市場調查報告書
商品編碼
1634208
全球消融設備市場 - 2025 - 2033Global Ablation Devices Market - 2025 - 2033 |
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2024年,全球消融器械市場規模達62億美元,預計2033年將達到141億美元,2025-2033年預測期間複合年成長率為9.7%。
消融裝置是用於各種治療過程中的專用醫療器械,透過定向能量去除、破壞或治療異常或患病組織。這些設備通常用於微創手術,提供精確且受控的治療方法,對周圍健康組織的損害最小。消融通常使用各種形式的能量來進行,例如熱、冷、電或光。消融設備在現代醫學中發揮著至關重要的作用,為各種醫療狀況的患者提供更安全、更有效、更侵入性的治療選擇。
在消融設備的進步、產品發布的增加以及對微創手術的日益偏好的推動下,消融設備市場正在經歷顯著成長。例如,2024 年 10 月,雅培實現了新的重大里程碑,以支持公司不斷成長的電生理學脈衝場消融 (PFA) 解決方案套件:提前完成支援 Volt PFA 系統的 VOLT-AF IDE 研究的註冊,並推出FOCALFLEX 試驗旨在評估該公司的TactiFlex Duo 消融導管、感測器啟用(SE),該導管將用於治療陣發性心房顫動患者。
驅動程式和限制
消融設備技術不斷進步
消融設備不斷進步的技術進步極大地推動了消融設備市場的成長,預計將在預測期內推動市場成長。技術進步,特別是影像和導引系統的進步,大大提高了消融手術的精確度。這些創新擴大了應用範圍,減少了手術時間,改善了患者的治療效果,並擴大了微創選擇的範圍。
先進電解剖測繪系統的整合徹底改變了其在心臟病學中的應用,特別是在治療心房顫動方面。精確繪製心臟電活動圖的能力可以提高治療後的成功率並降低心律不整的復發率。
例如,2024 年10 月,波士頓科學公司獲得美國食品藥物管理局(FDA) 批准用於治療陣發性心房顫動(AF) 的具有導航功能的FARAWAVE NAV 消融導管,並獲得FDA 510(k) 批准用於新型FARAVIEW該軟體將與 FARAPULSE 脈衝場消融 (PFA) 系統結合,為心臟消融手術提供可視化。
此外,2024 年10 月,美敦力(Medtronic) 宣布美國食品和藥物管理局(FDA) 批准配備Sphere-9 導管的Affera 標測和消融系統,這是一款一體化、高密度(HD) 標測和脈衝場(PF) 和射頻 (RF) 消融導管,用於治療持續性心房顫動 (AFib) 和射頻消融三尖瓣峽部 (CTI) 依賴性心房撲動。
機器人輔助消融系統正在提高手術的準確性和控制。例如,2024年12月,Stereotaxis Inc.和中國合作夥伴上海微創環保醫療科技有限公司的Magbot磁導航消融導管獲得國家藥品監督管理局批准,與Stereotaxis的機器人消融系統一起使用,治療抗藥性心律失常在中國。
潛在的副作用和併發症
與消融手術相關的潛在副作用和併發症是消融設備市場成長的重大挑戰。這些風險可能會阻止患者和醫療保健提供者採用消融技術,從而限制其廣泛使用。例如,在射頻或冷凍消融治療心房顫動期間,有造成食道損傷或對附近神經(例如膈神經)造成附帶損傷的風險,從而導致呼吸困難等併發症。
侵入性手術,例如基於導管的消融術,有插入部位感染和出血的風險。例如,肝臟腫瘤的微波消融(MWA)或射頻消融(RFA)與術後感染和出血有關,特別是對於預先存在肝功能障礙或凝血病的患者。
此外,用於換膚或除皺的雷射消融設備有時會導致表面燒傷或疤痕,引起患者的不滿並損害此類設備在美容應用中的聲譽。
消融療法,尤其是心律不整和某些腫瘤的消融療法,可能不會總是提供永久性的結果,從而導致病情復發。例如,接受消融治療的心房顫動患者可能在幾年內復發心律不整,需要重複手術或替代治療。
The global ablation devices market reached US$ 6.2 billion in 2024 and is expected to reach US$ 14.1 billion by 2033, growing at a CAGR of 9.7% during the forecast period 2025-2033.
Ablation devices are specialized medical instruments used in various therapeutic procedures to remove, destroy, or treat abnormal or diseased tissue through targeted energy. These devices are often used in minimally invasive procedures, offering precise and controlled methods of treatment with minimal damage to surrounding healthy tissues. Ablation is typically performed using various forms of energy such as heat, cold, electricity, or light. Ablation devices play a critical role in modern medicine, providing patients with safer, more efficient, and less invasive treatment options for a variety of medical conditions.
