Non-invasive Prenatal Testing Market by Gestation Periods (0-12 Weeks, 13-24 Weeks, and 25-36 Weeks), Risk Types (High & Average Risk and Low Risk), Methods (Ultrasound Detection, Biochemical Screening Tests, and Cell-free DNA in Maternal Plasma Tests), Technology (NGS, Array Technology, PCR, and Others), Products (Consumables & Reagents and Instruments), End-users (Hospitals & Clinics and Diagnostic Laboratories), and Regions (Asia Pacific, North America, Latin America, Europe, and Middle East & Africa) - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast 2021 – 2028

The global non-invasive prenatal testing market size was valued at USD 2.83 billion in 2020 and is anticipated to expand at a CAGR of 10.9% during the forecast period, 2021 – 2028. The growth of the market is attributed to the increasing incidence of chromosomal abnormalities coupled with growing product usage in new applications. Furthermore, advancements in existing tests in terms of advanced functions, advanced chemistry, and bioinformatics research are other key factors boosting the market. One of the main guiding forces of the market is the expansion of reimbursement plans for average and low-risk pregnancies.

Non-invasive prenatal testing (NIPT) is a method of determining the level of risks that the fetus might carry with certain genetic abnormalities after they are born. It analyzes small fragments of DNA circulating in a pregnant woman’s blood. Genes and chromosomes can sometimes mutate, putting an unborn child at risk for genetic defects. Trisomy 21 is one of the most common chromosomal anomalies, according to an article written by the Children's Hospital of Philadelphia, affecting about 5000 babies per year in the US.

To diagnose the possibility of fetal aneuploidy, NIPT analyzes the cell-free fetal DNA (cfDNA) found in a sample of maternal blood. Unlike other invasive treatments such as amniocentesis and chorionic villus sampling (CVS), these non-invasive tests are less costly and very effective in determining the same, which act as key driving factor for NIPT testing.

Market Trends, Drivers, Restraints, and Opportunities

• Increasing number of high maternal age mothers, which results to higher risk of genetic disorders in babies because of the improper chromosomal division. This is expected to boost the market.
• Growing R&D activities from several firms towards the advancement of cutting-edge screening technology that are extremely efficient and effective in the early identification of genetic disorders in babies. This acts as a major driving factor for the market.
• High cost of these tests and lack of the healthcare facilities in many developing countries are expected to restrict the NIPT market's development.
• Rising governments’ efforts and policies to improve healthcare infrastructure in the coming years, from emerging economies such as China, India, Brazil, and Mexico are expected to provide major growth opportunities for market players.

Scope of the Report

The report on the global non-invasive prenatal testing market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Global Non-Invasive Prenatal Testing Market Segment Insights

13 to 24 weeks segment accounted for a high revenue share
Based on gestation periods, the global non-invasive prenatal testing market is divided into 0-12 weeks, 13-24 weeks, and 25-36 weeks. The 13-24 weeks segment accounted for a key share of the market in terms of revenue in 2020 and is expected to register a substantial CAGR during the forecast period. The growth of the segment is due to wide adoption of the testing in these particular weeks as most of the non-invasive prenatal diagnosis occurs in the second trimester of pregnancy. These procedures also include significant secondary tests including ultrasound and alpha-fetoprotein serum screening. To create a more precise and effective NIPT, some companies are focusing on the study of cffDNA in a sample of maternal blood obtained in the first trimester.

High & average risk segment to constitute a large market share
On the basis of risk types, the market is bifurcated into high & average risk and low risk. The high & average risk segment is projected to constitute a large share of the market in the coming years owing to the extensive use of these tests in high-risk conditions for patients aged 35 and above. Moreover, the segment growth can be attributed to the availability of favorable payer reimbursement in this sector as well as rising knowledge regarding the prevention of chromosomal anomalies including Down syndrome. On the other hand, the low-risk segment is expected to grow at a rapid rate during the forecast period. Government support, such as budget allocation for average-risk births, is projected to be a positive factor for the segment growth.

Cell-free DNA-based segment to generate a considerable revenue share
Based on methods, the global non-invasive prenatal testing market is segmented into ultrasound detection, biochemical screening tests, and cell-free DNA in maternal plasma tests. The cell-free DNA-based NIPT segment is projected to generate a considerable revenue share of nearly 43.6% in 2020. The growth of the segment is attributed to the wide use of Cell-free DNA in prenatal treatment to predict the likelihood of genetic disorders through various genetic analyses. Several research projects are being conducted to improve the use of the tests available from this segment. Meanwhile, the ultrasound detection segment is anticipated to hold a large market share in the coming years due to the wide adoption of the testing during pregnancy. Ultrasound detection is used in combination 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 basis for additional fetal monitoring to detect anomalies.

