Digital Neuro Biomarkers Market By Biomarker Type (Motion and Gait, Cognitive and Speech, Visual and Oculomotor, Behavioral and Passive Signals); By Application (Clinical Trials, Remote Monitoring, Screening, Personalized Feedback); By End User (Pharmaceutical & Biotech Companies, Academic Institutions, CROs, Health Systems); By Geography, Segment Revenue Estimation, Forecast, 2024–2030

Introduction And Strategic Context

The Global Digital Neuro Biomarkers Market will post a strong CAGR of 18.6% , valued at around $540 million in 2024 , and is projected to cross $1.5 billion by 2030 , according to internal estimates by Strategic Market Research.

 

This space sits at the intersection of neurology, artificial intelligence, and digital therapeutics. Unlike traditional biomarkers measured in a lab, digital neuro biomarkers rely on real-time data from wearables, mobile apps, and behavioral tracking to assess neurological conditions. These tools are starting to transform how we diagnose, monitor, and predict diseases like Parkinson’s , Alzheimer’s , Multiple Sclerosis , and even mental health conditions like depression or schizophrenia .

 

What’s pushing the market forward? Three major macro forces. First, there’s the global neurological disease burden. With aging populations, the number of people living with cognitive decline is climbing fast. Second, regulators are warming up to digital endpoints. Agencies like the FDA and EMA are now reviewing digital biomarkers in clinical trials, particularly for hard-to-measure symptoms. And third, tech innovation is exploding. Smartphone sensors, gait trackers, speech analytics, and eye movement detection are all being adapted for neurological use cases.

 

This is more than a healthcare play—it’s a data strategy. The shift toward decentralized trials and remote patient monitoring is making digital neuro biomarkers essential for pharma R&D and real-world evidence programs. Instead of waiting for a clinic visit, researchers can capture disease progression passively, continuously, and objectively—often from a patient’s own phone.

 

The market includes a diverse set of stakeholders:

• Tech-driven startups developing app-based digital biomarker platforms.

• Pharma companies integrating these tools into drug trials to prove treatment efficacy.

• Academic centers validating digital signals in neurological disease cohorts.

• Healthcare providers exploring passive monitoring tools for chronic neuro care.

• Regulators and payers beginning to consider these tools in evidence frameworks.

To be honest, digital neuro biomarkers are still finding their footing. But the momentum is real. They offer a way to fill data gaps in neurology—where blood tests and imaging often fall short. And in a world moving toward personalized and preventive care, these tools could end up playing a defining role.

 

Market Segmentation And Forecast Scope

The digital neuro biomarkers market breaks down into four major dimensions— By Biomarker Type , By Application , By End User , and By Region . Each segment is evolving rapidly, shaped by tech capability, clinical adoption, and regulatory readiness.

By Biomarker Type

This is where the real innovation happens. Digital neuro biomarkers aren’t all built the same, and the market is starting to segment around signal sources:

• Motion and Gait Biomarkers : Data captured from wearables or smartphone sensors that measure tremor, rigidity, stride length, and posture. These are widely used in Parkinson’s and MS studies.

• Cognitive and Speech Biomarkers : Includes voice analysis, verbal fluency, language cadence, and passive typing or tapping patterns. Gaining traction for Alzheimer’s , MCI (Mild Cognitive Impairment) , and psychiatric disorders .

• Visual and Oculomotor Biomarkers : Tracks eye movement, blink rate, or pupil response via mobile eye-tracking tools. Growing usage in neurodevelopmental and neurodegenerative research.

• Behavioral & Passive Digital Signals : App usage, GPS mobility, sleep patterns, screen time—all subtle cues reflecting mood or cognitive shifts. Already being applied in depression and schizophrenia trials.

Motion and gait biomarkers are projected to account for over 34% of total market revenue in 2024 , due to their early validation in movement disorder studies. But behavioral signals are showing the steepest growth curve—especially in decentralized mental health trials.

 

By Application

The technology spans both diagnostic support and clinical research :

• Clinical Trials : Pharma and biotech firms are embedding digital neuro biomarkers into early-phase trials for CNS drug development . They serve as both inclusion criteria and continuous outcome measures.

• Remote Monitoring & Disease Management : Used by neurologists and care teams to track symptoms between visits—particularly valuable in chronic diseases like Parkinson’s or ALS .

• Screening and Early Detection : AI-driven tools can flag early cognitive decline or subtle behavioral changes, sometimes years before traditional symptoms emerge.

