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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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SKU: KLI15702503 Category: Diagnostics Market Research Pages: 140
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Description

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

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

Table of Contents

  1. EXECUTIVE SUMMARY

OVERVIEW

SCOPE AND METHODOLOGY

MARKET OVERVIEW

Table 1-1: Global Prenatal and Newborn Genetic Screening and Diagnostic Testing Market 2017-2022 (millions$)

Table 1-2: Global Prenatal and Newborn Diagnostic Test Kit Market 2017-2022 ($millions)

FUTURE GROWTH

  1. INTRODUCTION

WHY TEST? CLINICAL UTILITY OF TESTING FOR GENETIC DISORDERS

  1. PRENATAL AND NEWBORN GENETIC TESTING MARKET BY TYPE

TECHNOLOGIES USED FOR NEWBORN SCREENING

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

KARYOTYPING

FLUORESCENCE IN SITU HYBRIDIZATION

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

CHROMOSOMAL MICROARRAYS

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

POLYMERASE CHAIN REACTION AND OTHER NUCLEIC ACID AMPLIFICATION TECHNOLOGIES

Table 3-4: Selected Companies and Clinical Laboratories Offering PCR-based Tests

DNA SEQUENCING

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

MASS SPECTROMETRY

Table 3-6: Selected Companies and Clinical Laboratories Offering Mass Spectrometry-based Tests

PRENATAL TESTING TECHNOLOGIES CONVENTIONAL VS NON-INVASIVE PRENATAL TESTING

Table 3-7: Selected Companies Developing and/or Marketing Non-Invasive Prenatal Tests

4: SELECTED INHERITED DISORDERS

Table 4-1: Selected Inherited Disorders

CHROMOSOMAL ABNORMALITIES

Table 4-2: Selected Companies with Tests for Chromosomal Abnormalities

CYSTIC FIBROSIS

Table 4-3: 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

5: 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

  1. 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 6-1: Selected Investments and Other Financing Agreements for Prenatal and Newborn Genetic Screening and Diagnostic Testing

Mergers and Acquisitions

Table 6-2: Selected Acquisitions of or by Companies of Inherited Disease Testing

ETHICAL ISSUES

REIMBURSEMENT

FUTURE PROSPECTS

7: MARKET ANALYSIS

PRENATAL AND NEWBORN GENETIC TESTING MARKET OVERVIEW

Table 7-1: Global Prenatal and Newborn Genetic Screening and Diagnostic Testing Market 2017-2022 ($millions)

Diagnostic Market Kits for Inherited Disorders – Market Segment

Table 7-2: Global Prenatal and Newborn Diagnostic Test Kit Market 2017-2022 ($millions)

Table 7-3: Global Market for Diagnostic Kits for Prenatal and Newborn Chromosome Analysis and Inherited Disease Genetic Testing by Type 2017-2022 ($millions)

Figure 7-1: Global Market for Diagnostic Kits for Prenatal and Newborn Chromosome Analysis and Inherited Disease Genetic Testing by Type 2017

Figure 7-2: 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 7-4: Global Clinical Laboratory Services Market by Market Segments – Carrier Screening, Prenatal Testing, Newborn Screening and Newborn Testing, 2017-2022 ($millions)

Figure 7-3: Global Clinical Laboratory Services Market by Market Segments – Carrier Screening, Prenatal Testing, Newborn Screening and Newborn Testing, 2017

Figure 7-4: Global Clinical Laboratory Services Market by Market Segments – Carrier Screening, Prenatal Testing, Newborn Screening and Newborn Testing, 2022

PRENATAL TESTING MOVES TO NIPT

Table 7-5: Market Size and Growth for NIPT Prenatal Testing Market 2017-2022 ($millions)

GEOGRAPHICAL

North America

Table 7-6: North American Market Size and Growth for Prenatal Genetic Screening and Testing Market 2017-2022 ($millions)

European Union

Table 7-7: European Market Size and Growth for Prenatal Genetic Screening and Testing Market 2017-2022 ($millions)

Table 7-8: Selected EU Countries Prenatal Screening Policies

Asia-Pacific

Table 7-9: Asia Pacific Market Size and Growth for Prenatal Genetic Screening and Testing Market 2017-2022 ($millions)

Latin America

Table 7-10: Latin American Market Size and Growth for Prenatal Genetic Screening and Testing Market 2017-2022 ($millions)

Rest of World

Table 7-11: Rest of World Market Size and Growth for Prenatal Genetic Screening and Testing Market 2017-2022 ($millions)

COMPETITIVE LANDSCAPE

8: COMPANY PROFILES

ABBOTT LABORATORIES

Table 8-1: Abbott Corporate Summary

Company Overview

Product

Performance Review

Table 8-2: Abbott Revenues 2015-2017 (in millions $)

AFFYMETRIX, INC.

