表紙
市場調査レポート

分子診断市場

Molecular Diagnostics Markets

発行 TriMark Publications 商品コード 203892
出版日 ページ情報 英文 403 Pages
納期: 即日から翌営業日
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本日の銀行送金レート: 1USD=107.50円で換算しております。
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分子診断市場 Molecular Diagnostics Markets
出版日: 2013年11月01日 ページ情報: 英文 403 Pages
概要

第一世代の増幅、DNAプローブ、第二世代のバイオチップ、マイクロ流体、バイオセンサーなどの分子診断技術は、治療用分子の発見や患者のスクリーニングおよび診断、および投薬療法の最適化に影響を及ぼします。ここ数年で、同分野ではいくつかの画期的な開発が進められています。

当レポートは、世界の分子診断市場について調査し、分子診断のプラットフォーム技術の調査による実行可能な技術促進因子を特定しており、主な分子診断検査、実現可能な市場機会、世界の主要な分子診断市場の詳細分析と成長予測などを、概略下記の内容でお届けします。

第1章 概要

  • 調査内容
  • 当レポートについて
  • 調査範囲
  • 目的
  • 調査手法
  • エグゼクティブサマリー

第2章 分子診断およびPCR技術に関するイントロダクション

  • ゲノミクスとその機会:イントロダクション
  • 遺伝的変異性と病気
  • 分子診断に及ぼすヒトゲノムプロジェクトの影響
  • 分子診断の主な懸念事項
  • ポストゲノム時代の分子診断
  • 分子診断技術の発展
  • 分子診断検査技術とプラットフォーム
  • PCR試薬
  • 基本的な分子検査のワークフロー
  • 技術
  • 自動検査の進歩

第3章 分子診断市場のビジネス情勢

  • 市場概要
  • 分子診断市場:規模・成長・シェア・競合企業
  • 分子診断産業構造の概要
  • 商業化・市場浸透戦略
  • 市場成長の促進因子・阻害因子
  • 戦略的提言
  • 将来の課題は何か?
  • 将来の新しい動向は?
  • 近年の産業活動
  • 分子診断の将来に影響を及ぼす主な領域
  • 知的財産権

第4章 市場における臨床分子診断のプラットフォームの概要

  • Abbott
  • Affymetrix Gene Profiling Solutions
  • AutoGenomics
  • Becton Dickinson
  • Biomerieux
  • Cepheid
  • GenMark Dx
  • Hologic Gen-Probe
  • Illumina
  • Life Technologies/Applied Biosystems
  • Meridian Bioscience
  • Nanosphere
  • Qiagen
  • Roche
  • Siemens

第5章 分子診断検査・感染症

  • 感染症市場の分子検査
  • HIV分子検査
  • 肝炎分子検査
  • インフルエンザウィルス分子検査
  • 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(VRE)
  • 単純疱疹(ヘルペス)ウイルス(HSV)
  • クロストリジウムディフィシル
  • サイトメガロウイルス
  • 血液スクリーニング
  • ヒトパピロマーウィルス(HPV)

第6章 分子診断を用いた癌検知

  • 乳がん
  • 大腸癌
  • 前立腺癌
  • その他の癌
  • 癌の分子診断スクリーニング検査
  • 癌治療の比較診断検査

第7章 分子診断における遺伝子検査

  • 分子遺伝子検査の主な機能
  • 市場構造・競合状況
  • 拡大する遺伝子検査市場セグメント
  • 遺伝子疾患向けの主な診断・キャリア検査
  • 着床前遺伝子検査
  • 出生前/子宮内分子診断スクリーニング検査
  • 新生児遺伝子スクリーニング検査

第8章 産業検査・食品診断に用いられる分子診断

  • 市場
  • 分子診断フォレンジック検査市場

第8章 バイオテロリズムと分子診断

  • イントロダクション
  • 現在の生物学的脅威検知システム
  • 迅速な側方流動免疫測定法
  • バイオセンサー
  • 臨床サンプルにおける炭疽菌

第10章 規制要件

第11章 分子診断検査の医療費償還問題と請求情勢

第12章 企業プロファイル

図表

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目次
Product Code: TMRMDM13-1101

The technologies that constitute molecular diagnostics--like first-generation amplification, DNA probes, fluorescent in situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors, and molecular labels--are influencing the discovery of therapeutic molecules, the screening and diagnosis of patients, and the optimization of drug therapy. In the past few years, this rapidly evolving field has seen several fascinating developments. This TriMark Publications report describes the specific market segment of the in vitro diagnostics market known as molecular diagnostics and includes all of the generally accepted clinical analytical activities in use today. It examines the prevalent clinical-measurement devices, as well as their reagents and supplies as utilized in hospitals, clinics, large reference laboratories and doctor's offices. Diagnostic tests marketed primarily as over-the-counter are generally not included in this report, although there is inevitably some overlap. The main objectives of this analysis are: 1) identifying viable technology drivers through a comprehensive look at platform technologies for molecular diagnostics, including probe-based nucleic acid assays, microarrays and sequencing; 2) obtaining a complete understanding of the chief molecular diagnostics tests--i.e., predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic--from their basic principles to their applications; 3) discovering feasible market opportunities by identifying high-growth applications in different clinical diagnostic areas and by focusing on expanding markets, such as communicable diseases, cardiology and oncology; and 4) focusing on global industry development through an in-depth analysis of the major world markets for molecular diagnostics, including growth 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 and PCR Technology

  • 2.1. Introduction to Genomics and Its Opportunity
  • 2.2. Genetic Variability and Disease
  • 2.3. Impact of the Human Genome Project on Molecular Diagnostics
  • 2.4. Key Considerations for Molecular Diagnostics
  • 2.5. Molecular Diagnostics in the Post-Genomic Era
  • 2.6. Advances in Molecular Diagnostics Technologies
  • 2.7. Molecular Diagnostics Testing Technologies and Platforms
    • 2.7.1. Amplification Technologies
      • 2.7.1.1. PCR and PCR Derivative Platforms
      • 2.7.1.2. Multiple Displacement Amplification
      • 2.7.1.3. Multiple Annealing and Looping-based Amplification Cycles
      • 2.7.1.4. Whole Genome Amplification
      • 2.7.1.5. Nucleic Acid Sequence-based Amplification
      • 2.7.1.6. Ligase Chain Reaction
      • 2.7.1.7. Branched DNA
      • 2.7.1.8. Bio-Barcode Amplification Assay
    • 2.7.2. Detection of Amplified Gene Products
      • 2.7.2.1. High Resolution Melting Analysis
      • 2.7.2.2. Microparticle-based Flow Cytometry
    • 2.7.3. DNA and Oligonucleotide Microarrays and Chips
      • 2.7.3.1. Array Comparative Genomic Hybridization
    • 2.7.4. Gene Sequencing
      • 2.7.4.1. Sanger Sequencing
      • 2.7.4.2. Next Generation Sequencing
    • 2.7.5. Fluorescence in situ Hybridization
  • 2.8. PCR Reagents
  • 2.9. Basic Molecular Testing Work Flow
  • 2.10. Techniques
  • 2.11. Advances in Automated Testing

3. Business Landscape for the Molecular Diagnostics Market Sectors

  • 3.1. Market Overview
  • 3.2. Molecular Diagnostics Market: Size, Growth, Share, and Competitors
    • 3.2.1. Global Molecular Diagnostics Market
    • 3.2.2. U.S. Molecular Diagnostics Market
    • 3.2.3. Market Share
    • 3.2.4. Competitive Environment
    • 3.2.5. Marketing Strategies
  • 3.3. Snapshot of Molecular Diagnostics Industry Structure
  • 3.4. Commercialization and Market Penetration Strategies
    • 3.4.1. Partnerships
  • 3.5. Market Drivers and Restraints
  • 3.6. Market and Technology Trends
    • 3.6.1. Market Trends
    • 3.6.2. Technology Trends
  • 3.7. Strategic Recommendations
  • 3.8. What are the Challenges for the Future?
  • 3.9. What New Trends are in the Future?
  • 3.10. Recent Industry Activity
    • 3.10.1. M&A Activity
    • 3.10.2. License Agreements and Partnerships
  • 3.11. Key Areas Impacting Future of Molecular Diagnostics
    • 3.11.1. Pharmacogenetics and Pharmacogenomics
      • 3.11.1.1. Current Applications for Pharmacogenetics and Pharmacogenomics
      • 3.11.1.2. Pharmacogenomics and Personalized Medicine in MDx Infectious Disease Testing
      • 3.11.1.3. Companion Diagnostics and Personalized Medicine in the Oncology Sector
    • 3.11.2. Toxicogenomics
    • 3.11.3. Multiplex Molecular Diagnostics
    • 3.11.4. Point of Care Readers and Assays
    • 3.11.5. Next Generation Sequencing
  • 3.12. Intellectual Property Rights
    • 3.12.1. New Patents
    • 3.12.2. Current Patent Disputes

