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시장보고서
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심방세동 치료 기기 : 시장 인사이트, 경쟁 구도 및 시장 예측(-2034년)Atrial Fibrillation Devices - Market Insights, Competitive Landscape, and Market Forecast - 2034 |
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DelveInsight
심방세동 치료 기기는 가장 흔한 지속성 부정맥인 심방세동을 감지, 모니터링 및 치료하는 데 사용되는 진단·치료 기기를 말합니다. 본 조사의 대상 범위에는 고주파, 냉동 절제술, 펄스 전기장 에너지를 이용하여 폐정맥을 격리하고 부정맥을 근치하는 카테터, 제너레이터, 콘솔을 포함한 절제술 기기,절제를 유도하는 매핑 및 기록 시스템, 뇌졸중을 예방하는 좌심방귀개 폐쇄 장치, 그리고 이식형 루프 레코더 및 외부 모니터를 포함한 진단·모니터링 장치가 포함됩니다. 대표적인 제품으로는 보스턴 사이언티피크(Boston Scientific)사의 ‘FARAPULSE’ 및 ‘WATCHMAN’, 메드트로닉(Medtronic)사의 ‘PulseSelect’ 및 크라이오벌룬,존슨앤드존슨 메드텍사의 바이오센스-웹스터사 제조 ‘VARIPULSE’ 및 ‘CARTO’, 애보트사의 ‘Amulet’ 및 ‘EnSite’를 포함한 제품군, 그리고 메드트로닉사를 비롯한 각사의 모니터링 기기 등이 있습니다. 이 시장은 주변 조직을 보존하면서 심장 조직을 선택적으로 절제하는 펄스 필드 절제술로의 급속한 전환이 진행되고 있으며, 현재 시장은 펄스 필드 절제술의 도입, 좌심방 귀 폐쇄의 확대, 그리고 모니터링의 보급으로 특징지어지고 있습니다.
심방세동 치료 기기 시장의 주요 시장 성장 촉진요인
심방세동 치료 기기 시장의 성장에 기여하는 요인
시장 성장 촉진요인
고령화에 따른 심방세동의 유병률 증가
심방세동 치료 기기 시장의 근본적인 촉진요인은 인구 고령화에 따른 심방세동 유병률 증가입니다. 심방세동은 가장 흔한 지속성 부정맥으로, 인구의 상당 부분에 영향을 미치며, 그 비율은 나이가 들면서 급격히 높아집니다. 일반 인구의 극히 일부이지만, 65세 이상에서는 그 비율이 높아지고, 80세 이상에서는 상당한 비율을 차지하고 있으며, 지난 수십년동안 심방세동의 발생률과 유병률은 상승하고 있습니다. 인구 고령화에 따라 심방세동을 앓는 사람들의 수는 증가하고 있으며, 고혈압, 비만, 당뇨병, 심부전 등 심방세동의 위험 요인 유병률 상승 또한 그 발생률을 더욱 높이고 있습니다. 심방세동은 뇌졸중, 심부전 및 사망 위험을 높입니다. 또한, 심방세동 환자 수가 많고 계속 증가하고 있기 때문에 진단, 모니터링, 치료가 필요하며, 이것이 심방세동 치료 기기에 대한 수요를 견인하고 있습니다. 고령화와 위험 요인 증가로 인해 심방세동의 유병률이 상승함에 따라, 심방세동 치료 기기를 통한 진단 및 치료가 필요한 환자층이 확대되고 있습니다. 인구 고령화가 진행되고 심방세동의 유병률이 상승함에 따라, 심방세동 치료 기기가 필요한 환자 수도 이에 따라 증가하고 있습니다. 인구 고령화에 따른 심방세동 유병률의 상승은 예측 기간 동안 심방세동 치료 기기 시장의 성장을 뒷받침하는 기반이 되고 있습니다.
