Intravenous Immunoglobulin Market Outlook

Regulatory:

• Japanese Ministry of Health, Labour and Welfare approvals for Kenketsu GLOVENIN-I liquid IVIG and HYQVIA fSCIG.

2. GC Biopharma (Green Cross Corporation)

Product / Drug Candidate:

• Plasma-derived IVIG • Plasma Proteins developed as biologic therapies (e.g., IVIG products) — specific clinical registry entries historically include Green Cross IVIG formulations.

Clinical Trial Phases & Registry IDs:

• Phase 3:
• • An Open Phase 3 Study of IV-Globulin SN Inj.10% to treat immune thrombocytopenia (Clinical registry entry).

Mechanism of Action (MOA):

• Human plasma-derived immunoglobulin G (IgG) acts as replacement therapy and immunomodulator in autoimmune and immunodeficiency conditions, facilitating neutralization of auto-antibodies and modulation of immune effector functions.

Latest News / Updates:

• GC Biopharma continues global expansion — established plasma centers in the U.S. for IVIG and albumin manufacturing, potentially accelerating clinical development timelines.

Regulatory: