Prenatal and Newborn Genetic Testing Global Market Report 2024

The prenatal and newborn genetic testing market size has grown rapidly in recent years. It will grow from $5.87 billion in 2023 to $6.68 billion in 2024 at a compound annual growth rate (CAGR) of 13.9%. The growth observed during the historic period can be attributed to several factors, including advancements in improved non-invasive prenatal testing methods, a rise in maternal age, support from governmental initiatives and healthcare policies, and increased patient demand for early detection of potential health issues during pregnancy.

The prenatal and newborn genetic testing market size is expected to see rapid growth in the next few years. It will grow to $10.7 billion in 2028 at a compound annual growth rate (CAGR) of 12.5%. The anticipated growth in the forecast period can be attributed to the expansion of genetic test panels, a growing awareness of maternal health, adherence to prenatal and newborn screening guidelines, an increased focus on rare diseases, and considerations related to ethics and regulations. Major trends expected during the forecast period include the widespread adoption of non-invasive prenatal testing (NIPT), the utilization of genome sequencing (WGS) and whole exome sequencing, the integration of artificial intelligence (AI) in genetic testing processes, the practice of preimplantation genetic testing (PGT), and the popularity of 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 mounting occurrence of genetic disorders is expected to drive the proliferation of the prenatal and newborn genetic testing market in the future. Genetic disorders denote medical conditions arising from abnormalities or mutations within an individual's DNA or genetic material. Prenatal and newborn genetic testing play a crucial role in identifying these disorders at an early stage, often before any symptoms become evident. This early identification enables healthcare providers to initiate timely interventions and treatment strategies, thus potentially averting or mitigating the impact of such conditions. For instance, statistics from 2021 from the Centers for Disease Control and Prevention (CDC) reveal that congenital disabilities affect approximately 3% of babies born in the United States annually, making them the leading cause of infant deaths, accounting for 20% of all infant mortalities. Hence, the rising incidence of genetic disorders propels the prenatal and newborn genetic testing market.

The ethical and legal ramifications present a potential impediment to the growth of the market in the forecast period. These implications refer to the consequences, considerations, and obligations linked to actions or decisions that encompass both ethical and legal facets. Within the prenatal and newborn genetic testing markets, ethical and legal concerns serve as constraints, impacting the accuracy and reliability of test outcomes while raising privacy and autonomy issues. For instance, as of July 2022, reports from the American Civil Liberties Union have highlighted authorities' attempts to access blood samples from newborns for criminal investigations. This exploitation of vast genetic data for law enforcement jeopardizes public trust in this vital health initiative and threatens genetic privacy rights by using this information to potentially link a child's relative to a crime. Consequently, ethical and legal implications related to genetic testing impede the prenatal and newborn genetic testing markets.

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 July 2021, Genetic Technologies Limited, an Australia-based biotechnology research firm, completed the acquisition of EasyDNA for $4 million. This strategic move by Genetic Technologies Limited is designed to broaden its geographic presence and harness the specialized skills and capabilities of EasyDNA. The objective behind this acquisition is to facilitate the development, production, and increased accessibility of carrier testing and non-invasive prenatal tests (NIPT), thereby catering to previously unaddressed market requirements. EasyDNA, a Malta-based company, specializes in DNA testing services, particularly in pre-conception and prenatal testing.

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 2023. 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.

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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