Intravenous Immunoglobulin (IVIG) Market Forecast to Surge During the Forecast Period (2025-2034) with Rising Demand for Autoimmune and Immunodeficiency Treatments
The intravenous immunoglobulin (IVIG) market is experiencing significant growth due to the rising prevalence of autoimmune diseases, immune deficiencies, and neurological disorders. Advancements in biotechnology and an increased focus on personalized medicine are driving innovation in IVIG therapies.
LAS VEGAS, May 5, 2025 /PRNewswire/ — DelveInsight's IVIG Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, emerging IVIG therapy, market share of individual therapies, and current and forecasted IVIG market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Key Takeaways from the IVIG Market Report
As per DelveInsight's analysis, the total market size of IVIG in the 7MM is expected to surge significantly by 2034.
In 2024, BIVIGAM generated a revenue of approximately USD 50 million in the United States.
In 2024, chronic inflammatory demyelinating polyneuropathy affected approximately 21K patients in the United States.
Key companies in the market include ADMA Biologics, Grifols Therapeutics, OCTAPHARMA, Takeda Pharmaceuticals, Kedrion Biopharma, LFB Biopharmaceuticals, Biotest, Japan Blood Products Organization, KM Biologics, Teijin, Nihon Pharmaceutical, GC Biopharma, CSL Behring, Pfizer, Evolve Biologics, and others.
Some of the promising IVIG therapies include ASCENIV, BIVIGAM, GAMUNEX-C, OCTAGAM 5% & 10%, GAMMAGARD LIQUID; S/D (immune globulin infusion; Intravenous [human]), GAMMAPLEX 5% & 10%, IQYMUNE, INTRATECT, VENOGLOBULIN, KENKETSU VENILON, Kenketu GLOVENIN-I, YIMMUGO, ALYGLO, PRIVIGEN, PANZYGA, TAK-880, and others.
In September 2024, GC Biopharma USA, Inc. announced the launch and distribution of its IG product ALYGLO (IVIG), the company's first 10% IVIG therapy for the treatment of adult patients aged 17 years and older with PI.
Discover which therapies are expected to grab the IVIG market share @ Intravenous Immunoglobulin Market Report
IVIG Market Dynamics
The intravenous immunoglobulin market has seen significant growth over the last few years, driven by a combination of factors, including the increasing incidence of autoimmune and inflammatory disorders, the rising prevalence of immunodeficiencies, and advancements in the development of IVIG therapies. IVIG is used in a variety of indications, from autoimmune diseases like rheumatoid arthritis and lupus to primary and secondary immunodeficiencies. As the global demand for these therapies increases, so does the complexity of the supply chain, with manufacturers needing to ensure that they can meet the growing need for human plasma, a key raw material for IVIG production.
One of the biggest challenges in the IVIG market is the supply and demand imbalance of human plasma. Plasma collection is a time-intensive process, and the cost of obtaining plasma continues to rise, affecting the overall cost of IVIG production. This leads to fluctuating prices for IVIG, making it a significant concern for both healthcare providers and patients. Additionally, the rising demand for IVIG is outpacing the capacity of plasma donation centers, further exacerbating the supply issue.
On the other hand, technological advancements in manufacturing processes, such as the development of more efficient purification techniques, have the potential to improve production yields and reduce costs. The growing interest in alternative sources of immunoglobulins, such as recombinant immunoglobulins and synthetic antibodies, also adds a layer of competition to the traditional IVIG market. However, these alternatives are still in the early stages of adoption, with IVIG maintaining its dominant position due to its proven safety and efficacy profile.
Finally, regulatory and reimbursement policies play a critical role in shaping the IVIG market dynamics. Stringent regulations related to product safety, as well as reimbursement frameworks that vary from region to region, impact market access. Ongoing clinical research into new indications for IVIG, as well as efforts to improve patient outcomes, will be key drivers in shaping the market landscape in the coming years.
IVIG Treatment Market
Multiple VIG products have been approved in the U.S., each tailored to specific clinical needs. These include BIVIGAM, CARIMUNE, FLEBOGAMMA, GAMMAGARD S/D (a low IgA formulation), GAMMAGARD Liquid, GAMMAKED, GAMMAPLEX, GAMUNEX, OCTAGAM, and PRIVIGEN.
