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全球心臟瓣膜设备市场 - 2025 - 2033Global Heart Valve Devices Market - 2025 - 2033 |
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2024年,全球心臟瓣膜器械市场规模达127.6亿美元,预计到2033年将达到346亿美元,2025-2033年预测期间复合年增长率为12.34%。
心臟瓣膜装置是用于更换或修復受损或患病心臟瓣膜的医疗装置,这对于确保血液单向流过心室至关重要。人的心臟有四个主要瓣膜,分别是二尖瓣、三尖瓣、肺动脉瓣和主动脉瓣。这些瓣膜根据心动週期中的压力变化而打开和关闭,确保血液从心房平稳地流到心室并流出到身体,而不会回流。当这些瓣膜因狭窄(瓣膜收缩)或逆流(渗漏)等疾病而无法正常运作时,就会发生心臟瓣膜疾病,导致包括心臟衰竭在内的重大健康问题。
对心臟瓣膜设备的需求不断增长是预测期内推动市场的驱动因素。需求激增主要是由于心血管疾病发生频率的增加,随着生活方式的改变和人口老化,心血管疾病变得越来越常见。许多人需要进行心臟瓣膜手术来治疗主动脉瓣狭窄等问题,从而对新型设备产生了更大的需求。随着医疗保健技术的进步和更多微创手术的出现,心臟瓣膜设备的市场预计将显着成长。
驱动程式和限制
对心臟瓣膜装置的需求不断增加
对心臟瓣膜装置的需求不断增长预计将成为全球心臟瓣膜装置市场成长的重要因素。由于心血管疾病盛行率上升、技术进步、人们对心臟瓣膜装置的认识不断增强以及最近的推出和批准,对心臟瓣膜装置的需求正在增加。
随着个体年龄的增长以及肥胖和久坐行为等与生活方式相关的危险因素变得更加频繁,心臟瓣膜问题的盛行率也会上升。心血管疾病盛行率的上升需要新颖的解决方案,从而刺激了对能够恢復正常心臟功能并改善患者预后的心臟瓣膜装置的需求。例如,根据美国疾病管制与预防中心的数据,心臟病是美国男性、女性以及大多数种族和族裔群体的主要死亡原因。在美国,每 33 秒就有一人死于心血管疾病。美国约有 695,000 人死于心臟病,即每 5 个人中就有 1 人死于心臟病。
此外,3D 列印技术的进步已经改变了基于特定患者解剖结构的客製化心臟瓣膜植入物的製造。这种程度的客製化提高了贴合度和功能性,从而带来更好的临床结果。此外,生物工程心臟瓣膜的研究正在进行中,重点是使用患者自身的细胞或捐赠组织复製天然瓣膜结构。该策略旨在减少与合成材料相关的排斥和长期困难。对心血管研究和开发的持续投资将这些技术进步推向更深层次。当组织致力于创新和改进现有心臟瓣膜装置时,他们也在研究有望提高生物相容性和性能的创新材料和设计。
最近推出了采用最新技术製造的产品。例如,2024 年 6 月,全球医疗保健技术领导者美敦力公司 (Medtronic plc) 宣布推出其在心臟手术领域的最新创新产品 Avalus Ultra 瓣膜。这种下一代外科主动脉组织瓣膜旨在促进植入时的易用性和终生患者管理。对于从一开始就寻求适合未来的主动脉瓣解决方案的心臟外科医生及其患者来说,这是一个绝佳的选择。
程序和设备成本高
手术和设备的高成本等因素预计将阻碍全球心臟瓣膜设备市场。主要问题之一是心臟瓣膜手术所涉及的巨大价格负担,特别是经导管主动脉瓣置换术 (TAVR) 等现代技术。这些治疗通常不仅包括设备本身的费用,还包括术前影像、住院和术后护理等额外费用。这些高昂的费用可能使许多患者,特别是中低收入地区或没有足够保险的患者难以获得所需的治疗。因此,财务影响可能会阻碍患者获得及时治疗,从而减少市场总需求。
例如,根据美国国立卫生研究院的数据,使用机械和生物瓣膜进行瓣膜置换手术的自付费用中位数估计为 107,800 印度卢比(1684 美元)和 154,000 印度卢比(2406 美元),球囊瓣膜切开术的费用分别为14,456 印度卢比(367 美元)。每次机械和生物假体单瓣膜置换手术和球囊瓣膜切开术的总体成本估计分别为 127,919 印度卢比(1999 美元)、148,919 印度卢比(2372 美元)和 14,456 印度卢比(226 美元)。
The global heart valve devices market reached US$ 12.76 billion in 2024 and is expected to reach US$ 34.6 billion by 2033, growing at a CAGR of 12.34% during the forecast period 2025-2033.
