Non-invasive Prenatal Testing Market: Global Size, Share, Trends, Growth and Forecast, 2022-2032

Non-invasive Prenatal Testing Market Key Highlights

The Global Non-invasive Prenatal Testing Market is expected to grow from USD 4.2 Billion in 2021 to USD 16.1 Billion by 2032, at a CAGR of 10.6% during the forecast period 2022-2032.

Non-invasive Prenatal Testing Market: Overview and Definition

Non-invasive prenatal testing (NIPT) is a type of prenatal screening test that uses cell-free DNA (cfDNA) technology to analyze a sample of a pregnant woman's blood to detect chromosomal abnormalities in the fetus. This test is performed during the first or second trimester of pregnancy and is typically recommended for women who are at a high risk of having a baby with a chromosomal abnormality, such as those who are older than 35 years of age, have a family history of genetic disorders, or have previously given birth to a child with a chromosomal abnormality. NIPT is considered a non-invasive alternative to invasive prenatal tests, such as amniocentesis or chorionic villus sampling (CVS), which carry a small risk of miscarriage. The NIPT market includes companies that offer cfDNA-based tests for detecting fetal chromosomal abnormalities, including Down syndrome, Edwards syndrome, and Patau syndrome, as well as certain sex chromosome abnormalities.

Technological advancements have not only served as a helping hand to the entire mankind but have also proven to be massively beneficial in curbing sufferings of people by enabling the implementation of preventive measures in various fields, especially in the medical field. With the emergence of innovative diagnostic and screening techniques, and innumerable advancements in the healthcare industry, several methods of genetic testing among other testing’s having gained popularity. The Non-invasive prenatal testing stands as one of the most distinctive technologies in addressing the concerns related to genetic diseases. The Non-invasive prenatal testing (NIPT), also known as cell-free DNA testing is nascent genetic processes of examining a fetal cell free DNA, present in the mothers blood serum for detecting common fetal aneuploidies. It is carried out through methods such as ultrasound detection, biochemical screening tests etc. which can indicate if pregnancy is at low risk or high risk for common chromosome disorders, including: Down syndrome (trisomy 21), (trisomy 18), (trisomy 13). Some of the NIPTs currently available worldwide are MaterniT21 PLUS, Harmony, Panorama, NIFTY, PrenaTest, BambniTest, and others. Global NIPT global market is expected to have a market worth of around $15.14 Billion by 2032, growing at a comprehensive CAGR of around 18.1% from 2022.

Non-invasive Prenatal Testing Market: Growth Drivers

The growth of this market is attributed towards major relevant  factors including the increasing prevalence of chromosomal abnormalities with increasing maternal age, technological advancements in the healthcare industry such as wearable healthcare devices, sequencing technologies, regenerative medicine, genomic technologies, the expansion in the distribution services of the operating entities, growing preference for non-invasive techniques over invasive methods, improving reimbursement scenario for NIPT, and increasing awareness of NIPT.

Moreover, the evolution of prenatal testing, in the form of non-invasive tests serve as an intermediate step between screening and invasive tests in order to determine the probability of fetal abnormality as it offers detecting accuracy of more than 99% and displays screening in less time than other types of prenatal screening. Due to the rising incidence of miscarriage and complications and the increasing popularity among pregnant women as a lower-risk alternative to amniocentesis and awareness about prenatal genetic issues driving the non-invasive prenatal testing, it is predicted that non-invasive prenatal testing will become a standard test in the future, replacing other, and riskier screening tests. The development of NIPT for genetic conditions is a major commercial interest because of high demand in the disease segments such as Down syndrome.

Furthermore, as very few players offer non-invasive prenatal testing, several leading players are focusing on the development of more accurate and reliable NIPT for the analysis of cell-free fetal DNA (cffDNA) in a sample of maternal blood collected in the first trimester. Countries such as China, India, Brazil, and Mexico are already offering significant growth opportunities to market players. The high growth in these markets can majorly be seen due 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.

 However, lack of skilled professionals, reliability of test results, especially in obese women, high cost of testing and provisional tools for diagnosis are a few factors restraining the growth of this market.

Increasing awareness and acceptance of NIPT: There has been a growing awareness and acceptance of NIPT among expectant parents, healthcare professionals, and governments. This has led to increased demand for NIPT tests, which are considered a safer and more accurate alternative to invasive prenatal testing.

Advancements in cfDNA technology: The development of new technologies for analyzing cell-free DNA (cfDNA) in maternal blood samples has improved the accuracy and reliability of NIPT tests. The use of next-generation sequencing (NGS) and other advanced technologies has led to higher detection rates and lower false-positive results.

Increasing maternal age: The trend of delaying pregnancy has led to an increase in the number of older expectant mothers. Older mothers have a higher risk of having a baby with chromosomal abnormalities, making them more likely to undergo NIPT.

Growing prevalence of chromosomal abnormalities: The rising incidence of chromosomal abnormalities, such as Down syndrome, has led to an increased demand for NIPT tests that can detect these conditions.

Favorable reimbursement policies: The availability of favorable reimbursement policies from governments and private insurance companies has encouraged the adoption of NIPT tests, making them more accessible to a larger patient population.

Increasing demand for early and accurate prenatal diagnosis: NIPT is considered a valuable tool for early and accurate prenatal diagnosis, which can help expectant parents make informed decisions about the health and well-being of their unborn child.

