The global NIPT market was valued at US$ 0.53 Bn in 2013 and is expected to expand at a CAGR of 15.0% from 2015 to 2022 to reach US$ 2.38 Bn in 2022.
Non-invasive prenatal diagnosis refers to screening test recommended for the detection of certain specific chromosomal aneuploidies from maternal blood sample. Over the past two years, the global prenatal testing market has witnessed a paradigm shift from conventional prenatal screening and diagnostic methods such as maternal serum screening, nuchal translucency (NT) scan, amniocentesis, and chorionic villus sampling (CVS) to non-invasive prenatal testing. This was mainly because of the advantages associated with NIPTs such as safety, accuracy, and no risk of miscarriage during the genetic screening test for common chromosomal abnormalities (trisomy 21, trisomy 18, trisomy 13, monosomy X, etc.). Currently, NIPTs are recommended only to high-risk pregnant women; however, several companies are targeting their tests toward both low-risk and high-risk pregnancies.
BambniTest, Harmony, informaSeq, MaterniT21 PLUS, NIFTY, Panorama, PrenaTest, verifi, and VisibiliT are the commercially available NIPTs in the global market. These tests are based on the direct analysis of cell-free fetal DNA in the maternal blood. MaterniT21 (MaterniT21 PLUS) was the first non-invasive prenatal Laboratory Developed Test (LDT) that was launched by Sequenom, Inc. in October 2011 for the detection of trisomy 21. MaterniT21 PLUS gained advantage of being the first mover in the NIPT market and was the most accepted NIPT in 2013, accounting for 36.1% share of the market in terms of revenue. It is likely to lose market share during the forecast period from 2015 to 2022 due to increasing market penetration by other NIPTs such as NIFTY, Panorama, and verifi.
In terms of volume, MaterniT21 test was the leading segment in 2013. However, the number of MaterniT21 tests performed would decrease during the forecast period from 2015 to 2022. This is majorly due to commercialization of other non-invasive tests and their positioning strategies. Due to the recent CFDA approval for BambniTest (Berry Genomics), the number of tests performed would increase during the forecast period.
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Advantages offered by NIPT such as non-invasiveness, high accuracy and early detection; rising awareness, increasing market penetration in highly untapped countries in Europe and Asia; and continuous increase in average maternal age are the major factors expected to drive the growth of the global NIPT market during the forecast period. However, the market could face significant ethical and regulatory hurdles associated with the implementation of NIPT because of the belief that it is likely to increase the incidence of abortions. Therefore, various professional organizations such as the American College of Obstetricians and Gynecologists (ACOG), the International Society for Prenatal Diagnosis, the Japan Society of Obstetrics and Gynecology, and genetic counselors across the world have set up guidelines that limit the use of non-invasive prenatal testing only to pregnant women at high risk of chromosomal aneuploidies.
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Several companies are investing in the development of non-invasive prenatal tests. Quest Diagnostics is developing a non-invasive test by utilizing the patented technology of Sequenom, Inc. and the test is likely to be commercialized in 2015. Sequenom, Inc., Illumina, Inc. (Verinata Health, Inc.), Ariosa Diagnostics, Natera, Inc., BGI Diagnostics, LifeCodexx AG, LabCorp, and Berry Genomics are the major companies operating in the global non-invasive prenatal tests market.
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