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시장보고서
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죽종 절제술 기기 : 시장 인사이트, 경쟁 구도 및 시장 예측(-2034년)Atherectomy Devices - Market Insights, Competitive Landscape, and Market Forecast - 2034 |
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아테레크토미는 카테터를 이용한 저침습 시술로, 풍선 확장이나 영구 스텐트 삽입에만 의존하지 않고, 병변이 있는 관상동맥이나 말초동맥에서 죽종성 플라크, 석회화, 혈전을 기계적으로 제거하여 관강의 개통성을 회복시키는 시술입니다. 아테레크토미 기기는 플라크를 절단, 깎아내기, 연마 또는 광절제하기 위해 전용으로 설계되었으며, 방향성형, 회전형, 궤도형 또는 레이저(광절제)형 시스템으로 개발되었습니다. 각각은 부드럽고 편심된 플라크부터 고도로 석회화된 미만성 병변에 이르기까지 다양한 병변 형태에 적합합니다. 관상동맥 질환, 말초동맥 질환, 스텐트 내 재협착의 경우, 기존의 혈관 성형술로는 대처하기 어려운 중증의 석회화나 섬유화를 동반한 병변이 빈번하게 관찰되므로, 중재적 심장 전문의 및 혈관 전문의들은 혈관 준비나 단독 병변 제거 도구로서 아테렉토미에 대한 의존도를 높이고 있습니다. 이 시장은 제품별로는 방향성, 회전식, 궤도식 및 레이저 죽종 절제술 기기로 분류되며, 용도별로는 관상동맥 질환, 말초동맥 질환 및 스텐트 내 재협착으로 분류되고, 최종 사용자별로는 병원, 전문 클리닉 및 기타 외래 진료 시설로 분류됩니다. 전 세계 심혈관 질환 유병률 증가, 고령화 및 당뇨병 환자 증가, 외래 및 통원형 중재 치료로의 전환, 그리고 영상 통합형 및 다중 모달리티 기기의 급속한 기술 발전에 힘입어, 죽종 절제술 기기 제조업체는 현대 중재 심장학 및 혈관외과 생태계에서 필수적인 파트너가 되었습니다.
죽종 절제술 기기 시장의 주요 시장 성장 촉진요인
죽종 절제술 기기 시장의 성장에 기여하는 요인
시장 성장 촉진요인
관상동맥 질환 및 말초동맥 질환의 전 세계적 부담 증가
죽종 절제술 기기 시장의 가장 강력한 시장 성장 촉진요인은 심혈관 질환의 전 세계적 부담 증가입니다. 2024년 기준으로 전 세계적으로 약 2억 명이 관상동맥 질환을 앓고 있으며, 수백만 명이 말초동맥 질환이나 뇌졸중의 영향을 받고 있습니다. 고령자나 당뇨병 환자에서 흔히 심하게 석회화된 죽종성 플라크의 축적은 기존의 풍선 혈관 성형술로는 제거하기 어려운 경우가 많아, 근치적 치료 전에 기계적인 제거가 필요합니다. 고혈압, 당뇨병, 비만의 유병률이 전 세계적으로 계속 상승하는 가운데, 아테렉토미 수술 건수를 견인하는 기저 질환의 부담은 꾸준히 확대될 것으로 예상되며, 2034년까지 시장 성장을 뒷받침할 것으로 전망됩니다.
저침습 재혈관화 요법에 대한 선호도 증가
환자와 의사들 사이에서는 개흉 우회술보다 저침습적인 카테터를 이용한 치료법이 점점 더 선호되고 있습니다. 아테렉토미는 입원 기간 단축, 회복 가속화, 시술에 따른 신체적 부담 경감, 그리고 대부분의 경우 영구적인 스텐트 삽입을 피할 수 있다는 등 의미 있는 임상적 이점이 있습니다. 특히 방향성 아테렉토미는 영구적인 임플란트를 남기지 않고 플라크를 선택적으로 제거할 수 있으므로, 스텐트 내 재협착 등의 합병증 위험을 줄여줍니다. 외래 및 통원 심장 중재술이 지속적으로 확대되는 가운데, 아테렉토미의 시술적 및 경제적 이점은 예측 기간 동안 그 채택을 촉진할 것으로 예측됩니다.
