Albumin Market Analysis

Global Albumin Market Overview

The Albumin (as Excipient) Market Size was valued at USD 0.9 billion in 2022 and is projected to grow from USD 0.95 Billion in 2023 to USD 1.46 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 5.9% during the forecast period (2023 - 2032). Rising research and development activities and increased government investment are just a few market drivers.

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

March 2023 witnessed presentations by Albumedix and Heartseed for launching Recombumin as a key ingredient in the production of the company’s first-in-human trial of its HS-001 investigational cell therapy. In the final formulation, Recombumin is an excipient used together with other pharmaceutical ingredients to make Heartseed’s HS-001 product.

Sartorius, through its French-quoted subsidiary Sartorius Stedim Biotech, acquired Albumedix Ltd., a major source of recombinant albumin-based solutions located in Nottingham, United Kingdom, in September 2022.

BPL’s US headquarters are based in Durham, North Carolina, and its global headquarters and manufacturing facilities are in Elstree, UK. The US launch involves an ALBUMINEX 5% (human albumin) solution for injection and an ALBUMINEX 25% (human albumin) solution for injection. The two drugs have been approved by the Food and Drug Administration (FDA) for the treatment of hypovolemia, ascites including that due to burns, hypoalbuminemia from any cause, acute nephrosis, acute respiratory distress syndrome (ARDS), and cardiopulmonary bypass.

Valneva SE is a specialist vaccine company addressing unmet medical needs in infectious diseases, while Albumedix Ltd is an acknowledged global player on recombinant Human Albumin (rHA), focused on enabling advanced therapies and biopharmaceuticals. Just recently, Valneva´s inactivated COVID-19 vaccine (VLA2001) was given MHRA approval, but this was signed by the European Commission last November when it agreed to supply up to 60 million doses over two years, thereby making one more announcement concerning an advance purchase agreement made with Bahrain Kingdome in December where one million doses were to be supplied.

June 2023:

Albumedix Ltd., a renowned international frontrunner in Recombinant Human Albumin (rHA), which specializes in facilitating cutting-edge therapies and biopharmaceuticals, has announced today the augmentation of its current partnership with Valneva SE, a specialized vaccine company dedicated to preventing infectious diseases that have substantial unmet medical requirements. Albumedix Recombumin® rHA plays a crucial role in VLA2001 by being incorporated into both the production process and the final formulation of the vaccine. The partnership between the businesses commenced by incorporating Recombumin® into Valneva's single-shot vaccine candidate, VLA1553, which targets the mosquito-borne viral virus chikungunya. This vaccine candidate successfully concluded its crucial Phase 3 study in March 2022. Both companies are dedicated to manufacturing vaccinations that are safe, efficient, and capable of being expanded on a large scale. Albumin has been proven to facilitate advanced therapeutics and biopharmaceuticals, and the qualities of Recombumin® have been demonstrated to be advantageous for various types of vaccines. As a result, Albumedix's recombinant human albumin (rHA) is currently being used in several vaccine candidates that are being tested in clinical trials and in vaccines that are already on the market. This has led to over 210 million injections of Recombumin®, all of which have been proven to be safe.

May 2022:

Bio Products Laboratory (BPL), a prominent producer of plasma-derived protein therapies, has introduced ALBUMINEX 5% (human albumin) solution for injection and ALBUMINEX 25% (human albumin) solution for injection in the United States. BPL, headquartered in Durham, North Carolina, and with manufacturing facilities in Elstree, UK, is now offering these products with immediate availability. ALBUMINEX 5% and ALBUMINEX 25% have received approval from the US Food and Drug Administration for the treatment of several conditions, including hypovolemia, ascites, hypoalbuminemia (including cases resulting from burns), acute nephrosis, acute respiratory distress syndrome (ARDS), and cardiopulmonary bypass. BPL is delighted to announce the addition of ALBUMINEX to our range of products in the United States. ALBUMINEX's release marks their third product launch in the US within the last five years. This launch aligns with their company objective of consistently supplying dependable, top-notch plasma-derived products globally, thereby assisting healthcare professionals and patients on a daily basis.

