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United States Digital Biomarkers in Oncology Clinical Trial Market OCT 2025, FDA Approvals, Clinical Approvals | Global Companies - Philips Healthcare, Syneos Health, Oracle Corporation, Pfizer Inc, NantHealth
Digital Biomarkers in Oncology Clinical Trial
FDA Approvals
In H1 2025, the FDA issued multiple approvals expanding the role of biomarkers in oncology, including novel targeted therapies with companion diagnostic biomarkers guiding treatment choice.
FDA approvals increasingly support biomarker-based real time monitoring systems, integrating digital endpoints validated for clinical trial use, improving patient safety and trial efficiency.
The FDA is advancing regulatory frameworks to better accommodate digital health technologies and decentralized clinical trial methodologies which include digital biomarkers.
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Clinical Approvals and Ongoing Approvals in October 2025
October 2025 marked notable clinical trial progress and approvals involving digital biomarkers:
Phase 3 clinical data for BriaCell's immunotherapy (Bria-IMTTM) in metastatic breast cancer showed encouraging biomarker correlations that may improve survival and treatment decisions.
Digital biomarker-driven trials leveraging AI for colorectal cancer and multiple myeloma expanded through collaborations such as BostonGene with NIH's NCI and Lunit with the U.S. National Cancer Institute.
Several adaptive trials incorporating digital biomarkers for treatment monitoring and outcome prediction remain ongoing in the US, Europe, and Asia-Pacific.
Key Players:
Koneksa Healthcare, Medidata Solutions, Inc, IBM Watson Health, Philips Healthcare, Syneos Health, Oracle Corporation, Pfizer Inc, NantHealth, Medtronic, Curemetrix among others.
Investments
Global investment in digital biomarkers research, particularly in oncology, continues to grow, with the global digital biomarkers market projected to reach $24.88 billion by 2033 from $5.84 billion in 2025.
Funding focuses on wearable devices, mobile health apps, real-world data platforms, and AI/machine learning to enable precise real-time monitoring of treatment response and disease progression.
Investments include government grants, venture capital, and pharma collaborations aimed at advancing platform validation and regulatory acceptance
Growth Forecast Projected:
The Global Digital Biomarkers in Oncology Clinical Trial Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2032. In 2024, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.
Research Process:
Both primary and secondary data sources have been used in the global Digital Biomarkers in Oncology Clinical Trial Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.
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Key Segments:
By Product Type: Wearable Devices, Mobile Health Apps, Electronic Health Records (EHRs), Others
By Application: Early Detection & Diagnosis, Treatment Monitoring, Patient Management, Outcome Prediction
By End User: Pharmaceutical & Biotechnology Companies, Research Institutions, Hospitals and Clinics
Regulatory and Reimbursement Updates (October 2025)
The International Council for Harmonization (ICH) E6(R3) guideline on Good Clinical Practice, updated recently, promotes integration of digital health technologies-such as digital biomarkers-in clinical trials to improve patient safety and data integrity. This has facilitated regulatory acceptance for continuous monitoring and decentralized trial designs incorporating digital oncology biomarkers.
The European Society for Medical Oncology (ESMO) AI & Digital Oncology Congress 2025 presented new regulatory perspectives emphasizing validated AI-assisted biomarker platforms enhancing patient stratification and real-time trial decision-making.
Reimbursement policies in major markets, including the US and EU, are evolving to consider digital companion diagnostics and biomarkers under value-based care frameworks, encouraging adoption in oncology clinical workflows
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Oncology Digital Biomarker Products Approved by FDA in October 2025
While no specific new FDA approvals of standalone digital biomarker products were reported in October 2025, companion diagnostics with integrated digital biomarker components supported approvals of advanced oncology therapies such as:
Cemiplimab for cutaneous squamous cell carcinoma (PDUFA date October 2025) accelerated by biomarker-guided patient selection.
Lurbinectedin/atezolizumab combination therapy with biomarker-guided indications in lung cancer.
FDA is actively reviewing companion diagnostic assays that combine genomics with digital behavioral biomarker data for adaptive oncology treatment monitoring.
FAQ's
Q: How fast is the Digital Biomarkers in Oncology Clinical Trial Market growing?
A: The Market is on an impressive growth trajectory, expected to expand at a High CAGR from 2025 to 2032
Ongoing Oncology Digital Biomarker Clinical Trials
Several late-phase clinical trials are underway testing AI-powered digital biomarkers for monitoring metastatic breast cancer, pancreatic ductal adenocarcinoma, and colorectal cancer, enhancing predictive response and early relapse detection.
Trials integrating multimodal digital biomarkers-such as continuous physiological and behavioral monitoring, liquid biopsy, and imaging data fusion are expanding in North America, Europe, and Asia-Pacific.
National Cancer Institute (NCI) backed studies explore AI-guided digital endpoints for various hematologic and solid tumor cancers under programs like NIH/NCI PAR-25-170, emphasizing rigorous validation and regulatory pathway establishment.
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