Non invasive Prenatal Testing - Market Insights, Competitive Landscape, and Market Forecast - 2030

The market is expected to grow at a steady CAGR forecast till 2028 owing to the increasing prevalence of chromosomal disorders and the increasing demand for early and non-invasive fetal diagnosis across the globe.

The global non-invasive prenatal testing market was valued at USD 3,916 million in 2022, growing at a CAGR of 9.22% during the forecast period from 2023 to 2028 to reach USD 6,645 million by 2028. The demand for non-invasive prenatal testing is primarily being boosted by the surging late pregnancy numbers and rising prevalence of chromosomal disorders such as down syndrome, Edwards syndrome, fragile X syndrome, Klinefelter syndrome, triple-X syndrome, turner syndrome, and others. Further, improving reimbursement plans for noninvasive prenatal tests, an increasing number of doctors choosing advanced genetic testing for high-risk pregnancies, a desire to delay pregnancy, more pregnancy-related problems in the third- or second trimester, and innovation in devices among others are thereby contributing to the overall growth of the non-invasive prenatal testing market during the forecast period from 2023-2028.

Non-Invasive Prenatal Testing Market Dynamics:

The United Nations, an international organization, in the latest data provided that the estimated incidence of Down syndrome is between 1 in 1,000 to 1 in 1,100 live births worldwide. Each year, approximately 3,000 to 5,000 children are born with this chromosome disorder, across the globe.

The Down's Syndrome Association stated that around one in every 1000 babies born in the United Kingdom has Down's syndrome. In 2021, there were approximately 47,000 people in the UK with the condition.

Further, the World Health Organization (WHO) 2023, specified that approximately 240,000 newborns die worldwide within 28 days of birth every year due to congenital disorders. Congenital disorders cause a further 170,000 deaths of children between the ages of 1 month and 5 years. Also, nine of ten children born with a serious congenital disorder are in low- and middle-income countries.

Ultrasound, a type of non-invasive prenatal testing can be used to screen for down syndrome and major structural abnormalities during the first trimester, and for severe fetal anomalies during the second trimester. Maternal blood, another type of NIPT can be used for screening the placental markers to aid in the prediction of risk of chromosomal abnormalities or neural tube defects, or for free fetal DNA to screen for many chromosomal abnormalities. Diagnostic tests such as chorionic villus sampling and amniocentesis can be used to diagnose chromosomal abnormalities and infections in women at high risk.

Thus, the increasing figures of down syndrome and other chromosomal abnormalities will increase the demand for various non-invasive prenatal testing kits and instruments, thereby propelling the overall market.

Additionally, the advantages of non-invasive prenatal tests over other prenatal tests, such as the non-invasive nature of tests, better accuracy, and short duration of the procedure, are anticipated to hasten the growth of the NIPT market during the forecast period. Furthermore, awareness programs by public organizations are another factor propelling the market growth.

With existing key players operating in the NIPT market, the market is highly saturated. So the companies are forming partnerships and collaborations to maintain a stable market position. For instance, in May 2021, Illumina, a global leader in DNA sequencing and array-based technologies, and Next Generation Genomic, the Association of Southeast Asian Nations (ASEAN) leaders in laboratory services and reproductive science, did a partnership to launch VeriSeq™ NIPT solution in Thailand.

Therefore, the above-mentioned factors are contributing to the growth of the non-invasive prenatal testing market during the forecast period from 2023-2028.

However, stringent regulations and ethical concerns, a high rate of false positive results, and others may restrict the non-invasive prenatal testing market growth.

The non-invasive prenatal testing market experienced significant growth during the COVID-19 pandemic. In the initial period, the market suffered a temporary setback as lockdown restrictions were enforced as a necessary step to curb the spread of COVID-19. However, the demand for non-invasive prenatal testing kits and instruments increased during the pandemic owing to the sudden increase in the number of pregnancy cases. According to UNICEF 2020, globally, an estimated 116 million babies were born under the shadow of the COVID-19 pandemic, and almost a quarter of them which is approximately 29 million were born in South Asia. Countries in South Asia with the expected highest numbers of births in the nine months since the COVID-19 pandemic declaration were India (20 million), Pakistan (5 million), Bangladesh (2.4 million), and Afghanistan (1 million). The increasing number of pregnancy cases increased the demand for non-invasive prenatal testing, due to which various key players in the market accelerated the manufacturing of NIPT kits, reagents, and instruments. Henceforth, the afore-said factors propelled the demand for non-invasive prenatal testing during the pandemic and are estimated to grow similarly during the forecast period.

