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市場調查報告書
商品編碼
1871930
全球數位生物標記市場:未來預測(至2032年)-按生物標記類型、平台、治療領域、資料類型、最終用戶和地區進行分析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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根據 Stratistics MRC 的一項研究,預計到 2025 年,全球數位生物標記市場價值將達到 38 億美元,到 2032 年將達到 223 億美元,在預測期內的複合年成長率為 28.7%。
數位生物標記市場是支援數位生物標記獲取、檢驗、交易和利用的線上平台。數位生物標記是指透過穿戴式感測器、應用程式或連網裝置收集的可量化、客觀的生理或行為資料點。這些市場連接研究人員、醫療保健提供者和開發人員,促進數位健康指標的交換和標準化分析,用於疾病預測、監測和個人化治療,從而推動醫學、診斷和健康監測服務領域中數位生物標記的合作、創新和應用。
根據《自然醫學》報道,該數位生物標記平台匯總了來自消費者穿戴式裝置的數據,為製藥公司提供有關臨床試驗期間患者活動能力和用藥依從性的客觀、真實世界數據。
人們越來越關注個人化醫療
對個人化和精準醫療日益成長的重視正在推動數位生物標記市場的發展。醫療保健系統正從傳統的疾病治療模式轉型為個人化健康管理模式。數位生物標記能夠透過即時健康數據實現持續監測、疾病早期檢測和治療效果評估。隨著製藥公司和臨床研究機構將數位生物標記整合到藥物研發流程中,對互通性、數據驅動型平台的需求在多個治療領域持續加速成長。
資料隱私和同意方面的挑戰
由於對病患資料隱私、知情同意和資料所有權的擔憂,數位生物標記市場面臨許多限制。從穿戴式裝置、行動應用程式和連網裝置收集和交換敏感的生物識別和行為訊息,在GDPR和HIPAA等嚴格法規的約束下,帶來了合規性方面的挑戰。如何在確保安全透明的資料共用的同時維護使用者控制權,是大規模應用的主要障礙。缺乏統一的資料管治架構進一步削弱了病人與醫療機構之間的信任。
將人工智慧應用於臨床診斷
人工智慧在提升數位生物標記的準確性和預測能力方面具有巨大潛力。機器學習演算法能夠分析連續的健康資料流,並檢測與疾病進展相關的細微生理模式,從而實現早期診斷和個人化治療策略。將人工智慧與生物標記市場結合,可實現自動化的相關性分析、風險預測和自適應臨床試驗設計。人工智慧驅動的分析與連網設備的融合,正在建構新一代智慧化的、決策支援的醫療保健生態系統。
生物標記數據缺乏標準化
缺乏標準化的數據收集、檢驗和解讀通訊協定仍然是數位生物標記市場面臨的主要威脅。設備精度、資料收集方法以及平台間互通性的差異,使得研究間的比較變得複雜。缺乏公認的監管或技術標準,也使得數位生物標記難以整合到臨床工作流程中獲得監管核准。這種碎片化阻礙了擴充性,降低了臨床信任度,並削弱了數位生物標記作為依證工具在監管申報和醫療決策中的可靠性。
新冠疫情顯著加速了數位生物標記技術的應用。面對面就診的限制促使遠端監測、遠端醫療以及利用連網健康設備進行即時健康追蹤已廣泛應用。製藥公司已在臨床試驗中採用數位生物標記來遠端評估患者的治療效果。疫情凸顯了分散式資料收集和個人化監測的重要性,刺激了對數位健康基礎設施的投資,並強化了生物標記市場在全球醫療保健韌性和創新中的作用。
預計在預測期內,生理生物標記細分市場將佔據最大的市場佔有率。
由於感測器和穿戴式裝置被廣泛用於追蹤心率、呼吸和體溫等生命徵象,生理生物標記細分市場預計將在預測期內佔據最大的市場佔有率。這些設備具有非侵入性,且在慢性病管理和遠端健康監測領域的應用日益廣泛,這些都推動了該細分市場的強勁成長。連續感測技術的進步及其與臨床研究平台的整合,進一步鞏固了該細分市場在市場上的主導地位。
預計在預測期內,雲端基礎市場將呈現最高的複合年成長率。
預計在預測期內,雲端基礎市場將實現最高成長率,這主要得益於對能夠處理大型複雜健康資料集的可擴充性基礎設施的需求。雲端系統支援跨多個研究地點和裝置的即時資料整合、互通性和安全儲存。向分散式檢測、全球協作和符合監管要求的數據處理的轉變,正在推動雲端基礎的數位生物標記解決方案的普及,以支援高級分析和縱向健康監測策略。
預計亞太地區將在預測期內佔據最大的市場佔有率,這主要得益於數位醫療的普及、醫療保健投資的增加以及政府對人工智慧醫療創新的大力支持。日本、中國和韓國等國家正透過公共衛生數位化舉措和臨床研究合作主導此趨勢。智慧型手機普及率的提高、行動醫療平台的快速擴張以及大規模的患者群體正在加速全部區域數位生物標記市場的普及。
在預測期內,北美預計將實現最高的複合年成長率,這主要得益於其先進的數位基礎設施、強大的臨床研究生態系統以及對精準醫療技術的強勁需求。美國在人工智慧驅動的生物標記分析、穿戴式感測器開發以及將數位終點整合到臨床項目中的製藥-生物技術合作方面處於主導地位。監管機構對數位健康檢驗的支持力度不斷加大,以及許多領先技術創新者的存在,使北美成為數位生物標記領域成長最快的市場。
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.