TLDR: Across Europe most people with a mental health condition go untreated and waiting lists are the leading reason, while hybrid care built on digital therapeutics is emerging as the scalable response and a reimbursed market for life sciences.
The treatment gap is structural
Across EU and OECD countries about 67.5% of people with a mental health condition lack treatment coverage, and waiting lists rank as the single most cited reason for unmet care need, ahead of cost. The shortfall is structural rather than seasonal. The European Union faced an estimated shortage of around 1.2 million doctors, nurses and midwives in 2022, and the gap widens as demand rises and the workforce ages.
That framing matters for life sciences because a structural gap is a durable market. When demand outruns clinician capacity, health systems open procurement to anything that safely fills the space between referral and treatment. Digital therapeutics occupy exactly that space.
Hybrid, stepped care is the scalable answer
The workable response is hybrid, stepped care. Digital tools handle triage, continuous monitoring, and lower-intensity support, while clinicians concentrate their time on the patients who need them most. Patients move up and down care levels as standardized measures and dynamic signals indicate, from self-guided support to clinician-led intervention and crisis response, with human oversight and clear guardrails throughout.
Impact depends on integration. Pathways embed into primary-care referral, records stay interoperable through electronic health record (EHR) connections, workforce roles align, and procurement rewards outcomes over standalone tools. Each of those conditions favours vendors who bring evidence and fit existing systems, which describes a disciplined life-sciences playbook.
The same capacity gap is now reshaping care delivered at home, where an AI briefing spoken to a carer at the front door sits on a regulatory ladder of its own.
Digital therapeutics already cleared the evidence bar
The evidence question has answers. In 2022, Sleepio became the first digital therapeutic to receive NICE guidance, the United Kingdom’s cost-effectiveness standard, for insomnia. Built by Big Health on cognitive behavioural therapy for insomnia (CBT-I), Sleepio showed clinical improvement for 76% of patients in trials and reduced general-practitioner appointments and prescribing, which is the kind of system saving payers reward.
Germany turned that logic into a payment pathway. Its DiGA programme reimburses prescribed digital health applications, with mental health among the most active categories. Statutory insurers dispensed around 690,000 DiGA prescriptions in 2025 at a cost of roughly 171 million euros. Together these examples show that digital therapeutics can pass clinical scrutiny and reach reimbursement, the two gates that decide whether a product reaches patients at scale.
| Digital therapeutic | Evidence / cost-effectiveness gate | Reimbursement route | Market |
|---|---|---|---|
| Sleepio (Big Health), CBT-I for insomnia | NICE medical technologies guidance MTG70 (2022) | Recommended for use across NHS primary care | United Kingdom |
| DiGA-listed mental-health applications | BfArM fast-track assessment | Prescribed, reimbursed by statutory health insurance | Germany (~690,000 DiGA prescriptions, 2025) |
The buyers are public systems with national reach
Mental health procurement runs through national systems, which sets the rules of entry. Germany reimburses digital health applications through DiGA, and Scotland delivers digital care pathways at national scale through services such as Near Me. A product wins when it integrates into those pathways and proves cost-effectiveness on the standards those systems already use. The implication for life sciences is concrete: build for the payer and the pathway from day one.
What life-sciences and DTx teams can do
Digital therapeutics developers can build for stepped care from the start, designing products that occupy a defined level of a clinical pathway and escalate cleanly to human clinicians. Market access teams can treat NICE guidance and DiGA listing as the proof points that move a product from interesting to reimbursed. Pharmaceutical companies with mental health portfolios can pair drug therapy with validated digital support, which addresses the access gap their patients face before and between appointments. Each path treats the waiting list as a problem that evidence-backed products solve.
The hard part lives where clinical evidence, regulation, and commercial strategy meet, which is the terrain Kainjoo navigates with brands in health and life sciences. Demand for mental health care now outruns the capacity to deliver it. The companies that build evidence-backed digital care into that gap reach patients who wait today.
References
- Health at a Glance: Europe 2024 (OECD): https://www.oecd.org/en/publications/health-at-a-glance-europe-2024_b3704e14-en.html
- The health workforce crisis in the European Union (European Parliament, 2025): https://www.europarl.europa.eu/RegData/etudes/BRIE/2025/772481/ECTI_BRI(2025)772481_EN.pdf
- Sleepio becomes first digital therapeutic to receive NICE guidance (MobiHealthNews): https://www.mobihealthnews.com/news/emea/sleepio-becomes-first-digital-therapeutic-receive-nice-guidance
- Sleepio to treat insomnia and insomnia symptoms, medical technologies guidance MTG70 (NICE): https://www.nice.org.uk/guidance/mtg70
- Digital Health Applications (DiGA), Interesting facts (BfArM): https://www.bfarm.de/EN/Medical-devices/Tasks/DiGA-and-DiPA/Digital-Health-Applications/Interesting-facts/_artikel.html
- DiGA-Bericht des GKV-Spitzenverbandes 2025 (GKV-Spitzenverband): https://www.gkv-spitzenverband.de/media/dokumente/krankenversicherung_1/telematik/digitales/2025_DiGA_Bericht_GKV_SV.pdf
