Albumin Market Size, Share & Industry Analysis, By Product (Human Serum Albumin, Recombinant Albumin, and Bovine Serum Albumin), By Application (Therapeutics, Diagnostics, and Research), By End-user (Hospital & Clinics, Pharmaceutical & Biotechnology Industry, and Research Institutes), and Regional Forecast, 2024-2032

The global albumin market size was valued at USD 6.35 billion in 2023 and is projected to grow from USD 6.57 billion in 2024 to USD 10.19 billion by 2032, exhibiting a CAGR of 5.6% during the forecast period (2024-2032). Moreover, the U.S. albumin market size is projected to grow significantly, reaching an estimated value of USD 2.00 billion by 2032, driven by strong demand for non-therapeutic applications of these products, and rise in the plasma collection coupled with rising product approvals. 

Albumin is the most abundant circulating protein found in plasma. It is synthesized by the liver and necessary for regulating the osmotic pressure of the blood. Factors, such as increased prevalence of hypoalbuminemia and other medical conditions, rise in plasma fractionation facilities, and surge in plasma collection is driving the global albumin market growth.

• For instance, in September 2022, Takeda Pharmaceutical Company Limited invested nearly EUR 300 million (USD 300 million) to set up a new plasma fractionation plant at its existing Lessines site in Belgium.

Moreover, research activities that determine albumin's effectiveness are gaining momentum globally. Scientists have published several research studies in various journals enlisting treatment options for different conditions. In addition, innovations by prominent players in the market and a surge in the number of product approvals will present growth opportunities for the global market in the coming years.

• For instance, in July 2023, Grifols S.A., a leading manufacturer of plasma-derived medicines, announced the phase 3 completion of PRECIOSA to determine the potential of long-term albumin-based treatment with Grifols S.A.’s Albutein. The clinical study aims to increase the survival time of patients suffering from decompensated cirrhosis and ascites until a suitable transplant is available.

However, stringent government regulations in several countries and restrictions on reimbursement plans may hinder market growth to a certain extent.

The spread of the COVID-19 pandemic had a positive impact on the growth of the global albumin market. The growth was mainly attributed to the rising research and development initiatives to prove the effects of this product on COVID-19-positive patients. However, in 2021, the market experienced slow growth due to interruptions in plasma collection in the previous year. Nevertheless, in 2022 and 2023, the market experienced robust growth due to an improved supply of plasma and new product launches in the market.

Albumin Market Trends

Increased Presence of Recombinant Albumin in Diverse Application Areas Identified as Significant Market Trend

Albumin is witnessing huge demand in human therapeutics for restoring blood volume and replacing lost fluids during accidents, serious burn injuries, fetal erythroblastosis, hypoproteinemia, and surgeries. Recombinant albumin offers extensive benefits over human or animal-grade serum products in terms of higher purity, absence of animal material, and higher homogeneity. In addition, recombinant human serum products are hydrophobic, which offers them an excellent capacity to carry various ligands. This has increased their demand in drug delivery applications. Furthermore, prominent players in the global market are focused on several growth strategies, such as mergers and partnerships to strengthen their product portfolio to develop advanced therapies.

• For instance, in March 2021, Albumedix, Ltd. (Sartorius AG) announced a partnership with FUJIFILM Wako Pure Chemical Corporation to supply recombinant human albumin to the Japanese and Chinese markets. The partnership aimed to strengthen Albumedix's portfolio of advanced therapies and biopharmaceutical developers in the region.

In addition, several industry players have focused on the development of blood-free recombinant human serum albumin in recent years. InVitria is one of the companies involved in the production and development of blood-free recombinant human serum albumin. This product eliminates adventitious agents stemming from mammalian-derived serum and serum proteins, ultimately improving patient safety and treatment efficacy. Cellastim S, Exbumin, and Optibumin are some examples of blood-free albumin products manufactured by InVitria.

Moreover, recombinant albumin has applications in therapeutic drugs to treat low albumin levels caused by dialysis, surgery, pancreatitis, liver failure, abdominal infections, ovarian disorders caused by bypass surgery, fertility drugs, and other health disorders. Thus, these factors are expected to boost the market trends in the future.

