Ventricular Assist Device Market Size, Share & COVID-19 Impact Analysis, By Product (Left Ventricular Assist Device, Right Ventricular Assist Device and Bi-Ventricular Assist Device), By Type (Pulsatile Flow, and Continuous Flow), By Application (Bridge to Transplant (BTT), Bridge to Candidacy (BTC), Destination Therapy (DT) and Bridge to Recovery (BTR)), By End user (Hospitals & ASCs and Specialty Clinics & Others) and Regional Forecasts, 2021-2028

The global ventricular assist device market size was USD 1.12 billion in 2020 and is projected to grow from USD 1.23 billion in 2021 to USD 2.24 billion in 2028, at a CAGR of 8.9% during the 2021-2028 period. The global impact of COVID-19 has been unprecedented and staggering, with witnessing a positive impact on demand across all regions amid the pandemic. Based on our analysis, the global market exhibited a stellar growth of -9.19% in 2020 compared to the average year-on-year growth during 2017-2019. The sudden rise in CAGR is attributable to this market’s demand and growth, returning to pre-pandemic levels once the pandemic is over.

Globally, the incidence of heart failure is increasing due to the lifestyle changes and diseases associated with it. For instance, according to the Global Health Data Exchange (GHDx) registry, in 2020, globally 64.37 million people were suffering from heart failure. The mortality rate due to heart failure can be improved by using effective therapies and devices such as implantable cardiac defibrillator (ICD), cardiac resynchronization therapy (CRT) and ventricular assist devices, among others. VADs are used in patients with advanced heart failure as a final treatment or as a bridge to transplant, which acts as a device placed until the heart transplant.

The heart failure devices are often used in the treatment of patients suffering from the risk of cardiac complications. Thus, the demand is increasing for these devices to treat the underlying problem of heart failure. For instance, according to the Scientific Registry of Transplant Recipients (SRTR), it is estimated that approximately 42% of all heart transplant patients had a ventricular assist device at the time of heart transplant. Due to the increasing demand for heart failure devices, companies are focusing on the R&D of heart failure devices. For instance, in November 2020, Abbott launched CE marked new EnSite X EP System, a 3D cardiac mapping platform in Europe & Australia. The EnSite X System is the only system that offers the option to navigate cardiac anatomy two different ways on one platform.

To meet the global demand for heart failure devices, companies are focusing on the innovation and production of devices. For instance, Abbott sells the most widely used left ventricular assist devices in the world, which has been implanted in more than 26,600 patients till date. Thus, the factors such as the increasing prevalence of heart failure, awareness regarding treatment for heart failure and rising applications of these devices in heart failure are contributing to the growth of the ventricular assist device market during the forecast period of 2021-2028.

Decreasing Number of Heart Surgeries Slowed Down Market Growth during COVID-19

The outbreak of COVID-19 has had an overall negative impact on the market. Major players operating in the market reported a significant decline in their revenues from the sales of these devices during the COVID-19 pandemic.

Ventricular assist devices reported a significant decline in the demand due to factors such as decline in patient admissions during the COVID-19 pandemic resulting in a decrease in the number of heart surgeries and subsequently hampered the adoption and demand for these devices.

• For instance, according to the National Center for Biotechnology Information (NCBI), the in-hospital admissions for heart failure were reduced by 28% during the COVID-19 pandemic.

Key players reported decline in revenues generated from the sales of heart failure devices, including VAD, owing to the reduced number of heart surgeries as a result of COVID-19 pandemic.

• For instance, Medtronic reported 12.10% decline in sales in 2020 from the cardiac rhythm & heart failure segment as compared to 2019. Abbott recorded a 3.77% decrease in revenues from the heart failure segment as compared to 2019.

