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市場調查報告書
商品編碼
2046115
動靜脈瘻管裝置市場-全球產業規模、佔有率、趨勢、機會、預測:按類型、最終用途、地區和競爭格局分類,2021-2031年Arteriovenous Fistula Devices Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type, By End-use, By Region & Competition, 2021-2031F |
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全球動靜脈瘻管成形醫療設備市場預計將從 2025 年的 3.4432 億美元成長到 2031 年的 5.1557 億美元,複合年成長率為 6.96%。
該市場涵蓋血管鉗和外科手術配件等專用醫療器械,旨在建立動脈和靜脈之間的永久性連接,以輔助血液透析。推動這一市場成長的主要因素是末期腎病盛行率的上升,以及臨床實踐中自體動靜脈瘺優於人工血管移植的強烈偏好,因為自體動靜脈瘺具有更高的通暢率和更低的感染風險。例如,歐洲腎臟病學會2024年報告稱,根據註冊數據,56%接受腎臟替代治療的患者使用血液透析,這反映了對血管通路的高度依賴性。
| 市場概覽 | |
|---|---|
| 預測期 | 2027-2031 |
| 市場規模:2025年 | 3.4432億美元 |
| 市場規模:2031年 | 5.1557億美元 |
| 複合年成長率:2026-2031年 | 6.96% |
| 成長最快的細分市場 | AVF製造設備 |
| 最大的市場 | 北美洲 |
儘管市場需求強勁,但該行業仍面臨一項重大挑戰:“原發性動靜脈瘺成熟失敗”,即手術部位無法確保足夠的血流以進行有效的透析。這通常會導致需要進行修復手術或暫時依賴導管,增加醫療成本並延誤生命維持治療的啟動。因此,儘管市場呈現成長跡象,但動靜脈瘺成熟併發症此併發症仍然是一個重大挑戰,需要持續的臨床和技術努力,以確保患者能夠及時有效地接受治療。
末期腎功能衰竭和慢性腎臟病盛行率的不斷上升是全球動靜脈瘻管器械市場的主要促進因素。隨著需要腎臟替代治療的患者人數增加,對可靠血管通路的需求也日益成長,而自體動靜脈瘺則因其卓越的長期存活率,仍是標準治療方法。病患數量的增加直接推動了動靜脈瘻管成形術所需手術器械的採購。費森尤斯醫療於2024年3月發布的2023年度報告進一步刺激了這一需求,該報告估計全球約有420萬人正在接受常規透析治療,凸顯了依賴功能性血管通路系統的龐大人群。
同時,微創和經皮(AVF)技術的進步正在改變市場格局,為傳統開放性手術提供了替代方案。這些創新技術無需大切口即可創建瘻管,從而減少創傷並改善美容效果。這些技術均有可靠的安全資料支援。例如,2024年6月,美國國立衛生研究院(NIH)報告稱,一項為期兩年的多中心研究顯示,使用4F系統建立的血管內動靜脈瘺(AVF)的通暢率達到了97.3%。這些設備的重要性也體現在其應用的廣泛性上。正如DaVita公司在2024年指出的那樣,光是2023年第四季度,美國就進行了約725萬例透析治療。
原發性動靜脈瘻管破裂失敗的頻繁發生是全球動靜脈瘻管成形器市場成長的一大障礙。當手術建立的連接無法確保足夠的血流時,手術中使用的專用器械和配件便無法滿足患者的即時治療需求。這種臨床上的不確定性阻礙了標準動靜脈瘻管成形器的持續使用,迫使醫療專業人員依賴其他血管通路方法,例如無需這些專用器械的中央靜脈導管。因此,轉向非動靜脈瘻管替代方案直接減少了使用專用動靜脈瘻管成形器的手術數量。
此外,由於血管成熟失敗和導管使用時間過長而進行的矯正手術會消耗原本用於初始設備採購的資金。這種低效性將人工血管形成過程與不可預測的結果聯繫起來,從而阻礙了市場發展。根據美國腎臟數據系統(USRDS)2024年度數據報告,約82%的新血液透析患者在開始治療時使用導管,此數據通常歸因於人工血管在治療開始時尚未充分成熟。對導管的持續依賴凸顯了製造商在將人工血管確立為通用標準方面所面臨的挑戰,從而限制了市場擴張的潛力。
旨在加速動靜脈瘻管成熟的生物工程支架的出現是一項變革性趨勢,尤其能夠解決血液透析通路中靜脈發育不成熟這一關鍵問題。與傳統的合成移植物不同,這些無細胞組織工程血管(ATEV)旨在利用患者自身的細胞進行重建,從而提高其耐久性和抗感染能力。這項創新技術尤其適用於那些解剖結構不適合自體動靜脈瘻管形成的患者,為他們提供了一種再生醫學選擇,從而減少了對中央靜脈導管的依賴。 2024年7月,Humacyte公司在新聞稿中宣布,其III期V007臨床試驗結果顯示,接受ATEV治療的患者中有81.3%在6個月時仍保持功能性通暢性,顯著高於標準自體動靜脈瘻管對照組的66.4%。
同時,藥物釋放型球囊(DCB)在治療血管狹窄的應用日益廣泛。長期臨床數據證實了其與標準血管成形術相比的安全性和有效性,從而支持了這一趨勢。由於血管狹窄是動靜脈瘻管失敗的主要原因,DCB 的作用機轉是透過將抗增生藥物直接輸送到血管壁來預防再閉塞。近期的長期研究消除了先前對紫杉醇塗層裝置的死亡率擔憂,使其再次成為標準治療方案。根據《血管新聞》(Vascular News)2024年4月報道,在查令十字研討會上公佈的IN.PACT AV Access試驗的5年追蹤數據顯示,DCB組的全因死亡率為41%,與標準血管成形術組的46.5%相當,證明了該技術的長期安全性。
The Global Arteriovenous Fistula Devices Market is projected to expand from USD 344.32 Million in 2025 to USD 515.57 Million by 2031, registering a CAGR of 6.96%. This market encompasses specialized medical tools, such as vessel clamps and surgical accessories, designed to establish a permanent link between an artery and a vein to facilitate hemodialysis. Growth is primarily fuelled by the rising rates of end-stage renal disease and a strong clinical preference for autogenous fistulas over synthetic grafts, attributed to their higher patency rates and lower infection risks. Highlighting the dependence on vascular access, the European Renal Association reported in 2024 that registry data showed 56% of patients undergoing kidney replacement therapy utilized hemodialysis.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 344.32 Million |
| Market Size 2031 | USD 515.57 Million |
| CAGR 2026-2031 | 6.96% |
| Fastest Growing Segment | AVF Creation Devices |
| Largest Market | North America |
Despite robust demand, the industry encounters a major obstacle in the form of primary fistula maturation failure, where the surgical site does not achieve sufficient blood flow for effective dialysis. This issue often leads to necessary corrective procedures or the reliance on temporary catheters, resulting in escalated healthcare expenditures and delays in commencing vital therapy. Consequently, while the market is positioned for growth, the complication of non-maturing fistulas remains a critical challenge that necessitates ongoing clinical and technological attention to ensure timely and effective patient care.
