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Prenatal Diagnostics

Prenatal Diagnostics

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
Berry Genomics Co., Ltd.
BGI Genomics
F. Hoffmann-La Roche Ltd.
Hologic, Inc.
Illumina, Inc.

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1. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations
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
2. INDUSTRY OVERVIEW
Prenatal Testing: An Introductory Prelude
The Rationale for Prenatal Genetic Testing
Steady Growth Projected Over the Coming Years for Prenatal Testing
Developed Regions: Primary Revenue Contributors
Table 1: Developed Regions Account for Lion's Share of World Prenatal Diagnostics Market: Percentage Breakdown of Revenues for Developed and Developing Regions (2018E & 2022P) (includes corresponding Graph/Chart)
Fast Paced Growth Forecasts in Developing Regions
Table 2: Global Prenatal Diagnostics Market - Geographic Regions Ranked by CAGR (Revenues) for 2015-2022: Asia-Pacific, Latin America, Rest of World, Canada, Europe, US and Japan (includes corresponding Graph/Chart)
Northbound Trajectory in Healthcare Spending Creates Conducive Environment
Table 3: Global Pharmaceutical R&D Spending (in US$ Billion) for the Years 2010 through 2017 (includes corresponding Graph/Chart)
Table 4: Leading Countries with Highest Healthcare Spending as a Percentage (%) of GDP (2016) (includes corresponding Graph/Chart)
Table 5: Per Capita Healthcare Spending (in US$) in Select Countries for the Year 2016 (includes corresponding Graph/Chart)
Prevailing Economic Scenario Favors Increased Healthcare Spending
Table 6: World Real GDP Growth Rates in % (2016-2019P): Breakdown by Country/Region (includes corresponding Graph/Chart)
Progressive Momentum in Med Tech Sector Generates Parallel Opportunities
3. MARKET TRENDS, GROWTH DRIVERS & ISSUES
Non-Invasive Prenatal Testing (NIPT) Transforms Prenatal Testing Landscape
Major Factors Influencing Penetration of NIPT
Table 7: Price Comparison of Existing Tests and Screening Procedures for Down’s Syndrome
NIPT Eliminates Risks & Uncertainty of Conventional Procedures
Replacing Screening Tests – A More Conceivable Change through NIPT
Diversity in NIPT Usage on the Cards
Benefits Outweigh Snags in NIPT Tests
Whole Genome Sequencing Technology in NIPT
DNA – More Ideal Target for NIPT Analysis than Whole Cells
Conventional Invasive Techniques Loose Sheen
Chromosomal Abnormalities Lead the Prenatal Testing Space
Chromosomal Abnormalities – A Substantial Economic Burden
List of Genetic Disorders by Event, Genetic Manifestation and Prevalence
Significant Opportunities in Down’s Syndrome Testing
List of Select Screening Tests Available for T21 Screening and Confirmation
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
Increasing Congenital Disorder Incidence – Key Driver for Prenatal Diagnostics
Prenatal Testing – Effective Way of Alleviating Syphilis Related Deaths and Stillbirths
Molecular Diagnostics Widen Scope & Span of Prenatal Testing
NGS & MPS – Enabling Shorter Time to Test Results
Microarray-Based Prenatal Testing Gathers Steam
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
Counseling – An Imperative Measure Before and After Prenatal Testing
Role of Prenatal Testing in Managing Preterm Births
Lower Sensitivity & Specificity of Existing Tests – A Case for New Tests on the Anvil
Table 8: List of Available Prenatal Screening/ Diagnostic Tests by Accuracy
High Sensitivity Serum Tests May Not Have Many Takers
Ballooning Global Female Population Offers Increased Growth Opportunities
Table 9: Percentage Share of Female Population in the Age Group (15-54) by Country: 2015
Issues & Challenges
Prenatal Diagnostics: Treading Sensitive Ethical Issues
Controversy Related to “Incidental Findings” of Prenatal Tests
Opposition to NIPT Technique – A Significant Hurdle to Adoption
Unresolved Issues Hamper Widespread Testing for Monogenetic Disease
Dearth of Genetic Counselors – A Major Hurdle for Genetic Testing
4. PRODUCT OVERVIEW
Prenatal Testing
Factors Considered for Recommending Prenatal Tests
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
A Review of Prenatal Screening & Diagnostic Testing Methods
5. COMPETITIVE LANDSCAPE
Leading Players in the World Prenatal Diagnostics Market
Competition Intensifies in the NIPT Vertical
Select Companies Marketing/Developing NIPT Tests
Sequenom – A Major Player in the Non-Invasive Test Space
Overview of Sequenom NIPT Tests
MaterniT21™
SensiGene Fetal RhD
