Life Sciences & Health Care 03.04.2026

4-minute read

423,000 prescriptions in one year, a market volume of €152 million, and 59 approved apps listed in the BfArM directory: Germany’s DiGA (Digital Health Applications) market is expanding. At the same time, ten digital health applications have already been removed from the list – including four withdrawn for economic reasons. Prescription apps are no automatic success. This article takes stock amid boom and consolidation.

From Zero to 423,000: DiGA Growth in Numbers

When Germany launched the world’s first statutory reimbursement pathway for prescription digital health applications in 2020, it was hailed as pioneering. Five years later, the figures show the model works – but more slowly than hoped.

The McKinsey eHealth Monitor 2025 documents a clear upward trend: 423,000 prescriptions in 2024 – an 85% jump over the prior year. Meanwhile, 32% of physician practices have prescribed at least one DiGA, up from 26% the year before. Total market volume reached an estimated €152 million, with an average prescription price of €361.

These numbers sound encouraging – but context matters. With over 73 million statutory health insurance beneficiaries in Germany, 423,000 prescriptions represent less than 0.6% penetration. So far, DiGAs primarily reach younger, digitally savvy patients in urban centers. Uptake remains markedly lower in rural areas and among older patients.

59 Apps, 10 Withdrawals: The Market Is Self-Correcting

The BfArM (Federal Institute for Drugs and Medical Devices) directory currently lists 59 DiGAs – 41 permanently and 18 for trial use. The most common indications are mental health conditions (depression, anxiety disorders, sleep disorders), pain, and diabetes. This reflects the market’s focus: chronic conditions with large patient populations and measurable outcomes.

At the same time, ten DiGAs have already been removed from the directory. Four manufacturers voluntarily withdrew their apps – not because the apps failed technically, but because their business models proved unsustainable. The remaining six failed to meet evidence requirements: they could not demonstrate the required positive impact on healthcare delivery during the trial phase.

For the market, this culling isn’t a sign of weakness – it signals maturity. The BfArM process functions as a filter: if an app fails to prove measurable benefit within its one-year trial period, it’s removed. This protects the system from opportunists and strengthens the long-term credibility of the remaining DiGAs.

“A DiGA is not a panacea – but it is a tool that works, provided the indication is appropriate and the evidence robust.” – BfArM Technical Information on DiGA Evaluation (2025)

Why Physicians Hesitate – and What’s Changing

Despite growth, physician reluctance remains a bottleneck. A full 68% of practices have never prescribed a DiGA. The reasons are practical: until now, prescribing has been cumbersome (paper forms, manual entry into practice management systems), evidence for individual DiGAs is often unclear, and advising patients consumes significant time.

Starting in 2026, the electronic prescription (eVO) for DiGAs will streamline the process. Instead of paper prescriptions and manual data entry, physicians will prescribe DiGAs directly via their practice management system – much like e-prescriptions for medications. The Second Amendment to the DiGAV (Digital Healthcare Act), effective since February 2026, further clarifies evidence requirements and gives manufacturers clearer guidance on clinical study design.

Equally important for adoption: medical societies are beginning to include specific DiGAs in their clinical guidelines. When a physician reads in the S3 guideline for depression that DiGA X is recommended as an adjunct to psychotherapy, the barrier to prescribing drops significantly. This process has begun – but is far from complete.

Business Models Under Pressure: What DiGA Vendors Need to Know

An average price of €361 per prescription sounds attractive – but the math is complex. Typical DiGA development costs range from €1 million to €3 million (including clinical trials, BfArM approval, and infrastructure setup). The provisional listing window lasts just 12 months – if the required healthcare benefit isn’t demonstrated by then, the app is delisted.

Prices are under pressure: after the provisional phase, statutory health insurers negotiate individual prices – typically well below the initial launch price. For vendors targeting broad indications (e.g., depression or diabetes), volume can offset shrinking margins. For niche players serving small patient groups, financial calculations quickly tighten.

For IT service providers and mid-sized healthcare companies, a strategic question arises: Is developing your own DiGA worthwhile? The answer hinges on the target indication, existing data assets, and willingness to invest 12-24 months without revenue. Alternatives include acting as a technology partner for DiGA vendors (providing backend services, cloud infrastructure, or data security), or integrating existing DiGAs into proprietary care platforms.

International Perspective: Germany as Pioneer and Testbed

Germany is the world’s first country to establish a regular, statutory reimbursement pathway for digital health applications. That makes the German DiGA market a global reference model: Belgium, France, and South Korea are closely observing it. Several European countries are developing their own versions – drawing lessons from both Germany’s successes and missteps.

For DiGA vendors with international ambitions, successful listing in the BfArM directory offers more than German market access – it serves as a quality seal that eases entry into other markets. BfArM’s evidence requirements are stricter than those in most other countries. Meeting them confers a competitive edge.

At the same time, the European Health Data Space (EHDS) is poised to reshape the DiGA landscape. Once health data becomes cross-border accessible from 2029 onward, DiGAs will be able to generate effectiveness evidence on broader, more diverse datasets. And DiGA vendors may offer their apps across the EU without undergoing separate approval procedures in each member state.

In 2026, the DiGA market stands at a turning point. The first wave of euphoria has passed; consolidation is underway; the evidence base is growing. What remains are the applications that demonstrably deliver real clinical benefit – and the companies that have built sustainable business models behind them. For mid-sized firms, opportunity lies less in building their own DiGAs and more in infrastructure: cloud services, data security, KIS (hospital information system) integration, and regulatory affairs support for DiGA startups – exactly the competencies those startups must outsource.

Frequently Asked Questions

How many DiGAs are currently available in Germany?

The BfArM directory currently lists 59 DiGAs: 41 permanently and 18 for trial use. The most common indications are mental health conditions, pain, and diabetes. Ten DiGAs have already been removed.

What is the average cost of a DiGA?

The average price in 2024 stood at €361 per prescription. After the provisional listing phase, statutory health insurers negotiate individual prices – typically below the initial launch price. Total market volume in 2024 amounted to approximately €152 million.

Why were DiGAs removed from the directory?

Of the ten removed DiGAs, four were voluntarily withdrawn by their manufacturers due to unsustainable business models. The remaining six failed to demonstrate the required positive impact on healthcare delivery during their trial phase.

What changes does the electronic prescription (eVO) introduce in 2026?

The eVO will digitize the DiGA prescribing process: instead of paper prescriptions and manual entry, physicians will prescribe DiGAs directly through their practice management systems. This aims to lower the barrier for physicians and simplify the process for patients.

Header Image Source: Pexels / Tima Miroshnichenko (px:6010865)