About the Report
The transcending burden of cardiac arrhythmias has necessitated the incorporation of innovations into the manufacturing of the electrophysiology devices. The demand for high precision and controlled cardiac diagnostic and ablation procedures has enabled the massive adoption of minimally invasive electrophysiology therapies.
The interventionalists have shifted towards the adoption of disposable catheters for the intermittent cardiac procedure, which offer better sterility, safety, and are cost-effective. The electrophysiology market is expected to strengthen at a steady pace with the incoming innovative electrophysiology devices, increasing ratio of cardiac ablation procedures, and conducive reimbursement policies.
In its new study, ESOMAR-certified market research and consulting firm Future Market Insights (FMI) offer insights into the key factors driving the demand for electrophysiology devices. The report tracks the global sales of electrophysiology devices in 20+ high-growth markets, along with analysis of the COVID-19 impact on the medical device industry in general, and electrophysiology devices in particular.
What is the Future Outlook for Electrophysiology Market in Comparison to Historic Pattern of Growth?
Cardiac complications are grim health concerns, reported by the World Health Organization (WHO) for being the leading cause of death. Various interventional procedures and implantable cardiac devices are instrumentally implemented for the management of the cardiac arrhythmias.
Cardiac ablation procedures have witnessed a surge in application in a volume of procedures in various geographies. For instance, Japanese Catheter Ablation Registry conducted a registry in August 2017, covering over 250 hospitals which targetted over 70, 000 ablation procedures per year in Japan alone. The Registry Data for Arrhythmia Interventional Treatments in Mainland China has recorded over 170,000 cardiac radiofrequency ablation procedures were carried out in 2019 only. These escalating rationales of the electrophysiology procedures depict the spurring expansion of the electrophysiology market.
According to FMI’s analysis, the electrophysiology devices’ sales have spurred at 6.5% CAGR from 2015 to 2019.
Electrophysiology devices have been equipped with several ‘smart technologies’ and features to quench the demand for minimally invasive, safer and cost-effective diagnosis and therapies of cardiac arrhythmias. The next-generation technologies of advanced cardiac mapping and telerobotics, remote and real-time monitoring are shaping the legacy of the electrophysiology devices, therapies and procedures, and also to alleviate the challenges of lockdown and social distancing posed by the pandemic.
COVID19 pandemic has taken its toll on the medical device industry. The pandemic has caused unprecedented economic losses and has delayed several cardiac and electrophysiology procedures. The risk of hospital-acquired infection, the massive imposition of lockdown, social distancing, and the giant influx of COVID19 patients at various hospitals, clinics and healthcare centers have curbed the movement of the electrophysiology patients to pay a regular visit for their diagnosis and therapies.
The American College of Cardiology’s Electrophysiology Section and the American Heart Association’s Arrhythmias Committee of the Council on Clinical Cardiology, have re-strategize their conducting-protocols to limit the numbers of electrophysiology procedures. As a result, there was a striking declination in the number of interventional electrophysiology procedures amid the pandemic, to minimize the risk of COVID19 infection in 2020.
The guidelines for the electrophysiology procedures during the pandemic divided the electrophysiology cases into three categories into non-urgent/elective procedures, semi-urgent procedures and urgent/non-elective procedures. Out of which the elective procedures were kept on hold or postponed, while non-elective procedures were prioritized.
Only the symptomatic, hemodynamically significant and the cardioversion refractory cases were treated on a high priority basis. The supply chain interruptions and the economic downturns have jolted several small, and medium-sized enterprises. These ongoing turmoil has staggered the growth prospects of the electrophysiology market.
Although, the reopening of the economies and the gradual resuming of the electrophysiology therapies and procedures offer a gleam of hope to the electrophysiology market in 2021. The digital health and telemedicine equipped into the electrophysiology catheters and devices offer real-time monitoring through a secured cloud server. This eliminates the need for a physical visit to hospitals and clinics for the electrophysiology monitoring.
The updated safety strategies, advanced electrophysiology devices, and their increasing adoption guarantee a steady outlook for growth. FMI expects the global electrophysiology market to grow at 12.7% CAGR through 2030.
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What Is The Extent Of The Minimal Invasive Electrophysiology Procedure Impacting The Market?
