U.S. Intravenous Immunoglobulin Industry Overview
The U.S. intravenous immunoglobulin market size was valued at USD 5.91 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 6.8% from 2021 to 2028. Intravenous immunoglobulin (IVIG) is a therapeutic preparation used for the treatment of various diseases, including primary immune deficiency, secondary immune deficiency, immune thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP). According to the data published by the NIH, around 500,000 people in the U.S. are suffering from more than 200 different forms of primary immunodeficiency disorders (PIDDs). The growing incidences of primary and acquired immunodeficiency diseases, such as AIDS and X-linked hypogamma globulinemia, are expected to boost the demand for immunoglobulin therapies in the near future.
The COVID-19 pandemic has created an operational threat and a lucrative opportunity for the U.S. IVIG market. The pandemic has also united various key players and governments to aid the R&D of new hyper-immunoglobulin against COVID-19. This therapy is derived from recovered COVID-19 patients’ plasma as plasma-based therapies are being studied for their effectiveness in preventing complications due to severe acute viral respiratory infections, including COVID-19. In April 2020, CSL Behring announced a collaboration with Biotest, Octapharma, LFB, Takeda Pharmaceutical Company Limited, and BPL to develop hyperimmune therapy for COVID-19. In addition, in June 2020, Kedrion announced a collaboration with Kamada to manufacture and commercialize the plasma-derived Anti-SARs-COV-2 IgG for COVID-19.
Gather more insights about the market drivers, restrains and growth of the U.S. Intravenous Immunoglobulin market
Increasing FDA approval and the introduction of novel IVIG therapies in the U.S. are expected to significantly support the market growth over the forecast period. For instance, in May 2019, ADMA Biologics, Inc., a U.S.-based biopharmaceutical company, received the FDA approval for its Prior Approval Supplement (PAS) for BIVIGAM. BIVIGAM (IVIG, 10% liquid) is indicated for the treatment of primary humoral immunodeficiency. In another instance, in September 2017, CSL Behring, a U.S.-based key market player, received FDA approval for its new IVIG drug, Privigen. Privigen is indicated for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.
Furthermore, with the increase in adoption rate, the IVIG market is anticipated to witness rapid growth throughout the forecast period. The U.S. FDA has approved the use of IVIG in various disorders. IVIG treatment is also used in many off-label prescription disorders, such as myasthenia gravis, multifocal motor neuropathy, and Guillain-Barre syndrome. In addition, the preference for IVIG is increasing due to its safety and efficacy. For instance, there has been a significant increase in the volume of IVIG units consumed for the treatment of CIPD. The most common usage of IVIG is seen among patients suffering from CLL (Chronic Lymphocytic Leukemia), B-cell non-Hodgkin lymphoma, Hodgkin lymphoma, those undergoing donor stem cell transplant, CAR-T cell therapy, and those undergoing chemotherapy and other treatment regimes that lower B cell counts. Moreover, the alternatives to IVIG, i.e., plasma exchange and corticosteroids, are associated with severe adverse effects; therefore, patients and physicians prefer IVIG.
However, the high cost of IVIG therapies is expected to be a prominent factor restraining the market growth. Immunoglobulin infusions are generally administered once every 3 to 4 weeks and the treatment is lifelong (12-16 sessions annually). The average cost of IVIG is USD 73.89 per gram and the cost of the entire therapy is USD 10,000, depending on the severity of the disorder. Immunoglobulin replacement therapies are long-term therapies with an average duration of 6 months’ treatment. According to ABIM Foundation, the cost of IgG treatment therapy costs over USD 30,000 annually.
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U.S. Intravenous Immunoglobulin Market Segmentation
Grand View Research has segmented the U.S. intravenous immunoglobulin market on the basis of application and distribution channel:
U.S. IVIG Application Outlook (Revenue, USD Million, 2016 – 2028)
- Hypogammaglobulinemia
- CIDP
- Immunodeficiency Diseases
- Congenital AIDS
- Chronic Lymphocytic Leukemia
- Myasthenia Gravis
- Multifocal Motor Neuropathy
- ITP
- Kawasaki Disease
- Guillain-barre Syndrome
- Others
U.S. IVIG Distribution Channel Outlook (Revenue, USD Million, 2016 – 2028)
- Hospital Pharmacy
- Specialty Pharmacy
- Others
Key Companies profiled:
Some prominent players in the global U.S. Intravenous Immunoglobulin market include
- Biotest AG
- Octapharma AG
- LFB Biotechnologies S.A.S
- China Biologics Products Holdings, Inc.
- Grifols, S.A.
- Kedrion Biopharma, Inc.
- CSL Behring
- McKesson Corporation
- Takeda Pharmaceutical Company Limited
- Bio Products Laboratory Ltd.
- Pfizer, Inc.
- ADMA Biologics, Inc.
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