펄스 필드 절제술의 급속한 보급
펄스 필드 절제술의 급속한 보급은 절제술 시장을 혁신하고, 심방세동 치료 기기의 성장을 가속화하는 결정적인 촉진요인입니다. 펄스 필드 절제술은 조직 선택적 전기 에너지를 이용하여 심방세동을 유발하는 심근 조직을 절제하는 동시에, 열 절제술에서는 손상될 가능성이 있는 식도나 횡격막 신경 등 주변 구조물을 보존함으로써 폐정맥 격리에 대한 보다 안전하고 신속한 접근 방식을 제공합니다. 펄스 필드 절제술은 도입 이후 급속히 보급되어 왔으며, 심방세동 치료용으로 최초의 펄스 필드 절제술 시스템이 승인된 이후 현재는 여러 시스템이 이용 가능하게 되었습니다. 앞으로 이 기술이 절제 시술의 대부분을 차지하게 되어, 고주파 절제술이나 냉동 절제술을 대체할 것으로 예측됩니다. 주요 의료기기 제조업체들은 보스턴 사이언티피크(Boston Scientific)의 ‘FARAPULSE’, 메드트로닉(Medtronic)의 ‘PulseSelect’, 존슨앤드존슨 메드텍(Johnson & Johnson MedTech)의 ‘VARIPULSE’,애보트사의 시스템 등 펄스 필드 절제 시스템을 개발·출시하고 있으며, 이러한 시스템의 급속한 보급이 절제 시장의 성장과 구조 변화를 주도하고 있습니다. 펄스 필드 절제의 안전성, 속도, 유효성, 그리고 전기생리학자들의 신속한 채택이 절제 분야 및 시장 전체의 성장을 이끌고 있습니다. 펄스 필드 절제술이 급속히 보급되어 열 절제술을 대체함에 따라, 절제술 시장은 확대되고 펄스 필드 절제술로 전환될 것입니다. 펄스 필드 절제술의 급속한 보급은 예측 기간 동안 심방세동 치료 기기 시장의 성장을 유지 및 가속화할 것입니다.
시장 제약 요인
심방세동 치료 기기 시장은 성장을 저해하는 몇 가지 상호 연관된 제약 요인에 직면해 있습니다. 가장 큰 요인은 기기 및 시술 비용입니다. 절제술이나 좌심방귀개 폐쇄용 기기 및 시술에는 고가의 카테터, 콘솔, 매핑 시스템, 임플란트, 전문 시설, 전문 인력이 필요하며, 이러한 비용은 특히 예산이 제한된 의료 시스템이나 자원이 부족한 환경에서 치료 접근성을 제한할 가능성이 있습니다. 전문적인 전기생리학 시설, 장비 및 훈련을 받은 전기생리학 전문의의 필요성은 절제술 및 폐쇄술 수행 능력을 제약하고 있으며, 훈련을 받은 전기생리학 전문의의 부족과 전기생리학 검사실의 수용 능력이 시술 건수를 제한하고 있습니다. 절제술 및 폐쇄술의 복잡성, 펄스 필드 절제술과 같은 신기술의 습득 곡선, 그리고 시술에 수반되는 합병증 위험은 훈련과 경험을 필요로 하며, 도입을 제한하는 요인이 될 수 있습니다. 절제술 후 심방세동의 재발(특히 지속성 심방세동의 경우)이나 재시술의 필요성은 일부 환자의 경우 치료 성과나 가치 제안을 저해하는 요인이 됩니다. 보험 환급은 대체로 지원적이지만, 의료 제도나 시술에 따라 다르며, 접근성이나 도입을 제약할 가능성이 있습니다. 기기 치료와 약물 치료 간의 경쟁, 그리고 기기 치료에 적합한 환자 선별이 대상 환자층을 결정짓고 있습니다. 기술 혁신의 급속한 발전, 특히 펄스 필드 절제술로의 전환은 지속적인 투자를 필요로 하며, 기존 기술이 구식이 될 가능성이 있습니다. 특히 신흥 시장에서 지역별로 전기생리학적 검사나 기기 치료에 대한 접근성에 차이가 있다는 점이 시장 확대를 제약하고 있습니다. 이러한 요인들이 복합적으로 작용하여 도입 속도와 범위는 완만한 양상을 보이고 있으며, 제조업체들은 성장을 유지하기 위해 안전성, 유효성, 비용 효율성 및 가치를 입증하는 동시에 교육 및 시스템 구축을 지원해야 합니다.
