During the COVID-19 pandemic, close contact with the FDA resulted in Minimal Impact:
The COVID-19 epidemic had little impact on the market for non-invasive prenatal diagnostics. Several manufacturing companies were in regular contact with the U.S. Food and Drug Administration to keep them aware of any supply chain disruptions. In addition, many research studies were done to estimate the commercial impact of COVID-19.
In-vitro diagnostics manufacturers and clinical testing laboratories team with research organizations to determine the effect of SARS-CoV-2 infection on pregnancy and congenital disabilities in newborns, as well as the need for non-invasive prenatal testing during the COVID pandemic, according to a SeraCare report. However, the lack of established outcomes has cast doubt on the demand for these tests amidst the pandemic. Nevertheless, as per our analysis, the Global Non-Invasive Prenatal Testing (NIPT) Market was US$ 2.85 Billion in 2021.
Worldwide Non-Invasive Prenatal Testing (NIPT) Market Size is expected to grow at a CAGR of 15.2% during 2021-2027:
The rising frequency of chromosomal abnormalities, combined with increased product utilization in new applications, has driven organic revenue growth over the years. Furthermore, the market expansion is expected to be fuelled by innovations in existing tests in advanced functionality, improved chemistry, and bioinformatics analysis. One of the market's main driving forces is the improvement of payment policies for normal and low-risk pregnancies. Natera announced in December 2020 that its non-invasive prenatal testing (NIPT) would be covered by the most extensive U.S. health plan, Aetna, for all pregnancies.
Cell-Free DNA-Based NIPT Market Is Gauged to Generate the Highest Market Share:
In 2021 and during the forecast years, the cell-free DNA-based NIPT market is expected to have the highest market share. Cell-free DNA is increasingly being used to forecast the likelihood of genetic disorders in prenatal care through various genetic tests. Several research studies are now underway to improve the utilization of the tests available through this segment. Nonetheless, ultrasound detection is used with the NIPT test based on cell-free DNA. Furthermore, the ultrasound detection test serves as a foundation for subsequent testing of the baby to discover anomalies. Recent technological developments and 3D-4D imaging have increased the test's real-time monitoring, safety, and efficiency, driving the segment's growth.
NGSS Technology Remains to Be Dominant in All Aspects:
By technology, our analysis studies the markets for ELISA Kits, Next Generation Sequencing Systems, and Microarray Analysis. According to our findings, next-generation sequencing systems (NGSS) dominate the market and hold a significant proportion. Furthermore, the NGSS technology outperforms all other technologies in efficiency, availability, penetration, and technology. As a result, NGSS has become widely used in this field. However, several end users have reported difficulty interpreting results when using NGSS technology.
Over the forecast period, the Low-Risk Pregnancy Testing Market is expected to multiply:
As per our analysis, because of the increased uptake of these tests in high-risk situations in patients aged 35 and above, the market for non-invasive prenatal testing for high and average-risk pregnancies held the most significant share. The dominance of the high and average-risk segments is also due to favorable payer reimbursement and increased awareness regarding the prevention of chromosomal defects such as Down syndrome. The low-risk pregnancy testing market, on the other hand, is expected to rise rapidly over the projected period. Furthermore, government support, such as budget allocation for average-risk pregnancies, is predicted to positively influence the growth of the Low-Risk Pregnancy Testing Market.
Diagnostic Laboratories Holds Lion's Share:
Diagnostic laboratories are the primary end-users of non-invasive tests, so diagnostic laboratories dominate the market. It is predicted to increase at the fastest rate. Compared to hospitals, diagnostic laboratories are equipped with cutting-edge equipment that allows for safe and successful prenatal testing.
Furthermore, the most significant market share is due to well-drafted NIPT laboratory standards in developed regions and a substantial volume of NIPT tests performed in diagnostic laboratories. Moreover, some facilities outsource testing services to diagnostic laboratories, resulting in the segment's expansion.
Regional Insights for Non-Invasive Prenatal Testing (NIPT) Market:
Although the United States lacks national consensus policies on NIPT adoption; yet, it is extensively implemented across the country, resulting in North America's dominance. Furthermore, the recent inclusion of NIPT in major insurance companies' coverage plans is expected to boost the market growth in the United States.
Similarly, the Chancery Division, High Court of Justice, Patents Court of the United Kingdom has ruled that Ariosa's Harmony cell-free, DNA-based NIPT infringes on an Illumina European patent, ensuring the validity of patent claims. Such initiatives are fueling the region's revenue growth.
Key Companies:
Companies developing NIPT solutions operate in a highly competitive commercial environment worldwide. Major players are increasing their test repertoire to differentiate themselves and solidify their market position. Companies also focus on pitching new products and innovating to maintain and expand their market share.
Furthermore, corporations are producing items that meet worldwide needs while also increasing the use of existing products. Eurofins Scientific, F. Hoffman-La Roche, Illumina, Natera, Inc., PerkinElmer Inc., Quest Diagnostics, Thermo Fisher Scientific, and Agilent Technologies are significant competitors in the global non-invasive prenatal testing market.
