Global Prenatal & Maternal Diagnostic Market To 2020

Published: January 2016
No. of Pages: 359

A newly published analysis by Kelly Scientific Publications indicates that by 2021, the global prenatal, maternal and newborn screening diagnostic test market will be worth over $10.5 billion, up from $8 billion today. This market is subdivided into ultrasound, fetal MRI, maternal serum and noninvasive prenatal screening technologies and will see a five year compound annual growth rate of 4.1%. The new report, entitled GLOBAL PRENATAL AND MATERNAL DIAGNOSTIC MARKET ANALYSIS indicates that the launch of noninvasive prenatal screening tests (NIPTs) in 2011 dramatically altered the market dynamic, and this sub-section of the market will see an 18% CAGR to 2021.  This is at the expense of more invasive techniques as chorionic villus sampling (CVS) or amniocentesis.

Since the 1960s, technologies for testing fetuses for conditions including trisomies have been continually advancing. The initial nongenetic testing such as ultrasound and serum screening for protein level markers, have developed remarkably throughout the years. Yet, these conventional tests are limited in sensitivity and specificity. Parallel to the development of these conventional technologies, two invasive techniques called amniocentesis and chorionic villus sampling (CVS) were introduced in 1980s to offer near 100% detection rates for trisomies. Yet, the chances of injury to the fetus and the consequence of miscarriages deterred both patients and obstetricians from using these techniques and to this date the techniques are used in high-risk pregnancies for the confirmation of positive results from screening tests.

When human genome sequencing was successfully accomplished, experts in the healthcare industry expected that DNA sequencing would mainly focus on genetic diseases in adults. Instead, the impact of sequencing technology has been primarily on prenatal, newborn and preimplantation genetic diagnosis (PGD) tests (prior to in vitro fertilization). In a short span of four years, the different types of maternal serum screening tests and fetal ultrasound tests are getting gradually replaced by the new technology of  non-invasive prenatal tests (NIPTs). In the past four years, hundreds and thousands of these new tests have been performed in screening cffDNA from maternal blood.

The objective of this report is to provide an overview of the various technologies being employed for detecting genetic diseases in embryos, fetuses and newborns. The various chapters describe common pregnancy disorders, numerical chromosome disorders and structural chromosome disorders, single gene disorders inherited by fetuses, newborns and embryos. The global prenatal and maternal diagnostic test market is assessed with respect to:

  • Fetal Ultrasound
  • Prenatal MRI Screening
  • Maternal Serum Screening Tests
  • Noninvasive Prenatal Tests (NIPTs) using cffDNA
  • NIPTs by Product
  • Prenatal Diagnostic Invasive Tests
  • Newborn Screening for Genetic Diseases
  • Newborn Screening Market by Technology
  • Preimplantation Screening/Diagnosis (PGS/PGD)

SWOT and merger/acquisition analysis is also performed as is a comprehensive documentation of the legislation pertaining to newborn screening by geography and how clinical programs are implemented in developed and developing markets.

Emerging trends in associated markets are also analysed in order to give the reader a comprehensive overview of how prenatal and maternal diagnostic testing is affected by the following industries:

  • Molecular Diagnostics Market
  • Liquid Biopsy Market
  • Personalized Medicine Diagnostics Market
  • In vitro Diagnostics (IVD) Market

This is a comprehensive 359 page report strengthened with over 260 figures and tables. Published in January 2016, the GLOBAL PRENATAL & MATERNAL DIAGNOSTIC MARKET TO 2020 report by KellySciPubhas a detailed overview of 114 companies in the market with specifics pertaining to financial and business strategy, current products on the market and pipeline products.

1.3 Key Questions Answered in this Report

  • What are the major prenatal pregnancy complications?
  • What are the major genetic diseases detected in fetuses?
  • What are the appropriate technologies for the detection of aneuploidies, microdeletions, duplications, copy number variations and translocations?
  • How far is genetic counselling important in educating pregnant women and healthcare professionals?
  • What is the impact of recent advances in clinical genomics on genetic counselling?
  • What different noninvasive and invasive prenatal screening tests are performed during a pregnancy?
  • What are the detection rate, true positive rate and true negative rate for NIPTs?
  • Currently, in which countries are the NIPTs available?
  • What is the cost of NIPTs region-wise?
  • What is the uptake of conventional maternal serum tests, NIPTs and invasive diagnostic tests in the U.S.?
  • What is the average cost of maternal serum screening, NIPTs, fetal ultrasound screening and invasive diagnostic tests in the U.S.?
  • What are the strategies to be adopted for clinical implementation of NIPTs for all pregnancies?
  • What is the “patient directed model” for the integration of NIPTs into healthcare systems?
  • How does the detection rate of NIPTs compare with the rates of conventional maternal serum screening tests?
  • What are the genetic disorders detectable by different prenatal screening and diagnostic tests?
  • What is the reliability of amniocentesis and CVS results?
  • Is the future of invasive diagnostic tests uncertain?
  • Do the intact fetal cells in maternal blood have use in noninvasive prenatal diagnosis (NIPD)?
  • What about the use of trophoblast cells obtained from cervix in NIPD?
  • How many genetic conditions are detected during newborn genetic screening in the U.S.?
  • What is the status of newborn genetic screening in developed, developing and other countries?
  • What are the different preimplantation genetic screening (PGS) and preimplantation genetic diagnosis (PGD)?
  • What are the currently available PGS/PGD testing products available in the market?
  • What are the currently used advanced technologies in prenatal, newborn and PGD testing?
  • What is the global market for fetal ultrasound screening, through 2021?
  • Who are the market leaders in fetal ultrasound systems?
  • What is the global and regional market for prenatal screening by fetal MRI, through 2021?
  • What is the global and regional market for maternal screening tests, through 2021?
  • What is the global and regional market for NIPTs using cffDNA, through 2021?
  • What is the global and regional market for invasive prenatal diagnostic tests, through 2021?
  • What is the global and regional market for newborn screening tests, through 2021?
  • What is the global market for newborn screening tests by technology, through 2021?
  • What is the global and regional market for pre-implantation genetic diagnosis (PGD), through 2021?
  • What is the global market for molecular diagnostics, through 2021?
  • What is the global market for liquid biopsy tests, through 2021?
  • What is the overall global market for personalized medicine diagnostics, through 2021?
  • What is the overall global market for in vitro diagnostics (IVD), through 2021?
  • What are the recent acquisition activities in prenatal screening industry?
  • What are the important factors that drive the growth of prenatal &newborn genetic testing industry?
  • What are the challenges faced by the prenatal screening industry?
  • What are the possible future developments in prenatal screening industry?