The ablation devices market is experiencing significant growth, driven by advancements in ablation devices, rising product launches and an increasing preference for minimally invasive procedures. For instance, in October 2024, Abbott achieved new major milestones to support the company's growing suite of pulsed-field ablation (PFA) solutions in electrophysiology: early completion of enrollment in the VOLT-AF IDE Study supporting the Volt PFA System and the launch of the FOCALFLEX trial to assess the company's TactiFlex Duo Ablation Catheter, Sensor Enabled (SE), which will be used in the treatment of patients with paroxysmal atrial fibrillation.
Market Dynamics: Drivers & Restraints
Rising technological advancements in ablation devices
The rising technological advancements in ablation devices are significantly driving the growth of the Ablation Devices market and are expected to drive the market over the forecast period. Technological advancements, particularly in imaging and guidance systems, have greatly enhanced the precision of ablation procedures. These innovations are broadening the scope of applications, reducing procedure times, improving patient outcomes, and expanding access to minimally invasive options.
The integration of advanced electroanatomical mapping systems has revolutionized its use in cardiology, especially for treating atrial fibrillation. The ability to map the heart's electrical activity with precision has led to better success rates and lower recurrence of arrhythmias after treatment.
For instance, in October 2024, Boston Scientific Corporation received U.S. Food and Drug Administration (FDA) approval for the navigation-enabled FARAWAVE NAV Ablation Catheter for the treatment of paroxysmal atrial fibrillation (AF) and FDA 510(k) clearance for the new FARAVIEW Software, which will combine to provide visualization for cardiac ablation procedures with the FARAPULSE Pulsed Field Ablation (PFA) System.
Additionally, in October 2024, Medtronic plc announced United States Food and Drug Administration (FDA) approval of the Affera Mapping and Ablation System with Sphere-9 Catheter, an all-in-one, high-density (HD) mapping and pulsed-field (PF) and radiofrequency (RF) ablation catheter for treatment of persistent atrial fibrillation (AFib) and for RF ablation of cavotricuspid isthmus (CTI) dependent atrial flutter.
Robotic-assisted ablation systems are improving the accuracy and control of procedures. For instance, in December 2024, Stereotaxis Inc. and Chinese partner Shanghai Microport EP Medtech Co. Ltd. gained the National Medical Products Administration's approval of its Magbot magnetic navigation ablation catheter for use with Stereotaxis' robotic ablation system to treat drug-resistant cardiac arrhythmias in China.
Potential side effects and complications
Potential side effects and complications associated with ablation procedures are a significant challenge to the growth of the ablation devices market. These risks can deter patients and healthcare providers from adopting ablation technologies, limiting their widespread use. For instance, during radiofrequency or cryoablation for atrial fibrillation, there is a risk of causing esophageal injury or collateral damage to nearby nerves, such as the phrenic nerve, leading to complications like difficulty breathing.
Invasive procedures, such as catheter-based ablations, carry a risk of infection and bleeding at the insertion site. For instance, microwave ablation (MWA) or radiofrequency ablation (RFA) for liver tumors has been associated with post-procedural infections and bleeding, particularly in patients with pre-existing liver dysfunction or coagulopathies.
Additionally, laser ablation devices used for skin resurfacing or wrinkle reduction can sometimes lead to superficial burns or scarring, causing dissatisfaction among patients and tarnishing the reputation of such devices in cosmetic applications.
Ablation therapies, particularly for cardiac arrhythmias and certain tumors, may not always provide permanent results, leading to condition recurrence. For instance, atrial fibrillation patients treated with ablation may experience arrhythmia recurrence within a few years, requiring repeat procedures or alternative treatments.
The global ablation devices market is segmented based on technology, application, end-user and region.
The radiofrequency ablation segment is expected to dominate the ablation devices market share
In cardiac ablation, radiofrequency ablation is most commonly used to treat atrial fibrillation (AF) and other arrhythmias by destroying or isolating the abnormal electrical pathways in the heart. The global prevalence of AF is increasing, leading to a growing demand for radiofrequency ablation devices. For instance, according to the National Institute of Health (NIH), the worldwide prevalence of atrial fibrillation is 37,574 million cases (0.51% of the worldwide population), increased by 33% during the last 20 years.
