The Human Albumin market is anticipated to grow from US$ 4.68 billion in 2024 to US$ 6.98 billion by 2031; the market is expected to register a CAGR of 6.0% from 2025 to 2031. The human albumin Market growth is attributed to the rising prevalence of chronic diseases, advancements in biotechnology, and soaring demand in biopharmaceuticals.

Human albumin is a plasma protein produced by the liver, constituting about 60% of total blood proteins. It maintains colloid osmotic pressure, helping regulate fluid balance between blood vessels and tissues. Albumin also serves as a carrier for hormones, drugs, and fatty acids. Clinically, human albumin is used in intravenous therapy to treat hypovolemia, shock, burns, and hypoalbuminemia. Its administration supports circulation, reduces edema, and stabilizes patients in critical conditions.

The human albumin market in North America is segmented into the US, Canada, and Mexico. According to the US Department of Health & Human Services, approximately 39.9 million people globally were living with HIV in 2023, with many requiring albumin-based treatments for associated conditions. The American Cancer Society reported 41,210 new liver cancer cases in the US in 2023, leading to hypoalbuminemia, which boosts albumin demand. New product developments, such as Grifols' ALBUTEIN FlexBag, launched in November 2021, enhance usability and safety. Additionally, robust healthcare infrastructure, significant R&D investments, and regulatory support from the FDA ensure product quality and availability. The National Library of Medicine notes albumin's critical role in over 310 million global surgeries in 2022, with 40-50 million in the US, driving market expansion.

The CDC reported in 2023 that chronic liver diseases affect approximately 4.5 million US adults, requiring albumin for hypoalbuminemia treatment. The National Institutes of Health (NIH) noted ~450,000 burn injuries in 2024, where albumin is critical for fluid resuscitation. The FDA's 2023 approval of albumin-based drug delivery systems, including Abraxane for cancer therapy, broadens clinical uses. Increased healthcare spending, a growing aging population, and stringent FDA regulations ensuring product quality, as reported in 2024, support market expansion. Rising surgical procedures and critical care needs, documented by the CDC in 2024, contribute to the increasing demand for albumin.

Advancements in Recombinant Human Albumin Technology to Provide Market Opportunities in Future

Advancements in recombinant human albumin (rHA) technology are creating meaningful opportunities in the human albumin market. In China, for example, the annual demand for human serum albumin (HSA) in 2024 exceeded 1,000 tonnes, with imports accounting for more than 69 % of supply. A notable development is the regulatory approval of a rice derived recombinant HSA injection by the National Medical Products Administration (NMPA), based on genetically engineered rice bioreactors developed by Wuhan Healthgen Biotechnology Corp. On the product front, Indian company Shilpa Biologicals (a subsidiary of Shilpa Medicare) has filed a Drug Master File for a 20 % recombinant human albumin excipient grade with the U.S. Food and Drug Administration (FDA), highlighting global momentum toward rHA alternatives. Historically, recombinant HSA produced using yeast (e.g., Pichia pastoris) demonstrated structural and functional equivalence to plasma derived HSA in clinical studies. These innovations offer the potential to mitigate reliance on donor plasma sources, improve supply security, reduce pathogen risks, and expand application of albumin across excipients, drug delivery systems and cell therapies. As demand swells and product pipelines advance, recombinant albumin technologies are poised to become a strategic lever for biopharma manufacturers and supply chain stakeholders.

World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), National Center for Biotechnology Information (NCBI), American Chemical Society Publications, The U.S. Centers for Medicare & Medicaid Services (CMS), US Department of Health & Human Services, Public Health Agency of Canada (PHAC), French National Institute of Health and Medical Research (INSERM), Italian National Institute of Health (ISS), The Korean Journal of Internal Medicine, the Saudi Press Agency (SPA), UAE Ministry of Health and Prevention (MOHAP) are among the primary and secondary sources referred to while preparing the human albumin market report.