The global Non Invasive Prenatal Testing market size is expected to be worth around US$ xx billion by 2030, according to a new report by Vision Research Reports.
The global Non Invasive Prenatal Testing market size was valued at US$ 12.83 billion in 2020 and is anticipated to grow at a CAGR of 20.9% during forecast period 2021 to 2030.
The increasing incidence of chromosomal abnormalities coupled with growing product usage in new applications is driving the organic revenue growth in the market. Furthermore, advancements in the existing tests in terms of advanced functions, improved chemistry, and analysis are anticipated to spur market growth. Improving reimbursement policies for average and low-risk pregnancies is also one of the key driving factors of the market. In December 2020, Natera announced expanded coverage from the largest U.S. Health Plan, Aetna, for its non-invasive prenatal testing (NIPT) to all pregnancies.
This coverage was the result of the guidelines on aneuploidy screening options published by the American College of Obstetricians and Gynecologists (ACOG) in partnership with the Society for Maternal-Fetal Medicine (SMFM). Expansion of the technology for the detection of monogenic diseases further propels the revenue in the market. In April 2019, Progenity, Inc. launched Resura prenatal test for monogenic disease using sequencing-based non-invasive cell-free DNA technology to boost its portfolio compared to other competitive tests in the market.
Sequenom, Verinata Health, Natera, and Ariosa Diagnostics have acquired a major revenue share in the market, as these are early market entrants. Several commercial and academic laboratories, such as NIPD Genetics in Cyprus; BGI Health; Berry Genomics; the Chinese University of Hong Kong; Radboud University Nijmegen in the Netherlands; and LifeCodexx in Germany, are engaged in expanding their business in the cffDNA-based NIPT market for fetal aneuploidies and other genetic conditions.
This, in turn, has significantly accelerated the revenue generation in the non-invasive prenatal testing market over the past few years. The market witnessed a short-term revenue slowdown in 2020 due to the COVID-19 crisis, which led to a shift in business focus and delay in product launches. Initiatives pertaining to the management of the supply chain and access to testing services for patients are playing a critical role in minimizing the impact of the current global emergency.
The market for non-invasive prenatal testing for high- and average-risk pregnancies held the largest share of over 90% in 2020 due to the high adoption of these tests in high-risk cases in patients aged 35 years and above. The presence of favorable payer reimbursement in this segment coupled with rising awareness about the prevention of chromosomal anomalies, such as Down syndrome, has also contributed to the large share of this segment.
On the other hand, the low-risk pregnancy testing market is anticipated to witness the fastest CAGR over the forecast period. Support from the government, such as budget assignment for average-risk pregnancies, is expected to be a favorable factor for the market growth. For instance, according to the NCBI in 2019, testing in average-risk pregnancies allowed detection of a higher number of affected cases, resulting in an additional budget of USD 35 million for this group in Ontario.
The 13 to 24 weeks gestation period segment accounted for the highest revenue share of over 45% in 2020. This can be attributed to the fact that maximum non-invasive prenatal diagnosis is carried out in the second trimester of the pregnancy, and these tests also cover major complementary tests, such as ultrasound and serum screening for alpha-fetoprotein.
Several companies focus on the analysis of cffDNA in a sample of maternal blood collected in the first trimester to develop a more accurate and reliable NIPT. As a significantly fewer number of tests is carried out in a period of 25-36 weeks, the segment did not account for much revenue share. However, as fetal DNA can be detected from the 4th week of gestation, it can only be considered reliable post 7 weeks.
Moreover, fetal DNA concentration goes on increasing in the maternal blood during the gestation period, reaching 80 fetal genomes per mil blood in the third trimester from just 16 in the first trimester, which makes tests conducted in this trimester also highly reliable. However other non-invasive tests are prominent in this period, such as ultrasound and nonstress tests, for monitoring normal growth & response of the fetus.
The cell-free DNA-based NIPT market is estimated to generate the highest revenue share of 43.6% in 2020. Cell-free DNA is increasingly being employed in predicting the risk of genetic conditions in prenatal care through different genetic analyses. Several research studies are being carried out to further advance the use of tests offered through this segment.
For instance, a research study by Togneri et al. published in December 2019 implemented and validated cell-free DNA-based NIPT in the National Health Service (NHS) regional genetics laboratory. The researchers concluded that cfDNA-based NIPT can be conducted as a private test in patients with low risk of common trisomy or with other indications.
Ultrasound detection is deployed as complementary to the Cell-free DNA-based NIPT test, resulting in the lower share of this segment in the current market. However, the test provides a basis for further testing of the fetus for the identification of abnormalities. The recent advancements in technology and 3D-4D imaging have improved real-time monitoring, safety, and efficiency of the test, which is further expected to drive the growth of the segment.
NGS technology led the market in 2020 and accounted for the largest share of over 57%. This is because of the wide usage of NGS technology, including targeted genome sequencing, whole-genome sequencing, and whole-exome sequencing, for prenatal cfDNA testing. Whole-genome sequencing offers proven advantages over other technologies and has a comparatively lower failure rate.
