Digital Biomarkers Market Analysis

Digital Biomarkers Industry Insights

Component Analysis

• The data collection tools category accounts for more than 70% share in 2024.
• These tools aid in data gathering and the extraction of novel digital biomarkers that are more precise, patient-centric, clinically useful, and more objective than those extracted via conventional research approaches, such as subjective rating scales and patient diaries.
• Wearables, which include fitness bands and smartwatches by ActiGraph, Fitbit, Garmin, and a variety of other brands have been used successfully in clinical studies spanning several fields of medicine, such as oncology, cardiovascular diseases, diabetes, rehabilitation, and mental health, to assess step count, activity intensity, heart rate, sleep-related outcomes, blood oxygen level, and sweating intensity.
• Wearable devices are increasingly being employed as a key data source to develop highly personalized and adaptable patient treatment plans, thus allowing for the implementation of prompt therapeutic interventions based on minor changes in health patterns.
• Data integration software is the faster-growing category owing to the soaring demand for comprehensive health data management solutions.
• As digital health technologies are increasingly adopted, it becomes imperative to integrate the data coming from wearables, mobile health applications, and electronic health records.
• This enables healthcare providers to obtain an encompassing view of patients' health for regular monitoring and offering personalized care.
• The complexity in the maintenance of multimodal information necessitates integration tools that guarantee the accuracy and interoperability of the data.
• Advanced integration software improves clinical workflows, simplifies data analysis, and enables decision-making on a real-time basis.
• Additionally, the need to protect data and patient privacy raises the requirement for more-advanced integration software compliant with the regulations.

The components evaluated here are:

• Data Collection Tools (Larger Category)
  • Wearables
  • Implantables
  • Mobile apps
  • Others
• Data Integration Software (Faster-Growing Category)

Type Analysis

• Clinical trials are the larger category in the market for digital biomarkers because of the high importance of biomarkers in the drug development process.
• The integration of digital biomarkers in clinical trials enables more-accurate monitoring of a patient’s treatment and response, allowing for adaptive trial designs.
• This approach is cost-effective, improves the quality of the data captured, and diminishes the costs of trials.
• It also improves patients’ engagement through the real-time tracking of their health information.
• This increases the confidence of entities conducting clinical trials on the ability of digital biomarkers to give actionable insights through their advanced analytics capabilities.
• Clinical settings are the faster-growing category, at a CAGR of 30.0%, during the forecast period, driven by the rising need for personalized and proactive healthcare.
• Furthermore, as digital technologies are increasingly adopted by care providers, digital biomarkers are enhancing routine practice.
• Continuous health monitoring enables doctors to optimize disease management and treatment.
• Other strong drivers for this category include the emerging telehealth and remote monitoring technologies and the shift toward value-based and patient-centric care.

The types analyzed here are:

• Clinical Trials (Larger Category)
• Clinical Settings (Faster-Growing Category)

Clinical Practice Analysis

• The diagnostics category is expected to have the highest value, of USD 1.25 billion, in 2032.
• It is propelled by the rising use of connected digital devices and mobile health applications to diagnose various diseases, such as cardiovascular diseases, neurological illnesses, diabetes, and mental disorders.
• Voice patterns, texting behavior, and sleep data are analyzed to identify mood and predict incidents of depression and anxiety.
• For instance, Kardiacare Plus and KardiaMobile 6L are physiological biomarkers used for data collection and analysis for disease diagnosis and risk assessment.
• Monitoring is the fastest-growing category, because the advances in telehealth propel the demand for digital biomarkers that help in the continuous monitoring of patients with long-term diseases.
• They are essential for managing chronic conditions from home and remote locations.
• Additionally, people are investing more in smartwatches and wearables that help with proper and accurate health monitoring.
• Wearables improve the evaluation of patient conditions through sleep analysis, biometrics, heart rate tracking, and disease-specific data tracking.

The clinical practices evaluated here are:

• Diagnostic (Largest category)
• Monitoring (Fastest-Growing category)
• Predictive & Prognostic
• Others

End User Analysis

• Pharmaceutical & biopharmaceutical companies dominate the market with revenue of USD 1.5 billion in 2024.
• This is attributed to the consistent efforts by biopharmaceutical companies to develop a synergy between digital technologies and clinical procedures.
• Several biopharma companies apply digital health tools and data analytics to improve clinical trials and drug development.
• For instance, Pfizer applies automation, AI, and predictive analytics to digitalize the R&D process by leveraging large volumes of patient data with minimal chances of errors, while accelerating the time-to-market.
• The advancements in remote data collection through wearable devices and mobile apps also help participants become more engaged in clinical trials, further helping increase the efficacy of the drugs under development.
• Providers are the fastest-growing category, credited to their aim to improve health outcomes, understand patient responses, and optimize therapeutic interventions.
• The implementation of digital biomarkers in clinical practice allows for better management of diseases, early diagnoses, and tailored treatments.

The end users analyzed here are:

• Pharmaceutical & Biopharmaceutical Companies (Largest Category)
• Payers
• Providers (Fastest-Growing Category)
• Academic & Research Institutions
• Others

Application Analysis

• The cardiovascular category holds the largest share in 2024.
• This is due to a rise in the prevalence of cardiovascular disorders in the global population, as an upshot of numerous causes, such as high tobacco consumption, bad eating habits, and excessive alcoholism, which is likely to fuel the expansion of this category in the future.
• Digital biomarkers capture patient data and improve patient care and treatment outcomes.
• Psychiatric disorders are the fastest-growing category with 31.0% CAGR.
• This is because of the expanding prevalence of cognitive and behavioral problems, and the growing pace of technological improvements in the digital biomarker environment.
• Mood disorders affect the entirety of the world's population, thus resulting in a massive functional and economic burden.
• As a result, it is critical to diagnose and monitor mood and behavioral symptoms at an early stage, to detect clinical deterioration promptly.
• Current psychiatric assessment approaches are time-consuming and resource-intensive and require a trained clinician to evaluate various parameters.
• Digital biomarkers can greatly facilitate a scalable, time-sensitive, and cost-effective assessment of mood and behavior.
• For this purpose, measurements can be taken with the help of actigraphy (a technique that collects the user's gross activity level), which is useful in detecting mood-related disorders, because these disorders are frequently characterized by a significant increase or decrease in energy levels, in addition to behavioral symptoms.

The applications evaluated here are:

• Gastrointestinal Diseases
• Sleep & Movement Disorders
• Cardiovascular Diseases (Largest Category)
• Psychiatric Disorders (Fastest-Growing Category)
• Chronic Pain
• Neurodegenerative Diseases
• Diabetes
• Respiratory Diseases
• Others