시장 제약 요인
성장세가 강함에도 불구하고, 죽종 절제술 기기 시장은 중대한 제약에 직면해 있습니다. 아테렉토미 시스템 및 관련 시술의 높은 비용은 가격에 민감한 시장이나 예산이 제한된 의료 현장에서의 도입을 제한하고 있습니다. 혈관 천공, 박리, 수술 후 재협착 등 시술에 수반되는 합병증의 위험은 특정 환자 집단에서 의료진이 도입을 주저하게 만드는 요인이 되고 있습니다. 또한, 이 시장은 풍부한 장기 임상 데이터로 뒷받침되는 풍선 혈관 성형술, 스텐트 삽입, 약물 방출형 풍선과 같은 확립된 저비용 대체 요법과의 치열한 경쟁에도 직면해 있습니다. 아테렉토미 기술을 훈련받은 중재적 심장 전문의 및 혈관 외과 의사의 수가 제한적이라는 점이, 특히 개발도상 지역에서 이 기술의 도입을 제약하고 있습니다. 또한, 지역별로 분절되어 있고 끊임없이 변화하는 규제 체계는 여러 시장에서 승인을 목표로 하는 제조업체들에게 복잡성을 더하고 있습니다. 질병 부담 증가나 최소 침습 치료에 대한 선호와 같은 근본적인 촉진요인은 여전히 확고하지만, 국가별 보험 급여 제도의 불균일성이 도입 속도를 더욱 둔화시키고 있습니다.
Atherectomy Devices Market Summary
Atherectomy is a catheter-based, minimally invasive procedure that mechanically removes atherosclerotic plaque, calcium, and thrombus from diseased coronary and peripheral arteries to restore luminal patency without relying solely on balloon dilation or permanent stent placement. Atherectomy devices are purpose-built to cut, shave, sand, or photo-ablate plaque, and are engineered as directional, rotational, orbital, or laser (photo-ablative) systems, each suited to distinct lesion morphologies ranging from soft, eccentric plaque to densely calcified, diffuse disease. Because coronary artery disease, peripheral artery disease, and in-stent restenosis frequently involve heavily calcified or fibrotic lesions that resist conventional angioplasty, interventional cardiologists and vascular specialists increasingly turn to atherectomy as a vessel-preparation and standalone debulking tool. The market is organized by product across directional, rotational, orbital, and laser atherectomy devices; by application across coronary artery disease, peripheral artery disease, and in-stent restenosis; and by end-user across hospitals, specialty clinics, and other outpatient settings. Driven by the rising global prevalence of cardiovascular disease, an aging and increasingly diabetic population, the shift toward outpatient and ambulatory interventional care, and rapid technological advancement in imaging-integrated and multi-modality devices, atherectomy device manufacturers have become essential partners in the modern interventional cardiology and vascular surgery ecosystem.
Atherectomy Devices Market Key Growth Drivers
Key Companies in Atherectomy Devices Market
The competitive landscape is led by the following active device manufacturers:
Factors Contributing to the Growth of the Atherectomy Devices Market
Market Drivers
Rising Global Burden of Coronary and Peripheral Artery Disease
The most powerful driver of the Atherectomy Devices market is the escalating global burden of cardiovascular disease. An estimated 200 million people worldwide were living with coronary heart disease as of 2024, and millions more were affected by peripheral artery disease and stroke. Atherosclerotic plaque buildup, often heavily calcified in elderly and diabetic patients, frequently resists conventional balloon angioplasty and requires mechanical debulking before definitive treatment. As the prevalence of hypertension, diabetes, and obesity continues to rise worldwide, the underlying disease burden driving atherectomy procedure volumes is expected to expand steadily, anchoring market growth through 2034.
Growing Preference for Minimally Invasive Revascularization
Patients and physicians increasingly favor minimally invasive, catheter-based interventions over open surgical bypass. Atherectomy offers meaningful clinical advantages, including shorter hospital stays, faster recovery, reduced peri-procedural trauma, and, in many cases, avoidance of permanent stent implantation. Directional atherectomy in particular allows selective plaque debulking without leaving a permanent implant behind, reducing the risk of complications such as in-stent restenosis. As outpatient and ambulatory interventional cardiology continues to expand, the procedural and economic advantages of atherectomy are expected to sustain adoption across the forecast period.
