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Global Non-Invasive Prenatal Testing and Newborn Screening Market, 2017-2027

Published: Jun 09, 2017
Pages: 425
Product Code: RA10083
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It has been estimated that close to 131 million babies are born each year across the globe. Of these, approximately 7.9 million are born with birth defects. In fact, more than 7,000 genetic disorders have been identified so far and the number is rising.Genetic testing solutions that enable early detection of genetic abnormalities in fetuses and newborns are important to ensure that the person does not face complications later in life. With the emergence of innovative diagnostic and screening techniques, several methods of genetic testing have become popular. These include carrier testing, preimplantation genetic diagnosis / screening (PGD / PGS), prenatal testing, paternity testing and newborn screening. Amongst these, prenatal testing (primarily Non-invasive prenatal testing (NIPT)) and newborn screening have gained relatively more traction in prenatal and neonatal care.

 

Specifically, NIPT has emerged as an efficient screening method in prenatal care that can analyze the cell-free DNA (cfDNA) extracted from maternal blood sample during pregnancy. NIPTs offer several advantages over conventional prenatal testing procedures; in addition to being non-invasive, these tests offer shorter turnaround times and high accuracy. It has been reported that the increasing popularity of NIPTs has led to a 50% decline in the use of invasive prenatal testing procedures (such as amniocentesis and chorionic villus sampling (CVS)). With the changing mindset of people belonging to different cultural and socio-economic background, the uptake of NIPTs is likely to increase further. Moreover, with the rising awareness and availability of NIPTs designed for a wide array of disease indications, and development of innovative and versatile technologies, we expect that the interest will continue to grow.

 

Within neonatal care, the emergence of advanced technologies in this domain has reflected a gradual rise in the overall development of advanced newborn screening tests in the last few years. In fact, public service bodies in more than 70 countries across the globe have facilitated the establishment of newborn screening programs in their respective countries. With an already established platform, we expect the overall newborn screening market to continue its gradual rise driven by higher adoption, competitive prices and availability of these tests in various geographies across the globe.

 

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The “Global Non-Invasive Prenatal Testing and Newborn Screening Market, 2017-2027” report features an extensive study on the current market landscape of non-invasive prenatal testing (NIPT) and newborn screening diagnostics that are commercially available or are under development. NIPT and newborn screening tests are designed for the detection of different types of genetic abnormalities in fetuses and newborns. Detection of genetic disorders in prenatal and neonatal stages is critical tolower the child mortality rates. Moreover, early detection, treatment and management of these genetic disorders is important to avoid serious health problems at later stages in life. The study offers a comprehensive discussion on the future potential of these tests in prenatal and neonatal care.

 

Ever since the launch and subsequent success of the first NIPT, the NIFTY® test (launched by BGI in August 2011), several firms have taken initiatives to develop and commercialize NIPTs. Currently, a number of NIPTs that are designed to screen for conditions such as chromosomal abnormalities, sex chromosomal abnormalities and microdeletion syndromes are available in the market.In addition, many companies have entered into collaborations to distribute these tests across various geographies in order to expand the availability to a wider population. Examples of popular NIPT tests include Harmony® test (Ariosa Diagnostics, acquired by Roche), PraenaTest® / PrenaTest® (LifeCodexx, a subsidiary of GATC Biotech), Panorama® (Natera®), NIFTY® (BGI), Verifi® (Verinata Health, acquired by Illumina®), VisibiliTTM (SequenomTM, acquired by LabCorp®) and IONA® test / Safe NIPT (Premaitha Health).

 

The advent of routine newborn screening in the 1960s for the detection of phenylketonuria (PKU) established the role and importance of newborn screening in mitigating disorders in newborns. The field is continuously evolving as the awareness related to benefits of newborn screening increases. Moreover, introduction of advanced technologies such as next-generation sequencing (NGS) and tandem mass spectroscopy has notably accelerated the development in this domain. Newborn screening diagnostics are primarily available for conditions such as metabolic disorders, endocrine disorders, hemoglobin disorders, congenital heart disorders and hearing disorders.

 

Both prenatal testing and newborn screening offer several benefits in terms of disease management in neonatal care and has gathered interest from a wide range of companies worldwide. In total, we have identified 76 NIPT tests and 38 advanced newborn screening tests. In addition, there are several companies that are engaged in the development of basic tests, devices, systems and technology platforms for both prenatal testing and newborn screening. One of the key objectives of this report was to understand the current activity and the future potential of the NIPT and newborn screening markets. Amongst other elements, the report covers the following:

 

NIPT:

  • The overall landscape of NIPT tests with respect to the stage of development, sample type, technology platforms, type of indications, stage of pregnancy and result turnaround time. In addition, the report provides a detailed discussion and analysis on the various innovative technology platforms available for the development of NIPTs and the indications screened.
  • Comprehensive profiles of the leading players in the field of NIPT and their products, highlighting details of the company, financial and funding information (if available), product portfolio and a comprehensive future outlook. Likewise, the product profiles provide information on the product and their development history, technology platforms, test procedure, specifications, advantages and clinical information (if available).
  • An elaborate geographical coverage analysis of the NIPT tests available / under development across the globe, a comparative heat map analysis of NIPTs (on the basis of sensitivity, specificity, result turnaround time and stage of pregnancy when the test can be performed), harvey ball analysis highlighting the panel strength of each test based on the number of indications being screened, and the geographical distribution of the companies involved in the development of NIPTs.

 

Newborn Screening:

  • The overall landscape of newborn screening tests with respect to the stage of development, screening type, technology platform, type of indication, period of sample collection after birth and result turnaround time.
  • Detailed profiles of the players involved in the field of newborn screening and their products highlighting details on the company, financial and funding information (if available), product portfolio and a comprehensive future outlook. Likewise, the product profiles provide information on the product specifications and test methodology. In addition, the report includes a comprehensive list of the core and secondary disorders / deficiencies recommended for newborn screening.
  • An illustrative grid representation of the newborn screening tests based on screening type (basic newborn screening, expanded newborn screening, comprehensive newborn screening and advanced newborn screening) and technology platform, and an overview of the landscape of industry developers (start-ups, mid-sized and large-sized players).

 

Additionally, the report includes:

  • A detailed discussion of the existing regulatory landscape in the field of NIPT and the current status of the government mandated newborn screening programs established in various countries across the globe to provide proper medical care to newborns.
  • Partnerships that have been recently been inked amongst different stakeholders, covering product distribution / marketing agreements, development / commercialization agreements and mergers / acquisitions.
  • A detailed survey analysis primarily focused on gaining additional insights on the company’s tests or services, highlighting the focus area of the company, type of the products, purpose and commercial availability of the lead product(s).

 

The study features a detailed analysis on the existing size and future growth opportunities (2017-2027) in the NIPT and newborn screening markets. We have provided insights on the likely regional evolution of the NIPT market across patients in three risk group segments (high risk, average risk and low risk) covering North America (the US, Canada and Mexico), Europe (France, Germany, Italy, Spain, the UK and rest of Europe) Asia (Japan, China and India) and rest of the world. In addition, we have provided the likely distribution by type of indications, stage of pregnancy when the test can be conducted and the share of individual NIPTs. The forecast takes into account the impending price variations that are likely to emerge in the mid-long term as a result of growing adoption and increased competition. In order to account for uncertainties associated with some of the key parameters and to add robustness to our model, we have presented three different forecast scenarios, depicting conservative, base and optimistic tracks of the market’s evolution.

 

The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Actual figures have been sourced and analyzed from publicly available data and primary research discussions. For the purpose of the study, we invited over 150 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities, challenges and likely future trends. The opinions and insights presented in this study were also influenced by discussions conducted with experts in this field. These include contributions from Jim Patterson (Vice President, Sales and Marketing North America, EvolveGene®), Osama Fikry (Metabolic and Diagnostic Head, NewBridge Pharmaceuticals) and Silke Arndt (Medical Scientist and NGS Manager, Inqaba Biotec).All financial figures mentioned in this report are in USD, unless otherwise specified.

