U.S. Intravenous Immunoglobulin Market Size, Share & Trends Analysis Report By Application (Immunodeficiency Diseases, Multifocal Motor Neuropathy), By Distribution Channel, And Segment Forecasts, 2021 - 2028

Report 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 hypogammaglobulinemia, 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.

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.

Application Insights

The immunodeficiency diseases segment dominated the market with a share of over 22.0% in 2020 owing to the existing patient base, coupled with the long-term therapy requirement associated with these diseases. Primary immunodeficiency diseases represent over 150 rare disorders. Primary immunodeficiency diseases are among the FDA-approved indications for IVIG and are a major application for IVIG in the U.S.

The CIDP segment is anticipated to grow at a lucrative rate during the forecast period due to its user-friendly application and minimally invasive technique as compared to other treatment options. Conventional therapies for the treatment of CIDP, such as plasmapheresis, steroids, and immunosuppressive drugs, usually develop resistance and currently, treatment with IVIG is found to be safer and effective, thereby fueling the segment growth over the forecast period.

Distribution Channel Insights

Hospital pharmacy held the largest share of over 58.0% in 2020 owing to a large number of hospitals and the easy availability of products. Hospital pharmacies include both in-patient and out-patient hospital pharmacies. The increasing prevalence of primary immune deficiencies, hepatitis C, and other diseases has led to an increase in the total number of hospitalizations in the U.S., which has expanded the customer base for hospital pharmacies. Moreover, hospitals provide quick reimbursement and treatment and care to a large number of patients, facilitating an increase in the number of patients opting for hospital pharmacies.

The specialty pharmacy segment is expected to witness lucrative growth over the forecast period as specialty pharmacies facilitate easy treatment at home. Specialty drugs represent an important and growing part of the future pharmacy business. The number of approved specialty drugs is increasing rapidly owing to which the total spending on specialty drugs is increasing considerably, and this trend is expected to continue. As a result, specialty pharmacies are expected to grow at a lucrative rate.

Key Companies & Market Share Insights

Key players hold a major share in the market owing to their significant presence in the country. Emerging players are adopting organic growth strategies, such as novel drug development and product launches, to gain a significant market share. Some prominent players in the U.S. intravenous immunoglobulin (IVIG) 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.

U.S. Intravenous Immunoglobulin Market Report Scope 

Segments Covered in the Report

This report forecasts revenue growth at the country level and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2016 to 2028. For the purpose of this study, Grand View Research has segmented the U.S. intravenous immunoglobulin market report on the basis of application and distribution channel:

• 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

• Distribution Channel Outlook (Revenue, USD Million, 2016 - 2028)

  • Hospital Pharmacy

  • Specialty Pharmacy

  • Others