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全球介入性心臟病学市场 - 2024-2031Global Interventional Cardiology Market - 2024-2031 |
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市场规模
2023年,全球介入性心臟病学市场规模达到144.7亿美元,预计到2031年将达到286.7亿美元,2024-2031年预测期间复合年增长率为9.1%。
根据美国医学会的规定,介入性心臟病学是心臟病学中的一个医学分支,它藉助专门的影像和其他诊断技术来评估冠状动脉和心室的血流和压力,也涉及所使用的技术程序和药物对于那些损害心血管系统功能的异常。
介入性心臟病学市场动态
心血管疾病病例的不断增加、老年人口、生活方式的改变以及人们对心血管疾病的认识不断提高,正在推动全球介入性心臟病学市场的成长。
新产品的推出将在预测期内推动全球介入性心臟病学市场的发展。
新产品的推出推动了全球介入性心臟病学市场的成长。例如,2021 年 6 月,美国食品药物管理局批准雅培的 XIENCE 系列支架用于美国高出血风险 (HBR) 患者的为期一个月的双抗血小板治疗 (DAPT)。同样,2020 年 5 月,飞利浦影像导引治疗公司的 Reconnaissance PV .018 OTW 数位 IVUS 导管获得美国 FDA 510 (K) 批准。同样,2021 年3 月,美敦力(Medtronic) 的Harmony 经导管肺动脉瓣(TPV) 获得美国食品和药物管理局的产品批准,这是首个用于治疗典型右心先天性心臟病患者的微创疗法。
此外,2021 年 6 月,雅培的 Amplatzer Piccolo 封堵器在印度推出。它是世界上第一个透过微创手术植入最小婴儿(重量仅 700 克)的医疗设备,用于治疗动脉导管未闭 (PDA)。此外,2021年7月,私人医疗技术公司MedAlliance推出了两款高性能球囊ORIGIN SC和ORIGIN NC,用于为患有危及生命的冠状动脉和周边动脉疾病的患者进行血管准备。因此,新产品的推出将在预测期内推动全球介入性心臟病学市场。
严格的法规和高昂的成本阻碍了全球介入性心臟病学市场的成长。
然而,心臟病介入的高昂成本和严格的监管将在预测期内阻碍全球介入心臟病学市场。例如,美国 FDA 正在修订两份针对发明新型冠状动脉、週边血管和神经血管导丝的供应商的指导文件。 FDA 于 2018 年 6 月报告了该文件草案,但尚未收集对其中一份文件的评论。这些文件预计将涵盖性能测试、推荐标籤和润滑涂层,这将为行业和FDA 工作人员提供关于评估上市前批准申请(PMA)中提交的导管、导丝和输送系统性能的最不严格的方法的建议。此外,慢性完全阻塞的经皮冠状动脉介入治疗的平均成本为 14,946 ± 7,699 美元,使得大多数人无法进行手术,从而减缓了预测期内全球介入心臟病学市场的成长。
COVID-19 大流行损害了全球介入性心臟病学市场,因为在大流行期间,介入性心臟病学手术大幅下滑。例如,英国心血管介入学会对大流行封锁期间在英国进行的所有经皮冠状动脉介入治疗 (PCI) 进行了回顾性分析,并与大流行前时期的 PCI 数量进行了比较。
回顾性分析得出的结论是,PCI 减少了 49%,其中稳定型心绞痛受影响最严重,减少了 66%,而 ST 段抬高型心肌梗塞 (STEMI) 的 PCI 减少了 33%。此外,疫情改变了人们对健康生活方式选择的看法,导致心血管疾病病例减少,从而对全球介入性心臟病学产生了负面影响。
介入性心臟病学市场細項分析
预计在预测期内(2024-2031 年)支架的需求量将会很大。
由于全球介入性心臟病学市场的新推出和产品批准,预计在预测期内(2024-2031年),支架将主导全球介入心臟病学市场。例如,2021年8月,SINOMED与爱尔兰国立戈尔韦大学(NUI Galway)合作,在欧洲推出了HT Supreme涂药支架(DES),并在戈尔韦大学医院进行了首次商业植入。同样,2022 年 5 月,美国食品药物管理局 (FDA) 批准了美敦力公司的 Onyx Frontier 药物洗脱支架 (DES)。 Onyx Frontier DES 利用与 Resolute Onyx DES 相同的支架平台以及增强的输送系统。
同样,2021 年 1 月,FDA 批准了 Boston Scientific 的 Synergy Megatron 药物洗脱支架,旨在治疗主动脉附近的大近端支架。此外,2021 年 5 月,Alvimedica 的一种新型无聚合物自膨式 Amphilimus 洗脱支架 NiTiDES 获得了 CE 标誌,该支架用于治疗股浅动脉 (SFA) 病变。因此,从上述资料来看,预计支架将在整个预测期内主导全球介入性心臟病学市场。
介入性心臟病学市场地域份额
预计北美将主导全球介入性心臟病学市场。
由于心血管疾病病例的增加以及该地区主要市场参与者的存在,预计北美在预测期内(2023-2031年)将拥有一个巨大的市场。根据 CDC 统计,每 34 秒就有一名美国人死于心血管疾病。 2020年,心血管疾病导致超过697,000人死亡。此外,雅培、爱德华兹生命科学公司、波士顿科学公司、强生、美敦力和库克医疗公司等主要市场参与者的存在,透过不同的市场策略占据了全球介入性心臟病学市场的大量份额。该地区在全球介入性心臟病学市场的主导地位。例如,2021 年 9 月,雅培收购了 Walk Vascular, LLC,这是一家商业阶段的医疗器材公司,拥有微创机械抽吸血栓切除系统,旨在清除週边血块。
同样,2022 年 8 月,GE 医疗保健与波士顿科学公司合作,在印度提供创新的介入性心臟护理解决方案。此外,2022 年 1 月,美敦力收购了 Affero,扩大了美敦力的心臟消融产品组合。此外,2021 年 11 月,美敦力在印度推出了 Arctic Front 先进心臟冷冻消融导管技术,用于治疗心房颤动。因此,资料显示北美将在整个预测期内主导全球介入性心臟病学市场。
介入性心臟病学市场竞争格局
全球介入性心臟病学市场主要参与者包括雅培、波士顿科学公司、强生、美敦力、B.Barun Melsungen、Biosensors International Ltd.、Terumo Corporation、Biotronik SE and Co. KG、Edwards Lifesciences Corporation 和 Cook Medical Inc。正在采取各种策略,如产品发布、併购、合作伙伴关係和协作,为全球介入性心臟病学市场的成长做出贡献。例如,2022 年 7 月,Terumo India 与 Sensible Medical Innovations 签署了新的策略性商业分销合作伙伴关係。