Heart valve devices are medical devices used to replace or repair damaged or diseased heart valves, which are essential for ensuring unidirectional blood flow through the heart's chambers. The human heart has four primary valves, the mitral valve, tricuspid valve, pulmonary valve, and aortic valve. These valves open and close in response to pressure changes during the cardiac cycle, ensuring that blood flows smoothly from the atria to the ventricles and out to the body with no backflow. Heart valve disease occurs when these valves fail to function properly due to disorders such as stenosis (valve constriction) or regurgitation (leakage), leading to major health issues including heart failure.
The increasing demand for heart valve devices is the driving factor that drives the market over the forecast period. The surge in demand is due to this surge is primarily due to an increase in the frequency of cardiovascular diseases, which are becoming more common as lifestyles change and populations age. Many individuals require heart valve procedures to treat problems such as aortic stenosis, creating a greater demand for novel devices. As healthcare technology progresses and more minimally invasive procedures become available, the market for heart valve devices is expected to grow significantly.
Market Dynamics: Drivers & Restraints
Increasing demand for heart valve devices
The increasing demand for heart valve devices is expected to be a significant factor in the growth of the global heart valve devices market. The demand for heart valve devices is increasing owing to the rising prevalence of cardiovascular diseases, technological advancements, growing awareness regarding heart valve devices, and recent launches and approvals.
As individuals grow older and lifestyle-related risk factors such as obesity and sedentary behavior become more frequent, the prevalence of heart valve problems rises. The rising prevalence of cardiovascular disorders needs novel solutions, fueling demand for heart valve devices that can restore normal heart function and improve patient outcomes. For instance, according to the Centers for Disease Control and Prevention, heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States. One person dies every 33 seconds in the United States from cardiovascular disease. About 695,000 people in the United States died from heart disease, that's 1 in every 5 deaths.
Furthermore, advances in 3D printing technology have transformed the manufacturing of custom-made heart valve implants based on specific patient anatomy. This amount of customization improves fit and functionality, leading to better clinical outcomes. Furthermore, research on bioengineered heart valves is underway, with an emphasis on reproducing natural valve structures using a patient's own cells or donor tissues. This strategy is intended to reduce rejection and long-term difficulties associated with synthetic materials. Continuous investment in cardiovascular research and development drives these technological advancements to greater depths. As organizations work to innovate and improve existing heart valve devices, they are also investigating innovative materials and designs that promise improved biocompatibility and performance.
There are recent product launches that are manufactured using the latest technologies. For instance, in June 2024, Medtronic plc, a global leader in healthcare technology, announced the launch of its latest innovation in cardiac surgery, the Avalus Ultra valve. This next-generation surgical aortic tissue valve is designed to facilitate ease of use at implant and lifetime patient management. It's an excellent choice for cardiac surgeons and their patients seeking an aortic valve solution that can be fit for the future, right from the start.
High costs of procedures and devices
Factors such as high costs of procedures and devices are expected to hamper the global heart valve devices market. One of the primary issues is the significant price burden involved with cardiac valve procedures, particularly modern technology like transcatheter aortic valve replacement (TAVR). These treatments frequently include not only the cost of the devices themselves, but also additional costs such as preoperative imaging, hospital stays, and postoperative care. These high costs can make it difficult for many patients, particularly those in low- and middle-income areas or without adequate insurance coverage, to get the therapies they need. As a result, the financial implications may discourage patients from obtaining prompt treatment, reducing total market demand.
For instance, according to the National Institute of Health, The median out-of-pocket expenditure for valve replacement surgery using mechanical and bio-prosthetic valves was estimated to be INR107,800 (US$1684) and INR154,000 (US$2406), respectively, and for balloon valvotomy was estimated to be INR14,456 (US$367). Overall package cost per mechanical and bio-prosthetic single valve replacement surgery and balloon valvotomy procedure was estimated as INR127,919 (US$1999), INR148,919 (US$2372) and INR14,456 (US$226), respectively.
The global heart valve devices market is segmented based on heart valve replacement devices, position, heart valve repair devices, end-user, and region.
