Albumin Market Report: Size, Share and Outlook by 2031

The Albumin market is anticipated to grow from US$ 6.06 billion in 2024 to US$ 9.22 billion by 2031; the market is expected to register a CAGR of 6.3% from 2025 to 2031. The albumin market growth is attributed to the rising prevalence of chronic diseases, advancements in biotechnology, and soaring demand in biopharmaceuticals. 

Albumin is a vital plasma protein with diverse biological roles and wide-ranging medical applications. Produced by the liver, it constitutes about 60% of total blood protein and is crucial in maintaining fluid balance, transporting substances, and supporting critical care interventions. 

The 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. New product developments, such as recombinant albumin innovations funded by NIH with US$ 350 million in 2024, enhance safety and efficacy, driving demand. 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. 

Recombinant (Non-Plasma) Albumin Development to Provide Market Opportunities in Future 

The shift toward recombinant (non-plasma) albumin is driven by innovations that circumvent supply constraints and safety risks. In August 2024, Shilpa Medicare completed a Phase?I trial in India for its yeast-derived recombinant human albumin (rHA?20?%, sRbumin) in 62 healthy volunteers, which demonstrated comparable bioavailability, safety, and immunogenicity to plasma-derived albumin. Building on this development, the company secured approval to begin Phase?III trials, aiming to launch a scalable, reliable alternative by 2026. In China, Wuhan Healthgen Biotechnology gained approval in July 2025 for a rice-derived recombinant albumin, leveraging bioreactor rice technology—25?kg of rice yields the albumin equivalent of 5 liters of human plasma. The company’s current capacity is 10 tons of stock solution, set to expand to 130 tons by 2026, potentially replacing ~25% of China’s imported albumin.
In the biomanufacturing space, InVitria launched Optibumin?25, the world’s first 25?% recombinant human serum albumin (rHSA) optimized for closed-system cell and gene therapy manufacturing, offering a chemically defined, GMP-compliant, animal-origin-free alternative to plasma-derived albumin. Complementing these breakthroughs, Dyadic International entered into a development and commercialization deal for animal-free recombinant albumin with Proliant, aiming for product launch in the first half of 2025.

These converging technological advances from yeast and rice expression systems to closed-system biomanufacturing and strategic industry partnerships offer a scalable, safer, and more ethically sound path forward, positioning recombinant albumin as a cornerstone of future therapeutic supply and a frontier in emerging and established markets. 

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 albumin market report.