Atrial Fibrillation Devices Market Summary
Atrial fibrillation devices are the diagnostic and therapeutic devices used to detect, monitor, and treat atrial fibrillation, the most common sustained cardiac arrhythmia. The scope encompasses ablation devices, including the catheters, generators, and consoles that use radiofrequency, cryoablation, and pulsed field energy to isolate the pulmonary veins and eliminate the arrhythmia, mapping and recording systems that guide ablation, left atrial appendage closure devices that prevent stroke, and diagnostic and monitoring devices, including implantable loop recorders and external monitors. Leading products include the Boston Scientific FARAPULSE and WATCHMAN, the Medtronic PulseSelect and cryoballoon, the Johnson and Johnson MedTech Biosense Webster VARIPULSE and CARTO, the Abbott portfolio including the Amulet and EnSite, and the monitoring devices of Medtronic and others. The market is undergoing a rapid transition to pulsed field ablation, which selectively ablates cardiac tissue while sparing surrounding structures, and the contemporary market is defined by the adoption of pulsed field ablation, the growth of left atrial appendage closure, and the expansion of monitoring.
Atrial Fibrillation Devices Market Key Growth Drivers
Key Companies in Atrial Fibrillation Devices Market
The competitive field is led by cardiac rhythm and electrophysiology device companies, challenged by monitoring and specialty ablation companies. The leading participants in the atrial fibrillation devices market include the following:
Factors Contributing to the Growth of the Atrial Fibrillation Devices Market
Market Drivers
Rising Prevalence of Atrial Fibrillation with the Aging Population
The foundational driver of the atrial fibrillation devices market is the rising prevalence of atrial fibrillation, driven by the aging of the population. Atrial fibrillation is the most common sustained cardiac arrhythmia, affecting a substantial share of the population that rises steeply with age; a small percentage of the general population, a larger share of those over sixty-five, and a substantial share of those over eighty, and the incidence and prevalence of atrial fibrillation have risen over recent decades. The aging of the population increases the number of people with atrial fibrillation, and the rising prevalence of the risk factors of atrial fibrillation, including hypertension, obesity, diabetes, and heart failure, further increases its incidence. Atrial fibrillation increases the risk of stroke, heart failure, and mortality, and the large and growing population of patients with atrial fibrillation requires diagnosis, monitoring, and treatment, driving the demand for atrial fibrillation devices. The rising prevalence of atrial fibrillation, driven by aging and the growth of risk factors, enlarges the population requiring the diagnosis and treatment that atrial fibrillation devices provide. As the population ages and as the prevalence of atrial fibrillation rises, the number of patients requiring atrial fibrillation devices grows in step. The rising prevalence of atrial fibrillation with the aging population anchors the growth of the atrial fibrillation devices market across the forecast period.
Rapid Adoption of Pulsed Field Ablation
The rapid adoption of pulsed field ablation is a defining driver that is transforming the ablation market and accelerating the growth of atrial fibrillation devices. Pulsed field ablation uses tissue-selective electrical energy to ablate the cardiac tissue that causes atrial fibrillation while sparing the surrounding structures, including the esophagus and phrenic nerve, that thermal ablation can damage, and it offers a safer and faster approach to pulmonary vein isolation. Pulsed field ablation has been adopted rapidly since its introduction, with the first pulsed field ablation system approved for atrial fibrillation and multiple systems now available, and it is expected to account for the majority of ablation procedures, displacing radiofrequency and cryoablation. The leading device companies have developed and launched pulsed field ablation systems, including the Boston Scientific FARAPULSE, the Medtronic PulseSelect, the Johnson and Johnson MedTech VARIPULSE, and the Abbott system, and the rapid adoption of these systems drives the growth and the shift of the ablation market. The safety, speed, and efficacy of pulsed field ablation, and its rapid adoption by electrophysiologists, drive the growth of the ablation segment and the market. As pulsed field ablation is adopted rapidly and as it displaces thermal ablation, the ablation market grows and shifts toward pulsed field ablation. The rapid adoption of pulsed field ablation sustains and accelerates the growth of the atrial fibrillation devices market across the forecast period.
