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市場調查報告書
商品編碼
1847184
美國周邊血管內介入器材市場:市場規模、佔有率和趨勢分析(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,美國複合型周邊血管器械市場規模將超過64億美元。預計在預測期內,該市場規模將成長至近85億美元。
本報告涵蓋周邊支架、經皮血管成形術 (PTA) 球囊導管、藥物塗層球囊 (DCB)、動脈粥狀硬化斑塊切除術裝置、血管內碎石裝置、慢性完全閉塞 (CTO) 裝置、外科移植、血管支架、栓塞保護裝置、周邊血栓管理裝置和周邊血管內超音波(IVUS) 導管。
雖然有些裝置應用於冠狀動脈,但本期中的所有尺寸和預測都僅適用於周邊手術。
量化指標包括銷售量、平均售價、市場規模、成長率、手術例數和企業市場占有率。
定性資訊包括市場趨勢和促進因素、併購、技術和實踐趨勢,以及在血管內醫院、診所實驗室和門診機構中的競爭地位。
市場概覽
周邊動脈疾病和靜脈疾病是美國導致發病的主要原因。
治療方案正從開放性手術逐漸轉向血管內治療(在臨床條件允許的情況下),這樣可以縮短住院時間,並加快康復速度。
在動脈系統中,醫師使用經皮血管成形術(PTA)、藥物塗層球囊(DCB)、支架、動脈粥狀硬化斑塊切除術、血管內超音波(IVUS)、體外震波碎石術等方法來透過病灶、復位血管並維持通暢性。在治療主動脈瘤和周圍動脈瘤時,血管支架為開放性手術提供了微創替代方案。
在靜脈疾病領域,血栓切除術和栓塞術、靜脈支架植入術、血管內超音波導航以及肺動脈栓塞預防的需求日益成長。人們對這些疾病的認知不斷提高,影像技術的進步以及預測工具的增多,正在擴大可治療的患者群體並改善治療效果。
臨床項目也反映了實際的限制:價格壓力在辦公室實驗室最為明顯,折扣和捆綁優惠很常見。
尤其是在人們對紫杉醇安全性的擔憂導致 DCB 的成長預期低於 2019 年之前的趨勢之後,情況更是如此。
整體市場仍然多元化,技術創新不斷增加選擇,從而在整個預測期內實現穩步的價值成長。
市場促進因素
靜脈市場發展。靜脈疾病的發生率約為動脈疾病的五倍。肺動脈栓塞每年影響美國約60萬人,且常與下肢深層靜脈栓塞症有關。深部靜脈血栓形成每年影響約90萬人,但許多患者無症狀,猝死往往是首發症狀。隨著教育和篩檢的改進,接受靜脈阻塞和血栓栓塞性疾病治療的患者人數預計將會增加。在一些項目中,血管內超音波(IVUS)在深部靜脈治療的應用率已超過50%,並且與髂靜脈、髂股靜脈、股總靜脈和下腔靜脈病變的治療密切相關。
公眾意識的提高。醫療機構和公共機構的推廣工作提高了公眾對周邊動脈和靜脈疾病的認知。篩檢能夠識別出更多需要介入的患者,以便在出現嚴重症狀或危及肢體的缺血之前進行治療。卒中預防計畫強調頸動脈疾病的重要性。這些努力正促使更多患者進入涵蓋動脈和靜脈疾病的診斷和治療路徑。
創新。自 2015 年以來,新的治療選擇不斷湧現,拓展了治療套件。血管內碎石術和經頸動脈重組術 (TCAR) 為簡化複雜解剖結構或降低栓塞風險提供了新的選擇。藥物塗層球囊 (DCB) 的適應症在特定情況下持續擴展,例如動靜脈通路,預計膝下 DCB 將進入美國市場。減少或無需溶栓的血栓切除平台縮短了治療時間並降低了出血風險。血管支架移植物適應症也不斷擴展,覆膜支架、親水性導管和導管導引線因其能夠縮短手術時間和減少併發症而價格不菲。
市場限制
人們對紫杉醇的安全性感到擔憂。 2018 年的一項統合分析發現,在用於治療周邊動脈疾病 (PAD) 的紫杉醇塗層器械的試驗中,存在晚期死亡訊號。這促使美國食品藥物釋放型支架的使用量急劇下降,並轉向其他替代療法。儘管預計未來會有所回升,但長期收益仍低於重新評估之前。
