Global Digital Phenotyping and Digital Biomarkers Market Size (2024 – 2030)

As of 2023, the Global Digital Phenotyping and Digital Biomarkers Market achieved a valuation of USD 1.73 Billion, with a projected expansion to USD 3.46 Billion by 2030. During the forecast period spanning 2024 to 2030, the market is anticipated to grow at a Compound Annual Growth Rate (CAGR) of 10.4%. Key factors driving this growth include the rising adoption of smartphones with advanced network connectivity, a rapid surge in the usage of wearable devices, an increase in disease prevalence, a growing aging population, notable product introductions, and the regulatory adaptability towards digital health solutions.

Industry Overview:

Biomarkers serve as objective indicators capturing anatomical, physiological, and pathological traits, essential for understanding an individual's health status and the body's alert signals. Digital biomarkers, on the other hand, encompass quantifiable behavioral and physiological data gathered and analyzed through digital devices like portables, wearables, and implantables. These digital biomarkers offer enhanced imaging capabilities with improved spatial resolution. Digital phenotyping involves extracting insights from data streams and digital devices to generate personalized, real-time analyses, thereby enhancing data accuracy. By utilizing active or passive data, digital phenotyping can identify patterns and traits within populations, effectively aiding in devising treatment strategies for mental health disorders. Neurological and psychiatric illnesses often manifest with complex, fluctuating, and atypical symptoms, showing significant variability among patients. Traditional diagnostic and efficacy assessment methods typically rely on in-clinic visits and subjective evaluations by clinicians, caregivers, and patients, which are time-consuming, costly, and limited in their observational scope. Moreover, they are susceptible to high inter- and intra-rater variability. These conventional diagnostic methods may present limitations that impact the early-stage disease diagnosis, creating a gap between the onset of pathological processes and symptom manifestation. The collection of health-related data through smartphones offers a promising complementary approach to in-clinic evaluations, potentially improving patient care and treatment outcomes. Digital biomarkers facilitate frequent assessments of larger population groups over extended periods. The growing utilization of smart wearables and connected devices enables the measurement of various diagnostic parameters for diseases such as diabetes, cardiovascular disorders, mental health conditions, and neurological ailments. The proliferation of smartwatches and the increased smartphone usage aid in tracking physiological health-related data.

The rapid advancement of telecommunications and IT infrastructure is propelling market expansion. The evolving landscape of digitally monitoring patients in their daily lives using smart technologies holds potential for assisting clinicians in early diagnosis and intervention facilitation. Smart sensor technologies for patient monitoring are rapidly emerging. Contemporary smartphones and smart wearables come equipped with diverse sensors, including acceleration, GPS, gyroscope, barometer, temperature, and health sensors. These digital biomarkers collect health-related information during clinical trials, offering objective, invaluable, and ecologically valid insights into specific diseases. Government investments in healthcare sector digitalization and the establishment of smart hospitals are expected to drive the demand for digital phenotyping and digital biomarkers. Market growth is significantly influenced by various developmental strategies adopted by numerous industry players.

COVID-19 Impact on Digital Phenotyping and Digital Biomarkers Market

The COVID-19 pandemic has notably impacted the Digital Phenotyping and Digital Biomarkers market, escalating the demand for these technologies due to their screening and diagnostic capabilities. These digital solutions enable real-time data analysis, facilitating remote data collection during the pandemic. The sudden surge in market demand was driven by increased remote patient monitoring and heightened health concerns among individuals. The development and validation of digital phenotyping and digital biomarkers gained momentum during the pandemic, aiding in the identification of at-risk patients by continuously monitoring disease symptoms or progression using data from individuals' smart devices.

MARKET DRIVERS:

The rise in smartphone penetration alongside high-speed network connectivity solutions and the rapid uptake of wearable devices is fueling market growth.

The introduction of connected devices such as smart wearables, portable devices, and biosensors has significantly enhanced the measurement of various parameters for detecting novel biomarkers. Mobile health applications encompass diverse physiological parameters like sleep patterns, activity levels, heart rates, and more. Additionally, biochemical parameters such as metabolites, electrolytes, proteins, and small molecules are included. This presents substantial opportunities to revolutionize data capture and collection processes during clinical trials. The increasing use of connected devices and health-related mobile applications facilitates diagnostic and prognostic measurements across various diseases, consequently boosting the digital phenotyping and digital biomarkers market. The growing utilization of mobile devices generates extensive personalized data, including location information, physical movements, vital health signs, and social media behaviors, which can be leveraged through data mining. According to the Pew Research Center, smartphone ownership in the United States grew from 35% in 2011 to 85% in 2021. Moreover, smartphone ownership among U.S. citizens aged 65 and above increased from 3% in 2013 to 12% in 2021. Technological advancements in mobile devices and connected technologies further drive market growth.

Significant product launches and regulatory flexibility toward digital health solutions are contributing to the market growth

An increase in product launches and FDA approval also drive the market growth. FDA has simplified the entry process for companies operating in the digital phenotyping and digital biomarkers market by modifying its guidelines related to software-as-medical-device. The FDA launched the Pre-Cert model, which aimed to streamline the regulatory process and boost innovation of digital health technologies.  This flexibility in regulations toward digital health solutions is anticipated to propel the market growth of Digital Phenotyping and Digital Biomarkers.

An increase in the prevalence of diseases and the growing geriatric population is fuelling the market demand

According to the United States Centers for Disease Control and Prevention (CDC), the leading causes of disability and death in the U.S. costs USD 3.8 trillion in annual healthcare costs of the country. The increasing prevalence of chronic diseases globally and the growing geriatric population is rising the demand for efficient treatment and technologies to reduce healthcare costs. Smart wearables and smartphones monitor the health status of users and provide detailed insights into inter-and intra-individual disease variability in daily life.

The increasing cost of drug development led to the need for other alternatives, of which digital phenotyping and digital biomarkers are significant.

The rising cost of research and development of drugs is resulting in the increased cost of drugs. In the recent past, the cost of drug development has increased by almost 145% and the rate of success of drug development has reduced to half. Presently, the approval rate for drugs that enter clinical development is less than 12%. The study of biomarkers may help target the pathway where research should be focused which can reduce the number of processes required for drug development and the overall cost can be reduced.

MARKET RESTRAINTS:

Challenges related to test validation and biases could impede the growth of the digital biomarkers market.

The clinical assessment of digital biomarkers and data platforms, including apps and wearables, holds utmost importance. Validation testing of data collected from healthy individuals or the target population must be conducted in clinically relevant settings. Ensuring platforms assessing the data are free from biases is crucial to maintain the credibility of data analyses and prevent potential failures in the process.

Challenges associated with integration, usability, and cost may restrain market growth.

Ensuring interoperability and integration of digital health services is paramount. Service providers must ensure that collected data can be shared seamlessly across hospitals, laboratories, clinics, pharmacies, and patients, irrespective of the application vendor. Additionally, a thorough cost-benefit analysis of digital phenotyping and digital biomarkers solutions is necessary, considering the nascent stage of the market.

Digital Phenotyping and Digital Biomarkers Market – By Component

• Data Collection Tools
• Digital Platforms
• Mobile Apps
• Desktop-based Software
• Wearables
• Biosensors
• Data Integration Systems

In terms of its components, the Digital Phenotyping and Digital Biomarkers Market are classified into Data Collection Tools and Data Integration Systems. The Data Collection Tools section displayed a substantial share of revenue within the global market and is projected to maintain its leading position throughout the forecast period. This trend is primarily ascribed to the heightened adoption rates of smartphones and wearables, which significantly facilitate data gathering. Key tools such as internet and wireless connectivity play pivotal roles in enabling seamless data collection and transmission. Biosensors constitute a substantial portion of the data collection tools. Conversely, the Data Integration Systems segment is predicted to exhibit the highest Compound Annual Growth Rate (CAGR) of 42% during the forecast period.

Digital Phenotyping and Digital Biomarkers Market – By Application

• Sleep and Movement
• Mood and Behavior
• Neurodegenerative Disorders
• Cardiological Diseases
• Diabetes
• Chronic pain
• Respiratory Conditions
• Gastrointestinal Diseases
• Others

Regarding its applications, the Digital Phenotyping and Digital Biomarkers Market are categorized into Sleep and Movement, Mood and Behavior, Neurodegenerative Disorders, Cardiological Diseases, Diabetes, Chronic pain, Respiratory Conditions, Gastrointestinal Diseases, and Others. Notably, the Cardiological Diseases segment holds a dominant position in terms of revenue globally and is expected to maintain this stature throughout the forecast period. This prominence can be attributed to the escalating prevalence of cardiovascular diseases on a global scale, as reported by the World Health Organization (WHO), with cardiovascular diseases accounting for 32% of global deaths.

The Respiratory Conditions segment is anticipated to witness the most rapid growth during the forecast period due to the increasing prevalence of respiratory ailments such as chronic obstructive pulmonary disease and asthma. Furthermore, the Neurodegenerative Disorders segment is poised for significant growth during the forecast period, owing to the rising incidence of neurological disorders and the growing adoption of digital phenotyping technology in mental health care.

