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市场调查报告书
商品编码
1494804
到 2030 年嵌入式循环录音机市场预测:按产品、类型、最终用户和地区分類的全球分析Implantable Loop Recorders Market Forecasts to 2030 - Global Analysis By Product, Type, End User and By Geography |
根据 Stratistics MRC 的数据,2024 年全球植入式循环记录器市场规模将达到 19 亿美元,预计到 2030 年将达到 41 亿美元,预测期内复合年增长率为 13.7%。
植入式循环记录器 (ILR) 是一种小型电池供电设备,可插入胸部皮下,持续监测心律。这种小型设备可作为诊断工具来检测常规心电图 (ECG) 无法捕捉的不规则心率和心律不整。 ILR 就像一台小型心电图机,持续监测心臟的电活动并储存关心悸、晕厥和其他心律不整症状等事件的资料。
据美国心臟协会称,大约有 300 万至 600 万美国人患有房颤,预计到 2050 年这一数字将从 600 万增加到 1600 万。
心血管疾病增加
心血管疾病正在成为一个重大的全球健康问题,增加了对先进诊断工具的需求,以有效监测和管理这些疾病。植入式循环记录器提供连续的心臟监测,以检测心律不整和其他心臟异常,作为重要的诊断辅助。此外,可以在不干扰患者日常生活的情况下进行长期监测,这使得它对于诊断难以捉摸或散发的心臟疾病特别有用。
隐私和安全问题
隐私和安全问题是阻碍植入式循环记录器(ILR)市场成长的主要障碍。 ILR 旨在持续监测心臟活动,收集敏感的医疗资料。支援远端监控的无线连线功能也引发了对资料隐私和安全漏洞的担忧。患者担心他们的医疗资讯遭到未授权存取、潜在的骇客攻击和资料滥用。然而,医疗保健提供者面临着确保强大的加密和身份验证通讯协定以保护从 ILR 传输到医疗保健系统的患者资料的挑战。
远端患者监护的增加
植入式循环记录器是一种插入皮下持续监测心律的小型设备,受益于 RPM 技术的进步。 RPM 使医疗保健提供者能够即时远端监测患者的心臟活动,从而实现及时干预和个人化护理。这种远端监控功能不仅可以改善患者的治疗效果,还可以透过减少医院就诊次数和防止不必要的手术来降低医疗成本。
竞争格局
植入式循环记录器(ILR)市场的竞争格局是一把双面刃。激烈的竞争也阻碍了市场成长,因为它分散了众多参与者的资源和市场占有率,导致价格压力和盈利下降。然而,随着公司在努力超越竞争对手的同时争取合规性,对医疗设备的严格监管要求可能会使问题更加复杂。积极的营销策略和促销活动可能会升级并增加公司的成本。
COVID-19的爆发对植入式循环记录器(ILR)市场产生了重大影响,带来了挑战和机会。由于心血管疾病的流行,用于长期心率监测的 ILR 需求仍然强劲,但医疗服务和供应链的中断最初阻碍了市场成长。封锁、选择性手术的限制以及患者不愿意去医疗机构导致 ILR 植入暂时下降。然而,随着医疗保健系统适应新常态,人们越来越重视远端患者监护和远端医疗,从而推动了 ILR 的采用。
预计手动录音机市场在预测期内将是最大的市场
预计手动录音机市场在预测期内将是最大的市场。这些设备在监测心臟活动方面发挥重要作用,特别是对于心律不整或有突发心臟事件风险的患者。手动记录器部分提供了一种可携式、用户友好的设备,允许患者记录发生的心臟事件,为诊断和治疗计划提供有价值的资料。此细分市场的成长是由技术进步所推动的,例如电池寿命的延长、设备尺寸的缩小以及连接性的增强,使患者更容易获得和方便。
智慧型手机市场预计在预测期内复合年增长率最高。
智慧型手机市场预计在预测期内复合年增长率最高。传统上,ILR一直是独立的设备,需要专用的设备进行资料搜寻和分析,这限制了其普及。随着支援智慧型手机的 ILR 的出现,患者现在可以使用智慧型手机将资料直接发送给医疗保健提供者。这项创新不仅简化了患者监测过程,还实现了即时资料收集,使医疗保健专业人员能够快速评估心臟活动并在必要时进行干预。
在预测期内,亚太地区占据最大份额。由于全部区域意识的提高、医疗基础设施的改善以及心臟病患病率的上升等因素,ILR(植入皮下监测心律的小型设备)变得越来越普及。该地区的趋势是加强心臟病的早期发现和管理,从而降低死亡率和医疗负担。此外,远端监测和资料分析等先进技术已整合到ILR中,以促进即时病患监测并提高全部区域的诊断准确性。此外,亚太地区新兴市场采用 ILR 将促进医疗保健提供者和设备製造商之间的创新和竞争,最终推动产品进步和成本效率。
预计北美地区在预测期内将保持良好的成长。美国食品药物管理局(FDA) 和加拿大卫生署製定的严格法律规范可确保 ILR 在投放市场之前满足严格的性能和安全标准。此类法规透过鼓励製造商投资研发以满足全部区域的合规要求来鼓励创新。此外,监管促进了透明度和课责,使医疗保健专业人员和患者对 ILR 的品质和可靠性充满信心。这些因素正在推动该地区的成长。
According to Stratistics MRC, the Global Implantable Loop Recorders Market is accounted for $1.9 billion in 2024 and is expected to reach $4.1 billion by 2030 growing at a CAGR of 13.7% during the forecast period. Implantable loop recorders (ILRs) are small, battery-powered devices inserted just beneath the skin of the chest to monitor heart rhythms continuously. These compact devices serve as a diagnostic tool for detecting irregular heartbeats or arrhythmias that may not be captured during routine electrocardiograms (ECGs). Operating like miniature electrocardiogram machines, ILRs constantly monitor the heart's electrical activity, storing data on events such as palpitations, fainting, or other symptoms of cardiac irregularity.
