![]() |
市場調查報告書
商品編碼
2034916
全球主動脈內球囊擴張裝置市場:市場規模、佔有率和趨勢分析(2026-2032 年)Intra Aortic Balloon Device Market Size, Share & Trends Analysis | Global | 2026-2032 | Includes: Disposable Devices and Intra-Aortic Balloon Pump (IABP) Consoles |
||||||
※ 本網頁內容可能與最新版本有所差異。詳細情況請與我們聯繫。
全球主動脈內球囊擴張裝置市場報告(至2032年)
2025年全球主動脈內球囊擴張裝置的市場規模為2.267億美元。預計該市場將以3.9%的複合年成長率成長,到2032年達到2.959億美元。
本報告涵蓋全球主動脈內球囊裝置市場,包括主動脈內球囊(IAB)導管和主動脈內球囊幫浦(IABP)主機。
一次性腹腔內輸液導管市場包括傳統腹腔內輸液導管和光纖腹腔內輸液導管。分析內容包括銷售量、平均售價、手術例數、市場規模、市場佔有率、成長趨勢、至2032年的市場預測以及截至2022年的歷史數據。
市場成長主要得益於其在經皮冠狀動脈介入治療(PCI)中的應用、老舊IABP主機的替換以及光纖IABP導管的日益普及。然而,冠狀動脈繞道手術手術(CABG)的停滯不前、來自經皮心室輔助裝置(VAD)的競爭以及臨床試驗的負面結果,仍然阻礙著市場的進一步擴張。
市場概覽
全球主動脈內球囊擴張裝置市場包括一次性球囊導管和幫浦主機,用於提供臨時機械循環支援。這些裝置可用作某些經皮冠狀動脈介入治療(PCI)、冠狀動脈繞道手術(CABG)、急性心肌梗塞、急性心臟衰竭和心源性休克病例的輔助性治療。
此市場包括主動脈內球囊擴張導管(IAB導管)和主動脈內球囊反搏(IABP)主機。 IAB導管插入主動脈,並根據心動週期進行充氣和放氣。 IABP主機控制球囊擴張時間,並在治療過程中維持血流動力學穩定。
隨著臨床實務的演變,全球主動脈內球囊反搏(IABP)設備市場也逐漸改變。雖然IABP系統在某些心臟手術和重症監護病例中仍然使用,但其作用正日益受到更先進的機械循環支援設備的限制。
近期針對主動脈內球囊反搏(IABP)主機和一次性球囊導管的召回和監管措施,提高了醫院對安全性和更換計畫的重視程度。這導致採購環境趨於謹慎,優先考慮維護現有系統而非積極拓展市場。
市場促進因素
進行了大量的經皮冠狀動脈介入治療(PCI)手術
經經皮冠狀動脈介入治療(PCI)手術量龐大,是主動脈內球囊反搏(IABP)器械市場的重要促進因素。隨著經經皮插入式球囊導管的問世,IABP 的應用範圍已從冠狀動脈繞道手術手術(CABG)的外科手術植入擴展到其他領域。
這使得 IABP 得以進入介入性心臟病學領域,現在用於某些需要循環支持的高風險 PCI 患者。
IABP設備在PCI手術的應用率不斷提高,是IABP設備市場成長的主要驅動力。儘管IABP的使用率有限,但大量的手術為IABP設備創造了持續的市場機會,尤其是在那些仍然依賴IABP系統來支持複雜介入手術的醫院。
舊主機的替代品
IABP設備市場已經成熟並確立了穩固的地位。因此,歐洲、美國和亞洲部分地區的醫院已經安裝了大量的泵浦主機。
許多此類主機已達到使用壽命終點,需要更換。在某些醫療機構,安全建議、系統性能、維護需求或與新型導管技術的兼容性等因素都可能影響更換決定。
隨著新產品和改良產品的推出,一些醫院可能會在舊型號過時之前就購買新主機。預計更換舊主機將有助於緩解預測期內的銷售下滑,並有助於維持市場價值。
光纖IABP導管的廣泛應用
光纖IAB導管正在推動一次性導管市場的成長。與傳統IAB導管相比,這些裝置能夠向IAB主機傳輸更高品質的動脈壓訊號。
此外,光纖導管發出的訊號比傳統導管發出的訊號更快到達主機。這些優勢有助於提高治療過程中的時間控制精確度和系統反應速度。
這些優點使得光纖腹腔內引流導管的平均售價高於傳統腹腔內引流導管。隨著醫生逐漸從傳統導管轉向光纖導管,整個腹腔內引流導管市場的平均價格預計將上漲,從而推動整個腹腔內引流器械市場的成長。
市場限制
冠狀動脈繞道手術手術(CABG)手術數量停滯不前
IABP裝置在經皮冠狀動脈介入治療(PCI)和冠狀動脈繞道手術(CABG)中用作輔助性治療。然而,預計在預測期內,CABG手術的數量將保持穩定。
