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市場調査レポート
商品コード
1559456
機械的循環補助装置の世界市場:洞察、競合情勢、市場予測:2030年Mechanical Circulatory Support Devices - Market Insights, Competitive Landscape, and Market Forecast - 2030 |
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機械的循環補助装置の世界市場:洞察、競合情勢、市場予測:2030年 |
出版日: 2024年09月01日
発行: DelveInsight
ページ情報: 英文 150 Pages
納期: 2~10営業日
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機械的循環補助装置の市場規模は、2023年に24億7,000万米ドルとなりました。同市場は、2024年から2030年までの予測期間中に9.44%のCAGRで拡大し、2030年には42億4,000万米ドルに達すると予測されています。機械的循環補助装置の需要は、心不全、冠動脈疾患などの心血管疾患の世界の有病率の上昇によって、これらの装置の必要性が高まっていることが背景にあります。さらに、心臓ドナーの不足がこの需要をさらに強めています。ドナー臓器の入手可能性が限られているため、移植までの待ち時間が長くなり、患者や医療提供者は機械的循環補助装置のような代替ソリューションを求めるようになります。同時に、認知度の向上とスクリーニング・プログラムは心血管系疾患の早期発見と診断に貢献し、患者紹介の増加とこのような補助技術の必要性の高まりにつながっています。さらに、主要な市場参入企業による製品の発売や規制当局の承認が急増し、より先進的で効果的な機械的循環補助装置が市場に導入されたことも、市場を後押ししています。このような新製品の流入により、治療の選択肢とメーカー間の競合が強化され、2024年から2030年までの予測期間中にデバイス技術のさらなる革新と改善が促進されます。
冠動脈の狭窄や閉塞により心筋への血流が減少する冠動脈性心疾患は、しばしば心不全などの重篤な合併症を引き起こし、症状の管理や心機能の改善のために機械的循環補助装置の使用が必要となります。同様に、脳への血流障害によって引き起こされる脳卒中は、さまざまな心血管系合併症を引き起こす可能性があり、その結果生じる心臓の状態を管理するための補助技術を含む、支持的治療が必要となる場合があります。これらの疾患が広く発生することにより、機械的循環補助装置の必要性が高まり、それによって世界中の市場が活性化しています。
心臓移植は、世界中で末期心不全患者に対する最大の治療選択肢と広くみなされています。移植に利用できる臓器が不足しているため、移植を受けられる患者の割合は限られています。世界経済フォーラムが提供した最新の統計によると、2021年、米国で心臓移植を待つ患者数は3,500人となっています。しかし、ドナーの不足、待ち時間の長さ、不安定な患者の増加が、機械的循環補助装置の開発を後押ししています。
当レポートでは、世界の機械的循環補助装置市場について調査し、市場の概要とともに、製品別、エンドユーザー別、地域別動向、および市場に参入する企業のプロファイルなどを提供しています。
Mechanical Circulatory Support Devices Market by Product (Ventricular Assist Devices [Left Ventricular Assist Device, Right Ventricular Assist Device, and Biventricular Assist Device], Artificial Heart, Extracorporeal Membrane Oxygenation, and Intra-Aortic Balloon Pump), End-User (Hospitals, Ambulatory Surgical Centers, and Specialty Cardiology 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 mechanical circulatory support devices market was valued at USD 2.47 billion in 2023, growing at a CAGR of 9.44% during the forecast period from 2024 to 2030, to reach USD 4.24 billion by 2030. The demand for mechanical circulatory support 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 mechanical circulatory support 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 mechanical circulatory support 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.
Mechanical Circulatory Support 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 mechanical circulatory support 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 mechanical circulatory support 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 mechanical circulatory support devices.
The increasing number of product development activities in the region by regulatory bodies is further going to accelerate the growth of the Mechanical Circulatory Support 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).
Thus, the factors mentioned above are likely to boost the market for mechanical circulatory support devices during the forecasted period.
However, the risk of infection, mechanical issues, clot risks with mechanical circulatory support devices, and stringent regulatory concerns for product approval may hinder the future market of mechanical circulatory support devices.
Mechanical Circulatory Support Devices Market Segment Analysis:
Mechanical Circulatory Support Devices Market by Product (Ventricular Assist Devices [Left Ventricular Assist Device, Right Ventricular Assist Device, and Biventricular Assist Device], Artificial Heart, Extracorporeal Membrane Oxygenation, and Intra-Aortic Balloon Pump), End-User (Hospitals, Ambulatory Surgical Centers, and Specialty Cardiology Centers), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)
In the mechanical circulatory support 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 mechanical circulatory support 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 mechanical circulatory support devices market during the forecast period.
North America is expected to dominate the overall mechanical circulatory support devices market:
North America is expected to account for the highest proportion of the mechanical circulatory support 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 mechanical circulatory support 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 mechanical circulatory support 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 mechanical circulatory support 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 mechanical circulatory support devices across the region.
Additionally, the awareness programs in the United States aimed at addressing cardiac diseases focus on education, prevention, and early detection also boosts the market of mechanical circulatory support 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 mechanical circulatory support devices during the forecasted period across the region.
Additionally, companies are amplifying their production of mechanical circulatory support 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.
Therefore, the above-mentioned factors are expected to bolster the growth of the mechanical circulatory support devices market in the North America during the forecast period.
Mechanical Circulatory Support Devices Market Key Players:
Some of the key market players operating in the mechanical circulatory support 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 Mechanical Circulatory Support Devices Market:
Key Takeaways From the Mechanical Circulatory Support Devices Market Report Study:
Target Audience who can be Benefited From This Mechanical Circulatory Support Devices Market Report Study:
Frequently Asked Questions for the Mechanical Circulatory Support Devices Market:
Mechanical circulatory support devices are devices that replace or assist the pumping function of the ventricles. These devices support the functioning of a weak heart by pumping blood. They can be used as a bridge to transplantation, for destination therapy, or as a bridge to recovery postcardiotomy.
The mechanical circulatory support devices market was valued at USD 2.47 billion in 2023, growing at a CAGR of 9.44% during the forecast period from 2024 to 2030, to reach USD 4.24 billion by 2030.
The demand for mechanical circulatory support 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 mechanical circulatory support 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 mechanical circulatory support 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 mechanical circulatory support 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 mechanical circulatory support 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 mechanical circulatory support devices during the forecast period.