4. Overview of Clinical Molecular Diagnostic Platforms on the Market

  • 4.1. Abbott
    • 4.1.1. m2000 RealTime System
  • 4.2. Affymetrix Gene Profiling Solutions
    • 4.2.1. GeneChip System 3000Dx v.2
    • 4.2.2. Gene Profiling Array cGMP U133 P2
    • 4.2.3. Affymetrix Gene Profiling Reagents
  • 4.3. AutoGenomics
    • 4.3.1. INFINITI Plus Analyzer
  • 4.4. Becton Dickinson
    • 4.4.1. BD MAX System
    • 4.4.2. BD Viper System
    • 4.4.3. BD Affirm VPIII Microbial Identification System
    • 4.4.4. BD ProbeTec ET System
  • 4.5. Biomerieux
    • 4.5.1. NucliSENS EasyQ
    • 4.5.2. NucliSENS easyMAG
  • 4.6. Cepheid
    • 4.6.1. GeneXpert System
    • 4.6.2. SmartCycler System
  • 4.7. GenMark Dx
    • 4.7.1. eSensor XT-8 System
  • 4.8. Hologic Gen-Probe
    • 4.8.1. PANTHER System
    • 4.8.2. TIGRIS DTS System
  • 4.9. Illumina
    • 4.9.1. MiSeqDx Instrument
  • 4.10. Life Technologies/Applied Biosystems
    • 4.10.1. QuantStudio Dx Real-Time PCR
    • 4.10.2. Veriti Dx PCR Thermal Cycler
    • 4.10.3. 3500 Dx Genetic Analyzers CS2
    • 4.10.4. 7500 Fast Dx Real-Time PCR System
  • 4.11. Meridian Bioscience
    • 4.11.1. Illumipro-10
  • 4.12. Nanosphere
    • 4.12.1. Verigene System
  • 4.13. Qiagen
    • 4.13.1. Rotor-Gene Q MDx
    • 4.13.2. Rapid Capture System & Hybrid Capture 2 Modular System
  • 4.14. Roche
    • 4.14.1. COBAS 4800 System
    • 4.14.2. COBAS AmpliPrep / COBAS TaqMan System
    • 4.14.3. COBAS AMPLICOR Analyzer
    • 4.14.4. LightCycler 2.0 Instrument
  • 4.15. Siemens
    • 4.15.1. VERSANT 440 Molecular System

5. Molecular Diagnostic Testing and Infectious Diseases

  • 5.1. Molecular Testing of Infectious Disease Market
  • 5.2. HIV Molecular Testing
    • 5.2.1. Summary of Assays and Platforms
    • 5.2.2. HIV Molecular Diagnostics Market and Technology Trends
      • 5.2.2.1. Market Trends
      • 5.2.2.2. Technology Trends
      • 5.2.2.3. Strategic Recommendations
  • 5.3. Hepatitis Molecular Testing
    • 5.3.1. Hepatitis B Virus
      • 5.3.1.1. HBV Molecular Assays and Platforms
      • 5.3.1.2. Hepatitis B Market
    • 5.3.2. Hepatitis C Virus
      • 5.3.2.1. HCV Molecular Assays
      • 5.3.2.2. Hepatitis C Market
  • 5.4. Influenza Virus Molecular Testing
    • 5.4.1. Assays for Influenza Detection
    • 5.4.2. Influenza Molecular Diagnostic Market
      • 5.4.2.1. Market Trends
      • 5.4.2.2. Technology Trends
      • 5.4.2.3. Strategic Recommendations
  • 5.5. STD Testing (Chlamydia/Gonorrhea Molecular Diagnostic Testing)
    • 5.5.1. CT/NG Testing Competitive Structure and Market Share Analysis
      • 5.5.1.1. CT/NG Testing Market Trends
      • 5.5.1.2. Technology Trends
      • 5.5.1.3. Strategic Recommendations
    • 5.5.2. Chlamydia Molecular Diagnostic Testing
      • 5.5.2.1. Product Analysis: Instruments and Reagents for Testing Chlamydia
    • 5.5.3. Gonorrhea Molecular Diagnostic Testing
    • 5.5.4. Product Analysis: Instruments and Reagents
  • 5.6. Tuberculosis
    • 5.6.1. Product Analysis: Instruments and Reagents
    • 5.6.2. Tuberculosis Market
      • 5.6.2.1. Market Trends
      • 5.6.2.2. Technology Trends
      • 5.6.2.3. Strategic Recommendations
  • 5.7. Methicillin-Resistant Staphylococcus aureus
    • 5.7.1. Product Analysis: Instruments and Reagents
    • 5.7.2. MRSA Molecular Diagnostics Market
      • 5.7.2.1. Market Trends
      • 5.7.2.2. Technology Trends
      • 5.7.2.3. Strategic Recommendations
  • 5.8. Vancomycin-resistant Enterococci
    • 5.8.1. Product Analysis: Instruments and Reagents
    • 5.8.2. VRE Molecular Testing Market
      • 5.8.2.1. Market Trends
      • 5.8.2.2. Technology Trends
      • 5.8.2.3. Strategic Recommendations
  • 5.9. Herpes Simplex Virus
  • 5.10. C. difficile
  • 5.11. Cytomegalovirus
  • 5.12. Blood Screening
    • 5.12.1. Product Analysis: Instruments and Reagents
    • 5.12.2. Blood Screening Market
      • 5.12.2.1. Market Trends
      • 5.12.2.2. Technology Trends
      • 5.12.2.3. Strategic Recommendations
  • 5.13. Human Papillomavirus
    • 5.13.1. Molecular Instruments and Reagents for HPV Detection
    • 5.13.2. HPV Market
      • 5.13.2.1. North American Market
      • 5.13.2.2. European Market
      • 5.13.2.3. Market Trends
      • 5.13.2.4. Technology Trends
      • 5.13.2.5. Strategic Recommendations

