Exclusive Summary

• - Patent barriers largely cleared: core protection expired around 2020 in US/EU, enabling broad global entry.
• - Steady demand anchored in HCC: ~0.9M liver cancer cases/year with high systemic-therapy need in LMICs suits a low-cost oral TKI.
• - Clear therapeutic role: not first-line in many guidelines, but still recommended when IO/VEGF combos are inaccessible or contraindicated and for RAI-refractory DTC.
• - Crowded market but room to differentiate: multiple generics since 2020; EU-GMP/FDA, Zone IVb stability and reliable supply can win tenders in emerging markets.
• - Strong cost advantage: 70–95% discount to originator supports access-driven tenders and out-of-pocket markets.