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感染症検査における分子診断

Molecular Diagnostics in Infectious Disease Testing

発行 TriMark Publications 商品コード 203891
出版日 ページ情報 英文 265 Pages
納期: 即日から翌営業日
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感染症検査における分子診断 Molecular Diagnostics in Infectious Disease Testing
出版日: 2016年05月01日 ページ情報: 英文 265 Pages
担当者のコメント
TriMark Publicationsは、米国ニューヨークに本社を置く医療分野専門の市場調査会社です。世界市場の中でもアメリカ市場の分析を得意としています。比較的短いスパンで情報が更新されることから、最新データが網羅されているとして継続的に購入されるお客様が多い出版社の一つです。当レポートでは、2009年から2020年までの売上予測と市場シェアをお届けしております。
概要

現在の医療診断市場において、感染症検査での分子診断は最も成長の見込める分野のひとつとなっています。血液検体測定のためのマイクロアレイ装置の開発にともない、ゲノミクス、プロテオミクスなどの画期的技術開発の結果、市場が劇的に発展しました。特に分子診断は、感染症を診断するための最新分析技術としてその威力を発揮しています。

当レポートは、感染症検査における分子診断分野の動向を分析し、既存および新興の技術概要、米国および世界の市場規模、参入企業のプロファイル、売上予測と市場シェアなどをまとめてお届けします。

第1章 概要

第2章 感染症検査のための分子診断:イントロダクション

  • 感染症分野における分子診断検査および機会
  • 感染症の問題
  • ヒトゲノムプロジェクトが分子診断に及ぼす影響
  • 分子診断、臨床診断の機会
  • 分子診断検査市場の発展
  • 分子診断検査技術およびプラットフォーム
    • 増幅技術
    • 増幅遺伝子製品による検出
    • DNAおよびオリゴヌクレオチドのマイクロアレイ(チップ)
    • 遺伝子シークエンス
    • FISH法(蛍光in situハイブリダイゼーション)
    • 臨床診断のためのPCR試薬
  • 感染症検査のための分子診断技術
  • 市場促進因子および抑制因子
  • 市場および技術動向
  • 戦略的提言

第3章 感染症診断分子検査市場

  • 市場概要
  • NAT分子診断市場
  • 感染症診断分子検査市場
    • HIV
    • 肝炎
    • ヒトパピローマウイルス
    • インフルエンザウイルス
    • STD検査 (クラミジア/淋病分子診断検査)
    • 結核
    • メチシリン耐性黄色ブドウ球菌 (MRSA)
    • バンコマイシン耐性腸球菌
    • クロストリジウム・ディフィシル

第4章 感染症検査のための分子診断検査技術

  • 感染症診断検査
  • 感染症における分子検査の使用
  • 分子診断検査のコスト
  • 多重PCR試験の使用
  • 次世代シーケンシング
  • 患者フローソフトウェア
  • LAMP
  • 遺伝子配列解明技術のための Ion Proton システム
  • xMap Technology (Luminex)
  • The Invader Chemistry Platform (Hologic)

第5章 ビジネス

  • 技術および市場動向
  • M&A活動
  • 提携
  • 競合分析
  • 知的財産権
  • 機会と戦略的提言
  • 感染症分子診断製品の商業生産:要件

第6章 感染症分子診断のための医療費償還と請求環境

  • 概要
  • 医療費償還動向
  • 患者ケアと医療費償還動向
  • 収益に関する脅威
  • 請求規則

第7章 法規制の要件

第8章 分子診断検査を用いたビジネス判断

第9章 抗菌薬剤耐性の経済学

  • 耐性と抗生物質の使用
  • 感染防止プログラム

第10章 企業プロファイル

図表

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目次
Product Code: TMRMDIDT16-0501

This report describes the specific segment of the in vitro diagnostics market known as molecular diagnostics testing for infectious disease. In the current medical diagnostics market, molecular diagnostics in infectious disease testing offers one of the most promising areas for growth and innovation. The confluence of breakthroughs in genomics and proteomics--along with the development of microarray devices to measure analytes in the blood--has led to this revolutionary market development. Specifically, molecular diagnostics offers the power of advanced analytical techniques to diagnose infectious diseases. Whereas before, the detection of many infectious agents was slow and expensive due to reliance upon culturing methods, researchers are now at the cusp of overcoming such limitations via the use of nucleic acid-mediated molecular diagnostics testing. The purpose of this report is to describe the emerging field of molecular diagnostics in infectious disease testing. The infectious disease space is the most dominant and profitable sector of molecular diagnostics. Topics covered in this study include: 1) the existing and emerging technologies in the field, 2) the U.S. and global market size for molecular diagnostic products and 3) the profiles of companies that are focusing on the molecular diagnostic sector. The research examines drivers and restraints for sales growth, market share and technical trends. In addition, an in-depth analysis of the competitive situation of prominent market venders is provided with five-year sales forecasts.

