Your drug doesn't need to be first in class to win.
… But it does need to be smarter.
In crowded therapeutic areas, teams sometimes panic when competitors announce similar mechanisms. They assume the race is over.
Here's what they're missing: A precise biomarker strategy can transform a me-too molecule into a best-in-class opportunity.
Take the PD-1/PD-L1 space. When Pembrolizumab entered, it wasn't first. But Merck's decision to stratify by PD-L1 expression changed everything.
While competitors chased broad populations with modest response rates, Pembrolizumab identified the patients who actually responded—transforming overall response in the right population.
The result? A $20+ billion blockbuster that outpaced earlier entrants.
The lesson: Precision beats speed.
Your biomarker strategy can:
→ Identify the subset where your drug truly shines
→ Enable smaller, faster trials with stronger signals
→ Create a differentiated clinical story that matters to regulators and investors
→ Provide rationale to expand into other indications
Even in saturated markets, there's room for the smartest player.
Your drug doesn't need to be first—but it can be smartest. Biomarkers can help.
Is your team thinking about differentiation, or just trying to keep up?