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
- 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
- INTRODUCTION
WHY TEST? CLINICAL UTILITY OF TESTING FOR GENETIC DISORDERS
- 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
- 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 $)