Table of Contents

1. Overview

  • 1.1. Statement of Report
  • 1.2. About This Report
  • 1.3. Scope of the Report
  • 1.4. Objectives
  • 1.5. Methodology
  • 1.6. Executive Summary

2. Introduction to Molecular Diagnostics for Infectious Disease Testing

  • 2.1. Molecular Diagnostics Testing and Opportunities in the Infectious Disease Sector
  • 2.2. The Infectious Disease Problem
  • 2.3. Impact of the Human Genome Project on Molecular Diagnostics
  • 2.4. Opportunities for Molecular and Clinical Diagnostics
    • 2.4.1. Companion Diagnostics
  • 2.5. Development of Molecular Diagnostics Testing Markets
  • 2.6. Molecular Diagnostics Testing Technologies and Platforms
    • 2.6.1. Amplification Technologies
      • 2.6.1.1. PCR and PCR Derivative Platforms
      • 2.6.1.2. Multiple Displacement Amplification
      • 2.6.1.3. Multiple Annealing and Looping-Based Amplification Cycles
      • 2.6.1.4. Whole Genome Amplification
      • 2.6.1.5. Nucleic Acid Sequence-Based Amplification
    • 2.6.2. Detection of Amplified Gene Products
      • 2.6.2.1. High Resolution Melting Analysis
      • 2.6.2.2. Microparticle-Based Flow Cytometry
    • 2.6.3. DNA and Oligonucleotide Microarrays and Chips
      • 2.6.3.1. Array Comparative Genomic Hybridization
    • 2.6.4. Gene Sequencing
      • 2.6.4.1. Sanger Sequencing
      • 2.6.4.2. Next Generation Sequencing
    • 2.6.5. Fluorescence In situ Hybridization
    • 2.6.6. PCR Reagents for Clinical Diagnostics
  • 2.7. Molecular Diagnostics Technologies for Infectious Disease Testing
  • 2.8. Market Drivers and Restraints for Molecular Diagnostics of Infectious Diseases
    • 2.8.1. Market Drivers
    • 2.8.2. Market Restraints
  • 2.9. Market and Technology Trends
    • 2.9.1. Market Trends
    • 2.9.2. Technology Trends
  • 2.10. Strategic Recommendations