Companies Mentioned:

  • 23andMe Inc.
  • Abbott Laboratories
  • Abbott Molecular Inc.
  • Abcam plc
  • AB Sciex LLC
  • AdaltisS.r.l
  • Adaptive Biotechnologies Corp.
  • Affymetrix Inc.
  • Agena Biosciences Inc.
  • Agilent Technologies Inc.
  • Ambry Genetics Corp.
  • Analogic Corp.
  • Ariosa Diagnostics Inc.
  • Ansh Labs
  • Appistry Inc.
  • ARUP Laboratories
  • AssureRx Health Inc.
  • Asuragen Inc.
  • Athena Diagnostics Inc.
  • AutoGenomics Inc.
  • Base4 Innovation Ltd.
  • Beckman Coulter Inc.
  • Berry Genomics Co., Ltd.
  • Bina Technologies Inc.
  • Bio-Rad (Israel) Laboratories Inc.
  • BGI
  • Blueprint Genetics Oy
  • Boreal Genomics Inc.
  • Cambridge Epigenetix Ltd.
  • Claris Lifesciences
  • CeGaT GmbH
  • Centogene AG
  • Chromosystems Instruments & Chemicals GmbH
  • Chronix Biomedical Inc.
  • Claritas Genomics Inc.
  • CLC bio A/S
  • Combimatrix Corp.
  • Contec Medical Systems Co., Ltd.
  • Coriell Life Sciences Inc.
  • Correlagen Diagnostics Inc.
  • Counsyl Inc.
  • Courtagen Life Sciences Inc.
  • Creative Diagnostics
  • Cynvenio Biosystems Inc.
  • Diagnostic Automation/Cortex Diagnostics Inc.
  • Demeditec Diagnostics GmbH
  • DRG International Inc.
  • DNA Electronics Ltd.
  • DNA Link Inc.
  • DNAnexus Inc.
  • Eagle Biosciences Inc.
  • Eagle Genomics Ltd.
  • Enzymatics Inc.
  • Esoate SpA
  • Eurofins MWG Operon Inc.
  • Exiqon A/S
  • Fakuda Denshi Co, Ltd.
  • GATC Biotech AG
  • GE Healthcare Ltd.
  • GenapSys Inc.
  • Gene by Gene Ltd.
  • Genection Inc.
  • GeneDx Inc.
  • GenePeeks Inc.
  • Genesis Genetics
  • Genetadi Biotech S.L.
  • Genoma Group Srl
  • Genomed AG
  • GenPath Diagnostics
  • Genway Biotech Inc.
  • Good Start Genetics Inc.
  • Hitachi Medical Systems America Inc.
  • Hologic Inc.
  • Illumina Inc.
  • INEX Innovations Exchange Pte., Ltd.
  • Invitae Corp.
  • Laboratory Corporation of America Inc.
  • Monobind Inc.
  • Multiplicom NV
  • Myriad Genetics
  • Natera Inc.
  • Natus Medical Inc.
  • NewGene Ltd.
  • NIPD Genetics Ltd.
  • Oxford Gene Technology
  • Parabase Genomics Inc.
  • Pathway Genomics Corp.
  • PerkinElmer  
  • Premaitha Health PLC
  • Progenity Inc.
  • Qiagen N.V.
  • Quest Diagnostics Inc.
  • Ravgen Inc.
  • Recombine Inc.
  • Reproductive Genetics Institute Inc.
  • Reprogenetics Laboratories
  • Sebia Inc.
  • Sequenom Inc.
  • SeraCare Life Sciences Inc.
  • Siemens Healthcare
  • Sophia Genetics SA
  • SpOtOn Clinical Diagnostics Ltd.
  • Stra Biotech GmbH
  • Sygnis AG
  • SynapDx Corp.
  • Thermo Fisher Scientific Inc.
  • Transgenomic Inc.
  • Trivitron Healthcare Private Ltd.
  • Trovagene Inc.
  • Tute Genomics Inc.
  • Warp Drive Bio LLC
  • ZS Genetics Inc.
  • Zymo Research Corporation

Published By: Kelly Scientific Publications
Product Code: Kelly Scientific Publications10

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