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.
QUESTIONS ANSWERED
- 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?
PRODUCT DESCRIPTION
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
Shilpa Verma
Shilpa Verma, B.Pharm., Manager, Healthcare Research & Data Analytics, Infectious, Niche, and Rare Diseases. She has more than 11 years of work experience in competitive intelligence and medical affairs. Her expertise is in infectious diseases and immuno-inflammatory diseases. She received her bachelor’s degree in pharmacy from the Indian Institute of Technology at Banaras Hindu University. She also has a postgraduate degree in business management from the Narsee Monjee Institute of Management Studies.
Prior to joining Clarivate, Ms. Verma worked for WNS and Evalueserve, where her clients included leading pharmaceutical companies. She is also an expert in HIV. She did her internship at AstraZeneca and has experience working in the quality control department.
Bethany A. Kiernan, Ph.D.
Bethany A. Kiernan, Ph.D., Director, Healthcare Research & Data Analytics, Infectious, Niche, and Rare Diseases. Dr. Kiernan manages and supports a team of analysts and managers producing both syndicated and custom market research analyses in a range of niche / rare indications as well as infectious diseases. Dr. Kiernan has extensive experience in market forecasting and broad knowledge across a range of CNS disorders, rare diseases, and infectious diseases. Her previous experience includes eight years of scientific research conducted at Tufts University School of Medicine, Case Western Reserve University, and the College of the Holy Cross. She earned her doctorate in neurosciences from Case Western Reserve University.