Global Non-Invasive Prenatal Testing (NIPT) Market to Reach New Heights with 16% CAGR by 2029

The Global Non-Invasive Prenatal Testing (NIPT) Market is expected to grow at 16% by 2029. The high risk of chromosomal abnormalities with rising maternal age, the surge in the adoption of cell-free DNA screening, favorable reimbursement policies for average and low-risk pregnancies, and a growing number of genetic and congenital disorders are some of the key factors driving the market growth. 

Non-invasive prenatal testing (NIPT), sometimes called noninvasive prenatal screening (NIPS), is a method of determining the risk of whether the fetus of the mother will be born with certain genetic abnormalities. This testing also analyzes small fragments of Deoxyribonucleic acid (DNA) that are circulating in a pregnant woman’s blood. NIPT is a safe and highly effective way of screening for conditions such as Down syndrome (also called trisomy 21), Edwards syndrome (trisomy 18), Patau syndrome (trisomy 13), monosomy X, and Turner syndrome.

Currently, two types of NIPT methods are commercially available, massive parallel sequencing (MPS) technology and the single-nucleotide polymorphism (SNP) based method. Both NIPT methods screen for fetal genetic disorders that arise from extra or missing chromosomes, such as trisomy 21, trisomy 18, and trisomy 13, along with fetal sex and sex chromosome disorders. NIPT can also screen conditions where a small part of the chromosome is missing, called a microdeletion, such as Di-George, Cri-du-chat, Prader-Willi, or Angelman syndrome. Approximately, 1 in 150 live births is affected by a chromosomal abnormality worldwide.

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Shift towards Cell-Free DNA screening

The Discovery of cell-free DNA (cfDNA)-based non-invasive prenatal testing (NIPT) has rapidly shifted the paradigm of aneuploidy screening during pregnancy. It’s a simple blood test that can be performed during pregnancy. Clinical validation studies suggest that NIPT is more accurate than combined first-trimester screening (CFTS), with very high sensitivity (99.3%) and specificity (99.9%) for trisomy 21(Down syndrome). For instance,

NIPT is also safer than other invasive diagnostic techniques such as chorionic villus sampling and amniocentesis, which involves a risk of miscarriage (0.1–0.2%). However, NIPT is not a diagnostic test; it can only determine whether there is an increased risk of having a baby with an abnormality. Therefore, a high-risk result should be followed by invasive testing for confirmation. Furthermore, owing to its ability to detect the presence of chromosomal abnormalities in fetuses of pregnant women as early as 9 to 10 weeks of gestation, the demand for non-invasive prenatal testing is witnessing a rapid increase globally.

Advent of Advanced Technologies for NIPT Products

Prenatal diagnosis and prenatal screening have undergone rapid development in recent years. The advent of next-generation sequencing technology has enabled the sequencing of fetal DNA fragments that can be assembled into a full genetic map, allowing the fetal genome to be scanned prenatally and non-invasively. On the other hand, the inclusion of chromosomal microarray analysis (CMA) has allowed the detection of cryptic genomic imbalances (which were not identified by previous techniques), varying levels of mosaicism, and cases of uniparental disomy (UPD).  Developments in modern molecular technologies and the discovery of cell-free fetal DNA in maternal plasma have also led to novel screening methods for fetal chromosomal aneuploidies.

Currently, various types of NIPT tests are available in the market such as Panorama, Vistara, MaterniT GENOME, MaterniT 21 PLUS, and Harmony Test, among others which help in the screening of chromosomal abnormalities developing in the fetus. Moreover, several developments have been made to impact the quality of care for expectant mothers such as:

• In December 2022, Natera, Inc. disclosed in Prenatal Diagnosis a clinical experience study in twin pregnancies showcasing its Panorama single nucleotide polymorphism (SNP)-based non-invasive prenatal test (NIPT), demonstrating consistent real-world performance in line with previous reports and emphasizing the significance of Panorama's capacity to ascertain zygosity for risk evaluations
• In January 2022, QIAGEN entered into collaborations with Atila BioSystems to provide non-invasive prenatal testing (NIPT) solutions to QIAGEN’s dPCR franchise
• In June 2021, Illumina and Next-generation Genomic Thailand announced the launch of next-generation sequencing (NGS)-based VeriSeq NIPT Solution v2 in the country which helps to detect anomalies missed by targeted assays
• In December 2020, Natera announced expanded coverage from the largest U.S. Health Plan, Aetna, for its non-invasive prenatal testing (NIPT) for all pregnancies
• In June 2019, Cradle Genomics, a San Diego-based startup secured US$17 Mn in Series A funding to support clinical development, CLIA lab operations, corporate infrastructure, and commercial launch of the tests

