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市場調査レポート

米国の非侵襲式出生前診断市場の考察

US Non-Invasive Prenatal Diagnostics - Market Insight

発行 RNCOS E-Services Pvt. Ltd. 商品コード 248614
出版日 ページ情報 英文 60 Pages
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米国の非侵襲式出生前診断市場の考察 US Non-Invasive Prenatal Diagnostics - Market Insight
出版日: 2013年06月01日 ページ情報: 英文 60 Pages
概要

米国の出生前診断市場は、胎児監視・診断・予知検査の点で世界最大の市場の一つとなっています。その中でも非侵襲式出生前診断(NIPD)市場は、全体的にはまだ発展の初期段階にありますが、大きな成長可能性を秘めいています。

当レポートでは、米国における非侵襲式出生前診断の市場について分析し、出生前診断の全体的な市場構造や、現在・今後の市場動向・構造、治験の進行状況、主要企業のプロファイルなどを調査・推計して、その結果を概略以下の構成でお届けします。

第1章 アナリストの見解

第2章 分析手法

第3章 最新の統計データ:妊娠と染色体異常

第4章 米国の出生前診断市場の概要

  • イントロダクション
  • 出生前診断産業
    • 予備検査
    • 妊娠第1三半期検査
    • 妊娠第2三半期検査
    • 絨毛採取(CVS)検査
    • 羊水穿刺検査

第5章 米国の非侵襲式出生前診断市場の考察

  • 市場で実施可能な検査
    • MaterniT21 (Sequenom)
    • Verifi (Verinata)
    • Harmony Prenatal Test (Ariosa Diagnostics)
  • 現在・将来の市場規模(今後5年間分)
  • 規制に関する考察
    • 現在の規制シナリオ
    • 規制当局の見解
    • 診断検査実施企業の見解
    • 消費者の見解
    • アナリストの見解

第6章 市場における現在の技術

第7章 治験のプロジェクト

第8章 市場の制約

第9章 競争環境

  • Ariosa Diagnostics
    • 企業概要
    • 製品概要
    • 強み・弱み
  • Sequenom
    • 企業概要
    • 製品概要
    • 強み・弱み
  • Verinata
    • 企業概要
    • 製品概要
    • 強み・弱み
  • Natera
    • 企業概要
    • 製品概要
    • 強み・弱み

図表一覧

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目次

Abstract

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 diagnostics 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 100,000 samples were likely tested by MaterniT21 plus test alone by the first quarter of 2013 since its launch.

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.

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 diagnostics field, planning to enter the prenatal segment.

Table of 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 Health)
    • 5.1.3 Harmony Prenatal Test (Ariosa Diagnostics)
    • 5.1.4 Panorama (Natera)
  • 5.2 Current and Future Market Projections to 2017
  • 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. Constraints in NIPD Market

8. Competitive Assessment

  • 8.1 Ariosa Diagnostics
    • 8.1.1 Company Overview
    • 8.1.2 Product Overview
    • 8.1.3 Strengths and Weaknesses
  • 8.2 Sequenom
    • 8.2.1 Company Overview
    • 8.2.2 Product Overview
    • 8.2.3 Strengths and Weaknesses
  • 8.3 Verinata
    • 8.3.1 Company Overview
    • 8.3.2 Product Overview
    • 8.3.3 Strengths and Weaknesses
  • 8.4 Natera
    • 8.4.1 Company Overview
    • 8.4.2 Product Overview
    • 8.4.3 Strengths and Weaknesses

List of Figures:

  • 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$), 2012-2017
  • 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 (2017)
  • Figure 5-5: Forecast for Share of Players in NIPD Market (2017)
  • 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 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
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