Prenatal Genetic Testing Market

The global Prenatal Genetic Testing Market was valued at USD 9.5 Billion in 2022 and is projected to reach a value of USD 24.9 Billion by 2030 at a CAGR (Compound Annual Growth Rate) of 14.8% between 2023 and 2030.

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Due to a large pool of health-conscious consumers, growth and innovation in the medical devices industry for producing sophisticated diagnostic and screening devices present an opportunity for the prenatal and newborn genetic testing market. The escalating prevalence of congenital malformations and genetic abnormalities is the primary factor for market expansion. 6% of infants worldwide are born with a congenital anomaly, according to the World Health Organization (WHO), and it is one of the leading causes of the global burden of disease, especially in low- and middle-income countries. In addition, the increase in demand for non-invasive prenatal screening positively affects the market size of prenatal and newborn genetic testing. Doctors prefer non-invasive prenatal screening methods for genetic testing due to the benefits of non-invasive sample collection, high accuracy and precision, less pain, and rapid diagnosis compared to conventional methods.

In addition, the market for prenatal and newborn genetic testing is anticipated to be driven by the high potential in emerging markets, such as India and Japan, due to the availability of improved healthcare infrastructure, an increase in unmet healthcare needs, a rise in the pregnancy rate, and an increase in awareness about prenatal and newborn genetic testing. In addition, the healthcare industry in emerging economies is expanding rapidly due to increased demand for enhanced healthcare services and substantial government investments to improve healthcare infrastructure. The growth of the Prenatal and Newborn Genetic Testing Market is fueled by the fact that the demand for prenatal testing is not limited to developed nations but is also evident in developing nations such as China, Japan, and India.

In the coming years, factors such as a rise in the incidence of Down's syndrome, a rise in the number of women with advanced maternal age, a rise in R&D investments in the discovery & development of novel screening methods, and a rise in awareness about the early detection of diseases will create a lucrative market opportunity for prenatal and newborn genetic testing.

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In 2020, the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine reported that novel NIPT has the highest detection rate and the lowest number of false positive results for aneuploidies. However, the likelihood of miscarriage due to certain prenatal tests is the primary factor impeding the expansion of the prenatal and neonatal genetic testing market. During the second trimester of pregnancy, amniocentesis is the most common non-invasive prenatal test. However, it carries a risk of miscarriage. In addition, the high cost of screening methods and diagnostic tests is expected to impede market expansion. Chronic villus sampling, for example, costs approximately $3,050.

Economic Insights

The COVID-19 pandemic resulted in the most recessive state worldwide, projected to last a few more years. The worldwide economic graph showed some of the sharpest drops between 2022 and 2022. However, the proactiveness demonstrated by various governments through stimulus and forceful vaccination enabled most states and countries on a global scale to clean up the mess and experience reignited growth in the future. Regarding economic impact, the ongoing conflict between Russia and Ukraine is anticipated to deteriorate during the forecast period. The global economy is projected to slow due to large and historic shocks caused by Russia's actions against Ukraine. Factors such as rising inflationary pressures, dwindling confidence and household purchasing power, and rising dangers will likely impair global market income.