Sequenom’s Prenatal Diagnostics Portfolio in a Nutshell
Patent Wars in the NIPT Space
The Changing Regulatory Paradigm of LDT
Verifi™ Becomes the First Commercial Test in the Landscape of LDTs
M&A Activity
Select M&A Deals in the Prenatal Testing Market (2013-2018)
5.1 Focus on Select Global Players
ANGLE Plc (UK)
Berry Genomics Co., Ltd. (China)
BGI Genomics (Denmark)
F. Hoffmann-La Roche Ltd. (Switzerland)
Hologic, Inc. (USA)
Illumina, Inc. (USA)
Laboratory Corporation of America® Holdings (USA)
Sequenom, Inc. (USA)
Lifecodexx AG (Germany)
Natera, Inc. (USA)
Quest Diagnostics, Inc. (USA)
Ravgen, Inc. (USA)
5.2 Product Approvals/Launches
Angle Achieves Positive Results for Parsortix in NIPT
Counsyl Bags Regulatory Approval for Counsyl Prelude™ Prenatal Screen in New York
BGI Receives Thai FDA’s Import Certificate for BGISEQ-500 and NIFTY Kit
Illumina Receives CE Mark for Expanded VeriSeq NIPT Analysis Software in EU
Baylor Genetics Introduces PreSeek™ Non-Invasive Prenatal Multi-Gene Sequencing Screen
BGI Bags CE Certification for NIFTY® Test Kit for Fetal Chromosome Aneuploidy
5.3 Recent Industry Activity
Myriad Genetics Snaps Up Counsyl
Berry Genomics and Prenetics to Establish Joint Venture Firm
10x Genomics Teams Up with Berry Genomics
Illumina Inks NIPT Deal with Harvard Pilgrim Health Care
Konica Minolta Establishes Konica Minolta Precision Medicine
ANGLE Teams Up with QIAGEN NV
BGI Collaborates with Lunenfeld-Tanenbaum Research Institute
Illumina Leads the Launch of CAPS
Progenity Bags New Funding
Konica Minolta Acquires Ambry Genetics
Eurofins Scientific Acquires GATC Biotech
LifeCodexx Teams Up with LifeCell in India
6. GLOBAL MARKET PERSPECTIVE
Table 10: 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 Revenues in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 11: 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 Revenues in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 12: 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, 2018 & 2022 (includes corresponding Graph/Chart)
7. REGIONAL MARKET PERSPECTIVE
7.1 The United States
A. Market Analysis
The United States: Prime Market for Prenatal Diagnostics
Table 13: US Prenatal Diagnostics Market by End-Use Segment (2018E): Percentage Breakdown of Revenues for Clinics, Hospitals, and Others (includes corresponding Graph/Chart)
Table 14: US Prenatal Diagnostics Market by Technology (2018E): Percentage Breakdown of Revenues for Diagnostic and Screening (includes corresponding Graph/Chart)
Popularity of Screening & ACOG Guidelines Sink Invasive Prenatal Diagnosis Volumes
Leading NIPT Vendors
B. Market Analytics
Table 15: The US Recent Past, Current & Future Analysis for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 16: The US Historic Review for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
7.2 Canada
Market Analysis
Table 17: Canadian Recent Past, Current & Future Analysis for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 18: Canadian Historic Review for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
7.3 Japan
Market Analysis
Table 19: Japanese Recent Past, Current & Future Analysis for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 20: Japanese Historic Review for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
7.4 Europe
Market Analysis
Table 21: 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 Revenues in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 22: European Historic Review for Prenatal Diagnostics by Geographic Region - France, Germany, Italy, UK, Spain, Russia, and Rest of Europe Markets Independently Analyzed with Annual Revenues in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 23: 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, 2018 & 2022 (includes corresponding Graph/Chart)
7.4.1 France
Market Analysis
Table 24: French Recent Past, Current & Future Analysis for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 25: French Historic Review for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
7.4.2 Germany
Market Analysis
Table 26: German Recent Past, Current & Future Analysis for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 27: German Historic Review for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
7.4.3 Italy
Market Analysis
Table 28: Italian Recent Past, Current & Future Analysis for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 29: Italian Historic Review for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
7.4.4 The United Kingdom
A. Market Analysis
Prospects Remain Positive for Prenatal Testing
