A Promising Outlook for Digital Therapeutics (DTx) in Europe – how can biopharma capitalise?

The Digital Therapeutics (DTx or PDTs) market has taken large strides in the last few years, growing from infancy to a mature, well-respected older version of its predecessor, with widely developing business models and use-cases available to participate in commercial activities alongside other, more traditional pharmaceutical players. Regulators around the globe are also developing frameworks for research & development, clinical validation, as well as the general regulatory requirements needed for entering the market. ^{1, 2}

Driven by technological developments, healthcare cost pressure and consumer demand for convenience, the Digital Therapeutics (DTx, see below for a detailed overview) funding, has grown significantly over the past few years³ . Among the three continents – Asia, America and Europe, Europe is currently uniquely positioned to be a leader for DTx clear market access pathways into the public health systems with regulations currently existing in Germany, France, Belgium and recently Austria). Thanks to the regulatory pathways’ development in Europe, the above-mentioned EU markets often acts as an attractive market entry point, even for non-EU based companies.

In recent years, a lot has changed in terms of DTx regulations, adoption, and usage in Europe. In this report, we not only describe the status quo of DTx in Europe, but we also investigate – what we believe – is a promising future for DTx in Europe and what are best practices for DTx and biopharma companies in creating successful business models in DTx.

Digital therapeutics offer industry stakeholders an opportunity to craft more patient-centric approaches

DTx are patient-facing software applications designed to help patients treat, prevent, monitor and effectively self-manage a disease and those that have a proven clinical benefit. These solutions can function as standalone therapies or be prescribed in combination with medication, often leading to improved patient adherence. Digital health, digital medicine, and digital therapeutics also offer industry stakeholders an opportunity to craft more personalised experiences and new ways to become patient-centric.

Differences between digital health, digital medicine and digital therapeutics

What should life-science companies consider when developing DTx?

Biopharma companies need to assess their own capabilities very carefully and must acknowledge that DTx development requires a significantly different skillsets compared to drug development. Major considerations include the time and cost to build internal capabilities, which includes attracting the right talent vs. compromising on control regarding product features, user experience, ownership of data when partnering with a DTx developer.

State of DTx in Europe

In Europe, 2019 marked a significant milestone for digital therapeutics as they gained traction, with Germany pioneering the first regulatory pathway for DTx in Europe with many European countries following in its steps. DTx legislation is currently fragmented among European countries, therefore it is important to choose the best market access points. National regulatory differences lead to variations in which documents are submitted, which in return affects the amount of time spent preparing such documents. This has a direct impact on the evaluation time and key decisions, such as whether to follow fast-track versus standard procedures, reimbursement rates and even the likelihood of receiving reimbursement for the digital solution at all.

Summary, outlook, and invitation

In the short-term, increased complexity is to be anticipated as more countries continue to adopt regulatory frameworks for DTx. However, in the long-term, an EU-wide harmonisation could significantly accelerate DTx business models by cutting down on time-to-market and development cost by avoiding duplication. 

For broader perspective and more information please reach out to our full study on the opportunities of DTx in Europe.

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retrieved on: 25. 10. 2023.

³Digital Therapeutics – medical intervention
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⁴Life Sciences Regulation in Belgium: Overview (2023);
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⁷Price en chargé anticipée numerique (PECAN) (2023); URL: Prise en charge anticipée numérique (PECAN) | G_NIUS
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¹¹Evidence standard framework for (ESF) for
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¹²Market access pathways for digital health
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