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市场调查报告书
商品编码
1559453
心臟辅助设备 - 市场考察、竞争状况、市场预测 (2030)Cardiac Assist Devices - Market Insights, Competitive Landscape, and Market Forecast - 2030 |
2023年全球心臟辅助设备市场规模为28.9亿美元,预计到2030年将达到62.3亿美元,年复合成长率预计将成长13.70%。心臟衰竭和冠状动脉疾病等心血管疾病全球盛行率不断上升,推动了对心臟辅助设备的需求,增加了对这些设备的需求。此外,心臟捐赠者的短缺也加剧了这项需求。捐赠者器官的供应有限导致移植等待时间更长,并导致患者和医疗保健提供者寻求替代解决方案,例如心臟辅助设备。同时,提高意识和筛检计画有助于心血管疾病的早期发现和诊断,导致患者转诊数量增加以及对此类辅助技术的需求不断成长。此外,主要市场参与者的产品发布和监管批准的快速增加以及更先进、更有效的心臟辅助设备引进市场也推动了市场的发展。新产品的涌入将加强治疗方案和製造商之间的竞争,推动2024-2030年预测期内设备技术的进一步创新和改进。
心臟辅助设备的市场动态
根据英国心臟基金会发布的最新资料 (2024年) ,全球约有6.2亿人,约每13人中就有1人患有心臟和循环系统疾病。此外,根据同一消息来源,2021年,欧洲有 1亿人患有心臟和循环系统疾病,亚洲和澳洲有 3.4亿人患有心臟病和循环系统疾病。此外,根据英国心臟基金会提供的最新资料 (2024年) ,冠状动脉心臟病 (缺血性) 心臟病是世界上最常被诊断的疾病,影响全球约 2亿人。约 1.1亿男性和 8,000万名女性受到影响。此外,大约有 5,600万名女性和 4,500万名男性是中风倖存者。据估计,全世界至少有 1,300万人患有先天性心臟病,还有数百万人可能未被诊断出来。
冠状动脉心臟病会导致冠状动脉狭窄或阻塞,减少流向心肌的血流,通常会导致严重的併发症,例如可能需要使用心臟衰竭。同样,由大脑血流受损引起的中风可能会导致各种心血管併发症,并且需要支持性治疗,包括可能的辅助技术来控制由此产生的心臟病。此类疾病的广泛发生增加了对心臟辅助设备的需求并刺激了世界各地的市场。
心臟移植广泛认为是世界各地末期心臟衰竭患者的首选治疗选择。由于缺乏可供移植的器官,接受移植的患者比例有限。根据世界经济论坛提供的最新统计资料,2021年,美国有3,500名患者等待心臟移植。但捐赠者短缺、漫长的等待时间以及越来越多的不稳定患者阻碍心臟辅助设备的开发。
此外,该公司策略性地扩大其市场占有率,并透过扩大心臟辅助设备的生产和获得监管部门的批准来推动进一步成长。例如,2022年 10月 31 日,Abiomed 的Impella RP Flex 与 SmartAssist 获得 FDA 上市前批准。该装置被批准安全有效地治疗急性右心衰竭长达 14 天。它透过颈内静脉放置,患者可以走动,并采用双感测器技术以实现卓越的管理。因此,上述因素可能会在预测期内推动心臟辅助设备市场的发展。
然而,心臟辅助设备中的感染风险、机械问题、血栓风险以及对产品审批的严格监管问题可能会阻碍未来的心臟辅助设备市场。
本报告研究和分析了全球心臟辅助设备市场,提供了各地区的市场规模和预测、过去三年的产品/技术发展以及各细分市场的业绩和前景等资讯。
Cardiac Assist Devices Market by Product (Ventricular Assist Devices [Left Ventricular Assist Devices (LVAD), Biventricular Ventricular Assist Devices (BIVAD), and Right Ventricular Assist Devices (RVAD)], Artificial Heart, and Intra-Aortic Balloon Pump), Type (Transcutaneous and Implantable), Therapy (Bridge-To-Transplant (BTT) Therapy, Destination Therapy, and Bridge-To-Candidacy (BTC Therapy), End-User (Hospitals, Cardiac Centers, and Ambulatory Surgical Centers), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2030 owing to the rising burden of cardiovascular diseases, scarcity of heart donors, increasing awareness and screening programs, and increase in product launches and approvals by key market players across the globe.
