Hepatitis B immune globulin (human) is a Antibody owned by Biotest, and is involved in 6 clinical trials, of which 5 were completed, and 1 is ongoing.

HepaGam B provides passive immunization for individuals exposed to the hepatitis B virus, by binding to the surface antigen and reducing the rate of hepatitis B infection. HBIG may protect naive hepatocytes against infection through blockage of a putative HBV receptor. Alternatively, HBIG may neutralize circulating virions through immune precipitation and immune complex formation or may trigger an antibody-dependent cell-mediated cytotoxicity response resulting in target cell lysis. In addition, HBIG has been reported to bind to hepatocytes and interact with HBsAg within cells. Regardless of the mechanism, there is evidence of a dose-dependent response to HBIG treatment.

The revenue for Hepatitis B immune globulin (human) is expected to reach a total of $230m through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Hepatitis B immune globulin (human) NPV Report.

Hepatitis B immune globulin (human) is currently owned by Biotest. ADMA Biologics is the other company associated in development or marketing of Hepatitis B immune globulin (human).

Hepatitis B immune globulin (human) Overview

Hepatitis B Immune Globulin (Human) (Hepatect , Nabi-HB , Zutectra, Neohepatect, Fovepta) contains mainly immunoglobulin G (IgG) acts as passive immunizing preparation. It is formulated as injection administered via intravenous or intramuscular or subcutaneous route of administration. It is used for the prevention of hepatitis B virus re-infection after liver transplantation for hepatitis B induced liver failure and in the newborn of a hepatitis B virus carrier-mother. Zutectra also indicated for the early use of the Hepatitis B after liver transplantation.

ADMA Biologics Overview

ADMA Biologics is an integrated biopharmaceutical and specialty immunoglobulin company which develops, produces, and commercializes specialty biologics to treat immune deficiencies and prevent certain infectious diseases. The company develops Bivigam, a plasma-derived IVIG that contains a broad range of antibodies; and ASCENIV, a specialty plasma-derived, polyclonal, intravenous immune globulin, derived from human plasma containing naturally occurring polyclonal antibodies to treat Primary Immune Deficiency Disease. ADMA Biologics’ target treatment areas include bacterial infections, respiratory syncytial virus and primary immune deficiency diseases. It also operates bio centers which carry out plasma collection and offer blood plasma to manufacture the company’s products. ADMA Biologics is headquartered in Ramsey, New Jersey, the US.

The company reported revenues of (US Dollars) US$80.9 million for the fiscal year ended December 2021 (FY2021), an increase of 91.7% over FY2020. The operating loss of the company was US$58.4 million in FY2021, compared to an operating loss of US$63.9 million in FY2020. The net loss of the company was US$71.7 million in FY2021, compared to a net loss of US$75.8 million in FY2020. The company reported revenues of US$41.1 million for the third quarter ended September 2022, an increase of 21.2% over the previous quarter.

Quick View – Hepatitis B immune globulin (human)

Report Segments
  • Innovator (NME)
Drug Name
  • Hepatitis B immune globulin (human)
Administration Pathway
  • Intramuscular
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Infectious Disease
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.