Non-Invasive Prenatal Testing Market Report by Product (Consumables, Instruments), Method (Ultrasound Detection, Biochemical Screening, Cell-Free DNA in Maternal Plasma Tests), Application (Trisomy, Microdeletion Syndrome), End User (Diagnostic Laboratories, Hospitals, Research Institutes) - Global Industry Revenue Estimation and Demand Forecast to 2030

Market Overview

The non-invasive prenatal testing market value stood at $3,987.1 million in 2021, and it is expected to advance at a CAGR of 9.8% during 2021–2030, to reach $9,229.2 million by 2030.

The growth can be ascribed to the increasing prevalence of chromosomal abnormalities and rising demand for early detection methods. Approximately, 14% of the stillbirths are due to inherited diseases in pregnant women in the age group of <24 years, and the number rises to 38% in women 40–44 years of age.

Among all the genetic abnormalities, Trisomy 21 holds the largest share. Its annual prevalence is 1 in 800 newborns, which makes it the most-common chromosomal abnormality in the U.S. In absolute terms, in the U.S., more than 5,000 babies are born with Down syndrome (Trisomy 21) every year.

Down syndrome increases in likelihood as the mother ages, and most of the times, babies born with it weigh even less than 1,500 grams, which is way less than the weight of a normal infant. Moreover, approximately 85% of the individuals born with this condition die within a year, and only 50% live longer than 50 years.

Moreover, in the U.S., about 1 in 5,000 newborns have Trisomy 18, and approximately 1 in 16,000 have Trisomy 13. In the same way, the prevalence of sex chromosome disorders is about 1 in 2,000, and these conditions are brought about by various environmental factors, including UV radiation and smoking.

In order to broaden their share in the industry, biotech companies are focused on various methods, including product launches and collaborations with other companies. Specifically, major players have launched many sequencing, genotyping, and array-based solutions for DNA, RNA, and protein analysis. These tests work on the advanced whole-genome next-generation sequencing technology, which is able to detect the changes in maternal chromosomes and fetal DNA.

North America Holds Major Share in the World

North America held largest share, around 45%, 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 8%, 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. Additionally, the awareness about advanced technologies for treating such patients is increasing, thereby enhancing the growth potential of the market in this region.

Consumables Accounted for Largest Share in Product Segment

The consumables category held the largest share, over 60%, in 2021, 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 sale of instruments is growing at a remunerative rate too, 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.

Rising Adoption of Different Screening Methods Leads To High Revenue Generation

Among the various methods, such as ultrasound detection, biochemical screening, and cell-free DNA in maternal plasma tests, cell-free DNA in maternal plasma tests dominate this segment, followed by ultrasound detection, which can be used as complementary. The cell-free DNA method is 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.

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Trisomy Application Holds Largest Share in Global NIPT Market

Based on application, Trisomy accounted for the major share, 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.

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.

Major Players in Non-Invasive Prenatal Testing Market Are:

• Sequenom Inc.
• Ariosa Diagnostics Inc.
• Natera Inc.
• Illumina Inc.
• Eurofins LifeCodexx Inc.
• MedGenome Labs Ltd.
• Yourgene Health plc
• F. Hoffman-La Roche Ltd.
• Genesis Genetics
• CENTOGENE GmbH
• Myriad Women’s Health Inc.
• Progenity Inc.
• PerkinElmer Inc.
• Agilent Technologies Inc.

Market Size Breakdown by Segment

The study offers a comprehensive market segmentation analysis along with market estimation for the period 2017-2030.

Based on Product

• Consumables
  • Assay kits & reagents
  • Disposables
• Instruments
  • NGS systems
  • PCR instruments
  • Microarrays
  • Ultrasound devices
  • Other instruments

Based on Method

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

Based on Application

• Trisomy
• Microdeletion Syndrome

Based on End User

• Diagnostic Laboratories
• Hospitals
• Research Institutes

Geographical Analysis

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
• Asia-Pacific
  • Japan
  • China
  • India
  • South Korea
  • Australia
• Latin America
  • Brazil
  • Mexico
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • U.A.E