Market Restraints
The atrial fibrillation devices market faces several interrelated restraints that temper its growth. The foremost is the cost of devices and procedures, since ablation and left atrial appendage closure devices and procedures are costly, requiring expensive catheters, consoles, mapping systems, implants, specialized facilities and staff, and the cost can constrain access, particularly in cost-constrained systems and lower-resource settings. The requirement for specialized electrophysiology facilities, equipment, and trained electrophysiologists constrains the capacity to perform ablation and closure, and the shortage of trained electrophysiologists and the capacity of electrophysiology laboratories limit procedural volume. The complexity of ablation and closure procedures, the learning curve of new technologies such as pulsed field ablation, and the risk of procedural complications require training and experience and can limit adoption. The recurrence of atrial fibrillation after ablation, particularly in persistent atrial fibrillation, and the need for repeat procedures temper the outcomes and the value proposition for some patients. Reimbursement, while generally supportive, varies across systems and procedures and can constrain access and adoption. The competition of devices with drug therapy and the appropriate selection of patients for device therapy shape the addressable population. The rapid pace of technological change, particularly the transition to pulsed field ablation, requires continuous investment and can strand prior technology. The variability of access to electrophysiology and device therapy across regions, particularly in emerging markets, constrains the market. Together, these factors moderate the pace and scope of adoption and require manufacturers to demonstrate safety, efficacy, cost-effectiveness, and value and to support training and capacity to sustain growth.
Atrial Fibrillation Devices Market Segment Analysis
The global atrial fibrillation devices market is segmented by product (ablation devices, mapping and recording devices, left atrial appendage closure devices, diagnostic and monitoring devices), by ablation technology (pulsed field ablation, radiofrequency ablation, cryoablation, others), by indication (paroxysmal atrial fibrillation, persistent atrial fibrillation, long-standing persistent atrial fibrillation), by end-users (hospitals, ambulatory surgical centers, specialized cardiac clinics, and others), and by geography (North America, Europe, Asia-Pacific, and the Rest of the World).
By Product
Dominant Subsegment: Ablation Devices.
The ablation devices category is expected to dominate the market. The ablation devices segment accounted for a 48% share of the atrial fibrillation devices market in 2025. Ablation devices, including the catheters, generators, and consoles that ablate the cardiac tissue causing atrial fibrillation, are the leading product category because catheter ablation is the principal interventional therapy for atrial fibrillation and the ablation procedure consumes high-value catheters and consumables in growing volume. The dominance of the segment reflects the central role of catheter ablation in the treatment of atrial fibrillation, the high value of ablation catheters and systems, and the rapid growth and transition of ablation driven by pulsed field ablation. Ablation devices isolate the pulmonary veins to eliminate the source of atrial fibrillation using radiofrequency, cryoablation, and pulsed field energy, and the leading companies provide ablation catheters, generators, and consoles, including the rapidly adopted pulsed field ablation systems. The central role of ablation, the value of the devices, the growth of procedural volume, and the transition to pulsed field ablation drive the ablation devices segment. While mapping and recording systems, left atrial appendage closure devices, and diagnostic and monitoring devices are important product categories, the centrality, value, and growth of ablation devices sustain the leadership of the ablation devices segment across the forecast period.
By Ablation Technology
Dominant Subsegment: Pulsed Field Ablation.
The pulsed field ablation category is expected to dominate the market. The pulsed field ablation segment accounted for a 46% share of the atrial fibrillation devices ablation market in 2025. Pulsed field ablation, which uses tissue-selective electrical energy to ablate cardiac tissue while sparing surrounding structures, is the leading ablation technology because it has been adopted rapidly since its introduction and is displacing radiofrequency and cryoablation to become the predominant ablation modality. The dominance of the segment reflects the rapid adoption of pulsed field ablation, its safety and speed advantages over thermal ablation, and its embrace by electrophysiologists and the leading device companies. Pulsed field ablation spares the esophagus and phrenic nerve that thermal ablation can damage, isolates the pulmonary veins safely and quickly, and has been adopted rapidly, with the leading companies launching pulsed field ablation systems and the technology expected to account for the majority of ablation procedures. The safety, speed, efficacy, and rapid adoption of pulsed field ablation, and the investment of the leading companies, drive the segment. While radiofrequency ablation, the established modality, and cryoablation remain significant and widely used, the rapid adoption, advantages, and momentum of pulsed field ablation sustain the leadership of the pulsed field ablation segment across the forecast period, and it defines the direction of the ablation market.
