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US Non-Invasive Prenatal Diagnostics - Market Insight
Description:
The US prenatal diagnostics market is one of the largest markets in the world for fetal monitoring, diagnostics, and predictive testing. It consists of a series of physician prescribed tests for monitoring maternal and fetal health. The current invasive technologies such as CVS and amniocentesis that are used to detect chromosomal abnormalities pose serious risks of miscarriages and are being replaced by the non-invasive prenatal diagnostic technologies.
Although NIPD is a relatively nascent segment of the prenatal diagnostics, it presents a lucrative growth potential to industry participants. The segment is mainly supported by rising incidences of fetal health-related abnormalities and the urgent need for safe, accurate and early diagnosis. Products such as MaterniT21 Plus, Verifi, and Harmony prenatal tests are the current tests available in the market. Around 25,000-40,000 samples are likely to be tested by MaterniT21 plus test alone by the end of 2012.
Further the report “US Non-Invasive Prenatal Diagnostics - Market Insight”, provides a transparent view on the present regulatory framework elaborating on the existing loopholes. A thorough analysis has been done illustrating the views of regulatory authorities, players and consumers towards the regulatory stringency and the direction of regulations in the future have also been covered. Clinical trials in the NIPD field through an active participation of public and private players are provided to assess the research and innovation.
Currently, the US NIPD sector is characterized by the presence of players like Sequenom, Verinata, Ariosa and Natera. These companies are effectively taking steps to promote their LDTs among the US population, especially targeting physicians to recommend their products. In future, the launch of Natera’s test is expected to impact the market significantly, thereby boosting the potential size and sample volume.
The report, which provides a prudent analysis on the current and future size of the market weighing the possible pessimistic and optimistic scenarios, is a must buy for new market entrants in the diagnostic field planning to enter in the prenatal segment.
Although NIPD is a relatively nascent segment of the prenatal diagnostics, it presents a lucrative growth potential to industry participants. The segment is mainly supported by rising incidences of fetal health-related abnormalities and the urgent need for safe, accurate and early diagnosis. Products such as MaterniT21 Plus, Verifi, and Harmony prenatal tests are the current tests available in the market. Around 25,000-40,000 samples are likely to be tested by MaterniT21 plus test alone by the end of 2012.
Further the report “US Non-Invasive Prenatal Diagnostics - Market Insight”, provides a transparent view on the present regulatory framework elaborating on the existing loopholes. A thorough analysis has been done illustrating the views of regulatory authorities, players and consumers towards the regulatory stringency and the direction of regulations in the future have also been covered. Clinical trials in the NIPD field through an active participation of public and private players are provided to assess the research and innovation.
Currently, the US NIPD sector is characterized by the presence of players like Sequenom, Verinata, Ariosa and Natera. These companies are effectively taking steps to promote their LDTs among the US population, especially targeting physicians to recommend their products. In future, the launch of Natera’s test is expected to impact the market significantly, thereby boosting the potential size and sample volume.
The report, which provides a prudent analysis on the current and future size of the market weighing the possible pessimistic and optimistic scenarios, is a must buy for new market entrants in the diagnostic field planning to enter in the prenatal segment.
Contents:
1. Analyst View
2. Research Methodology
3. Statistical Snapshot - Pregnancies and Chromosomal Abnormalities
4. Overview of US Prenatal Diagnostics Market
4.1 Introduction
4.2 Prenatal Diagnostics Industry
4.2.1 Preliminary Prenatal Testing
4.2.2 First Trimester Screening
4.2.3 Second Trimester Screening
4.2.4 Chorionic Villus Sampling (CVS) Testing
4.2.5 Amniocentesis Testing
5. US Non-Invasive Prenatal Diagnostics - Market Insight
5.1 Tests Available in the Market
5.1.1 MaterniT21 (Sequenom)
5.1.2 Verifi (Verinata)
5.1.3 Harmony Prenatal Test (Ariosa Diagnostics)
5.2 Current and Future Market Projections to 2016
5.3 Regulatory Insight
5.3.1 Current Regulatory Scenario
5.3.2 Regulatory Authority Perspective
5.3.3 Diagnostic Test Provider Perspective
5.3.4 Consumers’ Perspective
5.3.5 Analyst Inputs
6. Current Technologies in the Market
7. Projects in Clinical Trials
8. Constraints in NIPD Market
9. Competitive Assessment
