Digital Biomarkers Market Trends

Growth Drivers

• Shift towards personalized and precision medicine: The healthcare sector is moving towards personalized medicines from a conventional “one-size-fits-all” strategy. In precision medicine, interventions and treatments are customized to individual patient profiles. Digital biomarkers are leveraging data from smartphones or wearables and monitoring the patterns of the patient consistently. For instance, devices such as Dexcom G6 or Abbott FreeStyle Libre measure glucose levels and send the obtained data to cloud platforms. Patients have achieved better glucose control with very less hypoglycemic episodes. These developments emphasize precision care, which is a prominent driver of the investment in digital biomarker technologies.
• Surge in integration of AI and ML in healthcare: According to the University of Minnesota School of Public Health in January 2025, more than 65% of the hospitals in the U.S. utilize AI-enabled predictive models. The inclusion of AI and ML algorithms directly supports the growth of digital biomarkers. The healthcare system is now ready to include real-time data for clinical decision-making. Digital biomarkers produce a vast stream of data, and the inclusion of AI provides a required infrastructure for hospitals to analyze and interpret data. Such synchronization ensures swift clinical validation and robust pathways for reimbursement, positioning digital biomarkers as the next big step in the evolution of AI-enabled healthcare.
• Rising chronic disease burden and aging population: The worldwide prevalence of chronic diseases is a major factor bolstering the market growth. According to the World Health Organization, non-communicable diseases killed at least 43 million people back in 2021. The non-communicable conditions, such as diabetes, cardiovascular diseases, etc., require continuous monitoring. Additionally, various health insurance companies are reimbursing digital health interventions, particularly in the management of chronic diseases. Digital biomarkers are offering a scalable and cost-efficient solution for the keen monitoring of long-term diseases and rendering customized care to the patients.

Challenge

• Data privacy and interoperability issues: The market often faces delays and financial losses due to volatility in regulatory criteria and interoperability. Additionally, closed ecosystems, such as Apple HealthKit, hinder seamless integration with hospital EHR systems, limiting clinical utility and adoption, according to the 2023 NIH report. These obstacles slow market expansion and complicate the large-scale deployment worldwide. Also, clinical validation remains a major hurdle for the market. There is presence of a notable gap that undermines trust among healthcare providers and payers.