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시장보고서
상품코드
1736681
세계의 전기생리학 디바이스 시장 : 유형별, 적응증별, 최종사용자별, 지역별(2026-2032년)Electrophysiology Devices Market By Type, Indication (Atrial Fibrillation, Supraventricular Tachycardia, Ventricular Tachycardia), End-User, Region for 2026-2032 |
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심혈관 질환, 특히 심방세동 유병률 증가는 전기생리학적 장치에 대한 수요를 주도하고 있습니다. 따라서 심혈관계 질환, 특히 심방세동의 유병률 증가는 시장 규모를 급증시켜 2024년 86억 달러를 넘어 2032년까지 193억 1,000만 달러에 달할 것으로 예측됩니다.
노인 인구 증가는 부정맥 발생을 증가시켜 전기 생리학 장치에 대한 수요를 증가시킬 것입니다. 따라서 노인 인구 증가로 인해 시장은 2026-2032년 연평균 11.73%의 연평균 복합 성장률(CAGR)을 보일 것입니다.
전기생리학 기기 시장 정의/개요
전기생리학 기기는 심장 부정맥 및 기타 전기적 이상을 진단하고 치료하는 데 중요한 역할을 합니다. 이러한 첨단 의료기기는 심장의 전기적 활동을 측정하고 분석하도록 설계되어 의료 전문가, 특히 심장 전문의와 전기 생리학자에게 중요한 정보를 제공합니다. 이러한 기기의 주요 기능은 비정상적인 심장 리듬을 식별하고, 심장 내 부정맥 발생 부위를 찾아내고, 적절한 심장 기능을 회복하기 위한 치료적 개입을 수행하는 데 도움을 주는 것입니다.
전기생리학 기기에는 절제용 카테터, 진단용 카테터, 매핑 시스템, 3D 전기해부학 매핑 시스템 등 다양한 도구가 포함됩니다. 진단용 카테터는 심장의 전기적 임펄스를 측정하는 데 도움이 되며, 절제용 카테터는 비정상적인 심장 리듬을 치료하기 위해 특정 부위에 에너지를 공급하는 데 사용됩니다. 매핑 시스템은 심장의 전기적 활동을 실시간으로 시각화하여 정확한 진단과 정확한 치료에 도움을 줍니다.
전기생리학적 장치의 발전은 심장 치료에 혁명을 가져왔으며, 카테터를 이용한 절제술과 같은 최소 침습적 시술이 가능해졌습니다. 이러한 시술은 환자에게 기존 개심술에 대한 대안을 제공하고, 회복 시간을 크게 단축하고 치료 결과를 개선할 수 있습니다. 심장 질환이 점점 더 흔해짐에 따라 전기생리학적 장치에 대한 수요는 증가할 것으로 예상되며, 현대 심혈관 의료에 필수적인 도구가 될 것으로 예측됩니다.
저침습적 치료에 대한 선호도가 높아지면서 전기생리학 기기의 주요 응용 분야인 카테터 절제술의 채택이 증가하고 있으며, 2021년 JAMA Network Open에 게재된 연구에 따르면 2010년부터 2018년까지 미국에서 심방세동에 대한 카테터 절제술 사용이 51% 증가했습니다. 카테터 절제술 사용이 51% 증가했습니다. 의료비 증가와 의료 인프라의 개선에 기인합니다. 특히 신흥국의 의료비 지출 증가는 첨단 전기 생리학 장치의 채택을 촉진하고 있습니다. 세계은행 보고서에 따르면, GDP 대비 세계 의료비 지출의 비율은 2010년 9.7%에서 2019년 9.9%로 증가하여 의료 기술에 대한 투자가 확대되고 있음을 보여줍니다.
병원 밖에서의 응용이 확대되고 있습니다. 원격 환자 모니터링을 위한 휴대용 및 웨어러블 전기생리학 기기의 사용이 증가하면서 새로운 시장 기회가 창출되고 있으며, Verified Market Research의 조사 보고서에 따르면, 심장 모니터링 기기를 포함한 원격 환자 모니터링 시장은 2023년 에 417억 7,000만 달러로 평가되었고, 2026-2032년 연평균 20% 성장하여 2032년까지 1,583억 9,000만 달러에 달할 것으로 예측됩니다. 또한, 전기 생리학 기술의 끊임없는 혁신으로 인해 이러한 기기의 기능과 용도가 확대되고 있으며, FDA는 2021년에 132개의 새로운 의료기기를 승인했으며, 그 중 상당수는 심혈관 분야에서 승인되었습니다.
2021년 Journal of Atrial Fibrillation에 발표된 연구에 따르면, 미국에서 심방세동 카테터 절제술의 평균 비용은 사용 기술 및 의료 환경에 따라 18,000-32,000달러로 나타났습니다. 사용하는 기술과 의료 환경에 따라 18,000달러에서 32,000달러에 이르는 것으로 나타났습니다. Heart Rhythm Society의 2022년 보고서에 따르면, 미국에는 인구 3억 3,000만 명 이상에 해당하는 심장 전기생리학 전문가가 약 3,500명밖에 없는 것으로 나타났습니다. 이는 인구 9만 4,000명당 약 1명의 전기생리학자가 있는 셈으로, 심각한 부족을 보여줍니다.
