Strengthening the European Digital Health Ecosystem



The Digital Therapeutics (DTx) market is projected to experience significant growth over the next 5 years, thanks to sustained investment and an ever-evolving understanding of the need and the value of DTx. During DTx Europe, which took place in London June 28-29, 2022, a large community of DTx innovators debated around the current and future status of this ecosystem and how to leverage it to remove barriers to DTx adoption.

Current Status of EU Digital Therapeutics Market

The case for DTx has never been stronger, as new solutions are scoring approvals and reaching the market through multiple channels. Some of these solutions are already integrated as part of the standard of care. Compared to the United States, Europe appears as a fragmented (no single harmonized process for national body approval/ reimbursement), hard-to-crack market for DTx innovators, even with new, global regulations such as MDR (EU regulation 2017/745). Some European countries have their own (and unique) way of assessing digital health meaning the reward is lower than for bigger markets (i.e. USA).

However, the tide is turning. Carried by a sustained pipeline of innovation on the continent and continuous efforts from policy makers to align incentives, European players are progressively making dents in the global DTx space. They are also benefitting from global efforts such as DTx Alliance “DTx Value Assessment and Integration Guide”, that aims to harmonize expectations related to DTx product quality, security, clinical evaluation, as well as regulatory requirements, thus helping them overcome the “structural barrier” to scaling-up DTx in Europe.


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