6. Cancer Detection Using Molecular Diagnostics

  • 6.1. Breast Cancer
    • 6.1.2. Breast Cancer Prognostic Assays
      • 6.1.2.1. Myriad Genetics (BRACA1 and BRACA2)
      • 6.1.2.2. Genomic Health (Oncotype DX)
      • 6.1.2.3. InterGenetics, Inc.
      • 6.1.2.4. LabCorp (HER-2)
      • 6.1.2.5. Clarient, Inc. (GE Healthcare)
      • 6.1.2.6. BioTheronostics (AviaraDx)
      • 6.1.2.7. Agendia B.V. (MammaPrint)
      • 6.1.2.8. Oncogene Science (Wilex)
      • 6.1.2.9. Ventana Medical Systems
    • 6.1.3. Competition and Comparison of Methods
    • 6.1.4. Competitive Structure and Market Share Analysis
      • 6.1.4.1. Breast Cancer Molecular Diagnostic Testing Market Size
      • 6.1.4.2. Market Forecasts
      • 6.1.4.3. Market Drivers and Restraints
      • 6.1.4.4. Breast Cancer Molecular Diagnostic Testing Assay Market and Technology Trends
  • 6.2. Colorectal Cancer Molecular Diagnostics Market
    • 6.2.1. Colon Cancer Testing Platforms
      • 6.2.1.1. Genomic Testing
      • 6.2.1.2. Screening Test
    • 6.2.2. Players in the Colorectal Cancer Space
    • 6.2.3. Competitive Structure and Market Share Analysis
      • 6.2.3.1. Colon Cancer Molecular Diagnostic Testing Market Size
      • 6.2.3.2. Market Forecasts
      • 6.2.3.4. Market Drivers and Restraints
      • 6.2.3.5. Colon Cancer Molecular Diagnostic Testing Assay Market and Technology Trends
  • 6.3. Prostate Cancer Molecular Diagnostics Market
    • 6.3.1. Screening for Prostate Cancer
      • 6.3.1.1. PSA Screening Test for Prostate Cancer
      • 6.3.1.2. PCA3 Screening Test for Prostate Cancer
      • 6.3.1.3. Gen-Probe
      • 6.3.1.4. Beckman Coulter (Danaher) Prostate Health Index
      • 6.3.1.5. Opko Health 4KScore
      • 6.3.1.6. Metabolon Prostarix DRE Urine Test
    • 6.3.2. Tests after Positive Biopsy
      • 6.3.2.1. Myriad Genetics (Prolaris)
      • 6.3.2.2. Genomic Health (Genomic Prostate Score)
      • 6.3.2.3. Bostwick Laboratories (ProstaVysion)
      • 6.3.2.4. Metamark Genetics (Biopsy Test)
    • 6.3.3. Tests After Negative Biopsy
      • 6.3.3.1. Mitomics (Prostate Core Test)
      • 6.3.3.2. MDxHealth (Confirm MDx)
    • 6.3.4. Tests After Surgery
      • 6.3.4.1. GenomeDx Sciences (Decipher)
      • 6.3.4.2. Iris International (Nadia ProsVue)
    • 6.3.5. Competition and Comparison of Methods
    • 6.3.6. Competitive Structure and Market Share Analysis
    • 6.3.7. Market Drivers and Restraints
      • 6.3.7.1. Market Drivers
      • 6.3.7.2. Market Restraints
    • 6.3.8. Prostate Cancer Molecular Diagnostic Testing Assay Market and Technology Trends
      • 6.3.8.1. Prostate Cancer Molecular Diagnostic Testing Assay Market Trends
      • 6.3.8.2. Prostate Cancer Molecular Diagnostic Testing Assay Technology Trends
      • 6.3.8.3. Prostate Cancer Testing Assay Strategic Recommendations
  • 6.4. Other Cancer Molecular Diagnostic Markets
    • 6.4.1. Bladder Cancer
    • 6.4.2. Lung Cancer
    • 6.4.3. Melanoma
  • 6.5. Molecular Diagnostic Screening Test for Cancer
  • 6.6. Companion Diagnostic Tests for Cancer Therapeutics