這意味著手術中使用的IAB的需求預計也將保持穩定。由於IAB設備的銷售與手術數量密切相關,冠狀動脈繞道手術(CABG)成長有限將成為限制其銷售量的因素。
雖然 IABP 在某些心臟外科手術中仍然有用,但 CABG(心血管旁路移植術)手術的放緩限制了其大幅擴大市場的潛力。
經皮VAD
經皮心室輔助裝置(IABP)對IABP市場構成重大競爭威脅。像Abiomed公司的Impella 2.5(R)這樣的裝置與IABP有相似的適應症,包括急性心肌梗塞、急性心臟衰竭、高風險PCI和CABG患者。
由於經皮VAD 可以提供更高水準的循環支持,因此在某些臨床情況下,它們與 IABP 直接競爭。
包括ISAR-SHOCK研究在內的多項臨床研究表明,Impella 2.5®在改善心摶出量和血流動力學方面比IABP裝置更有效。這給IABP的推廣應用帶來了壓力,尤其是在需要強力機械支援的情況下。
負面臨床研究
陰性的臨床研究結果限制了人們對主動脈內球囊反搏(IABP)療法的信心。儘管IABP療法已應用近30年,但前瞻性隨機對照試驗數據有限,難以證實其確切療效。
SHOCK試驗評估了在急性心肌梗塞合併心源性休克(IABP)治療的血流動力學效應。研究得出結論,與單獨藥物治療相比,額外使用IABP治療並未帶來顯著的血流動力學改善。
一項在最初試驗六年後進行的長期追蹤研究發現,IABP 對全因死亡率沒有影響。其他研究也表明,IABP 可能會增加卒中風險。這些發現仍然限制了 IABP 的廣泛應用,並影響醫生的選擇。
市場範圍和數據範圍
目標市場及區隔
IAB導管是一種一次性裝置,插入主動脈後,透過球囊的充氣和放氣提供臨時機械支撐。導管包括傳統IAB導管和光纖IAB導管。
光纖導管可提高壓力訊號品質,並加速訊號傳送至主動脈內球囊反搏(IABP)主機。這些優勢有助於提高平均售價(ASP),並促使醫生改變其使用偏好。
IABP主機是控制主動脈內球囊反搏治療時機和操作的大型裝置。此部分設備受更換週期、安裝數量、安全建議、監管措施和醫院資本投資預算等因素的影響。
每個細分市場都按市場規模、市場佔有率、治療數量、市場預測、市場成長率、銷售量和平均售價進行分析。
這種細分有助於製造商、投資者和策略團隊了解一次性導管的使用、主機更新、PCI 滲透率以及來自 pVAD 的競爭如何影響全球 IABP 設備市場。
競爭分析
2025年,Getinge是全球IABP市場的主要企業。該公司提供廣泛的主機產品組合,包括CARDIOSAVE® IABP Hybrid、CARDIOSAVE® IABP Rescue和採用Intellisense™技術的CS300™ IABP。
Getinge公司也提供一次性IABP導管,例如SENSATION® 7Fr光纖球囊。該公司目前的強勁市場地位反映了其收購IABP技術領域的領導企業Datascope所帶來的長期影響。
2024年,美國FDA建議醫療專業人員逐步淘汰部分Cardiosave系統,原因是安全性和品質問題。儘管如此,Getinge重申了對IABP領域的承諾,並宣布計劃將資源集中在其IABP和ECMO產品線。
Teleflex 預計在 2025 年全球 IABP 市場中排名第二。其醫療設備組合包括 AutoCAT® 2、AutoCAT® 2 WAVE 以及用於轉運應用的 AC3 Range™ IABP 系統。 AC3 Range™ 於 2025 年 4 月獲得 FDA 510(k) 批准,並於同年稍後上市銷售。
Teleflex 也提供與其主機使用的一次性 IAB 導管。 2024 年,該公司因製造問題導致部分 Arrow® FiberOptix™ 和 UltraFlex™ 導管套件可能影響球囊充氣,而被 FDA 列為一級召回產品。
技術與臨床實務的趨勢
光纖導管的廣泛應用
光纖 IABP 導管的市場佔有率正在不斷擴大,因為與傳統導管相比,它們能夠提供更高品質的動脈壓力訊號和更快的訊號傳輸速度。
這提高了主機的反應速度,使這些產品能夠獲得更高的平均售價(ASP)。
主機更換計劃
大量IABP主機的安裝造成了持續的更換需求。醫院必須更換已達使用壽命或有維護、安全或相容性問題的老舊系統。
這種更新周期支撐了成熟細分市場的市場價值。
謹慎的採購環境
近期產品召回和監管行動使得醫院在評估 IABP 系統和導管時更加謹慎。
