Ventricular Assist Devices Market

Market Overview

The global ventricular assist devices market size was valued at USD 2.62 billion in 2022. It is estimated to reach USD 11.01 billion by 2031, growing at a CAGR of 17.3% during the forecast period (2023–2031).

Ventricular Assist Devices (VADs) are mechanical devices used to help or replace the work of a weak or failing heart. They are designed to assist the heart's pumping action and help improve blood flow throughout the body. VADs are typically used in patients with end-stage heart failure or those awaiting heart transplantation. VADs work by taking blood from the patient's weakened ventricle (usually the left ventricle) and pumping it into the aorta, the main artery that carries oxygenated blood to the body. The device is surgically implanted with a pump, power source, and control system.

Depending on the type of VAD, the pump may be either an internal or external device. VADs can be a temporary solution, a bridge to recovery, or a long-term treatment option for patients not eligible for heart transplantation. Some advanced VADs also can monitor and adjust blood flow based on the patient's needs. Overall, Ventricular Assist Devices play a crucial role in improving the quality of life and survival rates for patients with severe heart failure by providing mechanical support to the heart's pumping function.

Market Dynamics

Global Ventricular Assist Devices Market Drivers

Increasing Prevalence of Cardiovascular Diseases

Cardiovascular diseases, including heart failure, hypertension, ventricular septal defect, and stroke, are significant health concerns worldwide. These conditions have increased prevalence due to various factors such as unhealthy lifestyles, sedentary behaviors, smoking, and alcohol consumption. These lifestyle choices contribute to the development and progression of cardiovascular diseases, placing a significant burden on healthcare systems globally.

The rise in cardiovascular disease prevalence among the senior population poses significant challenges to healthcare systems, necessitating the development and adoption of advanced medical technologies and treatments. Ventricular Assist Devices (VADs) are crucial in managing and treating heart failure, providing mechanical support to the weakened heart, and improving patient outcomes. These devices help alleviate symptoms, enhance quality of life, and prolong survival for patients with severe cardiovascular conditions.

Technological Advancements Pertaining to Novel Product Development

Miniaturized devices with complex functions, like infection-prevention technology, have been made possible by recent technological advances. Favorable outcomes associated with these devices, such as improved survival rate, longevity, durability, and functionality, are anticipated to boost the usage rate of VADs. The introduction of novel VADs for complex surgical interventions, especially in the pediatric population, is predicted to increase demand for these devices over the forecast period. For instance, the U.S. FDA approved the continuous-flow LVADs, Micromed HeartAssist 5TM Pediatric VAD, and the Berlin HeartTM EXCOR pediatric VAD for pediatric patients. Berlin HeartTM EXCOR has been approved for use as a bridge-to-transplantation device since 2011. Such factors are predicted to drive market growth over the forecast period.

Global Ventricular Assist Devices Market Restraint

High Procedure Cost

Procedural costs in VADs include the cost of the device, implantation, standard care hospitalization, readmission, and implant replacement. According to AP News, in October 2018, hospitals paid around USD 80,000 for a HeartWare device and USD 95,000 for HeartMate, as per the research by the Decision Resources Group. These costs, combined with other procedural costs, are expensive for consumers. In the U.S., most VADs for bridge-to-transplant and destination therapy are covered under Medicare. The overall cost of the procedure is higher in Asia-Pacific and the Middle East, even though the costs are reimbursable. Hence, high cost is a limiting factor likely to hamper market growth. Therefore, companies are constantly trying to develop cost-effective treatments with better survival rates and fewer readmission costs.

Global Ventricular Assist Devices Market Opportunity

Rising Government Initiatives

The global ventricular assist devices (VADs) market presents significant opportunities, particularly with the support of government initiatives such as funding from the National Institutes of Health (NIH). Government funding is vital in advancing research, development, and innovation in VADs. As a major research funding agency, the NIH provides financial support for various scientific investigations related to cardiovascular diseases, including developing and improving VAD technologies. This funding enables researchers and medical device companies to conduct clinical trials, explore new treatment approaches, and enhance the effectiveness and safety of VADs.

Government initiatives and funding also contribute to the adoption and accessibility of VADs in healthcare systems. They facilitate the evaluation and approval processes, regulatory compliance, and reimbursement policies, making VADs more accessible to needy patients. These initiatives also encourage collaboration between research institutions, medical device manufacturers, and healthcare providers, fostering innovation and driving advancements in VAD technology.

Regional Analysis

North America Dominates the Global Market

Based on region, the global market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America is the most significant global ventricular assist devices market shareholder and is anticipated to exhibit a CAGR of 17.5% over the forecast period. The North American region is experiencing significant growth in the ventricular assist devices (VADs) market due to various factors. Economic development, advanced research and development facilities, and renowned universities and hospitals contribute to the region's product development and commercialization capability. These factors provide a conducive environment for innovation and technological advancements in VADs. In addition, the increasing prevalence of cardiac diseases in North America is a major driver for market growth. Sedentary lifestyles, unhealthy dietary habits, high consumption of alcohol and tobacco, and substance abuse contribute to the rising incidence of cardiac conditions. As a result, there is an expanding requirement for effective treatment options like VADs to manage advanced heart failure and improve patients' quality of life. North America also benefits from well-established reimbursement policies, which are crucial for the acceptance and availability of VADs. Reimbursement support ensures that patients can afford these life-saving devices, encouraging their utilization and driving demand in the market.

