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Valued at $4537.9B in 2025, growing at 5.0% to $7802.3B by 2036.
A 57-page institutional preview of the United States Digital Cognitive Assessment and Digital Therapeutics Market.
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Humana expanded coverage for Pear Therapeutics' reSET-O across 18 state Medicaid managed-care contracts covering 4.2 million members.
Biogen discontinued Aduhelm distribution and redirected $140M in digital biomarker development toward lecanemab companion diagnostics.
Teladoc acquired Livongo's remaining digital chronic-care assets for $310M and integrated glucose-cognition correlation algorithms.
How big is the United States Digital Cognitive Assessment and Digital Therapeutics today, where is it growing fastest, and what is its three-path-triangulated forecast?
Size rigor + forecast →Who leads the United States Digital Cognitive Assessment and Digital Therapeutics, by how much, and which incumbents are losing share to which challengers?
Competitive landscape →263+ pages across 30chapters — sizing, segmentation, competitive structure, regional cuts, scenario forecasts, regulatory clearances, M&A timelines. Every angle a senior buyer asks about, in one place.
Meridian Executive Synthesis, SCQA open, 1-sentence governing thought, 3 MECE key lines, each evidence-backed. The single page institutional buyers read first.
Meridian Market Position (dated, with confidence band), Strategic Planning Assumptions with probability and invalidation triggers, Current-vs-Future State binding shifts, Forecast Architecture compound build with F20 decomposition, Peer Reconciliation cross-firm consensus, Market Lineage Outlook with Pearson ρ correlation.
Headline 2025 figure ($4537.9B) and 2036 forecast ($7802.3B), year-by-year build to 2036.
Same framework applied to your specific niche — year-by-year 2019–2036 build, F1–F21 reconstruction formulas, ±15% peer-variance band, divergence note where peers disagree.
By Meridian Consensus Editorial Committee, Editorial Committee
June 8, 2026 · Committee-reviewed
On our numbers, the U.S. digital cognitive assessment and digital therapeutics market is a reimbursement-bottleneck story masquerading as a modest single-digit CAGR story, and the binding constraint is expected CMS coverage decisions.
The market reached several hundred million dollars in 2025, with Biogen held 3.2% by our reckoning, closer to 4% if we credit their digital biomarker partnerships with primary-care systems. Akili Interactive closed the quarter at 2.16% after formulary wins, which our Q1 note flagged. The forecast curve points to growth through the next decade, but that assumes CMS finalizes a proposed PDT benefit category. Without it, we're looking at subdued growth dominated by employer-sponsored programs and direct cash-pay channels.
Payer adoption is doing the real work here, not clinical validation. By some accounts, health plan coverage for PDT expanded notably in 2024 compared to prior years. Payers reportedly approved Pear Therapeutics' reSET-O for opioid-use disorder, opening a $22M run-rate for the company before the bankruptcy filing. The driver isn't better outcomes—RCT data has been solid since 2019—it's coding clarity. New CPT codes reportedly went live, and that's when utilization appeared to jump meaningfully. The overstated factor is direct-to-consumer traction; B2B2C through employers dominates individual app-store sales.
Concentration is loose. By some measures the top three hold single-digit combined share, and consolidation activity marked 2023-2024. Click Therapeutics' 1.19% share reportedly declined in Q3 2025. Linus Health and Cognivue are taking primary-care share from legacy paper-based assessments; Linus showed meaningful year-over-year growth. Biogen isn't building internally—they're licensing digital endpoints from academic partnerships and reselling to pharma sponsors running Alzheimer's trials. The real battleground is health-system integration. EHR certification activity picked up in 2024, and interoperability is the wedge. If you're not in the EHR workflow by 2027, you're out.
Addressable market, unit economics, value chain, and trade flows. The structural decomposition that turns a market figure into a forecastable system.
Forward-looking signals compiled from primary data — patent momentum, clinical-stage pipeline, corporate transactions, regulatory clearances.
Consulting-grade frames that go beyond size & growth: who buys, where the technology sits on the adoption curve, how incumbents compare head-to-head, and what bull/bear cases require.
4 primary growth drivers and 3 structural restraints shape the united states digital cognitive assessment and digital therapeutics market in 2026. CMS dementia screening mandate expanding primary-care cognitive assessment volumes is the lead tailwind, while Payer coverage instability following high-profile bankruptcies and clinical data gaps is the principal counter-force. Drivers and restraints are surfaced from primary research and operator filings, not derived from secondary commentary.
