Appropriate selection of excipients during the new product development is one of the critical in the pharmaceutical formulations. Criteria for selection of suitable excipient depend on the physical, chemical and biological properties of the excipient. Primarily, it should help stabilize and protect the drug/active pharmaceutical ingredient (API) in the formulation against degradation, oxidation or aggregation, during manufacturing, transport and storage. Preformulation studies comprise investigation of drug-excipient interactions that help in selection of appropriate excipients to achieve the desired properties for the final drug product. Albumin is a well characterized protein and functions as a therapeutic, diagnostic agent, as well as an excipient. As an excipient, albumin has wide applications in drug formulation, drug delivery, vaccine manufacturing and as a component of media in vaccine production. Stable nature of albumin makes its handling and storage easier than other proteins, making it suitable for use as an excipient. Albumin due to its intrinsic stability can be heated at 60°C for 10 hours facilitating virus inactivation during manufacturing.
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The optimal formulation of active pharmaceutical ingredients (API) into efficacious dosage form to ensure stability and acceptable shelf life is a critical and prime prerequisite. The use of albumin as an excipient with proven preference in culture media, stabilizer in pharmaceutical and biotechnology products, vaccines, and as a drug carrier in the form of nanoparticles or microspheres has made it a multifunctional excipient in the formulation development. The unique features of albumin such as amphiphilicity and surface-active properties, as well as high glass transition temperature make it a suitable excipient. The global albumin market was valued at USD 704.9 million in 2013 and is expected to reach USD 828.2 million by 2020, growing at a CAGR of 2.3% during the forecast period 2014 to 2020. Improved product stability, enhancement in protein purification technology and emerging use of recombinant albumin are some factors propelling market growth.
The report also discusses the challenges faced by the albumin market across the world. Strict rules and regulations regarding the usage of albumin, high cost associated with it, and the concerns pertaining to the impact of albumin on human health are the major issues that the global albumin market is currently dealing with. The rising demand for serum-free, customized, and chemically defined media is likely to hamper the global albumin market over the forecast period.
According to the report, the global albumin market is evaluated on three front: type, application, and regional distribution. Based on type, the market is segmented into the bovine serum albumin, human serum albumin, and recombinant albumin markets. The human serum albumin market dominated the overall albumin market, generating a revenue of US$476.7 mn in 2013. The market segment is likely to retain its position, expanding at a CAGR of 2.20% between 2014 and 2020 and reach US$557 mn by 2020. However, the recombinant albumin market is likely to register the fastest growth, at a CAGR of 2.70% over the forecast period.
Transparency Market Research (TMR), a market intelligence and research firm, has recently announced the publication of a market study on the global albumin market, estimating it to expand at a CAGR of 2.30% during the period from 2014 to 2020 and reach US$828.2 mn by the end of 2020, from a market value of US$704.9 mn in 2013.The research report, titled “Albumin Market – Global Industry Analysis, Size, Share, Volume, Growth, Trends and Forecast 2014 – 2020”, states that the improved stability of products containing albumin as an excipient has driven the demand for albumin extensively in the global arena. Apart from this, the enhancement in molecular separation and protein purification technologies, together with increasing usage of recombinant albumin, is expected to fuel the global albumin market significantly over the forecast period.
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The report states that the global market for albumin is classified into drug formulation and delivery, component of medium, and vaccines on the basis of application. Among these, the drug formulation and delivery market is estimated to post the fastest CAGR of 2.40% from 2014 to 2020 and reach US$395.9 mn by the end of the forecast period.North America, Asia Pacific, Europe, and the Rest of the World are the key regional markets for albumin in the global arena, cites the research report. North America occupies the leading position in the worldwide albumin market, wherein the U.S. accounts for the largest share. The presence of a huge pharmaceutical industry, which is one of the major end users of albumin, is the main reason for the dominance of North America in the global albumin market.