Global Recombinant Human Serum Albumin Market Outlook 2031:
The global recombinant human serum albumin market size was valued at USD 71.98 Million in 2022 and is expected to reach USD 151.24 Million by 2031 projected to expand at a CAGR of 8.6% during the forecast period, 2023 – 2031. Major factor enabling the global recombinant human serum albumin market is scientific advancement in deriving high purification rHSA medium from sources other than blood plasma.
The demand for diagnostic kit manufacturing has increased, owing to the pandemic, thus driving the demand for rHSA. As per research, rHSA can be employed for the therapeutic used in the treatment of dialysis, hypovolemia, liver cirrhosis, and shocks & burns. rHSA is employed as a stabilizer in RTPCR COVID-19 tests. In the recent years, rHSA has been used for treating human colon cancer.
Human serum albumin (HSA) is a protein, abundantly found in human blood plasma, which is produced in the liver. Albumin aids in regulating colloidal osmotic blood pressure, maintaining plasma pH, and metabolizing exogenous and endogenous molecules such as steroids, fatty acids, hormones, and amino acids.
Recombinant human serum albumin (rHSA) is an engineered derivative of yeast (ScrHSA) and rice-based expression system (OsrHSA). It is extremely purified, bacteria-free, animal component-free, and virus-free. rHSA is structurally equivalent to plasma-derived HSA.
rHSA is plant-derived, thus eliminating the threat of viral and bacterial contaminations. Moreover, the high-quality consistency of rHSA reduces time and offers high-grade performance. rHSA supplements cell culture media to encourage cell growth and amplify recombinant protein yield. rHSA acts as an additive in serum-free or reduced serum culture media. It is used in the cryopreservation of cells.
rHSA is apt for applications such as electrophoresis, where protein contaminants are undesirable. rHSA is used in ELISA applications and as a blocking agent in Western blots. rHSA is more homogeneous than plasma-derived HSA. It lacks immunogenicity & toxicity and offers a distinct and uniform medium. rHSA helps in long-term storage.
It is used to enhance stem cell growth in liver, kidney, cardiac, keratinocyte, embryonic, mesenchymal, neural, and fibroblast stem cells. rHSA is used as an alternative to plasma-drive HSA in human therapeutics, cell culture media, diagnostic test kits, and research & development. The end-users of rHSA includes hospitals & clinics, pharmaceutical & biotechnological industry, and research institutes.
Regulatory agencies have encouraged pharmaceutical companies to use non–animal-derived sources for pharmaceutical production to eliminate the potential risk of viral contamination. The development of a cost-effective technique for the production of recombinant HSA (rHSA) by employing yeast or rice seeds was adopted. The contamination caused by pHSA and bHSA were overcomed by using rHSA.
The requirement of high dosage of human serum albumin in clinical applications surge for the large-scale production of OsrHSA. The manufacturing of OsrHSA requires field production of transgenic rice. Field trail of transgenic plant raises concerns of environmental safety, since rice is a staple food worldwide.
Recently, rice was listed as a favorable host for molecular farming since, rice is a highly self-pollinated crop, and rice pollen is remarkably short-lived (<10 min) when it is out of the anther; regarding biosafety assessment of transgenic rice, it showed a very low frequency (0.04–0.80%) of pollen-mediated gene flow between genetically modified (GM) rice and adjacent non-GM plants.
This low frequency can be decreased to negligible levels by a short spatial isolation. To manage the environmental impacts of plant-made pharmaceuticals, the US Department of Agriculture (USDA) and European regulatory authorities have already issued guidance for field testing of GM organisms intended for industrial and pharmaceutical use. Following the guidance, the USDA has approved 3358.3 hectares and 13 plant hosts for field trial since 2004.
Presently, OsrHSA transgenic rice was generated by using an endosperm-specific promoter for HSA gene expression and a callus-specific promoter for a selective marker gene, which could fundamentally reduce the environmental risk from selective marker and target genes exposure.
