Human Serum Albumin Market Report 2025

The human serum albumin market size has grown strongly in recent years. It will grow from $5.39 billion in 2024 to $5.79 billion in 2025 at a compound annual growth rate (CAGR) of 7.5%. The growth in the historic period can be attributed to rising healthcare demand, expanding applications of human serum albumin, an aging population, increasing need for blood plasma derivatives, and the growing prevalence of liver disorders and related health conditions.

The human serum albumin market size is expected to see strong growth in the next few years. It will grow to $7.63 billion in 2029 at a compound annual growth rate (CAGR) of 7.1%. The growth in the forecast period can be attributed to increasing access to essential medicines, broader therapeutic applications, a rising number of hospitals, expanding healthcare infrastructure, and supportive government initiatives. Major trends during this period include advancements in cell-free protein synthesis, CRISPR-based strain engineering, continuous manufacturing techniques, development of transdermal delivery systems, and improvements in lyophilization technologies.

The rising prevalence of liver diseases is anticipated to drive the growth of the human serum albumin market in the coming years. Liver diseases encompass a range of conditions that impair liver function, including hepatitis, fatty liver disease, cirrhosis, and liver cancer. The increase in these conditions is largely linked to the growing prevalence of obesity, as excess abdominal fat can lead to non-alcoholic fatty liver disease (NAFLD), resulting in fat accumulation, inflammation, and potential liver failure. Human serum albumin supports liver disease management by restoring blood volume, reducing fluid accumulation, protecting kidney function, and improving outcomes in complications such as ascites and hepatorenal syndrome. For example, according to a report released in July 2023 by the Office for Health Improvement & Disparities, a UK government department, hospital admissions with liver disease as the primary diagnosis rose by 22% in the financial year ending 2022, increasing from 67,458 cases in 2021 to 82,290 cases in 2022. Consequently, the rising prevalence of liver diseases is fueling the growth of the human serum albumin market.

Leading companies in the human serum albumin market are concentrating on creating innovative solutions, such as animal-free recombinant excipients, to improve product safety, scalability, and compliance with regulatory standards in biomanufacturing. Animal-free recombinant excipients are biologically engineered inactive substances produced using recombinant DNA technology without any animal- or human-derived components, ensuring high purity and safety for pharmaceutical and biomanufacturing applications. For instance, in April 2025, InVitri Inc., a US-based provider of animal-free recombinant proteins and excipients, introduced Optibumin 25, the first recombinant 25% human serum albumin designed specifically for closed-system biomanufacturing. It is optimized for downstream processing, formulation, and cryopreservation workflows and is currently available in 100 mL single-use bags. With its chemically defined, animal-origin-free composition, it ensures high purity, consistency, and reduced contamination risks. The product is GMP-ready, scalable to commercial production volumes, and provides a stable, sterile solution suitable for applications such as viral vector manufacturing, stem cell preservation, vaccine formulation, and regenerative medicine.

In August 2022, Sartorius AG, a Germany-based pharmaceutical and laboratory company, acquired Albumedix Ltd. for an undisclosed sum. This acquisition aims to enhance Sartorius’ portfolio in advanced therapy solutions, focusing on recombinant albumin-based technologies critical for producing innovative biopharmaceuticals, including cell therapies, viral therapies, and vaccines. Albumedix Ltd., a UK-based biotechnology company, specializes in recombinant human albumin solutions for advanced biopharmaceutical applications.

Major players in the human serum albumin market are Thermo Fisher Scientific Inc., Takeda Pharmaceutical Company Limited, Merck KGaA, CSL Behring (CSL), Baxter International Inc., Grifols S A, Sartorius AG, Octapharma AG, Kedrion Biopharma, Shanghai RAAS Blood Products Co Ltd., Biotest Aktiengesellschaft, LFB Group, Hualan Biological Engineering Inc., Taibang Biologic Group, Kamada Ltd., InVitria Inc., Reliance Life Sciences, Bio Products Laboratory, Mitsubishi Tanabe Pharma, and Sichuan Yuanda Shuyang Pharmaceutical Co Ltd.

North America was the largest region in the human serum albumin market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in human serum albumin market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the human serum albumin market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.

Human serum albumin is a protein present in human blood plasma that is essential for maintaining oncotic pressure, which regulates the exchange of water between blood vessels and body tissues. It also functions in transporting hormones, fatty acids, and other compounds, as well as buffering pH and binding various drugs, making it vital for numerous physiological processes.

The primary preparations of human serum albumin include recombinant human serum albumin and plasma-derived human serum albumin. Recombinant human serum albumin is produced in the laboratory using genetically modified cells such as yeast or bacteria. Key formulation types include injection solutions and lyophilized powder. These products are distributed through channels such as direct sales, online pharmacies, third-party distributors, and hospital pharmacies. Applications span volume expansion, drug delivery systems, nutritional support, and use as diagnostic agents. End users include hospitals, research laboratories, pharmaceutical companies, and blood banks.

The human serum albumin market research report is one of a series of new reports that provides human serum albumin market statistics, including human serum albumin industry global market size, regional shares, competitors with a human serum albumin market share, human serum albumin market segments, market trends and opportunities, and any further data you may need to thrive in the human serum albumin industry. This human serum albumin market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The human serum albumin market consists of sales of human serum albumin injection, plasma-derived albumin, albumin-based drug delivery systems, and albumin solutions for cell culture and diagnostics. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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