Table 8-3: Affymetrix Corporate Summary

Company Overview

Products

AGILENT, INC

Table 8-4: Agilent Corporate Summary

Company Overview

Products

Company Financials

Table 8-5: Agilent Corporation Revenue (2014-2017) ($ millions)

BERRY GENOMICS CO. LTD.

Table 8-6: Berry Genomics Corporate Summary

Company Overview

Products

BGI DIAGNOSTICS

Table 8-7: BGI Diagnostics Corporate Summary

Company Overview

Products

BIO-RAD LABORATORIES INC

Table 8-8: Bio-Rad Labs Corporate Summary

Company Overview

Products

Company Financials

Table 8-9: Bio-Rad Corporation Revenue (2014-2017) ($ millions)

COMBIMATRIX (INVITAE)

Table 8-10: CombiMatrix Corporate Summary

Company Overview

Products

COOPERGENOMICS

Table 8-11: CooperGenomics Corporate Summary

Company Overview

Products

COUNSYL

Table 8-12: Counsyl Corporate Summary

Company Overview

Products

GENEPEEKS, INC.

Table 8-13: GenePeeks Corporate Summary

Company Overview

Products

GENETADI BIOTECH S.L.

Table 8-14: Genetadi Biotech S.L. Corporate Summary

Company Overview

Products

GENOMA GROUP

Table 8–15: Genoma Corporate Summary

Company Overview

Products

ILLUMINA, INC.

Table 8-16: Illumina Corporate Summary

Company Overview

Products

Company Financials

Table 8-17: Illumina Corporation Revenue (2014-2017) ($ millions)

INNOVATIONS EXCHANGE PTE LTD (INEX) AND IGENE DIAGNOSTICS PTE LTD

Table 8-18: Innovations Exchange (INEX) and IGene Diagnostics Corporate Summary

Company Overview

Products

LABORATORY CORPORATION OF AMERICA (LABCORP)

Table 8-19: LabCorp Corporate Summary

Company Overview

Products

Company Financials

Table 8-20: LabCorp Corporation Revenue (2014-2017) ($ millions)

LIFECODEXX AG

Table 8-21: LifeCodexx AG Corporate Summary

Company Overview

Products

NATERA, INC.

Table 8-22: Natera Corporate Summary

Company Overview

Products

Company Financials

Table 8-23: Natera Corporation Revenue (2014-2017) ($ millions)

OXFORD GENE TECHNOLOGY

Table 8-24: Oxford Gene Technology Corporate Summary

Company Overview

Products

PERKINELMER

Table 8-25 : PerkinElmer Corporate Summary

Company Overview

Products

Company Financials

Prenatal and Newborn Genetic Screening and Testing Markets

June vi 2018 © Kalorama Information

Table 8-26: PerkinElmer Corporation Revenue (2014-2017) ($ millions)

PREMAITHA HEALTH

Table 8-27: Premaitha Health Corporate Summary

Company Overview

Products

Company Financials

Table 8-28: Premaitha Corporation Revenue (2014-2017) ($ millions)

QUEST DIAGNOSTICS

Table 8-29: Quest Diagnostics Corporate Summary

Company Overview

Products

Company Financials

Table 8-30: Quest Corporation Revenue (2014-2017) ($ millions)

RAVGEN

Table 8-31: Ravgen Corporate Summary

Company Overview

Products

REPRODUCTIVE GENETICS INNOVATIONS

Table 8-32: Reproductive Genetics Innovations Corporate Summary

Company Overview

Products

ROCHE DIAGNOSTIC CORPORATION

Table 8-33: Roche Diagnostic Corporate Summary

Company Overview

Products

Performance Review

Table 8-34: Roche Diagnostics (2014-2017) ($ millions)

SEQUENOM, INC.

Table 8-35: Sequenom Corporate Summary

Company Overview

Products

THERMOFISHER SCIENTIFIC

Table 8-36: ThermoFisher Scientific Corporate Summary

Company Overview

Product

Company Financials

Table 8-37: ThermoFisher 2015-2017 (in millions $)

 

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