Digital Biomarkers Market Size To Grow At 22.8% CAGR Till 2033

The digital biomarkers market size was exhibited at USD 4.25 billion in 2024 and is projected to hit around USD 33.14 billion by 2034, growing at a CAGR of 22.8% during the forecast period 2024 to 2034.

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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.

The growth is attributed to the increased popularity of recent innovations and remote technologies, the rapid advancement in healthcare technology along with rising healthcare expenditure coupled with growing demand for remote patient monitoring services. In addition, rising usage of smartphones coupled with the emergence of new wearables, expanding therapeutic area applications, and increasing investment in decentralized clinical trials are also driving the market.

As smartphones and wearables become more widely available, new inventive technology enables real-time monitoring of complicated diseases by detecting biomarkers like breathing, speech, heat, and eye movements. Particularly, vocal digital biomarkers (DBMs) have recently emerged and have considerable market growth potential. For instance, in June 2021, the Luxembourg Institute of Health launched CoLive Voice, a digital health company focusing on advancing risk prediction, diagnosis, and remote monitoring of various chronic conditions. These biomarkers are expected to offer a chance to collect information through audio recordings with little to no user load and can be done with tools that patients are already using, like smartphones.

In addition, DBMs developed by wearable sensors and cutting-edge algorithms provide a way to evaluate well investigational medicinal products performed continually and remotely in clinical trials. For instance, in February 2024, Rajant Health Incorporated (RHI) received medical experts endorsements from three industry leaders for its cutting-edge technology wearable Q-Stat, focused at detecting life-threatening medical event. Further providing transparency in measuring activity for remote health management with ECG, SpO2. In addition, cardiovascular diseases are expected to be the largest application segment for DBMs, and this is expected to continue, as cardiovascular disease is the leading cause of mortality worldwide, despite being a largely preventable disease.

The sharp increase in the usage of smartphones, smartwatches and wearable digital technological devices like medical bracelets and fitness trackers. The continuous growth in yearly smartwatch sales is also contributing to the expansion of the digital biomarkers market. In another instance, as per statistics published by GSM association report, the Mobile Economy 2024? the number of people connected to mobile services surpassed 4.4 billion in 2022, and the number of unique mobile subscribers was 5.4 billion in 2022, which is expected to reach 6.3 billion by 2030 (73% of the global population). The penetration of smartphones is also rising significantly. According to the Mobile Economy 2022, smartphone adoption & penetration was 67% in 2021 and is expected to reach 77% by 2025.

Government initiatives and collaborations with global manufacturers are significantly driving the market’s growth.Moreover, rising government support through funding and seeking grant applications for telehealth services is also promoting growth. For instance, in April 2024 NeuReality AI accelerator startup based in Israel, secured funding of USD 20 million from EU Council (EIC) Fund and European Innovation program to further develop its patented algorithms for cancer pathology. Hence, it can be seen as an attractive investment. These funds aimed at deployment of NeuReality’s NR1 AI inference solution to more regions and market segments in Europe.

The rising cost of drug research, combined with its relative low success rate, is fueling the rapid creation of DBMs. DBMs in this field assist in focusing on particular decentralized clinical study areas, including early-onset Alzheimer's or dementia, thereby lowering the time, failure rate of drug development, and cost. For instance, Biogen has invested more than USD 28 billion in neurological research and development since 2003, during which at least 100 medication development programs were abandoned in order to discover a novel therapeutic.

The lack of awareness and scarcity of skilled professionals, especially in developing regions like Latin America and MEA in comparison to Europe and North America, is resisting the market growth. Moreover, issues such as data privacy are anticipated to slow down the growth of the market over the forecast period. However, increasing government support in the form of initiatives and funding for the development of healthcare infrastructure in emerging nations such as India, Japan, and China is expected to drive the demand for market growth in the future.

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 By Clinical Practice Insights

Based on clinical practice, diagnostic digital biomarkers dominated the market with the largest revenue share in 2024. This growth is attributable to the increasing use of the linked digital devices and health-related mobile applications for diagnosis & monitoring of the measurements used for a variety of disease categories, including cardiovascular illnesses, mental health, neurological diseases, and diabetes. Owing to this, market players in the industry are investing in biomarker research, which is anticipated to drive growth. For instance, in May 2022, Imagene AI, an Israel-based digital biomarker firm, raised USD 21.5 million in investment, including a USD 3 million seed round headed by Blumberg Capital and a USD 18.5 million Series A round led by technology-driven cancer treatment investors, to focus on precision medicine in cancer care.