 

Example Highlights

  1. During our research, we identified 76 NIPTs; of the commercially available tests, majority are laboratory-developed tests while only a few are CE-IVD certified. The CE-IVD marked tests include Clarigo® (Multiplicom), Harmony® test (Ariosa Diagnostics, acquired by Roche), IONA® test (Premaitha Health), Prenatal BACs-on-BeadsTM (PerkinElmer®), PraenaTest® / PrenaTest® (LifeCodexx, a subsidiary of GATC Biotech), Prendia (Genesupport, FASTERIS, Swiss Institute for Bioinformatics), SerenityTM test (Genesis GeneticsTM) and Tranquility (Genoma, a subsidiary of ESPERITE).
  2. Of the total NIPTs (commercially available / under development), 83% are designed on the basis of massively parallel sequencing / next-generation sequencing methods (MPS / NGS) for the detection of diseases under their test panels. It is worth highlighting that some developers are utilizing a novel epigenetics based approach for the development of their NIPTs.
  3. The current market landscape features contributions from big pharmaceutical companies and small to mid-sized players. Established players engaged in the development of NIPTsinclude (in alphabetical order) BGI, Natera®, PerkinElmer®, SequenomTM (acquired by LabCorp®), Sonic Healthcare and Quest DiagnosticsTM. Small and mid-sized companies engaged in the field of NIPT include (in alphabetical order) Ariosa Diagnostics (acquired by Roche), Berry Genomics, EvolveGene, LifeCodexx (a subsidiary of GATC Biotech), NIPD Genetics, NxGen MDx, Premaitha Health and Verinata Health (acquired by Illumina®).
  4. Prominent academic institutions and universities involved in the field of NIPT include (in alphabetical order) the Birmingham Women’s Hospital, Cyprus Institute of Neurology and Genetics, Murdoch Children’s Research Institute, National University of Singapore, Stanford University, Swiss Institute for Bioinformatics, The Chinese University ofHong Kong and University of Antwerp.
  5. We also came across 38 advanced newborn screening tests available for the detection ofa large number of disorders / deficiencies including metabolic disorders, endocrine disorders, hemoglobin disorders, congenital heart disorders and hearing disorders. Of the total advanced newborn screening tests, 66% of the tests use blood as the testing sample (categorized as basic screening tests). This is followed by advanced screening tests and comprehensive screening tests capturing a share of 16% and 10%, respectively. Nearly 8% of the newborn screening tests utilize urine as the sample and are categorized as expanded newborn screening tests.
  6. Over 135 collaborations have been inked in the field of NIPT between 2011 and 2017. Although a significant proportion of these agreements focus on distribution / marketing of NIPTs to expand their access and coverage in different geographies (54%), we came across a number of product development / commercialization agreements (15%), merger / acquisition agreements (9%) and product / technology licensing agreements (8%). Several companies have entered into multiple collaborations; these include SequenomTM (24 agreements), Natera® (20 agreements), Premaitha Health (19 agreements), BGI (18 agreements), Ariosa Diagnostics (14 agreements) and Illumina® (13 agreements).
  7. The NIPT market, primarily driven by increasing awareness and adoption of NIPTs, is anticipated to grow at an annualized rate of 15% between 2017 and 2027. The current market is dominated by the tests offered to expectant women belonging to high risk category, capturing 52% market share. However, by 2027, the average risk market is likely to be amongst the key drivers; we expect its share to grow from 37% in 2017 to 45% by 2027.
  8. Amongst specific indications screened under NIPT test panels, chromosomal abnormalities (primarily including trisomy 21 (Down syndrome), trisomy 18 (Edward syndrome), trisomy 13 (Patau syndrome))are likely to capture the largest share of the market in both 2017 (44%) and 2027 (56%). This is followed by sex chromosomal abnormalities, capturing a share of 24% in 2017 and 28% in 2027. These include Turner syndrome, Klinefelter syndrome, Triple X syndrome and Jacob syndrome. Microdeletion syndromes, primarily including Cri-du-chat syndrome, DiGeorge syndrome, Prader-Willi syndrome, monosomy 1p36 and Wolf-Hirschhorn syndrome, are likely to account for a share of 22% in 2017 and 14% in 2027.
  9. With regard to the geographical activity, in 2017, the North America is likely to capture the maximum share (37%) followed by Europe (35%) and Asia (24%). Over the coming decade, Asian regions are likely to drive the growth resulting in a share of 29% in 2027. It is important to highlight that, within Asia, countries such as China, India, Japan, have several developers and distributors of NIPT tests, demonstrating an increasing interest in these regions.

 

Research Methodology

The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct extensive secondary research as well as interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market may evolve across different regions and sub-segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:

  • Annual reports
  • Investor presentations
  • SEC filings
  • Industry databases
  • News releases from company websites
  • Government policy documents
  • Industry analysts’ views

 

While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various sources of information.

 

Chapter Outlines

Chapter 2 provides an executive summary of the insights captured in our research. It offers a high level view on the current state of the NIPT and the newborn screening market and its likely evolution over the next decade.

 

Chapter 3 provides a general introduction of various types of chromosomal abnormalities and genetic disorders occurring in fetuses and newborns with information on their statistics, and the different types of genetic tests available for their detection. It outlines the concept of invasive and non-invasive prenatal testing. In addition, the chapter offers a discussion on the historical evolution of newborn screening.

 

Chapter 4 provides a holistic view of the NIPT and newborn screening market. It provides a comprehensive list of NIPT and newborn screening tests. The chapter includes a detailed analysis of the NIPTs based on the development stage, technology platforms, type of indications tested, stage of pregnancy and result turnaround time. In addition, it includes a detailed analysis of the newborn screening tests based on the screening type, technology platform, type of indication, period of sample collection after birth and result turnaround time. The chapter also lists the basic prenatal testing and newborn screening tests, devices, systems and technology platforms.

 

Chapter 5 is a compilation of key insights gained from this study. It includes a geographical coverage analysis that highlights the availability of each NIPT test in different regions across the globe, and a heat map representing the relative clinical performance of the commercially available NIPTs on the basis of sensitivity, specificity, result turnaround time and the stage of pregnancy when the test can be performed. In addition, it presents a Harvey ball analysis depicting the test panel strength on the basis of number of indications screened, and a world map to represent the geographical presence and the activity of companies involved in the field of NIPT. The chapter also includes a grid representation of the newborn screening tests, highlighting the distribution of these tests on the basis of screening type (basic newborn screening, expanded newborn screening, comprehensive newborn screening and advanced newborn screening) and the technology platforms used to design them. Additionally, it features a developer landscape of the companies involved in the field of newborn screening, distributed on the basis of the company size and geographical presence.

 

Chapter 6 offers a comprehensive discussion on NIPT tests, highlighting advantages and challenges associated with the development and use of these tests. The chapter features detailed company profiles of the leading players that are involved in the development of NIPT tests. Each profile includes a brief overview of the company, its financial information, funding details, product portfolio and an informed future outlook. It also includes detailed profiles of the products of these key players. Each product profile provides information on the development history, specifications, technology platform, procedure, advantages and clinical information of different products offered by the company. In addition, the chapter includes a development timeline marking the launch of the popular NIPT tests between 2011 and 2016. It also provides a commercial landscape of the most popular NIPTs on the basis of different characteristics of these tests.

 

Chapter 7 offers a comprehensive discussion on newborn screening. It talks about different types of next-generation newborn screening procedures. We have provided company profiles and product profiles of the key players engaged in the development of newborn screening tests. In addition, it includes brief profiles of other players involved in this field. The section also includes an elaborate discussion on the current spread of newborn screening programs established in various countries across the globe to provide proper medical care to newborns.

 

Chapter 8 provides details on the other diagnostic tests / services available for genetic testing in newborns and fetuses; these include carrier testing / preconception care, preimplantation genetic testing (PGT) (preimplantation genetic diagnosis / screening (PGD / PGS)), genetic counselling and direct to consumer (DTC) genetic testing services. We have provided a brief overview of these tests / services, highlighting their general procedure / workflow, indications being evaluated and their indicative development pipeline.

 

Chapter 9 features an elaborate discussion on the collaborations and partnerships that have been inked amongst players in both NIPT and newborn screening markets. We have also discussed the various partnership models that have been implemented, highlighting the most common forms of deals / agreements in this domain.

 

Chapter 10 highlights the market forecast and sizing of the overall NIPT and newborn screening markets. This chapter discusses, in detail, the parameters that are likely to influence the evolution of these markets. It features detailed insights on the likely evolution of the NIPT market for different patient risk group segments (high risk, average risk and low risk). The chapter highlights the likely distribution of the market across North America (US, Canada and Mexico), Europe (France, Germany, Italy, Spain, the UK and rest of Europe), Asia (Japan, China and India) and rest of the world. It also presents a detailed market segmentation by the key indications, stage of pregnancy when the tests can be performed and share of individual NIPT tests. In addition, the chapter offers a high-level view on the upcoming newborn screening market across the globe.

 

Chapter 11 summarizes the overall report and provides a recap of the key takeaways from the study. It also presents our independent opinion on the future of both NIPT and newborn screening market based on the research and analysis described in the previous chapters.

 

Chapter 12 is a collection of interview transcripts of the discussions held with key stakeholders in these fields.We have presented the insights provided to us by Jim Patterson (Vice President, Sales and Marketing North America, EvolveGene®),Osama Fikry (Metabolic and Diagnostic Head, NewBridge Pharmaceuticals) and Silke Arndt (Medical Scientist and NGS Manager, Inqaba Biotec).

 

Chapter 13 illustrates a detailed analysis on the survey conducted for gaining a deeper understanding on the nature of products and services offered by the companies involved in NIPT and / or newborn screening fields.

 

Chapter 14 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

 

Chapter 15 is an appendix, which provides the list of companies and organizations mentioned in the report.

