Non-invasive prenatal testing (NIPT) is used for screening pregnant women at high risk of developing fetal chromosomal aneuploidies such as Down syndrome (trisomy 21), Edwards syndrome (trisomy 18), Patau syndrome (trisomy 13), and Turner syndrome (monosomy X), and also for fetal sex determination. Until recently, amniocentesis, chorionic villus sampling (CVS), maternal serum screening and nuchal translucency (NT) scan were the primary diagnostic and screening methods for chromosomal abnormalities. Advent of non-invasive prenatal test is poised to eliminate disadvantages associated with these methods, such as low rate of accuracy with maternal serum screening and NT scan, and risk of miscarriage with invasive amniocentesis and CVS procedures. This report on non-invasive prenatal testing market studies the current market scenario and future potential for non-invasive prenatal tests globally. The major non-invasive prenatal tests studied in this report are BambniTest, Harmony, informaSeq, MaterniT21 PLUS, NIFTY, Panorama, PrenaTest, verifi, VisibiliT and others (IONA, NACE, etc.).
These tests have been extensively analyzed on the basis of factors such as the technology used, cost to patients, reimbursement coverage, accuracy and geographical reach (availability across various countries). The historical market size and forecast for each of these tests in terms of revenue (US$ Mn) and volume (Number of tests performed) have been given in the report for the period 2012 to 2022. In addition, the compounded annual growth rate (CAGR) of the overall non-invasive prenatal test market and the above tests has also been provided in the report for the forecast period 2015 to 2022, considering 2012 and 2013 as the base years. The report on non-invasive prenatal testing market also provides comparative analysis of major tests for the years 2013 and 2022.
In this research study, the global market for non-invasive prenatal testing has been geographically segmented into four regions, namely, North America, Europe, Asia-Pacific and Rest of the World (RoW). The non-invasive prenatal testing market size and forecast in terms of revenue (US$ Mn) and volume (Number of Tests Performed) for each region has been provided for the period 2012 to 2022 along with the CAGR for the forecast period 2015 to 2022. The non-invasive prenatal testing market study also includes qualitative analysis of the competitive scenario in these regions such as major collaboration and partnership, entry of new entrants, new product launch and other macro economic factors. The market overview section of the report on non-invasive prenatal testing market comprises qualitative analysis of the overall non-invasive prenatal testing market considering the factors determining the market dynamics such as drivers, restraints and opportunities along with the Porter’s five force analysis and market attractiveness analysis. The market overview chapter also provides information such as major chromosomal aneuploidies (Down syndrome, Edwards syndrome, Patau syndrome and monosomy X, and their incidence rate, technological approach for NIPT and major patents issued to players operating in the market and other companies and academic research institutions.
The report also includes a section on the competitive landscape of the market, wherein the market share analysis of leading players in the global non-invasive prenatal testing market, in terms of percentage share in 2013 has been discussed. A list of recommendations has also been included for new entrants as well as existing market players to help them establish a strong presence in the non-invasive prenatal testing market and accentuate market shares. The report concludes with the profiles of major players in the NIPT market such as Sequenom, Inc., Ariosa Diagnostics, Natera, Inc., Illumina, Inc. (Verinata Health, Inc.), BGI Diagnostics, LifeCodexx AG, Laboratory Corporation of America Holdings (LabCorp) and Berry Genomics. Each company profile comprises information such as company overview, financial overview, product portfolio, business strategies and recent developments.
The global non-invasive prenatal testing market is segmented as follows:
Global Non-Invasive Prenatal Testing Market, by Test
Global Non-Invasive Prenatal Testing Market, by Geography
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.
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.
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. A 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.
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.