NEW YORK, July 27, 2016 /PRNewswire/ -- 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.
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I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1 Disclaimers.............. I-2 Data Interpretation & Reporting Level I-2 Quantitative Techniques & Analytics I-3 Product Definitions and Scope of Study I-3 Prenatal Testing.............. I-3 Prenatal Screening Tests..............I-3 Prenatal Diagnostic Tests..............I-3 Non-Invasive Prenatal Diagnostic Tests I-4
II. EXECUTIVE SUMMARY
1. INDUSTRY OVERVIEW.............. II-1 Prenatal Testing - A Rudimentary Overview II-1 List of Available Prenatal Screening and Diagnostic Tests by Indication.............. II-2 Prenatal Testing Market to Rise..............II-2 The Rationale for Prenatal Genetic Testing II-4 Chromosomal Abnormalities Lead the Prenatal Testing Space II-5 Chromosomal Abnormalities - A Substantial Economic Burden II-5 List of Genetic Disorders by Event, Genetic Manifestation and Prevalence.............. II-6 Counseling - An Imperative Measure Before and After Prenatal Testing.............. II-6 Role of Prenatal Testing in Managing Preterm Births II-7 Conventional Invasive Prenatal Diagnostic Techniques - A Risky Affair.............. II-7 Lower Sensitivity and Specificity of Existing Tests - A Case for New Tests on the Anvil..............II-8 Table 1: List of Available Prenatal Screening/ Diagnostic Tests by Accuracy..............II-8 High Sensitivity Serum Tests May Not Have Many Takers II-8 Free Fetal DNA Discovery Revolutionizes Market with Non- Invasive Prenatal Diagnostics (NIPD/NIPT) II-9 NIPD Eliminates Risks and Uncertainty of Conventional Diagnostic Procedures..............II-10 Benefits Outweigh Snags in NIPD Tests II-10 Major Factors Influencing Penetration of NIPD Tests II-11 Table 2: Price Comparison of Existing Tests and Screening Procedures for Down's Syndrome II-11 Replacing Screening Tests - A More Conceivable Change through NIPD.............. II-11 Diversity in NIPD Usage on the Cards II-12
2. GROWTH DRIVERS & MARKET TRENDS..............II-13 Significant Opportunities in Prenatal Testing for Down's syndrome II-13 List of Select Screening Tests Available for T21 Screening and Confirmation..............II-13 Molecular Diagnostics Enhance Prenatal Testing II-14 Prenatal Diagnostics: Treading Sensitive Ethical Issues II-14 Controversy Related to "Incidental Findings" of Prenatal Tests II-16 NGS and MPS - Enabling Shorter Time to Test Results II-16 Microarray-Based Testing to See a Boost in Prenatal Diagnosis II-17 Whole Genome Sequencing Technology in NIPD - A New Advancement II-18 DNA - More Ideal Target for NIPD Analysis than Whole Cells II-18 Sequencing in Prenatal Testing - A Potential High Growth Market II-18 Ultrasound - An Indispensable Combination with Blood Based Screening Tests.............. II-19 New Sub-Targets on the Anvil for Ultrasound-Based Screening II-19 Increasing Congenital Disorder Incidence - Key Driver for Prenatal Diagnostics..............II-20 Beyond Down's Syndrome - Need to Test Additional Targets Crucial II-20 Trisomy 18 or Edward's Syndrome II-20 Trisomy 13 or Patau Syndrome..............II-21 Cystic Fibrosis Screening and Diagnosis II-21 Cystic Fibrosis Screening Market - Highly Fragmented II-22 ACOG and ACGM Recommendations Boost Demand for Prenatal CF Testing.............. II-22 Prenatal Testing Crucial to Detect Risk of Huntington's Disease II-22 Prenatal Testing - Effective Way of Alleviating Syphilis Related Deaths and Stillbirths II-24 Ballooning Global Female Population Offers Increased Growth Opportunities.............. II-24 Table 3: Percentage Share of Female Population in the Age Group (15-54) by Country: 2015 II-25 Improving Healthcare Expenditure to Drive Demand II-25 Table 4: Per-Capita Healthcare Expenditure in Select Regions: 2014 (includes corresponding Graph/Chart) II-26
Table 5: Healthcare Spending as a Percentage of GDP by Region: 2014 (includes corresponding Graph/Chart) II-27 Market Restraints.............. II-27 Opposition to NIPD Technique - A Significant Hurdle to Adoption II-27 Unresolved Issues Hamper Widespread Testing for Monogenetic Disease.............. II-27 Dearth of Genetic Counselors - A Major Hurdle for Genetic Testing.............. II-28
3. COMPETITIVE ENVIRONMENT..............II-29 Competition Intensifies in the NIPD Market II-29 Select Companies Marketing/Developing NIPD Tests II-30 Sequenom - A Major Player in the Non-Invasive Test Space II-30 Overview of Sequenom NIPD Tests II-31 MaterniT21™ (Sequenom)..............II-31 SensiGene Fetal (XY)..............II-32 SensiGene Cystic Fibrosis Carrier Screening Test II-32 SensiGene Fetal RhD..............II-32 Sequenom's Product Portfolio for Prenatal Diagnostics (As of 2016).............. II-32 Patent Wars in the NIPD Space..............II-33 The Changing Regulatory Paradigm of LDT II-33 Verifi™ Becomes the First Commercial Test in the Landscape of LDTs.............. II-33 TrovaGene's Transrenal Technology II-34