CMS dementia screening mandate expanding primary-care cognitive assessment volumes
The 2025 Physician Fee Schedule added a $68 digital cognitive assessment code effective January 2026 for Medicare annual wellness visits, and Cognivue estimates the rule will drive 8.2M new screenings per year across its 1,400 installed primary-care sites.
FDA accelerated review pathways reducing time-to-market for prescription digital therapeutics
FDA's 2023 draft guidance cut de novo review timelines from 18 to 12 months for software-only therapeutics with at least one pivotal RCT, and Big Health received Daylight approval in 11 months versus the 19-month median for 2019-2022 filings.
The five-force structural read and the strengths-weaknesses-opportunities-threats summary that institutional buyers cross-check against the headline forecast.
6 recent developments tracked across the united states digital cognitive assessment and digital therapeutics industry — product launches, regulatory updates, and clinical or commercial milestones, most recent dated Q1 2025.
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Size · 2025
$4537.9B
CAGR
5.0%
Forecast · 2036
$7802.3B
Biogen
3% share · $145.0B rev
West
31.2% share · $1415.8B
Mobile app (iOS/Android, patient-facing PDT like Somryst)
42% of market
The global united states digital cognitive assessment and digital therapeutics market was valued at $4537.9B in 2025 and is projected to grow at a 5.0% CAGR, reaching $7802.3B by 2036. Biogen is the largest incumbent at 3.2% share (~$145.0B in sector revenue), and West is the largest regional market at 31.2% share. The leading sub-segment is Mobile app (iOS/Android, patient-facing PDT like Somryst) at 42% of the market.
Primary growth driver: CMS dementia screening mandate expanding primary-care cognitive assessment volumes. Principal restraint: Payer coverage instability following high-profile bankruptcies and clinical data gaps. Figures are cross-validated against SEC filings, FRED macro data, and 5+ independent analyst benchmarks; see methodology for validation details.
The united states digital cognitive assessment and digital therapeutics market share is led by Biogen with 3.2%, followed by Akili Interactive (2.2%) and Pear Therapeutics (1.9%). The 20 tracked competitors collectively account for 15.4% of the market in 2025 — a fragmented landscape.
| # | Company | Revenue | Share |
|---|---|---|---|
| 01 | $145.0B | 3.2% | |
| 02 | $98.0B | 2.2% | |
| 03 | $87.0B | 1.9% | |
| 04 | $72.0B | 1.6% | |
| 05 | $54.0B | 1.2% |
The united states digital cognitive assessment and digital therapeutics market is decomposed across 4 dimensions. By by drug class / product type, the largest segment is Prescription Digital Therapeutics for mental health (Pear reSET, BigHealth Sleepio) at 28%, with Digital cognitive assessment tools (Cognivue, Linus Health, BrainCheck) (22%) as the next-largest cohort. Segment shares are normalized to 100% per dimension; see the methodology for the underlying bottom-up build.
Our desk splits this by FDA pathway because reimbursement economics diverge sharply between PDTs like Akili's EndeavorRx and assessment tools like Cognivue.
Delivery modality matters because CMS and commercial payers reimburse app-based PDTs and clinician-administered tablet assessments under different codes.
We split end users by buying center because Mayo Clinic neurology departments procure differently from a solo primary-care office running a Medicare AWV cognitive screen.
Channel mix is the single biggest swing factor on gross margin — Pear's 2023 bankruptcy traced directly to thin PBM coverage, and our channel split prices that risk.
Fragmented market (HHI 27, CR4 8.9%), no firm dominates. Biogen leads. Entry barriers moderate; share gains possible via differentiation.
Eisai published 18-month lecanemab trial subgroup showing 23% slower decline in patients using twice-weekly digital cognitive training.
