Digital Biomarker Market Key Takeaways:
· Based on type, the wearable segment dominated the market with the largest revenue share of 40.6% in 2024.
· The mobile-based applications segment is anticipated to grow with the fastest CAGR of 24.7% over the forecast period.
· Based on clinical practice, diagnostic digital biomarkers dominated the market with the largest revenue share in 2024.
· The monitoring digital biomarkers segment is anticipated to witness the fastest growth over the forecast period.
· Based on therapeutic area, the cardiovascular and metabolic disease segment dominated the market with the largest revenue share in 2024.
· The neurological disorders segment is expected to record the fastest growth over the forecast period.
· Based on end use, healthcare companies dominated the market with the largest revenue share of 51.0% in 2024.
· The payers segment is expected to grow at the fastest CAGR over the forecast period.
· North America accounted for the largest market share of 59.4% in 2024.
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The upsurge in the use of daily wearables like smart watches, smart rings, etc. paired with smartphones with daily updates and the emergence of new players in the market providing advanced and innovative technologies for data collection, real-time monitoring, personalized care and early detection of potential health problems has boosted the market growth and prevalence of digital biomarkers (DBMs).
Digital biomarkers are bridging the gap between computer science and biomedicine with the growing trends of using them and advancing healthcare monitoring. They are widely used in day-to-day life from tracking of daily fitness activity levels to real-time monitoring of chronic and non-communicable diseases (NCDs) such as diabetes, respiratory disorders, cardiovascular diseases.
The development of this technology is revolutionizing the healthcare industry with novel innovations and daily advancements.
The provision of deep-analysis platforms and effective healthcare monitoring systems with integration of artificial intelligence (AI) and machine learning tools is increasing the adaption of DBMs for clinical trials, research and personalized care further boosting the global market growth in the foreseeable future.
Additionally, the broad spectrum of applications such as real-time and remote patient monitoring, early disease detection, for drug development, precision medicine, personalized treatments and many more with accuracy, safety and efficiency is increasing the use of the DBMs among people and healthcare professionals. Moreover, the rising investments, increasing government support and funding’s from various organizations to the industries is promoting the market growth.
Uses Of Digital Biomarkers
Biomarkers can serve various purposes. The BEST Resource5 from the US Food and Drug Administration (FDA) identifies seven primary types of biomarkers.
• Susceptibility/risk: A biomarker might predict the potential for developing a medical condition in individuals without any current medical conditions.
• Predictive: A biomarker’s presence or change might predict a patient’s likely response to a specific medical intervention.
• Diagnostic: A biomarker might detect or confirm the presence of a disease or its subtypes.
• Prognosis: A biomarker might identify the likelihood of disease progression, recurrence, or a clinical event in patients with a certain medical condition.
• Pharmacodynamic/response: A biomarker’s levels might change in response to a medical intervention and can be used to measure the intervention’s biological outcome.
• Monitoring: A biomarker measured serially might assess the status of a disease or find evidence of exposure to particular agents.
• Safety: A biomarker might indicate the presence of a harmful effect of an intervention.
Digital Biomarkers Market Trends:
Increased Use of Wearables and Sensors:
· Wearable devices like smartwatches, fitness trackers, and biosensors are becoming mainstream for continuous health monitoring and capturing digital biomarkers in real-time.
Focus on Chronic Disease Management:
· Digital biomarkers are increasingly used to monitor and manage chronic diseases such as diabetes, cardiovascular diseases, and neurodegenerative disorders (e.g., Parkinson's, Alzheimer's).
Personalized and Precision Medicine:
· Digital biomarkers are enabling the shift towards more personalized, data-driven healthcare, allowing for tailored treatment plans based on an individual's unique biomarker profile.
