![]() |
市場調查報告書
商品編碼
1938800
氧合設備市場 - 全球產業規模、佔有率、趨勢、機會及預測(按產品類型、應用、最終用戶、地區和競爭格局分類,2021-2031年)Oxygenators Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product Type, By Type, By Application, By End User, By Region & Competition, 2021-2031F |
||||||
全球氧合設備市場預計將從 2025 年的 4.9 億美元成長到 2031 年的 6.6 億美元,複合年成長率為 5.09%。
這些專用醫療設備在心肺體外迴圈手術和體外膜氧合(ECMO)手術中至關重要,它們透過向靜脈血中輸送氧氣並去除二氧化碳,暫時取代肺部的呼吸功能,然後再將血液送回動脈系統。全球範圍內需要進行侵入性手術治療的嚴重心血管疾病和呼吸衰竭的發生率不斷上升,推動了該市場的發展。例如,根據美國心臟協會(AHA)2024年的報告,預計全球心血管疾病死亡人數將達到約1991萬,凸顯了對有效心肺支持技術的迫切需求。
| 市場概覽 | |
|---|---|
| 預測期 | 2027-2031 |
| 市場規模:2025年 | 4.9億美元 |
| 市場規模:2031年 | 6.6億美元 |
| 複合年成長率:2026-2031年 | 5.09% |
| 成長最快的細分市場 | 膜式氧合器 |
| 最大的市場 | 歐洲 |
儘管市場需求強勁,但由於醫療器材核准和品質保證方面的嚴格法規結構,該行業面臨許多挑戰。製造商必須應對複雜的合規標準,並進行廣泛的臨床試驗以確保患者安全,此過程會顯著延長產品開發週期。這些嚴格的要求推高了營運成本,提高了市場准入門檻,可能會減緩創新技術的商業化應用,並阻礙市場的快速擴張。
心血管和呼吸系統疾病的日益普遍正成為市場成長的主要催化劑,推動了冠狀動脈繞道手術手術和心臟瓣膜修復等介入治療的頻率。隨著這些慢性疾病負擔的加重,需要臨時心肺支持的手術數量也在增加,直接促進了人工肺的使用。主要臨床註冊機構的數據也印證了這一趨勢;例如,胸腔外科醫師協會報告稱,截至2025年3月,其成人心臟外科手術資料庫中已登記了超過830萬例手術。持續的臨床活動為主要製造商帶來了可觀的收入,Terumo Corporation於2025年5月公佈的截至2025年3月的會計年度財務業績(年銷售額達1.362兆日元)也證實了這些治療方法強勁的商業性發展勢頭。
同時,體外膜氧合(ECMO)在臨床上的日益普及,正將氧合設備的效用從傳統手術室擴展到加護病房。醫療設備生物相容性的提升,使得醫護人員能夠更長時間地使用ECMO系統來治療嚴重的急性呼吸衰竭和心臟麻痹,從而創造了清晰且快速成長的收入來源。生命支持技術的這種擴展應用也體現在全球註冊資料中。根據體外生命支持組織(ELSO)的數據,截至2025年4月,累計記錄的體外生命支持設備使用量已達245,291例,顯示這些先進技術正被深度整合到重症監護通訊協定中。
全球氧氣治療設備市場目前面臨許多挑戰,主要源自於嚴格的設備核准和品質保證法規結構。儘管臨床對心肺支援的需求日益成長,但將這些生命維持設備推向市場所需的複雜合規標準卻構成了一大瓶頸。製造商被迫投入大量資源來滿足這些嚴格的通訊協定,從而顯著延長了從產品概念到上市的時間。這種延誤擾亂了供應鏈,阻礙了先進氧氣治療技術及時交付給醫療機構。
此外,這些法規帶來的經濟負擔提高了進入門檻,限制了市場擴張。企業被迫長期承擔不斷上漲的研發成本,卻無法即時產生收入。根據歐洲醫療技術協會(MedTech Europe)預測,到2024年,根據現行法規,醫療設備核准的平均時間將為13至18個月。如此漫長的核准週期抑制了對新產品研發的投資,並給缺乏資金應對如此漫長核准流程的中小型創新企業帶來了過重的負擔,最終拖慢了整個行業的成長速度。
智慧氧合設備的出現正在改變市場格局,這些設備整合了感測器監測功能。它們能夠增強複雜灌注手術過程中的臨床決策。透過將即時感測功能直接整合到設備中,無需外部探頭即永續反饋氧飽和度、管路壓力等關鍵參數。這種整合最佳化了灌注師的工作流程,並透過最大限度地減少手術室設備面積來提高操作效率。這些系統的商業性成功體現在 LivaNova PLC 截至 2024 年 10 月的會計年度財務業績中,其中心肺支援設備業務的收入成長了 15.6%,主要得益於 Essenz 灌注系統及其耗材的銷售。
同時,聚甲基戊烯(PMP)中空纖維膜技術正在取代傳統的聚丙烯膜,尤其是在長期生命維持應用中。 PMP纖維具有卓越的抗血漿洩漏性能,使氧合器運作數天而非數小時。這滿足了對長期體外膜氧合(ECMO)日益成長的需求。這項材料創新正在推動對耐用一次性產品的需求,即使在整體供應鏈中出現波動的情況下也是如此。例如,Getinge於2024年10月發布的2024年7月至9月中期報告指出,其心肺業務部門的耗材成長尤為顯著,凸顯了急診護理領域對這些先進技術的持續依賴。
The Global Oxygenators Market is projected to expand from USD 0.49 Billion in 2025 to USD 0.66 Billion by 2031, reflecting a CAGR of 5.09%. These specialized medical devices are essential during cardiopulmonary bypass surgeries and extracorporeal membrane oxygenation procedures, temporarily assuming the lung's respiratory functions by enriching venous blood with oxygen and removing carbon dioxide before returning it to the arterial system. The market's foundation rests on the rising global incidence of severe cardiovascular diseases and respiratory failures that require invasive surgical solutions. For instance, the American Heart Association reported in 2024 that cardiovascular disease caused approximately 19.91 million deaths worldwide, highlighting the urgent and escalating need for effective cardiopulmonary support technologies.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 0.49 Billion |
| Market Size 2031 | USD 0.66 Billion |
| CAGR 2026-2031 | 5.09% |
| Fastest Growing Segment | Membrane Oxygenator |
| Largest Market | Europe |
Despite this robust demand, the industry encounters significant hurdles due to stringent regulatory frameworks concerning device approval and quality assurance. Manufacturers must navigate complex compliance standards and conduct extensive clinical testing to guarantee patient safety, a process that considerably lengthens product development timelines. These exacting requirements escalate operational expenses and establish high barriers to entry, which can delay the commercial introduction of innovative technologies and hinder the market's rapid expansion.
