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市场调查报告书
商品编码
1765034
欧洲球囊主动脉瓣成形术市场预测(至 2031 年)- 区域分析 - 依产品类型(非顺应性球囊和半顺应性球囊)Europe Balloon Aortic Valvuloplasty Market Forecast to 2031 - Regional Analysis - by Product Type (Non Compliant Balloons and Semi Compliant Balloons) |
2023 年欧洲球囊主动脉瓣成形术市场价值为 5,034 万美元,预计到 2031 年将达到 7,467 万美元;预计 2023 年至 2031 年的复合年增长率为 5.1%。
TAVI 技术的改进与研发结合,推动欧洲球囊主动脉瓣成形术市场发展
经导管主动脉瓣置换术(TAVR)最初仅用于无法手术或风险极高的严重主动脉瓣狭窄患者。然而,随着瓣膜技术的不断发展和随机试验的结果,其应用范围已扩大到更年轻、风险更低的患者,并使其成为主动脉瓣疾病的主流治疗方法。随着瓣膜生产技术的进步,生物瓣膜越来越受到年轻、风险较低患者的青睐。由于其微创特性,大多数瓣膜置换手术很快将透过TAVR进行。新一代经导管心臟瓣膜显着提高了手术效果、安全性和患者预后,使TAVR成为不同风险族群的理想选择。
预测心臟瓣膜植入后的表现对于 TAVR 的成功至关重要。为了确保瓣膜功能正常,并最大程度地减少植入后併发症,最好在植入前对选定的心臟瓣膜进行机械评估。将工程分析应用于心臟瓣膜机械评估的一个潜在且有效的解决方案是结合基于深度学习 (DL) 的系统,以推进和简化与 TAVR 相关的计算生物力学分析。近年来,深度学习技术的巨大发展已使许多电脑视觉任务(包括影像分类、影像分割和目标检测)的表现达到最高水准。深度学习已广泛应用于各种心臟影像应用,包括诊断、预后、风险分层以及治疗/外科治疗计划。许多研究已经探讨了使用深度学习方法评估 TAVR 结果以预测术后併发症和人工瓣膜缺陷。
透过不断研发,TAVR 未来充满突破性的可能性,进一步巩固其作为心血管医学变革疗法的地位。目前,只有 Edwards SAPIEN 3 Ultra、Medtronic EVOLUT FX 和 Abbott Navitor 瓣膜获得了 FDA 的批准。虽然 TAVR 的大部分临床经验都与 Edwards 和 Medtronic 瓣膜系统有关,但潜在的经导管心臟瓣膜阵容不仅限于这些领先者,还有多达五到十种新的 TAVR 瓣膜处于开发阶段。第四种经导管心臟瓣膜,即波士顿科学 Acurate-neo2 瓣膜,于 2020 年在欧洲获得批准;在某些地方,它已经对 1,500 名不同风险等级的患者完成了随机临床试验。第五种瓣膜 JenaValve(JenaValve 技术),已在欧盟获得批准,并拥有 FDA 的先进设备称号和研究设备豁免;然而,这种瓣膜主要针对纯主动脉瓣关闭不全患者进行开发。
除了对现有瓣膜进行改进外,全球各地的公司还在开发多种瓣膜,预计这些瓣膜将在未来几年提高输送能力、耐用性和临床疗效。 TAVR 的前景一片光明,适应症不断增加,手术量激增,提供该手术的临床中心也越来越多,但长期耐用性仍然是一个关键问题。目前可用的瓣膜瓣叶取自猪或牛心包组织。为了提高长期耐用性,正在开发结合创新瓣叶材料和其他设计创新的新型瓣膜平台。一些新的试验有望为寻求长期解决方案的 TAVR 手术人员提供重要指导。 SMART(即随机化小瓣环 Evolut 或 SAPIEN 试验)是第一个由业界(美敦力)赞助的随机化头对头比较试验,比较两种最常用的 TAVR 设备:SAPIEN 3 和 Evolut 在小解剖结构中的应用。该试验在北美、欧洲、中东和非洲的 83 个国际地点进行。试验招募了 716 名主动脉环较小(根据多侦测器电脑断层扫描,主动脉环面积为 430 平方毫米或更小)且有症状的重度先天性主动脉瓣狭窄的参与者。 2024 年 4 月,美国心臟学会宣布 SMART 试验的结果表明,与接受 SAPIEN 3 瓣膜 TAVR 的患者相比,接受 Evolut 瓣膜 TAVR 的小主动脉环患者在一年后具有相似的临床结果和更优异的瓣膜性能。研究人员表示,就两种瓣膜类型的临床结果而言,结果均令人鼓舞。他们指出,进一步的试验有助于阐明 TAVR 是否具有随时间持续的早期优势,以及哪种现有和即将推出的经导管心臟瓣膜能提供最佳效果。研究人员将在未来五年内继续追踪结果。因此,专注于改进 TAVI 程序的研究和开发活动可能会为球囊主动脉瓣成形术市场带来新的趋势。
欧洲球囊主动脉瓣成形术市场概况