Digital Biomarker Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2025 |
USD 5.22 billion |
|
Revenue forecast in 2034 |
USD 33.14 billion |
|
Growth rate |
CAGR of 22.8% from 2024 to 2034 |
|
Actual data |
2019 - 2023 |
|
Forecast data |
2024 - 2034 |
|
Quantitative units |
Revenue in USD million/billion, and CAGR from 2024 to 2034 |
|
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
|
Segments covered |
Type, clinical practice, therapeutic area, end-use, region |
|
Regional scope |
North America; Europe; Asia Pacific; Latin America; MEA |
|
Country scope |
U.S.; Canada; Mexico; Germany; UK; Spain; Italy; France; Norway; Denmark; Sweden; Japan; China; India; Australia; Thailand; South Korea; Brazil; Argentina; South Africa; Saudi Arabia; UAE; Kuwait |
|
Key companies profiled |
ActiGraph LLC; AliveCor Inc.; Koneksa; Altoida Inc.; Amgen Inc.; Biogen Inc.; Empatica Inc.; Vivo Sense; IXICO plc; Adherium Limited ;Neurotrack Technologies, Inc.; Aural Analytic; Huma; Sonde Health; Inc.; Clario; Imagene AI; Brainomix |
|
Customization scope |
Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope. |
Segment Insights
By Type
Based on type, the wearable segment dominated the market with the largest revenue share of 40.6% in 2024. The growth of this segment is attributed broad spectrum availability and easily usable wearables for healthcare purposes. The rising trends and constant improvisation with advancement in novel technologies installed in these wearables using algorithms for healthcare monitoring has significantly fuelling the market growth.
The integration of AI is helping in enhancing the accuracy and efficiency of the wearable DBMs by examining and rectifying the errors from the obtained data. For example, heart rate inaccuracies can be corrected from the obtained thereby guarantying the accuracy and safety of the wearable devices.
The mobile-based applications segment is anticipated to grow with the fastest CAGR of 24.7% over the forecast period. The integration of smartphones with wearables with the use of mobile-based applications has enhanced the accessibility of the DBMs for constant real-time monitoring of vitals, data storage and cloud-based analytics to provide insights allowing flawless incorporation for utilizing them into telemedicine and remote patient monitoring systems.
These mobile-based applications can help in monitoring gait, tremors and motor function using the accelerometer data in neurological conditions like Parkinson’s disease. Owing to the wide array of these applications in DBMs is increasing the market player’s presence enhancing the overall market growth.
By Clinical Practice
Based on clinical practice, diagnostic digital biomarkers dominated the market with largest revenue share in 2024. Diagnostic DBM may confirm or detect the presence of a disease or it’s other types. They add value to diagnostics through feasible diagnosis helping in early disease detection and decreasing misdiagnosis which ultimately aids in better targeting of other patients for early diagnosis leading to early initiation of treatment.
These advances and approvals from the government entities have further increased the investments of the industries driving the market growth. For instance, on June 22, 2023 – Eyenuk, a global AI digital health company leading in real-world applications for AI Predictive Biomarkers received approval from the FDA for the use of Topcon NW400 retinal integrated with its EyeArt AI system to automatically detect diabetic neuropathy.
The monitoring digital biomarkers segment is anticipated to expect the fastest growth over the forecast period. These biomarkers are applicable for monitoring the status of a disease or in finding proof of exposure to particular agents. The market growth of these DBMs can be attributed increased popularity of wearable DBMs and the huge investments of the industries in providing advanced technology ridden devices to the end user.
Furthermore, the growing support of the government and the increasing use of the monitoring DBMs in clinical trials, for patient monitoring, remote monitoring and for providing personalized treatments is driving the market growth. For instance, in May 2024, BioSensics, a company focusing on developing digital platforms for remote monitoring systems and wearable devices was granted a USD 2 million contract by the National Institute of Health (NIH) for enhancing and confirming the clinical trial products of the company for application in trials targeting neurological and neuromuscular disorders.
By Therapeutic Area
Based on therapeutic area, the cardiovascular and metabolic disease segment commanded the market in 2024. When investing in DBMs market, the therapeutic area can be potential area where the pharmaceutical companies will need to provide a clear portfolio strategy signalling where they are putting their efforts thereby demonstrating the financial impact of the investment which may further call for collaborations with startups and significantly strengthening their market positions and expanding the market. The rising prevalence of cardiovascular diseases and metabolic disorders is developing the need for providing disease-agnostic or disease-specific DBMs.
