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The Market for Prenatal, Newborn and Carrier Genetic Testing

  • May 2015
  • -
  • Kalorama Information
  • -
  • 269 pages

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

Table Of Contents

The Market for Prenatal, Newborn and Carrier Genetic Testing
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 and 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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