Top Market Trends

1. Rising Demand for Non-Invasive Prenatal Genetic Testing: High demand for early Non-Invasive Prenatal Testing (NIPT) and enhancements in the reimbursement scenario are expected to drive market growth during the forecast period. The reimbursement for non-invasive prenatal diagnostics varies across insurance plans due to contract differences. The prices listed for NIPT range from over $2,000 to less than $1,000. However, research indicates that first-line NIPT screenings have become extremely cost-effective and are now available at prices ranging from $619 to $744. Diverse nations, including the Netherlands, are implementing policies to entirely reimburse NIPT in the second trimester, increasing the use of these tests. In addition, countries like Germany intend to reimburse noninvasive prenatal diagnostics for chromosomal disorders like Down syndrome. In various countries, the demand for NIPT is increasing due to several factors, including physicians opting for advanced genetic testing for high-risk pregnancies, a desire to defer pregnancy, and an increase in pregnancy-related complications in the third or second trimester. Using invasive prenatal testing techniques, such as chorionic villus sampling and amniocentesis, can result in complications such as miscarriage. This has resulted in a decline in the use of these procedures and increased demand for more effective, noninvasive, and secure tests. Using cell-free fetal DNA (cffDNA) that circulates in the mother's blood, NIPT can detect common trisomies in the fetus, such as Turner syndrome, Down syndrome, fetal rhesus D status, and sex chromosome disorders, as well as determine fetal sex.
2. Rising Instances of Cancer: During a person's lifetime, genetic testing assists in identifying the risk of developing various forms of cancer. Genetic tests are available to detect inherited variants and mutations in the DNA sequence, which may result in excessive cell proliferation and cancer. For example, genetic testing for the identification of PALB2 (associated with increased risks of breast and pancreatic cancers), CHEK2 (associated with increased risks of breast and colorectal cancers), BRIP1 (associated with ovarian cancer), and RAD51C and RAD51D (associated with ovarian cancer). The increasing prevalence of cancers worldwide and the growing awareness of preventive diagnosis and personalized medicine among the global population are the primary factors propelling the cancer segment during the forecast period. The American Cancer Society projects that there will be approximately 1,898,160 new cancer cases and 608,570 cancer fatalities in the United States in 2021. According to the International Agency for Research on Cancer (IARC), the number of new cancer cases is projected to reach 30,2 million by 2040. Consequently, an increase in cancer incidence is anticipated to significantly contribute to the segment's growth.

Market Segmentation

The global Prenatal Genetic Testing market can be categorized on the following: Technology, Screening Method, Disease, End User, Product, and Region. Based on Technology, the market can be categorized into Diagnostics Methods, Polymerase Chain Reaction, Array Comparative Genomic Hybridization (ACGH), and Fluorescence in Situ Hybridization (FISH). Additionally, based on Screening Type, the market can be split further into Non-Invasive Prenatal Tests, Maternal Serum Screening, Screening Techniques, Carrier Screening, Sequential Screening, and Maternal Serum Quad Screening. Moreover, based on Diseases, the global market can be differentiated into Alzheimer's Disease, Cancer, Cystic Fibrosis, Sickle Cell Anemia, Duchenne Muscular Dystrophy, Thalassemia, Huntington's Disease, Rare Diseases, and Other Diseases. In addition, based on End Users, the market can be broken down into Hospitals, Clinics, and Diagnostic Centers. Additionally, based on Product, the market can be fragmented into Consumables, Assay Kits and Reagents, Disposables, Instruments, Next Generation Sequencing Systems, Polymerase Chain Reaction Instruments, Microarrays, Ultrasound Devices, and Other Instruments. Likewise, the market is segmented based on Region into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

Based on Technology

Diagnostics Methods to Target Higher Sales Due to Vast Applications

Diagnostic methods are the most employed technology in the Prenatal Genetic Testing market. This is because diagnostics methods offer vast applications in Prenatal Genetic Testing and provide exhaustive and accurate information about the fetus. In addition, diagnostic methods have a high degree of sensitivity, specificity, and accuracy, which makes them extremely reliable for prenatal diagnosis. In addition to being non-invasive, diagnostic methods are secure for both the fetus and the mother. These elements have contributed to recognizing diagnostic methods in the Prenatal Genetic Testing market. In addition, diagnostics methods can detect a vast array of genetic disorders, chromosomal abnormalities, and inherited diseases, which makes them highly advantageous for prenatal screening and diagnosis. These benefits have led to the widespread adoption of Diagnostic Methods in the market for Prenatal Genetic Testing.

Based on End User

Hospitals to Dominate Market Due to Better Service & Operability

Because of the availability of qualified medical staff in hospitals, which helps to offer better services to patients and gives extra benefits of diagnosis and treatment of neuromuscular diseases, including genetic abnormalities, the hospital's segment held the greatest market share in 2022. This was because hospitals assist in providing better services to patients. On the other hand, diagnostic centers are expected to have the highest growth rate throughout the forecast period. This is because these clinics provide comprehensive pre-pregnancy and prenatal treatment, minimizing the likelihood of issues arising during pregnancy.

