Digital Biomarkers Market Size, Share, Report 2024 to 2033

Digital Biomarkers Market Size and Growth 2024 to 2033

The global digital biomarkers market size was valued at USD 3.25 billion in 2023 and is expected to hit around USD 24.85 billion by 2033, growing at a CAGR of 22.55% from 2024 to 2033.

The digital biomarkers market is growing and this can be attributed mainly to the rising use of remote health monitoring, artificial intelligence, and advances in wearable technology. This market is concerned with the creation and marketing of diagnostic and prognostic digital instruments which gather and interpret a person’s body and behaviour for further practical use.

Digital biological markers or biomarkers are physiological and behavioural metrics which can be captured electronically on devices such as smartphones, wearables and sensors. These markers allow a real-time assessment of various conditions by tracking the heart rate, sleeping hours, activity, glucose, and other metabolic variables. Unlike traditional biomarkers which are usually acquired through a blood test or other invasive methods, biomarkers based on voluntary activity do not require extraction and can be used in naturalistic settings. Thus, enabling earlier diagnosis, creation of targeted therapies and improving health. This trend continues in multi-domain where chronic diseases, mental health and disease prevention are included in one approach trying to reform modern medicine from the data to the people.

• According to the National Center for Biotechnology Information, “Apple Insider estimates that more than 30 million Apple watches were sold in 2019 in addition to the 22 million sold in 2018”.
• According to an article by National Center for Biotechnology Information, “Digital biomarkers can increase diagnostic and therapeutic precision in the modern health care system by remotely and continuously measuring reliable clinical data and allowing continuous monitoring and evaluation”.

Report Highlights

• North America region emerged as the leading contributor, capturing an impressive 55.10% of the total revenue share in 2023.
• Europe region has captured 22.80% of the total revenue share in 2023.
• In 2023, the mobile application segment played a key role, capturing 38.90% of the revenue share.
• The healthcare companies segment led the way, accounting for a substantial 51.40% of the revenue share in 2023.

Digital Biomarkers Market Growth Factors

• Growing Prevalence of Chronic Diseases: The increasing incidence of chronic diseases, including diabetes, cardiovascular diseases, and respiratory illnesses is one of the key factors spurring the growth of the digital biomarkers market. Given that such ailments are often chronic and need regular or constant treatment, they do not provide the required level of immediacy and personalization owing to the nature of the available healthcare systems. The advent of digital biomarkers addresses these issues, making it possible to gather thousands of data points on each individual’s health via various digital devices on day-to-day basis in order to detect any changes in the health condition at the earliest stages. This is of utmost importance in chronic condition management as it leads to better outcomes and reduces the frequency of patients coming to the hospitals.
• Rising Adoption of Digital Healthcare Solutions: The increasing penetration of technology into the healthcare system, both patients and providers are utilizing digital tools, like wearable gadgets, mobile applications, and even telemedicine, to monitor and control the patients’ health conditions with normal supervision. Such solutions are non-invasive and provide around-the-clock data, enabling the creation of digital biomarker to assess parameters such as heart rate, physical exercises, and more away from the conventional health facilities. Such factors as the COVID-19 pandemic, the growth in artificial intelligence, and the shift towards home monitoring of patients as well as the desire for cheaper healthcare services have further expedited this advancement. As effective strategies for incorporation of digital health technologies into practices are developed, new preventive health care and chronic ailments management approaches will emerge by the way digital biomarkers will be embraced.
• Increased Pharmaceutical and Healthcare Collaborations: Pharmaceutical firms have been on the lookout for innovative ways of drug development through partnerships with technology companies, healthcare organizations, and academic research centers for their product pipelines and clinical studies over the years. These efforts hope to improve the efficiency of patient recruitment, conduct real-time surveillance of drug effect, and assess safety in a more effective manner. Such approaches allow these collaborative efforts to bring forth digital biomarker focusing on individual patients, which can help devise specific treatment measures for getting better patient results. Furthermore, the intersection of pharmaceutical frameworks with technological entrepreneurship, enhances the creation of new digital healthcare products, which help to improve clinical studies and quality of ongoing maintenance for patients in the real world. Digital Biomarkers Market Trends:
• Consumer Demand for Health Tracking: There has been a rising consumer interest for health tracking in the digital biomarkers segment. The growing concern for health and wellbeing among people is the major contributor. As the number of people who want to be personally responsible for their health increase, there is growing dependence on technologies such wearable devices, fitness mobile applications and health mobile applications that combine different functions such as tracking heart rate, sleep, and physical activity. The need for such trends is promoted by the seek for customization of the information such that the user is able to take action that maximizes their health or prevents diseases. This trend is further intensified by growing popularity of social media and posting of health contents which makes people more willing to document their health transformations and even share them.
• Data Privacy and Security Emphasis: Data privacy and security become a major part of the digital biomarkers market largely because of people's concern about patient data protection due to the continuously growing digital health landscape. As personal health information became a part of digital ecosystems, both consumers and regulators are looking for preventive measures to protect the data. This has forced digital biomarkers companies to design and strictly follow as some of the most important steps the user identification, encryption methods, information processing, and safe health data storage to keep intact patient's privacy.
• Telehealth Expansion: Currently, there are some of the trends, which have an impact on the biomarker market and one of them is telehealth expansion, especially during and after COVID-19 pandemic which fostered remote care solution. Healthcare providers’ shift to telehealth services is opening up new opportunities for the use of digital biomarkers to support the adequacy of remote monitoring and management of patients’ conditions. Such a trend permits caregivers to gather information concerning their patients and their respective activities via the use of wearables and mobile services in real-time, thus, ensuring that timely measures are taken and all treatment modalities are catered without the necessity of patients being physically present at the health facilities.