Radiofrequency ablation is also used in the treatment of chronic pain by targeting nerves that cause pain. It is especially used in conditions like osteoarthritis and back pain. This versatility in treating various pain conditions across multiple specialties has helped solidify radiofrequency ablation's market dominance. For instance, in July 2024, Stryker launched the MultiGen 2 Radiofrequency (RF) Generator, this technology provides physicians with the efficiency, control and reliability they need when performing RF ablation, a minimally invasive procedure that can provide lasting relief to those suffering from facet joint pain.
Advances in radiofrequency ablation technology, such as the development of more precise catheter designs, multi-electrode systems, and integrated mapping systems, have contributed to its increased efficiency and safety. For instance, in April 2024, a Minnesota-based medical technology company launched its OneRF Ablation System, which creates radiofrequency lesions in nervous tissue for functional neurosurgical procedures. According to a release from NeuroOne Medical Technologies, this system is the company's first device with a therapeutic indication. The thin-film, stereoelectroencephalopathy-guided radio frequency system is capable of both recording electrical activity and ablating nervous tissue while offering temperature control during surgical procedures.
North America is expected to hold a significant position in the ablation devices market share
North America, particularly the United States, is a global leader in the development and adoption of cutting-edge medical technologies. Many of the world's leading companies in the ablation devices market are based in North America, including Medtronic, Boston Scientific and Johnson & Johnson, which are pioneers in radiofrequency, cryoablation and microwave ablation technologies. The region continues to invest heavily in research and development, driving innovation in ablation devices.
For instance, in November 2024, Johnson & Johnson MedTech announced the U.S. Food & Drug Administration (FDA) approval of the VARIPULSE Platform for the treatment of drug-refractory paroxysmal Atrial Fibrillation (AFib). The VARIPULSE Platform is the first and only Pulsed Field Ablation (PFA) System in the U.S. fully integrated with the CARTO 3 Electro-anatomical Mapping System, driving efficiency, reproducibility and accuracy.
The U.S. Food and Drug Administration (FDA) plays a critical role in the regulatory approval of medical devices, and its rigorous yet supportive framework for innovative technologies has helped speed up the availability of new ablation devices. Devices such as Medtronic's Arctic Front Cryoballoon and Biosense Webster's ThermoCool SmartTouch Catheter have received FDA approval, ensuring that North America remains at the forefront of adopting the latest and most advanced ablation technologies. This rising FDA approvals of advanced ablation devices is driving the market in the region.
For instance, in August 2023, Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, announced that several products in its market-leading cardiac ablation portfolio have received approval for a zero fluoroscopy workflow from the U.S. Food and Drug Administration (FDA). The products that can be used in this workflow include: THERMOCOOL SMARTTOUCH SF catheter, the most commonly used ablation catheter in the world for RF ablation, THERMOCOOL SMARTTOUCH Catheter, CARTO VIZIGO Bi-Directional Guiding Sheath, PENTARAY NAV ECO High-Density Mapping Catheter, DECANAV Mapping Catheters, and Webster CS Catheter.
Asia-Pacific is growing at the fastest pace in the ablation devices market
The prevalence of chronic conditions, such as cardiovascular diseases (CVDs), cancer and diabetes, is rapidly increasing in the Asia-Pacific region, fueling the demand for ablation therapies. Conditions like atrial fibrillation and liver cancer are becoming more common, and ablation is a preferred treatment for these diseases due to its minimally invasive nature.
For instance, as the incidence of cancer increases, particularly liver, lung and kidney cancers, the need for tumor ablation devices is also rising. The World Health Organization (WHO) forecasts that cancer cases in India will rise by 40% by 2030, further driving demand for ablation therapies.
The Asia Pacific region is seeing significant improvements in healthcare infrastructure, especially in countries like China, India, Japan, South Korea, and Australia. These countries are investing heavily in modern healthcare technologies, leading to increased adoption of advanced medical devices, including ablation technologies. Many hospitals and healthcare facilities are expanding their capacity to provide cutting-edge treatments, driving the demand for ablation devices.
For instance, in September 2024, Kauvery Hospital launched Fluoroless Ablation for Atrial Fibrillation, setting a new benchmark in the treatment of one of the most common heart rhythm disorders. Kauvery Hospital continues to push the boundaries of medical innovation to ensure that patients receive the most effective and minimally invasive treatments available.
The major global players in the ablation devices market include Abbott Laboratories, Boston Scientific Corporation, Medtronic plc, Johnson & Johnson, Olympus Corporation, Stryker Corporation, Hologic, Inc., CONMED Corporation, Koninklijke Philips N.V., CooperSurgical, Inc. and among others.
The global ablation devices market report delivers a detailed analysis with 62 key tables, more than 64 visually impactful figures, and 187 pages of expert insights, providing a complete view of the market landscape.
Target Audience 2024
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