市場調査レポート

出生前検査・新生児検査・キャリア遺伝子検査市場

The Market for Prenatal, Newborn and Carrier Genetic Testing

発行 Kalorama Information 商品コード 330704
出版日 ページ情報 英文 269 Pages
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出生前検査・新生児検査・キャリア遺伝子検査市場 The Market for Prenatal, Newborn and Carrier Genetic Testing
出版日: 2015年05月01日 ページ情報: 英文 269 Pages
概要

当レポートでは、染色体分析、遺伝性疾患の診断、および遺伝性疾患のキャリアの発見に用いられている技術と検査について調査分析し、拡大する世界の遺伝子検査ラボサービス市場の分析、主要企業のプロファイルなどをまとめています。

第1章 エグゼクティブサマリー

第2章 イントロダクション

第3章 技術:遺伝性疾患の出生前・出生後検査およびキャリアスクリーニング

  • 新生児スクリーニングに用いられる技術
  • 染色体分析
  • In situ ハイブリダイゼーション (ISH) における蛍光性
  • 染色体マイクロアレイ
  • ポリメラーゼ連鎖反応およびその他の核酸増幅技術
  • DNAシーケンシング
  • 質量分析法
  • 出生前検査技術:従来型 vs. 低侵襲出生前検査

第4章 主な遺伝性疾患

  • 染色体異常
  • ミトコンドリア病
  • 嚢胞性線維症
  • アシュケナジム系ユダヤ人の遺伝子パネル
  • 発達障害または知的障害
  • 自閉症スペクトラム障害
  • 糖原病
  • リソソーム蓄積症
  • 血栓性素因
  • 成人期発症疾患
  • その他の遺伝性疾患

第5章 市場区分:遺伝性疾患の出生前・出生後検査

  • キャリアスクリーニング
  • 流産 / 習慣性流産
  • 出生前検査
  • 着床前遺伝子スクリーニングおよび着床前遺伝子診断 (PGD)
  • 新生児スクリーニング
  • 発達障害または知的障害の小児検査
  • 直販遺伝子検査市場

第6章 契約:遺伝性疾患検査

  • 遺伝性疾患検査企業・ラボへの投資・融資契約
  • その他企業との合意
  • 出生前・出生後検査企業・ラボの買収
  • その他の主な合意

第7章 市場促進因子・課題:キャリア検査および出生前・出生後検査

  • 法律で義務付けられた新生児スクリーニング
  • 多くの遺伝性疾患/少ない希少疾患検査数
  • 薬事未承認検査法およびFDA
  • 遺伝子差別に関する倫理的問題と懸念
  • 医療費償還
  • 将来の展望

第8章 市場分析

  • 遺伝子検査市場の概要:染色体分析と遺伝性疾患
  • 遺伝性疾患の診断市場 (キット) :市場区分
  • 嚢胞性線維症市場シェア分析
  • 臨床ラボ検査サービス市場:市場区分

第9章 企業プロファイル:出生前検査・新生児検査・その他遺伝性疾患検査の診断企業

図表

目次
Product Code: KLI5546954

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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