7. Genetics Testing in Molecular Diagnostics

  • 7.1. Key Functions of Molecular Genetic Testing
    • 7.1.1. Diagnostic Testing of Genetic Disorders
      • 7.1.1.1. Common Genetic Disorders
    • 7.1.2. Carrier Testing for Genetic Disorders
    • 7.1.3. Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening
    • 7.1.4. Prenatal/In utero Genetic Testing
    • 7.1.5. Newborn Genetic Screening Tests
    • 7.1.6. Presymptomatic and Predictive Testing for Adult Onset Disorders
    • 7.1.7. Pharmacogenomics
    • 7.1.8. Tissue and Blood Typing
      • 7.1.8.1. Human Leukocyte Antigen Determination
      • 7.1.8.2. Rhesus D Factor Determination
    • 7.1.9. Parentage/Relationship Testing (Paternity Testing)
    • 7.1.10. Genealogical DNA Testing
    • 7.1.11. Criminal and Forensics Testing
  • 7.2. Market Structure and Competitive Situation
    • 7.2.1. Primary Competitors
    • 7.2.2. Commercialization Strategies for Molecular Diagnostic Products
    • 7.2.3. Market Penetration Strategies for Genetic Testing
  • 7.3. Growing Genetic Testing Market Segments
    • 7.3.1. Personalized Medicine and Companion Diagnostics Market
    • 7.3.2. Predictive Molecular Diagnostics Market
    • 7.3.3. Parallel Genetic Tests for Drug Development
    • 7.3.4. Direct-to-Consumer Genetic Testing Market
    • 7.3.5. Detecting Genetic Disorders
    • 7.3.6. Pre-natal Screening
    • 7.3.7. Neonatal Screening
    • 7.3.8. Forensic Testing
    • 7.3.9. Parentage Testing
    • 7.3.10. Blood and Tissue Typing
    • 7.3.11. DNA Sequencing
  • 7.4. Select Diagnostic and Carrier Tests for Genetic Disorders
    • 7.4.1. CombiMatrix Diagnostics' DNAarray™ Pediatric Microarray Oligo 105K
    • 7.4.2. GeneDx's Genetic Testing for Hereditary Disorders
    • 7.4.3. Hologic's Factor V Reagents
    • 7.4.4. Progenika's FH Test
    • 7.4.5. Abbott Molecular's Cystic Fibrosis Genotyping Assay
    • 7.4.6. Counsyl's Universal Genetic Test
    • 7.4.7. Hologic's InPlex® CF Molecular Test
    • 7.4.8. Integrated Genetic's Inheritest Carrier Screen
    • 7.4.9. Luminex's xTAG Cystic Fibrosis (CFTR) v2 Assays
    • 7.4.10. Natera's Natera One Multi-Disease Genetic Carrier Screening Panel
    • 7.4.11. Sequenom's Heredi-T Cystic Fibrosis Carrier Screen Test
    • 7.4.12. Summary of Cystic Fibrosis Tests
  • 7.5. Pre-implantation Genetic Tests
    • 7.5.1. Natera's Preimplantation Genetic Diagnosis Test
  • 7.6. Prenatal/In Utero Molecular Genetic Screening Tests
    • 7.6.1. Cell-Free Fetal DNA Testing
      • 7.6.1.1. Ariosa Diagnostics' Harmony Prenatal Test
      • 7.6.1.2. Natera's Panorama
      • 7.6.1.3. Sequenom's MaterniT21 PLUS Test
      • 7.6.1.4. Verinata Health's verifi Prenatal Test
    • 7.6.2. Molecular Cytogenetic Tests
      • 7.6.2.1. Abbott Molecular's AneuVysion Multicolor DNA Probe Panel
      • 7.6.2.2. CombiMatrix Diagnostics' DNAarray Prenatal Microarrays
      • 7.6.2.3. Signature Genomics' Signature Precision Panel I Prenatal
      • 7.6.2.4. Signature Genomics' Signature PrenatalChip TE (Targeted Enhanced) Microarray
      • 7.6.2.5. Signature Genomics' Signature PrenatalChip OS Microarray
  • 7.7. Newborn Genetic Screening Tests
    • 7.7.1. Screening for Cystic Fibrosis with Molecular Diagnostic Assays
    • 7.7.2. Screening for SCID with the TREC Assay
      • 7.7.2.1. PerkinElmer Genetics

