The Emerging Space of Digital Biomarkers & Future Needs

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Digital Biomarker

Introduction

Healthcare is going through a technological transformation which is, in turn, transforming lives of patients. The increased use and popularity of smart wearable devices and health-related apps has produced a novel set of diverse and complex data. This data, in healthcare, is only valuable when paired with a strong body of clinical evidence. Biomarkers are quantitatively measured and evaluated indicators of biological and pathogenic processes.

As the world is increasingly going digital, healthcare now has access to a new type of biomarker – digital biomarker. Digital biomarkers are consumer-generated physiological and behavioral measures collected through connected digital tools that can be used to predict, explain and/or influence health-related outcomes. They provide an opportunity to render new data sources into informative and actionable insights. The obligation with the new data is on the system to turn it into relevant information that helps researchers, and consumers better understand states of both disease and health.

Consumer-facing digital tools – mobile health apps and sensors imbedded wearables – that can generate health data are on the rise. Companies have been working towards incorporating digital measurements across research and clinical care, making sure that connected devices can provide a holistic insights of patient’s health. Companies developing digital biomarkers indorse these tools for clinical research as a first step towards what may eventually become a validated digital diagnostic or a digital therapeutic. These factors are driving the global digital biomarkers market at a robust rate.

Healthcare Themes Impacting the Digital Biomarker Space

  • Remote Patient Monitoring (RPM): This refers to the measurement, understanding, and analysis of health metrics and functionality from fitness tracking, vital signs, temperature, heart rate, heart rate variability, and sleep, to more disease-specific biometrics including glucose monitoring, sweat analysis, electro-stimulation, and pressure sensors, outside of a traditional clinical setting. Technology in healthcare is currently moving toward wearables that are continuously monitoring health in a non-invasive, inobtrusive, and seamless manner, that is both convenient and comfortable.
  • The Covid-19 pandemic: Researchers and innovators at biopharmaceutical companies are looking and utilising data from wearable sensors that offer RPM solutions for patients infected with Covid-19. The data provides a measure of symptoms and identification of real-time digital biomarkers which are reported through analytics, often powered by AI. This method of data collection provides rapid, scalable, and objective measurements.
  • Consumer-led healthcare: Healthcare is transforming into a patient-centric, consumer-led mode. The industry is moving away from traditional analysis of patient care — an inefficient and costly method, with digital tools that are accessible for consumers in easily generating health data tracking and monitoring, driving a culture of awareness of one’s own health.
  • Big data: Digital tools such as wearables are a key tool in collecting large amounts of data and can easily be paired with software systems for analysis. Tech companies are developing algorithms that can interpret large collections of data from connected devices to be used to develop AI programs to automate many healthcare functions.
  • Value-based healthcare model: Connected digital devices have can distribute insights across the value chain and have a huge potential to address chronic conditions, which require long-term management with more complex care pathways. As digital biomarkers are defined and more widely adopted to inform patient care options, healthcare will become value-based.
  • The ageing population and rise of chronic diseases: With geriatric population growing globally, chronic conditions that are related to later life, such as diabetes, CVD, AD, and PD, are still a challenge to healthcare systems. The development of digital biomarkers play a large role in the tech-assisted transformation through connected devices and big data analytics in healthcare.

Digital Biomarkers in the Near Future

Digital biomarkers are expected to significantly benefit healthcare in bringing from a reactive towards a more preventive approach, as diseases will not only be explained better, but also more and more data will be available to analyze what healthy, normal states signify and to predict future health outcomes. As a result, research into digital biomarkers will rise in the coming years, boosting the global digital biomarkers market further.

However, there are several challenges to overcome in the near future. Standardized analysis are needed to be able to compare studies carried out with digital biomarkers. The standardized procedure ensures that sampling is carried out the same in every case, and thus results are comparable efficiently with other achievements. However, consumer-generated data might not be that evident. Measurements carried out with smartwatches or trackers could have completely different framework in each situation. It is also questionable to rely on certain tools, as not every wearable or health sensor is FDA- or CE-approved. The quality and details of the measurements may differ significantly, which might be essential for the researcher.

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Conclusion

The road to complete adoption is not an easy one. Digital biomarkers will face the some of the same regulatory challenges, if not largely, as traditional biomarkers. But since not all digital biomarkers are created equally, there is great potential to apply digital biomarkers to medical domains that are not well understood, such as psychiatry and neurology, especially if digital biomarkers are combined into phenotypic signatures. Creating insightful relationships is only the first step before the industry can truly understand the value of digital biomarkers.

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