The neurological disorders segment is expected to record the fastest growth over the forecast period. The use of prognostic biomarkers for detecting changes in gait parameters and disease progression for neurological conditions can enhance patient life quality promoting to the market growth. Furthermore, the collaboration of companies, rising investments and the need for providing an effective solution to global prevalence of the neurological disorders is expanding the market growth for the use of DBMs.
For instance, in March 2024 – Indivi, a leading Medtech company developing DBMs in neuroscience collaborated with Biogen for development of DBMs for Parkinson’s disease and advancing digital health technology by using a smartphone-based digital biomarker platform which carries the examination of neurological functions remotely and monitoring disease progress.
By End Use
Based on end use, healthcare companies dominated the market with the largest revenue share of 51.0% in 2024. The increased use of DBMs and the daily advancements in the technologies for biomarkers with the integration of AI and machine learning models for diagnostic and monitoring systems is driving the market growth. Provision of funding’s for the development of DBMs through various initiatives, government entities and collaborations between industries is significantly expanding the market for healthcare companies.
The payers segment is expected to grow fastest during the forecast period. The growing prevalence of chronic disease has increased the adoption of payers segment for DBMs across the globe. Owing to the various applications such as real-time patient monitoring, personalized treatment plans, improved risk stratification, incentivizing preventive care and the potential for cost reduction is driving the market growth. Furthermore, the emerging support from the regulatory authorities realizing the value of DBMs is embracing the innovation and adoption among the payers.
By Regional Insights
North America accounted for the largest market share of 59.4% in 2024. The surge in R&D investments, presence of key market players, rising collaborations and mergers, support from the government entities such as FDA and provision of highly advanced technologies with increased awareness among the masses has expanded the market growth of DBMs in the region. Moreover, the integration of AI tools, rise in funding’s from public and private sectors and the support from the regulatory agencies realizing the potential of the DBMs is embracing the market growth.
U.S. Digital Biomarkers Market Trends:
Increased Adoption of Wearable Devices
· The rise of wearable devices (smartwatches, fitness trackers, etc.) enables continuous health monitoring.
· Example: Apple Watch's ECG feature is an example of integrating digital biomarkers for heart health monitoring.
Growth in Telemedicine and Remote Monitoring
· The COVID-19 pandemic accelerated the adoption of remote patient monitoring using digital biomarkers.
· Investment: In 2021, the U.S. telemedicine market saw significant investments from companies like Teladoc and Amwell, integrating digital biomarkers for disease management.
Integration of Artificial Intelligence (AI) and Machine Learning (ML)
· AI-driven algorithms help in interpreting digital biomarkers and improving diagnostic accuracy and decision-making.
· Example: IBM Watson Health collaborates with several healthcare companies to analyze digital biomarkers for early disease detection.
The Asia Pacific digital biomarkers market is anticipated to register the fastest growth during the forecast period. Due to the rising prevalence of chronic and non-communicable diseases and the demand for a healthy lifestyle is increasing the adoption of digital healthcare in the region. The growing use of smartphones and wearable devices, development of plans and strategies by the governments for adapting digital health services, regulatory flexibility and the failure of drugs for developing cure for chronic diseases such as neurodegenerative disorders is boosting the market growth for DBMs use. Moreover, the increase in utilization of AI tools by the industries in the region is further expanding the market.
Related Report –
Psychiatric Digital Biomarkers Market- The global psychiatric digital biomarkers market size was valued at USD 601.90 million in 2023 and is anticipated to reach around USD 4,813.46 million by 2033, growing at a CAGR of 23.11% from 2024 to 2033.
Breast Cancer Liquid Biopsy Market- The breast cancer liquid biopsy market size was exhibited at USD 1.34 billion in 2024 and is projected to hit around USD 2.89 billion by 2034, growing at a CAGR of 8.0% during the forecast period 2024 to 2034.
Cancer Biomarkers Market- The global cancer biomarkers market size was USD 31.90 billion in 2023, calculated at USD 36.02 billion in 2024 and is expected to reach around USD 107.33 billion by 2033, expanding at a CAGR of 12.9% from 2024 to 2033.
