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市場調查報告書
商品編碼
1744545
2032 年結構性心臟器材市場預測:按產品、手術方式、年齡層、適應症、最終用戶和地區進行的全球分析Structural Heart Devices Market Forecasts to 2032 - Global Analysis By Product, Procedure, Age Group, Indication, End User and By Geography |
根據 Stratistics MRC 的數據,全球結構性心臟器材市場預計在 2025 年將達到 87.3 億美元,預計到 2032 年將達到 184.7 億美元,預測期內的複合年成長率為 11.3%。
被稱為結構性心臟裝置的醫療植入和器械,用於替換或修復破損或有缺陷的心臟部件,例如心臟壁、瓣膜和內部開口。這些器械在治療瓣膜狹窄、逆流、心房中隔缺損和左心耳關閉不全等疾病時至關重要。由於結構性心臟裝置比開胸手術能更快地幫助患者康復,且併發症更少,因此,隨著經導管手術等微創手術的進步,其使用量顯著增加。此外,人口老化和心血管疾病盛行率的上升,全球各個醫療保健系統對這些器械的需求也日益增加。
根據世界衛生組織 (WHO) 的數據,心血管疾病 (CVD) 是全球最大的死亡原因,每年約有 1,790 萬人因此喪命。這些疾病涵蓋一系列心血管疾病,例如心臟疾病心臟病、腦血管疾病和風濕性心臟疾病。
心血管疾病盛行率不斷上升
瓣膜性心臟病、室間隔缺損和左心耳畸形等結構性心臟病是全球心血管疾病 (CVD) 負擔日益加重的主要原因。根據世界衛生組織 (WHO) 統計,每年約有 1800 萬人死於心血管疾病 (CVD)。隨著需要手術或導管介入治療的疾病(如主動脈瓣狹窄和環狀成形術)的瓣膜閉鎖不全心臟器械的需求也隨之增加。這些疾病通常會隨著時間的推移而惡化,因此及時進行器械干預對於降低發病率和死亡率至關重要。
昂貴的設備和程序
結構性心臟介入治療,尤其是採用經導管瓣膜置換術(TAVR)和經導管主動脈瓣置換術(TMVR)等經導管技術的介入治療,手術和設備成本高。如果再加上住院、影像學檢查、術後護理,以及單一經導管瓣膜的高昂費用(可能高達3萬美元),患者和醫療保健系統的整體負擔將非常沉重。在中低收入國家(LMIC),保險覆蓋不足和醫療資金不足進一步限制了這些救命手術的可及性。此外,即使在已開發國家,醫療技術機構的成本效益評估也可能阻礙或延遲這些技術的廣泛應用,尤其是對於無症狀或中度風險患者而言。
打造客製化的尖端設備
開發安全性、堅固性和易用性更高的下一代結構性心臟裝置潛力巨大。為了減少併發症並改善手術管理,各公司正致力於製造更小、完全可回收和可重新定位的瓣膜。隨著數位影像和3D列印技術的發展,客製化、針對特定患者的裝置也可以進行設計,以最大限度地提高貼合度和功能,尤其是在解剖結構複雜的情況下。此外,這些裝置還可以整合智慧感測器和數位健康技術,提供即時監測,增強術後護理,並可能降低再入院率。
價格壓力大,市場競爭激烈
在競爭激烈的結構性心臟市場中,愛德華生命科學、美敦力、雅培和波士頓科學等領先公司不斷開發創新產品,並實現產品組合多元化。市場競爭激發創造力,但也帶來了定價壓力,尤其是在參與企業的情況下。醫院的競標採購慣例、消費者對經濟實惠解決方案日益成長的需求以及與醫療系統和保險公司的磋商,往往會降低成本。此外,這種價格敏感度可能會對利潤率產生不利影響,尤其對於規模經濟受限的新興企業公司和規模較小的公司。
新冠疫情在短期內對結構性心臟器械市場造成了重大衝擊,主要原因是擇期手術被推遲,以及醫院資源被重新分配至重症加護。在疫情高峰期,包括經導管瓣膜置換術和修復在內的許多結構性心臟手術被推遲,導致手術量和器械銷售量暫時下降。此外,全球供應鏈中斷也影響了醫療設備的生產和分銷。另一方面,疫情加速了數位醫療技術的普及,並凸顯了縮短住院時間和微創手術的重要性。
主動脈瓣狹窄預計將成為預測期內最大的細分市場
由於經導管主動脈瓣置換術(TAVR) 的廣泛應用及其在老年族群中的高盛行率,預計主動脈瓣狹窄領域將在預測期內佔據最大的市場佔有率。 TAVR 是一種比外科瓣膜置換術術侵入性較小的手術方式,因此越來越受歡迎,尤其適用於手術風險較高或中等的患者。由於手術效果的改善、低風險患者適應症的擴大以及器械設計的進步,TAVR 的採用率顯著上升。此外,由於認知度的提高、報銷支持力度的加大以及臨床成功率的提高,TAVR 領域已成為結構性心臟介入領域成長的主要驅動力。
預計預測期內門診手術中心 (ASC) 部分將以最高的複合年成長率成長。
預計門診手術中心 (ASC) 細分市場將在預測期內實現最高成長率。 ASC 具有許多優勢,例如手術成本更低、住院時間更短、病患週轉更快、醫院內感染風險更低。由於手術安全性的增加和設備體積的縮小,這些中心現在能夠進行多種結構性心臟介入手術,尤其是經導管手術。不斷增加的投資、有利的報銷改革以及患者對便捷治療環境的偏好,共同推動了 ASC 的爆炸式成長,使其成為結構性心臟介入領域的關鍵成長引擎。
在預測期內,北美預計將佔據最大的市場佔有率,這得益於該地區老齡人口的不斷成長、心血管疾病的高發病率以及先進的醫療基礎設施。除了主要市場參與者的存在和完善的報銷政策外,該地區還受益於大量的研發投入。此外,市場的強勁成長也得益於人們對微創手術的認知不斷提高,以及經導管主動脈瓣置換術(TAVR) 和左心耳封堵術等最尖端科技的日益普及。
預計亞太地區在預測期內將呈現最高的複合年成長率。人口老化、醫療保健的便利性以及人們對心血管疾病的認知不斷提高等諸多因素促成了這一快速成長。印度是結構性心臟器械市場的領導者。此外,左心耳封堵術 (LAAC) 和經導管主動脈瓣置換術(TAVR) 等微創手術的應用也推動了該地區市場的擴張。
According to Stratistics MRC, the Global Structural Heart Devices Market is accounted for $8.73 billion in 2025 and is expected to reach $18.47 billion by 2032 growing at a CAGR of 11.3% during the forecast period. Medical implants or instruments called structural heart devices are made to replace or fix broken or flawed cardiac components, such as walls, valves, or internal openings. When it comes to treating conditions like valve stenosis, regurgitation, atrial septal defects, and left atrial appendage closure, these devices are essential. Because structural heart devices offer patients a quicker recovery and fewer complications than open heart surgery, their use has increased dramatically due to advancements in minimally invasive procedures like transcatheter techniques. Moreover, the need for these devices is increasing in all global healthcare systems due to the aging population and the rising incidence of cardiovascular diseases.