The cardiac assist devices market was valued at USD 2.89 billion in 2023, growing at a CAGR of 13.70% during the forecast period from 2024 to 2030, to reach USD 6.23 billion by 2030. The demand for cardiac assist devices is motivated by a rise in the prevalence of cardiovascular diseases such as heart failure, coronary artery disease, and others globally which has led to an increased need for these devices. Additionally, the scarcity of heart donors further intensifies this demand, as the limited availability of donor organs leads to longer waiting times for transplantation, pushing patients and healthcare providers to seek alternative solutions such as cardiac assist devices. Concurrently, increasing awareness and screening programs contribute to early detection and diagnosis of cardiovascular conditions, leading to higher patient referrals and a greater need for such assistive technologies. Moreover, the market is fueled by a surge in product launches and regulatory approvals from key market players, which introduces more advanced and effective cardiac assist devices to the market. This influx of new products enhances treatment options and competition among manufacturers, driving further innovation and improvements in device technology during the forecast period from 2024 to 2030.
Cardiac Assist Devices Market Dynamics:
According to the latest data published by the British Heart Foundation (2024), globally, approximately 620 million people, or about 1 in 13 individuals, live with heart and circulatory diseases. Additionally, as per the same source, the prevalence of heart and circulatory diseases was 100 million in Europe and 340 million in Asia and Australia in 2021. Furthermore, as per the recent data provided by the British Heart Foundation (2024), coronary (ischemic) heart disease, the most commonly diagnosed worldwide, affects an estimated 200 million people globally. Approximately 110 million men and 80 million women are affected. Additionally, around 56 million women and 45 million men are stroke survivors. It is estimated that at least 13 million people worldwide live with congenital heart disease, with potentially millions more undiagnosed.
Coronary heart disease, which involves the narrowing or blockage of coronary arteries leading to reduced blood flow to the heart muscle, often results in severe complications like heart failure, which may necessitate the use of cardiac assist devices to manage symptoms and improve cardiac function. Similarly, stroke, caused by interruptions in blood flow to the brain, can lead to various cardiovascular complications that may require supportive treatments, including assistive technologies to manage the resulting heart conditions. The widespread occurrence of these diseases drives the need for cardiac assist devices thereby boosting the market across the globe.
Heart transplantation is widely regarded as the greatest therapeutic option for individuals with end-stage heart failure across the world. Only a limited percentage of patients get transplants due to the scarcity of organs available for transplantation. According to the most recent statistics, provided by the World Economic Forum, in 2021, the number of patients waiting for a heart transplant in the United States was 3,500. However, the scarcity of donors, long waiting times, and an increasing number of unstable patients have favored the development of cardiac assist devices.
Additionally, companies are amplifying their production of cardiac assist devices and securing regulatory approvals, thereby strategically expanding their market presence and driving further growth. For instance, in October 31, 2022, Abiomed received FDA pre-market approval for its Impella RP Flex with SmartAssist. The device was approved as safe and effective for treating acute right heart failure for up to 14 days. Implanted through the internal jugular vein, it allowed patient mobility and featured dual-sensor technology for enhanced management. Thus, the factors mentioned above are likely to boost the market of cardiac assist devices during the forecasted period.
However, the risk of infection, mechanical issues, clot risks with cardiac assist devices, and stringent regulatory concerns for product approval may hinder the future market of cardiac assist devices.
