CLINICAL TRIALS PROFILE FOR IMMUNE GLOBULIN (HUMAN)

Biosimilar Clinical Trials for immune globulin (human)

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01624805 ↗	Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome	Recruiting	National Cancer Institute (NCI)	Phase 2	2012-06-25	This phase II trial studies methylprednisolone, horse anti-thymocyte globulin, cyclosporine, filgrastim, and/or pegfilgrastim or pegfilgrastim biosimilar in treating patients with aplastic anemia or low or intermediate-risk myelodysplastic syndrome. Horse anti-thymocyte globulin is made from horse blood and targets immune cells known as T-lymphocytes. Since T-lymphocytes are believed to be involved in causing low blood counts in aplastic anemia and in some cases of myelodysplastic syndromes, killing these cells may help treat the disease. Methylprednisolone and cyclosporine work to suppress immune cells called lymphocytes. This may help to improve low blood counts in aplastic anemia and myelodysplastic syndromes. Filgrastim and pegfilgrastim are designed to cause white blood cells to grow. This may help to fight infections and help improve the white blood cell count. Giving methylprednisolone and horse anti-thymocyte globulin together with cyclosporine, filgrastim, and/or pegfilgrastim may be an effective treatment for patients with aplastic anemia or myelodysplastic syndrome.
NCT01624805 ↗	Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome	Recruiting	M.D. Anderson Cancer Center	Phase 2	2012-06-25	This phase II trial studies methylprednisolone, horse anti-thymocyte globulin, cyclosporine, filgrastim, and/or pegfilgrastim or pegfilgrastim biosimilar in treating patients with aplastic anemia or low or intermediate-risk myelodysplastic syndrome. Horse anti-thymocyte globulin is made from horse blood and targets immune cells known as T-lymphocytes. Since T-lymphocytes are believed to be involved in causing low blood counts in aplastic anemia and in some cases of myelodysplastic syndromes, killing these cells may help treat the disease. Methylprednisolone and cyclosporine work to suppress immune cells called lymphocytes. This may help to improve low blood counts in aplastic anemia and myelodysplastic syndromes. Filgrastim and pegfilgrastim are designed to cause white blood cells to grow. This may help to fight infections and help improve the white blood cell count. Giving methylprednisolone and horse anti-thymocyte globulin together with cyclosporine, filgrastim, and/or pegfilgrastim may be an effective treatment for patients with aplastic anemia or myelodysplastic syndrome.

All Clinical Trials for immune globulin (human)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000580 ↗	Interruption of Maternal-to-Infant Transmission of Hepatitis B by Means of Hepatitis B Immune Globulin	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1975-11-01	To evaluate whether hepatitis B immune globulin with a high level of antibody against the hepatitis B antigen would be capable of interrupting maternal-fetal transmission of hepatitis B virus, the single most important route of hepatitis spread in the entire Third World.
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.
NCT00000751 ↗	A Phase III Randomized, Double-Blind, Controlled Study of the Use of Anti-HIV Immune Serum Globulin (HIVIG) for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine (AZT)	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To evaluate the effect of anti-HIV immune serum globulin (HIVIG) versus immune globulin (IVIG) administered during pregnancy and to the newborn, in combination with zidovudine (AZT) administered intrapartum and to the newborn, on incidence of HIV infection in infants born to HIV-infected women who received AZT during pregnancy for medical indications. Vertical transmission of HIV from mother to child may occur before, during, or after parturition (via breast-feeding). It is believed that therapy administered both during pregnancy and intrapartum may help prevent vertical transmission. Additionally, adjunctive short-term antiretroviral therapy for the newborn, following the intensive viral exposure presumed to occur at birth, may be necessary.
NCT00000751 ↗	A Phase III Randomized, Double-Blind, Controlled Study of the Use of Anti-HIV Immune Serum Globulin (HIVIG) for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine (AZT)	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	1969-12-31	To evaluate the effect of anti-HIV immune serum globulin (HIVIG) versus immune globulin (IVIG) administered during pregnancy and to the newborn, in combination with zidovudine (AZT) administered intrapartum and to the newborn, on incidence of HIV infection in infants born to HIV-infected women who received AZT during pregnancy for medical indications. Vertical transmission of HIV from mother to child may occur before, during, or after parturition (via breast-feeding). It is believed that therapy administered both during pregnancy and intrapartum may help prevent vertical transmission. Additionally, adjunctive short-term antiretroviral therapy for the newborn, following the intensive viral exposure presumed to occur at birth, may be necessary.
NCT00000827 ↗	A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children	Completed	North American Biologicals Inc	Phase 1	1969-12-31	To evaluate the safety, tolerance, pharmacokinetics, and antiviral activity of human anti-HIV immune serum globulin ( HIVIG ) at three dosage levels in HIV-infected children. Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children.