欧洲球囊主动脉瓣成形术市场的成长与瓣膜疾病盛行率的上升以及人们对微创手术日益增长的偏好有关。心血管疾病持续成长,仍是德国的主要死亡原因之一。心臟瓣膜疾病的发生率随着年龄的增长而急剧上升。主动脉瓣狭窄是一种常见的心臟瓣膜疾病,如果不治疗,预后不佳。在这种情况下,建议采用经导管主动脉瓣瓣膜植入术 (TAVI) 或经导管主动脉瓣置换术 (SAVR)。 TAVI 是德国主动脉瓣狭窄的标准治疗方法。
根据2023年发表的一项题为《德国经导管主动脉瓣植入的医疗保健服务》的研究,2021年共实施了26,506例TAVI手术。与2021年相比,预计2035年TAVI手术将增加4,673例。此外,基于德国胸腔心臟血管外科协会(GSTCVS)于1980年建立的长期自愿登记系统,分析了2022年德国78个心臟外科部门实施的所有胸腔外科、心臟外科和血管外科手术的明确资料。 2022年共实施了93,913例心臟外科手术。其中,实施了38,492例心臟瓣膜手术,包括14,852例单瓣心臟瓣膜手术、2,880例双瓣心臟瓣膜手术和296例三瓣心臟瓣膜手术。此外,也进行了约20,272例经导管心臟瓣膜手术。重点关注2022年主动脉瓣膜手术的分布,向登记处报告了17,818例TAVI和7,798例SAVR。
FRANCE-TAVI 登记系统于 2022 年发布了一份关于法国队列中 TAVR 趋势和演变的最新报告。约有 85,000 名患者入组,平均年龄为 83 岁。手术数量从 2010 年的 1,556 例增加到 2021 年的 14,114 例。此外,TAVR 的使用主要局限于高风险族群,在法国年轻患者中仍然不常见。根据 2023 年发布的《法国经导管主动脉瓣置换术使用与年龄和性别的关係》报告,共有 107,397 名患者接受了单独主动脉瓣置换术(59.1% 为 TAVR,40.9% 为 SAVR)。在65岁及以上患者中,从2015年到2020年,TAVR的比例增加了63.2%。随着人口老化的加剧,心臟瓣膜疾病的盛行率预计将激增。
由于瓣膜疾病患者人数不断增加,以及老年人口(老年人更容易患瓣膜疾病)的不断增加,英国球囊主动脉瓣成形术市场可能会持续成长。根据英国註册慈善机构 Age UK 2020 年发布的一项研究,英国 65 岁及以上人口接近 1,200 万人。预计到 2030 年,英国百岁老人的数量将达到或超过 2.1 万,五分之一的人口将达到 65 岁及以上。根据 2021 年发表在开放取用期刊《Open Heart》上的一项题为《揭示英国重度主动脉瓣狭窄的可治疗负担》的研究,英国约有 30 万人患有主动脉瓣狭窄,这是一种可能致命的心臟病。在主动脉瓣狭窄患者中,约有 19.9 万人(68%)患有重度主动脉瓣狭窄。 2024年,172,859名患有严重主动脉瓣狭窄的患者死亡。随着人口老化,英国人口对主动脉瓣狭窄治疗的需求也增加。此外,根据《欧洲心臟杂誌》的数据,2015年英国约有150万65岁以上人士患有心臟瓣膜疾病,包括主动脉瓣狭窄。预计到2046年,这一数字将翻一番,到2056年将达到330万,这可以归因于人口老化。
法国政府机构为提高公众对瓣膜置换手术的认识而采取的倡议,促进了市场成长。欧洲经皮心血管介入协会 (ECI) 发起了「生命瓣膜」(Valve for Life) 倡议,旨在弥补欧洲心臟瓣膜疾病护理的缺口。该倡议始于2015年,旨在弥补心臟瓣膜护理方面的资讯缺口,提高公众对心臟瓣膜疾病的认识,并促进更广泛地获得导管瓣膜介入治疗。其目标是透过动员医生、政策制定者和医疗机构参与,鼓励实施挽救生命的手术,到2020年将严重心臟瓣膜疾病的治疗率提高20%。该计画已在法国、波兰和葡萄牙试行,并显着提高了患者接受的挽救生命的干预措施的数量。
为了提高人们对心臟瓣膜疾病的认识,各组织正致力于提高公众意识并资助相关研究计画。 「心臟瓣膜之声」是英国致力于心臟瓣膜疾病的慈善机构。它与患者和临床医生合作,致力于提高人们对心臟瓣膜疾病的认识,并改善诊断和治疗。它汇集了一群拥有真实心臟瓣膜疾病经验的人士,包括该领域的多学科专家团队(心臟病专家和心臟外科医生)、心臟病患者协会以及患者。此外,英国心臟基金会也筹集资金,用于研究心臟和循环系统疾病(包括心臟瓣膜疾病)的治疗方法。
欧洲球囊主动脉瓣成形术市场收入及预测(2031 年)(百万美元)
欧洲球囊主动脉瓣成形术市场细分
欧洲球囊主动脉瓣成形术市场依产品类型和国家分类。
根据产品类型,欧洲球囊主动脉瓣成形术市场细分为非顺应性球囊和半顺应性球囊。非顺应性球囊在2023年占据了较大的市占率。
依国家/地区划分,欧洲球囊主动脉瓣成形术市场分为德国、英国、法国、义大利、西班牙和欧洲其他地区。 2023年,德国占据了欧洲球囊主动脉瓣成形术市场份额的主导地位。
B Braun SE;TT Medical, Inc.;Balton;Becton Dickinson and Co;Edwards Lifesciences Corp;Balt;杭州启蒙医疗科技有限公司;以及 OSYPKA 是欧洲球囊主动脉瓣成形术市场的一些领先公司。
