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Market Research Report

Prenatal Diagnostics

Published by Global Industry Analysts, Inc. Product code 248920
Published Content info 197 Pages
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Prenatal Diagnostics
Published: June 1, 2016 Content info: 197 Pages
Description

This report analyzes the worldwide markets for Prenatal Diagnostics in US$ Million. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2015 through 2022. Also, a six-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 43 companies including many key and niche players such as -

ANGLE Plc
Ariosa Diagnostics, Inc.
BGI Diagnosis Co., Ltd.
Berry Genomics Co., Ltd.
Hologic, Inc.

Table of Contents
Product Code: MCP-7675

Table of Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

  • Study Reliability and Reporting Limitations
  • Disclaimers
  • Data Interpretation & Reporting Level
    • Quantitative Techniques & Analytics
  • Product Definitions and Scope of Study
    • Prenatal Testing
      • Prenatal Screening Tests
      • Prenatal Diagnostic Tests
        • Non-Invasive Prenatal Diagnostic Tests

II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW

  • Prenatal Testing - A Rudimentary Overview
  • List of Available Prenatal Screening and Diagnostic Tests by Indication
  • Prenatal Testing Market to Rise
  • The Rationale for Prenatal Genetic Testing
  • Chromosomal Abnormalities Lead the Prenatal Testing Space
  • Chromosomal Abnormalities - A Substantial Economic Burden
    • List of Genetic Disorders by Event, Genetic Manifestation and Prevalence
  • Counseling - An Imperative Measure Before and After Prenatal Testing
  • Role of Prenatal Testing in Managing Preterm Births
  • Conventional Invasive Prenatal Diagnostic Techniques - A Risky Affair
  • Lower Sensitivity and Specificity of Existing Tests - A Case for New Tests on the Anvil
    • Table 1: List of Available Prenatal Screening/ Diagnostic Tests by Accuracy
  • High Sensitivity Serum Tests May Not Have Many Takers
  • Free Fetal DNA Discovery Revolutionizes Market with Non-Invasive Prenatal Diagnostics (NIPD/NIPT)
  • NIPD Eliminates Risks and Uncertainty of Conventional Diagnostic Procedures
  • Benefits Outweigh Snags in NIPD Tests
  • Major Factors Influencing Penetration of NIPD Tests
    • Table 2: Price Comparison of Existing Tests and Screening Procedures for Down's Syndrome
  • Replacing Screening Tests - A More Conceivable Change through NIPD
  • Diversity in NIPD Usage on the Cards

2. GROWTH DRIVERS & MARKET TRENDS

  • Significant Opportunities in Prenatal Testing for Down's syndrome
  • List of Select Screening Tests Available for T21 Screening and Confirmation
  • Molecular Diagnostics Enhance Prenatal Testing
  • Prenatal Diagnostics: Treading Sensitive Ethical Issues
  • Controversy Related to "Incidental Findings" of Prenatal Tests
  • NGS and MPS - Enabling Shorter Time to Test Results
  • Microarray-Based Testing to See a Boost in Prenatal Diagnosis
  • Whole Genome Sequencing Technology in NIPD - A New Advancement
  • DNA - More Ideal Target for NIPD Analysis than Whole Cells
  • Sequencing in Prenatal Testing - A Potential High Growth Market
  • Ultrasound - An Indispensable Combination with Blood Based Screening Tests
  • New Sub-Targets on the Anvil for Ultrasound-Based Screening
  • Increasing Congenital Disorder Incidence - Key Driver for Prenatal Diagnostics
  • Beyond Down's Syndrome - Need to Test Additional Targets Crucial
  • Trisomy 18 or Edward's Syndrome
  • Trisomy 13 or Patau Syndrome
  • Cystic Fibrosis Screening and Diagnosis
    • Cystic Fibrosis Screening Market - Highly Fragmented
    • ACOG and ACGM Recommendations Boost Demand for Prenatal CF Testing
  • Prenatal Testing Crucial to Detect Risk of Huntington's Disease
  • Prenatal Testing - Effective Way of Alleviating Syphilis Related Deaths and Stillbirths
  • Ballooning Global Female Population Offers Increased Growth Opportunities
    • Table 3: Percentage Share of Female Population in the Age Group (15-54) by Country: 2015
  • Improving Healthcare Expenditure to Drive Demand
    • Table 4: Per-Capita Healthcare Expenditure in Select Regions: 2014 (includes corresponding Graph/Chart)
    • Table 5: Healthcare Spending as a Percentage of GDP by Region: 2014 (includes corresponding Graph/Chart)
  • Market Restraints
  • Opposition to NIPD Technique - A Significant Hurdle to Adoption
  • Unresolved Issues Hamper Widespread Testing for Monogenetic Disease
  • Dearth of Genetic Counselors - A Major Hurdle for Genetic Testing

