市場調查報告書
商品編碼
1559453
心臟輔助設備 - 市場考察、競爭狀況、市場預測 (2030)Cardiac Assist Devices - Market Insights, Competitive Landscape, and Market Forecast - 2030 |
2023年全球心臟輔助設備市場規模為28.9億美元,預計到2030年將達到62.3億美元,年複合成長率預計將成長13.70%。心臟衰竭和冠狀動脈疾病等心血管疾病全球盛行率不斷上升,推動了對心臟輔助設備的需求,增加了對這些設備的需求。此外,心臟捐贈者的短缺也加劇了這項需求。捐贈者器官的供應有限導致移植等待時間更長,並導致患者和醫療保健提供者尋求替代解決方案,例如心臟輔助設備。同時,提高意識和篩檢計畫有助於心血管疾病的早期發現和診斷,導致患者轉診數量增加以及對此類輔助技術的需求不斷成長。此外,主要市場參與者的產品發布和監管批准的快速增加以及更先進、更有效的心臟輔助設備引進市場也推動了市場的發展。新產品的湧入將加強治療方案和製造商之間的競爭,推動2024-2030年預測期內設備技術的進一步創新和改進。
心臟輔助設備的市場動態
根據英國心臟基金會發布的最新資料 (2024年) ,全球約有6.2億人,約每13人中就有1人患有心臟和循環系統疾病。此外,根據同一消息來源,2021年,歐洲有 1億人患有心臟和循環系統疾病,亞洲和澳洲有 3.4億人患有心臟病和循環系統疾病。此外,根據英國心臟基金會提供的最新資料 (2024年) ,冠狀動脈心臟病 (缺血性) 心臟病是世界上最常被診斷的疾病,影響全球約 2億人。約 1.1億男性和 8,000萬名女性受到影響。此外,大約有 5,600萬名女性和 4,500萬名男性是中風倖存者。據估計,全世界至少有 1,300萬人患有先天性心臟病,還有數百萬人可能未被診斷出來。
冠狀動脈心臟病會導致冠狀動脈狹窄或阻塞,減少流向心肌的血流,通常會導致嚴重的併發症,例如可能需要使用心臟衰竭。同樣,由大腦血流受損引起的中風可能會導致各種心血管併發症,並且需要支持性治療,包括可能的輔助技術來控制由此產生的心臟病。此類疾病的廣泛發生增加了對心臟輔助設備的需求並刺激了世界各地的市場。
心臟移植廣泛認為是世界各地末期心臟衰竭患者的首選治療選擇。由於缺乏可供移植的器官,接受移植的患者比例有限。根據世界經濟論壇提供的最新統計資料,2021年,美國有3,500名患者等待心臟移植。但捐贈者短缺、漫長的等待時間以及越來越多的不穩定患者阻礙心臟輔助設備的開發。
此外,該公司策略性地擴大其市場佔有率,並透過擴大心臟輔助設備的生產和獲得監管部門的批准來推動進一步成長。例如,2022年 10月 31 日,Abiomed 的Impella RP Flex 與 SmartAssist 獲得 FDA 上市前批准。該裝置被批准安全有效地治療急性右心衰竭長達 14 天。它透過頸內靜脈放置,患者可以走動,並採用雙感測器技術以實現卓越的管理。因此,上述因素可能會在預測期內推動心臟輔助設備市場的發展。
然而,心臟輔助設備中的感染風險、機械問題、血栓風險以及對產品審批的嚴格監管問題可能會阻礙未來的心臟輔助設備市場。
本報告研究和分析了全球心臟輔助設備市場,提供了各地區的市場規模和預測、過去三年的產品/技術發展以及各細分市場的業績和前景等資訊。
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.