$2.6 billion per approved drug. 10–15 year timelines. Declining ROI despite increasing spend.
Eroom's Law: the number of new drugs approved per billion dollars of R&D spending has halved roughly every nine years since 1950. The pharmaceutical innovation model is becoming exponentially less productive. This is structural, not cyclical.
The model was optimized for small-molecule drugs targeting single biological pathways. Remaining disease targets are complex, multi-system, and resistant to single-molecule intervention. But the regulatory apparatus, trial infrastructure, and business model all depend on the single-molecule paradigm. Non-patentable interventions cannot navigate the approval pathway because no entity will invest $2.6B in a product it cannot exclusively own.
Traditional pharma R&D is at Phase 4. AI drug discovery and alternative evidence frameworks are the replacement vectors. Long AI drug discovery platforms.