Prenatal and Newborn Genetic Testing Market Report 2025

This report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.

The prenatal and newborn genetic testing market size has grown rapidly in recent years. It will grow from $6.68 billion in 2024 to $7.61 billion in 2025 at a compound annual growth rate (CAGR) of 13.9%. The growth in the historic period can be attributed to improved non-invasive prenatal testing, increased maternal age, government support and healthcare policies, patient demand for early detection.

The prenatal and newborn genetic testing market size is expected to see rapid growth in the next few years. It will grow to $12.04 billion in 2029 at a compound annual growth rate (CAGR) of 12.1%. The growth in the forecast period can be attributed to expanded genetic test panels, increasing maternal health awareness, prenatal and newborn screening guidelines, rising focus on rare diseases, ethical and regulatory considerations. Major trends in the forecast period include non-invasive prenatal testing (NIPT), genome sequencing (WGS) and whole exome sequencing, integration of artificial intelligence (AI), preimplantation genetic testing (PGT), direct-to-consumer genetic testing.

Government initiatives and backing for prenatal testing and newborn genetic screening are anticipated to propel the expansion of the prenatal and newborn genetic testing markets in the foreseeable future. Such initiatives encompass specific actions, programs, or policies introduced by governmental bodies at various levels to address particular issues or promote the well-being of citizens. By advocating for and supporting prenatal and newborn genetic testing programs, governments contribute to the identification of genetic abnormalities or conditions in fetuses during pregnancy or shortly after birth. An illustration of this is seen in the Australian government's allocation of $1.3 million annually to the New South Wales (NSW) newborn screening program in June 2022. This funding facilitated free testing for severe combined immunodeficiency (SCID) and spinal muscular atrophy (SMA), providing genetic screening to all newborns in the state and potentially saving the lives of 13 infants with these genetic disorders among the 100,000 babies born yearly. Hence, government initiatives fortifying prenatal and newborn genetic screening drive the growth of the respective testing markets.

The rising incidence of genetic disorders is anticipated to drive growth in the prenatal and newborn genetic testing market in the future. Genetic disorders are medical conditions caused by abnormalities or mutations in an individual's DNA or genetic material. Prenatal and newborn genetic testing enables the early identification of these disorders, often before symptoms appear, allowing healthcare providers to implement timely interventions and treatment strategies. For example, in May 2024, the Centers for Disease Control and Prevention (CDC), a US-based public health agency, reported that sickle cell disease (SCD) affects approximately 100,000 individuals in the United States. Among those affected, over 90% are non-Hispanic Black or African American, while an estimated 3%-9% are Hispanic or Latino. Thus, the increasing prevalence of genetic disorders is propelling the growth of the prenatal and newborn genetic testing market.

Leading companies in the prenatal and newborn genetic testing sectors are concentrating on developing innovative screening tests, particularly noninvasive prenatal screening tests, to enhance accessibility and affordability while ensuring dependable services for customers. Noninvasive prenatal screening (NIPS) or noninvasive prenatal testing (NIPT) represents an advanced and secure genetic screening method conducted during pregnancy to evaluate the risk of specific fetal chromosomal abnormalities. An instance of this advancement is Juno Diagnostics Inc.'s introduction of Juno Hazel in November 2022. This noninvasive prenatal screening test identifies chromosomal anomalies and offers clinical content using a sample collection kit, eliminating the necessity for phlebotomy and enhancing accessibility. Additionally, the company intends to provide educational resources and personalized genetic counseling support by partnering with healthcare professionals and genetic counselors.

In February 2024, CooperSurgical Inc., a US-based medical equipment manufacturing company, formed a partnership with Fulgent Genetics to enhance its offerings in the prenatal and newborn genetic testing market. This collaboration aims to leverage Fulgent Genetics' expertise in advanced genetic testing solutions, particularly for families using the Cord Blood Registry. Fulgent Genetics Inc. specializes in providing a range of prenatal and newborn genetic testing services, which aligns with CooperSurgical's goals of expanding its portfolio and improving access to critical genetic testing options for expectant families.

Major companies operating in the prenatal and newborn genetic testing market report are F. Hoffmann-La Roche AG, Novartis AG, Sanofi S.A., Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Siemens Healthineers AG, Becton, Dickinson and Company, Quest Diagnostic Incorporated, Agilent Technologies Inc., Grifols S.A., Terumo Corporation, Illumina Inc., PerkinElmer Genomics, Quidel Corporation, Bio-Rad Laboratories Inc., Qiagen NV, Werfen S.A., DiaSorin S.p.A, Nova Biomedical, BGI Group, Natera Inc., Trinity Biotech PLC, Meridian Bioscience Inc., Sekisui Diagnostics, Chembio Diagnostics, PTS Diagnostics, Ariosa Diagnostics Inc., AccuBioTech Co. Ltd., Sequenom Inc.

North America was the largest region in the prenatal and newborn genetic testing market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the prenatal and newborn genetic testing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the prenatal and newborn genetic testing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The prenatal and newborn genetic testing market consists of revenues earned by entities by providing services such as prenatal screening tests, prenatal diagnostic tests, carrier screening for genetic conditions, and newborn screening tests. The market value includes the value of related goods sold by the service provider or included within the service offering. The prenatal and newborn genetic testing market also includes sales of electrophoresis equipment, genetic sequencing machines, and microarray analysis instruments. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

Prenatal and newborn genetic testing encompasses medical procedures and screenings conducted during pregnancy and after birth to assess the genetic health and risk factors of both the developing fetus and the newborn baby. These tests are crucial for detecting and identifying genetic disorders, congenital conditions, or hereditary diseases that may impact the child's health or development.

The primary product types within the prenatal and newborn genetic testing domain include consumables and instruments. Instruments refer to specialized tools or devices designed for specific tasks or measurements, including various genetic analyzers used by healthcare professionals to conduct screenings and tests. Various screening methods include non-invasive prenatal testing, chronic villus sampling, amniocentesis, maternal serum screening, and others. The tests aim to identify diseases such as Down syndrome, phenylketonuria, cystic fibrosis, and sickle cell anemia. These genetic testing products find application across diverse end-users, including hospitals, maternity and specialty clinics, and diagnostic centers.

The prenatal and newborn genetic testing market research report is one of a series of new reports that provides prenatal and newborn genetic testing market statistics, including prenatal and newborn genetic testing industry global market size, regional shares, competitors with a prenatal and newborn genetic testing market share, detailed prenatal and newborn genetic testing market segments, market trends and opportunities, and any further data you may need to thrive in the prenatal and newborn genetic testing industry. This prenatal and newborn genetic testing market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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