3. Infectious Disease Diagnostics Molecular Testing Market

  • 3.1. Molecular Diagnostics Market Overview
    • 3.1.2. Overall Infectious Disease Market Analysis
  • 3.2. Molecular Testing for Infectious Disease Diagnostics Market
  • 3.3. Infectious Disease Molecular Diagnostic Testing Market Segments
    • 3.3.1. HIV
      • 3.3.1.1. Disease Background and Statistics
      • 3.3.1.2. Overview of HIV Testing Methods
        • 3.3.1.2.1. Clinical Diagnostic Screening Tests for HIV
        • 3.3.1.2.2. HIV Monitoring Tests
        • 3.3.1.2.3. Measuring Viral Loads
        • 3.3.1.2.4. Genotyping Assays
        • 3.3.1.2.5. Phenotyping Assays
      • 3.3.1.3. Instruments and MDx Reagents
        • 3.3.1.3.1. Abbott Molecular
        • 3.3.1.3.2. Alere (becoming part of Abbott)
        • 3.3.1.3.3. Beckman Coulter
        • 3.3.1.3.4. bioMérieux
        • 3.3.1.3.5. Cepheid
        • 3.3.1.3.6. Grifols
        • 3.3.1.3.7. Hologic
        • 3.3.1.3.8. Qiagen
        • 3.3.1.3.9. Roche Diagnostics
        • 3.3.1.3.10. Siemens Healthcare Diagnostics
        • 3.3.1.3.11. LabCorp
      • 3.3.1.4. Market Size
        • 3.3.1.4.1. HIV Diagnostic Testing
      • 3.3.1.5. HIV Market Challenges and Strategic Recommendations
        • 3.3.1.5.1. HIV Molecular Diagnostic Market History
      • 3.3.1.6. Market Drivers and Restraints
        • 3.3.1.6.1. Market Drivers
        • 3.3.1.6.2. Market Restraints
      • 3.3.1.7. Market and Technology Trends
        • 3.3.1.7.1. Market Trends
        • 3.3.1.7.2. Technology Trends
      • 3.3.1.8. Strategic Recommendations
    • 3.3.2. Hepatitis
      • 3.3.2.1. Hepatitis B Virus
        • 3.3.2.1.1. Hepatitis B Disease Background and Statistics
        • 3.3.2.1.2. Clinical Applications of HBV MDx Testing
        • 3.3.2.1.3. MDx Instruments and Reagents for Hepatitis B Detection
          • 3.3.2.1.3.1. Abbott
          • 3.3.2.1.3.2. Beckman Coulter
          • 3.3.2.1.3.3. Grifols
          • 3.3.2.1.3.4. Hologic
          • 3.3.2.1.3.5. Roche
          • 3.3.2.1.3.6. Siemens
        • 3.3.2.1.4. Hepatitis B Market Size
          • 3.3.2.1.5. HBV Market Challenges and Strategic Recommendations
            • 3.3.2.1.5.1. Market Drivers and Restraints
              • 3.3.2.1.5.1.1. Market Drivers
              • 3.3.2.1.5.1.2. Market Restraints
          • 3.3.2.1.6. Market and Technology Trends
            • 3.3.2.1.6.1. Market Trends
            • 3.3.2.1.6.2. Technology Trends
          • 3.3.2.1.7. Strategic Recommendations
      • 3.3.2.2. Hepatitis C Virus Testing
        • 3.3.2.2.1. Disease Background and Statistics
        • 3.3.2.2.2. Instruments and Reagents for Hepatitis C Detection
          • 3.3.2.2.2.1. Roche
          • 3.3.2.2.2.2. Grifols
          • 3.3.2.2.2.3. Siemens
          • 3.3.2.2.2.4. Hologic
          • 3.3.2.2.2.5. Abbott
          • 3.3.2.2.2.6. Beckman Coulter
          • 3.3.2.2.2.7. Cepheid
        • 3.3.2.2.3. Hepatitis C Market Size
          • 3.3.2.2.3.1. HCV Market Share
        • 3.3.2.2.4. HCV Market Challenges and Strategic Recommendations
          • 3.3.2.2.4.1. Market Drivers and Restraints
            • 3.3.2.2.4.1.1. Market Drivers
            • 3.3.2.2.4.1.2. Market Restraints
          • 3.3.2.2.4.2. Market and Technology Trends
            • 3.3.2.2.4.2.1. Market Trends
            • 3.3.2.2.4.2.2. Technology Trends
        • 3.3.2.2.5. Strategic Recommendations
    • 3.3.3. Human Papillomavirus
      • 3.3.3.1. Disease Background and Statistics
      • 3.3.3.2. Instruments and Reagents for HPV Detection
        • 3.3.3.2.1. Hologic
        • 3.3.3.2.2. Qiagen
        • 3.3.3.2.3. Roche
        • 3.3.3.2.4. Cepheid
        • 3.3.3.2.5. AutoGenomics
        • 3.3.3.2.6. incellDx
        • 3.3.3.2.7. Fujirebio
        • 3.3.3.2.8. Greiner Bio-one
        • 3.3.3.2.9. Becton Dickinson
      • 3.3.3.3. HPV Market Size
      • 3.3.3.4. Market Challenges and Strategic Recommendations
        • 3.3.3.4.1. Market Drivers and Restraints
