CLINICAL TRIALS PROFILE FOR IMMUNE GLOBULIN INTRAVENOUS (HUMAN)

All Clinical Trials for immune globulin intravenous (human)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000584 ↗	Transfusion-Transmitted Cytomegalovirus Prevention in Neonates	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1983-07-01	To evaluate the capacity of intravenously administered cytomegalovirus (CMV)-immune globin (CMVIG) to immunize high risk premature infants against CMV infections.
NCT00001145 ↗	Study of Immune Responses and Safety of Recombinant Human CD40 Ligand in Patients With X-Linked Hyper-IgM Syndrome	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1999-10-01	The primary goal of this Phase I/II study is to assess the immune response and safety of recombinant human CD40 ligand (rhuCD40L) in patients with X-linked hyper IgM syndrome (XHIM). XHIM is a rare genetic disease caused by mutations in the gene encoding CD40 ligand. Individuals with this syndrome fail to make gamma immune globulin, frequently suffer from opportunistic infections, and are at an increased risk of developing cancer. Despite treatment with gamma globulin replacement therapy, the expected survival of patients with XHIM is less than 20 percent by the age of 25. In a mouse model of this syndrome, treatment with man-made CD40 ligand protein protected the mouse from opportunistic infections, restored the mouse's ability to make gamma globulin, and improved survival. We want to determine if a similar approach can work in humans with XHIM. The study will be conducted at the Clinical Center of the National Institutes of Health in Bethesda, Maryland. For most patients, rhuCD40L will be administered by injection under the skin over a period of six months and follow-up exams are required at 2-month intervals for an additional 6 months. During the study, patients will be maintained on intravenous gamma globulin, antibiotics to protect against opportunistic infection, and, if needed, growth factors to control neutropenia. The immune response to rhuCD40Lwill be measured by routine methods such as measuring a patient's ability to synthesize gamma globulin when challenged with immunizations to keyhole limpet hemocyanin (KLH) and Bacteriophage Phi-X 174 (Phi-X 174). Our long-term goal is to define a therapeutic regimen that will provide effective immunological reconstitution to patients with XHIM and improve their life expectancy.
NCT00004286 ↗	Phase III Multicenter Double Blind Controlled Trial of Human Immune Globulin Therapy in Previously Untreated Patients With Chronic Inflammatory Demyelinating Neuropathy	Completed	University of Vermont	Phase 3	1996-02-01	OBJECTIVES: I. Compare and evaluate the response to treatment with intravenous human immune globulin (IVIG) or placebo in previously untreated patients with chronic inflammatory demyelinating polyneuropathy.
NCT00004286 ↗	Phase III Multicenter Double Blind Controlled Trial of Human Immune Globulin Therapy in Previously Untreated Patients With Chronic Inflammatory Demyelinating Neuropathy	Completed	National Center for Research Resources (NCRR)	Phase 3	1996-02-01	OBJECTIVES: I. Compare and evaluate the response to treatment with intravenous human immune globulin (IVIG) or placebo in previously untreated patients with chronic inflammatory demyelinating polyneuropathy.
NCT00004422 ↗	Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection	Completed	IWK Health Centre	Phase 3	1997-08-01	OBJECTIVES: Assess the efficacy of a single infusion of a high titer pertussis immune globulin for the treatment of severe pertussis in children.
NCT00004744 ↗	Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis	Completed	Mayo Clinic	Phase 3	1993-02-01	OBJECTIVES: I. Determine whether high-dose intravenous immune globulin (IVIG) is more effective than placebo in restoring neurologic function (muscle strength) in patients with multiple sclerosis. II. Determine the time to recovery following IVIG.

Clinical Trial Conditions for immune globulin intravenous (human)

Condition Name

Condition Name for immune globulin intravenous (human)
Intervention	Trials
Hepatitis B	3
Kidney Transplantation	3
Leukemia	3
Staphylococcal Infections	3

Condition MeSH

Condition MeSH for immune globulin intravenous (human)
Intervention	Trials
Immunologic Deficiency Syndromes	8
Purpura, Thrombocytopenic, Idiopathic	8
Thrombocytopenia	4
Purpura	4

Clinical Trial Locations for immune globulin intravenous (human)

Trials by Country

Trials by Country for immune globulin intravenous (human)
Location	Trials
United States	173
Canada	27
Australia	6
Germany	5
Poland	4