4. PRODUCT OVERVIEW.............. II-35 Prenatal Testing.............. II-35 Factors Considered for Recommending Prenatal Diagnostic Testing II-35 Types of Prenatal Testing..............II-35 Prenatal Screening Tests..............II-35 Evolution of Screening Tests II-35 Ultrasound.............. II-36 Types of Ultrasound..............II-37 Ultrasound Examination Types and Use in Prenatal Screening of Fetus.............. II-37 Triple Screen Test..............II-37 Quad Screen Test..............II-37 Prenatal Diagnostic Tests..............II-38 Chorionic Villus Sampling..............II-38 The Procedure.............. II-38 Risks.............. II-39 Amniocentesis.............. II-39 The Procedure.............. II-39 Risks.............. II-40 Cordocentesis.............. II-40 Procedure.............. II-40 Risks.............. II-40 Overview of Current Analysis Methods for Invasive Tests II-40 Comparison of Competitive Technologies Employed in Invasive Prenatal Diagnosis..............II-41 Major Technologies Used in Analyzing Invasive Procedure- Derived Samples.............. II-41 Karyotyping.............. II-41 Fluorescence In Situ Hybridization (FISH) II-41 Digital PCR - Entering the Realm of Fetal Aneuploidy Detection II-41 Lower Fetal DNA Percentage Stifles Progression in Digital PCR Utility Research..............II-42 Non-Invasive Prenatal Diagnostic Tests II-42
5. PRODUCT INNOVATIONS/LAUNCHES..............II-43 Combimatrix to Launch NGS in Pre-implantation Genetic Screening II-43 Genetica Launches Panorama NIPT in Switzerland via Natera's Platform.............. II-43 Roche and Ariosa Announce Launch of Harmony Test in Australia and UK.............. II-43 Source BioScience Launches New NIPT Service II-43 Sequenom Laboratories to Launch MaterniT™ GENOME Test II-43 Ariosa Receives CE Approval for FORTE Software II-43 Quest Diagnostics Launches QNatal Advanced NIPT Service II-43 Berry Genomics and Illumina Receive Premarket Clearance from CFDA for NextSeq CN500 and NIPT II-44 Ariosa Introduces Microarray DNA Quantification for Harmony NIPT II-44 LabCorp Launches informaSeq Prenatal Test II-44 Eastern Biotech Launches NIPD Test to Detect Trisomy II-44
6. RECENT INDUSTRY ACTIVITY..............II-45 PerkinElmer Divests Prenatal Screening Business to Eurofins Scientific.............. II-45 LifeCodexx AG Enters Into Technology Partnerships to Enhance NIPT Availability..............II-45 PerkinElmer Completes Acquisition of Vanadis II-45 Applied Spectral Imaging and ScreenCell Enter Into Global Partnership.............. II-45 Sequenom Enters into Prenatal Diagnostic Services Agreement with United Healthcare..............II-45 A*STAR's IME and INEX Innovations Collaborate to Develop NIPT II-45 Illumina Enters Into Collaboration with Chinese Company Annoroad II-46 MedGenome and Natera Enter Into Product License Partnership II-46 Roche Acquires NIPT Player Ariosa Diagnostics II-46 BGI Europe and NIM Genetics Sign Technology Transfer Agreement II-46 Sequenom Acquires NIPT Intellectual Property from Isis Innovation II-46 Illumina Signs Agreements to Expand NIPT Reach in Europe II-46 BGI Europe and Genomed Enter into Strategic Partnership II-46 Illumina Acquires Verinata..............II-47 Quest Diagnostics to Offer Access to Natera's Panorama NIPT II-47
7. FOCUS ON SELECT GLOBAL PLAYERS..............II-48 ANGLE Plc. (UK).............. II-48 Ariosa Diagnostics, Inc. (US)..............II-48 BGI Diagnosis Co., Ltd. (China)..............II-48 Berry Genomics Co., Ltd. (China) II-49 Hologic, Inc. (US)..............II-49 Illumina, Inc. (US).............. II-49 Laboratory Corporation of America® Holdings (US) II-50 Lifecodexx AG (Germany)..............II-50 Natera, Inc. (US).............. II-51 Quest Diagnostics, Inc. (US)..............II-51 Ravgen, Inc. (US).............. II-52 Sequenom, Inc. (US).............. II-52 Sequenom Center for Molecular Medicine, LLC (US) II-53 TrovaGene, Inc. (US)..............II-53
8. GLOBAL MARKET PERSPECTIVE..............II-54 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).............. II-54
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) II-55
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)..............II-56
III. MARKET
1. THE UNITED STATES.............. III-1 A.Market Analysis.............. III-1 Current & Future Analysis..............III-1 Leading NIPT Tests..............III-1 Popularity of Screening and ACOG Guidelines Sink Invasive Prenatal Diagnosis Numbers..............III-2 Product Launches..............III-3 Strategic Corporate Developments III-4 Select Key Players..............III-5 B.Market Analytics..............III-10 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)..............III-10
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) III-11
2. CANADA.............. III-12 A.Market Analysis.............. III-12 Funding Uncertainty..............III-12 B.Market Analytics..............III-12 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)..............III-12