採購決策越來越注重安全性、可靠性、基於部署的支援和更換計劃,而不是快速擴張。
用於高風險PCI手術
IABP的應用也正透過經皮的方式擴展到介入性心臟病學領域。在某些高風險的PCI病例中,尤其是在熟悉該技術的醫療機構中,仍可使用IABP支援。
然而,與 pVAD 的競爭仍然對這種應用場景產生影響。
與提供更強支援的設備展開競爭。
隨著機械循環支援裝置功能的日益先進,主動脈內球囊反搏(IABP)的作用正變得越來越有限。在某些情況下,經皮心室輔助裝置(pVAD)可以提供更強的血流動力學支持,使其成為高風險患者的理想替代方案。
預計這一趨勢將在未來繼續影響醫生的選擇。
現有輔助支援的作用
雖然 IABP 系統仍然用於心臟外科手術和急診醫學,但其作用正變得越來越有限。
預計市場成長將主要來自替換需求和光纖導管的採用,而不是臨床應用的廣泛擴展。
地區
本報告提供了涵蓋北美、歐洲、亞太地區、拉丁美洲以及中東和非洲的全球研究成果。
iData Research 的《全球主動脈內球囊裝置市場報告》透過裝置層面的分析、基於手術的建模、平均售價 (ASP) 數據、企業市場占有率分析以及到 2032 年的預測來解答這些問題。該報告可用於評估全球主動脈內球囊裝置市場的需求、對標競爭對手、了解機械輔助趨勢以及製定產業計畫。
Global Intra-Aortic Balloon Device Market Report to 2032
The global intra-aortic balloon device market was valued at $226.7 million in 2025. It is expected to grow at a compound annual growth rate (CAGR) of 3.9%, reaching $295.9 million by 2032.
This report covers the global market for intra-aortic balloon (IAB) devices, including IAB catheters and intra-aortic balloon pump (IABP) consoles.
The disposable IAB catheter segment includes conventional and fiber-optic IAB catheters. The analysis includes unit sales, average selling prices (ASPs), procedure numbers, market size, market shares, growth trends, market forecasts through 2032, and historical data back to 2022.
Market growth is supported by use in PCI procedures, replacement of older IABP consoles, and increasing penetration of fiber-optic IABP catheters. However, stagnant CABG procedure volumes, competition from percutaneous VADs, and negative clinical studies continue to limit stronger expansion.
Market Overview
The global intra-aortic balloon device market includes disposable balloon catheters and pump consoles used to provide temporary mechanical circulatory support. These devices are used as adjunctive therapy in selected PCI, CABG, acute myocardial infarction, acute heart failure, and cardiogenic shock cases.