According to the American Heart Association, Inc. approximately 3 to 6 million Americans suffer with atrial fibrillation, and by 2050, the number is anticipated to rise to 6 to 16 million.
Rising incidence of cardiovascular diseases
With cardiovascular diseases emerging as a significant health concern globally, there is a growing demand for advanced diagnostic tools to monitor and manage these conditions effectively. Implantable Loop Recorders serve as crucial diagnostic aids, offering continuous cardiac monitoring to detect arrhythmias and other cardiac abnormalities. Additionally, their ability to provide long-term monitoring without disrupting patients' daily activities makes them particularly valuable in diagnosing elusive or sporadic cardiac events.
Privacy and security concerns
Privacy and security concerns are significant barriers hindering the growth of the Implantable Loop Recorders (ILRs) market. ILRs, designed to monitor heart activity continuously, collect sensitive medical data. The wireless connectivity features that enable remote monitoring also raise concerns about data privacy and security breaches. Patients worry about unauthorized access to their medical information, potential hacking, and data misuse. However, healthcare providers face the challenge of ensuring robust encryption and authentication protocols to safeguard patient data transmitted from ILRs to healthcare systems.
Rise in remote patient monitoring
Implantable Loop Recorders, small devices inserted beneath the skin to continuously monitor heart rhythms, are benefiting from the advancements in RPM technology. With RPM, healthcare providers can remotely monitor patients' cardiac activity in real-time, allowing for timely interventions and personalized care. This remote monitoring capability not only improves patient outcomes but also reduces healthcare costs by minimizing hospital visits and preventing unnecessary procedures.
Competitive Landscape
The competitive landscape in the Implantable Loop Recorders (ILRs) market presents a double-edged sword. Intense competition can also hinder market growth by fragmenting resources and market share among numerous players, leading to pricing pressures and reduced profitability. However, stringent regulatory requirements for medical devices can further complicate matters, as companies vie for compliance while striving to outperform rivals. Aggressive marketing strategies and promotional activities can escalate, increasing the overall cost burden on companies.
