Deloitte urges advanced therapy makers to adopt AI-driven digital staff to overcome operational bandwidth limits

Advanced therapy manufacturers are confronting an operational bottleneck as their pipelines expand rapidly. More than a thousand advanced therapies are in development and the U.S. patient pool is expected to rise from roughly 12,000 in 2020 to over 340,000 by 2030, creating unprecedented scale challenges.

Deloitte’s research highlights that the traditional model of adding headcount cannot keep pace with the growing complexity, especially given the high price points and thin margins of these therapies. Hiring has not up, and the economics do not justify expanding staff to fill the gap.

The firm proposes redesigning operating models around AI‑enabled “digital staff” to automate routine functions and free human talent for higher‑value work. This shift aims to sustain margins while managing the expanding geographic reach, treatment sites, and patient volumes.

If adopted, the digital‑staff approach could help manufacturers handle the projected surge in approvals-estimated at around 60 U.S. product‑indication approvals through 2030-without overburdening functional teams, thereby supporting continued growth in the advanced therapy sector.