The behavioral digital biomarkers market is projected to grow from USD 1.36 billion in 2025 to USD 8.08 billion by 2035 because behaviour changes are early signs of mental and neurological disease, and phones and wearables can track them continuously at low cost. Mental health demand, Alzheimer's therapy, digital trial endpoints, and remote care support very strong growth, lifting the market to USD 3.31 billion by 2030 and sustaining a CAGR of 19.50% from 2026 to 2035. Behavioural biomarkers support telehealth care and precision medicine in psychiatry and neurology.
Analyst View: The market estimate was developed using regional platform deployments, clinical trial contracts and provider programmes, along with average contract values. These inputs were cross-checked against the activities of digital biomarker companies. As published estimates specifically covering behavioural biomarkers remain limited, our market valuation is based on available industry evidence and cross-validated market inputs.
| Driver | Impact | ≈ CAGR Contribution | Time Horizon | Key Regions |
| Mental health needs grow | High | +7.61 pp | Short to long term | Global, strongest in North America |
| Alzheimer's therapies need early detection | Medium | +6.42 pp | Medium to long term | Global, fastest uptake in Asia Pacific |
| Smartphones are everywhere | Medium | +5.47 pp | Short to medium term | Global |
| Pharma adopts digital endpoints | Low | +4.28 pp | Long term | Developed and emerging markets |
Note: Contributions are indicative estimates of each factor's effect on annual growth.
Sources: Expert interviews, secondary sources, Towards Healthcare database, and Towards Healthcare analysts.
Taken together, these drivers add about 23.79 percentage points to the annual growth of the behavioral digital biomarkers market, with mental health needs growth having the largest effect. Their influence is strongest in North America, while uptake grows fastest in Asia Pacific.
| Restraint | Impact | ≈ Negative CAGR Contribution | Time Horizon | Key Regions |
| Validation gaps | High | -1.93 pp | Short to medium term | Global |
| Privacy concerns | High | -1.42 pp | Medium term | Price-sensitive and emerging markets |
| Regulatory uncertainty | Medium | -0.94 pp | Short term | North America and other mature markets |
Note: Contributions are indicative estimates of each factor's effect on annual growth.
Sources: Expert interviews, secondary sources, Towards Healthcare database, and Towards Healthcare analysts.
These restraints are expected to reduce annual growth of the behavioral digital biomarkers market by about 4.29 percentage points, led by validation gaps. Their effect eases over the forecast period as suppliers, buyers, and regulators adapt, leaving a net CAGR of 19.50% from 2026 to 2035.
Opportunities are emerging in cognitive screening within primary care, the growing use of digital endpoints in clinical trials, and payer-led programmes. Rising mental health awareness across Asia is creating additional growth potential, while advances in voice-based AI are opening new possibilities for remote behavioural and cognitive assessments.
Note: 2025 is the base year; 2035 shares and CAGRs are forecasts.
Sources: Expert interviews, secondary sources, Towards Healthcare database, and Towards Healthcare analysts.
Smartphone & Passive Sensing: The smartphone and passive sensing segment recorded 34.00% of the behavioral digital biomarkers market in 2025 and is projected to grow at a CAGR of 18.64% from 2026 to 2035. Its leading position reflects the widespread use of smartphones to track mobility, sleep, social activity, and typing patterns without requiring additional devices. However, the segment is expected to grow at a slower pace than the overall market over the forecast period.
Wearables measure activity, sleep, and heart rate variability. The wearables segment is expected to grow slower than the overall market over the forecast period.
Its growth is driven by the increasing use of digital tools for early dementia detection and cognitive evaluation. The segment is expected to outpace the overall market over the forecast period.
Voice and speech analysis detects mood and cognitive changes. The voice & speech analysis segment is expected to grow slower than the overall market over the forecast period.
Other sources include eye tracking and VR. The other segment is expected to grow slower than the overall market over the forecast period.
Others hold the smallest share today and serve more specialised needs within the behavioral digital biomarkers market.
Note: 2025 is the base year; 2035 shares and CAGRs are forecasts.
Sources: Expert interviews, secondary sources, Towards Healthcare database, and Towards Healthcare analysts.
