Number of pages: 100 | Report Format: PDF | Published date: February 02, 2023
Historical Years – 2020 | Base Year – 2021 | Forecasted Years – 2022-2030
Report Attribute |
Details |
Market Size Value in 2021 |
US$ 3.36 billion |
Revenue Forecast in 2030 |
US$ 7.64 billion |
CAGR |
7.64% |
Base Year for Estimation |
2021 |
Forecast Period |
2022-2030 |
Historical Year |
2020 |
Segments Covered |
Products & Services, Method, Application, End User, and Region |
Regional Scope |
North America, Europe, Asia Pacific, and the Rest of the World (RoW) |
According to the deep-dive market assessment study by Growth Plus Reports, the global non-invasive prenatal testing (NIPT) market was valued at US$ 3.36 billion in 2021 and is expected to register a revenue CAGR of 7.64% to reach US$ 7.64 billion by 2030.
Non-Invasive Prenatal Testing (NIPT) Market Fundamentals
Non-invasive prenatal screening, often known as NIPT, is used to determine fetal abnormalities, such as genetic disorders. During this examination, the blood of a pregnant lady is examined for tiny DNA fragments. The most frequent application of NIPT is screening for chromosomal diseases brought on by an extra or missing copy of a chromosome (aneuploidy). Trisomy 21 (Down syndrome), trisomy 18 (produced by an extra chromosome), trisomy 13 (caused by an extra chromosome), and extra or missing copies of the X and Y chromosomes are the main conditions that are examined using non-invasive prenatal testing (NIPT). Several non-invasive prenatal testing (NIPT) methods are used to analyze fetal cfDNA (Cell-free DNA). The most popular method for determining chromosomal aneuploidy is counting all cfDNA fragments (both fetal and maternal).
Apart from determining abnormalities in the fetus, non-invasive prenatal testing is also used in identifying the sex of a child, mostly in developed countries. The technique is based on an examination of cell-free fetal DNA found in the mother’s early pregnancy blood. The procedure precisely identifies the sex of the fetus in the early gestation period. Moreover, there are many health reasons to determine the sex of the child. For instance, the mother may be a carrier of an X-linked disease, such as Duchenne muscular dystrophy, and may want additional testing if the child is a male, as there will be a 50% chance that the condition may impact the male child.
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Non-Invasive Prenatal Testing (NIPT) Market Dynamics
Conceiving at 35 or older age, irrespective of whether it is the first childbirth, can increase the chances of chromosomal abnormalities in a child. In prenatal medical and obstetrical care, the percentage of women who become pregnant after age 35 has dramatically increased over the past 30 years. According to the Centers for Disease Control and Prevention (CDC), compared to younger ones, older mothers are more likely to give birth to a child with Down syndrome. In other words, as the mother’s age rises, so does the probability of Down syndrome. According to Stanford Medicine, a woman who gets pregnant at age 25 carries this risk of around 1 in 1,250. If a woman conceives when she is 40, the likelihood rises to roughly 1 in 100. Prenatal genetic consultation, which aids in predicting the risk of fetal chromosomal disorders based on age, has gained impetus in the past few years. This, in turn, is creating significant revenue growth opportunities in the global prenatal testing (NIPT) market during the forecast period.
In the past few years, prenatal diagnosis and prenatal screening technologies have significantly advanced. The development of next-generation sequencing (NGS) technology has made it possible to sequence fetal DNA fragments that can be put together to create a complete genetic map, enabling non-invasive scanning of the fetal genome. Contrarily, the addition of chromosomal microarray analysis (CMA) has enabled the detection of uniparental disomic instances, variable degrees of mosaicism, and cryptic genomic imbalances that could not be detected using conventional techniques. Novel screening techniques for fetal chromosomal aneuploidies have also been made possible by advances in contemporary molecular technologies and the identification of cell-free fetal DNA in maternal plasma.
Despite many factors influencing revenue growth in the market, certain factors can somewhat limit the market potential. High prices of diagnosis, low awareness, and limited accessibility in low-income countries, such as the Middle East and Africa, can hamper the revenue growth of the non-invasive prenatal testing (NIPT) market. In addition, monetary coverage is also limited in this region, due to which NIPT adoption in cost-sensitive countries is limited.
Non-Invasive Prenatal Testing (NIPT) Market Ecosystem
The global non-invasive prenatal testing (NIPT) market has been analyzed from five perspectives: products & services, method, application, end-user, and region.
Non-Invasive Prenatal Testing (NIPT) Market by Products & Services
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Based on products & services, the global non-invasive prenatal testing (NIPT) market is segmented into consumables, instruments, and services.
The consumables segment is sub-segmented into assay kits & reagents and disposables. The instruments segment is sub-segmented into ultrasound devices, next-generation sequencing systems, polymerase chain reaction instruments, and microarrays. The consumables segment accounts for the largest revenue share of the global non-invasive prenatal testing (NIPT) market due to increase in the introduction of new kits in the market. Moreover, increasing lab-based examination for research and development activities supports revenue growth in the market segment.
