Immune globulin (human) is a Antibody and Blood Derivative owned by Biotest, and is involved in 22 clinical trials, of which 19 were completed, and 3 are ongoing.

Human normal immunoglobulin (IVIg) interacts with a number of different components of the immune system, including cytokines, complement, Fc receptors and several cell surface immunocompetent molecules. IVIg also impacts different effector cells of the immune system (B and T lymphocytes, dendritic cells, etc.) and regulates a wide range of genes. Its main mechanism of actions are believed to be Fc-dependent and F(ab')2-dependent. IVIg competitively blocks gamma Fc receptors, preventing the binding and ingestion of phagocytes and suppressing platelet depletion. IVIg contains a number of different antibodies, which prevent infection by attaching to the surface of invading pathogens and aiding in their disposal before they can infect cells. Antibodies remove pathogens via complement activation, agglutination or precipitation, pathogen receptor blocking, macrophage “tagging” or neutralization (via binding) of pathogen toxins. Intact IVIg and F(ab')2 fragments of IVIg can also neutralize the activity of various autoantibodies. By triggering the production of interleukin-1 receptor antagonist, IVIg modulates of the production of cytokines and cytokine antagonists. It also prevents the generation of the C5b-9 membrane attack complex and subsequent complement-mediated tissue damage by binding active complement components. The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.

The revenue for Immune globulin (human) is expected to reach a total of $5.1bn 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 Immune globulin (human) NPV Report.

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

Immune globulin (human) Overview

Human immunoglobulin (Bivigam / Intratect / Yimmugo / Intraglobin F / Tectasim / Bivigam) is an immune sera and immunoglobulin preparation. It is formulated as injection solution for intravenous route of administration. Human immunoglobulin is used in the treatment of primary immunodeficiency syndromes with impaired antibody production, hypogammaglobulinemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed, pneumococcal immunisation, hypogammaglobulinemia in patients after allogeneic haematopoietic stem cell transplantation (HSCT) and congenital AIDS with recurrent bacterial infections. It is used for immunomodulation in primary immune thrombocytopenia, Guillain Barre syndrome and kawasaki disease. Human normal immunoglobulin is a replacement therapy in patients with primary humoral immunodeficiency.

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 – Immune globulin (human)

Report Segments
  • Innovator (NME)
Drug Name
  • Immune globulin (human)
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Central Nervous System
  • Genetic Disorders
  • Hematological Disorders
  • Immunology
  • 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.