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Next Generation Sequencing for Non-invasive Prenatal Testing: Global Insights

Next Generation Sequencing for Non-invasive Prenatal Testing: Global Insights

Report Scope:

The scope of the report includes NIPT methods, applications, patents and companies. The markets for NGS-based NIPT are given for the years 2017, 2018 and 2023.

This report reviews the main sequencing technologies and provides detailed discussion on next generation sequencing and its applications in different fields. The main focus of the study is NIPT. The market dynamics such as drivers and restraints for both NGS and NIPT market have been discussed in this report.

The report examines the markets by NIPT methods, high-risk and low-risk pregnancies and geography. The end-user segment of this market is based on disease area and healthcare setting. Disease areas include trisomies 21, 18 and 13 and Turner syndrome (a sex chromosome aneuploidy). Healthcare settings include diagnostic laboratories and hospitals.

Specific geographic markets are discussed, including North America, Europe, Asia-Pacific, and the rest of the world.

As a background study, industry sectors analyzed include sequencing instruments, target enrichment, informatics, clinical laboratory testing services, reproductive health diagnostics, liquid biopsy, immune sequencing, HLA typing, third generation sequencing and direct to consumer.

BCC Research provides a summary of the main industry acquisitions and strategic alliances from 2016 through April 2018, including key alliance trends.

Report Includes:

- 23 data tables and 61 additional tables
- An overview of the global insights of next generation sequencing (NGS) for non-invasive prenatal testing (NIPT) within the biotechnology industry
- Country specific data and analysis for United States, France, Germany, U.K., Italy, Spain, China, India, Japan, South Korea and rest of the world countries
- Analyses of global market trends with data from 2017, estimates for 2018, and projections of compound annual growth rates (CAGRs) through 2023
- Characterization and quantification of the market potential for NGS by geographical region, type, application sector, and end user industry
- Discussion of next generation sequencers, NGS technologies, NIPT methods, clinical applications and industry structure
- Examination of regional dynamics, and key technological updates for both NGS and NIPT market
- Comprehensive profiles of the leading companies involved in the clinical, genetic testing and sequencing industries, including 10X Genomics, Inc., 23andMe, Agilent Technologies, Inc., Illumina Inc. and Natera, Inc.


