Immune globulin (human) is a Antibody and Blood Derivative owned by Grifols, and is involved in 34 clinical trials, of which 33 were completed, and 1 is ongoing.

Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. It contains the IgG antibodies present in the normal population. The mechanism of action in indications other than replacement therapy includes immunomodulatory effects. The administered Human normal immunoglobulin (IVIg) interacts with a number of different components of the immune system, including cytokines, complement, Fc receptors and several cell surface incompetent molecules. It 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.

The revenue for Immune globulin (human) is expected to reach a total of $57.9bn 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 Grifols.

Immune globulin (human) Overview

Human Immunoglobulin G (also known as human normal immunoglobulin) (Flebogamma DIF/Gamimune N/Gammaked/ Gamunex C/ Flebogamma/ IGIVnex/ GamaSTAN S/D/ Gamunex/ Igamplia/ Plangamma/ Polyglobin/ GamaSTAN, Plitagamma) is an antibody preparation derived from plasma acts as passive immunizing preparation. It is formulated as solution for intramuscular or subcutaneous route of administration. Flebogamma DIF (Double Inactivation and Filtration) and Gamunex is used for replacement therapy in patients with primary immunodeficiency syndromes with impaired antibody production and for hypogammaglobulinemia in various pathological conditions. They also used for the treatment of primary immune thrombocytopenia (ITP), Guillain Barre syndrome and Kawasaki disease. Gamunex-C [Caprylate/Chromatography Purified] is used for the Primary Humoral Immunodeficiency, Idiopathic Thrombocytopenic Purpura (ITP) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Flebogamma DIF is indicated for the treatment of  chronic immune thrombocytopenia (ITP) in adults and children aged ≥2 years and primary immunodeficiency (PI) in adults. GamaSTAN S/D is prepared by cold ethanol fractionation from human plasma. GamaSTAN S/D and Igamplia is used for the prophylaxis of rubella, measles, varicella and hepatitis A. Flebogamma DIF and Gammunex injection solution are administered via intravenous route of administration. GamaSTAN S/D and Igamplia are administered by intramuscular route of administration.

The drug candidate is also under development for the treatment of immune-mediated necrotizing myopathy, Coronavirus disease 2019 (COVID-19), postural tachycardia syndrome, Alzheimer's disease, primary immunedeficiency disease. The drug candidate was also under development for the treatment of cutaneous lupus erythematosus, relapsing remitting multiple sclerosis, epilepsy, myasthenia gravis, stiff-person syndrome and occult choroidal neovascularization.

it was also under development for treatment induced neuropathy of diabetes and post-polio syndrome.

Grifols Overview

Grifols is a pharmaceutical and chemical manufacturing company engaged on enhancing the health and well-being of patients worldwide. It is focused on research, development, manufacturing and marketing of plasma-derived therapies, hospital pharmacy products and diagnostic technology for clinical use. It produces plasma derived protein therapies for patients suffering with rare, chronic and life-threatening infections. Grifols offers biological materials for clinical trials, biotechnology research, manufacturing pharmaceutical and diagnostic products. Grifols provides transfusion medicine, hemostasis and immunoassay solutions for blood banks, clinical laboratories and transfusion centers. The company offers its products to hospitals, pharmacies and healthcare professionals. It offers products in the US, Canada, Europe, and Rest of the world. Grifols is headquartered in Barcelona, Spain.

The company reported revenues of (Euro) EUR4,933.1 million for the fiscal year ended December 2021 (FY2021), a decrease of 7.6% over FY2020. In FY2021, the company’s operating margin was 12.1%, compared to an operating margin of 18.7% in FY2020. In FY2021, the company recorded a net margin of 3.8%, compared to a net margin of 11.6% in FY2020. The company reported revenues of EUR1,542.9 million for the second quarter ended June 2022, an increase of 21.8% over the previous quarter.

Quick View – Immune globulin (human)

Report Segments
  • Innovator (NME)
Drug Name
  • Immune globulin (human)
Administration Pathway
  • Intramuscular
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Cardiovascular
  • Central Nervous System
  • Genetic Disorders
  • Hematological Disorders
  • Immunology
  • Infectious Disease
  • Metabolic Disorders
  • Oncology
  • Ophthalmology
Key Companies
Highest Development Stage
  • Marketed

GlobalData

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, drug margins and company expenses. 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 valuation, 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.