U.S. Non Invasive Prenatal Testing Market (By Gestation Period; By Risk; By Method; By Technology; By Product; By Application: Trisomy, Microdeletion Syndrome; By End-use) - Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033

The U.S. non invasive prenatal testing market size was estimated at USD 1.77 billion in 2023 and it is expected to surpass around USD 3.91 billion by 2033, poised to grow at a CAGR of 8.22% from 2024 to 2033.

Key Pointers

• The 13-24 weeks segment dominated the U.S. NIPT market in 2023 with a revenue share of 52%. 
• The high & average pregnancy risk segment dominated the U.S. non invasive prenatal testing market in 2023 with a revenue share of 78%.
• The cell-free DNA in maternal plasma tests segment dominated the U.S. NIPT market in 2023 with a revenue share of 71%. 
• The others segment which include rolling cycle amplification, karyotyping, Sanger sequencing, ultrasound scanning, and other blood tests held the maximum revenue share of 55% in 2023.
• The consumables and reagents segment dominated the U.S. NIPT market with a share of over 73% in 2023. 
• The trisomy segment dominated the U.S. non-invasive prenatal testing market with a share of over 55% in 2023. 
• The diagnostic laboratories segment dominated the U.S. NIPT market with a share of over 63% in 2023.

U.S. Non Invasive Prenatal Testing Market Overview

The U.S. non-invasive prenatal testing (NIPT) market has witnessed significant growth in recent years, driven by advancements in prenatal screening technologies, rising maternal age, and increasing awareness about the benefits of non-invasive testing methods.

U.S. Non Invasive Prenatal Testing Market Growth Factors

The growth of the U.S. non-invasive prenatal testing (NIPT) market is propelled by the trend of increasing maternal age contributes significantly, as older mothers are at a higher risk of chromosomal abnormalities in their fetuses, necessitating early and accurate prenatal screening. Additionally, continuous technological advancements in NIPT methods enhance the accuracy, sensitivity, and specificity of testing, making them more reliable for detecting chromosomal abnormalities. Furthermore, heightened awareness among healthcare providers and patients about the benefits of NIPT, including reduced risk of miscarriage and invasive procedures, drives demand. Lastly, favorable reimbursement policies from government and private payers make NIPT procedures more accessible to a broader population, further fueling market growth. 

Report Scope of the U.S. Non Invasive Prenatal Testing Market

U.S. Non Invasive Prenatal Testing Market Trends:

• Increasing Maternal Age: The trend of delaying childbirth has led to a rise in maternal age, resulting in a higher prevalence of chromosomal abnormalities in fetuses. This demographic shift drives the demand for non-invasive prenatal testing (NIPT) as a means of early detection and informed decision-making.
• Rising Awareness: There is a growing awareness among healthcare professionals and expectant parents about the benefits of NIPT over traditional screening methods. NIPT offers greater accuracy, lower false positive rates, and reduced risk of miscarriage compared to conventional tests, driving its acceptance and adoption in clinical practice.
• Expansion of Reimbursement Coverage: Favorable reimbursement policies from government and private payers have increased access to NIPT for a broader population. Reimbursement support has made NIPT more affordable for patients, leading to increased utilization and demand for these tests.
• Integration of NIPT into Clinical Guidelines: NIPT has been increasingly incorporated into clinical practice guidelines for prenatal screening and diagnosis by leading medical organizations. Its inclusion reflects the growing recognition of NIPT as a standard of care for prenatal testing, further driving its adoption and integration into routine obstetric care.

Gestation Period Insights

The 13-24 weeks segment dominated the U.S. NIPT market in 2023 with a revenue share of 52%. As the maximum number of NIPT procedures are performed in the second trimester. Several companies have focused on the analysis of cfDNA in a sample of maternal blood collected in the first trimester to develop a more accurate and reliable NIPT. The market's expansion is anticipated to be fueled by the complementary use of ultrasonography with alpha-fetoprotein testing and NIPT beyond 12 weeks of pregnancy. Additionally, tests used in quad screening, including Alpha-Fetoprotein (AFP), Unconjugated Estriol (EU), Human Chorionic Gonadotropin (hCG), and Inhibin A, are helping to boost this segment's income.