Report Scope

Digital Biomarkers Market Dynamics

Drivers

Growing Demand for Personalized Medicine

• The closer attention given to patients and their individual preferences contributes substantially into the growth of the digital biomarkers market, and therefore this demand for personalized medicine is there to stay. However, with the pace of evolution of genetics, biotechnology and big data, healthcare practitioners are more and more aware that one treatment may not have the same outcomes on all subjects.
• Digital biomarkers are essential to this development as they capture patients’ physiological and behavioural data, providing up-to-the-minute information as well as developing a more holistic understanding of their health status and treatment response. Such an approach enables clinicians to implement a care strategy which would be customized to the individual’s genotype, lifestyle, and environment.

Consumer Awareness and Engagement

• Awareness and involvement of consumers act as the key catalysts in the further expansion of the digital biomarkers market due to the growing trend in proactive health management. As people gain increasing access to health information online and on social media, they become more aware of the need to track their health measures like heart rate, exercise levels or sleep. Such awareness creates a market for digital health where self-tracking and feedback devices are needed.
• Digital biomarkers become critical as more patients look for ways of managing their health and lifestyle changes, reinforcing the need for digital biomarker targeting in preventive care. Furthermore, the incorporation of gamification features and social sharing capabilities into health applications enhances user participation, which also facilitates growth.

Restraints

Interoperability Issues

• Generally, most digital health tools and wearable devices work in silos, resulting in incomplete health records which can make it difficult to monitor and analyze patients. Quality digital biomarker integration is hampered by the fact that such resources will become disorganized due to the variations in how the data is documented.
• Additionally, interoperability issues may prevent cooperation among stakeholders, such as healthcare providers, technology developers, and researchers, who could develop new solutions utilizing an alternative more complete source of health data.

Cost and Reimbursement

• The factors of pricing and reimbursement processes are the major limitations standing in the way of the growth of the market for digital biomarkers as they hamper the use of such solutions by both the patients and healthcare practitioners. The scenario is not helped by the fact that many digital health solutions such as wearable electronic devices and mobile applications are customarily purchased going by a premium which can limit potential clients or healthcare systems from using such innovations.
• On the other hand, the application of digital biomarkers into routine clinical practice has bemired mainly due to the absence of reimbursable motives. Insurance companies in most cases do not pay for the expenses incurred when employing some of the tools brought about by technology in healthcare and such costs are left on the patients.

Opportunities

Expanding Applications

• Digital biomarkers, as new applications are developed, provide a great opportunity for the digital biomarkers market to grow, along with the sector of health and wellness. Even though they are at an early stage there also, the potential of digital biomarkers is seen in preventing physical and mental health problems, managing chemical dependencies, and transforming lifestyles.
• Solvency of companies launches a direct pathway for cooperation with fitness companies, wellness apps, and corporate health programs. Thus, digital biomarkers become instrumental in development and management of holistic health. Best of all, the utilization of AI and machine learning have brought developments to future technologies, which translate to more accurate data analysis and customized predictions and treatments.

Integration with Electronic Health Records

• Interfacing with electronic Hhealth record (EHR) is a major opening for the development of the digital biomarkers market, as it will allow easy sharing of information and treatment through the virtual platform. By attaching digital biomarkers into EHR systems, healthcare providers can have access to a complete health rundown coming from real-time data thus, having the power to make better medical decisions and the creation of individualized treatment plans. This integration is a means to make sure the patients' health metrics data such as heart rate, level of activity, and quality of sleep are recorded together with the clinical information data, thus a holistic approach is provided to the patient status. Moreover, it makes the process faster and easier for healthcare professionals to monitor patients' recovery and manage the patient according to the latest findings.

