Global Prenatal & Maternal Diagnostic Market Analysis to 2021

  • ID: 3846242
  • Report
  • 389 pages
  • Kelly Scientific Publications
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The Noninvasive Prenatal Screening Tests (NIPTs) Market Will See an 18% CAGR to 2021

FEATURED COMPANIES

  • 23andMe Inc.
  • AssureRx Health Inc.
  • Claris Lifesciences
  • Eurofins MWG Operon Inc.
  • Genway Biotech Inc.
  • Pathway Genomics Corp.
  • MORE
Prenatal tests (fetus, embryos and newborns) currently on the market analyze chromosomes, DNA, RNA, genes, and/or gene products to determine whether an abnormality is present that is causative of a specific disease. Since 2011, the launch of noninvasive prenatal tests (NIPTs) is revolutionizing the prenatal screening industry providing detection rates of >99% and false positive rates of <0.1%. These screening results are only indicative of the risk and not confirmative. To confirm positive results of NIPT screening tests, prenatal diagnostic tests such as amniocentesis and chorionic villus sampling (CVS) are performed. Prior to NIPTs, ultrasound and maternal serum tests were routinely used to screen fetusus for genetic abnormalities.

Globally, 50 countries have effective newborn genetic test programs, the implementation of which is in various stages. In the U.S., four million newborns are tested annually, with 3,000 found to have metabolic and genetic diseases. The purpose of newborn screening is to identify affected newborns quickly and provide them with treatment to prevent mental retardation, prolonged illness and death. The newborn genetic screening market is crowded with different technologies, the common being tandem mass spectrometry, pulse oximetry, enzyme-based assays, DNA assays and electrophoresis.

Preimplantation genetic screening and preimplantation genetic diagnosis (PGS/PGD) are genetic tests performed in eight-celled embryos before implantation during in vitro fertilization (IVF) for the detection of genetic abnormalities and sex. These tests can detect and diagnose chromosomal rearrangements, X-linked diseases and help in reducing the incidence of spontaneous abortions, increase implantation rates, prevent trisomic offsprings and avoid the risk of transmitting single gene disorders. However, PGS and PGD results are not 100% accurate and after pregnancy, if required the diagnostic tests such as amniocentesis and CVS are to be performed to confirm the positive results of PGS/PGD. In the U.S. alone, more than 63,000 babies were born through IVF in 2013 and compared to 2012 data; it was an increase of 2,000 births.

The most important development in the field of prenatal screening, is the introduction of NIPTs using cell-free fetal DNA (cffDNA) in 2011. Obstetricians and patients who are deterred by the 10% to 15% false positive rates of ultrasound screening and 5% false positive rates of maternal serum tests are eagerly embracing NIPTs which claim to have only <0.1% of false positive results.

Within just four years, molecular genetics firms have successfully produced eight different types of kits for the detection of genetic abnormalities in the fetus. These products have been gradually marginalizing the maternal serum tests and in another decade, maternal serum tests are expected to become obsolete. If, companies can develop NIPTs with a 100% accuracy rate, maternal serum tests, amniocentesis and CVS will all be completely overshadowed by NIPTs. Despite the growing popularity of NIPTs, maternal serum tests still continue to have some market due to their low price. While the maternal serum tests are available for just $x to $x, NIPTs are priced between $x and $x. However, Sequenom reportedly sold over x tests in 2013 and so pricing does not seem to be a deterrent factor. The introduction of technologies such as digital PCR and next-generation sequencing (NGS) or massively parallel sequencing (MPS) have also enabled accurate estimation of very small differences in chromosome-specific sequences in 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) and carrier screening tests

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 390 page report strengthened with over 280 figures and tables. Published in September 2016, the GLOBAL PRENATAL & MATERNAL DIAGNOSTIC MARKET TO 2021 report has 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.

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 counseling important in educating pregnant women and healthcare professionals?
-  What is the impact of recent advances in clinical genomics on genetic counseling?
-  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?
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FEATURED COMPANIES

  • 23andMe Inc.
  • AssureRx Health Inc.
  • Claris Lifesciences
  • Eurofins MWG Operon Inc.
  • Genway Biotech Inc.
  • Pathway Genomics Corp.
  • MORE
1.0        Introduction                                       
1.1        Executive Summary                                   
1.2        Objectives of this Report                               
1.3        Key Questions Answered in this Report      

2.0        Prenatal Pregnancy Complications: An Overview                   
2.1        Advanced Maternal Age (AMA)                               
2.1.1    Risk of Down Syndrome with Increased AMA                       
2.1.2    Risk of Miscarriage with Increased AMA                       
2.1.3    Risk of Cesarean Section with Increasing AMA                       
2.1.4    Risk of Gestational Diabetes with AMA                           
2.1.5    Risk for Pregnancy-Induced Hypertension with AMA                   
2.1.6    Risk of Placenta Previa with AMA                           
2.1.7    Delayed First Pregnancy in the U.S.                           
2.1.7.1    First Birth Rates for 35-39 Aged U.S. Women by Race                   
2.2        Pre-Existing Maternal Medical Conditions                       
2.2.1    Pregnancy Outcome in Women with Renal Disease                   
2.2.2    Pregnancy Outcome in Diabetic Women                           
2.2.3    Pregnancy Outcome in Women with Pre-Existing Thyroid Disease           
2.2.4    Pregnancy Outcome in Obese Women                           
2.2.5    Pregnancy Outcome in Asthmatic Women                       
2.2.6    Pregnancy Outcome in Women with Epilepsy                       
2.2.7    Pregnancy Outcome in Women with Autoimmune Diseases               
2.2.8    Pregnancy Outcome in Women with Hemoglobinopathies               
2.2.9    Pre-Existing Chronic Diseases among Women of Reproductive Ages in the U.S.       
2.2.9.1    Chronic Disease Risk Behaviors and Risk Factors among Women of Reproductive Ages in the U.S.                                           
2.3        Medical Conditions Occurring During Pregnancy                   
2.3.1    Preeclampsia (Toxemia)                                   
2.3.1.1    Prevalence of Preeclampsia in the U.S.                           
2.3.2    Gestational Diabetes in the U.S.                               
2.3.2.1    Prevalence of Gestational Diabetes in the U.S.                       
2.4        Pregnancy-Related Issues                                  
2.4.1    Premature Labor                                   
2.4.1.1    Common Medical Complications in Premature Babies                   
2.4.1.2            Global Prevalence of Preterm Labor                           
2.4.1.3    Prevalence of Preterm Births in the U.S. by Stage                   
2.4.1.4    Prevalence of Preterm Births in the U.S. by Race/Ethnicity               
2.4.1.5    Prevalence of Preterm Births in the U.S. by Plurality of Birth               
2.4.1.6    Prevalence of Preterm Births in the U.S. by Maternal Age               
2.4.1.7    Multiple Births in the U.S.                               
2.4.2    Placenta Previa                                       
2.4.3    Breech Presentation                                   
2.4.4    Meconium Stained Liquor                               
2.4.5    Oligohydramnios and Polyhydramnios                           
2.5        Fetal Problems                                       
2.5.1    Fetal Growth Restriction                               
2.5.2     Imperforate Anus                                   
2.5.3     Congenital Heart Disease       

3.0         Types of Genetic Diseases in Fetuses: An Overview                   
3.1         Single Gene Disorders                                   
3.1.1     Autosomal Dominant Genetic Disorders                       
3.1.1.1     Huntington Disease (HD)                               
3.1.1.2     Familial Hypercholesterolaemia (FH)                           
3.1.1.3     Marfan syndrome                                   
3.1.1.4     Myotonic Dystrophy                                   
3.1.2     Autosomal Recessive Genetic Disorders                       
3.1.2.1     Cystic Fibrosis (CF)                                   
3.1.2.2     Canavan Disease                                   
3.1.2.3     Neutropenia                                       
3.1.2.4     Ellis-van Creveld Syndrome (EVC)                           
3.1.2.5     Familial Mediterranean fever (FMF)                           
3.1.2.6     Faconi Anemia (FA)                                   
3.1.2.7     Gaucher Disease                                   
3.1.2.8     Mucopolysaccharidosis (MPSs)                               
3.1.2.9     Phenylketonuria (PKU)                                   
3.1.2.10     Sickle Cell Disease                                   
3.1.2.11     Beta-Thalassaemia                                   
3.1.2.12     Inheritance Pattern of Autosomal Recessive Genetic Disorders               
3.1.2.13     Chances of Inheriting a Single Gene Disorder                       
3.1.2.14     Common Recessive Disease Traits in Selected Ethnic Groups               
3.1.2.15     Comprehensive List of Common Single Gene Disorders                   
3.1.3     X-Linked Dominant Genetic Disorders                           
3.1.3.1     Hypophosphotemic Rickets                               
3.1.3.2     Incontinentia Pigmenti                                   
3.1.3.3     Focal Dermal Hypoplasia                               
3.1.3.4     Orofaciodigital Syndrome                               
3.1.3.5     Inheritance of Sex-Linked Dominant Disorders                       
3.1.4     X-Linked Recessive Disorders                               
3.1.4.1     Lesch-Nyhan Syndrome                               
3.1.4.2     Menkes Disease (Kinky hair syndrome)                           
3.1.4.3     Hemophilia A and B                                   
3.1.4.4     Fabry’s Disease                                   
3.1.4.5     Wiskott-Aldrich syndrome (WAS)                           
3.1.4.6     Bruton’s Aggamaglobulinemia                               
3.1.4.7     Color Blindness                                   
3.1.4.8     Complete Androgen Insensitivity Syndrome                       
3.1.4.9     Inheritance of X-Linked Recessive Traits                       
3.2         Chromosomal Disorders                               
3.2.1     47, XXY (Klinefelter Syndrome)                           
3.2.1.1     Prenatal Diagnosis of Klinefelter Syndrome                       
3.2.2     47, XYY Syndrome                                   
3.2.2.1     Diagnosis of 47, XYY Syndrome                           
3.2.3     45, X Syndrome (Turner Syndrome)                           
3.2.3.1     Prenatal Diagnosis of Turner Syndrome                           
3.2.4     47, XXX (Triple X Syndrome)                               
3.2.4.1     Tests for Triple X Syndrome                               
3.2.5     Trisomy 21 (Down Syndrome)                               
3.2.5.1     Tests for Down Syndrome                               
3.2.5.2     Incidence of Down Syndrome by Maternal Age                       
3.2.5.3     Developmental Delay in Children with Down Syndrome                   
3.2.6     Trisomy 18 (Edward’s Syndrome)                           
3.2.6.1     Prenatal Diagnosis of Trisomy 18                           
3.2.6.2     Clinical Manifestations of Trisomy 18                           
3.2.7     Trisomy 13 (Patau Syndrome)                               
3.2.7.1     Prenatal Diagnosis of Trisomy 13                           
3.2.8     Triploid Syndrome                                   
3.2.8.1     Congenital Anomalies Associated with Triploidy                   
3.2.8.2     Prenatal Diagnosis of Triploidy                               
3.2.9     Prevalence of Trisomies in the U.S.                           
3.2.9.1     Trisomies and Abortions                               
3.2.10     Maternal Age-Related Frequencies of Aneuploid Fetuses               
3.2.11     Clinical Features of Common Chromosomal Aneuploidy               
3.2.12     Maternal Age and Chromosomal Aneuploidy                       
3.2.13     Sensitivity and Specificity of Maternal Serum and Ultrasound Tests for Aneuploids   
3.3         Structural Chromosomal Abnormalities                           
3.3.1     Autosomal Deletions                                   
3.3.1.1     Wolf-Hirschhorn Syndrome (WHS)                           
3.3.1.2     Cri du chat Syndrome                                   
3.3.1.3     Langer-Giedion Syndrome                               
3.3.2     Common Autosomal Microdeletion Syndrome                       
3.3.2.1     Williams Syndrome                                   
3.3.2.2     WAGR Syndrome                                   
3.3.2.3     Prader-Willi Syndrome (PWS)                               
3.3.2.4     Angelman Syndrome                                   
3.3.2.5     Miller-Dieker Syndrome                               
3.3.2.6     Smith-Magenis Syndrome (SMS)                           
3.3.2.7     Alagille Syndrome (ALGS)                               
3.3.2.8     CATCH 22 Syndrome                                   
3.3.2.9     DiGeorge Syndrome                                   
3.3.3     Autosomal Duplication Syndromes                           
3.3.3.1     Beckwith-Wiedemann Syndrome (BWS)                       
3.3.3.2    Charcot-Marie-Tooth Disease Type 1A (CMT1A)                   
3.3.3.3    Cat-Eye Syndrome                                   
3.3.4    Appropriate Technologies for the Detection of Microdeletions, Duplications and Copy Number Variants   

4.0        Genetic Counseling: An Overview                           
4.1        Impact of Recent Advances in Clinical Genomics on Genetic Counseling           
4.2        Genetic Counselors in DTC GT Industry                           
4.2.1    Types of Genetic Counseling Offered by DTC GT Companies               
4.2.2    Roles of Genetic Counselors in DCT GT Industry              

5.0        Prenatal Screening for Genetic Diseases: An Overview                   
5.1        Routine Prenatal Screening Tests                           
5.2        Less-Routine Prenatal Screening Tests                           
5.3        Beta Human Chorionic Gonadotropin (ß-hCG) Screening Test               
5.3.1    hCG Kits and Manufacturers                               
5.4        First Trimester Pregnancy-Associated Plasma Protein-A (PAPP-A) Screening Test   
5.5        Maternal Serum Alpha-Fetoprotein (MSAFP) Screening Test               
5.6        Second Trimester Serum ß-hCG Screening Test                       
5.7        Second Trimester Unconjugated Estriol (uE3) Screening Test               
5.8        Second Trimester Inhibin-A Screening Test                       
5.9        Second Trimester Hexosaminidase Test                           
5.10    Second Trimester Triple-Screen Quad Screen Tests                   
5.11    Second Trimester Screening of Cell-Free Fetal DNA (cffDNA)               
5.11.1     Sensitivity and Specificity of NIPTs                           
5.11.2     Diagnostic Applications of cffDNA                           
5.11.3     Time of Availability of cffDNA in Maternal Blood                   
5.11.4     The Cost of NIPTs                                   
5.11.5     Cost of NIPTs by Product                               
5.11.6     History of Aneuploidy Testing from 1970s to 2011                   
5.11.7     NIPT Methods of Detecting Aneuploidy                       
5.11.7.1     Shotgun Method                                   
5.11.7.2     Targeted Massively Parallel Sequencing (t-MPS)                   
5.11.7.3     Single Nucleotide Polymorphisms (SNPs)                       
5.11.8     Comparison of Amniocentesis and NIPT                       
5.11.9     Advantages of NIPTs                                   
5.11.10     Disadvantages of NIPTs                               
5.11.11     Comparison of Performance Criteria for Commonly used Prenatal Tests           
5.11.12     Comparison of NIPT Detection Rates with Traditional Tests               
5.11.13     False Positive Rates of NIPTs Compared with Those of Traditional Tests       
5.11.14     Fetal Genetic Disorders Detected by NIPTs and other Screening Tests           
5.12    First Trimester Ultrasound Screening Test                       
5.12.1     Nuchal Translucency (NT) Screening Test                       
5.13    Magnetic Resonance Imaging (MRI) in Prenatal Screening               
5.14    Prenatal Diagnosis of Genetic Disorders                           
5.14.1     Amniocentesis (AC)                                   
5.14.1.1     Reliability of Amniocentesis                               
5.14.2     Chorionic Villus Sampling (CVS)                           
5.14.2.1     Reliability of CVS Test                                   
5.14.3     Cordocentesis or Percutaneous Umbilical Blood Sampling               
5.15    Advantages and Disadvantages of Prenatal Diagnostic Tests               
5.16    Future of Invasive Prenatal Diagnostic Tests                       
5.16.1     Indispensability of Invasive Diagnostic Tests                       
5.17    Intact Circulating Fetal Cells for Noninvasive Prenatal Tests               
5.17.1     Scheme for Isolating Intact Fetal Cells from Maternal Blood               
5.18    Trophoblast Retrieval and Isolation from Cervix (TRIC)   

6.0        Newborn Screening                                   
6.1        Status of Newborn Screening in Developed and Developing Countries           
6.2        Status of Newborn Screening in Middle East and North Africa (MENA)           
6.3        Screening Tests Recommended for Newborns in the U.S.               
6.4        Most Common Newborn Genetic Disorders                       
6.4.1    Phenylketonuria (PKU)                                   
6.4.1.1    Screening Tests Used for Diagnosis of PKU                       
6.4.2    Congenital Hypothyroidism (CHT)                           
6.4.2.1    Inheritance of CHT                                   
6.4.2.2    Signs and Symptoms of CHC                               
6.4.2.3     Diagnosis of CHT                                   
6.4.3    Congenital Adrenal Hyperplasia                               
6.4.3.1    Inheritance of Congenital Adrenal Hyperplasia                       
6.4.3.2    Symptoms of Congenital Adrenal Hyperplasia                       
6.4.3.3    Diagnosis of Congenital Adrenal Hyperplasia                       
6.4.4    Galactosemia                                       
6.4.4.1    Signs and Symptoms of Galactosemia                           
6.4.4.2    Diagnosis of Galactosemia                               
6.4.5    Sickle Cell Disease (SCD)                               
6.4.5.1    Symptoms of SCD                                   
6.4.5.2    Diagnosis of SCD                                   
6.4.6    Biotidinase Deficiency                                   
6.4.6.1    Inheritance of Biotidinase Deficiency                           
6.4.6.2    Signs and Symptoms of Biotidinase Deficiency                       
6.4.6.3    Diagnosis of Biotidinase Deficiency                           
6.4.7    Homocystinuria                                       
6.4.7.1    Signs and Symptoms of Homocystinuria                           
6.4.7.2    Diagnosis of Homocystinuria                               
6.4.8    Maple Syrup Urine Disease (MSUD)                           
6.4.8.1    Inheritance of MSUD                                   
6.4.8.2    Diagnosis of MSUD       