Atrial Fibrillation Devices Market Region Analysis
Dominant Region: North America
North America accounted for a 42% share of the global atrial fibrillation devices market in 2025, representing the highest regional market share globally. The leadership of the region reflects the high prevalence and diagnosis of atrial fibrillation, the advanced adoption of ablation and left atrial appendage closure, the presence and headquarters of the leading device companies, and supportive reimbursement. The United States is the largest national market, supported by the high prevalence and diagnosis of atrial fibrillation, the advanced electrophysiology infrastructure, the rapid adoption of pulsed field ablation and left atrial appendage closure, the presence of the leading device companies, and the supportive reimbursement of ablation and closure. The advanced electrophysiology infrastructure, the high procedural volume, the rapid adoption of new technologies, and the strong reimbursement drive the market, and the leading device companies are headquartered and conduct extensive development and commercialization in the region. The high prevalence and diagnosis, the advanced adoption, the presence of the leading companies, and the supportive reimbursement reinforce the leadership of the region. The combination of disease burden, adoption maturity, company presence, and reimbursement sustains the position of North America as the largest regional market across the forecast period.
Fastest Growing Region: Asia-Pacific
Asia-Pacific is projected to register the fastest compound annual growth rate through 2034. The region combines large and aging populations, the rising prevalence and diagnosis of atrial fibrillation, the expansion of electrophysiology infrastructure, and the growing adoption of ablation and closure, which drives the fast growth of the market. China, Japan, and India are the principal national markets, supported by the aging of large populations, the rising prevalence and diagnosis of atrial fibrillation, the expansion of electrophysiology laboratories and cardiac centers, the adoption of ablation and left atrial appendage closure, and the growth of healthcare investment and access. The growth of the atrial fibrillation population, the expansion of electrophysiology infrastructure, and the adoption of advanced devices enlarge the demand for atrial fibrillation devices. As populations age, as the diagnosis of atrial fibrillation increases, and as electrophysiology infrastructure and the adoption of ablation and closure expand, the region increases its demand from a growing base, and the scale of the population and the expansion of infrastructure create substantial long-term demand. The combination of population scale, rising disease burden, infrastructure expansion, and device adoption positions Asia-Pacific as the fastest-growing regional market, and it attracts investment and commercial focus from the leading global device companies.
Regional Commentary
North America
North America leads the market, supported by the high prevalence and diagnosis of atrial fibrillation, the advanced adoption of ablation and left atrial appendage closure, the presence of the leading device companies, and supportive reimbursement. The United States dominates the region through its advanced electrophysiology infrastructure, the rapid adoption of pulsed field ablation and closure, and the presence of the leading companies. The high procedural volume and reimbursement sustain demand.
Europe
Europe is a substantial market shaped by advanced healthcare systems, the adoption of ablation and left atrial appendage closure, and the presence and development of the leading device companies. Germany, the United Kingdom, France, Italy, and Spain are the principal national markets, supported by the prevalence of atrial fibrillation, the adoption of pulsed field ablation and closure, and the electrophysiology infrastructure. Demand is sustained by the disease burden, the adoption of advanced devices, and the support of clinical evidence and guidelines.
Asia-Pacific
Asia-Pacific is the fastest-growing region, driven by large and aging populations, the rising prevalence and diagnosis of atrial fibrillation, the expansion of electrophysiology infrastructure, and the growing adoption of ablation and closure across China, Japan, and India. Aging populations, rising disease burden, and infrastructure expansion sustain rapid growth, and the region attracts commercial focus from the leading global device companies.
