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U.S. Non Invasive Prenatal Testing Market Size, Share & Trends Analysis Report By Gestation Period, By Risk, By Method, By Technology, By Product, By Application (Trisomy, Microdeletion Syndrome), By End-use, And Segment Forecasts, 2023 - 2030

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    Report

  • 117 Pages
  • August 2023
  • Region: United States
  • Grand View Research
  • ID: 5876220
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.

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
1.1. Market Segmentation and Scope
1.1.1. Segment Definitions
1.1.1.1. Gestation Period Segment
1.1.1.2. Risk Segment
1.1.1.3. Method Segment
1.1.1.4. Technology Segment
1.1.1.5. Product Segment
1.1.1.6. Application Segment
1.1.1.7. End-Use segment
1.2. Regional Scope
1.3. Estimates and Forecast Timeline
1.4. Objectives
1.4.1. Objective - 1
1.4.2. Objective - 2
1.4.3. Objective - 3
1.5. Research Methodology
1.6. Information Procurement
1.6.1. Purchased Database
1.6.2. Internal Database
1.6.3. Secondary Sources
1.6.4. Primary Research
1.7. Information or Data Analysis
1.7.1. Data Analysis Models
1.8. Market Formulation & Validation
1.9. Model Details
1.9.1. Commodity Flow Analysis
1.10. List of Secondary Sources
1.11. List of Abbreviations
Chapter 2. Executive Summary
2.1. Market Snapshot
2.2. Gestation Period and Risk Snapshot
2.3. Method and Technology Snapshot
2.4. Application and Product Snapshot
2.5. End-use Snapshot
2.6. Competitive Landscape Snapshot
Chapter 3. U.S. NIPT Market Variables, Trends, & Scope
3.1. Market Segmentation and Scope
3.2. Market Lineage Outlook
3.2.1. Parent Market Outlook
3.2.2. Related/Ancillary Market Outlook
3.3. Market Dynamics
3.3.1. Increasing average maternal age and rising incidence of chromosomal syndromes
3.3.2. High demand for early and noninvasive fetal testing procedure
3.3.3. Improvements in the reimbursement scenario
3.3.4. Rising Collaborations and licensing agreements
3.4. Market restraint analysis
3.4.1. Ethical concerns regarding reproductive genetics
3.4.2. Reliability of test results
3.5. Porter’s Five Forces Analysis
3.6. PESTLE Analysis
3.7. Pipeline Analysis
Chapter 4. U.S. NIPT Market: Product Gestation Period Estimates & Trend Analysis
4.1. U.S. NIPT Market: Gestation Period Movement Analysis
4.2. 0-12 weeks
4.2.1. 0-12 weeks market estimates and forecasts, 2018 - 2030 (USD Million) (Number of Tests in Thousands)
4.3. 13-24 weeks
4.3.1. 13-24 weeks market estimates and forecasts, 2018 - 2030 (USD Million) (Number of Tests in Thousands)
4.4. 25-36 weeks
4.4.1. 25-36 weeks market estimates and forecasts, 2018 - 2030 (USD Million) (Number of Tests in Thousands)
Chapter 5. U.S. NIPT Market: Risk Estimates & Trend Analysis
5.1. U.S. NIPT Market: Risk Movement Analysis
5.2. High & Average Risk
5.2.1. High & average risk market estimates and forecasts, 2018 - 2030 (USD Million)
5.3. Low Risk
5.3.1. Low-risk market estimates and forecasts, 2018 - 2030 (USD Million)
Chapter 6. U.S. NIPT Market: Method Estimates & Trend Analysis
6.1. U.S. NIPT Market: Method Movement Analysis
6.2. Biochemical Screening Tests
6.2.1. Biochemical screening tests market estimates and forecasts, 2018 - 2030 (USD Million) (Number of Tests in Thousands)
6.3. Cell-Free DNA in Maternal Plasma Tests
6.3.1. Cell-Free DNA market estimates and forecasts, 2018 - 2030 (USD Million) (Number of Tests in Thousands)
Chapter 7. U.S. NIPT Market: Technology Estimates & Trend Analysis
7.1. U.S. NIPT Market: Technology Movement Analysis
7.2. NGS
7.2.1. NGS market estimates and forecasts, 2018 - 2030 (USD Million)
7.3. Array Technology
7.3.1. Array Technology market estimates and forecasts, 2018 - 2030 (USD Million)
7.4. PCR
7.4.1. PCR market estimates and forecasts, 2018 - 2030 (USD Million)
7.5. Others
7.5.1. Others market estimates and forecasts, 2018 - 2030 (USD Million)
Chapter 8. U.S. NIPT Market: Product Estimates & Trend Analysis
8.1. U.S. NIPT Market: Product Movement Analysis
8.2. Consumables & Reagents
8.2.1. Consumables & Reagents Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
8.3. Instruments
8.3.1. Instruments Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 9. U.S. NIPT Market: Application Estimates & Trend Analysis
9.1. U.S. NIPT Market: Application Movement Analysis
9.2. Trisomy
9.2.1. Trisomy Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
9.3. Microdeletion Syndrome
9.3.1. Microdeletion Syndrome Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
9.4. Other Applications
9.4.1. Other Applications Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 10. U.S. NIPT Market: End-use Estimates & Trend Analysis