Market Driver
The increasing prevalence of cardiovascular and respiratory diseases acts as a primary catalyst for market growth, driving a higher frequency of invasive interventions like coronary artery bypass grafting and heart valve repairs. As the burden of these chronic conditions grows, the number of surgical procedures necessitating temporary cardiopulmonary support has risen, directly boosting the use of oxygenators. This trend is supported by data from major clinical registries; for example, The Society of Thoracic Surgeons reported in March 2025 that their Adult Cardiac Surgery Database included over 8.3 million cumulative procedures. This sustained clinical activity drives substantial financial results for major manufacturers, as evidenced by Terumo Corporation, which reported an annual revenue of ¥1,036.2 billion in May 2025 for the fiscal year ending March 31, 2025, confirming the strong commercial momentum behind these therapies.
Concurrently, the wider clinical adoption of Extracorporeal Membrane Oxygenation (ECMO) is expanding the utility of oxygenators beyond traditional operating theaters into intensive care units. Improvements in device biocompatibility enable healthcare providers to use ECMO systems for extended periods to treat severe acute respiratory failure and cardiac arrest, generating a distinct and fast-growing revenue stream. The growing application of this life support modality is highlighted by global registry data; according to the Extracorporeal Life Support Organization, a cumulative total of 245,291 extracorporeal life support runs were recorded by April 2025, illustrating the deepening integration of these advanced technologies into critical care protocols.
Market Challenge
The Global Oxygenators Market currently contends with significant obstacles arising from rigorous regulatory frameworks for device approval and quality assurance. Although the clinical necessity for cardiopulmonary support is increasing, the intricate compliance standards required to launch these life-sustaining devices serve as a major bottleneck. Manufacturers are compelled to allocate substantial resources to satisfy these strict protocols, which drastically prolongs the timeline from product conception to market availability. This delay disrupts supply chains and prevents the timely delivery of advanced oxygenation technologies to healthcare providers.
Furthermore, the financial burden of these regulations establishes high barriers to entry that restrict broader market expansion. Companies must shoulder elevated development costs for extended periods without immediate revenue generation. According to MedTech Europe, the average time to certification for medical devices under current regulations was reported in 2024 to range between 13 and 18 months. This extended cycle discourages investment in new product development and places a disproportionate strain on smaller innovators lacking the capital to survive such lengthy review processes, ultimately retarding the sector's overall growth rate.
Market Trends
The market is being transformed by the emergence of smart oxygenators equipped with integrated sensor monitoring, which enhances clinical decision-making during complex perfusion procedures. By incorporating real-time sensing capabilities directly into the device, these systems provide continuous feedback on vital parameters such as oxygen saturation and line pressure without the need for external probes. This integration optimizes perfusionist workflows and boosts operational efficiency by minimizing the equipment footprint in operating theaters. The commercial success of these systems is reflected in LivaNova PLC's October 2024 results, where Cardiopulmonary segment revenue rose by 15.6%, driven largely by sales of the Essenz Perfusion System and its consumables.
Simultaneously, the adoption of Polymethyl Pentene (PMP) hollow fiber technology is replacing traditional polypropylene membranes, especially for extended life support applications. PMP fibers provide superior resistance to plasma leakage, allowing oxygenators to operate effectively for days instead of hours, which supports the increasing requirement for long-duration extracorporeal membrane oxygenation (ECMO). This material innovation fuels the demand for durable disposables, even during broader supply chain fluctuations. For instance, Getinge noted in its interim report for July-September 2024, released in October 2024, that there was particularly strong growth in consumables within its Cardiopulmonary business area, underscoring the sustained reliance on these advanced technologies for acute care.
Report Scope
In this report, the Global Oxygenators 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 Oxygenators Market.
Global Oxygenators 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: