Non Invasive Prenatal Testing Market (By Gestation Period, By Pregnancy Risk, By Method, By Technology, By Product, By Application, By End-use) - Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2022-2030

Published Date : Aug 2022 | No. of Pages : 250 Pages | Category : Healthcare

The global Non Invasive Prenatal Testing market size is expected to be worth around US$ 8.5 billion by 2030, according to a new report by Vision Research Reports.

The global Non Invasive Prenatal Testing market size was valued at US$ 4.1 billion in 2021 and is anticipated to grow at a CAGR of 20.9% during forecast period 2022 to 2030.

Growth Factors

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.

Gestation Period Insights

The 13-24 weeks segment held the largest share of over 35.5% in 2021 owing to the maximum number of tests being carried out during this phase of pregnancy. Complementary application of ultrasound with alpha-fetoprotein screening and non-invasive prenatal testing after 12 weeks of pregnancy is expected to fuel the growth of this segment. Moreover, tests carried out in quad screening, such as Unconjugated Estriol (EU), Alpha-Fetoprotein (AFP), inhibin A, and Human Chorionic Gonadotropin (hCG) is contributing to the revenue generation for this segment.

The 0 to 12 weeks gestation period segment accounted for a considerable revenue share in 2021 owing to the availability of a large number of products in the market. The first-trimester aneuploidy screening and maternal-fetal DNA screening carried out during this period result in significant revenue generation in this segment. In addition, first-trimester risk screening is advantageous over other trimesters as the combined data from biochemistry and sonography can be used to detect genetic alterations with an accuracy level of 91% to 96%.

Pregnancy Risk Insights

The high and average risk segment accounted for the largest revenue share of over 75.8% in 2021. This can be attributed to the growing adoption of these tests in high-risk cases and pregnancies in women 35 years and above. Moreover, with an increase in the number of pregnancies over the age of 35 years, the risk of abnormalities also significantly rises, which is anticipated to impel the demand for prenatal tests in the forecast period.

The low-risk segment is expected to register the fastest CAGR from 2022 to 2030. Support from the government, such as budget assignment for average-risk pregnancies, is expected to be a favorable factor for 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.

Method Insights

The cell-free DNA in maternal plasma tests segment accounted for the largest revenue share of over 40.7% in 2021. It is increasingly being utilized in predicting the risk of genetic disorders in prenatal care via various genetic analyses. Technological advancements now have expanded the range of testing to whole-genome sequencing, and they can detect many additional chromosomal anomalies, such as microdeletions and sex chromosomal abnormalities.

Ultrasound detection is deployed as complementary to the Cell-free DNA-based NIPT test, resulting in a lower share of this segment. However, recent advancements in technology and 3D-4D imaging have improved real-time monitoring, safety, and efficiency of the test, which is further expected to propel the segment growth. For instance, in May 2022, General Electric Company (GE Healthcare) invested around USD 50 million in Pulsenmore, an Israeli startup. This allows expectant parents to chart their pregnancies at home and perform self-scans.

Application Insights

Trisomy led the market with a share of over 45.6% in 2021 owing to the rising incidence of chromosomal abnormalities. India has a heavy burden of genetic diseases. Various studies suggested that chromosomal abnormalities are found with a frequency of 1 in 166 newborns in the country, while trisomy 21 (down syndrome) has a high incidence rate of 1 in 800 births, resulting in the birth of 32,000 newborns with down syndrome every year.

Currently, technological advancements have expanded the range of testing to whole genome sequencing, and they can detect many additional chromosomal anomalies, such as microdeletions and sex chromosomal abnormalities. For instance, Panorama prenatal test by Natera Inc. helps detect sex chromosomal abnormalities, microdeletions, and triploidy. In addition, a 2021 NCBI article on a study based on 13,607 cases concluded that NGS NTP offers high sensitivities and specificities of more than 98.89%, and the failure rate is less than 0.72% in aneuploidy conditions such as trisomy 21, trisomy 18, trisomy 21 + 13, trisomy 13, and monosomy X.

Product Insights

The consumables and reagents segment dominated the market with a share of over 70.2% in 2021 owing to the presence of major players offering a wide range of consumables and reagents for NIPT. For instance, the CE-marked Harmony IVD Kit offered by Roche is an extensively studied and validated NIPT test and has been employed to screen more than 1.8 million pregnancies. The Harmony test is highly efficient and offers less than a 0.1% false-positive rate for trisomies 13, 18, and 21.

The instruments segment is expected to grow at a lucrative rate over the forecast period 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 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.

