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Report Scope:
The scope of the report includes NIPT methods, applications, patents and companies. The markets for NGS-based NIPT are given for the years 2017, 2018 and 2023.
This report reviews the main sequencing technologies and provides detailed discussion on next generation sequencing and its applications in different fields. The main focus of the study is NIPT. The market dynamics such as drivers and restraints for both NGS and NIPT market have been discussed in this report.
The report examines the markets by NIPT methods, high-risk and low-risk pregnancies and geography. The end-user segment of this market is based on disease area and healthcare setting. Disease areas include trisomies 21, 18 and 13 and Turner syndrome (a sex chromosome aneuploidy). Healthcare settings include diagnostic laboratories and hospitals.
Specific geographic markets are discussed, including North America, Europe, Asia-Pacific, and the rest of the world.
As a background study, industry sectors analyzed include sequencing instruments, target enrichment, informatics, clinical laboratory testing services, reproductive health diagnostics, liquid biopsy, immune sequencing, HLA typing, third generation sequencing and direct to consumer.
BCC Research provides a summary of the main industry acquisitions and strategic alliances from 2016 through April 2018, including key alliance trends.
Report Includes:
- 23 data tables and 61 additional tables
- An overview of the global insights of next generation sequencing (NGS) for non-invasive prenatal testing (NIPT) within the biotechnology industry
- Country specific data and analysis for United States, France, Germany, U.K., Italy, Spain, China, India, Japan, South Korea and rest of the world countries
- Analyses of global market trends with data from 2017, estimates for 2018, and projections of compound annual growth rates (CAGRs) through 2023
- Characterization and quantification of the market potential for NGS by geographical region, type, application sector, and end user industry
- Discussion of next generation sequencers, NGS technologies, NIPT methods, clinical applications and industry structure
- Examination of regional dynamics, and key technological updates for both NGS and NIPT market
- Comprehensive profiles of the leading companies involved in the clinical, genetic testing and sequencing industries, including 10X Genomics, Inc., 23andMe, Agilent Technologies, Inc., Illumina Inc. and Natera, Inc.
Summary
Non-Invasive Prenatal Testing (NIPT) is a type of testing method which is used to screen pregnancy for the risk of being affected with the most common chromosomal conditions such as Trisomy 21 (Down's Syndrome), Trisomy 18 (Edwards Syndrome) and Trisomy 13 (Patau Syndrome). It is available to all pregnant women from 9 to 10 weeks of gestation, who are at both low-risk and high-risk for chromosomal aneuploidies. This test carries no risk of miscarriage and it is the most accurate screening test. The detection rate is more than 99% accurate.
NIPT is performed on a blood sample of the pregnant woman. The cell-free fetal DNA (cffDNA) which exceeds 4% of all the cell-free DNA in nearly all women from 10 weeks onward is collected and analyzed using next generation sequencing technology, coupled with advanced bioinformatics analysis. In addition to screening for common chromosomal trisomy conditions, few NIPT tests offer analysis of the X and Y sex chromosomes and gender identification. NIPT also screens for the risk of sex aneuploidy conditions including Turner's (Monosomy X), Klinefelter (XXY) and Triple-X (XXX).
The companies/laboratories currently offering NIPT screening across the world include:
- Ariosa (USA): Harmony.
- BGI Health (China): NIFTY.
- Illumina (USA): Verifi.
- Natera (USA) Panorama.
- Premaitha (UK): IONA.
- Sequenom (USA): MATERNIT21 PLUS.
Several NIPT methods have been developed based on recent advances in molecular biology and sequencing technologies. Recently, shotgun massively parallel sequencing (s-MPS) method is being commonly used for sequencing of DNA, after isolation and amplification of the cfDNA, which is followed by mapping the sequences to their chromosome and comparing the results.
NIPT was first launched by commercial providers in the United States and China (Hong Kong) in 2011. It quickly moved into markets in Western Europe, the Middle East, South America, Asia and Africa, with samples from many of these countries being sent to the United States or China for testing. Studies show that adoption in developed countries is high and has significantly reduced the number of invasive tests performed.
Although NIPT is currently available through private providers, it is not yet widely available in publicly funded prenatal services. During the forecast period it is expected that even public service providers will adopt this test at a high rate.
Advantages offered by NIPT such as non-invasiveness, high accuracy and early detection. Coupled with raising awareness, increasing market penetration in Asia and Latin America and increase in average maternal age are the major factors expected to drive the growth of the global NIPT market during the forecast period.