 

 

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
 
2. EXECUTIVE SUMMARY
 
3. INTRODUCTION
3.1. Chapter Overview
3.2. Importance of Disease Detection: Screening Versus Diagnosis
3.3. Genetic Abnormalities: An Introduction
3.3.1. Classification of Genetic Disorders
3.3.1.1. Chromosomal Abnormalities
3.3.1.2. Single Gene Disorders
3.3.1.3. Teratogenic Problems
3.3.1.4. Complex / Multifactorial Problems
3.3.2. Statistics and Epidemiology of Genetic Disorders
3.3.3. Common Genetic Disorders: Causes and Symptoms
3.4. Genetic Tests: Importance in Prenatal and Neonatal Care
3.5. Prenatal Genetic Testing: A Detailed Overview
3.5.1. Conventional Methods of Prenatal Testing
3.5.1.1. Maternal Serum Screening
3.5.1.2. Ultrasonography
3.5.1.3. Invasive Confirmatory Tests
3.5.1.3.1. Amniocentesis
3.5.1.3.2. Chorionic Villus Sampling (CVS)
3.5.1.4. Fetal Cells in Maternal Blood (FCMB)
3.5.2. Non-Invasive Prenatal Testing (NIPT)
3.6. The Concept of Newborn Screening
3.6.1. Evolution of Newborn Screening
3.7. Ethical Issues Related to Prenatal Testing and Newborn Screening
 
4. NIPT AND NEWBORN SCREENING: MARKET LANDSCAPE
4.1. Chapter Overview
4.2. NIPT: Development Landscape
4.2.1. NIPT: Distribution by Stage of Development
4.2.2. NIPT: Distribution by Technology Platforms
4.2.3. NIPT: Distribution by Type of Indication
4.2.4. NIPT: Distribution by Stage of Pregnancy
4.2.5. NIPT: Distribution by Result Turnaround Time
4.3. NIPT: Technology Platforms
4.4. Prenatal Testing: Other Initiatives
4.5. Newborn Screening: Development Landscape
4.5.1. Newborn Screening: Distribution by Screening Type
4.5.2. Newborn Screening: Distribution by Technology Platforms
4.5.3. Newborn Screening: Distribution by Type of Indication
4.5.4. Newborn Screening: Distribution by Period of Sample Collection After Birth
4.5.5. Newborn Screening: Distribution by Result Turnaround Time
4.6. Newborn Screening: Other Initiatives
 
5. NIPT AND NEWBORN SCREENING: KEY INSIGHTS
5.1. Chapter Overview
5.2. NIPTs: Distribution by Geographical Coverage
5.3. Commercialized NIPTs: A Competitive Heat Map Analysis for Clinical Efficiency
5.4. NIPTs: Harvey Ball Analysis for Test Panel Strength
5.5. NIPTs: Geographical Distribution of Industry Players
5.6. Newborn Screening Grid Analysis: Distribution by Screening Type and Technology Platforms
5.7. Newborn Screening Developer Landscape: Distribution by Company Size and Geography
 
6. PRENATAL TESTING: FOCUS ON NIPT
6.1. Chapter Overview
6.2. Emergence of NIPT
6.3. NIPT Key Players: Company Profiles
6.3.1. Ariosa Diagnostics (Acquired by Roche)
6.3.1.1. Company Introduction
6.3.1.2. Financial Information
6.3.1.3. Product Portfolio
6.3.1.3.1. Harmony® Test
6.3.1.3.1.1. Product Overview and Development History
6.3.1.3.1.2. Product Specifications
6.3.1.3.1.3. Technology Overview
6.3.1.3.1.4. Procedure and Interpretation of Results
6.3.1.3.1.5. Advantages
6.3.1.3.1.6. Clinical Information
6.3.1.4. Future Outlook
6.3.2. BGI
6.3.2.1. Company Introduction
6.3.2.2. Financial Information
6.3.2.3. Product Portfolio
6.3.2.3.1. NIFTY® Test
6.3.2.3.1.1. Product Overview and Development History
6.3.2.3.1.2. Product Specifications
6.3.2.3.1.3. Technology Overview
6.3.2.3.1.4. Procedure and Interpretation of Results
6.3.2.3.1.5. Advantages
6.3.2.3.1.6. Clinical Information
6.3.2.4. Future Outlook
6.3.3. Natera®
6.3.3.1. Company Introduction
6.3.3.2. Financial Information
6.3.3.3. Product Portfolio
6.3.3.3.1. Panorama® Test
6.3.3.3.1.1. Product Overview and Development History
6.3.3.3.1.2. Product Specifications
6.3.3.3.1.3. Technology Overview
6.3.3.3.1.4. Procedure and Interpretation of Results
6.3.3.3.1.5. Advantages
6.3.3.3.1.6. Clinical Information
6.3.3.4. Future Outlook
6.3.4. SequenomTM (Acquired by LabCorp®)
6.3.4.1. Company Introduction
6.3.4.2. Financial Information
6.3.4.3. Product Portfolio
6.3.4.3.1. MaterniT® GENOME
6.3.4.3.1.1. Product Overview and Development History
6.3.4.3.1.2. Product Specifications
6.3.4.3.1.3. Procedure and Interpretation of Results
6.3.4.3.1.4. Advantages
6.3.4.3.1.5. Clinical Information
6.3.4.3.2. VisibiliTTM Test
6.3.4.3.2.1. Product Overview and Development History
6.3.4.3.2.2. Product Specifications
6.3.4.3.2.3. Procedure and Interpretation of Results
6.3.4.3.2.4. Advantages
6.3.4.3.2.5. Clinical Information
6.3.4.3.3. MaterniT21® PLUS Test
6.3.4.3.3.1. Product Overview and Development History
6.3.4.3.3.2. Product Specifications
6.3.4.3.3.3. Technology Overview
6.3.4.3.3.4. Procedure and Interpretation of Results
6.3.4.3.3.5. Advantages
6.3.4.3.3.6. Clinical Information
6.3.4.3.4. SensiGene® RhD Test
6.3.4.3.4.1. Product Overview and Development History
6.3.4.3.4.2. Product Specifications
6.3.4.3.4.3. Technology Overview
6.3.4.3.4.4. Procedure and Interpretation of Results
6.3.4.3.4.5. Advantages
6.3.4.3.4.6. Clinical Information
6.3.4.3.5. NextViewTM Array Diagnostic Test Platform
6.3.4.3.5.1. Product Overview and Development History
6.3.4.3.5.2. Product Specifications
6.3.4.4. Future Outlook
6.3.5. Verinata Health (Acquired by Illumina®)
6.3.5.1. Company Introduction
6.3.5.2. Financial Information
6.3.5.3. Product Portfolio
6.3.5.3.1. Verifi® Prenatal Test / InformaSeqSM
6.3.5.3.1.1. Product Overview and Development History
6.3.5.3.1.2. Product Specifications
6.3.5.3.1.3. Technology Overview
6.3.5.3.1.4. Procedure and Interpretation of Results
6.3.5.3.1.5. Advantages
6.3.5.3.1.6. Clinical Information
6.3.5.4. Future Outlook
6.4. Popular NIPTs: A Detailed Comparison 
6.5. NIPT: Regulatory Landscape
6.6. NIPT: Future Outlook
 
7. NEWBORN SCREENING: DETAILED OUTLOOK
7.1. Chapter Overview
7.2. Newborn Screening: Introduction and Classification
7.2.1. Classification of Newborn Screening Tests: By Sample Type
7.2.2. Classification of Newborn Screening Tests: By Period of Sample Collection After Birth
7.2.3. Classification of Newborn Screening: By Patient Risk Group
7.3. Technological Advances in Newborn Screening
7.4. Newborn Screening Key Players: Company Profiles
7.4.1. BGI
7.4.1.1. Company Introduction
7.4.1.2. Financial Information
7.4.1.3. Product Portfolio
7.4.1.3.1. NOVATM Newborn Genetic Test
7.4.1.3.1.1. Product Overview
7.4.1.3.1.2. Product Specifications and Test Methodology
7.4.1.3.2. NOVATM Metabolic Disease Screening
7.4.1.3.2.1. Product Overview
7.4.1.3.2.2. Product Specifications and Test Methodology
7.4.1.4. Future Outlook
7.4.2. Cordlife Group
7.4.2.1. Company Introduction
7.4.2.2. Financial Information
7.4.2.3. Product Portfolio
7.4.2.3.1. MetaScreenTM
7.4.2.3.1.1. Product Overview
7.4.2.3.1.2. Product Specifications and Test Methodology
7.4.2.4. Future Outlook
7.4.3. Genomi-k
7.4.3.1. Company Introduction
7.4.3.2. Product Portfolio
7.4.3.2.1. Audi-k® Service
7.4.3.2.1.1. Product Overview
7.4.3.2.1.2. Product Specifications and Test Methodology
7.4.3.2.2. Cardi-k® Service
7.4.3.2.2.1. Product Overview
7.4.3.2.2.2. Product Specifications and Test Methodology
7.4.3.2.3. Tami-k® Service
7.4.3.2.3.1. Product Overview
7.4.3.2.3.2. Product Specifications and Test Methodology
7.4.4. Genetadi Biotech
7.4.4.1. Company Introduction
7.4.4.2. Product Portfolio
7.4.4.2.1. Neonatal-One Plus
7.4.4.2.1.1. Product Overview
7.4.4.2.1.2. Product Specifications and Test Methodology
7.4.4.3. Future Outlook
7.4.5. NextlineTM Diagnostics
7.4.5.1. Company Introduction
7.4.5.2. Product Portfolio
7.4.5.2.1. BIRTHRIGHT
7.4.5.2.1.1. Product Overview
7.4.5.2.1.2. Product Specifications and Test Methodology
7.4.5.3. Future Outlook
7.4.6. Parabase Genomics
7.4.6.1. Company Introduction
7.4.6.2. Financial Information
7.4.6.3. Product Portfolio
7.4.6.3.1. NewbornDxTM Test
7.4.6.3.1.1. Product Overview
7.4.6.3.1.2. Product Specifications and Test Methodology
7.4.6.3.2. NewbornDxTM HL
7.4.6.3.2.1. Product Overview
7.4.6.3.2.2. Product Specifications and Test Methodology
7.4.6.4. Future Outlook
7.4.7. PerkinElmer® Genetics
7.4.7.1. Company Introduction
7.4.7.2. Financial Information
7.4.7.3. Product Portfolio
7.4.7.3.1. StepOne® Newborn Screening Panel
7.4.7.3.1.1. Product Overview
7.4.7.3.1.2. Product Specifications and Test Methodology
7.4.7.4. Future Outlook
7.4.8. SouthGenetics
7.4.8.1. Company Introduction
7.4.8.2. Product Portfolio
7.4.8.2.1. BabyGenesTM
7.4.8.2.1.1. Product Overview
7.4.8.2.1.2. Product Specifications and Test Methodology
7.4.8.3. Future Outlook
7.4.9. Other Prominent Players
7.4.9.1. AB SCIEX
7.4.9.2. Aegis Sciences
7.4.9.3. ARCHIMEDlife
7.4.9.4. Baby Genes
7.4.9.5. CENTOGENE
7.4.9.6. EGL Genetic Diagnostics
7.4.9.7. GeneTech
7.4.9.8. iLife Discoveries
7.4.9.9. Macrogen
7.4.9.10. MapmygenomeTM
7.4.9.11. Navigene Genetic Science
7.4.9.12. NeoGen Labs
7.4.9.13. Next Biosciences
7.4.9.14. NIMGenetics
7.4.9.15. Pediatrix Medical Group
7.4.9.16. PreventiNe Life Care
7.4.9.17. Synapse Diagnostics
7.4.9.18. Trivitron Healthcare
7.5. Newborn Screening Programs: Government Initiatives
7.5.1. Asia Pacific
7.5.2. Europe
7.5.3. Latin America
7.5.4. Middle East and North Africa (MENA)
7.5.5. North America
7.6. Newborn Screening: Future Outlook
 
