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市场调查报告书
商品编码
1765033
2031年亚太地区球囊主动脉瓣成形术市场预测 - 区域分析 - 依产品类型(非顺应性球囊和半顺应性球囊)Asia Pacific Balloon Aortic Valvuloplasty Market Forecast to 2031 - Regional Analysis - by Product Type (Non Compliant Balloons and Semi Compliant Balloons) |
2023 年亚太地区球囊主动脉瓣成形术市场价值为 4,205 万美元,预计到 2031 年将达到 6,916 万美元;预计 2023 年至 2031 年的复合年增长率为 6.4%。
主动脉瓣狭窄盛行率上升推动亚太地区球囊主动脉瓣成形术市场
心臟瓣膜疾病 (HVD) 是一种心臟缺陷,其与功能衰退的关联日益密切,尤其是在老年人群体中。 HVD 可导致四个瓣膜中的任何一个发生狭窄、逆流或两者兼而有之。随着 HVD 的发病率随着年龄增长而显着上升,预计未来几年全球将有数百万人受到影响。
主动脉狭窄会导致血液难以从心臟流向身体各部位,进而导致一种称为主动脉瓣狭窄的疾病。由于心臟在通过收缩的主动脉泵血时承受相当大的压力,导致呼吸急促、胸痛和疲劳等症状。高风险患者族群无法进行手术,也无法接受主动脉瓣置换术。根据2020年2月发表的题为《主动脉瓣狭窄和主动脉瓣关闭不全(AI)的流行病学》的研究,一项在欧洲、美国和台湾进行的荟萃分析发现,在75岁及以上患者中,主动脉瓣狭窄的患病率为12.4%,重度主动脉瓣狭窄的患病率为3.4%。主动脉瓣狭窄的盛行率随年龄呈指数成长,50-59岁族群的盛行率为0.2%,60-69岁族群的盛行率为1.3%,70-79岁族群的盛行率为3.9%,80-89岁族群的盛行率为9.8%。主动脉瓣狭窄的高盛行率使得球囊主动脉瓣成形术(BAV)的需求激增。 BAV比传统的开胸心臟外科手术创伤更小,因此对患者来说是一个更具吸引力的选择。
2021年澳洲国家迴声资料库资料显示,97,379名澳洲人患有严重主动脉瓣狭窄。预计2031年,澳洲中度至重度主动脉瓣狭窄病例将增加至20万例,2051年将增加至26.6万例。
同样,印度也饱受主动脉瓣狭窄的困扰。过去十年来,该国因钙化性主动脉瓣疾病死亡的人数显着增加。经导管主动脉瓣植入术 (TAVI),也称为经导管主动脉瓣置换术 (TAVR),已成为治疗严重主动脉瓣狭窄的成熟方法。球囊主动脉瓣置换术 (BAV) 是 TAVI 过程中至关重要的手术步骤,用于预先扩张瓣膜以增强经导管输送。 TAVI 已成为传统开胸心臟外科手术的一种突破性微创替代方案,主要针对因严重主动脉瓣狭窄而最初被认为不适合手术干预的老年患者。因此,全球主动脉瓣狭窄盛行率的不断上升推动了球囊主动脉瓣成形术市场的成长。
亚太地区球囊主动脉瓣成形术市场概况
十多年前,TAVI 仅在少数几家医疗中心开展,如今已在东北亚、东南亚和印度次大陆约 260 家医疗中心开展。随着亚洲人口老化,TAVI 的需求也将同步成长。根据 2022 年 5 月发表的一项名为《中国中危患者经导管主动脉瓣置换术与外科主动脉瓣置换术的经济性评估》的研究,65 岁以下患者的主动脉瓣狭窄盛行率为 0.16%,65-74 岁和 75 岁以上患者的盛行率分别为 0.41% 和 0.56%。根据美国国家生物技术资讯中心2022年8月发表的《中国经导管主动脉瓣置换术的现况》研究显示,2022年全国经导管主动脉瓣置换术患者中,TAVR装置置入手术成功率为97.85%。
根据2020年日本循环学会官方期刊《循环报告》,TAVI自2013年10月起在日本投入使用。最新的心臟瓣膜疾病管理指南建议,对于年龄<75岁的患者,进行外科主动脉瓣置换术(SAVR),对于年龄>80岁的患者,进行TAVI,无论手术存在何种风险。
2021年澳洲国家迴声资料库资料显示,97,379名澳洲人患有重度主动脉瓣狭窄。预计2031年,澳洲中度至重度主动脉瓣狭窄病例将增加至20万例,2051年将增加至26.6万例。主动脉瓣狭窄盛行率的不断上升,导致对球囊主动脉瓣成形术(BAV)的需求激增,因为BAV是一种用于治疗主动脉瓣狭窄的微创手术。此外,2022年发表在PubMed的文章《2004年至2019年澳洲主动脉瓣置换率》指出,2019年澳洲进行了约2683例TAVI手术,较2014年年增52%。 BAV从2004年的66例增加到2019年的862例。在过去16年中,主动脉瓣置换率显着上升,尤其是在老年族群。
