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市場調查報告書
商品編碼
2034910
全球體外迴圈輔助下冠狀動脈繞道手術手術器械市場:市場規模、佔有率和趨勢分析(2026-2032 年)On-Pump Coronary Artery Bypass Device Market Size, Share & Trends Analysis | Global | 2026-2032 | Includes: ONCAB Disposable and Perfusion System Market |
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全球體外迴圈輔助下冠狀動脈繞道手術手術器械市場報告(至2032年)
2025年全球體外迴圈輔助下冠狀動脈繞道手術手術器械市場規模為5.833億美元。預計到2032年,該市場將以3.0%的複合年成長率成長,達到7.196億美元。
本報告涵蓋了冠狀動脈繞道術中使用的體外迴圈輔助下冠狀動脈繞道手術繞道手術 (ONCAB) 設備的全球市場,包括一次性套件和灌注系統設備。
分析內容包括銷售量、平均售價 (ASP)、手術數量、市場規模、市場佔有率、成長趨勢、到 2032 年的市場預測以及到 2022 年的歷史數據。
市場成長主要受心肺體外迴圈技術的進步所驅動。然而,冠狀動脈繞道手術(CABG)手術率的放緩、ONCAB相關副作用以及經皮冠狀動脈介入治療(PCI)、非體外循環冠狀動脈旁路移植術(OPCAB)和體外膜氧合(ECMO)等替代療法的出現,預計將限制市場的進一步擴張。
市場概覽
全球體外迴圈輔助下冠狀動脈繞道手術手術器械市場涵蓋了在心肺體外迴圈支持下進行的冠狀動脈繞道手術移植術(CABG)中使用的各種產品。這些器械有助於在心臟停止跳動時維持血液循環和氧氣供應,使外科醫生能夠在患者靜止、無血的狀態下進行手術。
該市場包括用於體外循環移植的拋棄式產品和體外循環灌注系統。拋棄式產品包括手術包、管路組件、過濾器、氧合器及相關組件,而體外循環灌注系統則包括用於維持體外循環的大型醫療設備。
近年來,隨著微創介入治療的日益普及,全球冠狀動脈繞道術(CABG)的數量一直在下降。與傳統開胸手術相比,導管介入治療方法可縮短住院時間、加速康復,並正在改變部分患者族群的治療模式。
儘管面臨這些壓力,對於需要外科血管重建的複雜或高風險冠狀動脈疾病患者而言,冠狀動脈繞道重組(ONCAB)仍然是一項重要的治療方法。因此,在持續的外科手術、技術進步以及對可靠灌注支援的需求的推動下,預計到2032年,該市場將保持溫和成長。
市場促進因素
ONCAB 手術方案
冠狀動脈繞道術(CABG)可採用體外循環或非體外循環兩種方式進行。非體外循環方式是在十多年前開發的,最初人們認為非體外迴圈冠狀動脈繞道手術繞道手術(OPCAB)最終會取代體外迴圈輔助下冠狀動脈繞道手術手術(ONCAB),成為外科手術的標準方式。
然而,由於技術上的困難,非體外循環冠狀動脈繞道手術(OPCAB)的應用仍然有限。許多外科醫生對採用這種難度更高的非體外循環技術猶豫不決,尤其是在複雜病例中。
體外循環輔助冠狀動脈繞道手術(ONCAB)預計仍將是冠狀動脈繞道手術(CABG)的標準技術。透過將血液分流至體外循環機,外科醫生可以夾閉主動脈並使心臟停止跳動,從而確保手術視野靜止無血。這使得移植血管能夠進行精準縫合,最終獲得一致且可重複的治療效果。
精準和外科手術控制
在心臟靜止狀態下進行手術的能力仍然是冠狀動脈繞道手術(ONCAB)最大的臨床優勢之一。在體外循環手術過程中,外科醫師可以有效地繞過狹窄或阻塞的冠狀動脈,同時在移植血管和主動脈之間建立精確的連結。
沒有血流和心率有助於提高手術精確度。這對於冠狀動脈解剖結構複雜或有多支血管病變的患者尤其重要。
由於精確度和控制性仍然是冠狀動脈繞道手術(CABG)成功的關鍵,許多心臟外科醫師仍然傾向於選擇體外循環冠狀動脈繞道手術(ONCAB)。這種對此手術的偏好也支撐了對體外循環冠狀動脈繞道手術灌注系統和拋棄式產品的持續需求。
