Non-Invasive Prenatal Testing Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

The Non-Invasive Prenatal Testing Market is segmented by Component (Instruments, Reagents And Kits, And Services), Application (Down Syndrome, Edwards Syndrome, Patau Syndrome, Turner Syndrome, and Other Applications), End User (Hospitals And Diagnostic Labs), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The report offers the value (in USD million) for the above segments.

Market Snapshot

Non-Invasive Prenatal Testing Market Bar Graph
Study Period: 2018-2026
Base Year: 2021
Fastest Growing Market: Asia Pacific
Largest Market: North America
CAGR: 14.4 %
Non-Invasive Prenatal Testing Market Major Players

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Market Overview

The global non-invasive prenatal testing (NIPT) market was valued at approximately USD 1,490 million in 2020 and it is expected to reach USD 3,396 million by 2026, registering a CAGR of nearly 14.4% during the forecast period (2021-2026).

Though the COVID-19 pandemic continues to transform the growth of the various markets, the immediate impact of the outbreak is varied. The outbreak is expected to show impact on the non-invasive prenatal testing (NIPT) market due to the hold on non-invasive prenatal screening (NIPS) services in order to prevent the spread of the COVID-19 virus. In fact, the tremendous pressure on the hospitals to provide services to COVID-19 patients is also one of the factors inhibiting the hospitals and diagnostic centers in providing non-invasive prenatal screening (NIPS) services.

The COVID lockdown has also brought NIPT into the forefront, as NIPT offers high accuracy screening with low risk of infection, compared to invasive procedures, such as Amniocentesis and chorionic villus sampling (CVS), both of which may require hospital admission that can expose both doctors and patients to the risk of the COVID infection. Hence, there has been an increase in the prescription of NIPTs due to the current lockdown. The reasons could be multifactorial; the number of elective procedures in hospitals had reduced during lockdown, and there might have been patient reluctance as well for the fear of COVID infection.

The NIPT market is primarily driven by the rising prevalence of genetic disorders, quick adoption of next-generation sequencing, new product launches, and an upsurge in several non-invasive prenatal testing service providers. For instance, in August 2019, Axia Women's Health, the nation's largest independent women's healthcare group announced the launch of non-invasive prenatal testing (NIPT), the first of its kind in a US-obstetrician-gynecologist physician-owned laboratory.

The increasing number of stillbirth cases across the world is also expected to offer a sizeable growth opportunity for early disease diagnosis. According to the Australian Institute of Health and Welfare, the rate of stillbirth in Australia is 6.7 per 1,000 births, which equals almost 2,200 families each year. One in every 137 women who reach the 20-weeks-gestation may have a stillborn child. Hence, with the increasing cases of stillbirths, the demand for testing increases.​

Additionally, advantages of non-invasive prenatal tests over other prenatal tests, such as its non-invasive nature, better accuracy, and short duration of the procedure, are anticipated to hasten the growth of the global NIPT market during the forecast period. However, the lack of accessibility of the test in emerging countries, ethical concerns, and strict government regulations are the few factors that will hamper the growth in the global NIPT market.

Scope of the Report

As per the scope of the report, non-invasive prenatal testing (NIPT) which is also called non-invasive prenatal screening (NIPS), is a method for determining the risk that the fetus will be born with certain genetic abnormalities. This testing analyzes small fragments of DNA that are circulating in a pregnant woman’s blood. NIPT analyzes the genetic information contained in this DNA to screen for a number of abnormalities.

The non-invasive prenatal testing market is segmented by component (instruments, reagents and kits, and services), application (Down syndrome, Edwards syndrome, Patau syndrome, Turner syndrome, and other applications), end user (hospitals and diagnostic labs), and geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments.

