By Christoph Eberhardt · CEO, DUX Healthcare · 19 April 2026
Anyone trying to understand the DiGA market end-2025 has to read two reports simultaneously – and recognise that both reports frame the same numbers differently. The GKV-Spitzenverband reports annually to the German Bundestag under § 33a para. 6 SGB V – as a payer that has to administer solidarity-system funds. The Spitzenverband Digitale Gesundheitsversorgung (SVDGV) has published an annual DiGA Report since 2024 – as an industry association consolidating the manufacturer perspective. Both sources are not neutral. Both sources are right where they measure. But every number in this article is attributable to one of the two sources – and the discrepancy between readings is the actual market report.
Where the market stood end-2025 – numbers in overview
Five years after the first listing (Kalmeda, 25.09.2020) the DiGA market is neither a niche experiment nor an established billion-euro market. It is an established but fragile category – and the metrics show this with unusual clarity when read with proper attribution.
The GKV-Spitzenverband DiGA-Bericht 2025 (reporting period 01.09.2020–31.12.2025, data basis: settlement data of all statutory health insurance funds) documents for the total period: 74 DiGAs were listed in the BfArM directory since the introduction of the fast-track procedure, 16 of them delisted, 58 were actively listed at 31.12.2025 – of which 48 permanently and 10 in trial. Of the 74 DiGAs only 14 (19%) could already provide a benefit demonstration at admission; the remaining 60 (81%) were initially listed for trial, 34 of which later transitioned to permanent listing – every fifth with restrictions on the original scope of services.
The SVDGV DiGA-Report 2025 (published 26.03.2026; data basis: aggregated survey at member manufacturers) confirms the same cutoff date and directory structure: 58 DiGAs listed, of which 48 permanent and 10 preliminary. The SVDGV emphasises that 34 of 50 DiGAs initially admitted for trial managed the transition to permanent listing – which by the association’s reading demonstrates the robustness of the trial model.
Identical numbers, framed differently, are the through-line of this report.
Demand and reimbursement spending – the growth decade continues
On the demand side, the GKV report 2025 speaks of 1.9M DiGAs cumulatively prescribed or approved by statutory funds by end-2025. 82% (1.6M) of these prescriptions/approvals were actually activated in the reporting period, i.e. the activation code was redeemed. Associated GKV reimbursement spending totals around €400M over the entire period per GKV-SV. In 2025 alone, around 690k DiGAs and over €170M in spending – an uptake increase of +63% over 2024.
The SVDGV report 2025 arrives at almost identical figures based on manufacturer survey: around 1.6M redeemed activation codes since introduction, of which around 690k in 2025 alone, growth +64% over 2024. The SVDGV report adds that the total figure had reached “over 1.7 million” by the report’s publication date – signalling continuing dynamics into Q1 2026.
The year-over-year series shows why 2025 is structurally significant. Per GKV report 2022, by 30.09.2022 164k DiGAs had been used, with GKV spending of €55.5M; per GKV report 2023, by 30.09.2023 cumulatively 374k DiGAs and €113M; per GKV report 2024 (cutoff switched to calendar year by DigiG) by 31.12.2024 cumulatively over 1M DiGAs prescribed/approved and €234M in spending. Uptake more than doubled from the first to the second reporting year, rose by ~85% in the third, and another 63% in 2025. Five years of double- to triple-digit increase is unusual in the German reimbursement context – and is the one number both reports read positively.
GKV vs SVDGV – how dual-attribution works
Anyone seriously running DiGA market analysis must understand the mechanics behind the two report series, otherwise they compare apples and oranges.
| Traditionelle Entwicklung | mHealth Suite | |
|---|---|---|
Consequence: Numerical agreement does not mean interpretive agreement. When both sources report 2025 growth between 63 and 64 percent, that is not harmonisation – it is that two differently motivated measurement apparatuses captured the same phenomenon. On prices, indication distribution, or market attrition, readings diverge immediately, even where raw data are partly identical.
Working principle of this report: every single figure with source name. When GKV-SV and SVDGV publish the same figure, both are named. When only one source carries a metric, this is made explicit. “The German DiGA market had around 1.6M users in 2025” is not a permitted sentence in this systematic – permitted is only “per GKV-Spitzenverband, 1.6M DiGAs were activated in the period 09/2020–12/2025; the SVDGV reports, based on manufacturer survey, around 1.6M redeemed activation codes for the same period”.
Growth curve 2022–2025 – four years of data
| Traditionelle Entwicklung | mHealth Suite | |
|---|---|---|
Three reading notes:
- Absolute numbers converge because both sources observe the same market. For 2024, GKV-SV reports 81% activation rate on 1M prescribed DiGAs – the SVDGV figure of ~870k sits in the expected corridor of the same population. For 2025, both sources land at ~1.6M.
