Cytomegalovirus (CMV) is a common virus that typically causes mild or asymptomatic infections in people with healthy immune systems. However, congenital CMV can have serious consequences for newborns such as permanent hearing loss, neurodevelopmental delays, and cerebral palsy. Congenital CMV occurs when infected mothers transmit the virus to their unborn child, and it is the leading infectious cause of birth defects in the US, with approximately one in 200 babies born annually with congenital CMV. Early diagnosis and treatment are crucial for ensuring the best possible outcomes for these infants. According to the Centers for Disease Control and Prevention (CDC), CMV has already infected one-third of children under the age of five years and more than half of adults by the time they reach 40 years old.

Despite the potential complications associated with congenital CMV, there is currently no routine screening for CMV in pregnant women in many countries, including the US, Japan, and the UK. This lack of screening means that many cases of congenital CMV may go undetected, leading to delayed diagnosis and treatment for affected infants. According to GlobalData’s Products database, there are 60 marketed CMV tests, and nine in the pipeline, of which six tests are predicted to be released by 2029.

GlobalData forecasts the market size for CMV tests to be $40.1m by 2033, contracting slowly at a downward compound annual growth rate (CAGR) of 1.62% from 2023 to 2033. The decreasing market size is due to more affordable test availability and lower testing volume due to decreasing rates of congenital CMV, declining birth rates, and the release of a CMV vaccine shortly. The Moderna CMV vaccine candidate, mRNA-1647, is in Phase III clinical trials.  The market has the potential to increase in size if more countries prioritise implementing CMV screening during pregnancy.