CNS disorders generate a heavy and growing global burden; DALYs rose 16% from 2010 to 2019 and many conditions lack disease‑modifying treatments. Despite setbacks, fundamentals for innovation are improving—digital biomarkers, AI tools and novel trial designs are maturing. Yet digital therapeutics face barriers: unclear value propositions, regulatory hurdles, low prescriber awareness and uncertain business models. The paper forecasts modest market growth but notes pockets of rapid expansion where disease‑modifying therapies emerge. To succeed, CNS innovators must harness digital tools and evidence, prepare health systems, reassure payers, shape policy and include patients throughout development. Collaboration and patient inclusion are critical.

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