The 0-12 weeks segmentis expected to showcase lucrative growth during the forecast period due to a wide range of products being offered in the market. A considerable amount of income is generated in this segment as a result of the first-trimester aneuploidy testing and maternal-fetal DNA screening performed during this time. Additionally, the combined information from biochemistry and sonography can be used to detect genetic changes with an accuracy level of 91% to 96%, making first-trimester risk screening preferable to other trimesters.

Risk Insights

The high & average pregnancy risk segment dominated the U.S. non invasive prenatal testing market in 2023 with a revenue share of 78% owing to the wide adoption of NIPT in this risk segment. Moreover, the high-risk nature of pregnancies in women aged over 35 years is anticipated to drive the segment. The available products in the market provide sensitivity within the range of 99.0% to 99.9% for detecting Down syndrome. Additionally, extended health coverage and plans for NIPT drive the market growth.

For instance, in October 2020, Natera, Inc. A prominent health plan announced an extension of its coverage to all singleton pregnancies, adding 17 million new covered lives. According to the most recent round of medical policy revisions in 2020, the number of covered lives for average risk NIPT has more than doubled. According to Natera, 139 million commercial lives-or nearly 77% of covered lives-are currently covered in the United States for average risk NIPT.

The low-risk segment is expected to register the fastest CAGR during the forecast period. Support from the government, such as budget assignment for average-risk pregnancies, is expected to be a favorable factor for growth. For instance, as per the reports of the National Centre for Biotechnology Information published in the year 2019, testing in pregnancies with average risk made it feasible to find an increased percentage of afflicted cases, leading to an increase in funding for this group in Ontario of USD 35 million.

Method Insights

The cell-free DNA in maternal plasma tests segment dominated the U.S. NIPT market in 2023 with a revenue share of 71%. Wide acceptance, high cost of tests, and rapid adoption of tests that detect circulating biomarkers, such as cell-free DNA fragments, have contributed to the largest market share held by this segment. Moreover, rapid technological advancements and the launch of new products in the segment are likely to have a positive impact on market growth.

For instance, in September 2019, Laboratory Corporation of America Holdings published findings from the largest cell-free chromosomal DNA screening investigation in a multifetal pregnancy. The research, which was published in PLOS ONE, found that non invasive cell-free DNA testing utilizing the MaterniT21 PLUS test produced precise results that were comparable to those for singleton pregnancies.

Biochemical tests are projected to grow at a lucrative rate. They are conducted at 8 to 24 weeks of pregnancy. However, the adoption rate varies due to the accuracy’s dependency on the mother’s health, especially in conditions such as obesity, which can hinder test results. However, the adoption rate for these tests is still high. For instance, 75% to 90% of fetuses with defects in the neural tube are detected by alpha-fetoprotein testing. The wide adoption rate is anticipated to act as a driver for the segment.

Technology Insights

The others segment which include rolling cycle amplification, karyotyping, Sanger sequencing, ultrasound scanning, and other blood tests held the maximum revenue share of 55% in 2023. A companion test to the cell-free DNA-based NIPT is ultrasound detection. Massively parallel shotgun sequencing, digital PCR, and microarray-based techniques are the other methods included in NIPT. Also, the advancements in ultrasound detection techniques and 3D-4D imaging have improved real-time monitoring, safety, and efficiency of the test, which is further expected to propel the segment growth.

The NGS segment is the fastest-growing segment. Currently, most of the commercially approved products are based on whole exome and whole genome sequencing to detect chromosomal anomalies. Furthermore, expanding the technology for detecting monogenic diseases is likely to boost revenue in this segment. It is frequently used to detect chromosomal aneuploidies, microdeletions, and trisomy disorders. As opposed to other methods, NGS-based noninvasive prenatal diagnostics can be carried out as early as 10 weeks of pregnancy. Additionally, NGS-based assays are more accurate than other noninvasive prenatal diagnostics, which have an accuracy rate of above 99%.

Product Insights

The consumables and reagents segment dominated the U.S. NIPT market with a share of over 73% in 2023. Illumina Inc.; F. Hoffmann-La Roche Ltd.; Natera, Inc.; and other regional players offer a wide range of consumables & reagents for NIPT. These players offer various kits, consumables, reagents & instruments to perform prenatal tests. For instance, in August 2020, the Society for Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists released joint guidelines recommending that prenatal screening to detect fetal chromosomal abnormalities be offered to all pregnant women irrespective of their baseline risk & maternal age.

