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市场调查报告书
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1666188
全球体外和植入式心臟去颤器市场 - 2025 至 2033 年Global External and Implantable Cardiac Defibrillators Market - 2025-2033 |
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2024 年全球外部和植入式心臟去颤器市场规模达到 65.8 亿美元,预计到 2033 年将达到 121.6 亿美元,在 2025-2033 年预测期内的复合年增长率为 7.1%。
外部和植入式心臟去颤器是一种医疗设备,旨在透过施加可控电击来恢復正常心律,以治疗危及生命的心律不整,例如心室颤动 (VF) 和室性心动过速 (VT)。植入式心臟去颤器 (ICD) 透过手术植入体内,用于持续监测和治疗心律不整。它们通常用于治疗因患有先天性心臟缺陷、心肌病变、心臟衰竭或有危及生命的心律不整病史等而发生心臟骤停 (SCA) 风险较高的患者。
体外去颤器是一种便携式、非侵入式设备,用于紧急情况下透过放置在胸部的电极垫向心臟发送电击。这些设备通常由急救人员、紧急医疗团队和公共场所(如机场、商场和体育场)使用,以在心臟骤停期间恢復正常心律。自动体外去颤器(AED)是最常用的体外去颤器。它们的设计非常用户友好,具有内建演算法来分析心律并在必要时自动发出电击。旁观者只需经过最少的训练就可以使用 AED。
外部和植入式心臟去颤器的市场需求受到医疗需求、技术进步和心血管健康意识增强等因素的共同推动。在全球范围内,心臟病、心律不整、心臟衰竭和心臟骤停等心血管疾病(CVD)的发生率不断上升,对体外和植入式除颤器的需求也日益增加。例如,根据美国国立卫生研究院的数据,心血管疾病(CVD)是全球最大的死亡原因。在 2021 年 2,050 万心血管疾病相关死亡病例中,约 80% 发生在中低收入国家。
驱动因素与约束因素
除颤器设备的技术进步
除颤器设备的技术进步正在极大地推动外部和植入式心臟去颤器市场的成长,并预计在预测期内推动市场的发展。穿戴式心臟復律去颤器,例如 Zoll Medical 的 LifeVest 和 Element Science 的 Jewel Wearable Patch 心臟復律除颤器,为患有心臟骤停 (SCA) 风险较高但尚不适合植入 ICD 的患者提供了一种非侵入性解决方案。这些穿戴式装置可以监测心律,并在必要时自动发出电击。
例如,2024 年 7 月,Element Science 宣布其 Jewel Wearable Patch 心律转復除颤器(Jewel)获得了着名的红点设计奖。该奖项标誌着国际社会对 Jewel 独特设计的认可,该设计注重患者的舒适度,同时提供持续的保护,避免短暂性的心臟骤停 (SCA) 风险升高,这种风险通常发生在心臟病发作等心臟事件发生后的几週至几个月内。
植入式心臟復律去颤器 (ICD) 和自动体外去颤器 (AED) 中电池技术的改进大大延长了这些设备的使用寿命,减少了频繁更换的需要。就 ICD 而言,电池寿命已延长至 7-10 年,从而提高了设备的长期可行性并降低了医疗成本。
例如,美敦力 Evera MRI ICD 等设备的电池寿命延长(最长可达 10 年),透过降低患者和医疗保健提供者的整体拥有成本,促进了市场成长。它还确保设备可以使用更长时间,从而改善患者护理。
併发症和安全问题
儘管外部和植入式心臟去颤器在拯救生命方面发挥关键作用,但与之相关的併发症和安全问题一直是重大挑战,减缓了市场的成长。这些问题影响患者的治疗结果、临床应用和成本效益,导致患者在开立和使用这些设备时犹豫不决。
植入式心臟復律去颤器 (ICD) 最令人担忧的问题之一是可能产生不必要的电击,这可能会对患者造成身心伤害。错误或不适当的电击会导致患者焦虑、忧郁并降低生活品质。例如,根据《美国心臟病学会杂誌》的一项研究,大约 13% 的 ICD 患者会出现不适当电击,这些电击可能会导致住院率增加、心理困扰以及对患者造成潜在伤害。
在植入式除颤器中,与设备导线(电线)或电池相关的故障可能导致设备故障,需要手术进行更换或修復。导线移位、感染或硬体故障等併发症可能需要昂贵的介入。例如,根据美国食品药物管理局的公告,美敦力公司因高压能量输送持续存在问题,正在召回近35万台植入式心臟装置。此次召回被归类为 I 级,即最严重的类型。
The global external and implantable cardiac defibrillators market reached US$ 6.58 billion in 2024 and is expected to reach US$ 12.16 billion by 2033, growing at a CAGR of 7.1% during the forecast period 2025-2033.
External and implantable cardiac defibrillators are medical devices designed to treat life-threatening cardiac arrhythmias, such as ventricular fibrillation (VF) and ventricular tachycardia (VT), by delivering a controlled electric shock to restore normal heart rhythm. Implantable cardiac defibrillators (ICDs) are surgically implanted inside the body and are used for continuous monitoring and treatment of abnormal heart rhythms. They are typically prescribed to patients at high risk of sudden cardiac arrest (SCA) due to conditions like congenital heart defects, cardiomyopathy, heart failure, or a history of life-threatening arrhythmias.
External defibrillators are portable, non-invasive devices used in emergency situations to deliver an electric shock to the heart through electrode pads placed on the chest. These devices are commonly used by first responders, emergency medical teams, and public access locations (like airports, malls, and sports arenas) to restore normal heart rhythm during sudden cardiac arrest. Automated external defibrillators (AEDs) are the most commonly used external defibrillators. They are designed to be user-friendly, with built-in algorithms to analyze the heart's rhythm and automatically deliver shocks if necessary. AEDs can be used by bystanders with minimal training.
The market demand for external and implantable cardiac defibrillators is driven by a combination of medical needs, technological advancements and rising awareness about cardiovascular health. The global increase in cardiovascular diseases (CVDs) including heart attacks, arrhythmias, heart failure and sudden cardiac arrest has created a growing need for both external and implantable defibrillators. For instance, according to the National Institute of Health, cardiovascular diseases (CVDs) are the leading cause of deaths globally. Of the 20.5 million CVD-related deaths in 2021, approximately 80% occurred in low- and middle-income countries.
Market Dynamics: Drivers & Restraints
Technological Advancements in Defibrillator Devices
The rising technological advancements in defibrillator devices are significantly driving the growth of the external and implantable cardiac defibrillators market and are expected to drive the market over the forecast period. Wearable cardioverter defibrillators, such as the LifeVest by Zoll Medical and Jewel Wearable Patch Cardioverter Defibrillator by Element Science, offer a non-invasive solution for patients who are at high risk for sudden cardiac arrest (SCA) but are not yet candidates for an ICD. These wearable devices monitor heart rhythms and automatically deliver shocks when necessary.
For instance, in July 2024, Element Science announced that its Jewel Wearable Patch Cardioverter Defibrillator (Jewel) received the prestigious Red Dot Design Award. This award signals international recognition of Jewel's unique design, focusing on patient comfort while delivering continuous protection from temporary periods of elevated Sudden Cardiac Arrest (SCA) risk, which typically occurs in the weeks to months after suffering a cardiac event, such as a heart attack.
Improved battery technology in both implantable cardioverter defibrillators (ICDs) and automated external defibrillators (AEDs) has significantly extended the life of these devices, reducing the need for frequent replacements. In the case of ICDs, the battery life has been extended to 7-10 years, which improves the long-term viability of the device and reduces healthcare costs.
For instance, the extended battery life in devices like the Medtronic Evera MRI ICD (which lasts for up to 10 years) has contributed to market growth by reducing the overall cost of ownership for patients and healthcare providers. It also ensures that devices are available for longer periods, thus improving patient care.
Complications and Safety Concerns
Despite their critical role in saving lives, complications and safety concerns related to both external and implantable cardiac defibrillators have been significant challenges, slowing the growth of the market. These issues impact patient outcomes, clinical adoption and cost-effectiveness, contributing to hesitation in both prescribing and using these devices.
One of the most significant concerns with implantable cardioverter defibrillators (ICDs) is the possibility of unnecessary shocks, which can cause physical and psychological harm to patients. False or inappropriate shocks can lead to patient anxiety, depression and a diminished quality of life. For instance, according to a study in the Journal of the American College of Cardiology, inappropriate shocks occur in about 13% of ICD patients, and these shocks can lead to increased hospitalizations, psychological distress, and potential harm to the patient.
In implantable defibrillators, malfunctions related to the device's leads (wires) or battery can result in device failure, necessitating surgery for replacement or repair. Complications like lead displacement, infection, or hardware failure may require costly interventions. For instance, according to an announcement from the US Food and Drug Administration, Medtronic is recalling nearly 350,000 implantable cardiac devices due to continued problems with the delivery of high-voltage energy. The recall is categorized as a Class I, the most serious type.
The global external and implantable cardiac defibrillators market is segmented based on product type, imaging modality, application, procedure type, end-user and region.