PRIVIGEN is distinguished as one of the rare IVIG therapies approved in all major markets—the US, EU5, and Japan—demonstrating widespread clinical acceptance and strong regulatory endorsement for the treatment of immune deficiencies and autoimmune diseases.
In recent years, a global shortage of immunoglobulin has become a pressing concern, with Japan notably affected since 2019. The steep increase in demand has necessitated urgent imports. Two major factors driving this demand are the approval of IVIG for halting the progression of chronic inflammatory demyelinating polyneuropathy (CIDP) and the emergence of more concentrated IVIG formulations.
However, scaling up IVIG production and use poses significant challenges. Chief among them is maintaining a consistent plasma donor supply, a task made even harder during the pandemic due to widespread shutdowns of blood collection facilities. Additionally, IVIG must be administered by trained healthcare professionals in clinical settings, which places added strain on both patients and the healthcare infrastructure.
Learn more about the approved IVIG therapies @ IVIG Drugs
Key Emerging IVIG Therapies and Companies
Several companies—such as Grifols Therapeutics, ADMA Biologics, Takeda, LFB Biopharmaceuticals, OCTAPHARMA, Pfizer, CSL Behring, Biotest AG, and GC Biopharma—are actively involved in the development and commercialization of intravenous immunoglobulin therapies, with many already having approved products established in the market.
TAK-880, developed by Takeda, is a low IgA-IgG intravenous immunoglobulin formulation under investigation for treating primary immunodeficiency diseases, especially in patients with IgA hypersensitivity. It is currently undergoing regulatory filing with the FDA and EU for approval in this indication.
The anticipated launch of these emerging therapies are poised to transform the IVIG market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the IVIG market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about IVIG clinical trials, visit @ IVIG Therapies
IVIG Overview
Intravenous Immunoglobulin (IVIG) is a blood product derived from the pooled plasma of thousands of healthy donors, containing a broad spectrum of immunoglobulin G (IgG) antibodies. It is primarily used to treat patients with immune deficiencies, autoimmune diseases, and certain inflammatory conditions. In individuals with primary immunodeficiency disorders, IVIG helps provide the necessary antibodies their bodies cannot produce, thereby preventing recurrent infections. Additionally, IVIG plays a vital role in immune modulation, dampening harmful autoimmune responses in diseases like Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP), and immune thrombocytopenic purpura (ITP).
The mechanism of IVIG is complex and multifaceted, involving suppression of pathogenic autoantibodies, modulation of Fc receptors on immune cells, and alteration of cytokine production. Its clinical utility continues to expand, with ongoing research investigating its role in treating conditions like myasthenia gravis, systemic lupus erythematosus, and certain neurological disorders. While generally considered safe, IVIG can cause side effects such as headaches, infusion reactions, and, rarely, thromboembolic events or renal dysfunction, necessitating careful patient selection and monitoring. As a critical therapeutic option in immunology and neurology, IVIG remains a cornerstone for managing diverse immune-mediated disorders.
IVIG Epidemiology Segmentation
Primary immunodeficiency diseases had an estimated prevalence of around 38K cases across the EU4 and the UK in 2023. The IVIG market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