美敦力有限公司
美敦力公司是一家总部位于爱尔兰的美国医疗器材公司。美敦力公司成立于1949年,总部位于美国明尼苏达州明尼亚波利斯。美敦力负责四个不同的业务:微创治疗集团、糖尿病集团、恢復治疗集团以及心臟和血管集团。
美敦力 (Medtronic) 公司的产品组合。用于介入性心臟病学的 Endurant II 覆膜支架系统:该系统提供理想的护理,并在治疗腹主动脉瘤 (AAA) 方面拥有临床成功的历史。只有 Endurant 系列产品是为了解决囊退化问题而开发的。
Market Size
The Global Interventional Cardiology Market reached US$ 14.47 billion in 2023 and is expected to reach US$ 28.67 billion by 2031, growing at a CAGR of 9.1% during the forecast period 2024-2031.
As per the American Medical Association, interventional cardiology is a branch of medicine within cardiology that evaluates blood flow, and pressure in the coronary arteries and chambers of the heart with the help of specialized imaging and other diagnostic techniques also involves the technical procedures and medications utilized for those abnormalities impairing the functions of the cardiovascular system.
Interventional Cardiology Market Dynamics
The growing cases of cardiovascular diseases, geriatric populations, lifestyle changes, and increasing awareness about cardiovascular diseases are fueling the global interventional cardiology market growth.
The new product launches boost the global interventional cardiology market during the forecast period.
The new product launches fuel the growth of the global interventional cardiology market. For instance, in June 2021, the United States Food and Drug Administration approved Abbott's XIENCE family of stents for its one-month dual-antiplatelet therapy (DAPT) labeled for high bleeding risk (HBR) patients in the United States. Likewise, in May 2020, Philips Image Guided Therapy Corporation's Reconnaissance PV .018 OTW digital IVUS catheter was granted 510 (K) approval from the US FDA. Similarly, in March 2021, Medtronic was granted product approval from the United States Food and Drug Administration for its Harmony Transcatheter Pulmonary Valve (TPV), the first minimally invasive therapy for the treatment of patients with a typical type of congenital heart defect of the right ventricle (RV), one of four chambers of the heart, which makes it difficult for blood to travel from the heart to the lungs.
Furthermore, in June 2021, Amplatzer Piccolo Occluder from Abbott was launched in India. It is the world's first medical device for implantation in the tiniest babies (weighing as little as 700 gms) with a minimally invasive procedure for treating patent ductus arteriosus, or PDA. Moreover, in July 2021, MedAlliance, a privately held medical technology company, launched two high-performance balloons, ORIGIN SC and ORIGIN NC, for vessel preparation for patients suffering from life-threatening coronary and peripheral arterial disease. Thus, the new product launches will drive the global interventional cardiology market during the forecast period.
The stringent regulations and high costs hinder the global interventional cardiology market growth.
