The U. S. non invasive prenatal testing market is expected to reach USD 2.96 billion by 2030, growing at a CAGR of 8.18% from 2023 to 2030. Increased awareness and demand for non-invasive prenatal screening options, technological developments, and a need for more precise and thorough prenatal genetic testing all contributed to the expanding acceptance of NIPT. Non-invasive prenatal testing provided significant benefits over conventional screening techniques, including a higher rate of genetic disorder diagnosis and a decreased percentage of false positive rats.
Improvements in reimbursement policies for average and low-risk pregnancies are expected to drive the adoption of noninvasive prenatal screening tests. For instance, in the U. S., Medicaid programs cover noninvasive prenatal tests for high patients after first-trimester screening. Insurers cover NIPT for around 114 million women with average-risk singleton pregnancies in the U. S. Such initiatives are anticipated to increase the adoption of NIPT procedures.
Moreover, improvements in reimbursement policies and the inclusion of non invasive prenatal testing (NIPT) in national health programs across the country are encouraging market players to conduct R&D activities to develop novel tests. The reimbursement for noninvasive prenatal tests varies in insurance plans owing to the difference in contracts. The listed prices of NIPT range from under USD 1,000 to over USD 2,000. However, studies suggest that first-line NIPT screens have become highly cost-effective and are available at low prices ranging from USD 619 to USD 744.
The market is highly competitive with the key players forming partnerships and collaborations to maintain a stable position in the market. For instance, in January 2022 , QIAGEN and Atila BioSystems collaborated to provide NIPT solutions to boost the application portfolio of its digital PCR platform. The QIAcuity platform from QIAGEN N. V., which uses nanoplates to process samples in two hours as opposed to the five hours needed by competing systems, has added additional features to the expanding list of applications for its ultrasensitive digital PCR (dPCR) technology. Moreover, in March 2021, Natera entered into a strategic partnership with Tesis Labs, a U. S. multi-region laboratory services provider, in the field of prenatal genetic testing. This initiative allows Tesis to expand its portfolio in genetic testing offerings and strengthen its position in the screening market.
With lockdowns due to the COVID-19 pandemic, NIPT gained attention because it delivers high-accuracy screening with minimum risk of infection compared to invasive procedures such as chorionic villus sampling and amniocentesis, which raise the possibility of hospitalization and increase the danger of COVID-19 infection for patients and medical personnel. Moreover, there was increased demand for the prescription of NIPTs in the country. On the other hand, factors limiting market growth include fewer elective procedures being performed in hospitals as patients were reluctant to undergo treatments due to the fear of contracting COVID-19 infection.
The SARS-CoV-2 pandemic created unprecedented challenges in the U. S., such as supply chain disruptions across various healthcare domains, including diagnostics and therapies. The partial shutdown of several technology developers and raw material suppliers restricted the development of new products. Moreover, many companies reported a shortage of professionals in various sectors owing to new social distancing and quarantine policies. This has further elevated the supply and delivery challenges. However, despite a decline in customer activity due to the risk of contracting the infection, some companies have managed to maintain their revenue flow. Moreover, the COVID-19 pandemic negatively impacted the supply chain, production, and shipments. Hence, the distribution of NIPT testing solutions across some regions was hampered due to supply chain disruptions, negatively impacting the market.
Improvements in reimbursement policies for average and low-risk pregnancies are expected to drive the adoption of noninvasive prenatal screening tests. For instance, in the U. S., Medicaid programs cover noninvasive prenatal tests for high patients after first-trimester screening. Insurers cover NIPT for around 114 million women with average-risk singleton pregnancies in the U. S. Such initiatives are anticipated to increase the adoption of NIPT procedures.
Moreover, improvements in reimbursement policies and the inclusion of non invasive prenatal testing (NIPT) in national health programs across the country are encouraging market players to conduct R&D activities to develop novel tests. The reimbursement for noninvasive prenatal tests varies in insurance plans owing to the difference in contracts. The listed prices of NIPT range from under USD 1,000 to over USD 2,000. However, studies suggest that first-line NIPT screens have become highly cost-effective and are available at low prices ranging from USD 619 to USD 744.