8. OTHER ASSOCIATED TESTS AND SERVICES
8.1. Chapter Overview
8.2. Carrier Testing / Preconception Care
8.2.1. Carrier Testing / Preconception Care: An Overview
8.2.2. Carrier Testing / Preconception Care: Commercialized Tests
8.3. Preimplantation Genetic Diagnosis / Screening (PGD / PGS)
8.3.1. PGD / PGS: An Overview
8.3.2. PGD / PGS: Commercialized Tests
8.4. Genetic Counseling and Direct to Customer (DTC) Genetic Testing Services
 
9. RECENT COLLABORATIONS
9.1. Chapter Overview
9.2. Partnership Models
9.3. NIPT: Recent Collaborations
9.3.1. Recent Collaborations: Distribution by Year
9.3.2. Recent Collaborations: Distribution by Type of Model
9.3.3. Recent Collaborations: Most Active Companies
9.4. Newborn Screening: Recent Collaborations
9.4.1. Recent Collaborations: Distribution by Year
9.4.2. Recent Collaborations: Distribution by Type of Model
9.4.3. Recent Collaborations: Most Active Companies
 
10. NIPT AND NEWBORN SCREENING: MARKET SIZING AND FORECAST
10.1. Chapter Overview
10.2. NIPT: Scope and Forecast Methodology
10.3. NIPT: Forecast Assumptions
10.3.1. Patient Population
10.3.2. Price of Test
10.3.3. Adoption / Penetration Rate
10.4. NIPT: Forecast Projections, 2017-2027
10.4.1. NIPT Market, 2017-2027
10.4.2. NIPT Market: Distribution by Patient Risk Group
10.4.3. NIPT Market: Distribution by Geography
10.4.3.1. NIPT Market in North America
10.4.3.2. NIPT Market in Europe
10.4.3.3. NIPT Market in Asia
10.4.3.4. NIPT Market in Rest of the World
10.4.4. NIPT Market: Distribution by Indication
10.4.5. NIPT Market: Distribution by Stage of Pregnancy
10.4.6. NIPT Market: Distribution by Share of Individual NIPTs
10.5. Newborn Screening: Opportunity Analysis
 
11. CONCLUSION
11.1. Prenatal Testing and Newborn Screening Have Emerged as Popular Diagnostic Tools for Identification of Genetic Abnormalities in Fetuses and Newborns
11.2. Continuous Innovation has Led to the Development of NIPTs and Advanced Newborn Screening Tests
11.3. These Novel Screening Methods Cater to a Wide Spectrum of Disease Indications
11.4. The Interest has Steadily Risen with the Presence of Multiple Start-ups Across Different Geographies
11.5. The Growing Number of Partnerships are Indicative of a Lucrative Future Potential
11.6. Despite the Ethical Challenges in Developing Countries, the NIPT Market is  Likely to Prosper Significantly in the Long Term
11.7. While the Newborn Screening Market is Still Evolving with Advanced Techniques, the NIPT Diagnostic Market is Already Witnessing an Accelerated Growth
 
12. INTERVIEW TRANSCRIPTS
12.1. Chapter Overview
12.2. Jim Patterson, Vice President, Sales and Marketing North America, EvolveGene®
12.3. Osama Fikry, Metabolic and Diagnostic Head, NewBridge Pharmaceuticals
12.4. Silke Arndt, Medical Scientist and NGS Manager, Inqaba Biotec
 
13. SURVEY ANALYSIS
13.1. Chapter Overview
13.2. Seniority Level of Respondents
13.3. Focus Area of the Company
13.4. Type of Lead Product(s)
13.5. Purpose of Lead Product(s)
13.6. Commercial Availability of Lead Product(s)
13.7. Likely Market Size
 
14. APPENDIX 1: TABULATED DATA
 
15. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
 
 
 

 

Figure 3.1 Genetic Disorders: Categories
 
Figure 3.2 Chromosomal Abnormalities: Numerical and Structural Disorders
 
Figure 3.3 Genetic Disorders in Fetuses
 
Figure 3.4 Genetic Disorders in Newborns
 
Figure 3.5 Chromosomal Abnormalities: Distribution by Type
 
Figure 3.6 Common Causes of Deaths in Newborns
 
Figure 3.7 Genetic Tests in Prenatal and Neonatal Care
 
Figure 3.8 Genetic Testing: Benefits and Drawbacks
 
Figure 3.9 Reasons for Prenatal Testing
 
Figure 3.10 Evolution of Prenatal Testing
 
Figure 3.11 Conventional Prenatal Tests in Different Stages of Pregnancy
 
Figure 3.12 Maternal Serum Screening Tests: Available Options
 
Figure 3.13 Reasons to Perform Ultrasound at Various Stages in Pregnancy
 
Figure 3.14 Amniocentesis: General Procedure
 
Figure 3.15 Newborn Screening: Components
 
Figure 3.16 Newborn Screening: Key Milestones
 
Figure 4.1 NIPT: Distribution by Stage of Development
 
Figure 4.2 NIPT: Distribution by Technology Platforms
 
Figure 4.3 NIPT: Distribution by Type of Indication
 
Figure 4.4 NIPT: Distribution by Chromosomal Abnormalities
 
Figure 4.5 NIPT: Distribution by Sex Chromosomal Abnormalities
 
Figure 4.6 NIPT: Distribution by Microdeletion Syndromes
 
Figure 4.7 NIPT: Distribution by Stage of Pregnancy
 
Figure 4.8 NIPT: Distribution by Result Turnaround Time
 
Figure 4.9 Newborn Screening: Distribution by Screening Type
 
Figure 4.10 Newborn Screening: Distribution by Technology Platforms
 
Figure 4.11 Newborn Screening: Distribution by Type of Indication
 
Figure 4.12 Newborn Screening: Distribution by Period of Sample Collection After Birth
 
Figure 4.13 Newborn Screening: Distribution by Result Turnaround Time
 
Figure 5.1 NIPTs: Categorization by Heat Map Analysis
 
Figure 5.2 NIPTs: Geographical Distribution of Industry Players
 
Figure 5.3 Newborn Screening Grid Analysis: Distribution by Screening Type and Technology Platforms
 
Figure 5.4 Newborn Screening Developer Landscape: Distribution by Company Size and Geography
 
Figure 6.1 NIPTs: Key Objectives
 
Figure 6.2 NIPT Tests: Launch Timeline
 
Figure 6.3 Harmony® Test: Steps of Operation
 
Figure 6.4 BGI: Product Portfolio
 
Figure 6.5 NIFTY® Test: Key Milestones
 
Figure 6.6 NIFTY® Test: Eligible Patient Population
 
Figure 6.7 NIFTY® Test: Steps of Operation
 
Figure 6.8 Natera®: Annual Revenues, 2013-Q1 2017 (USD Million)
 