The external defibrillators segment is expected to dominate the external and implantable cardiac defibrillators market share
The increasing adoption of automated external defibrillators (AEDs) in public spaces like airports, shopping malls, schools, stadiums, homes and train stations has played a pivotal role in driving the demand for external defibrillators. Public access to AEDs is essential in emergencies, providing life-saving interventions before emergency medical teams arrive. For instance, according to the National Institute of Health (NIH), sudden cardiac death from ventricular arrhythmia kills about 350,000 people annually in the United States. About 70% of sudden cardiac deaths occur at home, where an AED is usually unavailable. This further accelerates the demand for AEDs.
The introduction of next-generation AEDs has revolutionized the way defibrillators are used in emergencies. Newer models come with features like real-time data transmission, cloud connectivity, AI-powered algorithms, and improved battery life. The next-generation AEDs are more efficient and reliable, which is a key factor contributing to their dominance in the market.
For instance, in March 2024, Stryker launched a next-generation LIFEPAK CR2 automated external defibrillator (AED) for cardiac care. The LIFEPAK CR2 is a revolutionary defibrillator designed to empower rescuers to provide high-quality CPR and deliver instant shock during sudden cardiac arrest (SCA) emergencies. This innovative device incorporates QUIK-STEP electrodes which peel directly off the base for faster placement on the patient's chest and a Shock Advisory System which is an ECG analysis system that advises whether a shock is appropriate.
North America is expected to hold a significant position in the external and implantable cardiac defibrillators market share
Cardiovascular diseases, including sudden cardiac arrest, arrhythmias and heart failure, are among the leading causes of death in North America particularly in the United States, contributing to the growing need for life-saving cardiac devices such as defibrillators. For instance, according to the Cardiac Arrest Foundation, there are more than 356,000 out-of-hospital cardiac arrests annually in the United States.
North America has extensive public education and CPR/AED training programs, increasing the number of trained individuals who are capable of using AEDs in emergency situations. This has contributed to a higher survival rate and widespread acceptance of defibrillators in both healthcare settings and public spaces.
For instance, in all, over 20 million people worldwide every year learn CPR through the American Heart Association (AHA). In the U.S., around 90% of healthcare providers have received AHA training. which has positively influenced the market by increasing the number of laypersons who can assist in life-saving procedures.
Additionally, in September 2024, the Smart Heart Sports Coalition launched the "AEDs for Youth" program, offering automated external defibrillators (AEDs) to schools and youth sports organizations at substantial discounts. In collaboration with leading AED companies Avive Solutions and Coro Medical, the program makes AEDs more accessible as students, teachers and athletes begin the new school year.
Asia-Pacific is growing at the fastest pace in the external and implantable cardiac defibrillators market
The Asia Pacific region has seen a significant increase in the prevalence of cardiovascular diseases (CVDs), which is a major driver for the demand for defibrillators. Changing lifestyles, rising levels of obesity, poor diet habits, increased smoking and sedentary behavior have contributed to the growing burden of heart diseases.
For instance, according to the World Health Organization (WHO), nearly 80% of CVD deaths occur in low- and middle-income countries in the APAC region. As per the Indian Heart Association, the annual number of deaths from CVD in India has risen from 2.26 million (1990) to 4.77 million (2020), leading to an urgent need for devices like ICDs and AEDs.
Many countries in the APAC region, particularly China, India, Japan and South Korea, have been rapidly improving their healthcare infrastructure. Governments and other private institutions have been raising awareness about the importance of defibrillators, leading to greater accessibility to advanced medical devices like implantable defibrillators (ICDs) and external defibrillators (AEDs).
For instance, in February 2024, the Udgam Group of Schools in Gujarat installed an Automated External Defibrillator (AED) in the premises of Udgam School for Children, Zebar School for Children, Satellite School for Children & Bodakdev School for Children. The initiative is part of a broader campaign to promote the usage of this life-saving technology in public spaces, particularly schools and colleges, with Udgam Group of Schools leading the way. These programs, often promoted by health organizations, government agencies, and NGOs, have significantly boosted AED usage in public places and emergencies.
The major global players in the external and implantable cardiac defibrillators market include Koninklijke Philips N.V., Nihon Kohden Corporation, Medtronic plc, Boston Scientific Corporation, Stryker Corporation, ZOLL Medical Corporation, Abbott Laboratories, MicroPort Medical Products Ltd., LivaNova PLC, Mindray Medical India Pvt. Ltd. and among others.
The global external and implantable cardiac defibrillators market report delivers a detailed analysis with 62 key tables, more than 51 visually impactful figures, and 171 pages of expert insights, providing a complete view of the market landscape.
Target Audience 2024
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