          • 3.3.3.4.1.1. Market Drivers
          • 3.3.3.4.1.2. Market Restraints
        • 3.3.3.4.2. Market and Technology Trends
          • 3.3.3.4.2.1. Market Trends
          • 3.3.3.4.2.2. Technology Trends
        • 3.3.3.4.3. Strategic Recommendations
    • 3.3.4. Influenza Viruses
      • 3.3.4.1. Disease Background and Statistics
      • 3.3.4.2. Instruments and Reagents for Influenza Detection
        • 3.3.4.2.1. Quest Diagnostics
        • 3.3.4.2.2. bioMérieux
        • 3.3.4.2.3. Cepheid
        • 3.3.4.2.4. Hologic
        • 3.3.4.2.5. Quidel
        • 3.3.4.2.6. Veredus Laboratories
        • 3.3.4.2.7. Alere (bought by Abbott)
        • 3.3.4.2.8. Luminex
        • 3.3.4.2.9. GenMark Diagnostic
        • 3.3.4.2.10. Nanosphere
        • 3.3.4.2.11. Roche
      • 3.3.4.3. Influenza Market Size
      • 3.3.4.4. Influenza Market Challenges and Strategic Recommendations
        • 3.3.4.4.1. Market Drivers and Restraints
          • 3.3.4.4.1.1. Market Drivers
          • 3.3.4.4.1.2. Market Restraints
        • 3.3.4.4.2. Market and Technology Trends
          • 3.3.4.4.2.1. Market Trends
          • 3.3.4.4.2.2. Technology Trends
        • 3.3.4.4.3. Strategic Recommendations
    • 3.3.5. STD Testing (including Chlamydia/Gonorrhea Molecular Diagnostic Testing)
      • 3.3.5.1. Disease Backgrounds and STD Statistics
        • 3.3.5.1.1. Chlamydia Disease Background and Statistics
        • 3.3.5.1.2. Gonorrhea Disease Background and Statistics
        • 3.3.5.1.3. Other STD Background and Statistics
          • 3.3.5.1.3.1. Herpes Simplex Virus
          • 3.3.5.1.3.2. Trichomoniasis
      • 3.3.5.2. Instruments and Reagents for STD Detection
        • 3.3.5.2.1. Becton Dickinson
        • 3.3.5.2.2. Roche Diagnostics
        • 3.3.5.2.3. Quest
        • 3.3.5.2.4. Hologic
        • 3.3.5.2.5. Siemens Healthcare
        • 3.3.5.2.6. Abbott
        • 3.3.5.2.7. Cepheid
        • 3.3.5.2.8. Quidel
        • 3.3.5.2.9. Luminex
        • 3.3.5.2.10. Qiagen
      • 3.3.5.3. Global STD (including Chlamydia/Gonorrhea) Molecular Diagnostic Testing Market
        • 3.3.5.3.1. Competitive Structure and Market Share Analysis
          • 3.3.5.3.1.1. Market Challenges
          • 3.3.5.3.1.2. Market Restraints
        • 3.3.5.3.2. Market and Technology Trends
          • 3.3.5.3.2.1. Market Trends
          • 3.3.5.3.2.2. Technology Trends
          • 3.3.5.3.2.3. Strategic Recommendations
    • 3.3.6. Tuberculosis
      • 3.3.6.1. Disease Background and Description
      • 3.3.6.2. Product Analysis: Instruments and Reagents
        • 3.3.6.2.1. Veredus Laboratories
        • 3.3.6.2.2. Abbott
        • 3.3.6.2.3. Seegene
        • 3.3.6.2.4. Cepheid
      • 3.3.6.3. Method Comparison
      • 3.3.6.4. Tuberculosis Market Size
      • 3.3.6.5. Competitive Structure and Market Share Analysis
      • 3.3.6.6. Market Challenges
        • 3.3.6.6.1. Market Drivers
        • 3.3.6.6.2. Market Restraints
      • 3.3.6.7. Market and Technology Trends
        • 3.3.6.7.1. Market Trends
        • 3.3.6.7.2. Technology Trends
      • 3.3.6.8. Strategic Recommendations
    • 3.3.7. Methicillin-Resistant Staphylococcus aureus (MRSA)
      • 3.3.7.1. Disease Background and Description
      • 3.3.7.2. Product Analysis: Instruments and Reagents
        • 3.3.7.2.1. Cepheid
        • 3.3.7.2.2. Roche
        • 3.3.7.2.3. Becton Dickinson
        • 3.3.7.2.4. Molecular Detection, Inc. (MDI)
      • 3.3.7.3. MRSA Market Size
      • 3.3.7.4. Competitive Structure and Market Share Analysis
      • 3.3.7.5. Market Challenges
        • 3.3.7.5.1. Market Drivers
        • 3.3.7.5.2. Market Restraints
      • 3.3.7.6. Market and Technology Trends
        • 3.3.7.6.1. Market Trends
      • 3.3.7.7. Strategic Recommendations
    • 3.3.8. Vancomycin-Resistant Enterococci
      • 3.3.8.1. Disease Background and Description
      • 3.3.8.2. Assay Kits
    • 3.3.9. C. difficile
      • 3.3.9.1. Product Analysis: Instruments and Reagents

