Enjoy complimentary customisation on priority with our Enterprise License!
The artificial heart market size is estimated to grow by USD 1.83 billion at a CAGR of 11.64% between 2023 and 2028. Heart failure (HF) is a growing global health concern, with an estimated 6.5 million Americans and 26 million people worldwide living with the condition. Risk factors for HF include hypertension, diabetes, obesity, and aging. The shortage of available organs for cardiac transplantation has led to a significant need for alternative solutions. Advances in ventricular assist device (VAD) technology have emerged as a promising solution for end-stage heart failure patients. VADs are mechanical pumps that help the heart pump blood effectively, improving patients' quality of life and extending their survival. These devices have evolved significantly over the years, with improvements in size, weight, and durability, making them a viable option for more patients. VADs offer a bridge to transplantation, allowing patients to wait for a donor organ while maintaining their health, and in some cases, they can even be a permanent solution for those who do not qualify for a transplant. The continued advancements in VAD technology are paving the way for a future where heart failure is no longer a death sentence.
For More Highlights About this Report, Request Free Sample
The market is witnessing significant growth due to the increasing prevalence of Cardiovascular disorders, particularly in the geriatric population. According to the Census Bureau, the number of people aged 65 and above is projected to grow, leading to a higher demand and ventricular assist devices (VADs). Recent technological advancements in materials science have led to the development of more efficient pumps and artificial hearts, providing an alternative to traditional transplantation. Healthcare units, including hospitals and manufacturing units, are integrating these advanced technologies to cater to the growing patient base. Heart sectors, such as heart valves and artificial hearts, are experiencing substantial research projects and collaborations with international universities to improve the functionality and durability of these devices. Patients and healthcare professionals require extensive knowledge about the regulatory scenario and the benefits of artificial hearts and VADs. The use of these devices can save lives, especially for those waiting for a heart transplant. The market is expected to grow at a steady pace, driven by the increasing demand for advanced heart solutions and the aging population. Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.
The increasing prevalence of HF and associated risk factors is notably driving market growth. The global market for heart devices, focusing on circulatory support systems, is witnessing significant innovation and growth due to the unmet need for effective alternatives to heart transplantation. Medical device manufacturers and academic institutions are investing heavily in research and development to address the shortage of donor organs and the scarcity of heart transplantation. Heart failure, a leading cause of cardiovascular disorders, affects a large patient pool, particularly the geriatric population. The prevalence of chronic heart conditions is projected to increase, with an estimated 7.65 million people in the US alone expected to have heart failure by 2025.
Furthermore, regulations play a crucial role in the market, with the FDA approval process and the European Medicines Agency's Medical Device Regulation and CE marking requirements ensuring the production and distribution of high-quality, safe products. The impact of regulations on the market includes product expansion and the development of advanced technologies such as bioprosthetic artificial hearts, miniaturization, improved durability, enhanced control algorithms, and biocompatibility. Technological advancements are also addressing concerns such as pump thrombosis and the need for long-term reliability. The market is expected to grow significantly, with a focus on addressing the challenges of blood compatibility and the unique requirements of individual patients. Thus, such factors are driving the growth of the market during the forecast period.
Clinical trials for the development of TAHs are a major trend in the market. The market is witnessing significant innovation and development as medical device manufacturers and academic institutions strive to address the unmet need for circulatory support in patients with heart failure due to the scarcity of donor organs for heart transplantation. The leading players in this market, such as CARMAT and SynCardia Systems, are focusing on creating high-quality, safe products that adhere to stringent regulatory requirements, including FDA approval processes and CE marking requirements from the European Medicines Agency and the Medical Device Regulation. CARMAT is pioneering the development of the first auto-regulating bioprosthetic Total Artificial Heart (TAH), which offers a long-term therapeutic solution for patients with advanced biventricular heart failure who are not eligible for transplantation. This intelligent TAH, called CARMAT, is designed with biocompatible materials for the surfaces in contact with blood to minimize thromboembolic risks. SynCardia Systems, on the other hand, is conducting clinical trials for its SynCardia 70cc TAH as a destination therapy for patients with end-stage heart failure who are ineligible for heart transplantation. Technological advancements include miniaturization, improved durability, enhanced control algorithms, and biocompatibility. The prevalence of chronic heart conditions, particularly in the geriatric population, continues to expand the patient pool for these devices. Regulatory scenarios, such as FDA approval processes and European Medicines Agency regulations, play a significant role in the impact of regulations on the market.
