세계의 기계식 순환 보조 장치 시장 : 인사이트, 경쟁 환경 및 시장 예측(-2030년)

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:

• In May 2024, BrioHealth Solutions, Inc., a medical technology company, announced that it received FDA Investigational Device Exemption (IDE) approval with conditions to start enrolling participants in its INNOVATE trial. The trial aimed to evaluate the effectiveness and safety of the BrioVAD(TM) System, a magnetically levitated ventricular assist device, for treating severe left ventricular heart failure. Following the approval, BrioHealth Solutions began clinical site start-up activities in the US.
• In December 2023, CARMAT, the designer and developer of the world's most advanced total artificial heart for patients with advanced biventricular heart failure, announced that it had opened its second production facility, BDA2, in Bois-d'Arcy, France.

Key Takeaways From the Mechanical Circulatory Support Devices Market Report Study:

• Market size analysis for current mechanical circulatory support devices size (2023), and market forecast for 6 years (2024 to 2030)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years
• Key companies dominating the mechanical circulatory support devices market.
• Various opportunities available for the other competitors in the mechanical circulatory support devices market space.
• What are the top-performing segments in 2023? How these segments will perform in 2030?
• Which are the top-performing regions and countries in the current mechanical circulatory support devices market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for mechanical circulatory support devices market growth in the coming future?

Target Audience who can be Benefited From This Mechanical Circulatory Support Devices Market Report Study:

• Mechanical circulatory support devices product providers
• Research organizations and consulting companies
• Mechanical circulatory support devices -related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and traders dealing in mechanical circulatory support devices
• Various end-users who want to know more about the mechanical circulatory support devices market and the latest technological developments in the mechanical circulatory support devices market.

Frequently Asked Questions for the Mechanical Circulatory Support Devices Market:

1. What are mechanical circulatory support devices?

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.

2. What is the market for mechanical circulatory support devices?

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.

3. What are the drivers for the mechanical circulatory support devices market?

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.

4. Who are the key players operating in the mechanical circulatory support devices market?

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.

5. Which region has the highest share in the 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.

Table of Contents

1. Mechanical Circulatory Support Devices Market Report Introduction

• 1.1. Scope of the Study
• 1.2. Market Segmentation
• 1.3. Market Assumption

2. Mechanical Circulatory Support Devices Market Executive Summary

• 2.1. Market at Glance

3. Competitive Landscape

4. Regulatory Analysis

• 4.1. The United States
• 4.2. Europe
• 4.3. Japan
• 4.4. China

5. Mechanical Circulatory Support Devices Market Key Factors Analysis

• 5.1. Mechanical Circulatory Support Devices Market Drivers
  • 5.1.1. The rising burden of cardiovascular diseases
  • 5.1.2. Scarcity of heart donors
  • 5.1.3. Increasing awareness and screening programs
  • 5.1.4. Increase in product launches and approvals by key market players across the globe.
• 5.2. Mechanical Circulatory Support Devices Market Restraints and Challenges
  • 5.2.1. The risk of infection, mechanical issues, and clot risks with mechanical circulatory support devices
  • 5.2.2. Stringent regulatory concerns for product approval
• 5.3. Mechanical Circulatory Support Devices Market Opportunities
  • 5.3.1. Ongoing research and development of non-invasive, compact, and advanced mechanical circulatory support devices

6. Mechanical Circulatory Support Devices Market Porter's Five Forces Analysis

• 6.1. Bargaining Power of Suppliers
• 6.2. Bargaining Power of Consumers
• 6.3. Threat of New Entrants
• 6.4. Threat of Substitutes
• 6.5. Competitive Rivalry

7. Mechanical Circulatory Support Devices Market Assessment

• 7.1. By Product
  • 7.1.1. Ventricular Assist Devices
    • 7.1.1.1. Left Ventricular Assist Devices (LVAD)
    • 7.1.1.2. Biventricular Ventricular Assist Devices (BIVAD)
    • 7.1.1.3. Right Ventricular Assist Devices (RVAD)
  • 7.1.2. Artificial Hearts
  • 7.1.3. Extracorporeal Membrane Oxygenation
  • 7.1.4. Intra-Aortic Balloon Pumps
• 7.2. By End-User
  • 7.2.1. Hospitals
  • 7.2.2. Cardiac Centers
  • 7.2.3. Ambulatory Surgical Centers
• 7.3. By Geography
  • 7.3.1. North America
    • 7.3.1.1. United States Mechanical Circulatory Support Devices Market Size in USD Million (2021-2030)
    • 7.3.1.2. Canada Mechanical Circulatory Support Devices Market Size in USD Million (2021-2030)
    • 7.3.1.3. Mexico Mechanical Circulatory Support Devices Market Size in USD Million (2021-2030)
  • 7.3.2. Europe
    • 7.3.2.1. France Mechanical Circulatory Support Devices Market Size in USD Million (2021-2030)
    • 7.3.2.2. Germany Mechanical Circulatory Support Devices Market Size in USD Million (2021-2030)
    • 7.3.2.3. United Kingdom Mechanical Circulatory Support Devices Market Size in USD Million (2021-2030)
    • 7.3.2.4. Italy Mechanical Circulatory Support Devices Market Size in USD Million (2021-2030)
    • 7.3.2.5. Spain Mechanical Circulatory Support Devices Market Size in USD Million (2021-2030)
    • 7.3.2.6. Rest of Europe Mechanical Circulatory Support Devices Market Size in USD Million (2021-2030)
  • 7.3.3. Asia-Pacific
    • 7.3.3.1. China Mechanical Circulatory Support Devices Market Size in USD Million (2021-2030)
    • 7.3.3.2. Japan Mechanical Circulatory Support Devices Market Size in USD Million (2021-2030)
    • 7.3.3.3. India Mechanical Circulatory Support Devices Market Size in USD Million (2021-2030)
    • 7.3.3.4. Australia Mechanical Circulatory Support Devices Market Size in USD Million (2021-2030)
    • 7.3.3.5. South Korea Mechanical Circulatory Support Devices Market Size in USD Million (2021-2030)
    • 7.3.3.6. Rest of Asia-Pacific Mechanical Circulatory Support Devices Market Size in USD Million (2021-2030)
  • 7.3.4. Rest of the World (RoW)
    • 7.3.4.1. Middle East Mechanical Circulatory Support Devices Market Size in USD Million (2021-2030)
    • 7.3.4.2. Africa Mechanical Circulatory Support Devices Market Size in USD Million (2021-2030)
    • 7.3.4.3. South America Mechanical Circulatory Support Devices Market Size in USD Million (2021-2030)

