U.S. Intravenous Immunoglobulin Market Insights by Size, Forecast 2028 | Key Players: Biotest AG, Octapharma AG, Grifols, S.A., Kedrion Biopharma, Inc., CSL Behring. | Grand View Research, Inc.
U.S. Intravenous Immunoglobulin Market Growth & Trends
The U.S. intravenous immunoglobulin market size is expected to reach USD 10.24 billion by 2028, according to a new report by Grand View Research, Inc. It is expected to expand at a CAGR of 6.8% from 2021 to 2028. Robust pipeline, approval and launch of novel products, and increasing government initiatives are expected to be the major factors driving the market.
Robust pipeline and increasing approvals and launches of novel products are anticipated to support the market growth over the forecast period. For instance, in April 2019, U.S.-based ADMA Biologics, Inc. received U.S. FDA approval for its new drug Asceniv. It is an IVIG drug indicated for the treatment of primary humoral immunodeficiency disease. Similarly, in December 2019, CSL Behring announced receiving orphan drug exclusivity for Hizentra from the U.S. FDA to treat Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). In another instance, in February 2021, Biotest AG announced that it was the first in Germany to manufacture an investigational hyper immunoglobulin from plasma protein for the COVID-19 treatment.
Furthermore, increasing initiatives by various government organizations to boost the development of novel products are expected to support market growth over the forecast period. For instance, in January 2018, the National Institutes of Health (NIH) awarded a grant of USD 3 million to the U.S.-based GigaGen Inc. to develop novel recombinant intravenous immunoglobulin for patients with primary immunodeficiency diseases.
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However, the manufacturing of IVIG requires a well-developed production facility and high capital investments, thereby leading to the high cost of the final product. Hence, this factor is anticipated to restrain the market growth. In addition, IVIG products undergo stringent regulations pertaining to safety and handling, which is another factor expected to impede the market growth. For instance, in 2018, the U.S. FDA delayed the approval of GC Pharma’s intravenous immunoglobulin product and demanded additional data related to the drug’s manufacturing process.
U.S. Intravenous Immunoglobulin Market Report Highlights
- By application, immunodeficiency diseases dominated the market in 2020 owing to the rising number of cases and the growing adoption of IVIG for the treatment of these diseases
- The multifocal motor neuropathy application segment is expected to register the fastest growth rate over the forecast period due to the high effectivity of IVIG in its treatment
- Based on distribution channel, hospital pharmacy held the largest share in 2020 owing to a large number of hospital pharmacies and the easy availability of products in the hospitals
- Market leaders are involved in the development of new plasma collection centers and other collaborative strategies to expand their geographical reach and widen their product portfolio
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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
List of Key Players of U.S. Intravenous Immunoglobulin (IVIG) Market
- 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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