7.0        Preconception/Carrier Screening                               
7.1        Introduction                                       
7.2        What are the Main Commercially Available Carrier Tests on the Market?           
7.3        Preimplantation Genetic Screening and Preimplantation Genetic Diagnosis (PGS/PGD)   
7.4        PGS/PGD Technologies                                   
7.4.1    Fluorescent in situ Hybridization (FISH)                           
7.4.2    Array Comparative Genome Hybridization (aCGH)                   
7.4.3    Single Nucleotide Polymorphism (SNP) Microarray                   
7.4.4    Oligonucleotide Genome Sequencing (OGS)                       
7.4.5    Express Genome Sequencing (EGS)                           
7.4.6    Next Generation Sequencing (NGS)                           
7.5        Strengths and Weaknesses of Currently Available PGS/PGD Technologies       
7.6        Genetic Diseases Detected During PGD                           
7.7        PGS/PGD Testing Products in the Market                       
7.8        Cost of in vitro Fertilization and Related Procedures      

8.0        Pregnancy, Prenatal, Newborn and PGD-Related Technologies: An Overview       
8.1        Beta Human Chorionic Gonadotopin (ß-hCG) Test                   
8.1.1    Setting up the Test Strip                                   
8.1.2    Procedure of the Test                                   
8.1.3    Interpretation of ß-hCG Test Result                           
8.2        Pregnancy Associated Plasma Protein-A (PAPP-A) Test                   
8.2.1    Principle of PAPP-A Test                               
8.3        Maternal Serum Alpha Fetoprotein (MSAFP) Test                   
8.3.1    Principle of MSAFP Test                               
8.4        Unconjugated Estriol (uE3) Test                               
8.4.1    Principle of uE3 Test                                   
8.5        Inhibin A Test                                       
8.5.1    Principle of Inhibin A Test                               
8.6        Fetal Karyotyping                                   
8.7        Extended Banding Chromosome Studies                           
8.8        Innovation in Invasive Prenatal Diagnosis                       
8.8.1    Microarray: An Alternative for Karyotyping                       
8.8.2    Rapid Aneuploid Detection by Quantitative Fluorescent PCR (QF-PCR)           
8.8.2.1     Principles of QF-PCR                                   
8.8.3    Fluorescence in situ Hybridization (FISH)                       
8.8.3.1     The Format of Fish Test Result                               
8.8.3.2     Commonly Used FISH-Based Tests                           
8.8.3.3     Microdeletions/Microduplications Detectable by FISH                   
8.8.3.4     Types of FISH Probes and Their Functions                       
8.8.4    Microarray-Based Comparative Genomic Hybridization (array-CGH)           
8.9        Advances in Prenatal Screening: The Power to Know Sooner               
8.9.1    NIPTs: An Overview of Tests and Technologies                       
8.9.1.1     Harmony Test                                       
8.9.1.2     InformaSeq                                       
8.9.1.3     Panorama Test                                       
8.9.1.4     Prena Test                                       
8.9.1.5     NIFTY Test                                       
8.9.1.6     IONA Test                                       
8.9.1.7     Verifi Test                                       
8.9.1.8     MaterniT GENOME Test                               
8.9.1.9     MaterniT21 PLUS Test                                   
8.9.1.10     HeridiT UNIVERSAL Carrier Screen                           
8.9.2    Comparison of MaterniT21 PLUS, Verifi, Harmony and Panorama Tests           
8.9.3    U.S. Patents for NIPTs by Company                           
8.9.3.1     Selected Issued Patents of NIPTs                           
8.9.3.2     Assignees of Major U.S. Patents and their Current Licensees               
8.9.4    Global Availability of NIPTs                               
8.9.5    Cost Effectiveness of NIPTs                               
8.9.6    Clinical Implementation Strategies to be adopted for NIPTs               
8.9.7    Integration of NIPT into Healthcare System: Patient-Directed Model           
8.10    Tandem Mass Spectrometry (MS/MS) in Newborn Screening               
8.11    Fetal Ultrasound in Prenatal Screening                           
8.11.1     Types of Fetal Ultrasound Exams                           
8.11.2     Best Obstetric and Gynecological Ultrasound Systems in the Market           
8.11.3     Best Premium Fetal Ultrasound Machines                       
8.11.3.1     Philips Epiq 7                                       
8.11.3.2     GE Voluson E8                                   
8.11.3.3     GE Voluson E10                                   
8.11.3.4     Samsung UGEO WS80A                               
8.11.4     High-End Systems                                         
8.11.4.1    Philips Epiq 5                                       
8.11.4.2    Philips Affinity 70                                   
8.11.4.3    GE Voluson E6                                       
8.11.4.4    GE Voluson S8                                       
8.11.5    Midrange Systems                                   
8.11.5.1    Philips Affinity 50                                   
8.11.5.2    GE Voluson S6                                       
8.11.5.3    Samsung AccuVix A30                                   
8.11.5.4    Philips Clear Vue 650                                   
8.11.6    Economy Systems                                   
8.11.6.1    Philips Clear Vue 550                                   
8.11.6.2    GE Logiq P5                                       
8.11.6.3    Samsung H60                                       
8.11.6.4    Alpinion Ecube 7                                   
8.11.7    Portable Systems                                   
8.11.7.1    GE Voluson 1                                       
8.11.7.2    Samsung UGEO HM70A                               
8.12    Therapeutic Genome Editing: A Breakthrough Technology               
8.12.1    Genome Editing Technologies                               
8.12.1.1    Growing Popularity of CRISPR Kits                           
8.12.2    Therapeutic Applications of Genome Editing                       
8.12.3    The First Genetically Modified Human Embryos      

9.0        Market Analysis                                   
9.1        Preconception/Carrier Screen Market Analysis                       
9.1.1    Major Players in the Preconception/Carrier Testing Market                
9.1.2    Market Size of Multi-Panel and Expanded Screening Market               
9.2        Prenatal Screening and Diagnostics: Market Overview                   
9.1        Global Market for Fetal Ultrasound                           
9.1.1    Market Leaders in Fetal Ultrasound                           
9.2        Global Market for Prenatal MRI Screening                       
9.3        Global Market for Maternal Serum Screening Tests                   
9.4        Global Market for Noninvasive Prenatal Tests (NIPTs) using cffDNA           
9.4.1    Global Market for NIPTs by Product                           
9.5        Global Market for Prenatal Diagnostic Invasive Tests                   
9.6         Global Market for Newborn Screening for Genetic Diseases               
9.6.1    Newborn Screening Market by Technology                       
9.7        Global Market for Preimplantation Screening/Diagnosis (PGS/PGD)         

10.0    Other Genetic Testing-Related Markets                           
10.1    Emerging Trends in Molecular Diagnostics Market                   
10.2    Emerging Trends in Liquid Biopsy Market                       
10.3    Emerging Trends in Personalized Medicine Diagnostics Market               
10.4    Emerging Trends in in vitro Diagnostics (IVD) Market   

11.0    Market SWOT and Strategy Analysis                           
11.1    Acquisition Activities in Prenatal Screening Industry                   
11.1.1    Acquisition of BlueGenome by Illumina                           
11.1.2    Illumina’s Acquisition of Verinata                           
11.1.3    Eurofin’s Joint Venture with Emory Genetics Laboratory                   
11.1.4    Roche’s Acquisition of Ariosa Diagnostics                       
11.1.5    Cooper Surgical’s Acquisition of Reprogenetics                       
11.2    Market Drivers                                       
11.3    Market Restraints                                   
11.4    Future of Prenatal Screening                               
11.5    Legislation Mandating Newborn Screening by Geography               
11.5.1    Newborn Screening Programs in Americas                       
11.5.2    Newborn Screening Programs in Asia/Pacific                       
11.5.3    Newborn Screening Programs in Europe                           
11.5.4    Newborn Screening Programs in Middle East and Northern Africa           
11.6    Ethical Voices against Problamatic Applications of NIPT and NIPD           
11.7    Clinical Implemention of NIPTs                               
11.7.1    Implementation of NIPTs in Developed Countries                   
11.7.3    Implementation of NIPTs in Developing and Under-Developed Countries       
11.8    Adoption Rates for Different Prenatal Tests in the U.S.          