3. COMPETITIVE ENVIRONMENT

  • Competition Intensifies in the NIPD Market
  • Select Companies Marketing/Developing NIPD Tests
  • Sequenom - A Major Player in the Non-Invasive Test Space
    • Overview of Sequenom NIPD Tests
      • MaterniT21(tm) (Sequenom)
      • SensiGene Fetal (XY)
      • SensiGene Cystic Fibrosis Carrier Screening Test
      • SensiGene Fetal RhD
      • Sequenom's Product Portfolio for Prenatal Diagnostics (As of 2016)
  • Patent Wars in the NIPD Space
  • The Changing Regulatory Paradigm of LDT
  • Verifi(tm) Becomes the First Commercial Test in the Landscape of LDTs
  • TrovaGene's Transrenal Technology

4. PRODUCT OVERVIEW

  • Prenatal Testing
  • Factors Considered for Recommending Prenatal Diagnostic Testing
  • Types of Prenatal Testing
  • Prenatal Screening Tests
    • Evolution of Screening Tests
    • Ultrasound
      • Types of Ultrasound
      • Ultrasound Examination Types and Use in Prenatal Screening of Fetus
    • Triple Screen Test
    • Quad Screen Test
  • Prenatal Diagnostic Tests
    • Chorionic Villus Sampling
      • The Procedure
      • Risks
    • Amniocentesis
      • The Procedure
      • Risks
    • Cordocentesis
      • Procedure
      • Risks
    • Overview of Current Analysis Methods for Invasive Tests
      • Comparison of Competitive Technologies Employed in Invasive Prenatal Diagnosis
  • Major Technologies Used in Analyzing Invasive Procedure-Derived Samples
    • Karyotyping
    • Fluorescence In Situ Hybridization (FISH)
    • Digital PCR - Entering the Realm of Fetal Aneuploidy Detection
      • Lower Fetal DNA Percentage Stifles Progression in Digital PCR Utility Research
      • Non-Invasive Prenatal Diagnostic Tests

5. PRODUCT INNOVATIONS/LAUNCHES

  • Combimatrix to Launch NGS in Pre-implantation Genetic Screening
  • Genetica Launches Panorama NIPT in Switzerland via Natera's Platform
  • Roche and Ariosa Announce Launch of Harmony Test in Australia and UK
  • Source BioScience Launches New NIPT Service
  • Sequenom Laboratories to Launch MaterniT(tm) GENOME Test
  • Ariosa Receives CE Approval for FORTE Software
  • Quest Diagnostics Launches QNatal Advanced NIPT Service
  • Berry Genomics and Illumina Receive Premarket Clearance from CFDA for NextSeq CN500 and NIPT
  • Ariosa Introduces Microarray DNA Quantification for Harmony NIPT
  • LabCorp Launches informaSeq Prenatal Test
  • Eastern Biotech Launches NIPD Test to Detect Trisomy

6. RECENT INDUSTRY ACTIVITY

  • PerkinElmer Divests Prenatal Screening Business to Eurofins Scientific
  • LifeCodexx AG Enters Into Technology Partnerships to Enhance NIPT Availability
  • PerkinElmer Completes Acquisition of Vanadis
  • Applied Spectral Imaging and ScreenCell Enter Into Global Partnership
  • Sequenom Enters into Prenatal Diagnostic Services Agreement with United Healthcare
  • A*STAR's IME and INEX Innovations Collaborate to Develop NIPT
  • Illumina Enters Into Collaboration with Chinese Company Annoroad
  • MedGenome and Natera Enter Into Product License Partnership
  • Roche Acquires NIPT Player Ariosa Diagnostics
  • BGI Europe and NIM Genetics Sign Technology Transfer Agreement
  • Sequenom Acquires NIPT Intellectual Property from Isis Innovation
  • Illumina Signs Agreements to Expand NIPT Reach in Europe
  • BGI Europe and Genomed Enter into Strategic Partnership
  • Illumina Acquires Verinata
  • Quest Diagnostics to Offer Access to Natera's Panorama NIPT

7. FOCUS ON SELECT GLOBAL PLAYERS

  • ANGLE Plc. (UK)
  • Ariosa Diagnostics, Inc. (US)
  • BGI Diagnosis Co., Ltd. (China)
  • Berry Genomics Co., Ltd. (China)
  • Hologic, Inc. (US)
  • Illumina, Inc. (US)
  • Laboratory Corporation of America(r) Holdings (US)
  • Lifecodexx AG (Germany)
  • Natera, Inc. (US)
  • Quest Diagnostics, Inc. (US)
  • Ravgen, Inc. (US)
  • Sequenom, Inc. (US)
  • Sequenom Center for Molecular Medicine, LLC (US)
  • TrovaGene, Inc. (US)

8. GLOBAL MARKET PERSPECTIVE

    • Table 6: World Recent Past, Current & Future Analysis for Prenatal Diagnostics by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 7: World Historic Review for Prenatal Diagnostics by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
    • Table 8: World 14-Year Perspective for Prenatal Diagnostics by Geographic Region - Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart)

III. MARKET

1. THE UNITED STATES

  • A. Market Analysis
    • Current & Future Analysis
    • Leading NIPT Tests
    • Popularity of Screening and ACOG Guidelines Sink Invasive Prenatal Diagnosis Numbers
    • Product Launches
    • Strategic Corporate Developments
    • Select Key Players
  • B. Market Analytics
    • Table 9: The US Recent Past, Current & Future Analysis for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 10: The US Historic Review for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

