Non-invasive prenatal testing (NIPT), is a method of determining the risk of whether the fetus of the mother will be born with specific genetic disorders. NIPT is a safe and extremely effective way of screening for conditions such as Down syndrome, Edwards syndrome, Patau syndrome, monosomy X, and Turner syndrome.
Currently, massive parallel sequencing (MPS) technology and the single-nucleotide polymorphism (SNP) based method are the two types of NIPT methods that are commercially accessible.
The Global Non-Invasive Prenatal Testing Market is expected to grow at a rate of 16% to reach ~$9 billion by 2026. Rising acceptance of cell-free DNA screening, advantageous reimbursement policies for average and low-risk pregnancies, high risk of chromosomal abnormalities with increasing maternal age, and increasing prevalence of genetic and congenital disorders are some of the main factors driving the global non-invasive prenatal testing market.
Change 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. It is a simple blood test that may be done while pregnant. Clinical validation research shows 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 like chorionic villus sampling and amniocentesis, which involves a risk of miscarriage (0.1–0.2%).
Arrival of Advanced 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. Advances 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.
The market now offers a variety of NIPT tests including Panorama, Vistara, MaterniT GENOME, Harmony Test, among others which help in the screening of chromosomal abnormalities developing in the fetus.
Additionally, several developments have been made to impact the quality of care for expectant mothers such as:
- 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.
“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
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Key Challenges/ Constraints: Non-Invasive Prenatal Testing Market
Some of the key challenges limiting 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.
North America: The Largest Non-Invasive Prenatal Testing Market
North America is the major market for NIPT with >45% revenue share, followed by Europe. Some of the main reasons propelling the North America market include the rising prevalence of genetic disorders in newborns associated with increasing maternal age, wider adoption, and the presence of top players working on fetal and neonatal care in this region.
The market in Europe is predicted to expand considerably 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 anticipated to witness the highest CAGR in the coming years.
Competitive Landscape Analysis of 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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