12.0    Company Profiles                                   
12.1    23andMe Inc.                                       
12.1.1    23andMe’s Agreement with Pfizer                           
12.1.2    23andMe’s Agreement with Genentech                           
12.1.3    FDA’s Approval for 23andMe’s Screening Test for Bloom Syndrome           
12.2    Abbott Laboratories                                   
12.2.1    ARCHITECT AFP Assay                               
12.3    Abbott Molecular Inc.                                   
12.3.1    AneuVysion                                       
12.3.2    Cystic Fibrosis Genotyping Assay                           
12.4    Abcam plc                                       
12.4.1    hCG Human ELISA Kit                                   
12.5    AB Sciex LLC                                       
12.6    Adaltis S.r.l                                       
12.6.1    CLIAgen Free Beta-hCG Kit                               
12.7    Adaptive Biotechnologies Corp.                               
12.7.1    ImmunoSEQ Platform                                   
12.7.2    ClonoSEQ                                       
12.7.3    Pipeline                                       
12.7.3.1     Quantifying Tumor Infiltration Lymphocytes in Solid Tumors               
12.7.3.2     Measuring Immune Reconstitution Post Transplant                   
12.7.3.3     Diagnosing Cutaneous T-Cell Lymphoma (CTCL)                   
12.7.3.4     Therapeutics                                       
12.8    Affymetrix Inc.                                       
12.8.1    Microarray Solutions                                   
12.8.2    Affymetrix’s Collaborating Partners                           
12.8.3    Affymetrix’s R&D Investment                               
12.9    Agena Biosciences Inc.                                   
12.9.1    MassARRAY System                                   
12.9.2    Acquisition of Sequenom’s Bioscience Business by Agena Biosciences           
12.10    Agilent Technologies Inc.                               
12.10.1     SureScan Microarray Scanner                               
12.10.2     OneSeq                                       
12.11    Ambry Genetics Corp.                                   
12.11.1    Clinical Diagnostic Tests                               
12.12    Analogic Corp.                                       
12.12.1    Flex Focus 500                                       
12.12.1    SonixTouchQ+                                       
12.12.3    SonixSP Q+                                       
12.13    Ariosa Diagnostics Inc.                                   
12.13.1    Harmony Test                                       
12.13.2    Granting of Licenses to Harmony Test                           
12.14    Ansh Labs                                       
12.14.1    picoPAPP-A ELISA Kit                                   
12.14.2    Inhibin A ELISA Kit                                   
12.15    Appistry Inc.                                       
12.15.1    GenomePilot                                       
11.15.2    Ayrris for NGS Analysis                               
12.15.3    Variant Annotation and Analysis Suite                           
12.15.4    CloudDx Translational                                   
12.15.5    CloudDx Clinical                                   
12.15.6    Appistry’s Partnership with LifeMap Sciences                       
12.16    ARUP Laboratories                                   
12.16.1    Prenatal Screening and Diagnosis                           
12.16.2    Next-Generation Sequencing (NGS)                           
12.16.3    Noninvasive Prenatal Test for Aneuploids                       
12.17    AssureRx Health Inc.                                   
12.17.1    GeneSight Psychotropic                                   
12.17.2    GeneSight Analgesic                                   
12.17.3    GeneSight ADHD                                   
12.17.4    GeneSight MTHFR                                   
12.18    Asuragen Inc.                                       
12.18.1    AmplideX FMR1 PCR                                   
12.18.2    AmplideX FMR1 mPCR                               
12.18.3    AmplideX Controls                                   
12.18.4    Quantidex Pan Cancer Kit                               
12.18.5    Quantidex BCR/ABL1 Quant Kit                           
12.18.6    Quantidex DNA Assay                                   
12.18.7    Signature Technology                                   
12.18.8    Signature KRAS Mutations                               
12.18.9    Signature BRAF Mutations                               
12.18.10    Signature LTx v2.0                                   
12.18.11    Signature NPM1 Mutations                               
12.19    Athena Diagnostics Inc.                                   
12.20    AutoGenomics Inc.                                   
12.20.1    INFINITI System                                   
12.21    Base4 Innovation Ltd.                                   
12.21.1    Microdroplet Sequencing                               
12.22    Beckman Coulter Inc.                                   
12.22.1    SPRIworks System I for Illumina Genome Analyzer                   
12.22.2    SPRIworks HT for Illumina NGS Platform                       
12.22.3    SPRIselect Reagent Kit                                   
12.22.4    Automated Sample Preparation                               
12.22.5    Genomic Services                                   
12.22.6    Access Total Beta-hCG Reagent                               
12.22.7    Access Inhibin A Assay                                   
12.23    erry Genomics Co., Ltd.                                   
12.23.1    Bambni Test                                       
12.23.2    Berry’s Partnership with Illumina                           
12.24    Bina Technologies Inc.                                   
12.24.1    Bina RAVE                                       
12.24.2    Bina AAiM                                       
12.24.3    Bina’s Collaboration with AsraZeneca                           
12.25    Bio-Rad (Israel) Laboratories Inc.                           
12.26    BGI                                           
12.27    Blueprint Genetics Oy                                   
12.27.1    Services                                       
12.28    Boreal Genomics Inc.                                   
12.28.1    OnTarget Mutation Detection System                           
12.28.2    Aurora Platform                                   
12.29    Cambridge Epigenetix Ltd.                               
12.29.1    TrueMethyl Seq Kit                                   
12.29.2    TrueMethyl Array                                   
12.30    Caris Lifesciences                                   
12.30.1    ADAPT Biotargeting System                               
12.30.2    Caris Molecular Intelligence                               
12.30.3    Collaboration between Caris Lifesciences and Syapse                   
12.31    CeGaT GmbH                                       
12.31.1    NGS Service                                       
12.31.2    ADME Research Panel                                   
12.31.3    Forschungsexom                                   
12.32    Centogene AG                                       
12.33    Chromsystems Instruments & Chemicals GmbH                       
12.34    Chronix Biomedical Inc.                               
12.34.1    Technology                                       
12.35    Claritas Genomics Inc.                                   
12.36    CLC bio A/S                                       
12.36.1    Products                                       
12.37    Combimatrix Corp.                                   
12.37.1    CombiSNP Array for Prenatal Diagnosis                           
12.37.2    CombiPGS                                       
12.38    Contec Medical Systems Co., Ltd.                           
12.38.1    CMS600P B-Ultrasound Diagnostic System                       
12.38.2    CMS600B3 B-Ultrasound Diagnostic System                       
12.39    Coriell Life Sciences Inc.                               
12.39.1    GeneDose                                       
12.40    Correlagen Diagnostics Inc.                               
12.41    Counsyl Inc.                                       
12.41.1    Family Prep Screen                                   
12.41.2    Informed Pregnancy Screen                               
12.41.3    Inherited Cancer Screen                                   
12.42    Courtagen Life Sciences Inc.                               
12.43    Creative Diagnostics                                   
12.43.1    Alpha-Fetoprotein, AFP ELISA Kit                           
12.43.2    hCG ELISA Kit                                       
12.43.3    Human Free Estriol ELISA Kit                               
12.44    Cynvenio Biosystems Inc.                               
12.44.1    LiquidBiopsy                                       
12.44.2    ClearID                                           
12.44.3    Thermo Fisher’s Distribution Agreement with Crynvenio               
12.44.4    Cynvenio’s Collaboration with the University of Southern Denmark           
12.45    Diagnostic Automation/Cortez Diagnostics Inc.                       
12.46    Demeditec Diagnostics GmbH                               
12.46.1    Estriol, Free/Uncojugated ELISA                           
12.47    DRG International Inc.                                   
12.47.1    DRG PAPP-A ELISA                                   
12.48    DNA Electronics Ltd.                                   
12.48.1    Genalysis                                       
12.49    DNA Link Inc.                                       
12.49.1    Services                                       
12.49.2    Partnership between Affymetrix and DNA Link Inc.                   
12.49.3    DNAGPS                                       
12.49.4    AccuID                                           
12.50    DNAnexus Inc.                                       
12.50.1    Adoption of DNAnexus’ Cloud Genomics Platform by Natera               
12.51    Eagle Biosciences Inc.                                   
12.51.1    Alport Syndrome Kit                                   
12.51.2    Free Beta-hCG ELISA                                   
12.52    Eagle Genomics Ltd.                                   
12.52.1    EagleCore                                       
12.52.2    EagleNsembl                                       
12.53    Enzymatics Inc.                                       
12.53.1    Reagents                                       
12.53.2    SPARK DNA Sample Preparation Kit                           
12.54    Esoate SpA                                       
12.54.1    MyLabGamma                                       
12.54.2    MyLab GOLD Platform                                   
12.54.3    MyLab 50                                       
12.54.4    MyLab 40                                       
12.54.5    MyLab 25Gold                                       
12.55    Eurofins MWG Operon Inc.                               
12.55.1    Products and Services                                   
12.56    Exiqon A/S                                       
12.56.1    Products and Services                                   
12.57    Fakuda Denshi Co., Ltd.                               
12.57.1    UF-400AX                                       
12.57.2    UF-550XTD                                       
12.57.3    UF-760AG                                       
12.57.4    UF-870AG                                       
12.58    GATC Biotech AG                                   
12.58.1    Sanger Sequencing                                   
12.59    GE Healthcare Ltd.                                   
12.59.1    VScan                                           
12.59.2    VScan with Dual Probe                                   
12.59.3     Logiq P5                                       
12.59.4     Logiq P6                                       
12.59.5     GE Venue 50                                       
12.59.6     GE Venue 40                                       
12.59.7     Logiq S8                                       
12.59.8     Logiq E9                                       
12.60    GenapSys Inc.                                       
12.60.1    GENIUS                                       
12.61    Gene by Gene Ltd.                                  
