![]() |
市場調查報告書
商品編碼
1765033
2031年亞太地區球囊主動脈瓣成形術市場預測 - 區域分析 - 依產品類型(非順應性球囊和半順應性球囊)Asia Pacific Balloon Aortic Valvuloplasty Market Forecast to 2031 - Regional Analysis - by Product Type (Non Compliant Balloons and Semi Compliant Balloons) |
2023 年亞太地區球囊主動脈瓣成形術市場價值為 4,205 萬美元,預計到 2031 年將達到 6,916 萬美元;預計 2023 年至 2031 年的複合年成長率為 6.4%。
主動脈瓣狹窄盛行率上升推動亞太地區球囊主動脈瓣成形術市場
心臟瓣膜疾病 (HVD) 是一種心臟缺陷,其與功能衰退的關聯日益密切,尤其是在老年人群體中。 HVD 可導致四個瓣膜中的任何一個發生狹窄、逆流或兩者兼而有之。隨著 HVD 的發病率隨著年齡成長而顯著上升,預計未來幾年全球將有數百萬人受到影響。
主動脈狹窄會導致血液難以從心臟流向身體各部位,進而導致一種稱為主動脈瓣狹窄的疾病。由於心臟在通過收縮的主動脈泵血時承受相當大的壓力,導致呼吸急促、胸痛和疲勞等症狀。高風險患者族群無法進行手術,也無法接受主動脈瓣置換術。根據2020年2月發表的題為《主動脈瓣狹窄和主動脈瓣關閉不全(AI)的流行病學》的研究,一項在歐洲、美國和台灣進行的薈萃分析發現,在75歲及以上患者中,主動脈瓣狹窄的患病率為12.4%,重度主動脈瓣狹窄的患病率為3.4%。主動脈瓣狹窄的盛行率隨年齡呈指數成長,50-59歲族群的盛行率為0.2%,60-69歲族群的盛行率為1.3%,70-79歲族群的盛行率為3.9%,80-89歲族群的盛行率為9.8%。主動脈瓣狹窄的高盛行率使得球囊主動脈瓣成形術(BAV)的需求激增。 BAV比傳統的開胸心臟外科手術創傷更小,因此對患者來說是一個更具吸引力的選擇。
2021年澳洲國家迴聲資料庫資料顯示,97,379名澳洲人患有嚴重主動脈瓣狹窄。預計2031年,澳洲中度至重度主動脈瓣狹窄病例將增加至20萬例,2051年將增加至26.6萬例。
同樣,印度也飽受主動脈瓣狹窄的困擾。過去十年來,該國因鈣化性主動脈瓣疾病死亡的人數顯著增加。經導管主動脈瓣植入術 (TAVI),也稱為經導管主動脈瓣置換術 (TAVR),已成為治療嚴重主動脈瓣狹窄的成熟方法。球囊主動脈瓣置換術 (BAV) 是 TAVI 過程中至關重要的手術步驟,用於預先擴張瓣膜以增強經導管輸送。 TAVI 已成為傳統開胸心臟外科手術的一種突破性微創替代方案,主要針對因嚴重主動脈瓣狹窄而最初被認為不適合手術干預的老年患者。因此,全球主動脈瓣狹窄盛行率的不斷上升推動了球囊主動脈瓣成形術市場的成長。
亞太地區球囊主動脈瓣成形術市場概況
十多年前,TAVI 僅在少數幾家醫療中心開展,如今已在東北亞、東南亞和印度次大陸約 260 家醫療中心開展。隨著亞洲人口老化,TAVI 的需求也將同步成長。根據 2022 年 5 月發表的一項名為《中國中危患者經導管主動脈瓣置換術與外科主動脈瓣置換術的經濟性評估》的研究,65 歲以下患者的主動脈瓣狹窄盛行率為 0.16%,65-74 歲和 75 歲以上患者的盛行率分別為 0.41% 和 0.56%。根據美國國家生物技術資訊中心2022年8月發表的《中國經導管主動脈瓣置換術的現況》研究顯示,2022年全國經導管主動脈瓣置換術患者中,TAVR裝置置入手術成功率為97.85%。
根據2020年日本循環學會官方期刊《循環報告》,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議,對於年齡<75歲的患者,進行外科主動脈瓣置換術(SAVR),對於年齡>80歲的患者,進行TAVI,無論手術存在何種風險。
2021年澳洲國家迴聲資料庫資料顯示,97,379名澳洲人患有重度主動脈瓣狹窄。預計2031年,澳洲中度至重度主動脈瓣狹窄病例將增加至20萬例,2051年將增加至26.6萬例。主動脈瓣狹窄盛行率的不斷上升,導致對球囊主動脈瓣成形術(BAV)的需求激增,因為BAV是一種用於治療主動脈瓣狹窄的微創手術。此外,2022年發表在PubMed的文章《2004年至2019年澳洲主動脈瓣置換率》指出,2019年澳洲進行了約2683例TAVI手術,較2014年年增52%。 BAV從2004年的66例增加到2019年的862例。在過去16年中,主動脈瓣置換率顯著上升,尤其是在老年族群。
