Prenatal and Newborn Genetic Screening and Testing Markets (by Application [Carrier Testing, Prenatal Screening, Newborn Testing, Newborn Screening], by Type [Services, Kits] by Geographic Region)

 
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Published Jun 5, 2018 | 140 Pages | Pub ID: KLI15702503

Prenatal and Newborn Genetic Screening and Testing Markets (by Application [Carrier Testing, Prenatal Screening, Newborn Testing, Newborn Screening], by Type [Services, Kits] by Geographic Region)

The prenatal and newborn genetic screening and diagnostic testing market has already become a significant market, and it continues to grow – driven by several major factors. The number of genetic tests continues to grow. While many discoveries have been made about the causes of genetic disorders, there remains much more to learn before many of these discoveries can be used as clinical tests – but progress is also being made on this front. While potential causes of inherited disorders are still often evaluated on a gene by gene basis, technology advances such as chromosomal microarrays and DNA sequencing are making it possible to test panels to detect mutations associated with many different disorders in a single test.

Double-Segmented for Services and IVD Test Kits

This Kalorama Information Report, Prenatal Screening and Testing Markets (by Application [Carrier Testing, Newborn Testing, Newborn Screening], by Type [Services, Kits] by Geographic Region) includes the following markets:

Global Clinical Laboratory Services Market by Market Segments, 2017-2022
  • Carrier Testing
  • Prenatal Testing ( inc NIPT)
  • Newborn Screening
  • Newborn Testing
Global Prenatal and Newborn Diagnostic Test Kit Market 2017-2022
  • Chromosome Analysis
  • Cystic Fibrosis
  • Thrombophilia
  • Others
The prenatal and newborn genetic screening and diagnostic testing market has already become a significant market, and it continues to grow – driven by several major factors. The number of genetic tests continues to grow. While many discoveries have been made about the causes of genetic disorders, there remains much more to learn before many of these discoveries can be used as clinical tests – but progress is also being made on this front. While potential causes of inherited disorders are still often evaluated on a gene by gene basis, technology advances such as chromosomal microarrays and DNA sequencing are making it possible to test panels to detect mutations associated with many different disorders in a single test.

Within the prenatal and newborn genetic screening market, non-invasive prenatal testing (NIPT) is driving the market. Much of the focus and attention in recent years has been on the emergence and growing use of complex LDTs based on technologies such as polymerase chain reaction (PCR), microarrays, next generation sequencing, or other complex technology. To generate test results that were not previously possible, LDTs are being developed and used in many different applications.

A 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 introduction of noninvasive prenatal testing (NIPT) has made it possible to perform prenatal screening of fetuses without the need for invasive procedures.  

Regional Market and Forecast

Geographically, North America is the largest market for prenatal and newborn genetic screening and diagnostic testing; but Asia Pacific is the fastest growing market. Ample opportunities exist for participants in the market due to the development of new technologies, changing government regulations and standards, and joint ventures and partnerships.  A truly global report, the report provides market sizing and forecast for the following geographic regions.

European Market Size and Growth for Prenatal Genetic Screening and Testing Market 2017-2022

Asia Pacific Market Size and Growth for Prenatal Genetic Screening and Testing Market 2017-2022

Latin American Market Size and Growth for Prenatal Genetic Screening and Testing Market 2017-2022

Rest of World Market Size and Growth for Prenatal Genetic Screening and Testing Market 2017-2022



Scope and Methodology

The global market for prenatal and newborn genetic screening and diagnostic testing are provided in U.S. dollars for 2017 to 2022. In addition, company revenues (when reported) are provided for the previous three years. During this period, there have been considerable fluctuations in exchange rates. For the overall market calculations, the average exchange rate for each year has been used to convert sales from other currencies to U.S. dollars. In addition, this report includes financial information on deals involving companies in the market or entering the market.

Market analyses in this report cover world markets for prenatal and newborn genetic screening and diagnostic testing markets. The information for this report was gathered using both primary and secondary research including comprehensive research of secondary sources such as company literature, databases, investment reports, and medical and business journals. Telephone interviews and email correspondence were the primary method of gathering information. For the purpose of this study, Kalorama Information conducted interviews with industry officials, consultants, health care providers, and government personnel. These sources were the primary basis in gathering information specifically relating to revenue and market share data presented in this report. Additional interviews were completed with relevant company representatives including marketing directors, division managers, and product representatives.

All market data pertains to the world market at the manufacturers’ level. The base year for data was 2017. Historical data was provided for the years 2015 and 2016, with forecast data provided for 2017 through 2022. Compound annual growth rates (CAGRs) are provided for 2017-2022 periods for each segment covered. The forecasted market analysis for 2017-2022 was largely based on demographic trends, new developments, innovative technology and global expansion.

