market size. Thereafter, market breakdown and data triangulation methods were adopted to estimate and analyze the market size of segments and sub-segments of the industry pertains to. Detailed methodology is explained below:

Analysis of Historical Market Size

Step 1: In-Depth Study of Secondary Sources:

Detail secondary study was conducted to obtain the historical market size of the pulsed field ablation (PFA) system market through company internal sources such as annual reports & financial statements, performance presentations, press releases, etc., and external sources including journals, news & articles, government publications, competitor publications, sector reports, third-party database, and other credible publications.

Step 2: Market Segmentation:

After obtaining the historical market size of the pulsed field ablation (PFA) systems market, we conducted a detailed secondary analysis to gather historical market insights and share for different segments & sub-segments for major regions. Major segments are included in the report as therapeutic area, product components, application area, and regions. Further country-level analyses were conducted to evaluate the overall adoption of testing models in that region.

Step 3: Factor Analysis:

After acquiring the historical market size of different segments and sub-segments, we conducted a detailed factor analysis to estimate the current market size of the pulsed field ablation (PFA) systems market. Further, we conducted factor analysis using dependent and independent variables such as therapeutic area, product components, application area, and regions of pulsed field ablation (PFA) systems. A thorough analysis was conducted for demand and supply-side scenarios considering top partnerships, mergers and acquisitions, business expansion, and product launches in the pulsed field ablation (PFA) systems market sector across the globe.

Current Market Size Estimate & Forecast

Current Market Sizing: Based on actionable insights from the above 3 steps, we arrived at the current market size, key players in the global pulsed field ablation (PFA) systems market, and market shares of the segments. All the required percentage shares split and market breakdowns were determined using the above-mentioned secondary approach and were verified through primary interviews.

Estimation & Forecasting: For market estimation and forecast, weights were assigned to different factors including drivers & trends, restraints, and opportunities available for the stakeholders. After analyzing these factors, relevant forecasting techniques i.e., the top-down/bottom-up approach were applied to arrive at the market forecast for 2030 00for different segments and sub-segments across the major markets globally. The research methodology adopted to estimate the market size encompasses:

• The industry’s market size, in terms of revenue (USD) and the adoption rate of the pulsed field ablation (PFA) systems market across the major markets domestically
• All percentage shares, splits, and breakdowns of market segments and sub-segments
• Key players in the global pulsed field ablation (PFA) systems market in terms of products offered. Also, the growth strategies adopted by these players to compete in the fast-growing market

Market Size and Share Validation

Primary Research: In-depth interviews were conducted with the Key Opinion Leaders (KOLs) including Top Level Executives (CXO/VPs, Sales Head, Marketing Head, Operational Head, Regional Head, Country Head, etc.) across major regions. Primary research findings were then summarized, and statistical analysis was performed to prove the stated hypothesis. Inputs from primary research were consolidated with secondary findings, hence turning information into actionable insights.

Split of Primary Participants in Different Regions

Market Engineering

The data triangulation technique was employed to complete the overall market estimation and to arrive at precise statistical numbers for each segment and sub-segment of the global pulsed field ablation (PFA) system market. Data was split into several segments & sub-segments post studying various parameters and trends in the areas of therapeutic area, product components, application area, and regions in the global pulsed field ablation (PFA) systems market.

The main objective of the Global Pulsed Field Ablation (PFA) System Market Study

The current & future market trends of the global pulsed field ablation (PFA) systems market were pinpointed in the study. Investors can gain strategic insights to base their discretion for investments on the qualitative and quantitative analysis performed in the study. Current and future market trends determined the overall attractiveness of the market at a regional level, providing a platform for the industrial participant to exploit the untapped market to benefit from a first-mover advantage. Other quantitative goals of the studies include:

• Analyze the current and forecast market size of the pulsed field ablation (PFA) systems market in terms of value (USD). Also, analyze the current and forecast market size of different segments and sub-segments.
• Segments in the study include areas of therapeutic area, product components, application area, and regions.
• Define and analyze the regulatory framework for the pulsed field ablation (PFA) system industry.
• Analyze the value chain involved with the presence of various intermediaries, along with analyzing customer and competitor behaviors of the industry.
• Analyze the current and forecast market size of the pulsed field ablation (PFA) systems market for the major region.
• Major countries of regions studied in the report include Asia Pacific, Europe, North America, and the Rest of the World.
• Company profiles of the pulsed field ablation (PFA) systems market and the growth strategies adopted by the market players to sustain in the fast-growing market
• Deep dive regional level analysis of the industry

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