The US prenatal diagnostics market is one of the largest markets in the world for fetal monitoring, diagnostics, and predictive testing. It consists of a series of physician prescribed tests for monitoring maternal and fetal health. The current invasive technologies such as CVS and amniocentesis that are used to detect chromosomal abnormalities pose serious risks of miscarriages and are being replaced by the non-invasive prenatal diagnostic technologies.
Although NIPD is a relatively nascent segment of the prenatal diagnostics, it presents a lucrative growth potential to industry participants. The segment is mainly supported by rising incidences of fetal health-related abnormalities and the urgent need for safe, accurate and early diagnosis. Products such as MaterniT21 Plus, Verifi, and Harmony prenatal tests are the current tests available in the market. Around 25,000-40,000 samples are likely to be tested by MaterniT21 plus test alone by the end of 2012.
Further the report “US Non-Invasive Prenatal Diagnostics - Market Insight”, provides a transparent view on the present regulatory framework elaborating on the existing loopholes. A thorough analysis has been done illustrating the views of regulatory authorities, players and consumers towards the regulatory stringency and the direction of regulations in the future have also been covered. Clinical trials in the NIPD field through an active participation of public and private players are provided to assess the research and innovation.
Currently, the US NIPD sector is characterized by the presence of players like Sequenom, Verinata, Ariosa and Natera. These companies are effectively taking steps to promote their LDTs among the US population, especially targeting physicians to recommend their products. In future, the launch of Natera’s test is expected to impact the market significantly, thereby boosting the potential size and sample volume.
The report, which provides a prudent analysis on the current and future size of the market weighing the possible pessimistic and optimistic scenarios, is a must buy for new market entrants in the diagnostic field planning to enter in the prenatal segment.