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Albumin Market Growth Factors

Increased Prevalence of Hypoalbuminemia and Other Medical Conditions to Drive Market Growth

There has been a considerable growth in the demand for plasma-derived therapies, especially albumin, across the world. This growth is mainly attributed to the rise in the cases of various life-threatening disorders, special liver diseases, infections, and cardiac surgeries, leading to hypoalbuminemia. Hypoalbuminemia is a condition that results in the decreased production of albumin or increased loss of this protein via the kidneys, gastrointestinal (GI) tract, skin, or extravascular space. It is the most predominant disorder in the critically ill and hospitalized patients. Such life-threatening disorders can be treated with albumin therapeutics or through specific albumin therapies. Hence, the growing requirement for such treatments is projected to drive the demand for albumin-based therapies.

• For instance, according to the data published by the American Liver Foundation, in 2022, around 100 million people suffered from some form of liver disease in the U.S., and the number is projected to grow over the forecast period. Albumin synthesis and secretion decreases due to liver failure. Thus, there is an increased demand for albumin-based therapies in these patients.

Similarly, other medical conditions, such as liver cirrhosis also require treatment with albumin. Thus, the rising prevalence of such medical conditions will increase the need for effective treatments with albumin.

• For instance, as per an article published by Critical Care in July 2023, albumin infusion is an important therapeutic strategy for septic patients with liver cirrhosis. This therapy reduces the mortality rate in patients diagnosed with this medical condition.


• Also, as per the data published by Healthline in February 2022, around 1 in 400 adults are living with cirrhosis in the U.S.

Furthermore, the growing awareness of various life-threatening disorders, including hypoalbuminemia is prompting the population to seek medical treatment even for minor symptoms, thereby positively influencing the demand for these products.

Rise in Number of Plasma Fractionation Facilities to Support Market Growth

There has been an increased demand for using plasma in drug development processes over the years due to its various advantages. This increased demand has led prominent manufacturers to set up multiple fractionation facilities in Australia, Italy, and Spain to maintain the demand-supply balance. These fractionation units allow the fragmentation of plasma into albumin and other plasma components.

• For instance, in December 2022, CSL opened a new plasma fractionation facility in Australia to fractionate human plasma to treat hemophilia, immune system problems, burns, and other life-threatening medical conditions. This move allowed Australia to step forward in medicine by introducing a plasma fractionation plant capable of producing nine million liters of plasma per year.

In addition, the increasing number of plasma fractionation facilities is helping pharmaceutical companies develop innovative products for therapeutics, diagnostics, and research applications, thereby influencing market growth over the forecast period.

RESTRAINING FACTORS

Stringent Government Regulations in Several Countries to Limit Product Adoption

Factors, such as lack of therapeutic products and stringent government regulations are hampering the widespread utilization of these products. The government bodies in developed and developing countries ensure that the plasma collected and delivered satisfies all the applicable quality, safety, and potency criteria.

• For instance, in the U.S., the FDA regulates the blood and plasma products collected, processed, and distributed by private companies under two national laws: the Public Health Service (PHS) Act and the Federal Food, Drug, and Cosmetic (FD & C) Act.

Furthermore, government bodies do not accept plasma as a starting material unless it meets the safety and quality standards. Thus, the lengthy product approval process and stringent government regulations might hamper the market's growth to a certain extent.

Albumin Market Segmentation Analysis

By Product Analysis

Human Serum Albumin Segment to Grow at Faster Pace Owing to Higher Sales of Drugs for Treating Hypoalbuminemia

On the basis of product, the market is segmented into human serum albumin, recombinant albumin, and bovine serum albumin. The human serum segment dominated the market in 2023. The segment’s growth is mainly attributed to regulatory approvals, launches of novel products in the market, and higher sales of drugs for treating hypoalbuminemia.

• For instance, in July 2023, Kedrion S.p.A. announced that China's National Institutes for Food and Drug Control (NIFDC) had granted its approval for the release of BPL's human albumin product in the Chinese market.


• For instance, in November 2021, Grifols S.A., a global manufacturer of plasma-derived medicines, announced the latest innovation in its albumin portfolio, ALBUTEIN FlexBag, in 5% and 25% concentrations.