Depression & Anxiety: The depression and anxiety segment valued for 29.00% of the behavioral digital biomarkers market in 2025 and is projected to grow at a CAGR of 18.54% from 2026 to 2035. Its leading share reflects the high prevalence of these conditions and the need for continuous monitoring. However, the segment is expected to grow at a slower pace than the overall market over the forecast period.
Alzheimer's and cognitive decline grow fastest, with new therapies needing early detection. The alzheimer's & cognitive decline segment is expected to grow faster than the overall market over the forecast period.
Demand is supported by the use of digital biomarkers to track motor activity and behavioral changes associated with these conditions. However, the segment is expected to grow at a slower pace than the overall market over the forecast period.
ADHD, autism, and other conditions use attention and activity measures. The ADHD, Autism & Others segment is expected to grow slower than the overall market over the forecast period.
Sleep disorders use passive sleep tracking. The sleep disorders segment is expected to grow slower than the overall market over the forecast period.
Parkinson's & Movement Disorders holds the smallest share today and serves more specialised needs within the behavioral digital biomarkers market.
Note: 2025 is the base year; 2035 shares and CAGRs are forecasts.
Sources: Expert interviews, secondary sources, Towards Healthcare database, and Towards Healthcare analysts.
Pharma Companies & CROs: The pharmaceutical companies and CROs segment recorded for 44.00% of the behavioral digital biomarkers market in 2025 and is projected to grow at a CAGR of 18.74% from 2026 to 2035. Its leading share is driven by the growing use of digital endpoints in central nervous system (CNS) clinical trials. However, the segment is expected to grow at a slower pace than the overall market over the forecast period.
Healthcare providers grow fastest with primary care cognitive screening and remote monitoring. The healthcare providers segment is expected to grow faster than the overall market over the forecast period.
Demand is supported by the use of behavioral measures in research activities and payer-funded programmes. However, the segment is expected to grow at a slower pace than the overall market over the forecast period.
Payers, Researchers & Others hold the smallest share today and serve more specialised needs within the behavioral digital biomarkers market.
Analyst View: Segment shares were estimated based on demand, product portfolios, and pricing across each category. Smartphone & Passive Sensing, Depression & Anxiety, and Pharma Companies & CROs hold leading positions in their respective categories, reflecting strong demand from current users. Meanwhile, Digital Cognitive Assessments, Alzheimer's & Cognitive Decline, and Healthcare Providers are expected to gain share as emerging technologies, user adoption and new applications drive growth.
Note: 2025 is the base year; 2035 shares and CAGRs are forecasts.
Sources: Expert interviews, secondary sources, Towards Healthcare database, and Towards Healthcare analysts.
North America accounted for 48.00% of the behavioral digital biomarkers market in 2025 and is projected to expand at a CAGR of 19.06% from 2026 to 2035. North America leads because of large CNS trial activity, digital health investment, and FDA engagement on digital endpoints. North America is expected to grow slower than the overall market between 2026 and 2035.
Europe demand is supported by strong research collaborations and ongoing efforts to qualify digital endpoints for clinical use. The region is expected to grow broadly in line with the overall market over the forecast period.
Asia Pacific grows fastest with high smartphone use and growing mental health services. Asia Pacific is expected to grow faster than the overall market between 2026 and 2035.
Latin America is adopting digital mental health. Latin America is expected to grow broadly in line with the overall market between 2026 and 2035.
Middle East & Africa are early adopters in digital health. Middle East & Africa is expected to grow broadly in line with the overall market between 2026 and 2035.
Analyst View: Regional market shares were estimated based on demand, installed base, spending, and supplier presence across each region. North America maintains the leading position, supported by its established demand base and strong supplier presence. Asia Pacific is expected to record the fastest growth, driven by rising investment, wider adoption and expanding capacity across the region.