此外,印度、中国和马来西亚蓬勃发展的医疗旅游业吸引了世界各地的心臟病患者前来治疗,促进了市场成长。儘管医疗费用对许多人来说可能是个大问题,但令人欣慰的是,与许多西方国家相比,印度提供的TAVI手术更具成本效益。印度TAVI的成本效益丝毫不会影响医疗质量,因为该国拥有一些全球最熟练、最有经验的心臟科医生和最先进的医疗设施。随着医疗领域的进步,印度致力于提供负担得起的医疗保健选择,确保全球患者都能获得包括TAVI在内的尖端治疗。
随着技术进步,市场参与者提供更多设备替代方案,TAVR 手术的可近性将显着提升。 Edwards Lifesciences Corp. 的 Edwards Sapien 3 TAVR 系统于 2020 年 6 月获得中国监管机构批准,用于治疗患有严重、有症状的主动脉瓣狭窄、患主动脉瓣狭窄风险较高或无法接受开胸心臟外科手术的患者。这项批准对于该国医生及其患有严重主动脉瓣狭窄且需要开胸心臟外科手术替代方案的患者而言,这是一个重要的里程碑。此外,2024 年 4 月,泰国领先的医疗机构诗里拉吉医院 (Siriraj Hospital) 凭藉 TAVI 手术,在主动脉瓣疾病治疗领域处于领先地位。与开胸心臟外科手术相比,这种微创手术减少了手术创伤并缩短了术后恢復时间,为高风险患者提供了可行的治疗方案。 2010 年,诗里拉吉医院成为泰国第一家为无法接受 SAVR 的患者引入 TAVI 手术的医院。该医院目前为 SAVR 中度风险患者和 80 岁以上患者提供 TAVI 作为治疗选择。
2021年,中国经导管瓣膜治疗和神经介入手术医疗器材市场的领导企业沛嘉医疗,在获得中国监管部门批准后,推出了其第二代TaurusElite经导管主动脉瓣置换术(TAVR)系统。此外,2022年1月,JenaValve Technology, Inc.宣布与中国沛嘉医疗有限公司达成策略性投资及独家技术授权协议。根据协议条款,沛嘉医疗获得在大中华区开发和商业化JenaValve Trilogy经导管主动脉瓣置换术(TAVR)系统的独家权利,用于治疗重度症状性主动脉瓣反流或症状性主动脉瓣狭窄患者。 2021年,公司启动了第三代TAVR系统的临床试验。 2023年7月,沛嘉医疗在该TAVR系统的多中心临床试验中招募了首位华人患者。除Sapien 3外,中国监管机构还批准了三种国产瓣膜:Venus-A瓣膜(启明星医疗)、J-Valve瓣膜(捷成医疗)和MicroPort VitaFlow瓣膜(微创医疗)。印度目前有两种国产瓣膜:MyVal(Meril Life Sciences Pvt Ltd生产的球囊扩张系统)和Hydra(Vascular Innovations Co Ltd生产的自扩张系统)。因此,这些国产瓣膜的核准促进了两国TAVI(经导管主动脉瓣置换术)的快速发展。 TAVI已成为传统开胸心臟外科手术的一种突破性微创选择,主要用于因严重主动脉瓣狭窄而不适合外科手术的老年患者。
亚太地区球囊主动脉瓣成形术市场收入及预测(2031 年)(百万美元)
亚太地区球囊主动脉瓣成形术市场细分
亚太地区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,亚太地区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。 2023年,非顺应性球囊占了较大的市占率。
依国家/地区划分,亚太地区球囊主动脉瓣成形术市场分为中国、日本、印度、韩国、澳洲和亚太其他地区。 2023年,中国占据了亚太地区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;以及杭州启明医疗科技有限公司是亚太地区球囊主动脉瓣成形术市场的一些领先公司。
The Asia Pacific balloon aortic valvuloplasty market was valued at US$ 42.05 million in 2023 and is expected to reach US$ 69.16 million by 2031; it is estimated to register a CAGR of 6.4% from 2023 to 2031.