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) III-13
3. JAPAN.............. III-14 Market Analysis.............. III-14 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)..............III-14
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) III-15
4. EUROPE.............. III-16 A.Market Analysis.............. III-16 Current & Future Analysis..............III-16 Strategic Corporate Developments III-16 B.Market Analytics..............III-17 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)..............III-17
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) III-18
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) III-19
4a. FRANCE.............. III-20 Market Analysis.............. III-20 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)..............III-20
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) III-21
4b. GERMANY.............. III-22 A.Market Analysis.............. III-22 Strategic Corporate Development III-22 Lifecodexx AG - A Key German-based Player III-22 B.Market Analytics..............III-23 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)..............III-23
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) III-24
4c. ITALY.............. III-25 Market Analysis.............. III-25 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)..............III-25
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) III-26
4d. THE UNITED KINGDOM..............III-27 A.Market Analysis.............. III-27 Current & Future Analysis..............III-27 Increasing Need for Less Risky Prenatal Diagnostic Methods in the UK.............. III-27 Product Launch.............. III-27 Angle plc - A Key Regional Player III-27 B.Market Analytics..............III-28 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)..............III-28
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) III-29
4e. SPAIN.............. III-30 Market Analysis.............. III-30 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)..............III-30
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) III-31
4f. RUSSIA.............. III-32 Market Analysis.............. III-32 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)..............III-32
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) III-33
4g. REST OF EUROPE.............. III-34 A.Market Analysis.............. III-34 Product Launch.............. III-34 Strategic Corporate Developments III-34 B.Market Analytics..............III-35 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) III-35
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).............. III-36
5. ASIA-PACIFIC.............. III-37 A.Market Analysis.............. III-37 China: NGS Assays Widely Used in Domestic NIPT Market III-37 Australia: Need for Standardized Approach III-37 Product Launches..............III-37 Strategic Corporate Developments III-38 Select Key Players..............III-38 B.Market Analytics..............III-40 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) III-40
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) III-41
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).............. III-42
5a. CHINA.............. III-43 Market Analysis.............. III-43 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)..............III-43
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) III-44
5b. INDIA.............. III-45 Market Analysis.............. III-45 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)..............III-45
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) III-46
5c. REST OF ASIA-PACIFIC..............III-47 Market Analysis.............. III-47 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) III-47
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).............. III-48
6. LATIN AMERICA.............. III-49 Market Analysis.............. III-49 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) III-49
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)..............III-50
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).............. III-51
6a. BRAZIL.............. III-52 Market Analysis.............. III-52 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)..............III-52
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) III-53
6b. REST OF LATIN AMERICA..............III-54 Market Analysis.............. III-54 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) III-54
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)..............III-55
7. REST OF WORLD.............. III-56 A.Market Analysis.............. III-56 Product Launch.............. III-56 B.Market Analytics..............III-56 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) III-56
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).............. III-57
IV. COMPETITIVE LANDSCAPE
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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