NIPT Market Size & Share Analysis - Trends, Drivers, Competitive Landscape, and Forecasts (2025 - 2032)

NIPT Market Trends and Growth Drivers

Technological Advancements Are Key Market Trend

• The usage of advanced technologies and a multi-modality approach for NIPT is the key trend in the market.
• One of the key advancements in this regard is next-generation sequencing (NGS), which has made it easier to detect and study the cell-free DNA (cfDNA) of the fetus in the blood of the mother.
• Moreover, AI is being utilized to find anomalies in fetal samples and compare them with historical data for enhanced diagnoses.
• New-generation NIPT assays, kits, and analyzers are also able to scan for microdeletions, which are small deletions in the chromosome.
• This makes it easier to detect critical life-long diseases such as sickle cell anemia and cystic fibrosis, which are caused by mutations in a single gene.
• As per studies, more than 500,000 babies around the world are born with sickle cell anemia each year.
• Similarly, the incidence of cystic fibrosis is around 1 in every 3,000 births in the U.S. In all, around 1,000 new cases of this condition are recorded each year, as per the Cystic Fibrosis Foundation.
• NIPT blood tests are also increasingly being used in combination with biochemical market analysis and fetal ultrasound to improve the precision of diagnoses.

High Risk of Genetic Disorders with Increasing Maternal Age Drives Market

• The increasing age of the mother can prompt a variety of medical issues, such as hypertension, reduced fertility, premature delivery, stillbirths, maternal mortality, and high chances of miscarriages.
• Moreover, due to irregular gene division, genetic disorders can increase in likelihood.
• Hence, the mother’s increasing age, which brings about a high chance of genetic disorders, drives the volume of prenatal testing.
• It is understood that the risk also increases for the second child if the first child is born with a genetic disorder.
• This is because one of the parents acts as the carrier of genetic disorders.
• Additionally, if the mother is the carrier, the risk is approximately 12%, and if the father is the carrier, the risk is about 3%.
• The risk also increases with the growing maternal age because with the maturing eggs, the risk of chronic disorders increases.
• Every year, approximately 6,000 people are born with Down syndrome, and for every case, the age of the mother has been above 30 years.
• Altered recombination is possibly the key factor responsible for Trisomy and other disorders that are related to the genes.

High Cost and Lack of Skilled Professionals Hamper Market Growth

• The high cost of these procedures and the lack of skilled lab technicians to conduct them hamper the growth of the market, especially in developing countries.
• These tests need cutting-edge analyzers that boast a high throughput and sensitive assays and kits, which are usually available at large hospitals or well-funded diagnostic labs.
• Additionally, there is a severe lack of trained professionals to safety obtain bodily samples without risking hospital-acquired infections, processing them in advanced analyzers, and effectively interpreting the findings.
• As per studies, there is a shortage of 7,000 lab technicians in the U.S.
• Considering these numbers, the problem is even bigger in LMICs, where the incidence of genetic conditions is rather high.
• As per the UNICEF, 685 children were infected by AIDS and 250 died of it each day in 2023 due to inadequate access to maternal and paternal HIV prevention solutions.
• Of the 1,370,000 children between the ages of 0 and 14 years living with HIV in 2023, 87% were in sub-Saharan Africa.

NIPT Market Analysis

Product Analysis

The consumables category holds the larger share, of 65%, in 2024, and it will also have the higher CAGR due to the existence of a high count of players providing consumables, including assay kits, reagents, and disposables. The largest share is also attributable to the improvements in the tests for NIPT and high count of approvals to various assays.

The instruments category is growing at the higher rate, and among all instruments, NGS systems are used the most for the identification of fetal chromosomal abnormalities. NGS is preferred for the sequencing of whole genomes as it possesses great clinical efficiency.

These products have been studied:

• Consumables (Larger and Faster-Growing Category)
  • Assay kits & reagents
  • Disposables
• Instruments
  • NGS systems
  • PCR instruments
  • Microarrays
  • Ultrasound devices
  • Others

Method Analysis

Cell-free DNA in maternal plasma tests dominate this segment, and they are also the fastest-growing, with 15% CAGR. This is because they are widely used because of its effectiveness in speculating the probability of genetic anomalies.

Moreover, as per government reports, out of every 15,000 patients above the age of 35 years, more than 80% have tested positive using the cell-free DNA method. Thus, due to the greatest accuracy of the results provided by cell-free DNA in maternal plasma tests, the majority of the individuals adopt this method.

Similarly, advanced technologies and the benefits real-time, quick monitoring of chromosomes drive the growth of the ultrasound detection category. The growth in the usage of the ultrasound method can also be credited to the accuracy of the results and the ability to see macro deformities with the naked eye.

The report offers insights into the following methods:

• Ultrasound Detection
• Biochemical Screening
• Cell-Free DNA in Maternal Plasma Tests (Largest and Fastest-Growing Category)

Application Analysis

Based on application, trisomy accounts for the major share, of 55%, credited to the increasing number of women becoming pregnant at a greater age, which significantly increases the risk of chromosomal abnormalities. As per observations, NIPT is the most sensitive and specific for Down syndrome; hence, Trisomy is the primary application and it is expected to grow at the highest CAGR during the forecast period.

