Fetal and Neonatal Alloimmune Thrombocytopenia – Executive Insights – Fetal and Neonatal Alloimmune Thrombocytopenia | Executive Insights | US/EU5

Fetal and neonatal alloimmune thrombocytopenia (FNAIT) is a rare, alloimmune thrombocytopenic disorder affecting fetuses / neonates, characterized in severe cases by intracranial hemorrhage. It can result in neurological disabilities in neonates and miscarriage in some pregnancies. FNAIT occurring in a woman’s first pregnancy usually remains undiagnosed due to a lack of routine screening techniques. No approved therapies are available for the treatment / prevention of FNAIT. Currently, patients are treated with off-label therapies such as IVIGs and/or platelet transfusions. The FNAIT pipeline is sparse, with Rallybio being the only company developing prophylactic therapies for this indication. Rallybio’s lead asset, the monoclonal antibody RLYB212, is being assessed in a Phase I clinical trial. Given the lack of approved therapies, unavailability of routine screening techniques, and the vulnerability of the patient population, the unmet need and market opportunities for new therapies for FNAIT are clear.


  • What is the diagnosed incidence of FNAIT, and how are patients in the markets under study treated today?
  • What are the key unmet needs and areas of opportunity in the management of FNAIT?
  • What is the potential impact of pipeline therapies, and how will these therapies affect future market dynamics in FNAIT?
  • What are the key drivers and limiters of the FNAIT market?
  • What market access and reimbursement challenges will new therapies for FNAIT likely face, according to interviewed KOLs?


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 DRUGS COVERED: Immunoglobulins, platelet transfusions, RLYB211 (NAITgam), RLYB212

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