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市场调查报告书
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1787888
心律不整监测设备市场预测(至 2032 年):按产品类型、应用、最终用户和地区进行的全球分析Cardiac Arrhythmia Monitoring Devices Market Forecasts to 2032 - Global Analysis By Product Type, Application, End User and By Geography |
根据 Stratistics MRC 的数据,全球心律不整监测设备市场预计在 2025 年达到 89.3 亿美元,预计到 2032 年将达到 160.2 亿美元,预测期内的复合年增长率为 8.7%。
心律不整监测设备是用来辨识和记录心律不整(或不规则心律)的专用设备。这些设备对于诊断和治疗心搏过缓、心搏过速和心房颤动等疾病至关重要。常见的持续或不定期追踪心臟电活动的装置包括心电图监测、事件记录器和植入式动态心电图监测仪。为了改善患者预后并降低中风和心臟衰竭等併发症的风险,这些监测仪提供即时或储存的数据,以协助医生确定心律不整的频率和严重程度,指导治疗决策并追踪治疗效果。
根据美国心臟协会 (AHA) 的数据,心房颤动 (AF) 是最常见的持续性心律不整,近年来已影响到美国约 270 万至 610 万人,预计到 2050 年将增加到约 1210 万至 1590 万人,55 岁及以上人群的一生中患病风险约为 37%。
心律不整盛行率增加
心律不整,尤其是心房颤动 (AF),在已开发国家和开发中国家的盛行率都在上升。美国心臟协会估计,美国有 270 万至 610 万人患有心房颤动,并预测到 2050 年这一数字将增至 1,210 万至 1,590 万。据估计,全球有超过 3,350 万人患有心房颤动。久坐不动的生活方式、肥胖、糖尿病和高血压是造成这项负担的主要原因。由于心律不整通常无症状且间歇性发作,难以检测,因此越来越需要持续或长期监测技术。此外,这种需求直接推动了植入式和移动式心臟监测设备市场的发展,这些设备可以提供精确的长期心律追踪。
昂贵的设备和监控服务
心律不整监测设备高成本是其广泛应用的最大障碍之一。行动心电遥测(MCT) 系统和植入式循环记录器 (ILR) 价格不菲,尤其是在包含装置植入、资料解读和持续订阅式监测服务费用的情况下。在医疗保险覆盖范围有限且医疗预算紧张的中低收入国家,这些费用可能令人望而却步。即使在已开发国家,共同支付和自付额也可能使患者不愿选择高级监测,尤其是在症状轻微或偶发的情况下。此外,这种成本负担限制了市场扩张,并阻碍了持续监测,尤其是对于老年和低收入患者而言。
整合巨量资料分析和人工智慧(AI)
融合人工智慧和机器学习演算法的心律不整监测设备正在创造革命性机会。透过评估复杂的心电图模式、减少假阳性和假阴性并提供即时警报,人工智慧 (AI) 可以显着提高心律不整检测的准确性。基于患者数据随时间变化趋势的预测分析也可以预测心律不整风险,从而实现更早的干预并获得更好的治疗效果。此外,云端基础的平台使医疗保健系统能够有效地储存、分析和共用海量心电图资料。随着该技术日益可靠并通过临床测试检验,人工智慧心臟监测器代表着一个重要的成长前沿。
网路安全和设备漏洞风险
云端平台、蓝牙和远端资料传输的普及使得心臟监测设备容易受到网路安全攻击。病患资料外洩可能造成严重的伦理、法律和经济后果。更重要的是,植入式或穿戴式装置一旦被入侵,不仅会影响隐私,还可能危及病人安全,尤其是在使用即时数据指导临床决策的情况下。儘管许多国家都已製定相关立法,但日益复杂的网路攻击带来的威胁仍在持续增长。设备製造商现在被要求在上市后监管和网路安全框架方面进行大量投资,这增加了成本和复杂性。此外,备受关注的安全漏洞或系统故障可能会严重损害公众信任和品牌声誉。
新冠疫情对心律不整监测设备市场产生了许多影响,其中大部分是正面的。儘管早期的面诊咨询、择期手术以及供应链中断暂时推迟了设备安装和诊断,但这场危机显着加速了远距远端医疗和远端患者监护(RPM) 系统的普及。随着医院尽量减少病患接触,并优先管理临床环境以外的慢性病,对穿戴式和行动心律不整监测仪(可从病患家中即时传输资料)的需求不断增长。此外,心肌炎和心律不整是需要监测的新冠后心臟併发症之一,这凸显了持续心电图监控的重要性。
