Bioequivalence Studies: Market Size & Forecast 2026

The global bioequivalence studies market sits at approximately USD 720 million in 2025 (base year), held in a structurally tight balance between accelerating generic-drug patent cliffs, divergent regional regulatory harmonisation, and chronic capacity concentration in a small panel of global contract research organisations (CROs). Study-unit economics are anchored to site cost-per-volunteer-day and bioanalytical laboratory throughput, with regulatory complexity the single largest cost-driver differential across geographies. > **Analyst Take.** The ICH M13A biowaiver expansion is the single most under-appreciated cost lever in the category. Roughly 40-45 percent of BE studies for IR solid oral dosage forms should qualify for in-vivo waivers under M13A criteria, yet procurement teams are still contracting as if every programme requires a full crossover PK study. The right sequence is: map

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