The market includes IAB catheters and IABP consoles. IAB catheters are inserted into the aorta and inflate and deflate in coordination with the cardiac cycle. IABP consoles control balloon timing and support hemodynamic performance during treatment.
The global IAB device market is experiencing a gradual transition as clinical practice continues to evolve. While IABP systems remain in use for selected cardiac surgery and critical care cases, their role is increasingly constrained by higher-support mechanical circulatory support devices.
Recent recalls and regulatory actions affecting both IABP consoles and disposable balloon catheters have increased hospital focus on safety and replacement planning. This has created a cautious purchasing environment centered on maintaining installed systems rather than aggressive market expansion.
Market Drivers
Large Volume of PCI Procedures
The large volume of PCI procedures is an important driver of the IAB device market. The introduction of balloon catheters capable of percutaneous insertion expanded IABP use beyond surgical insertion during CABG procedures.
This allowed IABPs to move into interventional cardiology, where they may be used in selected high-risk PCI patients requiring circulatory support.
Increasing penetration within PCI procedures has been a major source of growth for the IAB device market. Although use is selective, the large procedural base creates ongoing opportunity for IAB devices, especially in hospitals that continue to rely on IABP systems for support in complex interventional cases.
Replacement of Old Consoles
The IABP device market is mature and well established. As a result, there is a large installed base of pump consoles across hospitals in Europe, the United States, and parts of Asia.
Many of these consoles have been in use for their full lifespan and require replacement. In some facilities, replacement decisions may also be influenced by safety advisories, system performance, service needs, or compatibility with newer catheter technologies.
New and improved products can encourage some hospitals to purchase new consoles before older models stop functioning. Replacement of older consoles is expected to limit unit sales declines and support continued market value over the forecast period.
Increasing Penetration of Fiber-Optic IABP Catheters
Fiber-optic IABP catheters are supporting growth in the disposable catheter segment. These devices send higher-quality arterial pressure signals to the IABP console than conventional IAB catheters.
Signals from fiber-optic catheters also reach the console more quickly than signals from conventional catheters. These benefits can support more accurate timing and better system responsiveness during treatment.
Because of these advantages, fiber-optic IABP catheters command higher ASPs than conventional IABP catheters. As physician preference shifts from conventional to fiber-optic catheters, the total ASP of the IAB catheter market is expected to increase, supporting growth in the overall IAB device market.
Market Limiters
Stagnant CABG Procedures
IABP devices are used as adjunctive therapy during PCI and CABG surgery. However, the number of CABG procedures is expected to remain stable over the forecast period.
This means demand for IABPs used during surgeries is also expected to remain stagnant. Because IAB device sales are closely tied to procedure volumes, limited CABG growth constrains unit sales.
Even though IABPs remain useful in selected cardiac surgery cases, stagnant CABG procedure volumes limit the ability of this application to drive meaningful market expansion.
Percutaneous VADs
Percutaneous ventricular assist devices are a major competitive threat to the IAB device market. Devices such as Abiomed's Impella 2.5(R) have similar indications to IABPs, including acute myocardial infarction, acute heart failure, high-risk PCI, and CABG patients.
Because pVADs can provide higher levels of circulatory support, they directly compete with IABPs in several clinical settings.
Clinical studies, including ISAR-SHOCK, concluded that Impella 2.5(R) was more effective at improving cardiac output and hemodynamic performance than IABP devices. This has placed pressure on IAB adoption, especially in cases where stronger mechanical support is needed.
Negative Clinical Studies
Negative clinical studies have limited confidence in IABP therapy. Although IABP therapy has been used for nearly 30 years, there is limited prospective randomized data showing clear efficacy.
The SHOCK trial evaluated the hemodynamic effects of additional IABP treatment in patients with acute myocardial infarction complicated by cardiogenic shock. The study concluded that additional IABP treatment did not result in significant hemodynamic improvement compared with pharmacological therapy alone.
Long-term follow-up performed six years after the initial study found that IABP had no effect on all-cause mortality. Other studies have also indicated that IABPs may increase stroke risk. These findings continue to limit broader use and affect physician preference.
