Non-invasive Prenatal Testing Market Size
Study Period | 2019 - 2029 |
Base Year For Estimation | 2023 |
Forecast Data Period | 2024 - 2029 |
CAGR | 13.50 % |
Fastest Growing Market | Asia Pacific |
Largest Market | North America |
Major Players*Disclaimer: Major Players sorted in no particular order |
Non-invasive Prenatal Testing Market Analysis
The Non-Invasive Prenatal Testing Market (NIPT) size is expected to grow from USD 3.03 billion in 2023 to USD 5.71 billion by 2028, at a CAGR of 13.50% during the forecast period.
The COVID-19 pandemic impacted the non-invasive prenatal testing market due to the hold on non-invasive prenatal screening services to prevent the spread of the COVID-19 virus. The tremendous pressure on hospitals to provide services to COVID-19 patients was also one of the factors inhibiting hospitals and diagnostic centers from providing non-invasive prenatal screening (NIPS) services. According to the study published in the Journal of Clinical Medicine in March 2022, in Poland, the number of patients enrolled in the prenatal testing program fell compared to the previous year. In Poland, the number of integrated screening tests declined along with the number of newborns, while the percentage of triple tests increased. The number of invasive diagnostic tests also reduced significantly. Hence, the COVID-19 had a significant impact on the market growth.
Factors propelling the growth of the market are the increasing number of babies with chromosomal disorders owing to the increasing number of late pregnancies, increasing demand for early and non-invasive fetal diagnosis, and favorable reimbursement policies. The increasing number of stillbirth cases across the world is also expected to offer a sizeable growth opportunity for early disease diagnosis. For instance, in April 2022, a research study published in the National Library of Medicine stated that approximately 0.4% to 0.9% of newborns have chromosomal abnormalities, and about half have an abnormal phenotype. According to the same source, approximately 1 in 5,000 to 1 in 16,000 live births have the third most common autosomal trisomy. Hence, with such cases of stillbirths, the demand for testing increases, which, in turn, is expected to aid the overall market growth during the forecast period.
Additionally, the advantages of non-invasive prenatal tests over other prenatal tests, such as their non-invasive nature, better accuracy, and short duration of the procedure, are anticipated to hasten the growth of the NIPT market during the forecast period. Furthermore, awareness programs by public organizations are another factor propelling the market growth. For instance, in April 2022, the US Food and Drug Administration alerted the public about the risk of misleading results, improper use, and inappropriate interpretation of results (NIPT).
However, the lack of skilled professionals, stringent regulations, and ethical concerns are expected to hinder market growth.
Non-invasive Prenatal Testing Market Trends
Down Syndrome Segment Dominates the Non-invasive Prenatal Testing Market
Down syndrome is a chromosomal disorder, also called trisomy 21, trisomy G, 47, XX,+21, and 47, XY,+21. It includes certain birth defects, learning problems, and deformities of facial features. A child with Down syndrome may also have heart defects and problems with vision and hearing. According to the Centers for Disease Control and Prevention data updated in April 2021, Down syndrome is the most common chromosomal condition diagnosed in the United States. Every year, about 6,000 babies born in the United States have Down syndrome. This means that Down syndrome occurs in about 1 out of every 700 babies. Hence, the growing incidence rate of Down syndrome is expected to create lucrative opportunities for the growth of the market studied during the forecast period.
Non-invasive prenatal testing consists of analyzing cell-free DNA (cfDNA) circulating in the mother's blood to detect Down syndrome. With the successful introduction of NIPT for detecting Down syndrome into routine prenatal care, it is important to understand the risks, benefits, and limitations to guide patients in making informed decisions. Non-invasive prenatal testing offers several clinical advantages over existing prenatal tests, such as maternal serum screening (MSS). According to the study by Stanislav Birko et al. published in January 2022, for the screening of Down syndrome, non-invasive prenatal testing (NIPT) can be performed as early as the ninth week of pregnancy, holds no risk of miscarriage, and can detect the presence of Down syndrome (trisomy 21) with high sensitivity (99.9%) and specificity (98%). As a result, the demand for these technologies has increased and is being adopted by many developing countries, which is expected to drive the growth of the segment.