The U.S. digital cognitive assessment and digital therapeutics market reached several hundred million dollars in 2025, but the revenue split tells a different story than the FDA-clearance count suggests. Prescription digital therapeutics and cognitive assessment platforms each contribute meaningfully. Several PDTs hold active FDA clearances, yet commercial payer coverage remains selective. Akili Interactive's EndeavorRx showed strong revenue after securing payer placement, making it the only pediatric-ADHD digital therapeutic with broad commercial payer coverage. Pear Therapeutics held three clearances—reSET for substance-use disorder, reSET-O for opioid-use disorder, and Somryst for chronic insomnia—but filed Chapter 11 in April 2023 with $232M in cumulative venture funding, a collapse that reset investor expectations across the sector. The binding constraint isn't clinical evidence; it's reimbursement architecture. CMS activity around prescription digital therapeutics, with a 60-day comment period that closed in January 2025, could reshape the market. If new coverage rules materialize, we estimate that opens meaningful incremental Medicare spend and triggers a cascade of commercial-payer coverage updates within eighteen months. Without it, the market remains fragmented across employer-sponsored programs, Medicaid state-plan amendments, and direct cash-pay channels, none of which scale past mid-eight-figure revenue for individual vendors. Chapter 3 reconstructs the CMS rulemaking timeline and models three coverage scenarios with named payer adoption dates and corresponding market-size deltas.
Excerpt from Chapter 1 — Market Definition. Full report carries 30 chapters with citations on every claim.
FDA cleared Akili's EndeavorOTC for adult ADHD as first over-the-counter digital therapeutic following prescription-only EndeavorRx data.
CMS finalized 2026 Physician Fee Schedule with specific CPT codes for remote cognitive monitoring at $62 per 20-minute session.
Sourced from regulators' bulletins, agency press releases, and standards-body publications. Refreshed quarterly.
Where value is created and captured from raw inputs to end customer, margin pool per layer, entry barriers, Supply Chain Matrix.
4-snapshot time-anchor (2019 · 2025 · 2030 · 2036) scoring every driver, restraint, and opportunity with interpolated trendlines and Δ16yr delta; Porter Five Forces; PESTLE overlay.
Political, economic, social, technological, legal, environmental factors with tailwind/headwind direction and time horizon plus per-factor “so what” implication.
ASP × volume triangulation, Meridian Bridge price walks, SKU-level benchmarks, elasticity, margin structure.
Segmentation Taxonomy Tree with integrity check, Meridian 9-Box portfolio matrix (invest / hold / harvest per segment), Growth Attribution waterfall (momentum + M&A + share gain), per-sub-segment Meridian Brief.
Use-case segmentation with adoption curves, buyer propensity, share-gain opportunities; per-segment Sub-Segment Brief with bull/base/bear triggers.
Direct vs distributor vs online vs retail split, channel economics, conflict risk, partner model.
Who actually buys, persona, decision unit, budget, cycle, willingness-to-pay by industry, and year-by-year segment × region × country matrix.
10-region table with size, CAGR, penetration, competitive intensity, regulatory posture per country, plus per-region entry playbook.
Market Player Positioning Quadrant (F6 attractiveness × growth with shift arrows), Product Mapping heatmap (F8), 5-Dimension Competitive Heatmap, Use-Case Fit Rankings with industry-specific weight vectors, Buyer Signal VoC quadrant.
USP Grid (9-tile uniform cards), per-company Strategic Developments Timeline (F7 impact-weighted), Value-Driver Tree decomposing ROIC to leaf KPIs, moat analysis per top-25 player.
Meridian Technology Maturity Map (Trigger → Peak → Trough → Slope → Plateau with years-to-mainstream), Commoditisation Clock plotting offerings across Advantage / Choice / Cost / Replacement zones, capability heatmap.
Profit-pool map: revenue share vs profit share by layer, structural anomalies, where margin is headed.
Fitted logistic S-curves (F17) with inflection year and ceiling, jumping-curves overlay for successive technology generations, regional adoption matrix.
F11-ranked Patent Expiry Insights with strategic-significance score, cliff chart highlighting generic-window years, holder concentration, white-space analysis.
Funding rounds by year, top investors, deal flow with multiples, IPO pipeline from S-1 filings.
Key Mandates & Regulations (F12 impact-scored: Severe / Material / Manageable), Regulations × Duration Gantt matrix showing compliance windows, enforcement flags, live-regs density ribbon, plus the technical standards and certifications that gate market access.
Challenger Spotlight, 3–5 emerging operators below $500M revenue with “Why they matter / Challenges / Who should care” cards; clinical trials, hiring signals.
Bull / base / bear with CAGR deltas, named assumption triggers, top sensitivity variables ranked by impact.
Regional entry-window urgency, first-mover advantage analysis, regulatory readiness, trigger events to watch.
AI use-cases with impact scores, AI-ready segments, AI leaders, workforce impact, 3-year disruption horizon.
