01 Albumin, a water-soluble protein derived from human plasma or recombinant sources, plays a key role in maintaining oncotic pressure and transporting vital substances like hormones and fatty acids. Its widespread clinical use in critical care, hypoalbuminemia treatment, and drug delivery continues to drive demand globally. The market is growing, especially in emerging economies with improved healthcare infrastructure and rising access to plasma-derived therapies. Increasing cases of liver disease, nephrotic syndrome, and burns, along with more surgical procedures, are boosting consumption.
01 Recombinant Albumin Gains Ground as Safer, Scalable Alternative to Plasma-Derived Sources The albumin market is undergoing a notable transformation as biotechnology companies and pharmaceutical manufacturers shift toward recombinant human serum albumin (rHSA) to address concerns around plasma supply limitations, pathogen safety, and regulatory compliance. This reflects a broader move within the life sciences industry to adopt more consistent, ethically sourced, and scalable inputs, especially for vaccines, biologics, and cell-based therapies. For instance, in June 2024, Sartorius announced that its recombinant albumin, developed through its acquisition of Albumedix, played a key role in stabilising the world’s first FDA-approved chikungunya vaccine, IXCHIQ®. The rHSA was used as a formulation stabiliser, supporting cold-chain storage without compromising the vaccine’s potency. Institutions focused on biomanufacturing, gene therapy, and regenerative medicine are linking procurement decisions to quality certifications and recombinant sourcing, positioning suppliers of rHSA for long-term strategic growth.
March 2026 Kedrion Biopharma received U.S. FDA approval for an expanded indication of BIVIGAM®, reinforcing its plasma-derived therapeutics portfolio and strengthening its position in plasma protein manufacturing, including albumin-related products.
November 2025 Takeda expanded plasma-derived therapy manufacturing capacity at its Lessines, Belgium facility to increase production of albumin, immunoglobulins, and other plasma-derived medicines while improving supply reliability.
September 2025 Grifols announced the expansion of its plasma fractionation capacity to increase the production of human albumin and other plasma-derived therapies, addressing growing global demand for critical care and chronic disease treatments.
May 2025 CSL Behring expanded manufacturing operations at its Broadmeadows facility in Australia to boost production capacity for plasma-derived therapies, including human albumin, through advanced fractionation and purification technologies.