U.S. Intravenous Immunoglobulin Market Size to Hit USD 14.42 Billion by 2033

The U.S. intravenous immunoglobin market size was valued at USD 7.27 billion in 2024 and is projected to reach USD 14.42 billion by 2033, registering a CAGR of 7.9% from 2024 to 2033. The global U.S. intravenous immunoglobin market growth is attributed to the approval of new products and the increase in demand for immunoglobulin replacement therapies for the treatment of Primary Immunodeficiency Diseases (PIDD).

Key Takeaways:

·         The primary immunodeficiency diseases segment held the largest market share of 21.32% of the U.S. IVIG market in 2023.

·         The hospital pharmacies segment accounted for the largest revenue share of 58.46% of the U.S. IVIG market in 2023.

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The U.S. intravenous immunoglobin market deals with the collective exposure of the donor population to their environment, and it describes the potential adverse effects and identifies the mechanism of intravenous immunoglobulin. The global industry produces, distributes, and sells intravenous immunoglobulin products. IVIG is a concentrated form of antibodies obtained from pooled plasma of numerous donors, and it is administered intravenously and used to treat various autoimmune and immunodeficiency disorders.

The U.S. intravenous immunoglobin market has experienced significant growth in recent years due to various factors, such as growing awareness among healthcare professionals and patients, rising advancements in plasma collection and fractionation technologies, and an increase in the prevalence of immune-mediated disorders. In addition, the expanding use of IVIG in off-label indications, a rise in the geriatric population, and increasing healthcare expenditure further contributed to propel the market growth in the U.S.

One of the major opportunities driving the growth of the U.S. intravenous immunoglobulin market is the adoption of immunoglobulin-based therapies. The rising advancements in manufacturing processes and plasma fractionation techniques have improved the efficacy and safety of IVIG products. Developing purification methods and recombinant technologies produced highly concentrated and refined immunoglobulin products, allowed for more targeted therapies, and reduced the risk of adverse reactions. These technological advancements create major opportunities for improved patient outcomes and the development of novel immunoglobulin-based treatments.

Artificial intelligence can play an important role in improving intravenous immunoglobulin in the U.S. The AI-generated tools help in monitoring patient data and providing insights that improve long-term patient management and enhance personalized care. The integration of AI technologies helps in dialysis care to improve clinical decision-making, optimize treatment plans, and predict patient outcomes, thereby further expected to revolutionize the growth of the U.S. intravenous immunoglobulin market in the coming years.    

Market Trends

·         Improved awareness: improved awareness of autoimmune diseases, immunodeficiency disorders, and other diseases treated with IVIG leads to earlier treatment and diagnosis initiation, thereby more patients are identified as potential IVIG therapy candidates, contributing to market growth in the U.S.

·         Continuous advancements: The rising advancements in developing novel immunoglobulin products, purification techniques, and manufacturing processes with improved safety and efficacy, further drive the growth of the U.S. intravenous immunoglobulin market.

·         Increasing use of IVIG replacement therapy: IVIG replacement therapy is used for the treatment of various hematological, neurological, and autoimmune diseases and immunodeficiency, which further enhances the market growth in the U.S.

Report Scope of The U.S. Intravenous Immunoglobulin Market

 Report Coverage

 Details

Market Size in 2024

USD 7.27 Billion

Market Size by 2033

USD 14.42 Billion

Growth Rate From 2024 to 2033

CAGR of 7.9%

Base Year

2023

Forecast Period

2024-2033

Segments Covered

Application, Distribution Channel

Market Analysis (Terms Used)

Value (US$ Million/Billion) or (Volume/Units)

Regional Scope

U.S.

Key Companies Profiled

Biotest AG; Octapharma AG; LFB Biotechnologies S.A.S; China Biologics Products Holdings, Inc.; Grifols; S.A.; Kedrion S.P.A.; CSL ; Takeda Pharmaceutical Company Limited; Bio Products Laboratory Ltd.; Pfizer, Inc.; ADMA Biologics, Inc.

