Report Overview

According to the deep-dive market assessment study by Growth+ Reports, the global Prenatal and Newborn Genetic Testing market testing was pegged at US$ 5.3 billion in 2021. The market is expected to witness a CAGR of 10.2% from 2022 to 2030. 

Market Fundamentals

Prenatal genetic testing is performed during pregnancy to determine whether the fetus has a hereditary or congenital disability. These tests can determine a baby's risk for developing specific birth abnormalities, many of which are genetic diseases. These examinations include prenatal cell-free DNA screening, blood tests, and a particular kind of ultrasound. The first and second trimester is typically when prenatal screening tests are available. However, such tests cannot provide a conclusive diagnosis. These tests diagnose genetic diseases such as Down syndrome, Tay-Sachs disease, cystic fibrosis, sickle cell anemia, polycystic kidney disease, and thalassemia. The screening is further carried out after the birth. The blood sample is taken when the baby is 2 to 3 days older.

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Market Dynamics

The rising prevalence of genetic disorders in infants like Downs Syndrome, Patau syndrome, and Edwards syndrome is the major driving factor in the prenatal and newborn genetic testing market. Growing demand for detecting genetic disorders in the newborn and prenatal population is also pivotal in the market growth. Investments in research and development for genetic disorder diagnostics and new technology are steadily rising. Additionally, growing government initiatives to increase awareness of prenatal and newborn genetic testing are among the reasons driving the global prenatal and newborn genetic testing market. However, there are several ethical problems related to prenatal and newborn genetic testing, thus hampering the development of clinical services. The rise in the number of inaccurate results, also known as false-negative or false-positive results, and the miscarriage risk related to screening methods are some other factors restricting the growth of prenatal and newborn genetic testing market.

Market Ecosystem

The global prenatal and newborn genetic testing market has been analyzed from four perspectives: technology, disease, end user, and region. 

Prenatal and Newborn Genetic Testing Market by Technology

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Based on product, the global prenatal and newborn genetic testing market has been segmented into PCR (polymerase chain reaction), aCGH (array-comparative genetic hybridization), FISH (fluorescence in-situ hybridization), Maternal Serum Screening, Amniocentesis, Chorionic Villus Sampling, Non-invasive Prenatal Testing. Among these, the non-invasive prenatal testing (NIPT) segment holds the largest market share of the prenatal and newborn genetic testing market in 2021. Higher accuracy and safety against conventional diagnostic methods is the key factor supporting the dominance of this segment. This test gives highly accurate data regarding trisomy 21 (Down syndrome), trisomy 18 (Edward's Syndrome), and trisomy 13 (Patau syndrome). The research will improve the non-invasive prenatal testing use of advanced technologies such as AI.

Prenatal and Newborn Genetic Testing Market by Disease

Based on disease, the global prenatal and newborn genetic testing market is segregated into Down syndrome, phenylketonuria, cystic fibrosis, and sickle cell anemia. Down syndrome has the largest market share of the global prenatal and newborn genetic test in 2021. The large share of this segment is attributed to the higher incidence rate of Down syndrome in the general population. According to the WHO, the global incidence of Down syndrome is estimated to be between 1 in 1,000 and 1 in 1,100 live births. According to the NHS U.K., every year, approximately 750 babies are born with Down syndrome in the United Kingdom, and the condition affects an estimated 40,000 people in the country. 

Prenatal and Newborn Genetic Testing Market by End User

Based on the end users, the global prenatal and newborn genetic testing market is segregated into hospitals, maternity & specialty clinics, and diagnostic centers. The hospital segment holds the largest market share of the global prenatal and newborn genetic testing market in 2021. Hospitals have advanced facilities and infrastructure for genetic testing, thus attracting more patients. Rising government investment in hospitals, combined with a higher number of experienced and trained professionals in hospitals to provide precise diagnosis and management, support the leading position of this segment. 

Prenatal and Newborn Genetic Testing Market by Region

Based on region, the global prenatal and newborn genetic market has been segmented into North America, Europe, Asia Pacific, and the Rest of the World. North America will dominate the global prenatal and newborn genetic testing market in 2021, followed by Europe. The large share of North America in the global prenatal and newborn genetic testing market is attributed to the rise in the numbers of genetic disorders in the region, higher childbirth age of mothers, and increased demand for non-invasive prenatal tests (NIPT). According to the Centers for Disease Control and Prevention (CDC), approximately 6,000 newborns, or 1 in every 700, are born with Down syndrome every year. Patau syndrome affects 530 newborns, and Edwards syndrome affects 1190.

Competitive Landscape

Some key companies operating in the global prenatal and newborn genetic testing market are:

• Bio-Rad Laboratories Inc.
• Ariosa Diagnostics Inc. (Roche)
• Agilent Technologies Inc.
• Illumina, Inc.
• Qiagen NV
• Sequenom Inc.
• Berry Genomics Co. Ltd
• BGI Group
• Laboratory Corporation of America
• Trivitron Healthcare Pvt. Ltd.

Strategic Developments

• In May 2022, the NHS developed a new non-invasive prenatal test, which can determine the changes in the genes to detect retinoblastoma. This test was developed at the Birmingham Women’s and Children’s NHS Foundation Trust to identify the risk of developing retinoblastoma early, thus increasing the possibility of saving children's eyesight. 
• In Jan 2022, Medicover acquired NIPD Genetics. This leading innovative biotechnology company actively develops, produces, and provides in-vitro genetic testing solutions. NIPD Genetics' prenatal testing technology and expertise complement and expand Medicover's genetic providing in its markets. At the same time, NIPD Genetics' regional reach enables Medicover to enter new markets more quickly with a combined product portfolio.

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