OS Therapies Incorporated

DelveInsight forecasts that the osteosarcoma market across the seven major markets—the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan—will grow at a CAGR of 9% from approximately USD 60 million in 2025 through 2036, driven by eight emerging therapies including OST-HER2, DANYELZA, Vactosertib, and Risvutatug rezetecan. OST-HER2, developed by OS Therapies, is a HER2-targeted immunotherapy that has received FDA Fast Track and Orphan Drug Designations, with a planned Biologics License Application under the Accelerated Approval pathway in the second half of 2026, and is projected to generate about USD 37 million across the 7MM by 2036. Other notable candidates include SERB Pharmaceutical's DANYELZA, an anti-GD2 antibody with a niche profile, and GSK's Risvutatug rezetecan, an ADC targeting B7-H3 that received Breakthrough Therapy Designation in 2025. The pipeline remains concentrated in early-stage trials, with limited late-stage data posing challenges for regulatory approval, but increasing research in targeted and immunotherapies is expanding the landscape.