12.62    Genection Inc.                                       
12.63    GeneDx Inc.                                       
12.63.1    Cytogenetics and Biochemical Tests                           
12.63.2    Deletion/Duplication Analysis                               
12.63.3    Carrier Mutation-Specific Testing                           
12.64    GenePeeks Inc.                                       
12.64.1    Matchright Technology                                   
12.65    Genesis Genetics                                   
12.65.1    GeniSeq24                                        
12.65.2    UltraPGD                                           
12.65.3    ArrayCGH                                       
12.66    Genetadi Biotech S.L.                                   
12.66.1    AMNIOCHIP                                             
12.66.2    FERTICHIP                                       
12.66.3    PRENATAL GENE                                   
12.67    Genoma Group Srl                                   
12.68    Genomed AG                                       
12.68.1    Aneufast                                       
12.69    GenPath Diagnostics                                   
12.69.1    InheriGen, InheriGen Plus and InheriGen Tx                       
12.69.2    Prenatal Tests                                       
12.70    Genway Biotech Inc.                                   
12.71    Good Start Genetics Inc.                               
12.71.1    EmbryVu                                       
12.72    Hitachi Medical Systems America Inc.                           
12.72.1    Arietta 70                                       
12.72.2    ProSound Alpha 7                                   
12.72.3    Noblus                                           
12.72.4    ProSound F37                                       
12.73    Hologic Inc.                                       
12.73.1    InPlex CF Molecular Test                               
12.73.2    Rapid fFN Test                                       
12.74    Illumina Inc.                                       
12.74.1    The Verifi Prenatal Test                                   
12.75    INEX Innovations Exchange Pte Ltd.                           
12.75.1    iGene                                           
12.75.2    FlashFISH                                       
12.75.3    INEX’s Collaborative Agreement with BGI                       
12.76    Invitae Corp.                                       
12.77    Laboratory Corporation of America Inc.                           
12.77.1    Services                                       
12.78    LifeCodexx AG                                       
12.78.1    Prena Test                                       
12.79    Monobind Inc.                                       
12.79.1    Fertility VAST Panel: HCG, FSH, LH, SPRL                       
12.79.2    PAPP-A Test                                       
12.80    Multiplicom NV                                   
12.80.1    Clarigo                                           
12.81    Myriad Genetics                                   
12.82    Natera Inc.                                       
12.82.1    Panorama Prenatal Screen                               
12.82.1.1    Accuracy of Panorama Test                               
12.82.1.2    Minimal False Negatives in Panorama                           
12.82.2    Horizon Carrier Screening                               
12.82.3    Spectrum Preimplantation Test                               
12.82.4    Natera’s 24-chromosome PGS                               
12.82.5    Anora Miscarriage Test                                   
12.82.6    Prenatal Paternity Test                                   
12.82.7    Agreement between Natera and LifeLabs                       
12.83    Natus Medical Inc.                                   
12.83.1    ABaer                                           
12.83.2    Algo 5                                           
12.83.3    Algo 3i                                           
12.83.4    AuDX                                           
12.83.5    Echo-Screen III                                       
12.84    NewGene Ltd.                                       
12.84.1    Hereditary Disorders                                   
12.84.2    Alport Syndrome                                   
12.84.3    Aortopathy Panel                                   
12.84.4    RASopathy Gene Panel                                   
12.84.5    Familial Hypercholesterolaemia                               
12.85    NIPD Genetics Ltd.                                   
12.85.1    VERACITY Test (NIPT)                               
12.86    Oxford Gene Technology (OGT)                           
12.86.1    SureSeq NGS Library Preparation Kit                           
12.86.2    CytoSure Embryo Screen Array                               
12.86.3    Cytocell FISH Probes                                   
12.86.4    CytoSure Embryo Screen Array                               
12.86.5    CytoSure Aneuploidy Array                               
12.86.6    CytoSure Chromosome X Arrays                           
12.87    Parabase Genomics Inc.                                   
12.87.1    NewbornDx Test                                   
12.88    Pathway Genomics Corp.                               
12.88.1    Carrier Screening                                      
12.89    PerkinElmer Life and Analytical Sciences Inc.                       
12.89.1    DELFIA Xpress PIGF Assay                               
12.89.2    DELFIA Xpress PAPP-A Kit                               
12.89.3    AutoDELFIA PAPP-A Kit                               
12.89.4    StepOne Newborn Screens                               
12.90    Premaitha Health PLC                                   
12.90.1    IONA Test                                       
12.90.2    Premaitha’s Investment Agreement with Thermo Fisher                   
12.91    Progenity Inc.                                       
12.91.1    nxtPanel Test                                       
12.91.2    Verifi Test                                       
12.91.3    Acquisition of Carmenta Bioscience by Progenity                   
12.92    Qiagen N.V.                                       
12.92.1    Next-Generation Sequencing (NGS)                            
12.92.2    Target Enrichment Solutions                               
12.92.3     Library Construction                                   
12.93    Quest Diagnostics Inc.                                   
12.93.1    QNatal Advanced                                   
12.93.2    Inhibin A                                       
12.94    Ravgen Inc.                                       
12.94.1    Prenatal Downs Syndrome Testing                           
12.94.2    Single Gene Disorder Testing                               
12.95    Recombine Inc.                                       
12.95.1    CarrierMap                                        
12.96    Reproductive Genetics Institute Inc.                           
12.97    Reprogenetics Laboratories                               
12.97.1    Array CGH (aCGH)                                   
12.97.2    Single Gene Disorder Testing                               
12.97.3    WaferGen Biosystems’ Supply Agreement with Reprogenetics               
12.98    Sebia Inc.                                       
12.99    Sequenom Inc.                                       
12.99.1    MaterniT GENOME Test                               
12.99.1.1    Sensitivity and Specificity of MaterniT GENOME Test                   
12.99.2    MaterniT21 PLUS                                   
12.99.2.1    Sensitivity and Specificity of MaterniT21 PLUS                       
12.99.3    HerediT UNIVERSAL Carrier Screen                           
12.99.4    VisibiliT Prenatal Test                                   
12.99.5    HerediT Cystic Fibrosis Carrier Screen                           
12.99.5.1    Clinical Data for HerediT                               
12.99.6    SensiGene Fetal RHD Genotyping                           
12.99.7    NextView Prenatal Diagnostic Tests                           
12.100    SeraCare Life Sciences Inc.                               
12.100.1    Seraseq Trisomy 21 Aneuploidy Reference Material                   
12.101    Siemens Healthcare                                   
12.101.1    Acuson S2000                                       
12.101.2    Acuson X700                                       
11.101.3    Acuson X600                                       
12.101.4    Acuson X300 PE                                   
12.101.5    Acuson X150                                       
12.101.6    Acuson Antares                                       
12.101.7    Acuson P300                                       
12.102    Sophia Genetics SA                                   
12.102.1    Clinical Genomic Modules                               
12.103    SpOtOn Clinical Diagnostics Ltd.                           
12.103.1    Newborn Screening                                   
12.103.2    Ante-Natal Testing                                   
12.104    Stra Biotech GmbH                                   
12.105    Sygnis AG                                       
12.105.1    TruePrime Single Cell WGA Kit                           
12.105.2    TruePrime WGA Kit                                   
12.105.3    TruePrime RCA Kit                                   
12.105.4    SunScript Reverse Transcriptase RNaseH+ and RNaseH- Kits               
12.105.5    SensiPhi/QualiPhi                                   
12.106    SynapDx Corporation                                   
12.106.1    ASD Diagnosis                                           
12.107.1    Thermo Fisher’s Brands                                   
12.108    Transgenomic Inc.                                       
12.108.1    Technology Suite                                   
12.108.2    MX-ICP Technology                                   
12.108.3    ICEme Kit                                      
12.108.4    Other Products                                       
12.109    Trivitron Healthcare Private Ltd.                           
12.110    Trovagene Inc.                                       
12.110.1    PCM BRAF V600E Mutation Detection Test                       
12.110.2    PCM KRAS Mutation Detection Test                           
12.110.3    PCR EGFR Mutation Detection Test                           
12.110.4    HPV HR Detection Test                           
12.111    Tute Genomics Inc.                                   
12.111.1    Tute Platform                                       
12.112    Warp Drive Bio LLC                                 
12.112.1    Wrap’s New Approach                                   
12.112.2    Chemomemes                                       
12.112.3    Genomic Search Engine                                   
12.113    ZS Genetics Inc.                                   
12.113.1    3G Sequencing                                       
12.114    Zymo Research Corporation                               
12.114.1    DNA Methylation Products                               
12.114.1.1    Bisulfite Conversion                                   
12.114.1.2    Methylated DNA Standards                               
12.114.1.3    DNA Methyltransferases                               
12.114.1.4    5-mC ELISA                                       
12.114.1.5    5-mC Antibodies and Immunoprecipitation                       
11.114.1.6    Region-Specific DNA Methylation Analysis                       
12.114.1.7    Global 5-mC Quantification                               
12.114.1.8    Genome-wide 5-mC Analysis                               
12.114.2    DNA Purification Products                               
12.114.2.1    DNA Clean-up                                       
12.114.2.2    Plasmid DNA Purification                               
12.114.2.3    Genomic DNA                                         
12.114.2.4    Microbial and Environmental DNA Isolation                       
12.114.2.5    DNA/RNA Co-Purification                               
12.114.2.6    Sample Collection and Stabilization                           
12.114.2.7    DNA Ladders                                       
12.114.2.8    Enzymes                                       
12.114.2.9    High-Throughput/Automated Isolation                           
12.114.2.10    DNA Analysis Kits                                   
12.114.3    Other Products                                       