門診實驗室 (OBL) 的競爭與定價。門診實驗室的採購價格通常比醫院低約 30%。激烈的 OBL 合約競爭以及將核心治療器材與鞘套、導管導引線和導管捆綁銷售的模式,正在拉低平均售價。產品組合不全的小型公司面臨價格壓力,這會限制它們的投資能力;而市場整合則會降低市場多樣性,減緩創新。
股膕窩段的成熟。長期以來,對股膕窩疾病的關注催生了許多治療方案和穩定的臨床實踐。隨著其他適應症的出現和患者選擇的改進,股骨幹介入手術的成長速度預計將趨於穩定,更接近整體手術的成長速度,而不是像過去那樣呈指數級成長。
目標市場和數據範圍
定量分析:市場規模、市場佔有率、市場預測、成長率、銷售量、平均售價、手術例數。
定性內容:成長趨勢、市場限制、主要競爭對手的競爭分析和 SWOT 分析、併購、公司簡介和產品系列、FDA 批准和召回(如適用)、顛覆性技術、影響治療方法方案的疾病概述。
時段:基準年 2024 年,預測期間 2025-2031 年,歷史資料 2021-2023 年。
資料來源:對產業領導者的直接訪談、政府醫生和程序資料、監管資料、醫院和 OBL 輸入、進出口資料、iData Research 內部資料庫。
方法收入模型為單位乘以平均售價,並根據已安裝基數、手術組合、設定變化和政策影響檢驗。
目標市場及區隔
周邊血管支架市場
器械類型:動脈和靜脈支架。
PTA球囊導管市場
設備類型:標準型、高壓型、大型、小型、特殊型。
依應用進行單位分析:中心靜脈或血液透析機通路、股膕動脈通路、髂動脈通路、膝下動脈通路、腎動脈通路、頸動脈通路、主動脈通路等。
藥物塗層氣球市場
適應症:股淺動脈,膝蓋以下,動靜脈通路。
依治療場所進行單位分析:醫院和診所實驗室。
動脈粥狀硬化斑塊切除術器械市場
設備技術:雷射動脈粥狀硬化斑塊切除術裝置和機械動脈粥狀硬化斑塊切除術切除一次性裝置。
血管內碎石市場
治療環境。醫院和診所的實驗室。
CTO設備市場
器械技術。再入和再通術。
外科移植市場
適應症:下肢、主動脈修復、肛門外繞道手術。
材質:聚酯纖維和聚四氟乙烯。
血管支架市場
器械類型:腹部主動脈血管瘤、股動脈或股動脈入路相關用途、胸主動脈瘤。
栓塞保護裝置市場
設備類型:頸動脈和替代途徑。
周邊血栓管理市場
器械類型:常規血栓切除裝置、動態血栓切除裝置、定向溶栓裝置。
適應症:動靜脈通路、動脈通路、靜脈通路。
周邊血管內超音波市場
下腔靜脈濾網市場
器械類型:下腔靜脈濾器和下腔靜脈濾器取出裝置。
頸動脈分流術
經頸動脈重組(TCAR)市場
器械類型:經頸動脈裸金屬支架和TCAR神經保護系統。
診斷和介入導管市場
器械類型:診斷導管和支撐導管。
診斷和介入導管導引線市場
儀器類型:標準型和親水型型。
導引鞘市場
設備類型:標準型和導向型。
血管閉合裝置市場
設備類型:非侵入式與侵入式。
入路:橈動脈和股動脈。
經導管栓塞市場
設備類型:顆粒、線圈、液體、插頭。
競爭分析。
2024 年,WL Gore 憑藉其在血管支架移植物領域的領先地位以及在 VBX 髂動脈覆膜支架核准後在覆膜支架領域的成長,引領了整體複合周邊血管器械市場。
美敦力位居第二,其血管支架、藥物塗層球囊和動脈粥狀硬化斑塊切除術的銷售額顯著成長。該公司在藥物塗層球囊市場處於領先地位,充分利用其在醫院和門診手術中心提供的經皮腔內血管成形術、裸金屬支架和動脈粥狀硬化斑塊切除術產品組合。
波士頓科學公司憑藉一系列拓展產品組合的收購,包括收購BTG公司,躍升至第三名。該公司透過VICI靜脈支架強化了其靜脈產品組合,同時憑藉Wallstent支架保持了市場佔有率,並擴大了其在腫瘤學和深層靜脈栓塞症領域的地位。
