Prenatal and New-born Genetic Testing Market Size

Prenatal and New-born Genetic Testing Market Size

Prenatal and New-born Genetic Testing Market size was valued at over USD 4.5 billion in 2020 and is expected to grow at a CAGR of more than 11.5% between 2021 and 2027.

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Growing prevalence of genetic disorders including Edward syndrome, Down’s syndrome, Patau syndrome, and others in new-born is the major factor driving the prenatal and new-born genetic testing market growth. Increasing demand for detecting genetic abnormalities in the prenatal and newborn population is also contributing to the market expansion. Additionally, heavy investment in research activities, extensive research associated with proteomics and genomics have led to significant developments in technology.

Prenatal genetic testing refers to tests carried out during pregnancy to determine the possibility of genetic condition or birth defect in the fetus. It is carried to check the presence of genetic disorders such as Tay-Sachs disease, cystic fibrosis, sickle cell anaemia and Down’s syndrome among others. Screening is further continued after a baby is born, called newborn genetic testing to check for genetically inherited diseases or congenital anomalies such as phenylketonuria (PKU), muscular spinal atrophy, critical congenital heart disease, hearing loss, and others. Prenatal and new-born genetic testing is significant in determination of various options during pregnancy to improvise the health outlook for the baby. Prenatal and newborn screening helps in prevention of infant mortalities and enhances patient outcomes.

However, several ethical concerns related to prenatal and new-born testing may hamper the market progression. Prenatal and new-born genetic testing raises complex ethical issues further limiting the development of clinical services and implementation of public policy related to access and funding. The use of screening in selective abortion has raised several concerns. The rising occurrence of false results in prenatal and new-born genetic testing might decrease the adoption of genetic testing. For instance, around 5% of women are tested false-positive during prenatal testing for Down syndrome.

The Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) regulates prenatal and new-born genetic testing. The U.S. FDA mandates establishing efficacy, safety and security of biological products to ensure high quality offerings. As per the U.S. FDA, genetic testing is a special type of medical device and hence, falls under the FDA's regulatory purview. Recently, the FDA applied enforcement discretion to majority of the genetic tests but in the current regulatory scenario, the FDA regulates the test on the basis of its positioning. These test kit makers require approval from the FDA before commercializing the product. The stringent regulatory framework may refrain the prenatal and new-born genetic testing market share.