Furthermore, the market is expected to grow as the need for these devices increases to support the circulatory system in patients with cardiovascular disorders. The market is witnessing significant innovation and development as medical device manufacturers and academic institutions strive to address the unmet need for circulatory support in patients with heart failure due to the scarcity of donor organs for heart transplantation. The leading players in this market, such as CARMAT and SynCardia Systems, are focusing on creating high-quality, safe products that adhere to stringent regulatory requirements, including FDA approval processes and CE marking requirements from the European Medicines Agency and the Medical Device Regulation. CARMAT is pioneering the development of the first auto-regulating bioprosthetic Total Artificial Heart (TAH), which offers a long-term therapeutic solution for patients with advanced biventricular heart failure who are not eligible for transplantation. This intelligent TAH, called CARMAT, is designed with biocompatible materials for the surfaces in contact with blood to minimize thromboembolic risks. SynCardia Systems, on the other hand, is conducting clinical trials for its SynCardia 70cc TAH as a destination therapy for patients with end-stage heart failure who are ineligible for heart transplantation. Technological advancements in the field of artificial hearts include miniaturization, improved durability, enhanced control algorithms, and biocompatibility. The prevalence of chronic heart conditions, particularly in the geriatric population, continues to expand the patient pool for these devices. Regulatory scenarios, such as FDA approval processes and European Medicines Agency regulations, play a significant role in the impact of regulations on the market. The market is expected to grow as the need for these devices increases to support the circulatory system in patients with cardiovascular disorders. Thus, such trends will shape the growth of the market during the forecast period.
The high cost of artificial hearts is the major challenge that affects the growth of the market. The market for heart devices, including ventricular assist devices (VADs), is witnessing significant innovation as medical device manufacturers and academic institutions strive to address the unmet need for circulatory support due to the scarcity of donor organs for heart transplantation. Heart failure, a chronic condition affecting a growing patient pool, particularly the geriatric population, necessitates the development of high-quality, safe products that meet stringent regulations, such as the FDA approval process and the European Medicines Agency's Medical Device Regulation and CE marking requirements. Despite the potential benefits of these advanced heart devices, their high cost and maintenance expenses remain a significant challenge. For instance, the cost of a VAD ranges from USD100,000 to USD300,000, depending on the type, while a TAH transplant can cost between USD125,000 and USD150,000, not including annual maintenance costs of about USD18,000.
Furthermore, procedural costs can also vary significantly based on the complexity of the surgery, surgeon's expertise, complications, hospital costs, and insurance coverage. Additionally, end-users face additional expenses related to device maintenance, post-operative adjustments, and battery replacement. Technological advancements, such as miniaturization, improved durability, enhanced control algorithms, and biocompatibility, are addressing some of these challenges. Companies like CARMAT are developing bioprosthetic artificial hearts and mechanical devices to minimize pump thrombosis risks and provide better patient outcomes. Regulatory agencies' impact on the market includes the FDA's rigorous approval process and the European Medicines Agency's focus on safety and efficacy, which can influence product expansion and market growth. The prevalence of cardiovascular disorders and the increasing patient pool with chronic heart conditions further underscore the importance of addressing the unmet need for circulatory support. Hence, the above factors will impede the growth of the market during the forecast period
The market forecasting report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.
Customer Landscape
Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.
Abbott Laboratories - The company offers products such as Mitraclip, Epic Mitral Valve, Trifecta GT Valve.
The market research and growth report also includes detailed analyses of the competitive landscape of the market and information about key companies, including:
Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.
The market share growth by the VAD segment will be significant during the forecast period. The market encompasses heart devices designed for circulatory support, addressing the unmet need in heart failure patients due to the scarcity of donor organs for heart transplantation. Medical device manufacturers and academic institutions continue to innovate, developing high-quality, safe products that adhere to stringent regulatory requirements.
Get a glance at the market share of various regions Download the PDF Sample
The VAD segment showed a gradual increase in the market share of USD 1.85 billion in 2018. The FDA approval process and European Medicines Agency's Medical Device Regulation, including CE marking requirements, significantly impact market expansion. Leading players in this field include CARMAT, offering a bioprosthetic artificial heart, and those specializing in mechanical devices, such as pumps. The challenge of pump thrombosis and the need for improved durability, enhanced control algorithms, and biocompatibility are driving technological advancements. Miniaturization and improved durability are essential for catering to the growing patient pool, particularly the geriatric population, suffering from chronic heart conditions and cardiovascular disorders. Regulatory scenarios and the impact of regulations on product development remain crucial considerations.
For more insights on the market share of various regions Download PDF Sample now!
North America is estimated to contribute 44% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.