Challenges

Lack of Clinical Evidence

• The digital biomarkers market is facing a major obstacle in terms of the lack of strong clinical proof. Digital biomarkers are the future of healthcare and are expected to create a positive change in this field; however, their introduction is halted by insufficient clinical validation and scientific backing.
• A lot of healthcare providers and regulatory bodies ask for an intensive data reviews and signed off articles that show the efficacy, accuracy, and reliability of these digital biomarkers in disease diagnosis, and patient monitoring.
• The lack of standardized procedures for testing and validating biomarkers is an additional challenge. The hesitance in adaptability of such technology causes a discrepancy in results or even the misdiagnosis is the fear among professionals.

Technical Limitations

• Technical limitations are a major hurdle the digital biomarker market has to overcome, as the accuracy, reliability, and consistency of the data collected by mobile devices and health monitoring tools are not always secure.
• Variability in sensor quality, battery life, and environmental factors can result in inaccurate measurements or data gaps, thus reducing the clinical utility of digital biomarkers. Specifically, motion artefacts or poor connectivity can disrupt real-time acquisition of essential health metrics like heart rate and blood glucose levels, making it impossible to get complete or correct data. These inconsistencies, therefore, make the healthcare providers a bit reluctant to use digital biomarkers, consequently, they hesitate to integrate these ground-breaking technologies into their clinical practice.

Digital Biomarkers Market Segmental Analysis

Type Analysis

Wearable: Digital health wearable biomarkers constitute certain health-related data points which are retrieved through the wearable such as smartwatches, fitness trackers, and biosensors. The information they provide is real-time and it consists of a person's physiological and behavioural states. These devices monitor a variety of metrics, including heart rate, physical activity, sleep patterns, glucose levels, and even stress markers, allowing continuous patient monitoring outside of usual clinical settings. The information collected via wearable digital biomarkers is of the prime importance in the field of early disease detection, chronic disease management, and personalized medical aids.

Mobile Application: Mobile application digital biomarkers are data driven health technology that is gathered and computed through the devices such as a smartphone (medical apps), providing an accessible and convenient way for individuals to track their well-being through various activities. These biomarkers include metrics like how often you are exercising, sleep quality, your memory and mood, and even the heart rate which people can measure through smartphone sensors or wearable devices that are compatible with smartphones.

Therapeutic Area Analysis

Neurological Disorders: The digital biomarker application in the neurological disorders area is a fast-developing field of innovation and it opens up new opportunities for monitoring, diagnosing, and controlling diseases such as Alzheimer's, Parkinson's, multiple sclerosis, and epilepsy. Digital biomarkers gathered by means of wearable tools, smartphone apps, and sensors give real-time and objective estimations of motor function, cognitive ability, sleep patterns, and emotional status. These digital biomarkers are used to find small deviations in the function of the nervous system that might not be visible during the regular doctor check-up period; thereby making the diagnostic procedure more proper.

Respiratory Disease: Digital biomarkers play an increasingly important part in the management and monitoring of respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), and COVID-19. These biomarkers, collected through wearable devices, mobile apps, and smart inhalers, provide real-time data on respiratory function, including lung capacity, breathing patterns, oxygen saturation, and even coughing frequency. Through continuously monitoring these metrics, digital biomarkers allow for the early identification of exacerbations or asthma attacks by enabling personalized treatment adjustments to happen timely.

Cardiovascular Disease: Biomarkers that are digital in nature are playing a significant role in improving the management and treatment of cardiovascular diseases (CVD) like hypertension, atrial fibrillation, and heart failure through continuous and real-time monitoring of important health metrics. Wearable devices have become quite popular among people. These devices include smartwatches and fitness trackers. Measurements like heart rate, blood pressure, and electrocardiogram (ECG) patterns can be completed easily with these devices. This allows early stage diagnosis of problems such as arrhythmias or irregular heartbeats.

Diabetes: Patients with diabetes get precious help on their way as the disease is fought off with advancement in technology. This is achievable through continuous, real-time monitoring of blood sugar levels, activity patterns, and some health parameters with a new term as digital biomarkers. Wearable devices, like CGMs, and smart insulin pens have become the new unrecognized assistants that give the ultimate inspiration for customers developing diabetes or unhealthy lifestyle habit are finally realizing that practical electronics can bring overall health under control. Physical activities and food utilize technology to record, analyze and predict health aspects, enabling preventive health and healthier lifestyle.

