Genetico Center (CGRM, MOEX: GECO) has published an analytical review of the international markets for non-invasive prenatal testing (NIPT).
In 2023, more than 36 thousand NIPTs were conducted in Russia, which is 20% more than in 2022. Service penetration is also growing despite declining birth rates. In 2023, service penetration (the share of NIPTs performed among pregnant women who can undergo NIPT) was 3.6%, compared to 3% the year before. The potential volume of the Russian NIPT market is RUB 9,228 million (USD 104 million).
NIPT is a safe non-invasive test that helps to accurately determine the risk of fetal chromosomal abnormalities as early as in the 10th week of pregnancy. The test requires only a venous blood sample from the expectant mother. Today, NIPT is one of the most convenient, accurate and safe methods of obtaining information on the potential risk of chromosomal abnormalities of the fetus in early pregnancy. The accuracy of the method is up to 99%. Researchers note that NIPT is superior to all other traditional screening methods and provides more accurate results for trisomy 21 (Down syndrome).
In 2023, the global NIPT market was estimated at USD 4.2 billion. The global non-invasive prenatal testing market is expected to reach USD 8.16 billion by 2030, with a compound annual growth rate of 10.06% from 2024 to 2030.
In China, the NIPT penetration rate ranged from 25% to 49% as of January 2023. In the UK, this figure is about 29%.
In some countries, NIPT is used as a first-line test, with the government fully covering the cost for all pregnant women: Belgium, the Netherlands, France, Switzerland, Australia. Since the introduction of NIPT in the Netherlands as a first-line test in 2017, the penetration rate reached 46% in 2017-2018, while the rate of combination tests in the first trimester decreased dramatically.
Belgium was the first country to introduce state-funded reimbursement for NIPT as a first-level screening test and to offer it to all pregnant women. A consortium including all Belgian genetic testing centers reported successful implementation of NIPT in first-level screening; they observed a 52% reduction in the number of invasive procedures and fewer births with T21 anomaly (Down syndrome).
In Russia, NIPT is currently paid for by the end consumer. If NIPT is introduced into compulsory medical insurance as a second or first-line test, the penetration of the service in Russia may increase exponentially and gradually reach the levels of Belgium and the Netherlands of over 50-75%.
Genetico Center was one of the first companies in Russia to introduce NIPT into medical practice in 2014. In 2023, Genetico received approval for its own NIPT called Prenetix. Healthcare institutions can now legally provide prenatal screening services using Prenetix and purchase the test kit through government procurement.
In February 2024, at the Medtech Moscow Center for Innovation in Healthcare, experts discussed the need to expand standard prenatal screening to improve its effectiveness. According to Anna Aleksandrovna Zheleznyakova, Deputy Director of Federal State Budgetary Institution Center for Examination and Quality Control of Medical Care of the Russian Ministry of Health, all regulatory conditions for the introduction of NIPT into prenatal screening have been met. NIPT is included in some clinical guidelines and in the nomenclature of medical services. Experts noted that, compared with standard prenatal screening, the use of NIPT increases the detectability of fetal chromosomal abnormalities by 30% and reduces the number of false positives by 30 times, thus decreasing the rate of potentially invasive interventions.
With an average cost of RUB 30 thousand per test, the estimated annual budget costs for NIPT would amount to about RUB 7,163 million.