Figure 6.9 Natera®: Product Portfolio
 
Figure 6.10 Panorama® Test: Eligible Patient Population
 
Figure 6.11 Panorama® Test: Steps of Operation
 
Figure 6.12 SequenomTM: Evolution of the NIPT Portfolio
 
Figure 6.13 SequenomTM: Annual Revenues, 2011-Q1 2016 (USD Million)
 
Figure 6.14 SequenomTM: Product Portfolio
 
Figure 6.15 Verifi® Prenatal Test: Eligible Patient Population
 
Figure 6.16 Verifi® Prenatal Test: Steps of Operation
 
Figure 7.1 Newborn Screening: Modes of Operation
 
Figure 7.2 NOVATM Newborn Genetic Test: Eligible Patient Population
 
Figure 7.3 NOVATM Newborn Genetic Test: Steps of Operation
 
Figure 7.4 Cordlife Group: Annual Revenues, 2012-2016 (USD Million)
 
Figure 7.5 Cordlife Group: Product Portfolio
 
Figure 7.6 Genomi-k: Product Portfolio
 
Figure 7.7 PerkinElmer®: Annual Revenues, 2012-Q1 2017 (USD Million)
 
Figure 7.8 Newborn Screening Programs: Current Geographical Spread
 
Figure 8.1 Carrier Testing: General Procedure
 
Figure 8.2 Carrier Testing: Recessive Disorders Inheritance
 
Figure 8.3 Carrier Testing: Clinical Benefits
 
Figure 8.4 Types of Predictive Testing
 
Figure 8.5 PGD: General Procedure
 
Figure 8.6 PGD: Most Common Types of Genetic Disorders
 
Figure 8.7 Purpose of Opting for Genetic Counseling
 
Figure 8.8 Reasons for Opting for Genetic Counseling
 
Figure 8.9 Essential Components of Genetic Counseling
 
Figure 8.10 Types of Genetic Counseling Services
 
Figure 9.1 Recent Collaborations in NIPT: Distribution by Year
 
Figure 9.2 Recent Collaborations in NIPT: Distribution by Type of Model
 
Figure 9.3 Recent Collaborations in NIPT: Most Active Players
 
Figure 9.4 Recent Collaborations in Newborn Screening: Distribution by Year
 
Figure 9.5 Recent Collaborations in Newborn Screening: Distribution by Type of Model
 
Figure 9.6 Recent Collaborations in Newborn Screening: Most Active Players
 
Figure 10.1 NIPT Market (2017-2027): Base Scenario (USD Billion)
 
Figure 10.2 NIPT Market (2017-2027): Distribution by Patient Risk Group, Base Scenario (USD Billion)
 
Figure 10.3 NIPT Market: Share by Patient Risk Groups, 2017, 2027 (USD Billion, %)
 
Figure 10.4 NIPT Market (2017-2027): Distribution by Geography, Base Scenario (USD Billion)
 
Figure 10.5 NIPT Market (2017-2027): Distribution by Geography, Base Scenario (Test Volume, Million)
 
Figure 10.6 NIPT Market: Share by Geography, 2017, 2027 (%)
 
Figure 10.7 NIPT Market in North America (2017-2027): Base Scenario (USD Billion)
 
Figure 10.8 NIPT Market in North America (2017-2027): Base Scenario (Test Volume, Million)
 
Figure 10.9 NIPT Market in Europe (2017-2027): Base Scenario (USD Billion)
 
Figure 10.10 NIPT Market in Europe (2017-2027): Base Scenario (Test Volume, Million)
 
Figure 10.11 NIPT Market in Asia (2017-2027): Base Scenario (USD Billion)
 
Figure 10.12 NIPT Market in Asia (2017-2027): Base Scenario (Test Volume, Million)
 
Figure 10.13 NIPT Market in Rest of the World (2017-2027): Base Scenario (USD Billion)
 
Figure 10.14 NIPT Market in Rest of the World (2017-2027): Base Scenario (Test Volume, Million)
 
Figure 10.15 NIPT Market: Share by Indication, 2017, 2027 (%)
 
Figure 10.16 NIPT Market: Share by Stage of Pregnancy, 2027 (%)
 
Figure 10.17 NIPT Market: Share by Individual NIPTs, 2017 (%)
 
Figure 11.1 Overall NIPT Market (USD Billion), 2017, 2022 and 2027
 
Figure 13.1 Survey Analysis: Distribution by Type of Company
 
Figure 13.2 Survey Analysis: Distribution by Location of Respondents
 
Figure 13.3 Survey Analysis: Distribution by Seniority Level of Respondents
 
Figure 13.4 Survey Analysis: Distribution by Focus Area of the Company
 
Figure 13.5 Survey Analysis: Distribution by Type of Lead Products(s)
 
Figure 13.6 Survey Analysis: Distribution by Purpose of Lead Product(s)
 
Figure 13.7 Survey Analysis: Distribution by Commercial Availability of Lead Product(s)
 
Figure 13.8 Survey Analysis: Distribution by Likely Market Size of Prenatal Testing
 
Figure 13.9 Survey Analysis: Distribution by Likely Market Size of Newborn Screening
 

 

Table 3.1 Differences Between Screening and Diagnostic Tests
 
Table 3.2 Common Disorders: Annual Cost of Treatment
 
Table 3.3 Common Genetic Disorders: Causes and Symptoms
 
Table 3.4 Prenatal Testing: Invasive and Non-Invasive Methods
 
Table 3.5 Test Combinations in Triple and Quadruple Screen
 
Table 3.6 Triple Screen Assay: Abnormal Levels of Markers in Different Disorders
 
Table 3.7 Prenatal Screening Tests: Risk Assessment Strategies
 
Table 4.1 NIPTs: Development Landscape
 
Table 4.2 NIPT: Comparison of Sequencing based Technology Platforms
 
Table 4.3 NIPT: Technology Platforms
 
Table 4.4 Prenatal Testing: Other Initiatives 
 
Table 4.5 Newborn Screening Tests: Development Landscape
 
Table 4.6 Newborn Screening: Other Initiatives
 
Table 5.1 NIPTs: Distribution by Geographical Coverage
 
Table 5.2 Heat Map Analysis: Scoring Criteria
 
Table 5.3 Commercialized NIPTs: A Competitive Heat Map Analysis
 
Table 5.4 Harvey Ball Analysis: Evaluation Criteria
 
Table 5.5 NIPT Harvey Ball Analysis: Distribution by Indications Screened Under Test Panel
 
Table 6.1 Ariosa Diagnostics: List of Funding Instances and Investors
 
Table 6.2 Harmony® Test: Launch Details for Different Geographies
 
Table 6.3 Harmony® Test: Published Studies
 
Table 6.4 Harmony® and Traditional Screening Methods: Comparison of Clinical Performance
 
Table 6.5 Harmony® Test: Comparison of Clinical Performance for Tested Indications
 
Table 6.6 Harmony® Test: Comparison of PPV in Different Patient Cohorts
 
Table 6.7 BGI: List of Funding Instances and Investors
 
Table 6.8 NIFTY® Test: Launch Details for Different Geographies
 
Table 6.9 Common NIPT Tests: Comparative Performance Evaluation
 
Table 6.10 NIFTY® and Traditional Screening Methods: Comparison of Clinical Performance
 
Table 6.11 NIFTY® Test: Published Studies
 
Table 6.12 NIFTY® Test: Comparison of Test Performance for the Tested Indications
 
Table 6.13 Natera®: List of Funding Instances and Investors
 
Table 6.14 Natera®: Summary of Marketed Products
 
Table 6.15 Panorama® Test: Launch Details for Different Geographies
 
Table 6.16 Panorama® Test: Available Options and Cost Details
 
Table 6.17 Panorama® Test: Comparison of PPV in Different Patient Cohorts
 
Table 6.18 Panorama® and Traditional Screening Methods: Comparison of Clinical Performance
 
Table 6.19 Panorama® Test: Comparison of Clinical Performance for Tested Indications
 
Table 6.20 Panorama® Test: Ongoing Clinical Trials
 
Table 6.21 SequenomTM NIPTs: Launch Details for Different Geographies
 
Table 6.22 SequenomTM: List of Funding Instances and Investors
 
Table 6.23 SequenomTM: Product Details
 
Table 6.24 MaterniT® GENOME Test: Comparison with Fetal Karyotype Test
 
Table 6.25 MaterniT® GENOME Test: Comparison of Clinical Performance for Tested Indications
 
Table 6.26 MaterniT® GENOME Test: Reasons for Increase in Clinical Uptake
 
Table 6.27 VisibiliTTM Test: Comparison of Clinical Performance for Tested Indications
 
Table 6.28 MaterniT21® PLUS Test: Published Studies
 
Table 6.29 NextViewTM Array Diagnostic Test Platform: Panel Options
 
Table 6.30 Illumina®: Regional Laboratory Partners for Verifi® Prenatal Test
 
Table 6.31 Verinata Health: List of Funding Instances and Investors
 
Table 6.32 Verifi® Prenatal Test: Launch Details for Different Geographies
 
Table 6.33 Verifi® Prenatal Test: Comparison of Clinical Performance for Tested Indications
 