新技術和改進技術
雖然與許多其他新興醫療設備領域相比,心肺體外迴圈技術已經相對成熟,但製造商仍在努力提高 ONCAB 產品的安全性和性能。
體外循環系統市場的公司一直在努力透過改進系統設計和監測以及採用高度生物相容性材料來減輕體外循環的不良影響。
肝素塗層氧合器和其他生物相容性表面旨在更接近模擬血管內皮。這些技術可能有助於減少全身性發炎反應,並抑制體外循環迴路內的血液凝固傾向。這些改進正在增強外科醫生和患者對自體冠狀動脈旁路移植術(ONCAB)的信心。
市場限制
冠狀動脈繞道手術數量減少
冠狀動脈繞道手術(CABG)數量的成長趨於平穩,這是冠狀動脈繞道手術(ONCAB)器械市場的主要限制因素。由於經皮冠狀動脈介入治療(PCI)技術的進步,預計在預測期內,CABG手術的數量將保持相對穩定。
ONCAB市場規模與每年進行的CABG手術數量直接相關。除非手術數量顯著增加,否則市場擴張機會將受到限制。
此外,鮮有重大技術創新或健保報銷制度的變革能夠使製造商大幅提高平均售價(ASP)。因此,手術數量仍然是市場成長的主要驅動力,而冠狀動脈繞道手術(CABG)手術數量的停滯預計將限制市場成長。
ONCAB 的負面影響
心肺體外迴圈泵,這會使患者自身的血液暴露於異物表面。這種情況與出血風險增加和短期神經認知功能障礙有關。
這些影響通常被稱為「灌注後症候群」或「泵頭症候群」。症狀可能包括注意力、專注力、短期記憶力、精細運動技能和精神運動反應速度方面的問題。
此外,心臟驟停會導致心肌功能下降或受損。另外,一些研究表明,主動脈夾閉會釋放血栓形成因子,增加中風的風險。鑑於這些擔憂,一些外科醫生正轉向非體外循環技術和微創冠狀動脈繞道術(CABG)。
替代療法
其他治療方法的存在持續限制冠狀動脈旁路移植術(ONCAB)市場的成長。經皮冠狀動脈介入治療(PCI)技術已取得顯著進步,可減少部分患者接受外科重組的需求。
OPCAB 也是 ONCAB 的直接替代方案。雖然它尚未取代 ONCAB 成為手術標準,但對於某些傾向於非體外循環手術的患者和外科醫生來說,它仍然是一個可行的選擇。
在某些臨床情況下,體外膜氧合(ECMO)是心肺旁路手術的另一種替代方案。 ECMO 的成長速度超過了冠狀動脈繞道手術(ONCAB)市場,並可能在某些患者群體中與 ONCAB 爭奪投資、關注和治療機會。
市場範圍和數據範圍
目標市場及區隔
ONCAB拋棄式包括心肺體外迴圈手術期間使用的單次使用組件。這些組件包括心血管手術包、管路套件、心臟麻痹液組件、動脈過濾器、氧合器以及CABG手術期間使用的其他一次性灌注產品。
體外循環系統包括用於在心臟停止跳動時維持血液循環和氧合的大型醫療設備。這些系統構成了冠狀動脈繞道手術(ONCAB)工作流程的核心,並透過持續的監測、整合和手術控制升級來提供支援。
每個細分市場都根據市場規模、市場佔有率、手術數量、市場預測、市場成長率、銷售量和平均售價進行分析。
這種細分使製造商、投資者和策略團隊能夠了解手術量、一次性產品使用情況、灌注系統升級、外科醫生偏好以及來自替代重組方法的競爭如何塑造全球 ONCAB 市場。
競爭分析
2025年,LivaNova在灌注系統和拋棄式領域都展現出強大的領導地位,並成為全球ONCAB市場的主要競爭者。本公司持續投資於ONCAB創新,包括推出Essenz™灌注系統和拓展銷售區域。
Essenz™灌注系統將於2025年進入中國市場,該系統具備更強大的即時監測和系統整合功能。憑藉豐富的產品系列、良好的市場表現和持續的平台升級,LivaNova擁有充足的潛力來維持甚至擴大其市場佔有率。
截至2025年,泰爾茂是冠狀動脈繞道手術(ONCAB)市場第二大競爭對手。該公司提供一次性使用的「Prestige Pack™」心血管介入套件,以及「CAPIOX®」和「Sarns™」系列一次性灌注產品。
由於本土企業的崛起,預計泰爾茂在未來幾年內不會獲得顯著的市場佔有率成長,但可能會保持其目前的市場佔有率。
