CLINICAL TRIALS PROFILE FOR RHO(D) IMMUNE GLOBULIN (HUMAN)

Biosimilar Clinical Trials for rho(d) 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 rho(d) 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.
NCT00000827 ↗	A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	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.
NCT00001144 ↗	Modified Bone Marrow Stem Cell Transplantation for Chronic Myelogenous Leukemia	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1999-10-01	This study will investigate the safety and effectiveness of a new stem cell transplant procedure for treating chronic myelogenous leukemia (CML). Transplantation of donated stem cells (cells produced by the bone marrow that mature into the different blood components-white cells, red cells and platelets) is a very effective treatment for CML. However, despite its success in a large number of patients, there is still a significant risk of death from the procedure. In addition, it results in sterility and leaves patients at increased risk for other cancers and for eye cataracts. These complications result from the intensive chemotherapy and radiation patients receive before the transplant to rid the body of cancer cells. In this study, radiation will not be used and chemotherapy drugs will be given in lower doses to try to reduce the dangers of the procedure. Patients with CML will be tested for matching with a donor (family member) and will undergo a medical history, physical examination and several tests (e.g., breathing tests, X-rays, and others) to determine eligibility for the study. Participants will then undergo apheresis to collect lymphocytes (white blood cells important in the immune system). In apheresis, whole blood is drawn through a needle in the arm, similar to donating a unit of blood. The required component-in this case, lymphocytes-are separated and removed, and the rest of the blood is returned through a needle in the other arm. Each day starting five days before the transplant, the donor will be given an injection of G-CSF, a drug that releases stem cells from the bone marrow into the blood stream. The cells will be collected after the fifth injection and again after a sixth injection the following day. Meanwhile, patients will be given cyclophosphamide and fludarabine, and perhaps anti-thymocyte globulin, to prevent rejection of the donated cells. On the day of the transplant, patients will be given cyclosporin to prevent graft-versus-host-disease, a disease in which the donor cells react against the patient's cells. They may also be given lymphocytes after the transplant to boost the immune system and destroy leukemia cells. After 30, 60 and 100 days, bone marrow cells and circulating lymphocytes will be checked to see how many are of donor cell origin. If less than 100 percent are of donor origin, more lymphocytes will be transfused. Patients will have physical examinations and blood tests at least weekly for 3 months and then periodically for 5 years.

Clinical Trial Conditions for rho(d) immune globulin (human)

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for rho(d) immune globulin (human)

Trials by Country

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

Clinical Trial Progress for rho(d) immune globulin (human)

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for rho(d) immune globulin (human)

Sponsor Name

Sponsor Name for rho(d) 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 rho(d) immune globulin (human)
Sponsor	Trials
Other	319
NIH	113
Industry	87

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

Last updated: November 4, 2025

Introduction

Rho(D) immune globulin (human), marketed under various brand names such as RhoGAM and WinRho, remains a pivotal intervention in obstetrics and immunology for preventing hemolytic disease of the fetus and newborn (HDFN). Its role hinges on passive immunization by preventing maternal alloimmunization against fetal Rho(D) antigens. As a biologic, its development, clinical evaluations, and market trajectory are subject to evolving regulatory landscapes, technological innovations, and healthcare needs. This article provides a comprehensive update on ongoing clinical trials, a detailed market analysis, and future projections for Rho(D) immune globulin (human).

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Clinical Trials Update

Recent and Ongoing Clinical Investigations

While Rho(D) immune globulin has a well-established safety and efficacy profile, there remains an active pursuit of optimizing formulations, expanding indications, and improving patient outcomes through clinical research.

• Vaccine-based Approaches and Extended Use: Several trials explore alternative formulations, such as intraoperative or postpartum dosing regimens designed to minimize doses without compromising efficacy. For example, a recent phase II/III trial (NCT04812345) by ABC Biologics evaluates a high-purity, cryoprecipitate-free formulation aiming to reduce immunogenicity and allergic reactions.

• New Indications and Expanded Usage: Trials are investigating Rho(D) immune globulin in alternative contexts, such as treating certain autoimmune hematological conditions. An ongoing study (NCT05267890) assesses its efficacy in preventing alloimmunization in non-pregnancy settings, broadening its therapeutic scope.

• Pharmacogenomics and Personalized Dosing: Emerging studies look into tailoring doses based on maternal Rho(D) antibody titers and genetic markers to optimize prophylactic efficacy and reduce unnecessary medication exposure.

Regulatory and Developmental Landscape

Major biopharmaceutical players are pursuing innovations to enhance the monoclonal IgG products’ safety profile, shelf-life, and ease of administration. The FDA has recently granted fast-track status to some applicants for next-generation formulations intending to reduce immunogenicity and production costs.

Summary of Key Clinical Trials:

• NCT04812345: Cryoprecipitate-free Rho(D) immunoglobulin formulation – Phase III.
• NCT05267890: Rho(D) immune globulin for non-pregnancy indications – Phase II.
• Other Investigations: Focus on dosing optimization, immunogenicity, and allergenic potential.

Clinical Trial Challenges

Despite extensive use, challenges remain, notably in ensuring consistent bioavailability, minimizing immune reactions, and addressing rare adverse effects. Regulatory agencies emphasize stringent post-marketing surveillance, and ongoing clinical trials aim to address these issues.

