High risk of chromosomal abnormalities with increasing maternal age, rise in the adoption of cell-free DNA screening, favorable reimbursement policies for average and low-risk pregnancies, and increasing prevalence of genetic and congenital disorders are some of the key factors driving the global non-invasive prenatal testing market.
Non-invasive prenatal testing (NIPT), is a technique for evaluating if a mother’s child will be born with certain genetic disorders. NIPT is a safe and effective method of screening for Down syndrome, Edwards syndrome, Patau syndrome, monosomy X, and Turner syndrome.
There are now two commercially accessible NIPT approaches: massive parallel sequencing (MPS) technology and single-nucleotide polymorphism (SNP)-based methods.
Shift towards Cell-Free DNA screening in the Non-Invasive Prenatal Testing Market
The discovery of cell-free DNA (cfDNA)-based NIPT has resulted in a fast shift in the paradigm of prenatal aneuploidy screening. It is a simple blood test that may be done while pregnant. NIPT appears to be 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 less intrusive than other invasive diagnostic methods, including as chorionic villus sampling and amniocentesis, which have a 0.1–0.2% chance of miscarriage.
Advent of Advanced Technologies for NIPT Products Fuel the Non-Invasive Prenatal Testing Market
With the introduction of next-generation sequencing technology, fetal DNA fragments can now be sequenced and combined into a whole genetic map, allowing the fetal genome to be examined prenatally and non-invasively. The finding of cell-free fetal DNA in maternal plasma, as well as advances in molecular technology, have resulted in innovative screening approaches for fetal chromosomal aneuploidies.
Currently, numerous NIPT tests, such as Panorama, Vistara, MaterniT GENOME, and Harmony Test, are available on the market to aid in the screening of chromosomal abnormalities developing in the fetus. Furthermore, various advancements have been made to improve the quality of care for pregnant moms, including:
· In January 2022, QIAGEN entered into collaborations with Atila BioSystems to provide non-invasive prenatal testing (NIPT) solutions to QIAGEN’s dPCR franchise.
· In June 2021, Illumina and Next-generation Genomic Thailand announced the launch of next-generation sequencing (NGS)-based VeriSeq NIPT Solution v2 in the country which helps to detect anomalies missed by targeted assays.
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“Prenatal care is a dynamic and continuously evolving field. Development in new molecular technologies and the discovery of cell-free fetal DNA are fueling groundbreaking advancements to improve care for mother and child and to offer parents reproductive options.” — Senior Director, Head of Research & Product Development, Sequencing & Array-based Company, United States
Non-Invasive Prenatal Testing Market: Key Challenges/Restraints
Stringent government restrictions, as well as limits of NIPT, such as its high accuracy, are some of the primary hurdles limiting the growth of the non-invasive prenatal testing industry.
North America is the world’s largest NIPT market.
North America is the largest market for NIPT, accounting for more than 45% of total sales, followed by Europe. Some of the main factors driving the North America market include the increasing frequency of genetic abnormalities in infants related with increasing mother age, greater adoption, and the presence of top firms focusing on fetal and neonatal care in this area.
The NIPT 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 prominent players operating in the global non-invasive prenatal testing market are Agilent Technologies, BGI Genomics, Cradle Genomics, Berry Genomics, Sequenom, Roche (Ariosa Diagnostics), among others.
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