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Digital Neuro Biomarkers Market

The market for Digital Neuro Biomarkers was estimated at $743 million in 2024; it is anticipated to increase to $2.61 billion by 2030, with projections indicating growth to around $7.44 billion by 2035.

Report ID:DS1803002
Author:Debadatta Patel - Senior Consultant
Published Date:
Datatree
Life Science
Healthcare IT
Digital Neuro Biomarkers
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Report Summary
Market Data
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Table of Contents

Global Digital Neuro Biomarkers Market Outlook

Revenue, 2024

$743M

Forecast, 2034

$6.03B

CAGR, 2025 - 2034

23.3%

The Digital Neuro Biomarkers industry revenue is expected to be around $915.7 million in 2025 and expected to showcase growth with 23.3% CAGR between 2025 and 2034. Neuro biomarkers developed using digital technologies are becoming a cornerstone in neurology and psychiatry as health providers seek for objective, ongoing measures of brain function to support earlier diagnosis, the optimisation of treatments and precision psychiatry. Strong demand from the pharmaceutical industry for better digitally captured CNS trial endpoints is presently driving the CNS segment. Additionally, passive monitoring technologies are being used by service providers to help patients handle complex CNS disorder biomarkers and psychiatric disorder biomarkers in a large patient population. The majority of use, 74.8%, is in neurological disorders and psychiatric disorders. This is a reflection of the urgent need for better means of assessing in real world settings neurodegenerative diseases as well as mood, cognition and behaviour. The revenue generated by passive products in 2024 totalled $469.39 million, this trend underlines the preference of patients for the unobtrusive monitoring of medical conditions by use of smartphone and wearable technology. The increasing use of digital health platforms, AI driven analytics and digital phenotyping is enabling value based and personalized brain health care through the digital neuro biomarkers. This is further supported by remote monitoring of patients which produces real world evidence of a high standard.

Central nervous system functioning, disease progression and treatment efficacy can be described by the quantifiable, physiological and behavioural signals captured by software, sensors and mobile phones. These signals are a lot more detailed than others of assessment. The systems key functionalities include collection of various physiological data in a passive and unobtrusive manner, integration of data from various inputs including those related to the physical and mental status of the user, and automatic interpretation of this data to yield significant health related information. These are increasingly being used in numerous applications like Parkinsons disease, Alzheimers disease, multiple sclerosis, schizophrenia, depression and other CNS disorders. There they help in early diagnosis, patient segregation and constant monitoring of the dynamics of the symptoms. Digital health technologies are currently being increasingly used due to several factors including their integration into hybrid and decentralised clinical trials, their link to electronic health records and telemedicine services and the development of digital health outcomes which have been validated. Digital neuro biomarkers provide the building blocks for future neuro technology by allowing healthcare, medtech and the life sciences industries to gain meaningful insights, accelerate the development of new treatments and improve the quality of life for people with complex brain and mental health disorders.

Digital Neuro Biomarkers market outlook with forecast trends, drivers, opportunities, supply chain, and competition 2024-2034
Digital Neuro Biomarkers Market Outlook

Market Key Insights

  • The digital neuro biomarkers industry is forecast to grow from $742.7 million by 2024 to $6.03 billion by 2034. There was a compound annual growth rate of 23.3%, a reflection of growing interest in clinical neurodegeneration monitoring, cognitive function assessment and also mental health.

  • The main companies responsible for shaping this market are Biogen Inc., Altoida Inc. and Koneksa.

  • The US and Germany are the leading regions in the digital neuro biomarkers sector and are anticipated to display growth CAGR of 22.4% to 32.6% from 2024 to 2030.

  • The highest growth rate is anticipated to be seen in emerging markets such as India, Brazil and Mexico, with a Compound Annual Growth Rate of 17.5% to 24.2%.

  • ML, a technology expected to boost predictive power, will contribute to a rise in the digital neuro biomarkers industry worth $207 million by 2030.

  • Between 2024 and 2034, the Digital Neuro Biomarkers market is due to increase by $5.3 billion. The Psychiatric Disorders & Sleep Disorders application region will dominate the expansion in this market.

  • The digital neuro biomarkers market is expected to develop at a rate of 712% between 2034 and 2024 due to the increased application of neuroimaging technologies and the growing incidence of neurological disorders.

digital neuro biomarkers market size with pie charts of major and emerging country share, CAGR, trends for 2025 and 2032
Digital Neuro Biomarkers - Country Share Analysis

Opportunities in the Digital Neuro Biomarkers

In the development of CNS drugs, digital biomarkers such as mobile phone based cognitive function tests and digital motor tests could change the clinical trials conducted in Europe and the United States. Pharmaceutical companies are looking for milder clinical effects in their drugs to combat the brains disorders. Active therapeutic strategies produce high frequency data that may be used for the more accurate patient stratification and improved efficacy readouts through ML. By 2030, it is also predicted that clinical trial applications will be the most rapidly expanding use case, growing from $273.31 million in 2024 to $1039.02 million.

Growth Opportunities in North America and Europe

Digital neuro biomarkers are gaining acceptance in North America, primarily because there are a lot of people suffering from neurological conditions and there is funding for neuro research. This trend can be seen in clinical trials where they use devices like mobile apps and wearable fitness monitors to monitor patients after they have been prescribed medication. This allows doctors to gather real information and consider different ways of charging for treatment. There are key opportunities in the use of AI powered diagnostic tools integrated with electronic health records, expansion of patient centred pathways which are sponsored by payers, and partnerships between drug developers and analytical companies that specialise in the central nervous system. The region's high concentration of established pharmaceutical firms, IT service providers for healthcare and digital biomarker specialists leads to highly competitive conditions. It is necessary to secure validation from the regulatory authorities, combine data in multiple formats and provide evidence of health benefits in order to establish a presence on a larger scale in the region.
Europe is witnessing an increased focus on Digital Neuro Biomarkers in psychiatric illnesses, mainly because of a coherent government policy favouring mental health. High levels of data protection and unified public health campaigns further strengthen this position. It supports the usage of proven digital biomarkers for mood, behaviour and cognitive skills. It is in healthcare for depression, anxiety and psychosis that one may discover openings for integration of passive behavioural analytics and remote patient monitoring into the health systems of their nation. This can be done in collaboration with hospital sleep laboratories for patients with sleep disorders so as to promote more effective and efficient care. This field is highly competitive due to academic industry collaborations, regional medtech firms and health service providers with digital services. Success in this sector is based on the interoperability of pan European systems, patients being able to access information in their native language and digital biomarkers being clinically validated and eligible for reimbursement as per regional medical guidelines.

Market Dynamics and Supply Chain

01

Driver: Rapid Rise in Neurological Disorder Prevalence Coupled With Remote Monitoring Demand

The global surge in neurological and cognitive disorders, such as Alzheimer’s, Parkinson’s, multiple sclerosis, and other age‑related conditions, is also a central force driving adoption of digital neuro biomarkers. As populations age, these conditions are also increasing in both diagnosis and long‑term management needs, motivating healthcare systems to embrace tools that can also capture real‑world neurological indicators more effectively than traditional episodic assessments. Simultaneously, there is also growing demand for remote patient monitoring and telehealth capabilities. Digital neuro biomarkers embedded in wearable sensors, mobile apps, and cloud platforms enable continuous, non‑clinical data capturing, reducing the reliance on in‑person clinic visits and empowering decentralized clinical trials. This trend has also been accelerated by broader telemedicine adoption and the need to manage chronic neurological conditions outside traditional healthcare settings, improving patient convenience and clinical response times.

The market is also strongly propelled by technological innovation, particularly also advances in artificial intelligence, machine learning, and sensor technologies. AI and ML algorithms are also increasingly used to analyze complex neurological data from digital endpoints like gait patterns, speech analytics, and cognitive task performance, enabling earlier detection and prediction of disease progression with higher accuracy. This niche driver reflects a transition in diagnostics toward predictive, data‑rich insights rather than static measures. Sophisticated digital platforms combine high‑resolution sensors with cloud computing and analytics to deliver actionable neurobiological insights in real time, improving both clinical decision making and the development of targeted treatments.

02

Restraint: High Implementation Costs and Uneven Technology Accessibility

Significant costs associated with developing, validating, and deploying digital neuro biomarker technologies continue to restrict market expansion. Advanced sensors, AI analytics, and compliant platforms require substantial investment, which limits adoption, particularly among smaller healthcare providers and in low‑resource regions. In 2024, some high‑end platforms remained accessible mainly to leading research institutions due to their price, slowing broader clinical use.
03

Opportunity: Emerging demand for gamified Digital Neuro Biomarkers in pediatric ADHD care across North America and Rising demand for passive Digital Neuro Biomarkers in remote Parkinson’s monitoring among Japan’s population

Using neurobiological digital tools which gamify the experience, children with ADHD in North America can get support which does not only carry the stigma often associated with this condition. Games on mobile phones can continuously record user behaviour outside clinics by means of attention tasks, eye tracking and other interactive games. Among the untapped possibilities are digital therapeutics platforms being integrated, remote monitoring of treatment, and screening in schools. With rapid expansion anticipated for remote patient monitoring, tools that perform active cognitive assessments are likely to experience the most growth. Clinicians, educators and payers are placing more and more emphasis on objective data from the real world as a complement to traditional telehealth and standard assessment methods.
Patients with Parkinsons disease in Japan who are seen at infrequent clinic visits may particularly benefit from passive monitoring of gait, speech and tremors via digital neuro biomarkers. Using wearable and smartphone technology, real life data is collected and sent to healthcare systems via telemedicine or used in research applications involving precision neurology. This data is analysed using computer learning techniques. By the year 2030, the passive patient population is predicted to reach approximately 1.570 billion dollars. This growth is led by the Asia Pacific region, where remote monitoring of patients is becoming increasingly popular. Japan is a key driver in this region.
04

Challenge: Regulatory Uncertainty and Data Privacy Challenges

Ambiguous regulatory pathways and stringent data privacy requirements are major restraints for digital neuro biomarkers. Unlike traditional diagnostics, many digital endpoints lack clear validation frameworks, delaying approval and clinical acceptance. Combined with complex compliance across regimes such as HIPAA and GDPR, these issues erode patient trust, complicate cross‑border deployment, and can dampen investment enthusiasm from biopharma and tech firms.

