Grifols has announced the United States commercial launch of Yimmugo, an intravenous immunoglobulin (IVIg) therapy developed by its subsidiary Biotest.
The product, approved by the US Food and Drug Administration (FDA) in June 2024, is now available for the treatment of primary immunodeficiencies (PID). The launch represents a significant milestone for Biotest, marking its first FDA-approved medicine to enter the US market.
Yimmugo (IgG Next Generation) is a polyvalent immunoglobulin G preparation derived from human plasma, manufactured at Biotest’s “Next Level” production facility in Dreieich, Germany.
Strengthening Portfolio
The introduction of Yimmugo strengthens Grifols’ position in the immunoglobulin sector, a market with a projected compound annual growth rate of 6.9%, according to a report by Global Market Insights. The global immunoglobulin market is estimated to reach $36.7 billion by 2034, up from $20.1 billion in 2025.
“The US launch of Yimmugo marks a cornerstone in Biotest’s long-term strategy and highlights the company’s continuous growth trajectory,” said Dr. Jörg Schüttrumpf, Chief Scientific Innovation Officer at Grifols and CEO of Biotest AG. The product will be distributed in the United States by Kedrion Inc.
The US launch follows Yimmugo’s successful introduction in Europe in 2022 and is expected to contribute to Grifols’ future revenue. The company is advancing its product pipeline during a period of strategic refocus.
Yimmugo is the first of three Biotest plasma proteins planned for launch in markets including the US. The company’s pipeline includes a fibrinogen concentrate for acquired fibrinogen deficiency, which would be the first approved for this indication in the US, and trimodulin for severe community-acquired pneumonia. Both are in late-stage development.
The product’s label includes a boxed warning for risks of thrombosis, renal dysfunction, and acute renal failure, though it is formulated without sucrose, a stabilizer associated with renal complications in some other IVIg products.