Table 30: UK Non-Invasive Prenatal Testing Market by Gestation Period (2018E): Percentage Breakdown of Revenues for 0-12 Weeks, 13-24 Weeks, and 25-36 Weeks (includes corresponding Graph/Chart)
Increasing Need for Less Risky Prenatal Diagnostic Methods in the UK
B. Market Analytics
Table 31: The UK Recent Past, Current & Future Analysis for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 32: The UK Historic Review for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
7.4.5 Spain
Market Analysis
Table 33: Spanish Recent Past, Current & Future Analysis for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 34: Spanish Historic Review for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
7.4.6 Russia
Market Analysis
Table 35: Russian Recent Past, Current & Future Analysis for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 36: Russian Historic Review for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
7.4.7 Rest of Europe
Market Analysis
Table 37: Rest of Europe Recent Past, Current & Future Analysis for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 38: Rest of Europe Historic Review for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
7.5 Asia-Pacific
A. Market Analysis
Asia-Pacific Emerges as Fastest Growing Market for Prenatal Testing
Uptrend in IVD Sales Augurs Well for Market Growth
B. Market Analytics
Table 39: 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 Revenues in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 40: Asia-Pacific Historic Review for Prenatal Diagnostics by Geographic Region - China, India, and Rest of Asia-Pacific Markets Independently Analyzed with Annual Revenues in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 41: 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, 2018 & 2022 (includes corresponding Graph/Chart)
7.5.1 China
A. Market Analysis
Prenatal Testing Makes Robust Inroads into the Vast Chinese Market
Laboratory Equipment & Supplies Sector in China: An Overview
B. Market Analytics
Table 42: Chinese Recent Past, Current & Future Analysis for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 43: Chinese Historic Review for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
7.5.2 India
A. Market Analysis
Potential Opportunities for Prenatal Testing in India
Indian Lab Equipment & Supplies Market: An Overview
B. Market Analytics
Table 44: Indian Recent Past, Current & Future Analysis for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 45: Indian Historic Review for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
7.5.3 Rest of Asia-Pacific
Market Analysis
Table 46: Rest of Asia-Pacific Recent Past, Current & Future Analysis for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 47: Rest of Asia-Pacific Historic Review for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
7.6 Latin America
Market Analysis
Table 48: Latin American Recent Past, Current & Future Analysis for Prenatal Diagnostics by Geographic Region - Brazil, and Rest of Latin American Markets Independently Analyzed with Annual Revenues in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 49: Latin American Historic Review for Prenatal Diagnostics by Geographic Region - Brazil, and Rest of Latin American Markets Independently Analyzed with Annual Revenues in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 50: 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, 2018 & 2022 (includes corresponding Graph/Chart)
7.6.1 Brazil
Market Analysis
Table 51: Brazilian Recent Past, Current & Future Analysis for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 52: Brazilian Historic Review for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
7.6.2 Rest of Latin America
Market Analysis
Table 53: Rest of Latin American Recent Past, Current & Future Analysis for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 54: Rest of Latin American Historic Review for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
7.7 Rest of World
Market Analysis
Table 55: Rest of World Recent Past, Current & Future Analysis for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 56: Rest of World Historic Review for Prenatal Diagnostics Market with Annual Revenues in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
8. COMPANY PROFILES 109 Total Companies Profiled: 43 (including Divisions/Subsidiaries - 44)
The United States (19)
Europe (17)
- France (1)
- Germany (2)
- The United Kingdom (4)
- Spain (1)
- Rest of Europe (9)
Asia-Pacific (Excluding Japan) (6)
Middle-East (2)

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