U.S. Non Invasive Prenatal Testing Market Size To Hit USD 5.71 Billion By 2032

The global U.S. Non Invasive Prenatal Testing market size was exhibited at USD 2.6 billion in 2022 and it is expected to hit around USD 5.71 billion by 2032, growing at a CAGR of 8.19% during the forecast period from 2023 to 2032.

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Key Takeaways:

• The 13-24 weeks segment dominated the U.S. NIPT market in 2022 with a revenue share of 50.98%.
• The 0-12 weeks segmentis expected to showcase lucrative growth during the forecast period.
• The high & average pregnancy risk segment dominated the U.S. non invasive prenatal testing market in 2022 with a revenue share of 76.49%.
• The low-risk segment is expected to register the fastest CAGR during the forecast period.
• The cell-free DNA in maternal plasma tests segment dominated the U.S. NIPT market in 2022 with a revenue share of 69.83%.
• The others segment which include rolling cycle amplification, karyotyping, Sanger sequencing, ultrasound scanning, and other blood tests held the maximum revenue share of 53.26% in 2022.
• The NGS segment is the fastest-growing segment.
• The consumables and reagents segment dominated the U.S. NIPT market with a share of over 71.80% in 2022.
• The consumables and reagents segment is also projected to grow at the fastest CAGR during the forecast period.
• The trisomy segment dominated the U.S. non-invasive prenatal testing market with a share of over 53.86% in 2022.
• The microdeletion syndrome segment is anticipated to grow at the fastest rate over the forecast period.
• The diagnostic laboratories segment dominated the U.S. NIPT market with a share of over 61.98% in 2022
• The diagnostic laboratories segment is anticipated to grow at the fastest CAGR over the forecast period.

The market’s growth can be attributed to the increasing average maternal age, rising incidence of chromosomal disorders, and collaborations & licensing agreements among key players. Moreover, high adoption and demand for early non invasive prenatal testing (NIPT) and improvements in reimbursement scenarios are among the factors anticipated to boost market growth over the forecast period.

Due to a number of factors, including an increase in doctors preferring advanced genetic screening for pregnant women with elevated risk, a desire to delay childbearing, and an increase in pregnancy-related issues in the third or second pregnancy stage, NIPT has grown increasingly in demand worldwide. Amniocentesis and sampling of chorionic villus are two invasive prenatal testing methods that could result in complications like miscarriage. As a result, there is a significant need for tests that are more effective, noninvasive, and secure and to reduce falls in the use of these procedures. For the identification of frequently occurring trisomies in the fetus, such as Turner syndrome, Down syndrome, fetal rhesus D status, and sex chromosome disorders, as well as for fetal sex determination, NIPT uses cell-free fetal DNA (cffDNA) that circulates in the mother's blood.

The increasing incidence of chromosomal abnormalities is expected to accelerate market growth. Among all the countries, there is a substantial opportunity in the U.S. for noninvasive prenatal screening, with nearly 3.66 million annual births and an increasing number of high-risk pregnancies. In addition, there is a heavy burden of genetic diseases. As per the report published by Centres of Disease Control and Prevention in June 2023, a survey was conducted in the U.S., which reported that the reported incidence of major chromosomal abnormalities is 1 in 140 newborns in the country, with trisomy 21 (Down syndrome) having a high incidence of 1 in 700 births, resulting in the birth of 6,000 newborns with Down syndrome every year. Families can benefit from accurate and early screening using NIPT to know about their baby's genetic issue. Thus, this high incidence is anticipated to boost the demand for prenatal tests.

Furthermore, noninvasive fetal tests have a lower failure and false-positive rate, which has resulted in a considerable increase in the uptake of noninvasive tests in the last few years. Other advantages of NIPT include precise results in overweight & obese women and the detection of a higher number of genetic disorders such as microdeletions. Furthermore, key manufacturers in the market are undertaking several efforts to provide advanced products in the market. For instance, in June 2019, Illumina announced the launch of an expanded version of its VeriSeq NIPT, which now enables screening of a broader range of chromosomal conditions related to birth defects.

Moreover, key players are also involved in the product portfolio expansion, which drives the market growth. For instance, in January 2023, Juno Diagnostics announced the establishment of a clinical advisory board to support the portfolio of products for its non invasive prenatal screening (NIPS) procedure.The board comprises renowned professionals in reproductive medicine, women's health, and patient-focused prenatal care, which is projected to enhance the company's capacity to assist a larger community before, during, and following their pregnancies.

The COVID-19 pandemic slightly impacted the U.S. non invasive prenatal testing market. Several manufacturing companies maintained regular communication with the U.S. FDA to keep themselves informed of supply chain disruptions. In addition, several research studies were conducted to estimate the commercial impact of COVID-19. According to a SeraCare report, IVD developers and clinical testing facilities collaborated with research organizations to determine the effects of COVID-19 infection on pregnancy and congenital debilities in infants, as well as the requirement for NIPT during the COVID-19 pandemic. However, a lack of established outcomes may adversely impact the demand for NIPT tests during the COVID-19 pandemic. One of the barriers preventing diagnostic centers and hospitals from offering noninvasive prenatal screening services was the intense pressure to treat patients with COVID-19, as non invasive prenatal testing (NIPT) procedures were halted.

U.S. non invasive prenatal testing market include:

• 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

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2032. For this study, Nova one advisor, Inc. has segmented the U.S. Non Invasive Prenatal Testing market.

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

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