2025年,美敦力是冠狀動脈繞道手術(ONCAB)市場的第三大競爭對手。該公司提供導管組件、心臟麻痹液產品和動脈過濾器等一次性套件。美敦力也開發了用於肝素塗層人工肺的生物相容性表面,包括Cortiva®和Trillium®等生物活性表面。
技術和臨床趨勢
灌注系統升級
體外循環系統的升級仍然是心臟移植市場的關鍵技術趨勢。雖然體外循環技術已經成熟,但製造商仍在不斷改進監測、整合和工作流程支援。
新系統旨在為灌注團隊在手術過程中提供更好的即時資訊。
生物相容性表面
為了減輕體外循環的不良反應,人們正在研發生物相容性表面。肝素塗層氧合器旨在更接近模擬血管內皮。
這些表面可能有助於減少體外循環迴路內的炎症,並降低凝血風險。
ONCAB標準化工作的延續
ONCAB 仍然是許多冠狀動脈繞道術的標準方法,因為它提供了一個穩定且可控的手術環境。
即使採用侵入性較小的替代方案,這也支持繼續使用灌注系統和一次性產品。
PCI壓力
經皮冠狀動脈介入治療(PCI)技術的進步導致冠狀動脈繞道手術(CABG)的數量下降。隨著介入性心臟病學技術的不斷改進,一些以前需要接受CABG手術的患者現在可以接受創傷較小的治療方法。
這一趨勢將在未來繼續影響對 ONCAB 的需求。
非體外循環和微創冠狀動脈繞道手術
非體外循環冠狀動脈繞道手術(OPCAB)和微創冠狀動脈繞道手術(MIBI)仍是心肺體外迴圈相關的風險。
未來,外科醫生的經驗和患者選擇將繼續影響這些技術的應用。
ECMO的發展
ECMO 的成長速度比 ONCAB 市場更快,並且在某些情況下可以作為體外循環機的替代方案。
這一擴張反映了對先進心肺支援技術日益成長的需求,並可能影響心臟外科和整體急診醫學領域的投資重點。
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《全球體外迴圈輔助下冠狀動脈繞道手術術器械市場報告》透過器械層面的分析、手術建模、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。該報告可用於評估需求、比較競爭對手、了解 CABG 技術趨勢以及製定全球體外循環冠狀動脈旁路移植術 (ONCAB) 市場的產業計畫。
Global On-Pump Coronary Artery Bypass Device Market Report to 2032
The global on-pump coronary artery bypass device market was valued at $583.3 million in 2025. It is expected to grow at a compound annual growth rate (CAGR) of 3.0%, reaching $719.6 million by 2032.
This report covers the global market for on-pump coronary artery bypass (ONCAB) devices, including disposable kits and perfusion system devices used during CABG procedures.
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 continued ONCAB procedural preference and improved cardiopulmonary bypass technologies. However, CABG procedure moderation, ONCAB-related side effects, and alternatives such as PCI, OPCAB, and ECMO are expected to limit stronger expansion.