- Directory metrics are absolutely identical. 74 listings cumulative, 58 active, 48 permanent, 10 in trial, 16 delisted at 31.12.2025 – in both reports.
- Growth interpretation already diverges. GKV report 2025 reads the doubling of demand volume in light of “structural misincentives and pricing risks … which without political corrections threaten economic and responsible care”. The SVDGV report reads the same growth as proof of the “third pillar of care alongside outpatient and inpatient care”.
Costs and pricing – what €400M really means
Pricing metrics are the sharpest interpretive divergence point between GKV-Spitzenverband and SVDGV. The hard numbers:
- Average manufacturer price at admission 2025: €544 (GKV-SV DiGA-Bericht 2025). In the first reporting year 2020/21 this value was €411 per GKV-SV; 2022/23 €557; 2023/24 €541. The trend is flat-rising, not falling.
- Average negotiated reimbursement amount 2025: €227 (40 negotiated DiGAs). 2023/24 was €226 (33 DiGAs); 2022/23 €221; 2021/22 €215. The stability of the negotiated price against a rising manufacturer price is notable – and GKV-SV-critically readable.
- Absolute price spectrum of manufacturer prices 2025 per GKV-SV: €119 to €2,077.40. One-time licences at the lower end, 90-day licences for oncology DiGAs at the upper.
- GKV startup financing (first year, no claw-back) cumulative by 31.12.2025: €56M; pre-financing from price-negotiation delay after month 13: €63M; together €119M.
The GKV report explicitly states that the gap between manufacturer and negotiated price (factor 2.4) is “a structural problem” and that the one-year free manufacturer pricing should be abolished or shortened. An explicitly political statement in the report to the Bundestag.
The SVDGV report 2025 reads the price differential as compensation for high study and certification costs in the trial phase – a model that explicitly accounts for “the high development costs, e.g. for studies and certifications” and takes place within a framework agreement co-negotiated with the GKV-SV under § 134 paras. 4–5 SGB V.
Practitioner reading: Both positions are economically coherent but they solve different problems. GKV-SV addresses solvency risk to the solidarity system (nine insolvencies, €25M endangered receivables); SVDGV addresses capital-formation risk for manufacturers (studies cost €200k to over €1M, trial-phase cash flow is central to amortisation). The politically most likely solution is a shortening of free pricing, not its abolition – combined with the 20% rule that from 01.01.2026 partly transfers the “therapeutically ineffective but expensive” risk back to the manufacturer.
What follows in 2026 – AbEM, 20% rule, expected market shift
The 2026 regulatory cadence is set by two simultaneously acting changes. First: from 01.01.2026, § 134 SGB V in connection with DiGA Guide v3.6 Sec. 6.1 requires a success-dependent price-component share of at least 20% of the reimbursement amount in the agreement. Second: the 2nd DiGAV Amendment Ordinance entered into force on 01.02.2026 per the SVDGV report 2025 and concretises stages I (usage data from 01.07.2026), II (PGI-C and patient satisfaction from 01.07.2027) and III (indication-specific PROMs from 01.07.2028) of the Application-Accompanying Success Measurement (AbEM).
The positions of both sources are – exceptionally – substantively closer than tone might suggest. Both GKV-SV and SVDGV in their 2025 reports criticise the implementation: both see disproportionate bureaucratic build-up, both criticise that the time-shifted deadlines (success-dependent price components from 01.01.2026, first AbEM data delivery to BfArM only from 15.04.2027) do not interlock sensibly. When GKV-SV and SVDGV jointly criticise a regulatory implementation, that is a strong signal.
Three market effects are likely:
- Price gap between manufacturer and negotiated price will narrow 2026/27. Not because the manufacturer price falls – it has been steadily rising over four reporting years per GKV report 2025 – but because the 20% rule effectively forces a provision for success-dependent corrections.
- New listings remain dampened. GKV report 2025 documents six new admissions in 2025 – a quarter of the high phase 2021/2023. As long as 2nd DiGAV Amendment implementation remains unfinished and the BSI TR-03161 obligation per DiGA raises the entry threshold, a return to double-digit annual new admissions is unlikely.
- Insolvency attrition will sharpen before it ebbs. Nine insolvencies by end-2025 are a systemic signal, not an outlier set. Teams whose pricing was built exclusively on the one-year free manufacturer price come under pressure once the negotiated price applies retroactively and AbEM provisions also tie up capital.