9.1 Ariosa Diagnostics
9.1.1 Company Overview
9.1.2 Product Overview
9.1.3 Strengths & Weaknesses
9.2 Sequenom
9.2.1 Company Overview
9.2.2 Product Overview
9.2.3 Strengths and Weaknesses
9.3 Verinata
9.3.1 Company Overview
9.3.2 Product Overview
9.3.3 Strengths and Weaknesses
9.4 Natera
9.4.1 Company Overview
9.4.2 Product Overview
9.4.3 Strengths and Weaknesses
9.5 Fluidigm
9.5.1 Company Overview
9.5.2 Product Overview
9.5.3 Strengths and Weaknesses
List of Tables
Table 3-1: Number of Births and Abortions (2000-2010)
Table 3-2: Number of Multiple Pregnancies (2000-2009)
Table 3-3: Prevalence of Chromosomal Abnormalities
Table 4-1: Major Preliminary Prenatal Tests Performed
Table 4-2: Major First Trimester Screening Tests Performed
Table 4-3: Major Second Trimester Screening Tests Performed
Table 5-1: Inter-comparison of CLIA and FDA Regulatory Pathway
Table 6-1: Common Commercial Kits and Protocols for Isolation of ccff DNA from Maternal Plasma
Table 7-1: Key undergoing Non-invasive Prenatal Diagnostic (NIPD) Studies
List of Charts
Figure 3-1: Population Base (Million), 2000-2010
Figure 4-1: Prenatal Testing Market (Billion US$), 2012-2016
Figure 4-2: Preliminary Prenatal Testing Market (Million US$), 2012-2016
Figure 4-3: First Trimester Screening Market (Million US$), 2012-2016
Figure 4-4: Second Trimester Screening Market (Million US$), 2012-2016
Figure 4-5: CVS Testing Market (Million US$), 2012-2016
Figure 4-6: Amniocentesis Testing Market (Million US$), 2012-2016
Figure 5-1: Non-Invasive Prenatal Diagnostics Market (Million US$), 2012-2016
Figure 5-2: Share of Players in Number of NIPD Tests Performed (2012)
Figure 5-3: Share of Players in NIPD Market (2012)
Figure 5-4: Forecast for Share of Players in Number of NIPD Tests Performed (2016)
Figure 5-5: Forecast for Share of Players in NIPD Market (2016)
Figure 5-6: Laboratorians’ Attitudes towards FDAs Regulations on Lab Developed Tests (LDT)
2. Research Methodology
3. Statistical Snapshot - Pregnancies and Chromosomal Abnormalities
4. Overview of US Prenatal Diagnostics Market
4.1 Introduction
4.2 Prenatal Diagnostics Industry
4.2.1 Preliminary Prenatal Testing
4.2.2 First Trimester Screening
4.2.3 Second Trimester Screening
4.2.4 Chorionic Villus Sampling (CVS) Testing
4.2.5 Amniocentesis Testing
5. US Non-Invasive Prenatal Diagnostics - Market Insight
5.1 Tests Available in the Market
5.1.1 MaterniT21 (Sequenom)
5.1.2 Verifi (Verinata)
5.1.3 Harmony Prenatal Test (Ariosa Diagnostics)
5.2 Current and Future Market Projections to 2016
5.3 Regulatory Insight
5.3.1 Current Regulatory Scenario
5.3.2 Regulatory Authority Perspective
5.3.3 Diagnostic Test Provider Perspective
5.3.4 Consumers’ Perspective
5.3.5 Analyst Inputs
6. Current Technologies in the Market
7. Projects in Clinical Trials
8. Constraints in NIPD Market
9. Competitive Assessment
9.1 Ariosa Diagnostics
9.1.1 Company Overview
9.1.2 Product Overview
9.1.3 Strengths & Weaknesses
9.2 Sequenom
9.2.1 Company Overview
9.2.2 Product Overview
9.2.3 Strengths and Weaknesses
9.3 Verinata
9.3.1 Company Overview
9.3.2 Product Overview
9.3.3 Strengths and Weaknesses
9.4 Natera
9.4.1 Company Overview
9.4.2 Product Overview
9.4.3 Strengths and Weaknesses
9.5 Fluidigm
9.5.1 Company Overview
9.5.2 Product Overview
9.5.3 Strengths and Weaknesses
List of Tables
Table 3-1: Number of Births and Abortions (2000-2010)
Table 3-2: Number of Multiple Pregnancies (2000-2009)
Table 3-3: Prevalence of Chromosomal Abnormalities
Table 4-1: Major Preliminary Prenatal Tests Performed
Table 4-2: Major First Trimester Screening Tests Performed
Table 4-3: Major Second Trimester Screening Tests Performed
Table 5-1: Inter-comparison of CLIA and FDA Regulatory Pathway
Table 6-1: Common Commercial Kits and Protocols for Isolation of ccff DNA from Maternal Plasma
Table 7-1: Key undergoing Non-invasive Prenatal Diagnostic (NIPD) Studies
List of Charts
Figure 3-1: Population Base (Million), 2000-2010
Figure 4-1: Prenatal Testing Market (Billion US$), 2012-2016
Figure 4-2: Preliminary Prenatal Testing Market (Million US$), 2012-2016
Figure 4-3: First Trimester Screening Market (Million US$), 2012-2016
Figure 4-4: Second Trimester Screening Market (Million US$), 2012-2016
Figure 4-5: CVS Testing Market (Million US$), 2012-2016
Figure 4-6: Amniocentesis Testing Market (Million US$), 2012-2016
Figure 5-1: Non-Invasive Prenatal Diagnostics Market (Million US$), 2012-2016
Figure 5-2: Share of Players in Number of NIPD Tests Performed (2012)
Figure 5-3: Share of Players in NIPD Market (2012)
Figure 5-4: Forecast for Share of Players in Number of NIPD Tests Performed (2016)
Figure 5-5: Forecast for Share of Players in NIPD Market (2016)
Figure 5-6: Laboratorians’ Attitudes towards FDAs Regulations on Lab Developed Tests (LDT)
Companies Mentioned
- Ariosa Diagnostics
- Sequenom
- Verinata
- Natera
- Fluidigm
- Sequenom
- Verinata
- Natera
- Fluidigm
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