Europe is predicted to exhibit a CAGR of 17.1% over the forecast period. Europe, with its diverse population and a high proportion of elderly individuals, faces a significant burden of cardiovascular diseases (CVDs). The statistics provided by the European Society of Cardiology highlight the severity of the situation, with a mortality rate of nearly 50% for CVDs in Europe and 40% in the EU. The economic impact of these diseases is also substantial, estimated at around USD 215.9 billion for the EU. In addition, the high prevalence of CVDs in Europe creates a strong demand for effective treatment options, including implantable ventricular assist devices (VADs). These devices offer mechanical circulatory support to patients with advanced heart failure, helping to improve their quality of life and potentially prolonging their survival. With the growing senior population in Europe, the demand for VADs is expected to increase significantly over the forecast period.

The Asia-Pacific region is poised for high GDP growth in the coming years, primarily driven by economic progress in India, China, Singapore, Indonesia, and Australia. This economic growth creates favorable conditions for the healthcare sector, including adopting advanced medical devices and systems, including ventricular assist devices (VADs). Governments in the Asia Pacific region actively promote the adoption of advanced healthcare technologies, including medical devices, through various initiatives. These initiatives aim to enhance healthcare services and improve patient outcomes. By encouraging healthcare providers and organizations to adopt technologically advanced devices, governments are driving the growth of the VAD market in the region.

The Latin American region, supported by key economies like Brazil, Mexico, and Venezuela, is witnessing an increase in the prevalence of cardiovascular diseases. Efforts to improve healthcare access, reimbursement policies, and the demand for advanced medical devices drive the region's ventricular assist device market. The need for technological advancements and the rising incidence of heart diseases creates opportunities for developing and adopting advanced medical technologies in Latin America's healthcare industry.

The Middle East region's economic growth and development, particularly in countries like Saudi Arabia, Kuwait, Qatar, UAE, and Oman, are driving improvements in the healthcare sector. The focus on enhancing the reimbursement scenario, investments in healthcare infrastructure, and the burden of CVDs are important elements promoting the development of the ventricular assist device market in the region.

Segmental Analysis

The global ventricular assist devices market is bifurcated into products, types of flow, applications, and designs.

Based on products, the global market is bifurcated into left ventricular assist devices, right ventricular assist devices, bi-ventricular assist devices, and total artificial heart.

The left ventricular assist devices segment dominates the global market and is predicted to exhibit a CAGR of 16.90% over the forecast period. Left ventricular assist device segment can be further categorized as continuous-flow left ventricular assist devices and pulsatile-flow left ventricular assist devices. According to Annals of Cardiothoracic Surgery, in May 2021, continuous flow was the most widely used left ventricular assist device. In addition, these devices are featured with advanced ventricular assist device technology with increased reliability and durability, potentially beneficial for long-term support. For instance, HeartWare and HeartMate II left ventricular assist devices are among the key products available in the market for the treatment of heart failure. Key players in this market include Abbott, Medtronic, Evaheart, and Ventracor. These players focus on the development of innovative left ventricular assist devices.

Based on the type of flow, the global market is bifurcated into pulsatile flow and continuous flow.

The continuous flow devices segment owns the highest market share and is anticipated to exhibit a CAGR of 11.5% over the forecast period. The continuous component of the ventricular assist devices (VADs) market holds the largest revenue share, primarily due to the growing demand for miniature VADs that offer high durability and energy efficiency. Continuous-flow left ventricular assist devices have become the standard of treatment for long-term mechanical support, replacing pulsatile-flow LVADs in the past decade. This shift is supported by data showing the effectiveness of continuous-flow devices in bridging patients to heart transplantation and serving as destination therapy. In addition, continuous-flow VADs offer several mechanical advantages over pulsatile-flow devices. They are smaller, allowing for easier implantation, and they have longer endurance, reducing the need for frequent device replacements. Continuous-flow VADs are also simpler to operate and maintain than their pulsatile counterparts.

Based on the applications, the global ventricular assist devices market is bifurcated into bridge to transplant, destination therapy, and others.

The bridge-to-transplant segment dominates the global market and is projected to exhibit a CAGR of 16.2% over the forecast period. The bridge-to-transplant segment is expected to grow significantly during the forecast period. This might be connected to a rise in the number of heart transplant surgeries and the incidence of cardiovascular diseases. In addition, ventricular assist devices are bridge-to-transplantation devices to help patients stabilize their physiological stress during transplantation surgeries. Ventricular assist devices, in this case, are used for a short-term period (2 to 6 months only). 

Based on the design, the global market is bifurcated into implantable ventricular assist devices and transcutaneous ventricular assist devices.

The implantable ventricular assist devices segment owns the highest market share and is projected to exhibit a CAGR of 17.9% over the forecast period. Increasing preference for long-term treatment methods by patients not eligible for a heart transplant is expected to drive the segment's revenue. New companies are entering the market focused on developing innovative products. For instance, FineHeart SARL is a technology company that develops miniature implantable, pulsatile-flow VADs. Similarly, Abbott's HeartMate 3 LVAD is a magnetically levitated (MagLev) technology-based cardiac pump created to lower the trauma caused by blood flowing through pumps during the blood flow optimization process. However, risks associated with adopting these devices, such as severe bleeding, infection at the incision site, right HF, development of blood clots, and device malfunctions limiting the amount of blood pumped to the body, are anticipated to hamper segment growth.

Recent Developments

• March 2023- Abbott announced the launch of its new HeartMate 3 VAD, designed to be smaller, lighter, and more durable than previous models.
• February 2023- Medtronic announced the FDA approval of its HeartWare HVAD 3.0 VAD, the first VAD approved for use in children as young as 12.