The global market value for maternal serum screening tests, currently estimated at USD$388.37m, is expected to decline slightly between 2018 and 2028, to USD$385.52m, at a Compound Annual Growth Rate (CAGR) of -0.07%, due to the rising popularity of non-invasive prenatal testing (NIPT), and its continued adoption within key markets, says GlobalData, a leading data and analytics company.
Currently non-invasive prenatal testing (NIPT) is available in more than 60 countries; it is considered more sensitive and represents an attractive alternative to both maternal serum screening and invasive follow-up diagnostic techniques. NIPT is performed using cell-free DNA from maternal blood, which is amplified and sequenced.
Alison Casey, Medical Devices Analyst at GlobalData comments, “Due to the sequencing process, NIPT is more expensive than maternal serum screening methods and this represents a major barrier in its widespread clinical adoption. NIPT is not always covered by publicly funded services or private healthcare insurance. As such, in most markets NIPT tends to be used for diagnosis purposes for women deemed to be high-risk, or paid for by patients out of pocket.”
Traditional devices measure levels of maternal serum markers such as free-beta human chorionic gonadotropin (hCG), total hCG, pregnancy associated plasma protein-A (PAPP-A), Alpha-fetoprotein (AFP), unconjugated estriol (uE3), and/or inhibin A in the mother’s blood. These tests have been widely adopted around the world and are reimbursed by most governments as part of national screening strategies. If these maternal screening tests return a positive result, then prenatal diagnosis is typically performed via either amniocentesis or chorionic villus sampling (CVS). However, both amniocentesis and CVS are invasive techniques that have a risk of fetal death and miscarriage.
Casey concludes, “With Mother’s Day being a time to celebrate motherhood, there are numerous medical procedures performed during pregnancy, which aim to ensure the continued good health of both mother and child. NIPT appears a strong alternative to traditional maternal serum markets, and could challenge this market over the forecast period if funding becomes more widespread.”