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The global non-invasive prenatal testing (NIPT) market size was USD 2.95 billion in 2019 and is projected to reach USD 10.88 billion by 2027, exhibiting a CAGR of 17.8% during the forecast period.
Genes and chromosomes can sometimes undergo mutation and this can increase the risk of genetic abnormalities in an unborn child. According to an article published by Children's Hospital of Philadelphia, trisomy 21 is one of the most common chromosomal abnormalities, affecting around 5,000 babies each year in the United States. Increasing incidence of chromosomal anomalies has led to an increase in the demand for an effective screening tool for prenatal tests.
Non-invasive prenatal tests (NIPT) involve analysis of the cell-free fetal DNA (cfDNA) present in a sample of maternal blood in order to detect the likelihood of a fetal aneuploidy. The advantages offered by these tests over highly expensive and invasive procedures such as amniocentesis and Chorionic Villus Sampling (CVS). These advantages are likely to increase the adoption of such procedures, in turn contributing to the accelerated growth of the market.
Covid-19 Pandemic to Have Minimal Impact on the Market; Delays in Surgical Procedures May Slightly Affect Market Growth
The COVID-19 outbreak has had a limited impact on the non-invasive prenatal testing market. Several manufacturing companies are in close contact with the US FDA in order to keep them informed about any disruption in the supply chain.
Moreover, several research studies are being conducted in order to determine the impact of COVID-19 on the non-invasive prenatal testing (NIPT) industry. According to a report published by SeraCare, in-vitro diagnostics manufacturers and clinical testing laboratories are working in collaboration with research organizations to determine the interference of SARS-CoV-2 infection on the pregnancy and birth defects in newborns, and the need for non-invasive prenatal testing during COVID pandemic. However, limited established results have led to uncertainty over the growth in demand for these tests during covid-19 pandemic.
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Prenatal Testing Witnesses a Shift towards Non-invasive Tests
Prenatal screening or testing has been shifting its balance towards non-invasive tests, citing the clinical and economic benefits of these tests in recent years. The advent of technologically advanced non-invasive tests by market players, combined with established clinical effectiveness of these tests, have been instrumental in making this shift happen. Many countries have implemented policies where non-invasive prenatal tests are now the standard tests in prenatal screening, as opposed to invasive tests. In the Netherlands for example, non-invasive tests have been declared the standard tests for screening pregnant women in the country. Although invasive tests still have their applications in identification of specific disorders, but the non-invasive tests have demonstrated a growth in adoption globally.
Increase in the Prevalence of Chromosomal Abnormalities to Augment the Demand for NIPT
Recently, the maternal age at childbearing has shifted because of a wide range of social and economic factors. According to a report published by the Office for National Statistics (ONS) in England, the average age of mothers in 2017 increased to 30.5 years, from 30.4 years in 2016. This has resulted in an increase in the prevalence of down syndrome and other genetic complications in newborns.
According to a report published by EUROCAT – Surveillance of Congenital Anomalies in Europe: epidemiology of Down syndrome in 2019, it was estimated in Europe annually approximately 104,000 babies were born with congenital anomalies, of which 8,320 babies were suffering from Down Syndrome. This has led to the early screening of pregnant women through prenatal tests including non-invasive ones.
Moreover, favorable reimbursement policies and rising awareness about the advantages of non-invasive tests over invasive prenatal tests is likely to augment the adoption of these tests during the forecast period.
Constant Product Innovations Will Contribute to the Growth of the Market
Several companies are constantly focusing on the development of highly advanced screening technologies that are highly sensitive and accurate in early detection of the genetic disorders in babies. Manufactures are majorly emphasizing on the development of advanced noninvasive prenatal tests and entering into strategic partnerships and collaborations to strengthen their position in the non-invasive prenatal testing market.
For instance, in 2018, PerkinElmer Inc., received a CE-IVD mark for its Vanadic NIPT system for commercialization and distribution throughout Europe. This innovative technology allows lab technicians to run up 20,000 samples per year. The introduction of innovative technologies is likely to increase the adoption of these tests during the forecasts period.
Additionally, many countries are adopting screening policies in order to include non-invasive prenatal screening for the detection of chromosomal anomalies. In 2018, in the U.K., the NHS implemented initiatives to promote non-invasive prenatal testing in their public health policies. This has led to increased awareness about the benefits associated with these tests, in the country.
High Cost of Tests to Restrain the Market Growth
The high cost of these tests leading to relatively low affordability in many developing countries is expected to limit the adoption of these tests. According to the article published by Future Medicine currently the average cost of non-invasive prenatal testing in India is around USD 350 to USD 400. This has limited the uptake of these tests in emerging countries.
Additionally, lack of awareness among the general population in emerging countries, pertaining to high risks of genetic abnormalities, lower per capita healthcare spending, and lack of adequate reimbursement policies for tests, are additional factors limiting the growth of the market.
Consumables & Reagents Segment to Hold the Significant Market Share
Based on product, the market is segmented into consumables & reagents, and Instruments. The consumables & reagents segment holds a major share of the market. This is attributable to introduction of new test kits, by market players, and rising number of lab-based tests performed globally. Additionally, increased research methodologies and development activities for the screening of genetic disorders is one of the major factors fueling the demand for reagents and consumables.