Total Diagnosed Prevalent Cases of Selected Indications
Total Target Patient Pool by Indications
Total Treated Patients by Indications
IVIG Report Metrics
Details
Study Period
2020–2034
IVIG Report Coverage
7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]
Key IVIG Companies
ADMA Biologics, Grifols Therapeutics, OCTAPHARMA, Takeda Pharmaceuticals, Kedrion Biopharma, LFB Biopharmaceuticals, Biotest, Japan Blood Products Organization, KM Biologics, Teijin, Nihon Pharmaceutical, GC Biopharma, CSL Behring, Pfizer, Evolve Biologics, and others
Key IVIG Therapies
ASCENIV, BIVIGAM, GAMUNEX-C, OCTAGAM 5% & 10%, GAMMAGARD LIQUID; S/D (immune globulin infusion; Intravenous [human]), GAMMAPLEX 5% & 10%, IQYMUNE, INTRATECT, VENOGLOBULIN, KENKETSU VENILON, Kenketu GLOVENIN-I, YIMMUGO, ALYGLO, PRIVIGEN, PANZYGA, TAK-880, and others
Scope of the IVIG Market Report
IVIG Therapeutic Assessment: IVIG current marketed and emerging therapies
IVIG Market Dynamics: Conjoint Analysis of Emerging IVIG Drugs
Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
Unmet Needs, KOL's views, Analyst's views, IVIG Market Access and Reimbursement
Discover more about IVIG therapies in development @ IVIG Clinical Trials
Table of Contents
1
Key Insights
2
Report Introduction
3
IVIG Market Overview at a Glance in the 7MM
3.1
Market Share (%) Distribution by Therapies in 2024
3.2
Market Share (%) Distribution by Therapies in 2034
4
Epidemiology and Market Forecast Methodology
5
Executive Summary of IVIG
6
Key Events
7
IVIG Background and Overview
7.1
Introduction
7.2
Mechanism of Action
7.3
Potential of IVIG
7.4
Adverse Reactions to IVIG Therapy
7.4.1
Mild to Moderate Immediate Reactions
7.4.2
Serious Immediate Reactions
7.4.3
Delayed Reactions
7.4.4
Preventive Measures and Risk Mitigation
7.4.5
Risks and Drawbacks
7.5
Current and Emerging IVIG Therapies
7.6
IVIG in Different Indications
7.6.1
Immune-Mediated Polyneuropathies
7.6.1.1
Guillain-Barré Syndrome (GBS)
7.6.1.2
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
7.6.1.3
Multifocal Motor Neuropathy (MMN)
7.6.1.4
Small Fiber Neuropathy (SFN)
7.6.1.5
Myasthenia Gravis
7.6.1.6
Lambert-Eaton Myasthenic Syndrome (LEMS)
7.6.1.7
Stiff-Person Syndrome (SPS)
7.6.1.8
Autoimmune Encephalitis and Autoimmune Epilepsy
7.6.1.9
Neuromyelitis Optica Spectrum Disorder (NMOSD) and MOG Antibody-Associated Disease (MOGAD)
7.6.1.10
Secondary Immunodeficiency Diseases (SIDD)
7.6.2
Systemic Immune-Mediated Conditions
7.6.2.1
Systemic Vasculitis Syndromes
7.6.2.2
Systemic Lupus Erythematosus (SLE)
7.6.2.3
Systemic Sclerosis (SSc)
7.6.2.4
Inflammatory Myopathies
7.6.3
Hematological Disorders
7.6.3.1
Immimmune Thrombocytopenia (ITP)
7.6.3.2
Immune Thrombocytopenia (ITP)
7.6.3.3
Pediatric ITP
7.6.4
Pediatric Autoimmune Diseases
7.6.4.1
Kawasaki Disease
7.6.4.2
Giant Cell Hepatitis with Autoimmune Hemolytic Anemia (GCH with AIHA)
7.6.4.3
Fetal and Neonatal Autoimmune and Alloimmune Thrombocytopenia (FNAIT)
7.6.4.4
Gestational Alloimmune Liver Disease (GALD)
7.6.5
Dermatology
7.6.5.1
Bullous Autoimmune Dermatoses
7.6.5.2
Stevens-Johnson Syndrome (SJS)
7.6.6
SARS-CoV-2 Infection
7.6.6.1
Autoimmune Diseases Induced by SARS-CoV-2 Infection
7.6.6.2
Long COVID
8
Epidemiology and Patient Population
8.1
Key Findings
8.2
Total diagnosed prevalent cases of selected indications across 7MM
8.3
Total Target Patient Pool by indications across 7MM
8.4
Total Treated Patients by Indications in the 7MM
9
Marketed Therapies
9.1
Key cross
9.2
ASCENIV (immune globulin intravenous, human–slra): ADMA Biologics
