Non-invasive Prenatal Testing Market Size, Share & Trends Analysis Report By Product Type (Consumables, Instruments), By Technology (Next Generation Sequencing (NGS), Microarray, Polymerase Chain Reaction (PCR), Others), By Application (Trisomy, Microdeletion Syndrome, Others), By End User (Hospitals, Diagnostic laboratories) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2024-2032

Non-invasive Prenatal Testing Market Size

The global non-invasive prenatal testing market size was valued at USD 3.93 billion in 2023. It is projected to reach USD 8.98 billion by 2032, growing at a CAGR of 9.2% during the forecast period (2024–2032).

Non-invasive prenatal testing is a procedure used to determine the genetic abnormalities of the fetus. The procedure screens the fetus for genetic disorders such as Down syndrome, Edwards syndrome, and Patausyndrome. Small DNA fragments that are floating about in a pregnant woman's blood are examined by this test. It is regarded as non-invasive because just the pregnant patient's blood must be drawn, posing no risk to the fetus.

The market is witnessing high investments in technological improvements. High demand for non-invasive techniques and technological advancements by manufacturers to offer better solutions are expected to continue rising in the coming years. For instance, GE Healthcare launched LOGIQ E9 XDclear 2.0 ultrasound system and showcased 25 new products at the Radiological Society of North America. These products provide improved performance and better clinical results for clinicians and hospitals globally.

Non-invasive Prenatal Testing Market Growth Factors

Increasing Maternal Age

Maternal age around the world and the rising number of working women in developing regions are contributing significantly to the market growth. Advancing maternal age increases the number of the risk of genetic disorders in babies resulting in abnormalities such as microcephaly, short neck, upward slanted eyes, poor muscle tone, heart, intestine, and breathing problems. Over time, there is a rising likelihood of having a kid with down syndrome. A woman who conceives at age 25 runs a risk of around 1 in 1,250. If a woman conceives when she is 40, the likelihood rises to roughly 1 in 100. Prenatal genetic counseling, which aids in predicting the risk of fetal chromosomal disorders depending on age, has been in high demand as the frequency of pregnancies in older women has increased. This has fueled the growth of the non-invasive prenatal testing business.

Technological Advancements

The development of extremely sophisticated screening methods that are highly sensitive and accurate in the early detection of genetic abnormalities in newborns is a continuing priority for a number of businesses. Manufacturers are heavily focusing on the creation of advanced non-invasive prenatal testing and forming strategic alliances and collaborations to boost their market share. In order to find chromosomal anomalies, many nations are also including screening in their health care plans. This has accelerated the non-invasive prenatal testing market's rise.

Market Restraining Factors

Government Regulations

Despite the advancements, there are certain growth constraints on the non-invasive prenatal testing industry, such as strict regulations imposed by governments in various nations. Controlling regulations and ethical concerns are important factors that are anticipated to hinder the global market for non-invasive prenatal testing throughout the forecast period. However, in order to remain active in the market, manufacturers must create products that adhere to regulatory criteria for medical equipment. This regulatory change takes too long to approve medical equipment, which slows down the devices' rapid invention and development. As a result, the market for non-invasive prenatal testing is being restricted by stringent regulatory regulations.

Market Opportunities

Emerging Economies

Over the projection period, emerging nations like China, India, and Mexico are anticipated to present considerable growth prospects for the non-invasive prenatal testing industry. The presence of a sizable target patient population, improved healthcare facilities, rising public healthcare spending, and greater awareness of cutting-edge technologies are all key contributors to the rapid growth in these markets. Major market players are concentrating on strategies like partnerships, collaborations, and expansions to improve their product availability and distribution networks in these nations in order to address the growing need for early diagnosis and treatment and take advantage of market growth opportunities.

Regional Insights

North America Dominates the Global Market

North America holds the largest market share in the non-invasive prenatal testing market. The growing prevalence of chromosomal aneuploidies in the fetus and the increasing adoption of non-invasive prenatal testing are primarily propelling the industry's growth in the region. North America is likely to lead the market due to an increase in maternal age. For instance, according to CDC, in 2016, around 10% of babies were born to first-time mothers at the age of 35 years or older. In addition, the average age of first-time mothers rose from 24.9 years in 2000 to 28 years in 2020 in the US.

Asia-Pacific: Fastest growing region with the highest CAGR

Asia Pacific's non-invasive prenatal testing market is expected to witness significant growth on account of increasing cases of miscarriages due to insufficient nutritional intake during pregnancy, decreased fertility, and increasing maternal age, especially in India and China. China has the greatest population of people with rare diseases in the world, and it has a very difficult time responding to these disorders. Faced with these obstacles, China has implemented a number of efforts to enhance the care provided to patients with rare diseases, such as a newborn screening program and the reimbursement of medical costs for infants with congenital heart disease and leukemia. NIPT has been used in China since 2010, and the majority of the NIPT technology is produced by US businesses. China had the most examined samples, over twice as many as the US and 33 times as many as Europe, indicating a sizable NIPT market in that country.

