Electrophysiology Devices Market

Market Overview

The global electrophysiology devices market size was valued at USD 7.6 billion in 2023 and is projected to reach USD 20.2 billion by 2032, registering a CAGR of 11.3% during the forecast period (2024-2032). An increase in the occurrence of cardiac arrhythmias, a rise in the geriatric population, technological improvements, and developing countries focusing on strengthening healthcare infrastructure are projected to fuel worldwide Electrophysiology Devices market growth.

Electrophysiology (EP) devices are medical equipment used to detect and treat cardiac arrhythmias and other electrical disorders of the heart. These devices are critical in measuring the heart's electrical activity, mapping arrhythmias, administering therapeutic therapies, and tracking patient outcomes. 

Furthermore, the rising prevalence of chronic diseases such as diabetes, hypertension, and thyroid disorders is driving the expansion of the electrophysiology devices market share. People with diabetes and hypertension are more likely to develop atrial fibrillation. Furthermore, the rise in the prevalence of senior patients, who are more vulnerable to cardiac arrhythmia illnesses as they age, drives market growth. However, the high cost is projected to limit electrophysiology (EP) market growth over the projection period. 

Moreover, technological advancements in the pharmaceutical industry to create advanced electrophysiology catheters will likely provide lucrative prospects for worldwide market expansion throughout the forecast period.

Highlights

• Ablation Catheters occupy the maximum share of the market based on device type.
• Atrial Fibrillation (AF) generates the highest revenue share by indication.
• Inpatient Facilities are the major end-users of the market.

Market Dynamics

Global Electrophysiology Devices Market Drivers:

Increasing Prevalence of Cardiac Arrhythmias

The increasing frequency and prevalence of cardiac arrhythmias such as atrial fibrillation, atrial flutter, and ventricular tachycardia are important market drivers for electrophysiology devices. Aging populations, sedentary lifestyles, obesity, and the increased burden of cardiovascular disease all contribute to an increase in the prevalence of arrhythmias globally. The American Heart Association estimates that atrial fibrillation (AFib) will affect 6 million people in the United States by 2023. AFib is the most prevalent abnormal heart rhythm in the United States, affecting between 2.7 and 6.1 million people at any one time. The number of patients with AFib is expected to climb to 12.1 million by 2030. This number will likely climb dramatically in the coming years as populations age and risk factors become more prevalent. In 2023, the age-standardized prevalence of atrial fibrillation (AF) was 2.3% in persons over 40 and 5.9% in those over 65. 

Similarly, the incidence of ventricular arrhythmias varies with the underlying heart disease. According to AHA Journals, the age-adjusted incidence of idiopathic ventricular arrhythmias is 51.86 per 100,000, and it rises with age. The prevalence of ventricular tachycardia is similar in both sexes. However, PVCs are more common in women. Supraventricular tachycardia (SVT) is another common cardiac arrhythmia distinguished by fast heart rates that originate above the ventricles. According to the NCBI, the prevalence of supraventricular tachycardia (SVT) is 2.25 per 1,000 people, with women having twice the chance of getting SVT as men. SVT is a type of arrhythmia that affects cardiac tissue in the His bundle or higher. It is most common among adults aged 35 to 48. 

As the prevalence of arrhythmias grows, there is an increasing demand for enhanced diagnostic and therapeutic solutions given by electrophysiological devices to improve patient outcomes and lower the risk of complications associated with these disorders. 

Global Electrophysiology Devices Market Restraints:

Limited Reimbursement Policies

Inadequate reimbursement for electrophysiological procedures and equipment may limit market expansion. Payment policies varied among countries and healthcare systems, resulting in inequities in access to modern electrophysiological technologies. A lack of proper remuneration may discourage healthcare practitioners from investing in expensive equipment and conducting complex operations, impacting market demand and adoption. 

Additionally, in 2023, the United States Centers for Medicare & Medicaid Services (CMS) reduced coverage for many sophisticated electrophysiology (EP) ablation operations. The changes are primarily connected to ablation operations, which decreased considerably between 2021 and 2023 physician payments. While Medicare and commercial insurance companies usually fund medically essential electrophysiological procedures, reimbursement rates may not accurately reflect the expenses of these sophisticated operations. The Omnibus Spending Bill, passed by Congress on December 19, 2022, partially reduces Medicare Physician Fee Schedule (MPFS) payment reduction in 2023 and 2024. However, the bill does not include a clause directing CMS to use the RUC-recommended values for add-on ablation services. 

