Digital therapeutics (DTx) are software-based products for the prevention, management and treatment of health conditions. They are defined by the Digital Therapeutic Alliance as evidence-based therapeutic interventions that are driven by high-quality software programs to prevent, manage or treat a medical disorder or disease.1 Digital therapeutics are a subcategory of digital medicine products, which in turn are a subset of digital health (see Figure 1 for definitions). A feature of DTx is that they require both clinical evidence and evidence from real-world outcomes. As such, they need to be reviewed and approved by regulatory bodies for claims of safety, risk and efficacy.
"A lot of people have doubts that software can have such an impact, but it is astonishing to see the results of digital therapeutic interventions in randomised controlled clinical trials”
DTx products may be used as a standalone alternative to pharmacological interventions (monotherapy). Alternatively they may be used to augment or complement medication, devices or other treatments for improving health outcomes.
Digital therapeutics are developed for a variety of indications, particularly chronic diseases like diabetes, respiratory diseases and mental health disorders, where traditional pharmacological therapies cannot fill the gap in unmet needs and behavioural change is required for end-to-end disease management.
According to a recent Deloitte report, digital therapeutics are one of five forcesithat will have a disruptive impact on the future of biopharmaceutical companies and the patients they serve.2 They are increasingly effective and scalable non-pharmaceutical (digital) interventions – including those focused on behaviour modifications – that might also reduce or even eliminate the demand for medications. According to our 2025 predictions for the future of the healthcare and life sciences sector, medicine will undergo a paradigm shift from healthcare to holistic health, and clinicians will base their diagnoses and treatment decisions on predictive, preventative, personalised and participatory care (4Ps). This shift, towards prevention and well- being replacing or complementing traditional care in healthcare facilities, will be driven by technological and scientific advancements which include digital therapeutics, epigenetics and artificial intelligence (AI).3