Regulatory harmonisation (WHO PQ, FDA Real-Time OTC) is compressing launch-to-launch cycles to <24 months, while tender consolidation is intensifying competitive intensity among GlaxoSmithKline, Merck, Sanofi, Serum Institute, and emerging mRNA players. Supply-chain dynamics are pivoting toward regional fill-finish hubs to mitigate stock-outs, and consumer behaviour is shifting as vaccine-hesitant parents increasingly demand single-dose, preservative-free presentations. North America retains the largest revenue share (38%) thanks to high ACIP uptake and premium pricing, whereas South-East Asia—powered by India, Indonesia, and Vietnam—is the fastest-growing region (>10% CAGR) through Gavi transitions and private-sector expansion. Strategic planners should therefore prioritise capacity localisation, differentiated clinical-value narratives, and innovative access models to capitalise on this sustained industry expansion.