The NGS technology is dominant in all aspects including efficiency, availability, penetration, and technology. This has resulted in the wide application of in this space. For instance, Illumina offers whole-genome sequencing-based methods for NIPT. Ariosa Diagnostics, Inc.; Verinata Health, Inc.; Natera; Sequenom, Inc.; Berry Genomics Co.; BGI; GENNET; and LifeCodexx AG are other key companies that offer NGS-based NIPT testing for common chromosomal conditions, including trisomy 13 (Patau syndrome), 18 (Edwards’ syndrome), and trisomy 21 (Down syndrome).
However, several end users experience difficulty in result interpretation while using NGS technology. This, in turn, has created opportunities for array-based tests. Also, better efficiency of Chromosomal Microarray Analysis (CMA) than conventional karyotyping boosts revenue in this segment.
Consumables & reagents accounted for the largest revenue share of over 76% in 2020 owing to the high adoption of NGS-based prenatal test that requires various reagents and assays to run sequencing process. Also, the presence of a substantial number of suppliers that offer solutions to isolate cell-free DNA is driving the segment growth.
On the other hand, the instruments segment is expected to register the fastest CAGR from 2021 to 2028 owing to continuous efforts undertaken by instrument manufacturers to develop advanced platforms. PerkinElmer, Inc. offers Vanadis NIPT System—an automated instrument to overcome the limitations associated with NIPT test cost, complexity, and capacity of other NIPT technologies for screening of aneuploidy.
The system is the only NIPT screening platform that enables analysis of the targeted cfDNA without PCR or next-generation sequencing. This is done by direct capture and labeling of targeted DNA fragments. The Ariosa cfDNA System offered by Roche and VeriSeq NIPT Microlab STAR system offered by Illumina are some of the key instruments available commercially for NIPT and are driving the segment revenue through their improved efficiency.
Diagnostic laboratories dominated the market with a revenue share of 59% in 2020. The key developers, such as Illumina, are outsourcing their sample processing to Illumina CLIA labs when in-house facilities are not sufficient. Also, the laboratories that are engaged in conducting NIPT tests across the U.S. are operating in compliance with quality-assurance regulations to safeguard the test quality and reproducibility.
Well-drafted laboratory standards for NIPT in developed regions coupled with a high volume of NIPT tests conducted in diagnostic laboratories have also contributed to the largest revenue share of this segment. In addition, some facilities also outsource testing services to diagnostic laboratories, thereby driving the segment growth.
North America captured the maximum revenue share of over 45.9% in 2020 followed by Europe. The U.S. lacks national consensus policies on the implementation of NIPT; however, it is being widely adopted across the country, resulting in the dominance of North America. Furthermore, the recent addition of NIPT in coverage plans of major insurance companies is anticipated to boost the market growth in the U.S. In June 2019, Illumina won an infringement suit against Roche’s Ariosa Diagnostics (Roche) pertaining to NIPT.
A judgment was issued by the U.K. High Court of Justice, Chancery Division, Patents Court stating that Harmony cell-free, DNA-based NIPT developed by Ariosa infringes the European patent issued by Illumina, assuring the validity of patent claims. Such activities are propelling revenue growth in the region. Asia Pacific is anticipated to be the fastest-growing regional market during the forecast period. The presence of companies, such as BGI in China, which is a prominent entity in the NIPT market, is expected to boost the market growth.
Genesis Genetics (CooperSurgical, Inc.)
Illumina, Inc. (Verinata Health, Inc.)
Eurofins LifeCodexx GmbH
MedGenome Labs Ltd.
F. Hoffmann-La Roche Ltd. (Ariosa Diagnostics)
Myriad Women’s Health, Inc. (Myriad Genetics Inc/Counsyl, Inc.)
Laboratory Corp. of America Holdings
Quest Diagnostics, Inc.
Gestation Period Outlook
Risk Type Outlook
High & Average Risk
Biochemical Screening Tests
Cell-Free DNA in Maternal Plasma Tests
Consumables & Reagents
Hospitals & Clinics
The Non Invasive Prenatal Testing market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.
The report provides size (in terms of volume and value) of Non Invasive Prenatal Testing market for the base year 2020 and the forecast between 2021 and 2030. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.
This report focuses on the global Non Invasive Prenatal Testing market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Non Invasive Prenatal Testing market development in United States, Europe and China.
It is pertinent to consider that in a volatile global economy, we haven’t just conducted Non Invasive Prenatal Testing market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.
In terms of production side, this report researches the Non Invasive Prenatal Testing capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.
In terms of consumption side, this report focuses on the consumption of Non Invasive Prenatal Testing by regions (countries) and application.
Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Non Invasive Prenatal Testing market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2030. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.
With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Non Invasive Prenatal Testing market companies.
Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Non Invasive Prenatal Testing market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.
The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.
Overall, this is an in-depth research report specifically for the Non Invasive Prenatal Testing industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.
The Non Invasive Prenatal Testing market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Non Invasive Prenatal Testing market.
Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Non Invasive Prenatal Testing market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.
Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Non Invasive Prenatal Testing market. These factors have benefited the growth of the global market for Non Invasive Prenatal Testing. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.
New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Non Invasive Prenatal Testing. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).
In this study, the years considered to estimate the market size of Non Invasive Prenatal Testing are as follows:
Reasons to Purchase this Report:
- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.
This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.
Market Size Estimation
Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).
The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.
Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.
All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.
Market Breakdown and Data Triangulation
After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.
Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.
In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.
The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.
The study objectives of this report are:
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