Rest of World
The Rest of World, spanning Latin America, the Middle East, and Africa, represents an emerging opportunity as the diagnosis of atrial fibrillation and electrophysiology infrastructure grow. Growth is supported by the rising prevalence and diagnosis of atrial fibrillation, the expansion of cardiac and electrophysiology infrastructure, and the growing adoption of ablation and closure, though access and infrastructure vary by market. Device companies pursue these markets through devices and training suited to expanding electrophysiology.
Atrial Fibrillation Devices Market Competitive Landscape
The global atrial fibrillation devices market is classified as Consolidated. A small group of large cardiac rhythm and electrophysiology device companies holds the majority of the market through comprehensive portfolios spanning ablation, mapping, closure, and monitoring, while specialty ablation, monitoring, and robotics companies compete in specific segments. Competition centers on the performance and safety of ablation, particularly the transition to pulsed field ablation, the integration of ablation with mapping, the breadth of the portfolio across ablation, closure, and monitoring, clinical evidence, and the training and support of electrophysiologists. The pulsed field ablation transition, product launches, and clinical trials intensify the contest. The competitive landscape is evaluated across the following dimensions:
Atrial Fibrillation Devices Market Recent Developmental Activities
In late 2023, Medtronic plc received Food and Drug Administration approval for the PulseSelect pulsed field ablation system, the first pulsed field ablation system approved for atrial fibrillation in the United States. Strategic significance: the approval marked the arrival of pulsed field ablation in the United States and initiated the rapid transition of the ablation market.
In 2024, Boston Scientific Corporation advanced and commercialized the FARAPULSE pulsed field ablation system, which achieved rapid adoption and strong clinical outcomes in pulmonary vein isolation. Strategic significance: the commercialization of FARAPULSE established a leading position in pulsed field ablation and drove the transition of the ablation market.
Atrial Fibrillation Devices Market Segmentation
Atrial Fibrillation Devices Market Assessment by Product
Atrial Fibrillation Devices Market Assessment by Ablation Technology
Atrial Fibrillation Devices Market Assessment by Indication
Atrial Fibrillation Devices Market Assessment by End-User
Atrial Fibrillation Devices Market Assessment by Geography
Key Takeaways from the Atrial Fibrillation Devices Market Report Study
Target audience who can benefit from this atrial fibrillation devices market report study
Q1. At what rate is the atrial fibrillation devices market expected to grow?
The global atrial fibrillation devices market is projected to grow at a compound annual growth rate of 11.3% during the forecast period from 2026 to 2034.
Q2. What is the current and projected size of the atrial fibrillation devices market?
The global atrial fibrillation devices market was valued at USD 14.50 billion in 2025 and is projected to reach USD 38.00 billion by 2034.
Q3. Which region dominates the atrial fibrillation devices market?
North America dominated the atrial fibrillation devices market with a 42% share in 2025, driven by the high prevalence and diagnosis of atrial fibrillation, the advanced adoption of ablation and left atrial appendage closure, the presence of the leading device companies, and supportive reimbursement. Asia-Pacific is projected to record the fastest compound annual growth rate through 2034, driven by large and aging populations and the expansion of electrophysiology infrastructure across China, Japan, and India.
Q4. What are the key factors driving growth in the atrial fibrillation devices market?
The principal drivers are the rising prevalence of atrial fibrillation with the aging population; the rapid adoption of pulsed field ablation, which spares surrounding structures; the growth of left atrial appendage closure for stroke prevention; the expansion of diagnosis and continuous monitoring; the increasing procedural volume of catheter ablation; and the strong clinical evidence and guideline support for ablation and closure.
Q5. Who are the major players in the atrial fibrillation devices market?
The market is consolidated and led by Boston Scientific Corporation, Medtronic plc, Johnson & Johnson MedTech, and Abbott Laboratories, alongside AtriCure, Inc., Biotronik SE & Co. KG, MicroPort Scientific Corporation, Koninklijke Philips N.V., GE HealthCare Technologies Inc., and Stereotaxis, Inc. Additional participants including CardioFocus, Inc., Adagio Medical, Inc., and Kardium Inc. compete across ablation, closure, mapping, and monitoring.
For illustrative purposes, only the top 10 companies are listed in the Table of Contents. The report may include analysis and references to additional companies where relevant to the market assessment.