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

According to Nova one advisor, the global Non Invasive Prenatal Testing market size is expected to hit around USD 8.71 billion by 2030 from valued at USD 4.38 billion in 2022 and growing at a CAGR of 10.6% from 2022 to 2030.

https://www.novaoneadvisor.com/reportimg/Non-Invasive-Prenatal-Testing-Market-2022-to-2030.jpg

Key Takeaways:

  • By gestation period, 13-24 weeks dominated the market in 2021 owing to the maximum number of non-invasive prenatal procedures carried out in the second trimester of the pregnancy
  • The low-risk pregnancy risk segment is expected to witness significant growth over the forecast period. Support from the government such as budget assignment for average-risk pregnancies contributed to the segment growth
  • Based on product, the cell-free DNA in maternal plasma tests segment accounted for the largest revenue share in 2021. Cell-free DNA is increasingly being utilized in predicting the risk of genetic disorders in prenatal care via various genetic analyses
  • Asia Pacific is expected to exhibit the highest CAGR over the forecast period. Rising maternal age and improving healthcare infrastructure are likely to strengthen the market growth
  • North America dominated the market in 2021 due to high R&D investments, the presence of advanced healthcare facilities, and the development of whole genome sequencing

Increasing incidence of chromosomal abnormalities is expected to accelerate market growth. Of all the countries, there is a substantial opportunity in China for non invasive prenatal screening, with nearly 14.65 million annual births and increasing number of high-risk pregnancies.

In addition, 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. Families can benefit from accurate and early screening using NIPT to know about their baby's genetic issue. Thus, this high incidence rate is anticipated to boost the demand for prenatal tests.

With lockdowns due to COVID-19, NIPT gained attention because it delivers high accuracy screening with minimum risk of infection compared to invasive procedures like chorionic villus sampling and amniocentesis, both of which may necessitate hospitalization and put patients and medical professionals at risk of contracting COVID-19 infection. Moreover, there was increased demand for prescription of NIPTs; however, it was limited to a smaller number of eligible people due to the lack of infrastructure and adoption of telemedicine facilities in most countries.

The reimbursement scenario pertaining to non invasive prenatal testing is highly variable. However, the support from the government and favorable insurance policies boost market growth. For instance, in the Netherlands, prenatal testing expenses are fully reimbursed in the second trimester, leading to increased adoption of these tests. Increase in government initiatives to encourage the bio- and pharmaceutical industry in emerging economies such as India and China is anticipated to boost the demand for noninvasive prenatal testing solutions and services.

Key players in the market are focusing on new product development to strengthen their product portfolios and offer innovative products to customers. In March 2020, Agilent Technologies launched three new microarrays to support prenatal and postnatal research by cytogenetic laboratories. The probes on the cyto microarrays offer high-resolution detection of copy number variation and copy-neutral loss of heterozygosity related to neuropsychiatric disorders, developmental delay, intellectual disability, and congenital anomalies in constitutional DNA samples.

Report Scope of the Non Invasive Prenatal Testing Market

Report Coverage

Details

Market Size

USD 8.71 Billion by 2030

Growth Rate

CAGR of 10.6% from 2022 to 2030

Largest Market

North America

Fastest Growing Market

Asia Pacific

Base Year

2021

Forecast Period

2022 to 2030

Segments Covered

Gestation period, pregnancy risk, method, technology, product, application, end-use and Region,

Companies Mentioned

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. (Counsyl; Inc.); QIAGEN; Laboratory Corp. of America Holdings; Progenity, Inc.; Quest Diagnostics, Inc.

 

Gestation Period Insights

The 13-24 weeks segment held the largest share of over 35.0% 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 75.0% 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 40.0% 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 45.0% 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 70.0% 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 60.0% 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 25.0% 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 40.0% 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.

Some of the prominent players in the Non Invasive Prenatal Testing Market include:

  • 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. (Counsyl, Inc.)
  • Progenity, Inc.
  • Qiagen
  • Laboratory Corp. of America Holdings
  • Quest Diagnostics, Inc.

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2030. For this study, Nova one advisor, Inc. has segmented the global Non Invasive Prenatal Testing market

  • Gestation Period
    • 0-12 Weeks
    • 13-24 Weeks
    • 25-36 Weeks
  • Pregnancy Risk
    • High & Average Risk
    • Low Risk
  • Method
    • Ultrasound Detection
    • Biochemical Screening Tests
    • Cell-free DNA in Maternal Plasma Tests
  • Technology
    • NGS
    • Array Technology
    • PCR
    • Others
  • Product
    • Consumables & Reagents
    • Instruments
  • Application
    • Trisomy
    • Microdeletion Syndrome
    • Other Applications
  • End-use
    • Hospitals & Clinics
    • Diagnostic Laboratories

By Geography

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East & Africa (MEA)

Key Benefits for Stakeholders

  • This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the global Non Invasive Prenatal Testing industry analysis from 2022 to 2030 to identify the prevailing Non Invasive Prenatal Testing industry opportunity.
  • The market research is offered along with information related to key drivers, restraints, and opportunities.
  • Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
  • In-depth analysis of the global Non Invasive Prenatal Testing industry segmentation assists to determine the prevailing market opportunities.
  • Major countries in each region are mapped according to their revenue contribution to the global market.
  • Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
  • The report includes the analysis of the regional as well as global Non Invasive Prenatal Testing industry trends, key players, market segments, application areas, and market growth strategies.

Report Detail

  • Report Code:7533
  • No. of Pages:150+
  • Format:PDF/PPT/Excel

Proceed To Buy

USD 3500
USD 7000