The invasive surgical interventions are associated with several risks for patients with pre-existing medical comorbidities such as hypertension, diabetes, etc. Also, the prevalence of cardiac arrhythmias including atrial fibrillation, atrial flutter, Wolff-Parkinson-White syndrome, and others is on its rise, therefore, it necessitates a safer, cost-effective and minimally invasive interventional procedure for the cardiac arrhythmia.
The American Heart Association has stated that over 2.7 million Americans suffers from atrial fibrillation. The minimally invasive technology offered by cardiac ablation catheters and diagnostic catheters imperatively drive the electrophysiology market’s growth spurt. The manufacturers are focused to provide advanced ablation and diagnostic catheters, and devices which are minimally invasive and offers a short recovery period.
What is the Commercial Potential of the Smart Technologies in Electrophysiology Devices?
Manufacturers are increasingly including smart and next-generation technologies. The advanced cardiac electromapping machines equipped with next generation basket catheter scanning offers expedited, detailed and efficient cardiac tissue mapping. The advanced technology of contact force-sensing ablation catheters offers high precision lesion formation.
Manufacturers have been seen at the forefront to strengthen their electrophysiology portfolio. Several companies have undergone acquisitions to expand their electrophysiology offerings. For instance, On June 05, 2018, Philips Healthcare acquired EPD, to strengthen the electrophysiology ablation image-guiding systems. Baylis Medical and Japan Lifeline collaborated to penetrate their advanced electrophysiology procedure solutions in the Europe and North America region.
Several players such as Johnson & Johnson (Biosense Webster, Inc.), Abbott Laboratories, Acutus Medical Inc. and Microport Scientific Corporation have recently earned approvals and launched multiple electrophysiology catheters and mapping systems.
How are Innovations Driving Electrophysiology Market?
Manufacturers are focusing on alleviating issues associated with the conventional cardiac ablation catheters, diagnostic catheters, cardiac mapping machine, and access devices. The electrophysiology market has been introduced with next-generation electrophysiology devices, loaded with advanced features that offer elevated safety and precision.
The conventional ablation catheters have been associated with off-targeting ablations, burns and limited flexibility to access the target tissue site. The latest ablation catheters include contact force-sensing technology which provides control and precision for ablation, balloon inflation pulmonary vein isolation that allows to access the challenging anatomy of the target tissue, and irrigated tip technology avoids ablation induced burns to the healthy cardiac tissues. Such advanced technology elevates the adoption of catheter ablation procedures by nullifying the potential risks.
The cradiac electromapping machines are loaded with next-generation basket catheter which rapidly scans cardiac tissues point-by-point, also the use of a magnetic sensor or use of multiple ultrasound electrode basket for expedited and precise scanning.
Medical devices in this decade are getting smarter, which are not just technological advancements, but also an essentiality amid the challenges of the pandemic. The interventionalists cannot afford to delay the cardiac therapies and on the same time, the hospital visits are also needed to be restricted to avoid hospital-acquired infection. Manufacturers have started including digital cloud technology to access and manage electrophysiology data for the monitoring of the cardiac rhythm data. This nullifies the need of physically visiting the interventionalist.
What is the Regulatory Impact on Global Electrophysiology Sales?
The World Health Organization (WHO) has highlighted the dire scenario of the causality and risk posed by cardiovascular diseases. The WHO has stated that cardiac diseases are the number one cause of global deaths, claiming over 17.9 million lives every year. Out of which heart attacks and strokes are the reason for the 80% of the deaths caused by cardiovascular diseases.
The increasing prevalence and incidence rates of the cardiac arrhythmias such as atrial fibrillation, atrial flutter, Wolff-Parkinson-White (WPW), Ventricular Tachycardia and Atrioventricular Nodal Reentry Tachycardia. A wide range of electrophysiology devices are covered under the umbrella of the reimbursement policies.
A reimbursement system often covers hospital outpatient, comprehensive electrophysiology studies, catheter ablation, intracardiac echo / transeptal access (add-on services), esophageal recording and induction of arrhythmia, individual studies, mapping on add ons, hospital inpatient, electrophysiology, intracardiac echocardiography and outpatient facility services & inpatient facility services.
