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The hemolytic disease of the fetus and newborn market is driven by the challenges associated with addressing maternal alloimmunization and its effects on fetal health. HDFN occurs when maternal antibodies, usually against RBC antigens different from those in a mother’s blood, cross the placenta into a fetus’ circulation to begin attacking the Fetal RBCs. It can cause very severe anemia jaundice and intrauterine death in some cases.
The HDFN market has registered growth in recent years, driven by many factors. Quite striking during this time has been the growing awareness among healthcare professionals of the health risks posed by HDFN if not detected and managed with success at the possible earliest stages.
NIPT has revolutionized prenatal care in that it detects the fetal RhD status and other relevant antigens non-invasively from maternal blood, allowing earlier and less invasive assessment of HDFN risk, enabling more proactive management strategies, and improving outcomes for affected pregnancies.
It has seen an inflow of research and development of new therapeutic interventions. The pipeline includes, but is not limited to, monoclonal antibodies against specific pathways in HDFN, for instance, FcRn blockers like nipocalimab.
These therapies prevent the transfer of the maternal antibody to the fetus and hence may reduce the chances of the unborn baby developing HDFN, thus avoiding invasive procedures like intrauterine transfusions.
Such developments not only hold the potential to revolutionize the face of treatment, but—just as these statements have attested—are also giving a louder voice to this growing demand for real solutions in maternal-fetal medicine that was already characterizing this decade.
Hemolytic disease of the fetus and newborn (HDFN), also known as erythroblastosis fetalis, is a condition that occurs when there is an incompatibility between the blood types of a mother and her fetus. The most common cause is Rh (Rhesus) incompatibility, where the mother is Rh-negative and the fetus is Rh-positive. HDFN can also result from other blood group antigen incompatibilities such as ABO, Kell, Duffy, and others.
Causes and Mechanism:
Diagnosis and Management:
Global Hemolytic Disease Of The Fetus And Newborn Market was valued at $XX Billion in 2023 and is projected to reach $XX Billion by 2030, reflecting a compound annual growth rate (CAGR) of XX% from 2024 to 2030.
Non-Invasive Prenatal Testing (NIPT)
The development of NIPT technologies further refines the methods to arrive at an even earlier and more precisely detected fetal RhD status and other relevant antigens implicated in HDFN. These tests analyze cell-free fetal DNA in maternal blood, giving critical information without invasive procedures.
Genetic Screening and Counseling
Advances in genetic screening technologies can help identify genetic variants associated with an increased risk of HDFN. This facilitates tailored counseling of families and assessment of risk, thus guiding decisions regarding the monitoring and intervention during pregnancy.
Telemedicine and Remote Monitoring
Telemedicine platforms and remote monitoring technologies offer optimum management of pregnancies at risk for HDFN, with regular monitoring for maternal antibodies and fetal growth and well-being traditionally requiring frequent hospital visits but now being possible while bringing down the need for frequent visits to the hospital, all the while allowing for timely interventions.
cfDNA-based fetal RhD
Natera, Inc. (NASDAQ: NTRA), a leading cell-free DNA and genetic testing company, had announced a cfDNA-based fetal RhD test designed to support Ob/Gyn physicians and patients amid a critical shortage of Rho(D) immune globulin therapy, RhIg. The test determined fetal RhD status as early as nine weeks of gestation and analyzed the blood of pregnant patients, including complex pseudogene and RhD-CE-D hybrid variants. This feature differed it from most of the remaining NIPT laboratories that did not provide fetal RhD assessment and used core Natera’s SNP-based technology. As many as 15% of pregnant patients are RhD negative, which is associated with risks of alloimmunization against and hemolytic disease of the fetus and newborn in the presence of an RhD-positive fetus. Until recently, all pregnant RhD-negative women were treated with RhIg despite that only 60% carry an RhD-positive fetus. Due to the shortage of RhIg, a recommendation by ACOG was made to consider NIPT in an effort to ration the RhIg supply. The product launch was supported by a large validation study of over 650 RhD-negative pregnancies for which the fetal RhD status was confirmed by newborn serology. This study, much larger than those of other labs, showed the test’s performance with 100% sensitivity and more than 99% specificity. In relation to that, their effort in Natera was a landmark step toward the management of hemolytic disease risk, giving important ammunition to healthcare providers and patients impacted by the challenges of RhIg shortages.
UNITY Fetal Antigen Single-Gene Noninvasive Prenatal Test (sgNIPT)
BillionToOne, Inc., a leader in molecular diagnostics, had launched UNITY fetal antigen sgNIPT as part of the UNITY Screen for solving important management problems in alloimmunized pregnant patients. This novel NIPT is targeted to genetic variants associated with the C, c, D, E, Duffy, or Kell red blood cell antibodies, which are critical for the assessment of risks related to HDFN. The UNITY fetal antigen NIPT is available from 10+ weeks of gestation and represents the non-invasive approach to the detection of fetal antigens that will yield relevant clinical information in the management of pregnancies at risk of HDFN. Alloimmunization is a relatively rare complication of pregnancy, occurring in approximately 1% of all pregnancies. Sometimes, maternal antibodies can attack fetal red blood cells due to this very process of alloimmunization, leading to severe complications like anemia or hyperbilirubinemia. Prior to this test being available, patients who were alloimmunized needed very close monitoring throughout their pregnancy with frequent blood titers and ultrasounds to monitor the fetus for any signs that may call for interventions like early delivery or intra-uterine transfusions. The high sensitivity and specificity of greater than 99.9% for detecting specific fetal antigens, as confirmed in the UNITY test, was expected to lessen the unnecessary healthcare burden on many visits and anxiety for families. BillionToOne’s effort took prenatal care a step ahead by giving back to the clinician a reliable tool for the risk management of better pregnancies affected by immunization that could prevent devastating outcomes of HDFN.
Nipocalimab
Johnson & Johnson had announced nipocalimab. This new medicine was granted the breakthrough therapy designation by the U.S. FDA intended for treating pregnant ladies who are at high risk of severe HDFN until alloimmunized. This designation was based on promising results from the Phase 2 UNITY clinical trial. Nipocalimab represented an important innovation as a single treatment agent, being developed in clinical trials to address specifically severe HDFN, a rare, potentially life-threatening condition caused by the incompatibility of blood types between a pregnant person and fetus. It was an investigational monoclonal antibody designed to block FcRn, reducing circulating IgG antibodies, including those responsible for HDFN when they cross the placenta. The drug, nipocalimab, was in Phase 3 of clinical trials and held much promise as a potential treatment to mitigate the risk of HDFN by preventing the transfer of maternal alloantibodies to the fetus. This approach was designed to manage a condition where, until now, therapeutic options were barely any and afforded some hope for improved outcomes in affected pregnancies. In conferring this breakthrough status, Johnson & Johnson underscored the critical need for innovative therapies in maternal-fetal medicine and hit the important milestone in the quest to effectively address HDFN.