4. Molecular Diagnostic Testing Technology for Infectious Disease Testing

  • 4.1. Infectious Disease Diagnostic Tests
    • 4.1.1. Molecular Diagnostic Tools Solutions
    • 4.1.2. Technology of Gene Expression Analysis
      • 4.1.2.1. Amplification and Detection of RNA
      • 4.1.2.2. Analysis of Multiple Genes
      • 4.1.2.3. Advanced Information Technology
  • 4.2. Use of Molecular Tests in Infectious Disease
    • 4.2.1. Molecular Screening
    • 4.2.2. Early Detection
    • 4.2.3. Detection of Specific Resistance Genes and Viral Loading Tests
    • 4.2.4. Pharmacogenomics and Personalized Medicine in Molecular Diagnostic Infectious Disease Testing
    • 4.2.5. Molecular Strain Typing
  • 4.3. Cost of Molecular Diagnostic Testing
  • 4.4. Use of Multiplex PCR Tests
    • 4.4.1. Advantages of Multiplex PCR
    • 4.4.2. Applications of Multiplex PCR
  • 4.5. Next-Generation Sequencing
  • 4.6. Patient Flow Software
  • 4.7. LAMP
  • 4.8. Ion Proton System for Gene Sequencing
  • 4.9. xMap Technology (Luminex)
  • 4.10. The Invader® Chemistry Platform (Hologic)