By Component
Instruments
Kits and Reagents
Services
By Application
Down syndrome (trisomy 21)
Edwards syndrome (trisomy 18)
Patau syndrome (trisomy 13)
Turner syndrome
Other Applications
By End User
Hospitals
Diagnostic Labs
Geography
North America
United States
Canada
Mexico
Europe
Germany
United kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East and Africa
GCC
South Africa
Rest of Middle East and Africa
South America
Brazil
Argentina
Rest of South America

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Key Market Trends

Down Syndrome Segment Dominates the Non-Invasive Prenatal Testing Market

Down syndrome is a chromosomal disorder, also called trisomy 21, trisomy G, 47, XX,+21, and 47, XY,+21. It includes certain birth defects, learning problems, and deformity of facial features. A child with Down syndrome may also have heart defects and problems with vision and hearing. According to the Centers for Disease Control and Prevention 2019, down syndrome is the most common chromosomal condition diagnosed in the United States. Every year, about 6,000 babies born in the United States have Down syndrome. This means that Down syndrome occurs in about 1 out of every 700 babies.

NIPT offers several clinical benefits over existing prenatal screening tests, such as maternal serum screening (MSS). According to a 2019 article published by Stanislav Birko et.al for the screening of Down syndrome NIPT can be performed as early as in the ninth week of pregnancy, holds no risk of miscarriage, and is able to detect the presence of Down syndrome (trisomy 21) with high sensitivity (99.9%) and specificity (98%).

Non-invasive prenatal testing (NIPT) consists of analyzing cell-free DNA (cfDNA) circulating in the mother’s blood in order to detect Down syndrome.​ With the successful introduction of NIPT, for the detection of Down syndrome, into routine prenatal care, it is important to understand the risks, benefits, and limitations in order to guide patients in making an informed decision. As a result, the demand for these technologies has increased and is being adopted by many developing countries, which may drive the segment’s growth.

Non-Invasive Prenatal Testing Market Latest Trends

North America Dominates the Global Non-invasive Prenatal Testing Market

North America is expected to hold a leading position in the NIPT market during the forecast period. High preterm birth rate, high maternal mortality rate, and rising incidences of chromosomal abnormalities will likely increase the adoption and demand for tests in this region.

According to Trisomy 18 Foundation, Edwards syndrome (Trisomy 18) error occurs in about 1 out of every 2,500 pregnancies in the United States and 1 in 6,000 live births. North America accommodates several major companies working on fetal and neonatal care from around the world, with direct distribution channels and third-party services for distribution in relation to medical/hospitals requirement. In April 2019, Progenity, Inc. announced the launch of the Resura Prenatal Test for Monogenic Disease. It is a commercially available, customizable, NIPT test for single-gene disorders.​

Furthermore, high rates of diagnosis, wider adoption and awareness among the people, and the introduction of new and technologically advanced tests are also contributing to the growth of the market in North America.

Non-Invasive Prenatal Testing Market Growth Rate By Region

Competitive Landscape

The non-invasive prenatal testing market is very competitive with most of the players competing to maximize their market shares. Strong competition, rapid technological advancements, recurrent changes in government policies, and the prices are key factors that confront the market. Several biotechnology companies are now indulging in the research and development of such NGS-based NIPT products. Key market players in the market are BGI, CENTOGENE AG, Eurofins Scientific, F. Hoffmann-La Roche Ltd (Roche Sequencing), Invitae Corporation, Illumina, Inc., Natera, Inc., Progenity, Inc., PerkinElmer Inc., Quest Diagnostics, etc.

Recent Developments

In March 2020, Agilent Technologies Inc. introduced three new microarrays to meet the needs of cytogenetic laboratories conducting both prenatal and postnatal research. The probes on the cyto microarrays provide high-resolution detection of copy number variations, and copy-neutral loss of heterozygosity associated with developmental delay, neuropsychiatric disorders, intellectual disability, congenital anomalies, or unexplained dysmorphic features in constitutional DNA samples.