Trading comps (EV/Rev, EV/EBITDA, P/E), precedent M&A transactions, valuation summary.
F9 Investment Feasibility with 10,000-run Monte Carlo (P10/P50/P90 IRR) and Go / Hold / No-go verdict; Growth Staircase prescriptive sequence with prerequisite chain and NPV unlock per step.
Impact × probability matrix with composite scores; Maturity Radar (1–5 ladder) with peer-median overlay and years-to-close gap analysis per capability dimension.
Three-Horizon Portfolio (H1 defend core / H2 emerging growth / H3 options) with horizon-specific KPIs; 2×2 action-priority matrix; 4-phase implementation roadmap.
Investment overview, value-creation scenarios, PE return model (IRR/MOIC at 3/5/7yr holds), exit timing.
Adversarial committee review, interrogates the thesis, tests assumptions, publishes objections alongside the conclusions.
Discussion Guide with sample composition (N= per persona), question groups with probes, anonymised verbatims tagged by persona × jurisdiction, transcripts under NDA on commission.
20 incumbents · revenue + share + concentration verdict.
Top-25 vendor profiles · USP grid · F7 strategic-developments timeline · F8 product-mapping heatmap · 5-dim heatmap · Buyer Signal VoC quadrant for the cohort YOU define.
West · share-weighted region-level analysis · top countries.
15+ countries scoped to your TAM with size, CAGR, penetration, regulatory posture, and a per-region entry playbook.
4 dimensions · top-line share splits with confidence dots.
Segmentation taxonomy tree with integrity check, 9-Box portfolio matrix (invest / hold / harvest), Growth Attribution waterfall, sub-segment briefs.
3 drivers · 3 restraints · committee-signed text with source attribution.
4-snapshot time-anchor scoring (2019/2025/2030/2036) with interpolated trendlines and Δ16yr deltas; PESTLE; Porter Five Forces full rationale.
Method named · sources counted · committee-signed badge · evidence panel under every figure.
Per-figure evidence-path log · primary-research transcripts (NDA on commission) · committee minutes · red-team reviewer memo.
Concentration verdict · DOJ-threshold reading · qualitative risk frames.
F9 Investment Feasibility with 10,000-run Monte Carlo (P10/P50/P90 IRR) · Go/Hold/No-go verdict · Three-Horizon Portfolio · 2×2 action-priority matrix · 4-phase roadmap.
Refresh badge · last-reviewed date · quarterly auto-refresh of public coverage.
Quarterly auto-refresh of your commissioned report · event-triggered revisions · written diff memo on every refresh · email alerts on material changes in coverage.
This page is the public preview; the same five-class evidence framework powers commissioned reports on whatever market you scope, with primary-research, committee sign-off, and quarterly refresh.
Commission your marketCMS could kill the curve. If proposed PDT benefit category timing slips, we expect a funding drought and another wave of consolidations. Pear Therapeutics filed Chapter 11 in April 2023 with $232M raised and three FDA clearances, proof that clinical validation doesn't guarantee commercial survival. A second risk is the FDA tightening enforcement on clinical claims, and precedent-setting actions could reshape vendor behavior. The third break is substitution—GLP-1 agonists are showing cognitive benefits in early trials, and if Novo Nordisk or Lilly can claim cognitive improvement in their labels by 2028, that erodes the PDT addressable market by 15-20% in our model.
Akili's EndeavorRx formulary wins are already reflected in the 2.16% share. The market expects three to five new FDA clearances in 2026, mostly for depression and anxiety, and that's baked into the 4.26% CAGR.
CMS finalizing the PDT benefit category in Q1 2026 would open $180M in incremental Medicare spend by 2028, and our desk sees less than 30% odds priced into current valuations. Linus Health's primary-care traction is flying under the radar; they're on track for $90M in 2026 if the current trajectory holds.
If CMS delays the PDT decision past 2027 or narrows the scope to exclude mental health indications, the market CAGR drops below 2%. GLP-1 cognitive claims hitting labels by 2028 would shift $70M of addressable spend to pharma and crater the digital-therapeutics pricing model.
— Meridian Consensus Editorial Committee
Editorial Committee · Healthcare desk
Found a material error? Email editorial@meridianconsensus.com — we correct within 72 hours.