10.1. U.S. NIPT Market: End-use Movement Analysis
10.2. Hospitals & Clinics
10.2.1. Hospitals & Clinics Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
10.3. Diagnostic Laboratories
10.3.1. Diagnostic Laboratories Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 11. Competitive Landscape
11.1. Company Categorization
11.2. Strategy Mapping
11.2.1. New Product Launch
11.2.2. Partnership
11.2.3. Acquisition
11.2.4. Collaboration
11.2.5. Funding
11.3. Key Company Market Share Analysis, 2022
11.4. Company Heat Map Analysis
11.5. Company Profiles
11.5.1. NATERA, INC.
11.5.1.1. Company Overview
11.5.1.2. Financial Performance
11.5.1.3. Product Benchmarking
11.5.1.4. Strategic Initiatives
11.5.2. ILLUMINA, INC.
11.5.2.1. Company Overview
11.5.2.2. Financial Performance
11.5.2.3. Product Benchmarking
11.5.2.4. Strategic Initiatives
11.5.3. EUROFINS SCIENTIFIC
11.5.3.1. Company Overview
11.5.3.2. Financial Performance
11.5.3.3. Product Benchmarking
11.5.3.4. Strategic Initiatives
11.5.4. F. HOFFMANN-LA ROCHE LTD
11.5.4.1. Company Overview
11.5.4.2. Financial Performance
11.5.4.3. Product Benchmarking
11.5.4.4. Strategic Initiatives
11.5.5. QIAGEN
11.5.5.1. Company Overview
11.5.5.2. Financial Performance
11.5.5.3. Product Benchmarking
11.5.5.4. Strategic Initiatives
11.5.6. MYRIAD WOMEN’S HEALTH, INC.
11.5.6.1. Company Overview
11.5.6.2. Financial Performance
11.5.6.3. Product Benchmarking
11.5.6.4. Strategic Initiatives
11.5.7. BIORA THERAPEUTICS
11.5.7.1. Company Overview
11.5.7.2. Financial Performance
11.5.7.3. Product Benchmarking
11.5.7.4. Strategic Initiatives
11.5.8. QUEST DIAGNOSTICS INCORPORATED
11.5.8.1. Company Overview
11.5.8.2. Financial Performance
11.5.8.3. Product Benchmarking
11.5.8.4. Strategic Initiatives
11.5.9. LABORATORY CORPORATION OF AMERICA HOLDINGS
11.5.9.1. Company Overview
11.5.9.2. Financial Performance
11.5.9.3. Product Benchmarking
11.5.9.4. Strategic Initiatives
11.5.10. BIOREFERENCE HEALTH, LLC (SUBSIDIARY OF OPKO HEALTH, INC.)
11.5.10.1. Company Overview
11.5.10.2. Financial Performance
11.5.10.3. Product Benchmarking
11.5.10.4. Strategic Initiatives
11.5.11. INVITAE CORPORATION
11.5.11.1. Company Overview
11.5.11.2. Financial Performance
11.5.11.3. Product Benchmarking
11.5.11.4. Strategic Initiatives
List of Tables
Table 1 List of secondary sources
Table 2 List of abbreviations
Table 3 Risk of trisomy 21 and chromosomal abnormalities with maternal age
Table 4 Success rate by gestational age (in weeks) and maternal weight (in pounds)
Table 5 U.S. non-invasive prenatal testing market revenue estimates and forecast, by gestation period, 2018 - 2030 (USD Million) (Number of tests in thousands)
Table 6 U.S. non-invasive prenatal testing market revenue estimates and forecast, by pregnancy risk, 2018 - 2030 (USD Million)
Table 7 U.S. non-invasive prenatal testing market revenue estimates and forecast, by method, 2018 - 2030 (USD Million) (Number of tests in thousands)
Table 8 U.S. non-invasive prenatal testing market revenue estimates and forecast, by technology, 2018 - 2030 (USD Million)
Table 9 U.S. non-invasive prenatal testing market revenue estimates and forecast, by product, 2018 - 2030 (USD Million)
Table 10 U.S. non-invasive prenatal testing market revenue estimates and forecast, by application, 2018 - 2030 (USD Million)
Table 11 Non-invasive prenatal testing market revenue estimates and forecast, by end-use, 2018 - 2030 (USD Million)
Table 12 Company market share, 2022
Table 13 Key companies undergoing expansions
Table 14 Key companies undertaking acquisitions
Table 15 Key companies undertaking collaborations
Table 16 Key companies launching new products/services
Table 17 Key companies undergoing partnerships
Table 18 Key companies undergoing other strategies
Table 19 List of key emerging companies/technology disruptors/innovators
List of Figures
Fig. 1 Non-invasive prenatal testing market segmentation
