Albumin Excipient Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Human Serum Albumin, Recombinant Albumin), By End user (Pharmaceutical And Biotechnology Industry, Research Institutes, Others), By Region and Competition, 2020-2030F

Market Overview

The Global Albumin Excipient Market, valued at USD 4.98 Billion in 2024, is projected to experience a CAGR of 8.01% to reach USD 7.91 Billion by 2030. Albumin excipient is a highly purified protein, typically derived from human plasma or engineered recombinantly, utilized in pharmaceutical formulations as an inactive ingredient. Its primary functions include stabilizing active drug components, enhancing solubility, prolonging product shelf-life, and serving as a crucial element in cell culture media, vaccine production, and advanced drug delivery systems. The market's expansion is significantly driven by the escalating global demand for biopharmaceuticals and biologics, an increasing incidence of chronic diseases necessitating intravenous therapies, and continuous technological advancements in albumin production and purification processes.

According to the Plasma Protein Therapeutics Association (PPTA), in August 2025, a specific recombinant human serum albumin approved in China for liver cirrhosis treatment represented less than ten percent of total global albumin use. However, market growth faces a significant impediment due to the inherently high production costs associated with both plasma-derived and recombinant albumin manufacturing.

Key Market Drivers

The global albumin excipient market is significantly propelled by the increasing demand for biopharmaceuticals and biologics, which rely heavily on albumin for stabilization and enhanced delivery. As the pharmaceutical industry increasingly focuses on complex protein-based therapies, albumin's unique properties as a non-immunogenic and effective stabilizer become indispensable. For example, according to the FDA's Center for Drug Evaluation and Research (CDER), in 2024, biologics accounted for 32% of all new drug approvals, a notable increase from the 28% average over the prior six years. This expanding pipeline and approval rate directly translate into a greater need for high-quality albumin excipients to ensure the safety, efficacy, and shelf-life of these advanced therapeutic products.

Concurrently, the rising global prevalence of chronic diseases drives substantial growth in the albumin excipient sector. Conditions such as autoimmune disorders, oncology, and metabolic diseases often necessitate long-term or injectable treatments, where albumin functions as a critical component in formulation to improve drug solubility, reduce aggregation, and facilitate targeted delivery. The scale of this health burden is considerable; according to the World Health Organization's 'Noncommunicable diseases' fact sheet, published in September 2025, noncommunicable diseases were responsible for at least 43 million deaths in 2021, equating to 75% of non-pandemic-related deaths globally. This persistent and growing demand for therapies for chronic conditions underpins the continuous expansion of the albumin excipient market, requiring robust supply chains for both plasma-derived and recombinant albumin. Reflecting the foundational role of albumin in these therapies, the Plasma Protein Therapeutics Association (PPTA) states that its members collectively produce over 60% of the plasma protein therapies utilized globally.

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Key Market Challenges

The challenging factor for the Global Albumin Excipient Market is the inherently high production costs associated with both plasma-derived and recombinant albumin manufacturing. This significant impediment stems from the complex and resource-intensive processes required for both sources. For plasma-derived albumin, extensive collection networks, rigorous purification, and stringent safety testing contribute substantially to expenses. Similarly, recombinant albumin manufacturing necessitates sophisticated biotechnological processes, specialized equipment, and considerable research and development investments. These factors collectively drive up the cost of the final excipient.

High production costs directly hamper market growth by increasing the final price of albumin excipients, making them a less viable option for pharmaceutical formulations where more economical alternatives exist. This limits the broad adoption of albumin, particularly in cost-sensitive therapeutic areas and emerging markets, despite its superior stabilizing and solubilizing properties. According to Centro Nazionale Sangue, in 2024, 906,938 kilograms of plasma were collected for industrial fractionation in Italy, reflecting a 3% increase from 880,000 kilograms in 2023. Such substantial raw material volumes and the intensive processing required worldwide for plasma-derived products underscore the significant cost burden that ultimately restricts the overall market expansion for albumin excipients.

Key Market Trends

Two prominent trends are significantly shaping the Global Albumin Excipient Market. The increasing adoption of recombinant albumin excipients addresses critical supply and safety considerations. Unlike plasma-derived albumin, recombinant alternatives offer enhanced consistency, a reduced risk of viral contamination, and overcome the ethical and supply chain challenges associated with human plasma sourcing. This shift is becoming increasingly necessary; according to the International Plasma and Fractionation Association (IPFA) and European Blood Alliance (EBA) symposium proceedings in August 2025, the European Medicines Agency anticipated plasma shortages to affect 14 European countries in 2024, highlighting the persistent supply challenges for plasma-derived products. Such supply constraints underscore the growing appeal of recombinant options. The use of recombinant human albumin has expanded considerably, with Sartorius-Albumedix stating in 2024 that their Recombumin® product has been dosed over 200 million times and supports over 45% of the top 20 blue-chip pharmaceutical companies globally.

