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市场调查报告书
商品编码
1963955
非血压监测仪市场-全球产业规模、份额、趋势、机会、预测:按产品类型、最终用户、地区和竞争对手划分,2021-2031年Cuffless Blood Pressure Monitor Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product Type, By End User, By Region & Competition, 2021-2031F |
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全球无袖带血压监测仪市场预计将从 2025 年的 16.9 亿美元成长到 2031 年的 29.3 亿美元,复合年增长率为 9.61%。
这些非侵入式设备利用光电脉搏波检测法和传播时间分析等感测器技术来计算血压指标,无需使用气动袖套阻断动脉。市场成长的主要驱动因素是对持续远端患者监护需求的不断增长以及这些被动式系统带来的便利性提升。全球慢性心血管疾病发生率的上升也大大推动了这一趋势。根据世界卫生组织 (WHO) 估计,到 2024 年,全球约有 14 亿成年人将患有高血压,这表明对有效的长期管理工具的需求非常迫切。
| 市场概览 | |
|---|---|
| 预测期 | 2027-2031 |
| 市场规模:2025年 | 16.9亿美元 |
| 市场规模:2031年 | 29.3亿美元 |
| 复合年增长率:2026-2031年 | 9.61% |
| 成长最快的细分市场 | 腕戴式 |
| 最大的市场 | 北美洲 |
然而,该行业在临床准确性和设备监管标准化方面面临许多挑战。为了获得医学界的支持,必须证明基于感测器的估计值能够在广泛的患者群体中可靠地达到与传统听诊相当的准确性。卫生当局为防止误诊而製定的严格检验通讯协定进一步加剧了这一难度。因此,满足严格的准确性标准是製造商必须克服的主要障碍,才能将这些设备从消费保健产品提升为公认的临床设备。
全球高血压和心血管疾病发生率的激增是推动全球无袖带血压监测市场发展的主要动力。随着这些慢性疾病达到流行程度,间歇性、诊所测量的限制日益凸显,迫切需要连续、非侵入性的监测方式。近期统计数据也印证了这项迫切需求。根据 MedCloudInsider 于 2025 年 7 月发布的题为「FDA核准首款商用无袖带血压监测仪进入美国市场」的报告,目前美国近 50% 的成年人患有高血压。如此高的盛行率促使人们转向能够在日常生活中追踪血压波动的设备,市场也正从阻塞式测量技术转向被动式监测工具。
同时,穿戴式生物感测器和光学技术的突破性进展正在改变这一领域,将医疗级精度带入消费级产品设计中。光电容积脉搏波描记法 (PPG) 和感测器融合技术的检测法使得可靠的血压估算功能得以整合到智慧型手錶和智慧戒指中,显着提升了产品的实用性和普及度。这些创新技术的商业性潜力得到了大量资金筹措的支持。例如,Aktiia 在 2025 年 5 月的新闻稿中宣布,已筹集 4,200 万美元,用于加速其光学血压监测生态系统的全球部署。此外,这些进展也直接解决了使用者持续接受度的挑战。根据 MedCloudInsider 2025 年的报告,临床研究表明,91% 的未控制高血压患者更倾向于使用无袖带、智慧型手机连接的血压监测系统,而不是传统的监测方法。
阻碍市场发展的核心障碍在于对临床准确性和监管标准的严格要求。儘管感测器技术不断发展,但获得医疗设备认证仍然是一项艰鉅的任务。医疗机构和监管机构要求强有力的证据,证明这些设备在各种条件下都能提供与动脉内检测法或标准听诊一样精确的测量结果。在获得这种检验之前,这些监测设备无法从消费级健康小工具转变为适用于诊断和治疗高血压的合法医疗设备。
由于缺乏经认证的可靠性,这些血压监测仪在临床应用中受到极大限制。据美国心臟协会称,到2025年,全球流通的血压监测仪中约有80%缺乏正式检验测试的公开数据,而无袖带血压监测技术由于缺乏标准化的测试通讯协定,这一差距尤为显着。因此,由于无法达到既定的准确性标准,这些产品难以获得医生的广泛信任,实际上被排除在医疗市场的核心之外,并将收入潜力限制在监管较少的消费者医疗保健领域。
人工智慧的整合正在从根本上改变市场格局,它提高了光学感测器的讯号保真度,并使其达到医疗级标准。製造商正利用先进的机器学习演算法,从运动伪影和环境干扰中分离出纯净的光电脉搏波测量数据,从而解决无袖带技术长期以来面临的精度挑战。这项技术进步凸显了软体驱动解决方案的有效性。例如,Binah.ai 在 2025 年 3 月发布的「SDK 5.9.1 血压精度报告」中指出,其人工智慧增强的扫描技术在 87.9% 的收缩压测量案例中达到了目标误差范围内的精度,证明了其适用于可靠的远端健康评估。
同时,业界正明显转向智慧戒指和穿戴设备,认为它们是持续被动监测的最佳形式。与智慧型手錶相比,这些小巧的设备具有更佳的皮肤接触性和佩戴舒适度,能够在不干扰日常生活的情况下持续采集时间序列数据。主要产业参与者正积极研发符合监管规定的戒指式创新产品,加速这项转变。根据 MedTech Dive 于 2025 年 10 月发表的报导《Oura 智慧戒指血压测量功能申请 FDA 批准》报道,Oura Health 已核准启动一项新功能的检验研究,该功能可检测慢性高血压的生理指标。这标誌着隐藏式戒指管理工具的商业化迈出了重要一步。
The Global Cuffless Blood Pressure Monitor Market is projected to expand from USD 1.69 Billion in 2025 to USD 2.93 Billion by 2031, reflecting a compound annual growth rate (CAGR) of 9.61%. These non-invasive devices utilize sensor technologies, including photoplethysmography and transit time analysis, to calculate blood pressure metrics without the need for arterial occlusion via an inflatable cuff. Market growth is primarily driven by the rising demand for continuous remote patient monitoring and the enhanced convenience these passive systems provide. This trajectory is heavily supported by the increasing global incidence of chronic cardiovascular diseases; the World Health Organization estimated that in 2024, approximately 1.4 billion adults worldwide were affected by hypertension, underscoring the critical need for effective long-term management tools.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 1.69 Billion |
| Market Size 2031 | USD 2.93 Billion |
| CAGR 2026-2031 | 9.61% |
| Fastest Growing Segment | Wrist-Based |
| Largest Market | North America |
However, the industry encounters significant hurdles related to clinical accuracy and the regulatory standardization of these devices. Securing endorsement from the medical community necessitates demonstrating that sensor-based estimations can reliably match the precision of traditional auscultatory methods across a wide range of patient demographics. This difficulty is exacerbated by the stringent validation protocols mandated by health authorities to avoid misdiagnosis. As a result, meeting rigorous accuracy standards stands as a pivotal barrier that manufacturers must surmount to elevate these devices from consumer wellness items to accepted clinical instruments.