Chapter 1 Introduction
Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Intended Audience
Methodology
Geographic Breakdown
Analyst's Credentials
Related BCC Research Reports
Chapter 2 Summary and Highlights
Chapter 3 Next Generation Sequencing Overview
Technology Background
Structure and Importance of DNA
Genetic Variation and Analysis
Types of Genetic Variation
Genetic Analysis Technologies
DNA Sequencing Technologies
Whole Genome Sequencing
Targeted Resequencing
ChIP Sequencing
RNA Sequencing
Methylation Sequencing
History of DNA Sequencing
Sanger Sequencing
Introduction to Next-Generation Sequencing (NGS)
Roche 454 Pyrosequencing
Illumina Next-Generation Sequencing
Thermo Fisher Scientific (Life Technologies) NGS
Sequencing Instruments
Benchtop Sequencers
Informatics Technologies
Factors driving NGS Market
Improvements in Clinical NGS Informatics
Growing Need for Better Diagnostics as Part of Molecular Diagnostics Trend
Shift towards Precision Medicine
Factors Restraining NGS Market
Lack of reimbursement coverage and coding
Other Clinical Sequencing Technology Challenges
Chapter 4 Next Generation Sequencing Applications
Drug Discovery/Personalized Medicine
Agriculture and Animal Research
Infectious Diseases/Diagnostics
Genetic Screening
Cancer
Cardiovascular Diseases
Food-Borne Illness
HLA-Typing
Immune Diseases
Metabolic Diseases
Neurological Disorders
Mendelian Disorders
Infectious Diseases
Reproductive Health
Chapter 5 Next Generation Sequencing Based Non-Invasive Prenatal Testing
NIPT-Introduction and Technology Overview
Other Conventional Prenatal Testing Methods
Advantages of NIPT
Positive Predictive Value
Implementation of NIPT Process
In-House Testing
As a Service
Factors Driving NIPT Market
Average Risk NIPT
Favorable Reimbursement
New Advances in Genomic Technologies
Preference for Non-invasive Techniques Over Invasive Methods
Patient Counseling and Awareness
Increasing Collaborations with Local Entities
Increasing Mean Maternal Age
Restraints
Legal and regulatory issues
Access to the Advancing Technologies
Fetal Cell NIPT Industry
Current Market Scenario
Cost of NIPT
Chapter 6 Market Breakdown by NIPT Methods
NGS-based NIPT
NGS Sequencers for NIPT
VeriSeq NIPT Solution
MiSeqDx
NextSeq 550x
NextSeq 550AR
Non-Invasive Prenatal Tests Available in Market
NIFTY
Verifi Prenatal Test
Panorama
MaterniT21
IONA Test
Bambni Test
InformaSeq
Prena Test
VisibiliT
Veracity
Chapter 7 NGS-NIPT End Users
By Disease Area
Down's Syndrome
Edwards Syndrome (Trisomy 18)
Patau syndrome (Trisomy 13)
Turner Syndrome
Others
By Healthcare Setting
Diagnostic laboratories
Hospitals
Chapter 8 Market Breakdown by Region
North America
USA
Europe
Asia-Pacific
Rest of the World
Chapter 9 Patent Review
Patent Review by Year
Chapter 10 Analysis of Market Opportunities
Market Share Analysis
PEST Analysis
Political
Economical
Social
Technological
Chapter 11 Competitive Landscape
Mergers and Acquisitions
New Product Launches
Agreements, Collaborations, and Partnerships
Chapter 12 Company Profiles
10X GENOMICS
Business Overview
Financials
Products and Services
23ANDME
Business Overview
Products and Services
AGILENT TECHNOLOGIES, INC.
Business Overview
Financials
Products and Services
Business Highlights
ANNOROAD
Business Overview
Products and Services
BERRY GENOMICS
Business Overview
Products and Services
BGI (BEIJING GENOMICS INSTITUTE)
Business Overview
Products and Services
Business Highlights
EUROFINS GATC BIOTECH
Business Overview
EUROFIN GATC - LIFECODEXX AG
Business Overview
Products and Services
Business Highlights
ILLUMINA INC.
Business Overview
Financials
Products and Services
Business Highlights (2017-2018)
KNOME, INC. / TUTE GENOMICS / PIERIAN DX
Business Overview
PIERIANDX, INC.
Products and Services
LABCORP-SEQUENOM LABORATORIES
Business Overview
LABCORP
Business Overview
Labcorp's Businesses
Financials
Products and Services
NATERA, INC.
Business Overview
Financials
Products and Services
Business Highlights
NIPD GENETICS
Business overview
OXFORD NANOPORE TECHNOLOGIES LTD.
Business Overview
Financials
Products and Services
PACIFIC BIOSCIENCES OF CALIFORNIA
Business Overview
Financials
Products and Services
Business Highlights
PERKINELMER, INC.
PREMAITHA HEALTH PLC
Business Overview
Financials
Products and Services
Business Highlights
QIAGEN NV
Business Overview
Financials
Net Sales by Geographic Region
Products and Services
Business Highlights
ROCHE HOLDING AG
Business Overview
Financials
Products and Services
Historic Mergers and Acquisitions
THERMO FISHER SCIENTIFIC INC.
Business Overview
Financials
Products and Services
Business Highlights
List of Tables
Summary Table : Global Market for NIPT, by Region, Through 2023
Table 1 : DNA Translation and Transcription
Table 2 : Long-range DNA Structure
Table 3 : Genetic Variant Types
Table 4 : Molecular Diagnostic Technology Platforms
Table 5 : DNA Sequencing Workflow
Table 6 : DNA Sequencing Historical Timeline
Table 7 : Sequencing Technology Development, 1990-2020+
Table 8 : Cost to Sequence a Single Human Genome, 2001-2018
Table 9 : Sanger Sequencing Summary
Table 10 : Sanger Sequencing Improvements
Table 11 : Next-Generation Sequencing Technologies
Table 12 : Roche Next-Generation Sequencing Workflow
Table 13 : Illumina Next-Generation Sequencing Workflow
