[144 Pages Report] The global non-invasive prenatal testing (NIPT) market is estimated to reach USD 7.3 billion by 2024 from USD 3.9 billion in 2019, at a CAGR of 13.5% during the forecast period. Growth in this market is driven by the high risk of chromosomal abnormalities with increasing maternal age, growing preference for non-invasive techniques over invasive methods, improving reimbursement scenario for NIPT, and increasing awareness of NIPT. However, a dearth of skilled professionals is restraining the growth of this market.

The cfDNA in maternal plasma tests segment is expected to grow at the highest CAGR during the forecast period

By method, the NIPT products market is segmented into ultrasound detection, biochemical screening tests, and cell-free DNA in maternal plasma tests. The cfDNA in maternal plasma tests segment is expected to grow at the highest CAGR during the forecast period. The high growth of this segment is attributed to technological advancements and increasing company initiatives to develop new products.

The trisomy applications segment accounted for the largest share of the global NIPT market in 2018.

Based on application, the non-invasive prenatal testing (NIPT) market is segmented into trisomy, microdeletion syndrome, and other applications (gender identification and the detection of monogenic disorders, Klinefelter syndrome, and Rhesus (Rh) blood type). In 2018, trisomy was the largest application segment of the NIPT market. This segment is also estimated to grow at the highest CAGR during the forecast period. The large share and high growth of this segment can primarily be attributed to factors such as the increasing maternal age and the rising incidence of chromosomal abnormalities.

The diagnostic laboratories segment accounted for the largest share of the NIPT products market in 2018.

Based on end user, the NIPT products market is classified into diagnostic laboratories and hospitals. In 2019, diagnostic laboratories formed the largest and fastest-growing end users of NIPT products. This can primarily be attributed to factors such as the implementation of initiatives by diagnostic laboratories to provide safe and effective prenatal tests and rising incidence of chromosomal abnormalities.

North America accounted for the largest share of the NIPT market in 2018.

Geographically, the non-invasive prenatal testing market is segmented into North America, Europe, Asia, and the Rest of the World (RoW). In 2019, North America accounted for the largest market share, followed by Europe. On the other hand, Asia is expected to grow at the highest CAGR during the forecast period. The developing healthcare infrastructure, rising awareness programs & conferences, and rising focus of prominent players on expanding their presence in Asia are driving market growth in this region

Market Dynamics

Driver: High risk of chromosomal abnormalities with increasing maternal age

Maternal age refers to the age of women at the time of delivery. Advancing maternal age can result in a number of health complications, such as decreased fertility, high blood pressure, and an increase in the risk of miscarriage, stillbirths, and maternal death. Moreover, advancing maternal age can increase the risk of genetic disorders in babies as a result of the improper chromosomal division. The resulting abnormalities in babies may include microcephaly; short neck; upward slanted eyes; poor muscle tone; and heart, intestine, and breathing problems.

In the US, around 10% of babies were born to first-time mothers aged 35 and over, in 2016. Also, the median age of first-time mothers in the country increased from 24.9 years in 2000 to 26.3 years in 2014 (Source: CDC).

According to Eurostat, in 2017, around 45% of women in the European Union who gave birth to their first child belonged to the average age group of 29.1 years. Also, in the same year, around 78,275 births of first children were reported in women aged more than 40 years.

In England, the average age of first-time mothers increased from 27.9 years in 2011 to 28.8 years in 2017 (Source: Office for National Statistics).

In Australia, the average age of first-time mothers increased from 27.8 years in 2003 to 29.0 years in 2016 (Source: Australian Institute of Health and Welfare).

These findings suggest that worldwide, there has been an increase in the advanced maternal age, which is likely to result in increased health complications. In order to detect genetic abnormalities resulting from improper chromosomal division, there is a growing demand for developing advanced and effective diagnostic procedures for early screening in expecting mothers. Non-invasive prenatal testing is one such upcoming field which utilizes cell-free DNA in maternal plasma/fetal cells in maternal blood to determine genetic abnormalities. Thus, the increasing maternal age, coupled with the increasing incidence of chromosomal abnormalities, is expected to drive the demand for NIPT tests.

Opportunity: Untapped emerging markets

Emerging countries such as China, India, Brazil, and Mexico are expected to offer significant growth opportunities to market players in the coming years. The high growth in these markets can majorly be attributed to the improving healthcare infrastructure, increasing public healthcare expenditure, the presence of a large target patient population, and growing awareness and availability of advanced technologies.

To address the growing need for early diagnosis and treatment and leverage market growth opportunities, major market players are focusing on the strategies of agreements, partnerships, collaborations, and expansions to enhance their product availability and distribution networks in these countries. For instance, in February 2017, Premaitha Health plc (UK) acquired Yourgene Bioscience Co., Ltd. (Taiwan), a NIPT bioinformatics specialist. This acquisition will help Premaitha to increase its market in Asia for NIPT. Yourgene has also partnered with a NIPT service provider for increasing the use of NIPT testing in Indonesia. In December 2014, Prenetics (China) received USD 2.65 million from investors for conducting NIPT and the development of screening kits in Hong Kong. Furthermore, in October 2014, BGI Dx, a subsidiary of BGI (China) and Bioscience Genomics, signed a five-year Framework Agreement for the transfer of healthcare technologies in the field of personalized medicine and NIPT between China and Italy. Due to the presence of a favorable and less-stringent regulatory scenario, market players are focusing on expanding their presence in the emerging markets.

