U.S. Non-invasive Prenatal Testing (NIPT) Market Size, Share & Industry Analysis, By Product (Consumables & Reagents and Instruments), By Technology (Next Generation Sequencing (NGS), Microarray, Polymerase Chain Reaction (PCR), and Rolling Circular Amplification), By End-User (Hospitals and Clinical Laboratories), and Country Forecast, 2024-2032

The U.S. non-invasive prenatal testing (NIPT) market size was valued at USD 0.93 billion in 2023. The market is projected to grow from USD 1.04 billion in 2024 to USD 2.57 billion by 2032, exhibiting a CAGR of 12.0% during the forecast period.

A non-invasive prenatal test is performed on pregnant women to assess fetal health and determine the possibility of genetic abnormalities, including chromosomal disorders. The test is performed through a maternal blood sample to analyze cell-free DNA (cfDNA) in maternal plasma.

The growing prevalence of chromosomal disorders, early disease detection, and rising preference of healthcare professionals for advanced genetic tests to minimize risks are major factors contributing to the U.S. non-invasive prenatal testing (NIPT) market growth. For instance, according to a report published by the Centers for Disease Control and Prevention (CDC) in June 2023, Down syndrome is the most common chromosomal disorder, which affects around 6,000 babies annually born in the U.S.

Moreover, factors such as rising government initiatives to create awareness and increasing focus of the market players on new technologically advanced product launches have been fueling the market growth.

During the COVID-19 pandemic, 2020, the market experienced slow growth due to the disruption of the global supply chain of medical equipment, diagnostic devices, and others. This led to the limited availability of products in the market. However, in 2021 and 2022, the market experienced significant growth. The penetration of NIPT boosted post-COVID-19 because of the increasing awareness about the advantages of these tests, such as their non-invasive nature, cost-effectiveness, and high accuracy.

U.S. Non-invasive Prenatal Testing (NIPT) Market Trends

Expanding Test Panels Encourage Medicaid Programs to Cover NIPT as Primary Screening Test

Initially, non-invasive prenatal testing (NIPT) was only focused on common chromosomal abnormalities such as Down syndrome, Edward syndrome, and Patau syndrome. However, recent advancements are expanding these tests' test panels and applications. This leads to a comprehensive analysis of test samples to detect copy number variations (CNVs) and rare autosomal aneuploidies (RATs). In addition, expanding applications is leading to a surge in the use of these tests, which is gaining the attention of health insurers in the U.S.

• According to an article published in January 2023, the coverage for non-invasive prenatal testing (NIPT) is rising under health insurance, and more state Medicaid programs are covering the test as primary screening in the U.S.


• According to the American College of Obstetricians and Gynecologists, approximately 80% of the insured population in the U.S. is covered for non-invasive prenatal testing, and the government aims to provide 100% coverage for the test.

U.S. Non-invasive Prenatal Testing (NIPT) Market Growth Factors

Growing Burden of Congenital Anomalies has been Fueling the Demand for Non-invasive Prenatal Testing

Congenital anomalies, such as Down syndrome, muscular dystrophy, and others, can occur in the fetus during intrauterine life. The prevalence of congenital anomalies has been increasing significantly over the past few years.

• For instance, in June 2023, according to the data published by the Centers for Disease Control and Prevention (CDC), there were 3,963 infant deaths in the year 2021 due to congenital anomalies. Moreover, congenital abnormalities affect one in every 33 babies born in the U.S. each year, which accounts for 3.0% of the total newborn population.

NIPT helps detect these chromosomal and genetic congenital abnormalities at the early stages of pregnancy. Therefore, the increasing prevalence of congenital anomalies has fueled the demand for these tests.

Improving Reimbursement Policies by Government and Private Sector has been Fueling the Adoption of Non-invasive Prenatal Testing (NIPT)

Governments in many states of the U.S. have been working on initiatives to create awareness to fuel the adoption of non-invasive prenatal testing among pregnant women. Favorable reimbursement policies and insurance coverage in the U.S. have enabled the timely termination of pregnancies by adopting non-invasive prenatal testing (NIPT) techniques.