According to the World Health Organization (WHO), cardiovascular diseases (CVDs) are the leading cause of death globally, claiming an estimated 17.9 million lives each year. These diseases encompass a range of heart and blood vessel disorders, including coronary heart disease, cerebrovascular disease, and rheumatic heart disease.
Increasing cardiovascular disease prevalence
Structural heart conditions like valvular heart disease, septal defects, and abnormalities of the left atrial appendage are major contributors to the growing global burden of cardiovascular diseases (CVDs). Almost 18 million deaths annually are attributed to CVDs, according to the World Health Organization. Demand for structural heart devices like transcatheter valves, occluders, and annuloplasty rings is fueled by the rising prevalence of conditions like aortic stenosis and mitral valve regurgitation, which call for surgical or catheter-based intervention. Timely device-based intervention is crucial in lowering morbidity and mortality because these conditions frequently worsen over time.
Expensive equipment and procedures
High procedural and device costs are linked to structural heart interventions, particularly those that use transcatheter techniques like TAVR or TMVR. When hospital expenses, imaging, and post-operative care are added to the high cost of a single transcatheter valve-which can reach $30,000-the overall burden on patients and healthcare systems is substantial. Access to these life-saving procedures is further limited in low- and middle-income countries (LMICs) by a lack of insurance coverage and inadequate healthcare funding. Additionally, health technology agencies' cost-effectiveness evaluations can impede or postpone broad adoption, even in developed countries, especially for patients who are asymptomatic or at intermediate risk.
Creation of customized and up-and-coming equipment
The development of next-generation structural heart devices that provide enhanced safety, robustness, and usability has enormous potential. In order to reduce complications and increase procedural control, companies are concentrating on creating smaller, fully retrievable, and repositionable valves. owing to developments in digital imaging and 3D printing, customized and patient-specific devices can also maximize fit and function, particularly in cases that present anatomical challenges. Furthermore, these devices may offer real-time monitoring, enhance post-procedure care and lower hospital readmission rates by incorporating smart sensors and digital health technologies.