预计心电图监测市场在预测期内将占据最大份额
由于成本效益高、可靠性强且临床应用广泛,因此预计心电图监测领域将在预测期内占据最大市场占有率。这些可携式装置提供持续的心电图监控(通常持续 24 至 48 小时),使医疗保健专业人员能够识别标准心电图可能无法检测到的无症状性和间歇性心律不整。心搏过缓、心房颤动和室性早搏都可以透过心电图监测检测到。随着 MCT 和植入式设备等更先进的选择在某些患者群体中变得越来越普遍,这些设备凭藉其良好的业绩记录、广泛的报销范围以及与全球循环系统工作流程的整合,将继续占据市场主导地位。
预计诊断中心部分在预测期内的复合年增长率最高
预计诊断中心细分市场将在预测期内实现最高成长率。诊断中心正迅速成为心律不整监测设备成长最快的终端用户管道。这些中心提供广泛的门诊心电图服务,包括行动遥测系统、心电图监测和事件记录仪,以识别透过简单的临床测试可能无法检测到的无症状性和间歇性心律不整。此外,诊断中心对于寻求有效心臟评估的医生和患者都具有吸引力,因为它们集便利性、先进的诊断工具和门诊服务于一体。
在预测期内,预计北美将占据最大的市场占有率,这得益于先进的医疗保健系统、心房颤动等心臟病的高发病率以及最尖端科技的大力采用。美敦力、通用电气医疗和 iRhythm Technologies 等主要市场参与企业的存在、优惠的报销政策以及广泛的诊断服务,有助于该地区占据主导地位。基于人工智慧的心电图分析的整合、远端患者监护的使用日益增多以及对早期心律不整检测的认识的提高,进一步加强了美国和加拿大的市场地位。此外,北美的技术、临床和财务优势使其成为心律不整监测收益和创新的领先地区。
预计亚太地区在预测期内的复合年增长率最高。心血管疾病负担加重、医疗成本上涨以及中国、印度、日本和韩国等国家对早期心臟病诊断意识的不断提升,都是推动这快速成长的因素。该地区政府大力倡议医疗基础设施升级,穿戴式装置和远端监控技术的使用日益普及,医疗服务的可近性也日益提升。此外,亚太地区是全球心律不整监测设备最具活力、变化最快的市场,而该地区庞大且老化的人口结构以及价格实惠的心臟监测解决方案的日益普及,进一步推动了这一市场的发展。
According to Stratistics MRC, the Global Cardiac Arrhythmia Monitoring Devices Market is accounted for $8.93 billion in 2025 and is expected to reach $16.02 billion by 2032 growing at a CAGR of 8.7% during the forecast period. Cardiac arrhythmia monitoring devices are specialized instruments used to identify and document arrhythmias, or irregular heart rhythms. To diagnose and treat conditions like bradycardia, tachycardia, and atrial fibrillation, these devices are essential. Common varieties that track the electrical activity of the heart either continuously or sporadically include Holter monitors, event recorders, and implantable loop recorders. In order to improve patient outcomes and lower the risk of complications like stroke or heart failure, these monitors assist doctors in determining the frequency and severity of arrhythmias, guiding treatment decisions, and tracking the efficacy of therapies by providing real-time or stored data.
