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.
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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 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.
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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.