8. Mechanical Circulatory Support Devices Market Company and Product Profiles

• 8.1. Abbott Laboratories
  • 8.1.1. Company Overview
  • 8.1.2. Company Snapshot
  • 8.1.3. Financial Overview
  • 8.1.4. Product Listing
  • 8.1.5. Entropy
• 8.2. Teleflex Incorporated
  • 8.2.1. Company Overview
  • 8.2.2. Company Snapshot
  • 8.2.3. Financial Overview
  • 8.2.4. Product Listing
  • 8.2.5. Entropy
• 8.3. SynCardia Systems
  • 8.3.1. Company Overview
  • 8.3.2. Company Snapshot
  • 8.3.3. Financial Overview
  • 8.3.4. Product Listing
  • 8.3.5. Entropy
• 8.4. St. Jude Medical Inc.
  • 8.4.1. Company Overview
  • 8.4.2. Company Snapshot
  • 8.4.3. Financial Overview
  • 8.4.4. Product Listing
  • 8.4.5. Entropy
• 8.5. CARMAT
  • 8.5.1. Company Overview
  • 8.5.2. Company Snapshot
  • 8.5.3. Financial Overview
  • 8.5.4. Product Listing
  • 8.5.5. Entropy
• 8.6. CorWave SA
  • 8.6.1. Company Overview
  • 8.6.2. Company Snapshot
  • 8.6.3. Financial Overview
  • 8.6.4. Product Listing
  • 8.6.5. Entropy
• 8.7. Medtronic plc.
  • 8.7.1. Company Overview
  • 8.7.2. Company Snapshot
  • 8.7.3. Financial Overview
  • 8.7.4. Product Listing
  • 8.7.5. Entropy
• 8.8. Terumo Heart, Inc.
  • 8.8.1. Company Overview
  • 8.8.2. Company Snapshot
  • 8.8.3. Financial Overview
  • 8.8.4. Product Listing
  • 8.8.5. Entropy
• 8.9. NovaPump GmbH
  • 8.9.1. Company Overview
  • 8.9.2. Company Snapshot
  • 8.9.3. Financial Overview
  • 8.9.4. Product Listing
  • 8.9.5. Entropy
• 8.10. Getinge AB
  • 8.10.1. Company Overview
  • 8.10.2. Company Snapshot
  • 8.10.3. Financial Overview
  • 8.10.4. Product Listing
  • 8.10.5. Entropy
• 8.11. Balton Ltd.
  • 8.11.1. Company Overview
  • 8.11.2. Company Snapshot
  • 8.11.3. Financial Overview
  • 8.11.4. Product Listing
  • 8.11.5. Entropy
• 8.12. Meril Life Sciences Pvt. Ltd.
  • 8.12.1. Company Overview
  • 8.12.2. Company Snapshot
  • 8.12.3. Financial Overview
  • 8.12.4. Product Listing
  • 8.12.5. Entropy
• 8.13. Thoratec Corporation
  • 8.13.1. Company Overview
  • 8.13.2. Company Snapshot
  • 8.13.3. Financial Overview
  • 8.13.4. Product Listing
  • 8.13.5. Entropy
• 8.14. CardiacAssist, Inc
  • 8.14.1. Company Overview
  • 8.14.2. Company Snapshot
  • 8.14.3. Financial Overview
  • 8.14.4. Product Listing
  • 8.14.5. Entropy
• 8.15. Berlin Heart GmbH
  • 8.15.1. Company Overview
  • 8.15.2. Company Snapshot
  • 8.15.3. Financial Overview
  • 8.15.4. Product Listing
  • 8.15.5. Entropy
• 8.16. BrioHealth Solution Inc.
  • 8.16.1. Company Overview
  • 8.16.2. Company Snapshot
  • 8.16.3. Financial Overview
  • 8.16.4. Product Listing
  • 8.16.5. Entropy
• 8.17. BiVACOR, Inc.
  • 8.17.1. Company Overview
  • 8.17.2. Company Snapshot
  • 8.17.3. Financial Overview
  • 8.17.4. Product Listing
  • 8.17.5. Entropy
• 8.18. Magenta Medical
  • 8.18.1. Company Overview
  • 8.18.2. Company Snapshot
  • 8.18.3. Financial Overview
  • 8.18.4. Product Listing
  • 8.18.5. Entropy
• 8.19. Abiomed
  • 8.19.1. Company Overview
  • 8.19.2. Company Snapshot
  • 8.19.3. Financial Overview
  • 8.19.4. Product Listing
  • 8.19.5. Entropy
• 8.20. SynCardia
  • 8.20.1. Company Overview
  • 8.20.2. Company Snapshot
  • 8.20.3. Financial Overview
  • 8.20.4. Product Listing
  • 8.20.5. Entropy

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