The recombinant albumin segment is projected to grow steadily over the forecast period. Factors, such as absence of animal-derived components, high homogeneity, and high purity will be responsible for the growth of this segment over the forecast period. Along with this, strategic initiatives by key players in the market, such as acquisitions are projected to drive the segment’s growth in the coming years.

• For instance, in August 2022, Sartorius AG acquired Albumedix, Ltd., a U.K.-based manufacturer of recombinant human albumin-based products. This acquisition will help Sartorius AG strengthen its product portfolio in recombinant-based products.

The bovine serum segment accounted for the second-highest market share in 2023. The segment’s growth is mainly attributed to the low cost and stable nature of bovine serum products as a protein standard.

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By Application Analysis

Therapeutics Propel Growth with Regulatory Approvals and Innovative R&D

Based on application, the market is segmented into therapeutics, diagnostics, and research. The therapeutics segment is projected to account for the largest albumin market share during the forecast period. The segment’s expansion is attributed to the growing number of product approvals from national regulatory authorities, increased demand for albumin in R&D activities, leading to innovative product launches, and surge in the adoption of these products for therapeutic purposes.

• For instance, in July 2023, Kedrion Biopharma announced that China's National Institutes for Food and Drug Control (NIFDC) had approved BPL's human Albumin product for release into the Chinese market for therapeutic use.

In terms of revenue, the diagnostics segment is projected to grow at a comparatively significant rate owing to the growing need for early detection of diseases.

• For instance, in July 2019, EKF Diagnostics announced the availability of its Lucica Glycated Albumin-L test to be used for patient monitoring at the 2019 AACC Clinical Lab Expo.

The research segment accounted for the second-highest market share in 2023. The increasing prevalence of various life-threatening diseases and rare disorders coupled with increasing investments in R&D and clinical trials for drug development are factors responsible for the significant growth of the segment.

By End-user Analysis

Hospitals & Clinics to be Major Product End-Users Due to Increased Prescription of Drugs from These Medical Centers

Based on end-user, the market is segmented into hospital & clinics, pharmaceutical & biotechnology industry, and research institutes. The hospital & clinics segment dominated the global market share in 2023. The segment is projected to record a considerable CAGR during the forecast period. This dominance is due to growth in the albumin-based therapeutic treatments and administration of these therapeutics in hospital settings.

• For instance, according to an article published by the NCBI in 2021, albumin-based products are mostly utilized for hypovolemia & hypotension, sepsis & septic shock, and intradialytic hypotension treatments in hospitals. They are most frequently ordered by nephrology, critical care, and surgical departments.

The pharmaceutical & biotechnology industry segment is expected to record the fastest CAGR during the forecast period. The growing usage of albumin in developing new therapeutic solutions is projected to drive the growth of this segment in the upcoming years. Additionally, the biopharmaceutical companies are focusing on conducting clinical trials for the development of albumin-related products.

• For instance, in July 2023, Grifols announced that it had completed the enrollment in the phase-3 trial of Albutein (albumin-human injection) for the treatment of patients with decompensated cirrhosis.

The research institutes segment accounted for a considerable market share in 2023. Growth in the number of R&D activities to expand the application areas of these recombinant products might result in a comparatively higher segment growth during the forecast period.

REGIONAL INSIGHTS

On the basis of region, the global market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

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Asia Pacific accounted for the highest share in this market. The region was valued at USD 3.42 billion in 2023. China is the world's largest human albumin market as there is a significant demand for these products. The regional market’s growth is characterized by the expansion of manufacturing units in China, growing investments in R&D, and robust adoption of therapeutic products.

• For instance, in June 2020, Biotest AG marked a major milestone by expanding its sales of human albumin in China to treat chronic conditions.

In addition, several research studies were carried out in China for the development of nanotechnology-based albumin products for advanced drug delivery systems. Human serum albumin has received much attention from researchers in the study of drug delivery systems as it is associated with advantages, such as non-toxicity, good biocompatibility, non-immunogenicity, and long half-life.

North America accounted for the second-highest market share in 2023. High use of these products in R&D activities, strong demand for them in the U.S., growing non-therapeutic applications of these products, rising product approvals, and rise in the plasma collection in the region are factors that are projected to help the regional market grow steadily.

