Digital biomarkers are becoming a hot topic. Investors are lining up. Pharma companies are eager to secure the best digital biomarker development companies to support their clinical and commercial initiatives. But what makes the digital biomarkers so attractive? There are four reasons of why digital biomarkers are getting the attention of the investors.
Until the digital biomarkers came to the scene, there has been one type of data, that can be called as “traditional biomarkers“, for medical treatment, for diagnosing a chronic condition, and for prognostic information about overall health of a patient. These biomarkers are being collected through clinical tests done by nurses or doctors while seeing the patients face-to-face in the hospitals or clinics. Blood glucose measurements, blood pressure levels or the PHQ-9 test scores to decide the severity of mental health problems can be given as examples of traditional biomarkers.
However, since the digital tools like smartphones, wearable devices and fitness trackers are being used more and more to collect real-time physical data continuously from the patients, ‘digital biomarkers’ has gotten a lot of attention lately.
Digital biomarkers can be defined as the objective and measurable physiological and behavioural health data, that is collected via digital consumer devices. What distinguishes the digital biomarker from the traditional biomarkers is the fact that digital biomarkers are collected continuously and remotely from the patient’s body for 24/7, and further interpreted with the AI and machine learning algorithms to define and predict the health status of the patient.
Knowing the difference between traditional and digital biomarkers, the partnerships and investment rounds of digital health and pharma companies have already showed the signs of their growing interest in digital biomarkers. In May 2020, Mindstrong, a digital mental health platform measuring mental health symptoms via smartphone behaviour of the patients, had announced $100M funding. It is followed by Oura Health, the health tech company behind the Oura ring that can track various vital signs of a patient continuously, also raised $100M funding in the Q2 2021 and sold 500,000 rings globally. Another digital therapeutics company, Pear Therapeutics, has closed licensing and partnership deals in April 2021 with Empatica and KeyWise AI in order to integrate biomarkers and wearable sensor technologies especially for its digital mental health and behavioural change services (Interested in learning more about how can digital mental health solutions be improved, click here.).
It is not only the digital health companies leveraging the usage of digital biomarkers. As the healthcare industry is getting more consumer oriented, and the consumer technology companies entering in the healthcare industry, pharma companies are left with not so much choice but to collaborate with the health tech companies for innovations and efficiency. Janssen Pharmaceuticals, one of the pharma companies of Johnsson&Johnsson, announced its partnership with physIQ to use the latter’s biomarker platform to improve the efficiency of clinical trials. Otsuka Pharmaceuticals also shows its commitment to merging with the digital technologies, through its latest partnership with Click Therapeutics, to conduct a fully-remote clinical trial in adults with major depressive disorders.
But what exactly makes the digital biomarkers so attractive for the pharma and digital health companies?
4 Main Reasons of Why Digital Biomarkers Are Getting Popular
It is clear from the investment rounds that there is a growing enthusiasm among the digital health companies as well as the pharma companies, for improving and integrating digital biomarkers to be used for their commercial and R&D developments. There are four reasons behind this growing enthusiasm for the digital biomarkers.
Provide early diagnosis and reduce the cost of treatment:
When the wearable devices and tracking technologies that send digital biomarkers continuously to healthcare providers and health insurance companies, this helps them to diagnose the chronic diseases and triggers early enough before it is too late. NuvoAir, digital health company for chronic respiratory disease management, recently announced that a new patient-facing application will catch the cough data of the users in day and night, to understand the cough symptoms and its recurrence for better diagnosis. Additionally, digital biomarker sensors are used for reducing the cost of medical intervention as well. The digital mental health solution operating in the USA, Feel claims that its wrist bands for detecting mental status of the users are claimed to reduce the cost of traditional psychotherapy sessions by 50%.
Increase the efficiency in clinical trials:
With the help of smartphones, smart watches and other wearable medical devices, digital biomarkers provide a sensitive, continuous, and objective data for the clinical trials of drug development. Digital health companies, like nQ Medical and physIQ, are already on the forefronts in the market to partner with pharma companies in discovering novel digital biomarkers for different research purposes and increasing the efficiency in clinical trials.
Support service expansion into other chronic conditions:
Biomarkers are used by the digital health solution providers to expand into other conditions, since many patients with a chronic condition live also with comorbidities and looking for digital solutions serving for multiple conditions. A digital health platform connected to biomarker sensing technologies can expand faster than the other competitors and start offering services for multiple conditions. (Interested in learning more about what drives success in digital therapeutics, click here). Sonde, a digital health company that is leveraging the voice-biomarkers for diagnosis and disease management, has started as a platform for respiratory conditions first, and expanded the usage of voice-biomarkers for their mental health services later on. Another example is the German digital health and device company, Cosinuss, which presents various case studies regarding its in-ear device that captures four vital physiological data being useful for self-management of various chronic conditions.
The existing functionality of smartphones is in use for developing novel digital biomarkers. For example, the vocal biomarkers collected from the microphones of the smartphones, and the biomarkers of touch-screen behaviour of patients are already being leveraged for early diagnosis of the neurodegenerative, and mild and major depressive disorders. Ki:Elements is currently working on improving their AI and machine learning algorithms with clinical research partnerships to detect the earlier sensors of Alzheimer’s, Parkinson’s, depression, and multiple sclerosis diseases via the typing pattern of the patients on their smartphones. Kenkou, a Berlin based health-tech company, is revolutionizing heartbeat measurement by transforming a smartphone into a real-time cardio diagnostic tool to measure vital signs, analyze personal results and get an in-depth look into the body’s current state. (To learn more about the company, read the interview with Matthias Puls, CEO here)
Digital biomarkers are entering into the healthcare industry with a high speed. But still, this does not mean that there are not any challenges. The adoption of the digital biomarkers requires more clinical studies, FDA and CE clearances, and support from the health systems as well as from the healthcare providers. Otsuka Pharmaceuticals had failed in its attempt to integrating ingestible sensors to collect novel digital biomarkers from the body of the patients after swallowing the pill, in spite of the FDA approval, because of the lack of support from the patients and their doctors. Its partner in this project, Proteus Digital Health, filed for bankruptcy in August 2020. Nowadays, etectRx, a digital health company, is the only one working further on developing the ingestible sensors.
On the one hand, this kind of incidences shows that the market for digital biomarkers is still quite young and needs to prove itself to all the stakeholders in the healthcare industry. On the other hand, the digital health solution providers, as well as the pharma companies, are not giving up on improving and integrating the digital biomarkers. They can and will change the course of traditional practices of medicine in future.
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