Non-invasive prenatal testing (NIPT) is a deoxyribonucleic acid (DNA) test on maternal blood to screen pregnancies for the most common fetal chromosome anomalies such as trisomy 21 that is Down syndrome, trisomy 18 Edwards syndrome and trisomy 13 Patau syndrome. During non-invasive prenatal testing of the mother and fetus, the DNA is extracted from maternal blood sample and it is recommended for women who have risk factors for having a baby who has a chromosomal condition. Increasing launches and approvals of new non-invasive prenatal tests (NIPT) along with increasing prevalence of chromosomal disorders is expected to propel the market growth during the forecasted period.
Global non-invasive prenatal testing market is estimated to be valued at US$ 1,350.9 million in 2022 and is expected to exhibit a CAGR of 18.5% during the forecast period (2022-2030).
Figure 1. Global Non-invasive Prenatal Testing Market Share (%), by Application, 2022
Global Non-invasive Prenatal Testing Market- Drivers
High prevalence of chromosomal disorders is expected to propel growth of the global non-invasive prenatal testing market over the forecast period. For instance, in February 2020, a paper was published by National Center for Biotechnology Information according to the which, down syndrome is the most common genomic disorder occurs in the neonatal and is caused by trisomy of Homo sapiens chromosome 21 (HSA21). The prevalence of down syndrome is increasing substantially as the global population is growing. For example, prevalence of down syndrome in USA from year 1950- 2013 is increased from 50,000 to 212,000 respectively.
Moreover, increasing adoption of inorganic growth strategies such as agreement by key players is anticipated to drive the market during the forecast period. For instance, in February 2018, Illumina Inc., a biotechnology company, signed a value-based contract with Harvard Pilgrim Health Care, a non-profit health services company. This agreement is aimed at enhancing patient access and the reimbursement of next-generation sequencing for non-invasive prenatal testing (NIPT).
Figure 2. Global Non-invasive Prenatal Testing Market Share (%), by Region, 2022
Global Non-invasive Prenatal Testing Market – Impact of Coronavirus (COVID-19) Pandemic
The COVID-19 outbreak was first reported on December 31, 2019 in Wuhan, China. According to the Coronavirus (COVID-19) Weekly Epidemiological Update by the World Health Organization (WHO), over 619,770,633 cases and 6,539,058 deaths due to the coronavirus were reported till October 12th, 2022 across the globe.
The COVID-19 pandemic and subsequent lockdown in various countries have negatively impacted the financial status of businesses across all sectors.
The COVID-19 pandemic has impacted the entire supply chain of the healthcare industry mainly due to strict lockdown in several regions. Likewise, it is expected to have a significant impact on global non-invasive prenatal testing (NIPT) market, in terms of both demand and supply. For instance, in December, 2021, Society for Maternal-Fetal Medicine (SMFM) suggests that, the number of ultrasound appointments in the first trimester can be reduced by performing one ultrasound examination for dating and nuchal translucency (NT) to reduce the chances of COVID-19 exposure. NIPT can be performed at home utilizing remote services such as mobile blood draw networks. This will help maintain expectant mother’s safety during the pandemic with minimum social contact.
|Base Year:||2021||Market Size in 2022:||US$ 1,350.9 Mn|
|Historical Data for:||2017 to 2020||Forecast Period:||2022 to 2030|
|Forecast Period 2022 to 2030 CAGR:||18.5%||2030 Value Projection:||US$ 5,247.5 Mn|
F. Hoffmann-La Roche Ltd, BGI Group, Berry Genomics Co., Ltd., Illumina, Inc., Eurofins LifeCodexx Gmbh , Natera, Inc., Sequenom, Inc. ,Axia Women’s Health , Eluthia, BillionToOne, Inc., Quest Diagnostics Incorporation, Igenomix, Agilent Technologies, Inc, Laboratory Corporation of America Holdings., PerkinElmer, Inc., ThermoFisher Scientific, Yourgene Health PLC
|Restraints & Challenges:||
Global Non-invasive Prenatal Testing Market: Key Developments
Recommendation of new guidelines is expected to propel growth of the global non-invasive prenatal testing market over the forecast period. For instance, in August 2020, American College of Obstetricians and Gynecologists recommend new guidelines for Non-Invasive Prenatal Testing (NIPT). For example, diagnostic testing (chorionic villus sampling [CVS] or amniocentesis) options should be discussed and offered to all pregnant patients regardless of maternal age or risk of chromosomal abnormality, all patients should be offered a second-trimester ultrasound for fetal structural defects, etc.
Major players in the global non-invasive prenatal testing market are focused on raising funds to enhance their market share. For instance, in March 2020, BillionToOne, Inc. raised US$ 15 million to support the commercial expansion of UNITY, a prenatal screen that directly assesses the baby’s risk for common and severe inherited disorders such as cystic fibrosis, spinal muscular atrophy, and hemoglobinopathies, to all the U.S.
Global Non-invasive Prenatal Testing Market: Restraint
High possibilities of the results obtained from the non-invasive prenatal tests (NIPT) are false positive. For instance, according to paper published by National Center for Biotechnology Information in August 2022, even though there is lot of research going on in the field of NIPT, still screening efficacy in the first trimester is not available. The results obtained from the tests have high rates of deviation. The results are false positive which shows that the person is infected or defects are present, but actually there are no defects.
Global Non-invasive Prenatal Testing Market- Key Players
Major players operating in the global non-invasive prenatal testing market include F. Hoffmann-La Roche Ltd, BGI Group, Berry Genomics Co., Ltd., Illumina, Inc., Eurofin Scientific, Natera, Inc., Sequenom, Inc., Axia Women’s Health, Eluthia, BillionToOne, Inc., Quest Diagnostics Incorporation., Igenomix, Agilent Technologies, Inc., Laboratory Corporation of America Holdings., PerkinElmer, Inc., ThermoFisher Scientific, Yourgene Health PLC
Noninvasive prenatal testing (NIPT) is also known as noninvasive prenatal screening (NIPS). It is a procedure used to determine the chromosomal abnormalities or disorders of the fetus which generally occur due to missing or an extra copy (aneuploidy) of a chromosome. NIPT examines small deoxyribonucleic acid (DNA) fragments which are circulating in the blood of pregnant woman. These small fragments are freely floating and hence are called cell-free DNA. NIPT is carried out for the detection of trisomy 18, trisomy 13, Down syndrome, and missing or extra copies of X and Y chromosomes. NIPT is found to be useful during the COVID-19 pandemic situation to avoid the risk of infection. The potential to isolate fetal DNA and fetal cells from maternal blood during pregnancy has revealed exciting opportunities for upgraded noninvasive prenatal testing (NIPT).
Obtaining reimbursement for tests from payers is expected to offer lucrative growth opportunities for players in the global non-invasive prenatal testing market. Vendors may focus on obtaining insurance coverage for NIPT tests offered by them, considering the high costs of these tests. Moreover, attention towards health education, subsidies for NIPT, and genetic counseling is also expected to aid in growth of the market. For instance, in September 2020, researchers from Fudan University, China, and University College London, U.K., reported that, in China, compared with Zhengzhou participants, a higher proportion of Shenzhen women had heard of NIPT (87.30% vs. 64.03%), were willing to receive NIPT (91.80% vs. 80.43%) and had taken NIPT (83.12% vs. 54.54%), while their satisfaction level was lower.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.