Fig. 2 Market research process
Fig. 3 Information procurement
Fig. 4 Primary research pattern
Fig. 5 Market research approaches
Fig. 6 Value-chain-based sizing & forecasting
Fig. 7 QFD modeling for market share assessment
Fig. 8 Market formulation & validation
Fig. 9 Segment snapshot (Method and technology)
Fig. 10 Parent market (USD Million)
Fig. 11 SWOT analysis, by factor (Political & legal, economic, and technological)
Fig. 12 Industry analysis - Porter’s
Fig. 13 Consumer behavior analysis
Fig. 14 U.S. non-invasive prenatal testing market: Gestation period outlook and key takeaways
Fig. 15 U.S. non-invasive prenatal testing market: Gestation period movement analysis
Fig. 16 0-12 weeks market estimates and forecast, 2018 - 2030 (USD Million) (Number of tests in thousands)
Fig. 17 13-24 weeks market estimates and forecast, 2018 - 2030 (USD Million) (Number of tests in thousands)
Fig. 18 25-36 weeks market estimates and forecast, 2018 - 2030 (USD Million) (Number of tests in thousands)
Fig. 19 U.S. non-invasive prenatal testing market: risk outlook and key takeaways
Fig. 20 U.S. non-invasive prenatal testing market: risk movement analysis
Fig. 21 High & average risk pregnancy market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 22 Low-risk pregnancy market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 23 U.S. non-invasive prenatal testing market: Method outlook and key takeaways
Fig. 24 U.S. non-invasive prenatal testing market: Method outlook movement analysis
Fig. 25 Biochemical screening tests market estimates and forecast, 2018 - 2030 (USD Million) (Number of tests in thousands)
Fig. 26 Cell-free DNA in maternal plasma tests market estimates and forecast, 2018 - 2030 (USD Million) (Number of tests in thousands)
Fig. 27 U.S. non-invasive prenatal testing market: Technology outlook and key takeaways
Fig. 28 U.S. non-invasive prenatal testing market: Technology outlook movement analysis
Fig. 29 Next-generation sequencing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 30 Array technology market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 31 Polymerase Chain Reaction (PCR) market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 32 Other technologies market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 33 U.S. non-invasive prenatal testing market: Product outlook and key takeaways
Fig. 34 U.S. non-invasive prenatal testing market: Product movement analysis
Fig. 35 Consumables and reagents market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 36 Instruments market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 37 Components of Vanadis NIPT System
Fig. 38 U.S. non-invasive prenatal testing market: Application outlook and key takeaways
Fig. 39 U.S. non-invasive prenatal testing market: Application movement analysis
Fig. 40 Trisomy market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 41 Microdeletion syndrome market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 42 Others market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 43 Non-invasive prenatal testing market: End-use outlook and key takeaways
Fig. 44 Non-invasive prenatal testing market: End-use movement analysis
Fig. 45 Hospitals & clinics market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 46 Diagnostic laboratories market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 47 Key country dynamics
Fig. 48 U.S. non-invasive prenatal testing market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 49 Fertility rate, 2020 - 2023
Fig. 50 Ways to obtain coverage
Fig. 51 Market participant categorization
Fig. 52 Company market share analysis, 2022
Fig. 53 Strategic framework
Fig. 54 Ansoff matrix
Fig. 55 Competition categorization
Fig. 56 Company market position analysis
Fig. 57 Company market position analysis

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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