According to the American Heart Association (AHA), atrial fibrillation (AF)-the most common sustained arrhythmia-is projected to affect approximately 2.7 to 6.1 million people in the U.S. in recent years, rising to ≈12.1-15.9 million by 2050, representing a lifetime risk of ~37% in those aged 55 and older.
Increasing heart arrhythmia prevalence
The prevalence of cardiac arrhythmias, especially atrial fibrillation (AF), is rising in both developed and developing nations. The American Heart Association estimates that between 2.7 and 6.1 million Americans suffer from AF, and by 2050, that figure is predicted to increase to between 12.1 and 15.9 million. It is estimated that over 33.5 million people worldwide suffer from AF. The main causes of this increasing burden are sedentary lifestyles, obesity, diabetes, and hypertension. Continuous or long-duration monitoring technologies are becoming more and more necessary because arrhythmias are often asymptomatic and intermittent, making them difficult to detect. Moreover, the market for implantable and ambulatory cardiac monitoring devices that provide precise and extended rhythm tracking capabilities is directly driven by this demand.
Expensive equipment and monitoring services
The high cost of cardiac arrhythmia monitoring devices, both initially and over time, is one of the biggest obstacles to their widespread adoption. Mobile cardiac telemetry (MCT) systems and implantable loop recorders (ILRs) can be costly, particularly when you include the price of device implantation, data interpretation, and ongoing subscription-based monitoring services. In low- and middle-income nations with limited health insurance coverage and tight healthcare budgets, these expenses may be unaffordable. Co-pays and deductibles can discourage patients from choosing advanced monitoring, even in developed nations, especially if their symptoms are mild or sporadic. Additionally, this cost burden limits market expansion and prevents patients, particularly those who are elderly or have low incomes, from having access to ongoing monitoring.
Integration of big data analytics and artificial intelligence (AI)
Arrhythmia monitoring devices that incorporate AI and machine learning algorithms are creating revolutionary opportunities. By evaluating intricate ECG patterns, lowering false positives and negatives, and delivering real-time alerts, artificial intelligence (AI) can greatly improve the accuracy of arrhythmia detection. Based on trends in patient data over time, predictive analytics can also predict the risk of arrhythmias, allowing for earlier intervention and better results. Furthermore, cloud-based platforms make it possible for healthcare systems to effectively store, analyze, and share enormous amounts of ECG data. AI-powered cardiac monitors are positioned as a major growth frontier as the technology becomes more reliable and validated through clinical trials.
Risks to cybersecurity and device vulnerabilities
The prevalence of cloud platforms, Bluetooth, and remote data transmission has made cardiac monitoring devices more susceptible to cybersecurity attacks. Serious ethical, legal, and financial repercussions may result from any breach involving patient data. More importantly, if an implanted or wearable device is compromised, it may impact patient safety as well as privacy, particularly if clinical decisions are being made using real-time data. The threat posed by increasingly sophisticated cyber attacks is growing, even though many nations have laws in place. These days, it is expected of device manufacturers to make significant investments in post-market surveillance and cybersecurity frameworks, which raises the cost and complexity. Moreover, public trust could be severely damaged, and a brand's reputation severely damaged, by a well-publicized security breach or system failure.
The COVID-19 pandemic affected the market for cardiac arrhythmia monitoring devices in a variety of ways, most of which were favorable. The crisis greatly sped up the adoption of telehealth and remote patient monitoring (RPM) systems, even though initial in-person clinic visits, elective procedures, and supply chain disruptions temporarily slowed device installations and diagnostics. Demand for wearable and ambulatory arrhythmia monitors that could send real-time data from patients' homes increased as hospitals placed a higher priority on minimizing patient exposure and managing chronic conditions outside of clinical settings. Additionally, myocarditis and arrhythmias are among the post-COVID cardiac complications that require monitoring, which emphasizes the importance of continuous ECG monitoring.