Cardiac Assist Devices Market Segment Analysis:
Cardiac Assist Devices Market by Product (Ventricular Assist Devices [Left Ventricular Assist Devices (LVAD), Biventricular Ventricular Assist Devices (BIVAD), and Right Ventricular Assist Devices (RVAD)], Artificial Heart, and Intra-Aortic Balloon Pump), Type (Transcutaneous and Implantable), Therapy (Bridge-To-Transplant (BTT) Therapy, Destination Therapy, and Bridge-To-Candidacy (BTC Therapy), End-User (Hospitals, Cardiac Centers, and Ambulatory Surgical Centers), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)
In the cardiac assist devices market product segment under the ventricular assist devices category, left ventricular assist devices are expected to hold a significant share in 2023. Left Ventricular Assist Devices (LVADs) are dominating the overall market of cardiac assist devices due to their pivotal role in managing severe heart failure and their widespread adoption in clinical settings. LVADs serve as a critical bridge to heart transplantation for patients with end-stage heart failure, offering life-saving support by enhancing the heart's pumping ability and improving blood flow to vital organs. Their effectiveness in improving patient outcomes, coupled with advances in technology that enhance device performance and patient comfort, has driven their prominence. Post implantation of LVAD, patients witness improvement in their health and can return and resume their daily activities including driving, and others. LVADs offer intermediate to long-term treatment solutions for severe heart failure patients.
Additionally, LVADs are increasingly being used as destination therapy for patients who are not candidates for transplantation, further expanding their market reach. The high demand for LVADs is also supported by a growing patient population with chronic heart conditions, advancements in device technology, and ongoing clinical trials demonstrating their benefits. For instance, in October 2023, Magenta Medical reported positive results from the US early feasibility study of the Elevate(TM) heart pump. The Elevate(TM) is the smallest and most powerful percutaneous left ventricular assist device (pLVAD) in the world and was shown to provide effective temporary mechanical circulatory support during high-risk percutaneous coronary intervention (HR-PCI) procedures.
Therefore, owing to the above-mentioned factors, the left ventricular assist devices category is expected to generate considerable revenue thereby pushing the overall growth of the global cardiac assist devices market during the forecast period.
North America is expected to dominate the overall cardiac assist devices market:
North America is expected to account for the highest proportion of the cardiac assist devices market in 2023, out of all regions. This can be ascribed to the increasing prevalence of cardiac disease across the region, shortage of heart donors, increased government initiatives coupled with increased awareness programs for cardiac disease, and the presence of key market players engaged in mergers, acquisitions, product launches, and other market activities across the region are expected to escalate the market of cardiac assist devices during the forecast period.
According to the recent data and stats provided by the Health Resource and Service Administration, in 2024, there were 103,223 men, women, and children on the national transplant waiting list. Each day, 17 people die while waiting for an organ transplant. Among them, 3,436 patients were specifically on the waiting list for a heart transplant in the United States. The substantial number of people on the national transplant waiting list and the daily fatalities due to organ shortages highlighted a critical need for effective alternatives. This situation emphasized the gap between the supply of donor organs and the demand for heart transplants, driving the need for interim solutions like cardiac assist devices.
Additionally, according to recent data from the Centers for Disease Control and Prevention (2024), approximately 4.9% of adults were diagnosed with coronary heart disease in 2022. Furthermore, by 2023, an estimated 12.1 million individuals in the United States were projected to have atrial fibrillation. Additionally, each year, over 795,000 people in the U.S. experience a stroke, with around 610,000 of these being first-time strokes. Notably, nearly 185,000 of these strokes, or about one in four, occur in individuals who have previously had a stroke.
The prevalence of coronary heart disease, atrial fibrillation, and stroke highlights a significant and expanding patient base with complex cardiovascular needs, driving the demand for cardiac assist devices. These heart disease often leads to heart failure and other severe complications, creating a critical need for devices that can support heart function and improve patient outcomes thereby boosting the overall market of cardiac assist devices across the region.
Additionally, the awareness programs in the United States aimed at addressing cardiac diseases focus on education, prevention, and early detection and also boost the market of cardiac assist devices across the region as public awareness campaigns educate individuals about the importance of regular screenings and preventive measures. For example, February is designated as American Heart Month, during which various organizations, including the American Heart Association (AHA) and the Centers for Disease Control and Prevention (CDC), promote awareness through campaigns, events, and educational materials. These efforts emphasize the importance of heart health, risk factors, and preventive measures which can also boost the market of cardiac assist devices during the forecasted period across the region.
