Johnson & Johnson (US) received CE mark approval for the THERMOCOOL SMARTTOUCH SF catheter for the treatment of cardiac arrhythmias
The global ablation technology market was valued at USD 5.58 billion in 2023 and reached USD 6.11 billion in 2024. It is projected to expand at a CAGR of 9.5% from 2024 to 2029, achieving an estimated value of USD 9.62 billion by 2029. This robust growth reflects the increasing preference for minimally invasive procedures, broader applications of ablation systems in diverse clinical settings, and expanding access to healthcare services worldwide.
The rising global burden of chronic diseases such as cancer and cardiovascular disorders, coupled with advancements in medical device technologies, has created substantial opportunities for the ablation technology market. Additionally, supportive reimbursement policies, public awareness campaigns promoting early disease detection, and rising healthcare expenditure are accelerating adoption rates.
Emerging markets such as India, China, and Brazil are offering lucrative growth opportunities, driven by expanding private healthcare infrastructure and a growing patient population.
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Key Market Drivers
* Emerging Ablation Technologies
One of the primary drivers of the ablation technology market is the rapid emergence of advanced ablation methods, such as pulsed field ablation (PFA). These next-generation technologies offer precision treatment with minimal collateral tissue damage and reduced procedural risks.
Pulsed field ablation (PFA) is an innovative, non-thermal ablation technique that selectively targets cardiac tissue while sparing surrounding structures. Clinical studies have demonstrated strong efficacy and safety outcomes for treating cardiac arrhythmias using PFA.
Major medical device companies are investing heavily in R&D and clinical trials to commercialize new ablation technologies. For instance:
* In 2024, BioSense Webster (Johnson & Johnson, US) received European CE approval for the VARIPULSE pulsed field ablation system to treat paroxysmal atrial fibrillation.
* In September 2024, Boston Scientific Corporation obtained PMDA approval in Japan for its FARAPULSE PFA system, marking a significant milestone in the global adoption of PFA technology.
These developments underscore the industry’s shift toward safer, more efficient, and patient-friendly ablation procedures.
* Expanding Access to Healthcare Services
The growth of healthcare infrastructure, especially in developing regions, has expanded access to advanced medical treatments, including ablation procedures. Governments are prioritizing early disease detection, preventive care, and healthcare digitalization — factors that collectively strengthen the ablation technology market.
Moreover, the global trend toward minimally invasive surgeries continues to fuel adoption. Patients and physicians increasingly prefer ablation therapies due to their shorter recovery times, reduced complications, and lower costs compared to traditional surgical interventions.
Market Restraint: Rigorous Regulatory Framework
Despite strong growth momentum, the stringent regulatory environment for medical devices presents a challenge for manufacturers. In the United States, the FDA classifies most ablation devices as Class II and some as Class III. These classifications require extensive testing, clinical evaluations, labeling compliance, and post-market surveillance.
For Class II devices, in-vivo testing must validate the safety and performance of the system under expected usage conditions, including electromagnetic compatibility (EMC), electrical safety, and thermal safety. These requirements extend product development timelines and increase costs, slowing down innovation and market entry for new devices.
Market Opportunity: Rising Demand in Emerging Economies
Emerging economies such as India, China, Mexico, and Brazil are poised to offer significant growth opportunities for the ablation technology market. These regions are witnessing a steady rise in healthcare spending, an expanding middle-class population, and an increase in private healthcare investments.
For instance:
* According to the Economic Survey 2022-23, India’s public healthcare expenditure rose to 2.1% of GDP in FY 2023.
* In China, healthcare spending accounted for 7.19% of GDP in 2023, reflecting continuous investment in advanced medical technologies.
The Asia Pacific middle-class population is expected to increase from 354 million households in 2024 to 684 million by 2034, driving demand for affordable and quality healthcare services. As access improves, ablation procedures for cancer, cardiovascular, and aesthetic treatments are expected to become more widespread in these regions.
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Market Challenge: Therapeutic Risks and Safety Concerns
While ablation therapies offer numerous benefits, they are not without risk. During cardiac ablation procedures, patients may experience fatigue, bleeding, infection, or vascular damage. These side effects can discourage adoption in some cases, leading physicians to recommend alternative treatments such as medication.
Similarly, cryotherapy, which uses cryogenic gases like nitrogen, argon, or nitrous oxide, carries potential hazards. Exposure to extremely low temperatures can cause frostbite, suffocation, or eye injuries. Improper handling of cryogenic gases can result in oxygen depletion, posing risks to patients and healthcare workers. These challenges underscore the need for stringent safety protocols and continued innovation to minimize complications.
Market Segmentation Insights
By Technology: Radiofrequency Ablation Leads
In 2023, the radiofrequency (RF) ablation segment dominated the market. RF ablation is widely adopted in aesthetic procedures, oncology, and cardiology due to its proven safety, efficacy, and cost-effectiveness. The growing popularity of non-surgical aesthetic treatments, such as wrinkle reduction and body contouring, has also boosted segment growth.
Recent regulatory approvals have further strengthened this segment:
* In 2023, Biosense Webster (Johnson & Johnson) received FDA clearance for the THERMOCOOL SMARTTOUCH SF catheter, a leading RF ablation product.
* In 2021, Medtronic Plc (US) secured FDA approval for its DiamondTemp Ablation (DTA) System, designed for temperature-controlled RF ablation in atrial fibrillation patients.
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