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  • Published On : Jun 2022
  • Code : CMI5040
  • Industry : Biotechnology
  • Pages : 160
  • Formats :

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

rHu Albumin  | Coherent Market Insights

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.

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rHu Albumin Market Report Coverage

Report Coverage Details
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
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Source: Oryza sativa, Pichia pastoris, Others (Saccharomyces cerevisiae, etc.)
  • By Application: Cell Culture Media (Nutrient and stabilizer, Medium Supplement), Stem Cell Therapy, Drug Formulations, Cryopreservation, Others (Stabilization of Vaccines, etc.)
  • By End User: Pharmaceutical & Biotechnological Industry, Research Institutes
Companies covered:

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.

Growth Drivers:
  • Increasing number of clinical trials
  • Increasing advantages of rHu albumin
  • Increasing facility expansions by market players 
Restraints & Challenges:
  • Increasing challenges associated with manufacturing of recombinant human serum albumin

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

rHu Albumin  | Coherent Market Insights

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 Dynamics

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:

  • This report provides an in-depth analysis of the global rHu albumin market , provides market size (US$ Million), and compound annual growth rate (CAGR%) for the forecast period (2022-2030), considering 2021 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrix for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, regional outlook, and competitive strategies adopted by the leading players
  • It profiles leading players in the global rHu albumin market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments and strategies, and future plans
  • Key companies covered as a part of this study 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.
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decision regarding their future product launch, technology up-gradation, market expansion, and marketing tactics
  • The Global rHu Albumin Market report caters to various stakeholders in this industry including investors, suppliers, manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision making through various strategy matrices used in analyzing the global rHu albumin market

Detailed Segmentation:

  • Global rHu Albumin Market , By Source:
    • Oryza sativa
    • Pichia pastoris
    • Others (Saccharomyces cerevisiae, etc.)
  • Global rHu Albumin Market , By Application:
    • Cell Culture Media
      • Nutrient and stabilizer
      • Medium Supplement
    • Stem Cell Therapy
    • Drug Formulations
    • Cryopreservation
    • Others
  • Global rHu Albumin Market , By End User:
    • Pharmaceutical & Biotechnological Industry
    • Research Institutes
  • Global rHu Albumin Market , By Region:
    • North America
      • By Country:
        • U.S.
        • Canada
    • Latin America
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Country:
        • U.K.
        • Germany
        • Italy
        • Spain
        • France
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Country
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Country/Region:
        • South Africa
        • Central Africa
        • North Africa
  • Company Profiles
    • Merck KGaA *
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Recent Developments/Updates
      • Strategies
    • HiMedia Laboratories Pvt. Ltd.
    • Albumin Bioscience
    • Albumedix
    • ScienCell Research Laboratories, Inc.
    • InVitria
    • Lazuline Biotech Private Limited
    • Lee Biosolutions, Inc.
    • Abcam Plc
    • Shandong Kingtone Biotechnology Co.,Ltd.

 “*” marked represents similar segmentation in other categories in the respective section.

Frequently Asked Questions

Global rHu albumin market is expected to exhibit a CAGR of 10.0% during the forecast period (2022-2030).
The market is estimated to be valued at US$ 84.9 Mn in 2022.
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. are some of the prominent players operating in the market.
The market is expected to be valued at US$ 182.5 Mn in 2030.
North America is the prominent region in the market.
Increasing number of clinical trials, increasing advantages of rHu albumin and research and increasing facility expansion by market players are some of the driving factors, which are expected to drive growth of the market.

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