Brief · Use case · Innovation

Digital Therapeutics Market Landscape.

LiveLandscape

Give the board a view of the digital therapeutics market: how it is defined, how big it is by each source, who plays where and what it means for a partner.

MarketDigital therapeutics for chronic disease

GeographyUnited States and Europe

ReaderBoard of a mid-size pharma company

ExpertGlobal Market Access Director

Not askedA ranking of players

LengthComprehensive

Digital Therapeutics Market Landscape is a ready-made use case for Innovation. It ships under the Landscape template.

For corporate development and market access leads taking a market to a board. You get the picture in three sentences, the boundary and inclusion rule, every size estimate side by side, who plays where by segment and what it means for you. Figures are cited or marked as gaps.

Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.

The decision

What is the landscape of the digital therapeutics market for chronic disease in the United States and Europe, for a mid-size pharma company considering a partnership?

What is mapped

The boundary comes first. The Digital Therapeutics Alliance defines digital therapeutics as clinically evaluated software that delivers medical treatment, in three categories: to treat, manage or prevent a disease. The landscape uses that definition and says what falls outside it.

Segment or source	What it holds	What the landscape does with it
United States: FDA clearances	Software treatments cleared by FDA, which can be found by product code. For insomnia, FDA’s records show Somryst cleared on 23 March 2020 and Sleepio on 5 August 2024, both under product code QVO.^{2U.S. Food and Drug Administration. 510(k) premarket notification K191716, Somryst, Pear Therapeutics, Inc. Decision date 23 March 2020.,3U.S. Food and Drug Administration. 510(k) premarket notification K233577, Sleepio, Big Health, Inc. Decision date 5 August 2024.}	Lists each clearance with its number and date.
Germany: the DiGA directory	The statutory insurers’ report to the end of 2025 counts 58 products in the BfArM’s directory, 48 permanent and 10 provisional, with 1.6 million used and about 400 million euros of benefit expenditure. One obesity application accounted for 44.1 percent of the redeemed codes in 2025.^{4Federal Institute for Drugs and Medical Devices (BfArM). Digital Health Applications (DiGA): Interesting facts. DiGA Guide version 3.6, 10 December 2025.,5GKV-Spitzenverband. DiGA-Bericht des GKV-Spitzenverbandes 2025, report under section 33a(6) SGB V, covering 1 September 2020 to 31 December 2025.}	The BfArM’s directory and the GKV-Spitzenverband’s fifth DiGA report.
France: early access	Digital medical devices covered for one year of early access, followed by a request for permanent listing within six months for a digital therapeutic.^{6Agence du Numérique en Santé (G_NIUS). Advance Digital Care (PECAN): early access reimbursement for digital medical devices.}	The national digital health agency’s description of PECAN.

What the landscape does

The market is defined before it is sized. The landscape uses the Alliance’s definition and its three categories, and says what it excludes, for example wellness applications that make no medical claim. Commercial market-size estimates for this field differ widely because they count different things, so the landscape shows each with its definition and source and does not average them.^{1Digital Therapeutics Alliance. Understanding DTx.}

Public records first. The landscape builds the list of players from FDA records and the German directory, which are public and dated, and marks any product known only from a company announcement.^{2U.S. Food and Drug Administration. 510(k) premarket notification K191716, Somryst, Pear Therapeutics, Inc. Decision date 23 March 2020.,3U.S. Food and Drug Administration. 510(k) premarket notification K233577, Sleepio, Big Health, Inc. Decision date 5 August 2024.,4Federal Institute for Drugs and Medical Devices (BfArM). Digital Health Applications (DiGA): Interesting facts. DiGA Guide version 3.6, 10 December 2025.}

Concentration is a finding. In the German record one product accounted for 44.1 percent of redeemed activation codes in 2025, and only 14 of 74 products added over the reporting period could show a benefit at admission. The landscape reports both, notes that they come from the insurers’ association, and says what they mean for a partner.^{5GKV-Spitzenverband. DiGA-Bericht des GKV-Spitzenverbandes 2025, report under section 33a(6) SGB V, covering 1 September 2020 to 31 December 2025.}

What is shaping it. At Comprehensive length the landscape names the forces: the evidence payers require, the reimbursement route in each country, regulatory classification, and the entry of new players.^{4Federal Institute for Drugs and Medical Devices (BfArM). Digital Health Applications (DiGA): Interesting facts. DiGA Guide version 3.6, 10 December 2025.,6Agence du Numérique en Santé (G_NIUS). Advance Digital Care (PECAN): early access reimbursement for digital medical devices.}

Recommended length

Comprehensive

The forces behind the market matter to the decision. Comprehensive adds the section on what is shaping it.

You can pick another length on the form. The other two stay available.

Assumptions the landscape checks

The landscape states the assumptions its boundary and its sizes rest on, and says what each gap limits. Examples for this market:

The Alliance’s definition matches what the board means by a digital therapeutic.
The public records capture the players that matter.
The German figures, which come from the payers, are a fair guide to the market.

Standards, guidance and sources

Definition and primary records

Digital Therapeutics Alliance, Understanding DTx: definition and categories.^{1Digital Therapeutics Alliance. Understanding DTx.}
FDA 510(k) records K191716 and K233577, product code QVO.^{2U.S. Food and Drug Administration. 510(k) premarket notification K191716, Somryst, Pear Therapeutics, Inc. Decision date 23 March 2020.,3U.S. Food and Drug Administration. 510(k) premarket notification K233577, Sleepio, Big Health, Inc. Decision date 5 August 2024.}
BfArM, DiGA directory and fast-track process.^{4Federal Institute for Drugs and Medical Devices (BfArM). Digital Health Applications (DiGA): Interesting facts. DiGA Guide version 3.6, 10 December 2025.}

Market data from payers

GKV-Spitzenverband, DiGA-Bericht 2025, covering 1 September 2020 to 31 December 2025.^{5GKV-Spitzenverband. DiGA-Bericht des GKV-Spitzenverbandes 2025, report under section 33a(6) SGB V, covering 1 September 2020 to 31 December 2025.}
Agence du Numérique en Santé, Advance Digital Care (PECAN).^{6Agence du Numérique en Santé (G_NIUS). Advance Digital Care (PECAN): early access reimbursement for digital medical devices.}

The decision practice behind the memo itself is on the template page.

What gets flagged

Any size estimate that counts something different from the definition, any product known only from a company announcement, and any figure that comes from a payer body with a stated position.

What arrives

The picture in brief
Scope and boundary
The market in numbers
Who plays where
What is shaping it
What it means for us
What we could not source

What it will not do

It does not rank players or give a single market size. It shows estimates side by side with their sources, and a position on a map is labeled analyst judgment.

It is not a valuation of any player, and it does not recommend a partner.

It does not give a single market size when the sources disagree. It shows each estimate and says why they differ.

It does not rank players. A map places them on defined axes and labels the placement as judgment.

It is a snapshot of one date, from public sources. A player it could not find is listed as a gap.

References

[1] Digital Therapeutics Alliance. Understanding DTx. Read on 9 October 2026.
[2] U.S. Food and Drug Administration. 510(k) premarket notification K191716, Somryst, Pear Therapeutics, Inc. Decision date 23 March 2020. Read on 9 October 2026.
[3] U.S. Food and Drug Administration. 510(k) premarket notification K233577, Sleepio, Big Health, Inc. Decision date 5 August 2024. Read on 9 October 2026.
[4] Federal Institute for Drugs and Medical Devices (BfArM). Digital Health Applications (DiGA): Interesting facts. DiGA Guide version 3.6, 10 December 2025. Read on 9 October 2026.
[5] GKV-Spitzenverband. DiGA-Bericht des GKV-Spitzenverbandes 2025, report under section 33a(6) SGB V, covering 1 September 2020 to 31 December 2025. Figures as given in search excerpts summarizing the report; the report was not read. The association is a payer body with a stated position on the fast track.
[6] Agence du Numérique en Santé (G_NIUS). Advance Digital Care (PECAN): early access reimbursement for digital medical devices. Read on 9 October 2026.

Links checked 9 October 2026

These are the sources the template drew on. None of their authors or issuers has reviewed it.

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