According to a key opinion leader (KOL) interviewed by GlobalData, 52.4%** of pregnancies in the US will be screened using an NIPT* test—a type of diagnostic that is not authorized, cleared or approved by the Food and Drug Administration (FDA). Advice published by the FDA in April, warning of the dangers associated with these tests, is likely to lead practitioners towards alternatives such as prenatal diagnostics tests (such as chorionic villus sampling, which analyses a placenta sample for potential genetic foetal abnormalities), PAPP-A*** and the free beta hCG**** test.

NIPTs are designed to indicate the potential risk of a fetus developing genetic disorders. However, there is a common misunderstanding around ‘potential of risk’ that can lead to unnecessary terminations. The FDA advises that action should not be taken based on the NIPT alone, and further diagnostic tests should follow.

Selena Yu, Medical Devices Analyst at GlobalData, comments: “Current discussions around the use of NIPTs may lead practitioners to look for alternative tests, decreasing the market share of NIPTs in the global prenatal screening market, which stood at 62.8% in 2021.”

As a result of the FDA’s guidance, as well as the fact that the US is the largest user of NIPTs, GlobalData predicts that the NIPT market will decrease the most in the US.

Yu continues: “PAPP-A and free beta hCG tests are alternatives that may benefit in the reduction of NIPTs in the US. Currently, only 40% and 30% of pregnancies are screened using these tests, respectively. They will likely see an increase due both their lower cost and their ability to detect chromosomal defects in the fetus (alike NIPTs). In the US, PAPP-A and free beta hCG tests cost a combined $13.26, versus the average selling price of an NIPT ($124.32).”

* NIPT = Non-invasive prenatal testing

** Based on 2022 data

*** PAPP-A = Pregnancy Associated Plasma Protein A

**** hCG = Total Human Chorionic Gonadotrophin