Table 6.34 Popular NIPTs: A Detailed Comparision
 
Table 7.1 Traditional and Next-Generation Newborn Screening: Comparison
 
Table 7.2 Newborn Screening: List of Companies Profiled
 
Table 7.3 NOVATM Newborn Genetic Test: Clinical Performance Validation
 
Table 7.4 Cordlife Group: List of Funding Instances and Investors
 
Table 7.5 MetaScreenTM Testing Platforms: A Detailed Comparison
 
Table 7.6 MetaScreenTM: Available Options
 
Table 7.7 Parabase Genomics: List of Funding Instances and Investors
 
Table 7.8 PerkinElmer® Diagnostics Segment: Product Details
 
Table 7.9 PerkinElmer® Genetics: Available Products and Cost Details
 
Table 7.10 AB SCIEX: Company Profile
 
Table 7.11 Aegis Sciences: Company Profile
 
Table 7.12 ARCHIMEDlife: Company Profile
 
Table 7.13 Baby Genes: Company Profile
 
Table 7.14 CENTOGENE: Company Profile
 
Table 7.15 EGL Genetic Diagnostics: Company Profile
 
Table 7.16 GeneTech: Company Profile
 
Table 7.17 iLife Discoveries: Company Profile
 
Table 7.18 Macrogen: Company Profile
 
Table 7.19 MapmygenomeTM: Company Profile
 
Table 7.20 Navigene Genetic Science: Company Profile
 
Table 7.21 NeoGen Labs: Company Profile
 
Table 7.22 Next Biosciences: Company Profile
 
Table 7.23 NIMGenetics: Company Profile
 
Table 7.24 Pediatrix Medical Group: Company Profile
 
Table 7.25 PreventiNe Life Care: Company Profile
 
Table 7.26 Synapse Diagnostics: Company Profile
 
Table 7.27 Trivitron Healthcare: Company Profile
 
Table 7.28 Recommended Uniform Screening Panel (RUSP): Core and Secondary Disorders
 
Table 8.1 Carrier Testing: Most Prominent Disorders
 
Table 8.2 Carrier Testing / Preconception Care: Commercialized Tests
 
Table 8.3 PGD / PGS: Commercialized Tests
 
Table 9.1 NIPT: Recent Collaborations (2011-2017)
 
Table 9.2 Newborn Screening: Recent Collaborations (2011-2017)
 
Table 10.1 NIPT Forecast Assumptions: Patient Population
 
Table 10.2 NIPT Forecast Assumptions: Price Estimation
 
Table 10.3 NIPT Forecast Assumptions: Adoption Rates and Geographical Trends
 
Table 10.4  Newborn Screening: Opportunity Analysis, 2017-2027
 
Table 13.1 Survey Response: Overview of the Participating Companies
 
Table 13.2 Survey Response: Seniority Level of Respondents
 
Table 13.3 Survey Response: Focus Area of the Company
 
Table 13.4 Survey Response: Type of Lead Product(s)
 
Table 13.5 Survey Response: Purpose of Lead Product(s)
 
Table 13.6 Survey Response: Commercial Availability of Lead Product(s)
 
Table 13.7 Survey Response: Likely Market Size
 
Table 14.1 Chromosomal Abnormalities: Distribution by Type
 
Table 14.2 Common Causes of Deaths in Newborns
 
Table 14.3 NIPT: Distribution by Stage of Development
 
Table 14.4 NIPT: Distribution by Technology Platform
 
Table 14.5 NIPT: Distribution by Type of Indications
 
Table 14.6 NIPT: Distribution by Chromosomal Abnormalities
 
Table 14.7 NIPT: Distribution by Sex Chromosomal Abnormalities
 
Table 14.8 NIPT: Distribution by Microdeletion Syndromes
 
Table 14.9 NIPT: Distribution by Stage of Pregnancy
 
Table 14.10 NIPT: Distribution by Result Turnaround Time
 
Table 14.11 Newborn Screening: Distribution by Screening Type
 
Table 14.12 Newborn Screening: Distribution by Technology Platforms
 
Table 14.13 Newborn Screening: Distribution by Type of Indications
 
Table 14.14 Newborn Screening: Distribution by Screening Type on the Basis of Period of Sample Collection After Birth
 
Table 14.15 Newborn Screening: Distribution by Result Turnaround Time
 
Table 14.16 Natera®: Annual Revenues, 2013-Q1 2017 (USD Million)
 
Table 14.17 SequenomTM: Annual Revenues, 2011-Q1 2016 (USD Million)
 
Table 14.18 Cordlife Group: Annual Revenues, 2012-2016 (USD Million)
 
Table 14.19 PerkinElmer®: Annual Revenues, 2012-Q1 2017 (USD Million)
 
Table 14.20 Recent Collaborations in NIPT: Distribution by Year
 
Table 14.21 Recent Collaborations in NIPT: Distribution by Type of Model
 
Table 14.22 Recent Collaborations in NIPT: Most Active Players
 
Table 14.23 Recent Collaborations in Newborn Screening: Distribution by Year
 
Table 14.24 Recent Collaborations in Newborn Screening: Distribution by Type of Model
 
Table 14.25 Recent Collaborations in Newborn Screening: Most Active Players
 
Table 14.26 NIPT Market: Distribution by Patient Population into Risk Groups
 
Table 14.27 NIPT Market (2017-2027): Base Scenario (USD Billion)
 
Table 14.28 NIPT Market (2017-2027): Optimistic Scenario (USD Billion)
 
Table 14.29 NIPT Market (2017-2027): Conservative Scenario (USD Billion)
 
Table 14.30 NIPT Market (2017-2027): Distribution by Patient Risk Group, Base Scenario (USD Billion)
 
Table 14.31 NIPT Market (2017-2027): Distribution by Patient Risk Group, Optimistic Scenario (USD Billion)
 
Table 14.32 NIPT Market (2017-2027): Distribution by Patient Risk Group, Conservative Scenario (USD Billion)
 
Table 14.33 NIPT Market: Share by Patient Risk Group, 2017, 2027 (USD Billion, %)
 
Table 14.34 NIPT Market (2017-2027): Distribution by Geography, Base Scenario (USD Billion)
 
Table 14.35 NIPT Market (2017-2027): Distribution by Geography, Optimistic Scenario (USD Billion)
 
Table 14.36 NIPT Market (2017-2027): Distribution by Geography, Conservative Scenario (USD Billion)
 
Table 14.37 NIPT Market (2017-2027): Distribution by Geography, Base Scenario (Test Volume, Million)
 
Table 14.38 NIPT Market (2017-2027): Distribution by Geography, Optimistic Scenario (Test Volume, Million)
 
Table 14.39 NIPT Market (2017-2027): Distribution by Geography, Conservative Scenario (Test Volume, Million)
 
Table 14.40  NIPT Market: Share by Geography, 2017, 2027 (%)
 
Table 14.41  NIPT Market in North America (2017-2027): Base Scenario (USD Billion)
 
Table 14.42  NIPT Market in North America (2017-2027): Optimistic Scenario (USD Billion)
 
Table 14.43  NIPT Market in North America (2017-2027): Conservative Scenario (USD Billion)
 
Table 14.44  NIPT Market in North America (2017-2027): Base Scenario (Test Volume, Million)
 
Table 14.45  NIPT Market in North America (2017-2027): Optimistic Scenario (Test Volume, Million)
 
Table 14.46  NIPT Market in North America (2017-2027): Conservative Scenario (Test Volume, Million)
 
Table 14.47  NIPT Market in Europe (2017-2027): Base Scenario (USD Billion)
 
Table 14.48  NIPT Market in Europe (2017-2027): Optimistic Scenario (USD Billion)
 
Table 14.49  NIPT Market in Europe (2017-2027): Conservative Scenario (USD Billion)
 
Table 14.50  NIPT Market in Europe (2017-2027): Base Scenario (Test Volume, Million)
 
Table 14.51  NIPT Market in Europe (2017-2027): Optimistic Scenario (Test Volume, Million)
 
Table 14.52  NIPT Market in Europe (2017-2027): Conservative Scenario (Test Volume, Million)
 
Table 14.53  NIPT Market in Asia (2017-2027): Base Scenario (USD Billion)
 
Table 14.54  NIPT Market in Asia (2017-2027): Optimistic Scenario (USD Billion)
 
Table 14.55  NIPT Market in Asia (2017-2027): Conservative Scenario (USD Billion)
 
Table 14.56  NIPT Market in Asia (2017-2027): Base Scenario (Test Volume, Million)
 
Table 14.57  NIPT Market in Asia (2017-2027): Optimistic Scenario (Test Volume, Million)
 
Table 14.58  NIPT Market in Asia (2017-2027): Conservative Scenario (Test Volume, Million)
 
Table 14.59  NIPT Market in Rest of the World (2017-2027): Base Scenario (USD Billion)
 
Table 14.60  NIPT Market in Rest of the World (2017-2027): Optimistic Scenario (USD Billion)
 
Table 14.61  NIPT Market in Rest of the World (2017-2027): Conservative Scenario (USD Billion)
 
Table 14.62  NIPT Market in Rest of the World (2017-2027): Base Scenario (Test Volume, Million)
 