The Covid-19 pandemic significantly impacted the Implantable Loop Recorders (ILRs) market, introducing both challenges and opportunities. While the demand for ILRs, which are used for long-term heart rhythm monitoring, remained steady due to the prevalence of cardiovascular diseases, disruptions in healthcare services and supply chains initially hindered market growth. Lockdowns, restrictions on elective procedures, and patients' reluctance to visit healthcare facilities led to a temporary decline in ILR implantations. However, as healthcare systems adapted to the new normal, there emerged a greater emphasis on remote patient monitoring and telemedicine, propelling the adoption of ILRs.
The Manual Recorders segment is expected to be the largest during the forecast period
Manual Recorders segment is expected to be the largest during the forecast period. These devices play a crucial role in monitoring cardiac activity, especially in patients with irregular heart rhythms or those at risk of sudden cardiac events. The Manual Recorders segment offers portable, user-friendly devices that allow patients to record cardiac events as they occur, providing valuable data for diagnosis and treatment planning. This segment's growth is driven by advancements in technology, such as improved battery life, smaller device sizes, and enhanced connectivity features, which make them more accessible and convenient for patients.
The Smartphone Compatible segment is expected to have the highest CAGR during the forecast period
Smartphone Compatible segment is expected to have the highest CAGR during the forecast period. Traditionally, ILRs have been standalone devices requiring specialized equipment for data retrieval and analysis, limiting their widespread use. With the advent of smartphone-compatible ILRs, patients can now conveniently transmit data directly to healthcare providers using their smartphones. This innovation not only simplifies the monitoring process for patients but also allows for real-time data collection, enabling healthcare professionals to promptly assess cardiac activity and intervene if necessary.
Asia Pacific region dominated the largest share during the projected time frame. ILRs, compact devices implanted under the skin to monitor heart rhythms, are witnessing increased penetration due to factors like growing awareness, improved healthcare infrastructure, and rising prevalence of cardiac disorders across the region. This regional trend is bolstering early detection and management of cardiac conditions, consequently reducing mortality rates and healthcare burdens. Additionally, the integration of advanced technologies in ILRs, such as remote monitoring and data analytics, facilitates real-time patient monitoring and enhances diagnostic accuracy across the region. Moreover, as emerging markets in Asia Pacific embrace ILRs, it fosters innovation and competition among healthcare providers and device manufacturers, ultimately driving product advancements and cost efficiencies.
North America region is poised to hold lucrative growth over the extrapolated period. Stringent regulatory frameworks, such as those set forth by the Food and Drug Administration (FDA) in the United States and Health Canada, ensure that ILRs meet rigorous standards for performance and safety before entering the market. These regulations foster innovation by encouraging manufacturers to invest in research and development to meet compliance requirements throughout the region. Moreover, regulations promote transparency and accountability, providing healthcare professionals and patients with confidence in the quality and reliability of ILRs. These elements are boosting the regional growth.
Key players in the market
Some of the key players in Implantable Loop Recorders market include Medtronic, Abbott Laboratories, Angel Medical Systems, Inc, Boston Scientific Corporation, LivaNova PLC, MicroPort Scientific Corporation, Shree Pacetronix Ltd., Lepu Medical Technology (Beijing) Co., Ltd, Ecardio Diagnostics, Biophan Technologies, Inc and Shanghai Microport Orthopedics.
In May 2023, Medtronic announced the U.S. FDA clearance to apply the AccuRhythm Artificial Intelligence (AI) algorithms to the Reveal LINQ insertable cardiac monitor (ICM) Medtronic expects the reduction of around 80.2% of pause and 89.5% of AF false alerts with Reveal LINQ.
In May 2023, Abbott announced the FDA approval of Assert-IQ implants, an ICM that offers 2 battery life options and can be in place for around 6 years. Furthermore, in July 2021, Abbott announced the launch of Jot Dx, an ICM to detect arrhythmia in the U.S. market. It offers improved diagnosis accuracy and enables remote detection of arrhythmia in patients.