Companies Covered Include:
  • Abbott Laboratories
  • Affymetrix, Inc.
  • Agilent, Inc
  • Berry Genomics Co. Ltd.
  • Bgi Diagnostics
  • Bio-Rad Laboratories Inc.
  • Combimatrix (Invitae)
  • Coopergenomics
  • Counsyl
  • Genepeeks, Inc.
  • Genetadi Biotech S.L.
  • Genoma Group
  • Illumina, Inc.
  • Innovations Exchange Pte Ltd (Inex) and Igene Diagnostics Pte Ltd
  • Laboratory Corporation of America (LabCorp)
  • LifeCodexx Ag
  • Natera, Inc.
  • Oxford Gene Technology
  • Perkin Elmer
  • Premaitha Health
  • Quest Diagnostics
  • Ravgen
  • Reproductive Genetics Innovations
  • Roche Diagnostic Corporation
  • Sequenom, Inc.
  • Thermo Fisher Scientific
  • Executive Summary
    • Overview
    • Scope and Methodology
    • Market Overview
      • Table Global Prenatal and Newborn Genetic Screening and Diagnostic Testing Market 2017-2022 (millions$)
      • Table Global Prenatal and Newborn Diagnostic Test Kit Market 2017-2022 ($millions)
    • Future Growth
  • Introduction
    • Why Test? Clinical Utility of Testing for Genetic Disorders
  • Prenatal and Newborn Genetic Testing Market by Type
    • Technologies Used for Newborn Screening
      • Table Selected Examples of Companies Marketing Products for Newborn Screening for Inherited Disorders
    • Karyotyping
    • Fluorescence In Situ Hybridization
      • Table Selected Examples of Companies Marketing FISH Tests or Probes for Inherited Disorders
    • Chromosomal Microarrays
      • Table Selected Companies and Clinical Laboratories Offering Microarray-Based Tests
    • Polymerase Chain Reaction and Other Nucleic Acid Amplification Technologies
      • Table Selected Companies and Clinical Laboratories Offering PCR-based Tests
    • DNA Sequencing
      • Table Selected Companies and Clinical Laboratories Offering Sequencing-based Tests
    • Mass Spectrometry
      • Table Selected Companies and Clinical Laboratories Offering Mass Spectrometry-based Tests
    • Prenatal Testing Technologies Conventional vs Non-Invasive Prenatal Testing
      • Table Selected Companies Developing and/or Marketing Non-Invasive Prenatal Tests
  • Selected Inherited Disorders
    • Table Selected Inherited Disorders
    • Chromosomal Abnormalities
      • Table Selected Companies with Tests for Chromosomal Abnormalities
    • Cystic Fibrosis
      • Table Selected Companies Developing and/or Marketing Molecular Diagnostics for Cystic Fibrosis and other Inherited Disorders Caused by Single Mutations
    • Glycogen Storage Diseases
    • Lysosomal Storage Disorders
    • Thrombophilia
    • Ashkenazi Jewish Genetic Panel
    • Other Inherited Disorders Caused by a Single Gene Mutation
  • Prenatal and Newborn Screening and Diagnostic Testing Market
    • Carrier Screening
    • Miscarriage/Recurrent Pregnancy Loss
    • Prenatal Testing
    • Preimplantation Genetic Screening and Preimplantation Genetic Diagnosis
    • Newborn Screening
  • Market Drivers and Challenges – Prenatal and Newborn Genetic Screening and Diagnostic Testing
    • Legislation Mandating Newborn Screening
    • Large Number of Inherited Disorders/Many Small Volume Rare Disease Tests
    • Laboratory Developed Test Regulations
      • Directive 98/79/EC
    • Direct-to-Consumer Genetic Testing
    • Investments, Mergers and Acquisitions
      • 2016 and 2017 Investment in Prenatal and Newborn Genetic Screening and Diagnostic Testing
        • Table Selected Investments and Other Financing Agreements for Prenatal and Newborn Genetic Screening and Diagnostic Testing
      • Mergers and Acquisitions
        • Table Selected Acquisitions of or by Companies of Inherited Disease Testing
    • Ethical Issues
    • Reimbursement
    • Future Prospects
  • Market Analysis
    • Prenatal and Newborn Genetic Testing Market Overview
      • Table Global Prenatal and Newborn Genetic Screening and Diagnostic Testing Market 2017-2022 ($millions)
      • Diagnostic Market Kits for Inherited Disorders – Market Segment
        • Table Global Prenatal and Newborn Diagnostic Test Kit Market 2017-2022 ($millions)
        • Table Global Market for Diagnostic Kits for Prenatal and Newborn Chromosome Analysis and Inherited Disease Genetic Testing by Type 2017-2022 ($millions)
        • Table Global Market for Diagnostic Kits for Prenatal and Newborn Chromosome Analysis and Inherited Disease Genetic Testing by Type 2017
        • Table Global Market for Diagnostic Kits for Prenatal and Newborn Chromosome Analysis and Inherited Disease Genetic Testing by Type 2022
    • Clinical Laboratory Test Services Market – Market Segments
      • Table Global Clinical Laboratory Services Market by Market Segments – Carrier Screening, Prenatal Testing, Newborn Screening and Newborn Testing, 2017-2022 ($millions)
      • Table Global Clinical Laboratory Services Market by Market Segments – Carrier Screening, Prenatal Testing, Newborn Screening and Newborn Testing, 2017