Recombinant Human Serum Albumin Market Dynamics
The production of rHSA has increased as a substitute to plasma-derived human serum albumin (HSA) due to the contingent risk of bacterial contamination of HSA, which is a derivative of fractionation of pooled donor blood and its rising demand in therapeutic applications. rHSA is derived from plants, which reduces the risk of viral and bacterial contaminations. rHSA is used as an additive in serum-free culture media or reduced-serum.
rHSA is employed in cell culture media for enabling the growth of diverse types of cells such as induced pluripotent stem cells (iPSCs), immune cells, T-cells, mesenchymal stem cells (MSCs), and embryonic stem cells (ESCs). rHSA helps to reduce the time required for cell culture media, while offering superior performance. The pricing of rHSA is low, which enables a reduction in downstream product cost with no loss of quality.
rHSA is ideal for cell culture media supplement, as it fosters cell growth and enhances recombinant protein yield. The recombinant human serum albumin is used to treat low albumin levels caused by abdominal infections, dialysis, surgery, pancreatitis, liver failure, respiratory distress, and ovarian disorders caused by fertility drugs, bypass surgery, and other health conditions.
rHSA has extensive usage in diagnostic tests and the ongoing pandemic has increased the usage of rHSA, thus offering market players immense opportunities. The use of rHSA enables effectiveness in COVID-19 diagnostic tests by acting as an excipient which includes RT-PCR, RT-LAMP, and LAMP test kits. rHSA helps in saving precious time required in preparing samples.
The purity of rHSA allows magnification to take place even with limited levels of template DNA. rHSA assists to thwart non-specific reagents adsorption to the PCR tube while acting as an enhancer that binds PCR inhibitors and enabling quicker signal achievement (LAMP, RT-LAMP). The aforementioned factors are creating opportunities in the market.
The demand for rHSA for cryopreserving stem cells has increased, as rHSA is beneficial in cryopreservation of cells owing to its abilities and its property of concealing cell surface, thus stabilizing the solution and facilitating the cryopreservation of cells. The usage of rHSA in stem cells assists in maintaining viability and functionality. Recombinant human serum albumin is safe for optimized cell performance, as it is free from animal and human components.
rSHA provides regulatory advantages while offering batch-to-batch consistency and enhancing cell viability. High availability, high production, and usage of pHSA impedes the growth of the recombinant human serum albumin market despite it being more cost-effective and safer alternative to plasma-derived human serum albumin (pHSA) and bovine serum albumin.
Scope of Recombinant Human Serum Albumin Market Report:
The report on the global recombinant human serum albumin market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.
||Recombinant Human Serum Albumin Market - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast
||2016 – 2021
||By Types (OsrHSA and ScrHSA), By Application (Cell Culture Media, Stem Cell Therapy, Vaccine Production, Drug Formulations, Medical Device Coating, and Others), and By End-users (Pharmaceutical and biotechnology companies, Hospitals and clinics, and Research Institutes)
||Asia Pacific, North America, Latin America, Europe, and Middle East & Africa
||Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, Market Trends, and Revenue Forecast
|Key Players Covered in the Report
||Albumedix, Merck KGaA, InVitria, HiMedia Laboratories, Wuhan Healthgen Biotechnology Corp, Cyagen Biosciences, ScienCell Research Laboratories, Inc., Lee BioSolutions (Medix Biochemica), Lazuline, Akron Biotech, and Proteintech Group, Inc.
Recombinant Human Serum Albumin Market Segmental Outlook
In terms of types, the global recombinant human serum albumin is categorized as OsrHSA and ScrHSA. The ScrHSA segment held significant share of the market in 2019. This market share may be attributed to increasing applications in the drug formulations, diagnostic test kits, and cell culture media. The ScrHSA segment is anticipated to expand at a significant CAGR during the forecast period.