NGS segment dominated the market
In terms of technology, the market is segmented into NGS, array technology, PCR, and others. The NGS segment dominated the market in 2020 and is expected to continue its trend in the coming years. The growth of the segment is attributed to the usage of NGS technology, including targeted genome sequencing, whole-genome sequencing, and whole-exome sequencing, for prenatal cfDNA testing. Whole-genome sequencing has been shown to have benefits over other methods including a reduced failure rate. In terms of performance, affordability, adoption, and technology, NGS technology is unmatched. As a result, NGS has become increasingly popular in this market. Several end users, however, have reported difficulties interpreting results while using NGS technology. As a result, array-based experiments have become more feasible for these users.

Consumables & reagents segment accounted for a major share
Based on product, the global non-invasive prenatal testing market is bifurcated into consumables & reagents and instruments. The consumables & reagents segment accounted for a major revenue share in 2020 and is projected to grow at a significant rate in the coming years. The growth of the segment is attributed to the widespread acceptance of NGS-based prenatal tests, which involve different reagents and assays to operate the sequencing procedure. The availability of a large number of suppliers who have solutions for isolating cell-free DNA is also propelling the segment forward. The instruments market, on the other hand, is projected to grow at a fast rate from 2021 to 2028, owing to instrument manufacturers' ongoing efforts to build advanced platforms. For example, PerkinElmer, Inc. provides the Vanadis NIPT System, an automated instrument that overcomes the cost, complexity, and capability limitations of other NIPT technologies for aneuploidy screening.

Diagnostic laboratories segment dominated the market
On the basis of end-users, the market is bifurcated into hospitals & clinics and diagnostic laboratories. The diagnostic laboratories segment dominated the market in 2020 and is expected to register a robust CAGR during the forecast period. The growth of the segment is attributed to the key players such as Illumina, which are outsourcing their sample processing to Illumina CLIA labs when in-house facilities are not sufficient. In addition, laboratories performing NIPT research throughout the US operate in accordance with quality-assurance requirements to ensure test quality and reproducibility.

North America is a dominant market
In terms of regions, the market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America held a dominant share in terms of revenue share in 2020, which is followed by Europe. The recent incorporation of NIPT in large insurance companies' business policies is expected to fuel market growth in the US. In June 2019, Illumina secured an infringement suit involving NIPT against Roche's Ariosa Diagnostics (Roche). The market in Asia Pacific is expected to be a fast-growing regional market owing to the increasing involvement of companies like BGI in China, which is a major player in the NIPT industry, is expected to propel the market growth.

Segments

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

• High & Average Risk
• Low Risk

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

• NGS
• Array Technology
• PCR
• Others

• Consumables & Reagents
• Instruments

• Hospitals & Clinics
• Diagnostic Laboratories

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

• Genesis Genetics
• Natera, Inc.
• Centogene N.V.
• Illumina, Inc.
• Eurofins LifeCodexx GmbH
• MedGenome Labs Ltd.
• F. Hoffmann-La Roche Ltd.
• Myriad Women’s Health, Inc.
• Progenity, Inc.
• Qiagen
• Laboratory Corp. of America Holdings
• Quest Diagnostics, Inc.

Competitive Landscape

Some of the major players competing in the global non-invasive prenatal testing market are Genesis Genetics; Natera, Inc.; Centogene N.V.; Illumina, Inc.; Eurofins LifeCodexx GmbH; MedGenome Labs Ltd.; F. Hoffmann-La Roche Ltd.; Myriad Women’s Health, Inc.; Progenity, Inc.; Qiagen; Laboratory Corp. of America Holdings; and Quest Diagnostics, Inc.

To differentiate themselves and solidify their market share, major players are widening their test portfolio. Companies are now concentrating on introducing new products to maintain and expand their market share. Illumina released an updated version of its VeriSeq NIPT in June 2019, allowing for the diagnosis of a wider spectrum of chromosomal interactions with birth defects. Moreover, Natera announced the extension of coverage for its Panorama offering in April 2020, which was made available to all targeted patients, regardless of age or illness.