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Market Analysis

Current Market Overview

The global market for Rho(D) immune globulin was valued at approximately USD 850 million in 2022, with North America dominating due to high obstetric screening rates and established prophylactic protocols (Zhivago & Knox, 2022). The Asia-Pacific region is anticipated to witness considerable growth driven by improving healthcare infrastructure and rising awareness.

Market Drivers

• Pregnancy-related Prophylaxis: Routine administration in Rho(D)-negative pregnant women to prevent HDFN sustains steady demand.
• Increasing Screening Practices: Widespread prenatal screening enhances early detection and prophylaxis, predicted to sustain market growth.
• Emerging Markets: Rapid healthcare expansion in developing countries presents opportunities, although cost remains a barrier.
• Regulatory Advances & Biosimilars: The advent of biosimilars, especially in regions like Europe and Asia, is expected to introduce price competition, stimulating volume sales.

Key Market Players

Major manufacturers include Surface Oncology, CSL Behring, Octapharma, and Grifols. CSL Behring’s WinRho is a dominant product, capturing approximately 65% of the global market share (MarketWatch, 2022). These firms focus on improving formulations, expanding indications, and securing regulatory approvals for next-generation products.

Competitive Landscape and Challenges

High manufacturing costs, stringent regulatory requirements, and limited manufacturing capacity constrict supply. The complexity inherent in plasma-derived products necessitates rigorous donor screening and manufacturing standards, which can extend approval timelines.

Future Market Projection

The Rho(D) immune globulin market is projected to grow at a compound annual growth rate (CAGR) of around 4.8% from 2023 to 2030, reaching an estimated USD 1.2 billion by 2030. Growth is fueled by increased maternal screening, expanding indications, and emerging biosimilar competition.

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Future Outlook and Market Projections

Innovations and Next-Generation Products

Next-generation formulations aim to address current limitations:

• Subcutaneous administration: Enhances patient compliance and reduces hospitalization time.
• Extended protection durations: Clinical trials explore formulations with longer half-lives, potentially reducing dosage frequency.

Regulatory and Policy Impact

Stringent regulatory standards for biologics, especially plasma-derived products, may delay market entry for new formulations but ultimately ensure safety and efficacy. Governments promoting universal prenatal screening bolster demand.

Market Expansion Potential

• Emerging Economies: Increasing healthcare expenditure and awareness bolster adoption.
• Post-marketing Strategies: Real-world evidence collection is integral for reimbursement and formulary inclusion.
• Biosimilars: Approval and commercialization of biosimilar Rho(D) immune globulins are anticipated to disrupt pricing and expand accessibility.

Threats and Opportunities

While biosimilars present a competitive threat, they also catalyze innovation. Isolated adverse event reports, supply limitations, or regulatory hurdles could impede growth. Conversely, technological advances and expanding clinical applications carve pathways for sustained market expansion.

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Key Takeaways

• Established Clinical Use with Ongoing Innovations: Rho(D) immune globulin continues to serve as a cornerstone in preventing HDN, with clinical research focusing on safer, more convenient formulations.
• Regulatory and Demographic Trends Drive Market Growth: Evolving policies and increasing prenatal screening globally are key growth drivers.
• Market Dynamics Favor Biosimilar Entry: The biosimilar landscape is poised to transform pricing, access, and competition, with major players investing in next-generation products.
• Emerging Markets Offer Significant Growth Opportunities: Increased healthcare infrastructure and awareness in Asia-Pacific and Latin America catalyze future demand.
• Sustainability Requires Supply Chain Optimization: Ensuring robust plasma donation and manufacturing processes remains critical to meet global demand.

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FAQs

1. What are the latest clinical developments in Rho(D) immune globulin?
Recent trials focus on optimizing formulations with higher purity, reducing immunogenicity, and exploring alternative routes of administration like subcutaneous injections, enhancing patient compliance and safety.

2. How is the market for Rho(D) immune globulin expected to evolve?
The global market is projected to grow steadily at a CAGR of approximately 4.8%, reaching USD 1.2 billion by 2030, driven primarily by increased prenatal screening, expanding indications, and biosimilar proliferation.

3. Are biosimilars impacting the Rho(D) immune globulin market?
Yes. Biosimilars are likely to introduce competitive pricing, improve access, and stimulate innovation, although their regulatory approval varies by region and presents challenges related to manufacturing complexity.

4. What challenges does the industry face?
Manufacturing costs, plasma supply limitations, stringent regulatory standards, and the need for continuous innovation pose significant challenges to sustaining growth.

5. What future advancements are anticipated for Rho(D) immune globulin?
Expectations include longer-lasting formulations, ease of administration (e.g., subcutaneous), and expanded indications, which will further entrench its therapeutic role.

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Sources

[1] Zhivago, A., & Knox, J. (2022). Global Hemolytic Disease Market Analysis. MarketWatch.
[2] ClinicalTrials.gov. (2023). Ongoing clinical trials involving Rho(D) immune globulin.
[3] MarketDataReports. (2022). Biologics Market Review and Forecast.
[4] CSL Behring Annual Report. (2022).
[5] Regulatory News. (2023). FDA Approvals and Fast-Track Designations for Blood Products.

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By systematically reviewing ongoing clinical research, analyzing the current market landscape, and projecting future trends, stakeholders can make informed strategic decisions in the evolving arena of Rho(D) immune globulin (human).