 

Segment Insights

By Application Insights

The primary immunodeficiency diseases segment held the largest market share of 21.32% of the U.S. IVIG market in 2023.  The segment growth in the market is attributed to the rising number of patients requiring treatment and the high cost of treatment. In addition, the increasing presence of companies including the Immune Deficiency Foundation, which aims at improving the treatment and diagnosis of PIDDs through advocacy, education, and research, which further expected to enhance the adoption of intravenous immunoglobulin therapy among patients.

·         For instance, in June 2024, The FDA approved immune globulin intravenous, human-dira to treat patients with primary immunodeficiencies (PID). The innovative intravenous immunoglobulin (IVIG) was the first of Biotest’s portfolio to be approved by the FDA.

The CIDP segment is expected to grow fastest during the forecast period. Various market players are focusing on developing novel formulations for the treatment and maintenance of CIPD, which is anticipated to drive the segment growth in the U.S. intravenous immunoglobulin market.

·         For instance, in January 2024, Halozyme Therapeutics, Inc. announced that Takeda received European Commission (EC) approval for HYQVIA co-formulated with Halozyme's ENHANZE® drug delivery technology as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG).

By Distribution Channel Insights

The hospital pharmacies segment accounted for the largest revenue share of 58.46% of the U.S. IVIG market in 2023. The segment growth in the market is driven by factors such as the easy availability of products in the hospitals and the large number of hospitals. As hospital-owned outpatient pharmacies have access to a patient's electronic health record, they have an advantage over traditional retail pharmacies. Thereby, without a doctor’s prescription, patients can obtain the required medications, further enhancing the segment growth in the U.S. intravenous immunoglobulin market.

The specialty pharmacy segment is expected to grow fastest during the forecast period. Specialty pharmacy focuses on high-touch and high-cost medication therapies for patients with complicated disease conditions. Medications in specialty pharmacy range from oral to advanced biologic and injectable products. The disease states are treated range from rheumatoid arthritis, multiple sclerosis, and cancer to rare genetic conditions. 

·         For instance, in April 2024, Walgreens launched gene and cell services expanding its specialty pharmacy services and investing in its capabilities as the company further grows its core pharmacy business to provide greater value to partners and payers and improve patient outcomes.

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U.S. Intravenous Immunoglobulin Market Top Companies

·         Biotest AG

·         China Biologics Products Holdings, Inc.

·         Octapharma AG

·         LFB Biotechnologies S.A.S

·         Takeda Pharmaceutical Company Limited

·         Bio Products Laboratory Ltd.

·         Pfizer, Inc.

·         CSL

·         ADMA Biologics, Inc.

·         Grifols, S.A.

·         Kedrion S.P.A.

U.S. Intravenous Immunoglobulin Market Recent Developments 

·         In June 2024, The FDA approved immune globulin intravenous, human-dira to treat patients with primary immunodeficiencies (PID). The innovative intravenous immunoglobulin (IVIG) was the first of Biotest’s portfolio to be approved by the FDA.

·         In September 2024, GC Biopharma USA, Inc. announced the launch and distribution of the company’s first 10% intravenous immunoglobulin therapy, immunoglobulin (IG) product ALYGLO for the treatment of adult patients aged 17 years and older with primary humoral immunodeficiency (PI).

·         In July 2024, Kedrion Biopharma Inc. announced that it has established the framework for a long-term agreement with Biotest AG for the full distribution and commercialization of the immunoglobulin therapy Yimmugo in the U.S. 

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. intravenous immunoglobulin market.

By Application

·         Primary Immunodeficiency

·         Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

·         Primary Immunodeficiency Diseases (PIDD)

·         Congenital AIDS

·         Chronic Lymphocytic Leukemia

·         Myasthenia Gravis

·         Multifocal Motor Neuropathy

·         Immune Thrombocytopenia (ITP)

·         Kawasaki Disease

·         Guillain-Barre Syndrome

·         Others

By Distribution Channel

·         Hospital Pharmacy

·         Specialty Pharmacy

·         Others

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