The Europe balloon aortic valvuloplasty market was valued at US$ 50.34 million in 2023 and is expected to reach US$ 74.67 million by 2031; it is estimated to register a CAGR of 5.1% from 2023 to 2031.
Improvements in TAVI Combined with Research and Development Fuel Europe Balloon Aortic Valvuloplasty Market
TAVR was originally considered only for patients with severe aortic stenosis who were considered inoperable or at very high risk. However, continuous technological evolution in valve technology and the results of randomized trials have expanded its usage to younger and lower-risk patients, making it a mainstream treatment for aortic valve disease. With developments in valve production technologies, bioprosthetic heart valves are becoming more popular and applicable to younger and lower-risk patients. With its minimally invasive feature, a majority of valve replacements will soon be via TAVR. New-generation transcatheter heart valves have substantially improved procedural efficacy, safety, and patient outcomes, making TAVR an appealing option for different patient risk groups.
Predicting the performance of the heart valve upon implantation is critically important for a successful TAVR. It is desirable to mechanically assess selected heart valves before implantation to ensure proper valve function with minimal complications after implantation. A potential practical and effective solution for applying engineering analysis to the mechanical assessment of heart valves is incorporating deep learning (DL)-based systems to advance and simplify the computational biomechanical analyses relevant to TAVR. In recent years, immense developments in DL techniques have led to state-of-the-art performances in many computer vision tasks, including image classification, image segmentation, and object detection. DL has been extensively investigated for various cardiac imaging applications, including diagnostic, prognostic, risk stratification, and therapeutic/surgical treatment planning. Numerous studies have investigated DL approaches for assessing TAVR outcomes to predict postoperative complications and prosthetic valve defects.
