US Non-Invasive Prenatal Testing Market Outlook 2018 -




Published: March 2014 | Pages: 65 | Format: PDF

 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 2018”, the rise in high risk births has been contributing to the growth of the NIPT market which is anticipated to grow at a CAGR of over 20% for the next 5 years. Our report provides a detailed insight into the current scenario and future outlook of the US NIPT. This market’s potential and the actual market have been deduced and it has been inferred that 2/3 rd 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 2013 and 2018. 

 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. 

 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, which 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. 

 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 (2013 & 2018) 

 8. US NIPT Market Projections to 2018 

 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 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), 2013-2018 

 Figure 6-2: Male- Female Ratio (%), 2013 

 Figure 6-3: Number of Births (Million), 2009-2013 

 Figure 6-4: Number of Births (Million), 2014-2018 

 Figure 7-1: Number of Births by Mother’s Risk of Down’s syndrome (%), 2013 

 Figure 7-2: High Risk NIPT Potential Market (Million US$), 2013 & 2018 

 Figure 7-3: Medium Risk NIPT Potential Market (Million US$), 2013 & 2018 

 Figure 8-1: Non-Invasive Prenatal Diagnostics Market (Million US$), 2013-2018 

 Figure 8-2: NIPT Market Penetration in High Risk Category (2013) 

 Figure 8-3: Share of Players in Number of NIPT Tests Performed (2013) 

 Figure 8-4: Share of Players in NIPT Market (2013) 

 Figure 8-5: Forecast for Share of Players in Number of NIPT Tests Performed (2018) 

 Figure 8-6: Forecast for Share of Players in NIPT Market (2018) 

 Figure 9-1: Laboratorians’ Attitudes towards FDAs Regulations on Lab Developed Tests (LDT) 

  

 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 (%), 2010-2013 

 Table 6-2: Top Ten States by Number of Births (2011 & 2012) 

 Table 6-3: Prevalence of Chromosomal Abnormalities 

 Table 9-1: Inter-comparison of CLIA and FDA Regulatory Pathway 

 Table 10-1: Comparative Analysis of Tests Available in US NIPT Market