RHU ALBUMIN MARKET ANALYSIS

Recombinant Human Albumin (rHu Albumin) is a product that is structurally comparable to native human serum albumin (HSA) but does not contain any animal components or serum rHu Albumin is a single-chain polypeptide with a molecular weight of 66 kilo kDa (kilo Dalton), which is non-glycosylated. It is made without the use of any ingredients sourced from animals or humans. rHu Albumin (recombinant human albumin) is a well-defined, animal-free product that outperforms plasma-derived HSA. It's a popular choice for cell culture applications.

Global rHu Albumin Market - Impact of the Coronavirus (COVID-19) Pandemic

Coronavirus (COVID-19) outbreak was first reported on December 31, 2019, in Wuhan, China. The World Health Organization declared COVID-19 as pandemic on March 11, 2020. According to the Coronavirus (COVID-19) Weekly Epidemiological Update by the World Health Organization, over 527 million cases and 6.28 million deaths due to coronavirus disease (COVID-19) were reported till June 01, 2022, across the globe.

Impact of COVID-19 on Demand and Supply of rHu Albumin

The COVID-19 pandemic and lockdown in various countries across the globe have impacted the financial status of businesses across all sectors including private healthcare sector. The COVID-19 pandemic has impacted the entire supply chain of the healthcare industry mainly due to strict lockdown in several regions. The COVID-19 pandemic has affected the economy of various regions across the globe in three main ways; by directly affecting the production and demand of healthcare products; by creating disruptions in distribution channels; and by affecting the companies and various markets financially. Several countries such as Thailand, Indonesia, and Singapore are facing problems with regards to transportation and distribution of healthcare products.

There was a strong impact on rHu albumin market during COVID-19 pandemic, owing to its use in vaccine production. Market players are concentrating on employing rHu albumin as a stabilizer in vaccine production. For instance, Albumedix Ltd., a science-driven, biotechnology company, is offering a recombinant human serum albumin called Recombumin which is expressed in Saccharomyces cerevisiae. Recombumin has already been employed in marketed vaccines as well as a variety of clinical and pre-clinical studies.

The Global rHu Albumin Market is estimated to be valued at US$ 84.9 Mn in 2022, and is expected to exhibit a CAGR of 10.0 % over the forecast period (2022-2030).

Figure 1: Global rHu Albumin Market Share (%) Analysis, By Source, 2022

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Increasing number of clinical trials and research in rHu albumin is expected to drive growth of the global rhu albumin market over the forecast period.

For instance, in November 2021, Shilpa Medicare Limited, a company that manufactures Active Pharmaceutical Ingredients (API) Formulation and Development services, announced that the Central Drugs Standard Control Organization (CDSCO) has granted permission to conduct a Phase I human clinical study on its flagship novel product, recombinant Human Albumin (NavAlbumin), through its wholly owned subsidiary, Shilpa Biologicals Pvt Ltd (SBPL). The product is a synthetically developed product,  and it is governed by a global patent.

Increasing advantages offered by recombinant human serum albumin over human or animal serum albumin

Additional benefits of using recombinant human serum albumin over human or animal grade serum albumin for various applications is expected to fuel growth of the global rHu albumin market over the forecast period.

• To alleviate the numerous problems associated with standard albumin procurement methods, recombinant human albumin was developed
• The recombinant product is favored due to factors such as absence of animal material, reliable supply, higher purity, absence of host-derived proteases, high homogeneity, higher free thiol content, absence of known or unknown human pathogens, batch-to-batch consistency, and presence of a reputable regulatory pathway
• Recombinant albumin in drug formulation has been reported to prevent surface adsorption, aggregation, fibrillation, and oxidation
• Moreover, introduction of recombinant human albumin — an animal-free, cGMP raw material with high consistency and purity, into the field of stem cell cultivation has improved the definition and control of culture media. These media are favored by regulatory bodies because they provide comprehensive quality data for all constituents, in addition to allowing for improved cell growth repeatability.

Global rHu Albumin Market- Restraint

Increasing challenges associated with manufacturing of recombinant human serum albumin are expected to hamper growth of the global rHu albumin market over the forecast period. Production of recombinant human serum albumin (rHSA) is fraught with challenges, particularly in terms of large-scale manufacturing and biosafety. The manufacturing process comprises expression of rHSA from several expression systems, with a focus on the protein's expression levels, downstream processing, cost-effectiveness, and impurity-related safety concerns. A very high expression level is thus the minimal need for commercially producing rHSA at an economically viable level. High recombinant protein deposition may cause unexpected harmful effects in the host, and recombinant protein levels may be reduced via breakdown or aggregation.

Global rHu Albumin Market – Regional Analysis

On the basis of region, the Global rHu Albumin Market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.

North America region is expected to exhibit lucrative growth opportunity for the rHu albumin market, owing to growth strategies adopted by market players such as developing manufacturing centers to expand their product portfolio .For instance, in December 2021, InVitria (a company based in Colorado, U.S. that develops, manufactures, and markets high performance products used in cell culture, vaccines, and others) announced facility expansion to ensure customer satisfaction while offering a local supply for UK customers. The company completed the facility expansion to serve UK customers from its operations in Munich, Germany. 

Moreover, increasing research and development activities of rHu albumin in Europe are expected to drive growth of the market in the region. For instance, according to a study published in clinicaltrials.gov, a pilot study is being conducted by the University Hospital, Ghent, Belgium, which started on March 3, 2021, with the aim to investigate the beneficial effect of bicarbonate buffered medium containing hyaluronan and recombinant human albumin (EmbryoGlue, Vitrolife) in patients with documented repeated implantation failure on live birth per randomized subject as primary endpoint. The estimated study completion date is April 2023.

Figure 2: Global rHu Albumin Market Value (US$ Mn), by Region, 2022

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Global rHu Albumin Market – Competitive Landscape

Major players operating in the global rHu albumin market include Merck KGaA, HiMedia Laboratories Pvt. Ltd., Albumin Bioscience, Albumedix, ScienCell Research Laboratories, Inc., InVitria, Lazuline Biotech Private Limited, Lee Biosolutions, Inc., Abcam Plc, and Shandong Kingtone Biotechnology Co.,Ltd.