Market Driver
The increasing incidence of End-Stage Renal Disease and Chronic Kidney Disease serves as the principal catalyst for the Global Arteriovenous Fistula Devices Market. As the number of patients requiring renal replacement therapy grows, the demand for dependable vascular access intensifies, with autogenous fistulas remaining the standard of care due to their superior long-term viability. This rising patient burden directly drives the procurement of surgical tools required for fistula creation. Reinforcing this demand, Fresenius Medical Care's 'Annual Report 2023', released in March 2024, estimates that approximately 4.2 million individuals globally are regular dialysis patients, underscoring the substantial population reliant on functional vascular access systems.
Concurrently, the market is being transformed by advancements in minimally invasive and percutaneous AVF technologies, which provide alternatives to traditional open surgery. These innovations enable fistula creation without significant incisions, thereby reducing trauma and enhancing cosmetic results, supported by strong safety data. For instance, the National Institutes of Health reported in June 2024 that a study titled 'Multi-Center Two-Year Patency Outcomes of Endovascular Arteriovenous Fistulas Created with a 4 French System' achieved a technical success rate of 97.3%. The critical nature of these devices is further highlighted by treatment volumes, as DaVita Inc. noted in 2024 that approximately 7.25 million dialysis treatments were administered in the U.S. during the fourth quarter of 2023 alone.
Market Challenge
The frequent occurrence of primary fistula maturation failure presents a significant impediment to the growth of the global arteriovenous fistula devices market. When a surgically created connection fails to establish sufficient blood flow, the specialized instruments and accessories employed during the procedure become ineffective for the patient's immediate treatment needs. This clinical uncertainty deters the consistent use of standard fistula creation devices, often forcing healthcare providers to resort to alternative vascular access methods, such as central venous catheters, which do not require these specific tools. As a result, the shift toward non-fistula alternatives directly diminishes the number of procedures that utilize fistula-specific devices.
Additionally, the requirement for corrective surgeries or extended catheter usage arising from maturation failure consumes financial resources that might otherwise fund primary device procurement. This inefficiency disrupts market momentum by linking fistula procedures with unpredictable outcomes. According to the United States Renal Data System's 2024 Annual Data Report, nearly 82% of new hemodialysis patients began therapy using a catheter, a statistic often linked to the fistula's failure to mature in time for treatment. This continued dependence on catheters highlights the challenges manufacturers face in establishing fistulas as the universal standard, thereby restricting the market's expansion potential.
Market Trends
The emergence of bioengineered scaffolds designed to accelerate fistula maturation represents a transformative trend, specifically addressing the critical issue of vein non-maturation in hemodialysis access. Unlike conventional synthetic grafts, these acellular tissue-engineered vessels (ATEVs) are intended to be repopulated by the patient's own cells, offering potential improvements in durability and resistance to infection. This innovation is particularly beneficial for patients with anatomies unsuitable for autogenous fistulas, providing a regenerative option that lessens reliance on central venous catheters. In July 2024, Humacyte, Inc. announced in a press release regarding their Phase 3 V007 clinical trial that 81.3% of patients receiving the ATEV maintained functional patency at six months, significantly surpassing the 66.4% rate seen in the standard autogenous fistula control group.
Simultaneously, the market is observing an increased use of Drug-Coated Balloons (DCB) for managing stenosis, supported by long-term clinical data confirming their safety and effectiveness compared to standard angioplasty. Since vessel narrowing is the primary cause of fistula failure, DCBs function by delivering anti-proliferative drugs directly to the vessel wall to prevent recurrent blockages. Recent long-term studies have resolved previous mortality concerns related to paclitaxel-coated devices, reinstating them as a standard of care. As reported by Vascular News in April 2024, five-year data from the IN.PACT AV Access study presented at the Charing Cross Symposium showed an all-cause mortality rate of 41% for the DCB group, comparable to the 46.5% for standard angioplasty, thereby validating the technology's long-term safety profile.
Report Scope
In this report, the Global Arteriovenous Fistula Devices Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies present in the Global Arteriovenous Fistula Devices Market.
Global Arteriovenous Fistula Devices Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report: