The DiGA Fast Track provides both a reimbursement model and quality stamp for digital health solutions looking to enter the German market. However, download rates of recently approved solutions show that listing as DiGA alone does not ensure a high adoption rate. Companies will therefore have to develop a comprehensive market entry strategy and select appropriate distribution channel to achieve higher outreach among HCPs and patients.
As the largest economy in Europe with an extensive healthcare system, Germany has long seemed like an attractive market for digital health start-ups around the world. There are 105 public health insurance companies that cater to 75 million people, which is almost 90% of the total population. The rest of the population is divided up among more than 40 private insurance companies. Germany spends about 12% of its total GDP on healthcare expenditures, reaching 410.8 billion Euros in 2019, or about 5,000 Euros per inhabitant.
While the market potential has always been significant, restrictive regulations and a rigid system meant that many companies attempting to launch innovative products either moved out or failed altogether. This prompted the German Federal Parliament to pass the Digital Healthcare Act (DVG) in 2019. The new law allows low-risk digital health applications (class I or IIa) to be prescribed by either a physician or psychotherapist and reimbursed by statutory health insurance via the process called the DiGA Fast Track.
As of now, 68 solutions have been submitted for DiGA status to the BfARM. From them 12 have been approved, most of which focus on mental health. Only 2 applications have been rejected so far, while the rest remain under review.
In addition, apps which have been listed as DiGA show an immediate increase in downloads after DiGA listing. However, this growth does not appear to be sustained in the mid-term. One reason for that is the expected slow adoption among HCPs, who must incorporate digital health solutions into their daily routines.
Thus, it is clear that achieving this regulatory approval is just one possible first step in entering the complex German market. As foreign investors and companies turn their sight towards Germany, they must address a set of challenges relevant to the German market to make a successful entry.
The new white paper “DiGA in Germany: Entering the German market with a digital health solution” from R2G outlines the challenges and possible entry strategies for digital health solutions in light of the new DiGA process.
One area where companies should work is selecting the appropriate channel or channel combinations. In that regard there are several both innovative and traditional options they can select from, some of which are described below.
(A detailed description of the distribution channels is available in the “DiGA in Germany” white paper)
DiGA is surely a great opportunity for digital health providers aiming to enter the German market, as it provides both a reimbursement model and a quality stamp. However, it alone cannot determine whether a solution will be successful. Companies must make sure that they take all the necessary strategic steps to achieve sufficient outreach to doctors and patients. Only then will they see higher adoption of their solutions.
At Research2Guidance, we provide high-quality, informed market research and strategy consulting from our headquarters in Berlin, Germany. Specializing in only digital health, we have assisted clients from large pharmaceutical companies to small service providers in shaping their go-to-market strategy both in Germany and beyond.
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