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

The global Non Invasive Prenatal Testing (NIPT) market size was USD 3.48 billion in 2020 and is projected to grow from USD 4.11 billion in 2021 to USD 13.16 billion in 2028, exhibiting a CAGR of 18.1% during the 2021-2028 period. Based on our analysis, the global market exhibited an increased growth of 17.9% in 2020 as compared to the average year-on-year growth during 2017-2019. The global impact of COVID-19 has been unprecedented and staggering, with NIPT witnessing no impact on demand across all regions amid the pandemic. 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, increasing 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.

The market is witnessing significant technological advancements to improve testing capabilities. Various established players and new start-ups seek funding to conduct research and clinical testing of the NIPT techniques. Government and private organizations are actively finding research institutes and start-ups to develop innovative testing procedures to detect key genetic disorders through NIPT. For instance, in June 2019, Cradle Genomics, a San-Diego-based start-up, raised over US$ 17 Mn in Series A funding that was carried out to support clinical development, CLIA lab operations, corporate infrastructure, and commercial launch of the tests.  The investors included Illumina Ventures, Sea Lane Ventures, Axon Ventures, Listwin Ventures, and Alexandria Real Estate Equities.

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 market. Several manufacturing companies are in close contact with the U.S. FDA to keep them informed about any disruption in the supply chain.

Moreover, several research studies are being conducted to determine the impact of COVID-19 on the market. According to a report published by SeraCare, in-vitro diagnostics manufacturers and clinical testing laboratories collaborate with research organizations to determine the interference of SARS-CoV-2 infection on the pregnancy and congenital disabilities 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 instead of invasive tests. For example, in the Netherlands, non-invasive tests have been declared the standard tests for screening pregnant women. Although invasive tests still have their applications in identifying specific disorders, non-invasive tests have demonstrated high growth in adoption globally.

DRIVING FACTORS

Growing Prevalence of Chromosomal Abnormalities to Augment 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 increased 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 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 Market Growth

Several companies are constantly focusing on developing 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 market. Human genome sequencing has enabled huge developments in the detection of aneuploidies among the neonatal population. For instance, in 2019, Progenity, Inc., a biotechnology company, announced the launch of the Resura Prenatal Test for Monogenic Disease, the first customizable, Non Invasive prenatal test for single-gene disorders.

Additionally, many countries are adopting screening policies to include non-invasive prenatal screening to detect chromosomal anomalies. In 2018, 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 likely to limit their adoption. According to an article published by Future Medicine, the average cost of NIPT 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 global Non Invasive prenatal testing market growth.

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 screening genetic disorders is one of the major factors driving and 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 announced a strategic partnership 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 various 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 cfDNA 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 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, providing lucrative growth opportunities for this segment.

REGIONAL INSIGHTS

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The 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 differentiate between maternal and fetal DNA in the chromosomes of interest. Such novel developments are likely to boost the adoption and propel market growth in this region in the upcoming years.

Latin America and Middle East market growth is attributable to factors such as the rising prevalence of genetic disorders in the population and increased risk of chromosomal abnormalities with increasing maternal age and rising preference of customers for non-invasive techniques compared to invasive ones.

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 September 2020, Yourgene announced the launch of IONA Nx NIPT workflow, the Company’s new innovative non-invasive prenatal test. It offers clinical labs a high-performing, flexible, and innovative NIPT service in-house.

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 introduce new products and tests. For instance, in June 2021, Illumina and Next-generation Genomic Thailand announced to launch a next-generation sequencing (NGS)-based VeriSeq NIPT Solution v2 in the country and will allow NGG Thailand to present the Qualifi Prenatal Test and to become the first lab in Southeast Asia to detect anomalies missed by targeted assays.

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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

This 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 introducing 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:

• July 2021 - Pacific Biosciences signed a definitive merger agreement to acquire Omniome, a San Diego-based company. This collaboration will help expand market opportunities for sequencing in innovative ways that will add value to customers. Omniome will help through its novel approach to get a precise short-read sequencing platform to enter large, fast-growing clinical application areas in oncology and Non Invasive prenatal testing.


• 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.

REPORT COVERAGE

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The Non Invasive prenatal testing market 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