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US Non-Invasive Prenatal Testing Market Outlook 2020

  • ID: 3229914
  • Report
  • May 2015
  • Region: United States
  • 70 pages
  • RNCOS E-Services Private Limited
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The non invasive prenatal testing market in US is extremely lucrative and a growing segment of the diagnostics industry with market is driven by companies developing and offering these tests. The average age of women giving birth in United States has increased over the years. It’s no longer unusual for women to have a first child at age 35 or even 40. This trend has been attributed to numerous factors such as recession and associated affordability issues, and women being more focused on their careers than before. However, increased age of the mother also increases the risk of her child developing chromosomal abnormalities. This risk has thus paved the way for NIPT tests which have emerged as the next big thing in the field of prenatal diagnostics.

According to our report, “US Non-Invasive Prenatal Testing Market Outlook 2020”, the rise in high risk births has been contributing to the growth of the NIPT market which is anticipated to witness an impressive double digit growth in the next few years. The report provides a detailed insight into the current scenario and future outlook of the US NIPT market. It has been inferred that most of the total market remains untapped. Contribution of every NIPT player has also been provided in terms of current and future market shares.

The demographic scenario of United States has been discussed with focus on the current and future number of births, with the demographics segregated by age and state. Although, the market has witnessed stupendous growth and new tests have gained acceptance rapidly, much of it still remains untapped due to various reasons. This has been discussed in the section dedicated to the potential market for 2014 and 2020.

A thorough analysis has been done illustrating the views of regulatory authorities, players and consumers towards regulatory stringency and the direction of regulations in the future have also been covered.

Research and innovation in this field is at its peak, and market players are conducting validation studies to check the level of specificity and sensitivity while comparing clinical tests. Already several clinical trials in the pipeline upon completion may impact the overall market in a significant manner.

The US NIPT sector is characterized by the presence of players like Sequenom, Verinata, Ariosa and Natera. These players have been profiled with their strengths and weaknesses and latest developments in the field of NIPT. The report provides a prudent analysis of the current and future size of the market weighing the possible pessimistic and optimistic scenarios, is a must buy for players planning to enter the prenatal segment.
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1. Analyst View

2. Research Methodology

3. Tests Available in the US NIPT Market
3.1 MaterniT21
3.2 Verifi
3.3 Panorama
3.4 Harmony

4. Current Technologies in the Market

5. Association of Down’s syndrome Risk to Fetus with Mother's Age

6. Demographics Outlook
6.1 Population Demographics
6.2 Number of Births: Current and Future
6.2.1 By Age Group
6.2.2 By State
6.3 Disease Demographics

7. US NIPT - Potential Market (2014 & 2020)

8. US NIPT Market Projections to 2020
8.1 Market Size and Forecast
8.2 Market Share of Players

9. Regulatory Insight
9.1 Current Regulatory Scenario
9.2 Regulatory Authority Perspective
9.3 Diagnostic Test Provider Perspective
9.4 ACOG Opinion
9.5 Consumers’ Perspective
9.6 Analyst Inputs

10. Reimbursement Scenario for US NIPT Market

11. Competitive Assessment
11.1 Ariosa Diagnostics
11.1.1 Business Overview
11.1.2 Strengths and Weaknesses
11.1.3 Recent Developments
11.2 Sequenom
11.2.1 Business Overview
11.2.2 Strengths and Weaknesses
11.2.3 Recent Developments
11.3 Verinata
11.3.1 Business Overview
11.3.2 Strengths and Weaknesses
11.3.3 Recent Developments
11.4 Natera
11.4.1 Business Overview
11.4.2 Strengths and Weaknesses
11.4.3 Recent Developments

List of Tables
Table 3-1: Comparison of Features of Key NIPT Tests in APAC NIPT Market
Table 3-2: MaterniT21 PLUS Test Validation Results
Table 4-1: Common Commercial Kits and Protocols for Isolation of ccff DNA from Maternal Plasma
Table 6-1: Births by Women Age-Group (%), 2014-2020
Table 6-2: Top Ten States by Number of Births (2012 & 2013)
Table 6-3: Prevalence of Chromosomal Abnormalities
Table 9-1: Inter-comparison of CLIA and FDA Regulatory Pathway

List of Figures
Figure 3-1: Verifi Test Validation Results
Figure 3-2: Panorma Test Validation Results
Figure 3-3: Harmony Test Validation Results
Figure 5-1: Risk of Down's syndrome with Rise in Maternal Age
Figure 6-1: Population (Million), 2014-2020
Figure 6-2: Male-Female Ratio (%), 2014
Figure 6-3: Number of Births (Million), 2010-2014
Figure 6-4: Number of Births (Million), 2014-2020
Figure 7-1: Number of Births by Mother's Risk of Down's syndrome (%), 2014
Figure 7-2: High Risk NIPT Potential Market (Million US$), 2014 & 2020
Figure 7-3: Medium Risk NIPT Potential Market (Million US$), 2014 & 2020
Figure 8-1: Non-Invasive Prenatal Diagnostics Market (Million US$), 2014-2020
Figure 8-2: NIPT Market Penetration in High Risk Category (2014)
Figure 8-3: Share of Players in Number of NIPT Tests Performed (2014)
Figure 8-4: Share of Players in NIPT Market (2014)
Figure 8-5: Forecast for Share of Players in Number of NIPT Tests Performed (2020)
Figure 8-6: Forecast for Share of Players in NIPT Market (2020)
Figure 9-1: Laboratorians' Attitudes towards FDAs Regulations on Lab Developed Tests (LDT)
Table 10-1: Comparative Analysis of Tests Available in US NIPT Market
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- Ariosa Diagnostics
- Natera
- Sequenom
- Verinata

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Note: Product cover images may vary from those shown