Non-Invasive Prenatal Testing Market Size, Share, Industry, Forecast and outlook (2024-2031)

Global Non-Invasive Prenatal Testing Market is segmented By Component(Instruments & Consumables, Kits and Services), By Application(Down syndrome(trisomy 21) ,Edwards syndrome (trisomy 18), Patau syndrome (trisomy 13), Turner syndrome and Other), By End-User(Hospitals, Diagnostic Centers and Others), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031

Report Overview

Global Non-Invasive Prenatal Testing market is estimated to grow at a CAGR of 18% during the forecast period 2024-2031. The market is expected to grow due to increasing demand from Hospitals, Diagnostic Centers. The competitive rivalry intensifies with BGI, Eurofins Scientific., Progenity, and others operating in the market.

Non-invasive prenatal testing (NIPT), also known as non-invasive prenatal screening (NIPS), is a technique for determining the likelihood that a foetus will be born with certain genetic abnormalities. This test examines small fragments of DNA that circulate in the blood of a pregnant woman.

Market Summary

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Market Dynamics

The technological advancement in the non-invasive testing is expected to drive the global non-invasive prenatal testing market

In recent years, the field of prenatal genetic testing has exploded with new non-invasive technologies and test options. It is difficult for women's healthcare providers to keep up with many publications and provide patients with the most accurate and up-to-date information on prenatal testing. For instance, non-invasive prenatal testing (NIPT) offers early genetic screening for chromosomal conditions using just one tube of blood as early as 10 weeks into a pregnancy. Non-invasive testing has a high detection rate, a low false-positive rate and poses no risk to the mother or baby.

The current trend in prenatal testing can be defined as a massive shift away from invasive sampling and toward using a non-invasive or, more precisely, a less-invasive source in the form of blood. The most used technology platforms for NIPT are whole-genome sequencing using next-generation sequencing (NGS) or various targeted methods. Some of the NIPT-targeted technologies are single nucleotide polymorphism (SNP) analysis, microarray analysis, and rolling circle amplification. Targeted approaches examine only a subset of specific chromosomes. The most technologically advanced NIPT is the PrenatalSafe test. It looks for genome-wide chromosomal abnormalities and severe genetic disorders in the foetus by analyzing circulating cell-free foetal DNA (cfDNA) in maternal blood.

In January 2019, Illumina expanded its NIPT platform portfolio with the release of its VeriSeq NIPT Solution v2.

Lack of accessibility of non-invasive prenatal test and limitation of tests are expected to hamper the market growth

In emerging countries, the accessibility of non-invasive prenatal tests is very less. Despite the potential benefits of NIPT, there are some significant limitations. False-positive and false-negative test results do occur, and they may occur at a higher rate in clinical practice than reported in carefully controlled, small clinical trials. The emergence of NIPT raises a number of ethical concerns for doctors, patients, and society as a whole. It has been commercially marketed, with practitioners concerned that failing to recommend the test may be perceived as sub-optimal care, exposing them to medico-legal or reputational risk.

The NIPT is a screening test that can produce false positives and negatives. When testing for diseases with low morbidity, positive predictive values, while high in accuracy, are not very high. Furthermore, the accuracy of NIPT in detecting genetic disorders, excluding trisomy 21, 18, and 13, has not been sufficiently validated; thus, if it is to be used in clinical practice, it must be explained to and fully understood by patients.

COVID-19 Impact on Market

The COVID-19 situation has dramatically altered the delivery of prenatal care. The situation due to COVID-19 did not allow the patient to travel to the hospital for any kind of invasive procedure to evaluate the genetic risk of their child. They were instead offered, non-invasive prenatal testing (NIPT) to evaluate this risk.

Market Segmentation Analysis

Down Syndrome segment held the largest share in the global non-invasive prenatal testing market

Due to the increasing incidence of down syndrome and the rising demand for testing is expected to dominate the market. According to the World Health Organization, the global incidence of down syndrome ranges from one in 1,000 to one in 1,100 live births. The non-invasive prenatal test (or NIPT and known by brand names such as Harmony or Percept) is a newer, highly sensitive method of screening for Down syndrome. A simple blood test is used to analyse DNA from the baby that has entered the mother's bloodstream. The test is administered after 10 weeks and is more than 99 per cent accurate in detecting Down syndrome. Medicare does not cover NIPT tests, which are only performed in private clinics. This test type is best suited for women who are at a higher risk of having a child with Down syndrome. Research has shown that NIPTs are more accurate than standard screenings in predicting the risk of Down syndrome and Edwards syndrome (NIPTs are 99 percent accurate).

NIPT can let the patient know if they have a chance of having a baby with trisomy 21 (Down syndrome), trisomy 18 or other chromosomal differences during your pregnancy. When compared to traditional screening, NIPT can more accurately predict the likelihood of having a baby with trisomy 21 and trisomy 18 during pregnancy (eFTS or MSS).

Market Geographical Share

North America region accounted  for the largest market share in the global non-invasive prenatal testing market

The rising prevalence of chromosomal abnormalities and the high maternal mortality rate is expected to dominate the market growth in this region. The overall prevalence of Edward syndrome in the United States is approximately 1 in 2500, with a liveborn prevalence of 1 in 8600. Females have a higher prevalence than males (3:2). However, males have a higher foetal loss than females, and females have a higher survival rate than males. Furthermore, high rates of diagnosis, broader adoption and awareness among the public, and the introduction of new and technologically advanced tests are all factors. For instance, in April 2019, Progenity, Inc. launched the Resura Prenatal Test for Monogenic Disease. It is a commercially available NIPT test for single-gene disorders.

Non-Invasive Prenatal Testing Companies

The non-invasive prenatal testing market is highly competitive with rapid technological advancements. Some of the key players in the global non-invasive prenatal testing market are BGI, CENTOGENE AG, Eurofins Scientific, F. Hoffmann-La Roche Ltd (Roche Sequencing), Invitae Corporation, Illumina, Inc., Natera, Inc., Progenity, Inc., PerkinElmer Inc., Quest Diagnostics.