APPENDIX

Appendix 1: Representative Companies in Prenatal and Maternal Diagnostics and their Products   
Appendix 2: Sources for Tables and Graphs                               

INDEX OF FIGURES

Figure 1.1: Summary of Prenatal Screening, Prenatal Diagnosis, Newborn Screening and PGS/PGD Markets, Through 2021                                           
Figure 2.1: Risk of Down Syndrome and Chromosomal Abnormalities Due to AMA           
Figure 2.2: Maternal Age and Pregnancy Loss Rate                           
Figure 2.3: Risk of Cesarean Section with Increasing AMA                       
Figure 2.4: Risk of Gestational Diabetes with AMA                           
Figure 2.5: Risk of Placenta Previa with AMA                           
Figure 2.6: Delayed First Pregnancy in the U.S.                           
Figure 2.7: First Birth Rates for 35-39 Aged U.S. Women by Race                   
Figure 2.8: Pre-Existing Chronic Diseases among Women of Reproductive Ages in the U.S.       
Figure 2.9: Chronic Disease Risk Behaviors and Risk Factors among Women of Reproductive Ages in the U.S.                                               
Figure 2.10: Prevalence of Preeclampsia during Pregnancy by Race/Ethnicity in the U.S.       
Figure 2.11: Prevalence of Preeclampsia by Maternal Age in the U.S.                   
Figure 2.12: Prevalence of Gestational Diabetes by Maternal Age in the U.S.               
Figure 2.13: Prevalence of Gestational Diabetes by Maternal Race/Ethnicity in the U.S.       
Figure 2.14: Causes of Preterm Labor                               
Figure 2.15: Prevalence of Preterm Births in the U.S. by Stage                   
Figure 2.16: Prevalence of Preterm Births in the U.S. by Race/Ethnicity               
Figure 2.17: Prevalence of Preterm Births in the U.S. by Plurality of Birth               
Figure 2.18: Prevalence of Preterm Births in the U.S. by Maternal Age               
Figure 2.19: Prevalence of Multiple Births in the U.S.                       
Figure 3.1: Inheritance of Autosomal Dominant Faulty Gene When One Parent is a Carrier       
Figure 3.2: Inheritance of Autosomal Dominant Faulty Gene When Both Parents are Carriers       
Figure 3.3: Percent of Patients taking Sweat Chloride Test Reported in the U.S. Registry       
Figure 3.4: Age at CF Diagnosis for all People Reported in the U.S. Registry, 2013           
Figure 3.5: Distribution of Race/Ethnicity among People with CS in the U.S., 2013           
Figure 3.6: Percent of New CF Diagnosis in U.S. Newborn Screenings, 1990-2013           
Figure 3.7: The Six Most Common CFTR Mutations in the U.S.                   
Figure 3.8: Autosomal Recessive Inheritance when Both Parents are Carriers                
Figure 3.9: Autosomal Recessive Inheritance with Carrier Mother and Non-Carrier Fath       
Figure 3.10: Autosomal Recessive Inheritance from Homozygous Recessive Mother and Carrier Father                                                       
Figure 3.11: Autosomal Recessive Inheritance from Two Affected Parents               
Figure 3.12: Inheritance Pattern of Sex-Linked Dominant Disorder with Affected Mother and Carrier Father                                                       
Figure 3.13: X-Linked Recessive Inheritance with a Carrier Mother and Non-Carrier Father       
Figure 3.14: X-Linked Recessive Inheritance with Normal Mother and Affected Father       
Figure 3.15: Incidence of Down Syndrome by Maternal Age in the U.S.               
Figure 3.16: Prevalence of Trisomies in the U.S.                           
Figure 3.17: Relative Frequencies of Chromosomal Anomalies in Spontaneous Abortions       
Figure 3.18: Maternal Age and Chromosomal Aneuploidy Detected at Amniocentesis           
Figure 5.1: Genetic Disorders (%) Detectable by Prenatal Testing Methods               
Figure 5.2: Nuchal Translucency as Seen in an Ultrasound Scan                   
Figure 5.3: The Amniocentesis Procedure                               
Figure 5.4: Chorionic Villus Sampling Procedure                           
Figure 5.5: Transvaginal CVS Procedure                               
Figure 5.6: Decline in Number of Amniocentesis at Yale New Haven Hospital and Bridgeport Hospital in the U.S. between 2011 and 2013                                   
Figure 5.6: Scheme for Isolating Intact Fetal Cells for Prenatal Genetic Diagnosis           
Figure 6.1: Number of Newborn Genetic Diseases Screened in Selected Countries           
Figure 6.2: The Top Four Countries with Homocystinuria Population (per 100,000)           
Figure 7.1: Indications for PGD                                   
Figure 8.1: Markings on the Test Strip                               
Figure 8.2: Procedure of ß-hCG Test                               
Figure 8.3: Interpretation of ß-hCG Test Result                           
Figure 8.4: Fetal Karyotype Showing Trisomy 21 (Down Syndrome)                   
Figure 8.5: Pek Heights Indicating Aneuploidy in QF-PCR Study                   
Figure 8.6: Diagrammatic Representation of Steps Involved in FISH Test               
Figure 8.7: FISH Test Showing Chromosomal Deletion                       
Figure 8.8: Steps Involved in Array-CGH                               
Figure 8.9: History of Innovations in NIPTs from 2011-2015                       
Figure 8.10: Detection Rate of Harmony Test Compared with Traditional Maternal Serum Tests   
Figure 8.11: Global Availability of NIPTs                               
Figure 8.12: Preference of NIPTs by Pregnant Women at Santa Clara Valley Medical Center       
Figure 8.13: Patient-Directed Model of Integrating NIPTs into Healthcare Setting           
Figure 8.14: Growing Popularity of CRISPR-Cas9 Kits                       
Figure 9.1: Global Carrier Screen Test Market 2015-2020                       
Figure 9.2: Geographical Breakdown of Carrier Screen Test Market, USA, EU, RoW 2015-2020    
Figure 9.3: Ultrasound Imaging Market Share (%) by Clinical Application               
Figure 9.4: Global Market for Fetal Ultrasound Screenong by Geography (U.S., Europe, RoW), Through 2021                                                
Figure 9.5: Global Fetal Ultrasound Market Share by Company, 2014               
Figure 9.6: Global Market for MRI Prenatal Screening by Geography (U.S., Europe, RoW), Through 2021                                                       
Figure 9.7: Global Market for Maternal Serum Screening Tests by Geography (U.S., Europe, RoW), Through 2021                                               
Figure 9.8: Share of NIPTs Market by Geography (North America, Europe, RoW)           
Figure 9.9: Global Market for NIPTs by Geography (North America, Europe, RoW), Through 2021   
Figure 9.10: Global Market for NIPTs by Product                           
Figure 9.11: Global Market for Prenatal Invasive Diagnostic Tests by Geography (U.S., Europe, RoW), Through 2021                                           
Figure 9.12: Global Market for Newborn Screening, Through 2021                   
Figure 9.13: Global Market for Newborn Screening by Technology, Through 2021           
Figure 9.14: Global Market for MS/MS in Newborn Screening, Through 2021           
Figure 9.15: Global Market for Pulse Oximetry in Newborn Screening, Through 2021           
Figure 9.16: Global Market for Enzyme-Based Assays in Newborn Screening, Through 2021       
Figure 9.17: Global Market for DNA Assays in Newborn Screening, Through 2021           
Figure 9.18: Global Market for Electrophoresis in Newborn Screening, Through 2021           
Figure 9.19: Geographical Share of PGS/PGD Market                       
Figure 9.20: Global Market for PGS/PGD by Geography (North America, Europe, RoW)       
Figure 10.1: Global Market for Molecular Diagnostics, Through 2021               
Figure 10.2: Global Market for Liquid Biopsy by Geography (North America, Europe, RoW), Through 2021                                                       
Table 10.3: Global Market for Personalized Medicine by Business Segment, Throgh 2021       
Figure 10.4: Percent Share of IVD Market by Business Segments                   
Figure 10.5: Global IVD Market by Geography (North America, Europe, RoW), Through 2021   
Figure 12.1: Comparison of False Negative Rates                           
Figure 12.2: Sensitivity and Specificity of MaterniT GENOME Test                   