Through continuous research and development, the future of TAVR promises breakthrough possibilities, further strengthening its place as a transformative therapy in cardiovascular medicine. Currently, only the Edwards SAPIEN 3 Ultra, Medtronic EVOLUT FX, and Abbott Navitor valves have been approved by the FDA. Although most of the clinical experience with TAVR is linked to the Edwards and Medtronic valve systems, the potential transcatheter heart valves lineup extends beyond these leaders, with as many as five to ten new TAVR valves in the development phase. A fourth transcatheter heart valve, the Boston Scientific Acurate-neo2 valve, was approved in 2020 in Europe; in a few places, it has accomplished its randomized clinical testing with 1,500 patients across all levels of risk. A fifth valve, the JenaValve (JenaValve Technology), is approved in the EU and has an advance-device designation and an investigational device exemption from the FDA; however, this valve is being developed mainly for patients with pure aortic regurgitation.
In addition to modifications to the valves that are already available, several valves are under development by companies worldwide, and these are expected to enhance deliverability, durability, and clinical outcomes in the years to come. The future of TAVR appears bright, with indications growing, procedural volumes soaring, and an increasing number of clinical sites offering the procedure, although long-term durability remains a key concern. The leaflets of currently available valves are derived from porcine or bovine pericardial tissue. New valve platforms incorporating creative leaflet materials and other design innovations are being developed to increase long-term durability. Some new trials promise to offer crucial guidance for TAVR operators seeking to offer long-term solutions. The SMART (i.e., Small Annuli Randomized to Evolut or SAPIEN) trial is the first randomized industry-sponsored (Medtronic) head-to-head comparison of the two most commonly used TAVR devices: SAPIEN 3 and Evolut in small anatomies. The trial was conducted at 83 international sites in North America, Europe, and the Middle East & Africa. The trial enrolled 716 participants with a small aortic annulus (aortic annulus area of 430 mm2 or less based on multi-detector computed tomography) and symptomatic severe native aortic stenosis. In April 2024, the American College of Cardiology announced that findings from the SMART trial demonstrated that patients with a small aortic annulus who underwent TAVR with Evolut valve had similar clinical outcomes and superior valve performance at one year compared with patients who underwent TAVR with SAPIEN 3 valve. Researchers said the results are encouraging in terms of the clinical outcomes of both valve types. They noted that further trials could help shed light on whether TAVR offers an early advantage that is sustained with time and which of the current and upcoming transcatheter heart valves offer the best results. Researchers will continue to track outcomes over the next five years. Thus, the research and development activities focused on improving TAVI procedures are likely to bring in new trends in the balloon aortic valvuloplasty market.
Europe Balloon Aortic Valvuloplasty Market Overview
The Europe balloon aortic valvuloplasty market growth is associated with the rising prevalence of valvular diseases and the growing preference for minimally invasive surgeries. Cardiovascular diseases continue to increase and are still among the leading causes of death in Germany. The incidence of heart valve disease progresses immensely with age. Aortic stenosis is a common valvular heart disease with a dismal prognosis when untreated. TAVI or SAVR is recommended in such conditions. TAVI is a standard treatment for aortic valve stenosis in the country.
As per a study titled "Healthcare provision of transcatheter aortic valve implantation in Germany," published in 2023, a total of 26,506 TAVI procedures were performed in 2021. Compared to 2021, an increase of 4,673 TAVI procedures is to be expected by 2035. Moreover, based on a longtime voluntary registry founded by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS) in 1980, well-defined data of all thoracic, cardiac, and vascular surgical procedures performed in 78 German heart surgery departments during 2022 were analyzed. A total of 93,913 heart surgical procedures were performed in 2022. Of these, 38,492 heart valve procedures were performed, including 14,852 isolated heart valve procedures performed as single, 2,880 as double, and 296 as triple valve procedures. In addition, about 20,272 transcatheter heart valve procedures were carried out. Focusing on the distribution of aortic valve procedures for 2022, 17,818 TAVI and 7,798 SAVRs were reported to the registry.
