By Kateryna Hronska and Kamran Zamanian, Ph.D., iData Research Inc.
More than 5.4 million cardiac procedures were performed worldwide in 2022 to manage and monitor heart rhythm.1 Each year, this number increases due to the increasing prevalence of cardiovascular diseases, obesity and diabetes associated with the aging of the population. This article will discuss the key drivers for the growth of these medical devices along with varying usage goals.
Cardiac Rhythm Management Trends and Market Overview
The worldwide growth of cardiac rhythm management (CRM) devices can be attributed to the aging population. Cardiovascular diseases are much more common in patients over the age of 55. Therefore, the aging of the population is directly correlated with the increase in the incidence rate of cardiovascular diseases and the growing need to address them.
According to the World Health Organization, ischemic heart disease is the leading cause of death worldwide, accounting for 32% of all deaths worldwide.2 Therefore, affordable, accurate, and timely diagnostics and treatment options are critical to reducing mortality rates associated with cardiovascular disease. Therefore, companies must be ready to meet the growing demand for CRM devices.
A number of major competitors in the cardiovascular market are benefiting from this market growth, along with new competitors who are bringing new technology to the market.
With the high cost of most CRM devices, North America and Western Europe account for the highest percentage of the total market.1 CRM devices are slowly becoming more prevalent across the world.1
Diagnosis of cardiovascular diseases
As cardiovascular disease remains the leading cause of death worldwide, rapid, affordable and accurate detection of abnormal heart rhythm is crucial to reducing patient morbidity and mortality. Even though the technology is widely available in high-income countries, it is important to note that low-income counties experience a shortage of equipment and understaffed and overcrowded hospitals. It is therefore necessary that public health policies improve the quality of life of patients with cardiovascular diseases.
There are several first-line cardiac tests, which may include blood tests, chest X-rays, stress tests, and an electrocardiogram (ECG). Additionally, there are more complex tests that help in obtaining detailed information about a patient’s heart activity.
Laboratory systems are commonly used devices for cardiac testing. These include 3D mapping systems and electrophysiology (EP) recording systems. These systems combine signals with CT scans to display simultaneous heart maps. With his realistic view of the heart, the doctor can help locate and define a heart problem. To perform the procedure, the hospital must have a specialized laboratory, which is very expensive. Moreover, the number of laboratories available in some countries is very limited, which makes it inaccessible to people living in rural areas or low-income countries. Therefore, this market is developing slowly and facing pressure to lower prices.1 Many countries have no laboratory system at all, including Venezuela, Qatar, Cambodia, Nigeria and others.1
Implantable loop recorders (ILRs) are one type of test available for patients with irregular heart symptoms. Due to the irregularity of symptoms, the doctor may want to implant an ILR, which can monitor heart rate for up to three years to help narrow the scope of the diagnostic process. The ILR is one of the most dynamic markets in CRM, with an annual growth of procedures of more than 10%.1 As of 2022, the ILR market is well established in North America and Western Europe.1 At the same time, other regions of the world are adopting the technology and are expected to experience low double-digit unit sales growth in the near future.1 The downside of the device is its high price and the risks associated with the procedure, such as infection, bleeding, and damage to the heart and/or blood vessels.
Diagnostic cardiac electrophysiology is another strong growth market for cardiac diagnostics. During the procedure, catheters are inserted into an area of the heart to observe electrical activity. Since the doctor can choose to look at different parts of the heart, there are a number of catheters on the market. Conventional catheters make up the largest portion of the market, followed by intracardiac echocardiography (ICE) catheters. The use of ICE catheters is set to grow rapidly.1 ICE catheters have obtained CE and FDA approval for reprocessing, putting downward pressure on catheter market prices. This could be beneficial, as ICE catheters are currently quite expensive, which has led to resistance to widespread adoption.
