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The Market for Prenatal, Newborn and Carrier Genetic Testing: Forecasts to 2019

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SKU: KLI5546954 Category: Diagnostics Market Research Pages: 269
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Description

The Market for Prenatal, Newborn and Carrier Genetic Testing

The Market for Prenatal, Newborn and Carrier Genetic Testing discusses the technologies and tests used in chromosomal analysis and in the diagnosis of inherited disorders and the detection of carriers of inherited diseases. The growing global genetic testing laboratory services market is discussed, including:

  • carrier testing
  • prenatal testing
  • newborn screening
  • neonatal/pediatric testing
  • testing for adult onset genetic disorders

The growing number of genetic tests has been made possible by advances in technology, including advances in chromosomal analysis – from traditional karyotyping to fluorescence in situ hybridization (FISH), and then to chromosomal microarrays and next generation sequencing. Detection of single gene mutations has been made possible with FISH and polymerase chain reaction (PCR) technology, and is moving into even new possibilities with sequencing based tests that can evaluate large numbers of genes simultaneously. The recent introduction of noninvasive prenatal testing (NIPT) has made it possible to perform prenatal screening of fetuses without the need for invasive procedures. The technologies used for newborn screening discussed in the report include:

  • Karyotyping
  • Fluorescence in situ Hybridization
  • Chromosomal Microarrays
  • Polymerase Chain Reaction and Other Nucleic Acid Amplification Technologies
  • DNA Sequencing
  • Mass Spectrometry
  • Conventional versus Non-Invasive Prenatal Testing

The Market for Prenatal, Newborn and Carrier Genetic Testing provides the world markets for prenatal, newborn, postnatal, and carrier genetic testing for 2014 to 2019. In addition, company revenues are provided for the previous three years. Further, this report includes financial information on deals involving companies in the molecular diagnostic inherited disease/prenatal testing field, summarized within report tables.

Prenatal testing can be used to identify fetuses with chromosomal abnormalities or genetic mutations that would result in the birth of an affected newborn. Women who are experience recurrent miscarriages can be tested to determine if there is a genetic cause, if their fetuses could not survive due to an inherited disorder. Children may also be tested, often to identify the cause of developmental or intellectual delay. These and other applications of inherited disease testing are discussed in the report.

The report also discusses

  • Genetic Testing Services Market
  • Diagnostic Kits

Currently in vitro diagnostic companies are developing or marketing molecular diagnostic kits to clinical laboratories, and also many clinical laboratories have developed laboratory developed tests (LDTs) and are offering genetic testing services to aid physicians as they diagnose patients with these genetic disorders. Other applications of genetic testing, including preimplantation genetic screening (PGS) and preimplantation genetic diagnosis (PGD) assays used before in vitro fertilization, and also the direct-to-consumer genetic testing market, are discussed as well.

Inherited disease testing was already a large market, but the potential for rapid growth has attracted companies and investors. The report highlights recent activities in this rapidly evolving market. Leading competitors and product developers are listed in the manufacturer profiles. The profiled companies include:

  • 23andMe, Inc.
  • AB SCIEX (A Danaher Corporation Company)
  • Abbott Laboratories
  • Affymetrix, Inc.
  • Agena Bioscience Inc.
  • Agilent Technologies Inc.
  • Ambry Genetics Corp.
  • ARUP Laboratories
  • Astra Biotech GmbH
  • Asuragen, Inc.
  • Athena Diagnostics, Inc. (A Quest Diagnostics Business)
  • AutoGenomics, Inc.
  • Berry Genomics Co., Ltd.
  • BGI-Shenzhen
  • Bio-Rad Laboratories, Inc.
  • Bio-Reference Laboratories, Inc. (BRLI)
  • Centogene AG
  • Chromsystems Instruments & Chemicals GmbH
  • Claritas Genomics, Inc.
  • Color Genomics, Inc.
  • CombiMatrix Corporation
  • Counsyl, Inc.
  • Courtagen Life Sciences, Inc.
  • GenapSys
  • Gene by Gene, Ltd.
  • Genection, Inc. (An Invivoscribe Company)
  • GeneDx
  • GenePeeks, Inc.
  • Genesis Genetics
  • Genetadi Biotech S.L.
  • Genetic Technologies Limited / Phenogen Sciences, Inc. (U.S. Division)
  • GenMark Diagnostics, Inc.
  • Genoma Group
  • Genomed AG
  • GenPath / GenPath Women’s Health
  • Good Start Genetics, Inc.
  • Hologic, Inc.
  • Illumina, Inc.
  • Innovations Exchange Pte Ltd (INEX) and iGene™ Diagnostics Pte Ltd (an INEX Company)
  • Invitae Corporation
  • Laboratory Corporation of America (LabCorp) Integrated Genetics
  • Life Technologies Corporation (Acquired by Thermo Fischer Scientific Inc.)
  • LifeCodexx AG (Subsidiary of GATC Biotech AG)
  • Multiplicom NV
  • Myriad Genetics, Inc.
  • Natera, Inc.
  • NewGene Ltd.
  • NIPD Genetics, Ltd.
  • Oxford Gene Technology
  • Parabase Genomics
  • Pathway Genomics Corporation
  • PerkinElmer, Inc.
  • Premaitha Health
  • Progenity, Inc.
  • QIAGEN N.V.
  • Quest Diagnostics
  • Ravgen
  • Recombine, Inc.
  • Reproductive Genetics Institute
  • Reprogenetics
  • Roche
  • Sebia, Inc.
  • Sequenom, Inc.
  • Sophia Genetics
  • SpOtOn Clinical Diagnostics Limited
  • SynapDx Corporation
  • Transgenomic, Inc.

The information presented in this report is derived from publicly available information sources such as company reports and announcements, government reports and databases, medical organization reports, medical associations, and other publications. The analysis is based on the author’s industry knowledge combined with literature searches and discussions with industry professionals and experts in the areas of point-of-care tests, decentralized healthcare and healthcare economics.

Table of Contents

ONE: EXECUTIVE SUMMARY

Overview

Scope and Methodology

Market Overview

Prognosis for Growth

TWO: INTRODUCTION

Overview of Genetic Mutations and Inherited Disorders

Why Test? Clinical Utility of Testing for Genetic Disorders

Point-of-View

THREE: TECHNOLOGY – PRENATAL AND POSTNATAL TESTING, CARRIER SCREENING FOR INHERITED DISORDERS

Technologies Used for Newborn Screening

Karyotyping

Fluorescence in situ Hybridization

Chromosomal Microarrays

Polymerase Chain Reaction and Other Nucleic Acid Amplification Technologies

DNA Sequencing

Mass Spectrometry

Prenatal Testing Technologies – Conventional versus Non-Invasive Prenatal Testing

FOUR: SELECTED INHERITED DISORDERS

Chromosomal Abnormalities

Mitochondrial Disease

Cystic Fibrosis

Ashkenazi Jewish Genetic Panel

Developmental or Intellectual Delay Disorders

Autism Spectrum Disorders

Glycogen Storage Diseases

Lysosomal Storage Disorders

Thrombophilia

Adult Onset Disorders

Other Inherited Disorders

FIVE: MARKET SEGMENTS – PRENATAL AND POSTNATAL TESTING FOR INHERITED DISORDERS

Carrier Screening

Miscarriage/Recurrent Pregnancy Loss

Prenatal Testing

Preimplantation Genetic Screening (PGS) and Preimplantation Genetic Diagnosis(PGD)

Newborn Screening

Pediatric Testing for Developmental or Intellectual Delay Disorders

Direct-to-Consumer Genetic Testing Market

SIX: DEALS – INHERITED DISEASE TESTING

Investments and Financing Agreements for Inherited Disease Testing Companies and

Laboratories

Agreements with Other Companies

Acquisitions of Prenatal/Postnatal Genetic Testing Companies and Laboratories

Selected Other Agreements

SEVEN: MARKET DRIVERS AND CHALLENGES – CARRIER, PRENATAL AND POSTNATAL TESTING

Legislation Mandating Newborn Screening

Large Number of Inherited Disorders/ Many Small Volume Rare Disease Tests

Laboratory Developed Tests and the FDA

Ethical Issues and Concerns about Genetic Discrimination

Reimbursement

Future Prospects

EIGHT: MARKET ANALYSIS

Genetic Testing Market Overview – Chromosomal Analysis and Inherited Disorders . 120