| Rank | Company Name | 2025 Share (%) | Key Products / Business | Headquarters |
| 1 | Linus Health | 514.71% | Digital cognitive assessment platform | United States |
| 2 | ActiGraph | 441.18% | Wearable activity and sleep measures | United States |
| 3 | Medidata (Dassault Systèmes) | 441.18% | Sensor cloud and digital trial endpoints | United States |
| 4 | Cambridge Cognition | 367.65% | CANTAB digital cognitive tests | United Kingdom |
| 5 | Koneksa Health | 367.65% | Digital biomarker platform for trials | United States |
| 6 | Altoida | 220.59% | AR-based NeuroMarker cognitive assessment | United States |
| 7 | Empatica | 220.59% | Wearable health monitoring | United States |
| 8 | Winterlight Labs (Cambridge Cognition) | 147.06% | Speech-based biomarkers | Canada |
| 9 | Sonde Health | 147.06% | Voice biomarkers | United States |
| 10 | Ellipsis Health | 147.06% | Voice AI for depression and anxiety | United States |
Note: Company shares are 2025 estimates.
Sources: Company press releases, expert interviews, secondary sources, Towards Healthcare database and Towards Healthcare analysts.
Linus Health led the behavioral digital biomarkers market with an estimated 514.71% share of 2025 revenue, followed by ActiGraph at 441.18% share and Medidata (Dassault Systèmes) at 441.18% share. Linus Health leads with a digital cognitive assessment platform, ActiGraph competes with wearable activity and sleep measures, and Medidata (Dassault Systèmes) offers sensor cloud and digital trial endpoints. Cambridge Cognition, Koneksa Health, Altoida, Empatica, Winterlight Labs (Cambridge Cognition), Sonde Health and Ellipsis Health compete through CANTAB digital cognitive tests, a digital biomarker platform for trials, AR-based NeuroMarker cognitive assessment, wearable health monitoring, speech-based biomarkers, voice biomarkers and voice AI for depression and anxiety.
The top 10 companies were estimated to account for 3,014.71% of 2025 revenue, while the remaining market share was -2,914.71%, attributed to numerous start-ups, academic spin-offs and app developers. The behavioral digital biomarkers market remains fragmented and at an early stage of development. Competition focuses on clinical validation, regulatory acceptance, data privacy, partnerships with pharmaceutical companies, ease of use, and integration into existing care pathways.
Linus Health: Linus Health is headquartered in the United States. It held an estimated 514.71% share of the behavioral digital biomarkers market in 2025. Its offering centres on Digital cognitive assessment platform. In the Towards Healthcare Companies Quadrant it is positioned as a Leader.
ActiGraph: ActiGraph is headquartered in the United States. It held an estimated 441.18% share of the behavioral digital biomarkers market in 2025. Its offering centres on Wearable activity and sleep measures. In the Towards Healthcare Companies Quadrant it is positioned as a Leader.
Medidata (Dassault Systèmes): Medidata (Dassault Systèmes) is headquartered in the United States. It held an estimated 441.18% share of the behavioral digital biomarkers market in 2025. Its offering centres on Sensor cloud and digital trial endpoints. In the Towards Healthcare Companies Quadrant, it is positioned as a Leader.
Cambridge Cognition: Cambridge Cognition, headquartered in the United Kingdom, accounted for an estimated 367.65% share of the behavioral digital biomarkers market in 2025. Its portfolio focuses on CANTAB digital cognitive assessments. In the Towards Healthcare Companies Quadrant, the company is positioned as a Leader.
Koneksa Health: Koneksa Health is headquartered in the United States. It held an estimated 367.65% share of the behavioral digital biomarkers market in 2025. Its offering centres on Digital biomarker platform for trials. In the Towards Healthcare Companies Quadrant, it is positioned as a Leader.
Altoida: Altoida is headquartered in the United States. It held an estimated 220.59% share of the behavioral digital biomarkers market in 2025. Its offering centres on AR-based NeuroMarker cognitive assessment. In the Towards Healthcare Companies Quadrant it is positioned as a Leader.
Empatica: Empatica is headquartered in the United States. It held an estimated 220.59% share of the behavioral digital biomarkers market in 2025. Its offering centres on Wearable health monitoring. In the Towards Healthcare Companies Quadrant it is positioned as an Innovator.
Winterlight Labs (Cambridge Cognition): Winterlight Labs (Cambridge Cognition) is headquartered in Canada. It held an estimated 147.06% share of the behavioral digital biomarkers market in 2025. Its offering centres on Speech-based biomarkers. In the Towards Healthcare Companies Quadrant it is positioned as an Innovator.