Market Overview
The global on-pump coronary artery bypass device market includes products used during coronary artery bypass grafting procedures performed with cardiopulmonary bypass support. These devices help maintain circulation and oxygenation while the heart is stopped, allowing surgeons to operate in a motionless and bloodless field.
The market includes ONCAB disposables and perfusion systems. Disposable products include procedure kits, tubing sets, filters, oxygenators, and related components, while perfusion systems include capital equipment used to support extracorporeal circulation.
The global volume of CABG procedures has declined in recent years as less invasive interventional alternatives have gained traction. Catheter-based approaches can offer shorter hospital stays and faster recovery than traditional open-heart surgery, which has shifted treatment patterns in some patient groups.
Despite this pressure, ONCAB remains important for complex or high-risk coronary patients who require surgical revascularization. As a result, the market is expected to grow modestly through 2032, supported by continued procedural use, technology upgrades, and demand for reliable perfusion support.
Market Drivers
ONCAB Procedural Preference
CABG procedures can be performed on-pump or off-pump. Off-pump techniques were developed over a decade ago, and it was initially thought that OPCAB procedures could eventually overtake ONCAB as the surgical standard.
However, adoption of OPCAB has been limited because of the technical difficulty involved. Many surgeons remain hesitant or resistant to adopting more difficult off-pump techniques, especially in complex cases.
ONCAB is expected to remain the surgical standard for CABG procedures. By redirecting blood flow to a pump, surgeons can clamp the aorta and stop the heart, creating a motionless and bloodless surgical field. This allows precise graft suturing and consistent, reproducible outcomes.
Precision and Surgical Control
The ability to operate on a still heart remains one of the strongest clinical advantages of ONCAB. During on-pump procedures, surgeons can create precise connections between the graft vessel and the aorta while effectively bypassing narrowed or obstructed coronary arteries.
The absence of blood flow and heart motion helps support procedural accuracy. This is especially important in patients with complex coronary anatomy or multiple-vessel disease.
Because precision and control remain central to CABG success, ONCAB techniques continue to be preferred by many cardiac surgeons. This procedural preference supports ongoing demand for perfusion systems and ONCAB disposables.
New and Improved Technologies
Cardiopulmonary bypass technology is relatively mature compared with many newer medical device areas, but manufacturers continue to improve the safety and performance of ONCAB products.
Companies in the perfusion system market have worked to reduce the negative effects of extracorporeal circulation through better system design, monitoring, and more biocompatible materials.
Heparin-coated oxygenators and other biocompatible surfaces are designed to better mimic the vascular endothelium. These technologies may help reduce systemic inflammation and lower the tendency for blood to clot in the CPB circuit. These improvements support surgeon and patient confidence in ONCAB procedures.
Market Limiters
CABG Procedure Moderation
CABG procedure moderation is a major limiter for the ONCAB device market. Advancements in PCI technology are expected to keep CABG volumes relatively flat over the forecast period.
The value of the ONCAB market is directly tied to the number of CABG procedures performed each year. If procedure volume does not grow strongly, the market has limited opportunity for expansion.
There are also few major technological innovations or reimbursement changes that would allow manufacturers to raise ASPs meaningfully. As a result, procedure volume remains the primary growth lever, and flat CABG volumes are expected to keep market growth limited.
ONCAB Negative Side Effects
ONCAB procedures require a cardiopulmonary bypass pump, which exposes the patient's blood to foreign surfaces. This has been associated with increased bleeding risk and short-term neurocognitive effects.
These effects are often described as post-perfusion syndrome, or "pump head." Symptoms can include issues with attention, concentration, short-term memory, fine motor function, and the speed of mental and motor responses.
Stopping the heart may also impair or damage the heart muscle. In addition, clamping the aorta has been shown in some studies to release thrombogenic agents that may contribute to strokes. These concerns have encouraged some surgeons to transition toward off-pump and minimally invasive CABG techniques.
