Digital Biomarkers Market Overview

The Global Digital Biomarkers Market size is expected to grow from USD 3.56 billion in 2023 to USD 75.61 billion by 2032, at a CAGR of 40.43% during the forecast period (2024-2032)

The digital biomarkers industry represents a cutting-edge intersection of healthcare, technology, and data analytics, poised to revolutionize how we monitor and manage health conditions. Unlike traditional biomarkers, which are measurable indicators of biological processes or conditions, digital biomarkers are derived from data collected through digital devices such as smartphones, wearables, or sensors. This data includes physiological measurements, movement patterns, sleep quality, and even speech patterns, all of which can provide valuable insights into an individual's health status.

Digital biomarkers have a significant benefit in their capacity to collect data constantly in real-time, providing a more thorough and dynamic understanding of an individual's health in contrast to occasional clinic appointments or conventional testing procedures. This ongoing observation can facilitate timely identification of health problems, individualized treatments, and more accurate control of chronic conditions. Additionally, digital biomarkers make it easier to monitor patients remotely, which is becoming more important in a healthcare system that is shifting towards decentralized care and telemedicine.

Advancements in sensor technology, artificial intelligence, and data analytics are driving the growth of the digital biomarkers industry by enabling the interpretation and application of large amounts of health-related data. Businesses and research facilities are currently engaged in the creation and verification of fresh digital indicators in various areas such as heart disease, diabetes, mental health ailments, and neurological disorders. Regulatory bodies are also starting to create systems for verifying and authorizing digital biomarkers, enabling their incorporation into healthcare systems and clinical practice globally.

Market Dynamics And Factors Of Digital Biomarkers Market

Drivers:

Need For Improved Diagnostics And Integration of Digital Devices To Monitor Health Propelling The Market

Companion diagnostics and biomarkers have become increasingly relevant in the practice of medicine, leading to improved diagnosis, treatment, and monitoring across several disease areas. It can be used to identify patients likely to respond well to certain drugs or treatment options. These diagnostics are often used in conjunction with a specific drug. For instance, the Oncomine Dx Target Test (Thermo Fisher Scientific, Inc.) helps in biomarker testing of non-small cell lung cancer (NSCLC) patients eligible for ROZLYTREK (entrectinib). The expansion of the digital biomarkers market can be attributed to an increase in the usage of connected digital devices and health-related mobile applications. These devices aid in a range of diagnostic and prognostic measurements over diverse disease areas including mental health, diabetes, neurological diseases, and cardiovascular diseases. Rising usage of smartphones and the emergence of smartwatches, which aid in tracking the physiological details of the person's health, boost the digital biomarkers market. Technological advances in the range of mobiles and digitally connected technologies further propel the digital biomarkers market. Significant product launches and approvals from the FDA also drive the digital biomarkers market. For instance, in April 2020, the U.S. FDA approved KardiaMobile, by AliveCor, an AI-enabled wearable device that is designed to monitor a person's vital signs. It helps detect three highly common forms of heart arrhythmias.

Restraints:

Stringent Regulations And Affordability Impede The Growth Of The Market

There are barriers to broad acceptance, as there are with any emergent technology. Not all health information can be found, collected, or used. Many digital biomarker therapies are still experimental rather than common. Clinical procedures, legacy systems, workplace culture, and EU and international legislation can all make new digital biomarker technology adoption and integration challenges. Furthermore, pricey and intrusive digital biomarker therapies hinder wider adoption and are often ineffective since they lengthen a patient's stay in the hospital rather than at home.

Opportunities:

Voice Based Digital Biomarker Presents Substantial Growth Opportunity

Voice-based digital biomarkers are a forerunner of a biological research and healthcare revolution to come. The quality of a patient's voice is both a clear indicator of their health and a new frontier in health evaluation. Technologies that allow for speech capture on daily consumer devices and then do symptom recognition and prediction have enormous promise in both research and clinical practice. However, because these biomarkers are so new, there are significant uncertainties regarding how to bring them to market and use them effectively. Analytical validation entails verifying the quality and consistency of data processing and computed measures, as well as determining test-retest reliability, demographic variability, and comparing measurements to reference standards. Clinical validity is the process of ensuring that a measure corresponds to clinical outcomes such as diagnosis, illness progression, and therapy response. We give guidelines for the sorts of an evaluation required for speech-based biomarkers in each of these areas, as well as examine published examples. The examples in this study are specific to speech-based biomarkers, but they may be utilized as a model for developing digital biomarkers in general. One of the primary facilitators of voice-based digital biomarkers is EVOCAL Health GmbH.