Albumin Market Trends

• Increased demand for certified Albumin (as Excipient) products to propel market growth

Human Albumin is frequently used as a plasma expander or replacement for therapeutic purposes. The use of human Albumin as a non-therapeutic substance or excipient for commercial settings has, however, been under investigation by the healthcare sector for more than ten years. Emerging markets for human Albumin as a component of vaccines, a surgical sealant, and a coating for medical equipment and devices are anticipated to drive production across all of these application areas. The demand for Albumin in laboratories is rising as people become more aware of its advantages. It functions as a pharmaceutical stabilizer to lessen the denaturation of the proteins' active components. Additionally, human serum albumin has a number of advantages that make it a good option for vaccine formulations. It is anticipated that advances in molecular separation and protein purification technology will significantly boost the market. Thus, this aspect is expected to accelerate Albumin (as an excipient) market revenue globally.

There are several benefits of using Albumin during drug formation. Pharmaceutical drug development faces a challenge in creating safe and stable formulations, and selecting excipients can play a significant role in the formulation's success. This is especially important for difficult-to-formulate active pharmaceutical ingredients (APIs) and may determine whether a drug candidate is abandoned during development or succeeds as a pharmaceutical. When creating different APIs, Albumin has been shown to have advantages over other excipients and to be able to help with some formulation difficulties. Historically, Albumin has been incorporated into a variety of formulations. Human serum albumin that was chemically defined (recombinant) is now more commonly used than the original form derived from plasma. Recombinant products are advantageous because they don't contain animal-derived ingredients, have a reliable supply, are highly pure, don't contain host-derived proteases, are homogeneous, have a high free thiol content, don't contain known or unknowable human pathogens, are consistent from batch to batch, and have a well-established regulatory pathway.

Moreover, Albumin is helpful in the production and administration of stem cell and other cell therapies, as well as numerous regenerative pharmaceutical products. Cell therapies frequently need to be cryopreserved for shipping and storage. To safeguard these sensitive biologic treatments, uniform, reproducible media is necessary, and HSA is frequently a key component. 7 In order to improve consistency, quality, and reproducibility, it is frequently used right from the start of the manufacturing processes for cell therapies. Additionally, it has been demonstrated to enhance adeno-associated virus vector transduction (AAVs). Such increasing use of Albumin is anticipated to boost the market CAGR during the forecast period.

Albumin (as Excipient) Market Segment Insights

Albumin (as Excipient) Type Insights

The Market segments of Albumin (as Excipient), based on Type, includes human, bovine, and recombinant serum albumin. The human segment held the majority share in 2022 in the Albumin (as Excipient) Market data. In the life sciences sector, recombinant human serum albumin is utilized for various purposes, such as microbial culture media and a component of cells, growth booster in recombinant DNA, blocking agent in blotting, and hybridoma technology. This is anticipated to fuel the segment's growth in the years to come. Recombinant serum albumin is anticipated to grow at the fastest CAGR during the forecast period owing to the increasing use of these in R&D activities..

Figure 2: Albumin (as Excipient) Market, by Type, 2022 & 2030 (USD Billion)Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Albumin (as Excipient) Application Insights

The Albumin (as Excipient) Market data, based on Application, includes drug formulation, drug delivery, vaccines, medical device coating, and diagnostics. The drug delivery segment dominated the Albumin (as Excipient) market revenue in 2022 and is projected to be the faster-growing segment during the forecast period, 2022-2030. Albumin's biochemical and biophysical characteristics make it a perfect drug delivery platform. Recent improvements in albumin-based therapies and our understanding of albumin physiology strongly incline us to believe that albumin-based therapies are superior to other technologies in terms of half-life, stability, versatility, safety, and ease of manufacturee.

Albumin (as Excipient) Regional Insights

By region, the study provides market insights into North America, Europe, Asia-Pacific, and the Rest of the World. North America Albumin (as excipient) market accounted for USD 0.4 billion in 2022 with a share of around 45.80% and is expected to exhibit a significant CAGR growth during the study period. It is anticipated that a number of research organizations and biopharmaceutical companies will increase their investments in the life sciences, which will likely boost the global market in these regions during the forecast period. The market is expanding due to the increasing use of plasma fractionation facilities and growing R&D activities in this region to the rising demand for Albumin. For instance, according to clinicaltrials.gov, as of June 2020, there were approximately 107 ongoing clinical trials in the United States involving Albumin in various stages of development and for multiple indications.

Further, the major countries studied in the market report are: The U.S., Canada, Germany, France, the  UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 3: ALBUMIN (AS EXCIPIENT) MARKET SHARE BY REGION 2022 (%)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Europe Albumin market accounts for the second-largest market share. It is anticipated that introducing new products, adopting crucial initiatives like partnerships and acquisitions, and rising investments will propel the market. The biopharmaceutical industry's growing drug discovery and development efforts are anticipated to fuel the albumin market. Moreover, the UK market of Albumin (as excipient) held the largest market share, and the Germany market of Albumin (as excipient) was the fastest-growing market in the region.