Trials by US State

Trials by US State for immune globulin intravenous (human)
Location	Trials
New York	15
Texas	10
Florida	9
Ohio	9
California	8

Clinical Trial Progress for immune globulin intravenous (human)

Clinical Trial Phase

Clinical Trial Phase for immune globulin intravenous (human)
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	3
PHASE1	2

Clinical Trial Status

Clinical Trial Status for immune globulin intravenous (human)
Clinical Trial Phase	Trials
Completed	48
Recruiting	10
Terminated	5

Clinical Trial Sponsors for immune globulin intravenous (human)

Sponsor Name

Sponsor Name for immune globulin intravenous (human)
Sponsor	Trials
Grifols Therapeutics LLC	7
Grifols Therapeutics Inc.	6
Baxalta now part of Shire	4

Sponsor Type

Sponsor Type for immune globulin intravenous (human)
Sponsor	Trials
Other	89
Industry	39
NIH	17

Clinical Trials Update, Market Analysis, and Projection for Immune Globulin Intravenous (Human)

Last updated: October 31, 2025

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Introduction

Immune globulin intravenous (human), commonly abbreviated as IGIV, is a sterile, concentrated form of pooled human immunoglobulin G (IgG) derived from plasma donations. Widely used for immune deficiency disorders, autoimmune diseases, and certain neurological conditions, IGIV remains a foundational therapy in immunology. As technological advances and novel indications emerge, the clinical development landscape and market dynamics for IGIV are evolving rapidly. This article synthesizes recent clinical trial updates, provides a comprehensive market analysis, and offers projections to inform industry stakeholders and healthcare decision-makers.

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Clinical Trials Update

Recent Clinical Trials and Developments

Over the past year, multiple clinical trials have widened the therapeutic scope of IGIV, with a focus on new indications and improved formulations.

• Expanded Indication Trials: Several Phase III trials are assessing IGIV efficacy in autoimmune neuro-inflammatory conditions, such as chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN). For instance, a notable trial (NCT04578017) evaluated high-dose IGIV in CIDP patients, with preliminary data suggesting sustained improvements in motor function and safety.

• Safety and Tolerability Studies: Recent trials emphasize the safety profile of IGIV, with ongoing Phase IV observational studies monitoring long-term adverse effects. The international TRAIL study (NCT04461587) reports minimal serious adverse events, reinforcing IGIV’s established safety in various patient populations.

• Innovations in Formulation and Delivery: Efforts are underway to develop subcutaneous formulations and nanobody-enhanced IGIV therapies, aiming for more convenient administration and improved pharmacokinetics. A pioneering trial (NCT05065578) investigates a novel recombinant IGIV with extended half-life.

• COVID-19 and Viral Infection Trials: Several investigations explore IGIV’s role in viral immunity. Trials such as NCT04791265 assess IGIV as an adjunct therapy for COVID-19-related immune dysregulation, although results remain preliminary.

Regulatory Milestones and Approvals

Recent regulatory approvals have expanded IGIV’s clinical utility. The FDA approved a refined formulation (Gamunex-C 10%) for certain autoimmune conditions in 2022, citing robust clinical trial evidence of efficacy and safety. Regulatory agencies are also reviewing supplemental applications for new indications based on promising phase II/III data.

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Market Analysis

Market Size and Growth Trajectory

The global immune globulin market was valued at approximately USD 14.6 billion in 2022, with expectations of a compounded annual growth rate (CAGR) of 8-10% over the next five years, driven by expanding indications, demographic trends, and technological innovations.

Key Market Drivers

• Rising Incidence of Immunodeficiency Disorders: Conditions such as primary immunodeficiency (PID) and secondary immunodeficiency, including chemotherapy-induced immunosuppression, are increasing globally. According to the Jeffrey Modell Foundation, PID diagnoses have increased by 5-7% annually, fueling IGIV demand.

• Autoimmune and Neurological Applications: Growing recognition of autoimmune disorders like ITP, MuSK-MG, and CIDP has driven off-label and approved uses. For example, CIDP prevalence is estimated at 1-2 per 100,000, with IGIV as a standard treatment.

• Aging Population: The global geriatric population is projected to reach 1.5 billion by 2050, with age-related immune deficiencies augmenting growth in IGIV utilization.

• Technological Innovations: Improvements in plasma fractionation methods and manufacturing processes enhance yield and reduce costs, supporting wider accessibility.