Diagnostic Market (Kits) for Inherited Disorders – Market Segments

Cystic Fibrosis Market Share Analysis

Clinical Laboratory Test Services Market – Market Segments

NINE: COMPANY PROFILES: DIAGNOSTIC COMPANIES IN PRENATAL, NEWBORN, AND OTHER INHERITED DISEASE TESTING

23andMe, Inc.

AB SCIEX (A Danaher Corporation Company)

Abbott Laboratories

Recent Revenue History

Company Overview – Focusing on Diagnostics

Affymetrix, Inc.

Recent Revenue History

Company Overview

Agena Bioscience Inc.

Agilent Technologies Inc.

Recent Revenue History

Company Overview

Ambry Genetics Corp.

ARUP Laboratories

Astra Biotech GmbH

Asuragen, Inc.

Athena Diagnostics, Inc. (A Quest Diagnostics Business)

AutoGenomics, Inc.

Berry Genomics Co., Ltd.

BGI-Shenzhen

Bio-Rad Laboratories, Inc.

Recent Revenue History

Company Overview

Bio-Reference Laboratories, Inc. (BRLI)

Recent Revenue History

Company Overview

Centogene AG

Chromsystems Instruments & Chemicals GmbH

Claritas Genomics, Inc.

Color Genomics, Inc.

CombiMatrix Corporation

Recent Revenue History

Company Overview

Counsyl, Inc.

Courtagen Life Sciences, Inc.

GenapSys

Gene by Gene, Ltd.

Genection, Inc. (An Invivoscribe Company)

GeneDx

GenePeeks, Inc.

Genesis Genetics

Genetadi Biotech S.L

Genetic Technologies Limited / Phenogen Sciences, Inc. (U.S. Division)

GenMark Diagnostics, Inc.

Recent Revenue History

Company Overview

Genoma Group

Genomed AG

GenPath / GenPath Women’s Health

Good Start Genetics, Inc.

Hologic, Inc.

Recent Revenue History

Company Overview

Illumina, Inc.

Recent Revenue History

Company Overview

Innovations Exchange Pte Ltd (INEX) and iGene™ Diagnostics Pte Ltd (an INEX Company)

Invitae Corporation

Recent Revenue History

Company Overview

Laboratory Corporation of America (LabCorp) Integrated Genetics

Recent Revenue History

Company Overview

Life Technologies Corporation (Acquired by Thermo Fischer Scientific Inc.)

Recent Revenue History

Company Overview

LifeCodexx AG (Subsidiary of GATC Biotech AG)

Multiplicom NV

Myriad Genetics, Inc.

Recent Revenue History

Company Overview

Natera, Inc.

NewGene Ltd.

NIPD Genetics, Ltd.

Oxford Gene Technology

Company Overview

Parabase Genomics

Pathway Genomics Corporation

PerkinElmer, Inc.

Recent Revenue History

Company Overview

Premaitha Health

Progenity, Inc.

QIAGEN N.V.

Recent Revenue History

Company Overview

Quest Diagnostics

Recent Revenue History

Company Overview

Ravgen

Recombine, Inc.

Reproductive Genetics Institute

Reprogenetics

Roche

Recent Revenue History

Company Overview

Sebia, Inc.

Sequenom, Inc

Recent Revenue History

Company Overview

Sophia Genetics

SpOtOn Clinical Diagnostics Limited

SynapDx Corporation

Transgenomic, Inc.

