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市场调查报告书
商品编码
1871930
全球数位生物标记市场:未来预测(至2032年)-按生物标记类型、平台、治疗领域、资料类型、最终用户和地区进行分析Digital Biomarker Marketplaces Market Forecasts to 2032 - Global Analysis By Biomarker Type, Platform, Disease Area, Data Type, End User, and By Geography. |
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根据 Stratistics MRC 的一项研究,预计到 2025 年,全球数位生物标记市场价值将达到 38 亿美元,到 2032 年将达到 223 亿美元,在预测期内的复合年增长率为 28.7%。
数位生物标记市场是支援数位生物标记获取、检验、交易和利用的线上平台。数位生物标记是指透过穿戴式感测器、应用程式或连网装置收集的可量化、客观的生理或行为资料点。这些市场连接研究人员、医疗保健提供者和开发人员,促进数位健康指标的交换和标准化分析,用于疾病预测、监测和个人化治疗,从而推动医学、诊断和健康监测服务领域中数位生物标记的合作、创新和应用。
根据《自然医学》报道,该数位生物标记平台汇总了来自消费者穿戴式装置的数据,为製药公司提供有关临床试验期间患者活动能力和用药依从性的客观、真实世界数据。
人们越来越关注个人化医疗
对个人化和精准医疗日益增长的重视正在推动数位生物标记市场的发展。医疗保健系统正从传统的疾病治疗模式转型为个人化健康管理模式。数位生物标记能够透过即时健康数据实现持续监测、疾病早期检测和治疗效果评估。随着製药公司和临床研究机构将数位生物标记整合到药物研发流程中,对互通性、数据驱动型平台的需求在多个治疗领域持续加速成长。
资料隐私和同意方面的挑战
由于对病患资料隐私、知情同意和资料所有权的担忧,数位生物标记市场面临许多限制。从穿戴式装置、行动应用程式和连网装置收集和交换敏感的生物识别和行为讯息,在GDPR和HIPAA等严格法规的约束下,带来了合规性方面的挑战。如何在确保安全透明的资料共用的同时维护使用者控制权,是大规模应用的主要障碍。缺乏统一的资料管治架构进一步削弱了病人与医疗机构之间的信任。
将人工智慧应用于临床诊断
人工智慧在提升数位生物标记的准确性和预测能力方面具有巨大潜力。机器学习演算法能够分析连续的健康资料流,并检测与疾病进展相关的细微生理模式,从而实现早期诊断和个人化治疗策略。将人工智慧与生物标记市场结合,可实现自动化的相关性分析、风险预测和自适应临床试验设计。人工智慧驱动的分析与连网设备的融合,正在建构新一代智慧化的、决策支援的医疗保健生态系统。
生物标记数据缺乏标准化
缺乏标准化的数据收集、检验和解读通讯协定仍然是数位生物标记市场面临的主要威胁。设备精度、资料收集方法以及平台间互通性的差异,使得研究间的比较变得复杂。缺乏公认的监管或技术标准,也使得数位生物标记难以整合到临床工作流程中获得监管核准。这种碎片化阻碍了扩充性,降低了临床信任度,并削弱了数位生物标记作为依证工具在监管申报和医疗决策中的可靠性。
新冠疫情显着加速了数位生物标记技术的应用。面对面就诊的限制促使远端监测、远端医疗以及利用连网健康设备进行即时健康追踪已广泛应用。製药公司已在临床试验中采用数位生物标记来远端评估患者的治疗效果。疫情凸显了分散式资料收集和个人化监测的重要性,刺激了对数位健康基础设施的投资,并强化了生物标记市场在全球医疗保健韧性和创新中的作用。
预计在预测期内,生理生物标记细分市场将占据最大的市场份额。
由于感测器和穿戴式装置被广泛用于追踪心率、呼吸和体温等生命体征,生理生物标记细分市场预计将在预测期内占据最大的市场份额。这些设备具有非侵入性,且在慢性病管理和远端健康监测领域的应用日益广泛,这些都推动了该细分市场的强劲成长。连续感测技术的进步及其与临床研究平台的整合,进一步巩固了该细分市场在市场上的主导地位。
预计在预测期内,云端基础市场将呈现最高的复合年增长率。
预计在预测期内,云端基础市场将实现最高成长率,这主要得益于对能够处理大型复杂健康资料集的可扩充性基础设施的需求。云端系统支援跨多个研究地点和装置的即时资料整合、互通性和安全储存。向分散式检测、全球协作和符合监管要求的数据处理的转变,正在推动云端基础的数位生物标记解决方案的普及,以支援高级分析和纵向健康监测策略。
预计亚太地区将在预测期内占据最大的市场份额,这主要得益于数位医疗的普及、医疗保健投资的增加以及政府对人工智慧医疗创新的大力支持。日本、中国和韩国等国家正透过公共卫生数位化倡议和临床研究合作主导此趋势。智慧型手机普及率的提高、行动医疗平台的快速扩张以及大规模的患者群体正在加速全部区域数位生物标记市场的普及。
在预测期内,北美预计将实现最高的复合年增长率,这主要得益于其先进的数位基础设施、强大的临床研究生态系统以及对精准医疗技术的强劲需求。美国在人工智慧驱动的生物标记分析、穿戴式感测器开发以及将数位终点整合到临床项目中的製药-生物技术合作方面处于主导地位。监管机构对数位健康检验的支持力度不断加大,以及许多领先技术创新者的存在,使北美成为数位生物标记领域成长最快的市场。
