Non-invasive prenatal testing is gradually being accepted by pregnant women with high-risk for screening common fetal chromosomal aneuploidies such as Edward’s syndrome (trisomy 18), Down syndrome (trisomy 21), Turner syndrome (monosomy X) and Patau syndrome (trisomy 13).
Accuracy, safety, and non-invasiveness are the key factors credited to the acceptance of these tests amongst gynecologists and expecting mothers related to invasive tests such as amniocentesis and chorionic villus sampling (CVS). MaterniT21 was the first NIPT introduced in October 2011 by Sequenom, Inc. of the U.S. Since then, it has been the leader of the market, accounting for the biggest share in terms of volume as well as revenue. However, BGI’s NIFTY is likely to overtake MaterniT21 PLUS in terms of volume in the global market. Sequenom, Inc. is likely to maintain its leadership position in North America through 2024. Panorama, verifi, informaSeq, Harmony, VisibiliT, BambniTest and PrenaTest are the other commercially available NIPTs for detecting chromosomal abnormalities.
Next generation sequencing is used in the sequencing technologies that immensely parallelize the DNA sequencing process rather than limited few fragments or to a single of DNA. The next generation sequencing (NGS) technology permits rapid sequencing and yields thousands and millions of sequences in single run using next generation sequencers. Such technologies have been rapidly developing owing to the constant demand for high-throughput sequencers which incline to lesser the cost of DNA sequencing.
According to the Department of Biology, University of Copenhagen, There are almost 7000 rare diseases that have been reported globally. Although most of them occur with an incidence of less than one in 2000, in total around 6% of the population suffers from rare diseases. These rare diseases are mostly caused by changes in genes, which is presently lack of effective treatment. The quick advancement of next generation sequencing technology boosts the discovery of new causative gene for these rare diseases, as well as the genetic diagnosis in clinic practice. The innovation of cell-free fetal DNA, coupling with next generation sequencing, makes NIPT possible for rare diseases. However, for most of the current routine prenatal genetic testing for rare diseases require collection of fetal samples through an invasive process, which sometimes might lead to maternal anxiety, or even lead to miscarriage. Hence, developing an effective method to perform noninvasive prenatal test (NIPT) for rare diseases is the crucial challenge to inhibit birth defect in the future.
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The exponential progress of the NIPT market is supported by factors such as no risk of miscarriage with NIPT, high incidence rate of babies born with Down syndrome, and shifting trend toward child bearing at advanced maternal age. Maternal age is closely related to 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.
Geographically, the market for non-invasive prenatal testing products has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. Europe is the biggest market with more number of cases followed by North America. Adoption in Asia pacific is lesser due to less awareness. North America is expected to grow at highest CAGR in the forecast period. According to Down Syndrome Education (DSE), the incidence rate for Down syndrome is one in every 830 children births in the U.S., while the incidence rate is one in every 920 babies born in Europe, indicating a large potential consumer base for NIPT. Conventional invasive prenatal genetic tests such as chorionic villus sampling (CVS) and amniocentesis are related 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.
Some of the market players in this industry are., Illumina, Inc., Agilent Technologies, Inc, Biomatters, Ltd., BGI (Beijing Genomics Institute), Pacific Biosciences, Oxford Nanorpore Technologies, Ltd., Dnastar, Inc., Life Technologies Corporation, EMC Corporation, Genomatix Software GMBH, Ocimum Biosolutions, Ltd., Macrogen, Inc., Partek Incorporated, Qiagen N.V., Perkinelmer, Inc., Knome, Inc. and GATC biotech AG.