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
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.
|Base Year:||2021||Market Size in 2022:||US$ 84.9 Mn|
|Historical Data for:||2017 to 2020||Forecast Period:||2022 to 2030|
|Forecast Period 2022 to 2030 CAGR:||10.0%||2030 Value Projection:||US$ 182.5 Mn|
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.
|Restraints & Challenges:||
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.
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
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.
A biopharmaceutical is a medicinal product that is derived from biological sources such as animals, humans, and microorganisms using biotechnology. They are manufactured using stem cells, mammalian cells, etc., through tissue culture methods.
Tissue culture methods rely on cell culture medium, which contains a number of essential components such as carbohydrates, amino acids, vitamins, minerals, and a pH buffer system that keep the cell culture healthy and supply nutrition for the production of therapeutic recombinant molecules or biopharmaceuticals.
One such component of cell culture is recombinant human albumin. Recombinant human albumin (rHu) has applications in cell culture media and stem cell therapy. It is particularly a nutrient supplement and stabilizer in the cell culture medium. Moreover, it plays a role in cryopreservation for stem cell therapies.
Market players are focusing on various strategies such as distribution agreements which is expected to drive market growth over the forecast period. In April 2021, Albumedix, a science-driven, biotechnology Company, announced that they had entered into a distribution agreement with established and well recognized reagent supplier Fujifilm Wako Pure Chemical Corporation in Japan and China including Hong Kong.
Research and/or academic institutes are focused on research and development activities related to rHu albumin, which is expected to drive growth of the global rHu albumin market over the forecast period. For instance, in June 2019, The First Hospital of Jilin University, a leading national research university located in Changchun, China, initiated a phase I, single-center, randomized, double-blind, placebo-controlled single dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of recombinant human albumin injection in healthy volunteers for treatment of ascites.
Increasing research and development activities of rHu albumin in the region is expected to drive growth of the global rHu albumin market. For instance, according to a study published in clinicaltrials.gov, a trial, which started on April 8, 2021, is being conducted by Protgen Ltd, a research and development-oriented high-tech enterprise, based in Beijing, China. The trial is aimed at adopting a single-center, randomized, double-blind, dose-escalation, placebo-controlled design to evaluate the safety, tolerability, pharmacokinetics, and efficacy of a single administration of recombinant human serum albumin in healthy subjects. The study is estimated to be completed by December 31, 2022.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.