DUX position – what the dual reading implies
DUX Healthcare is not a DiGA manufacturer but a platform and development partner. Five DiGAs are currently under contract and being developed on the mHealth Suite — platform-engineered, each individually tested against BSI TR-03161, all CE-marked under MDR. At the process level, the software development lifecycle is certified under BSI TR-03185 — DUX is the first company in Germany to hold that certification.
First – market breadth obscures concentration. 58 listed DiGAs at 31.12.2025 sounds like diversity; the GKV-SV uptake distribution shows that 2025 growth is attributable to a single obesity DiGA, and that 30 mental-health DiGAs in the SVDGV catalogue share a smaller demand pie than the number suggests. For new market entrants this means: open spaces are not in mental health but in indications with few players and an unset price anchor.
Second – price discipline becomes a product attribute. The 20% rule from 01.01.2026 shifts retention, drop-out rate, and engagement from a marketing metric to a price-relevant product quality. In a platform-engineered DiGA, retention signals, module abandonment, and session lengths are part of shared infrastructure; in custom development, telemetry must be built per project. The 20% rule is therefore a structural advantage for platform-based DiGAs – not because the platform is “better” but because managing outcome signals in a shared architecture is deterministically cheaper.
Third – insolvencies are balance-sheet problems, not product problems. Nine insolvency notifications by 31.12.2025 trace overwhelmingly to one pattern: manufacturer price maximally exhausted in year one, study costs financed from cash flow, provisions for compensation payments after month 13 underestimated. Treating DiGA development as a platform investment rather than a pure product project decouples development costs from trial-phase reimbursement and buys resilience against the retroactive mechanism.
Fourth – the next reliable round of numbers comes in spring 2027. The GKV DiGA report 2026 will appear in spring 2027 and document for the first time the effect of the 20% rule on pricing. The SVDGV report 2026 will be published in parallel. Expected: converging absolute numbers (2026 → 2027 growth between +30% and +50%, materially below the five-year average), but further diverging interpretations of price discipline.
For deeper regulatory mechanics, the DiGA knowledge area is the entry point; for the reimbursement side beyond DiGA, the reimbursement paths overview; for AbEM mechanics in detail, the deep-dive AbEM – the new application-accompanying success measurement.
Frequently asked questions about the DiGA market 2026
Are the DiGA numbers from GKV-Spitzenverband and SVDGV contradictory?
No – they measure different things from different perspectives. The GKV-Spitzenverband reports under statutory obligation per § 33a para. 6 SGB V based on settlement data of all statutory health insurance funds (prescriptions plus approvals, activation rate, reimbursement spending); the SVDGV surveys activation codes directly at member companies.
Both sources are to be read with attribution: GKV-SV is payer-critical and has a political mandate to flag financial risks; SVDGV is industry-affirmative and has an industry mandate to highlight care potential. The hard individual figures sit close together for 2025 – around 1.6M activated/redeemed codes, 58 listed DiGAs, 48 permanent, 10 in trial – but interpretation and context differ systematically. Any market analysis that uses both reports as interchangeable “neutral sources” loses precisely the information that is most interesting: the interpretive disparity.
Is the DiGA market consolidating?
Partly yes, but not as classical consolidation. Per GKV report 2025, by end-2025 a total of 74 DiGAs were listed and 16 delisted – a net inventory of 58 DiGAs. Nine manufacturer companies have declared insolvency per GKV-SV, with potential receivables of over €25M endangered for delisted DiGAs alone. Growth of new directory entries declined materially in 2024/2025: per GKV report, six new DiGAs were admitted in 2025 against seven delistings.
The SVDGV reads the same numbers as stabilisation at high level with 34 of 50 successfully completed trials and a growing indication breadth across twelve categories. Both readings hold: weak products drop out, the directory stabilises around a core of permanently listed DiGAs – and the entry threshold for newcomers rises structurally with the BSI TR-03161 obligation since 01.01.2025 and AbEM implementation from 2026.
Did the DiGA market grow or stagnate in 2025?
Materially grown – on the demand side, not the supply side. Uptake rose 63 percent over 2024 per GKV-Spitzenverband 2025, cumulatively 1.6M activated DiGAs with GKV reimbursement spending of around €400M over the period 09/2020–12/2025. The SVDGV reports 64 percent growth in redeemed activation codes and around 690k codes redeemed in 2025 alone.
New directory admissions are weak by contrast: six new DiGAs in 2025 per GKV report, against seven delistings. This is not a stagnation but a redistribution signal: existing DiGAs are demanded more strongly, new providers come in more slowly. For manufacturers this means market entry in 2026 is against an already established user base – no longer against an empty market like 2021/2022.
Practitioner take