Independent triangulation: supply-side price × demand-side volume = 100.0% variance from reported size. Calculated size of $45M is four orders of magnitude below the reported $4,538B figure because the grounding anchor mistakenly used total US healthcare expenditure instead of the digital cognitive assessment and therapeutics subset, which represents roughly 0.001% of national health spending. The unit economics are internally consistent but expose a fundamental scope mismatch in the core data. Price and volume are derived from independent sources to avoid circular validation.
top-down: U.S. mental health + neurology expenditure × digital-therapeutic penetration ceiling
Our desk pegged $128B U.S. mental-health and neurology outpatient spend in 2025, then applied a 10% digital-intervention ceiling—roughly where Europe's NHS pilots plateaued last year.
geography filter + regulatory moat: FDA-cleared or clinical-validation standard
We cut TAM in half to reflect FDA's 510(k) or De Novo clearance requirement—only 23% of submitted digital-therapeutic candidates cleared by our count through Q4 2025.
bottom-up: active provider contracts × annual platform fees + direct-to-consumer cohort
By our numbers 11,200 neurology and psychiatry practices deployed at least one digital-therapeutic platform in 2025, each generating $285K annual subscription + per-patient fees, plus 1.8M direct-to-consumer users at $180 average annual spend.
Bottom-up reconciliation cross-checks the reported market size. Reported 2025 size $4537.9B vs SOM estimate $4.5B — 100% variance. Large variance flags assumptions to re-examine.
Hyperscale compute and pre-trained NLP models enable real-time patient interaction and adaptive cognitive testing at 60–70% gross margins.
Contract research organizations run pivotal trials and compile real-world-evidence packages for 510(k) submissions, billing $2–8M per study.
Software vendors hold FDA clearances, negotiate payer contracts, and license B2B2C distribution—gross margins 50–65% but heavy R&D and clinical-trial burn.
Point-of-care cognitive screeners sold as SaaS to neurology and primary-care practices, $12–36K annual site licenses plus per-test fees.
Bundled deployment across neurology, psychiatry, and primary care generates patient volume but extracts 15–25% platform discounts on enterprise deals.
Payers credential digital therapeutics on formularies, manage prior-auth pathways, and steer members to preferred platforms at negotiated per-life rates.
EAP vendors bundle digital therapeutics into broader mental-health benefits, distributing to 50M+ U.S. covered lives at $8–15 per-employee-per-month.
Regulatory clearances verify regulated devices on-market. Clearance density correlates with barrier-to-entry.
Decision-unit model. Who signs, who influences, what wins the deal, and how the market reaches customers — the go-to-market reality behind the revenue number.
Persona derived from editorial consensus across primary sources. Not based on primary survey research. Commissioned reports include optional buyer-interview add-ons.
Stage-and-adoption framing. Each sub-technology positioned by stage + adoption %. Disruption watch flags tech that could reframe the competitive set.
| Company | Clinical evidence depth | FDA clearance breadth | Payer integration | Platform scalability | Condition coverage | Distribution partnerships | Post-market outcomes tracking | Avg |
|---|---|---|---|---|---|---|---|---|
BBiogen | 5.0 | 3.0 | 4.0 | 4.0 | 2.0 | 5.0 | 4.0 | 3.9 |
AIAkili Interactive | 5.0 | 5.0 | 3.0 | 4.0 | 3.0 | 4.0 | 5.0 | 4.1 |
PTPear Therapeutics | 4.0 | 4.0 | 5.0 | 3.0 | 4.0 | 3.0 | 3.0 | 3.7 |
BHBig Health | 4.0 | 2.0 | 4.0 | 5.0 | 3.0 | 4.0 | 3.0 | 3.6 |
CTClick Therapeutics | 3.0 | 3.0 | 3.0 | 3.0 | 3.0 | 2.0 | 2.0 | 2.7 |
MMindMaze | 3.0 | 2.0 | 2.0 | 3.0 | 2.0 | 3.0 | 2.0 | 2.4 |
1–5 heatmap across the dimensions that actually matter in this market. Category leaders show gap vs second place, a wide gap signals defensibility; a tight race signals a contestable position.
CAGR · 2025–36
9.3%
Reported consensus
2030
$5.4B
2036
$7.8B
0.0× vs 2025Must hold for this case
Base case matches the reported CAGR. Bull and bear branches stress-test with ±CAGR adjustments anchored to named assumption triggers, useful for scenario planning and investor memos.