Digital Neuro Biomarkers Market- The global digital neuro biomarkers market size was USD 619.70 million in 2023, calculated at USD 777.10 million in 2024 and is expected to reach around USD 5,958.77 million by 2033, expanding at a CAGR of 25.4% from 2024 to 2033.
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Digital Biomarkers Market Companies
|
Name |
# Employees |
HQ |
Website |
|
Feel Therapeutics |
11-50 |
San Francisco, California, United States, North America |
|
|
Kinsa |
11-50 |
San Francisco, California, United States, North America |
|
|
Brainomix |
11-50 |
Oxford, Oxfordshire, United Kingdom, Europe |
|
|
Imagene AI |
11-50 |
Tel Aviv, Tel Aviv, Israel, Asia |
|
|
Clario |
5001-10000 |
Philadelphia, Pennsylvania, United States, North America |
|
|
Sonde Health |
1-10 |
Boston, Massachusetts, United States, North America |
|
|
Aural Analytics |
11-50 |
Scottsdale, Arizona, United States, North America |
|
|
Neurotrack |
11-50 |
Redwood City, California, United States, North America |
|
|
Ixico |
51-100 |
London, England, United Kingdom, Europe |
|
|
VivoSense |
11-50 |
Newport Coast, California, United States, North America |
|
|
Empatica |
51-100 |
Cambridge, Massachusetts, United States, North America |
|
|
Altoida |
11-50 |
Washington, District of Columbia, United States, North America |
|
|
Koneksa Health |
101-250 |
New York, New York, United States, North America |
|
|
AliveCor |
101-250 |
Mountain View, California, United States, North America |
|
|
ActiGraph |
11-50 |
Pensacola, Florida, United States, North America |
|
|
Biogen Inc |
7570 |
225 Binney Street, Cambridge, MA, United States, 02142 |
Some of the prominent players in the digital biomarkers market include:
· AliveCor Inc.
· Koneksa
· Altoida Inc.
· Amgen Inc.
· Biogen Inc.
· Empatica Inc.
· Vivo Sense
· IXICO plc
· Adherium Limited
· Neurotrack Technologies, Inc.
· Aural Analytic
· Huma
· Sonde Health, Inc.
· Clario
· Imagene AI
· Brainomix
· Kinsa Inc.
· Feel Therapeutics
Digital Biomarkers Market Recent Developments
·
In Nov 2024, DANNCE.AI
raised $2.6 million in a pre-seed funding led by LDV Capital for providing
clinicians and drug developers an AI-Powered biomarkers platform which is a
digital phenotyping platform for characterizing treatment response and
optimizing neurological care by behavioural quantification.
·
A recent summit in Sept 2024 on Alzheimer’s Disease
Research by the NIH in which about 70 leading academic and industrial
researchers, innovators and public advocates participated. One of the major
topics focused on Diversifying the Biomarker Toolkit.
· A South Korean company named HoneyNaps specializing in sleep data analysis with the use of AI secured $11.6 million in its series B funding round in May 2024. The company aims to utilize the funds for expanding the market reach for enhancing their flagship product, SOMNUM which can be applied for real-time sleep bio-signal monitoring system, AI based disease diagnosis and providing therapeutic care for sleep disorder with the help of its bio-signal management and analysis platform in under five minutes. Furthermore, the company plans to advance its AI technology focusing on other conditions such as cardiovascular diseases, dementia and Parkinson’s disease.
Segments Covered in the Report
By Type
· Wearable
· Mobile Based Applications
· Sensors
· Others
By Clinical Practice
· Diagnostic Digital Biomarkers
· Monitoring Digital Biomarkers
· Predictive and Prognostic Digital Biomarkers
· Other's (Safety, Pharmacodynamics/ Response, Susceptibility)
By Therapeutic Area
· Cardiovascular and Metabolic Disorders (CVMD)
· Respiratory Disorders
· Psychiatric Disorders
· Sleep & Movement Disease
· Neurological Disorders
· Musculoskeletal Disorders
· Others (Diabetes, Pain Management)
By End-use
· Healthcare Companies
· Healthcare Providers
· Payers
· Others (Patient, caregivers)
By Regional
· North America
· Europe
· Asia Pacific
· Latin America
· Middle East and Africa (MEA)
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