The publisher's latest report Non-Invasive Prenatal Testing (NIPT) Market, Global Forecast By Method (Ultrasound Detection, Biochemical Screening Tests, Cell-free DNA in Maternal Plasma Tests, Others), Technology (ELISA Kits (Enzyme-Linked Immunosorbent Assay Kits), Next Generation Sequencing Systems, Microarray Analysis), Risk Type ( High & Average Risk, Low Risk), End User (Specialty Clinics, Hospitals, Diagnostic Centers), Region (North America, Europe, Asia, Rest of the World (RoW)), Companies (Eurofins Scientific, F. Hoffman-La Roche, Illumina, Natera, Inc., PerkinElmer Inc., Quest Diagnostics, Thermo Fisher Scientific, and Agilent Technologies) provides a detailed analysis of Non-Invasive Prenatal Testing (NIPT) Industry.
Method - Market has been covered from 4 viewpoints:
1. Ultrasound Detection
2. Biochemical Screening Tests
3. Cell-free DNA in Maternal Plasma Tests
4. Others
Technology - Market has been covered from 3 viewpoints:
1. ELISA Kits (Enzyme-Linked Immunosorbent Assay Kits)
2. Next Generation Sequencing Systems
3. Microarray Analysis
Risk Type - Market has been covered from 2 viewpoints:
1. High & Average Risk
2. Low Risk
End User - Market has been covered from 3 viewpoints:
1. Specialty Clinics
2. Hospitals
3. Diagnostic Centers
Region - Market has been covered from 4 viewpoints:
1. North America
2. Europe
3. Asia
4. Rest of the World
Company Insights:
- Overview
- Recent Development & Strategies
- Financial Insights
CompaniesCovered:
1. Eurofins Scientific
2. F. Hoffman-La Roche
3. Illumina
4. Natera, Inc.
5. PerkinElmer Inc.
6. Quest Diagnostics
7. Thermo Fisher Scientific
8. Agilent Technologies
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Report Attribute | Details |
---|---|
No. of Pages | 135 |
Published | March 2022 |
Forecast Period | 2021 - 2027 |
Estimated Market Value ( USD | $ 2.85 Billion |
Forecasted Market Value ( USD | $ 6.65 Billion |
Compound Annual Growth Rate | 15.2% |
Regions Covered | Global |
No. of Companies Mentioned | 8 |
Table of Contents
Companies Mentioned
- Eurofins Scientific
- F. Hoffman-La Roche
- Illumina
- Natera, Inc.
- PerkinElmer Inc.
- Quest Diagnostics
- Thermo Fisher Scientific
- Agilent Technologies
Methodology
In this report, for analyzing the future trends for the studied market during the forecast period, the publisher has incorporated rigorous statistical and econometric methods, further scrutinized by secondary, primary sources and by in-house experts, supported through their extensive data intelligence repository. The market is studied holistically from both demand and supply-side perspectives. This is carried out to analyze both end-user and producer behavior patterns, in the review period, which affects price, demand and consumption trends. As the study demands to analyze the long-term nature of the market, the identification of factors influencing the market is based on the fundamentality of the study market.
Through secondary and primary researches, which largely include interviews with industry participants, reliable statistics, and regional intelligence, are identified and are transformed to quantitative data through data extraction, and further applied for inferential purposes. The publisher's in-house industry experts play an instrumental role in designing analytic tools and models, tailored to the requirements of a particular industry segment. These analytical tools and models sanitize the data & statistics and enhance the accuracy of their recommendations and advice.
Primary Research
The primary purpose of this phase is to extract qualitative information regarding the market from the key industry leaders. The primary research efforts include reaching out to participants through mail, tele-conversations, referrals, professional networks, and face-to-face interactions. The publisher also established professional corporate relations with various companies that allow us greater flexibility for reaching out to industry participants and commentators for interviews and discussions, fulfilling the following functions:
- Validates and improves the data quality and strengthens research proceeds
- Further develop the analyst team’s market understanding and expertise
- Supplies authentic information about market size, share, growth, and forecast
The researcher's primary research interview and discussion panels are typically composed of the most experienced industry members. These participants include, however, are not limited to:
- Chief executives and VPs of leading corporations specific to the industry
- Product and sales managers or country heads; channel partners and top level distributors; banking, investment, and valuation experts
- Key opinion leaders (KOLs)
Secondary Research
The publisher refers to a broad array of industry sources for their secondary research, which typically includes, however, is not limited to:
- Company SEC filings, annual reports, company websites, broker & financial reports, and investor presentations for competitive scenario and shape of the industry
- Patent and regulatory databases for understanding of technical & legal developments
- Scientific and technical writings for product information and related preemptions
- Regional government and statistical databases for macro analysis
- Authentic new articles, webcasts, and other related releases for market evaluation
- Internal and external proprietary databases, key market indicators, and relevant press releases for market estimates and forecasts
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