Non Invasive Prenatal Testing Market Trends

Strand Life Sciences has announced the launch of its prenatal screening and diagnostics portfolio in April 2024. The portfolio includes two groundbreaking developments: MaatriSeq (Non-Invasive Prenatal Screening) and CNSeq (sequencing-based identification of aneuploidies and copy number variations). CNSeq represents a substantial advancement in prenatal diagnostics by incorporating the most recent Next Generation Sequencing technology into a critical prenatal test. 

CNSeq provides unparalleled precision in the identification of Copy Number Variations (CNVs) by utilizing proprietary software, surpassing conventional molecular and cytogenetic methods. On the other hand, MaatriSeq is the first Non-Invasive Prenatal Screening (NIPS) solution to be validated on the most recent high-throughput Illumina NovaSeq X Plus sequencing platform. This innovation provides a cost-effective and highly precise solution that is accessible to a broader community in India. The company's dedication to the advancement of genetic diagnostics and the alleviation of the burden of rare diseases in India is emphasized by these innovations.

Yourgene Health, a prominent international molecular diagnostics group, has implemented the first non-invasive prenatal testing (NIPT) protocol in Morocco, which is based on the IONA® test, at the Centre de Biologie Riad (Laboriad), in November 2023. Laboriad can expand its service offerings and offer pregnant women fast, dependable results that reduce the necessity for invasive tests and the resulting tension and anxiety for expectant parents by providing this service locally. 

The test can also be employed to ascertain the sex of the fetus. It is a comprehensive CE-IVD product designed for laboratories that desire to provide their own in-house NIPT service. The test results are available within three days after the analysis is conducted on a maternal blood sample using next-generation sequencing technology. It has been validated on a methodology that is highly scalable and flexible, making it suitable for sample throughputs ranging from low to high volume. This enables clinical laboratories to adapt and expand in response to their increasing demands.

Non-Invasive Prenatal Testing (NIPT) Market Trends

Worldwide demand for NIPT is rising due to several factors, including a rise in doctors' preferences for sophisticated genetic screening for high-risk pregnancies, an eagerness to put off having children, and a boom in pregnancy-related problems in the last or second trimester. The devastating effect of COVID-19 has been unexpected and catastrophic worldwide, and NIPT has not seen any change regarding demand across all regions due to the pandemic. When the pandemic is finished, this market's demand and growth will resume to pre-pandemic levels, which will explain the increase in CAGR. A child's chance of developing genetic defects increases when genes and chromosomes mutate. According to reports, trisomy 21 is one of the most prevalent chromosomal disorders, affecting about 5,000 newborns annually in the United States.

The demand for an efficient screening tool for prenatal tests has increased due to the rising prevalence of chromosomal defects. Amniocentesis and chorionic villus sampling are invasive prenatal testing methods that might result in complications like miscarriage. As a result, there is a significant need for more effective, non-invasive, and safe tests and a fall in using these procedures. NIPT can be used to detect common trisomies in the fetus, such as Down syndrome, fetal rhesus D status, Turner syndrome, and sex chromosomal problems, as well as to determine the fetal sex. This is done using cell-free fetal DNA (cffDNA), which circulates in the mother's blood. Significant technological developments are being made in the sector to enhance testing capabilities. Many well-known companies and fresh start-ups seek financing for NIPT technique development and clinical testing. Government and business organizations are searching for research facilities and start-ups to provide cutting-edge testing methods to identify important genetic abnormalities through NIPT. Many nations have adopted rules that make non-invasive prenatal diagnostics the norm for prenatal screening rather than invasive examinations.

NIPT is the testing procedure done during the pregnancy period to monitor the fetal growth and related diagnosis. Annually it is predicted that around 21 million girls aged 15 to 19 years give birth in developing regions around the globe.

Thus, it is among the reasons why NIPT is needed for safe delivery of the baby.  

The birth rate is expected to increase during the forecast period.

Market Influencer

Rising cases of premature pregnancy in developing and underdeveloped countries.

Non-Invasive Prenatal Testing (NIPT) Market Drivers

• Growing global population.


• Adoption of unhealthy lifestyle habits during pregnancy.


• Rising awareness of non-invasive prenatal testing.

Non-Invasive Prenatal Testing (NIPT) Market Restraints

• Availability of alternative techniques for prenatal testing.


• Less accuracy of non-invasive prenatal testing compared to the invasive prenatal testing.

Non-Invasive Prenatal Testing (NIPT) Market Segment Insights

Non-Invasive Prenatal Testing Product Insights

The Non-Invasive Prenatal Testing (NIPT) Market based on product type is broadly segmented into devices, consumables, and others.

• Devices: This segment is further sub-segmented into ultrasound devices, polymerase chain reaction instruments, microarrays, sequencing systems, and others. Ultrasound devices are generally known as a sonogram. They use the ultrasound frequency for imaging of the fetal in pregnant women. Polymerase chain reaction instruments are used to amplify the DNA sequence for the analysis of any genetic issues related to pregnant women. Microarray is used to determine the levels of genes. It helps understand the conditions and plan the treatment accordingly. Sequencing systems are automated devices used for sequencing the DNA. It helps in the identification of the genomes. Other devices include fetal doppler machine and neonatal stress testers.