Based on Product

Consumables will be Sold at a Maximum Rate owing to Increasing Product Launches

Large companies offering a diverse selection of NIPT consumables and reagents contributed to the dominance of the consumables and reagents section of the market in 2022. As a result, this segment held the dominating portion of the market. For instance, Roche's CE-marked Harmony IVD Kit is a non-invasive prenatal testing method subjected to considerable research and validation. This method has been used to screen more than 1.8 million pregnancies. The Harmony test is extremely accurate and has a false-positive rate of less than 0.1% for trisomies 13, 18, and 21. As a result of the persistent efforts that instrument manufacturers put into developing cutting-edge platforms, it is anticipated that the instruments sector will experience profitable growth over the projection period. Vanadis NIPT System is an automated device offered by PerkinElmer, Inc. It is designed to solve the limits associated with the cost, complexity, and capacity of other NIPT technologies that screen for aneuploidy. This platform is the only one available for NIPT screening that enables analysis of targeted cfDNA without PCR or next-generation sequencing.

Based on Region

North America is to be Valued at the Maximum owing to the Presence of Dominant Players

North America dominated the prenatal and new-born genetic testing market in 2022 and is anticipated to maintain its dominance throughout the forecast period due to the strong presence of several major players, such as Abbott Laboratories, PerkinElmer Inc., and Mettler Toledo, as well as technological advancements in PCR diagnostic methods. Additionally, the increasing number of expectant women undergoing genetic screening in this region contributes to expanding the market. In addition, high purchasing power and rising awareness of numerous inherited genetic diseases are anticipated to drive market expansion. World Down Syndrome Day is observed annually on March 21 to raise awareness about diagnosing and treating individuals with Down syndrome.

During the forecast period, the Asia Pacific is anticipated to expand at the highest rate. This is due to several regional medical device manufacturers and the rising purchasing power of populous nations like Japan and India. In addition, the increase in healthcare expenditures, the growing adoption of innovative screening methods, and the rise in the pregnancy rate all contribute to the expansion of the market. In addition, the Asia-Pacific region has the largest medical device industry, with abundant raw materials that are readily accessible to manufacturers; this, in turn, drives the market growth. Asia-Pacific offers lucrative opportunities for key players operating in the prenatal and newborn genetic testing market, thus registering the fastest growth rate during the forecast period due to rising disposable incomes and the region's well-established presence of domestic companies. In addition, the increase in genetic abnormalities among newborns contributes to expanding the market.

Competitive Landscape

This market is consolidated due to the extensive product offerings and robust distribution networks of key players in developing and developed nations. In addition, businesses are implementing various strategic initiatives, such as partnerships, mergers, acquisitions, and product expansions, to strengthen their market position. For example, Next-Generation Genomic Co., Ltd. and Illumina, Inc. introduced VeriSeq NIPT Solution v2 in Thailand in June 2021. VeriSeq NIPT Solution provides accurate, dependable, scalable, and rapid genome-wide Prenatal Genetic Testing from beginning to end.

The key players in the global Prenatal Genetic Testing market include - Abbott (U.S.), Siemens Healthineers AG (Germany), Quidel Corporation (U.S.), F. Hoffman-La Roche Ltd. (Switzerland), Danaher. (U.S.), B.D. (U.S.), Chembio Diagnostics (U.S.), Trinity Biotech plc (Ireland), Instrumentation Laboratory (U.S.), Nova Biomedical (U.S.), PTS Diagnostics (U.S.), Sekisui Diagnostics (U.S.), Thermo Fisher Scientific (U.S.), DiaSorin S.p.A (Italy), AccuBioTech Co., Ltd. (China), Meridian Bioscience (U.S.), GeneSTAT Molecular Diagnostics, LLC (U.S.), Terumo Corporation (Japan), Grifols, S.A (Spain) among others.

Recent Market Developments

• June 2022: Prenetics Group Limited, a leader in genomic and diagnostic testing, has introduced ColoClear by Circle (ColoClear), a novel, non-invasive, at-home screening test for detecting early symptoms of colorectal cancer.
• May 2022: In Europe, Illumina, a company specializing in genome sequencing, has introduced a cancer test that tests for many tumor genes in a single tissue sample, potentially facilitating the matching of patients with rare diseases to appropriate treatments.

Segmentation of the Global Prenatal Genetic Testing Market