Table 14.63  NIPT Market in Rest of the World (2017-2027): Optimistic Scenario (Test Volume, Million)
 
Table 14.64  NIPT Market in Rest of the World (2017-2027): Conservative Scenario (Test Volume, Million)
 
Table 14.65 NIPT Market: Share by Indication, 2017, 2027 (%)
 
Table 14.66 NIPT Market: Share by Stage of Pregnancy, 2017 (%)
 
Table 14.67 NIPT Market: Share by Individual NIPTs, 2017 (%)
 
Table 14.68 Overall NIPT Market Summary (USD Billion): 2017, 2022 and 2027
 
Table 14.69 Survey Analysis: Distribution by Type of Company
 
Table 14.70 Survey Analysis: Distribution by Location of Respondents
 
Table 14.71 Survey Analysis: Distribution by Seniority Level of Respondents
 
Table 14.72 Survey Analysis: Distribution by Focus Area of the Company
 
Table 14.73 Survey Analysis: Distribution by Lead Product(s)
 
Table 14.74 Survey Analysis: Distribution by Purpose of Lead Product(s)
 
Table 14.75 Survey Analysis: Distribution by Commercial Availability of Lead Product(s)
 
Table 14.76 Survey Analysis: Distribution by Likely Market Size of Prenatal Testing
 
Table 14.77 Survey Analysis: Distribution by Likely Market Size of Newborn Screening
 
