세계의 심장 보조 기기 시장 규모는 2023년에 28억 9,000만 달러로 평가되었고, 2030년까지 62억 3,000만 달러에 달할 것으로 예측되며, 예측 기간 동안 복합 연간 성장률(CAGR) 13.70% 성장이 예상됩니다. 심장 보조 기기에 대한 수요는 심부전, 관상 동맥 질환과 같은 심혈관 질환의 세계적인 유병률이 증가하고 이러한 장치의 필요성이 증가함에 따라 환기되고 있습니다. 게다가 심장 기증자 부족은 이 수요를 더욱 강화하고 있습니다. 기증자로부터 장기의 이용 가능성이 제한되어 이식까지의 대기 시간이 길어지고 환자와 의료 제공업체는 심장 보조 기기와 같은 대체 솔루션을 요구하게 됩니다. 동시에, 인지도 향상 및 스크리닝 프로그램은 심혈관 질환의 조기 발견 및 진단에 기여하며, 환자 소개 증가와 이러한 보조 기술에 대한 요구 증가로 이어집니다. 게다가 주요 시장 진출기업에 의한 제품의 발매와 규제 당국의 승인이 급증하고, 보다 선진적이고 효과적인 심장 보조 기기가 시장에 도입된 것도 시장을 뒷받침하고 있습니다. 이러한 신제품 유입은 치료 옵션과 제조업체 간의 경쟁을 강화하고 2024년부터 2030년까지의 예측 기간 동안 장비 기술의 추가 혁신과 개선을 촉진합니다.
심장 보조 기기 시장 역학
British Heart Foundation이 발표한 최신 데이터(2024년)에 의하면, 세계 전체에서 약 6억 2,000만명, 약 13명에 1명이 심장,순환기 질환을 안고 있습니다. 게다가 같은 자료에 따르면 2021년 심장,순환기 질환의 유병률은 유럽에서 1억명, 아시아와 호주에서 3억 4,000만명이었습니다. 게다가 British Heart Foundation이 제공한 최근의 데이터(2024년)에 따르면, 세계에서 가장 많이 진단되고 있는 관상동맥(허혈성) 심장 질환은 세계에서 추정 2억 명이 앓고 있습니다. 약 1억 1,000만 명의 남성과 8,000만 명의 여성이 병을 앓고 있습니다. 또한 약 5,600만 명의 여성과 4,500만 명의 남성이 뇌졸중 생존자입니다. 전 세계적으로 적어도 1,300만 명이 선천성 심장 질환을 앓고 있는 것으로 추정되며, 수백만 명이 더 이상 진단되지 않았을 수 있습니다.
관상 동맥의 협착과 폐색으로 심근로의 혈류가 감소하는 관상 동맥 성 심장 질환은 심부전과 같은 심각한 합병증을 유발할 수 있으며 증상을 관리하고 심장 기능을 개선하기 위해 보조 인공 심장 사용 필요할 수 있습니다. 유사하게, 뇌로의 혈류 장애에 의해 야기되는 뇌졸중은 다양한 심혈관계 합병증을 유발할 수 있으며, 그 결과 심장 상태를 관리하기 위한 보조 기술을 포함한 지지적 치료가 필요합니다. 가 될 수 있습니다. 이러한 질병이 광범위하게 발생함에 따라 심장 보조 기기의 필요성이 높아지고 시장이 활성화되고 있습니다.
심장 이식은 전 세계적으로 말기 심부전 환자에 대한 가장 큰 치료 옵션으로 널리 간주됩니다. 이식에 사용할 수 있는 기관이 부족하기 때문에 이식을 받을 수 있는 환자의 비율이 제한되어 있습니다. World Economic Forum이 제공한 최신 통계에 따르면 2021년 미국에서 심장 이식을 기다리는 환자 수는 3,500명이었습니다. 그러나 기증자 부족, 긴 대기 시간, 불안정한 환자 증가가 심장 보조 기기의 개발을 뒷받침하고 있습니다.
또한 기업은 심장 보조 기기의 생산을 확대하고 규제 당국의 승인을 확보함으로써 시장에서의 존재를 전략적으로 확대하고 성장을 가속하고 있습니다. 예를 들어, 2022년 10월 31일, Abiomed는 Impella RP Flex with SmartAssist의 FDA 시판 전 승인을 받았습니다. 이 장치는 급성 우심부전 치료에 최대 14일 동안 안전하고 효과적인 것으로 승인되었습니다. 내 경정맥에서 유치되어 환자의 이동이 가능하며, 우수한 관리를 위한 듀얼 센서 기술을 갖추고 있습니다. 따라서 위의 요인은 예측 기간 동안 심장 보조 기기 시장을 밀어 올릴 가능성이 높습니다.
그러나 감염 위험, 기계 문제, 심장 보조 기기의 혈전 위험, 제품 승인에 대한 엄격한 규제 우려가 미래의 심장 보조 기기 시장을 방해할 수 있습니다.
본 보고서는 세계의 심장 보조 기기 시장에 대한 조사 분석을 통해 각 지역 시장 규모와 예측, 지난 3년간의 제품/기술 개발, 각 부문의 실적과 전망 등의 정보를 제공합니다.
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.