5. Business

  • 5.1. Technology and Market Trends
    • 5.1.1. Technology Trends
    • 5.1.2. Market Trends and Financial Considerations
  • 5.2. M&A Activity
  • 5.3. Partnerships
  • 5.4. Competitive Analysis
    • 5.4.1. Primary Competitors
    • 5.4.2. Industry Challenges and Strategic Recommendations
    • 5.4.3. Commercialization of Molecular Diagnostic Products
  • 5.5. Intellectual Property Rights
    • 5.5.1. Patents
  • 5.6. Opportunities and Strategic Recommendations
    • 5.6.1. The Key Technical Opportunities with Significant Market Appeal in the Molecular Diagnostic Space in the Next Five Years
    • 5.6.2. Developments for Molecular Diagnostic Instrumentation Products
    • 5.6.3. Market Penetration Strategies for Infectious Disease Testing
  • 5.7. Commercial Manufacturing of Molecular Diagnostics Infectious Disease Products: Requirements
    • 5.7.1. Elements of Commercial Manufacturing
      • 5.7.1.1. Regulatory Requirements
      • 5.7.1.2. Manufacturing Process Scale
      • 5.7.1.3. In-House Manufacturing
    • 5.7.2. Contract Manufacturing: Commercial and Academic
    • 5.7.3. Sales and Marketing Strategies for Infectious Disease Tests

6. Reimbursement and Billing Landscape for Molecular Diagnostics Testing for Infectious Disease

  • 6.1. Overview
    • 6.1.1. Gap Filling
  • 6.2. Trends in Reimbursement Practice
    • 6.2.1. Medicare Reimbursement Threats
    • 6.2.2. Analysis of ROI for Molecular Diagnostic Tests for Infectious Disease Using Current Medicare Reimbursement Rules
  • 6.3. Trends in Patient Care and Reimbursement
  • 6.4. Revenue Threats
    • 6.4.1. Medicare Payment Exceptions
    • 6.4.2. Three Areas for Denial of Claims
  • 6.5. Billing Rules
    • 6.5.1. Medicare Billing Procedures

7. Regulatory Requirements

  • 7.1. Food and Drug Administration
  • 7.2. CLIA Regulations
  • 7.3. Clinical Laboratory Improvement Act
  • 7.4. State Licensing for Service Laboratories
  • 7.5. IVDMIAs
  • 7.6. FDA Draft Guidance on In Vitro Companion Diagnostic Devices
  • 7.7. 510(k) Clearance
  • 7.8. Pre-Market Approval
  • 7.8.1. Pre-Market Approval Application
  • 7.9. Analyte Specific Reagents
  • 7.9.1. Laboratory Developed Tests
  • 7.10. What Regulatory Guidance is Needed for Companion Biomarkers?
  • 7.11. U.S. Patent and Trademark Office
  • 7.12. IRB Approval in Clinical Trials
  • 7.13. CE Marking and the European In Vitro Diagnostic Device Directive
  • 7.14. De Novo Classification
  • 7.15. Research Use Only Reagents
  • 7.16. FDA Recommendations on MRSA and SA Testing
  • 7.17. FDA Guidance on Molecular Diagnostic Instruments with Combined Functions

8. Business Decisions using Molecular Diagnostic Tests in Infectious Disease Testing

  • 8.1. What are Key Opportunities in Infectious Disease Testing Development and Commercialization?
  • 8.2. What are the Current Obstacles for Molecular Diagnostic Infectious Disease Testing Implementation?
  • 8.3. How do Business Strategies, Such as Those Relating to Acquisition, Drive Molecular Diagnostic Strategies?
  • 8.4. How might Novel Infectious Disease Molecular Diagnostic Test Development Lead to Acquisition Strategies and their Implications for Deal Making?
  • 8.5. How can Molecular Diagnostic Tests Increase Value in an Associated Drug Marketing Plan?
  • 8.6. Which Types of Infectious Disease Molecular Diagnostic Testing should be Developed by Diagnostic Companies at Various Stages in the Development Pipeline?
  • 8.7. How can Regulatory Oversight Drive Approval and Adoption of New Technologies?
  • 8.8. How will Platform Technology Companies Enter the Space?
  • 8.9. Will Pharma Integrate with Diagnostics?
  • 8.10. How do Platform Technology Companies Position Themselves for Diagnostics Development?
  • 8.11. Evaluate How Partnering and M&As will Alter the Competitive Landscape
  • 8.12. How can Big Pharma and Diagnostic Companies Co-Develop Biomarkers in a Model for Regulatory Acceptance?
  • 8.13. How to Maximize Business Development Through Biomarker Strategies?
  • 8.14. What is the Best Type of Business Model for Developing Genetic Biomarkers for Infectious Disease?
  • 8.15. How Best have Genetic Biomarkers Provided the Most Benefit in Infectious Disease Testing?
  • 8.16. What are the Most Innovative Methods in Development of Molecular Diagnostic Biomarkers?
  • 8.17. What are the Best Values for Genetic Biomarkers in Drug Development and in Diagnostics?
  • 9. Economics of Anti-Microbial Drug Resistance: The Persistent Need for Antibacterials
  • 9.1. Resistance and Antibiotic Usage
  • 9.2. Infection Control Programs

