Non-invasive Prenatal Testing Market

Market Overview

The global non-invasive prenatal testing market size was valued at USD 3.60 billion in 2022. It is projected to reach USD 7.96 billion by 2031, growing at a CAGR of 9.2% during the forecast period (2023–2031).

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 non-invasive prenatal testing 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.

Market Dynamics

Market Drivers

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 Restraint

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 Analysis

The market is segmented into four geographical regions: North America, Europe, Asia Pacific, and Latin America, and the Middle East & Africa (LAMEA).

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 non-invasive prenatal testing 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'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. 

Segmental Analysis

The global non-invasive prenatal testing market is segmented by product, method, application, and end user.

By Product, the market is segmented into consumables and instruments.

Consumables are expected to grow at the fastest CAGR as these are preferred over instruments and are always in high demand. Products that are consumed or depleted during use are referred to as consumables. They are further segmented into assay kits & reagents, and disposables.

There are many different instruments used in non-invasive prenatal testing, including NGS systems, PCR equipment, microarrays, ultrasound devices, and others (centrifuges, microscopes, UV systems, incubators)

By Method, the market is segmented into biochemical screening tests, ultrasound detection, cell-free DNA in maternal plasma tests, and fetal cells in maternal blood tests.

Ultrasound detection is expected to hold the largest market share as it is cost-effective and widely available in developing regions.

Based on application, the market is segmented into trisomy, microdeletion syndrome, and other applications.

The trisomy segment will have the highest growth rate over the forecast period on account of increasing incidences of chromosomal abnormalities with an increasing maternal gap. The non-invasive prenatal testing has revolutionized prenatal screening for common trisomies 13, 18, and 21.

Based on end-user, the market is segmented into diagnostic laboratories and hospitals.

Diagnostic laboratories are expected to hold the largest market share. This is due to a number of causes, including the deployment of programs by diagnostic laboratories to provide safe and efficient prenatal diagnostics and an increase in the frequency of chromosomal abnormalities. Efforts by companies to provide advanced products to diagnostic laboratories are contributing to the growth of the segment.

Recent Developments

June 2021- Illumina has partnered with Next Generation Genomic Co., Ltd., the Association of Southeast Asian Nations (ASEAN) leaders in laboratory services and reproductive science, to launch the availability of the CE-IVD VeriSeq™ NIPT Solution v2 in Thailand following its regulatory approval in November 2020.

July 2021- PacBio announced the acquisition of Omniome for about $800 million. Through the acquisition, PacBio will have a special combination of two gene-sequencing technologies. PacBio plans to use the two technologies for non-invasive prenatal testing in particular.