Decoding Health – Unravelling the Power of Digital Biomarkers

The evolution of the healthcare industry is being driven by advancements in technology and rising adoption of telemedicine & digital biomarker. With increasing digitization across the globe, the need for real-time data access, management and analysis of health data has gained remarkable importance. The growing use of wearable devices and mobile applications to monitor health parameters is leading to increased consumerization of healthcare. Unlike the past, when healthcare offerings were primarily organization oriented, digital tools have led to patients taking charge of their own health. Further, the use of artificial intelligence has supported clinical decision making, automated clinical documentation and predicted patient outcomes based on historical data-based algorithms.

A major concern within the life sciences domain is the volume of patient data generated. However, inefficiency to utilize such huge amounts of data obstructs physicians from making informed decisions. By leveraging the capabilities of artificial intelligence and machine learning, the healthcare system can potentially analyze vast volumes of patient data for identification of patterns and correlations that are not possible to be detected manually. Besides data abundance, data quality also holds remarkable significance in developing AI-based healthcare models.  Robust infrastructure and efficient data management platforms can ensure credibility can accessibility of high-quality data.

Digital Biomarker Solution Developers – Current Market Landscape

The digital biomarkers market is dominated by the presence of companies headquartered in North America, followed by those based in Europe and Asia-Pacific. Most of the digital biomarker solutions are currently under research and development, followed by those which are marketed. It is worth highlighting that over 45 digital biomarker solutions have been approved by regulatory authorities, such FDA and EMA for commercialization, thereby ascertaining the credibility and clinical relevance of digital biomarkers. Examples of digital biomarker solutions approved by the FDA include Embrace 2 (Empatica), NEURONAUTE® (BioSerenity), QP-Prostate® (Quibim) and Zilia Ocular (Zilia).

Digital Biomarker Development - Roots Analysis

The digital biomarkers are of different types, including monitoring digital biomarkers (for patients suffering from a wide range of disorders), diagnosis digital biomarkers, disease risk assessment digital biomarkers and prognosis digital biomarkers. Further, majority (over 40%) of the digital solutions collect / analyze / integrate information related to different physiological digital biomarkers (such as pulse rate, heart rate variability, sweat parameters and blood pressure), followed by digital biomarkers of cognitive function (over 25%).

Key Initiatives in the Digital Biomarkers Domain 

  • Partnerships:

Stakeholders in this domain are known to adopt a variety of partnership models in order to collaborate with other companies / organizations. Such deals are inked to not only allow companies to advance their respective technology offerings, but also gain visibility as a reliable digital biomarker developer. Notably, product / technology integration agreements emerged as the most popular type of partnership model adopted by stakeholders in the digital biomarker solutions domain. Examples of some partnerships in this domain include:

  • In January 2024, Quibim partnered with Merck to advance the development of imaging biomarkers for diagnostics of cancer using precision medicine. Under the terms of the agreement, leveraging its expertise in developing AI-based predictive and prognostic models, the former company will develop advanced models for patient stratification and treatment response prediction of patients, while the latter company aims to integrate these algorithms within its drug development initiatives for data-driven decision-making.
  • In December 2023, Oura partnered with Headspace to integrate the latter company’s audio sessions for meditations, breathing exercises and sleep into the former company’s Oura App, thereby enabling their users to understand how their bodies tackle and overcome stress.
  • In October 2023, Huma partnered with Google with an aim to integrate Google Cloud’s generative artificial intelligence within its patient monitoring platforms.
  • Funding and Investments:

Stakeholders engaged in the digital biomarkers industry have raised investments from several public and private investors in order to fund their business operations. It is worth noting that most of the funding instances recorded in this domain were venture capital investments, followed by grants and seed funding. Examples of funding and investments raised by players engaged in this domain include:

  • In November 2023, BioSerenity raised a sum of EUR 24 million through private placement from Jolt Capital to advance the company’s mission to improve personalized medicine by offering unique service offerings to patients.
  • In October 2023, GeroSense raised an investment worth USD 6 million through venture series A round of financing led by Melnicheck Investments, with an aim to enhance its technology platform for finding cures for age-related disorders.
  • In March 2023, ArteraAI raised a sum of USD 90 million through a venture capital funding round, with investments from Coatue, Johnson & Johnson Innovation, Koch Disruptive Technologies, Walden Catalyst Ventures, TIME Ventures, Breyer Capital, The Factory, Marc Benioff, Jim Breyer, Lip-Bu Tan, Chris Re, Andy Jacques, Amarjit Gill, Jeff Dean, Steve Blank, Dennis Wong, Clarence So and Michael Driscoll. The firm utilized the capital raised to distribute its flagship ArteraAI Prostate Test, across the US and globe. Further, the proceeds from this round will support development of tests for detection of other cancers.
  • Global Events and Conferences:

The companies engaged in the development of digital biomarker solutions have participated in numerous global events (including conferences, summits, congress, meetings and webinars) in order to showcase their innovation and establish the reliability of their solutions. Participation in such events also aids stakeholders to increase their visibility within the overall domain and build connections with potential partners. Examples of global events conducted to discuss the advancements in the digital biomarkers industry include:

  • In February 2024, 19th Annual Biomarkers Congress was held in London, UK
  • In November 2023, The Power of Digital Biomarkers 2023 was held in Paris, France
  • In November 2023, 4th Annual Digital Biomarkers and Digital Measurements East Summit was held in Massachusetts, US
  • In July 2023, 2nd Digital Biomarkers & Clinical Measures in Neurology Summit was held in Massachusetts, US
  • In June 2023, 4th Annual Digital Biomarkers and Digital Measurements West Summit was held in California, US

Further, the following upcoming events related to digital biomarkers have been announced to be conducted in the coming months:

  • 23rd Annual Bio-IT World Conference and Expo
  • World Congress on Biomarkers, Clinical Research & Therapeutics
  • 4th Annual Clinical Trials Innovation Summit 2024
  • 3rd Annual Biomarkers Europe Congress

Digital Biomarker Market Growth Drivers

  1. Rising Adoption of Smart Devices: The elevated emphasis on personal health has led to a surge in the adoption of smart healthcare devices and wearables. The advent of such technologies in healthcare has enabled continuous monitoring of patient health parameters, leading to data-driven decision making.
  2. Increasing Number of Decentralized Clinical Trials: With the rise in virtual clinical trials, the need for digital biomarkers in clinical trials that provide accurate, real-time information on patient health has remarkably increased. Such trial designs are extremely patient-centric and promote participation of a large number of patients.
  3. Use of Digital Biomarkers in Neurological Disorders: Conventional drugs targeting neurological disorders often end up showing non-promising results in clinical trials. Digital biomarkers are increasingly being used to analyze cognitive and behavioral patterns and track effectiveness of treatment, leading to improved therapeutic outcomes for patients.

Digital Biomarker Market Growth Restraints

  1. Risk of Data Breach: Digital therapeutic solutions as well as digitally derived patient data is vulnerable to cyber-attacks. With rising adoption of digital health technologies, such risks are also anticipated to grow. Maintaining a balance between collection of valuable heath data and safeguarding the privacy of patients is a persistent challenge.
  2. Requirement of High Capital Investments: In comparison to conventional testing methods, the process of discovery, development and validation of digital biomarkers is cost intensive. Further, developers are required to make high capital investments to run numerous clinical trials as well as address the regulatory requirements.
  3. Lack of Clinical Validation: Despite the advantages of digital biomarker solutions, clinical validation has been remarkably low, especially in certain mental health disorders. The development of digital biomarker solutions requires large scale data sets to produce consistent and reliable predictions, and account for patient variability.

For more details, you can also download the SAMPLE REPORT on Digital Biomarkers by Roots Analysis.

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