Market Restraints
Despite strong momentum, the Atherectomy Devices market faces material constraints. The high cost of atherectomy systems and associated procedures limits adoption in price-sensitive markets and budget-constrained healthcare settings. The risk of procedural complications, including vessel perforation, dissection, and post-procedure restenosis, tempers physician adoption in certain patient populations. The market also faces strong competition from established, lower-cost alternatives such as balloon angioplasty, stenting, and drug-coated balloons, which benefit from extensive long-term clinical data. A limited pool of interventional cardiologists and vascular surgeons trained in atherectomy techniques constrains adoption, particularly in developing regions, while fragmented and evolving regulatory frameworks across geographies add complexity for manufacturers seeking multi-market approval. Reimbursement variability across countries further tempers the pace of adoption, even as the underlying drivers of rising disease burden and minimally invasive preference remain firmly intact.
Atherectomy Devices Market Segment Analysis
The Atherectomy Devices Market by Product (Directional Atherectomy Devices, Rotational Atherectomy Devices, Orbital Atherectomy Devices, and Laser Atherectomy Devices), Application (Coronary Artery Disease, Peripheral Artery Disease, and In-Stent Restenosis), End-User (Hospitals, Specialty Clinics, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of World).
By Product
Dominant Subsegment: Directional Atherectomy Devices.
Dominant: Directional Atherectomy Devices ~ 40%
The directional atherectomy devices segment accounted for approximately 40% of the Atherectomy Devices market in 2025. Directional atherectomy is the leading product category because of its exceptional versatility and precision across both peripheral and coronary lesions. Its blade-within-housing design enables selective removal of eccentric and bulky plaque without significant damage to the healthy vessel wall, preparing the artery for subsequent balloon angioplasty or drug-coated balloon treatment and reducing the need for permanent stenting. Prominent directional atherectomy devices include Medtronic's HawkOne Directional Atherectomy System and Boston Scientific's Jetstream Atherectomy System. While rotational and orbital atherectomy are highly effective for heavily calcified lesions, and laser atherectomy is gaining traction in complex occlusions, the broad applicability and established safety profile of directional atherectomy devices secure their leading position. Laser atherectomy devices are projected to register the fastest growth of the forecast period, propelled by their unique photo-ablative mechanism, expanding use in chronic total occlusions and in-stent restenosis, and rising adoption as a vessel-preparation tool ahead of drug-coated balloon or stent placement.
By Application
Dominant Subsegment: Peripheral Artery Disease.
Dominant: Peripheral Artery Disease ~ 50%
The peripheral artery disease segment accounted for approximately 50% of the Atherectomy Devices market in 2025. Peripheral artery disease is the leading application because atherectomy is a first-line debulking strategy for femoropopliteal and below-the-knee lesions, particularly in patients with heavily calcified plaque where balloon angioplasty alone offers poor durability. Rising rates of diabetes and an aging population are directly expanding the pool of patients with critical limb ischemia and claudication requiring intervention. Coronary artery disease is the second-largest application, with rotational and orbital atherectomy increasingly used to prepare severely calcified coronary lesions ahead of stent deployment, supporting steady procedure volumes in cath labs worldwide. In-stent restenosis is the fastest-growing application, as laser and directional atherectomy are increasingly used to debulk neointimal and calcified tissue within previously stented segments, reducing the recurrence of restenosis and extending the durability of prior interventions. While in-stent restenosis is scaling quickly, the sheer prevalence and treatment volume of peripheral artery disease secures its leadership across the forecast period.
Atherectomy Devices Market Region Analysis
Dominant Region: North America
North America accounted for approximately 42% of the global Atherectomy Devices market revenue in 2025, representing the highest regional market share globally. The region's dominance reflects a high cardiovascular disease burden, advanced catheterization infrastructure, and favorable reimbursement conditions, particularly in the United States. Millions of U.S. adults are diagnosed with coronary heart disease, atrial fibrillation, and stroke each year, and an estimated 38.4 million people in the U.S. were living with diabetes in 2024, a major contributor to accelerated peripheral artery disease. North America also hosts a dense ecosystem of leading device manufacturers and a continuous pipeline of new product approvals, including the FDA's January 2025 clearance of the Rotarex Atherectomy System. Strong reimbursement, regulatory clarity, and a culture of continuous innovation anchor the region's continued leadership across the forecast period.
Fastest Growing Region: Asia-Pacific
Asia-Pacific is the fastest-growing region in the Atherectomy Devices market. The region's elevated CAGR is driven by a large and aging population, rapid healthcare infrastructure development, rising disposable income, and growing awareness of minimally invasive treatment options across China, India, Japan, South Korea, and Australia. China and India are making substantial investments in hospital infrastructure and training a new generation of interventional specialists, while Japan, Australia, and Singapore maintain well-established regulatory pathways that support faster product introductions. Rising rates of obesity, hypertension, and diabetes are fueling atherosclerosis prevalence across the region, and ongoing regulatory harmonization efforts are expected to streamline market entry for manufacturers. The combination of high disease burden, infrastructure build-out, and rising healthcare spending positions Asia-Pacific as the principal source of incremental growth over the forecast period.