“Prenatal care is a dynamic and continuously evolving field. Development in new molecular technologies and the discovery of cell-free fetal DNA are fueling groundbreaking advancements to improve care for mother and child and to offer parents reproductive options.” - Senior Director, Head of Research & Product Development, Sequencing & Array-based Company, United States

Key Challenges/ Constraints: Non-Invasive Prenatal Testing Market

Some of the key challenges restricting the growth of the non-invasive prenatal testing market are stringent government regulations and limitations of NIPT despite its high accuracy, it is still considered a screening test and false positive and negative results can still occur. NIPT only focuses on the common trisomies and cannot test for other genetic diseases. Various professional committees believe that the implementation of NIPT and the subsequent rise in the uptake of prenatal testing is likely to increase the incidence of abortions.

North America: The Largest Non-Invasive Prenatal Testing Market

North America is the largest market for NIPT with >45% revenue share, followed by Europe. The growing prevalence of genetic disorders in newborns associated with increasing maternal age, wider adoption and rising awareness about NIPT among the people, the introduction of new technologically advanced tests, and the presence of leading players working on fetal and neonatal care in this region are some of the key factors driving the North America market.

The market in Europe is expected to grow significantly over the forecast period due to the adoption of the latest technology, new product launches, increased awareness regarding NIPT, and a strong reimbursement framework for these tests in the region. The Asia Pacific region is expected to witness the highest CAGR in the coming years, as there is an increasing demand for early diagnosis of chromosomal disorders during pregnancies in emerging countries. Also, key market players are expanding their foothold in the emerging Asia-Pacific countries by engaging in partnerships and collaborations with domestic market players due to the presence of a large patient base in the region.

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Product Segment Insights

The non-invasive prenatal testing (NIPT) market is segmented into consumables, kits & reagents, and instruments, each playing a crucial role in the overall market share. Consumables, including blood collection tubes and other materials necessary for sample preparation, hold a significant portion of the market due to their recurring usage in every test. Kits & reagents are another critical segment, encompassing the essential components for the detection and analysis of fetal genetic material from maternal blood. This sub-segment is driven by the continuous advancements in genetic testing technologies and the increasing demand for high-accuracy diagnostic tools. Instruments, such as sequencing systems and PCR machines, also constitute a substantial market share, as they are indispensable for the precise analysis and interpretation of NIPT results. The growing adoption of these sophisticated instruments in diagnostic laboratories and hospitals contributes to their strong market presence.

Application Segment Insights

The application segment of the non-invasive prenatal testing (NIPT) market is prominently categorized into trisomy and microdeletion syndrome testing, each significantly influencing market share. Trisomy testing, which includes screening for conditions such as Trisomy 21 (Down syndrome), Trisomy 18 (Edwards syndrome), and Trisomy 13 (Patau syndrome), commands the largest market share due to the high prevalence and clinical importance of these chromosomal abnormalities. The widespread adoption of trisomy NIPT is driven by its high accuracy, early detection capabilities, and the increasing preference for non-invasive methods over traditional invasive procedures like amniocentesis. On the other hand, testing for microdeletion syndromes, which involve smaller chromosomal deletions that can lead to conditions such as DiGeorge syndrome and Cri-du-chat syndrome, is rapidly gaining traction. Although currently a smaller segment compared to trisomy testing, the market share for microdeletion syndrome NIPT is expanding due to advancements in genomic technologies that enhance detection sensitivity and accuracy. Additionally, the growing awareness among healthcare providers and expectant parents about the availability and benefits of microdeletion testing is contributing to its increasing adoption, thereby steadily boosting its market share.

Competitive Landscape Analysis: Non-Invasive Prenatal Testing Market

Some of the prominent players operating in this market are Agilent Technologies, Inc., PerkinElmer, Inc., Illumina, Inc., Eurofins LifeCodexx AG, Natera, Inc., Igenomix SL, F. Hoffman-La Roche Ltd., BGI Genomics, Quest Diagnostics, Berry Genomics, and Yourgene Health among others.

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