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市场调查报告书
商品编码
1744545
2032 年结构性心臟器材市场预测:按产品、手术方式、年龄层、适应症、最终用户和地区进行的全球分析Structural Heart Devices Market Forecasts to 2032 - Global Analysis By Product, Procedure, Age Group, Indication, End User and By Geography |
根据 Stratistics MRC 的数据,全球结构性心臟器材市场预计在 2025 年将达到 87.3 亿美元,预计到 2032 年将达到 184.7 亿美元,预测期内的复合年增长率为 11.3%。
被称为结构性心臟装置的医疗植入和器械,用于替换或修復破损或有缺陷的心臟部件,例如心臟壁、瓣膜和内部开口。这些器械在治疗瓣膜狭窄、逆流、心房中隔缺损和左心耳关闭不全等疾病时至关重要。由于结构性心臟装置比开胸手术能更快地帮助患者康復,且併发症更少,因此,随着经导管手术等微创手术的进步,其使用量显着增加。此外,人口老化和心血管疾病盛行率的上升,全球各个医疗保健系统对这些器械的需求也日益增加。
根据世界卫生组织 (WHO) 的数据,心血管疾病 (CVD) 是全球最大的死亡原因,每年约有 1,790 万人因此丧命。这些疾病涵盖一系列心血管疾病,例如心臟疾病心臟病、脑血管疾病和风湿性心臟疾病。
心血管疾病盛行率不断上升
瓣膜性心臟病、室间隔缺损和左心耳畸形等结构性心臟病是全球心血管疾病 (CVD) 负担日益加重的主要原因。根据世界卫生组织 (WHO) 统计,每年约有 1800 万人死于心血管疾病 (CVD)。随着需要手术或导管介入治疗的疾病(如主动脉瓣狭窄和环状成形术)的瓣膜闭锁不全心臟器械的需求也随之增加。这些疾病通常会随着时间的推移而恶化,因此及时进行器械干预对于降低发病率和死亡率至关重要。
昂贵的设备和程序
结构性心臟介入治疗,尤其是采用经导管瓣膜置换术(TAVR)和经导管主动脉瓣置换术(TMVR)等经导管技术的介入治疗,手术和设备成本高。如果再加上住院、影像学检查、术后护理,以及单一经导管瓣膜的高昂费用(可能高达3万美元),患者和医疗保健系统的整体负担将非常沉重。在中低收入国家(LMIC),保险覆盖不足和医疗资金不足进一步限制了这些救命手术的可及性。此外,即使在已开发国家,医疗技术机构的成本效益评估也可能阻碍或延迟这些技术的广泛应用,尤其是对于无症状或中度风险患者而言。
打造客製化的尖端设备
开发安全性、坚固性和易用性更高的下一代结构性心臟装置潜力巨大。为了减少併发症并改善手术管理,各公司正致力于製造更小、完全可回收和可重新定位的瓣膜。随着数位影像和3D列印技术的发展,客製化、针对特定患者的装置也可以进行设计,以最大限度地提高贴合度和功能,尤其是在解剖结构复杂的情况下。此外,这些装置还可以整合智慧感测器和数位健康技术,提供即时监测,增强术后护理,并可能降低再入院率。
价格压力大,市场竞争激烈
在竞争激烈的结构性心臟市场中,爱德华生命科学、美敦力、雅培和波士顿科学等领先公司不断开发创新产品,并实现产品组合多元化。市场竞争激发创造力,但也带来了定价压力,尤其是在参与企业的情况下。医院的竞标采购惯例、消费者对经济实惠解决方案日益增长的需求以及与医疗系统和保险公司的磋商,往往会降低成本。此外,这种价格敏感度可能会对利润率产生不利影响,尤其对于规模经济受限的新兴企业公司和规模较小的公司。
新冠疫情在短期内对结构性心臟器械市场造成了重大衝击,主要原因是择期手术被推迟,以及医院资源被重新分配至重症加护。在疫情高峰期,包括经导管瓣膜置换术和修復在内的许多结构性心臟手术被推迟,导致手术量和器械销售量暂时下降。此外,全球供应链中断也影响了医疗设备的生产和分销。另一方面,疫情加速了数位医疗技术的普及,并凸显了缩短住院时间和微创手术的重要性。
主动脉瓣狭窄预计将成为预测期内最大的细分市场
由于经导管主动脉瓣置换术(TAVR) 的广泛应用及其在老年族群中的高盛行率,预计主动脉瓣狭窄领域将在预测期内占据最大的市场占有率。 TAVR 是一种比外科瓣膜置换术术侵入性较小的手术方式,因此越来越受欢迎,尤其适用于手术风险较高或中等的患者。由于手术效果的改善、低风险患者适应症的扩大以及器械设计的进步,TAVR 的采用率显着上升。此外,由于认知度的提高、报销支持力度的加大以及临床成功率的提高,TAVR 领域已成为结构性心臟介入领域成长的主要驱动力。
预计预测期内门诊手术中心 (ASC) 部分将以最高的复合年增长率成长。
预计门诊手术中心 (ASC) 细分市场将在预测期内实现最高成长率。 ASC 具有许多优势,例如手术成本更低、住院时间更短、病患週转更快、医院内感染风险更低。由于手术安全性的增加和设备体积的缩小,这些中心现在能够进行多种结构性心臟介入手术,尤其是经导管手术。不断增加的投资、有利的报销改革以及患者对便捷治疗环境的偏好,共同推动了 ASC 的爆炸式增长,使其成为结构性心臟介入领域的关键增长引擎。
在预测期内,北美预计将占据最大的市场占有率,这得益于该地区老龄人口的不断增长、心血管疾病的高发病率以及先进的医疗基础设施。除了主要市场参与者的存在和完善的报销政策外,该地区还受益于大量的研发投入。此外,市场的强劲成长也得益于人们对微创手术的认识不断提高,以及经导管主动脉瓣置换术(TAVR) 和左心耳封堵术等最尖端科技的日益普及。
预计亚太地区在预测期内将呈现最高的复合年增长率。人口老化、医疗保健的便利性以及人们对心血管疾病的认识不断提高等诸多因素促成了这一快速增长。印度是结构性心臟器械市场的领导者。此外,左心耳封堵术 (LAAC) 和经导管主动脉瓣置换术(TAVR) 等微创手术的应用也推动了该地区市场的扩张。
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.