8. Molecular Diagnostics Uses in Industrial Testing and Food Diagnostics

  • 8.1. The Market
    • 8.1.1. Detection of Helicobacter pylori by PCR
    • 8.1.2. Detection of Escherichia coli 0157
    • 8.1.3. Detection of Enteric Viruses
    • 8.1.4. Industrial Microorganisms
  • 8.2. Molecular Diagnostics Forensics Testing Market
    • 8.2.1. Analysis by PCR-based DNA Typing
    • 8.2.2. Rapid Isolation of DNA for Restriction Fragment Length Polymorphism (RFLP) and PCR
    • 8.2.3. DNA for PCR-STR Typing

9. Bioterrorism and Molecular Diagnostics

  • 9.1. Introduction
  • 9.2. Current Biological Threat Detection Systems
    • 9.2.1. Use of DNA Microarrays and Biochips for Gene Expression Profiles in BWAs
    • 9.2.2. Advantages and Disadvantages of Host Gene Expression Profiling as a Biothreat Detection
    • 9.2.3. Biological Warfare Agents
    • 9.2.4. Anthrax
    • 9.2.5. Botulinum Toxin
    • 9.2.6. Ricin
    • 9.2.7. IVD Industry and Bioterrorism Preparedness
    • 9.2.8. Brucellosis
    • 9.2.9. Cholera
  • 9.3. Rapid Lateral Flow Immunoassays
  • 9.4. Biosensors
  • 9.5. Anthrax in Clinical Samples
    • 9.5.1. Rapid Tests

10. Regulatory Requirements

  • 10.1. U.S. Food and Drug Administration
    • 10.1.1. FDA Labeling Requirements
    • 10.1.2. U.S. Government Regulation of Medical Devices
    • 10.1.3. FDA's Qualification of Biomarkers
    • 10.1.4. FDA's Voluntary Genomic Data Submission
  • 10.2. Clinical Laboratory Improvement Act
  • 10.3. CLIA Regulations
  • 10.4. State Licensing for Service Laboratories
  • 10.5. Multivariate Index Assays
  • 10.6. FDA Draft Guidance on In Vitro Companion Diagnostic Devices
  • 10.7. FDA Draft Guidance on Molecular Diagnostic Instruments with Combined Functions
  • 10.8. 510(k) Clearance
  • 10.9. Pre-Market Approval
  • 10.10. Pre-market Approval Application
  • 10.11. Laboratory Developed Tests
  • 10.12. Analyte Specific Reagents
  • 10.13. What Regulatory Guidance is needed for Companion Biomarkers?
  • 10.14. IRB Approval in Clinical Trials
  • 10.15. CE marking and the European In Vitro Diagnostic Device Directive
  • 10.16. De Novo Classification
  • 10.17. Research Use Only Reagents
  • 10.18. Ethical, Legal and Social Issues Related to the Use of Genetic Information
  • 10.19. Regulatory Issues for Direct to the Consumer Genetic Tests
  • 10.20. The Genetic Information Nondiscrimination Act of 2008
  • 10.21. Genetic Tests and Medical Records
  • 10.22. Recommendations by the American College of Medical Genetics and Genomics

11. Reimbursement Issues and Billing Landscape for Molecular Diagnostics Testing

  • 11.1. Overview
    • 11.1.1. Gap Filling
  • 11.2. Trends in Healthcare Reimbursement Practices
    • 11.2.1. Molecular Genetics Testing Reimbursement
  • 11.3. Medicare Reimbursement Program
  • 11.4. Medicare Billing Procedure
  • 11.5. CPT Coding Rules for Molecular Diagnostics
    • 11.5.1. Former Coding Rules for Molecular Diagnostics
    • 11.5.2. Current Coding Rules for Molecular Diagnostics
      • 11.5.2.1. Gapfilling
      • 11.5.2.2. Reimbursement Delays for Molecular Diagnostics
  • 11.6. Revenue Threats
    • 11.6.1. Medicare Payment Exceptions
    • 11.6.2. Three Areas for Denial of Claims
  • 11.7. Bundled Payments for Care Improvement Initiative
  • 11.8. Infectious Disease Billing Strategies
  • 11.9. Analysis of ROI for MDx Tests for Cancer Using Medicare Reimbursement Rules
    • 11.9.1. Reimbursement for Insight Dx, MammaPrint and Oncotype Dx
    • 11.9.2. Reimbursement for JAK2 Mutation Testing for Myeloproliferative Neoplasms