The instruments segment is anticipated to register revenue growth at a higher CAGR during the forecast period. The ultrasound devices sub-segment leads the instruments segment. Technological advancements in non-invasive prenatal testing devices are bringing automation to the instruments. The three most prevalent chromosomal aneuploidy disorders can be accurately screened using the high-precision non-invasive prenatal assay Vanadis® NIPT Trisomy 21, 18, and 13. This laboratory-developed test, which uses the PerkinElmer Vanadis® technology, was created to provide a cost-effective testing option that can offer accurate and reliable findings.
Non-Invasive Prenatal Testing (NIPT) Market by Method
In terms of method, The global non-invasive prenatal testing (NIPT) market is segmented into ultrasound detection, biochemical screening testing, and cell-free DNA maternal plasma tests.
The ultrasound detection segment accounts for the majority of the revenue share of the market. This is attributed to rise in the utilization of the method in clinical settings due to its advantages, such as accuracy, safety, and high rates of fetal chromosomal aneuploidy and structural abnormality diagnosis.
Non-Invasive Prenatal Testing (NIPT) Market by Application
Based on the application, the global non-invasive prenatal testing (NIPT) market is segmented into trisomy, microdeletion syndrome, and others.
The trisomy segment leads the global non-invasive prenatal testing (NIPT) market, attributed to increase in the usage of NIPT to simultaneously reduce false-positive results and invasive examinations. In the average-risk or general population, NIPT is an efficient and secure prenatal screening tool for trisomy 21, 18, and 13. Moreover, NIPT is highly recommended in in-vitro fertilization (IVF) pregnancies due to its excellent sensitivity and specificity in screening for fetal aneuploidy in such patient groups.
Non-Invasive Prenatal Testing (NIPT) Market by End-user
Based on the end-user, the global non-invasive prenatal testing (NIPT) market is segmented into diagnostic laboratories and hospitals.
The diagnostic laboratories segment accounts for the majority of the revenue share of the non-invasive prenatal testing (NIPT) market. Due to the presence of well-equipped facilities and a skilled workforce, the diagnostic labs are now receiving a bigger volume of tests, supporting their market revenue share. Additionally, the expansion of the market in diagnostic laboratories is anticipated to be facilitated by the rising number of initiatives to deliver safe and reliable prenatal testing during the forecast period.
Non-Invasive Prenatal Testing (NIPT) Market by Region
Regionally, the global non-invasive prenatal testing (NIPT) market has been segmented into North America, Europe, Asia Pacific, and the rest of the world.
North America accounts for the dominant position in the global market. Down syndrome is becoming more common in newborns, particularly in the United States, and this is expected to have a significant impact on the revenue growth of the North America market. Large-scale businesses in this region are increasingly investing in research and development of effective NIPT, which is anticipated to be advantageous for the non-invasive prenatal testing (NIPT) market revenue growth in North America.
The Europe market for non-invasive prenatal testing (NIPT) is characterized by the presence of many top players offering NIPT solutions and services. Regional operations are common among businesses and partners. LifeCodexx primarily provides its services all over Europe. Moreover, support from many administrative bodies is also helping revenue growth in the non-invasive prenatal testing (NIPT) Market in Europe. In this region, non-invasive prenatal testing has been included in 14 national policies or programs. Two nations: Belgium and the Netherlands, provide NIPT to all expecting mothers, while a majority of other European nations provide it to only higher-risk women following the first-trimester screening.
Asia Pacific is expected to register revenue growth at a higher CAGR during the forecast period. This is attributed to the growing number of advanced-age pregnancies, leading to children born with Down syndrome. Several countries, such as China, provide non-invasive prenatal testing at lower prices, primarily to augment the uptake of NIPT tests by the general population. Moreover, technological developments, such as the combination of NGS with conventional diagnostic procedures, are improving the region’s healthcare standards.
Non-Invasive Prenatal Testing (NIPT) Market Strategic Developments
Non-Invasive Prenatal Testing (NIPT) Market Competitive Landscape
The prominent players operating in the global non-invasive prenatal testing (NIPT) market are:
The increasing prevalence of chromosomal abnormalities in pregnancies drives revenue growth in the global non-invasive prenatal testing (NIPT) market. Additionally, prenatal diagnosis and screening have advanced quickly in some parts of the world, resulting in the expansion of the product portfolio of market players.
YOURGENE HEALTH Plc, Illumina, Inc., Natera, Inc., F. Hoffmann-La Roche AG, and Perkin Elmer Inc. are among the prominent players in the global market.
The high price of diagnosis, low awareness, and limited accessibility in low-income countries, such as the Middle East and Africa, are likely to hamper the revenue growth of the global non-invasive prenatal testing (NIPT) market. In addition, limited coverage of these tests in health insurance policies also limits the uptake of these tests.
The global non-invasive prenatal testing (NIPT) market is expected to register a revenue CAGR of 9.56% during the forecast period from 2022 to 2030.
The diagnostic laboratories segment dominates the global non-invasive prenatal testing (NIPT) market.
*Insights on financial performance are subject to the availability of information in the public domain