Recombinant human serum albumin (rHSA)
Recombinant human serum albumin (rHSA) replaces plasma-derived HSA (pHSA) — constrained by donor blood supply and viral contamination risk since the 1940s — with biosynthetic production in yeast (Pichia pastoris, Hansenula polymorpha) or plant (rice endosperm) hosts: Healthgen Biotech's OsrHSA (奥福民®) became the world's first NMPA-approved rHSA injection (July 2025) with 1-million-vial annual capacity and a 22-centre Phase III in decompensated liver cirrhosis; InVitria's Exbumin (rice-derived, ExpressTec platform) is the excipient in Merck's ERVEBO Ebola vaccine — the first FDA/EMA/PMDA-approved rice rHSA in an injectable — and Optibumin 25 (launched April 2025) is the first recombinant 25% HSA for closed-system biomanufacturing; Proliant launched AlbufreeDX (June 24, 2026) for diagnostics; Basic Pharma (NL) + ARTES Biotechnology (DE) make Hansenula polymorpha rHSA; Shilpa Medicare's sRbumin® became India's first rHA Phase 1 completion (August 2024), with CDSCO Phase III nod (November 2024) and an Orion Europe commercialization deal. The global rHSA market stood at USD 166M in 2025, projected to USD 421M by 2035 (CAGR 9.75%).
specialty-fine-chem
15 min