Table 14 : Thermo Fisher Next-Generation Sequencing Workflow
Table 15 : NGS Instruments
Table 16 : Benchtop and Handheld Sequencer Platforms
Table 17 : Characteristics of NGS Platforms
Table 18 : Next-Generation Sequencing Bioinformatics Workflow
Table 19 : Sequence Annotation Steps
Table 20 : Comparison between Sanger Sequencing, Real-Time Sequencing and Next- Generation Sequencing
Table 21 : Codes for Genomic Sequencing Procedures and Other Molecular Multianalyte Assays
Table 22 : CPT/HCPCS Codes
Table 23 : Future Challenges for Implementing Clinical Next-Generation Sequencing
Table 24 : Genetic Screening Applications
Table 25 : Examples of Genetic Etiology of Monogenic Cardiovascular Diseases Using Next-Generation Sequencing
Table 26 : Next Generation Sequencing Approaches in Cardiovascular Diseases
Table 27 : Variants Associated with Systemic Autoimmune Diseases Identified or Validated by NGS
Table 28 : Examples of Novel Genes Associated with Neurodegenerative Diseases Identified by the Use of Exome Sequencing
Table 29 : Examples of Mutations in the Same Genes Causing Different Diseases
Table 30 : Applications for NGS Diagnostics for Reproductive Health
Table 31 : Ethical Issues Associated with Prenatal and Newborn Screening
Table 32 : Fetal Cell NIPT Industry
Table 33 : NIPT Test Prices Across the Globe (2017)
Table 34 : Global NIPT Market, by Risk Type, Through 2023
Table 35 : NGS NIPT Industry
Table 36 : Number of Tests and Market for NIPT, by Region and Company, 2015
Table 37 : Germany NGS-based Non-invasive Prenatal Diagnostic Companies
Table 38 : Global Market for NIPT, by Method, Through 2023
Table 39 : NIPTs Offered by Various Companies
Table 40 : Positive Predictive Values for High- and Average Risk Cohorts
Table 41 : Comparison with Other NIPTs Which are Based on Counting Technologies
Table 42 : Iona Test Market, by Country/Region, 2016-2017
Table 43 : InformaSeq Tests
Table 44 : Test Performance in the Most Common Chromosomal Aneuploidies
Table 45 : Test Performance in the Most Common Sex Chromosomes
Table 46 : VisibiliT Test Performance
Table 47 : Global Market for NIPT, by Region, Through 2023
Table 48 : North American Market for NIPT, by Country, Through 2023
Table 49 : Commercial Landscape of Noninvasive Prenatal Testing for Fetal Aneuploidy in the United States
Table 50 : United States Patents and Applications for Institutions Commercializing Noninvasive Prenatal Tests, 2012
Table 51 : European Market for NIPT, by Country, Through 2023
Table 52 : Asia-Pacific Market for NIPT, by Country, Through 2023
Table 53 : Patent Review of NIPT, by Year, 2010-2018
Table 54 : Mergers and Acquisitions of Key Players, 2016-2018
Table 55 : New Products Launched by Key Players of NGS-NIPT Industry, 2017-2018
Table 56 : Agreements, Collaborations and Partnerships Among NGS-NIPT Key Players, 2017-2018
Table 57 : 10x Genomics Products and Services
Table 58 : 23andMe Products and Services
Table 59 : Agilent Technologies Financials, 2016-2017
Table 60 : Agilent Technologies Products and Services
Table 61 : Annoroad Products and Services
Table 62 : Berry Genomics Products and Services
Table 63 : BGI Products and Services
Table 64 : Lifecodexx Products and Services
Table 65 : Illumina Financials, 2016-2017
Table 66 : Illumina Products and Services
Table 67 : PDx Products and Services
Table 68 : LabCorp Financials, 2016-2017
Table 69 : LabCorp Products and Services
Table 70 : Natera Financials, 2016-2017
Table 71 : Natera Products and Services
Table 72 : Oxford Nanopore Technologies Products and Services
Table 73 : Pacific Biosciences Financials, 2016-2017
Table 74 : PacBio Products and Services
Table 75 : Iona Test Revenue Analyzed, by Country/Region, 2016-2017
Table 76 : Premaitha Financials, 2016-2017
Table 77 : Premaitha Products and Services
Table 78 : Qiagen Financials, 2016-2017
Table 79 : Qiagen Products and Services
Table 80 : Roche Diagnostic Division Sales, 2016-2017
Table 81 : Roche Products and Services
Table 82 : Thermo Fisher Financials, 2016-2017
Table 83 : Thermo Fisher Products and Services
List of Figures
Summary Figure : Global Market for NIPT, 2017-2023
Figure 1 : Whole Genome Sequencing
Figure 2 : The Road from NGS to Personalized Medicine
Figure 3 : NIPT Using Massively Parallel Sequencing (MPS)
Figure 4 : Global NIPT Market, by Risk Type, 2017-2023
Figure 5 : Clinical Performance of NIFTY Test
Figure 6 : Clinical Performance of Harmony Test
Figure 7 : Clinical Performance of Panorama Test
Figure 8 : Prevalence of Down’s Syndrome by Mother’s Age
Figure 9 : North American Market for NIPT, by Country, 2017-2023
Figure 10 : European Market for NIPT, by Country, 2017-2023
Figure 11 : European NIPT Market Share, 2017
Figure 12 : Mean Maternal Age in EU5 Countries, 2016
Figure 13 : Total Number of Pregnancies and NIPT Procedures in EU5 Countries, 2016
Figure 14 : Asia-Pacific Market for NIPT, 2017-2023
Figure 15 : RoW Market for NIPT, 2017-2023
Figure 16 : Ten Key Players of Next-Generation Sequencing Companies
Figure 17 : NIPT Industry Market Share, by Key Players, 2017
Figure 18 : Net Sales, by Region, 2017
Figure 19 : Thermo Fisher Scientific Market Share, by Business Segment, 2018 (Q1)

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