Europe is likely to emerge as the third largest non-invasive prenatal testing market globally. This can be attributed to the rising maternal age in the region. For instance, Eurostat reported in 2013 that around 40.6% of first-time mothers belonged to the age group of 30 years and above. Additionally, around 65,500 births of first children were reported in women aged more than 40 years in the same year. Fourteen nations in Europe have made NIPT a part of their national policies. Only two nations—Belgium and the Netherlands—provide NIPT to all expectant mothers, while the majority of other European nations only give it to higher-risk women following the first-trimester screening.

LAMEA is expected to witness steady growth in the forecast period. Lack of awareness about these technologies and the poor economic condition of African countries are the factors for the steady growth of the market. In the developing world, the accessibility of prenatal genetic technologies varies greatly. Prenatal testing is more accessible and has more information in urbanized areas, where most upper-class and upper-middle-class people reside. Prenatal care is unavailable in rural areas, urban slums, or other areas with few resources. Patients who have better levels of education, higher incomes, and insurance coverage are more likely to use non-invasive prenatal testing in the region. 

Non-invasive Prenatal Testing Market Segmentation Analysis

By Product Type

In the product type category, consumables dominate the non-invasive prenatal testing (NIPT) market due to their essential role in conducting each test. Consumables include reagents, assays, and kits, which are necessary for processing samples and obtaining accurate test results. Each NIPT cycle requires a fresh set of consumables, leading to their recurrent and continuous demand. As the number of NIPT procedures increases globally, the demand for these consumable products grows correspondingly. Additionally, ongoing advancements in consumable products, such as improved reagents and more sensitive assays, enhance the precision and reliability of tests, driving further adoption of NIPT. This constant need for consumables in every test cycle, coupled with technological advancements that improve test accuracy, supports their dominance in the market. As NIPT becomes more widely adopted for early detection of genetic abnormalities, the consumables segment will likely continue to see robust growth.

By Test Type

Cell-free DNA in maternal plasma tests are the dominant test type in the non-invasive prenatal testing (NIPT) market due to their high accuracy and ability to detect chromosomal abnormalities early in pregnancy. These tests analyze small fragments of fetal DNA circulating in the mother's blood, offering a non-invasive and safe alternative to traditional invasive procedures like amniocentesis. Unlike ultrasound detection and biochemical screening tests, which may require further confirmatory testing, cfDNA tests can detect conditions such as Down syndrome with a high degree of sensitivity and specificity. Their non-invasive nature, coupled with the ability to provide early and reliable results, makes cfDNA testing the preferred choice for both healthcare providers and patients, driving its dominance in the market.

By Technology

Next Generation Sequencing (NGS) is the leading technology in the NIPT market due to its high accuracy and ability to detect multiple genetic conditions in a single test. NGS allows for detailed analysis of fetal DNA with greater precision, making it the preferred method for detecting chromosomal abnormalities such as trisomies and microdeletions. Its ability to provide detailed insights into the fetal genome with minimal errors has positioned NGS as the gold standard in prenatal testing. The increasing adoption of NGS technology is supported by ongoing advancements that improve speed, reduce costs, and enhance the accessibility of testing.

By Application

In the application category, trisomy testing is the dominant segment. Trisomy refers to the presence of an extra chromosome, with Trisomy 21 (Down syndrome) being the most common condition screened for in prenatal testing. The high prevalence of trisomies and the significant impact these conditions have on fetal development drive the demand for trisomy testing. Early detection of trisomies is crucial for informed decision-making and management during pregnancy, contributing to the prominence of this application in the NIPT market. As awareness of genetic conditions increases, so does the demand for trisomy testing as part of routine prenatal care.

By End User

Diagnostic laboratories are the primary end users in the NIPT market, due to their specialized infrastructure and expertise in conducting genetic testing. Laboratories are equipped with advanced technologies and skilled personnel necessary for accurate analysis of NIPT results. They handle a large volume of tests, making them central to the NIPT ecosystem. The complexity of genetic testing requires the precision and reliability that diagnostic laboratories provide, which contributes to their dominance in the market. Additionally, collaborations between laboratories and healthcare providers ensure efficient testing and timely delivery of results, further solidifying their role as the leading end user segment.

Recent Developments

• In January 2024, Ivy Fertility, a global leader in family-building services, announced a new partnership with SMP Pharmacy Solutions, a fertility specialty pharmacy, aimed at enhancing the patient experience across Ivy’s 13 fertility centers through a groundbreaking co-branding initiative. The two organizations will introduce co-branded packaging for fertility medications, designed to create a seamless experience from clinic to home. This collaboration underscores both organizations’ commitment to empowering patients on their path to parenthood by providing comprehensive support and innovative solutions.

• In March 2024, Alife Health, a leading fertility technology company specializing in artificial intelligence (AI) tools for in vitro fertilization (IVF), announced a groundbreaking partnership with Boston IVF, one of the largest fertility clinic networks in the U.S. This collaboration aims to pilot the country’s first AI tool for optimizing IVF medication use, enhancing treatment efficiency, and reducing costs for patients.