◆英語タイトル：Non-Invasive Prenatal Testing Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)
The global Non-Invasive Prenatal Testing Market 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).
The COVID-19 pandemic continues to transform the growth of 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 hold on non-invasive prenatal screening (NIPS) services in order to prevent the spread of the COVID-19 virus and in fact, the tremendous pressure on the hospitals in providing services to COVID-19 patients is also one of the factors which are inhibiting the hospitals and diagnostic centers in providing non-invasive prenatal screening (NIPS) services.
The COVID lockdown has thus brought NIPT into the forefront because NIPT is found to offer 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 which can expose both doctor and patient to the risk of COVID infection. Hence, there has been an increase in prescription of NIPT’s due to the COVID lockdown. The reasons could be multifactorial, the number of elective procedures in hospital had reduced during lockdown, and there might have been patient reluctance as well for fear of COVID infection.
The non-invasive prenatal testing 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 announces the launch of non-invasive prenatal testing (NIPT), the first of its kind in a United States obstetrician-gynecologist physician-owned laboratory.
The increasing number of stillbirth’s 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 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 non-invasive nature, better accuracy, and short duration of the procedure are anticipated to hasten the growth of the global non-invasive prenatal testing market during the forecast period. However, the lack of accessibility of test in emerging countries, ethical concerns, and strict government regulations are the few factors that will hamper the growth in the global Non-Invasive prenatal testing market.
Key Market Trends
Down Syndrome Segment Dominates the Non-Invasive Prenatal Testing Market
Down syndrome is a chromosomal disorder and also called trisomy 21, trisomy G, 47, XX,+21, and 47, XY,+21. It includes certain birth defects, learning problems, and 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 nine weeks 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%).
Noninvasive prenatal testing (NIPT) consists of analyzing cell-free DNA (cfDNA) circulating in the maternal blood in order to detect Down’s syndrome. With the successful introduction of noninvasive prenatal testing (NIPT) for 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 also being adopted in many developing countries., which may drive the segment growth.
North America Dominates the Global Non-Invasive Prenatal Testing Market
North America holds a leading position in the Non-Invasive Prenatal Testing market during the forecast period. High preterm birth rate, maternal mortality rate, and rising incidences of chromosomal abnormalities will 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 2500 pregnancies in the United States and 1 in 6000 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 Apr 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, high 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.
The non-Invasive Prenatal Testing market is very competitive with most of the players competing to maximize 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.
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1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing Number of Babies with Chromosomal Disorders owing to Increasing Number of Late Pregnancies
4.2.2 Increasing Demand for Early and Non-invasive Fetal Diagnosis
4.2.3 Favorable Reimbursement Policies
4.3 Market Restraints
4.3.1 Lack of Skilled Professionals
4.3.2 Stringent Regulations and Ethical Concerns
4.4 Porter’s Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION
5.1 By Component
5.1.2 Kits and Reagents
5.2 By Application
5.2.1 Down syndrome (trisomy 21)
5.2.2 Edwards syndrome (trisomy 18)
5.2.3 Patau syndrome (trisomy 13)
5.2.4 Turner syndrome
5.3 By End User
5.3.2 Diagnostic Labs
5.4.1 North America
188.8.131.52 United States
184.108.40.206 United kingdom
220.127.116.11 Rest of Europe
18.104.22.168 South Korea
22.214.171.124 Rest of Asia-Pacific
5.4.4 Middle East and Africa
126.96.36.199 South Africa
188.8.131.52 Rest of Middle East and Africa
5.4.5 South America
184.108.40.206 Rest of South America
6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.2 CENTOGENE AG
6.1.3 Eurofins Scientific
6.1.4 F. Hoffmann-La Roche Ltd
6.1.5 Illumina, Inc.
6.1.6 Myriad Genetics, Inc.
6.1.7 PerkinElmer Inc.
6.1.8 Quest Diagnostics
6.1.9 GE Healthcare
6.1.10 Agilent Technologies, Inc.
7 MARKET OPPORTUNITIES AND FUTURE TRENDS