In February 2020, PerkinElmer, Inc. announced its selection as one of the providers of a newborn screening test for Severe Combined Immunodeficiency (SCID) in collaboration with Public Health England’s SCID evaluation program. Public Health England (PHE) has agreed to use PerkinElmer’s VICTOR EnLite instrument and EnLite Neonatal TREC Kit as part of an evaluation to screen newborn babies for the rare inherited genetic condition.

Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Increasing Number of Babies with Chromosomal Disorders owing to Increasing Number of Late Pregnancies

      2. 4.2.2 Increasing Demand for Early and Non-invasive Fetal Diagnosis

      3. 4.2.3 Favorable Reimbursement Policies

    3. 4.3 Market Restraints

      1. 4.3.1 Lack of Skilled Professionals

      2. 4.3.2 Stringent Regulations and Ethical Concerns

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION

    1. 5.1 By Component

      1. 5.1.1 Instruments

      2. 5.1.2 Kits and Reagents

      3. 5.1.3 Services

    2. 5.2 By Application

      1. 5.2.1 Down syndrome (trisomy 21)

      2. 5.2.2 Edwards syndrome (trisomy 18)

      3. 5.2.3 Patau syndrome (trisomy 13)

      4. 5.2.4 Turner syndrome

      5. 5.2.5 Other Applications

    3. 5.3 By End User

      1. 5.3.1 Hospitals

      2. 5.3.2 Diagnostic Labs

    4. 5.4 Geography

      1. 5.4.1 North America

        1. 5.4.1.1 United States

        2. 5.4.1.2 Canada

        3. 5.4.1.3 Mexico

      2. 5.4.2 Europe

        1. 5.4.2.1 Germany

        2. 5.4.2.2 United kingdom

        3. 5.4.2.3 France

        4. 5.4.2.4 Italy

        5. 5.4.2.5 Spain

        6. 5.4.2.6 Rest of Europe

      3. 5.4.3 Asia-Pacific

        1. 5.4.3.1 China

        2. 5.4.3.2 Japan

        3. 5.4.3.3 India

        4. 5.4.3.4 Australia

        5. 5.4.3.5 South Korea

        6. 5.4.3.6 Rest of Asia-Pacific

      4. 5.4.4 Middle East and Africa

        1. 5.4.4.1 GCC

        2. 5.4.4.2 South Africa

        3. 5.4.4.3 Rest of Middle East and Africa

      5. 5.4.5 South America

        1. 5.4.5.1 Brazil

        2. 5.4.5.2 Argentina

        3. 5.4.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 BGI

      2. 6.1.2 CENTOGENE AG

      3. 6.1.3 Eurofins Scientific

      4. 6.1.4 F. Hoffmann-La Roche Ltd

      5. 6.1.5 Invitae Corporation

      6. 6.1.6 Illumina, Inc.

      7. 6.1.7 Natera, Inc.

      8. 6.1.8 Progenity, Inc.

      9. 6.1.9 PerkinElmer Inc.

      10. 6.1.10 Quest Diagnostics

      11. 6.1.11 GE Healthcare

      12. 6.1.12 Agilent Technologies, Inc.

      13. 6.1.13 Laboratory Corporation of America Holdings

      14. 6.1.14 Yourgene Health

      15. 6.1.15 Thermo Fisher Scientific Inc.

      16. 6.1.16 Centogene N.V.

      17. 6.1.17 Myriad Genetics, Inc.

      18. 6.1.18 Igenomix

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Competitive Landscape covers- Business Overview, Financials, Products and Strategies, and Recent Developments

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Frequently Asked Questions

The Global Non-Invasive Prenatal Testing Market market is studied from 2018 - 2026.

The Global Non-Invasive Prenatal Testing Market is growing at a CAGR of 14.4% over the next 5 years.

Asia Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2021.

BGI, CENTOGENE AG, Eurofins Scientific, F. Hoffmann-La Roche Ltd (Roche Sequencing), PerkinElmer Inc. are the major companies operating in Global Non-Invasive Prenatal Testing Market.

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