Asia Pacific Albumin (as Excipient) Market is expected to grow at the fastest CAGR from 2022 to 2030. Some of the factors contributing to the growth of the market in this region include growing government investment and research and development for creating technologically advanced products. Additionally, it is anticipated that increasing rates of blood-related diseases in people, such as blood infections, will fuel the demand for Albumin in the years to come. Further, the China market of Albumin (as excipient) held the largest market share, and the India market of Albumin (as excipient) was the fastest-growing market in the region.

Albumin (as Excipient) Key Market Players & Competitive Insights

Major market players are launching new products that can be used to meet the rising demand from various end-use industries. Companies are also adopting various initiatives to grow their market share with key market developments such as new product launches, contractual agreements, mergers and acquisitions, increased investments, and collaborations with other companies.

One of the strategies adopted by manufacturers in the global Albumin (as excipient) industry to benefit clients is expanding the manufacturing capacities and manufacturing products locally. In recent years, the Albumin (as Excipient) industry has also had some investments that will be used in studying the product and its applications. The Albumin market major players include Albumedix A/S, Albumin Therapeutics, LLC Baxalta Incorporated, Baxter International Inc., Biotest AG, CSL Behring LLC, China Biologic Products Inc., Grifols International, HiMedia Laboratories Pvt. Ltd.

Albumedix A/S is a company that is the technology and product leader in the world for recombinant human Albumin. company's albumin-based technologies offer new ways to optimize drug dosing and improve therapeutic performance by extending the half-life, payload capacity, and tissue-specific delivery of active pharmaceutical agents. In March 2021, Albumedix Ltd. announced that they had signed a distribution contract with FUJIFILM Wako Pure Chemical Corporation (FUJIFILM Wako), a supplier of reagents, for Hong Kong, China, and Japan. The partnership reinforces Albumedix's dedication to regional biopharmaceutical and advanced therapy developers. According to the terms of the contract, FUJIFILM Wako will serve as a commercialization partner and distributor for Albumedix's recombinant human albumin products (Recombumin), including joint marketing initiatives in China, Hong Kong, and Japan.

Grifols is a global healthcare company that, since 1909, develops, produces and provides essential plasma-derived medicines and transfusion medicine. Grifols inaugurated its new albumin purification and filling facility at its global manufacturing and supply hub in Dublin, Ireland, for the production, packaging, and global distribution of Grifols treatments.

Key Companies in the market of Albumin (as excipient) includes

• Albumedix A/S


• Albumin Therapeutics


• LLC Baxalta Incorporated


• Baxter International Inc.


• Biotest AG


• CSL Behring LLC


• China Biologic Products Inc.


• Grifols International


• HiMedia Laboratories Pvt. Ltd., among others

Albumin (as Excipient) Industry Developments

April 2022 Apotex Corp. releases its generic version of Abraxane, Paclitaxel protein-bound particles for injection (albumin-bound), which was made available in the US. Adenocarcinoma of the pancreas, non-small cell lung cancer, and metastatic breast cancer are all indicated for treatment with paclitaxel protein-bound particles for injectable suspension.

May 2020 Bio Products Laboratory (BPL) announced the US launch of ALBUMINEX 5% (human albumin) solution for injection and ALBUMINEX 25% (human albumin) solution for injection. The US and are currently in stock. The US Food and Drug Administration has given the drugs ALBUMINEX 5% and ALBUMINEX 25% approval for the treatment of cardiopulmonary bypass, acute nephrosis, acute respiratory distress syndrome (ARDS), ascites, and hypoalbuminemia, including that resulting from burns.

Albumin (as Excipient) Market Segmentation

Albumin (as Excipient) Type Outlook (USD Billion, 2018-2030)

• Arabica


• Robusta


• Others

Albumin (as Excipient) End-User Outlook (USD Billion, 2018-2030)

• Whole


• Ground

Albumin (as Excipient) Application Outlook (USD Billion, 2018-2030)

• Store-Based


• Non-Store-Based

Albumin (as Excipient) Regional Outlook (USD Billion, 2018-2030)

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  North America

  
  
  
  
  • US
  
  
  • Canada
  
  
  
  


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  Europe

  
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


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  Asia-Pacific

  
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


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  Rest of the World

  
  
  
  
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    Middle East

    
    
  
  
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    Africa

    
    
  
  
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    Latin America