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市場調査レポート

米国の非侵襲的出生前遺伝学的検査 (NIPT) 市場の見通し

US Non-Invasive Prenatal Testing Market Outlook 2020

発行 RNCOS E-Services Pvt. Ltd. 商品コード 297684
出版日 ページ情報 英文 70 Pages
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米国の非侵襲的出生前遺伝学的検査 (NIPT) 市場の見通し US Non-Invasive Prenatal Testing Market Outlook 2020
出版日: 2015年05月01日 ページ情報: 英文 70 Pages
概要

米国における出産女性の平均年齢は、年々上がってきています。初産が35歳、あるいは40歳でも、珍しいことではありません。しかし、母親の年齢が上がるにつれて、その子供が染色体異常を発症するリスクは増加します。米国の非侵襲的出生前遺伝学的検査 (NIPT) 市場は、今後数年間で2桁成長を遂げると予測されています。

当レポートでは、米国のNIPT市場について調査分析し、検査の概要、現在の技術、ダウン症のリスク、人口統計の見通し、潜在的市場、市場の予測、規制環境、償還シナリオを提供するほか、主要企業プロファイルも含めて、体系的な情報を提供しています。

第1章 アナリストの見解

第2章 調査手法

第3章 米国のNIPT市場で利用可能な検査

  • MaterniT21
  • Verifi
  • Panorama
  • Harmony

第4章 市場における現在の技術

第5章 胎児に対するダウン症 (DS) のリスクと母親の年齢との関連

第6章 人口統計の見通し

  • 人口統計
  • 出生数:現在・将来
  • 疾患の人口統計

第7章 米国のNIPT:潜在的市場

第8章 米国のNIPT市場の予測

  • 市場規模と予測
  • 企業の市場シェア

第9章 規制の考察

第10章 米国のNIPT市場の償還シナリオ

第11章 競合評価

  • 事業概要、強みと弱み、最近の動向
    • Ariosa Diagnostics
    • Sequenom
    • Verinata
    • Natera

図表

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目次

The non-invasive prenatal testing market in US, which is extremely lucrative and a growing segment of the diagnostics industry, 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. Our 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 too 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 and is a must buy for players planning to enter the prenatal segment.

Table of Contents

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 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)

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