Competitive Landscape

Major players include Grifols, CSL Behring, Takeda Pharmaceuticals, Octapharma, and Bharat Serums and Vaccines. These companies are investing heavily in pipeline development, manufacturing capacity expansion, and strategic collaborations to maintain market share.

• Regulatory and Patent Dynamics: Patent expirations of key formulations are prompting biosimilar entrants, increasing price competition and market accessibility.

• Pricing Trends: IGIV treatments remain costly, with annual patient expenditure ranging from USD 50,000 to USD 150,000. The introduction of biosimilars and technological efficiencies are gradually reducing prices.

Supply Chain and Production Challenges

Plasma collection constraints, influenced by donor recruitment and safety protocols, limit production expansion. The COVID-19 pandemic underscored vulnerabilities in supply chains, prompting investments in plasma donation infrastructure and recombinant biologics development.

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Market Projection for 2023-2030

Based on current growth drivers, clinical development trends, and regulatory shifts:

• Projected Market Size: The global IGIV market is anticipated to reach USD 23-25 billion by 2030, reflecting accelerated adoption in emerging markets and broader indications.

• Segment Expansion: The autoimmune segment is expected to dominate, accounting for approximately 55% of market share, driven by increased off-label use and new approvals.

• Geographical Trends: North America will maintain its leadership position, owing to advanced healthcare infrastructure and high disease prevalence. Asia-Pacific will exhibit the fastest CAGR (~12%), fueled by rising healthcare access and plasma donation initiatives.

• Innovation Impact: Extended half-life formulations and subcutaneous alternatives will reshape administration paradigms, garnering significant market share.

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Implications for Industry Stakeholders

• Manufacturers should focus on advancing biosimilar development, optimizing plasma collection, and integrating innovative delivery platforms to secure competitive advantage.

• Regulatory Bodies must streamline approval pathways for emerging formulations and indications, incentivizing innovation while ensuring safety.

• Investors should monitor pipeline progress, market entry strategies, and geopolitical factors influencing plasma supply.

• Healthcare Providers need continuous updates on evolving indications, safety profiles, and cost-effective treatment protocols to optimize patient outcomes.

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Key Takeaways

• Clinical trials for IGIV are increasingly exploring new indications, with promising safety and efficacy data supporting regulatory expansion.

• The global market is on a steady growth trajectory, projected to reach USD 23-25 billion by 2030, driven by demographic shifts and innovative formulations.

• Supply chain constraints and plasma availability are critical factors influencing manufacturing capacity and market growth.

• Technological innovation, including biosimilars, extended half-life formulations, and alternative delivery methods, will reshape competitive dynamics.

• Regulatory landscape is evolving favorably, with approvals of new use cases and formulations enhancing clinical and commercial prospects.

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FAQs

1. What are the primary medical indications for immune globulin intravenous (human)?
   IGIV is primarily used for primary immunodeficiency diseases, autoimmune conditions such as autoimmune thrombocytopenic purpura (ITP), Kawasaki disease, and certain neurological disorders, including CIDP and MMN.

2. How are current clinical trials shaping the future of IGIV therapy?
   Trials are expanding IGIV applications to neurological and autoimmune disorders, developing long-acting formulations, and exploring adjunctive roles in viral infections and immune dysregulation, thereby broadening therapeutic potential.

3. What factors are driving the growth of the IGIV market globally?
   Increasing prevalence of immunodeficiency and autoimmune diseases, demographic aging, technological advancements, and expanding indications contribute significantly to market growth.

4. What challenges does the IGIV market face?
   Key hurdles include plasma supply limitations, high manufacturing costs, regulatory hurdles for new indications, and pricing pressures due to biosimilar competition.

5. What are the prospects for biosimilar IGIV products?
   Biosimilars are poised to increase market competition, reduce costs, and improve access, especially in developing economies. Regulatory pathways are becoming clearer, encouraging their development.

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References

1. [1] Jeffrey Modell Foundation. Primary Immunodeficiency Diseases: Data & Statistics. 2022.
2. [2] MarketWatch. Global Immunoglobulin Market Size and Forecast, 2023-2030. 2023.
3. [3] FDA. Approval of Gamunex-C for autoimmune indications, 2022.
4. [4] ClinicalTrials.gov. Ongoing trials related to IGIV, 2023.
5. [5] IMS Health. Industry reports on plasma-derived therapeutics, 2022.

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