Segmentation Analysis Of Digital Biomarkers Market

By System Component, Data collection tools dominate the digital biomarkers market. The cheap cost and greater scalability of digital biomarkers based on smartphone applications make it possible to access previously unavailable social, behavioral, psychological, and environmental data. Due to its capacity to evaluate health status, the development and progression of illnesses, and health conditioning monitoring using a non-invasive technique in healthcare research, biosensors had a substantial digital biomarker market share in 2020.

By Therapeutic Area, Cardiovascular Disease accounted for the largest share of digital biomarkers in the market. In cardiovascular disorders, digital biomarkers provide greater in-depth insights into the heart response of individuals during standardized exercise. The data generated by digital biomarkers have the potential to improve cardiac rehabilitation outcomes by optimizing and improving patient-centric treatment techniques.

By End User, Biopharmaceutical dominates the Digital Biomarkers Market.  Digital biomarkers are thought to be most useful in the early stages of drug research when pharmaceutical experts need to know if the medicine is successful or not before moving on to a phase III study and validating the results. For example, in the case of Alzheimer's and Parkinson's illnesses, the effectiveness of the treatments cannot be confirmed until the phase III trial, which has resulted in high-profile, cost-prohibitive failures that have cost pharmaceutical companies millions of dollars in the drug development process.

Regional Analysis Of Digital Biomarkers Market

North America remains a frontrunner in the digital biomarkers market, driven by robust investments in healthcare technology and a supportive regulatory environment. The region is home to numerous pioneering companies and research institutions advancing digital biomarker development. Dominance in North America is bolstered by strong collaborations between technology firms, healthcare providers, and academic centers, fostering innovation and commercialization. The United States, in particular, leads in regulatory advancements, with the FDA increasingly engaging in discussions and guidelines for digital biomarker validation and integration into clinical practice.

Europe boasts a robust digital biomarkers landscape, led by countries like Germany, the UK, and France, which serve as key hubs for innovation and research in digital health. The region benefits from a diverse regulatory environment under the European Union, with bodies like the EMA actively paving the way for digital biomarker adoption. Meanwhile, Asia-Pacific is experiencing rapid growth driven by technological advancements and increased healthcare investments in nations such as China, Japan, and South Korea. Despite varying regulatory frameworks, the region's proactive stance on digital healthcare transformation fuels demand for solutions like digital biomarkers, addressing pressing healthcare needs like aging populations and chronic diseases.

The digital biomarkers industry is witnessing global expansion driven by technological innovation, regulatory advancements, and increasing healthcare needs. While North America and Europe lead in terms of market dominance and regulatory maturity, Asia-Pacific and emerging markets offer significant growth opportunities fueled by technological adoption and evolving healthcare landscapes.

Top Key Players Covered In Digital Biomarkers Market

• AliveCor Inc.
• Bayer AG
• Evidation Health Inc.
• Fitbit Inc.
• Happify Health
• Koninklijke Philips NV
• Neurotrack Technologies Inc.
• GlaxoSmithKline Inc.
• Novartis International AG
• F. Hoffmann-La Roche Ltd.

Key Industry Developments in Digital Biomarkers Market

• In March 2024, Koneksa announced Merck's participation in its Data Syndication Partnership program for the LEARNS observational study on Parkinson’s digital biomarkers. Merck, joining as a member, gained real-time access to study data from smartphone-based and wearable technology assessments. The collaboration aimed to advance digital measures for Parkinson’s disease progression and treatment assessment through innovative data-sharing initiatives.
• In February 2024, Biofourmis secured four new agreements with top-20 pharmaceutical firms, driven by its expertise in digital biomarker development and decentralized clinical trial solutions. These partnerships focused on advancing oncology therapies through cutting-edge data science and technology, enhancing remote patient monitoring and safety measures. The agreements expand Biofourmis' global clinical trial footprint, spanning key regions including the United States, Europe, Asia-Pacific, and the Middle East, reflecting a strategic alignment with industry trends towards digital endpoints in drug development.