• Personalized Treatment Feedback : These tools can also give patients insight into how well a therapy is working, helping tweak dosage or timing based on real-time symptom tracking.

Right now, clinical trial usage leads the market , making up around 41% of all demand in 2024 . But remote care is picking up steam, driven by digital health reimbursement pilots and post-pandemic momentum.

 

By End User

• Pharmaceutical and Biotech Companies : These are the primary adopters, using digital biomarkers to optimize recruitment, measure efficacy, and generate real-world evidence.

• Academic Medical Centers & Research Institutions : A major hub for validation studies and NIH-backed pilot programs.

• Digital Health Startups : Companies developing apps, sensors, and algorithms—often in partnership with academia or pharma.

• Payers and Health Systems : Still in the exploratory phase but showing interest in reimbursable models for digital monitoring.

Pharma and biotech dominate right now, but academic centers are closing the gap as more grants and longitudinal studies go digital.

 

By Region

• North America : Leads the way due to FDA support, NIH funding, and a deep digital health startup ecosystem.

• Europe : Catching up fast. The EMA has begun pilot frameworks for digital endpoints in neurodegenerative disease trials.

• Asia Pacific : Japan and South Korea are strong players, while China is investing in AI-driven cognitive screening tools.

• LAMEA : Still early-stage. Adoption here is mainly in academic research or pilot diagnostic studies.

North America currently claims the largest market share, but Asia Pacific is poised to post the fastest CAGR through 2030 , especially as aging populations drive cognitive health demand.

This segmentation reflects a market in transition—from pilots to mainstream. But the core value stays the same: faster, more continuous, and more patient-centric insight into the brain.

 

Market Trends And Innovation Landscape

Digital neuro biomarkers are tapping into some of the biggest currents in tech and neuroscience right now. What started as niche pilot projects has evolved into full-scale partnerships between pharma, AI labs, and wearable tech firms. Here's what’s shaping the innovation landscape.

AI is the engine behind everything

Let’s be clear—without AI, this market wouldn’t exist. It’s machine learning that makes sense of noisy, real-world data. Algorithms now detect voice tremors, spot micro-expressions, or analyze finger-tapping speeds across thousands of sessions. Some models are even trained to predict cognitive decline months before it shows up in clinical tests.

More importantly, AI is getting FDA attention. A handful of digital neuro biomarkers are now part of formal drug trials. Sponsors are seeking regulatory clearance not just for the drug—but for the digital endpoint that helps prove its effect. That’s a big deal.

 

Multimodal data is the next frontier

No one type of data tells the whole story. That’s why vendors are combining multiple signals—say, gait plus speech plus phone usage—to build richer neurological profiles. These multimodal approaches are showing stronger correlation with disease progression and treatment response.

One European startup recently launched a neuro platform that merges facial expressivity with speech cadence for Parkinson’s tracking. In trials, it matched neurologist-rated scales more accurately than legacy clinical assessments.

 

Smartphones are the new lab bench

There’s a race to build tools that work on devices people already own. Phone-based eye tracking, keyboard monitoring, and background voice sampling are now viable. And the data’s surprisingly robust.

In fact, some firms are skipping wearables entirely—choosing software-only approaches that run on iOS and Android. That makes deployment faster, cheaper, and more scalable in global studies. A major U.S. Alzheimer’s study just went fully app-based for longitudinal cognitive monitoring.

 

Partnerships are heating up

Big Pharma isn’t going it alone. They’re licensing platforms, co-developing tools, and funding digital biomarker pilots. Key partnerships include:

• Neurotech startups teaming with CROs to validate digital endpoints for regulatory filings.

• Academic spinouts working with device makers to integrate sensors into real-world tracking platforms.

• AI vendors collaborating with pharma R&D on digital phenotyping to improve patient stratification.

A recent example: A leading neurology-focused pharma entered a multi-year partnership with a digital health company to co-develop gait-based biomarkers for Parkinson’s and ALS trials.

 

Regulatory acceptance is shifting

Both the FDA and EMA have released draft guidance encouraging the use of digital biomarkers in clinical research. They’re especially interested in real-world monitoring tools that improve inclusivity and reduce trial burden. This is opening the door for more fast-track approvals and expanded use cases.

That said, regulators still expect rigorous validation . Tools must show accuracy, reliability, and clinical relevance. Digital novelty alone doesn’t cut it anymore—proof is everything.