According to Stratistics MRC, the Global Digital Biomarker Marketplaces Market is accounted for $3.8 billion in 2025 and is expected to reach $22.3 billion by 2032 growing at a CAGR of 28.7% during the forecast period. Digital Biomarker Marketplaces are online platforms that enable the acquisition, validation, trading, and utilization of digital biomarkers-quantifiable, objective physiological and behavioral data points captured via wearable sensors, apps, or connected devices. These marketplaces connect researchers, healthcare providers, and developers, facilitating exchange and standardized analysis of digital health indicators for disease prediction, monitoring, and personalized treatment. They drive collaboration, innovation, and adoption of digital biomarkers in pharmaceuticals, diagnostics, and health monitoring services.
According to Nature Medicine, digital biomarker platforms aggregate data from consumer wearables to provide pharmaceutical companies with objective, real-world evidence on patient mobility and medication adherence during clinical trials.
Growing focus on personalized medicine
The increasing emphasis on personalized and precision medicine is driving the growth of digital biomarker marketplaces. Healthcare systems are shifting from traditional disease treatment models to individualized health management approaches. Digital biomarkers enable continuous monitoring, early disease detection, and the evaluation of treatment effectiveness through real-time health data. As pharmaceutical and clinical research organizations integrate digital biomarkers into drug development pipelines, demand for interoperable, data-driven platforms continues to accelerate across multiple therapeutic areas.
Data privacy and consent challenges
The digital biomarker marketplace faces significant restraint due to concerns around patient data privacy, informed consent, and data ownership. The collection and exchange of sensitive biometric and behavioral information from wearables, mobile applications, and connected devices raise compliance challenges under stringent regulations such as GDPR and HIPAA. Ensuring secure, transparent data sharing while maintaining user control represents a major hurdle for large-scale adoption. Lack of unified data governance frameworks further limits trust among patients and institutions.
AI integration in clinical diagnostics
Artificial intelligence presents a substantial opportunity for enhancing the accuracy and predictive power of digital biomarkers. Machine learning algorithms can analyze continuous health data streams to detect subtle physiological patterns linked to disease progression, enabling earlier diagnosis and personalized treatment strategies. Integrating AI with biomarker marketplaces allows for automated correlation, risk prediction, and adaptive trial design. This intersection of AI-driven analytics and connected devices is creating a new generation of intelligent, decision-support healthcare ecosystems.
