US Intravenous Immunoglobulin Market is expected to reach US$ 7,105.63 million by 2028

Publisher: The Insight Partners

IgG Segment to Lead US Intravenous Immunoglobulin Market During 2022–2028 

According to our latest study on “US Intravenous Immunoglobulin Market Forecast to 2028 – COVID-19 Impact and Country Analysis – by Type, Application, Distribution Channel, and End User,” the market was valued at US$ 4,439.26 million in 2022 and is projected to reach US$ 7,105.63 million by 2028; it is estimated to grow at a CAGR 8.2% during 2023–2028. The report highlights key factors governing the intravenous immunoglobulin market growth and prominent players with their developments in the market. The US intravenous immunoglobulin market growth is primarily attributed to the rising immunodeficiency disease prevalence and increasing geriatric population in the US. However, the adverse effects of immunoglobulin therapy hinder the market growth.

Immunoglobulins are the antibodies produced naturally by the body’s immune system, which help fight infection and disease. Individuals with immunoglobulin deficiency require the external administration of immunoglobulin and 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. IVIGs are extracted from human plasma. These antibodies are used in the treatment of various immunological, hematological, and neurological illnesses.

Based on type, the US intravenous immunoglobulin market is segmented into IgG, IgM, IgA, and others. The IgG segment held the largest market share in 2022. IgG is the only class of immunoglobulins that can cross the placenta and reach fetal circulation. Human IgG can be divided into four subclasses—IgG1, IgG2, IgG3, and IgG4—based on unique antigenic determinants on their heavy chain constant-region domains and associated biologic functions. Intravenous immunoglobulin (IVIG) is a replacement therapy and treatment for patients with antibody deficiencies or for those who suffer from immunodeficiency disorders. For instance, in primary or secondary hypogammaglobulinemia, IVIG replacement therapy protects against infections by providing an adequate amount of IgG in the blood. Additionally, IVIG is a blood product prepared from serum derived from 1,000 to 15,000 donors per batch where only IgG is purified from plasma to produce IVIG products. Therefore, therapeutic IVIG preparations contain 95–98% pure IgG with small amounts of other plasma proteins, including IgA and IgM. 

Impact of COVID-19 Pandemic on US Intravenous Immunoglobulin Market   

The COVID-19 pandemic hampered the US intravenous immunoglobulin market. The COVID-19 Treatment Guidelines Panel prohibited the use of intravenous immunoglobulin (IVIG) to treat acute COVID-19 in children and adults, excluding in a clinical trial (AIII). Thus, the demand for intravenous immunoglobulin (IVIG) decreased during the pandemic. For instance, in February 2022, CSL reported that its core franchise, the immunoglobulin portfolio, was impacted by industrywide constraints on plasma collections during the COVID-19 crisis. Immunoglobulin products are manufactured from plasma, and travel restrictions and lockdowns made it difficult for people to donate plasma at CSL's collection centers. CSL stated immunoglobulin sales declined 9% in the first half-year of 2022.

US Intravenous Immunoglobulin Market: Competitive Landscape and Key Developments

Takeda Pharmaceuticals Co Ltd, Grifols SA, Pfizer Inc, ADMA Biologics, Bio Products Laboratory Ltd, Octapharma AG, Kedrion SpA, CSL Ltd, LFB Group, and Prothya Biosolutions BV are among the key companies operating in the US intravenous immunoglobulin market. Leading players adopt strategies such as the launch of new products, expansion and diversification of their market presence, and acquisition of a new customer base for tapping prevailing business opportunities.   

• In April 2021, BPL and Atlantic Research Group entered into a long-term collaboration. This agreement establishes ARG as BPL's preferred contract research organization (CRO) for conducting clinical research and providing supportive services for the company's new global product development programs. The agreement builds on BPL and ARG's previous successful collaboration on clinical trial programs.
• In April 2021, ADMA Biologics, Inc. announced that the US Food and Drug Administration (FDA) granted approval for its expanded manufacturing process, enabling fractionation and purification of a 4,400-liter plasma pool for the manufacturing of IVIGs.
• In June 2021, octagam 10%, a human plasma-derived IVIG offering of Octapharma, was granted approval in the European Union (EU) as an immunomodulatory therapy for adults suffering from dermatomyositis. Following the EU approval, octagam 10% received national approval in Germany on May 11, 2021. The company further expects approval in other European member states in the coming years.

The Report Segments US Intravenous Immunoglobulin Market as Follows:

The US intravenous immunoglobulin market is segmented on the basis of type, application, distribution channel, and end user. Based on type, the market is segmented into IgG, IgA, IgM, and Others. Based on application, the US intravenous immunoglobulin market is segmented 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. Based on distribution channel, the US intravenous immunoglobulin market is segmented into hospital pharmacy, retail pharmacy, and others. By end user, the US intravenous immunoglobulin market is segmented into hospitals, specialty clinics, and others.

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