With the increasing advanced stage pregnancies in women, there has been an increasing demand for pre-natal genetic screening and testing as a part of reproductive genetics that help to predict the risk of fetal chromosomal abnormalities depending on age. Further, pre-natal testing became the need of the hour owing to the increasing number of cases of various genetic disorders, such as Down syndrome, spina bifida, cleft palate, sickle cell anemia, thalassemia, fragile X syndrome, and Tay–Sachs disease. All of these conditions are the consequences of the mutant genes and an abnormal chromosomal structure.
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Technological advancements in the healthcare industry have always played a crucial role in the overall development of the industry. Among the innumerable advancements witnessed by the industry, reproductive genetics has emerged as one of the most distinctive technologies in curbing concerns related to genetic diseases. The recent advancements in the life science industry, such as sequencing technologies, regenerative medicine, and genomic technologies, supported by breakthroughs in the field of genome sequencing, and molecular research, have opened up new and promising pathways to combat genetic diseases and reduce the overall global economic burden.
The global reproductive genetics market generated $4,402.8 million in 2020. The highest market share of 38.81% among all the regions was held by North America owing to the presence of a large number of genetic testing companies and a high level of awareness for such tests.
Various regulatory bodies across the world claim that the implementation of reproductive genetics tests such as NIPT and the subsequent rise in uptake of pre-natal testing is likely to increase the incidence of abortions. Therefore, professional organizations such as the American College of Obstetricians and Gynecologists (ACOG), International Society for Prenatal Diagnosis (ISPD), U.S. National Society of Genetic Counselors (NSGC), and the Japan Society of Obstetrics and Gynaecology have set up guidelines that limit the use of non-invasive pre-natal testing only to pregnant women at high risk of chromosomal aneuploidies. The women at high risk of fetal chromosomal aneuploidies include women aged 35 years and older, women with a personal or family history of aneuploidies, and those with positive results from conventional screening methods such as ultrasonography and maternal serum tests indicating a high risk of aneuploidies.
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According to the ACOG, tests like NIPT should not be considered routine laboratory testing, and instead, should be seen as an informed patient choice post-pre-test counseling. In many countries like India and China, where termination of female fetuses is considered illegal, implementation of pre-natal testing for reproductive genetics has raised a serious ethical concern since these tests are misused to illegally determine the sex of the fetus.
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