Published: Jul, 2018
Transparency Market Research (TMR) has published a new report titled, “Albumin (as Excipient) Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2018–2026”. According to the report, the global albumin (as excipient) market was valued at US$ 750 Mn in 2017 and is anticipated to reach US$ 1200 Mn by 2026 at a CAGR of over 5.0% from 2018 to 2026. Grant of regulatory approvals coupled with subsequent launch of albumin based products is the key factor expected to propel the market during the forecast period.
Albumin is a water soluble globular protein produced in the liver. It accounts for 50% of blood plasma proteins. These play a vital role in regulating blood volume and act as transporters for molecules such as few hormones, bile salts, and ions. Albumin is commonly used as blood volumizer in rare diseases, burns, shocks, liver conditions, and other blood loss trauma and surgeries. However, usage of albumin as multifunctional excipient is increasing due to rise in consumption of albumin for applications such as drug formulation, vaccines, drug discovery, culture medium, stabilizing agent, and diagnostics. Albumin has been widely used as a versatile drug carrier in systems such as albumin fusion protein, albumin-drug nanoparticles, and pro-drugs. It is used as a drug carrier for the treatment of various diseases such as rheumatoid arthritis, diabetes, cancer, and hepatitis. It also has the ability to bind to extraordinarily diverse range of molecules, as it provides depository for a wide variety of compounds. These factors make albumin most suitable to be used as an excipient in vaccine and drug production.
High Initial Investment for Plant Setup to Restrict Growth
High cost and expertise required to set up a production plant and stringent regulatory criteria hamper the growth of the global albumin (as excipient) market. Extraction of recombinant human serum albumin and processing incurs significant cost. Additionally, expert staff is required to handle operations, as recombinant technology attracts stringent laws and regulations. Moreover, cost associated with refinement of recombinant albumin to attain high purity is a major concern among the industry players. This acts as a major restraint of the market.
Recombinant Albumin Product Segment to Grow at a Rapid Pace
Recombinant human serum albumin is an advanced form of HSA, which is produced on large scale through gene sequence modification. Manufacture of rHSA is carried out using vectors. The recombinant albumin segment is anticipated to grow at the highest CAGR of 6.5% during the forecast period from 2018 to 2026. Demand for recombinant proteins is rising across the globe, due to less chance of infections. Recombinant human serum albumin has insignificant immunogenicity in a patient’s body which reduces the chances of antibody formation against it and the drug candidate. rHSA acts as a multifunctional excipient to stabilize the drug product by reducing oxidation, aggregation, and surface adsorption. These features make rHSA a preferred choice as an excipient in drug formulations. Several vaccines are produced using recombinant albumin as an excipient such as MMR, MMRV, and rotavirus vaccine live.
Drug Delivery to be Most Promising Application Segment
The drug delivery segment accounted for 25.0% market share in 2017 and the trend is expected to continue in the near future. Usage of human serum albumin nanoparticles as drug delivery systems with applications in various diseases such as cancer is likely to boost the growth of the segment. The drug delivery sub-segment held leading share of the recombinant albumin segment. Ongoing collaborations between biopharmaceutical companies for recombinant albumin-based drug delivery systems are anticipated to fuel the growth of the segment during the forecast period. For instance, in May 2015, Serendex Pharmaceutical initiated phase I trials of Molgradex, a drug candidate for treating rare pulmonary diseases. The drug candidate uses Novozymes’s Recombumin, a recombinant human albumin for the effective delivery of the biologic to lungs.
Pharmaceutical & Biotechnology Industry to be Key End-user
The pharmacy and biotechnology industry segment is expected to dominate the market. The segment was valued at US$ 500 Mn in 2017. Rise in research and developmental activities for development of technologically advanced products and increase in government funding have led the growth of the segment. Recombinant human serum albumin is used in the life sciences industry for a wide range of applications, including component of cell and microbial culture media, blocking agent in blotting, growth supporter in recombinant DNA, and hybridoma technology. This is likely to boost the growth of the segment.
Asia Pacific to Grow at a Rapid Pace
Demand for albumin is high in countries such as India and China. However, uptake of these therapeutics is low due to lack of awareness about these products and their therapeutic uses. Hence, awareness programs conducted by organizations such as PPTA, which include International Plasma Awareness Week, to help increase awareness about plasma donation and the different plasma protein therapies available along with their potential uses are expected to increase the uptake of these therapeutics in treating various conditions. The albumin market in Asia Pacific is projected to witness exponential growth during the forecast period. The region is anticipated to gain market share to capture around 26.0% in terms of revenue by 2026.
CSL Behring LLC, Grifols International, S.A., Inc., and Baxter to Lead Market
The albumin market witnesses moderate competition, as only a few players dominate the market. Key players operating in the market include CSL Behring LLC, Grifols International, S.A., Baxter, and Octapharma AG. New entrants refer to new companies that are interested in manufacturing and developing albumin as an excipient. Existing players have substantially large sales, marketing, financial, manufacturing, and other resources, which could pose a major challenge for new entrants. Additionally, stringent government regulations set by the U.S. FDA to monitor the quality of albumin could pose a barrier for new entrants. Players with strong financial and R&D background are anticipated to survive in this competitive market. Other players in the market include InVitria, Novozyme A/S, Sigma-Aldrich Co., HiMedia Laboratories Pvt. Ltd., Albumin Therapeutics, LLC, Medxbio Pte Ltd., RayBiotech, Inc., and SeraCare Life Sciences etc.
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