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.
QUESTIONS ANSWERED
- 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?
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: Rallybio
KEY DRUGS COVERED: Immunoglobulins, platelet transfusions, RLYB211 (NAITgam), RLYB212
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.
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.