Microdeletion syndrome is the fastest-growing category as this test can help detect a range of genetic conditions, including 22q11.2 deletion syndrome, Angelman syndrome, and Prader–Willi syndrome. The category is driven by the increasing awareness of the impact of these conditions on the development of children. For instance, Angelman syndrome, which affects 1 in 20,000 children, leads to delayed development, severe cognitive disability, ataxia, and speech impairment.

Similarly, with an incidence of 1 in 30,000 children, Prader–Willi syndrome causes poor feeding, muscle weakness, and stunted development.

Below are the applications analyzed in the report:

• Trisomy (Largest Category)
• Microdeletion Syndrome (Fastest-Growing Category)
• Others

End User Analysis

Diagnostic laboratories dominate the market, and they are the fastest-growing category will 15.5% CAGR. This is attributed to the affordability these places offer over full-fledged hospitals. Additionally, diagnostic laboratories have short waiting times and a quick turnaround. Moreover, small hospitals and neighborhood clinics also mostly outsource the testing to standalone diagnostic labs, which drives the latter’s dominance on the market. With the increasing awareness of genetic conditions, diagnostic laboratories are witnessing increasing patient counts.

Here are the end users examined during the study:

• Diagnostic Laboratories (Largest and Fastest-Growing Category)
• Hospitals
• Research Institutes

NIPT Market Geographical Outlook

North America holds the largest share, of 40%, in the NIPT market in 2021. This is attributed to the strong healthcare infrastructure and technological advancements in the field of diagnostics.

In North America, the U.S. holds the leading position, and it will grow with a CAGR of 13%, attributed to the strong financial support. The increasing incidence of chromosomal abnormalities in the U.S. has led to a rise in the demand for prenatal testing. Since the U.S. offers advanced tests for genetic conditions, it leads the regional market. Additionally, the whole-genome next-generation sequencing technology is being used for the purpose in the U.S. and Canada as it offers quicker and more-accurate results.

Moreover, as regional governments are focusing strongly on the reimbursement policy for NIPT, the adoption of prenatal testing has enhanced. In addition, due to the recent technological advancements, consumers and doctors are shifting from invasive methods to non-invasive testing methods.

Researchers in the U.S. estimate that 1 in every 1,200 people are suffering from Down syndrome. African–American babies have a higher risk of Down syndrome compared to Caucasian babies. The survival rate of babies diagnosed with this condition is approximately 90% up to 1 year and 80% up to 20 years of age. Moreover, in recent years, the quality of life of patients has improved dramatically, mainly credited to early diagnosis and management.

Moreover, the American College of Obstetricians and Gynecologists and the Society for Maternal–Fetal Medicine endorse NIPT as it has the fewest false positive chances and highest accuracy for various genetic disorders.

The Asia-Pacific region is expected to show significant development due to the increasing need for the treatment of chromosomal abnormalities in developing nations, such as India and China. The region is home to a large population suffering from genetic diseases. As per the Press Information Bureau, 5 million babies are born in India with genetic diseases each year. To address this issue, the Centre for DNA Fingerprinting and Diagnostics (CDFD) and CSIR-Centre for Cellular and Molecular Biology have been working together to offer diagnoses since 2019.

Additionally, the awareness about advanced technologies for treating such patients is increasing, thereby enhancing the growth potential of the market in this region. The market growth is also credited to the advancement of the healthcare infrastructure and the incorporation of next-generation sequencing in laboratory workflows.

Here is the geographical breakdown of the market:

• North America (Largest Regional Market)
  • U.S. (Larger and Faster-Growing Country Market)
  • Canada
• Europe
  • Germany (Largest Country Market)
  • U.K. (Fastest-Growing Country Market)
  • France
  • Italy
  • Spain
  • Rest of Europe
• Asia-Pacific (APAC) (Fastest-Growing Regional Market)
  • Japan
  • China (Largest Country Market)
  • India (Fastest-Growing Country Market)
  • South Korea
  • Australia
  • Rest of APAC
• Latin America (LATAM)
  • Brazil (Largest Country Market)
  • Mexico (Fastest-Growing Country Market)
  • Rest of LATAM
• Middle East and Africa (MEA)
  • Saudi Arabia (Largest Country Market)
  • South Africa
  • U.A.E. (Fastest-Growing Country Market)
  • Rest of MEA

NIPT Market Share

• The market is fragmented due to the presence of a large number of companies offering such solutions.
• The diversity of the consumables, instruments, and technologies needed and of the applications is mainly behind this fragmentation.
• Additionally, while the instruments are technically and financially demanding to develop, consumables are not.
• Pipettes, beakers, test tubes, droppers, gloves, and face masks are cheap to develop, which is why a large number of companies sell them around the world.
• The safety protocols for testing procedures and associated supplies vary by country, along local companies to prosper in LMICs.

NIPT Market News

• In October 2024, Illumina introduced its MiSeq i100 Series of benchtop NGS systems.
• In October 2024, Eurofins Scientific announced plans to acquire the diagnostics operations of SYNLAB in Spain.
• In October 2024, Yourgene Health launched its NIPT services in Colombia, in collaboration with Genetix, using the former’s IONA Nx NIPT workflow.
• In December 2024, PerkinElmer acquired Covaris to extend the former’s life sciences portfolio into the field of diagnostics.