• Consumables: It segment is further segmented into assay kits & reagents, disposables, and others. Assay kits & reagents comprise of ultrasound transmission gel, cleaning solution, and others. The disposables comprises of swipes, cottons, hand gloves, ad others.


• Others: Other consumable comprises ultrasound transducers, probes, printers, related services, and others.

Non-Invasive Prenatal Testing Techniques Insights

The non-Invasive prenatal testing (NIPT) market based on technique is segmented into biochemical screening tests and ultrasound detection.

• Biochemical Screening Tests: It is used for down syndrome, aneuploidies, and other genetic disorders. The test depends mainly on evaluating hormones and other proteins produced by the placenta.

• Ultrasound Detection: This is the most preferred and utilized technique for In this method, the ultrasound machine is used. This machine provides 2D image of the fetal. The machine uses high-frequency sound waves and their echoes. During the testing the sound pulses frequencies of the range 1 to 5 megahertz is transmitted into the body using a probe. The probe also acts as a receiver for the sound waves that are reflected from tissue surfaces.

Non-Invasive Prenatal Testing Application Insights

• Trisomy: It is a genetic disorder with three copies of a chromosome instead of two. There are different types of trisomy, such as down syndrome, Edward syndrome, Patau syndrome, and others. NIPT helps in identifying and planning the possible treatment as per the results.


• Microdeletion syndrome: It is a genetic disorder caused by a deletion of several genes on a certain chromosome.


• Others: It includes pregnancy screening to monitor fetal growth. It is mostly used for non-invasive testing. It also helps in imaging the fetal in its development phases and helps in maintaining the health of the fetal as well as the patient.

Non-Invasive Prenatal Testing End-User Insights

• Diagnostic Laboratories: Diagnostic laboratories are the testing setting where the NIPT test is been carried out. The labs provide various NIPT testing services as per the requirement of the patients. The diagnostic laboratories are largest segment owing to a large number of diagnostic labs/centers that provides NIPT testing products and services.


• Hospitals: Hospitals play a very important role in prenatal testing. It provides in house testing facility to in-house patients. It helps in prompt testing of the pregnant patient that helps accurate treatments as per the diagnoses.


• Research Institutes: Research and developments are being done by various institutes. Studies such as free cell DNA screening are also carried out. For instance, Mayo Foundation for Medical Education and Research has published various research articles about the free cell DNA screening. This indicates that there is a potential for research and development in NIPT marketing.

Non-Invasive Prenatal Testing Regional Insights

• Americas: America is the fastest-growing region owing to technological advancements in NIPT.

• Europe: In Europe, regulatory agencies are active towards NIPT related activities which is supporting the market growth in respective regions.

• Asia-Pacific: This is the fastest-growing non-Invasive prenatal testing (NIPT) market on account of the increasing population in China and India which is approximately 1,389.61 million and about 1,311.55 million, respectively, in 2019.

• Middle East & Africa: This region has a low share is owing to the limited technological development, restricting the growth of the non-Invasive prenatal testing (NIPT) market.

Non-Invasive Prenatal Testing (NIPT) Market Key Players

• Illumina, Inc. (US)


• Thermo Fisher Scientific, Inc. (US)


• General Electric Company [GE Healthcare] (US)


• Perkinelmer, Inc. (US)


• Agilent Technologies, Inc. (US)


• Beijing Genomics Institute (China)


• Hoffman-La Roche Ltd. (Switzerland)


• Tarsa Therapeutics, Inc. (US)


• PhytoHealth Corporation (Taiwan)


• Laboratory Corporation of America Holdings (US)


• Natera, Inc. (US)


• Yourgene Health (UK)


• Centogene Holding AG [CENTOGENE AG ] (Germany)

November 2023

• 
  

  Natera, Inc. announces that it has received FDA approval for its Panorama NIPT test to detect Down syndrome, trisomy 18, and trisomy 13 in pregnancies as early as 9 weeks of gestation. This is the earliest gestational age at which any NIPT test has been approved by the FDA.

  
  


• 
  

  Sequenom Laboratories announces that it has launched its new MaterniT21 PLUS test, an NIPT test that can detect Down syndrome, trisomy 18, and trisomy 13, as well as several other genetic disorders, in pregnancies as early as 10 weeks of gestation. The MaterniT21 PLUS test is the first NIPT test to be able to detect a wider range of genetic disorders.

  
  


• 
  

  Ariosa Diagnostics, Inc. announces that it has partnered with Illumina, Inc. to develop a new NIPT test that can be used to detect a wider range of genetic disorders, including single gene disorders. The partnership will combine Ariosa's expertise in NIPT with Illumina's expertise in sequencing technology to develop a new test that is more accurate and comprehensive than current NIPT tests.