10. Company Profiles

  • 10.1. Abbott Laboratories
  • 10.2. AdvanDx
  • 10.3. Affymetrix
  • 10.4. AutoGenomics, Inc.
  • 10.5. Beckman Coulter
  • 10.6. Becton, Dickinson and Company
  • 10.7. bioMérieux
  • 10.8. Cepheid
  • 10.9. GenMark Diagnostics, Inc.
  • 10.10. Genomica S.A.U.
  • 10.11. Great Basin Corporation
  • 10.12. Grifols
  • 10.13. Hologic
  • 10.14. Illumina, Inc.
  • 10.15. Luminex Corp.
  • 10.16. Nanosphere
  • 10.17. Qiagen N.V.
  • 10.18. Quidel
  • 10.19. Roche Diagnostics (Roche Ltd.)
  • 10.20. Siemens AG
  • 10.21. Veredus Laboratories

INDEX OF FIGURES

  • Figure 2.1: Relationship of DNA Testing to Key Areas of Clinical Diagnosis
  • Figure 2.2: Finding Genes with Microassays
  • Figure 2.3: The Use of Microassays for Studying Gene Expression
  • Figure 2.4: Overall Structure of Nucleic Acid Testing Market
  • Figure 2.5: The PCR Cycle
  • Figure 2.6: Multiple Displacement Amplification
  • Figure 2.7: Using DNA Microassays to Measure Gene Expression
  • Figure 3.1: Global Market for Molecular Diagnostics, 2012-2020
  • Figure 3.2: Global Market for Molecular Diagnostics Testing, 2015
  • Figure 3.3: Share of Molecular Diagnostics Testing by Testing Type, 2015
  • Figure 3.4: Key Players Market Share in Global Molecular Diagnostics Testing Markets, 2015
  • Figure 3.5: Global Revenue for Molecular Diagnostics Testing for Infectious Disease, 2012-2020
  • Figure 3.6: U.S. Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2012-2020
  • Figure 3.7: Infectious Disease Testing Revenue Market Share of the Total U.S. Molecular Diagnostics Market, 2010 and 2020
  • Figure 3.8: European Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2012-2020
  • Figure 3.9: Japanese Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2012-2020
  • Figure 3.10: Rest of World (ROW) Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2012-2020
  • Figure 3.11: Infectious Disease Testing Revenue Market Share by Region, 2015
  • Figure 3.12: Total Global Infectious Disease Molecular Diagnostics Markets, 2015
  • Figure 3.13: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2015
  • Figure 3.14: Total Global Infectious Disease Molecular Diagnostics Markets, 2020
  • Figure 3.15: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2020
  • Figure 3.16: Global Population Living with HIV, 2001-2014
  • Figure 3.17: Global View of HIV Infection, 2013
  • Figure 3.18: Top Selling AIDS Drugs, 2014
  • Figure 3.19: CDC Recommendations for HIV Testing in Laboratories, 2014
  • Figure 3.20: Distribution of HIV Molecular Diagnostic Testing by Purpose
  • Figure 3.21: Estimated Market for Global HIV Molecular Diagnostic Testing, 2014-2020
  • Figure 3.22: Estimated Market for U.S. HIV Molecular Diagnostic Testing, 2014-2020
  • Figure 3.23: Global Market Share Viral Load HIV Molecular Diagnostic Testing
  • Figure 3.24: Geographic Distribution of Chronic HBV Infection
  • Figure 3.25: Global Prevalence of Hepatitis C
  • Figure 3.26: Incidence of Acute Hepatitis C in the U.S., 1982-2013
  • Figure 3.27: Primary Causes of Chronic Liver Disease
  • Figure 3.28: Global Market Share of HCV Molecular Diagnostic Market, 2015
  • Figure 3.29: Hybrid Capture 2 (HC2) versus PCR--Analytical Sensitivity and Clinical Sensitivity
  • Figure 3.30: Basic Steps in Hybrid Capture 2 Technology
  • Figure 3.31: Global Market Share Estimates for Molecular Diagnostic HPV Testing, 2015
  • Figure 3.32: Influenza Positive Tests Reported to the CDC, 2015-2016 Season
  • Figure 3.33: Number of Reported and Confirmed Cases of Influenza by Virus Sub-Type Worldwide, 2013
  • Figure 3.34: U.S. Rates of Sexually Transmitted Diseases, 1940-2012
  • Figure 3.35: Reported Cases of Chlamydia in the U.S. by Sex, 1994-2014
  • Figure 3.36: Reported Cases of Gonorrhea in the U.S. by Sex, 1994-2014
  • Figure 3.37: Global Market Share of Chlamydia/Gonorrhea Molecular Diagnostic Market, 2013
  • Figure 3.38: Global Estimated Tuberculosis Incidence Rates, 2014
  • Figure 3.39: Global Market Share of Tuberculosis Molecular Diagnostic Testing
  • Figure 3.40: Global Market Share of MRSA Molecular Diagnostic Market, 2015
  • Figure 3.41: Global Frequency of Vancomycin-Resistant Enterococci, 2006
  • Figure 4.1: Using DNA Microassays to Measure Gene Expression
  • Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients
  • Figure 4.3: Personalized Medicine in Treatment of Infectious Disease
  • Figure 5.1: FDA Co-Developed Products as a Model for Collaboration
  • Figure 6.1: Reimbursement for Diagnostics in Healthcare Decision Making 218 INDEX OF TABLES
  • Table 1.1: Market Trends in Infectious Disease DNA Testing
  • Table 1.2: Molecular Diagnostics Infectious Disease Market: Market Drivers Ranked in Order of Impact
  • Table 1.3: Molecular Diagnostics Infectious Disease Market: Market Restraints Ranked in Order of Impact
  • Table 1.4: Strategic Recommendations on Molecular Diagnostic Sector Business Functions
  • Table 2.1: Top Ten Causes of Death Worldwide, 2012
  • Table 2.2: Prevalent Infectious Diseases Worldwide
  • Table 2.3: Emerging Molecular Diagnostic Technologies
  • Table 2.4: DNA Microarray Applications
  • Table 2.5: Companies Involved in Next Generation Sequencing Platforms
  • Table 2.6: Desired Characteristics for Clinical Versus Discovery Next Generation Sequencing
  • Table 2.7: Automated Molecular Diagnostics Platforms for Infectious Disease Testing
  • Table 2.8: Companies Marketing Products in Molecular Diagnostics Infectious Disease Sector
  • Table 2.9: FDA-Approved Molecular Diagnostic Commercial Kits for the Detection of Infectious Agents
  • Table 2.10: Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
  • Table 2.11: Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
  • Table 2.12: Attractive Growth Areas for Molecular Diagnostic Testing
  • Table 3.1: Global Market for Molecular Diagnostics Testing, 2012-2020
  • Table 3.2: U.S. Market for Molecular Diagnostics Testing, 2012-2020
  • Table 3.3: European Market for Molecular Diagnostics Testing, 2012-2020
  • Table 3.4: Japanese Market for Molecular Diagnostics Testing, 2012-2020
  • Table 3.5: Summary of Molecular Diagnostics Testing Sectors
  • Table 3.6: Share of Global Molecular Diagnostics Testing by Testing Type, 2015
  • Table 3.7: Key Players and Market Share in Global Molecular Diagnostics Testing Market, 2015
  • Table 3.8: Revenue Model for Molecular Diagnostics Testing
  • Table 3.9: Molecular Infectious Disease Diagnostics Market: Market Drivers Ranked in Order of Impact
  • Table 3.10: Molecular Infectious Disease Diagnostics Market: Market Restraints Ranked in Order of Impact
  • Table 3.11: Global Revenue for Molecular Diagnostics Testing for Infectious Disease, 2012-2020
  • Table 3.12: U.S. Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2012-2020
  • Table 3.13: European Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2012-2020
  • Table 3.14: Japanese Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2012-2020