However, the high cost of cardiological intervention and stringent regulations will hamper the global interventional cardiology market during the forecast period. For instance, the U.S. FDA is revising two guidance documents for vendors inventing new coronary, peripheral, and neurovascular guidewires. The FDA reported the draft documents in June 2018 and is yet to gather comments on one of the documents. These documents are expected to cover the performance testing, recommended labeling, and lubricious coatings, which will provide industry and FDA staff with suggestions on the least tyrannical means of evaluating the performance of catheters, guidewires, and delivery systems submitted in premarket approval applications (PMAs) or 510(k) premarket notifications. Furthermore, the average cost of percutaneous coronary intervention for chronic total occlusions was $14,946 +- 7,699, leaving a majority of the population unable to get it performed, thus slowing the global interventional cardiology market growth during the forecast period.
The COVID-19 pandemic hurt the global interventional cardiology market since, during the pandemic, there was a large downfall in interventional cardiology procedures. For instance, the British Cardiovascular Interventional society performed a retrospective analysis of all percutaneous coronary interventions (PCI) performed in the United Kingdom during the lockdown imposed by the pandemic in comparison with PCI volumes in the pre-pandemic period.
The retrospective analysis concluded that there was 49% less PCI, with stable angina being hit the hardest, showing a 66% reduction, while the PCI for ST-elevation MI (STEMI) was down by 33%. Furthermore, the pandemic changed people's perspective toward healthy lifestyle choices, which caused a reduction in the cases of cardiovascular diseases, therefore impacting global interventional cardiology negatively.
Interventional Cardiology Market Segmentation Analysis
The stents are predicted to have a high demand during the forecast period (2024-2031).
The stents are expected to dominate the global interventional cardiology market during the forecast period (2024-2031), owing to the new introductions and product approvals in the global interventional cardiology market. For instance, in August 2021, SINOMED launched its HT Supreme Drug-Eluting Stent (DES) in Europe through the first commercial implantation at University Hospital Galway in partnership with the National University of Ireland Galway (NUI Galway). Likewise, in May 2022, the United States Food and Drug Administration (FDA) approved Medtronic plc's Onyx Frontier drug-eluting stent (DES). Onyx Frontier DES leverages the same stent platform as Resolute Onyx DES and with an enhanced delivery system.
Similarly, in January 2021, the FDA approved the Synergy Megatron Drug Eluting stent from Boston Scientific, designed to treat large proximal near the aorta. Furthermore, in May 2021, the CE mark was received by a novel polymer-free self-expanding Amphilimus eluting stent, NiTiDES, from form Alvimedica for superficial femoral artery (SFA) lesions. Therefore, from the above data, stents are anticipated to dominate the global interventional cardiology market throughout the forecast period.
Interventional Cardiology Market Geographical Share
North America is predicted to command the global interventional cardiology market.
North America is estimated to hold a large market over the forecast period (2023-2031) owing to the rising cases of cardiovascular diseases and the presence of key market players in this region. According to the CDC, a U.S. American dies every 34 seconds because of cardiovascular disease. In 2020, cardiovascular disease caused over 697,000 deaths. Furthermore, the existence of key market players such as Abbott, Edwards Lifesciences Corporation, Boston Scientific Corporation, Johnson & Johnson, Medtronic, and Cook Medical Inc., holding large shares of the global interventional cardiology market through different market strategies, are based in the United States, ensures the dominance of this region over the global interventional cardiology market. For instance, in September 2021, Abbott acquired Walk Vascular, LLC, a commercial-stage medical device company with a minimally invasive mechanical aspiration thrombectomy system designed to remove peripheral blood clots.
Similarly, in August 2022, GE Healthcare collaborated with Boston Scientific to provide innovative interventional cardiac care solutions in India. Furthermore, in January 2022, Medtronic acquired Affero expanding Medtronic's cardiac ablation portfolio. Also, in November 2021, Medtronic launched Arctic Front Advanced Cardiac Cryoablation Catheter Technology for treating Atrial Fibrillation in India. Thus, the data shows North America will dominate the global interventional cardiology market throughout the forecast period.
Interventional Cardiology Market Competitive Landscape
The major global interventional cardiology market players are Abbott, Boston Scientific Corporation, Johnson & Johnson, Medtronic, B.Barun Melsungen, Biosensors International Ltd., Terumo Corporation, Biotronik SE and Co. KG, Edwards Lifesciences Corporation and Cook Medical Inc. The key players are adopting various strategies such as product launches, mergers & acquisitions, partnerships, and collaborations, contributing to the growth of the interventional cardiology market globally. For instance, in July 2022, Terumo India signed a new strategic commercial distribution partnership with Sensible Medical Innovations.
Medtronic, Plc.
Medtronic plc is Ireland based American medical device company. Medtronic was founded in 1949 and is headquartered in Minneapolis, Minnesota, United States. Medtronics deals with four different businesses: the Minimally Invasive Therapies Group, the Diabetes Group, the Restorative Therapies Group, and the Cardiac and Vascular Group.
The product portfolio of Medtronic, Plc. for interventional cardiology contains Endurant II Stent Graft Systems: Which provides the ideal of care with a history of clinical success in treating abdominal aortic aneurysms (AAA). Only the Endurant family of products was developed to address sac regression.