Major players in the electrophysiology devices and equipment market are St. Jude Medical, Boston Scientific Corporation, Abbott Laboratories, GE Healthcare and Philips Healthcare. The global electrophysiology devices and equipment market is expected to grow from $3.
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41 billion in 2020 to $3.93 billion in 2021 at a compound annual growth rate (CAGR) of 15.2%. The growth is mainly due to the companies rearranging their operations and recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $5.85 billion in 2025 at a CAGR of 10.5%.
The electrophysiology devices and equipment market consists of sales of electrophysiology devices and equipment and related services.Electrophysiology devices and equipment are used in the diagnosis and treatment of heart rhythm disorders through electrical activity.
The market is segmented by product type into electrophysiology ablation catheters, electrophysiology diagnostic catheters and electrophysiology lab systems.
Lack of uniformity in the regulations governing the electrophysiology devices and equipment industry sometimes restrict the companies in the market from expanding globally, thereby hampering the market’s growth.The impact of individual country regulatory requirements can have huge implications to the availability of new electrophysiology devices and equipment.
According to regulations in few geographies, the manufacturers are required to conduct clinical trials (premarket and/or post-market) be either in whole or in part within a country.However, in markets such as Brazil, Japan, India, and China where local regulations are still in nascent stage, the cost to run the trials incur to the manufacturers.
Example, trials for devices like cardiac rhythm management (CRM) in multiple countries has less merit, and does not reflect the true test results as it becomes difficult for the manufacturers to provide sufficient devices to run tests.
In July 2018, Boston Scientific acquired the rest of 65% stake in Cryterion Medical Inc. for $202 million in cash. The acquisition has made Boston Scientific, the first company to have both cryothermal and radiofrequency (RF) single-shot ablation therapies in its portfolio. The acquisition is expected to improve the revenue of Boston Scientific in near the future with new expanded product portfolios. Cryterion Medical Inc. focuses on single-shot cryoablation platform for the treatment of atrial fibrillation or AF disease. It was founded in 2016 and is headquartered in California, USA.
In order to increase the profit margins and sales, the companies operating in the Electrophysiology (EP) devices and equipment industry are coming up with new technologies aimed towards improving EP mapping and localization technology.EP mapping is a procedure used to diagnose the origins of the abnormal heart rhythms.
This procedure uses an electrically sensitive catheter.With improved mapping technologies it becomes easy to detect and locate the abnormalities in heart.
For example, in January 2019, Abbott started its sensor-enabled TactiCath contact force ablation catheter for the treatment of atrial fibrillation. It is designed to provide accurate images of the heart extended with real-time electricity activity information .
The Reuse of single use device (SUD) is permitted by The Medicines and Healthcare products Regulatory Agency (MHRA) may impact the electrophysiology devices and equipment market growth as few of the products within the market may be reused.The MHRA allows the reuse of electrophysiology catheters, however, the device should be adherent to the medical devices directive and should have a CE mark.
The reuse or reprocessing of electrophysiology catheters by electrophysiology (EP) laboratories in the US helps in reducing the costs of these devices and lessen the environmental burden of the discarded bio-waste materials. As there is no clear regulation on reuse in the developing nations such as Africa, Asia, Eastern Europe, Central America, and South America, the electrophysiology devices and equipment market may face few challenges.
Increase in prevalence rate of cardiovascular diseases (CVD) forms one of the major driver for the industries operating in electrophysiology devices and equipment market.CVD cases remains the leading cause of death across globe, which increases the demand for a quick and effective treatment of the disease, thus increasing the demand for electrophysiology devices.
According to the data released by American Heart Association (AHA) in 2019, at least 48% of all the adults in the USA have some form of cardiovascular disease. CVD prevalence excluding high blood pressure among adults in the USA is 9% (24.3 million in 2016). Also, according to the Centers for Disease Control and Prevention (CDC), by 2030, 12.1 million people in the United States will suffer from atrial fibrillation , which is the most common type of heart arrhythmia.
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