Non-invasive prenatal testing (NIPT), is a method of determining the risk of whether the fetus of the mother will be born with certain genetic abnormalities. NIPT is a safe and highly effective way of screening for medical conditions such as Down syndrome, Edwards syndrome, Patau syndrome, monosomy X, and Turner syndrome.
Presently, there are two types of NIPT methods that are available, massive parallel sequencing (MPS) technology and the single-nucleotide polymorphism (SNP) based method.
Rapid Shift towards Cell-Free DNA screening
The Discovery of cell-free DNA (cfDNA)-based NIPT has created a rapid shift in the paradigm of aneuploidy screening during pregnancy. Itâ€™s a simple blood test that can be performed during pregnancy. Clinical validation studies suggest that NIPT is more accurate than combined first-trimester screening (CFTS), with very high sensitivity (99.3%) and specificity (99.9%) for trisomy 21(Down syndrome). NIPT is also safer than other invasive diagnostic techniques such as chorionic villus sampling and amniocentesis, which involves a risk of miscarriage (0.1â€“0.2%).
Advent of Advanced Healthcare Technologies for NIPT Products
The advent of next-generation sequencing technology has enabled the sequencing of fetal DNA fragments that can be assembled into a full genetic map, allowing the fetal genome to be scanned prenatally and non-invasively. Developments in molecular technologies and the discovery of cell-free fetal DNA in maternal plasma have also led to novel screening methods for fetal chromosomal aneuploidies.
Currently, various types of NIPT tests are available in the market such as Panorama, Vistara, MaterniT GENOME, Harmony Test, among others which help in the screening of chromosomal abnormalities developing in the fetus.
Market Challenges: Non-Invasive Prenatal Testing Market
Some of the major challenges restricting the growth of the non-invasive prenatal testing market are stringent government regulations, and limitations of NIPT such as despite its high accuracy, it is still considered a screening test.
Geographic Assessment: North America is the Largest NIPT Market
North America is the largest market for NIPT with >45% revenue share, followed by the European market. The rising prevalence of genetic disorders in newborns associated with increasing maternal age, wider adoption, and the presence of leading players working on fetal and neonatal care in this region are the key factors driving the North America NIPT market.
The market in Europe is expected to grow significantly over the forecast period due to the adoption of the latest technology, new product launches, and a strong
reimbursement framework for these tests in the region. The Asia Pacific region is expected to witness the highest CAGR in the coming years.
Competitive Landscape Analysis: Non-Invasive Prenatal Testing Market
Some of the top industry players operating in the global NIPT market are Agilent Technologies, BGI Genomics, Cradle Genomics, Berry Genomics, Sequenom, Roche (Ariosa Diagnostics), among others.
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