此外,印度、中國和馬來西亞蓬勃發展的醫療旅遊業吸引了世界各地的心臟病患者前來治療,促進了市場成長。儘管醫療費用對許多人來說可能是個大問題,但令人欣慰的是,與許多西方國家相比,印度提供的TAVI手術更具成本效益。印度TAVI的成本效益絲毫不會影響醫療質量,因為該國擁有一些全球最熟練、最有經驗的心臟科醫生和最先進的醫療設施。隨著醫療領域的進步,印度致力於提供負擔得起的醫療保健選擇,確保全球患者都能獲得包括TAVI在內的尖端治療。
隨著技術進步,市場參與者提供更多設備替代方案,TAVR 手術的可近性將顯著提升。 Edwards Lifesciences Corp. 的 Edwards Sapien 3 TAVR 系統於 2020 年 6 月獲得中國監管機構批准,用於治療患有嚴重、有症狀的主動脈瓣狹窄、患主動脈瓣狹窄風險較高或無法接受開胸心臟外科手術的患者。這項批准對於該國醫生及其患有嚴重主動脈瓣狹窄且需要開胸心臟外科手術替代方案的患者而言,這是一個重要的里程碑。此外,2024 年 4 月,泰國領先的醫療機構詩里拉吉醫院 (Siriraj Hospital) 憑藉 TAVI 手術,在主動脈瓣疾病治療領域處於領先地位。與開胸心臟外科手術相比,這種微創手術減少了手術創傷並縮短了術後恢復時間,為高風險患者提供了可行的治療方案。 2010 年,詩里拉吉醫院成為泰國第一家為無法接受 SAVR 的患者引入 TAVI 手術的醫院。該醫院目前為 SAVR 中度風險患者和 80 歲以上患者提供 TAVI 作為治療選擇。
2021年,中國經導管瓣膜治療和神經介入手術醫療器材市場的領導企業沛嘉醫療,在獲得中國監管部門批准後,推出了其第二代TaurusElite經導管主動脈瓣置換術(TAVR)系統。此外,2022年1月,JenaValve Technology, Inc.宣布與中國沛嘉醫療有限公司達成策略性投資及獨家技術授權協議。根據協議條款,沛嘉醫療獲得在大中華區開發和商業化JenaValve Trilogy經導管主動脈瓣置換術(TAVR)系統的獨家權利,用於治療重度症狀性主動脈瓣反流或症狀性主動脈瓣狹窄患者。 2021年,公司啟動了第三代TAVR系統的臨床試驗。 2023年7月,沛嘉醫療在該TAVR系統的多中心臨床試驗中招募了首位華人患者。除Sapien 3外,中國監管機構還批准了三種國產瓣膜:Venus-A瓣膜(啟明星醫療)、J-Valve瓣膜(捷成醫療)和MicroPort VitaFlow瓣膜(微創醫療)。印度目前有兩種國產瓣膜:MyVal(Meril Life Sciences Pvt Ltd生產的球囊擴張系統)和Hydra(Vascular Innovations Co Ltd生產的自擴張系統)。因此,這些國產瓣膜的核准促進了兩國TAVI(經導管主動脈瓣置換術)的快速發展。 TAVI已成為傳統開胸心臟外科手術的一種突破性微創選擇,主要用於因嚴重主動脈瓣狹窄而不適合外科手術的老年患者。
亞太地區球囊主動脈瓣成形術市場收入及預測(2031 年)(百萬美元)
亞太地區球囊主動脈瓣成形術市場細分
亞太地區球囊主動脈瓣成形術市場依產品類型和國家分類。
根據產品類型,亞太地區球囊主動脈瓣成形術市場細分為非順應性球囊和半順應性球囊。 2023年,非順應性球囊佔了較大的市佔率。
依國家/地區分類,亞太地區球囊主動脈瓣成形術市場分為中國、日本、印度、韓國、澳洲和亞太其他地區。 2023年,中國佔據了亞太地區球囊主動脈瓣成形術市場佔有率的主導地位。
B Braun SE;TT Medical, Inc.;Balton;Becton Dickinson and Co;Edwards Lifesciences Corp;Balt;以及杭州啟明醫療科技有限公司是亞太地區球囊主動脈瓣成形術市場的一些領先公司。
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.