LATEST TRENDS

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Increasing Technological Developments Is Boosting Demand for Cardiac Assist Devices

Technological advancements in the healthcare industry are assisting healthcare professional’s record and monitor the clinical data regularly through artificial intelligence with minimal errors. The high-performance capabilities of artificial intelligence (AI) algorithms is the great aid to the healthcare industry. Artificial intelligence can be used to predict risks in certain cardiovascular diseases and improve risk prediction among patients. AI can be used for surgical decision making to help address diverse sources of information, such as patient risk factors, anatomy, history of the disease, patient values and cost, and assist surgeons and patients in making better predictions regarding the consequences of surgical decisions. In cardiothoracic surgery, the machine learning algorithms can outperform standard operative risk scores in predicting intra-hospital mortality after cardiac procedures. Thus, the development of technology in cardiac procedures is likely to propel these devices.

The technological developments in medical devices have enhanced the efficiency of these devices. Thus, the rate of infection through the devices is reduced simultaneously. Latest devices such as HeartMate III and DuraHeart have features such as lower rotational speeds, smaller size, higher efficiency, and enhanced anatomic design. In October 2019, Medtronic received U.S. Food and Drug Administration (FDA) for its new fully implantable device named as HVAD systems. The LVAD is fully implanted without a cable line extending to a power source outside the body. It provides mechanical circulatory support to patients with weakened hearts and helps pump oxygenated blood from the left ventricle into the ascending aorta. Thus, the development of effective these devices in the market is expected to propel the growth of the ventricular assist device market during the forecast period.

DRIVING FACTORS

Increasing Incidence of the Heart Failure to Foster Adoption of these Devices

Heart failure is one of the leading causes of mortality worldwide, affecting more than 1-2% of the population in western countries. According to the American Heart Association (AHA), the prevalence of heart failure is expected to increase at a significant growth rate by 2030, in the U.S. projected to reach over 8 million patients. In 2020, globally, more than 5.5 million individuals will be affected by heart failure.

Citing the increasing number of patients suffering from the condition, various manufacturers are undertaking initiatives for the availability of these devices. For instance, in June 2021, Abbott announced that the company extended its capacity for the effective supply of its ventricular assist device named HeartMate 3 for their patients.

Long Waiting Periods for Heart Transplant Procedures Globally to Propel Product Demand

As the incidence of cardiovascular diseases (CVD) and heart failure is increasing globally, the demand for heart transplantation has increased significantly. However, the unavailability of adequate heart donors to meet the demand has globally resulted in a shortage crisis. According to the Health Resources and Services Administration (US), as of March 2018, there are about 3,980 candidates on the waiting list for heart transplant.

Ventricular assist device is an important tool for the management of heart failure as destination therapy (DT) and bridge-to-transplantation (BTT). Destination therapy and bridge-to-transplantation are the treatments performed for the end-stage heart failure. The U.S. Food and Drug Administration (USFDA) approved the LVADs for the patients with the end-stage heart failure as destination therapy. Also, for bridge-to-transplantation (BTT), the Heartmate III, HVAD and Heartmate II are approved by USFDA. Organ shortages, along with the increasing number of heart failure patients and technological advances in mechanical circulatory support, have increased demand for these devices. According to the data published by the Journal of American Heart Association, during the period of 2007 and 2017, more than 50% of all heart transplant recipients were implanted with these devices in the U.S. Thus, the significant gap between the supply and demand of heart donors is expected to fuel the growth of the market in the coming years.

RESTRAINING FACTORS

Side Effects Associated with these Devices to Limit the Adoption of these Devices

VADs are mechanical circulatory support devices implanted in patients with heart failure. These devices are the life-saving devices for heart failure patients; however, there are several complications are associated with them such bleeding complications, ischemic and hemorrhagic stroke, thrombosis, infections and multi-organ failure. If these conditions are kept untreated, they can be fatal to the patients. For instance, according to the University of Michigan Frankel Cardiovascular Center, almost within 90 days, 60% of patients developed an infection which is responsible for the limited adoption and hampering the ventricular assist device market growth.