ScrHSA is a rich dietary source of folate widely used in stem cells, easy availability of Saccharomyces Cerevisiae is anticipated to boost the market. The OsrHSA segment is anticipated to boost at a significant CAGR during the forecast period. Low cost and virus-free nature of OsrHSA are key factors driving the demand for OsrHSA, particularly in the cell culture media.
Preference for OsrHSA in the cryopreservation of cells is rising, which in turn, fuels segment growth in the industry. Moreover, increasing research to develop OsrHSA is likely to create growth opportunities in the OsrHSA segment during the forecast period.
On the basis of application, the global recombinant human serum albumin market is segmented into cell culture media, stem cell therapy, vaccine production, drug formulations, medical device coating and others. The cell culture media segment is anticipated to grow at rapid pace during the forecast period in the global recombinant human serum albumin market.
This growth can be attributed to its rising demand of rHSA in biopharmaceuticals. On the other hand, the stem cell therapy segment is estimated to expand at a considerable CAGR of during 2020-2027 forecast period owing to increasing awareness stem cell therapy and rise in its prevalence. This trend is anticipated to fuel the growth of the stem cell therapy during the forecast period.
Based on end-users, the global recombinant human serum albumin market is categorized into pharmaceutical and biotechnology companies, hospitals and clinics, and research institutes.
The pharmaceutical and biotechnology companies segment held a significant market share in 2019 and is anticipated to grow at a significant CAGR. This growth can be attributed to the increasing usage of rHSA as a biomaterial in pharmaceuticals and also as a carrier protein and an excipient. On the other hand, rHSA is increasingly studied for new applications and used as a plasma volume expander and drug carrier. This is anticipated to boost the research institutes segment growth.
Region Wise Outlook
On the basis of regions, the global recombinant human serum albumin market is categorized as North America, Europe, Asia Pacific, Latin America, and Middle East & Africa (MEA). The market in the Asia Pacific is anticipated to grow at a considerable pace during the forecast period owing to the increasing demand for stem cell therapy in the region.
North America holds a significant market share of the global recombinant human serum albumin market and is estimated to grow at a substantial CAGR during the forecast period. Favorable government regulations and increasing demand from end-users is projected to fuel the market growth in North America.
Key Benefits for Industry Participants & Stakeholders
- In-Depth Analysis of the Global Recombinant Human Serum Albumin Market.
- Historical, Current and Projected Market Size In Terms Of Value.
- Potential & Niche Segments And Regions Exhibiting Promising Growth Covered
- Industry Drivers, Restraints And Opportunities Covered In The Study
- Recent Industry Trends And Developments
- Competitive Landscape & Strategies Of Key Players
- Neutral Perspective On From Global Recombinant Human Serum Albumin Market Performance
- Cell Culture Media
- Stem Cell Therapy
- Vaccine Production
- Drug Formulations
- Medical Device Coating
- Pharmaceutical and biotechnology companies
- Hospitals and clinics
- Research Institutes
- North America
- Asia Pacific
- Latin America
- Middle East & Africa (MEA)
- Merck KGaA
- HiMedia Laboratories
- Wuhan Healthgen Biotechnology Corp
- Cyagen Biosciences
- ScienCell Research Laboratories Inc.
- Lee BioSolutions (Medix Biochemica)
- Akron Biotech
- Proteintech Group Inc
- Key players in the global recombinant human serum albumin market are Albumedix, Merck KGaA, InVitria, HiMedia Laboratories, Wuhan Healthgen Biotechnology Corp, Cyagen Biosciences, ScienCell Research Laboratories, Inc., Lee BioSolutions (Medix Biochemica), Lazuline, Akron Biotech, and Proteintech Group, Inc. These companies are considered as key market players of global recombinant human serum albumin market, based on their revenue, research & development (R&D) activities in the areas of improving offerings, and regional presence.
- The players are adopting key strategies such as product development, geographical expansion, mergers and acquisition and many other strategies to cater the increasing demand for global recombinant human serum albumin market.