Non Invasive Prenatal Testing (NIPT) Market Trends

Growth Drivers

• Increasing demand for non-invasive prenatal testing (NIPT)- The popularity of non-invasive prenatal testing is witnessing an uptick through collaborative research and strategic public-private partnerships. Initiatives that incorporate NIPT into healthcare programs at the national level have acted in recognition of its potential to revolutionize prenatal care. As per National Institute of Health (NIH), NIPT will be much safer compared to the invasive diagnostic procedures of chorionic villus sampling and amniocentesis, which includes a small but significant miscarriage risk (0.1–0.2%). According to the International Society for Prenatal Diagnosis, the NIPT uptake significantly increases, reaching more than 85% among pregnant women in some developed countries by 2023.

• Rising incidence of congenital disorders- Congenital disorders are among the major global health problems. According to the World Health Organization, in 2023, an estimated 265,000 newborn babies died during the neonatal period resulting from congenital anomalies. Congenital anomalies are disproportionately prevalent in low- and middle-income countries, with some studies estimating that up to 95% of cases of severe congenital disorders occur in these countries. This perhaps might result from unavailable health resources or prenatal screening.
  
  In 2020, a report by the NLM indicated an 8% increase in the global burden of congenital disorders since 2010. This growing need for accessible and accurate prenatal testing methods is expected to boost non invasive prenatal testing market growth in developing economies.

Challenges

• High cost of non-invasive prenatal testing (NIPT)- The high cost of non-invasive prenatal testing (NIPT) remains a significant barrier to widespread adoption, particularly in developing countries. Despite technological advancements, the financial burden of these tests continues to limit accessibility for many expectant parents.
  
  An article published in the American Journal of Obstetrics and Gynecology shows that these out-of-pocket costs of NIPT vary from USD 100 at the lowest quote, ranging up to as high as USD 2,000 under various insurance coverage and provider policies within the United States itself. As a result, the price variability creates inequities in access and influences some major decisions with wide implications for prenatal care.

• Regulatory landscape and health considerations- The regulatory framework for NIPT varies hugely across different countries or regions. On one hand, a strict and regulated environment is conducive to ensuring the quality of testing and patient safety; on the other hand, it definitely will bring challenges to the access to the non invasive prenatal testing market  and the innovation speed. For example, the FDA established in late 2022 a risk-based framework with which to regulate NIPT in a way that could simplify premarket reviews but also uphold their excellent standards. As a consequence, the implementation of the In Vitro Diagnostic Regulation (IVDR) in Europe has led to an escalation in the requirements for the validation of NIPT-market surveillance.