Clinical Validation is Required Before Digital Biomarkers Can Be Recommended to Patients

According to National Institute of Environment Health Sciences, a biomarker is an objective the measure that captures physiologic, pathologic, or anatomic characteristics of a person to understand the state of being, more precisely a warning system of the body. With the recent technological advancements in the field of mobile and digitally connected technologies, the concept of biomarkers has diverged into a new class altogether called digital biomarkers. This new emerging concept of digital biomarkers has found implications in both clinical trials as well as clinical care. The technology enables the collection of consumers generated physiological and behavioral data with the help of digitally connected tools such as wearable, implantable, and ingestible devices and sensors.

The hype around wearable technology has cleared and the uptake of the same has significantly skyrocketed in the past five years. According to a report from the European Commission, the shipment of wearables is expected to increase to $150 billion by 2026 from the estimated level of $30 billion in 2016. The growth in this market can be attributed to increasing consumer demand for user-friendly and self-monitoring devices, the surge in the prevalence of chronic diseases, and increasing health awareness. The market is also driven by technological advancements and attractive product features such as smartphone app connectivity.

The use of wearables in clinical research have immense potential to convert longitudinal biometric data sets into meaningful and actionable intelligence that can be used as a digital therapeutic to treat medical conditions. The number of clinical trials conducted using wearable devices was consistent during the period of 2008 to 2018, i.e. 5-12 trials annually. However, the number surged significantly in the year 2016 and 2017, with 27 and 32 trials commencing each year respectively using mobile devices. The primary reason for the spike in 2016 and 2017 were found to be a considerable surge in the sponsorship for these studies.

The digital biomarkers market can be categorized on the basis of environment a digital biomarker is being used in. As of 2018, a clinical setting holds the largest market share wherein a clinician monitors/detects/ diagnoses a specific condition of a patient with the help of digital biomarkers. On the other hand, digital biomarkers also require clinical validation before they can be recommended to patients, hence, digital technology vendors are increasingly collaborating with biopharma companies to validate their claims and products. This segment is expected to account for approximately 91% of the overall digital biomarkers market from a current share of 7.76% (2018).