The market encompasses various heart sectors, including heart ventricles, manufacturing units, hospitals, and healthcare units. With the Census Bureau projecting an aging population, the demand for artificial hearts and related devices, such as heart valves and ventricular assist devices (VADs), is expected to surge. Recent technology advancements in healthcare technology, materials science, robotics, and biotechnology have led to the development of innovative solutions, including total artificial hearts and heart-lung machines. The growing prevalence of cardiovascular disorders, driven by factors like smoking and sedentary lifestyles, necessitates low-cost, effective treatments. Reimbursement policies and insurance coverage play a crucial role in the market's growth. Medical device manufacturers are working closely with healthcare professionals to improve the design, functionality, and regulatory approvals of artificial hearts, adhering to FDA policies. End-users, including clinics, healthcare centers, and hospitals, are increasingly opting for VADs as an alternative to traditional transplantation. As the market evolves, the labor force in the healthcare industry must adapt to the latest technological advancements to provide optimal patient care. The market's growth is further influenced by the increasing number of heart surgeries and diagnosis facilities, offering various treatments for cardiovascular disorders.
The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD billion " for the period 2024-2028, as well as historical data from 2018 - 2022 for the following segments.
Artificial Organs Market: Artificial Organs Market by Product, Usage, and Geography - Forecast and Analysis
Cardiac Prosthetic Devices Market: Cardiac Prosthetic Devices Market Analysis North America, Europe, Asia, Rest of World (ROW) - US, Germany, UK, China, Canada - Size and Forecast
Prosthetic Heart Valves Market: Prosthetic Heart Valves Market by Product and Geography - Forecast and Analysis
The global market is witnessing significant growth due to the increasing prevalence of cardiovascular disorders, an aging population, and recent technological advancements. According to the Census Bureau, cardiovascular diseases account for over 30% of all deaths in the US. Smoking and sedentary lifestyles are major contributors to this statistic. Manufacturing units and healthcare technology companies are focusing on developing advanced artificial hearts, such as mechanical hearts and ventricular assist devices (VADs), to address the growing demand for alternatives to traditional transplantation. These devices, made from advanced materials like biocompatible polymers and metals, are designed to mimic the functions of heart ventricles. End-users, including hospitals, clinics, healthcare centers, diagnosis facilities, and treatments centers, are adopting these devices due to their lower costs and easier availability compared to transplants.
Furthermore, reimbursement policies and insurance coverage for artificial hearts are also improving, making them more accessible to patients. Regulatory approvals, such as those from the FDA, and favorable policies, like the FDA's approval of the first total artificial heart, are propelling the market forward. The use of robotics, materials science, and biotechnology in the development of artificial hearts is also emphasized, as these technologies offer potential for more efficient and effective devices. In conclusion, the market is poised for continued growth, driven by the increasing burden of cardiovascular disorders, an aging population, and technological advancements. Healthcare professionals and patients alike are gaining valuable knowledge about these devices and their potential to revolutionize heart care.
Market Scope |
|
Report Coverage |
Details |
Page number |
140 |
Base year |
2023 |
Historic period |
2018 - 2022 |
Forecast period |
2024-2028 |
Growth momentum & CAGR |
Accelerate at a CAGR of 11.64% |
Market growth 2024-2028 |
USD 1.83 billion |
Market structure |
Fragmented |
YoY growth 2023-2024(%) |
10.12 |
Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
Performing market contribution |
North America at 44% |
Key countries |
US, Germany, France, Japan, and China |
Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
Key companies profiled |
Abbott Laboratories, Berlin Heart GmbH, BiVACOR Inc., Boston Scientific Corp., Calon Cardio Technology Ltd., CARMAT SA, Corcym Srl, CorWave SA, Cryolife Inc., Edwards Lifesciences Corp., Evaheart Inc., Jarvik Heart Inc., JenaValve Technology Inc., Johnson and Johnson Services Inc., LivaNova PLC, Medtronic Plc, MyLVAD Foundation LTD., Quest Diagnostics Inc., SynCardia Systems LLC, and Terumo Corp. |
Market dynamics |
Parent market analysis, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, Market condition analysis for market forecast period |
Customization purview |
If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Product
7 Customer Landscape
8 Geographic Landscape
9 Drivers, Challenges, and Opportunity/Restraints
10 Competitive Landscape
11 Competitive Analysis
12 Appendix
Get the report (PDF) sent to your email within minutes.
Get lifetime access to our
Technavio Insights
Quick Report Overview:
Cookie Policy
The Site uses cookies to record users' preferences in relation to the functionality of accessibility. We, our Affiliates, and our Vendors may store and access cookies on a device, and process personal data including unique identifiers sent by a device, to personalise content, tailor, and report on advertising and to analyse our traffic. By clicking “I’m fine with this”, you are allowing the use of these cookies. Please refer to the help guide of your browser for further information on cookies, including how to disable them. Review our Privacy & Cookie Notice.