 

Bottom line? This market is built on iteration. There’s no “one big tech” driving it. Instead, we’re seeing constant refinements: better sensors, smarter models, tighter integrations. The innovation feels messy at times—but that’s typical in a space this new and high-stakes.

And if the last two years are any sign, digital neuro biomarkers aren’t just promising—they’re quietly becoming essential.

 

Competitive Intelligence And Benchmarking

This market’s not flooded with big names—yet. Instead, it’s a curated field of tech-forward startups , digital health platforms , and pharma-backed innovators all racing to validate their approach. But make no mistake, the competition is heating up fast.

Here’s how the key players stack up:

Evidation Health

One of the earliest and most prominent players, Evidation focuses on gathering and analyzing real-world behavioral and physiological data through everyday devices. Their platform has supported multiple large-scale neurological studies, including Alzheimer’s and depression monitoring.

They partner with pharma firms to validate passive digital biomarkers for cognitive decline, focusing on longitudinal signal quality and user compliance . Evidation’s strength? They’ve mastered large-scale, real-world data collection while maintaining clinical-grade standards.

 

Altoida

Altoida uses augmented reality (AR) and smartphone sensors to detect early signs of cognitive impairment. Their tool simulates real-world tasks in a gamified format, measuring motor function, spatial navigation, and memory patterns.

In 2023, they earned FDA Breakthrough Device designation for their Alzheimer’s detection platform. That puts them in rare company. They’re actively collaborating with major pharma players in CNS trials, making them a frontrunner in digital diagnostics.

 

Rune Labs

Rune Labs offers a platform that collects and analyzes neurobehavioral and movement data for Parkinson’s disease. Their differentiator? A tight integration with Apple’s Movement Disorder API, which pulls passively collected tremor and mobility data from Apple Watch users.

They’ve secured FDA clearance for their platform as a medical device, allowing for real-world symptom tracking outside the clinic. Rune is also pursuing partnerships in gene therapy trials for Parkinson’s— a clear signal they’re not just tracking symptoms, but aiming to support precision treatment design.

 

Koneksa Health

Koneksa focuses heavily on digital biomarkers for use in clinical trials, offering validated modules for speech, mobility, and activity. Their tools are often embedded into pharma-run CNS studies, acting as secondary endpoints or tools to improve recruitment and retention.

They’re known for their deep ties to pharma, offering high compliance and regulatory-aligned data pipelines. One advantage they have is a scalable backend designed for Good Clinical Practice (GCP) standards, which makes integration into global trials much easier.

 

Mindstrong (exited but influential)

Mindstrong made waves by turning passive smartphone interactions—like typing speed and scrolling behavior—into mental health biomarkers. While they shut down in 2023 due to funding challenges, their approach influenced how many startups now structure their behavioral analytics pipelines.

Their IP and methodology live on through acquisitions and licensing deals, and their clinical research helped open doors with regulators for app-based cognitive assessments.

 

Apple and Google (Indirect Influence)

While not direct competitors, both tech giants are increasingly shaping the space:

• Apple’s ResearchKit and CareKit have enabled large-scale neurological studies using iPhones and Apple Watches.

• Google’s Fit and AI research arms have collaborated with hospitals on passive mental health monitoring and cognitive apps.

They’re not building neuro biomarker platforms per se, but their ecosystems are foundational for data collection and third-party tool deployment.

 

Competitive Landscape Summary

• Evidation and Koneksa dominate real-world and clinical trial integrations.

• Altoida leads in early detection and diagnostics, particularly for Alzheimer’s.

• Rune Labs owns the Parkinson’s remote monitoring niche.

• Academic partnerships (e.g., with UCSF, Karolinska , or MIT) remain critical for validation pipelines.

• Big Tech isn’t directly in the race—but they’re shaping the road everyone else runs on.

To be honest, it’s not about feature checklists anymore. The winners in this market will be the ones who prove their biomarkers matter in real clinical settings —and can scale that across diverse populations.

 

Regional Landscape And Adoption Outlook

The digital neuro biomarkers market has global relevance—but local realities shape adoption. From FDA-cleared tools in the U.S. to pilot programs in Asia and cautious scaling in Europe, the picture is nuanced. Let’s break it down.

North America

No surprise here— North America leads . The U.S. is the single most active region in both clinical trials and commercial deployments of digital neuro biomarkers.