The cost of these devices is also very high, which comes along with the higher readmission rates and higher cost for initial hospitalization. For instance, approximately the cost per device comes around USD 85,000, and the overall cost for the initial hospitalization is around USD 197,957 and USD 151,646 for a heart transplant. Thus, the costs associated with the implantation of these devices are very high, which is responsible for limited adoption and subsequently hampering the growth of the market.

SEGMENTATION

By Product Analysis

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Increasing Implantations to Surge Growth of the LVAD Segment

Left ventricular assist device (LVAD) accounted for the highest ventricular assist device market share in 2020 due to the highest number of implantation procedures amongst patients globally. Market players are focusing on the development of these devices for patients with heart failure and other cardiovascular diseases as these devices help the heart to function normally by supporting the chambers of the heart in the patients. For example, in February 2020, Abbott bagged the Breakthrough Device designation from the U.S. FDA for its in-development Fully Implantable Left Ventricular Assist System (FILVAS).

The biventricular assist device (Bi-VAD) segment registers significant share in the market. Bi-VADs are more effective than LVADs in individuals diagnosed with severely decompensated heart failure as they enable efficient working in the heart ventricles. These devices help both the left and right ventricles to move blood through the heart. Thus, above mentioned benefits are responsible for the adoption of these devices and are expected to boost the growth of the market during the forecast period.

By Type Analysis

Numerous Benefits Associated with the Continuous Flow over Pulsatile Flow Devices to Surge Segment Growth

Based on type, the market is segmented into pulsatile flow and continuous flow.

Continuous flow accounted for the highest ventricular assist device market share in 2020, owing to the benefits of continuous flow over pulsatile flow. Continuous flow devices have benefits such as lower maintenance, minimal noise, rare replacements and lesser rotating parts. These benefits of continuous flow devices make it the popular choice among physicians and researchers. To meet the demand in the market, the major market players such as Abbott and Terumo Heart Inc have launched DuraHeart and HeartMate 3 LVADs which are continuous flow devices.

The pulsatile flow device is projected to grow during the forecast period of 2021 to 2028. Pulsatile flow devices have become an accepted therapy for the support of patients with severe heart failure as a ‘bridge to transplantation. As pulsatile flow, systems can closely mimic blood flow characteristics within the heart and vasculature system.

By Application Analysis

Increasing Awareness About Importance of Predictive Diagnostic Testing to Drive Market Growth

In terms of application, this market is segmented into bridge to transplant (BTT), bridge to candidacy (BTC), destination therapy (DT) and bridge to recovery (BTR).

The destination therapy accounts for the highest ventricular assist device market share during 2020 owing to factors such as increase in end-stage cardiac failure incidence. The destination therapy (DT) is an alternative to transplants that can improve functional capacity, extend patients' lives, and relieve symptoms of heart failure. LVADs are used in destination therapy applications for heart patients who are not eligible to undergo heart transplant surgeries.

The increasing government approvals for the use of these devices for destination therapy are driving the growth of the market. For instance, in October 2018, Abbott’s third generation device received an approval by the FDA for implantation in patients with advanced heart failure ineligible for a heart transplant as destination therapy.

However, bridge to transplant (BTT) is growing at a higher growth rate during the forecast period. The assist devices in the bridge to transplant therapy are used for a limited period of time till the patient receives a donor for heart transplant. As these devices are used for a short time, the complications are less for the patients.

By End User Analysis

Hospitals & Ambulatory Surgery Centers (ASCs) to Register Higher CAGR Owing to Demand in Surgical Procedures

In terms of end-user, the ventricular assist device market is segmented into hospitals & ASCs, and specialty clinics & others. The hospitals & ASCs segment is expected to hold the dominant share in the market during the forecast period due to an increase in hospital stay of patients undergoing heart surgeries such as device placement or implant procedure. For instance, according to the article by Medical News Today, a person undergoing heart surgery need to stay in the hospital for at least 7-10 days. This also includes at least a day in the intensive care unit.

The specialty clinics & others are expected to grow at a higher CAGR during the forecast period due to increased number of specialty clinics along with the increase in number of physicians in the developed and emerging countries is projected to support the growth during the forecast period. For instance, by 2021, there are more than 33,368 cardiologists present in the U.S.