In addition, in Europe, reimbursement regulations for electrophysiology operations vary by country and healthcare system. While some nations offer extensive coverage for electrophysiological services, others may have rigorous reimbursement criteria or low reimbursement rates for specific operations. For example, Germany reimburses all 13 ATMPs for 14 indications, the Netherlands reimburses six ATMPs, and England and Wales reimburse 11 of the 12 assessed ATMPs. 

Global Electrophysiology Devices Market Opportunity:

Expanding Indication and Application

Emerging indications, such as premature ventricular contractions (PVCs), represent an increasing market opportunity for electrophysiological device manufacturers. PVCs, while frequently benign, can cause palpitations, chest discomfort, and syncope in certain patients. Catheter ablation has emerged as a viable therapeutic option for symptomatic PVCs, providing comfort and increasing the quality of life for those affected. Developing specialized ablation catheters and mapping technologies for PVC ablation operations creates prospects for device innovation and market expansion.

In addition, catheter ablation can eradicate premature ventricular contractions (PVCs) in up to 85% of patients, making it more successful than medications for PVC treatment. The success rate for catheter ablation is between 80% and 95%. The procedure improves systolic left ventricular function in PVC-induced cardiomyopathy patients. As people become more aware of PVC-related symptoms and treatment possibilities, there will be a greater need for electrophysiological devices to assist PVC ablation treatments.

Furthermore, Pediatric arrhythmias are another area of opportunity for electrophysiology device manufacturers, as children with congenital heart problems or acquired cardiac disorders may require specialist electrophysiological interventions. Developing pediatric-specific electrophysiological devices and techniques customized to pediatric patients' unique anatomy and physiology opens up new business prospects. By addressing unmet clinical needs, developing customized devices for emerging indications, and exploring new therapeutic areas, players can leverage these opportunities to drive development and innovation in the worldwide electrophysiological devices market.

Regional Analysis

The global electrophysiology devices market share is bifurcated into North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global electrophysiology devices market shareholder and is estimated to grow at a CAGR of 11.4% over the forecast period. North America dominated the industry in 2023, accounting for 50% of worldwide sales due to high rates of heart failure, cardiac arrest, and cardiac arrhythmia. The existence of modern healthcare infrastructure, as well as attractive reimbursement rules, are projected to boost the region's growth over the forecast period. 

Additionally, product releases, technological developments, and prominent players in the field of electrophysiology drive market growth. For example, in January 2022, Abbott announced that it had received FDA approval for the EnSite X EP System with EnSite Omnipolar Technology (OT), a new cardiac mapping platform available in the United States and Europe that is intended to help physicians better treat abnormal heart rhythms, also known as cardiac arrhythmias.

Asia-Pacific is anticipated to exhibit a CAGR of 11.8% over the forecast period. The region's expansion is driven mainly by its large senior population, increased risk of heart disease, and unmet therapeutic needs. The region's improved healthcare infrastructure, increased patient awareness, and rising healthcare expenditure levels will help manufacturers capitalize on these accessible prospects. Rapid advancements in healthcare infrastructure and an increase in disposable wealth in emerging economies like India and China are expected to drive up demand for EP systems. 

Furthermore, technological advances in the region are a factor driving market expansion. For example, in August 2021, Shanghai Microport EP Medtech Co., Ltd. partnered with Stereotaxis, Inc. According to the terms of the agreement, Microport EP will distribute Robotic Magnetic Navigation technology for EP in China.

Europe holds a significant market share. The electrophysiological devices market in Europe is expected to increase significantly. The rising frequency of cardiovascular illnesses in Europe will likely drive up demand for electrophysiology devices in the region. For example, an article published in the NCBI indicated that the prevalence of atrial fibrillation in Germany was roughly 2.3% of the overall population.

Segmental Analysis

The global electrophysiology devices market is segmented based on device type, indication, and end-use.

The market is further segmented by device type into Ablation Catheters, Diagnostic Catheters, Laboratory Devices, and Access Devices.

The ablation catheters segment dominated the Electrophysiology Devices market in 2023. Ablation catheters are specialized devices used in cardiac electrophysiology operations to administer energy, such as radiofrequency or cryotherapy, to generate specific lesions in the cardiac tissue. These injuries block the aberrant electrical circuits that cause cardiac arrhythmias, thereby restoring normal heart rhythm. Ablation catheters are available in various designs, including irrigated-tip catheters for efficient energy delivery and contact force sensor catheters for optimal tissue contact and lesion formation. These devices are essential in catheter ablation treatments to treat disorders like atrial fibrillation, ventricular tachycardia, and accessory pathway-mediated arrhythmias. Increased usage of ablation techniques for atrial fibrillation primarily drives this category. 

