Personalized medicine of the "the right drug for the right patient at the right time" ethos may help patients, but Forbes' Henry Miller writes that it might not be right for drug companies.
"[W]hen drugs are ultimately approved based on the use of biomarkers, the description of the medication’s approved uses on the label might be narrower, or more restrictive, thereby reducing the size of the patient population for whom the drug is intended — and the revenue potential," he says.
Additionally, Miller writes that regulatory burden may become difficult to shoulder, as drugmakers will need more focused clinical trials to show efficacy and larger studies to prove safety.
That in combination with the time and resources needed to uncover biomarkers and develop them into a diagnostic test or clinical algorithm to accompany the drug "could impose huge development costs that might never be recovered by the manufacturers."