Here’s why:

• Regulatory momentum : The FDA has created pathways for digital health tools to support neurological trials. Several platforms now have clearance as “digital measurement tools,” which signals increasing comfort with non-traditional endpoints.

• NIH funding : Major neuroscience initiatives like All of Us and the BRAIN Initiative are investing in digital tools to monitor cognitive and motor health in real-world settings.

• Pharma partnerships : U.S.-based pharma giants are embedding these tools into Alzheimer’s, Parkinson’s, and depression studies. That pipeline is helping digital biomarkers go from optional to expected .

As one neurotech executive put it: “If your digital biomarker isn’t FDA-visible in the U.S., it’s not in the real game yet.”

 

Europe

Europe is gaining ground, but the path is different. Digital biomarker development here tends to be more academic and publicly funded, especially in:

• Germany and Sweden : Known for their strong neuropsychiatric research programs. Universities and hospitals here often lead early validation studies.

• UK and Netherlands : Home to several neuro-AI startups working on speech and facial biometrics.

The EMA (European Medicines Agency) is exploring frameworks to evaluate digital endpoints, but progress is slower than in the U.S. Still, sustainability and privacy regulations in Europe make this region a prime test bed for ethical, low-impact data collection platforms.

That said, commercial adoption lags. Many tools remain in pilot mode or early trial phases.

 

Asia Pacific

Asia Pacific is where things get interesting. It’s the fastest-growing region , largely thanks to:

• Aging populations in Japan, South Korea, and China that are driving demand for dementia screening tools.

• High smartphone penetration , which makes app-based cognitive screening more scalable than in some Western countries.

• Government R&D funding , especially in South Korea, which supports AI and neuro-diagnostics innovation.

Japan has already rolled out mobile tools for mild cognitive impairment screening via national health programs. And in China, several local tech firms are entering the market with phone-based mental health and cognition trackers.

Still, clinical validation remains a hurdle. While usage is rising, long-term, regulator-accepted studies are less common compared to the West.

 

LAMEA (Latin America, Middle East, and Africa)

Adoption here is very early stage—but there are bright spots.

• In Brazil , academic centers are exploring passive depression monitoring tools using smartphones, supported by public research grants.

• Middle Eastern countries like the UAE are investing in neuro-health pilots as part of broader AI-in-healthcare strategies.

• Africa remains mostly untapped, though international research collaborations are starting to explore mobile-based neurological assessments.

The main barriers? Cost, internet access , and clinical infrastructure . But there’s strong potential for growth—especially if cloud-based platforms become more affordable.

 

Regional Outlook Summary

• North America dominates on trials, regulation, and commercial integration.

• Europe is innovation-heavy but cautious on deployment.

• Asia Pacific is scaling quickly, with government-backed momentum.

• LAMEA represents a long-term opportunity for accessible, mobile-first neuro tools.

In short: This isn’t a single-speed global market. It’s a patchwork—highly mature in some pockets, just beginning in others.

 

End-User Dynamics And Use Case

Who’s actually using digital neuro biomarkers—and why? The answer varies. Some view these tools as R&D accelerators, others see them as clinical support systems, and for many, they’re a strategic edge in competitive therapeutic areas. Let’s break it down by end user type.

Pharmaceutical and Biotech Companies

This is the core customer group today.

Pharma companies are embedding digital neuro biomarkers into clinical trials to:

• Improve recruitment by objectively screening for symptom severity.

• Measure efficacy continuously, not just at clinic visits.

• Generate real-world evidence for regulatory submissions and payers.

They're especially useful in CNS drug development , where traditional endpoints are subjective, and placebo response is high. These tools bring objective digital endpoints into studies for Parkinson’s, Alzheimer’s, depression, and schizophrenia.

One digital biomarker platform was even used by a top-5 pharma company in its Phase 2 Alzheimer’s trial to monitor gait and voice data in real-time—across 3 countries.

 

Academic and Research Institutions

Universities and neuroscience research centers are at the heart of validation efforts . These groups are:

• Running long-term studies to correlate digital signals with clinical disease progression.

• Leading NIH- and EU-funded programs that test new behavioral and physiological markers.

• Publishing the evidence base that eventually feeds into regulatory and clinical acceptance.

That said, budget constraints mean many projects remain proof-of-concept unless supported by pharma or government grants. Academic centers often act as incubators for the IP and data science that startups later commercialize.