Digital Biomarker Market By Therapeutic Area Insights

Based on therapeutic area, the cardiovascular and metabolic disease segment dominated the market with the largest revenue share in 2024. The growth is attributed to the growing number of therapeutic applications and increasing incidences of cardiovascular disorders globally. Moreover, market players are strengthening their market position by adopting strategies such as collaborations with regional companies to expand their client base and offer better solutions at lower costs, For instance, in July 2024, Cardiovascular Network of Canada augmented its digital health platform VIRTUES, improving the delivery of cardiac care to patients across Canada, such instances are anticipated to promote overall growth over the forecast period.

Digital Biomarker Market By End-use Insights

Based on end use, healthcare companies dominated the market with the largest revenue share of 51.0% in 2024. This can be attributed to the fact that healthcare companies have been working toward integrating digital measurements across the spectrum of clinical care & research to ensure connected devices provide a comprehensive view of patient health.

The payers segment is expected to grow at the fastest CAGR over the forecast period. The growth of the segment is attributed to the rising adoption of novel digital biomarkers in insurance firms and payers' ability to use these tools to satisfy patient needs further & develop individualized care plans with schedules for prior authorization.

Digital Biomarker Market By Regional Insights

North America accounted for the largest market share of 59.4% in 2024 owing to the increase in investments in R&D, strong presence of leading market players, growing approval of smart devices, significant product launches, and improved awareness of the effectiveness of digital biomarkers in the region. Besides, the increasing number of initiatives supporting the development of healthcare infrastructure is further driving market growth.

U.S. Digital Biomarkers Market Trends:

1.??? Increased Adoption of Wearable Devices

• The rise of wearable devices (smartwatches, fitness trackers, etc.) enables continuous health monitoring.

o?? Example: Apple Watch's ECG feature is an example of integrating digital biomarkers for heart health monitoring.

2.??? Growth in Telemedicine and Remote Monitoring

• The COVID-19 pandemic accelerated the adoption of remote patient monitoring using digital biomarkers.

o?? 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.

Some of the prominent players in the digital biomarkers market include:

• 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
• Kinsa Inc.
• Feel Therapeutics

Digital Biomarker Market Recent Developments

• In February 2024, Biofourmis, a prominent global entity in digital biomarker development and decentralized clinical trial solutions, declares the establishment of four new partnerships with leading pharmaceutical companies. These collaborations is fueled by Biofourmis' demonstrated excellence in digital biomarker innovation, strengthen their clinical trial programs across the U.S, Europe, Asia-Pacific, and the MEA.
• In March 2024, Indivi and Biogen announced that they have entered into an agreement for integration and advancement of digital health technology and further build digital biomarkers associated with Parkinson’s disease. Collaboration aims at utilizing administration of a digital biomarker platform Konectom, further being managed within the Phase 2b LUMA study, which assesses the effectiveness and safety of BIIB122 for individuals with early-stage Parkinson's disease. This study is also being conducted in partnership with Denali Therapeutics Inc.
• In March 2024, Koneksa announced that it has extended its partnership with SSI strategy to expand the scale the adoption of in-house digital biomarkers solutions for clinical trials and the SSI likely to be functioning to meet this demand
• In February 2024, ActiGraph, LLC, and uMotif announced a partnership to provide patient-centered solutions for clinical research, combining ActiGraph's wearable technology with uMotif’s patient engagement platform
• In November 2022, KT Corporation , a South Korean telecommunication leader made USD 2 million strategic investment in the U.S.-based voice analysis platform Sonde Health. With this investment, the companies may use Sonde’s speech analysis technique to modify KT’s AI-enabled voice business solutions.
• In November 2022, Empatica, Inc. announced the approval of its health monitoring platform by the U.S. FDA. The health monitoring platform of the company is an advanced data collection solution for healthcare professionals.

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2034. For this study, Nova one advisor, Inc. has segmented the digital biomarkers market

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, Pharmaco dynamics/ 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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