The standard healthcare system and the conducive reimbursement policies are giving impetus to the electrophysiology market. The healthcare system has witnessed several improvements to make it more accessible to the public reach. For instance, the Affordable Care Act in the U.S. was implemented that allows 40 million uninsured U.S. citizens to have access to the healthcare facilities.
England provides a large portion of its healthcare facilities for free to its citizens. The National Health Service (NHS) offers hospital services, preventive medicines and primary care to the ordinary residents. Several radical changes were introduced into the NHS to offer social care leaders to devise facilities to the individual patients, formally and it has been made available at the hospital.
The practice of reprocessing catheters in the electrophysiology interventions helps to curb the expenses of the diagnosis and procedure, thus increasing the affordability of the electrophysiology therapies. Such conducive healthcare system, along with the reimbursement policies covering the wide spectrum of the electrophysiology devices widens the horizon of growth for the electrophysiology market.
How huge is the Opportunity in the U.S.?
According to a research conducted by FMI, North America has been observed to be the most lucrative markets throughout the forecast period. One of the key factors fueling the regions’ electrophysiology market, is its substantial healthcare expenditure and infrastructure. The preliminary forecasts by CMS’ Office of the Actuary have stated that the overall healthcare expenditure of the U.S. alone is likely to increase to 5.4% from 2019 to 2028, and outpacing the nation’s GDP by 4.3%.
Furthermore, U.S. standout to be the largest medical device market in the globe, and the invariable lucrative pocket for the electrophysiology market. SelectUSA has stated that the U.S. medical devices market accounted for 40% of the global market in 2017, and is expected to reach US$203 billion by 2023.
According to the Centers for Medicare & Medicaid Services (CMS), the U.S. has recorded the retail expenditure of US$54.4 billion for durable medical equipment, in 2017. This medical device expenditure is anticipated to elevate further in future, thus creating a remarkable scope for expansion of the electrophysiology market.
The massive population base and expanding geriatric population promises a strong ground in growth for U.S. electrophysiology market. The robust healthcare infrastructure having 17% of its total hospitals equipped with EP lab facilities such as cardiac stimulators, EP recording systems, RF ablation generators, 3D mapping systems and intracardiac echocardiography (ICE) systems.
The country also has the diagnosis rate of the atrial fibrillation cases of 37% and 90% of its AF studies have undergone through ablation procedures in 2019. The remarkable penetration of the diagnosis and accessibility to the ablation therapies of cardiac arrhythmias in the U.S. paints a lucrative picture of electrophysiology market for current and prospects.
How Electrophysiology Labs In Germany Are Influencing Its Dominance In The Europe?
In Germany, the Federal Statistical Office has reported the spike in the healthcare expenditure by 4% from 2017 to 2018. Germany has recorded the healthcare expenditure of 11.7% of the GDP, in 2018.
Germany has an impressive healthcare infrastructure equipped with the latest technological facilities for its electrophysiology labs. Germany has EP lab facilities in over 30% of its total hospitals. The potential patient base, advanced healthcare infrastructure, high-tech interventional procedures and well ample trained medical staffs are thrusting the thrust the growth of the Germany electrophysiology market.
Germany had over 55% of its atrial fibrillation cases diagnosed and over 81% of its AF studies have undergone through ablation procedures, in 2019. The impressive diagnosis rate, advanced electrophysiology lab facilities and the awareness of the cardiac arrhythmias and electrophysiological interventions are driving the dominance of Germany in the Europe electrophysiology market.
How Big is Opportunity for electrophysiology market in France?
France has electrophysiology labs in over 8% of its hospitals. The country has a prevalence rate of 1.8% of atrial fibrillation. The research and therapeutic interventions in the domain of cardiac arrhythmias are advanced in France. It has been recorded that over 9% of the atrial fibrillation cases have undergone the electrophysiology procedures in 2019. Over 41% of its atrial fibrillation cases are diagnosed and 87% of its AF studies have undergone through ablation procedures, in 2019.
France spends 11.25% of its GDP into its healthcare expenditure in 2018, as recorded by the World Bank. France priorities healthcare as the national responsibility in the country, also the favorable government policies and the massive incidence rates of the cardiac arrhythmias and high volume of cardiac interventional procedures in France are flourishing the electrophysiology market in the nation.