The diagnostic catheters segment is expected to rise at a substantial CAGR throughout the projection period. Diagnostic catheters are utilized during electrophysiology examinations to record heart electrical impulses and map cardiac arrhythmias. These catheters often have many electrodes or sensors positioned down their shaft to record electrical activity from various parts of the heart. Diagnostic catheters help identify arrhythmia mechanisms, localize aberrant electrical pathways, and detect conduction abnormalities. They are critical for making treatment decisions, arranging ablation treatments, and evaluating treatment outcomes in patients with cardiac arrhythmias. Rising investment by market players in developing novel mapping systems and catheters is one of the key factors expected to drive sector expansion in the coming years.

Based on indication, the market is fragmented into Atrial Fibrillation (AF) and Non-Atrial Fibrillation.

The atrial fibrillation category dominated the market in 2023, accounting for the highest revenue share of 65%. Atrial fibrillation (AF) is a common cardiac arrhythmia characterized by an irregular and often fast heart rate that originates in the atrium. AF is linked to an increased risk of stroke, heart failure, and other cardiac problems. AF is usually managed with rate and rhythm control and anticoagulant medication. Electrophysiology devices are essential in diagnosing and treating AF, including catheter ablation techniques that restore sinus rhythm by ablating aberrant electrical pathways in the atria.

In addition, diagnostic catheters are used in AF management to map arrhythmia substrates, ablation catheters to deliver energy to specific areas, and implantable devices such as pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac monitors for rhythm monitoring and stroke prevention. The British Heart Association predicts that roughly 1.5 million people in the UK will suffer from atrial fibrillation by 2022. Furthermore, the country is estimated to have 270,000 undetected atrial fibrillation patients over the age of 65. The disease's high prevalence accounts for the segment's significant proportion.

Non-atrial fibrillation arrhythmias include various cardiac rhythm problems besides AF, such as ventricular arrhythmias, supraventricular tachycardia (SVT), atrial flutter, and premature ventricular contractions. These arrhythmias can result from a variety of cardiac substrates, including structural heart disease, hereditary arrhythmia syndromes, and electrolyte abnormalities. Electrophysiology devices diagnose, localize, and treat non-AF arrhythmias, including catheter ablation, diagnostic electrophysiology investigations, and implantable device therapies. Diagnostic catheters, mapping systems, ablation catheters, and implanted devices are essential in controlling non-AF arrhythmias, allowing targeted therapies to restore normal heart rhythm and improve clinical outcomes.

The market can be further bifurcated by end-use into Inpatient and outpatient Facilities.

The inpatient facility segment had the most significant global revenue share, accounting for 85%. Inpatient facilities are healthcare settings where patients receive treatment that necessitates admission and overnight stays, such as hospitals and specialized cardiac care units. Electrophysiology procedures are carried out in dedicated electrophysiology labs, or catheterization laboratories outfitted with modern imaging systems, electrophysiology mapping technology, and surgical equipment. Interventional cardiologists' adoption of technologically improved cardiac rhythm management and EP devices, as well as the rising incidence of Cardiovascular Disease (CVD), account for the segment's significant share. According to a study published in April 2018, daily short-term rhythm strip recordings revealed a 13.0% increase in the older population hospitalized for atrial fibrillation, resulting in an overall prevalence of 46.0% among hospitalized patients. 

The outpatient facilities segment is expected to develop at the quickest CAGR throughout the projection period. Outpatient electrophysiological procedures may involve diagnostic investigations, catheter ablation, device interrogation, and follow-up visits. Electrophysiology equipment used in outpatient facilities is designed to be portable, compact, and user-friendly, making them easy to use in ambulatory settings and promoting efficient workflow for healthcare personnel. A shift toward minimally invasive outpatient procedures and significant cost reductions are helping to drive segment development. 

For example, a Health Affairs study found that ASC operations are cost- and time-effective. It takes around 25% less time than inpatient facilities, resulting in savings of USD 360 to USD 1,000 for each patient due to lower fixed expenditures.

Recent Developments

• March 2024- Boston Scientific got FDA approval for their AGENT™ drug-coated balloon.
• January 2024- The FDA approved Medtronic's Percept™ RC neurostimulator with proprietary BrainSense™ technology.
• January 2024- Abbott launched a global clinical trial of its Volt™ Pulsed Field Ablation System for treating abnormal heart rhythms.
• February 2024- Biosense Webster received CE Mark clearance in Europe for its VARIPULSE™ Pulsed Field Ablation (PFA) Platform.
• March 2024- BIOTRONIK introduced the world's first and only CE-approved system for left bundle branch area pacing (LBBAP).