Non-Invasive Prenatal Testing Market Segment Analysis:

Non-Invasive Prenatal Testing Market By Product Type (Instruments and Kits and Reagents), Indication (Down Syndrome, Edwards Syndrome, Patau Syndrome, Turner Syndrome, and Others), End-User (Hospitals, Diagnostic Labs, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World).

In the product segment of the non-invasive prenatal testing market, the kits and reagents category is expected to amass significant revenue share in the year 2022. This can be ascribed to the presence of major players offering a wide range of consumables, kits, and reagents for NIPT.

The non-invasive prenatal test kits are innovative genetic screening procedures for pregnant women who are at risk of fetal Patau syndrome, Edward's Syndrome, or Down syndrome. These rapid, reliable, and safe kits quickly and effectively detect trisomy 13, 18, and 21, and can be carried out by the healthcare provider.

These kits can be prescribed early stage of pregnancy, after only 10 weeks of pregnancy. The results of the blood test available in around 7 working days. These kits are efficient, safe, and remarkably accurate. The kits have been found to reduce unnecessary invasive sampling by up to 95%.

Further, 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.

Also, the Vanadis Core T21/T18/T13 Reagent Cartridge, by PerkinElmer, is a qualitative assay intended for an in vitro diagnostic in screening for the risk of trisomy 21, 18, and/or 13 in fetus using cell-free DNA from pregnant women of at least 10 weeks of gestation.

Therefore, owing to the above factors, the demand for kits and reagents is predicted to increase thereby driving the growth of the overall non-invasive prenatal testing market during the forecast period.

North America is expected to dominate the overall Non-Invasive Prenatal Testing Market:

Among all the regions, North America is estimated to account for the largest share of the non-invasive prenatal testing market in the year 2022. Factors such as the high preterm birth rate, high maternal mortality rate, and rising incidences of chromosomal abnormalities such as down syndrome, among others will create a positive impact on the North American non-invasive prenatal testing market. Furthermore, sophisticated healthcare infrastructure, regulatory approval for new products, high diagnosis rates, wider adoption and awareness among the people, and the introduction of new and technologically advanced tests also helped the market growth in this region.

Further, the United States holds the major share in North America and the globally non-invasive prenatal testing market, one of the key reasons includes the rising number of down syndrome in the United States population. As per the Centers for Disease Control and Prevention (CDC) 2022, each year, about 6,000 babies born in the United States have Down syndrome. This means that Down syndrome occurs in about 1 in every 700 babies, in the US.

Furthermore, high diagnosis rates, increased adoption and awareness, and the introduction of new and technologically advanced tests are all contributing to market growth in North America. In addition to the current IONA test, which offers to screen for trisomies 21, 18, and 13, Yourgene launched IONA Care in the US, in May 2021. IONA care is a non-invasive prenatal test (NIPT) service offering to measure whether a pregnant woman is carrying a fetus with sex chromosome aneuploidies (SCA) and autosomal aneuploidies (AA). As a result, such product launches are expected to boost market growth during the forecast period.

Moreover, the strong geographical foothold of players in the US offering advanced tests has been pivotal in the growing adoption of these tests in the US. For instance, the Panorama test, developed by Natera, analyses DNA using single-nucleotide polymorphism (SNP) technology and is the only test that can distinguish between maternal and fetal DNA in the chromosomes of interest. Such innovative developments are likely to accelerate the adoption of NITP and thereby drive the North America non-invasive prenatal testing market forward during the forecast period.

Non-Invasive Prenatal Testing Market Key Players:

Some of the key market players operating in the non-invasive prenatal testing market include PerkinElmer Inc., Natera, Inc., Invitae Corporation, CENTOGENE N.V., F. Hoffmann-La Roche Ltd, Quest Diagnostics Incorporated, MedGenome Labs Ltd, Ravgen, Eurofins Scientific, BGI, Illumina, Inc., MedGenome Labs Ltd., YOURGENE HEALTH, Qiagen, Agilent Technologies, Inc., and others.

