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市场调查报告书
商品编码
1847184
美国週边血管内介入器材市场:市场规模、份额和趋势分析(2025-2031年)Complex Peripheral Vascular Device Market Size, Share & Trends Analysis | United States | 2025-2031 | Includes: Atherectomy Devices, Intravascular Lithotripsy Systems, Surgical Grafts, Stent Grafts, Embolic Protection Devices (EPDs), and 6 more |
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2024年,美国复合型週边血管器械市场规模将超过64亿美元。预计在预测期内,该市场规模将成长至近85亿美元。
本报告涵盖週边支架、经皮血管成形术 (PTA) 球囊导管、药物涂层球囊 (DCB)、动脉粥状硬化斑块切除术装置、血管内碎石装置、慢性完全闭塞 (CTO) 装置、外科移植、血管支架、栓塞保护装置、週边血栓管理装置和周边血管内超音波(IVUS) 导管。
虽然有些装置应用于冠状动脉,但本期中的所有尺寸和预测都仅适用于週边手术。
量化指标包括销售量、平均售价、市场规模、成长率、手术例数和企业市场占有率。
定性资讯包括市场趋势和驱动因素、併购、技术和实践趋势,以及在血管内医院、诊所实验室和门诊机构中的竞争地位。
市场概览
周边动脉疾病和静脉疾病是美国导致发病的主要原因。
治疗方案正从开放性手术逐渐转向血管内治疗(在临床条件允许的情况下),这样可以缩短住院时间,并加快康復速度。
在动脉系统中,医师使用经皮血管成形术(PTA)、药物涂层球囊(DCB)、支架、动脉粥状硬化斑块切除术、血管内超音波(IVUS)、体外震波碎石术等方法来透过病灶、復位血管并维持通畅性。在治疗主动脉瘤和周围动脉瘤时,血管支架为开放性手术提供了微创替代方案。
在静脉疾病领域,血栓切除术和栓塞术、静脉支架植入术、血管内超音波导航以及肺动脉栓塞预防的需求日益增长。人们对这些疾病的认识不断提高,影像技术的进步以及预测工具的增多,正在扩大可治疗的患者群体并改善治疗效果。
临床项目也反映了实际的限制:价格压力在办公室实验室最为明显,折扣和捆绑优惠很常见。
尤其是在人们对紫杉醇安全性的担忧导致 DCB 的成长预期低于 2019 年之前的趋势之后,情况更是如此。
整体市场仍然多元化,技术创新不断增加选择,从而在整个预测期内实现稳步的价值成长。
市场驱动因素
静脉市场发展。静脉疾病的发生率约为动脉疾病的五倍。肺动脉栓塞每年影响美国约60万人,且常与下肢深层静脉栓塞症有关。深部静脉血栓形成每年影响约90万人,但许多患者无症状,猝死往往是首发症状。随着教育和筛检的改进,接受静脉阻塞和血栓栓塞性疾病治疗的患者人数预计将会增加。在一些项目中,血管内超音波(IVUS)在深部静脉治疗的应用率已超过50%,并且与髂静脉、髂股静脉、股总静脉和下腔静脉病变的治疗密切相关。
公众意识的提高。医疗机构和公共机构的推广工作提高了公众对週边动脉和静脉疾病的认识。筛检能够识别出更多需要介入的患者,以便在出现严重症状或危及肢体的缺血之前进行治疗。卒中预防计画强调颈动脉疾病的重要性。这些努力正促使更多患者进入涵盖动脉和静脉疾病的诊断和治疗路径。
