The cardiovascular devices market was valued at about USD 47,105 million in 2020, and it is expected to register a CAGR of 6.7% over the forecast period, 2021-2026.
The COVID-19 pandemic impacted the production of cardiovascular devices in 2020. Furthermore, the delay of elective procedures due to COVID-19-related measures has adversely affected the cardiovascular medical devices market, especially in 2020. While some cardiovascular procedures are considered urgent, others have been postponed and delayed since the beginning of the global pandemic. Hence, lifestyle changes and medication can be temporarily prescribed instead of cardiovascular procedures for some patients. Another factor negatively impacting the market is the reduction in the diagnosis of cardiovascular diseases due to healthcare resources being reserved for COVID-19 patients. Many medical device companies have experienced losses in their cardiovascular devices business due to the pandemic. For example, Medtronic announced a 33% reduction in its cardiac and vascular business sector in its 2020 quarterly financial results.
However, there are several drivers that are expected to boost the market over the forecast period. The major factor driving the market is the rising global burden of various coronary heart diseases, such as stroke and cardiomyopathy, which cause a global burden of cardiac deaths. Cardiovascular diseases are found to be most prevalent across the world, and they are the leading causes of death. As per the 2020 updates of WHO, ischemic heart disease is responsible for 16% of the world’s total deaths. Since 2000, the largest increase in deaths has been for ischemic heart disease, rising by more than 2 million to 8.9 million deaths in 2019. Such high prevalence leads to a huge economic burden on healthcare systems of every country. As per the 2018 white paper of the Global Coalition for Circulatory Health, by 2030, the total global cost of CVD is set to rise from approximately USD 957 billion in 2015 to USD 1,044 billion.
Moreover, technologies used in the development of cardiology devices have improved significantly over the past decade, and indications for these devices have expanded. This has led to an increasing number of patients being managed with cardiology devices, resulting in exponential therapeutical and monitoring outcomes. Artificial intelligence is one such advancement having a significant positive impact on cardiology with improved capabilities to diagnose certain heart conditions. For instance, in October 2020, GE Healthcare received the US FDA 510k clearance for its ultra-edition package of vivid cardiovascular ultrasound systems, which include new features based on artificial intelligence (AI) that enable clinicians to acquire faster, more repeatable exams consistently.
However, the stringent regulatory policies are expected to be one of the major factors restraining the growth of the cardiovascular devices market. Furthermore, if the devices do not comply with the guidelines mentioned by regulatory authorities, they are not approved in the market, which can result in significant loss of investment for the manufacturers. When the devices do not meet the USFDA criteria, there are chances for device recalls, which are very high in the case of cardiovascular devices, thereby negatively impacting the market studied. For instance, in February 2020, the USFDA issued Class I recall to Abbott’s NC Trek RX and NC Traveler RX Coronary Dilatation Catheters due to failure of the balloon (diameter 4.0mm, 4.5mm, and 5.00mm) to deflate.
Key Market Trends
The ECG Sub-segment Dominated the Diagnostic and Monitoring Devices Segmentation
On the diagnostic and monitoring front, a new generation of portable and compact ECGs is driving its greater adoption, especially in the home healthcare segment. There has been an increase in the incidence of cardiovascular diseases (CVD), wherein long-term ECG monitoring is necessary.
Moreover, with the introduction of wireless ECG, doctors can monitor and diagnose the patient remotely on time, which further fuels the market. In September 2020, Cardiologs, an artificial intelligence (AI) cardiology diagnostics company, entered an exclusive distribution agreement in France with MicroPort CRM for the reselling of its cloud analysis solution for Holter ECGs.
Among the new technologies in cardiac devices, wearable smart devices equipped with heart-monitoring capabilities, such as bands, watches, and rings, have become the norm for many people globally. In September 2020, Fitbit received the US FDA clearance for its heart-monitoring electrocardiogram (EKG) app on Fitbit’s new Sense smartwatch. The feature can track heart rhythms and look for signs of atrial fibrillation, the most common type of irregular heartbeat.
In October 2019, iRhythm, a digital healthcare company, launched its Zio system in the United Kingdom to support the identification and clinical diagnoses of cardiac arrhythmias, such as atrial fibrillation (AF). The Zio system is a small wearable heart monitor that attaches to the patient’s chest for a period of up to 14 days. With the rapid pace of technological advancements in cardiac monitoring and diagnostic devices, the future of cardiovascular devices looks promising.
The United States is Expected to Dominate the Market Over the Forecast Period
The United States dominates the cardiovascular devices market, owing to the high prevalence of cardiovascular diseases, the high adoption rate of minimally invasive procedures, the presence of reimbursements, the rising geriatric population, and the high demand for continuous and home-based monitoring.
According to the American Heart Association Research Report 2018, heart disease accounts for 1 in 7 deaths in the United States. Coronary heart disease is the leading cause (43.8%) of deaths attributable to cardiovascular disease in the United States, followed by stroke (16.8%), heart failure (9.0%), high blood pressure (9.4%), diseases of the arteries (3.1%), and other cardiovascular diseases (17.9%). This scenario is leading to a higher demand for better treatment with efficient medication, driving the market in the United States.
Additionally, few of the key market players in the country are developing novel products and technologies to compete with the existing products, while others are acquiring and partnering with other companies trending in the market. In September 2020, Abbott restarted its LIFE-BTK clinical trial to evaluate the safety and effectiveness of the company’s new Esprit BTK Everolimus Eluting Resorbable Scaffold System. This is the first investigational device exemption (IDE) trial in the United States to evaluate a fully bioresorbable stent to treat blocked arteries below the knees, or critical limb ischemia (CLI), in people battling advanced stages of peripheral artery disease (PAD).
Furthermore, supportive awareness initiatives to create disease awareness are projected to support the market for cardiovascular devices in the North American region. For instance, in 2020, Mexico joined the HEARTS initiative to strengthen primary healthcare for CVD. Promoted by the Pan American Health Organization/World Health Organization (PAHO/WHO), the initiative aims to improve the prevention and control of hypertension at the primary care level.
The cardiovascular devices market is consolidated and highly competitive. The major players have established themselves in specific segments of the market. Furthermore, the companies are competing in the emerging regions with global players, as well as with established local players. Key players are developing and launching novel products and technologies to compete with the existing products, while others are acquiring and partnering with other companies trending in the market. For instance, in January 2020, Medtronic PLC received the US Food and Drug Administration (FDA) approval for its Micra AV, the world’s smallest leadless pacemaker with atrioventricular (AV) synchrony.
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