The holter monitors segment is expected to be the largest during the forecast period
The holter monitors segment is expected to account for the largest market share during the forecast period, driven by their cost-effectiveness, dependability, and broad clinical adoption. By providing continuous ECG monitoring, usually for 24 to 48 hours, these portable devices enable medical professionals to identify asymptomatic or intermittent arrhythmias that might go undetected during standard ECGs. Bradycardia, atrial fibrillation, and premature ventricular contractions can all be detected with Holter monitors. Even though more sophisticated options like MCT and implantable devices are becoming popular for particular patient groups, they still dominate the market because of their solid track record, extensive reimbursement coverage, and integration into cardiology workflows worldwide.
The diagnostic centers segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the diagnostic centers segment is predicted to witness the highest growth rate. Diagnostic centers are quickly becoming the end-user channel with the fastest rate of growth for cardiac arrhythmia monitoring devices. These centers provide a wide range of ambulatory ECG services, such as mobile telemetry systems, Holter monitors, and event recorders, to identify asymptomatic or intermittent arrhythmias that might not be picked up by brief clinical testing. Furthermore, diagnostic centers appeal to both doctors and patients looking for effective cardiac evaluations because they offer a combination of convenience, cutting-edge diagnostic tools, and outpatient access.
During the forecast period, the North America region is expected to hold the largest market share, propelled by its sophisticated healthcare system, high incidence of heart conditions like atrial fibrillation, and robust uptake of cutting-edge technologies. The presence of significant market players like Medtronic, GE Healthcare, and iRhythm Technologies, as well as favorable reimbursement policies and broad access to diagnostic services, all contribute to the region's advantages. Further solidifying the market position in the United States and Canada are the integration of AI-based ECG analysis, the growing use of remote patient monitoring, and growing awareness of early arrhythmia detection. Moreover, North America is the leading region in arrhythmia monitoring revenue and innovation due to its technological, clinical, and financial advantages.
Over the forecast period, the Asia-Pacific region is anticipated to exhibit the highest CAGR. A growing burden of cardiovascular diseases, rising healthcare costs, and increased awareness of early cardiac diagnostics in nations like China, India, Japan, and South Korea are all contributing factors to this fast growth. Strong government initiatives to update healthcare infrastructure, increased use of wearable and remote monitoring technologies, and increased access to healthcare services are all happening in the region. Additionally, Asia-Pacific is the most dynamic and rapidly changing market for arrhythmia monitoring devices worldwide, and this is further supported by the region's large, aging population and the growing availability of reasonably priced cardiac monitoring solutions.
Key players in the market
Some of the key players in Cardiac Arrhythmia Monitoring Devices Market include Boston Scientific, Koninklijke Philips N.V, Spacelabs Healthcare Inc., Medtronic PLC, Welch Allyn, GE Healthcare, BioTelemetry, Inc., Abbott Laboratories, iRhythm Technologies Inc., Biotronik Inc, Applied Cardiac Systems, Inc., Fukuda Denshi Co. Ltd., AliveCor Inc., Nihon Kohden Corporation and Schiller AG.
In April 2025, Medtronic plc announced a strategic agreement to distribute the advanced Dragonfly(TM)* pancreaticobiliary system from Dragonfly Endoscopy, Inc. in the United States. This innovative platform introduces significant enhancements in pancreaticobiliary endoscopy - a field where procedural standards have remained largely unchanged for decades.
In March 2025, Boston Scientific Corporation announced it has entered into a definitive agreement to acquire SoniVie Ltd., a privately held medical device company that has developed the TIVUS(TM) Intravascular Ultrasound System. An investigational technology, the TIVUS system is designed to denervate nerves surrounding blood vessels to treat a variety of hypertensive disorders, including renal artery denervation (RDN) for hypertension.
In January 2025, GE HealthCare Technologies Inc. signed a seven-year agreement with Sutter Health to provide AI-powered medical technology and software upgrades to the California nonprofit health system, the companies. The agreement is expected to generate $1 billion in revenue over the span of the partnership, GE Healthcare said. It marks one of the largest deals for the medical technology company since the firm was spun off from General Electric Co. two years ago.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.