The need to consider market access for pharmaceutical investment decisions: a primer.

Biotech/Pharma investors employ valuation methods to support capital deployment that consider the costs of drug development, projected sales and risks of failure. Often, the major focus for valuation is placed on the likely success rates of taking a compound from phase I to regulatory approval, with the notion being that just by obtaining regulatory approval sales will follow. However, as exemplified by recent cases with hemophilia gene therapies, achieving forecasted sales depends not only on regulatory success but crucially on market access outcomes. This primer examines how pharmaceutical investment decisions must consider market access factors, particularly in light of recent regulatory changes such as the US Inflation Reduction Act and European Union Joint Clinical Assessment. Effective market access strategies can enhance commercial success through better pricing, broader reimbursement, and/or faster uptake, and having a clear market access plan should encourage investment by providing a clearer path to commercial success. As health technology assessment processes become more sophisticated globally, treating market access as an essential strategic capability rather than a tactical exercise will be important for attracting investment and ultimately, successful drug development and commercialization.