INDEX OF TABLES

Table 1.1:   Summary of Prenatal Screening, Prenatal Diagnosis, Newborn Screening and PGS/PGD Markets, Through 2021                                           
Table 2.1:   Risk of Down Syndrome and Chromosomal Abnormalities Due to AMA           
Table 2.2:   Maternal Age and Pregnancy Loss Rate                           
Table 2.3:   Risk of Cesarean Section with Increasing AMA                       
Table 2.4:   Risk of Gestational Diabetes with AMA                           
Table 2.5:   Risk of Placenta Previa with AMA                           
Table 2.6:   Delayed Fist Pregnancy in the U.S.                           
Table 2.7:   First Birth Rates for 35-39 Aged U.S. Women by Race                   
Table 2.8:   Maternal and Fetal Concerns due to Pre-Existing Maternal Medical Issues       
Table 2.9:   Pregnancy Outcome in Women with Renal Diseases                   
Table 2.10: Pregnancy Outcome in Women with Pre-Existing Thyroid Disease           
Table 2.11: Risks Associated with Obesity in Pregnant Women                   
Table 2.12: Pregnancy Complications in Asthmatic Women                       
Table 2.13: Pregnancy Complications and Neonatal Outcome in Women with Epilepsy       
Table 2.14: Maternal and Fetal Complications in Women with Autoimmune Diseases           
Table 2.15: Complications due to Hemoglobinopathies in Pregnancy                   
Table 2.16: Prevalence of Gestational Diabetes in the U.S.                       
Table 2.17: Countries with Higher and Lower Rates of Preterm Births               
Table 2.18:  Prevalence of Preterm Births in the U.S. by Stage                   
Table 2.19:  Prevalence of Preterm Births in the U.S. by Race/Ethnicity               
Table 2.20:  Prevalence of Preterm Births in the U.S. by Plurality of Birth               
Table 2.21:  Prevalence of Preterm Births in the U.S. by Maternal Age               
Table 2.22:  Related Complications of Placenta Previa                       
Table 2.23:  Mode of Delivery for Breech Presentation                       
Table 2.24:  Perinatal Outcome due to Meconium Stained Liquor                   
Table 2.25:  Pregnancy Outcome due to Polyhydramnios                       
Table 2.26:  Causes of Fetal Growth Restriction                           
Table 2.27:  Prevalence of Congenital Cardiovascular Diseases in the U.S.               
Table 3.1:   Worldwide Prevalence of Huntington Disease by Selected Country           
Table 3.2:   Prevalence of 25 Most Common CFTR Mutations in the U.S., 2013           
Table 3.3:   Molecular Diagnostic Tests for Canavan Disease                       
Table 3.4:   Incidence of Sickle Cell Disease in the U.S.                       
Table 3.5:   Red Blood Cell Indices in Beta-Thalassaemia                       
Table 3.6:   Molecular Genetic Tests for Beta-Thalassaemia                       
Table 3.7:   Chances of Inheriting a Single Gene Disorder                       
Table 3.8:   More Common Recessive Disease Traits in Selected Ethnic Groups           
Table 3.9:   A Comprehensive List of Genetic Disorders                       
Table 3.10: Turnaround Time and Average Cost for Hemophilia Genetic Tests           
Table 3.11: Incidence of Chromosomal Abnormalities                       
Table 3.12: Karyotypes Commonly Associated with Klinefelter Syndrome               
Table 3.13: Features of Turner Syndrome in Different Age Groups                   
Table 3.14: Some Complications of Trisomy 21 (Down Syndrome)                   
Table 3.15: Incidence of Down Syndrome by Maternal Age                       
Table 3.16: Developmental Delay in Children with Down Syndrome                   
Table 3.17: Frequently Observed Anomalies in Babies with Trisomy 18               
Table 3.18: Common Clinical Features of Trisomy 13                       
Table 3.19: Congenital Anomalies Associated with Triploidy                       
Table 3.20: Relative Frequencies of Different Chromosomal Anomalies in Spontaneous Abortions   
Table 3.21: Maternal Age-Related Frequencies of Aneuploid Fetuses Detected Prenatally       
Table 3.22: Clinical Features of Common Chromosomal Aneuploidy                   
Table 3.23: Maternal Age and Chromosomal Aneuploidy                       
Table 3.24: Sensitivity and Specificity of Maternal Serum and Ultrasound Tests for Aneuploids   
Table 3.25: Common Autosomal Deletions, Resulting Syndromes and Clinical Features       
Table 3.26: Common Autosomal Microdeletion Syndromes                       
Table 3.27: Commonly Encountered Problems in Prader-Willi Syndrome               
Table 3.28: Tests for Prader-Willi Syndrome                               
Table 3.29: Molecular Genetic Tests for CATCH 22 Syndrome                   
Table 3.30: Autosomal Duplication Syndromes                           
Table 3.31: Molecular Genetic Tests for Beckwith-Wiedemann Syndrome               
Table 3.32: Molecular Diagnostic Tests for CMT1A                           
Table 4.1:   Genetic Counseling Services by DTC GT Companies                   
Table 4.2:   A List of Genetic Counseling Companies and Their Websites               
Table 5.1:   Major Prenatal Screening Tests during the First and Second Trimesters           
Table 5.2:   Other Routine and Non-Routine Prenatal Screening Tests                   
Table 5.3:   hCG Levels from Date of Conception to 40th Week                   
Table 5.4:   Selected ß-hCG Kits and Manufacturers                           
Table 5.5:   Selected PAPP-A Kits and Manufacturers                       
Table 5.6:   Selected MSAFP Test Kits and Manufacturers                       
Table 5.7:   Selected uE3 Test Kits and Manufacturers                       
Table 5.8:   Selected Inhibin-A Test Kits and Manufacturers                       
Table 5.9:   Selected Hexosaminidase Test Kits and Manufacturers                   
Table 5.10: Comparison of the Four Maternal Serum Screening Analyte Patterns           
Table 5.11: The Five Popular Commercially Available Noninvasive Prenatal Tests (NIPTs)       
Table 5.12: Sensitivity and Specificity of NIPTs                           
Table 5.13: Diagnostic Applications of cffDNA                           
Table 5.14: Time of Availability of cffDNA in Maternal Blood                   
Table 5.15: The Costs of NIPTs by Region/Country                           
Table 5.16: Costs of NIPTs by Product in the U.S.                           
Table 5.17: History of Aneuploidy Screening                           
Table 5.18: NIPT Methods for Detecting Aneuploidy                       
Table 5.19: Comparison of Amniocentesis and NIPTs                       
Table 5.20: Advantages and Disadvantages of NIPTs                           
Table 5.21: Comparison of Performance Criteria for Commonly Used Prenatal Tests           
Table 5.22: Comparison of NIPT Detection Rates with Traditional Tests               
Table 5.23: False Positive Rates of NIPTs Compared with those of Traditional Tests           
Table 5.24: Different Applications of Ultrasound in Different Trimesters               
Table 5.25: MRI Indications for Prenatal Screening when Ultrasound Screening is Inadequate       
Table 5.26: Prenatal Diagnostic Tests by Pregnancy Stage                       
Table 5.27: Comparison of CVS and Amniocentesis                           
Table 5.28: Advantages and Disadvantages of Prenatal Diagnostic Tests               
Table 5.29: Comparison of Prenatal Tests using Cell-Free Fetal DNA (cffDNA) and Intact Fetal Cells from Maternal Blood                                           
Table 6.1:   Thirty One Core Conditions Detected During Newborn Screening           
Table 6.2:   Categories of Newborn Genetic Disorders                           
Table 6.3:   Metabolic Genetic Disorders Detectable by MS/MS and their Scores           
Table 6.4:   Incidence of PKU by Region                               
Table 6.5:   Molecular Genetic Tests for Biotidinase Deficiency                   
Table 7.1:   Number of Genetic Disease States with Carrier Status                   
Table 7.2:   Carrier Risk of Most Common Genetic Diseases by Ethnic Group           
Table 7.3:   Select Commercially Available Genetic Assays for Carrier Screening by Company and Diseases Detected                                               
Table 7.4:   Advantages and Disadvantages of Currently Available PGS/PGD Technologies       
Table 7.5:   Genetic Diseases Detected During PGS/PGD                       
Table 7.6:   Currently Available Products for PGS/PGD                       
Table 7.7:   Cost of in vitro Fertilization and Related Procedures                   
Table 8.1:   Karyotype vs. Microarray                               
Table 8.2:   The Format of FISH Test Result                               
Table 8.3:   Some Commonly Used FISH-Based Tests                       
Table 8.4:     Microdeletions/Microduplications Detectable by FISH                   
Table 8.5:     FISH Probes and Functions                               
Table 8.6:     Presentation Format of Array-CGH Test Report                       
Table 8.7:     Harmony vs. Traditional Down Syndrome Tests                       
Table 8.8:     Predictive Value, Sensitivity and Specificity of InformaSeq Test               
Table 8.9:   Detection Rates of Panorama Test                           
Table 8.10: NIFTY Test Options                                   
Table 8.11: Clinical Data for IONA Test                               
Table 8.12: Sensitivity and Specificity of Verifi Test                           
Table 8.13: Sensitivity and Specificity of Verifi’s Microdeletion Panel               
Table 8.14: Comparison of MaterniT GENOME Test and Karyotype                   
Table 8.15: Sensitivity and Specificity of MaterniT GENOME Test                   
Table 8.16: MaterniT21 PLUS’ Independent Validation                       
Table 8.17: The Three Panels Offered by HeridiT UNIVERSAL Carrier Screen           
Table 8.18: Comparison of the Four Major NIPT Products available in the U.S. Market       
Table 8.19: U.S. Patents for NIPTs by Company                           
Table 8.20: Selected Issued Patents of NIPTs                           
Table 8.21: Major U.S. Patents and Applications                           
Table 8.22: Countries in Which NIPT is currently Marketed                       
Table 8.23: Detection, Uptake, False Positive and Failure Rates for NIPTs               
Table 8.24: Cost of Different Prenatal Screens                           
Table 8.25: Disease Types Targeted by Different Nuclease Platforms                   
Table 9.1:   Global Carrier Screen Test Market 2015-2020 US$ Million               
Table 9.2:   Geographical Carrier Screen Test Market 2015-2020 US$ Millions, USA, EU, RoW   
Table 9.3:   Global Market for Fetal Ultrasound Screenong by Geography (U.S., Europe, RoW), Through 2021                                               
Table 9.4:  Global Fetal Ultrasound Market Share by Company, 2014                   
Table 9.5:  Global Market for MRI Prenatal Screening by Geography (U.S., Europe and RoW), Through 2021                                                       
Table 9.6:  Global Market for Maternal Serum Screening Tests by Geography (U.S., Europe, RoW), Through 2021                                               
Table 9.7:  Global Market for NIPTs by Geography (North America, Europe, RoW), Through 2021   
Table 9.8:  Global Market for NIPTs by Product                           
Table 9.9:  Global Market for Prenatal Invasive Diagnostic Tests by Geography (U.S., Europe, RoW), Through 2021                                           
Table 9.10:Global Market for Newborn Screening by Technology, Through 2021           
Table 9.11:Global Market for PGS/PGD by Geography (North America, Europe, RoW), Through 2021
Table 10.1:  Global Market for Liquid Biopsy by Region (North America, Europe, RoW), Through 2021                                                        
Table 10.2:  Global Market for Personalized Medicine by Business Segment, Throgh 2021       
Table 10.3:  Global IVD Market by Geography (North America, Europe, RoW), Through 2021   
Table 11.1   Adoption Rates for Different Prenatal Tests in the U.S.                   
Table 12.1:  Financial Data for Affymetrix                               
Table 12.2:  Selected Financial Data for Agilent Technologies                   
Table 12.3:  Comparison of Harmony and Other Traditional Tests                   
Table 12.4:  CombiSNP Prenatal Targeted Array Disorder List                   
Table 12.5:  Genetic Tests Offered by Correlagen by Gene and Disease               
Table 12.6:  GeneDx’s Cytogenetics and Biochemical Tests                       
Table 12.7:  Hologic’s Financial Data                               
Table 12.8:  Performance of Verifi Test                               
Table 12.9:  Verifi Prenatal Test Lab Partners in the U.S.                       
Table 12.10: Illumina’s Financial Data                               
Table 12.11: Comparison of Prenatal Test Performance                       
Table 12.12: Comparison of False Negative Rates                           
Table 12.13: A Small Sample of Diseases Screened by Horizon Test                   
Table 12.14: Natus Medical’s Financial Data                               
Table 12.15: Clinical Data for IONA Test                               
Table 12.16: Sensitivity and Specificity of MaterniT GENOME Test                   
Table 12.17: Sequenom’s Financial Data                               
Table 12.18: Sensitivity and Specificity of MaterniT21 PLUS Test                   
Table 12.19: Three Options Offered by HeridiT UNIVERSAL Carrier Screen               
Table 12.20: Clinical Evaluation Performance of VisibiliT Prenatal Test               
Table 12.21: CF Detection Rates for Standard and Expanded Panels                   
Table 12.22: Accuracy, Sensitivity and Specificity of SensiGene Fetal RHD               
Table 12.23: NextView Diagnostic Test Platforms                           
Table 12.24: Trovogene’s Financial Data                               
Table Ap. 1.1: Participating Companies and their Products and Services
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FEATURED COMPANIES