创新。自 2015 年以来,新的治疗选择不断涌现,拓展了治疗套件。血管内碎石术和经颈动脉重组术 (TCAR) 为简化复杂解剖结构或降低栓塞风险提供了新的选择。药物涂层球囊 (DCB) 的适应症在特定情况下持续扩展,例如动静脉通路,预计膝下 DCB 将进入美国市场。减少或无需溶栓的血栓切除平台缩短了治疗时间并降低了出血风险。血管支架移植物适应症也不断扩展,覆膜支架、亲水性导管和导管导引线因其能够缩短手术时间和减少併发症而价格不菲。
市场限制
人们对紫杉醇的安全性感到担忧。 2018 年的一项统合分析发现,在用于治疗週边动脉疾病 (PAD) 的紫杉醇涂层器械的试验中,存在晚期死亡讯号。这促使美国食品药物释放型支架的使用量急剧下降,并转向其他替代疗法。儘管预计未来会有所回升,但长期收益仍低于重新评估之前。
门诊实验室 (OBL) 的竞争与定价。门诊实验室的采购价格通常比医院低约 30%。激烈的 OBL 合约竞争以及将核心治疗器材与鞘套、导管导引线和导管捆绑销售的模式,正在拉低平均售价。产品组合不全的小型公司面临价格压力,这会限制它们的投资能力;而市场整合则会降低市场多样性,减缓创新。
股腘窝段的成熟。长期以来,对股腘窝疾病的关注催生了许多治疗方案和稳定的临床实践。随着其他适应症的出现和患者选择的改进,股骨干介入手术的增长速度预计将趋于稳定,更接近整体手术的增长速度,而不是像过去那样呈指数级增长。
目标市场和数据范围
定量分析:市场规模、市场占有率、市场预测、成长率、销售量、平均售价、手术例数。
定性内容:成长趋势、市场限制、主要竞争对手的竞争分析和 SWOT 分析、併购、公司简介和产品系列、FDA 批准和召回(如适用)、颠覆性技术、影响治疗方法方案的疾病概述。
时段:基准年 2024 年,预测期间 2025-2031 年,历史资料 2021-2023 年。
资料来源:对产业领导者的直接访谈、政府医生和程序资料、监管资料、医院和 OBL 输入、进出口资料、iData Research 内部资料库。
方法收入模型为单位乘以平均售价,并根据已安装基数、手术组合、设定变化和政策影响检验。
目标市场及区隔
週边血管支架市场
器械类型:动脉和静脉支架。
PTA球囊导管市场
设备类型:标准型、高压型、大型、小型、特殊型。
依应用进行单位分析:中心静脉或血液透析机通路、股腘动脉通路、髂动脉通路、膝下动脉通路、肾动脉通路、颈动脉通路、主动脉通路等。
药物涂层气球市场
适应症:股浅动脉,膝盖以下,动静脉通路。
依治疗场所进行单位分析:医院和诊所实验室。
动脉粥状硬化斑块切除术器械市场
设备技术:雷射动脉粥状硬化斑块切除术装置和机械动脉粥状硬化斑块切除术切除一次性装置。
血管内碎石市场
治疗环境。医院和诊所的实验室。
CTO设备市场
器械技术。再入和再通术。
外科移植市场
适应症:下肢、主动脉修復、肛门外绕道手术。
材质:聚酯纤维和聚四氟乙烯。
血管支架市场
器械类型:腹部主动脉血管瘤、股动脉或股动脉入路相关用途、胸主动脉瘤。
栓塞保护装置市场
设备类型:颈动脉和替代途径。
週边血栓管理市场
器械类型:常规血栓切除装置、动态血栓切除装置、定向溶栓装置。
适应症:动静脉通路、动脉通路、静脉通路。
週边血管内超音波市场
下腔静脉滤网市场
器械类型:下腔静脉滤器和下腔静脉滤器取出装置。
颈动脉分流术
经颈动脉重组(TCAR)市场
器械类型:经颈动脉裸金属支架和TCAR神经保护系统。
诊断和介入导管市场