Clinical Trial Conditions for immune globulin (human)

Condition Name

Condition Name for immune globulin (human)
Intervention	Trials
Leukemia	54
Lymphoma	36
Myelodysplastic Syndromes	31
Multiple Myeloma and Plasma Cell Neoplasm	21

Condition MeSH

Condition MeSH for immune globulin (human)
Intervention	Trials
Leukemia	73
Myelodysplastic Syndromes	54
Preleukemia	52
Syndrome	47

Clinical Trial Locations for immune globulin (human)

Trials by Country

Trials by Country for immune globulin (human)
Location	Trials
United States	641
Canada	44
China	26
Germany	21
France	12

Trials by US State

Trials by US State for immune globulin (human)
Location	Trials
California	49
Texas	47
New York	45
Ohio	37
Maryland	35

Clinical Trial Progress for immune globulin (human)

Clinical Trial Phase

Clinical Trial Phase for immune globulin (human)
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	5

Clinical Trial Status

Clinical Trial Status for immune globulin (human)
Clinical Trial Phase	Trials
Completed	151
Recruiting	46
Terminated	35

Clinical Trial Sponsors for immune globulin (human)

Sponsor Name

Sponsor Name for immune globulin (human)
Sponsor	Trials
National Cancer Institute (NCI)	60
M.D. Anderson Cancer Center	23
National Heart, Lung, and Blood Institute (NHLBI)	20

Sponsor Type

Sponsor Type for immune globulin (human)
Sponsor	Trials
Other	319
NIH	113
Industry	87

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

Last updated: November 1, 2025

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Introduction

Human immune globulin (IG), also known as intravenous immunoglobulin (IVIG), represents a critical therapeutic option for a spectrum of immune deficiency disorders and autoimmune conditions. It comprises pooled IgG antibodies extracted from thousands of human plasma donors, providing passive immunity and immune modulation. The global market for IG is experiencing notable growth driven by increasing prevalence of primary immunodeficiency diseases (PIDs), expanding therapeutic indications, and technological advances in plasma processing and purification.

This article delivers a comprehensive update on clinical trials, provides a detailed market analysis, and projects future industry trends for human immune globulin.

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Clinical Trials Landscape for Human Immune Globulin

Ongoing and Recent Clinical Trials

The efficacy and safety profile of IG has been extensively studied, with ongoing trials aiming to expand indications, optimize dosing, and evaluate novel formulations. As per ClinicalTrials.gov, over 80 active investigations focus on IG's application across autoimmune, infectious, and neurological disorders.

Key recent trials include:

• Autoimmune Diseases: Multiple studies evaluate subcutaneous immunoglobulin (SCIG) versus IVIG in conditions such as chronic inflammatory demyelinating polyneuropathy (CIDP), Guillain-Barré syndrome, and myasthenia gravis [1]. These trials assess dosing regimens, long-term safety, and patient quality of life.

• Immunodeficiency Disorders: Investigations aim to refine personalized dosing protocols and explore genetically engineered plasma-derived Ig products for better specificity ([2]).

• Emerging Indications: Trials are exploring IG's role in COVID-19-related complications, with preliminary data suggesting potential benefits in immune modulation, though conclusive evidence remains pending ([3]).

Regulatory Approvals and Innovations

Recent approvals include newer formulations with improved tolerability, such as high-concentration IVIG and recombinant Ig products. Regulatory agencies like the FDA have approved therapeutic products with extended shelf-life and reduced infusion-related adverse effects. The promotion of subcutaneous Ig (SCIG) as a home-administered alternative accelerates patient-centered care models.

Challenges in Clinical Development

Despite favorable outcomes, clinical development faces challenges such as:

• Heterogeneity of patient populations requiring tailored dosing strategies.
• Limited availability of plasma donors, constraining supply.
• Infections risk from plasma-derived products, mandating rigorous screening and pathogen reduction techniques.

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Market Analysis

Market Size and Historical Growth

The global immune globulin market was valued at approximately USD 10 billion in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 7-8% through 2030 ([4]). Growth drivers include rising incidence of primary immunodeficiency (estimated at 1 in 10,000 live births), autoimmune disorders like multiple sclerosis, and Kawasaki disease.

Regional Market Dynamics

• North America: Leading market, driven by high diagnosis rates, reimbursement policies, and advanced healthcare infrastructure.
• Europe: Significant growth, supported by a broad adoption of immunoglobulin therapies and expanding approved indications.
• Asia-Pacific: Fastest-growing segment, with increasing awareness, improved healthcare access, and rising prevalence of autoimmune diseases.

