Non-invasive prenatal testing is increasingly being adopted by high-risk pregnant women for screening common fetal chromosomal aneuploidies such as Down syndrome (trisomy 21), Edwards syndrome (trisomy 18), Patau syndrome (trisomy 13), and Turner syndrome (monosomy X). Non-invasiveness, accuracy, and safety are the major factors attributed to the popularity of these tests among gynecologists and expecting mothers compared to invasive tests such as chorionic villus sampling (CVS) and amniocentesis. MaterniT21 (now known as MaterniT21 PLUS) was the first NIPT launched in October 2011 by U.S.-based Sequenom, Inc. Since then, it has led the market, accounting for the largest share in terms of revenue as well as volume (number of tests performed in a year). However, BGI’s NIFTY is expected to outperform MaterniT21 PLUS in terms of volume in the global market by the end of 2014. Sequenom, Inc. is likely to maintain its leadership position in North America through 2022. Harmony, verifi, Panorama, informaSeq, VisibiliT, PrenaTest, and BambniTest are the other commercially available NIPTs for detecting chromosomal abnormalities.
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The exponential growth of the NIPT market is supported by factors such as high incidence rate of babies born with Down syndrome, no risk of miscarriage with NIPT, and shifting trend toward child bearing at advanced maternal age (35 years or older). Maternal age is closely associated with the risk of developing a fetus with chromosomal abnormalities; hence, rising maternal age is likely to contribute to the increasing incidence of babies born with chromosomal aneuploidies. According to Down Syndrome Education (DSE), the incidence rate for Down syndrome is one in every 830 child births (around 4,700 annually) in the U.S., while the incidence rate is one in every 920 babies born (around 9,000 annually) in Europe, indicating a large potential consumer base for NIPT. Conventional invasive prenatal genetic tests such as amniocentesis and chorionic villus sampling (CVS) are associated with the risk of miscarriage; hence, these are being replaced with new non-invasive prenatal tests. These new NIPTs are based on the analysis of cell-free DNA floating in the maternal plasma and pose no risk of miscarriage.
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North America held the largest share of the global NIPT market in terms of revenue as well as volume in 2013, accounting for 58.8% and 51.0%, respectively, of the market. Major players domiciled in the U.S. and relatively high awareness levels about NIPT in North America are the key factors attributed to the region’s leadership position. In Europe, market growth largely depends upon increasing penetration of these U.S.-based test developers and increase in acceptance of these tests. Japan, Australia, China, and India represent high growth potential markets in Asia-Pacific. Large population of women preferring late pregnancy is likely to act as a major driver of the NIPT market in the region. The NIPT market in China is dominated by two local players: BGI Diagnostics and Berry Genomics. In addition, the recent CFDA approval for BambniTest would propel the growth of the market in this region.
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Sequenom, Inc., Illumina, Inc. (Verinata Health, Inc.), Ariosa Diagnostics, Natera, Inc., BGI Health, LifeCodexx AG, LabCorp, and Berry Genomics are the key players competing in the non-invasive prenatal testing market. These players operate by marketing their proprietary non-invasive prenatal tests by forming alliances with hospitals, clinical laboratories, and physician offices.
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