12. Company Profiles

  • 12.1. Abbott Laboratories
  • 12.2. AdvanDx
  • 12.3. Agendia
  • 12.4. Arcxis Biotechnologies
  • 12.5. Agilent Technologies
  • 12.6. Ambry Genetics
  • 12.7. Atlas Genetics
  • 12.8. AutoGenomics, Inc.
  • 12.9. Beckman Coulter
  • 12.10. Becton, Dickinson and Company
  • 12.11. Biodesix
  • 12.12. Biohelix Corporation
  • 12.13. bioMérieux
  • 12.14. Bio-Rad Laboratories
  • 12.15. Cancer Genetics, Inc.
  • 12.16. Celera (acquired by Quest Diagnostics)
  • 12.17. Cepheid
  • 12.18. Clarient, Inc. (GE Healthcare)
  • 12.19. CombiMatrix Corporation
  • 12.20. Cytocell Technologies Ltd.
  • 12.21. DiagnoCure, Inc.
  • 12.22. Enzo Biochem
  • 12.23. Epigenomics
  • 12.24. Exact Sciences Corporation
  • 12.25. Exagen Diagnostics, Inc.
  • 12.26. Exiqon
  • 12.27. Genera Biosystems
  • 12.28. GenMark Diagnostics, Inc.
  • 12.29. Genomic Health
  • 12.30. Great Basin Corporation
  • 12.31. Hologic
  • 12.32. Illumina
  • 12.33. IntegenX
  • 12.34. InterGenetics, Inc.
  • 12.35. LabCorp
  • 12.36. Life Technologies Corporation
  • 12.37. Luminex
  • 12.38. Myriad Genetics, Inc.
  • 12.39. Nanosphere
  • 12.40. Nanostring
  • 12.41. Natera
  • 12.42. NetBio
  • 12.43. Neogenomics
  • 12.44. Nuvera Biosciences
  • 12.45. Orion Genomics
  • 12.46. PerkinElmer Genetics
  • 12.47. Progenika
  • 12.48. QIAGEN N.V.
  • 12.49. Roche Diagnostics
  • 12.50. Rosetta Genomics Ltd.
  • 12.51. Seegene
  • 12.52. Sequenom, Inc.
  • 12.53. Siemens Healthcare Diagnostics (Siemens)
  • 12.54. Spartan Bioscience
  • 12.55. Thorne Diagnostics
  • 12.56. Transgenomic
  • 12.57. TrimGen
  • 12.58. Trovagene, Inc.
  • 12.59. Veredus Laboratories
  • 12.60. Veridex