Market Segmentation

• Product Type: IVIG (intravenous), SCIG (subcutaneous), and recombinant Ig.
• Indications: Primary immunodeficiency, autoimmune diseases, infectious diseases, neurological disorders.
• Formulation: Liquid, lyophilized, concentrated preparations.

Competitive Landscape

Leading players include CSL Behring, Grifols, Takeda Pharmaceutical, Octapharma, and Bio Products Laboratory. These companies focus on expanding product portfolios, improving manufacturing efficiencies, and strategic collaborations to address supply constraints.

Supply Chain and Manufacturing Challenges

Plasma collection remains a critical bottleneck. The COVID-19 pandemic temporarily disrupted plasma donation programs, impacting supply. Innovations such as recombinant Ig and plasma fractionation technologies aim to mitigate these issues.

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Market Projection and Future Trends

Projected Growth Drivers

• Expanding therapeutic indications: New trials in autoimmune and neurology indications will broaden market penetration.
• Technological advancements: Recombinant and engineered Ig products promise higher safety, consistent quality, and potential for personalized therapy.
• Regulatory support: Incentives for expanded access, orphan drug designations, and streamlined approvals will foster innovation.

Emerging Opportunities

• Analytical enhancements: Increased utilization of biomarker-driven patient stratification.
• Home infusion models: Growing demand for self-administration options reduces healthcare burden and enhances patient compliance.
• Global plasma collection campaigns: Initiatives to bolster plasma supply through donor recruitment.

Market Risks

• Supply constraints: Plasma shortages, especially in emerging markets.
• Pricing pressures: Cost containment efforts by payers could impact profitability.
• Regulatory hurdles: Stringent standards for plasma product safety and manufacturing quality.

Long-term Outlook

By 2030, the global immune globulin market is estimated to reach approximately USD 18-20 billion, driven by innovation, expanding indications, and increasing awareness. The convergence of biologics advancements and personalized medicine is anticipated to redefine therapeutic paradigms, with synthetic or recombinant Ig products increasingly supplementing plasma-derived options.

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Conclusion

The human immune globulin market is poised for sustained growth, driven by robust clinical research, expanding indications, and technological innovations. While challenges such as plasma supply and pricing persist, strategic investments in manufacturing, alternative plasma sources, and product innovation will sustain industry expansion.

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Key Takeaways

• Clinical trials predominantly focus on supporting IG's efficacy in autoimmune and neurological disorders, with promising results for subcutaneous formulations.
• The global IG market is projected to grow at a CAGR of around 7-8% through 2030, reaching up to USD 20 billion.
• North America currently leads the market, with Asia-Pacific emerging rapidly due to rising healthcare access.
• Supply constraints from plasma donor shortages pose ongoing challenges; innovative solutions like recombinant Ig are essential.
• Future growth hinges on expanding indications, technological innovations, and optimizing supply chain capabilities.

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FAQs

1. What are the primary therapeutic indications for human immune globulin?
Primarily used for primary immunodeficiency diseases, autoimmune conditions such as CIDP, Kawasaki disease, and certain neurological disorders, IG offers passive immunity and immune modulation.

2. How are clinical trials influencing IG's future applications?
Ongoing research explores new indications, optimized dosing regimens, and alternative delivery modes, potentially broadening IG's therapeutic scope and improving patient outcomes.

3. What are the main challenges facing the IG market?
Key challenges include plasma donation shortages, high manufacturing costs, supply chain disruptions, and regulatory hurdles impacting product availability and affordability.

4. How is innovation impacting the IG product landscape?
Technological advancements in recombinant protein production, plasma fractionation, and product formulations enhance safety, consistency, and patient convenience, fostering market growth.

5. What is the impact of emerging markets on the IG industry?
Rapid economic development, increasing disease awareness, and improved healthcare infrastructure are propelling Asia-Pacific to become a significant and fast-growing segment in the global IG market.

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References

[1] ClinicalTrials.gov. (2022). Active trials involving immunoglobulin.

[2] Milone, M. et al. (2021). Advances in immunoglobulin therapy for immunodeficiency. Immunology and Allergy Clinics.

[3] Smith, L. et al. (2022). Emerging role of IVIG in COVID-19 management. Journal of Infectious Diseases.

[4] MarketWatch. (2022). Global immunoglobulin market size and forecasts.

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Note: Data are based on the latest available market reports, regulatory updates, and clinical trial repositories, representing industry trends up to early 2023.