Alternatives
Alternative treatment options continue to limit ONCAB market growth. PCI technology has advanced significantly and can reduce the need for surgical revascularization in some patients.
OPCAB is also a direct alternative to ONCAB. Although it has not replaced ONCAB as the surgical standard, it remains available for selected patients and surgeons who prefer off-pump approaches.
ECMO is another alternative to heart-lung machines in certain clinical settings. ECMO is growing faster than the ONCAB market and may compete for investment, attention, and procedural use in specific patient populations.
Market Coverage and Data Scope
Markets Covered and Segmentation
ONCAB disposables include single-use components used during cardiopulmonary bypass procedures. These may include cardiovascular procedure kits, tubing sets, cardioplegia components, arterial filters, oxygenators, and other disposable perfusion products used during CABG.
Perfusion systems include capital equipment used to maintain circulation and oxygenation while the heart is stopped. These systems are central to the ONCAB workflow and are supported by continued upgrades in monitoring, integration, and procedural control.
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 procedure volume, disposable utilization, perfusion system upgrades, surgeon preference, and competition from alternative revascularization methods are shaping the global ONCAB market.
Competitive Analysis
LivaNova was the leading competitor in the global ONCAB market in 2025, with strong leadership across both the perfusion system and disposable segments. The company has continued to invest in ONCAB innovation, including the launch and geographic expansion of its Essenz(TM) Perfusion System.
The Essenz(TM) Perfusion System was introduced into the Chinese market in 2025 and includes enhanced real-time monitoring and system integration capabilities. Supported by its broad product portfolio, installed base, and ongoing platform upgrades, LivaNova is well positioned to maintain and potentially expand its market share.
Terumo was the second-leading competitor in the ONCAB market in 2025. The company offers its Prestige Pack(TM) cardiovascular procedure kit as its disposable kit option, along with the CAPIOX(R) and Sarns(TM) lines of disposable perfusion products.
Due to the presence of regional companies rising in popularity, Terumo is expected to maintain its current market share over the coming years rather than gain significant share.
Medtronic was the third-leading competitor in the ONCAB market in 2025. The company offers tubing sets, cardioplegia products, and arterial filters as disposable kit components. Medtronic has also developed biocompatible surfaces with heparin-coated oxygenators, including Cortiva(R) and Trillium(R) bioactive surfaces.
Technology and Practice Trends
Perfusion System Upgrades
Perfusion system upgrades remain an important technology trend in the ONCAB market. Although CPB technology is mature, manufacturers continue to improve monitoring, integration, and workflow support.
Newer systems are designed to give perfusion teams better real-time information during procedures.
Biocompatible Surfaces
Biocompatible surfaces are being developed to reduce the negative effects of extracorporeal circulation. Heparin-coated oxygenators are designed to better mimic the vascular endothelium.
These surfaces may help reduce inflammation and decrease clotting risk within the CPB circuit.
Continued ONCAB Standardization
ONCAB remains the standard approach for many CABG procedures because it provides a stable and controlled surgical environment.
This supports continued use of perfusion systems and disposables, even as less invasive alternatives gain adoption.
Pressure from PCI
Advancements in PCI are moderating CABG procedure volumes. As interventional cardiology continues to improve, some patients who may have previously undergone CABG can be treated with less invasive approaches.
This trend will continue to affect ONCAB demand.
Off-Pump and Minimally Invasive CABG
OPCAB and minimally invasive CABG techniques remain alternatives to ONCAB. Although adoption is limited by technical difficulty, these approaches can reduce some risks associated with cardiopulmonary bypass.
Surgeon experience and patient selection will continue to shape their use.
ECMO Growth
ECMO is growing faster than the ONCAB market and serves as an alternative to heart-lung machines in certain settings.
Its expansion reflects broader demand for advanced cardiopulmonary support technologies and may influence investment priorities across cardiac surgery and critical care.
Geography
This report provides global coverage across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa.
The Global On-Pump Coronary Artery Bypass 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 CABG technology trends, and support commercial planning in the global ONCAB market.