Global Noninvasive Prenatal Diagnostics Market

The global noninvasive prenatal diagnostics market was valued USD 2.8 billion in 2020 and is estimated to reach USD 6.5 billion by 2028, expanding at a CAGR of 10.9% during the forecast period, between 2021 and 2028. Innovations in existing tests in terms of advanced functionality, improved chemistry, and bioinformatics analysis is expected to fuel the growth of the market.

The improvement of payment policies for ordinary and low-risk pregnancies is fueling the market growth. For instance, Natera announced extended coverage from the major US carrier in December 2020. Moreover, Aetna's health plan for providing non-invasive prenatal testing (NIPT) to all pregnant women is helping the company expand its market share.

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The COVID-19 pandemic continues to alter the growth of numerous markets. The suspension of non-invasive prenatal screening (NIPS) services to limit the spread of the COVID-19 virus negatively impacted the non-invasive prenatal testing (NIPT) industry.

The COVID-19 virus has also positively impacted NIPT services as it provides high-accuracy screening with a low risk of infection, as opposed to invasive procedures such as amniocentesis and chorionic villus sampling (CVS), both of which can necessitate hospitalization and expose both doctors and patients to the COVID-19 infection. As a result of the lockdown, a surge in the prescription of NIPTs was observed in 2020.

Market Drivers, Restraints, and Opportunities

• Increasing prevalence of chromosomal abnormalities, as well as increased product utilization in new applications, is driving the market growth.
• The rise in the number of non-invasive prenatal testing service providers are driving the market.
• Lack of test accessibility in emerging nations, ethical issues, and rigorous government regulations is expected to restrain the market growth.
• The improved healthcare infrastructure and increasing public healthcare expenditure are some of the major factors driving the growth of the market.
• The presence of a big target patient population, and expanding awareness and availability of modern technology are all contributing to the market growth.

Scope of Noninvasive Prenatal Diagnostics Market Report

The report on Global Noninvasive Prenatal Diagnostics Market includes an assessment of the market, size, share, trends, segments, and regional markets. Overview and dynamics have been included in the report.

Global Noninvasive Prenatal Diagnostics Market Segment Insights

High & average risk to dominate the market

Based on risk types, the market can be bifurcated into segmented into high & average risk and low risk. The high & average risk segment to dominate the market during the forecast period due to the increased uptake of these tests in high-risk instances in patients aged 35 years and above. The substantial proportion of this segment is due to the prevalence of advantageous payer reimbursement in this segment, as well as increased awareness regarding the avoidance of chromosomal defects like Down syndrome.

The low-risk segment, on the other hand, is expected to grow at a healthy rate during the projected period. Government support, such as budget allocation for average-risk pregnancies, is likely to be a positive driver in market growth. According to the NCBI, testing in average-risk pregnancies enabled for a higher number of impacted cases to be detected in 2019, resulting in an increased budget of USD 35 million for this group in Ontario.

13-24 weeks segment to grow at a robust pace

On the basis of gestation period, the market can be segmented into 0-12 weeks, 13-24 weeks, 25-36 weeks. The 13- 24 weeks segment accounted for almost 40% market share due to the fact that most non-invasive prenatal diagnosis is done during the second trimester of pregnancy, and these tests also include significant complimentary procedures like ultrasonography and alpha-fetoprotein serum screening.

To produce a more accurate and trustworthy NIPT, several firms are focusing on the analysis of cffDNA in a sample of maternal blood collected in the first trimester. However, while fetal DNA can be discovered as early as the fourth week of pregnancy, it can only be trusted after seven weeks.

Furthermore, fetal DNA concentration in maternal blood rises throughout pregnancy, reaching 80 fetal genomes per mil blood in the third trimester, up from 16 in the first trimester, making tests performed in this trimester highly trustworthy

Cell-free DNA in maternal plasma tests segment to account a considerable market share

In terms of methods, the market can be fragmented into ultrasound detection, biochemical screening tests, and cell-free DNA in maternal plasma tests. In 2020, cell-free DNA in maternal plasma tests segment accounted for more than 40% market share. Through various genetic tests, cell-free DNA is increasingly being used to forecast the likelihood of genetic disorders in prenatal care.

Several research studies are now underway to improve the utilization of the tests available through this segment. The National Health Service (NHS) published a study in December 2019 that adopted and verified cell-free DNA-based NIPT. The researchers concluded that cfDNA-based NIPT can be used as a private test in patients who have a low risk of common trisomy or for other reasons.

Ultrasound detection is used in conjunction with the Cell-free DNA-based NIPT test, resulting in a lower market share for this segment. The test, on the other hand, serves as a starting point for future fetal testing to detect anomalies. Recent technological improvements and 3D-4D imaging have increased real-time monitoring, safety, and efficiency of the test, which is projected to fuel the segment's expansion.

NGS segment to constitute a major market share

Based on technology, the market can be divided into NGS, array technology, PCR, and others. In 2020, the NGS segment held a market share of more than 55% market share due to the widespread use of NGS technology for prenatal cfDNA testing, which includes targeted genome sequencing, whole-genome sequencing, and whole-exome sequencing.

