Non-invasive Prenatal Testing (NIPT) Market Size, Share & COVID-19 Impact Analysis, By Product (Instruments and Consumables & Reagents), By Technology (Next Generation Sequencing (NGS), Microarray, Polymerase Chain Reaction (PCR), and Rolling Circular Amplification), By End-User (Hospitals and Clinical Laboratories), and Regional Forecast, 2023-2030

The Non-Invasive Prenatal Testing (NIPT) market size was valued at USD 5.20 billion in 2022 and is projected to grow USD 6.07 billion in 2023 to USD 19.09 billion by 2030, exhibiting a CAGR of 17.8% during 2023-2030. North America dominated the global market with a share of 51.15% in 2022. Moreover, the U.S. non-invasive prenatal testing market size is projected to grow significantly, reaching an estimated value of USD 2.56 billion by 2032, driven by growing burden of congenital anomalies.

Non-invasive Prenatal Test (NIPT) is performed to determine the presence or risk of any chromosomal abnormality, such as Down syndrome, Edward syndrome, Patau syndrome, and others in the fetus. These tests analyze cell-free DNA in maternal plasma to test for fetal chromosomal conditions.

Genes and chromosomes can sometimes undergo mutation, increasing the risk of genetic abnormalities in an unborn child. According to the CDC, trisomy 21 or Down syndrome, is the most common chromosomal abnormality affecting about 1 in 700 babies born in the U.S., and around 6,000 babies are born with Down syndrome annually. The increasing incidence rate of chromosomal abnormalities has led to a surge in demand for effective screening tools for prenatal tests.

The market is witnessing significant technological advancements to improve testing capabilities. Various established players and new start-ups seek funding to conduct research and clinical testing of the NIPT techniques. Government and private organizations are actively finding research institutes and start-ups to develop innovative testing procedures to detect key genetic disorders through non-invasive prenatal testing. For instance, in December 2022, BillionToOne, Inc., a precision diagnostics company, raised USD 48.5 million in funding from existing investors, which enabled the development and commercialization of its non-invasive prenatal screening test and oncology products. The investors included Hummingbird Ventures, Libertus Capital, Baillie Gifford, and Neotribe Ventures.

COVID-19 IMPACT

Increased Adoption of NIIPT During COVID-19 Pandemic Aided Market Growth

The COVID-19 outbreak had a limited impact on this market. The limited impact attributed to the adoption of non-invasive instead of invasive prenatal tests due to restricted travel to the hospital for any invasive procedure to evaluate their child's genetic risk. According to a recent article by MedGenome, NIPT helped many pregnant women during the COVID-19 pandemic. Also, several manufacturing companies were in close contact with the U.S. FDA to keep them informed about any disruption in the supply chain.

Moreover, several research studies are being conducted to determine the impact of COVID-19 on market growth. According to a report published by SeraCare, in-vitro diagnostics manufacturers and clinical testing laboratories collaborated with research organizations. The collaboration aimed to assess the interference of SARS-CoV-2 infection on pregnancy and congenital disabilities in newborns and the need for non-invasive prenatal testing during the COVID-19 pandemic. However, limited established results led to uncertainty in demand for these tests during the COVID-19 pandemic.

LATEST TRENDS

Prenatal Testing Market Witnesses a Shift Toward Non-invasive Tests 

Prenatal screening or testing has been shifting its balance toward 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 the established clinical effectiveness of these tests, has been instrumental in making this shift happen. For instance, in July 2022, Genetic Technologies Limited, an Australian company, announced its expansion in European and Indian markets by acquiring U.S.-based EasyDNA.

Moreover, many countries have implemented policies where non-invasive prenatal tests are now the standard tests in prenatal screening instead of invasive tests. For example, in the Netherlands, non-invasive tests have been declared the standard tests for screening pregnant women. Although invasive tests still have applications in identifying specific disorders, non-invasive tests have demonstrated high growth in adoption globally.

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NON-INVASIVE PRENATAL TESTING (NIPT) MARKET GROWTH FACTORS

Growing Prevalence of Chromosomal Abnormalities to Increase the Demand for these Tests

Recently, the maternal age at childbearing has shifted due to various social and economic factors. According to a recent news article by NBC News, the average age of the U.S. women giving birth has increased from 27 to 30. According to the CDC, women aged 35 years or older are more likely to have an affected pregnancy by Down syndrome than women who become pregnant at a younger age. Both the factors mentioned above are related and led to the increased prevalence of Down syndrome and other genetic complications in newborns.