Rising Prevalence of Aortic Valve Stenosis Drives Asia Pacific Balloon Aortic Valvuloplasty Market
Heart valve disease (HVD) is a cardiac defect increasingly linked to functional decline, especially in aging individuals. HVD can cause stenosis, regurgitation, or a combination of the two in any of the four valves. As the incidence of HVD prominently increases with aging, it is estimated to affect millions globally in the upcoming years.
The narrowing of the aorta can make it difficult for blood to flow from the heart to various parts of the body, resulting in a condition called aortic stenosis. As the heart is under considerable pressure while pumping blood through the constricted aorta, it leads to symptoms such as shortness of breath, chest pain, and fatigue. The high-risk patient populations are inoperable and cannot undergo surgical aortic valve replacement procedures. As per the study titled "Epidemiology of aortic valve stenosis and of aortic valve incompetence (AI)," published in February 2020, a meta-analysis conducted in Europe, the US, and Taiwan found that aortic stenosis had a prevalence rate of 12.4% and severe aortic stenosis reported prevalence rate of 3.4% in patients aged 75 years and over. Aortic stenosis prevalence exponential increases with age, displaying 0.2% in people aged 50-59 years, 1.3% in the 60-69 year group, 3.9% in the 70-79 year group, and 9.8% in people aged 80-89 years. The high prevalence of aortic valve stenosis is surging the demand for balloon aortic valvuloplasty (BAV) devices. BAV is less invasive than conventional open-heart surgery, making it a more attractive option for patients.
The National Echo Database of Australia data 2021 reveals that 97,379 Australians suffered from severe aortic stenosis. The number of moderate to severe aortic stenosis cases in Australia is estimated to grow to 200,000 patients in 2031 and 266,000 by 2051.
Similarly, India is also overburdened with aortic stenosis. The number of fatalities due to calcific aortic valve disease has increased significantly over the past decade in the country. Transcatheter aortic valve implantation (TAVI), also called transcatheter aortic valve replacement (TAVR), has become a well-established therapeutic option for severe aortic stenosis. BAV is a crucial procedural step during TAVI to predilate the valve in order to enhance transcatheter delivery. TAVI has emerged as a ground-breaking, minimally invasive alternative to traditional open-heart surgery, primarily designed for aged patients initially considered unsuitable for surgical intervention due to severe aortic stenosis. Thus, the growing prevalence of aortic valve stenosis worldwide drives the balloon aortic valvuloplasty market growth.
Asia Pacific Balloon Aortic Valvuloplasty Market Overview
From a few centers over a decade ago, TAVI is now performed in about 260 centers throughout Northeast Asia, Southeast Asia, and the Indian subcontinent. As the population in Asia advances in age, the demand for TAVI is poised to increase simultaneously. As per a study, "Economic Evaluation of Transcatheter Aortic Valve Replacement Compared to Surgical Aortic Valve Replacement in Chinese Intermediate-Risk Patients," published in May 2022, the prevalence of aortic stenosis was 0.16% in patients younger than 65 years and 0.41% and 0.56% in people aged 65-74 and above 75 years, respectively. According to the study "The current practice of transcatheter aortic valve replacement in China," published in the National Center for Biotechnology Information in August 2022, TAVR device implementation procedures were successful in 97.85% of patients who underwent transcatheter aortic valve replacement procedures in the country in 2022.
According to the Circulation Report from the Official Journal of the Japanese Circulation Society published in 2020, TAVI has been available in Japan since October 2013. The latest guideline on managing valvular heart disease recommends surgical aortic valve replacement (SAVR) for patients aged <75 years and TAVI for patients aged >80 years, regardless of the risks associated with the surgery.
