Cardiac Assist Devices (CADs) are hemodynamic support devices that improve the pumping efficiency and maintain optimum blood flow throughout the body. They are used to treat end stage heart failure.
The global cardiac assist devices market size was worth $ 977 million in 2018 and is forecasted to reach $ 2384 million by 2026, at a CAGR of 11.8% during the forecast period (2019-2026).
Market Dynamics: Drivers, Restraints, Opportunities Challenges:
The cardiac assist devices market growth is driven by increasing prevalence of heart failures and number of patients with cardiovascular diseases (CVDs) which drives the demand for cardiac assist devices as they helps mechanically pump blood in patients with heart failures or weakened heart.
According to the National Health and Nutrition Examination Survey (NHANES) data (2016), an estimated 6.2 million American adults ≥20 years of age (2.2%) had heart failure between 2013 and 2016 compared with an estimated 5.7 million between 2009 and 2012. More than 5.7 million Americans suffer from heart failure, and there are approximately 915,000 new patients diagnosed with the disease annually. For patients with advanced heart failure stage, ventricular assist devices support the weakened heart by pumping blood through the body.
Increasing technological advancements in devices is also fuelling the growth of the cardiac assist devices globally. For instance, in June 2017, International Biophysics, a global medical device manufacturer, launched FloPump 32, the smallest centrifugal pumps in the world at 32ml prime, which is designed and intended to be used in conjunction with the Maquet® RotaFlow™ console. Also in August 2017, Abbott launched its Full MagLev™ HeartMate 3™ Left Ventricular Assist System (also known as an LVAD). The HeartMate 3 system provides a new option for physicians managing advanced heart failure patients in need of short-term hemodynamic support (bridge-to-transplant or bridge to myocardial recovery). Hence, the advancements in devices improve the quality of life for patients recovering from heart failures.
In addition, lack of heart donors, rising number of patients waiting for heart transplantation is driving the demand for alternative approaches such as ventricular assist devices (VADs). According to the organ donation data by the U.S. Department of Health & Human Services, approximately 115,000 people in the U.S. were on the waiting list for a lifesaving organ transplant by August 2017.
Rising government funding for product development along with ongoing research activities are also driving the growth of the cardiac assist devices market. For instance, in 2018, CorWave, a France based medical equipment company raised about USD 16.5 million to support CALYPSO Research and Development (R&D) program involved in the development of CorWave Neptune device, a new LVAD. Also, in 2016, Jarvik Heart received an approval for Investigational Device Exemption (IDE) clinical trial to test its miniature LVAD system in infants and children.
However, high cost of ventricular assist devices (VADs) for advanced heart failure coupled with expensive follow up care is restraining the growth of the cardiac assist devices market. On an average, the VADs costs around US$ 100,000 and the total procedure costs around US$ 700,000 over a six year period. The high cost of the device and procedures is too expensive for the low and middle income patient population, hence, declining the demand and growth of the market.
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Global Cardiac Assist Devices Market, By Type:
• Ventricular Assist Device
o Left Ventricular Assist Device (LVAD)
o Right Ventricular Assist Device (RVAD)
o Bi-Ventricular Assist Device (BIVAD).
• Total Artificial Heart
• Intra-Aortic Balloon Pump
Among these, the ventricular assist devices segment accounted for the largest market share of the cardiac assist devices in 2018, owing to the high adoption of the product among patients. Ventricular assist device (VAD) consists of an electric motor & a driveline which is implanted in the patient’s chest. It helps in pumping the blood through the heart to the entire body and has the required force to distribute sufficient blood throughout the body.
The ventricular assist device is further classified into Left Ventricular Assist Device (LVAD), Right Ventricular Assist Device (RVAD), and Bi-Ventricular Assist Device (BIVAD). Among these, left ventricular assist device held the largest market share of more than 70% in 2018, due to rising number of LVAD implantation. For instance, till May 2018, approximately, 26,600 heart failure patients were implanted with HEARTMATE II LVAD by Abbott. Also, increasing advancements in LVAD technologies is expected to further propel this demand. For instance, In October 2018, Abbott received US FDA approval for the HeartMate 3™ Left Ventricular Assist Device (LVAD) as a destination therapy for people living with advanced heart failure. Also, in 2016, ReliantHeart received CE mark, for aVAD-a left VAD. It includes features such as flow measurement and remote monitoring.
Global Cardiac Assist Devices Market, By Application:
• Bridge-to-transplant (BTT) Therapy
• Destination Therapy
• Others (such as bridge-to-recovery (BTR) therapy, and bridge-to-candidacy (BTC) therapy).
Among these, the destination therapy is estimated to grow at the highest CAGR during the forecast period (2019-2026), owing to high success rate, structural innovations, and higher quality of life with ventricular assist devices for destination therapy. For instance, from 2006 to 2007, more than 42% of VAD patients were listed for transplant and only 14.5% for destination therapy. The trend was reversed later, as from 2011 to 2013, there were more than 41% implanted devices were for destination therapy and only 21% for the transplant. In October 2019, Abbott received FDA approval for the HeartMate 3 left ventricular assist device (LVAD) as destination therapy for advanced heart failure patients ineligible for a transplant. The heart pump was approved as a bridge-to-transplant option in August 2017, but is now available for use as a destination therapy. It has been approved in Europe for both indications since October 2015. Hence, the increasing product approval by manufacturers is expected to increase the adoption of VAD for destination therapy.
North America is dominating the cardiac assist devices market in 2018 and estimated to hold largest market size over the forecast period (2019-2026), owing to the rising prevalence of heart failure cases. According to the American Heart Association, in 2017, approximately, 790,000 people in U.S. have heart attacks each year. In addition, rising number of people suffering from cardiovascular diseases and growing technological advancements are boosting the demand and adoption rate of cardiac assist devices in this region. In the United States, there are about 4,000 people on the heart transplant listed. Only about 2,000 hearts become available per year. The LVAD is used “bridge” these patients to transplant when waiting is no longer possible.
With increasing number of clinical trials, rising patient awareness about the variety of available products, the demand for cardiac assist devices is increasing in North America. There are various ventricular assist devices programs in various hospitals in this region, which leads to higher adoption rate among patients as these programs are aimed at creating awareness about ventricular assist device systems. For instance, Cleveland Clinic has one of the most experienced ventricular assist devices (VAD) programs in the United States. The Cleveland Clinic has access to FDA- approved ventricular assist devices, as well as new investigational devices. Other programs include Inova’s Heart Failure Program, MedStar Advanced Heart Failure Program, and Michigan Medicine VAD Program.
The Cardiac Assist Devices market is dominated by few major players including Biophan Technologies, Berlin Heart GmbH, Calon Cardio-Technology Ltd., MAQUET GmbH & Co., Teleflex Incorporated, Heart Ware International, Abiomed Inc., Thoratec Corporation, SynCardia Systems, and Bioheart. The players are focusing on product approvals and developing innovative products to strengthen their product portfolio that intensifies the market competition. The key players are adopting various growth strategies such as product launches, mergers & acquisitions, partnerships, and collaborations which are contributing to the growth of the Cardiac Assist Devices market globally. For instance,
• In May 2019, Abiomed launched commercially the Impella CP with SmartAssist at the 2019 Society for Cardiovascular Angiography & Interventions (SCAI).
• In October 2018, Abbott received US FDA approval for the HeartMate 3™ Left Ventricular Assist Device
• (LVAD) as a destination therapy for people living with advanced heart failure.
• In 2018, Calon Cardio-Technology has launched a clinical trial of the UK’s first artificial heart pump
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