2020년 European Heart Journal에 발표된 대규모 연구에 따르면, 전체 카테터 절제술 치료의 합병증 발생률은 5.5%이며, 이중 1.7%는 심각한 합병증을 경험한 것으로 나타났습니다. 5.5%, 환자의 1.7%가 심각한 합병증을 경험한 것으로 나타났습니다. 새로운 전기생리학 기기에 대한 길고 복잡한 규제 경로로 인해 시장 성장 둔화: 미국 FDA는 2022년 연례 성과 보고서에서 의료기기 시판 전 승인(PMA) 신청에 대한 결정이 내려지기까지 평균 365일이 걸렸다고 보고했습니다. 이러한 타임라인의 연장은 새로운 전기생리학 기술 시장 출시를 크게 지연시킬 수 있습니다.
The rising incidence of cardiovascular diseases, particularly atrial fibrillation, is driving the demand for electrophysiology devices. Thus, the increasing prevalence of cardiovascular diseases, especially atrial fibrillation surged the growth of market size surpassing USD 8.6 Billion in 2024 to reach the valuation of USD 19.31 Billion by 2032.
Increasing geriatric population increases the incidences of cardiac arrhythmias increases, boosting the demand for electrophysiology devices. Thus, the growing aging population enables the market to grow at a CAGR of 11.73% from 2026 to 2032.
Electrophysiology Devices Market: Definition/ Overview
Electrophysiology devices play a critical role in the diagnosis and treatment of cardiac arrhythmias and other electrical abnormalities of the heart. These sophisticated medical instruments are designed to measure and analyze the heart's electrical activity, providing vital information to healthcare professionals, particularly cardiologists and electrophysiologists. The primary function of these devices is to identify abnormal heart rhythms, pinpoint arrhythmogenic areas within the heart, and assist in delivering therapeutic interventions to restore proper cardiac function.
Electrophysiology devices encompass a wide range of tools, including ablation catheters, diagnostic catheters, mapping systems, and 3D electroanatomical mapping systems. Diagnostic catheters help in measuring electrical impulses in the heart, while ablation catheters are used to deliver energy to specific areas to treat abnormal heart rhythms. Mapping systems provide real-time visualization of the heart's electrical activity, aiding in accurate diagnosis and precise treatment.
The advancement of electrophysiology devices has revolutionized cardiac care, allowing for minimally invasive procedures like catheter-based ablations. These procedures offer patients an alternative to traditional open-heart surgery, significantly reducing recovery time and improving outcomes. As cardiac conditions become more prevalent, the demand for electrophysiology devices is expected to grow, making them indispensable tools in modern cardiovascular medicine.
The growing preference for minimally invasive procedures is boosting the adoption of catheter ablation, a key application of electrophysiology devices. A study published in JAMA Network Open in 2021 found that the use of catheter ablation for atrial fibrillation increased by 51% between 2010 and 2018 in the United States. Rising healthcare expenditure and improving healthcare infrastructure. Increased healthcare spending, particularly in emerging economies, is facilitating the adoption of advanced electrophysiology devices. The World Bank reports that global healthcare expenditure as a percentage of GDP increased from 9.7% in 2010 to 9.9% in 2019, indicating a growing investment in healthcare technologies.
Expanding applications in out-of-hospital settings. The increasing use of portable and wearable electrophysiology devices for remote patient monitoring is opening new market opportunities. According to a report by Verified Market Research, the Remote Patient Monitoring Market, which includes cardiac monitoring devices, was valued at USD 41.77 Billion in 2023 and is expected to reach USD 158.39 Billion by 2032, with a growing CAGR of 20% from 2026 to 2032. In addition, the continuous innovations in electrophysiology technologies are expanding the capabilities and applications of these devices. The FDA approved 132 new medical devices in 2021, many of which were in the cardiovascular space.
The expensive nature of electrophysiology procedures and devices can limit market growth, especially in developing countries. According to a study published in the Journal of Atrial Fibrillation in 2021, the average cost of catheter ablation for atrial fibrillation in the United States ranged from $18,000 to $32,000, depending on the technology used and the healthcare setting. The lack of trained professionals to perform complex electrophysiology procedures restrains market expansion. A 2022 report by the Heart Rhythm Society stated that there were only about 3,500 board-certified cardiac electrophysiologists in the United States, serving a population of over 330 million. This translates to approximately 1 electrophysiologist per 94,000 people, indicating a significant shortage.
The potential for adverse events during electrophysiology procedures can deter some patients and healthcare providers. A large-scale study published in the European Heart Journal in 2020 found that the overall complication rate for catheter ablation procedures was 5.5%, with 1.7% of patients experiencing major complications. Lengthy and complex regulatory pathways for new electrophysiology devices slow down market growth. The U.S. FDA reported in its 2022 annual performance report that the average time to decision for premarket approval (PMA) applications for medical devices was 365 days. This extended timeline significantly delays the introduction of new electrophysiology technologies to the market.