What Forces Are Driving Market for Electrophysiology in China?
China houses the gigantic population of 1,433,783,686 recorded by Worldometer in 2019. Cardiac arrhythmias such as atrial fibrillation have a prevalence rate of 0.70% in China. China has 23% of its atrial fibrillation cases received the diagnosis and 87% of its AF studies have undergone through ablation procedures, in 2019.
The increasing adoption of latest technology, the presence of key players and the massive burden of cardiac arrhythmias are driving the growth spurt of the electrophysiology market in China. The expanding greying population is also fueling the growth spurt of the electrophysiology market in China.
What Factors Supporting Uptake Of Electrophysiology Ablation Catheters?
The procedure of ablation catheterization is known to be highly efficient in ablating or destroying the arrhythmic cardiac tissues. For which the adoption of ablation catheters has seen a surge in the adoption for a wide range of arrhythmias such as atrial fibrillation, atrial flutter, ventricular tachycardia and others. The improvisations implemented into the ablation catheters that offers controlled and safer ablation of the cardiac tissues, with improved targeting.
The precision in ablation is elevated with the technology of contact-force monitoring and irrigated tip ablation catheters and balloon catheters. These factors are fueling the massive and dominating share of the electrophysiology ablation catheters with the market share of 46% in 2020 and are expected to elevate further in 2030, to reach the market share of 47%.
Why Atrial Fibrillation holds Accounts for High Share in Electrophysiology Market?
Atrial fibrillation held the leading share of 48% in 2020 and the share is expected to further escalate to 52.6% in 2030. The increasing prevalence rate of atrial fibrillation impacted by the demographic changes in the regions like Europe has expanded its dominance in the electrophysiology market.
The U.S. has a prevalence of 1.45% for atrial fibrillation in 2019. Over 3,586,878 of atrial fibrillation in the U.S. has been estimated in the research conducted by FMI for the electrophysiology market. Out of which, over 34.50% of the atrial fibrillation cases are diagnosed and 25% of the cases undergo electrophysiology studies.
The diagnosis rate and protocols for atrial fibrillation are well established. The incoming advanced technologies of cardiac electromapping, ablation and diagnostic catheterization has also rocketed the atrial fibrillation share in the electrophysiology market.
Opportunities Abound for the Hospitals?
According to FMI, hospitals holds a substantial share in the electrophysiology market owing to its advanced electrophysiology lab facilities that thrives to provide cardiac stimulators, electrophysiology recording systems, radiofrequency (RF) ablation generators, 3D mapping systems and intracardiac echocardiography (ICE) systems. The advanced infrastructure, well-trained interventionalists and the advanced expenditure of the diagnosis, therapy and prescription for the electrophysiology procedures drive the growth of the hospital segment in the electrophysiology market.
Manufacturers in the electrophysiology market are aiming at strategic collaborations with other key players of the electrophysiology domain to strengthen their offerings of the ablation catheters, diagnostic catheters, electrophysiology laboratory devices and access devices. The manufactures have also collaborated with regional players to elevate their penetration into other geographies.
The focus on product launches of electrophysiology devices has been highly progressive. The market has witnessed the debut of several electrophysiology devices loaded with advanced technologies. For instance, Medtronic Plc has been observed to have an aggressive venture in the approval and launching of over 12 of its proprietary electrophysiology catheters and other devices in Indonesia, Uzbekistan, and two catheters in Australia, from 2017 to 2020.
The distribution networks have been targeted for reaching the potential markets, for instance, Baylis Medical Japan Lifeline came under the collaboration in November 2020, for the launching of advanced electrophysiology procedure solutions such as 2F microcatheter and 6F guiding catheters, in the Europe region.
Acutus Medical and Biotronik partnered to offer comprehensive electrophysiology solutions for catheter-based therapy of cardiac arrhythmias in regions of Europe and Asia. This resulted in the integration of the AcQMap system of Acutus Medical with the SuperMap multi-mode mapping facilities by Biotronik for the non-contact mapping of the irregular cardiac rhythms.
There has been a deliberated focus on the technological advancements to bear edge in the electrophysiology interventional products. Manufactures has infused remote access monitoring, telerobotics in ablation, digital cloud services for data access and advanced software and algorithms for electromapping of heart.