Challenge: Reliability of test results, especially in obese women

NIPT tests can be performed in patients between 10 and 20 weeks of the gestation period. These tests require the extraction of fetal DNA from maternal blood to determine chromosomal abnormalities. The majority of cell-free DNA circulating in maternal blood is of maternal origin, and only 10�15% is of fetal origin. The amount of fetal fraction in the blood is affected by a number of factors. Maternal weight is one such factor, which significantly influences the quantity of fetal fraction in maternal blood. The plasma of obese women has low traces of fetal DNA and hence, may not produce appropriate results for analyzing trisomy and other disorders. As a result, patients weighing more than 250 pounds are at risk of giving inconclusive results (Source: Non-invasive Prenatal Testing Services to Change for Texas Medicaid, March 2016). This inhibits the use of NIPT in screening chromosomal abnormalities in obese women. In addition, positive results given by NIPT may further require a confirmatory test with the help of invasive methods, such as amniocentesis and CVS. This poses a major challenge to the growth of the NIPT market.

Scope of the Report

Report Metric Details Market size available for years 2017�2024 Base year considered 2018 Forecast period 2019�2024 Forecast units Value (USD) Segments covered Product and Service, Application, and Region Segments covered (NIPT products and service) Method and End user Geographies covered North America (US and Canada), Europe (Germany, UK, France, and RoE), Asia, and the Rest of the World Companies covered Illumina, Inc. (US), Thermo Fisher Scientific Inc. (US), GE Healthcare (US), BGI (China), Agilent Technologies, Inc. (US), F. Hoffmann-La Roche Ltd. (Switzerland), PerkinElmer Inc. (US), Laboratory Corporation of America Holdings (US), Natera, Inc. (US), and Yourgene Health (UK)

The research report categorizes the global NIPT market into the following segments and subsegments:

Non-invasive Prenatal Testing Market, by Product

Products

Consumables

Assay Kits & Reagents

Disposables

Instruments

NGS Systems

PCR Instruments

Microarrays

Ultrasound Devices

Other Instruments

Services

Note: Other instruments include centrifuges, UV systems, incubators, and microscopes.

Non-invasive Prenatal Testing Products Market, by Method

Ultrasound Detection

Biochemical Screening Tests

Cell-free DNA in Maternal Plasma Tests

Non-invasive Prenatal Testing Market, by Application

Trisomy

Microdeletion Syndrome

Other Applications

Non-invasive Prenatal Testing Products Market, by End User

Diagnostic Laboratories

Hospitals

Non-invasive Prenatal Testing Market, by Region

North America

US

Canada

Europe

Germany

France

UK

Rest of Europe (RoE)

Asia

Rest of the World (RoW)

Key Players in the Global NIPT Market

The NIPT market is diversified and highly competitive, with a large number of players competing for market space. The prominent players in the market are Illumina, Inc. (US), Thermo Fisher Scientific Inc. (US), GE Healthcare (US), BGI (China), Agilent Technologies, Inc. (US), F. Hoffmann-La Roche Ltd. (Switzerland), PerkinElmer Inc. (US), Laboratory Corporation of America Holdings (US), Natera, Inc. (US), and Yourgene Health (UK)

Illumina, Inc. (US)

Illumina is one of the major players in the non-invasive prenatal testing market. The company offers a range of highly interconnected products related to sequencing, genotyping, gene expression, and molecular diagnostics. It also offers whole-genome sequencing, genotyping, NIPT, and support services which further strengthen its market position.

Over the past three years, Illumina has launched several products to sustain its leading position in the NIPT market. For this purpose, the company has invested a significant amount of its revenue on R&D expenditure. In 2018, Illumina invested 18.6% of its revenue on R&D. In January 2019, Illumina expanded its NIPT platform portfolio with the launch of its VeriSeq NIPT Solution v2.

The company also focuses on inorganic strategies with leading players in the market to co-develop advanced technologies and strengthen its research & commercialization capabilities. Illumina is expected to grow at a high rate in the NIPT market during the forecast period, owing to its strong product portfolio, product innovation capabilities, and wide geographic presence.

Recent Developments

In June 2019, BGI and Eluthia (Germany) launched the NIFTY test (non-invasive prenatal test), under the brand name PreviaTest in Germany.

In January 2019, Illumina expanded its NIPT platform with the launch of VeriSeq NIPT Solution v2.

In November 2018, Illumina and Pacific Biosciences signed an agreement for Illumina to acquire Pacific Biosciences. This acquisition will allow Illumina to strengthen its sequencing solutions platform with accurate long-read sequencing capabilities.

In January 2017, Agilent Technology acquired Multiplicom N.V. (Belgium) in order to create comprehensive offerings for next-generation sequencing solutions. Multiplicom develops and commercializes molecular diagnostic solutions which are useful in the identification of congenital defects early in pregnancy and other genetic diseases

Key Questions Addressed by the Report

Where will all these developments take the industry in the mid to long-term?

What types of annual and multi-year partnerships are NIPT product and service companies exploring?

Which are the key players in the market and how intense is the competition?

Which are the recent contracts and agreements key players have signed?

What are the recent trends affecting NIPT product and service providers?

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