High levels of price pressure and market competition
Major companies like Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific are constantly innovating and diversifying their portfolios in the fiercely competitive structural heart market. Although competition encourages creativity, it also increases pricing pressure, particularly as more businesses enter the market. Hospitals' tender-based procurement practices, consumers' increasing desire for economical solutions, and discussions with health systems and insurers frequently result in lower costs. Moreover, profit margins may be adversely affected by this price sensitivity, especially for startups or smaller businesses with constrained economies of scale.
The COVID-19 pandemic had a significant short-term impact on the Structural Heart Devices Market, primarily due to the postponement of elective procedures and the reallocation of hospital resources toward critical care. Procedure volumes and device sales temporarily decreased as a result of the postponement of numerous structural heart interventions, such as transcatheter valve replacements and repairs, during the height of pandemic waves. Additionally, the production and distribution of medical devices were also impacted by disruptions in the global supply chain. On the other hand, the pandemic also hastened the adoption of digital health technologies and reaffirmed the significance of shorter hospital stays and minimally invasive procedures, which ultimately favor structural heart interventions.
The aortic valve stenosis segment is expected to be the largest during the forecast period
The aortic valve stenosis segment is expected to account for the largest market share during the forecast period, due to the widespread use of Transcatheter Aortic Valve Replacement (TAVR) procedures and their high prevalence in the elderly population. A less invasive option to surgical valve replacement, TAVR has gained popularity, especially for patients with high or intermediate surgical risk. Adoption rates have been greatly increased by improvements in procedure outcomes, expanded indications for lower-risk patients, and device design advancements. Furthermore, this segment is a major driver of growth in the structural heart intervention landscape due to rising awareness, reimbursement support, and clinical success rates.
The ambulatory surgical centers (ASCs) segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the ambulatory surgical centers (ASCs) segment is predicted to witness the highest growth rate. because of the increasing trend toward outpatient care and minimally invasive procedures. ASCs have several benefits, including lower procedure costs, shorter hospital stays, quicker patient turnover, and a lower chance of hospital-acquired infections. These centers can now perform many structural heart interventions, particularly transcatheter procedures, owing to improvements in procedural safety and device miniaturization. Growing investments, advantageous reimbursement reforms, and patient preference for convenient care settings are all contributing to ASCs' explosive growth and establishing them as a key growth engine in the field of structural heart treatment.
During the forecast period, the North America region is expected to hold the largest market share, driven by its growing geriatric population, high prevalence of cardiovascular diseases, and sophisticated healthcare infrastructure. In addition to the presence of major market players and established reimbursement policies, the region benefits from large investments in research and development. Additionally, strong market growth is also a result of growing awareness of minimally invasive procedures and the growing use of cutting-edge technologies like transcatheter aortic valve replacement (TAVR) and left atrial appendage closure.
Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR. Numerous factors, such as an aging population, easier access to healthcare, and growing awareness of cardiovascular diseases, are responsible for this rapid expansion. India is leading the way in the market for structural heart devices. Furthermore, driving market expansion in the area is the use of minimally invasive procedures like Left Atrial Appendage Closure (LAAC) and Transcatheter Aortic Valve Replacement (TAVR).
Key players in the market
Some of the key players in Structural Heart Devices Market include Boston Scientific Corporation, Artivion, Inc., Medtronic Plc, Edwards Lifesciences Corporation, Abbott Laboratories, JenaValve Technology, Inc., LivaNova PLC, Meril Lifesciences Pvt. Ltd, LifeTech Scientific Corporation, Terumo Corporation, Numed Inc, Atricure, Inc, Cook Group Incorporated, Lepu Medical Inc and Braile Biomedica Inc.
In May 2025, Artivion, Inc announced that it entered into separate, privately negotiated exchange agreements with certain holders of its 4.250% Convertible Senior Notes due 2025. Under the exchange agreements, the company will, subject to customary closing conditions, repurchase approximately $95 million principal amount of Existing Convertible Notes in exchange for a number of shares of the company's common stock to be determined based on the trading price of the common stock over a four trading day averaging period beginning.
In April 2025, Medtronic plc announced a strategic agreement to distribute the advanced Dragonfly(TM)* pancreaticobiliary system from Dragonfly Endoscopy, Inc. in the United States. This innovative platform introduces significant enhancements in pancreaticobiliary endoscopy - a field where procedural standards have remained largely unchanged for decades. Financial terms of the agreement were not disclosed.
In March 2025, Boston Scientific Corporation announced it has entered into a definitive agreement to acquire SoniVie Ltd., a privately held medical device company that has developed the TIVUS(TM) Intravascular Ultrasound System. An investigational technology, the TIVUS system is designed to denervate nerves surrounding blood vessels to treat a variety of hypertensive disorders, including renal artery denervation (RDN) for hypertension.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.