其他參與企業在球囊、支架、動脈粥狀硬化斑塊切除術、血栓切除術、血管內超音波、碎石術和血管閉合術等領域展開競爭。
優點包括產品組合廣度、性能、OBL定價策略以及對血管團隊的支援計劃。
科技與臨床趨勢
將血管內超音波(IVUS)應用於靜脈治療。深部靜脈治療計畫經常使用血管內超音波進行靜脈支架的尺寸測量和定位,以及評估阻塞情況。
體外震波碎石術和血管準備。血管內碎石術結合鈣化管理有助於更好地擴張血管,並減少複雜病變的併發症。
動脈粥狀硬化斑塊切除術和血栓切除術裝置。人們對無需溶栓藥物的治療平台越來越感興趣。
覆膜支架和血管支架:覆膜解決方案透過減少血管再阻塞、防止栓塞和實現持久重塑,正在獲得市場佔有率。
規範流程。每個程序都針對每種適應症和設客製化定托盤和通訊協定,從而提高效率並減少變異性。
治療地點
這些機構包括醫院、綜合血管中心、中風中心、進行選擇性血管內手術的社區醫院、專注於周邊介入治療的門診實驗室以及為特定病例提供支援的門診診所。
配置差異會影響設備選擇、捆綁銷售、服務合約和可實現的價格分佈。
地區
本報告涵蓋美國。
到 2031 年,美國綜合周邊血管器械市場中最大、成長最快的機會是什麼?支架、球囊、藥物塗層球囊、斑塊動脈粥狀硬化斑塊切除術、碎石術、慢性完全閉塞病變 (CTO) 器械、血管支架、血栓管理、血管內超音波 (IVUS) 和血管閉合技術將如何各自創造價值?
周邊設備市場與美國整體經濟和醫療保健提供者運作(包括人員配備、資本預算以及向辦公室實驗室的過渡)有何關係?
未來哪些因素會影響市場走向,包括人們對靜脈疾病的認知、透析的發展、鈣管理、血管支架適應症的擴大,以及頸動脈通路栓塞預防的持續作用?
計畫應如何規劃股動脈、髂動脈、膝下動脈、腎動脈、頸動脈和主動脈適應症的產品選擇?在每種適應症中,有哪些證據支持使用血管內超音波、覆膜支架和血管準備?
醫院採購和外部採購之間的平衡點將如何?捆綁定價、庫存計劃和服務協議將如何影響平均售價和供應商選擇?
對紫杉醇的擔憂將如何影響藥物塗層球囊(DCB)的採用和收入結構?在某些適應症中,哪些替代方案可能會填補空白?
靜脈置入術將在哪些領域發展最快? May-Thurner 症候群和其他阻塞模式將如何影響靜脈支架和 IVUS 的需求?
血栓切除術在動靜脈通路、動脈和靜脈適應症的前景如何?減少溶栓藥物使用的裝置將如何改變手術時間、風險和成本?
供應商和服務商如何建立永續的途徑,包括標準化托盤、員工培訓和數據追蹤,以支持成果和經濟效益?
哪些風險可能會減緩成長,例如報銷壓力、OBL 領域的競爭加劇、導致競爭力下降的整合以及高階血管內技術的能力限制?
iData Research 的「美國複雜周邊血管器械市場報告」透過區隔和配置模型、企業市場占有率分析、流程和定價細節以及將適應症選擇與器械需求聯繫起來的覆蓋範圍來回答這些問題。
利用這份報告來拓展覽類機會、規劃產品藍圖、協調 OBL 和醫院項目,並設定定價、合約和庫存目標。
圖表清單
圖表列表
美國周邊血管器械市場概覽
競爭分析
新興市場與技術
市場趨勢
市場趨勢
流程分段
待調查的程式碼
市場區隔
關鍵分析更新
版本歷史記錄
調查方法
全球關稅的影響
美國周邊血管器械市場概覽
手術次數
周邊血管支架市場
PTA球囊導管市場
藥物塗層氣球市場
動脈粥狀硬化切除器械市場
血管內碎石市場
CTO設備市場
外科移植市場
血管支架市場
栓塞保護裝置市場
周邊血栓管理市場
周邊血管內IVUS導管市場
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