Blood products

Human Serum Albumin

Human Albumin 25%

Albumin

Albumin is a protein produced by liver and circulates in plasma.  Serum Albumin as a medicine increases plasma volume or albumin level in the blood. It is used in people with low albumin level caused by surgery, dialysis and etc. Todays, very few manufacturers currently supply human albumin for non-therapeutic applications as an excipient

Medical Uses of Serum Albumin

Human albumin is a generic name that can be found with different brand names such as Albuked, Albuminar-25, Alburx, Albutein, Buminate, Flexbumin, Human Albumin Grifols, Kedbumin, Plasbumin-25, and Plasbumin-5. It used to

  • Treat or prevent low blood volume resulting from trauma such as severe burns or an injury that causes blood loss, shock and also low blood pressure.
  • Replace albumin in people with low blood albumin levels caused by surgery, dialysis, abdominal infections, liver failure, pancreatitis, respiratory distress, bypass surgery, ovarian problems caused by fertility drugs, and etc.
  • Add back fluid after a fluid loss.

Albumin level

Albumin is known as a plasma substitute’s medication. This naturally-occurring protein found in plasma and helps to transport a number of the body’s substances like bilirubin and maintain the oncotic pressure of blood. Other physiological functions of this protein include antioxidant properties, free radical scavenging, in addition to maintenance capillary membrane integrity. It stabilizes circulating blood volume and carries hormones, enzymes, medicines, and toxins.

More albumin in the blood helps to draw fluid from the body into the blood vessels and so that increase the volume of the blood in the blood vessels. This is the case in treating shock when blood can’t carry enough oxygen to tissues in the body due to various causes, including serious injury, bleeding, surgery, or severe burns. It can also replace low blood protein. Its  solutions are also used to treat acute liver failure because it can bind excess bilirubin, a substance produced by the liver, and increase the volume of blood.

This Serum helps to increase the oncotic pressure of the intravascular system and moving fluids from the interstitial space so that decreasing edema and increasing the circulating blood volume. The increase in blood volume reduces the concentration and viscosity of blood and maintain cardiac output in shock in patients with decreased circulating blood volume.

Biosimilars

The primary protein present in human blood plasma is Human Serum Albumin. One brand of it is known as Albumin 5% or 25%; it is prepared from the pooled plasma of US donors in FDA-licensed facilities in the US. This bio-similar drug was approved for a biological license at both 5% and 25% concentrations by the FDA on June 21, 2018

ABI-009 (a nanoparticle albumin-bound version of the mTOR inhibitor sirolimus or rapamycin developed by Celgene) and rIX-FP, Vivekanandan, rIX-FP (a recombinant fusion protein linking coagulation factor IX with albumin used for the treatment of hemophilia B, with dosing intervals of up to 14 days) are some of the key products in which this protein is being used as a drug formulation agent, stabilizer or fusion protein for half-life extension. It is also expected Albutein for Alzheimer’s disease launch in late 2020.

Human Serum Albumin in the Market

Human albumin is widely known as a plasma replacement or expander for therapeutic purposes. But, the healthcare industry has been exploring the use of it as a non-therapeutic substance/excipient for commercial settings for over a decade.  It is expected that emerging opportunities for this protein  as a drug formulation agent, vaccine ingredient, sealant in surgeries, and coating for medical devices and equipment drive production across these application areas.  Analysis of the Global Human Albumin Market and Product has shown that the non-therapeutic use of this protein  as an excipient has generated plenty of interest from the industry and will attract a potential customer base comprising academics, research institutes, and pharmaceutical and biopharmaceutical companies and also a pharmaceutical supplier in turkey like Dano Health. But very few manufacturers currently supply it for non-therapeutic applications as an excipient. It is the case about pharmaceutical wholesaler in turkey.

This market is dominated by a few top participants. In the market, there are only about 10 key human albumin products from blood plasma manufacturers that can be used in fluid replacement therapy. Manufacturers, global drug wholesalers alongside drug wholesaler in turkey will adopt premium pricing in the non-therapeutic application segment because it is expected that this drug volume growth slows down during the forecast period so that they can meet their profit margins.

Now, Albumin price in the shape of Albutein intravenous solution 5% is around $43 for a supply of 50 milliliters. Generally, the share of albumin in the blood plasma market has decreased from about 40 percent in the 1980s to 10 percent in 2015, but the analysts have expected that the global human albumin market grows at a CAGR of 4.97% during the period 2016-2020.

Future Markets

Ideation as Albumin-based therapies such (CSL654 rIX-FP) produced by CSL Behring, received marketing approval from the US FDA in March 2016 and from the EMA in May 2016. It is also expected that Albutropin (TV-1106) by Teva Pharmaceuticals, Ampion by Ampio Pharmaceuticals, and Albutein by Grifols (for Alzheimer’s disease) enter the market in the future.

In APAC countries like India and China, demand for albumin is high. The global increase in the fractionation of blood and rise in demand for human albumin in these countries will sustain production rates. In India, regulatory pressures and pricing control of albumin are being eased for meeting the therapeutic needs of the population. It is likely that global manufacturers foray into the market because of the shortage of albumin products in India.  But in China, the this market grows steadily.

However, due to the lack of awareness about these products and their therapeutic uses, the uptake of these therapeutics is less. Thus, organizations such as PPTA conducted awareness programs. they wanted to help increase the awareness about plasma donation and the different plasma protein therapies available, along with their potential uses.Therefore, they could increase the uptake of these therapeutics in treating various conditions. It is also expected that a large number of biotech and bio-pharmaceutical firms develop recombinant versions of albumin. their aim is to explore its potential in extending the half-life and stability to biologic and biosimilars.