The increasing number of product development activities in the region by regulatory bodies is further going to accelerate the growth of the cardiac assist devices market. For example, in November 2023, BiVACOR, Inc., a clinical-stage medical device company developing a total artificial heart, announced that the FDA approved their BiVACOR Total Artificial Heart (BTAH) to begin an investigational device exemption (IDE) for its first-in-human Early Feasibility Study (EFS).
Therefore, the above-mentioned factors are expected to bolster the growth of the cardiac assist devices market in North America during the forecast period.
Cardiac Assist Devices Market Key Players:
Some of the key market players operating in the cardiac assist devices market include Abbott Laboratories, Teleflex Incorporated, SynCardia Systems, LLC, St. Jude Medical Inc, CARMAT, CorWave SA, Medtronic PLC, Terumo Heart, Inc., NovaPump GmbH, Getinge AB, Balton Ltd., Meril Life Sciences Pvt. Ltd., Thoratec Corporation, CardiacAssist, Inc., Berlin Heart GmbH, BrioHealth Solutions, Inc., BiVACOR, Inc., Magenta Medical, Abiomed, SynCardia, and others.
Recent Developmental Activities in the Cardiac Assist Devices Market:
Key Takeaways From the Cardiac Assist Devices Market Report Study:
Target Audience who can be Benefited From This Cardiac Assist Devices Market Report Study:
Frequently Asked Questions for the Cardiac Assist Devices Market:
Cardiac Assist Devices (CAD) are a type of mechanical pump that operate together with the heart to increase the effectiveness of pumping and maintain optimal blood flow across the body. To treat end-stage heart failure, cardiac aid systems are used that are determined by the individual's needs. As a result of the scarcity of cardiac donors, temporary cardiac assist devices are utilized to provide long-term assistance for individuals.
The cardiac assist devices market was valued at USD 2.89 billion in 2023, growing at a CAGR of 13.70% during the forecast period from 2024 to 2030, to reach USD 6.23 billion by 2030.
The demand for cardiac assist devices is motivated by a rise in the prevalence of cardiovascular diseases such as heart failure, coronary artery disease, and others globally which has led to an increased need for these devices. Additionally, the scarcity of heart donors further intensifies this demand, as the limited availability of donor organs leads to longer waiting times for transplantation, pushing patients and healthcare providers to seek alternative solutions such as cardiac assist devices. Concurrently, increasing awareness and screening programs contribute to early detection and diagnosis of cardiovascular conditions, leading to higher patient referrals and a greater need for such assistive technologies. Moreover, the market is fueled by a surge in product launches and regulatory approvals from key market players, which introduces more advanced and effective cardiac assist devices to the market. This influx of new products enhances treatment options and competition among manufacturers, driving further innovation and improvements in device technology during the forecast period from 2024 to 2030.
Some of the key market players operating in the Cardiac Assist Devices market include Abbott Laboratories, Teleflex Incorporated, SynCardia Systems, LLC, St. Jude Medical Inc., CARMAT, CorWave SA, Medtronic PLC, Terumo Heart, Inc., NovaPump GmbH, Getinge AB, Balton Ltd., Meril Life Sciences Pvt. Ltd., Thoratec Corporation, CardiacAssist, Inc., Berlin Heart GmbH, BrioHealth Solutions, Inc., BiVACOR, Inc., Magenta Medical, Abiomed, SynCardia, and others.
North America is expected to account for the highest proportion of the cardiac assist devices market in 2023, out of all regions. This can be ascribed to the increasing prevalence of cardiac disease across the region, shortage of heart donors, increase government initiatives coupled with increased awareness programs for cardiac disease, and the presence of key market players engaged in merges, acquisition, product launches, and other market activities across the region are expected to escalate the market of cardiac assist devices during the forecast period.