Whole-genome sequencing has been shown to have advantages over other technologies, including a lower failure rate. The NGS technology is superior, including efficiency, availability, penetration, and technology. As a result, NGS has become widely used in this field.

For instance, Illumina offers whole-genome sequencing-based approaches. Several end-users, however, have reported trouble interpreting results while employing NGS technology. As a result, array-based tests have become more feasible. Additionally, Chromosomal microarray analysis (CMA) is more efficient than traditional karyotyping.

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Consumables & reagents dominated the market in 2020

On the basis of products, the market can be classified as consumables & reagents and instruments. The consumables & reagents segment accounted for more than 70% market share in 2020 due to rapid adoption of NGS-based prenatal tests, which require numerous reagents and assays to perform the sequencing process.

The availability of a large number of suppliers who provide solutions for isolating cell-free DNA is further propelling the segment growth. The instruments segment, on the other hand, is estimated to expand at a high CAGR during the forecast period owing to instrument manufacturers' ongoing efforts to build improved platforms.

For instance, PerkinElmer, Inc. offers Vanadis NIPT System, an automated instrument that overcomes the cost, complexity, and capacity restrictions of previous NIPT technologies for aneuploidy screening. The system is the only NIPT screening technology that allows for non-PCR or next-generation sequencing examination of the targeted cfDNA. This is accomplished by directly capturing and tagging certain DNA pieces.

Diagnostic laboratories segment to dominate the market

In terms of end-uses, the market can be segregated into hospitals & clinics and diagnostic laboratories.  The diagnostic laboratories segment led the market in 2020. The insufficiency of in-house facilities has encouraged developers such as Illumina to outsource sample processing to Illumina CLIA labs. Additionally, laboratories conducting NIPT testing across the US operate in accordance with quality-assurance rules to ensure test quality and reproducibility.

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North America is anticipated to dominate the market

Based on regions, the market can be segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. In 2020, North America accounted for a major revenue share, followed by Europe. The US lacks national consensus policies on NIPT adoption; yet, it is extensively implementing across the country, resulting in market dominance.

Furthermore, the recent inclusion of NIPT in major insurance companies' coverage plans is expected to drive the market growth in the US. In June 2019, Illumina won an infringement complaint involving NIPT against Roche's Ariosa Diagnostics (Roche).

The market in Asia Pacific is expected to exhibit a high CAGR during the forecast period due to existence of firms such as BGI in China, which is a major player in the industry. Growing frequency of stillbirths around the world is estimated to provide a significant growth opportunity for early illness detection.

According to the Australian Institute of Health and Welfare, the rate of stillbirth in Australia is 6.7 per 1,000 births or nearly 2,200 families per year. A stillborn infant can occur in one out of every 137 women who reach the 20-week mark of their pregnancy. Such factors is expected to spur the regional market growth.

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Segments

By Risk Types

• High & Average Risk
• Low Risk

By Products

• Consumables & Reagents
• Instruments

By Gestation Period

• 0-12 Weeks
• 13-24 Weeks
• 25-36 Weeks

By Technology

• NGS
• Array Technology
• PCR
• Others

By Methods

• Ultrasound Detection
• Biochemical Screening Tests
• Cell-free DNA in Maternal Plasma Tests

By End-uses

• Hospitals & Clinics
• Diagnostic Laboratories

By Regions

• North America
• Europe
• Latin America
• Asia Pacific
• Middle East & Africa

By Key Players

• CooperSurgical, Inc.
• Natera, Inc.
• CENTOGENE N.V.
• Illumina, Inc.
• Eurofins LifeCodexx GmbH
• MedGenome
• F. Hoffmann-La Roche Ltd.
• Myriad Genetics Inc/Counsyl, Inc.
• Progenity, Inc.

Competitive Landscape

Some prominent players in the global noninvasive prenatal testing market include CooperSurgical, Inc., Natera, Inc., CENTOGENE N.V., Illumina, Inc., Eurofins LifeCodexx GmbH, MedGenome, F. Hoffmann-La Roche Ltd., Myriad Genetics Inc/Counsyl, Inc., and Progenity, Inc.

Major market participants are focused on strategies of agreements, partnerships, collaborations, and expansions to expand their product availability and distribution networks in these countries to satisfy the growing requirement for early diagnosis and treatment and maximize market development possibilities.

In June 2019, Illumina announced the release of latest version of VeriSeq NIPT, allowing for the detection of a broader spectrum of chromosomal correlations with birth abnormalities.

In August 2019, Axia Women's Health, an independent women's healthcare organization, announced the debut of non-invasive prenatal testing (NIPT), the first of its kind in the US-based obstetrician-gynecologist-owned laboratory.

In February 2017, Premaitha Health plc (UK) acquired Yourgene Bioscience Co., Ltd. (Taiwan), an NIPT bioinformatics specialist. This is anticipated to help Premaitha to expand in noninvasive prenatal diagnostics (NIPT) market in Asia Pacific. In order to increase the use of NIPT testing in Indonesia, Yourgene has partnered with an NIPT service provider.