2. CANADA

  • A. Market Analysis
    • Funding Uncertainty
  • B. Market Analytics
    • Table 11: Canadian Recent Past, Current & Future Analysis for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 12: Canadian Historic Review for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

3. JAPAN

  • Market Analysis
    • Table 13: Japanese Recent Past, Current & Future Analysis for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 14: Japanese Historic Review for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4. EUROPE

  • A. Market Analysis
    • Current & Future Analysis
    • Strategic Corporate Developments
  • B. Market Analytics
    • Table 15: European Recent Past, Current & Future Analysis for Prenatal Diagnostics by Geographic Region - France, Germany, Italy, UK, Spain, Russia, and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 16: European Historic Review for Prenatal Diagnostics by Geographic Region - France, Germany, Italy, UK, Spain, Russia, and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
    • Table 17: European 14-Year Perspective for Prenatal Diagnostics by Geographic Region - Percentage Breakdown of Dollar Sales for France, Germany, Italy, UK, Spain, Russia, and Rest of Europe Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart)

4a. FRANCE

  • Market Analysis
    • Table 18: French Recent Past, Current & Future Analysis for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 19: French Historic Review for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4b. GERMANY

  • A. Market Analysis
    • Strategic Corporate Development
    • Lifecodexx AG - A Key German-based Player
  • B. Market Analytics
    • Table 20: German Recent Past, Current & Future Analysis for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 21: German Historic Review for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4c. ITALY

  • Market Analysis
    • Table 22: Italian Recent Past, Current & Future Analysis for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 23: Italian Historic Review for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4d. THE UNITED KINGDOM

  • A. Market Analysis
    • Current & Future Analysis
    • Increasing Need for Less Risky Prenatal Diagnostic Methods in the UK
    • Product Launch
    • Angle plc - A Key Regional Player
  • B. Market Analytics
    • Table 24: The UK Recent Past, Current & Future Analysis for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 25: The UK Historic Review for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4e. SPAIN

  • Market Analysis
    • Table 26: Spanish Recent Past, Current & Future Analysis for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 27: Spanish Historic Review for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4f. RUSSIA

  • Market Analysis
    • Table 28: Russian Recent Past, Current & Future Analysis for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 29: Russian Historic Review for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4g. REST OF EUROPE

  • A. Market Analysis
    • Product Launch
    • Strategic Corporate Developments
  • B. Market Analytics
    • Table 30: Rest of Europe Recent Past, Current & Future Analysis for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 31: Rest of Europe Historic Review for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

5. ASIA-PACIFIC

  • A. Market Analysis
    • China: NGS Assays Widely Used in Domestic NIPT Market
    • Australia: Need for Standardized Approach
    • Product Launches
    • Strategic Corporate Developments
    • Select Key Players
  • B. Market Analytics
    • Table 32: Asia-Pacific Recent Past, Current & Future Analysis for Prenatal Diagnostics by Geographic Region - China, India, and Rest of Asia-Pacific Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 33: Asia-Pacific Historic Review for Prenatal Diagnostics by Geographic Region - China, India, and Rest of Asia-Pacific Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
    • Table 34: Asia-Pacific14-Year Perspective for Prenatal Diagnostics by Geographic Region - Percentage Breakdown of Dollar Sales for China, India, and Rest of Asia-Pacific Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart)

5a. CHINA

  • Market Analysis
    • Table 35: Chinese Recent Past, Current & Future Analysis for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 36: Chinese Historic Review for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

5b. INDIA

  • Market Analysis
    • Table 37: Indian Recent Past, Current & Future Analysis for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 38: Indian Historic Review for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

5c. REST OF ASIA-PACIFIC

  • Market Analysis
    • Table 39: Rest of Asia-Pacific Recent Past, Current & Future Analysis for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 40: Rest of Asia-Pacific Historic Review for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

6. LATIN AMERICA

  • Market Analysis
    • Table 41: Latin American Recent Past, Current & Future Analysis for Prenatal Diagnostics by Geographic Region - Brazil, and Rest of Latin American Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 42: Latin American Historic Review for Prenatal Diagnostics by Geographic Region - Brazil, and Rest of Latin American Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
    • Table 43: Latin American 14-Year Perspective for Prenatal Diagnostics by Geographic Region - Percentage Breakdown of Dollar Sales for Brazil, and Rest of Latin American Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart)

6a. BRAZIL

  • Market Analysis
    • Table 44: Brazilian Recent Past, Current & Future Analysis for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 45: Brazilian Historic Review for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

6b. REST OF LATIN AMERICA

  • Market Analysis
    • Table 46: Rest of Latin American Recent Past, Current & Future Analysis for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 47: Rest of Latin American Historic Review for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

7. REST OF WORLD

  • A. Market Analysis
    • Product Launch
  • B. Market Analytics
    • Table 48: Rest of World Recent Past, Current & Future Analysis for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 49: Rest of World Historic Review for Prenatal Diagnostics - Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

COMPETITIVE LANDSCAPE

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