TMVR (Transcatheter Mitral Valve Replacement) segment is expected to dominate the global heart valve devices market share
The TMVR (Transcatheter Mitral Valve Replacement) segment is anticipated to dominate the global heart valve devices market owing to its growing importance in treating mitral valve disorders, technological advancements, recent launches and approvals, and increase in the number of mitral regurgitations. As people live longer, the prevalence of age-related heart diseases, including MR, increases, needing better treatment options. TMVR provides a less intrusive alternative to standard surgical techniques, making it especially appealing to patients who are at high risk of complications from open-heart surgery. This shift toward less intrusive procedures is consistent with general trends in healthcare, which show an increasing preference for interventions that shorten recovery time and hospital stays. For instance, with a global prevalence of over 2%, mitral regurgitation is a common valvular abnormality with various causes, including congenital conditions, rheumatic fever, and degenerative changes in the valve.
Technological advances in TMVR devices have also led to their projected market dominance. Recent advances have resulted in the creation of more complex and dependable equipment that improves procedural success rates and patient outcomes. These developments include improved valve designs that provide greater hemodynamic performance and biocompatibility, as well as upgraded delivery systems that make implantation easier. As these technologies advance, they are projected to gain broader acceptability among healthcare practitioners and patients, increasing demand for TMVR solutions.
For instance, in May 2024, 4C Medical Technologies, a Minnesota-based medical device company focused on structural heart disease, received the FDA's breakthrough device designation for its AltaValve System for transcatheter mitral valve replacement (TMVR). The supra-annular AltaValve System was designed to treat both primary and secondary mitral regurgitation (MR) patients. It is implanted via transseptal access and positioned above the native mitral valve when implanted.
North America is expected to hold a significant position in the global heart valve devices market share
North America will likely account for a significant share of the global heart valve devices market, owing to its advanced healthcare infrastructure, a high prevalence of cardiovascular disorders, technological advancements, and recent launches and approvals. The rising prevalence of cardiovascular disorders needs novel solutions, fueling demand for heart valve devices that can restore normal heart function and improve patient outcomes.
For instance, according to the National Institute of Health, approximately 82.6 million people in the United States currently have one or more forms of cardiovascular disease (CVD), making it a leading cause of death for both men and women. Common types of cardiovascular disease include coronary heart disease (CHD), stroke, hypertension, and congestive heart failure. An estimated 16.3 million Americans aged 20 and older have CHD, a prevalence of 7 percent. The prevalence for men is 8.3 percent and for women is 6.1 percent. About 7 million Americans aged 20 or older have had a stroke. Each year approximately 610,000 experience their first stroke and another 185,000 experience a recurrence. Approximately 87 percent of all strokes are ischemic of which 10 percent result from intracerebral hemorrhage and 3 percent result from subarachnoid hemorrhage.
The region has established itself as a pioneer in the use of advanced medical technologies, particularly in cardiovascular care. One of the most significant developments is the invention and execution of transcatheter heart valve replacement (TAVR) operations, which have transformed the therapeutic landscape for patients with aortic stenosis and other valvular disorders. TAVR is a minimally invasive alternative to standard open-heart surgery that allows for faster recovery and shorter hospital stays, which is especially useful for older patients or those with complications.
For instance, in December 2024, Heart valve developer Anteris Technologies made its U.S. stock market debut one of the few initial public offerings by a MedTech company. The successful funding from this IPO is projected to considerably boost Anteris' capabilities in creating minimally invasive cardiac solutions, aligning with the increasing demand for cardiac surgery in aging populations.
Asia Pacific is growing at the fastest pace in the global heart valve devices market
The Asia Pacific region is emerging as the fastest-growing market for heart valve devices, owing to a combination of demographic trends, increased healthcare investment, recent launches, technological advancements, and a rising number of cardiovascular disorders. Cardiovascular diseases (CVDs) continue to be a prominent cause of morbidity and mortality globally, and their prevalence is significantly increasing in the Asia Pacific area. Inactive lifestyles, poor dietary habits, smoking, and increased stress are all contributing factors to this growth.
For instance, according to the National Institute of Health, annual number of deaths from CVD in India is projected to rise from 2.26 million (1990) to 4.77 million (2020). Coronary heart disease prevalence rates in India have been estimated over the past several decades and have ranged from 1.6% to 7.4% in rural populations and from 1% to 13.2% in urban populations.
The major global players in the global heart valve devices market include Abbott, Medtronic, Artivion, Inc., Boston Scientific Corporation, Micro Interventional Devices, Edwards Lifesciences Corporation, Sorin Medical Group, TTK Heartvalve, JenaValve, Lepu Medical Technology (Beijing)Co., Ltd. among others.
Emerging Players
Capstan Medical, Vesalius Cardiovascula, and Orchestra BioMed among others
The global heart valve devices market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.
Target Audience 2024
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