• In March 2020, a research study published by John Wiley & Sons, Inc., stated that in the U.S., all the commercial insurance companies cover non-invasive prenatal testing (NIPT) for high-risk patients, which includes patients who are above 35 years of age or with positive combined first-trimester screening (cFTS). Also, in some states, the Medicaid programs cover NIPT for average-risk women.

Moreover, the increasing focus of private insurance providers on expanding NIPT coverage has also been fueling growth in the U.S. non-invasive prenatal testing (NIPT) market revenue.

• For instance, in November 2021, EmblemHealth, a U.S.-based insurance company, announced the expansion of insurance coverage for non-invasive prenatal trisomy screening to include pregnant patients who are 30 or older.

Thus, the implementation of reimbursement policies by the insurance companies and the focus of key players to expand the coverage of these tests is expected to expand the market in the country.

RESTRAINING FACTORS

Rising Consequences of False Results to Restrict Market Growth

Many studies and research conducted to assess the outcome of non-invasive prenatal tests revealed a high occurrence of false positive results. Despite being the most advanced screening test, non-invasive prenatal testing (NIPT) is not infallible. The occurrence of false results may lead to inaccurate medical decisions, stress, and risk of miscarriage along with pregnancy termination in a few cases.

Besides, according to the U.S. Food and Drug Administration (FDA), all NIPT tests available in the market are laboratory-developed tests, and most of them are offered without review by the FDA. Thus, the rapid occurrence of false results and unclear regulatory scenarios are anticipated to limit the market growth during the forecast period.

• For instance, according to an article published in April 2022 by the U.S. Food and Drug Administration (FDA), non-invasive prenatal screening tests and their performances are not reviewed by the FDA.


• Moreover, as per the same article, the FDA warned the public about the risk of false NIPT test results, inappropriate use, and wrong interpretation of the results.

U.S. Non-invasive Prenatal Testing (NIPT) Market Segmentation Analysis

By Product Analysis

Increasing Demand for NIPT Tests due to the Growing Burden of Congenital Anomalies Drives Consumables & Reagents Segment Growth

On the basis of product, the market is segmented into consumables & reagents and instruments. The consumables & reagents segment dominated the U.S. non-invasive prenatal testing (NIPT) market in 2023. The increased prevalence of congenital anomalies has resulted in a higher adoption of next-generation sequencing (NGS) and polymerase chain reaction (PCR) based methods for non-invasive prenatal testing (NIPT), which have contributed to the segment's growth.

• For instance, in June 2023, according to the data published by the Centers for Disease Control and Prevention (CDC), congenital abnormalities affect one in every 33 babies born in the U.S. annually, accounting for 3.0% of the total newborn population.

On the other hand, the instruments segment is expected to witness significant growth in the forthcoming years. The increasing focus of the market players on new advanced product development and launches is anticipated to fuel the segment’s growth in the forecast period.

By Technology Analysis

Various Advantages Associated with the Use of Next Generation Sequencing is Responsible for the Segment’s Dominance

By technology, the market is segmented into next generation sequencing (NGS), microarray, polymerase chain reaction (PCR), and rolling circular amplification.

The next generation sequencing (NGS) segment held the largest share in 2023 and is anticipated to register a significant CAGR during the forecast period. The factors responsible for the segment's dominance are the high capabilities of next-generation sequencing to perform comprehensive analysis of potential genetic abnormalities and the rising availability of this technology. Additional factors responsible for its high demand include high reliability compared to other technologies and rising technological advancements.

• For instance, according to an article published by Frontiers Media S.A. in November 2022, the integration of artificial intelligence in NGS helped develop different non-invasive prenatal screening methods. The fragment distance-based aiD-NIPT performed better than conventional fragment count FC-based NIPT methods.

The microarray segment is expected to grow at a substantial CAGR during the forecast period. The increasing use of microarray technology for varied indications of prenatal screening has been fueling the segment’s growth.

