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Non Invasive Prenatal Testing (NIPT) Market Size, Share & COVID-19 Impact Analysis, By Product (Instruments, and Consumables & Reagents), Technology (Next Generation Sequencing, Microarray, PCR, and Rolling Circular Amplification), End-User (Hospitals, and Clinical Laboratories) and Regional Forecast, 2021-2028

Region : Global | Format: PDF | Report ID: FBI100998

 

KEY MARKET INSIGHTS

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The global Non Invasive Prenatal testing market size was USD 3.48 billion in 2020. The global impact of COVID-19 has been unprecedented and staggering, with NIPT witnessing no impact on demand across all regions amid the pandemic. Based on our analysis, the global market will exhibit an increased growth of 17.9% in 2020 as compared to the average year-on-year growth during 2017-2019. The market is projected to grow from USD 4.82 billion in 2021 to USD 13.16 billion in 2028 at a CAGR of 18.1% in the 2021-2028 period. The rise in CAGR is attributable to this market’s demand and growth, returning to pre-pandemic levels once the pandemic is over.


Genes and chromosomes can sometimes undergo mutation, and this can increase the risk of genetic abnormalities in an unborn child. According to an article published by the Children's Hospital of Philadelphia, trisomy 21 is one of the most common chromosomal abnormalities affecting around 5,000 babies each year in the United States. The increasing incidence of chromosomal anomalies has led to a surge in demand for an effective screening tool for prenatal tests.


Non Invasive Prenatal tests involve analysis of the cell-free fetal DNA (cfDNA) present in a sample of maternal blood in order to detect the likelihood of fetal aneuploidy. The advantages offered by these tests over highly expensive and invasive procedures such as amniocentesis and Chorionic Villus Sampling (CVS) have improved the adoption of NIPT testing. These advantages are likely to increase the adoption of such procedures, in turn contributing to the accelerated growth of the market.


Minimal Impact Backed by Close Contact with FDA during COVID-19 Pandemic


The COVID-19 outbreak has had a limited impact on the Non-Invasive Prenatal testing (NIPT) market. Several manufacturing companies are in close contact with the U.S. FDA in order to keep them informed about any disruption in the supply chain.


Moreover, several research studies are being conducted in order to determine the impact of COVID-19 on the Non Invasive Prenatal testing market. According to a report published by SeraCare, in-vitro diagnostics manufacturers and clinical testing laboratories are working in collaboration with research organizations to determine the interference of SARS-CoV-2 infection on the pregnancy and birth defects in newborns and the need for Non-Invasive Prenatal testing during the COVID pandemic. However, limited established results have led to uncertainty over the growth in demand for these tests during the COVID-19 pandemic.


LATEST TRENDS


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Prenatal Testing Witnesses a Shift towards Non-invasive Tests


Prenatal screening or testing has been shifting its balance towards non-invasive tests, citing the clinical and economic benefits of these tests in recent years. The advent of technologically advanced non-invasive tests by market players, combined with the established clinical effectiveness of these tests, has been instrumental in making this shift happen. Many countries have implemented policies where Non Invasive Prenatal tests are now the standard tests in prenatal screening, as opposed to invasive tests. In the Netherlands, for example, non-invasive tests have been declared the standard tests for screening pregnant women in the country. Although invasive tests still have their applications in the identification of specific disorders, non-invasive tests have demonstrated high growth in adoption globally.


DRIVING FACTORS


Increasing Prevalence of Chromosomal Abnormalities to Augment the Demand for NIPT


Recently, the maternal age at childbearing has shifted because of a wide range of social and economic factors. According to a report published by the Office for National Statistics (ONS) in England, the average age of mothers in 2017 increased to 30.5 years, from 30.4 years in 2016. This has resulted in an increase in the prevalence of Down syndrome and other genetic complications in newborns.


According to a report published by EUROCAT – Surveillance of Congenital Anomalies in Europe: epidemiology of Down syndrome in 2019, it was estimated that annually approximately 104,000 babies were born with congenital anomalies in Europe, out of which 8,320 babies were suffering from Down Syndrome. This has led to the early screening of pregnant women through prenatal tests, including non-invasive ones.


Moreover, favorable reimbursement policies and raising awareness about the advantages of non-invasive tests over invasive prenatal tests are likely to augment their adoption during the forecast period.


Constant Product Innovations Will Contribute to the Growth of the Market


Several companies are constantly focusing on the development of highly advanced screening technologies that are very sensitive and accurate in the early detection of genetic disorders in babies. Manufactures are majorly emphasizing the development of advanced Non Invasive Prenatal tests and entering into strategic partnerships and collaborations to strengthen their positions in the NIPT market. Human genome sequencing has enabled huge developments in the detection of aneuploidies among the neonatal population.