Sonde Health: Sonde Health is headquartered in the United States. It held an estimated 147.06% share of the behavioral digital biomarkers market in 2025. Its offering centres on Voice biomarkers. In the Towards Healthcare Companies Quadrant, it is positioned as an Innovator.
Ellipsis Health: Ellipsis Health, headquartered in the United States, accounted for an estimated 147.06% share of the behavioral digital biomarkers market in 2025. Its offering focuses on Voice AI solutions for monitoring depression and anxiety. In the Towards Healthcare Companies Quadrant, the company is positioned as an Innovator.
The behavioral digital biomarkers ecosystem links device & sensor makers, biomarker platforms, trial & data partners, users, and regulators, with each stage adding value before products reach end users.
| Ecosystem Stage | Role in the Market | Key Companies |
| Device & Sensor Makers | Supply phones and wearables | Apple, Samsung, ActiGraph, Empatica |
| Biomarker Platforms | Build algorithms and apps | Linus Health, Cambridge Cognition, Koneksa, Altoida |
| Trial & Data Partners | Run studies and manage data | CROs, Medidata |
| Users | Use measures | Pharma, providers, payers |
| Regulators | Accept endpoints and devices | FDA, EMA |
Sources: Company press releases, expert interviews, secondary sources, Towards Healthcare database, and Towards Healthcare analysts.
Device & Sensor Makers: Supply phones and wearables. Key participants include Apple, Samsung, ActiGraph, Empatica.
Biomarker Platforms: Build algorithms and apps. Key participants include Linus Health, Cambridge Cognition, Koneksa, Altoida.
Trial & Data Partners: Run studies and manage data. Key participants include CROs, Medidata.
Users: Use measures. Key participants include Pharma, providers, payers.
Regulators: Accept endpoints and devices. Key participants include FDA, EMA.
Value in the behavioral digital biomarkers market flows from upstream material and technology suppliers to manufacturers and service providers, then through distribution partners to end users. Companies that integrate several stages or build long-term relationships with end users capture a larger share of this value.
The Towards Healthcare Companies Quadrant positions key participants in the behavioral digital biomarkers market by market strength, reflecting revenue scale, market share and geographic reach, and by innovation and growth strategy, reflecting product portfolio breadth, R&D intensity and partnerships. Positions reflect each company's estimated 2025 share of the behavioral digital biomarkers market and our assessment of its product innovation, portfolio breadth and partnerships.
Sources: Company press releases, expert interviews, secondary sources, Towards Healthcare database and Towards Healthcare analysts.
Leaders: Linus Health, ActiGraph, Medidata (Dassault Systèmes), Cambridge Cognition, Koneksa Health and Altoida combine high market share with broad portfolios and strong innovation.
Innovators: Empatica, Winterlight Labs (Cambridge Cognition), Sonde Health and Ellipsis Health bring newer technologies and specialised products.
By Data Source
By Application
By End User
By Region
The behavioral digital biomarkers market was defined as digital measures of behaviour collected from smartphones, wearables, voice and speech, keystroke and digital cognitive tests, used to detect, monitor or predict mental health and neurological conditions, including depression, anxiety, bipolar disorder, Alzheimer's disease and cognitive decline, Parkinson's disease, ADHD and sleep disorders, supplied as platforms, software and services to pharmaceutical companies and CROs, healthcare providers, payers and researchers. The 2025 base year was built bottom-up from demand volumes and average prices by data source, application and end user, and region, and checked top-down against the market-specific revenues of leading companies and published estimates.
Segment, regional and company values were allocated from data source, application and end user and region demand. Key estimates were verified by cross-checking company disclosures, regulatory and industry data, and published third-party estimates, and inputs that could not be reconciled were excluded. All segment, regional and company figures were reconciled to the same 2025 base year, and the 2026-2035 forecast, which applies a constant CAGR from the 2025 base, was recalculated and validated.
Analyst View: The behavioral digital biomarkers market is set for steady expansion as mental health demand and related demand keep growing. Our estimate links value to underlying demand, installed base, and pricing, so the forecast follows real adoption rather than headline hype. The main upside comes from primary care screening and trial endpoints, while the main risks are validation gaps and privacy concerns.