Regional Commentary
North America
North America accounted for approximately 42% of the global Atherectomy Devices market revenue in 2025. The United States dominates on the strength of its high cardiovascular disease burden, advanced catheterization infrastructure, and favorable reimbursement environment, while a continuous pipeline of regulatory clearances and a dense manufacturer base reinforce its leadership.
Europe
Europe is a large and advanced regional market, supported by a high prevalence of cardiovascular disease within a rapidly aging population and a strong regional preference for minimally invasive procedures. Reimbursement policies vary across countries, with Germany, France, and the United Kingdom maintaining robust frameworks that encourage device adoption, while CE Mark approvals such as AngioDynamics' September 2024 clearance for the Auryon Atherectomy System continue to expand the region's treatment options.
Asia-Pacific
Asia-Pacific is the fastest-growing region, propelled by a large and aging population, rapid healthcare infrastructure build-out, and rising healthcare spending across China, Japan, India, South Korea, and Australia. Expanding hospital networks, growing patient awareness, and gradual regulatory harmonization are accelerating regional adoption of atherectomy technology.
Rest of World
The Rest of World region, spanning the Middle East, Africa, and South America, is an emerging growth frontier. Expanding healthcare infrastructure, rising diagnosis rates of coronary and peripheral artery disease, and gradual alignment of regulatory frameworks with global standards are broadening access, while international partnerships support the build-out of interventional cardiology capacity.
Atherectomy Devices Market Competitive Landscape
The Atherectomy Devices market is classified as Highly Consolidated. A small group of major players, including Medtronic, Boston Scientific, and Abbott, dominate the market through extensive R&D capabilities, broad product portfolios, and global distribution networks, while specialized innovators such as AngioDynamics, Avinger, Ra Medical Systems, REX Medical, and Cardio Flow compete through focused technology platforms and expanding regulatory clearances.
The competitive landscape can be evaluated across the following dimensions:
Atherectomy Devices Market Recent Developmental Activities
In January 2025, AngioDynamics, Inc., initiated a new clinical trial to expand the indications of its Auryon Atherectomy System to treat below-the-knee peripheral artery disease. Strategic significance: Broadens the addressable patient population for a leading laser atherectomy platform.
In January 2025, the FDA cleared a 510(k) submission for the Rotarex Atherectomy System, covering revised instructions for use aimed at reducing helix breakage. Strategic significance: Reinforces device reliability and sustains physician confidence in rotational atherectomy.
Atherectomy Devices Market Segmentation
Atherectomy Devices Market by Product
Atherectomy Devices Market by Application
Atherectomy Devices Market by End-User
Atherectomy Devices Market by Geography
Key Takeaways from the Atherectomy Devices Market Report Study
Target audience who can benefit from this atherectomy devices market report study
Q1. What is the growth rate of the atherectomy devices market?
The atherectomy devices market is projected to expand at a CAGR of 8.5% during the forecast period from 2026-2034.
Q2. What is the market size of the atherectomy devices market?
The atherectomy devices market is estimated at USD 1.12 billion in 2025 and is projected to reach USD 2.34 billion by 2034.
Q3. Which region dominates the atherectomy devices market?
North America dominated the Atherectomy Devices market with a 42% share of global revenue in 2025, supported by a high cardiovascular disease burden, advanced catheterization infrastructure, and favorable reimbursement conditions. Asia-Pacific is the fastest-growing region over the forecast period.
Q4. What are the key drivers of the atherectomy devices market?
The principal drivers are the rising global burden of coronary and peripheral artery disease, with an estimated 200 million people living with coronary heart disease worldwide in 2024; growing preference for minimally invasive revascularization; continuous technological advancement in imaging-integrated and multi-modality devices; and accelerating regulatory approvals and label expansions.
Q5. Who are the major players in the atherectomy devices market?
The major players include Koninklijke Philips N.V., Medtronic PLC, Boston Scientific Corporation, AngioDynamics Inc., Abbott Laboratories, Avinger, BD, Ra Medical Systems, REX Medical, and Cardio Flow, Inc., among other active providers profiled in the Competitive Landscape section. Medtronic, Boston Scientific, and Abbott lead through broad product portfolios and global distribution networks.