This article has been developed and funded by Otsuka Pharmaceutical Europe Limited.

With the ever-increasing prominence of digital technologies in healthcare, digital therapeutics (DTx) present a novel treatment avenue across disease areas, which could support and improve existing care strategies. Today we focus our lens on the mental health care space, where DTx are already in use and having an impact.

With mental health conditions affecting one in two people by the age of 75, there is substantial need for therapeutic solutions for the one billion people living with mental health conditions globally.1,2

Social stigma remains a significant hurdle, with affected individuals often hesitating to seek medical assistance, leading to delays in diagnoses and subsequent treatment. Limited access to care and trained healthcare providers, due to lack of funding, present further barriers.1-3

Digital therapeutics (DTx) are well-positioned to address these challenges, offering clinicians a supportive addition to help treat the growing number of individuals struggling with their mental health within healthcare systems that are under increasing pressure.1,2

Continued impact

DTx are a class of software applications designed to treat or alleviate an individual’s symptoms through their smartphone or tablet. These digital interventions represent a new therapeutic modality across a range of conditions, which could complement existing approaches to care.4-6

DTx have the potential to transform the treatment of various conditions, in fact, they already do!4-5

DTx as treatments in current use come in two main types:7

  1. Computerised versions of behavioural therapies used in clinician-delivered treatment, taking some of the strain off over-burdened healthcare systems.
  2. Custom-designed software with treatments not typically provided by clinicians, such as gamification, giving patients access to novel therapies they might not otherwise receive.

DTx in mental health

DTx mental health is standardised, scalable, convenient, private and regulated. Owing to this DTx present an avenue for overcoming the access hurdles that some individuals with mental health conditions face.4,5

Standardised: Digitised therapies can provide treatment in a standardised format, which could contribute to every person receiving the same quality and level of care, with important implications for healthcare equity.5,8

Scalable: DTx are highly scalable as they are neither subject to the training timelines required to upskill clinicians nor the production limitations that exist for pills and injections.5,9

Convenient: Digital delivery means patients can access DTx when and where it is convenient to them, which may improve patient outcomes and adherence.5,10

Private: As DTx can be used outside of a doctor’s office, patients can access the care they need in the privacy of their own homes, free from concerns about perceived stigma.11

Regulated: In the European Union (EU) and the United Kingdom (UK), DTx are considered medical devices and therefore require a ‘CE mark’ or ‘UKCA mark’ to demonstrate they are compliant with relevant EU/UK regulations ensuring they are safe and perform as indicated.12-14

A new frontier

Given the challenges that people living with mental health conditions face and the substantial global impact of these conditions, there is a need for more scalable solutions that can expand access to care.2,15

Despite the extent of their potential benefits, the use of DTx in Europe is still limited and only a handful of countries have made progress in integrating them into care pathways.15 In the UK, the NHS is working collaboratively with the National Institute for Health and Care Excellence (NICE), the Medicines and Healthcare products Regulatory Agency (MHRA) and other partners to create a clear policy framework and market pathway – to scale digital health technologies in the NHS.16

As markets and legislation keep maturing, this will definitely be a market to watch.

Job code: OPE-CNS-2400002 v1.0
Date of preparation: May 2024

  1. McGrath, J, et al. Lancet Psychiatry. 2023;10:668-681.
  2. World Health Organization. (2022). World Mental Health Report: Transforming mental health for all. Available from: https://iris.who.int/bitstream/handle/10665/356119/9789240049338-eng.pdf?sequence=1 [Accessed April 2024].
  3. US Department of Health and Human Services. (2016). National Projections of Supply and Demand for Selected Behavioral Health Practitioners: 2013-2025. US Food and Drug Administration. Available from: https://www.documentcloud.org/documents/5063776-National-Projections-of-Supply-and-Demand-for [Accessed April 2024].
  4. Patel, N. & Butte, A. NPJ Digit Med. 2020;3:159.
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  8. Refolo, P., et al. Eur Rev Med Pharmacol Sci. 2022;26(18):6418-6423.
  9. Ellis, T.D. and Earhart, G.M. J Parkinsons Dis. 2021;11(S1):S95-S101.
  10. Vindigni, G. BJHMR. 2023;10(3),177-204.
  11. Huh, K.Y., et al. Healthc. Inform. Res. 2022;28(3):188–197.
  12. European Medicines Agency. (n.d.). Medical devices. Available from: https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices [Accessed April 2024].
  13. European Data Protection Supervisor. (n.d.). Digital Therapeutics (Dtx). Available from: Digital Therapeutics (DTx) | European Data Protection Supervisor (europa.eu). [Accessed April 2024].
  14. Digital Therapeutics Alliance. (2021). DTx by country: Digital Therapeutics in the United Kingdom. Available from: https://dtxalliance.org/wp-content/uploads/2021/06/DTA_DTx-Overview_UK.pdf [Accessed April 2024].
  15. EFPIA. (2023). Improving access to Digital Therapeutics in Europe. Available from: https://www.efpia.eu/media/677347/improving-access-to-digital-therapeutics-in-europe.pdf [Accessed April 2024].
  16. GOV.UK. (n.d.). Supporting innovation and adoption of technology across the NHS. Available from: https://www.gov.uk/government/speeches/supporting-innovation-and-adoption-of-technology-across-the-nhs [Accessed April 2024].