Clinical Practice Analysis

Monitoring Clinical Practice: Monitoring the clinical practice with the help of digital biomarkers is a very significant part of the present-day health industry, which is improving the exactness of treatment, the efficacy of medicine, and the personalization of patient care. Digital biomarkers, which are gathered through wearable devices, mobile applications, and sensors, can track the real-time health parameters such as heart rate, glucose levels, sleep patterns, and activity levels of the patients. Aside from the clinical settings, these biomarkers also offer the healthcare providers the opportunity to have continuous and objective data, which in turn notifies them how well a patient is doing outside the more typical medical settings.

Diagnostic Clinical Practice: Digital biomarkers are rapidly becoming a defining factor in the diagnosis of clinical practice by providing information that significantly enhances the speed and accuracy of the diagnosis of various health issues. With the help of sensors wearable devices, and mobile apps digital biomarkers have emerged as the most promising tools for the continuous monitoring of physiological and behavioral data like heart rate, respiratory function, glucose levels, and cognitive performance. These observing entry points help the physician distinguish the health of the patient considerably and systematically from traditional clinical settings.

Prognostic Clinical Practice: The digital biomarkers on the patients has transformed the prognostics clinical practice because these devices give more exact real time information. Digital health applications are the next healthcare success as they can be applied in diagnosing and managing diseases which usually require long hours of observation, or regular monitoring of health data. Among these are the biomarkers of collective through wearable devices, mobile applications, and biosensors. The "Digital Health Applications and IoT Devices" the occurrence guide the patient through their condition in real-time and hence enabling patients to be better informed treatment seekers.

End User Analysis

Healthcare Providers: The digital biomarkers are highly instrumental for healthcare providers along with offering cutting-edge technologies for patient care, decision making in clinics and ultimately effective treatment. Furthermore, physicians can assess the patients' health metrics, including but not limited to their heart rates, the breadth of the pulse, glucose readings which were achieved by them through mobile health applications, wearable devices, and biosensors. This piece of information that will be used to tailor treatment specifically to the patient on real-time, dynamic basis, and thus patient monitoring will become thorough.

Healthcare Consumers: Digital biomarkers are being adopted by consumers who play an important part in their fitness and health lifestyle as key tools for managing their health and wellness, thereby, allowing them to be in control of their health. Wearable devices, mobile health applications, and sensors that are used, make it possible for people to observe not only the physical movement they take but also the activities of the heart, the quantity and quality of sleep, and sugar levels in time. In turn, the data provided through the regular updating of their health information sources was seen as crucial by consumers. Indeed, it will allow them to become healthy thereby recognizing the problems around them and associating them with the behaviours that caused it and deciding which way will get them to be better.

Digital Biomarkers Market Regional Analysis

Why is North America leading the digital biomarkers market?

• The North America digital biomarkers market size was estimated at USD 1.79 billion in 2023 and is poised to surpass around USD 13.69 billion by 2033. North America is experiencing a huge growth in technology advancement; the same trend is mirrored by the growing emphasis on personalized medicine and the significant boost of healthcare expenditures.
• North America is the leading region in healthcare infrastructure, and it has the highest adoption of digital health solutions such as wearable devices, mobile applications, and telehealth platforms. Top healthcare centers and leading tech companies are allocating massive funds to the innovation and integration of digital biomarkers to clinical practice, leading to the realization of real-time biological data monitoring for indicators such as cardiovascular function, glucose levels, and mental health.
• Moreover, the increasing health and wellbeing awareness among consumers are driving the sales of health and wellness tools that support the practice of self-monitoring and proactive health maintenance.

Europe digital biomarkers market is rapidly evolving

• The Europe digital biomarkers market size was accounted for USD 0.74 billion in 2023 and is projected to garner around USD 5.67 billion by 2033. Europe market is rapidly evolving, represented by a gradually increasing concentration on personalized healthcare, digital health technology advancements, and the increase in chronic disease management awareness, is characteristic of the dynamic nature of the sector. The fact that the region boasts a solid medical infrastructure and backs it up with a package of regulations aimed at facilitating the use of digital health solutions including wearable gadgets and mobile health apps is a big advantage.
• Embracing the concept of digital biomarkers, most countries of Europe are working on the integration of digital biomarkers into clinical practice to improve patient monitoring, diagnosis accuracy and to bring timely interventions. Chronic illnesses, such as diabetes, cardiovascular disorders, and respiratory conditions, are the main factors driving the demand for effective monitoring solutions which can be offered by digital biomarkers.

Why is Asia-Pacific expected to grow rapidly in the digital biomarkers market?