The ablation catheter segment holds a dominant position in the electrophysiology devices market, driven by its critical role in managing irregular heartbeats that are unresponsive to medication. Ablation catheters are utilized to perform procedures such as radiofrequency (RF) ablation, cryoablation, and pulse field ablation, each offering distinct methods to target and treat abnormal electrical pathways in the heart. The rising incidence of heart failure and arrhythmias, particularly in aging populations. As the elderly are more susceptible to cardiovascular diseases, the demand for effective and reliable electrophysiology treatments, such as ablation catheters, is expected to surge during the forecast period.
The growing awareness of the reliability and success rates of electrophysiology procedures, coupled with continuous advancements in electrophysiology (EP) technology, has significantly boosted the adoption of these devices. Minimally invasive procedures have become increasingly popular, as they offer shorter recovery times, fewer complications, and better patient outcomes compared to traditional open-heart surgeries. Ablation catheters are at the forefront of this shift, as they provide precise, safe, and effective treatment options for a wide range of arrhythmias.
The atrial fibrillation (AF) segment is emerging as a dominant in the electrophysiology devices market, driven by the rising incidence of risk factors such as valvular heart disease, high blood pressure, coronary artery disease, and cardiomyopathy, all closely linked to AF. With the global prevalence of AF steadily increasing, there is growing awareness of its severe complications, including stroke, which has heightened the demand for effective treatment options. One of the most impactful treatments is catheter ablation, and its widespread adoption is playing a pivotal role in driving the growth of this segment.
The integration of combination therapies, where electrophysiology devices are used alongside medications to manage various arrhythmias, is further shaping market trends. This multifaceted approach not only improves treatment outcomes but also boosts demand for advanced electrophysiology devices. Additionally, ongoing research into expanding the scope of ablation procedures for arrhythmias beyond AF is expected to create new growth opportunities. As more indications for electrophysiology procedures emerge, niche segments within the market are likely to experience increased investment and innovation. The prominence of AF treatments, particularly catheter ablation, and the continuous advancements in technology ensure that the AF segment will continue to dominate the electrophysiology devices market in the coming years.
The increasing incidence of cardiovascular diseases, especially atrial fibrillation, is a major driver for the electrophysiology devices market in North America. According to the American Heart Association's 2022 Heart Disease and Stroke Statistics update, an estimated 12.1 million people in the United States are projected to have atrial fibrillation by 2030. This represents a significant increase from the 5.2 million cases reported in 2010, indicating a growing need for electrophysiology devices and procedures.
North America's advanced healthcare system and substantial healthcare spending contribute significantly to the growth of the electrophysiology devices market. The Centers for Medicare & Medicaid Services (CMS) reported that U.S. healthcare spending grew 2.7% in 2021 to reach USD 4.3 Trillion, or $12,914 per person. This high level of healthcare expenditure facilitates the adoption of advanced medical technologies, including electrophysiology devices.
The growing preference for minimally invasive electrophysiology procedures is driving market growth in North America. A study published in the Journal of the American College of Cardiology in 2021 reported that the use of catheter ablation for atrial fibrillation in the United States increased by 26% between 2016 and 2020. The study also found that minimally invasive ablation procedures were associated with shorter hospital stays and lower complication rates compared to traditional surgical approaches, further driving their adoption.
The increasing incidence of cardiovascular diseases, especially atrial fibrillation, is driving the demand for electrophysiology devices in Europe. According to the European Society of Cardiology's 2021 Cardiovascular Disease Statistics, over 11 million people in Europe were living with atrial fibrillation in 2020. The report projected this number to increase by 70% by 2030, reaching nearly 17 million cases. This significant growth in atrial fibrillation cases is expected to boost the demand for electrophysiology devices and procedures in the region.
Europe's aging population and rising life expectancy are contributing to the growth of the electrophysiology devices market. Eurostat reported in 2022 that the proportion of people aged 65 years and over in the EU is projected to increase from 20.8% in 2021 to 31.3% by 2100. This demographic shift is likely to increase the incidence of cardiac arrhythmias, driving the demand for electrophysiology devices and procedures.
The European market is seeing a growing adoption of advanced electrophysiology technologies and minimally invasive procedures. A study published in the European Heart Journal in 2023 reported that the number of catheter ablation procedures for atrial fibrillation in Europe increased by 15% between 2019 and 2022. The study also noted that centers performing these procedures grew from 498 to 579 during the same period, indicating a widespread adoption of advanced electrophysiology techniques across the continent.
The Electrophysiology Devices Market is a highly competitive landscape, driven by factors such as technological advancements, increasing prevalence of heart diseases, and growing demand for minimally invasive procedures. Several key players operate in this market, offering a range of products and services to meet the diverse needs of healthcare providers and patients.
The organizations are focusing on innovating their product line to serve the vast population in diverse regions. Some of the prominent players operating in the electrophysiology devices market include: