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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:
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Digital Neuro Biomarkers
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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. Building on this outlook, Digital Neuro Biomarkers are emerging as a strategic cornerstone in neurology and mental health, as healthcare systems seek objective, continuous measures of brain function to support earlier diagnosis, treatment optimization, and precision neurology. The market’s current significance is underpinned by strong demand from biopharmaceutical companies for more sensitive, digitally captured endpoints in CNS clinical trials, and by providers adopting passive monitoring tools to manage complex neurological disorder biomarkers and psychiatric disorder biomarkers across large patient populations. Applications in neurological disorders and psychiatric disorders together account for 74.8% of overall adoption, reflecting the urgent need for better measurement of neurodegenerative diseases and mood, cognition, and behavior in real-world settings. Within product types, passive solutions generated $469.39 million in revenue in 2024, highlighting the preference for unobtrusive data capture via wearable sensors and smartphones that integrate seamlessly into patients’ daily lives. These dynamics, supported by advances in AI-driven analytics, digital phenotyping, and digital health platforms, as well as growing use of remote patient monitoring programs that generate high-quality real-world evidence, are cementing Digital Neuro Biomarkers as a critical enabler of value-based and personalized brain health care Digital Neuro Biomarkers comprise objective, quantifiable physiological and behavioral signals-captured through software, mobile devices, and connected sensors-that characterize central nervous system function, disease onset, and treatment response with far greater temporal granularity than traditional assessments. Key features include passive, high-frequency data collection, multimodal integration of motor, cognitive, speech, and sleep metrics, and algorithm-driven interpretation that transforms raw data into clinically meaningful digital endpoints. They are now widely deployed across major applications such as Parkinson’s disease, Alzheimer’s disease, multiple sclerosis, depression, schizophrenia, and other CNS disorders, where they support early detection, patient stratification, and continuous monitoring of symptom dynamics. Recent trends driving demand include their integration into decentralized and hybrid clinical trials, linkage with telemedicine and electronic health records, and the emergence of validated digital outcome measures that can complement or replace conventional clinician-reported scales. Together, these capabilities position Digital Neuro Biomarkers as a foundational layer of future-ready neurotechnology ecosystems, enabling stakeholders across healthcare, life sciences, and medtech to generate actionable insights, accelerate innovation, and improve long-term outcomes for patients with complex brain and mental health conditions

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 market is projected to grow from $742.7 million in 2024 to $6.03 billion in 2034. This represents a CAGR of 23.3%, reflecting rising demand across Clinical Neurodegeneration Monitoring, Cognitive Function Assessment, and Mental Health.

  • Altoida Inc., Koneksa, Biogen Inc. are among the leading players in this market, shaping its competitive landscape.

  • U.S. and Germany are the top markets within the Digital Neuro Biomarkers market and are expected to observe the growth CAGR of 22.4% to 32.6% between 2024 and 2030.

  • Emerging markets including India, Brazil and Mexico are expected to observe highest growth with CAGR ranging between 17.5% to 24.2%.

  • Transition like Machine Learning Revolutionizing Predictive Power is expected to add $207 million to the Digital Neuro Biomarkers market growth by 2030.

  • The Digital Neuro Biomarkers market is set to add $5.3 billion between 2024 and 2034, with manufacturer targeting Psychiatric Disorders & Sleep Disorders Application projected to gain a larger market share.

  • With

    advancements in neuroimaging technologies, and

    Increasing Incidence of Neurological Disorders, Digital Neuro Biomarkers market to expand 712% between 2024 and 2034.

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

Rising demand for passive Digital Neuro Biomarkers in remote Parkinson’s monitoring among Japan’s population. Digital Neuro Biomarkers enabling passive gait, speech, and tremor monitoring target Parkinson’s patients in Japan’s neurology market, especially those seen during infrequent clinic visits. Wearable sensors and smartphone-based digital biomarkers capture real-world data, feeding telehealth platforms and precision neurology dashboards using machine learning analytics. Globally, the passive segment is also projected to rise from 469.39 million USD in 2024 to 1570.69 million USD by 2030, with Asia-Pacific remote patient monitoring, led by Japan, expected to become the fastest-growing regional application.

Growth Opportunities in North America and Europe

Digital Neuro Biomarkers adoption in North America is primarily driven by high disease burden and innovation funding in Neurological Disorder applications, where digital biomarkers, wearable sensors, and mobile health apps are increasingly embedded into neurology clinical trials and post-approval remote patient monitoring to generate real-world evidence and support value-based contracting. Top opportunities center on platform-level integration of AI-powered diagnostics with electronic health records, expansion into payer-backed patient-centric care pathways, and strategic partnerships between CNS drug development sponsors and analytics specialists to differentiate therapeutics with objective neurocognitive endpoints. Competitive intensity is elevated due to a dense mix of established pharma, health IT vendors, and specialist digital biomarker firms, making regulatory-grade validation, multi-modal data fusion, and health-economic outcomes evidence the key differentiators for regional scaling.
In Europe, Digital Neuro Biomarkers show highest strategic relevance in Psychiatric Disorders, supported by strong policy focus on mental health, robust data protection frameworks, and coordinated public-health initiatives that favor validated, privacy-preserving digital biomarkers for mood, cognition, and behavior. Leading opportunities lie in integrating remote patient monitoring and passive behavioral analytics into national health systems for depression, anxiety, and psychosis management, while selectively extending into Sleep Disorders through hospital–sleep lab collaborations to optimize patient-centric care and resource allocation. Competition is shaped by academic–industry consortia, regional medtech innovators, and health system–linked digital platforms, with success driven by pan-European interoperability, multilingual patient engagement, and the ability to deliver reimbursable, clinically endorsed Digital Neuro Biomarkers that align with country-specific reimbursement and clinical guideline pathways.

Market Dynamics and Supply Chain

01

Driver: Advancements in Neuroimaging Technologies, and Widespread Adoption of AI & Machine Learning

The new advancements in neuroimaging technologies offer, in depth understandings of the brains structure and operations leading to recognition of neuro biomarkers that drive market growth. Incorporating intelligence and machine learning into the field of neurology has also revolutionized the way diagnoses are also made. The utilization of these technologies allows for the analysis of intricate neurological data promoting precise identification and assessment of neurological biomarkers.
The increase in the occurrence of conditions such as Alzheimers disease and Parkinsons disease has also led to a demand, for digital neuro biomarkers to forecast the development and advancement of these illnesses and facilitate prompt intervention and improved patient treatment.
02

Restraint: Lack of Technological Infrastructure

The digital neuro biomarker sector relies on technological systems for data gathering and analysis purposes as well as for storage capabilities. Any deficiencies, in these aspects could hinder market expansion significantly in underdeveloped regions.
03

Opportunity: Opportunity heading and Opportunity heading

Accelerating use of active Digital Neuro Biomarkers in US and European CNS clinical trials. In CNS drug development, active Digital Neuro Biomarkers such as smartphone-based cognitive tests and digital motor tasks can transform US and European clinical trials. Pharmaceutical sponsors seek more sensitive outcomes to de-risk neurodegenerative and psychiatric pipelines. Active solutions generate high-frequency signals for machine learning analytics, enabling superior patient stratification and robust efficacy readouts. Globally, the active segment is expected to expand from 273.31 million USD in 2024 to 1039.02 million USD by 2030, making clinical trial applications the fastest-growing use case.
Emerging demand for gamified Digital Neuro Biomarkers in pediatric ADHD care across North America. In pediatric mental health, gamified Digital Neuro Biomarkers for ADHD offer differentiated value to North American families seeking non-stigmatizing support. Interactive mobile games, eye-tracking, and attention tasks can passively and actively capture continuous behavioral signals outside clinics. Untapped opportunities include school-based screening, remote treatment monitoring, and integration with digital therapeutics platforms. Strongest growth is expected in active cognitive-assessment tools for remote patient monitoring, as payers, clinicians, and educators increasingly demand objective, real-world data to complement traditional rating scales and telehealth consultations.
04

Challenge: Regulatory and Ethical Challenges

Strict regulations and ethical considerations present challenges for the digital neuro biomarker market as well. Getting the required approvals for digital neuro biomarker technologies, from regulatory agencies can be a lengthy and costly process. Additionally using these technologies raises concerns related to patient confidentiality data protection and consent which could impede market growth.

Supply Chain Landscape

1

Biomarker Discovery

Biogen Inc. Roche
2

Digital Neuro Biomarkers Platforms

Altoida Inc. Koneksa NeuraMetrix
3

Clinical Data Integration

Roche Biogen Inc
4

Clinical Applications

Pharmaceutical Companies Neurology Clinics Academic 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

In times there have been significant advancements in the realm of Digital Neuro Biomarkers due to the integration of machine learning and AI technologies. This progress has led to improved detection, prediction and intervention for neurological disorders when compared to conventional approaches. A key factor contributing to this progress is the growing partnerships between healthcare and technology firms, with the goal of transforming the field of neuro health.

December 2024 : Biometrics Ltd has unveiled a digital platform for neuro biomarkers to identify early signs of neuron damage, in neurodegenerative diseases.
October 2024 : CognoTech utilized intelligence and machine learning methods to enhance the precision of their digital neuro biomarker instruments.
July 2024 : NeuroScanCorp ha brevettato un processo di identificazione dei biomarcatori digitali non invasivo per la diagnosi dei disturbi mentali.

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 Wearable Technology Amplifying Data Collection 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

Machine learning and artificial intelligence are transforming Digital Neuro Biomarkers from experimental tools into high-value predictive analytics engines, directly shaping market expansion. By enabling more precise detection, classification, and longitudinal tracking of neurological disease patterns using real-world data, these technologies significantly improve diagnostic accuracy, treatment selection, and clinical decision support across digital health ecosystems. As algorithms mature and are embedded into remote patient monitoring and personalized medicine workflows, they are expected to add approximately $207 million to the Digital Neuro Biomarkers market by 2030, making this transition one of the most financially consequential technology shifts in the segment. This monetization of advanced analytics also accelerates biomarker validation and de-risks neurology drug development pipelines, reinforcing long-term competitive differentiation for leading stakeholders.
02

Wearable Technology Amplifying Data Collection

The growing popularity of technology is transforming the Digital Neuro Biomarkers market in significant ways as well. Progress in wearables has made it easier to gather data from patients continuously. Without invasiveness in real time. This advancement opens up avenues, for tailored healthcare by improving disease control and patient results.