Digital Biomarkers: Opening New Doors In The Healthcare Industry

The healthcare market has a risk averse nature and complex regulatory landscape and is hence slow to adopt to change. However, #healthcaretechnology is seeing an increased pace of innovation in the recent few years and acceptance to digital health has been growing, digital transformation is no longer only an IT project.

Connected digital devices and health-related mobile apps are becoming increasingly popular among various demographics. These produce large, diverse, and complex data sets known as “digital biomarkers”, which can be defined as objective, quantifiable, physiological, and behavioral measures that are collected by sensors embedded in portable, wearable, implantable, or ingestible devices.?

The Advent of Smartwatches and Fitness Trackers: In the last ten years, smartwatches have increased in popularity and their technical functionality has constantly improved. In 2018, smartwatches accounted for nearly 60% of the overall wearables market, according to GlobalData figures, mostly attributed to the remarkable performance of Apple Watches, Xiaomi-backed Huami’s Misfit, and Fitbit Versa.?They are now widely accepted for tracking everyday fitness and activity, which has led to growth of “worried well” culture. These devices are powered by rechargeable lithium-ion batteries and are synced to smartphones via Bluetooth. Apple, Samsung, Fitbit, and Garmin some of the big tech players that have dominated the market with their predominantly fitness-tracking smartwatches. As smartwatch adoption increases, their manufacturing costs are decreasing, making way for low-cost competitors to disrupt the market. Individualized health monitoring in CVD, #diabetes, epilepsy, and neurological disorders is now available with smart-watches. Wearable and portable technologies can collect and track longitudinal patient data providing both preventative and predictive analysis into disease. Advanced analytics can then be applied to the data-collected by smartwatches enabling the HCP or caregiver to understand the patient requirements better.

GlobalData estimates there will be 7.4 billion global smartphone subscriptions in 2024, up from 5.6 billion in 2020.?

Disease-Oriented Devices and Applications:?Moving away from purely fitness tracking, market leaders in the digital biomarkers market are targeting specific therapeutic conditions. For example, the Apple watch has collaborated with Janssen/Johnson & Johnson in a study called heartline to assess the risk of AFIB to reduce stroke.?The Peerbridge COR system, offers portable ECG testing and has the FDA 510(k) clearance.

Other examples of disease-specific devices ?are Empatica’s watch for epilepsy, OMRON’s HeartGuide for blood pressure monitoring, and Great Lakes Neurotechnologies KinesiaU for PD. GlobalData predicts that more wrist-worn devices are in development that target specific diseases, their symptoms, and treatment compliance. These devices can create a variety of #digitalbiomarkers that can be used to enhance patient care.

In addition to the mobile apps that are connected to portable, wearable, and ingestible devices, the market also has witnessed introduction of standalone healthcare apps that can be used to collect and analyze patient data and digital biomarkers for health tracking as well as for clinical trials. These apps can be connected to external devices are for chronic disease management such as in #diabetes and CVD. Apps used for neuropsychological conditions such as AD or #mentalhealth disorders use embedded voice or speech digital biomarkers or cognitive tests and do not need to be synced with external devices.

Shifting Culture Towards Awareness of One’s Own Health: The healthcare industry is evolving with the help of digitalization, and the doctor alone is not the only source of information. Digital biomarkers generate easily accessible health data tracking and monitoring that can be validated clinicians. This trend is driving a culture of increased awareness individual’s over all wellbeing. Connected health from wearable devices and a variety of sensors generate rich data-sets that can be analyzed and informed decisions for patient care for patient care can be made from identifying digital biomarkers and studying their trends. With changing pathways and increasing adoption of consumer-led healthcare model, growth in healthcare will be driven in new ways and collaborations. Technology, pharma, patients, doctors, and investors will have to partner in new ways in the future as digital tools become the primary support for overall healthy living, diagnosis and therapeutic requirements.

Empatica’s Embrace watch has a 98% accuracy in detecting generalized tonic-clonic seizures and has CE certified in Europe as well as holds a 510(k) from FDA.

In addition to the above trends, increasing number of geriatric patients and rise in chronic diseases which is a concern in many nations will keep the demand for digital biomarkers high.

Next Generation Biomarkers: There is a constant demand for development of non-invasive sampling methodologies?and hence demand for research on potential noninvasive biomarkers is high. Voice and audio measurements, sweat analytics, post-operative care analytics are some areas which are seeing the introduction of new bio markers. Sweat contains electrolytes, proteins, and lipids and can provide a potential pool of non-invasive biomarkers across a wide range of indications including infectious diseases, immunology, neurology, psychiatry, endocrinology, pulmonology, nephrology, oncology, and pharmacology. Voice features can be linked to different diseases including PD, #adhd , #bipolardisorder, and depression, and makes remote monitoring possible to evaluate patients. Cough sounds are also being used in mobile applications to identify infectious diseases and respiratory disorders. Wearable technology used by post-operative patients could allow significant insight into rehabilitation progress and send alerts when necessary. This can also reduce the number of times the patient needs to go back for periodic checkups.?

Ingestible technology is a novel concept which consists of involves non-invasive device made up of sensors, microprocessors, controllers, and a power supply. They can be used in disease diagnostics and tracking of medication adherence, as well as pH, temperature, and pressure.

Leading innovators are closing millions of dollars’ worth funding for development of digital biomarkers. In August 2022, ADDF Diagnostics received Accelerator Funding for FTD Biomarker Development. These funds represent $2.5 million in support from AFTD, matched by $2.5 million allocation of the ADDF’s DxA funds. In March 2022, VivoSense raised $25 million in Series A funding for wearable sensor #biomarkers to advance clinical trials.

Regulations Hindering Innovation:?Regulatory control of #digitalbiomarkers is a complex and continually changing. International regulatory frameworks and standardized assay methods for medical devices (biomaterials and implantable) are based on risk assessment. In a bid to encourage innovation, local authorities are encouraged to provide clear and appropriate guidance. Low-risk general wellness wearable technology including fitness and smartwatches is normally not subject to regulation by the FDA; however, recent releases like Qardio’s QardioCore have been granted clearance by the FDA as mobile ECG sensors to detect heart disease, anxiety, and more. This represents a move forward by the FDA where it is stepping up its regulatory oversight to provide more precise guidance. The FDA views wearable devices as general wellness products that promote wellness and present very low risk to user safety, thus they refrain from regulating them.

The digital biomarkers market for digital tools is becoming more personalized and disease-specific which is made plausible with help of advances in AI, ML and IoT. More and more technology is involved in the new discovered digital biomarkers indicating ?multi-stakeholder development and delivery. AI based processing of data collected by connected devices and sensors, driven by the integration of virtual personal assistants such as Apple’s Siri on its Watch and AirPod headphones, and Google’s Assistant on Wear OS watches will continue to prove beneficial to the healthcare industry. Amazon and Microsoft that do not make the wearables themselves are gaining ground with AI assistants Alexa and Cortana, that are becoming increasingly integrated in other wearable devices. Sensoria Fitness is another example that provides consumers with Mara, an AI in-app coach to improve running routines using performance analytics.

When paired with emerging technologies in #artificialintelligence, and easing regulations, digital biomarkers market will grow by leaps and bounds in the near future.

If you are interested in more in-depth insights on digital biomarkers, visit our report page?here.

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