Recent Developmental Activities in the Non-Invasive Prenatal Testing Market:

• In August 2022, Natera Inc. filed a pre-submission to the Food and Drug Administration (FDA) for its panorama non-invasive prenatal test (NIPT) as part of the Q-Sub process. The company filed its pre-submission in June 2022 for fetal chromosomal aneuploidies and 22q11.2 deletion syndrome.
• In July 2022, Genetic Technologies Limited acquired EasyDNA as the company expanded the availability on its websites of Carrier Testing and Non-Invasive Prenatal Tests (NIPT) in Europe.
• In March 2020, Yourgene Health acquired AGX-DPNI, its distribution partner for its Iona noninvasive prenatal test in France, for €2.4 million ($2.7 million) in cash and up to €1.7 million in cash earn-out payments based on sales growth performance.
• In June 2019, June 2019, Illumina, Inc., announced the launch of VeriSeq™ NIPT Solution v2, a CE-IVD, next-generation sequencing (NGS)-based approach to noninvasive prenatal testing (NIPT). The automated comprehensive solution allows laboratories to screen for a broader range of chromosomal and sub-chromosomal conditions associated with birth defects and adverse pregnancy outcomes than the standard NIPT menu.

Key Takeaways from the Non-Invasive Prenatal Testing Market Report Study

• Market size analysis for current non-invasive prenatal testing market size (2022), and market forecast for 5 years (2023-2028)
• The effect of the COVID-19 pandemic on this market is significant. To capture and analyze suitable indicators, our experts are closely watching the non-invasive prenatal testing market.
• Top key product/services/technology developments, mergers, acquisitions, partnerships, and joint ventures happened for the last 3 years
• Key companies dominating the global non-invasive prenatal testing Market.
• Various opportunities available for the other competitor in the non-invasive prenatal testing market space.
• What are the top-performing segments in 2022? How these segments will perform in 2028.
• Which are the top-performing regions and countries in the current non-invasive prenatal testing market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for non-invasive prenatal testing market growth in the coming future?

Target Audience who can be benefited from this Non-Invasive Prenatal Testing Market Report Study

• Non-invasive prenatal testing products providers
• Research organizations and consulting companies
• Non-invasive prenatal testing-related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and Traders dealing in non-invasive prenatal testing
• Various End-users who want to know more about the non-invasive prenatal testing market and the latest technological developments in the non-invasive prenatal testing market.

Frequently Asked Questions for the Non-Invasive Prenatal Testing Market:

1. What is non-invasive prenatal testing?

Non-invasive prenatal testing (NIPT), also called non-invasive prenatal screening (NIPS), is a method for determining the risk that the fetus will be born with certain genetic abnormalities. This testing analyses small DNA fragments circulating in a pregnant woman's blood. NIPT analyses the genetic information contained in this DNA to screen for several abnormalities.

2. What is the market for global non-invasive prenatal testing?

The global non-invasive prenatal testing market was valued at USD 3,916 million in 2022, growing at a CAGR of 9.22% during the forecast period from 2023 to 2028 to reach USD 6,645 million by 2028.

3. What are the drivers for the global non-invasive prenatal testing market?

The demand for non-invasive prenatal testing is primarily being heightened by the increasing number of babies with chromosomal disorders such as down syndrome, and Edwards syndrome owing to the increasing number of late pregnancies and increasing demand for early and non-invasive fetal diagnosis. In addition, the advantages of non-invasive prenatal testing over other prenatal tests such as their non-invasive nature, better accuracy, and short duration of the procedure, increasing product launches and approvals, and innovation in product development thereby contribute to the overall growth of the non-invasive prenatal testing market during the forecast period from 2023-2028.

4. Who are the key players operating in the global non-invasive prenatal testing market?

Some of the key market players operating in the non-invasive prenatal testing market include PerkinElmer Inc., Natera, Inc., Invitae Corporation, CENTOGENE N.V., F. Hoffmann-La Roche Ltd, Quest Diagnostics Incorporated, MedGenome Labs Ltd, Ravgen, Eurofins Scientific, BGI, Illumina, Inc., MedGenome Labs Ltd., YOURGENE HEALTH, Qiagen, Agilent Technologies, Inc., and others.

5. Which region has the highest share in the non-invasive prenatal testing market?

North America is expected to dominate the overall non-invasive prenatal testing market during the forecast period from 2023-2028. Factors such as the high preterm birth rate, high maternal mortality rate, and rising incidences of chromosomal abnormalities, among others will create a positive impact on the North American non-invasive prenatal testing market. Furthermore, sophisticated healthcare infrastructure, regulatory approval for new products, high diagnosis rates, wider adoption and awareness among the people, and the introduction of new and technologically advanced tests also helped the market growth in this region.


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