 

Contract Research Organizations (CROs)

CROs play a behind-the-scenes but increasingly critical role. They:

• Help validate digital biomarker platforms under GCP compliance .

• Manage the digital tools embedded into pharma-sponsored trials.

• Offer operational support, such as patient onboarding, device distribution, and data integration.

Lately, CROs are bundling digital biomarker support into their standard trial services, positioning it as a differentiator. For neuro-focused biotech sponsors, asking for digital endpoints is now more common than not.

 

Health Systems and Clinicians

This group is still in the early stages. Some neurologists and psychiatrists are beginning to explore digital neuro biomarkers for:

• Remote symptom tracking between visits.

• Supporting decisions in ambiguous diagnoses.

• Monitoring treatment response more objectively.

But adoption is slow due to workflow complexity , reimbursement gaps , and validation concerns in real-world care. That said, some large hospital systems are piloting these tools in memory clinics and movement disorder units .

 

Use Case Highlight

A leading neuroscience institute in Switzerland partnered with a digital health startup to monitor cognitive decline in early-stage Alzheimer’s patients. The platform collected passive smartphone data—screen time, typing rhythm, mobility—from 180 participants over 12 months.

Clinicians used the system to flag changes in daily patterns that correlated with MMSE (Mini-Mental State Exam) scores. In two cases, it caught pre-symptomatic declines before the patients themselves reported issues. Based on these findings, the platform was integrated into a new prevention program and is now part of a pan-European study.

Result? Earlier intervention, improved monitoring, and proof that digital biomarkers can spot cognitive shifts sooner than traditional tests.

 

Recent Developments + Opportunities & Restraints

Recent Developments (Last 2 Years)

• Rune Labs received FDA clearance (2023) for its StrivePD platform, a software-as-a-medical-device that uses Apple Watch motion data to monitor Parkinson’s symptoms in real-time. This marked one of the first digital neuro biomarkers cleared for use in clinical workflows.

• Altoida secured FDA Breakthrough Device designation (2023) for its AR-based tool to predict Alzheimer's disease risk using smartphone interactions and digital tasks.

• Evidation Health expanded its partnership with the Alzheimer’s Drug Discovery Foundation (ADDF) in 2024 to gather behavioral and cognitive data from over 5,000 aging adults through smartphones.

• Apple enhanced its Movement Disorder API (2023) to allow researchers to track tremor and dyskinesia more precisely via Apple Watch, enabling better Parkinson’s trial design.

• Koneksa launched new modules for speech and mood tracking (2024), enabling more robust depression and schizophrenia assessments in decentralized clinical trials.

 

Opportunities

• CNS Trial Optimization : Pharma sponsors are under pressure to reduce trial timelines and improve endpoint sensitivity. Digital neuro biomarkers offer faster, more continuous data collection—cutting noise and boosting signal clarity.

• Preventive Neurology : Tools that detect subtle cognitive or behavioral shifts before traditional symptoms appear are opening up a whole new market in early intervention and risk stratification .

• Regulatory Acceptance : Both the FDA and EMA are becoming more open to digital endpoints. As guidance solidifies, vendors that align with clinical validation standards will have first-mover advantage.

 

Restraints

• Validation Complexity : To be accepted clinically or by regulators, these tools need to prove accuracy, reproducibility, and real-world relevance . Many current products lack the rigorous longitudinal data needed.

• Data Privacy and Ethics : Passive behavioral tracking often involves sensitive data—mobility, speech, app usage. Without strong governance and transparency, adoption could stall over trust issues.

To be honest, the excitement is real—but so are the hurdles. What comes next will depend less on tech… and more on trust, clinical proof, and smart execution.

 

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 540 Million
Revenue Forecast in 2030	USD 1.5 Billion
Overall Growth Rate	CAGR of 18.6% (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Biomarker Type, Application, End User, Geography
By Biomarker Type	Motion and Gait, Cognitive and Speech, Visual and Oculomotor, Behavioral and Passive
By Application	Clinical Trials, Remote Monitoring, Screening, Personalized Feedback
By End User	Pharmaceutical & Biotech Companies, Academic Institutions, CROs, Health Systems
By Region	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Country Scope	U.S., UK, Germany, China, Japan, South Korea, Brazil, etc.
Market Drivers	- Rising CNS drug development with demand for digital endpoints - Growth in remote neurology care - Regulatory support for real-world evidence
Customization Option	Available upon request