The National Echo Database of Australia data 2021 revealed that 97,379 Australians suffered from severe aortic stenosis. The number of moderate to severe aortic stenosis cases in Australia is estimated to grow to 200,000 patients in 2031 and 266,000 by 2051. The growing prevalence of aortic valve stenosis is surging the demand for balloon aortic valvuloplasty (BAV) devices, as BAV is a minimally invasive procedure utilized to treat aortic valve stenosis. In addition, as stated in the article "Aortic valve replacement rates in Australia from 2004 to 2019," published in PubMed in 2022, about 2,683 TAVI procedures were performed in 2019 in Australia, representing a 52% annual increase from 2014. BAV increased from 66 procedures in 2004 to 862 in 2019. Rates of aortic valve replacements have increased significantly over the past 16 years, especially in older people.
Further, the thriving medical tourism industry in India, China, and Malaysia attracts heart patients worldwide for treatment, facilitating the market growth. Although the cost of medical treatments can be a significant issue for many individuals, it is reassuring that India offers cost-effective TAVI procedures compared to many Western countries. The cost-effectiveness of TAVI in the country does not compromise the quality of care, as the country boasts some of the world's most skilled and experienced cardiac specialists and state-of-the-art medical facilities. As the medical field progresses, India's commitment to providing affordable healthcare options ensures that patients globally can access cutting-edge treatments, including TAVI.
As market players offer more device alternatives due to advancements in technology, access to TAVR procedures will increase significantly. Edwards Lifesciences Corp. received Chinese regulatory approval for the Edwards Sapien 3 TAVR system in June 2020 to treat patients suffering from severe, symptomatic aortic stenosis or are at high risk for developing aortic stenosis or unable to undergo open-heart surgery. The approval marked a significant milestone for the country's physicians and their patients living with severe aortic stenosis in need of alternatives to open-heart surgery. Additionally, in April 2024, Siriraj Hospital, a leading healthcare institution in Thailand, stood at the forefront of aortic valve disease treatment with TAVI. The minimally invasive procedure reduces surgical trauma and post-surgery recovery time when compared to open-heart surgery, providing a viable option for high-risk patients. In 2010, Siriraj Hospital was the first hospital in Thailand to introduce the TAVI procedure for patients who were unable to receive a SAVR. The hospital now provides TAVI as a treatment option for patients with intermediate risks for SAVR and patients aged over 80 years.
In 2021, Peijia Medical, a leading Chinese player in the transcatheter valve therapeutic and neuro-interventional procedural medical device market, launched its second-generation TaurusElite TAVR system after obtaining regulatory approval in China. Additionally, in January 2022, JenaValve Technology, Inc. announced a strategic investment and exclusive technology licensing agreement with Peijia Medical Limited in China. Under the terms of the agreement, Peijia obtained exclusive rights to develop and commercialize JenaValve's Trilogy TAVR system in the Greater China region to treat patients with severe symptomatic aortic regurgitation or symptomatic aortic stenosis. In 2021, the company started clinical trials for its third-generation TAVR system. In July 2023, Peijia Medical enrolled the first Chinese patient in its multicenter clinical trial for these TAVR systems. Apart from the Sapien 3, the Chinese regulatory has approved three locally manufactured valves: the Venus-A valve (Venus MedTech), J-Valve (Jie Cheng Medical Technologies), and MicroPort VitaFlow valve (MicroPort Medical). Two indigenous valves are available in India: MyVal (a balloon-expandable system from Meril Life Sciences Pvt Ltd) and Hydra (a self-expanding system from Vascular Innovations Co Ltd). Thus, the approval of these domestic valves promoted the rapid development of TAVI in both countries. TAVI has emerged as a ground?breaking, minimally invasive choice to traditional open?heart surgery, primarily designed for aged patients who were considered unsuitable for surgical intervention due to severe aortic stenosis.
Asia Pacific Balloon Aortic Valvuloplasty Market Revenue and Forecast to 2031 (US$ Million)
Asia Pacific Balloon Aortic Valvuloplasty Market Segmentation
The Asia Pacific balloon aortic valvuloplasty market is categorized into product type and country.
Based on product type, the Asia Pacific 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 Asia Pacific balloon aortic valvuloplasty market is segmented into China, Japan, India, South Korea, Australia, and the Rest of Asia Pacific. China dominated the Asia Pacific balloon aortic valvuloplasty market share in 2023.
B Braun SE; TT Medical, Inc.; Balton; Becton Dickinson and Co; Edwards Lifesciences Corp; Balt; and Venus MedTech HangZhou Inc are some of the leading companies operating in the Asia Pacific balloon aortic valvuloplasty market.