The market is highly competitive with the key players forming partnerships and collaborations to maintain a stable position in the market. For instance, in January 2022 , QIAGEN and Atila BioSystems collaborated to provide NIPT solutions to boost the application portfolio of its digital PCR platform. The QIAcuity platform from QIAGEN N. V., which uses nanoplates to process samples in two hours as opposed to the five hours needed by competing systems, has added additional features to the expanding list of applications for its ultrasensitive digital PCR (dPCR) technology. Moreover, in March 2021, Natera entered into a strategic partnership with Tesis Labs, a U. S. multi-region laboratory services provider, in the field of prenatal genetic testing. This initiative allows Tesis to expand its portfolio in genetic testing offerings and strengthen its position in the screening market.
With lockdowns due to the COVID-19 pandemic, NIPT gained attention because it delivers high-accuracy screening with minimum risk of infection compared to invasive procedures such as chorionic villus sampling and amniocentesis, which raise the possibility of hospitalization and increase the danger of COVID-19 infection for patients and medical personnel. Moreover, there was increased demand for the prescription of NIPTs in the country. On the other hand, factors limiting market growth include fewer elective procedures being performed in hospitals as patients were reluctant to undergo treatments due to the fear of contracting COVID-19 infection.
The SARS-CoV-2 pandemic created unprecedented challenges in the U. S., such as supply chain disruptions across various healthcare domains, including diagnostics and therapies. The partial shutdown of several technology developers and raw material suppliers restricted the development of new products. Moreover, many companies reported a shortage of professionals in various sectors owing to new social distancing and quarantine policies. This has further elevated the supply and delivery challenges. However, despite a decline in customer activity due to the risk of contracting the infection, some companies have managed to maintain their revenue flow. Moreover, the COVID-19 pandemic negatively impacted the supply chain, production, and shipments. Hence, the distribution of NIPT testing solutions across some regions was hampered due to supply chain disruptions, negatively impacting the market.
U. S. Non Invasive Prenatal Testing Market Report Highlights
- The 13-24 weeks segment held a dominant share of the U. S. NIPT market in 2022 owing to the effective and quick test for determining the status of uncertain tissue. When the test is done between 13 and 24 weeks into the pregnancy, expectant parents can get the results before the window for some prenatal procedures or additional diagnostic tests, including amniocentesis or chorionic villus sampling, closes
- The high and average risk segment held the dominant share of the market in 2022. It provides a precise and non-invasive method for testing for prevalent chromosomal diseases like Down syndrome
- The cell-free DNA in maternal plasma tests segment dominated the market in 2022 owing to its high precision and lack of invasiveness compared to more conventional invasive prenatal diagnostic procedures
- The others segment held the maximum revenue share in 2022 owing to the increase in the adoption of digital PCR techniques
- A few of the key players include Laboratory Corporation of America Holdings; Illumina, Inc.; Natera, Inc.; QIAGEN; Ariosa Diagnostics (Roche); Myriad Women’s Health, Inc.; Biora Therapeutics, Inc.; and Quest Diagnostics Incorporated
Table of Contents
Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. U.S. NIPT Market Variables, Trends, & Scope
Chapter 4. U.S. NIPT Market: Product Gestation Period Estimates & Trend Analysis
Chapter 5. U.S. NIPT Market: Risk Estimates & Trend Analysis
Chapter 6. U.S. NIPT Market: Method Estimates & Trend Analysis
Chapter 7. U.S. NIPT Market: Technology Estimates & Trend Analysis
Chapter 8. U.S. NIPT Market: Product Estimates & Trend Analysis
Chapter 9. U.S. NIPT Market: Application Estimates & Trend Analysis
Chapter 10. U.S. NIPT Market: End-use Estimates & Trend Analysis
Chapter 11. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
- NATERA, INC.
- ILLUMINA, INC.
- EUROFINS SCIENTIFIC
- F. HOFFMANN-LA ROCHE LTD
- QIAGEN
- MYRIAD WOMEN’S HEALTH, INC.
- BIORA THERAPEUTICS
- QUEST DIAGNOSTICS INCORPORATED
- LABORATORY CORPORATION OF AMERICA HOLDINGS
- BIOREFERENCE HEALTH, LLC (SUBSIDIARY OF OPKO HEALTH, INC.)
- INVITAE CORPORATION
Methodology
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Table Information
Report Attribute | Details |
---|---|
No. of Pages | 117 |
Published | August 2023 |
Forecast Period | 2022 - 2030 |
Estimated Market Value ( USD | $ 1.6 Billion |
Forecasted Market Value ( USD | $ 2.96 Billion |
Compound Annual Growth Rate | 8.1% |
Regions Covered | United States |
No. of Companies Mentioned | 11 |