Moreover, according to the WHO factsheet published in February 2023, annually, an estimated 240,000 newborns die within 28 days, and around 170,000 children die aged between 1 month to 5 years. This has led to the early screening of pregnant women through prenatal tests, including non-invasive ones.

Moreover, favorable reimbursement policies and raising awareness about the advantages of non-invasive tests over invasive prenatal tests are likely to augment their adoption during the forecast period.

Constant Product Innovations to Contribute to Market Growth

Several companies are constantly focusing on developing highly advanced screening technologies that are very sensitive and accurate in the early detection of genetic disorders in babies. Manufacturers are emphasizing the development of advanced non-invasive prenatal tests and entering into strategic partnerships and collaborations to strengthen their positions in the market. Human genome sequencing has enabled huge developments in detecting aneuploidies among the neonatal population. For instance, in September 2022, BillionToOne Inc., a U.S.-based molecular diagnostic company, announced the launch of the UNITY fetal antigen single-gene non-invasive prenatal test (sgNIPT). The test identifies the genetic variants that code for the corresponding fetal antigens and is available at 10+ weeks gestation.

Additionally, many countries are adopting screening policies to include non-invasive prenatal screening to detect chromosomal anomalies. For instance, according to an article published in December 2022 in the European Journal Of Human Genetics, many European countries are integrating non-invasive prenatal testing into their publicly funded healthcare systems to screen chromosomal aneuploidies. Also, in 2022, these tests became available in Germany as a publicly reimbursed test.

RESTRAINING FACTORS

High Cost of Tests to Restrain Market Growth

The high cost of these tests, leading to relatively low affordability in many developing countries, will limit their adoption. According to an article published by Future Medicine, the average cost of non-invasive prenatal testing in India is around USD 350 to USD 400. According to an article published by the Australian Broadcasting Corporation in May 2022, an NIPT costs around USD 500 and is a high out-of-pocket cost during pregnancy, pressuring families to terminate their pregnancies after the first positive test for Down’s syndrome. This has limited their uptake in emerging countries.

Additionally, the lack of awareness among the general population in emerging countries about genetic abnormalities risks would hamper growth. At the same time, the lower per capita healthcare spending and lack of adequate reimbursement policies for tests are some of the additional factors that may limit the global non-invasive prenatal testing market growth.

SEGMENTATION

By Product Analysis

Increasing Number of Lab-Based Tests to Boost Consumables & Reagents Segment Growth

Based on the 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 market players' introduction of new test kits and the rising number of lab-based tests performed globally. Additionally, the increasing number of research and development activities for screening genetic disorders is one of the major factors fueling the demand for reagents and consumables.

The technological advancements in instruments and increasing collaborations among players to introduce highly sensitive and cost-effective instruments for detecting trisomy during pregnancies are driving the adoption of these services globally. For instance, in January 2022, YOURGENE HEALTH entered into a strategic partnership agreement with EKF Diagnostics Holdings plc. The alliance aimed to use the accredited U.S. laboratories of EKF Diagnostics Holdings plc. for non-invasive prenatal testing and oncology testing.

By Technology Analysis

Growing NGS Use in Clinical Applications to Aid Next-generation Sequencing Segment Growth

Based on the technology, the market is segmented into next-generation sequencing (NGS), microarray, polymerase chain reaction (PCR), and rolling circular amplification. The next-generation sequencing segment dominates the market owing to the growing use of next-generation sequencing (NGS) in various clinical applications, majorly in sequencing the whole genome to identify the risk of fetal chromosomal anomalies. Moreover, the superior clinical efficiency of next-generation sequencing (NGS) technology to analyze cfDNA fragments across the whole genome over other technologies, such as microarray and PCR, is expected to boost the adoption of instruments and tests based on this technique. For instance, in June 2021, Illumina and Next Generation Genomic (NGG Thailand) announced the launch of VeriSeq NIPT Solution v2, an NGS-based test, in Thailand.

Rolling circular amplification is a new technology developed by PerkinElmer Inc., which eliminates the use of polymerase chain reaction (PCR) and sequencing to provide cfDNA testing. Moreover, affordable prices will allow many laboratories to use this technology for screening tests, further accelerating the demand in the upcoming years.

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By End-user Analysis

Safe and Effective Prenatal Tests to Drive Clinical Laboratories Segment Growth

On the basis of the end-user, the market is segmented into hospitals and clinical laboratories. Clinical laboratories dominated the market in 2022, are the major end-users of non-invasive prenatal tests. Compared to hospitals, clinical laboratories are equipped with highly innovative technology that provides safe and effective prenatal tests for chromosomal abnormalities, providing lucrative growth opportunities for this segment.

