Grifols has expanded its portfolio of plasma-derived therapies in the United States with the launch of Biotest’s intravenous immunoglobulin (IVIg) treatment Yimmugo, following FDA approval earlier this year.

Yimmugo, developed and manufactured by Biotest – part of the Grifols Group – will be available for people living with primary immunodeficiencies (PID). The condition affects an estimated one in every 1,200 people in the US and occurs when the body’s immune system cannot properly fight infection.

The approval marks the first Biotest-developed medicine authorised for the US market and represents a significant milestone for the company. Yimmugo is produced at Biotest’s FDA-certified Next Level manufacturing facility in Dreieich, Germany, which uses a modern purification process designed to ensure high product consistency and safety.

Biotest first launched Yimmugo in Europe in 2022, where it has already been used in patients with immune deficiencies. Its US introduction adds to Grifols’ broad range of immunoglobulin therapies, which include both intravenous and subcutaneous formulations.

Demand for immunoglobulin medicines continues to increase worldwide, driven by higher diagnosis rates and expanding indications. The global market is projected to grow at a compound annual rate of about 6.9%, reaching an estimated value of US$36.7 billion by 2034, up from US$20.1 billion in 2025.

Jörg Schüttrumpf, chief scientific innovation officer at Grifols and chief executive of Biotest, said: “The US launch of Yimmugo marks a cornerstone in Biotest’s long-term strategy and highlights the company’s continuous growth trajectory. It also demonstrates Grifols’ and Biotest’s shared commitment to innovation and to improving the lives of people worldwide by expanding access to care.”

In the United States, Yimmugo will be distributed by Kedrion Inc., which specialises in plasma-derived treatments. The partnership aims to ensure broad availability for patients and healthcare providers.

With the addition of Yimmugo, Grifols strengthens its position in the competitive immunoglobulin sector, a key part of the company’s core plasma business. The move also underscores its long-term goal of developing complementary therapies across its subsidiaries, while maintaining a focus on manufacturing quality and supply reliability.