U.S. Intravenous Immunoglobulin Market Size & Trend Report, 2023-2032
The U.S. Intravenous Immunoglobulin market size was exhibited at USD 6.65 billion in 2022 and is projected to hit around USD 13.21 billion by 2032, growing at a CAGR of 7.1% during the forecast period 2023 to 2032.
Key Pointers:
U.S. Intravenous Immunoglobulin Market Report Scope
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Report Coverage |
Details |
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Market Size in 2023 |
USD 7.12 Billion |
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Market Size by 2032 |
USD 13.21 Billion |
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Growth Rate from 2023 to 2032 |
CAGR of 7.1% |
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Base year |
2022 |
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Forecast period |
2023 to 2032 |
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Segments covered |
Application, distribution channel |
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Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
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Key companies profiled |
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. |
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 24.19% in 2022 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 60.9% in 2022 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.
Some of the prominent players in the U.S. Intravenous Immunoglobulin Market include:
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 2018 to 2032. For this study, Nova one advisor, Inc. has segmented the global U.S. Intravenous Immunoglobulin market.
By Application
By Distribution Channel
Chapter 1 Methodology and Scope
1.1 Market segmentation & scope
1.2 Market definition
1.3 Information procurement
1.3.1 Purchased database
1.3.2 Nova one advisor’s internal database
1.3.3 Secondary sources & third party perspectives
1.3.4 Primary research
1.4 Information analysis
1.4.1 Data analysis models
1.5 Market formulation & data visualization
1.6 Data validation & publishing
Chapter 2 Executive Summary
2.1 Market Outlook
2.2 Segment Outlook
2.3 Competitive Insights
Chapter 3 U.S. Intravenous Immunoglobulin (IVIG) Market Variables, Trends & Scope
3.1 Market Lineage Outlook
3.1.1 Parent Market Outlook
3.1.2 Ancillary Market Outlook
3.2 Penetration and Growth Prospect Mapping
3.3 Market Dynamics
3.3.1 Market driver analysis
3.3.1.1 Rising number of immunodeficiency disease cases
3.3.1.2 Rising adoption of immunoglobulin replacement therapies
3.3.1.3 Approval and launch of novel products
3.3.1.4 Increasing R&D investments
3.3.2 Market restraint analysis
3.3.2.1 Cost-intensive nature of immunoglobulin replacement therapy
3.3.2.2 Stringent regulations pertaining to production and approval
3.3.3 Industry opportunity
3.4 U.S. Intravenous Immunoglobulin (IVIG) Market Analysis Tools
3.4.1 Industry analysis - Porter’s
3.4.1.1 Supplier Power
3.4.1.2 Buyer Power
3.4.1.3 Substitution Threat
3.4.1.4 Threat from new entrants
3.4.1.5 Competitive Rivalry
3.4.2 PESTEL Analysis
3.4.2.1 Political Landscape
3.4.2.2 Environmental Landscape
3.4.2.3 Social landscape
3.4.2.4 Technology landscape
3.4.2.5 Legal Landscape
3.4 COVID-19 Impact on U.S. Intravenous Immunoglobulin (IVIG) Market
Chapter 4 U.S. Intravenous Immunoglobulin (IVIG) Market - Competitive Analysis
4.1 Recent Developments & Impact Analysis, by Key Market Participants
4.2 Vendor Landscape
4.2.1 List of key distributors and channel partners
4.3 Public Companies
4.3.1 Company market position analysis
4.3.2 Competitive dashboard analysis
4.4 Private Companies
4.4.1 List of key emerging companies
4.4.2 Company market position analysis