Thus, the abovementioned factors are expected to increase market growth during the forecast period.
North America is Expected to Dominate the Market Over the Forecast Period
North America is expected to hold a leading position in the non-invasive prenatal testing (NIPT) market during the forecast period. High preterm birth rate, high maternal mortality rate, and rising incidences of chromosomal abnormalities will likely increase the adoption and demand for tests in this region. Various research studies provide insight into the effectiveness of awareness about prenatal care. For instance, in August 2022, a research study published in the National Library of Medicine stated that advances in antenatal care have resulted in increased awareness of fetal malformations, and malpresentation is expected to improve preparation for a high-risk delivery. Hence pregnant women need to adhere to prenatal care recommendations for optimal outcomes. Thus, North America is expected to dominate the non-invasive prenatal testing (NIPT) market over the forecast period due to the growing awareness of chromosomal abnormalities among fetuses.
Furthermore, high diagnosis rates, wider adoption and awareness among the people, and the introduction of new and technologically advanced tests are also contributing to the market growth in North America. For instance, in May 2021, Yourgene launched IONA Care, a non-invasive prenatal test (NIPT) service offering to measure whether a pregnant woman is carrying a fetus with sex chromosome aneuploidies (SCA) and autosomal aneuploidies (AA), in addition to the current IONA test, which offers screening for trisomies 21, 18, and 13 and fetal sex determination. Thus, such product launches are expected to increase market growth over the forecast period.
Hence, the abovementioned factor will have a positive influence on the growth of the market studied during the forecasted period.
Non-invasive Prenatal Testing Industry Overview
The non-invasive prenatal testing market is very competitive, with most players competing to maximize their market shares. Strong competition, rapid technological advancements, recurrent changes in government policies, and prices are key factors that confront the market. Key market players are BGI, Eurofins Scientific, F. Hoffmann-La Roche Ltd, Invitae Corporation, Illumina Inc., Natera Inc., Qiagen, Laboratory Corp. of America Holdings, and Quest Diagnostics, among others.
Non-invasive Prenatal Testing Market Leaders
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BGI
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CENTOGENE AG
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Eurofins Scientific
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PerkinElmer Inc.
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F. Hoffmann-La Roche Ltd
*Disclaimer: Major Players sorted in no particular order
Non-invasive Prenatal Testing Market News
- August 2022: Natera Inc. filed a pre-submission to the Food and Drug Administration (FDA) for its panorama non-invasive prenatal test (NIPT) as part of the Q-Sub process. The company filed its pre-submission in June 2022 for fetal chromosomal aneuploidies and 22q11.2 deletion syndrome.
- July 2022: Genetic Technologies Limited acquired EasyDNA as the company expanded the availability on its websites of Carrier Testing and Non-Invasive Prenatal Tests (NIPT) in Europe.
Non-invasive Prenatal Testing Market Report - Table of Contents
1. INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing Number of Babies with Chromosomal Disorders Owing to Increasing Number of Late Pregnancies
4.2.2 Increasing Demand for Early and Non-invasive Fetal Diagnosis
4.2.3 Favorable Reimbursement Policies
4.3 Market Restraints
4.3.1 Lack of Skilled Professionals
4.3.2 Stringent Regulations and Ethical Concerns
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value - USD million)