Johnson & Johnson (Biosense Webster, Inc.) has recently launched Cartonet Analytics Software in 2019, which offers real-time monitoring of the cardiac data through its cloud server. Stereotaxis and Acutus Medical collaborated to launch the first Integrated Cardiac Ablation Procedure having AcQMap systems of Acutus Medical and Stereotaxis Robotic Magnetic Navigation for the arrhythmia treatment.
The leading players in the domain of the electrophysiology market:
- Abbott Laboratories
- Johnson & Johnson (Biosense Webster, Inc.)
- Medtronic Plc
- Boston Scientific Corporation
- Japan Lifeline
- Koninklijke Philips N.V.
- Merit Medical Systems
- Biotronik SE & Co. KG
- Microport Scientific Corporation
- APN Health, LLC
- Baylis Medical Company, Inc.
*The list is not exhaustive, and only for representational purposes. Full competitive intelligence is available in the report.
Scope of the Report
Historical Data Available for
USD Million for value and Units for Volume
Key Regions Covered
North America, Latin America, Europe, East Asia, South Asia, Oceania Middle East & Africa
Key Countries Covered
U.S., Canada, Brazil, Mexico, Argentina, U.K., Germany, France, Italy , Spain, Russia, Belgium, Netherlands, Luxemburg, Poland, Switzerland, Ukraine, India, Thailand, Malaysia, Indonesia, China, Japan, South Korea, Australia, New Zealand, South Africa, Turkey, Saudi Arabia, UAE, Kuwait, Oman, Bahrain and Qatar.
Key Segments Covered
Product Type, Indication, End User and Region
Key Companies Profiled
Market Forecast, brand share analysis by region, competition intelligence, Market volume by each segment, DROT analysis, Market Dynamics and Challenges, Strategic Growth Initiatives
Customization & Pricing
Key Questions Answered in the Report
Q1. Which is the most lucrative market for electrophysiology?
The U.S. currently leads the global electrophysiology market. The sales in the US is estimated to reach 55% of total demand throughout the forecast period.
Q2. Which is the top-selling electrophysiology device?
Electrophysiology ablation catheters are the highest sought-after in every market. The demand for electrophysiology ablation catheters is expected to remain high in the forecast period, propelled by the massive volume of ablation procedures indicated for the cardiac arrhythmias.
Q3. Which indication is driving sales of the electrophysiology market?
Atrial fibrillation leading the indication segment of the electrophysiology market, owing to its massive prevalence and well-established diagnosis and ablation treatment available for the indication.
Q4. Which are some of the leading companies offering electrophysiology devices?
Some of the leading companies offering electrophysiology devices include Abbott Laboratories, Johnson & Johnson (Biosense Webster, Inc.), Medtronic Plc, Boston Scientific Corporation Japan Lifeline Co., Koninklijke Philips N.V., Merit Medical Systems, Biotronik SE & Co. KG, Microport Scientific Corporation, APN Health, LLC, Baylis Medical Company, Inc. among others.
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Electrophysiology Market: Segmentation
- Electrophysiology Laboratory Devices
- 3D Mapping Systems
- Electrophysiology Recording Systems
- Radiofrequency (RF) Ablation Systems
- Intracardiac Echocardiography (Ice) Ultrasound Imaging Systems
- Cardiac Stimulators
- Electrophysiology Ablation Catheters
- Cryoablation Electrophysiology Catheters
- Radiofrequency (RF) Ablation Catheters
- Irrigated Tip RF Ablation Catheters
- Laser Ablation Catheters
- Electrophysiology Diagnostic Catheters
- Conventional Electrophysiology Diagnostic Catheters
- Advanced Electrophysiology Diagnostic Catheters
- Ultrasound Electrophysiology Diagnostic Catheters
- Access Devices
- Atrial Fibrillation
- Atrial Flutter
- Wolff-Parkinson-White Syndrome (WPW)
- Atrioventricular Nodal Reentry Tachycardia (AVNRT)
- Ventricular tachycardia (VT)
- Cardiac Catheterization Laboratories
- Ambulatory Surgery Centers
- North America
- Latin America
- East Asia
- South Asia
- The Middle East and Africa (MEA)