The advent of technologically advanced instruments and increase in collaborations among players to introduce highly sensitive and cost effective instruments for the detection of trisomy during pregnancies. For instance, in 2019, Natera and QIAGEN entered into a strategic partnership with an aim to develop breakthrough cell-free DNA assays for use on QIAGEN’s GeneReader NGS System.
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Next Generation Sequencing Segment to hold a Dominant Market Share
Based on the product, the market is segmented into the Next Generation Sequencing, Microarray, PCR, and Rolling Circular Amplification. The next-generation sequencing segment dominated the market owing to the growing use of NGS in variety of clinical applications, majorly in sequencing of whole genome to identify the risk of fetal chromosomal anomalies. Moreover, superior clinical efficiency of next-generation sequencing (NGS) technology to analyze cfDNA fragments across the whole genomes, over other technologies such as microarray and PCR is likely to boost the adoption of instruments and tests based on this technique.
The rolling circular amplification is a new technology developed by PerkinElmer Inc., which eliminates the use of PCR and sequencing to provide cffDNA testing. Moreover, affordable prices will allow large numbers of laboratories to use this technology for conducting screening tests, further accelerating the demand in the coming years.
Clinical Laboratories Segment to Hold a Dominant Position in the Global Market
On the basis of the end user, the global non-invasive prenatal testing market is segmented into hospitals, and clinical laboratories. The diagnostic laboratories are the major end users of non-invasive tests. The segment is expected to be the fastest growing segment. In comparison to hospitals, clinical laboratories are equipped with highly innovative technology that provides safe and effective prenatal tests for chromosomal abnormalities, further boosting the growth opportunities of this segment.
North America Non-Invasive Prenatal Testing (NIPT) Market Size, 2019 (USD Billion)
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The non-invasive prenatal testing market size in North America stood at USD 1.52 billion in 2019. This is attributable to the increasing penetration of non-invasive prenatal testing, and the higher incidence of down syndrome in newborns. Moreover, strong geographical foothold of the players in the U.S. offering advanced tests, has been pivotal in the growing adoption of these tests in the U.S., and Canada.
The Panorama test developed by Natera, works on single-nucleotide polymorphism (SNP)-based technology to analyze DNA and is the only test that can also differentiate between maternal and fetal DNA in the chromosomes of interest. Such novel development is likely to boost the adoption and propel the market growth in region in coming years.
The market in Europe is likely to witness significant growth in the coming years. This is attributable to the strong reimbursement framework for these tests, and the new product launches by the players in the region. For instance, in April 2017, Illumina, Inc., announced the launch of the Verse NIPT Solution, next-generation sequencing (NGS)-based tests in Europe.
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The market in Asia Pacific is expected to exhibit a comparatively higher growth. In emerging nations such as China and India there is growing demand for early diagnosis of chromosomal disorders during pregnancies. This along with domestic market players emphasizing on strategies such as partnerships and collaborations with global players, is projected to lead to introduction of new products and tests. For instance, in 2017 YOURGENE HEALTH acquired Your Gene Bioscience, a test manufacturer in Taiwan. This acquisition will help YOURGENE HEALTH to expand its market presence in Asia, further providing opportunities for joint development of the expanded non-invasive prenatal testing in the region.
Additionally, the significant growth in Asia Pacific markets can majorly be attributed to the improving healthcare infrastructure, the presence of a large patient population, and growing awareness about the advanced technologies in prenatal testing.
Strong Product Portfolio has Propelled Illumina, Inc., Sequenom Laboratories, LabCorp Inc., and Natera to Lead the Global Market
The market is consolidated owing to the wide range of product offering and robust distribution network of major companies in developed and emerging nations. Currently Illumina, Inc., Sequenom Laboratories, LabCorp Inc., Natera are the leading players in the market. Certain factors such as a robust research & development domain and increased focus on introduction of innovative products are expected to maintain its position in the market.
Other key players such as YOURGENE HEALTH, Eurofins, LifeCodexx GmbH, F. Hoffmann-La Roche, Perkin Elmer, Inc. are planning to strengthen their foothold in the market intelligence by adopting newer strategies such as investing in development of novel technologies such for the early screening of chromosomal abnormalities and collaborations with the research organizations and other key players.
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The non-invasive prenatal testing (NIPT) market research report provides a detailed market analysis and focuses on crucial aspects such as leading companies, application, disposable types, and distribution channels. Also, the report offers insights into Industry trends and highlights vital industry developments. In addition to the factors mentioned above, the report encompasses various factors that have contributed to the growth of the market over recent years.
Value (USD Billion)
Product; Technology; End User and Geography
By End User
Fortune Business Insights says that the global market size was USD 2.95 billion in 2019 and is projected to reach USD 10.88 billion by 2027.
In 2019, the market value stood at USD 10.88 billion
Growing at a CAGR of 17.8%, the market will exhibit steady growth in the forecast period (2020-2027).
The Next Generation category is expected to be the leading segment under the technology segment in this market during the forecast period.
The growing demand for safe and effective screening test and increase in the prevalence of chromosomal birth defects are to drive market growth.
Illumina, Inc., YOURGENE HEALTH, Natera, Eurofins LifeCodexx GmbH are few of the leading players in the global market.
North America dominated the global market in 2019.
Rising awareness and the introduction of highly advanced technology to provide ease in the demand of sanitary products.
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