According to the deep-dive market assessment study by Growth+ Reports, the global Prenatal and Newborn Genetic Testing market testing was valued at ~US$ 5.3 billion in 2021. The market is expected to witness a CAGR of ~10.2% from 2022 to 2030.
The growing prevalence of genetic disorders in infants such as Down syndrome, Patau syndrome, and Edwards syndrome is a key factor resulting in high demand for prenatal and newborn genetic tests. Furthermore, the uptake of such tests has further grown due to technological advancements facilitating non-invasive prenatal tests. There is also a steady increase in investments in developing genetic disorder testing and the swift adoption of such technologies in mainstream applications. Furthermore, increasing government initiatives to raise awareness about preventing congenital abnormalities is another factor driving the global prenatal and newborn genetic testing market. However, several ethical issues related to prenatal and newborn genetic testing impede the development of clinical services. The risk of inaccurate results, also known as false-negative or false-positive results, and ethical implications are some factors limiting the growth of the prenatal and newborn genetic testing market.
Domestic governments and organizations worldwide are taking numerous initiatives to create awareness regarding the availability and accuracy of prenatal and newborn genetic testing. The initiative by the Centers for Disease Control and Prevention‘s (CDC) National Center for Environmental Health has the most successfully run public health program called Newborn Screening Quality Assurance Program, wherein all the babies born in the U.S. are screened for over 100 metabolic and genetic conditions. Similarly, the National Health Service (NHS) U.K. also provides screening programs for expecting mothers. This test has an 85 % to 90% chance of detecting genetic disorders. The Indian government has also made newborn screening mandatory, a state-funded program.
The rising prevalence of genetic abnormalities is a crucial reason for facilitating the growth of this market. The increasing age of childbirth is a key causative factor for the same. According to the WHO, genetic disorders and congenital abnormalities affect approximately 2% to 5% of all live births, accounting for up to 30% of pediatric hospital admissions and about 50% of childhood deaths in industrialized countries. According to the European Commission, rare disease affects up to 36 million people in the E.U. Approximately 80% of rare diseases have a genetic basis, and 70% begin in childhood. The possibility of having a child with Down syndrome rises with maternal age, from 1 in 600 births for mothers under 30 to 1 in 50 births for mothers over 40. In the United Arab Emirates (UAE), congenital abnormalities are now acknowledged as the primary cause of infant mortality. At the same time, Bahrain, Kuwait, Oman, and Qatar rank second. In most developing countries, consanguinity also nearly doubles the risk for newborn and childhood mortality, intellectual disability, and other anomalies and raises the occurrence of rare genetic birth disorders.
Quick adoption of technologically advanced testing solutions uses artificial intelligence in the screening process. Moreover, the utilization of advanced non-invasive technology such as advanced ultrasounds and increasing innovations in next-generation sequencing (NGS) and chromosomal microarray analysis (CMA).
However, there are some risks related to prenatal screening methods, such as anxiety, pain, or a possible miscarriage. According to NHS, procedures such as chorionic villus collection and amniocentesis have a chance of miscarriage up to 1 in 100 tests. Decreased childbearing capacity, leaking amniotic fluids, and impending risk of false positive tests. It is estimated that 5% of all the reports are false reports.
Europe is among the leading regional markets for prenatal and newborn genetic testing. The presence of a well-developed healthcare infrastructure with skilled and well-trained healthcare professionals and the rise in the demand for non-invasive prenatal genetic testing are the key attributes to the prominence of the Europe market. The governments in the region are providing different programs for prenatal and newborn genetic screening.
Some of the prominent players operating in the prenatal and newborn genetic testing market are Bio-Rad Laboratories Inc., Ariosa Diagnostics Inc. (Roche), Agilent Technologies Inc., Illumina, Inc., Qiagen NV, Sequenom Inc., Berry Genomics Co. Ltd, BGI Group, Laboratory Corporation of America, and Trivitron Healthcare Pvt. Ltd, amongst others.