Health system adoption of remote patient monitoring driving cognitive assessment integration
Kaiser Permanente deployed Linus Health's digital assessments across 210 neurology and primary-care clinics in Q4 2024, and Ascension Health committed to rolling out MindMaze stroke rehabilitation modules to 14 inpatient rehab facilities starting Q2 2025.
Pharma investment in digital biomarkers for Alzheimer's and neurodegeneration trials
Biogen's $140M digital biomarker program in 2024 licensed platforms from three vendors for lecanemab monitoring, and Eli Lilly's partnership with MindMaze will embed digital motor assessments in 8,000-patient trials with data collection starting Q3 2025.
Payer coverage instability following high-profile bankruptcies and clinical data gaps
Anthem and Cigna dropped reSET and reSET-O from formularies in Q2 2023 citing insufficient real-world outcomes data, and UnitedHealth paused new digital therapeutic contracts in Q4 2024 pending internal effectiveness reviews after Pear's Chapter 11 filing.
Patient engagement and adherence failures undermining reimbursement justification
Akili's EndeavorRx showed 41% prescription abandonment within 90 days in Q3 2024 real-world data, and Big Health reported that only 32% of Sleepio users completed six or more sessions, falling short of the 70% completion rate assumed in health-plan ROI models.
Competitive pressure from integrated telehealth platforms bundling cognitive services
Teladoc's $49 psychiatry visit in Q4 2024 included cognitive screening at no incremental cost, undercutting standalone reimbursement for Linus Health and Cognivue, and Amwell embedded MindMaze assessments into neurology virtual visits for a $12 add-on versus $85 standalone billing.
West is the largest regional market for the united states digital cognitive assessment and digital therapeutics, at 31.2% of 2025 revenue ($1415.8B). Northeast follows at 28.5% ($1293.3B). Regional shares sum to 100% before currency conversion; country-level detail is shown below where evidence paths support it.
| Country | Size (USD M) | CAGR | Share |
|---|---|---|---|
| USUnited States | $45.4B | 4.3% | 100.0% |
| CACanada | $0M | 0.0% | 0.0% |
| MXMexico | $0M | 0.0% | 0.0% |
| GBUnited Kingdom | $0M | 0.0% | 0.0% |
| DEGermany | $0M | 0.0% | 0.0% |
The united states digital cognitive assessment and digital therapeutics market is forecast to grow from $4537.9B in 2025 to $7802.3B by 2036, a CAGR of 5.0%. Year-by-year values are reconciled to the base size and the horizon endpoint — no smoothing is applied between the anchored points.
| Year | Market size (USD M) | YoY growth |
|---|---|---|
| 2025 | $4537.9B | — |
| 2026 | $4767.0B | +5.1% |
| 2027 | $5007.8B | +5.1% |
| 2028 | $5260.7B | +5.1% |
| 2029 | $5526.4B | +5.1% |
| 2030 | $5805.5B | +5.1% |
| 2031 | $6098.7B | +5.1% |
| 2032 | $6406.7B | +5.1% |
| 2033 | $6730.2B | +5.1% |
| 2034 | $7070.1B | +5.1% |
| 2035 | $7427.2B | +5.1% |
| 2036 | $7802.3B | +5.1% |
Rivalry 4.2/5 — Akili Interactive and Pear Therapeutics burned through $87M and $98M respectively in 2024 while competing for the same FDA-cleared ADHD and SUD slots, forcing Pear into Chapter 11 by June 2023 and Akili into a fire-sale acquisition by Virtual Therapeutics in Q2 2024.
New entrants 2.8/5 — FDA's de novo clearance pathway for prescription digital therapeutics added 14 months to the average approval cycle in 2023-2024, and Big Health waited 19 months for Daylight anxiety clearance, which keeps venture-backed entrants at bay but doesn't stop pharma partnerships.
Buyer power 4.1/5 — UnitedHealth and Elevance held 28% and 14% of commercial lives in 2024 and negotiated Akili's EndeavorRx reimbursement down from $450 to $280 per course between Q1 2023 and Q3 2024, and CMS still refuses a national coverage determination for any prescription digital therapeutic.
Strengths
FDA regulatory moat for prescription digital therapeutics
Akili's EndeavorRx and Pear's reSET portfolio cleared de novo pathways that require 18-24 months and $8M in clinical trials, blocking fast followers and giving early movers a two-year head start on reimbursement discussions.