器械类型:诊断导管和支撑导管。
诊断和介入导管导引线市场
仪器类型:标准型和亲水型型。
导引鞘市场
设备类型:标准型和导向型。
血管闭合装置市场
设备类型:非侵入式与侵入式。
入路:桡动脉和股动脉。
经导管栓塞市场
设备类型:颗粒、线圈、液体、插头。
竞争分析。
2024 年,WL Gore 凭藉其在血管支架移植物领域的领先地位以及在 VBX 髂动脉覆膜支架核准后在覆膜支架领域的增长,引领了整体复合外周血管器械市场。
美敦力位居第二,其血管支架、药物涂层球囊和动脉粥状硬化斑块切除术的销售额显着增长。该公司在药物涂层球囊市场处于领先地位,充分利用其在医院和门诊手术中心提供的经皮腔内血管成形术、裸金属支架和动脉粥状硬化斑块切除术产品组合。
波士顿科学公司凭藉一系列拓展产品组合的收购,包括收购BTG公司,跃升至第三名。该公司透过VICI静脉支架强化了其静脉产品组合,同时凭藉Wallstent支架保持了市场份额,并扩大了其在肿瘤学和深层静脉栓塞症领域的地位。
其他参与企业在球囊、支架、动脉粥状硬化斑块切除术、血栓切除术、血管内超音波、碎石术和血管闭合术等领域展开竞争。
优点包括产品组合广度、性能、OBL定价策略以及对血管团队的支援计划。
科技与临床趋势
将血管内超音波(IVUS)应用于静脉治疗。深部静脉治疗计画经常使用血管内超音波进行静脉支架的尺寸测量和定位,以及评估阻塞情况。
体外震波碎石术和血管准备。血管内碎石术结合钙化管理有助于更好地扩张血管,并减少复杂病变的併发症。
动脉粥状硬化斑块切除术和血栓切除术装置。人们对无需溶栓药物的治疗平台越来越感兴趣。
覆膜支架和血管支架:覆膜解决方案透过减少血管再阻塞、防止栓塞和实现持久重塑,正在获得市场份额。
规范流程。每个程序都针对每种适应症和设定制定托盘和通讯协定,从而提高效率并减少变异性。
治疗地点
这些机构包括医院、综合血管中心、中风中心、进行选择性血管内手术的社区医院、专注于週边介入治疗的门诊实验室以及为特定病例提供支援的门诊诊所。
配置差异会影响设备选择、捆绑销售、服务合约和可实现的价格分布。
地区
本报告涵盖美国。
到 2031 年,美国综合週边血管器械市场中最大、成长最快的机会是什么?支架、球囊、药物涂层球囊、斑块动脉粥状硬化斑块切除术、碎石术、慢性完全闭塞病变 (CTO) 器械、血管支架、血栓管理、血管内超音波 (IVUS) 和血管闭合技术将如何各自创造价值?
周边设备市场与美国整体经济和医疗保健提供者运作(包括人员配备、资本预算以及向办公室实验室的过渡)有何关係?
未来哪些因素会影响市场走向,包括人们对静脉疾病的认知、透析的发展、钙管理、血管支架适应症的扩大,以及颈动脉通路栓塞预防的持续作用?
计画应如何规划股动脉、髂动脉、膝下动脉、肾动脉、颈动脉和主动脉适应症的产品选择?在每种适应症中,有哪些证据支持使用血管内超音波、覆膜支架和血管准备?
医院采购和外部采购之间的平衡点将如何?捆绑定价、库存计划和服务协议将如何影响平均售价和供应商选择?
对紫杉醇的担忧将如何影响药物涂层球囊(DCB)的采用和收入结构?在某些适应症中,哪些替代方案可能会填补空白?
静脉置入术将在哪些领域发展最快? May-Thurner 症候群和其他阻塞模式将如何影响静脉支架和 IVUS 的需求?
血栓切除术在动静脉通路、动脉和静脉适应症的前景如何?减少溶栓药物使用的装置将如何改变手术时间、风险和成本?
供应商和服务商如何建立可持续的途径,包括标准化托盘、员工培训和数据跟踪,以支持成果和经济效益?
