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市場調查報告書
商品編碼
1787888
心律不整監測設備市場預測(至 2032 年):按產品類型、應用、最終用戶和地區進行的全球分析Cardiac Arrhythmia Monitoring Devices Market Forecasts to 2032 - Global Analysis By Product Type, Application, End User and By Geography |
根據 Stratistics MRC 的數據,全球心律不整監測設備市場預計在 2025 年達到 89.3 億美元,預計到 2032 年將達到 160.2 億美元,預測期內的複合年成長率為 8.7%。
心律不整監測設備是用來辨識和記錄心律不整(或不規則心律)的專用設備。這些設備對於診斷和治療心搏過緩、心搏過速和心房顫動等疾病至關重要。常見的持續或不定期追蹤心臟電活動的裝置包括心電圖監測、事件記錄器和植入式動態心電圖監測儀。為了改善患者預後並降低中風和心臟衰竭等併發症的風險,這些監測儀提供即時或儲存的數據,以協助醫生確定心律不整的頻率和嚴重程度,指導治療決策並追蹤治療效果。
根據美國心臟協會 (AHA) 的數據,心房顫動 (AF) 是最常見的持續性心律不整,近年來已影響到美國約 270 萬至 610 萬人,預計到 2050 年將增加到約 1210 萬至 1590 萬人,55 歲及以上人群的一生中患病風險約為 37%。
心律不整盛行率增加
心律不整,尤其是心房顫動 (AF),在已開發國家和開發中國家的盛行率都在上升。美國心臟協會估計,美國有 270 萬至 610 萬人患有心房顫動,並預測到 2050 年這一數字將增至 1,210 萬至 1,590 萬。據估計,全球有超過 3,350 萬人患有心房顫動。久坐不動的生活方式、肥胖、糖尿病和高血壓是造成這項負擔的主要原因。由於心律不整通常無症狀且間歇性發作,難以檢測,因此越來越需要持續或長期監測技術。此外,這種需求直接推動了植入式和移動式心臟監測設備市場的發展,這些設備可以提供精確的長期心律追蹤。
昂貴的設備和監控服務
心律不整監測設備高成本是其廣泛應用的最大障礙之一。行動心電遙測(MCT) 系統和植入式循環記錄器 (ILR) 價格不菲,尤其是在包含裝置植入、資料解讀和持續訂閱式監測服務費用的情況下。在醫療保險覆蓋範圍有限且醫療預算緊張的中低收入國家,這些費用可能令人望而卻步。即使在已開發國家,共同支付和自付額也可能使患者不願選擇高級監測,尤其是在症狀輕微或偶發的情況下。此外,這種成本負擔限制了市場擴張,並阻礙了持續監測,尤其是對於老年和低收入患者而言。
整合巨量資料分析和人工智慧(AI)
融合人工智慧和機器學習演算法的心律不整監測設備正在創造革命性機會。透過評估複雜的心電圖模式、減少假陽性和假陰性並提供即時警報,人工智慧 (AI) 可以顯著提高心律不整檢測的準確性。基於患者數據隨時間變化趨勢的預測分析也可以預測心律不整風險,從而實現更早的干涉並獲得更好的治療效果。此外,雲端基礎的平台使醫療保健系統能夠有效地儲存、分析和共用海量心電圖資料。隨著該技術日益可靠並通過臨床測試檢驗,人工智慧心臟監測器代表著一個重要的成長前沿。
網路安全和設備漏洞風險
雲端平台、藍牙和遠端資料傳輸的普及使得心臟監測設備容易受到網路安全攻擊。病患資料外洩可能造成嚴重的倫理、法律和經濟後果。更重要的是,植入式或穿戴式裝置一旦被入侵,不僅會影響隱私,還可能危及病人安全,尤其是在使用即時數據指導臨床決策的情況下。儘管許多國家都已製定相關立法,但日益複雜的網路攻擊帶來的威脅仍在持續成長。設備製造商現在被要求在上市後監管和網路安全框架方面進行大量投資,這增加了成本和複雜性。此外,備受關注的安全漏洞或系統故障可能會嚴重損害公眾信任和品牌聲譽。
新冠疫情對心律不整監測設備市場產生了許多影響,其中大部分是正面的。儘管早期的面診諮詢、擇期手術以及供應鏈中斷暫時推遲了設備安裝和診斷,但這場危機顯著加速了遠距遠端醫療和遠端患者監護(RPM) 系統的普及。隨著醫院盡量減少病患接觸,並優先管理臨床環境以外的慢性病,對穿戴式和行動心律不整監測儀(可從病患家中即時傳輸資料)的需求不斷成長。此外,心肌炎和心律不整是需要監測的新冠後心臟併發症之一,這凸顯了持續心電圖監控的重要性。
預計心電圖監測市場在預測期內將佔據最大佔有率
由於成本效益高、可靠性強且臨床應用廣泛,因此預計心電圖監測領域將在預測期內佔據最大市場佔有率。這些可攜式裝置提供持續的心電圖監控(通常持續 24 至 48 小時),使醫療保健專業人員能夠識別標準心電圖可能無法檢測到的無症狀性和間歇性心律不整。心搏過緩、心房顫動和室性早搏都可以透過心電圖監測檢測到。隨著 MCT 和植入式設備等更先進的選擇在某些患者群體中變得越來越普遍,這些設備憑藉其良好的業績記錄、廣泛的報銷範圍以及與全球循環系統工作流程的整合,將繼續佔據市場主導地位。
預計診斷中心部分在預測期內的複合年成長率最高
預計診斷中心細分市場將在預測期內實現最高成長率。診斷中心正迅速成為心律不整監測設備成長最快的終端用戶管道。這些中心提供廣泛的門診心電圖服務,包括行動遙測系統、心電圖監測和事件記錄儀,以識別透過簡單的臨床測試可能無法檢測到的無症狀性和間歇性心律不整。此外,診斷中心對於尋求有效心臟評估的醫生和患者都具有吸引力,因為它們集便利性、先進的診斷工具和門診服務於一體。
在預測期內,預計北美將佔據最大的市場佔有率,這得益於先進的醫療保健系統、心房顫動等心臟病的高發病率以及最尖端科技的大力採用。美敦力、通用電氣醫療和 iRhythm Technologies 等主要市場參與企業的存在、優惠的報銷政策以及廣泛的診斷服務,有助於該地區佔據主導地位。基於人工智慧的心電圖分析的整合、遠端患者監護的使用日益增多以及對早期心律不整檢測的認知的提高,進一步加強了美國和加拿大的市場地位。此外,北美的技術、臨床和財務優勢使其成為心律不整監測收益和創新的領先地區。
預計亞太地區在預測期內的複合年成長率最高。心血管疾病負擔加重、醫療成本上漲以及中國、印度、日本和韓國等國家對早期心臟病診斷意識的不斷提升,都是推動這快速成長的因素。該地區政府大力舉措醫療基礎設施升級,穿戴式裝置和遠端監控技術的使用日益普及,醫療服務的可近性也日益提升。此外,亞太地區是全球心律不整監測設備最具活力、變化最快的市場,而該地區龐大且老化的人口結構以及價格實惠的心臟監測解決方案的日益普及,進一步推動了這一市場的發展。
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.