US Non-Invasive Prenatal Diagnostics - Market Insight

NEW YORK, Aug. 16, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

http://www.reportlinker.com/p0945468/US-Non-Invasive-Prenatal-Diagnostics---Market-Insight.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Diagnostics

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.

1. Analyst View2. Research Methodology3. Statistical Snapshot - Pregnancies and Chromosomal Abnormalities4. Overview of US Prenatal Diagnostics Market4.1 Introduction4.2 Prenatal Diagnostics Industry4.2.1 Preliminary Prenatal Testing4.2.2 First Trimester Screening4.2.3 Second Trimester Screening4.2.4 Chorionic Villus Sampling (CVS) Testing4.2.5 Amniocentesis Testing5. US Non-Invasive Prenatal Diagnostics - Market Insight5.1 Tests Available in the Market5.1.1 MaterniT21 (Sequenom)5.1.2 Verifi (Verinata)5.1.3 Harmony Prenatal Test (Ariosa Diagnostics)5.2 Current and Future Market Projections to 20165.3 Regulatory Insight5.3.1 Current Regulatory Scenario5.3.2 Regulatory Authority Perspective5.3.3 Diagnostic Test Provider Perspective5.3.4 Consumers' Perspective5.3.5 Analyst Inputs6. Current Technologies in the Market7. Projects in Clinical Trials8. Constraints in NIPD Market9. Competitive Assessment9.1 Ariosa Diagnostics9.1.1 Company Overview9.1.2 Product Overview9.1.3 Strengths & Weaknesses9.2 Sequenom9.2.1 Company Overview9.2.2 Product Overview9.2.3 Strengths and Weaknesses9.3 Verinata9.3.1 Company Overview9.3.2 Product Overview9.3.3 Strengths and Weaknesses9.4 Natera9.4.1 Company Overview9.4.2 Product Overview9.4.3 Strengths and Weaknesses9.5 Fluidigm9.5.1 Company Overview9.5.2 Product Overview9.5.3 Strengths and Weaknesses

List of Figures:

Figure 3-1: Population Base (Million), 2000-2010Figure 4-1: Prenatal Testing Market (Billion US$), 2012-2016Figure 4-2: Preliminary Prenatal Testing Market (Million US$), 2012-2016Figure 4-3: First Trimester Screening Market (Million US$), 2012-2016Figure 4-4: Second Trimester Screening Market (Million US$), 2012-2016Figure 4-5: CVS Testing Market (Million US$), 2012-2016Figure 4-6: Amniocentesis Testing Market (Million US$), 2012-2016Figure 5-1: Non-Invasive Prenatal Diagnostics Market (Million US$), 2012-2016Figure 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)

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 AbnormalitiesTable 4-1: Major Preliminary Prenatal Tests PerformedTable 4-2: Major First Trimester Screening Tests PerformedTable 4-3: Major Second Trimester Screening Tests PerformedTable 5-1: Inter-comparison of CLIA and FDA Regulatory PathwayTable 6-1: Common Commercial Kits and Protocols for Isolation of ccff DNA from Maternal PlasmaTable 7-1: Key undergoing Non-invasive Prenatal Diagnostic (NIPD) Studies

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