Market Coverage and Data Scope
Markets Covered and Segmentation
IAB catheters are disposable devices inserted into the aorta to provide temporary mechanical support through balloon inflation and deflation. The catheter segment includes conventional IAB catheters and fiber-optic IAB catheters.
Fiber-optic catheters offer improved pressure signal quality and faster signal transmission to the IABP console. These benefits support higher ASPs and are contributing to a shift in physician preference.
IABP consoles are capital systems that control the timing and operation of intra-aortic balloon therapy. This segment is influenced by replacement cycles, installed base size, safety advisories, regulatory actions, and hospital capital budgets.
Each segment is analyzed by market size, market shares, procedure numbers, market forecasts, market growth rates, units sold, and average selling prices.
This segmentation helps manufacturers, investors, and strategy teams understand how disposable catheter utilization, console replacement, PCI penetration, and competition from pVADs are shaping the global IAB device market.
Competitive Analysis
In 2025, Getinge was the leading competitor in the global IABP market. The company offers a broad portfolio of consoles, including CARDIOSAVE(R) IABP Hybrid, CARDIOSAVE(R) IABP Rescue, and the CS300(TM) IABP with Intellisense(TM) technology.
Getinge also offers disposable IAB catheters such as the SENSATION(R) 7Fr fiber-optic balloon. Its strong position reflects the long-term impact of its acquisition of Datascope, a former leader in IABP technology.
In 2024, the U.S. FDA issued an advisory recommending that healthcare providers phase out certain Cardiosave systems because of safety and quality concerns. Despite this, Getinge reaffirmed its commitment to the IABP segment and announced plans to focus resources on its IABP and ECMO product lines.
Teleflex ranked as the second-leading competitor in the global IABP market in 2025. The company's capital equipment portfolio includes the AutoCAT(R)2, AutoCAT(R)2 WAVE, and the transport-oriented AC3 Range(TM) IABP system. The AC3 Range(TM) received U.S. FDA 510(k) clearance in April 2025 and entered commercial distribution later that year.
Teleflex also offers disposable IAB catheters designed for use with its consoles. In 2024, the company was subject to an FDA Class I recall involving certain Arrow(R) FiberOptix(TM) and UltraFlex(TM) catheter kits due to a manufacturing issue that could affect balloon inflation.
Technology and Practice Trends
Fiber-Optic Catheter Adoption
Fiber-optic IABP catheters are gaining share because they provide higher-quality arterial pressure signals and faster signal transmission than conventional catheters.
This supports improved console responsiveness and helps these products command higher ASPs.
Console Replacement Planning
The large installed base of IABP consoles creates ongoing replacement demand. Hospitals must replace aging systems as they reach the end of their useful life or become affected by service, safety, or compatibility concerns.
This replacement cycle supports market value in a mature segment.
Cautious Purchasing Environment
Recent recalls and regulatory actions have made hospitals more cautious when evaluating IABP systems and catheters.
Purchasing decisions are increasingly focused on safety, reliability, installed base support, and replacement planning rather than rapid expansion.
Use in High-Risk PCI
IABP use has expanded into interventional cardiology through percutaneous insertion. Selected high-risk PCI cases may still use IABP support, especially in facilities familiar with the technology.
However, pVAD competition continues to influence this use case.
Competition from Higher-Support Devices
Higher-support mechanical circulatory support devices are limiting the role of IABPs. pVADs can offer stronger hemodynamic support in some cases, making them attractive alternatives for high-risk patients.
This trend is expected to continue shaping physician preference.
Mature Adjunctive Support Role
IABP systems remain part of cardiac surgery and critical care practice, but their role is increasingly selective.
The market is expected to grow through replacement demand and fiber-optic catheter adoption rather than broad expansion of clinical use.
Geography
This report provides global coverage across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa.
The Global Intra-Aortic Balloon Device Market Report from iData Research answers these questions with device-level analysis, procedure-based modeling, ASP data, company share insights, and forecasts through 2032. Use it to evaluate demand, benchmark competitors, understand mechanical support trends, and support commercial planning in the global IAB device market.