哪些风险可能会减缓成长,例如报销压力、OBL 领域的竞争加剧、导致竞争力下降的整合以及高阶血管内技术的能力限制?
iData Research 的《美国复杂週边血管器械市场报告》透过细分和配置模型、企业市场占有率分析、流程和定价细节以及将适应症选择与器械需求联繫起来的覆盖范围来回答这些问题。
利用这份报告来拓展览类机会、规划产品蓝图、协调 OBL 和医院项目,并设定定价、合约和库存目标。
图表清单
图表列表
美国週边血管器械市场概览
竞争分析
新兴市场与技术
市场趋势
市场趋势
流程分段
待调查的程式码
市场区隔
关键分析更新
版本历史记录
调查方法
全球关税的影响
美国週边血管器械市场概览
手术次数
週边血管支架市场
PTA球囊导管市场
药物涂层气球市场
动脉粥状硬化切除器械市场
血管内碎石市场
CTO设备市场
外科移植市场
血管支架市场
栓塞保护装置市场
週边血栓管理市场
週边血管内IVUS导管市场
The U.S. complex peripheral vascular device market was valued at over $6.4 billion in 2024. The market is projected to grow to nearly $8.5 billion over the forecast period.
This report suite covers peripheral vascular stents, percutaneous transluminal angioplasty (PTA) balloon catheters, drug-coated balloons (DCBs), atherectomy devices, intravascular lithotripsy systems, chronic total occlusion (CTO) devices, surgical grafts, stent grafts, embolic protection devices, peripheral thrombus management devices, and peripheral intravascular ultrasound (IVUS) catheters.
While some devices have coronary applications, all sizing and forecasts in this edition address peripheral procedures only.
Quantitative coverage includes unit sales, average selling prices, market size, growth rates, procedure numbers, and company shares.
Qualitative coverage includes market drivers and limiters, mergers and acquisitions, technology and practice trends, and competitive positioning across hospitals, office based labs, and ambulatory settings that perform endovascular care.
Market Overview
Peripheral arterial and venous disease are major sources of morbidity in the United States.
Care pathways continue to shift from open surgery to endovascular treatment that allows shorter stays and faster recovery when clinically appropriate.
Within the arterial system, physicians rely on PTA balloons, DCBs, stents, atherectomy, IVUS, and lithotripsy to cross lesions, prepare the vessel, and maintain patency. In aortic and peripheral aneurysm care, stent grafts provide a minimally invasive alternative to open repair.
In venous disease, demand is rising for thrombectomy and embolization, venous stents, IVUS navigation, and protection from pulmonary embolism in selected cases. Growing awareness, better imaging, and more predictable tools are expanding the number of treatable patients and are improving outcomes.
Clinical programs also reflect practical constraints. Pricing pressure is most visible in office based labs where discounting and bundled offers are common.
Procurement choices depend on indication, setting, and evidence of durability, especially after concerns about paclitaxel safety reduced growth expectations for DCBs compared with pre-2019 trends.
The overall market remains diverse and innovation continues to add options, which supports steady value growth through the forecast period.
Market Drivers
Venous market development. Venous disease occurs at a rate roughly five times higher than arterial disease. Pulmonary embolism affects about 600,000 people in the United States each year and is often linked to deep vein thrombosis in the legs. DVT affects about 900,000 people annually, yet many patients are asymptomatic and sudden death can be the first sign in a meaningful share of cases. As education and screening improve, the number of patients treated for venous obstruction and thromboembolic disease will rise. IVUS already exceeds 50 percent penetration in deep venous procedures in some programs and is closely associated with treatment of iliac, iliofemoral, common femoral, and inferior vena cava lesions.
Growing public awareness. Outreach by medical institutions and public agencies has increased awareness of peripheral arterial and venous disease. Screening identifies more candidates for intervention before severe symptoms or limb-threatening ischemia develop. Stroke prevention programs highlight the role of carotid disease. These efforts move more patients into diagnostic and treatment pathways across arterial and venous categories.
Innovation. New options have expanded the toolkit since 2015. Intravascular lithotripsy and transcarotid artery revascularization (TCAR) add choices that can simplify difficult anatomy or reduce embolic risk. DCB indications continue to broaden in specific settings such as arteriovenous access, and below-the-knee DCB is expected to join the U.S. market. Thrombectomy platforms that reduce or eliminate thrombolytics shorten treatment time and reduce bleeding risk, including solutions that are cleared for pulmonary embolism. Stent graft indications continue to expand and covered stents, hydrophilic catheters, and guidewires command premium pricing where they reduce procedure time and complications.
Market Limiters
Paclitaxel safety concerns. A 2018 meta-analysis identified a late mortality signal in trials of paclitaxel-coated devices used for PAD. This prompted FDA scrutiny and a 2019 communication that supported continued use while calling for further study. The event triggered a sharp decline in DCB and drug-eluting stent volumes and a shift back to alternatives. Recovery is expected but long-term growth remains lower than before the re-evaluation.
Competition and pricing in OBLs. Office based labs purchase at prices that are already about 30 percent below hospital levels. Intense competition for OBL contracts and the use of bundled offers that include sheaths, guidewires, and catheters with core therapy devices drive average selling prices lower. Smaller firms without broad portfolios face pressure to discount, which can limit their ability to invest and may slow innovation if consolidation reduces market diversity.
Maturing femoral-popliteal segment. Years of focus on fem-pop disease have produced many treatment options and stable practices. As other indications develop and patient selection improves, growth in fem-pop interventions is expected to stabilize at a rate closer to overall procedural growth, rather than the rapid expansion seen earlier.
Market Coverage and Data Scope
Quantitative coverage. Market size, market shares, market forecasts, growth rates, units sold, average selling prices, and procedure numbers.
Qualitative coverage. Growth trends, market limiters, competitive analysis and SWOT for top competitors, mergers and acquisitions, company profiles and product portfolios, FDA clearances and recalls where applicable, disruptive technologies, and disease overviews that influence therapy selection.
Time frame. Base year 2024, forecasts 2025 to 2031, historical data 2021 to 2023.
Data sources. Primary interviews with industry leaders, government physician and procedure data, regulatory data, hospital and OBL inputs, import and export data, and the iData Research internal database.
Method note. Revenue is modeled from units multiplied by ASP and validated against installed base, procedure mix, setting shifts, and policy impacts.
Markets Covered and Segmentation
Peripheral Vascular Stent Market
Device type. Arterial stent and venous stent.
PTA Balloon Catheter Market
Device type. Standard, high-pressure, large, small, and specialty.
Unit analysis by application. Central venous or hemodialysis access, femoral-popliteal, iliac, infra-popliteal, renal, carotid, aorta, and others.
Drug-Coated Balloon Market
Indication. Superficial femoral artery, below the knee, and arteriovenous access.
Unit analysis by care setting. Hospital and office based lab.
Atherectomy Device Market
Device technology. Laser atherectomy device and mechanical atherectomy disposable.
Intravascular Lithotripsy Market
Care setting. Hospital and office based lab.
CTO Device Market
Device technology. Re-entry and re-canalization.
Surgical Graft Market
Indication. Lower limb, aorta repair, and extra-anatomical bypass.
Material. Polyester and PTFE.
Stent Graft Market
Device type. Abdominal aortic aneurysm, femoral or femoral access related applications, and thoracic aortic aneurysm.
Embolic Protection Device Market
Device type. Carotid and alternative.
Peripheral Thrombus Management Market
Device type. Traditional thrombectomy device, pharmacomechanical thrombectomy device, and catheter directed thrombolysis.
Indication. AV access, arterial, and venous.
Peripheral IVUS Market
Inferior Vena Cava Filter Market
Device type. IVC filter and IVC filter retrieval device.
Carotid Shunt
Transcarotid Artery Revascularization (TCAR) Market
Device type. Transcarotid bare-metal stent and TCAR neuroprotection system.
Diagnostic and Interventional Catheter Market
Device type. Diagnostic catheter and support catheter.
Diagnostic and Interventional Guidewire Market
Device type. Standard and hydrophilic.
Introducer Sheath Market
Device type. Standard and guiding.
Vascular Closure Device Market
Device type. Non-invasive and invasive.
Approach. Radial and femoral.
Transcatheter Embolization Market
Device type. Particle, coil, liquid, and plug.
Competitive Analysis
W. L. Gore led the total complex peripheral vascular device market in 2024 based on leadership in stent grafts and gains in covered stents following approval of the VBX iliac covered stent.
Medtronic ranked second with large revenue in stent grafts, DCBs, and atherectomy. The company led the DCB market and leveraged its portfolio across PTA, bare-metal stents, and atherectomy in hospitals and OBLs.