End-use Insights

Diagnostic laboratories held the largest revenue share of over 60.3% in 2021 owing to the presence of a large number of diagnostic laboratories that offer NIPT across the globe. Labs such as MedGenome Labs Ltd. offer MedGenome Claria NIPT tests for the diagnosis of Trisomies 21, 18, and 13; Monosomy X; and other sex chromosomal abnormalities. Similarly, Claria NIPT Plus offered by MedGenome is used to detect Down Syndrome; Edwards’ Syndrome; Patau Syndrome; Triploidy; Monosomy X (Turner Syndrome); Klinefelter Syndrome, Triple X; Jacob’s Syndrome; 22q11.2 Deletion Syndrome; 1p36 Deletion Syndrome; Prader-Willi Syndrome; Angelman Syndrome; and Cri-du-chat Syndrome.

The presence of public and private hospitals that offer NIPT across the globe is fueling the growth of the hospitals and clinics segment. In addition, the rise in research studies in hospitals is expected to increase testing rates in hospital settings. For instance, in May 2019, a nationwide study was conducted across 10 Indian hospitals to analyze the effectiveness of NIPT.

Technology Insights

Next-generation Sequencing (NGS) accounted for the largest revenue share of over 25.5% in 2021. It has gained immense popularity in NIPT. It is commonly used for the identification of trisomy conditions, micro-deletions, and aneuploidies in chromosomes. NGS-based noninvasive prenatal tests are different from other techniques as they can be performed as early as 10 weeks of pregnancy. In addition, other noninvasive prenatal tests offer about 96% accuracy, whereas NGS-based tests are more than 99% accurate.

The adoption of Polymerase Chain Reaction (PCR) for NIPT has increased with the commercial launch of Eurofins LifeCodexx-one of the world's first quantitative real-time PCR NIPT assays to detect fetal trisomy 21 (qNIPT). This novel PCR-based quantitative NIPT assay offers enhanced speed and lower costs as compared to classical NIPT methods. Owing to its benefits, Eurofins LifeCodexx is considered an affordable and reliable prenatal testing method.

Regional Insights

North America dominated the market with over 40.4% share in 2021, followed by Europe. High R&D investments, high preterm birth rate, a well-established research framework, and the development of whole-genome sequencing in the region are among the factors anticipated to boost the growth of the North American market.

The recent addition of non-invasive prenatal testing (NIPT) in coverage plans of major insurance companies is anticipated to boost the adoption of NIPT in the U.S. Moreover, 46% of average risk and 96% of high-risk pregnancies qualify to receive reimbursement coverage in the nation. These factors are anticipated to positively impact the North American market growth.

Asia Pacific is expected to exhibit the fastest growth over the forecast period owing to the rising maternal age, which contributes to the growing incidence of chromosomal aneuploidies in babies, leading to a rise in the potential customer base. Significant developments in China and Japan, technological integration of NGS procedures, and improving healthcare infrastructure are expected to boost market growth.

Key Players

  • Genesis Genetics (CooperSurgical, Inc.)

  • Natera, Inc.

  • Centogene N.V.

  • 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.)

  • Progenity, Inc.

  • Qiagen

  • Laboratory Corp. of America Holdings

  • Quest Diagnostics, Inc.

Market Segmentation

  • Gestation Period Outlook 

    • 0-12 Weeks

    • 13-24 Weeks

    • 25-36 Weeks

  • Risk Type Outlook

    • High & Average Risk

    • Low Risk

  • Method Outlook 

    • Ultrasound Detection

    • Biochemical Screening Tests

    • Cell-Free DNA in Maternal Plasma Tests

  • Technology Outlook 

    • NGS

    • Array Technology

    • PCR

    • Other Technologies

  • Product Outlook

    • Consumables & Reagents

    • Instruments

  • End-use Outlook 

    • Hospitals & Clinics

    • Diagnostic Laboratories

  • Regional Outlook 

    • North America

      • U.S.

      • Canada

    • Europe

      • Germany

      • U.K.

      • France

      • Italy

      • Spain

    • Asia Pacific

      • Japan

      • China

      • India

      • Singapore

      • Australia

    • Latin America

      • Brazil

      • Mexico

    • MEA

      • South Africa

      • Saudi Arabia

 

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:

  • Historic Year: 2017-2020
  • Base Year: 2021
  • Forecast Year 2021 to 2030

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

Research Methodology:

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

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.

Primary Sources

 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:

  • To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2030);
  • Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
  • Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
  • To define, describe and forecast the market by type, application and region.
  • To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
  • To identify significant trends and factors driving or inhibiting the market growth.
  • To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
  • To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
  • To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
  • To strategically profile the key players and comprehensively analyze their growth strategies.

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