Lack of standardization in biomarker data
The absence of standardized protocols for data capture, validation, and interpretation remains a key threat to the digital biomarker marketplace. Variability in device accuracy, data collection methodologies, and interoperability across platforms complicates cross-study comparisons. Without recognized regulatory or technical standards, integration into clinical workflows and regulatory approvals becomes challenging. This fragmentation hampers scalability, limits clinical trust, and reduces the reliability of digital biomarkers as evidence-based tools for regulatory submissions and medical decision-making.
The COVID-19 pandemic significantly accelerated the adoption of digital biomarker technologies. Restrictions on in-person care led to widespread use of remote monitoring, telemedicine, and connected health devices for real-time health tracking. Pharmaceutical companies adopted digital biomarkers in clinical trials to assess patient outcomes remotely. The pandemic highlighted the importance of decentralized data collection and personalized monitoring, triggering investments in digital health infrastructure and strengthening the role of biomarker marketplaces in global healthcare resilience and innovation.
The physiological biomarkers segment is expected to be the largest during the forecast period
The physiological biomarkers segment is expected to account for the largest market share during the forecast period, owing to the widespread use of sensors and wearables for tracking vital parameters such as heart rate, respiration, and body temperature. Their non-invasive nature, coupled with increasing adoption in chronic disease management and remote health monitoring, underpins strong growth. Advances in continuous sensing technologies and integration into clinical research platforms further contribute to the segment's dominant position in the marketplace.
The cloud-based platforms segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the cloud-based platforms segment is predicted to witness the highest growth rate, reinforced by the need for scalable infrastructure capable of handling large, complex health datasets. Cloud systems facilitate real-time data integration, interoperability, and secure storage across multiple research sites and devices. The shift toward decentralized trials, global collaborations, and regulatory-grade data processing drives the adoption of cloud-based digital biomarker solutions powering advanced analytics and longitudinal health monitoring strategies.
During the forecast period, the Asia Pacific region is expected to hold the largest market share, ascribed to its expansive digital health adoption, rising healthcare investments, and strong government support for AI-powered medical innovation. Countries such as Japan, China, and South Korea are leading uptake through public health digitization initiatives and clinical research collaborations. Growing smartphone penetration, rapid mHealth platform expansion, and large patient populations accelerate deployment of digital biomarker marketplaces throughout the region.
Over the forecast period, the North America region is anticipated to exhibit the highest CAGR associated with advanced digital infrastructure, robust clinical research ecosystem, and strong demand for precision health technologies. The United States leads in AI-enabled biomarker analytics, wearable sensor development, and pharma-biotech partnerships integrating digital endpoints in clinical programs. Expanding regulatory support for digital health validation and the presence of major technology innovators position North America as the fastest-growing market for digital biomarker marketplaces.
Key players in the market
Some of the key players in Digital Biomarker Marketplaces Market include Evidation Health, Verily, Philips, Roche Diagnostics, Biogen, Medidata, Sensorion, uMotif, Owkin, Datavant, IQVIA, Sensyne Health, Apple, Fitbit, Amazon, Verana Health, and ActiGraph.
In October 2025, Evidation Health launched an upgraded version of its Achievement platform, improving accuracy in detecting early, subclinical cognitive decline through passive smartphone monitoring. The update supports real-time data licensing for pharmaceutical companies seeking digital endpoints for Alzheimer's disease clinical trials.
In September 2025, Verily expanded its Project Baseline platform to support over 50 novel digital biomarkers derived from its study cohort. The update includes AI-driven predictive models for cardiovascular event risk and personalized data-sharing consent management for participants.
In August 2025, Announced a deepened partnership to integrate Apple Watch sensor data (including sleep patterns, activity, and heart rate variability) with Roche's NAVIFY platform. The collaboration enhances the validation of digital biomarkers for managing chronic conditions like heart failure and provides clinicians with trend-based insights.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.