The U.S. intravenous immunoglobulin market size is expected to reach USD 10.24 billion by 2028. 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.
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
Market driver analysis
Rising number of immunodeficiency disease cases
Rising adoption of immunoglobulin replacement therapies
Approval and launch of novel products
Increasing R&D investments
Market restraint analysis
Cost-intensive nature of immunoglobulin replacement therapy
Stringent regulations pertaining to production and approval
U.S. Intravenous Immunoglobulin (IVIG) Market Analysis Tools
Industry analysis - Porter's
COVID-19 Impact on U.S. Intravenous Immunoglobulin (IVIG) Market