DiGA Review 2025: Market Growth & Regulatory Conflict

Key Facts: Figures, Data, and Sources of Studies

Boom and Budget (Sources: GKV-SV & SVDGV): By the end of 2025, the market will have recorded over 1.7 million redemptions. The year 2025 alone saw record growth of +64% (approx. 690,000 redemptions) and drove total GKV expenditures to over 400 million euros (171 million euros in 2025 alone).

The pricing dispute (Sources: DiGA Report by GKV-SV / DiGA Report by SVDGV): The health insurance association criticizes “economic support” totaling 119 million euros during the pilot year, as the manufacturers’ prices (average: 544 euros) are far above the negotiated prices (average: 227 euros). The SVDGV counters: The amounts represent legitimate compensation for immense upfront investments in clinical trials.

Patients and Trends (Sources: SVDGV / GKV-SV): DiGAs are not exclusively for young people. According to the SVDGV report, the 50- to 64-year-old age group is the largest user group, accounting for 40%. According to the GKV report, metabolic health apps (37% market share) are the primary drivers of the market, led by Oviva Direkt, which is projected to account for 44% of all redemptions in 2025.

Scientific Standard (Source: SVDGV): Despite bureaucratic hurdles (BSI certification extends approval from 3 to 9 months), approximately 70% of the apps achieve permanent listing. Currently, 8 out of 9 provisionally listed DiGAs are already demonstrating their efficacy through RCT studies (the scientific gold standard).

Strategic Pharmaceutical Factor (Source: Digital Oxygen Industry Analysis): Pharmaceutical companies (such as Bayer Vital, Pohl-Boskamp, and MEDICE) are increasingly using DiGAs for “Drug + Digital” models (blended care). The goal is to use apps to ensure adherence to traditional medications and to leverage new real-world data from the Research Data Center (FDZ).

The Numbers and Different Interpretations

With over 1.7 million uses, DiGA are viewed as an integral part of healthcare in Germany, both by the GKV-Spitzenverband (GKV-SV) and the Spitzenverband Digitale Gesundheitsversorgung (SVDGV). This is because the figures as of December 31, 2025, show significant growth: In 2025 alone, approximately 690,000 activation codes were redeemed, an increase of 64% compared to the previous year. The cost to health insurance companies: a total of over 400 million euros, with over 170 million euros in 2025.

Average manufacturer-listed prices of 544 euros contrast with negotiated prices of 227 euros. The GKV Association refers to this as “start-up financing” funded by insurance premiums and calls for an end to pilot programs that lack final proof of benefit.

The SVDGV, however, rejects this characterization as “misleading.” It emphasizes that manufacturers must comply with maximum payment limits—which the GKV-SV itself helped negotiate—from day one. Furthermore, the amounts paid are not “financing,” but rather legally legitimate compensation for services that require significant investments in clinical trials and compliance with over a dozen new regulatory requirements.

Over the entire period since the service was introduced, a total of 74 DiGAs were added to the DiGA directory; of these, 58 were still included in the GKV service catalog as of the end of 2025. Sixteen DiGAs (22%) were removed from the DiGA directory.

Evidence and Market Access

The trial year remains a key point of contention. The GKV-SV criticizes the fact that many digital health applications (DiGA) are reimbursed without having completed a proof of benefit. The SVDGV counters that systematic data analyses are already mandatory for provisional inclusion. It is noteworthy that currently, 8 out of 9 provisionally listed applications have already demonstrated their efficacy based on randomized controlled trials (RCTs), the scientific gold standard.

At the same time, increasing bureaucratic hurdles are weighing on the sector. According to manufacturers, the application process has been extended from three to as many as nine months due to complex data security requirements (BSI TR-03161). The industry warns that this could slow down digital innovation.

Marketing and Patient Autonomy

The health insurer’s report also criticizes “aggressive marketing” and “prescription services.” The SVDGV counters that lawmakers deliberately created a low-threshold access system in which a confirmed diagnosis (indication) is the decisive factor. The GKV-SV’s criticism, it argues, questionably disregards patients’ actual need for treatment and practitioners’ freedom to choose therapy.

Obesity Apps as Key Growth Drivers

One notable trend is the dominance of metabolic applications, which accounted for about 37% of usage in 2025. The Oviva Direkt app alone accounted for 44% of all redemptions in 2025.

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DiGA data recorded on a continuous basis. (Source: GKV-SV DiGA Report | Graphic: Screenshot by Hanna Sachse / PEIX)

Focus on Pharmaceuticals: Synergies and Strategic Positioning

For the pharmaceutical industry, the development of digital health applications (DiGA) is of great strategic importance, as it marks the transition from a pure product manufacturer to an integrated solutions provider.

So-called “prescription services” and marketing strategies focused on patients are viewed with particular skepticism.

Dr. Sigrid Bender and Torsten Christann of Digital Oxygen

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Classified by Bender and Christann:

This is exactly where the pharmaceutical industry comes into play. Many of the challenges facing the DiGA market mirror traditional issues in the pharmaceutical industry: generating evidence, assessing benefits, reimbursement policies, and integration into care pathways. Pharmaceutical companies have decades of experience in these areas and could become key partners for DiGA manufacturers.

Collaborations are already on the rise. Companies such as Bayer Vital are actively involved in digital therapy and care solutions; Pohl-Boskamp entered the DiGA market early on and is working on additional digital adherence approaches; and MEDICE has positioned itself as an active player in digital health through investments and platform strategies. Mid-sized pharmaceutical companies, in particular, see DiGAs as an opportunity to supplement traditional medications with digital care components.

Digital health applications (DiGA) are relevant to the pharmaceutical industry for several reasons. First, they enable closer patient monitoring between doctor’s visits and can improve adherence and treatment outcomes. Second, digital applications provide valuable real-world data on care and usage. Third, new “Drug + Digital” models are emerging in which medications and digital therapy options are designed in tandem—for example, in the treatment of obesity, mental health conditions, or chronic pain.

This is precisely where the pharmaceutical industry's new role could lie: as a bridge between innovation, evidence, and patient care.

Number of DiGAs over time. (Source: SVDGV DiGA Report | Graphic: Screenshot by Hanna Sachse / PEIX)

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DiGA: Caught in the Crossfire of Interest Groups

Six years after their market launch, digital health applications (DiGA) are now firmly established in healthcare. The GKV-Spitzenverband acknowledges this, but criticizes the costs. For the pharmaceutical industry, these applications have become an integral part of modern treatment pathways.