For instance, in 2018, PerkinElmer Inc. received a CE-IVD mark for its Vanadic NIPT system for commercialization and distribution throughout Europe. This innovative technology allows lab technicians to run up to 20,000 samples per year. The introduction of innovative technologies is likely to increase the adoption of these tests during the forecast period.


Additionally, many countries are adopting screening policies in order to include Non Invasive Prenatal screening for the detection of chromosomal anomalies. In 2018, in the U.K., the NHS implemented initiatives to promote Non Invasive Prenatal testing in their public health policies. This has led to the increased awareness about the benefits associated with these tests in the country.


RESTRAINING FACTORS


High Cost of Tests to Restrain the Market Growth


The high cost of these tests leading to relatively low affordability in many developing countries is expected to limit their adoption. According to an article published by Future Medicine, currently, the average cost of Non Invasive Prenatal testing in India is around USD 350 to USD 400. This has limited their uptake in emerging countries.


Additionally, the lack of awareness among the general population in emerging countries pertaining to risks of genetic abnormalities would hamper growth. At the same time, the lower per capita healthcare spending and lack of adequate reimbursement policies for tests are some of the additional factors that may limit the growth of the market.


SEGMENTATION


By Product Analysis


Consumables & Reagents Segment to Hold Significant Market Share


Based on the product, the market is segmented into consumables & reagents, and instruments. The consumables & reagents segment holds a major share of the market. This is attributable to the introduction of new test kits by market players and the rising number of lab-based tests performed globally. Additionally, the increasing number of research and development activities for the screening of genetic disorders is one of the major factors fueling the demand for reagents and consumables.


The technological advancements in instruments and increasing collaborations among players to introduce highly sensitive and cost-effective instruments for the detection of trisomy during pregnancies are driving the adoption of these services worldwide. For instance, in 2019, Natera and QIAGEN entered into a strategic partnership with an aim to develop breakthrough cell-free DNA assays for use on QIAGEN’s GeneReader NGS System.


By Technology Analysis


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Next-Generation Sequencing Segment to Hold a Dominant Market Share


Based on the technology, the market is segmented into next-generation sequencing, microarray, PCR, and rolling circular amplification. The next-generation sequencing segment dominated the market owing to the growing use of NGS in a variety of clinical applications, majorly in the sequencing of the whole genome to identify the risk of fetal chromosomal anomalies. Moreover, superior clinical efficiency of next-generation sequencing (NGS) technology to analyze cfDNA fragments across the whole genome over other technologies such as microarray and PCR is likely to boost the adoption of instruments and tests based on this technique. 


The rolling circular amplification is a new technology developed by PerkinElmer Inc., which eliminates the use of PCR and sequencing to provide cffDNA testing. Moreover, affordable prices will allow a large number of laboratories to use this technology for conducting screening tests, further accelerating the demand in the upcoming years.


By End-User Analysis


Clinical Laboratories Segment to Hold Dominant Position in the Global Market


On the basis of the end-user, the global Non Invasive Prenatal testing market is segmented into hospitals and clinical laboratories. Clinical laboratories are the major end-users of non-invasive tests. It is expected to be the fastest-growing segment. In comparison to hospitals, clinical laboratories are equipped with highly innovative technology that provides safe and effective prenatal tests for chromosomal abnormalities, which could provide lucrative growth opportunities for this segment.


REGIONAL INSIGHTS


North America Non Invasive Prenatal Testing (NIPT) Market Size, 2020 (USD Billion)

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The Non-Invasive Prenatal testing market size in North America stood at USD 1.79 billion in 2020. This is attributable to the increasing penetration of Non-Invasive Prenatal testing and the higher incidence of Down syndrome in newborns. Moreover, the strong geographical foothold of players in the U.S. offering advanced tests has been pivotal in the growing adoption of these tests in the U.S. and Canada.


The Panorama test developed by Natera works on single-nucleotide polymorphism (SNP)-based technology to analyze DNA and is the only test that can also differentiate between maternal and fetal DNA in the chromosomes of interest. Such novel developments are likely to boost the adoption and propel the market growth in this region in the upcoming years.


The market in Europe is likely to witness significant growth in the upcoming years. This is attributable to the strong reimbursement framework for these tests and the launch of new products by players in the region. For instance, in April 2017, Illumina, Inc. announced the launch of Verse NIPT industry Solution, next-generation sequencing (NGS)-based tests in Europe.


The market in Asia Pacific is expected to exhibit comparatively higher growth. In emerging nations such as China and India, there is a growing demand for the early diagnosis of chromosomal disorders during pregnancies. This, along with domestic market players emphasizing strategies such as partnerships and collaborations with global players, is projected to lead to the introduction of new products and tests. For instance, in 2017, YOURGENE HEALTH acquired Your Gene Bioscience, a test manufacturer in Taiwan. This acquisition will help YOURGENE HEALTH to expand its market presence in Asia, further providing opportunities for joint development of the expanded Non-Invasive Prenatal testing in the region.