REGIONAL INSIGHTS

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The market size in North America stood at USD 0.45 billion in 2020. The dominance of this regional market is attributable to the increasing adoption of advanced diagnostics for the detection of heart failure and the growing prevalence of cardiovascular diseases in the region. According to the Centers for Disease Control and Prevention (CDC), in 2020, an estimated 6.2 million adults in the U.S. will have heart failure. Moreover, an increasing number of collaborations and agreements amongst the key players emphasizing the development of this market is boosting the adoption of these devices in the region.

Europe held the second-largest share in the market and is expected to grow at a significant CAGR owing to the rising investments in the market coupled with newer product launches. For instance, in January 2021, CorWave raised an investment of USD 40 million and is focusing on the development of an implantable heart pump (LVAD) based on a breakthrough technology called the wave membrane pump. Thus, the increasing investments by the key players of the market is emphasizing on the adoption of these devices, which is projected to boost its demand in the region.

The market in the Asia Pacific exhibited a higher CAGR owing to the advancements in the healthcare facilities and favorable government policies. For instance, in India, government initiatives such as ‘Make in India’ are encouraging companies to manufacture and assemble products in India. Thus, the medical device companies are making investments in the region for these devices to increase its adoption in the market, which is projected to boost the market growth.

Latin America and the Middle East & Africa accounted for a comparatively lower share of the market owing to a lack of awareness about these devices and recent developments in the healthcare sector. Moreover, the awareness programs initiated by government organizations lead to the increase in diagnosis and treatment rates for heart failure in these countries, fueling the demand for these devices.

KEY INDUSTRY PLAYERS

Partnerships and Product Innovations to Widen Offerings are Assisting the Firms in Expansion of Business

The global market is fragmented. Abiomed, Medtronic, Abbott are among the top players in the market. The key players focus on developing innovative products and establishing strategic partnerships and collaborations to strengthen their position in the global market. For example, in June 2020, Abiomed received approval for its investigational device exemption application to start an early feasibility study with a first-in-human trial of the 9 French (Fr) Impella ECP heart pump. Also, in June 2021, Abbott expanded its manufacturing capacity and supply to effectively support the growing demand for mechanical circulatory support (MCS) devices for the effective treatment of advanced heart failure.

In October 2019, Medtronic received FDA’s breakthrough device designation for a new implantable heart pump, ‘HVAD’ which is developed to treat patients with advanced heart failure.

Moreover, the other device manufacturers in emerging nations are focusing on developing relatively lower-cost products leading to further market characterization. Other key players offering a wide range of products include Berlin Heart, Cardiac Assist, Inc., Jarvik Heart, Inc., ReliantHeart, Inc., Sun Medical Technology Research Corp and others.

LIST OF KEY COMPANIES PROFILED:

• Abbott Laboratories (U.S.)


• Berlin Heart GmbH (Germany)


• Medtronic (Ireland)


• Cardiac Assist, Inc. (U.S.)


• Jarvik Heart, Inc. (U.S.)


• ReliantHeart (U.S.)


• ABIOMED (U.S.)


• Sun Medical Technology Research Corp (Japan)

KEY INDUSTRY DEVELOPMENTS:

• May 2021 – Abiomed has received approval from the Ministry of Health, Labor and Welfare (MHLW) in Japan for the Impella CP heart pump. This approval marks a significant milestone to provide Impella hemodynamic support for heart failure patients, which will boost the growth of the company.


• December 2020- Abbott has received U.S. Food and Drug Administration (FDA) approval for the updated labeling for the company's HeartMate 3 heart pump to be used in pediatric patients with advanced refractory left ventricular heart failure.

REPORT COVERAGE

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The ventricular assist device market research report provides a detailed analysis of the market and focuses on key aspects such as leading companies, product types, and leading applications of the product. Besides this, the report offers insights into the market trends and highlights key industry developments.                   

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