9.2.1
Product Description
9.2.2
Regulatory Milestones
9.2.3
Other Developmental Activities
9.2.4
Clinical Development
9.2.5
Safety and Efficacy
9.3
BIVIGAM (Immune Globulin Intravenous (Human), 10%): ADMA Biologics
9.3.1
Product Description
9.3.2
Regulatory Milestones
9.3.3
Safety and Efficacy
9.4
GAMUNEX-C (immune globulin injection (Human), 10%): Grifols Therapeutics
9.4.1
Product Description
9.4.2
Regulatory Milestones
9.4.3
Safety and Efficacy
9.5
OCTAGAM 5% & 10%: OCTAPHARMA
9.5.1
Product Description
9.5.2
Regulatory Milestones
9.5.3
Other Developmental Activities
9.5.4
Clinical Development
9.5.5
Safety and Efficacy
9.6
GAMMAGARD LIQUID; S/D (immune globulin infusion; Intravenous [human]): Takeda Pharmaceuticals
9.6.1
Product Description
9.6.2
Regulatory Milestones
9.6.3
Safety and Efficacy
9.7
GAMMAPLEX 5% & 10% (Immune Globulin Intravenous (Human), 10%): Kedrion Biopharma
9.7.1
Product Description
9.7.2
Regulatory Milestones
9.7.3
Safety and Efficacy
9.8
IQYMUNE: LFB Biopharmaceuticals
9.8.1
Product Description
9.8.2
Regulatory Milestones
9.9
INTRATECT: Biotest/Grifols
9.9.1
Product Description
9.9.2
Regulatory Milestones
9.9.3
Other Developmental Activities
9.10
VENOGLOBULIN: Japan Blood Products Organization
9.10.1
Product Description
9.10.2
Regulatory Milestones
9.10.3
Other Developmental Activities
9.10.4
Safety and Efficacy
9.11
KENKETSU VENILON: KM Biologics/ Teijin
9.11.1
Product Description
9.11.2
Regulatory Milestones
9.11.3
Other Developmental Activities
9.11.4
Safety and Efficacy
9.12
Kenketu GLOVENIN-I: Nihon Pharmaceutical/ Takeda
9.12.1
Product Description
9.12.2
Regulatory Milestones
9.12.3
Other Developmental Activities
9.12.4
Safety and Efficacy
9.13
YIMMUGO: Biotest AG
9.13.1
Product Description
9.13.2
Regulatory Milestones
9.13.3
Other Developmental Activities
9.13.4
Clinical Development
9.13.5
Safety and Efficacy
9.14
ALYGLO: GC Biopharma
9.14.1
Product Description
9.14.2
Regulatory Milestones
9.14.3
Other Developmental Activities
9.14.4
Clinical Development
9.14.5
Safety and Efficacy
9.15
PRIVIGEN: CSL Behring
9.15.1
Product Description
9.15.2
Regulatory milestones
9.15.3
Other Developmental Activities
9.15.4
Clinical Development
9.15.5
Safety and Efficacy
9.16
PANZYGA: Pfizer/Octapharma
9.16.1
Product Description
9.16.2
Regulatory Milestones
9.16.3
Other Developmental Activities
9.16.4
Clinical Development
9.16.5
Safety and Efficacy
10
Emerging Therapies
10.1
Key Cross Competition
10.2
TAK-880 : Takeda
10.2.1
Product Description
10.2.2
Other Developmental Activities
10.2.3
Analyst View
11
IVIG: 7 Major Market Analysis
11.1
Key Findings
11.2
Market Outlook
11.3
Key Market Forecast Assumptions
11.4
Market Size of IVIG in the 7MM
11.5
The United States
11.5.1
Total Market Size of IVIG in the United States
11.5.2
Market Size of IVIG by Products in the United States
11.6
EU4 and the UK
11.6.1
Total Market Size of IVIG in EU4 and the UK
11.6.2
Market Size of IVIG by Products in EU4 and the UK
11.7
1.5 Japan
11.7.1
Total Market Size of IVIG in Japan
11.7.2
Market Size of IVIG by Products in Japan
12
KOL Views
13
SWOT Analysis
14
Unmet Needs
15
Market Access and Reimbursement
15.1
United States
15.1.1
Centre for Medicare and Medicaid Services (CMS)
15.2
EU4 and the UK
15.2.1
Germany
15.2.2
France
15.2.3
Italy
15.2.4
Spain
15.2.5
United Kingdom
15.3
Japan
15.3.1
MHLW
15.4
Market Access and Reimbursement in IVIG
15.4.1
ASCENIV
15.4.2
BIVIGAM
15.4.3
PANZYGA
15.4.4
PRIVIGEN
15.4.5
ALYGLO
15.4.6
IQYMUNE
16
Appendix
16.1
Bibliography
16.2
Report Methodology
17
DelveInsight Capabilities
18
Disclaimer
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