Hemolytic Disease of the Fetus and Newborn – Executive Insights – Hemolytic Disease of the Fetus and Newborn | Executive Insights | US/EU5

Hemolytic disease of the fetus and newborn (HDFN), also known as alloimmune HDFN or erythroblastosis fetalis, is a rare red blood cell disorder in which maternal antibodies attack the red blood cells of fetuses and newborn babies. Improving the hematocrit levels in fetuses and reducing the total serum bilirubin levels in newborns are the key goals of treatment. Anti-D prophylaxis is approved to prevent HDFN, but there is no approved curative therapy. Patients are managed with phototherapy, transfusions, and off-label drugs such as intravenous immunoglobulins. The only treatment in the prenatal stage is an invasive and risky intrauterine transfusion. The pipeline for HDFN is sparse; only a few companies are developing therapies for the indication. Janssen’s nipocalimab, a promising FcRn antagonist, is expected to launch in the United States and Europe in the next few years. In the meantime, treatment of HDFN is associated with substantial unmet need, including the lack of a cure. This therapy market represents significant commercial opportunity.


  • What is the diagnosed incidence of HDFN?
  • What is the current market landscape, including the diagnostic and management practices in the various markets under study?
  • What are the emerging therapies, expected launch dates, and the estimated cost of treatment in the countries under study?
  • What are the key unmet needs in the management of HDFN?
  • What are the key market drivers and limiters of the HDFN therapy market?
  • What are experts’ views of the different aspects of HDFN?


Executive Insights provides indication-specific market intelligence with world-class epidemiology, keen insight into current treatment paradigms, biotherapeutic pipelines, key clinical unmet needs, and competitive landscapes, supported by primary and secondary research. This solution provides succinct insights to any biopharma function or business professional looking to quickly grasp a new indication of interest.

GEOGRAPHY: United States, EU5

PRIMARY RESEARCH: 13 KOL interviews from November 2021 to January 2022

KEY COMPANIES COVERED: Janssen Research & Development, CSL Behring

KEY DRUGS COVERED: Nipocalimab, anti-D prophylaxis (Rhophylac), intravenous immunoglobulins

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