 
  1. 23andMe
  2. A*STAR’s Institute of Microelectronics (IME)
  3. AB SCIEX
  4. Abbott Molecular
  5. Abbott Pathology
  6. Academy of Finland
  7. Accela
  8. Acibadem Healthcare Group
  9. American College of Medical Genetics and Genomics (ACMG)
  10. American Congress of Obstetrics and Gynecology (ACOG)
  11. Adgenix
  12. Advance Medical
  13. Advanced Liquid Logic
  14. Aegis Sciences
  15. Aetna
  16. Affymetrix
  17. Agena Bioscience
  18. Agilent Technologies
  19. AL Borg Medical Laboratories
  20. Alafi Capital
  21. Alloy Ventures
  22. Alpert Medical School, Brown University
  23. Amarey Nova Medical Group
  24. Amedes
  25. American Association for Laboratory Accreditation (A2LA)
  26. American Association of Blood Banks (AABB)
  27. American Clinical Laboratory Association (ACLA)
  28. American Medical Association (AMA)
  29. American Hospital of Paris
  30. Ani Biotech
  31. Ani Labsystems
  32. Annoroad Gene Technology
  33. Anthem Blue Cross and Blue Shield
  34. Antisel
  35. APHL - Association of Public Health Laboratories
  36. Applied Spectral Imaging (ASI)
  37. Arabian Genetic Testing Company (AGTC)
  38. ARCEDI Biotech
  39. ARCHIMEDlife
  40. Ariosa Diagnostics
  41. ARUP Laboratories
  42. Asia Pacific Capital Management
  43. Asper Biotech
  44. Astoria-Pacific
  45. Atlas Genomics
  46. Australian Clinical Lab
  47. AutoGenomics
  48. Baby Genes
  49. Baebies
  50. Bangkok Cytogenetics Center
  51. Bangkok R.I.A LAB
  52. Basetra
  53. Baylor Genetics
  54. BEAZ
  55. Berry Genomics
  56. BGI
  57. BGI Agriculture
  58. BGI College
  59. BGI Diagnosis
  60. BGI Forensics
  61. BGI Genomics
  62. BGI Health
  63. BGI Manufacturing
  64. BGI Research
  65. BGI Tech
  66. Big Belli
  67. BioGen Medical
  68. Biomnis
  69. BioPoint
  70. Bio-Rad Laboratories
  71. BioReference Laboratories
  72. Bioscience Genomics
  73. Bioscience Institute
  74. Birmingham Women’s Hospital
  75. BlueGenome
  76. Bome Sanayi Ürünleri Dış Ticaret
  77. Brown University
  78. CairoGene
  79. California Department of Health
  80. CAPP Medical
  81. Catholic Health Initiatives (CHI)
  82. Cell Genetics
  83. CellScape
  84. Cenata
  85. Center for Human Genetics and Laboratory Diagnostics
  86. Center for Medical Genetics, Houston
  87. Center for Medical Genomics (CMG)
  88. Centers for Disease Control and Prevention (CDC)
  89. Centers for Medicare and Medicaid Services (CMS)
  90. CENTOGENE
  91. CENTOGENE ARABIA
  92. Centrum Badan DNA Group
  93. CGC Genetics
  94. Children’s Mercy Hospital, Kansas
  95. China National GeneBank
  96. China’s National Health and Family Planning Commission
  97. Chinese Food and Drug Administration
  98. Cigna
  99. Cinven
  100. Claremont Creek Ventures
  101. Clarity Medical Systems
  102. CML Healthcare Collection Centers
  103. CMS Computers
  104. Coalition for Access to Prenatal Screening (CAPS)
  105. College of American Pathologists (CAP)
  106. Color Genomics
  107. CombiMatrix
  108. Commission for Office Laboratory Accreditation
  109. Complete Genomics
  110. Cooper SurgicalTM
  111. CooperGenomics
  112. Cordlife Group
  113. Cordlife Sciences
  114. Council of Regional Networks for Genetic Services
  115. Counsyl
  116. Cypher Genomics
  117. Cyprus Institute of Neurology and Genetics
  118. Cytogenomic External Quality Assessment Service (CEQAS)
  119. DaAn Gene
  120. Danaher Corporation
  121. DASA Group
  122. Datar Genetics
  123. DBS Systems
  124. deCODEme genetics
  125. Department of Health and Human Services (HHS), US
  126. Devyser
  127. DiagCor
  128. Diputación de Bizkaia
  129. DNA Diagnostics Center (DDC)
  130. Domain Associates
  131. Dorevitch Pathology
  132. Douglass Hanly Moir Pathology
  133. Dr Lal PathLabs
  134. DrGene
  135. Eastern Biotech & Life Sciences
  136. Echevarne
  137. EGL Genetic Diagnostics
  138. ELAN Group
  139. ELIPS
  140. Elite PharmaLab Solutions
  141. Elucigene Diagnostics
  142. Emory Genetic Diagnostics
  143. Emory University's School of Medicine
  144. Empireo Molecular Diagnostic
  145. Eone Life Science Institute and Diagnomics
  146. EONE-DIAGNOMICS Genome Center (EDGC)
  147. ePlanet Ventures
  148. ESPERITE
  149. Eurofins Clinical Genetics India (ECGI)
  150. Eurofins Scientific
  151. European Diagnostics Services Group
  152. European Molecular Genetics Quality Network (EMQN)
  153. EvolveGene®
  154. Famina Healthcare
  155. FASTERIS
  156. Food and Drug Administration (FDA)
  157. Fetal Medicine Foundation
  158. Fidelity Growth
  159. Finnish Funding Agency for Innovations
  160. Flatiron Health
  161. Fleury Medicina e Saúde (Fleury Group)
  162. Florida Agency for Health Care and Administration
  163. Foundation for the Accreditation of Cellular Therapy (FACT)
  164. Foundation Medicine
  165. Founders Fund
  166. Franklin Templeton Investments
  167. Federal Trade Commission (FTC)
  168. GATC Biotech
  169. GENDIA (GENetic DIAgnostic Network)
  170. Gene by Gene
  171. GeneDx
  172. GeneMetrics
  173. Geneplus
  174. GeneProof
  175. Genesis GeneticsTM
  176. Genesis GeneticsTM South Africa
  177. GeneSupport
  178. Genetadi Biotech
  179. GeneTech
  180. GeneTech Kazusa Laboratory
  181. Genetic Associates
  182. Genesis Genetics International
  183. GeNext
  184. Genia Technologies
  185. GENNET
  186. Genoks
  187. GenoLogics Life Sciences Software
  188. Genoma
  189. Genomed
  190. Genomic Diagnostics
  191. Genomics For life
  192. Genomi-k
  193. Genomill Health
  194. GenomixLAB
  195. Genopharm
  196. Genos
  197. GenPath Diagnostics
  198. Genpharm Services
  199. Gentica
  200. GENYCA
  201. GigaScience
  202. GN Otometrics
  203. Good Start Genetics
  204. Google India
  205. GRAIL
  206. GTL DNA
  207. Harmony Partners
  208. Headland Capital
  209. Health Professional Council of South Africa (HPCSA)
  210. Health Resources and Services Administration (HRSA)
  211. HealthCor Partners
  212. Helicos BioSciences
  213. Helix Holdings
  214. HemaXis
  215. HemoFlux
  216. Henry Schein Medical
  217. Hitech Diagnostic Centre
  218. Hive Technologies
  219. Hologic
  220. Hong Kong Molecular Pathology Diagnostic Centre
  221. Hong Kong Screening Centre
  222. Hospital Israelita Albert Einstein
  223. Humana
  224. IBL International
  225. Icahn School of Medicine at Mount Sinai
  226. Integrated Gulf Biosystems
  227. iGene Diagnostics
  228. IGENOMIX
  229. Igentify
  230. iLife Discoveries
  231. Illumina®
  232. IMUA Family Services
  233. India Value Fund Advisors (IVFA)
  234. Indian Department of Biotechnology
  235. INEX (Innovations Exchange)
  236. InKaryo
  237. Innermost Healthcare
  238. Innovation Elite
  239. Inova Translational Medical Institute
  240. Inqaba Biotec
  241. Insight Medical Genetics
  242. Institute of Medical Genetics, College of Life Science, Sichuan University
  243. Integrated Genetics
  244. Intercare Salubrity
  245. International 22q11.2 Foundation
  246. InterWest Health
  247. Invitae
  248. IQuum
  249. Isis Innovation
  250. International Society for Prenatal Diagnosis (ISPD)
  251. Istenhegyi Centre for Genetic Diagnostics
  252. IVF Michigan
  253. IVIOMICS
  254. Jennison Associates
  255. Joaquim Chaves Group
  256. Joint Commission on Accreditation of Healthcare Organizations
  257. Just4Me Genetics
  258. K3
  259. Kalorama Information
  260. Kansas City School of Medicine, University of Missouri
  261. Kapa Biosystems and Signature Diagnostics
  262. KellBenx
  263. Knome
  264. Knox Audiology
  265. LABCO Quality Diagnostics
  266. Laboratoire Cerba
  267. Laboratory Corporation of America® Holding
  268. LaboSud
  269. Labsystems Diagnostics
  270. Laverty Pathology
  271. Li Ka Shing Institute of Health Sciences
  272. Life TechnologiesTM
  273. LifeCodexx
  274. LifeGlobal Group
  275. LifeLabs Genetics
  276. Lightspeed Venture Partners
  277. Lilac Insights
  278. Macrogen
  279. Magee-Women’s Hospital of UPMC Center for Medical Genetics
  280. Mahidol University
  281. MAICO Diagnostics
  282. Malaysia Fetal Genome
  283. MAP Diagnostics
  284. Mapmygenome™
  285. Maryland Department of Health and Mental Hygiene
  286. Masimo® Corporation
  287. Maternal and Child Health Bureau (MCHB)
  288. Maverix Biomics
  289. Mayo Medical Laboratories
  290. McKesson Medical-Surgical
  291. MedGen
  292. MedGenome
  293. Medical Chambers Kensington
  294. Medical Genetics Laboratory, Baylor College of Medicine
  295. Medical Genomics
  296. Medisupport
  297. MedLab Asia Group
  298. MEDNAX
  299. Meritech Capital Partners
  300. Metis Genetics
  301. Metropolis
  302. Ministry of Science and Technology, India
  303. MIT Angels
  304. Mohr Davidow Ventures
  305. Molecular Devices
  306. Monobind
  307. MOR Institute for Medical Data
  308. Mount Sinai Genetic Testing Laboratory
  309. MSA Safety
  310. MultiCare
  311. Multigene Diagnostics
  312. MultiPlan
  313. Multiplicom
  314. Murdoch Children’s Research Institute
  315. MyGenetx
  316. MyMedLab
  317. Myraqa
  318. National Accreditation Board for Testing and Calibration Laboratories (NABL)
  319. Natera®
  320. National Health and Family Planning Commission (NHFPC)
  321. National Institutes of Health (NIH)
  322. National Newborn Bloodspot Screening Laboratory (NNBSL), Temple Street    Children’s University Hospital
  323. National Society of Genetic Counselors
  324. National University of Singapore (NUS)
  325. Natus® Medical
  326. Navigene Genetic Science
  327. NeoGen Labs
  328. NEUROSPEC
  329. New Born Solutions
  330. New York Department of Health
  331. New York State Laboratory
  332. Newborn Foundation
  333. NewBorn Gene ID
  334. NewBridge Pharmaceuticals
  335. Next Biosciences
  336. NextBio
  337. NextlineTM Diagnostics
  338. NicView
  339. NIMGenetics
  340. NIPD Genetics
  341. North-West University
  342. Novogene
  343. NX Prenatal
  344. NxGen MDx
  345. Onsite Neonatal Partners
  346. OPKO Health
  347. OrbiMed
  348. Otometrics
  349. Oxford Biosystems
  350. Oxford Gene Technology (OGT)
  351. OZ Systems
  352. PacGenomics
  353. Pacific Rim Pathology
  354. Padtan
  355. Paperboy Ventures
  356. Parabase Genomics
  357. Paragon Genomics
  358. Pathology Associates Medical Laboratories (PAML)
  359. Pathway Genomics
  360. Pediatrix Medical Group
  361. Pennsylvania Department of Health
  362. Perinatal Quality Foundation (PQF)
  363. PerkinElmer® Genetics
  364. Personal Genomics
  365. Phoebus Genetics
  366. Pink Newborn Services
  367. PlexBio
  368. Positive Bioscience
  369. Postnatal Peace
  370. Pregnicare
  371. Premaitha Health
  372. Prenatal Diagnosis Centers (PDC)
  373. Prenatal Genetics
  374. Prenetics
  375. Pressure BioSciences
  376. PreventiNe Life Care
  377. Previvo Genetics
  378. Primary Health Care
  379. Profema
  380. Progenesis
  381. Progenitest
  382. Progenity
  383. Pronto Diagnostics
  384. ProPath
  385. Providence Health & Services
  386. QML Pathology
  387. Quantum Diagnostics
  388. Quest Diagnostics
  389. RA Capital Management
  390. Ramathibodi Hospital, Thailand
  391. Rarecells
  392. Ravgen
  393. Recombine
  394. Red Rock Fertility Center
  395. Reproductive Genetic Innovations (RGI)
  396. Reprogenetics
  397. Rhode Island Department of Health
  398. Roche
  399. Rothschild Ventures Asia
  400. S.R.L
  401. Safembryo
  402. Sagentia
  403. Science Labs NIPT
  404. ScreenCell
  405. Sebia
  406. Secretary's Advisory Committee on Heritable Disorders in Newborns and Children    (SACHDNC)
  407. Secuvita
  408. Sengenics
  409. Seoul National University Hospital (SNUH)
  410. SequenomTM
  411. Sequenom Center for Molecular Medicine (SCMM)
  412. Sequoia Capital
  413. SeraCare Life Sciences
  414. Servicios Genéticos OriGen
  415. Shenz Medical Center
  416. Shenzhen BGI Unicare Clinic
  417. Shenzhen Chi-Next Exchange
  418. Shimadzu Corporation
  419. Sichuan University
  420. Siemens
  421. Silicon Biosystems
  422. Singapore Angel Network
  423. Singlera Genomics
  424. Siriraj Hospital, Thailand
  425. Sistemas Genómicos
  426. SNPgenomics
  427. Sofinnova Ventures
  428. SOFIVA Genomics
  429. Solstas Lab Partners
  430. Sonic Healthcare
  431. Sophia Genetics
  432. Source BioScience
  433. SouthGenetics
  434. SpOtOn Clinical Diagnostics
  435. Srushti Hospital, India
  436. St. George’s University
  437. St. George's Hospital
  438. Stanford University
  439. StartUp Health
  440. Sutter Hill Ventures
  441. Swiss Institute for Bioinformatics
  442. SXE Ventures
  443. Synapse Diagnostics
  444. SYNERGY Medical Systems
  445. SYNLAB
  446. Tasmanian Medical Laboratories
  447. TATAA Biocenter
  448. Teva Pharmaceutical
  449. Thailand Center of Excellence for Life Sciences (TCELS)
  450. The Chinese University of Hong Kong
  451. The Doctors Laboratory (TDL)
  452. The Fetal Medicine Centre, London
  453. The Society for Maternal-Fetal Medicine (SMFM)
  454. Thermo Fisher Scientific
  455. This Is My
  456. TMC Life Sciences
  457. TOMA Advanced Biomedical Assays
  458. Tor Vergata University, Rome
  459. Translational Health Science Technology Institute (THSTI)
  460. Trivitron Healthcare
  461. TrovaGene
  462. Tulip Diagnostics
  463. Tute Genomics
  464. UK Centre of Excellence
  465. UK NEQAS
  466. UNIConnect
  467. Unilabs
  468. United Overseas Bank Venture Management
  469. UnitedHealthcare
  470. University of Antwerp
  471. University of California
  472. University of Hong Kong
  473. University of Rochester
  474. University of Turku
  475. University of Washington
  476. Vanadis Diagnostics
  477. Vantari Genetics
  478. Venrock
  479. Verinata Health
  480. Victorian Clinical Genetics Services (VCGS)
  481. Viollier
  482. Virion-Serion
  483. Visional Medical
  484. Visunex Medical Systems
  485. Vivosonic
  486. Walnut Venture Associates
  487. West Midlands Regional Genetics Laboratory
  488. Western Diagnostic Pathology
  489. Wolfson Institute of Preventive Medicine
  490. Women and Infant's Hospital, Rhode Island
  491. World Health Organization (WHO)
  492. WuXi AppTec (WuXi Biologics)
  493. Xcelom
  494. Yale School of Medicine
  495. Yale Women and Children’s Center
  496. Yikon Genomics
  497. Yourgene Bioscience
  498. ZenTec

 

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