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市場調查報告書
商品編碼
1494804
到 2030 年嵌入式循環錄音機市場預測:按產品、類型、最終用戶和地區分類的全球分析Implantable Loop Recorders Market Forecasts to 2030 - Global Analysis By Product, Type, End User and By Geography |
根據 Stratistics MRC 的數據,2024 年全球植入式循環記錄器市場規模將達到 19 億美元,預計到 2030 年將達到 41 億美元,預測期內複合年成長率為 13.7%。
植入式循環記錄器 (ILR) 是一種小型電池供電設備,可插入胸部皮下,持續監測心律。這種小型設備可作為診斷工具來檢測常規心電圖 (ECG) 無法捕捉的不規則心率和心律不整。 ILR 就像一台小型心電圖機,持續監測心臟的電活動並儲存關心悸、暈厥和其他心律不整症狀等事件的資料。
據美國心臟協會稱,大約有 300 萬至 600 萬美國人患有房顫,預計到 2050 年這一數字將從 600 萬增加到 1600 萬。
心血管疾病增加
心血管疾病正在成為一個重大的全球健康問題,增加了對先進診斷工具的需求,以有效監測和管理這些疾病。植入式循環記錄器提供連續的心臟監測,以檢測心律不整和其他心臟異常,作為重要的診斷輔助。此外,可以在不干擾患者日常生活的情況下進行長期監測,這使得它對於診斷難以捉摸或散發的心臟疾病特別有用。
隱私和安全問題
隱私和安全問題是阻礙植入式循環記錄器(ILR)市場成長的主要障礙。 ILR 旨在持續監測心臟活動,收集敏感的醫療資料。支援遠端監控的無線連線功能也引發了對資料隱私和安全漏洞的擔憂。患者擔心他們的醫療資訊遭到未授權存取、潛在的駭客攻擊和資料濫用。然而,醫療保健提供者面臨著確保強大的加密和身份驗證通訊協定以保護從 ILR 傳輸到醫療保健系統的患者資料的挑戰。
遠端患者監護的增加
植入式循環記錄器是一種插入皮下持續監測心律的小型設備,受益於 RPM 技術的進步。 RPM 使醫療保健提供者能夠即時遠端監測患者的心臟活動,從而實現及時干預和個人化護理。這種遠端監控功能不僅可以改善患者的治療效果,還可以透過減少醫院就診次數和防止不必要的手術來降低醫療成本。
競爭格局
植入式循環記錄器(ILR)市場的競爭格局是一把雙面刃。激烈的競爭也阻礙了市場成長,因為它分散了眾多參與者的資源和市場佔有率,導致價格壓力和盈利下降。然而,隨著公司在努力超越競爭對手的同時爭取合規性,對醫療設備的嚴格監管要求可能會使問題更加複雜。積極的行銷策略和促銷活動可能會升級並增加公司的成本。
COVID-19的爆發對植入式循環記錄器(ILR)市場產生了重大影響,帶來了挑戰和機會。由於心血管疾病的流行,用於長期心率監測的 ILR 需求仍然強勁,但醫療服務和供應鏈的中斷最初阻礙了市場成長。封鎖、選擇性手術的限制以及患者不願意去醫療機構導致 ILR 植入暫時下降。然而,隨著醫療保健系統適應新常態,人們越來越重視遠端患者監護和遠端醫療,從而推動了 ILR 的採用。
預計手動錄音機市場在預測期內將是最大的市場
預計手動錄音機市場在預測期內將是最大的市場。這些設備在監測心臟活動方面發揮重要作用,特別是對於心律不整或有突發心臟事件風險的患者。手動記錄器部分提供了一種可攜式、方便用戶使用的設備,允許患者記錄發生的心臟事件,為診斷和治療計劃提供有價值的資料。此細分市場的成長是由技術進步所推動的,例如電池壽命的延長、設備尺寸的縮小以及連接性的增強,使患者更容易獲得和方便。
智慧型手機市場預計在預測期內複合年成長率最高。
智慧型手機市場預計在預測期內複合年成長率最高。傳統上,ILR一直是獨立的設備,需要專用的設備進行資料搜尋和分析,這限制了其普及。隨著支援智慧型手機的 ILR 的出現,患者現在可以使用智慧型手機將資料直接髮送給醫療保健提供者。這項創新不僅簡化了患者監測過程,還實現了即時資料收集,使醫療保健專業人員能夠快速評估心臟活動並在必要時進行干預。
在預測期內,亞太地區佔據最大佔有率。由於全部區域意識的提高、醫療基礎設施的改善以及心臟病患病率的上升等因素,ILR(植入皮下監測心律的小型設備)變得越來越普及。該地區的趨勢是加強心臟病的早期發現和管理,從而降低死亡率和醫療負擔。此外,遠端監測和資料分析等先進技術已整合到ILR中,以促進即時病患監測並提高全部區域的診斷準確性。此外,亞太地區新興市場採用 ILR 將促進醫療保健提供者和設備製造商之間的創新和競爭,最終推動產品進步和成本效率。
預計北美地區在預測期內將保持良好的成長。美國食品藥物管理局(FDA) 和加拿大衛生署製定的嚴格法律規範可確保 ILR 在投放市場之前滿足嚴格的性能和安全標準。此類法規透過鼓勵製造商投資研發以滿足全部區域的合規要求來鼓勵創新。此外,監管促進了透明度和課責,使醫療保健專業人員和患者對 ILR 的品質和可靠性充滿信心。這些因素正在推動該地區的成長。
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.