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.

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

Condition MeSH

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

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

Rho(d) immune globulin (human) Market Analysis and Financial Projection

Last updated: May 10, 2026

Rho(D) Immune Globulin (Human): Clinical Trials Update, Market Analysis, and 2030 Projection

What is rho(D) immune globulin (human) and where is it used clinically?

Rho(D) immune globulin (human) is an antibody product used to prevent RhD alloimmunization in RhD-negative individuals exposed to RhD-positive red blood cells. It is used in settings including obstetrics (prenatal prophylaxis and postpartum prophylaxis after fetomaternal hemorrhage), miscarriage or termination of pregnancy, ectopic pregnancy, abdominal trauma, and other sensitizing events.

In most markets, product demand correlates with:

• Number of pregnancies and live births
• Coverage and compliance for prophylaxis
• Rates of sensitizing events treated with RhIG
• Pricing and payer reimbursement dynamics
• Concentration, dosing schedules, and formulation mix (liquid vs lyophilized where relevant)

What is the current clinical trials update for rho(D) immune globulin (human)?

A complete, trial-by-trial clinical update requires an authoritative registry pull (e.g., ClinicalTrials.gov, EU CTR) by product name and manufacturer. That registry-level sourcing is not available in the provided context. With no trial-level inputs, the update cannot be stated accurately.

Clinical trials update status in this report: No registry-verified, trial-specific update can be produced from the supplied information.

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Who holds the commercial supply and how is the market structured?

The RhIG market is characterized by:

• Multiple brands across the US, EU, UK, Canada, Australia, and Latin America
• Competition based on availability, package size, dosing convenience, and contracting with maternal care providers
• Procurement through hospital tenders and payer contracts
• Significant sensitivity to manufacturing continuity, lot release timelines, and plasma fractionation capacity

Market structure (high level):

• Developed markets: concentrated, with brand switching driven by contracting and supply
• Emerging markets: driven by access and reimbursement constraints, with higher variability in uptake

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What does historical demand look like and what drives growth?

RhIG is mature and generally demand is volume-led (pregnancy-related prophylaxis). Growth tends to come from:

• Population growth and birth rates
• Increased adoption of prophylaxis protocols (where underuse exists)
• Better identification of sensitizing events
• Pricing changes and payer coverage expansion

Primary downside risks:

• Guideline changes that reduce prophylaxis intensity (rare, but policy-dependent)
• Substitution by alternative dosing strategies or competing biologics if they gain coverage
• Supply constraints that create temporary shortages and force stockpiling behavior

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How big is the market and what is the base-case projection to 2030?

A market projection requires (1) a verified current market size, (2) historical shipment volumes or patient counts, (3) penetration/coverage assumptions by region, and (4) pricing assumptions. None of these inputs are provided.

2030 projection status in this report: No defensible market sizing or CAGR forecast can be produced from the supplied information.

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What are the product- and lifecycle-related patent and competition considerations?

RhIG is a biologic, and product-level exclusivity typically depends on:

• Primary patent coverage (formulation, manufacturing process, dosage regimen)
• Second-generation patents (stability, packaging, concentration, purification process)
• Regulatory exclusivity and data protection frameworks by jurisdiction
• Biosimilar or follow-on biologic pathways (where available) and interchangeability/clinical equivalence requirements

Without a jurisdiction-specific patent landscape and expiry dates, no actionable infringement-risk or launch-timing analysis can be stated.

Patent and competition status in this report: No jurisdiction-grade patent expiry or competitor schedule can be produced from the supplied information.

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Market and R&D Decision Points (Actionable but Non-Quantitative)

Where do manufacturers win in this category?

• Contracting reliability: sustained supply and lot release performance
• Formulation and administration fit: dosing convenience and package availability
• Regional tender alignment: price and distribution alignment with hospital purchasing cycles
• Protocol fit: evidence positioning for prophylaxis across pregnancy and sensitizing event scenarios

Where do R&D teams focus next?

For RhIG, near-term R&D in practice usually targets:

• Improved manufacturing yield and product consistency
• Stability and shelf-life improvements
• Delivery/administration convenience (without changing clinical intent)
• Population and regimen refinement to improve adherence and reduce variability in administration

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Key Takeaways

• Clinical trials update: cannot be provided as a registry-verified, trial-specific summary with the information available in this input.
• Market analysis and 2030 projection: cannot be quantified without baseline market size, regional volume inputs, and pricing assumptions.
• Actionable insights remain operational: winning levers are supply reliability, contracting execution, and protocol-aligned product positioning.
• Patent and competitive timing: cannot be assessed without jurisdiction-specific patent and exclusivity data.

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FAQs

1. Is rho(D) immune globulin (human) considered a mature biologic class?
   Yes. It is a standard-of-care prophylactic antibody product used across pregnancy-related and sensitizing event settings.

2. What drives demand more: price or utilization?
   Utilization typically drives demand in RhIG because use is tied to pregnancy and clinical protocols; pricing affects revenue per unit once coverage is established.

3. Do new clinical outcomes often change RhIG usage?
   Changes usually come from guideline updates and practical protocol adoption rather than from major new efficacy paradigms.

4. How does supply constraint affect the market?
   Supply constraints can drive short-term procurement behavior (stockpiling and tender rescheduling) and shift share toward reliable suppliers.

5. Can biosimilar or follow-on products materially change this market?
   They can, but impact depends on regulatory pathway, interchangeability, clinical acceptance, and payer tender behavior.

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References

1. ClinicalTrials.gov. Database of privately and publicly funded clinical studies. https://clinicaltrials.gov/
2. European Clinical Trials Register (EU CTR). https://www.clinicaltrialsregister.eu/
3. EMA. European public assessment reports and product information for biologicals. https://www.ema.europa.eu/
4. FDA. Biological product information and related regulatory materials. https://www.fda.gov/