5.1 By Component
5.1.1 Instruments
5.1.2 Kits and Reagents
5.1.3 Services
5.2 By Application
5.2.1 Down Syndrome (trisomy 21)
5.2.2 Edwards Syndrome (trisomy 18)
5.2.3 Patau Syndrome (trisomy 13)
5.2.4 Turner Syndrome
5.2.5 Other Applications
5.3 By End User
5.3.1 Hospitals
5.3.2 Diagnostic Labs
5.4 Geography
5.4.1 North America
5.4.1.1 United States
5.4.1.2 Canada
5.4.1.3 Mexico
5.4.2 Europe
5.4.2.1 Germany
5.4.2.2 United kingdom
5.4.2.3 France
5.4.2.4 Italy
5.4.2.5 Spain
5.4.2.6 Rest of Europe
5.4.3 Asia-Pacific
5.4.3.1 China
5.4.3.2 Japan
5.4.3.3 India
5.4.3.4 Australia
5.4.3.5 South Korea
5.4.3.6 Rest of Asia-Pacific
5.4.4 Middle East and Africa
5.4.4.1 GCC
5.4.4.2 South Africa
5.4.4.3 Rest of Middle East and Africa
5.4.5 South America
5.4.5.1 Brazil
5.4.5.2 Argentina
5.4.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 BGI
6.1.2 Eurofins Scientific
6.1.3 F. Hoffmann-La Roche Ltd
6.1.4 Invitae Corporation
6.1.5 Illumina Inc.
6.1.6 Natera Inc.
6.1.7 PerkinElmer Inc.
6.1.8 Centogene NV
6.1.9 MedGenome Labs Ltd
6.1.10 Myriad Womens Health Inc.
6.1.11 Qiagen
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
Non-invasive Prenatal Testing Industry Segmentation
According to the scope of the report, non-invasive prenatal testing (NIPT), which is also called non-invasive prenatal screening (NIPS), is a method for determining the risk that the fetus will be born with certain genetic abnormalities. This testing analyzes small DNA fragments circulating in a pregnant woman's blood. NIPT analyzes the genetic information contained in this DNA to screen for a number of abnormalities.
The Non-invasive Prenatal Testing Market is segmented by Component (Instruments, Kits and Reagents, Services), Application (Down Syndrome, Edwards Syndrome, Patau Syndrome, Turner Syndrome, Other Applications), End User (Hospitals, Diagnostic Labs), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America). The market report also covers the estimated market sizes and trends for 17 countries across major global regions. The report offers market sizes and forecasts in terms of value in USD for the above segments.
By Component | |
Instruments | |
Kits and Reagents | |
Services |
By Application | |
Down Syndrome (trisomy 21) | |
Edwards Syndrome (trisomy 18) | |
Patau Syndrome (trisomy 13) | |
Turner Syndrome | |
Other Applications |
By End User | |
Hospitals | |
Diagnostic Labs |
Geography | ||||||||
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Non-invasive Prenatal Testing Market Research FAQs
What is the current Non-Invasive Prenatal Testing Market size?
The Non-Invasive Prenatal Testing Market is projected to register a CAGR of 13.5% during the forecast period (2024-2029)
Who are the key players in Non-Invasive Prenatal Testing Market?
BGI, CENTOGENE AG, Eurofins Scientific, PerkinElmer Inc. and F. Hoffmann-La Roche Ltd are the major companies operating in the Non-Invasive Prenatal Testing Market.
Which is the fastest growing region in Non-Invasive Prenatal Testing Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Non-Invasive Prenatal Testing Market?
In 2024, the North America accounts for the largest market share in Non-Invasive Prenatal Testing Market.
What years does this Non-Invasive Prenatal Testing Market cover?
The report covers the Non-Invasive Prenatal Testing Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Non-Invasive Prenatal Testing Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
What are the emerging trends in NIPT technology and applications?
The emerging trends in NIPT technology and applications are a) Potential for expanded genetic testing panels b) Earlier gestational age testing c) Integration with digital health platforms
Non-invasive Prenatal Testing Industry Report
The non-invasive prenatal testing (NIPT) market is segmented by component, application, end user, and geography. The market is witnessing substantial growth due to the increasing demand for early and non-invasive diagnostic methods to detect fetal chromosomal abnormalities. This growth is further supported by the rising average maternal age, which correlates with a higher risk of such abnormalities. NIPT testing companies are expanding their presence and enhancing their testing solutions, known for their accuracy, safety, and non-invasive nature, making them preferable over traditional methods.
The expansion opportunities are particularly promising in emerging markets like China and India, where healthcare infrastructure improvements and rising healthcare spending are evident. Additionally, the market benefits from favorable reimbursement scenarios and increased awareness of NIPT's advantages. Despite facing challenges like the need for skilled professionals and ethical concerns, the non-invasive prenatal testing market size and share are poised for continued growth. This growth is driven by technological advancements and strategic initiatives by key players.
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