Digital Biomarkers Market

The digital biomarkers market is projected to reach USD 17.73 billion by 2031, growing from USD 7.41 billion in 2026 at a CAGR of 19.1% during the forecast period. The rate of growth of the digital biomarker market is largely dependent on its adoption rate in the pharmaceutical and biotechnology industry, especially in relation to the clinical trial process. As the pharmaceutical industry is becoming more data-centric and patient-centric, pharmaceutical sponsors are using digital biomarker platforms and tools to collect continuous real-world data from patients in various stages of the clinical trial process. As per the database provided in ClinicalTrials.gov, clinical trials conducted by the pharmaceutical industry, especially in the pharmaceutical and biotech sectors, are a significant percentage of global trials, indicating their importance in relation to the adoption process. In parallel, more than 130 pharmaceutical and biotechnology organizations have already implemented AI-powered digital biomarkers and sensor-based technologies to capture clinical endpoints, with over 1,300 digital endpoints analyzed across trials, of which more than 25% are now used as primary endpoints. This indicates a clear shift from traditional, site-based data collection toward decentralized and digitally enabled trial models. Overall, the expanding volume of industry-sponsored clinical trials and the growing reliance on digital endpoints are accelerating the demand for robust digital biomarker software and platforms.

Major players operating in the digital biomarkers market are IXICO PLC (UK), Ametris, LLC (US), Empatica, Inc. (US), AliveCor, Inc. (US), CONNEQT Health (US),  VivoSense (US), BioSensics (US),  Lunit, Inc. (South Korea), Akili, Inc. (US), Quibim (Spain), Clario (US), Proscia, Inc. (US), Koneksa Health (US), and Linus Health (US).

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IXICO PLC

IXICO PLC (UK) is a renowned digital biomarkers software solutions and analytics company that specializes in neurodegenerative disease research. IXICO offers advanced neuroimaging analytics solutions that allow for the extraction of quantitative biomarkers from neuroimaging and patient information. IXICO’s solutions help in improving clinical trial efficiency and data quality, which can help in the development of new therapies for neurodegenerative diseases. In July 2025, IXICO signed a strategic collaboration agreement with Global Alzheimer's Platform Foundation (US) to support the Bio-Hermes-002 study. This is aimed at improving the diagnosis of Alzheimer’s. IXICO has offered advanced neuroimaging analytics solutions for this purpose. This can help in the precise evaluation of the disease progression and incorporation of digital biomarkers in clinical trial environments. IXICO is dedicated to developing software-driven solutions that can help in improving patient monitoring and research for neurodegenerative diseases.

Ametris, LLC

Ametris, LLC, a US-based digital health technology company, provides software platform solutions for clinical trials. These solutions involve collecting, integrating, and analyzing digital biomarkers for clinical trials. In February 2026, Ametris, LLC, announced that it had entered a strategic partnership with AliveCor, Inc., which provides medical-grade ECG monitoring solutions. This partnership was aimed at integrating AliveCor's ECG monitoring solutions into the Ametris platform. This allows for the collection of ECG data and QT interval data in a remote manner. This is in line with the concept of digital cardiac endpoints in clinical trials. This partnership is focused on increasing accessibility, data-driven insights, and adoption of software-driven solutions for digital biomarkers in decentralized clinical trials.

Empatica, Inc.

Empatica, Inc. is a prominent digital biomarker software and analytics company in the US. It is a leading developer of neurological and physiological monitoring platforms. Empatica has developed AI-driven platforms that collect, integrate, and analyze continuous patient data to generate digital endpoints. In October 2025, Empatica, Inc. completed an acquisition deal with PKG Health, a UK-based company. PKG Health is a prominent developer of wearable-based monitoring systems for Parkinson's disease. PKG Health uses movement analytics to generate clinically validated biomarkers. With this acquisition, Empatica enhanced its neurological digital biomarker solutions. Empatica, Inc. has developed a comprehensive monitoring system for neurodegenerative disorders. This acquisition has enhanced Empatica’s digital endpoint solutions, thus boosting software-driven digital biomarkers.

Market Ranking

Companies such as IXICO PLC, Ametris, LLC, Empatica, Inc., AliveCor, Inc., and CONNEQT Health are driving innovation with comprehensive digital platforms that enable AI-powered analytics, remote patient monitoring, neurocognitive and behavioral assessments, cardiac monitoring, and imaging-based biomarker analysis. These top players focus on integrating digital endpoints into clinical trials, decentralized research, and real-world evidence generation, providing scalable solutions that enhance patient accessibility, data quality, and regulatory compliance. At the same time, specialized providers such as VivoSense, BioSensics, Lunit, Inc., Akili, Inc., Quibim, Clario, Proscia, Inc., Koneksa Health, and Linus Health are establishing strong presences in therapeutic- and disease-specific domains, delivering software-driven solutions for cognitive, neurological, cardiac, and behavioral biomarkers. Together, these companies are strengthening the overall digital biomarker ecosystem and advancing the adoption of data-driven, software-enabled healthcare solutions.

Related Reports:

Digital Biomarkers Market by Type (Physiological, Vocal, Idiosyncratic), Therapy [Cardio, Onco (Lung, Breast Cancer), Mental Health, Neuro], Application [Clinical Research (Phase IV)], End User (Pharma & Biotech Companies, CROs) – Global Forecast to 2031

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