The FRANCE-TAVI Registry published an updated report of trends and evolution of TAVR in the French cohort in 2022. About 85,000 patients were enrolled, with an average age of 83 years. The number of procedures increased from 1,556 in 2010 to 14,114 in 2021. In addition, the use of TAVR was mainly restricted to those at high risk and remained uncommon in young patients in the country. According to the "Association of Age and Sex with Use of Transcatheter Aortic Valve Replacement in France," published in 2023, a total of 107,397 patients underwent an isolated aortic valve replacement (59.1% TAVR, 40.9% SAVR). In patients aged 65 years and above, the proportion of TAVR increased by 63.2% from 2015 to 2020. With a rising aging population, the prevalence of valvular heart disease is projected to surge.
The balloon aortic valvuloplasty market in the UK is likely to grow due to the rising number of people suffering from valvular diseases and the increasing geriatric population who are more susceptible to valvular diseases. According to a study published by Age UK-a registered charity in the UK-in 2020, there were nearly 12 million people aged 65 and above in the UK. It is estimated that the number of centenarians living in the UK will be 21,000 or more, and one in five people will be aged 65 and above by 2030. As per the research study titled "Uncovering the treatable burden of severe aortic stenosis in the UK," published in 2021 in the open-access journal Open Heart, ~300,000 people have aortic valve stenosis, a potentially deadly heart condition in the UK. Of the people with aortic stenosis, ~199,000 (68%) had severe aortic stenosis disease. 172,859 of these patients with severe aortic stenosis succumbed to death in 2024. The UK population's need for treatment of aortic stenosis rises as the population ages. Moreover, according to the European Heart Journal, about 1.5 million people in the UK aged 65 or over suffered from heart valve disease, including aortic stenosis, in 2015. The number is projected to double by 2046 and reach 3.3 million by 2056, which can be attributed to the aging population.
Initiatives undertaken by French government organizations to enhance awareness regarding valve replacement surgeries support market growth. The European Association of Percutaneous Cardiovascular Interventions launched the Valve for Life initiative to address the gap in heart valve disease care in Europe. It started in 2015 with the intention of addressing information gaps in heart valve care, increasing public awareness of heart valve disease, and facilitating better access to catheter-based valve interventions. The goal was to achieve a 20% improvement in the treatment of severe heart valve disease in 2020 by involving doctors, policymakers, and healthcare authorities to encourage the implementation of life-saving procedures. The program was trialed in France, Poland, and Portugal, where it led to a measurable increase in life-saving interventions for patients.
In order to raise understanding of heart valvular disease, various organizations are working toward making people more aware and funding research projects. Heart Valve Voice is a UK-dedicated heart valve disease charity. It works with patients and clinicians to improve people's awareness regarding heart valve disease and enhance diagnosis and treatment. It is a collection of people with real experiences of heart valve disease, including a multi-disciplinary group of experts in the field (cardiologists and cardiac surgeons), cardiac patient societies, and patients. Additionally, the British Heart Foundation raises funds to research cures and treatments for heart and circulatory diseases, including heart valve disease.
Europe Balloon Aortic Valvuloplasty Market Revenue and Forecast to 2031 (US$ Million)
Europe Balloon Aortic Valvuloplasty Market Segmentation
The Europe balloon aortic valvuloplasty market is categorized into product type and country.
Based on product type, the Europe balloon aortic valvuloplasty market is segmented into non compliant balloons and semi compliant balloons. The non compliant balloons segment held a larger market share in 2023.
By country, the Europe balloon aortic valvuloplasty market is segmented into Germany, the UK, France, Italy, Spain, and the Rest of Europe. Germany dominated the Europe balloon aortic valvuloplasty market share in 2023.
B Braun SE; TT Medical, Inc.; Balton; Becton Dickinson and Co; Edwards Lifesciences Corp; Balt; Venus MedTech HangZhou Inc; and OSYPKA are some of the leading companies operating in the Europe balloon aortic valvuloplasty market.