Exclusive Summary

• 1) Plasma-derived IVIG has no composition patent or first-generic exclusivity; market entry depends on GMP and viral safety rather than IP. 2) Strong demand across Kawasaki disease, ITP, GBS and CIDP, with hundreds of thousands to over a million patients annually worldwide. 3) IVIG is guideline-endorsed as first-line or critical rescue therapy; WHO EML (complementary list) includes IVIG for Kawasaki disease, enabling public tenders. 4) Supply is periodically tight and prices are high; EP compliance, pH4 viral inactivation, reliable supply and lower tender pricing are key differentiators. 5) Complete 5% presentations (25/50/100 mL) support weight-based dosing and minimize wastage, fitting well with a Distribution model.