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Additionally, the significant growth in the Asia Pacific market can majorly be attributed to the improving healthcare infrastructure, the presence of a large patient population, and surging awareness about advanced technologies in prenatal testing.


KEY INDUSTRY PLAYERS


Strong Product Portfolio to Help Illumina, Inc., Sequenom Laboratories, LabCorp Inc., and Natera Lead the Global Market


The market is consolidated owing to the wide range of product offerings and robust distribution networks of major companies in developed and emerging nations. Currently, Illumina, Inc., Sequenom Laboratories, LabCorp Inc., and Natera are the leading players in the market. Certain factors such as robust research & development activities and increased focus on the introduction of innovative products are expected to help maintain their positions in the market.


Other major players such as YOURGENE HEALTH, Eurofins, LifeCodexx GmbH, F. Hoffmann-La Roche, and Perkin Elmer, Inc. are planning to strengthen their foothold in the market by adopting newer strategies such as investments in the development of novel technologies for the early screening of chromosomal abnormalities and collaborations with research organizations and other key players.


LIST OF KEY COMPANIES PROFILED:



  • Illumina, Inc(U.S.)

  • YOURGENE HEALTH (U.K.)

  • Natera   (U.S.)

  • F. Hoffmann-La Roche Ltd (Switzerland)

  • PerkinElmer Inc. (U.S.)

  • Laboratory Corporation of America (U.S.)

  • Eurofins LifeCodexx GmbH (Germany)

  • Others


KEY INDUSTRY DEVELOPMENTS:



  • March 2020 –YOURGENE HEALTH acquired AGX-DPNI, a privately held company based in Versailles. It sells cytogenetic and pharmaceutical laboratory products for the distribution of NIPT in France.

  • January 2019: Illumina, Inc. announced the launch of VeriSeq NIPT Solution v2, which provides accurate data regarding the fetal chromosomal status in the period of 10 weeks of gestation.


REPORT COVERAGE


An Infographic Representation of Non-Invasive Prenatal Testing Market

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The Non Invasive Prenatal Testing (NIPT) market research report provides a detailed analysis of the industry and focuses on crucial aspects such as leading companies, applications, disposable types, and distribution channels. Also, it offers insights into market trends and highlights vital industry developments. In addition to the factors mentioned above, the report encompasses various factors that have contributed to the growth of the market over recent years.


Report Scope & Segmentation


















































  ATTRIBUTE



  DETAILS



Study Period



   2017-2028



Base Year



  2020



Forecast Period



  2021-2028



Historical Period



  2017-2019



Unit



  Value (USD Billion)



Segmentation



  Product; Technology; End User and Geography



By Product


 




  • Consumables & Reagents

  • Instruments



By Technology


 




  • NGS

  • Microarray

  • PCR

  • Rolling Circular Amplification



By End-User


 




  • Hospitals

  • Clinical Laboratories



By Geography


 




  • North America

    • By Product

    • By Technology

    • By End-User

    • By Country

      • USA (By Product)

      • Canada (By Product)





  • Europe

    • By Product

    • By Technology

    • By End-User

    • By Country

      • UK (By Product)

      • Germany (By Product)

      • France (By Product)

      • Italy (By Product)

      • Spain (By Product)

      • Rest of Europe (By Product)





  • Asia Pacific

    • By Product

    • By Technology

    • By End-User

    • By Country

      • Japan (By Product)

      • China (By Product)

      • India (By Product)

      • Australia (By Product)

      • South Korea (By Product)

      • Rest of Asia Pacific (By Product)





  • Latin America

    • By Product

    • By Technology

    • By End-User

    • By Country

      • Brazil (By Product)

      • Mexico (By Product)

      • Rest of Latin America (By Product)





  • Middle East & Africa

    • By Product

    • By Technology

    • By End-User

    • By Country

      • GCC (By Product)

      • South Africa (By Product)

      • Rest of Middle East & Africa (By Product)







Frequently Asked Questions

Fortune Business Insights says that the global market size was USD 3.48 billion in 2020 and is projected to reach USD 13.16 billion by 2028.

In 2020, the market value stood at USD 3.48 billion.

Registering a CAGR of 18.1%, the market will exhibit steady growth in the forecast period (2021-2028).

The next-generation category is expected to be the leading segment under the technology criterion in this market during the forecast period.

The rising demand for safe and effective screening tests and the increasing prevalence of chromosomal birth defects are the key factors driving the market growth.

Illumina, Inc., YOURGENE HEALTH, Natera, and Eurofins LifeCodexx GmbH are a few of the leading players in the global market.

North America dominated the global market in terms of share in 2020.

Rising awareness and the introduction of highly advanced technology are set to drive the adoption of NIPT testing.

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Non-Invasive Prenatal Testing Market  Size, Share and Global Industry Trend Forecast till 2026
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