      • Table Global Clinical Laboratory Services Market by Market Segments – Carrier Screening, Prenatal Testing, Newborn Screening and Newborn Testing, 2022
    • Prenatal Testing moves to NIPT
      • Table Market Size and Growth for NIPT Prenatal Testing Market 2017-2022 ($millions)
    • Geographical
      • North America
        • Table North American Market Size and Growth for Prenatal Genetic Screening and Testing Market 2017-2022 ($millions)
      • European Union
        • Table European Market Size and Growth for Prenatal Genetic Screening and Testing Market 2017- 2022 ($millions)
        • Table Selected EU Countries Prenatal Screening Policies
      • Asia-Pacific
        • Table Asia Pacific Market Size and Growth for Prenatal Genetic Screening and Testing Market 2017- 2022 ($millions)
      • Latin America
        • Table Latin American Market Size and Growth for Prenatal Genetic Screening and Testing Market 2017-2022 ($millions)
      • Rest of World
        • Table Rest of World Market Size and Growth for Prenatal Genetic Screening and Testing Market 2017-2022 ($millions)
    • Competitive Landscape
  • Company Profiles
    • Abbott Laboratories
      • Table Abbott Corporate Summary
      • Company Overview
      • Product
      • Performance Review
        • Table Abbott Revenues 2015-2017 (in millions $)
    • Affymetrix, Inc.
      • Table Affymetrix Corporate Summary
      • Company Overview
      • Products
    • Agilent, Inc
      • Table Agilent Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Agilent Corporation Revenue (2014-2017) ($ millions)
    • Berry Genomics Co. ltd.
      • Table Berry Genomics Corporate Summary
      • Company Overview
      • Products
    • BGI Diagnostics
      • Table BGI Diagnostics Corporate Summary
      • Company Overview
      • Products
    • Bio-Rad Laboratories Inc.
      • Table Bio-Rad Labs Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Bio-Rad Corporation Revenue (2014-2017) ($ millions)
    • CombiMatrix (Invitae)
      • Table CombiMatrix Corporate Summary
      • Company Overview
      • Products
    • CooperGenomics
      • Table CooperGenomics Corporate Summary
      • Company Overview
      • Products
    • Counsyl
      • Table Counsyl Corporate Summary
      • Company Overview
      • Products
    • GenePeeks, Inc.
      • Table GenePeeks Corporate Summary
      • Company Overview
      • Products
    • Genetadi Biotech S.L.
      • Table Genetadi Biotech S.L. Corporate Summary
      • Company Overview
      • Products
    • Genoma Group
      • Table Genoma Corporate Summary
      • Company Overview
      • Products
    • Illumina, Inc.
      • Table Illumina Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Illumina Corporation Revenue (2014-2017) ($ millions)
    • Innovations Exchange Pte Ltd (INEX) and iGene Diagnostics Pte Ltd
      • Table Innovations Exchange (INEX) and IGene Diagnostics Corporate Summary
      • Company Overview
      • Products
    • Laboratory Corporation of America (LabCorp)
      • Table LabCorp Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table LabCorp Corporation Revenue (2014-2017) ($ millions)
    • LifeCodexx AG
      • Table LifeCodexx AG Corporate Summary
      • Company Overview
      • Products
    • Natera, Inc.
      • Table Natera Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Natera Corporation Revenue (2014-2017) ($ millions)
    • Oxford Gene Technology
      • Table Oxford Gene Technology Corporate Summary
      • Company Overview
      • Products
    • PerkinElmer
      • Table PerkinElmer Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table PerkinElmer Corporation Revenue (2014-2017) ($ millions)
    • Premaitha Health
      • Table Premaitha Health Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Premaitha Corporation Revenue (2014-2017) ($ millions)
    • Quest Diagnostics
      • Table Quest Diagnostics Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Quest Corporation Revenue (2014-2017) ($ millions)
    • Ravgen
      • Table Ravgen Corporate Summary
      • Company Overview
      • Products
    • Reproductive Genetics Innovations
      • Table Reproductive Genetics Innovations Corporate Summary
      • Company Overview
      • Products
    • Roche Diagnostic Corporation
      • Table Roche Diagnostic Corporate Summary
      • Company Overview
      • Products
      • Performance Review
        • Table Roche Diagnostics (2014-2017) ($ millions)
    • Sequenom, Inc.
      • Table Sequenom Corporate Summary
      • Company Overview
      • Products
    • ThermoFisher Scientific
      • Table ThermoFisher Scientific Corporate Summary
      • Company Overview
      • Product
      • Company Financials
        • Table ThermoFisher 2015-2017 (in millions $)

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