• The Asia-Pacific digital biomarkers market was valued at USD 0.51 billion in 2023 and is expanding to USD 3.90 billion by 2033. It is expected to grow at a substantial rate which is driven by the increasing prevalence of chronic diseases, rising health awareness, and rapid advancements in technology. The region dynamic and varying health issues of the population are creating an environment of possibility in terms of the implementation of various digital healthcare solutions such as wearables, mobile applications, and biosensors.
• China, India, and Japan are the furthest that are pouring money into the digital health sectors in a bid to improve healthcare accessibility and at the same time raising the satisfaction rate of the patient by quality care. The focus on personalized medicine and efforts to prevent diseases are increasing the use of digital biomarkers which are sought by patients as a tool to monitor their health and take the lead in the wellness effort.

LAMEA Digital Biomarkers Market is Emerging

• The LAMEA digital biomarkers market size was valued at USD 0.21 billion in 2023 and is expanding around USD 1.59 billion by 2033. The LAMEA market is emerging as a promising sector by the digital health technologies also been recognized by the voice of public health and also the patient. This region has been growing its soil for digital health innovation which is the most potent plans of technology non-invasive treatments made feasible.
• One notable trend is the transition from manual to automatic technology through the broadening of smartphones usage, higher internet availability and an increase in the number of very health-aware people, the middle class in the Greater Brazil thereof. Nations in Latin America are supporting wearable devices and mobile health programs to help the chronic diseases be curable in such a way that diabetes, cardiovascular conditions, and respiratory disorders enable the patients' involvement and the monitoring to be remote states.

Digital Biomarkers Market Top Companies

• Feel Therapeutics
• Amgen Inc.
• Verily Life Sciences LLC
• Brainomix
• Empatica
• Koneksahealth
• ActiGraph LLC
• Sonde Health, Inc.
• Clario
• AliveCor
• Altoida Inc.
• Vivo Sense

The entrance of new key players in the digital biomarkers industry has been witnessed to be a dynamic process that not only accelerates the innovation but also the enlargement of the landscape through the introduction of top-notch technologies and creative solutions that foster the monitoring and care of patients. These start-ups in this industry are seizing the opportunities that artificial intelligence, machine learning, and data analytics are giving to produce the most sophisticated algorithms that enhance the accuracy and prognostic power of digital biomarkers.

One of the key growth areas is getting to make digital health tools more flexible and easily used by application of tech in mental health monitoring, remote chronic disease management, and personalized wellness solutions.

CEO Statements

Savan Devani, CEO of BioTrillion:

"By generating “LIFEdata,” a subset of health data collected via common smart device sensors, then using advancements in AI to convert them into digital biomarkers of key diseases, BioEngine4D can yield more effective and scalable applications to detect serious diseases earlier than would otherwise be possible."

Recent Developments

Key players in the digital biomarkers market are instrumental in driving advancements in cancer diagnostics and personalized medicine. They are at the forefront of developing innovative solutions that enhance the accuracy and efficiency of cancer detection and monitoring. Notable developments in the market include:

• In February 2024, Biofourmis has announced the formation of four new partnerships with major pharmaceutical companies, leveraging its proven expertise in digital biomarker innovation to enhance their clinical trial programs in the U.S, Europe, Asia-Pacific, and the MEA.
• In March 2024, Indivi and Biogen have partnered to integrate and advance digital health technology and develop digital biomarkers linked to Parkinson’s disease. The collaboration will involve using the Konectom digital biomarker platform in the Phase 2b LUMA study to evaluate the efficacy and safety of BIIB122 for people in the early stages of Parkinson's disease. This study is being conducted in collaboration with Denali Therapeutics Inc.

These developments underscore a significant expansion in the digital biomarkers market, driven by strategic acquisitions and groundbreaking projects. Companies are focusing on enhancing cancer diagnostics through advanced technologies, improving the precision of detection and monitoring, and broadening the applications of digital biomarkers in personalized medicine.

Market Segmentation

By Type

• Mobile Application
• Wearable
• Sensors
• Others

By Therapeutic Area

• Diabetes
• Cardiovascular And Metabolic Disorders (CVMD)
• Respiratory Disorders
• Psychiatric Disorders
• Sleep & Movement Disease
• Neurological Disorders
• Musculoskeletal Disorders
• Others

By Clinical Practice

• Prognostic
• Diagnostic
• Monitoring
• Others (Safety, Pharmaco Dynamics/ Response, Susceptibility)

By End-Users

• Healthcare Companies
• Healthcare Providers
• Payers
• Others (Patient, Caregivers)

By Region

• North America
• Europe
• APAC
• LAMEA