• For instance, in February 2021, a research study published by the Multidisciplinary Digital Publishing Institute (MDPI) stated that using microarray analysis in prenatal diagnostics for different indications has led to an additional rate of pathogenic findings if the karyotype is normal.

By End-user Analysis

Increasing Number of Clinical laboratories is Responsible for the Segment’s Dominance in the Market

By end-user, the market is bifurcated into clinical laboratories and hospitals.

The clinical laboratories segment accounted for a major proportion of the market share in 2023 and is anticipated to register a notable CAGR during the forecast period. The increasing laboratory test utilization, growing partnerships of clinical laboratories with payers and providers, and increasing clinical laboratories are responsible for the segment’s growth.

The hospitals segment is anticipated to grow substantially during the forecast period. The segment's growth is attributed to the increasing government initiatives regarding NIPT through government healthcare facilities and the increasing adoption of these tests by pregnant women.

List of Key Companies in U.S. Non-invasive Prenatal Testing (NIPT) Market

Increasing Focus of Market Players on Mergers and Acquisitions for the Development of Technologically Advanced Products has been Fueling their Growth

Companies including Illumina, Inc., Laboratory Corporation of America Holdings, and Natera, Inc. accounted for a significant U.S. non-invasive prenatal testing (NIPT) market share in 2023. The key factors driving the market growth are the wide product portfolio, rising collaborations between major players and laboratories, growing R&D activities by industry players, and the increasing usage of non-invasive prenatal testing to screen the risk of genetic abnormalities.

• For instance, in July 2023, the Laboratory Corporation of America Holdings signed an agreement with Legacy Health, a non-profit hospital system. Under the agreement, Laboratory Corporation of America Holdings acquired selected assets, including laboratory equipment and facilities, to increase access and expand offerings related to laboratory tests.

Moreover, other players in the market, such as F. Hoffmann-La Roche Ltd, Revvity Inc., and Laboratory Corporation of America Holdings, have been focusing on adopting advanced technology to enhance their product offerings.

LIST OF KEY COMPANIES PROFILED:

• Illumina, Inc. (U.S.)


• Natera, Inc. (U.S.)


• F. Hoffmann-La Roche Ltd (Switzerland)


• Revvity Inc. (U.S.)


• Laboratory Corporation of America Holdings (U.S.)


• Eurofins Scientific (Germany)


• Myriad, Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• January 2024 – Natera Inc. acquired the non-invasive prenatal screening and carrier screening business from Invitae Corporation. According to the acquisition, Invitae Corporation transferred its non-invasive prenatal screening and carrier screening patients to Natera Inc.


• October 2023 – Revvity Inc. collaborated with ELEMENT BIOSCIENCES, a U.S.-based developer of genetic analysis tools, to launch workflow solutions that save the time and effort required for genomic analysis of samples. This collaboration is aimed to enhance the use of next-generation sequencing for genetic testing.


• March 2021 – Natera Inc. entered into a collaboration with Tesis Labs, a U.S.-based multi-region lab services provider with labs in Colorado, Texas, and Arizona, to broaden its portfolio of genetic testing offerings.


• March 2021 – Illumina, Inc. and Harvard Pilgrim Health Care (HPHC) successfully conducted research demonstrating the cost-effectiveness of non-invasive prenatal testing (NIPT) among all pregnant women.


• June 2020 – Illumina, Inc. announced the acquisition of BlueBee, a cloud-based software company to accelerate the processing, analysis, and sharing of next-generation sequencing (NGS) data at a larger scale.

REPORT COVERAGE

The U.S. non-invasive prenatal testing (NIPT) market research report provides a detailed competitive landscape. It also includes key insights, such as top industry developments covering partnerships, mergers, and acquisitions. Additionally, it focuses on key points, such as new product launches in the market. Furthermore, the report covers market forecast, analysis of different segments, profiles of key market players, market trends, and the impact of COVID-19 on the market. The report consists of quantitative and qualitative insights that have contributed to the market's growth.

Report Scope & Segmentation