REGIONAL INSIGHTS

Geographically, the market is studied across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

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North America NIPT market size stood at USD 2.66 billion in 2022. The region’s dominance of the global market is attributed to the increasing penetration of non-invasive prenatal testing and the higher incidence of Down syndrome in newborns. Moreover, the strong geographical foothold of 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 differentiate between maternal and fetal DNA in the chromosomes of interest. Such novel developments are anticipated to boost the adoption and propel market growth in North America in the upcoming years.

The European market is expected to witness a significant growth in the upcoming years. This is attributable to the strong reimbursement framework for these tests and the launch of new products by players in the region. For instance, in May 2022, YOURGENE HEALTH announced the launch of the Accelerator Phase for its Microdeletions Plugin, which expanded the clinical menu and capabilities of the class-leading IONA Nx NIPT Workflow offering.

Asia Pacific is expected to exhibit comparatively higher market growth. The growth is attributed to the growing demand for the early diagnosis of chromosomal disorders during pregnancies in emerging countries, such as India and China. The improving healthcare infrastructure, large patient population, and surging awareness about advanced technologies in prenatal testing drive market growth in the region.

Market growth for Latin America and the Middle East & Africa regions is attributable to factors, such as the rising prevalence of genetic disorders in the population, increased risk of chromosomal abnormalities with increasing maternal age, and rising customer preferences for non-invasive techniques compared to invasive ones.

KEY INDUSTRY PLAYERS

Strong Product Portfolio to Help Illumina, Inc., Sequenom Laboratories, LabCorp Inc., and Natera Lead the Global Market

This market is consolidated owing to the wide range of product offerings and robust distribution networks of major companies in developed and emerging nations. Illumina, Inc., Sequenom Laboratories, LabCorp Inc., and Natera are expanding their portfolio to capture more non-invasive prenatal testing (NIPT) market share. Certain factors, including robust research & development activities and increasing focus on innovative product launches, are expected to help maintain their positions in the market.

Other major players include YOURGENE HEALTH, Eurofins, LifeCodexx GmbH, F. Hoffmann-La Roche, and Perkin Elmer, Inc. These companies plan to strengthen their foothold in the market by adopting newer strategies, such as investments in developing novel technologies for the early screening of chromosomal abnormalities and collaborations with research organizations and other key players.

LIST OF KEY COMPANIES IN NON-INVASIVE PRENATAL TESTING (NIPT) MARKET:

• Illumina, Inc.  (U.S.)


• YOURGENE HEALTH (U.K.)


• Natera   (U.S.)


• F. Hoffmann-La Roche Ltd (Switzerland)


• PerkinElmer Inc. (U.S.)


• Laboratory Corporation of America (U.S.)


• Eurofins LifeCodexx GmbH (Germany)

KEY INDUSTRY DEVELOPMENTS:

• September 2022 - YOURGENE HEALTH received Health Sciences Authority (HSA) approval for its IONA Nx NIPT Workflow in Singapore for use in clinical laboratories.


• September 2022 - Eurofins Genoma launched a non-invasive preimplantation genetic aneuploidy screening test (niPGT-A) to meet the diverse diagnostic needs of reproductive genetics and provide IVF centers with an accurate alternative to traditional testing.


• August 2022 – Natera filed a pre-submission to the FDA for its Panorama NIPT as part of the Q-Sub process for fetal chromosomal aneuploidies and 22q11.2 deletion syndrome.


• July 2021 - Pacific Biosciences signed a definitive merger agreement to acquire Omniome, a San Diego-based company. This collaboration will help Pacific Biosciences expand market opportunities for sequencing in innovative ways that will add value to customers. Omniome will help through its novel approach to getting a precise short-read sequencing platform to enter large, fast-growing clinical application areas in oncology and non-invasive prenatal testing.


• August 2020 – Eurofins Scientific, the European front-runner in non-invasive prenatal testing, signed an agreement with Noritsu Koki Co., Ltd. to acquire GeneTech Inc., a leading player in NIPT and genetic analysis in Japan. This acquisition will help Eurofins to become the market leader in non-invasive prenatal testing.

REPORT COVERAGE

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The market report provides a detailed market analysis. It focuses on key aspects, such as an overview of the product, the prevalence of several diseases and disorders, key countries, and pricing analysis. Additionally, it includes an overview of reimbursement scenarios for diagnostic procedures, key industry developments, such as mergers, partnerships, & acquisitions, the impact of COVID-19 on the market, and brand analysis. Besides these, the report offers insights into the market trends and highlights key industry developments. In addition to the above-mentioned factors, the report encompasses several factors that have contributed to the market's growth in recent years. The report also covers a regional analysis of different segments.

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