The consumables and reagents segment is also projected to grow at the fastest CAGR during the forecast period. The market for consumables and reagents in NIPT is impacted by a number of variables, including supplier competition, regulatory restrictions, and technical improvements. Companies operating in this market concentrate on creating consumables and reagents that are of the highest caliber, most dependable, and easiest to use to satisfy the needs of NIPT laboratories and healthcare providers.

Application Insights

The trisomy segment dominated the U.S. non-invasive prenatal testing market with a share of over 55% in 2023. Growing incidence of trisomy, increasing awareness among people, and favorable initiatives undertaken by government bodies are key factors propelling the segment’s growth. High diagnosis rates, widespread acceptance, and public awareness, as well as the launch of novel and cutting-edge tests, are further factors driving market expansion in the United States.

For instance, in May 2021, in addition to the current IONA test, which provides screening for trisomies 21, 18, and 13, as well as fetal sex determination, Yourgene established IONA Care, a non invasive prenatal test service. This test can determine whether a pregnant woman is carrying a fetus with autosomal aneuploidies and sex chromosome aneuploidies. Therefore, during the projection period, such product introductions are anticipated to boost market growth.

However, the microdeletion syndrome segment is anticipated to grow at the fastest rate over the forecast period. To identify specific microdeletions linked to particular syndromes, NIPT for microdeletion syndromes examines the mother's blood for cell-free DNA (cfDNA). The NIPT can be used to screen for a number of microdeletion syndromes, including the DiGeorge syndrome, Cri-du-chat syndrome, Angelman syndrome, Prader-Willi syndrome, and Wolf-Hirschhorn syndrome.

The scope of prenatal genetic screening has been broadened with the inclusion of microdeletion syndromes in NIPT, enabling expecting parents to acquire more thorough information about the genetic health of their child. Even though NIPT can detect certain diseases, confirmation of the diagnosis frequently necessitates further diagnostic procedures, such as fluorescence in situ hybridization (FISH) or chromosomal microarray analysis.

End-use Insights

The diagnostic laboratories segment dominated the U.S. NIPT market with a share of over 63% in 2023, attributable to numerous diagnostic facilities offering NIPT all over the world. For the diagnosis of Trisomies 21, 18, and 13, Monosomy X, and other sex chromosomal abnormalities, laboratories like MedGenome Labs Ltd. offer MedGenome Claria NIPT testing. Similar to this, MedGenome's Claria NIPT Plus can identify Angelman syndrome, Edwards' syndrome, Down syndrome, 1p36 deletion syndrome, Klinefelter syndrome, Triple X, triploidy, monosomy X (Turner syndrome), Jacob's syndrome, 22q11.2 deletion syndrome, Prader-Willi syndrome, Patau syndrome, and Cri-du-chat syndrome.

Key developers, such as Illumina, are outsourcing their sample processing to Illumina CLIA labs when in-house facilities are not sufficient. Moreover, laboratories conducting NIPT tests across the U.S. are operated in compliance with quality-assurance regulations to safeguard test quality and reproducibility.

The diagnostic laboratories segment is anticipated to grow at the fastest CAGR over the forecast period. The NIPT market has experienced rapid growth, and diagnostic laboratories are essential to providing and carrying out NIPT services. These labs offer the tools, personnel, and technology required to conduct the screening test and provide accurate findings to medical professionals and pregnant parents.

U.S. Non Invasive Prenatal Testing Market Key Companies

• Illumina, Inc.
• Natera, Inc.
• Laboratory Corporation of America Holdings
• Ariosa Diagnostics (Roche)
• QIAGEN
• Myriad Women’s Health, Inc.
• Biora Therapeutics, Inc.
• Quest Diagnostics Incorporated
• Eurofins Scientific
• BioReference Health, LLC (Subsidiary of OPKO Health, Inc.)
• Invitae Corporation

U.S. Non Invasive Prenatal Testing Market Segmentations:

By Gestation Period 

• 0-12 weeks
• 13-24 weeks
• 25-35 weeks

By Risk 

• High & Average Risk
• Low Risk

By Method 

• Biochemical Screening Tests
• Cell-free DNA in Maternal Plasma Tests

By Technology 

• NGS
• Array Technology
• PCR
• Others

By Product 

• Consumables & Reagents
• Instruments

By Application

• Trisomy
• Microdeletion Syndrome
• Other Applications

By End-use 

• Hospitals & Clinics
• Diagnostic Laboratories