  • Table 3.15: Rest of World (ROW) Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2012-2020
  • Table 3.16: Molecular Diagnostic Markets for Infectious Disease Testing, 2015
  • Table 3.17: Molecular Diagnostic Markets for Infectious Disease Testing, 2020
  • Table 3.18: Business Factors Influencing Advanced Infectious Disease MDx Testing Services
  • Table 3.19: Global Summary of the HIV/AIDS Epidemic, 2014
  • Table 3.20: Global HIV Statistics, 2014
  • Table 3.21: Estimated Number of New HIV Cases in the U.S. by Age, 2014
  • Table 3.22: Top Ten States with New HIV Cases in the U.S., 2014
  • Table 3.21: HIV Resistance Testing Recommendations
  • Table 3.22: Summary of HIV Viral Load, Genotyping, and Donor Screening Molecular Assays
  • Table 3.23: Global Market for Molecular Diagnostic HIV Testing, 2014-2020
  • Table 3.24: U.S. Market for HIV Molecular Diagnostic Testing, 2014-2020
  • Table 3.25: HIV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
  • Table 3.26: HIV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
  • Table 3.27: Estimated Number of New Cases of HBV in the U.S., 2011-2013
  • Table 3.28: Lower Detection Limits of HBV DNA Assays
  • Table 3.29: Clinical Application of Quantitative HBV DNA Testing
  • Table 3.30: Summary of Molecular Diagnostic Assays for Testing HBV
  • Table 3.31: Global Market for HBV Diagnostic Testing, 2014-2020
  • Table 3.32: U.S. Market for HBV Diagnostic Testing, 2014-2020
  • Table 3.33: HBV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
  • Table 3.34: HBV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
  • Table 3.35: Worldwide Rate of HCV Cases
  • Table 3.36: Commercially Available Molecular Diagnostic Products for HCV Assay
  • Table 3.37: Global Market for NAT HCV Diagnostic Testing, 2014-2020
  • Table 3.38: U.S. Market for NAT HCV Diagnostic Testing, 2014-2020
  • Table 3.39: HCV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
  • Table 3.40: HCV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
  • Table 3.41: Recommendations for HCV Diagnostic Testing
  • Table 3.42: Commercially Available Molecular Diagnostic Products for HPV Assay
  • Table 3.43: Global Market for HPV Molecular Diagnostic Testing, 2014-2020
  • Table 3.44: U.S. Market for HPV Molecular Diagnostic Testing, 2014-2020
  • Table 3.45: HPV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
  • Table 3.46: HPV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
  • Table 3.47: Commercially Available Molecular Diagnostic Products for Influenza Assay
  • Table 3.48 Global Market for Influenza Molecular Diagnostic Testing, 2014-2020
  • Table 3.49: U.S. Market for Influenza Molecular Diagnostic Testing, 2014-2020
  • Table 3.50: Influenza Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
  • Table 3.51: Influenza Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
  • Table 3.52: Commercially Available Molecular Diagnostic Assays for STDs
  • Table 3.53: Global Market for STD Molecular Diagnostic Testing, 2014-2020
  • Table 3.54: U.S. Market for STD Molecular Diagnostic Testing, 2014-2020
  • Table 3.55: STD Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
  • Table 3.56: STD Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
  • Table 3.57: Commercially Available Molecular Diagnostic Assays for Testing TB
  • Table 3.58 Global Market for Tuberculosis Molecular Diagnostic Testing, 2014-2020
  • Table 3.59: U.S. Market for Tuberculosis Molecular Diagnostic Testing, 2014-2020
  • Table 3.60: Tuberculosis Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
  • Table 3.61: Tuberculosis Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
  • Table 3.62: Global Market for MRSA Diagnostic Testing, 2014-2020
  • Table 3.63: U.S. Market for MRSA Diagnostic Testing, 2014-2020
  • Table 3.64: MRSA Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
  • Table 3.65: MRSA Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
  • Table 3.66: In Vitro Susceptibility of Staphylococci to New Agents in Development
  • Table 4.1: Key Elements for Business Competition in Molecular Diagnostic Testing for Infectious Disease
  • Table 4.2: Key Elements for Future Success in Molecular Testing for Infectious Disease
  • Table 4.3: Examples of Personalized Medicine in Treatment of Infectious Disease
  • Table 4.4: Molecular Methods for Epidemiologic Typing of Microorganisms
  • Table 4.5: Drivers of Molecular Diagnostic Methods for Infectious Disease Testing in the Clinical Setting
  • Table 4.6: Barriers to Molecular Diagnostic Methods for Infectious Disease Testing in the Clinical Setting
  • Table 5.1: Technology Trends in Molecular Diagnostic Infectious Disease Testing
  • Table 5.2: Clinical Testing Trends in Molecular Diagnostic Infectious Disease Testing
  • Table 5.3: Business Market Trends in Molecular Diagnostics Infectious Disease Testing
  • Table 5.4: Expected Changes in Healthcare
  • Table 5.5: Lab Customer Feedback for Automated Molecular Diagnostic Instruments
  • Table 5.6: Molecular Diagnostics Infectious Disease Market: Market Drivers Ranked in Order of Impact
  • Table 5.7: Molecular Diagnostics Infectious Disease Market: Market Restraints Ranked in Order of Impact
  • Table 5.8: Advantages of European Markets for Molecular Diagnostic Testing
  • Table 5.9: Disadvantages of European Markets for Molecular Diagnostic Testing
  • Table 5.10: Summary of Recent M&A Activity in the Molecular Diagnostics Sector
  • Table 5.11: High Value Opportunities in Collaborative and Strategic Partnerships
  • Table 5.12: Principal Competitive Factors in the Molecular Diagnostics Infectious Disease Testing Market
  • Table 5.13: Molecular Diagnostics Infectious Disease Testing Market: Strategic Recommendations on Molecular Diagnostic Sector Business Functions
  • Table 5.14: Molecular Diagnostics Infectious Disease Market: Impact of Top Industry Challenges in the U.S.
  • Table 5.15: Documents for Protecting Intellectual Property Rights
  • Table 5.16: Patents Related to PCR, Nucleic Acid Amplification and Sample Prep
  • Table 5.17: Specific Opportunities for Automated Instrumentation and Reagent Systems in Molecular Diagnostics for Infectious Disease Testing
  • Table 5.18: The Required Elements of a Manufacturing Facility
  • Table 5.19: CMO Qualification Audit: Points to Investigate
  • Table 5.20: Strategies and POA for Marketing Infectious Disease Diagnostic Products
  • Table 5.21: Key Elements of Molecular Diagnostic Companies Marketing Plan
  • Table 6.1: Factors Determining Third-Party Payment for Molecular Diagnostic Tests for Infectious Disease
  • Table 7.1: Regulatory Rules that Affect the Ability of a Diagnostic Testing Reagent Company to Conduct Business
  • Table 7.2: Strengths of the 510k Process
  • Table 7.3: Drawbacks of the 510k Process
  • Table 7.4: Focus Areas for the FDA Critical Path Initiative
  • Table 8.1: Impediments to Incorporating Promising Molecular Tests into Clinical Practice
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