Supply Chain Landscape

1

Biomarker Discovery

Biogen Inc.Roche
2

Digital Neuro Biomarkers Platforms

Altoida Inc.KoneksaNeuraMetrix
3

Clinical Data Integration

RocheBiogen Inc
4

Clinical Applications

Pharmaceutical CompaniesNeurology ClinicsAcademic Research
Digital Neuro Biomarkers - Supply Chain

Use Cases of Digital Neuro Biomarkers in Clinical Neurodegeneration Monitoring & Cognitive Function Assessment

Clinical Neurodegeneration Monitoring : Digital Neuro Biomarkers are essential for monitoring and tracking conditions like Alzheimers and Parkinsons diseases accurately and continuously without invasion to improve diagnosis accuracy and treatment effectiveness in patients neurological state. Moreover ongoing improvements promote discovery and preventive healthcare methods with established players such as Neurotrack and Biogen, in the industry.
Cognitive Function Assessment : By incorporating AI methods into the mix Digital Neuro Biomarkers enable the evaluation of abilities, which proves valuable in assessing brain health detecting cognitive deficiencies and enhancing tailored treatment strategies. Instruments developed by companies such as Cognixtion and Cambridge Cognition aid medical professionals in comprehending subtle shifts, in behavior presenting an exceptional chance to refine therapies like never before.
Mental Health : Digital Neuro Biomarkers have been widely utilized in the management and monitoring of health issues for their valuable role in providing an objective assessment of brain health without relying solely on subjective self reports. Its implementation has notably improved the precision of diagnoses and the effectiveness of treatments resultinig in overall mental health outcomes. Established market players such as Headspace Health and Mindstrong are leveraging these tools to pioneer novel approaches, in mental healthcare.

Recent Developments

Recent digital neuro biomarkers developments show rapid integration of AI analytics, wearable sensors, and telemedicine platforms into real‑world neurology workflows. Regulatory momentum is building as digital endpoints are increasingly accepted in clinical trials and neurological drug development, expanding remote patient monitoring and personalized neurodiagnostics use cases. Market growth is supported by partnerships between pharma, tech firms, and research institutions that enhance automated cognitive and motor function tracking, improving early detection and longitudinal disease management. Overall, adoption of machine learning, multiclass signal interpretation, and real‑time neurological health tracking continues as a key trend driving clinical and commercial value.

April 2025 : Altoida secured $25 million in funding to scale its AI‑based neurodiagnostic platform that uses augmented reality and smartphone sensors for early detection of Alzheimer’s disease up to five to ten years before clinical symptoms appear.
January 2025 : Biogen partnered in a real‑world study with Eisai and Aural Analytics to use digital speech biomarkers to monitor cognitive decline in Alzheimer’s patients, leveraging smartphone and voice analytics for remote tracking.
November 2024 : Koneksa expanded its digital biomarker platform to include neurodegenerative conditions, integrating gait analysis and voice biomarker capabilities via smartphone technology to support decentralized monitoring.

Impact of Industry Transitions on the Digital Neuro Biomarkers Market

As a core segment of the Healthcare IT industry, the Digital Neuro Biomarkers market develops in line with broader industry shifts. Over recent years, transitions such as Machine Learning Revolutionizing Predictive Power and From Episodic Assessments to Predictive AI Driven Diagnostics have redefined priorities across the Healthcare IT sector, influencing how the Digital Neuro Biomarkers market evolves in terms of demand, applications and competitive dynamics. These transitions highlight the structural changes shaping long-term growth opportunities.
01

Machine Learning Revolutionizing Predictive Power

Digital neuro biomarkers are now being utilised as highly valuable predictive analytics engines thanks to advancements in AI and ML, which are also expanding their market scope. These technologies enable better digital health ecosystems by using real world data to more precisely classify, track over time and detect neurological disease patterns. As a result, digital health ecosystems get enhanced diagnostic accuracy, clinical decision support and treatment selection. By 2030 the impact on the Digital Neuro Biomarkers industry of algorithms being incorporated into medical systems for personal medicine and patient monitoring should be approximately $207 billion. This is likely to be one of the most significant shifts seen in this field. This acceleration in monetisation of advanced analytics not only speeds up drug development, but also reduces the risks associated with the drugs. This has given a competitive edge to these pharmaceutical companies in the long term.
02

From Episodic Assessments to Predictive AI Driven Diagnostics

Another major transition is the move from static, point-in-time neurological assessments to predictive, AI driven diagnostics. Traditional diagnostic tools capture snapshots of disease state, often missing early or subtle changes in neurological function. AI empowered digital biomarkers leverage longitudinal data from smartphones, wearables, and behavioral analytics to forecast risk and progression, enabling earlier intervention and personalized care plans. For instance, platforms that combine gait analysis, speech patterns, and cognitive metrics now help stratify risk before clear clinical symptoms emerge.