Market Driver
The surging global incidence of hypertension and cardiovascular diseases acts as the primary engine driving the global cuffless blood pressure monitor market. As these chronic conditions reach epidemic levels, the inadequacies of episodic, clinic-based readings have become increasingly evident, fueling an urgent requirement for continuous and unobtrusive monitoring capabilities. This pressing need is emphasized by recent statistics; a July 2025 report by MedCloudInsider, titled "FDA Clears First Over-the-Counter Cuffless Blood Pressure Monitor for U.S. Market," indicates that hypertension currently affects nearly 50% of the adult population in the United States. Such high prevalence mandates a transition toward devices capable of tracking blood pressure variability in everyday environments, steering the market away from occlusion-based techniques in favor of passive surveillance tools.
Concurrently, technological breakthroughs in wearable biosensors and optical methods are transforming the sector by facilitating medical-grade precision within consumer-friendly designs. Developments in photoplethysmography and sensor fusion have enabled the integration of dependable blood pressure estimation into smartwatches and rings, greatly improving utility and adoption rates. The commercial promise of these innovations is highlighted by significant financial backing; for instance, Aktiia announced in a May 2025 press release that it had raised $42 million to fast-track the global rollout of its optical blood pressure monitoring ecosystem. Moreover, these advancements directly tackle user adherence issues, as noted by MedCloudInsider in 2025, which reported that clinical studies found 91% of patients with uncontrolled hypertension preferred cuffless, smartphone-integrated systems over traditional monitoring approaches.
Market Challenge
The central obstacle hindering market progress is the strict requirement for clinical accuracy and regulatory standardization. Although sensor technology has evolved, securing medical-grade certification continues to be a difficult challenge. Healthcare providers and regulatory agencies demand robust evidence that these devices can provide precise readings that align with intra-arterial or standard auscultatory methods under diverse conditions. Failing to achieve this validation keeps these monitors from evolving beyond consumer wellness novelties into legitimate medical devices appropriate for diagnosing or managing hypertension.
This absence of certified reliability significantly limits adoption within clinical environments. According to the American Heart Association in 2025, approximately 80% of globally available blood pressure measurement devices lacked published data from formal validation testing, a gap that is particularly acute among cuffless technologies due to the lack of standardized testing protocols. Consequently, the failure to meet these established precision benchmarks inhibits widespread confidence among physicians, effectively excluding these products from the core healthcare market and confining their revenue potential to the less regulated direct-to-consumer wellness segment.
Market Trends
The incorporation of artificial intelligence is fundamentally transforming the market by improving the signal fidelity of optical sensors to achieve medical-grade standards. Manufacturers are increasingly utilizing sophisticated machine learning algorithms to separate clean photoplethysmography data from motion artifacts and environmental interference, thereby addressing the historical accuracy limitations of cuffless technologies. This technological progress is confirming the effectiveness of software-driven solutions; for example, Binah.ai reported in March 2025, within their "Blood Pressure Accuracy Report of SDK 5.9.1," that their AI-enhanced scanning technology attained systolic blood pressure measurement accuracy within the target error margin in 87.9% of instances, proving its suitability for reliable remote health evaluations.
At the same time, the industry is observing a distinct move toward smart rings and hearables as the preferred form factors for continuous, passive monitoring. These compact devices provide better skin contact and user comfort relative to smartwatches, facilitating consistent longitudinal data gathering without interrupting daily routines. This shift is being hastened by leading industry players actively pursuing regulatory-compliant ring-based innovations. As reported by MedTech Dive in October 2025, in the article "Oura to pursue FDA clearance of blood pressure feature for smart ring," Oura Health received approval to initiate a validation study for a new feature designed to detect physiological markers of chronic hypertension, representing a major stride toward commercializing unobtrusive ring-based management tools.
Report Scope
In this report, the Global Cuffless Blood Pressure Monitor Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies present in the Global Cuffless Blood Pressure Monitor Market.
Global Cuffless Blood Pressure Monitor Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report: