
Published On: Oct 2023
Published On: Oct 2023
According to our latest study on " North America Intravenous Immunoglobulin Market Size and Forecast to 2030 – Regional Analysis – by Type, Application, Distribution Channel, and End User," the North America intravenous immunoglobulin market size was valued at US$ 5,042.91 million in 2022 and is expected to reach US$ 8,747.81 million by 2030. It is estimated to register a CAGR of 7.1% during 2022–2030. The report highlights the key factors and trends impacting the market and focuses on prominent players and their strategies.
Immunoglobulins are the antibodies produced naturally by the body’s immune system, which help fight infection and disease. The deficiency of immunoglobulin requires the external administration of immunoglobulin and is known as immunoglobulin replacement therapy (IgRT). IgRT can be given intravenously and subcutaneously. Intravenous immunoglobulin (IVIg) and subcutaneous immunoglobulin (SCIg) are selected based on the indication and severity. IVIg is manufactured from human plasma. It contains antibodies and is used to treat many immunologic, haematologic, and neurologic illnesses.
Plasma-derived immunoglobulins are used for treating autoimmune and inflammatory disorders, among others. In addition to autoimmune and acute inflammatory conditions, primary immune deficiency disease (PIDD), chronic inflammatory demyelinating polyneuropathy (CIDP), and multifocal motor neuropathy (MMN) are the chronic and acute conditions that are treated with immunoglobulins. Immunoglobulins are also increasingly used to manage infectious diseases, dermatological conditions, rheumatological/nephrological conditions, and heart disease. Thus, the demand for intravenous immunoglobulins is on the rise with the surging use of these antibodies for treating various conditions
Table: Common Use and Dosing for Intravenous Immunoglobulins
Disease/Medical Condition | FDA Approval Status | Goal of Therapy |
B-Cell Chronic Lymphocytic Leukemia (CLL) | Yes | Prevention of bacterial infections due to hypogammaglobinemia |
Bone Marrow Transplantation Complications | Yes | Prevention of infections, pneumonitis, and acute graft-versus-host disease (GVHD) following bone marrow transplantation |
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Yes | Improvements in patients suffering from neuromuscular disability and impairment, and maintenance therapy to prevent relapse |
HIV Infection | Yes | Reduction of serious bacterial infections in pediatric patients infected with HIV |
Idiopathic Thrombocytopenic Purpura (ITP, CITP) | Yes | Increase platelet count in ITP to prevent or control bleeding |
Kawasaki Disease | Yes | Prevention of coronary artery aneurism associated with Kawasaki disease |
Multifocal Motor Neuropathy (MMN) | Yes | Modulation of immune-inflammatory condition, improvement of muscle strength, and management of disability in adult patients |
Primary Immunodeficiency Disease (PIDD) | Yes | Protection against frequent and/or severe infections (bacterial and viral) |
Source: Academy of Managed Care Pharmacy
Leading players in the intravenous immunoglobulin market have multiple projects and many biological products in pipelines based on proprietary technologies. Evolve Biologics plans to manufacture and market plasma-derived therapeutics using its proprietary PlasmaCap EBA purification technology. It completed the Phase III clinical trial for its IVIG candidate in February 2021, and it intends to develop a portfolio of this product candidate. Similarly, Biotest, offering plasma protein products and biotherapeutic drugs, is developing IgG Next Generation, a newly developed polyvalent immunoglobulin preparation from human plasma to treat immunodeficiencies and autoimmune diseases through intravenous administration. In September 2020, the company completed its Phase III trial investigating the administration of IgG Next Generation for treating patients with PIDs. In May 2020, the US Food and Drug Administration (FDA) approved Octapharma’s Investigational New Drug (IND) application to initiate a Phase 3 trial of Octagam (immune globulin intravenous) to treat patients suffering from COVID-19, with severe disease progression.
Companies are investing in scientific and technical excellence to develop and introduce new IVIG therapies against immunodeficiencies. Thus, a strong pipeline of IVIG candidates would lead to a significant growth trend in the North America intravenous immunoglobulin market in the future.
Takeda Pharmaceutical Co Ltd; Grifols SA; Pfizer Inc.; ADMA Biologics, Inc.; Bio Products Laboratory Ltd; Octapharma AG; Kedrion SpA.; CSL Ltd.; LFB Group; and Prothya Biosolutions B.V are among the key players operating in the global North America intravenous immunoglobulin market.
The North America intravenous immunoglobulin market, by type, is segmented into IgG, IgA, IgM, and others. In 2022, the IgG segment held the largest share and is expected to record the fastest CAGR during 2022–2030. Based on application, the North America intravenous immunoglobulin market is classified into immunodeficiency diseases, chronic inflammatory demyelinating polyneuropathy, idiopathic thrombocytopenic purpura, multifocal motor neuropathy, hypogammaglobulinemia, Guillain-Barre syndrome, specific antibody deficiency, inflammatory myopathies, myasthenia gravis, and others. In 2022, the immunodeficiency diseases segment held the largest market share, and it is expected to register the highest CAGR during 2022–2030. Based on distribution channel, the North America intravenous immunoglobulin market is segmented into hospital pharmacy, retail pharmacy, and others. In 2022, the hospital pharmacy segment held the largest share, and it is expected to record the fastest CAGR during 2022–2030. Based on end user, the North America intravenous immunoglobulin market is classified into hospitals, specialty clinics, and others. In 2022, the hospitals segment held the largest share, and it is expected to register the fastest CAGR during 2022–2030. Based on country, the North America intravenous immunoglobulin market is segmented into the US, Canada, and Mexico. In 2022, the US held the largest market share. The intravenous immunoglobulins market in Canada is expected to grow at the highest CAGR during 2022–2030.
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