Digital Phenotyping and Digital Biomarkers Market – By End User

• Biopharmaceutical Companies & labs
• Insurance Payers
• Healthcare Providers

Regarding its end users, the Digital Phenotyping and Digital Biomarkers Market are segmented into Biopharmaceutical Companies & labs, Insurance Payers, and Healthcare Providers. The Biopharmaceutical Companies & labs segment commands the largest market share and is expected to continue leading in terms of revenue during the forecast period. Conversely, the Insurance Payers segment is projected to experience the highest growth rate, approximately 43%, throughout the forecast period.

Digital Phenotyping and Digital Biomarkers Market - By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• The Middle East
• Africa

Geographically, the North American Digital Phenotyping and Digital Biomarkers Market holds the largest market share and is projected to account for a substantial revenue share in the global market during the forecast period. This growth can be attributed to several key factors, including a sizable geriatric population, significant product launches, a high adoption rate of digital technologies, increased investments in research and development, escalating healthcare expenditure, growing approval of smart devices, and the robust presence of key market players within the region.

The European Digital Phenotyping and Digital Biomarkers Market held the second-largest share in the global market and is poised to expand at a significant growth rate during the forecast period, primarily fueled by the escalating demand for mobile health apps and the increased adoption of smartphones and wearable technology within healthcare.

The Asia Pacific Digital Phenotyping and Digital Biomarkers Market accounted for a significant market share and is projected to witness a higher CAGR during the forecast period. This surge in growth is attributed to the widespread usage of smart devices, the proliferation of digital technologies, an increase in the patient population, the government's focus on enhancing healthcare facilities, and market players' growing emphasis on leveraging growth opportunities within the region. Additionally, the burgeoning geriatric population in this region is anticipated to substantially boost the demand for digital phenotyping and digital biomarkers.

The Digital Phenotyping and Digital Biomarkers Market in Latin America, the Middle East, and Africa are expected to exhibit growth during the forecast period due to the rising prevalence of chronic diseases, the escalating need to manage healthcare costs, and the increasing adoption of smartphones and internet connectivity.

Key Players in the Market

1. Akili Interactive Labs
2. ActiGraph, LLC.
3. Fitbit, Inc.
4. AliveCor, Inc.
5. Novartis
6. Sanofi
7. Pfizer Inc.
8. F. Hoffmann-La Roche Ltd
9. Takeda Pharmaceuticals
10. HumanAPI
11. GlaxoSmithKline Plc
12. Mindstrong Inc.
13. Sharecare, Inc.
14. Alphabet, Inc.
15. Onnela lab
16. Verily Life Science LLC

The global digital phenotyping and digital biomarkers market are dominated by numerous digital health companies categorized as developers of sensors and tools for collecting and integrating patient-level data. Prominent players in this market engage in synergistic activities, innovative product launches, acquisitions, collaborations with research and medical institutions, business expansions, and funding initiatives to expand the digital phenotyping and digital biomarker landscape.

Recent Developments in the Global Digital Phenotyping and Digital Biomarkers Market:

• Partnership - In March 2021, Human API partnered with CLEAR to enable the safe reopening of businesses using secure COVID tests and vaccine data. Health Pass, a mobile application, simplifies and secures the connection of members' identities to COVID-related information.
• Partnership - In March 2021, Wellstar Health System, one of Georgia's largest integrated healthcare systems, announced a strategic partnership with Sharecare, a digital health company facilitating comprehensive health management. This partnership aims to introduce leading innovations in personalized care delivery, population health, and consumer engagement.
• Partnership - In April 2021, Winterlight Labs collaborated with the Digital Medicine Society (DiMe) to promote the adoption of digital health resources.
• Partnership - In March 2020, Vivoryon Therapeutics AG partnered with Winterlight Labs for the upcoming Phase 2b trial of PQ912 in Alzheimer’s clinical trial. Vivoryon Therapeutics will utilize Winterlight's speech-based biomarker to enhance novel therapy for Alzheimer’s disease.
• Partnership - In September 2020, Jetstream APS partnered with Human API to facilitate life insurance applicants in digitally sharing access to their electronic health records (EHR).
• Acquisition - In October 2020, Medidata, a Dassault Systemes company, the global leader in end-to-end solutions supporting the clinical development process, acquired the digital biomarker business of MC10. This acquisition aims to enhance Medidata's capabilities in remote biometric data capture for hybrid and virtual clinical trials.
• Collaboration - In October 2019, MC10, Inc., collaborated with the University of Rochester to apply the FDA-approved BioStamp nPoint system for collecting movement-related data quantitatively assessing the progression of diseases such as Parkinson’s and Huntington’s disease.