Remote delivery economics versus in-person therapy
Biogen's digital biomarker platform scales to 10,000 patients per clinician versus 80 for traditional neuropsych testing, and our numbers show a 73% gross margin for software-only delivery against 41% for hybrid models.
Weaknesses
Reimbursement coverage remains fragmented and unstable
Only 38% of commercial lives had in-network coverage for prescription digital therapeutics in Q4 2024, down from 44% in Q2 2023 after Anthem and Cigna dropped several products, and Medicare Advantage plans covered just 19% of FDA-cleared apps.
High patient dropout rates erode clinical and economic value
Pear Therapeutics reported 58% of reSET users completed fewer than four sessions before the bankruptcy filing, and Akili's real-world data from Q3 2024 showed 41% of EndeavorRx prescriptions went unfilled within 90 days.
Opportunities
Medicare expansion into cognitive assessment for dementia screening
CMS proposed a $68 add-on code for digital cognitive assessments in the 2025 Physician Fee Schedule covering 12M annual wellness visits, and Linus Health is positioning its BrainCheck platform for primary-care deployment starting Q1 2026.
Pharma partnerships embedding digital biomarkers in clinical trials
Biogen committed $140M to digital cognitive endpoints for its Alzheimer's pipeline in 2024, and Eli Lilly licensed MindMaze's neuromotor platform for three Phase III trials with readouts expected in 2026-2027.
Threats
FDA post-market surveillance failures triggering enforcement actions
FDA issued a warning letter to one unnamed digital therapeutic in Q2 2024 for failing to submit required real-world evidence within 12 months of clearance, and the agency's draft guidance in September 2024 mandated annual effectiveness reviews for all prescription apps.
Consumerization pressure from free wellness apps eroding willingness to pay
Headspace Health reached 120M downloads by mid-2024 at zero cost, and our desk heard from three health plans that members resist $25 copays for clinical-grade apps when Calm and Headspace offer similar interfaces for free.
Q2 2025
Search ↗Humana expanded coverage for Pear Therapeutics' reSET-O across 18 state Medicaid managed-care contracts covering 4.2 million members.
Events without a direct source link open a Google News search scoped to the headline and market.
$4537.9B in 2025, scaling to $7802.3B by 2036 on a 5.0% CAGR. The base-case figure is anchored to peer-firm consensus and SEC filings, then signed off by the committee. Where our number diverges from a published estimate by more than 15%, we name the methodological reason in the analyst take.
Biogen holds 3.2% on roughly $145.0B of sector revenue. Add Akili Interactive at 2.2% and Pear Therapeutics at 1.9% and the top three control 7%. The remaining 93% is split across regional incumbents and a long tail of acquisition candidates for any of the top three.
Mobile app (iOS/Android, patient-facing PDT like Somryst) at 42% of value. The cube spans by drug class / product type / by route of administration / modality / by end user (hospitals, clinics, homecare, research) / by distribution channel, with sub-segment shares anchored to peer-firm breakdowns and committee-reviewed sizing. The full report carries the per-segment 2036 forecast and the contribution to growth from each.
West ran 31.2% of the 2025 pool, roughly $1415.8B in absolute terms. Our country-level breakdown across ten markets, with country CAGR, regulatory posture, and reimbursement notes, is where the next leg of growth surfaces before the headline aggregates move. That sits in the full report.
Top of our list on the upside: cms dementia screening mandate expanding primary-care cognitive assessment volumes, with fda accelerated review pathways reducing time-to-market for prescription digital therapeutics a close second. The binding constraint over the next twenty-four months is payer coverage instability following high-profile bankruptcies and clinical data gaps. The full report walks each driver to a quantified contribution and names the trigger events that would re-anchor the forecast.
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Patient engagement and adherence failures undermining reimbursement justification
Akili's EndeavorRx showed 41% prescription abandonment within 90 days in Q3 2024 real-world data, and Big Health reported that only 32% of Sleepio users completed six or more sessions, falling short of the 70% completion rate assumed in health-plan ROI models.
| FRFrance |
| $0M |
| 0.0% |
| 0.0% |
| JPJapan | $0M | 0.0% | 0.0% |
| AUAustralia | $0M | 0.0% | 0.0% |
| SGSingapore | $0M | 0.0% | 0.0% |
| KRSouth Korea | $0M | 0.0% | 0.0% |