An Array of Application Areas Continue to Uplift Growth Prospects of Albumin Market
Human serum albumin, the most abundantly found protein in blood, is a physiological plasma expander that is administered in acute conditions to restore circulating blood volume used as replacement fluid in therapeutic plasma exchange. It is also a potential protein replacer in a number of diseases. Albumin has a wide range of application areas, viz. as a vaccine ingredient, drug formulation agent, coating for medical devices and equipment, and sealant in surgeries. Albumin has long been used in medical treatments of liver diseases, cardiopulmonary bypass, hemodialysis, and trauma resuscitation, besides its application in treatment of patients of burns, hypovolemia, surgical blood loss, hypoalbuminemia, acute respiratory distress syndrome, and hemorrhage, acute liver failure. The global albumin market thus continues to rise at a promising pace.
Growing Demand for Plasma Derived Medicines to Elevate Albumin Market Growth
The global plasma fractionation market is >US$ 25 Bn worth market and growing with robust high single digit growth rate. Albumin is the second largest segment of plasma derived medicinal products after intravenous immunoglobulin (IVIG). It captures roughly 15% of global plasma derived products revenue. Nearly 85-90% of plasma used for manufacturing medicinal products and remaining little fraction of unused plasma derived from whole blood donated for transfusion purposes. Advances made in blood separation processes combined with the advent of specialised plasma-related products, is anticipated to impart a large growth momentum to the plasma protein market and subsequently albumin market. The plasma protein market has been growing due to the emergence and growth of several specialty products. Over the years, the US Food and Drug Administration (FDA), and other international drug regulatory authorities have approved multiple products. Albuminex and Kedbumin are the two recent FDA-approved biologics.
COVID-19 Pandemic Adds to Already Strained Albumin Demand-Supply Landscape
Most plasma used for manufacturing medicinal products is collected as source plasma by apheresis from donors in dedicated plasma collection centers. As per plasma protein therapeutics association (PPTA), U.S. is the largest contributor (~71%) to the global source plasma supply in 2017. Only 4 European countries (Germany, Austria, Czech Republic, and Hungary) allow remuneration for plasma donors. In Asia Pacific, China allows for donor compensation and collects a significant portion of the global plasma supply. So. Most of the countries are import dependent of plasma or the derived products to meet their demand. In 2019, intravenous immunoglobulin (IVIG) has been in short supply and resulted in local shortages and rationing.
In Asian countries like China, high albumin usage is attributed in part to cultural preferences (Chinese treat albumin as an energy supplement), and in part by the aggressive commercial distribution of albumin facilitated by imports. With the COVID-19 pandemic the global plasma supply has come under tremendous pressure. The donor pool has been reduced by COVID-19 infections or fear of exposure to COVID-19 in the collection center setting. Ironically, The COVID-19 pandemic caused an additional need for plasma threatening an already stressed system.
Human Serum Albumin Dominant; Recombinant Albumin Holds High Potential
Different types of serum albumin (Human serum albumin, bovine serum albumin and recombinant albumin) are widely used in clinical applications. Human serum albumin and bovine serum albumin are obtained from human plasma and bovine plasma, respectively. On the other hand, recombinant albumin is manufactured by recombinant techniques in yeast and bacteria strains. Human serum albumin is the dominant segment in the global albumin market. New product developments and increase in usage of in non-therapeutic applications resulted in high demand of Human serum albumin. Nontherapeutic application of human albumin as an excipient has garnered plenty of interest from the industry and resulted in creating potential customer base comprising biopharmaceutical companies, research institutes and academia.
Recombinant albumin is set to register robust growth in the forecast period. The industry is shifting from animal and human derived albumin to chemically-defined albumin. This shift is due to several advantages of recombinant albumin - high purity, certainty of supply, high free thiol content, high homogeneity, absence of known or unknown human pathogens, and the presence of an established regulatory pathway.
Highly Fragmented Market to Consolidate Further with M&A Deals
Top three manufacturers - CSL Limited, Grifols S.A., and Takeda Pharmaceutical Company Limited together capture over 50% of the market. These companies are further strengthening their positions with strategic M&A deals involving Chinese suppliers. In 2017, CSL Limited acquired Wuhan Zhong Yuan Rui De Biologics (Ruide) in China for US$352 Mn. In 2020, Grifols acquired Green Cross’ fractionation plant in Canada, and 11 plasma centers in the US. Some of the key players in the global albumin market are Biotest AG, Novozymes, Kedrion S.P.A., Merck KGgA, Seracare Life Sciences, Hualan Biologics, and Shanghai Raas.