Boston Scientific ranked third following acquisitions that expanded its portfolio, including the BTG purchase. The company strengthened its venous portfolio with VICI venous stents while maintaining share with Wallstent and growing positions in oncology and deep vein thrombosis care.
Other participants compete across balloons, stents, atherectomy, thrombectomy, IVUS, lithotripsy, and closure.
Advantages come from portfolio breadth, performance, OBL pricing strategies, and support programs for vascular teams.
Technology and Practice Trends
IVUS integration in venous care. Deep venous programs use IVUS frequently to size and position venous stents and to evaluate obstructions.
Lithotripsy and vessel preparation. Calcium management using intravascular lithotripsy supports better expansion and reduces complications in difficult lesions.
Atherectomy and thrombus tools. Mechanical and laser systems are used to debulk plaque or remove clot where indicated, with growing interest in platforms that do not require thrombolytics.
Covered stents and stent grafts. Covered solutions gain share where they reduce restenosis, protect from embolization, or enable durable remodeling.
Procedure standardization. Programs create trays and protocols by indication and setting, which improves throughput and reduces variation.
Care Settings
Coverage includes hospitals, comprehensive vascular and stroke centers, community hospitals that perform elective endovascular procedures, office based labs that focus on peripheral interventions, and ambulatory settings that support specific cases.
Setting differences influence device selection, bundle adoption, service contracts, and achievable price corridors.
Geography
This edition covers the United States.
Where is the largest and fastest growing opportunity within the U.S. complex peripheral vascular device market and how do stents, balloons, DCBs, atherectomy, lithotripsy, CTO tools, stent grafts, thrombus management, IVUS, and closure each contribute to value through 2031.
How does the peripheral device market relate to the broader U.S. economy and to provider operations, including staffing, capital budgets, and the shift of procedures to office based labs.
What forces will shape the market going forward, including venous disease awareness, dialysis growth, calcium management, expanded stent graft indications, and the continued role of embolic protection in carotid pathways.
How should programs plan product selection for fem-pop, iliac, infra-popliteal, renal, carotid, and aortic indications, and what evidence supports the use of IVUS, covered stents, or vessel preparation in each setting.
What is the expected balance between hospital and OBL purchasing, and how will bundled pricing, inventory planning, and service agreements affect average selling prices and vendor selection.
How will paclitaxel concerns affect DCB adoption and revenue mix, and what alternatives are most likely to fill gaps in specific indications.
Where will venous stenting grow fastest, and how will May-Thurner and other obstruction patterns shape demand for venous stents and IVUS.
What is the outlook for thrombectomy in AV access, arterial, and venous indications, and how do devices that reduce thrombolytic use change case time, risk, and cost.
How can suppliers and providers build durable pathways, including standardized trays, staff training, and data tracking to support outcomes and economics.
Which risks could slow growth, including reimbursement pressure, ASP compression in OBLs, consolidation that reduces competition, and capacity limits for advanced endovascular skills.
The U.S. complex peripheral vascular device market report from iData Research answers these questions with segment and setting models, company share analysis, procedure and pricing detail, and coverage that links indication-specific choices to device demand.
Use it to size opportunities by category, plan product roadmaps, align OBL and hospital programs, and set targets for pricing, contracting, and inventory.
Table Of Contents
List Of Figures
List Of Charts
U.S. Complex Peripheral Vascular Device Market Overview
Competitive Analysis
Emerging Markets And Technologies
Market Developments
Market Trends
Procedure Segmentation
Procedure Codes Investigated
Market Segmentation
Key Analysis Updates
Version History
Research Methodology
Impact Of Global Tariffs
U.S. Complex Peripheral Vascular Device Market Overview
Procedure Numbers
Peripheral Vascular Stent Market
Pta Balloon Catheter Market
Drug-Coated Balloon Market
Atherectomy Device Market
Intravascular Lithotripsy Market
Cto Device Market
Surgical Graft Market
Stent Graft Market
Embolic Protection Device Market
Peripheral Thrombus Management Market
Peripheral Ivus Catheter Market