  • 23andMe Inc.
  • AssureRx Health Inc.
  • Claris Lifesciences
  • Eurofins MWG Operon Inc.
  • Genway Biotech Inc.
  • Pathway Genomics Corp.
  • MORE
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 to 2021 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.

According to the WHO, nearly 140 million babies are born every year, out of which 5 million die in the first month of life, mostly in developing countries. For example, in India, about 5% to 15% of sick newborns have a metabolic disorder. This emphasizes the need for newborn screening for preventing disability and death by early intervention, follow-up and counselling.

Globally, the use of maternal serum marker screening and ultrasound imaging for the detection of chromosome aneuploidies and other birth defects constitute a routine part of prenatal care in the first and/or second trimesters. Yet, both of these techniques have the disadvantages of high false positive rates, varying from 2% to 7%. If the results of these tests show that a fetus is at increased risk of aneuploidy, invasive approaches such as chorionic villus sampling (CVS) or amniocentesis are recommended for diagnosis.

Fetal Ultrasound Screening Market

Today, ultrasound is used on average five times per pregnancy before delivery. The fetal ultrasound screening market generated revenues of about $x million in 2014 with the potential to earn $x million in 2021, growing at a CAGR of x%. Fetal MRI prenatal screening is performed rarely, only when the ultrasound screening provides an ambiguous result and to detect suspected central nervous system (CNS) disorders in the fetus during the second trimester. The fetal MRI segment had generated estimated revenue of $x million in 2014 with a potential to earn $x million in 2021.

Maternal Serum Testing Market

The global maternal serum test market was worth $x million in 2014 and is forecast to grow and reach $x million by 2021. The market consists of test methods for:
- Pregnancy-associated plasma protein (PAPP-A)
- Alpha-fetoprotein (AFP)
- Human chorionic gonadotropin (hCG)
- Estriol
- Inhibin-A

Had it not been for the launch of noninvasive prenatal tests (NIPTs) in 2011, this market would have fared much better.

Noninvasive Prenatal Test Market

Noninvasive prenatal tests (NIPTs) are the future of prenatal screening and have shown signs of surpassing the traditional maternal serum test revenues by earning about $x million in 2014. With a CAGR of x%, this market is forecast to reach $x million in 2021.

Newborn Screening Market

Newborn screening is an accepted national health policy in about 52 countries. It is a well-entrenched routine of newborn care in the U.S., U.K., Japan, Australia and most western European countries for the last three decades. In the Asian continent, China, Philippines and Thailand have developed admirable newborn screening programs in a relatively short period of time. Mass spectrometry has become the standard technique for newborn screening. Using this technique, medical technologists are capable of screening as many as 30 metabolic disorders from a single sample of blood. The global market for newborn screening has been valued at $x million in 2014 and it will be worth about $x million by 2021.

Preimplantation Genetic Diagnosis Market

Preimplantation genetic diagnosis (PGD) has been in practice for more than twenty years in about 60 countries globally.  PGD testing is performed to identify genetic defects in embryos. The tests are usually performed in cases of a known genetic defect, in late age pregnancy, or in patients with a history of repeated miscarriages. PCR, FISH, CGH, and SNP analysis are some of the most common techniques used, and PCR is the most widely used technology. The global market for PGD was worth about $x million in 2014 and this has been predicted to enlarge and reach $x million in 2021.
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- 23andMe Inc.
- Abbott Laboratories
- Abbott Molecular Inc.
- Abcam plc
- AB Sciex LLC
- Adaltis S.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.
- LifeCodexx AG
- 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 Life and Analytical Sciences Inc.
- 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
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