Chapter 5 U.S. Intravenous Immunoglobulin (IVIG) Market: Application Estimates And Trend Analysis
5.1 Definition & Scope
5.2 Application Market Share Analysis, 2023 & 2032
5.3 Segment Dashboard
5.4 Market, by Application, 2020 to 2032
5.5 Market Size & Forecasts and Trend Analyses, 2020 to 2032
5.5.1 Hypogammaglobulinemia
5.5.1.1 Market Estimates and Forecasts, 2020 to 2032
5.5.2 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
5.5.2.1 Market Estimates and Forecasts, 2020 to 2032
5.5.3 Immunodeficiency Diseases
5.5.3.1 Market Estimates and Forecasts, 2020 to 2032
5.5.4 Congenital AIDS
5.5.4.1 Market Estimates and Forecasts, 2020 to 2032
5.5.5 Chronic Lymphocytic Leukemia
5.5.5.1 Market Estimates and Forecasts, 2020 to 2032
5.5.6 Myasthenia Gravis
5.5.6.1 Market Estimates and Forecasts, 2020 to 2032
5.5.7 Multifocal Motor Neuropathy
5.5.7.1 Market Estimates and Forecasts, 2020 to 2032
5.5.8 ITP
5.5.8.1 Market Estimates and Forecasts, 2020 to 2032
5.5.9 Kawasaki Disease
5.5.9.1 Market Estimates and Forecasts, 2020 to 2032
5.5.10 Guillain-Barré Syndrome (GBS)
5.5.10.1 Market Estimates and Forecasts, 2020 to 2032
5.5.11 Others
5.5.11.1 Market Estimates and Forecasts, 2020 to 2032
Chapter 6 U.S. Intravenous Immunoglobulin (IVIG) Market: Distribution Channel Estimates And Trend Analysis
6.1 Definition & Scope
6.2 Market Share Analysis, 2023 & 2032
6.3 Segment Dashboard
6.4 Market, by Distribution Channel, 2020 to 2032
6.5 Market Size & Forecasts and Trend Analyses, 2020 to 2032
6.5.1 Hospital Pharmacy
6.5.1.1 Market Estimates and Forecasts, 2020 to 2032
6.5.2 Specialty Pharmacy
6.5.2.1 Market Estimates and Forecasts, 2020 to 2032
6.5.3 Others
6.5.3.1 Market Estimates and Forecasts, 2020 to 2032
Chapter 7 Company Profile
7.1 Company Profiles
7.1.1 Biotest AG
7.1.1.1 Company overview
7.1.1.2 Financial Performance
7.1.1.3 Product benchmarking
7.1.1.4 Strategic initiatives
7.1.2 Octapharma AG
7.1.2.1 Company overview
7.1.2.2 Financial Performance
7.1.2.3 Product benchmarking
7.1.2.4 Strategic initiatives
7.1.3 LFB Biotechnologies
7.1.3.1 Company overview
7.1.3.2 Financial Performance
7.1.3.3 Product benchmarking
7.1.3.4 Strategic initiatives
7.1.4 China Biologics Products, Holdings, Inc.
7.1.4.1 Company overview
7.1.4.2 Financial Performance
7.1.4.3 Product benchmarking
7.1.4.4 Strategic initiatives
7.1.5 Grifols, S.A.
7.1.5.1 Company overview
7.1.5.2 Financial Performance
7.1.5.3 Product benchmarking
7.1.5.4 Strategic initiatives
7.1.6 Kedrion Biopharma, Inc.
7.1.6.1 Company overview
7.1.6.2 Financial Performance
7.1.6.3 Product benchmarking
7.1.6.4 Strategic initiatives
7.1.7 CSL Behring
7.1.7.1 Company overview
7.1.7.2 Financial Performance
7.1.7.3 Product benchmarking
7.1.7.4 Strategic initiatives
7.1.8 McKesson Corporation
7.1.8.1 Company overview
7.1.8.2 Financial Performance
7.1.8.3 Product benchmarking
7.1.8.4 Strategic initiatives
7.1.9 Takeda Pharmaceutical Company (Shire plc)
7.1.9.1 Company overview
7.1.9.2 Financial Performance
7.1.9.3 Product benchmarking
7.1.9.4 Strategic initiatives
7.1.10 Bio Products Laboratory Ltd
7.1.10.1 Company overview
7.1.10.2 Financial Performance
7.1.10.3 Product benchmarking
7.1.10.4 Strategic initiatives
7.1.11 ADMA Biologics, Inc.
7.1.11.1 Company overview
7.1.11.2 Financial Performance
7.1.11.3 Product benchmarking
7.1.11.4 Strategic initiatives
7.1.12 Pfizer Inc.
7.1.12.1 Company overview
7.1.12.2 Financial Performance
7.1.12.3 Product benchmarking
7.1.12.4 Strategic initiatives
Cross-segment Market Size and Analysis for
Mentioned Segments
Additional Company Profiles (Upto 5 With No Cost)
Additional Countries (Apart From Mentioned Countries)
Country/Region-specific Report
Go To Market Strategy
Region Specific Market DynamicsRegion Level Market Share Import Export AnalysisProduction AnalysisOthers