Another significant trend is the growing integration of albumin excipients in nanoparticle drug delivery systems. Albumin's inherent biocompatibility, biodegradability, and natural affinity for various drug compounds make it an ideal carrier for advanced drug delivery. Its ability to encapsulate poorly soluble drugs, facilitate targeted delivery to specific tissues, and improve drug pharmacokinetics is particularly valuable in complex therapeutic areas. According to a July 2024 publication in the International Journal of Nanomedicine, "Albumin appears to be a promising carrier for drug delivery with superior biocompatibility and enhanced targeting capacity," further noting that "Albumin nanoparticles are highly favored in many disease therapies" due to their advantageous properties. This integration enhances therapeutic efficacy, reduces systemic toxicity, and opens new possibilities for treating challenging diseases.

Segmental Insights

The Global Albumin Excipient Market is experiencing significant expansion, with Human Serum Albumin (HSA) emerging as the fastest-growing segment. This rapid ascent is primarily driven by HSA's indispensable role as a versatile and multifunctional excipient in pharmaceutical and biotechnology applications. Its inherent high stability, biocompatibility, and non-immunogenic profile make it an optimal choice for stabilizing sensitive biological drug formulations, including vaccines, and enhancing the efficacy of various drug delivery systems. Furthermore, increasing demand for advanced therapeutics to combat the rising incidence of chronic diseases, combined with established regulatory acceptance from authorities such as the U. S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for cGMP-compliant HSA, solidly underpins its market leadership.

Regional Insights

North America leads the Global Albumin Excipient Market, primarily driven by its robust healthcare infrastructure and extensive research and development activities. The region benefits from a significant patient population requiring albumin-based therapies for chronic diseases and an aging demographic. Additionally, the presence of advanced biotechnology and pharmaceutical sectors, alongside strong regulatory oversight from bodies like the U. S. Food and Drug Administration, necessitates high-quality excipients. This environment fosters the early adoption of innovative drug delivery systems and continuous advancements in albumin production and application.

Recent Developments

• In October 2025, Dyadic Applied BioSolutions announced reaching a $500,000 productivity milestone in its recombinant human albumin partnership with Proliant Health & Biologicals. This collaboration is advancing the development and commercialization of recombinant human albumin, with the product sampling initiated and a commercial launch targeted for late 2025 or early 2026. This progress highlights continuous efforts in company collaborations to enhance the availability and application of recombinant human albumin, a critical excipient for various biopharmaceutical formulations. The anticipated commercialization is poised to contribute to the global albumin excipient market by offering a high-quality, recombinant option.

• In February 2025, InVitria announced the launch of Optibumin 25, marking a significant new product introduction in the global albumin excipient market. Optibumin 25 is presented as the first and only recombinant human serum albumin (rHSA) available as a 25% solution. This chemically defined, animal-origin-free alternative is designed to replace serum-derived human serum albumin in closed-system biomanufacturing. Its introduction directly addresses concerns regarding batch-to-batch variability and potential pathogen risks associated with blood-derived components, thereby offering an advanced excipient solution for cell and gene therapy, vaccine production, and regenerative medicine.

• In September 2024, Merck achieved the industry's first EXCiPACT cGMP certification for Pharmaceutical Auxiliary Materials (PAMs) at its major global Cell Culture Media (CCM) production sites. This certification is crucial for ensuring the safety, quality, and efficacy of cell culture media components, including excipients such as albumin, which are essential raw materials in the manufacturing of life-saving therapies. This development represents a significant stride in maintaining high standards for excipients used in biomanufacturing, encompassing vaccine manufacturing, gene therapy, and monoclonal antibody production, thereby reinforcing confidence in the quality of albumin-based excipients.

• In April 2024, Tonghua Anrui Biopharmaceutical Co., Ltd. (Anrui) achieved a notable breakthrough with the approval of its recombinant human albumin injection for marketing in Russia by the Ministry of Health of the Eurasian Economic Union-Russian Federation. This approval for three concentrations (5%, 10%, and 20%) establishes Anrui as a pioneer in the global biopharmaceutical landscape, filling a gap in the supply of recombinant human albumin. The growing demand for recombinant human albumin as a pharmaceutical excipient in various applications, including medical device coatings, cell therapy, and vaccine research, underscores the broader impact of this advancement on the albumin excipient market by enhancing global supply and technological validation.

Key Market Players

• Albumin Therapeutics LLC
• Biotest AG
• CSL Limited
• HiMedia Laboratories
• Medxbio Pte Ltd.
• Octapharma AG
• RayBiotech Inc
• SeraCare (LGC Clinical Diagnostics, Inc.)
• Sigma-Aldrich (Merck KGaA)
• LFB USA , Inc.

Report Scope:

In this report, the Global Albumin Excipient Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Albumin Excipient Market, By Product:

o   Human Serum Albumin

o   Recombinant Albumin

• Albumin Excipient Market, By End user:

o   Pharmaceutical and Biotechnology Industry

o   Research Institutes

o   Others

• Albumin Excipient Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Albumin Excipient Market.

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Company Information

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