Europe is projected to record a considerable growth rate over the forecast period. The regional market’s growth is mainly attributed to the strategies adopted by the key players, such as establishment of plasma fractionation centers to expand their product portfolios, mergers & partnerships, and new product launches.

Furthermore, Latin America and the Middle East & Africa accounted for a considerable market share in 2023. The market is projected to grow over the forecast period due to the increased penetration of plasma fractionation facilities to promote manufacturing of these products and initiation of R&D activities.

List of Key Companies in Albumin Market

CSL Behring (CSL), Grifols, S.A, and Takeda Pharmaceutical Company Ltd. to Dominate Market Owing to Diversified Product Portfolio

The major players in the global market include CSL Behring (CSL), Grifols, S.A, and Takeda Pharmaceutical Company Limited, which held the majority of the market share in 2023.

The market was dominated by CSL Behring (CSL) in 2023 owing to its strong focus on obtaining approval for key products and emphasis on mergers and partnerships with other companies to strengthen its presence.

• For instance, in March 2021, CSL Behring (CSL) announced its partnership with Qingdao Baheal Medical Co. Ltd. ("Baheal Medical"). The two companies were focused on providing effective and accessible drug solutions, including human albumin products, to Chinese patients.

Furthermore, companies, such as Grifols, S.A and Takeda Pharmaceutical Company Limited accounted for a significant market share in 2023 owing to its strong focus on increasing its manufacturing capacity to meet the product demand.

• In April 2023, Takeda Pharmaceutical Company Limited received the U.S. FDA approval to expand the use of HYQVIA to treat primary immunodeficiency in children.


• In September 2022, Takeda Pharmaceutical Company Limited invested over USD 300 million to build a new production facility for plasma-derived therapies in Belgium.

Other players including Kedrion S.p.A., Octapharma AG, Albumin Bioscience, Aspira Chemical, ALBUMEDIX (Sartorius AG), and Cyagen Biosciences are focusing on strategic initiatives, such as mergers & acquisitions, new product launches, and regulatory approvals to expand their geographical presence in the global market.

LIST OF KEY COMPANIES PROFILED:

• CSL Behring (CSL), (U.S.)


• Kedrion S.p.A. (Italy)


• Takeda Pharmaceutical Company Limited (Japan)


• Lazuline Bio (India)


• InVitria (U.S.)


• Biorbyt Ltd. (U.K.)


• Grifols, S.A. (Spain)


• Octapharma AG (Switzerland)


• Albumin Bioscience (U.S.)


• Aspira Chemical (U.S.)


• ALBUMEDIX (Sartorius AG) (Germany)


• Cyagen Biosciences (U.S.)


• Merck KGaA (Germany)


• Thermo Fisher Scientific Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• August 2023: Dyadic International, Inc., a biotechnology company, announced positive results from the third-party analytical testing of its animal-free recombinant serum albumin.


• July 2023: Kedrion Biopharma, an international biopharmaceutical company manufacturing plasma-derived therapeutic products, announced the expansion of its human serum albumin products in the China market to treat rare diseases.


• June 2023: Sartorius AG (ALBUMEDIX) collaborated with Cell and Gene Therapy Catapult (CGT Catapult) to investigate using the company’s albumin-based solutions for advanced therapy applications, including viral vector manufacturing.


• May 2023: American Regent, Inc. announced the launch of paclitaxel protein-bound particles for injectable suspension (Albumin-Bound), an alternative to Abraxane.


• July 2021: Octapharma AG received the U.S. Food and Drug Administration (FDA) approval to expand its production facility in Springe, Germany as an additional manufacturing site for Fraction II.


• May 2020: Bio Products Laboratory Ltd. announced the U.S. launch of ALBUMINEX 5% (human albumin) solution for injection and ALBUMINEX 25% (human albumin) solution for injection to treat hypovolemia, ascites, and hypoalbuminemia.

REPORT COVERAGE

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The report offers a detailed market analysis and overview. It focuses on key aspects, such as competitive landscape, key products, applications, end-users, and regions. Besides this, it offers insights into the market drivers, trends, dynamics, and other key insights. In addition to the factors mentioned above, the report encompasses several factors that have contributed to the growth of the market in recent years.

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