Recent Revenue History

Company Overview

LIST OF EXHIBITS

ONE: EXECUTIVE SUMMARY

Table 1-1: Global Laboratory Services Market for Chromosome Analysis and Inherited

Disease Genetic Testing, 2014 and 2019

THREE: TECHNOLOGY – PRENATAL AND POSTNATAL TESTING, CARRIER SCREENING FOR INHERITED DISORDERS

Table 3-1: Selected Examples of Companies Marketing Products for Newborn Screening for Inherited Disorders

Table 3-2: Selected Examples of Companies Marketing FISH Tests or Probes for Inherited Disorders

Table 3-3: Selected Companies and Clinical Laboratories Offering Microarray-Based Tests for Inherited Disorders

Table 3-4: Selected Companies and Clinical Laboratories Offering PCR-Based Tests for Inherited Disorders

Table 3-5: Selected Companies and Clinical Laboratories Offering Sequencing-Based

Tests for Inherited Disorders

Table 3-6: Selected Companies and Clinical Laboratories Offering Mass Spectrometry- Based Tests for Newborn Screening or Inherited Disorders

Table 3-7: Selected Companies and Clinical Laboratories Developing and/or Marketing Non-Invasive Prenatal Tests (NIPT)

FOUR: SELECTED INHERITED DISORDERS

Table 4-1: Selected Inherited Disorders

Table 4-2: Selected IVD Companies and Clinical Laboratories with Tests for Chromosomal Abnormalities

Table 4-3: Selected IVD Clinical Laboratories with Tests for Mitochondrial Diseases

Table 4-4: Selected IVD Companies Developing and/or Marketing Molecular Diagnostic IVD Kits for Cystic Fibrosis and Other Inherited Disorders Caused by Single Gene Mutations

Table 4-5: Selected Companies with CLIA Laboratories and Other Clinical Laboratories Offering Molecular Diagnostic Tests for Inherited Disorders Caused by Single Gene Mutations

Table 4-6: Selected Companies and Clinical Laboratories with Genetic Tests for Autism Spectrum Disorders

FIVE: MARKET SEGMENTS – PRENATAL AND POSTNATAL TESTING FOR INHERITED DISORDERS

Table 5-1: Recommended Uniform Screening Panel for Newborn Screening(March 2015)

SIX: DEALS – INHERITED DISEASE TESTING

Table 6-1: Selected Investments and Other Financing Agreements for Diagnostic Companies and Clinical Laboratories in Inherited Disease Testing

Table 6-2: Selected Agreements between Prenatal/Neonatal/Inherited Disease Diagnostics Companies and Other Diagnostic Companies or Clinical Laboratories

Table 6-3: Selected Agreements between Inherited Disease Diagnostics Companies and Pharmaceutical or Biopharmaceutical Companies

Table 6-4: Selected Agreements between Two Companies in Inherited Disease Testing

Table 6-5: Selected Agreements between Diagnostic Companies in Inherited Disease

Testing and Other Companies or For Profit Organizations

Table 6-6: Selected Acquisitions of or by Companies in Inherited Disease Testing

Table 6-7: Selected Agreements between Inherited Disease Testing Companies and Academic or Other Non-Profit Organizations

SEVEN: MARKET DRIVERS AND CHALLENGES – CARRIER, PRENATAL AND POSTNATAL TESTING

Table 7-1: Selected Clinical Laboratories Offering Inherited Disease Tests

Table 7-2: Selected IVD Companies Developing/Marketing Chromosome Analysis or Inherited Disease Test Kits to Clinical Laboratories

EIGHT: MARKET ANALYSIS

Table 8-1: Global Markets for Chromosome Analysis and Inherited Disease Genetic

Testing, 2014 and 2019 (Global Market for Diagnostic Kits, Global Laboratory Services Market)

Table 8-2: Geographical Distribution of Laboratories Performing Genetic Testing Services (United States, Europe, Rest of World, Total)

Table 8-3: Global Market for Diagnostic Kits for Chromosome Analysis and Inherited Disease Genetic Testing, 2014 and 2019 – Market Segments by Type of Inherited Disorder (Chromosome Analysis, Cystic Fibrosis, Thrombophilia, Other,Total Market)

Figure 8-1: Estimated Competitive Market Shares for Diagnostic Companies in the Cystic Fibrosis Test Market, 2014

Table 8-4: Global Clinical Laboratory Services Market by Market Segments – Carrier

Screening, Prenatal Testing, Newborn Screening, Neonatal and Pediatric Testing, and Adult Onset Disorders, 2014-2019

 

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