Non-invasive Prenatal Testing Market: Challenges

Limited test coverage: NIPT is currently primarily designed to detect common chromosomal abnormalities such as Down syndrome, Edwards syndrome, and Patau syndrome. The test has limited coverage for other genetic conditions, and the accuracy of NIPT for rare genetic conditions is not well-established.

Regulatory challenges: The regulation of NIPT tests varies by country, and there is a lack of harmonization of regulations between countries. This can create challenges for NIPT test manufacturers who must navigate different regulatory requirements in different markets.

Ethical considerations: NIPT raises ethical considerations, including questions about the use of NIPT for non-medical purposes, such as gender selection. There are also concerns about the potential for NIPT to lead to a decrease in the number of individuals with certain genetic conditions.

Cost: NIPT can be expensive, and the cost may limit its accessibility for some women. The cost may be a barrier for women who do not have insurance coverage or whose insurance does not cover the cost of the test.

False-positive and false-negative results: Although NIPT has a high accuracy rate, there is still a risk of false-positive and false-negative results. This can cause anxiety and confusion for patients and can lead to unnecessary invasive procedures.

Limited access in developing countries: NIPT is not widely available in developing countries due to limited resources and infrastructure. This can limit access to prenatal care and increase the risk of adverse outcomes for both the mother and the fetus.

Non-invasive Prenatal Testing Market: Segmentation

By Product Type:

• Consumables
• Instruments
• Services

By Method Type:

• Biochemical Screening Tests
• Ultrasound Detection
• Cell-Free DNA in Maternal Plasma Tests
• Fetal Cells in Maternal Blood Tests

By Application Type:

• Trisomy
• Microdeletion Syndrome
• Others

By End User: 

• Diagnostic Laboratories
• Hospitals

By Region: 

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa

Non-invasive Prenatal Testing Market: Regional Synopsis

North America: North America is one of the largest markets for NIPT, driven by a high level of awareness and acceptance of the technology. The US is the largest market in North America, and the country's large population and high healthcare spending contribute to the growth of the market.

Europe: Europe is a significant market for NIPT, driven by increasing maternal age and a growing prevalence of chromosomal abnormalities. Countries such as the UK, Germany, and France have favorable reimbursement policies for NIPT, which has also contributed to the growth of the market.

Asia Pacific: The Asia Pacific region is expected to see significant growth in the NIPT market due to the growing demand for prenatal testing and increasing awareness and acceptance of the technology. China is the largest market in the region, and the country's large population and rising healthcare spending are expected to contribute to the growth of the market.

Latin America: The Latin America region is a relatively small market for NIPT, but it is expected to see significant growth in the coming years. The growth is driven by increasing healthcare spending and a growing awareness of the benefits of prenatal testing.

Middle East and Africa: The Middle East and Africa region is a small but growing market for NIPT. The growth is driven by increasing demand for prenatal testing, growing healthcare spending, and the availability of advanced technologies in the region.

In 2019, North America accounted for the largest market share, followed by Europe because of factors including high diagnostic and treatment rate of trisomy disorders, high awareness for prenatal testing, presence of laboratories offering NIPT services, focus on improving technology and alliances and partnerships among key market players, high R&D investments, availability of technologically advanced healthcare research framework, the development of WGS in the region and also capital intensive. This trend is projected to grow throughout the next decade.

On the other hand,  due to high adoption rate of non-invasive prenatal tests, developing healthcare infrastructure, technological integration of NGS methodologies, rising awareness programs & conferences, clinical development frameworks in countries like India, Japan China, Australia and New Zealand, the Asia-Pacific region is expected to grow at the highest CAGR in the next few years.

Few Key Players In Non-Invasive Prenatal Testing Market

• Agilent Technologies Inc.
• Berry Genetics Inc.
• BGI Genomics Co. Ltd.
• Eurofins LifeCodexx GmbH
• F. Hoffmann-La Roche AG
• GE Healthcare
• Igenomix
• Illumina Inc.
• Laboratory Corporation
• Natera Inc.
• Perkinelmer Inc.
• Thermo Fisher Scientific Inc.
• Yourgene Health
• Other Players

Recent Developments:

• In January 2019, Illumina expanded its NIPT platform portfolio with the launch of its VeriSeq NIPT Solution v2.
• In September 2020, Illumina (the gene sequencing giant that formed the cancer diagnostics developer and spun it out as a separate company four years ago) announced to Acquire Cancer Diagnostics Developer Grail in an $8B Deal.
• In Oct 2020, Healthcare Insurer, Cantene extended coverage of Natera’s (a pioneer and global leader in cell-free DNA testing and non-invasive prenatal testing) panorama noninvasive prenatal test (NIPT) to all pregnant women in the regions where it provided its services.

Research Scope and Deliverables

Overview & Executive Summary

Market Drivers, Trends, Challenges and Opportunities

Market Size and Forecast Projections

Macroeconomic Indicators of Various Countries Impacting the Growth of the Market

Extensive Coverage of Industry Players including Recent Product Launches and Market Activities

Porter’s Five Force Analysis

Market Segmentation Analysis:

Industry report analyses the global NIPT market by the following segments:

- Product Type

- Method Type

- Application Type

- End User

Customization: We also offer customization’s in the industry report as per the company’s specific needs.

Key Questions Answered in the Global NIPT Industry Report

• What is the overall market size in 2019? What will be the market growth during the forecast period i.e. 2020-2025?
• Which region would have high demand for product in the upcoming years?
• What are the factors driving the growth of the market?
• Which sub-market will make the most significant contribution to the market?
• What are the market opportunities for existing and entry-level players?
• What are various long-term and short-term strategies adopted by the market players?