Cardiac Management Devices
As the incidence of cardiovascular disease increases, so does the need to care for people with heart rhythm disorders. As of 2021, these are the four most popular implantation methods used to manage an irregular heartbeat: pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy, and cardiac ablation procedures.
Generally, the implantation of these devices does not interfere with a person’s life activities. For a time, people living with pacemakers and implantable cardioverter defibrillators had to avoid MRI machines so as not to interfere with the programming of the device. Many manufacturers have recently started offering MRI-compatible pacemakers. These MRI-compatible pacemakers are more expensive than their non-MRI-compatible counterparts, which is hugely beneficial to the overall market as more and more patients opt for an MRI-compatible pacemaker. Medtronic was the first to market its FDA-approved MRI-safe pacemaker in the United States, Revo MRI SureScan.
Pacemakers are the most popular cardiac management devices on the market, with over 1.5 million procedures performed in 2022.1 The device is usually implanted in patients with bradycardia and regulates heart rhythm by sending electrical impulses.3 There are currently four types of devices available on the market: single chamber, dual chamber, triple chamber and lead-free. The fastest growing market in terms of unit sales is for lead-free pacemakers. However, in absolute terms, the dual-chamber pacemaker market will experience the highest growth.1 Although the lead-free pacemaker is a relatively new technology, preliminary reports of its long-term performance and complications are promising, including low complications, few system revisions, and stable pacing parameters.
Implantable cardioverter defibrillators (ICDs) are implanted for patients at risk of sudden cardiac arrest. Clinical trials have shown that ICDs significantly improve the likelihood of patient survival compared to prescribed anti-arrhythmic drugs, such as amiodarone. Similar to pacemakers, there are four types of ICD devices on the market: single chamber, dual chamber, triple chamber, and subcutaneous. The fastest growing market in terms of unit sales and market value is expected to be the S-ICD market, surpassing even the major dual-chamber ICD market.1 Boston Scientific EMBLEM The S-ICD was the first S-ICD in the world to provide protection for patients at risk of sudden cardiac death while avoiding the risks and complications associated with transvenous catheters. One of the main brakes in the market is the high price of the implementation, which varies from $30,000 to $40,000.
Cardiac resynchronization therapy (CRT) devices improve the pumping action of the heart, especially in patients with left ventricular dysfunction and electrical desynchronization between the right and left ventricles. The device market includes cardiac resynchronization therapy pacemakers (CRT-P) and cardiac resynchronization therapy defibrillators (CRT-D). CRT-D devices are very popular, in part because they have the ability to treat most types of arrhythmias and can act as a defibrillator in the event of a sudden cardiac event. Medtronic is the market leader with its CLARIA MRI-compatible CRT-D devices, as well as WIDE, and MRI MRI CRT-D devices with Sure Scan Technology.1
The global CRM market has evolved and grown tremendously in the past, and it is expected to maintain its growth as the needs of the people increase. ICDs and CRTs are the largest markets and are expected to overtake pacemakers in the near future.1 Medtronic remains the leading company in the global market.
- iData Research Inc. Global Cardiac Rhythm Management Device Market – 2022. Published December 2022. https://idataresearch.com/product/cardiac-rhythm-management-market. Accessed December 2022.
- World Health Organization. (nd). The 10 leading causes of death. World Health Organization. Retrieved July 19, 2022, from https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death
- Cardiac Rhythm Management Devices. Australian Journal of General Medicine. (nd). Retrieved July 19, 2022, from https://www1.racgp.org.au/ajgp/2018/may/cardiac-rhythm-management-devices/
About the authors:
Kateryna Hronska is a Research Analyst at iData Research. She works on research projects concerning the medical device industry, publishing the Global Devices for Cardiac Rhythm Management, Electrophysiology and Cardiac Ablation research report.
Kamran Zamanian, Ph.D., is CEO and founding partner of iData Research. He has spent over 20 years working in the market research industry with a dedication to studying medical devices used in the health of patients around the world.
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