INDEX OF FIGURES

  • Figure 2.1: Segment of Double-Stranded DNA Showing the Base-Pair Relationship
  • Figure 2.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients
  • Figure 2.3: The PCR Cycle
  • Figure 2.4: Multiple Displacement Amplification
  • Figure 2.5: Using DNA Microassays to Measure Gene Expression
  • Figure 3.1: Overall Structure of Nucleic Acid Testing Market
  • Figure 3.2: Global Market for Molecular Diagnostics Testing, 2012
  • Figure 3.3: Molecular Diagnostics Market Segmentation by Technology
  • Figure 3.4: Share of Molecular Diagnostics Testing by Application, 2012
  • Figure 3.5: Key Players Market Share in Global Molecular Diagnostics Testing Markets
  • Figure 3.6: FDA Co-developed Products as a Model for Collaboration
  • Figure 5.1: Global Market for Infectious Disease Treatments, 2008-2014
  • Figure 5.2: Global Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2018
  • Figure 5.3: U.S. Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2018
  • Figure 5.4: Infectious Disease Testing Revenue Market Share of Total U.S. MDx Market, 2012 and 2018
  • Figure 5.5: Infectious Disease Testing Revenue Market Share by Region, 2012 and 2018
  • Figure 5.6: Markers of Acute HCV Infection as a Function of Time after Exposure to Infection
  • Figure 5.7: Pipeline for TB Diagnostics, 2005-2015
  • Figure 5.8: The Development Pipeline for New TB Drugs, July 2012
  • Figure 5.9: U.S. Market Share of MRSA Molecular Diagnostic Market, 2012
  • Figure 5.10: Global Market Share (Excluding U.S.) of MRSA Molecular Diagnostic Market, 2012
  • Figure 5.11: U.S. Market Share of VRE Molecular Diagnostic Market, 2012
  • Figure 5.12: Hybrid Capture 2 (HC2) versus PCR - Analytical Sensitivity and Clinical Sensitivity
  • Figure 5.13: Basic Steps in Hybrid Capture 2 Technology
  • Figure 5.14: U.S. Market Share of HPV Molecular Diagnostic Market, 2012
  • Figure 5.15: Global Market Share (Excluding U.S.) of HPV Molecular Diagnostic Market, 2012
  • Figure 5.16: Market Share Estimates for Molecular Diagnostic HPV Testing, 2012
  • Figure 6.1: HER-2/NEU Protein as a Target in Cancer Therapy
  • Figure 6.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC
  • Figure 6.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH
  • Figure 6.4: Action of Herceptin in Breast Cancer Patients
  • Figure 6.5: Analysis of Cancer Tissue by Microarray
  • Figure 6.6: Global Market Size and Share of Breast Cancer Molecular Diagnostic Market, 2012
  • Figure 6.7: HNPCC Mutation Increases Risk of Cancer
  • Figure 6.8: APC Mutation Increases the Risk of Cancer
  • Figure 6.9: Prostate-Specific Membrane Antigen
  • Figure 6.10: PCA3 Score Nomogram
  • Figure 6.11: Estimates for PCA3 Test Volume in the U.S., 2005-2012
  • Figure 7.1: Segmentation of the Biomarker Development Market
  • Figure 10.1: Current Regulations for Laboratory Testing
  • Figure 10.2: Existing Regulatory Framework for LDTs
  • Figure 11.1: Reimbursement for Diagnostics in Healthcare Decision Making
  • Figure 11.2: MAC Jurisdiction Map, 2012

INDEX OF TABLES

  • Table 2.1: Key Assay Technologies for Molecular Diagnostics
  • Table 2.2: Emerging Molecular Diagnostic Technologies
  • Table 2.3: DNA Microarray Applications
  • Table 2.4: Companies Involved in Next Generation Sequencing Platforms
  • Table 2.5: Desired Characteristics for Clinical Versus Discovery Next Generation Sequencing
  • Table 3.1: Applications of Molecular Diagnostics Technology Platforms
  • Table 3.2: Global Market for Molecular Diagnostics Testing, 2010-2018
  • Table 3.3: U.S. Market for Molecular Diagnostics Testing, 2010-2018
  • Table 3.4: Share of Molecular Diagnostics Testing by Application, 2012
  • Table 3.5: Key Players and Market Share in the Global Molecular Diagnostics Testing Market
  • Table 3.6: Revenue Model for Molecular Diagnostics Testing
  • Table 3.7: Companies Marketing Multiple Products in Molecular Diagnostics Sector
  • Table 3.8: Companies Marketing Clinical Genotyping Technologies
  • Table 3.9: Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
  • Table 3.10: Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
  • Table 3.11: Molecular Diagnostic Testing Market Trends
  • Table 3.12: Molecular Diagnostic Testing Technology Trends
  • Table 3.13: Attractive Growth Areas for Molecular Diagnostic Testing
  • Table 3.14: Molecular Diagnostics Market: Strategic Recommendations on MDx Sector Business Functions
  • Table 3.15: Potential Benefits of Pharmacogenetics
  • Table 3.16: Select Drugs with Commercially Available Pharmacogenetic Tests
  • Table 3.17: Examples of Personalized Medicine in Treatment of Infectious Disease
  • Table 3.18: Documents for Protecting Intellectual Property Rights
  • Table 3.19: Recent Patents Related to PCR, Nucleic Acid Amplification and Sample Prep
  • Table 4.1: Molecular Diagnostic High-Throughput Automated Testing Systems
  • Table 5.1: Global Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2018
  • Table 5.2: Molecular Infectious Disease Diagnostics Market: Market Restraints Ranked in Order of Impact
  • Table 5.3: Molecular Infectious Disease Diagnostics Market: Market Drivers Ranked in Order of Impact
  • Table 5.4: U.S. Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2018
  • Table 5.5: Molecular Diagnostic Markets for Infectious Disease Testing, 2012
  • Table 5.6: Molecular Diagnostic Markets for Infectious Disease Testing, 2018
  • Table 5.7: Business Factors Influencing Advanced Infectious Disease MDx Testing Services
  • Table 5.8: Key Players in Global Molecular Diagnostics Infectious Disease Testing Market
  • Table 5.9: Summary of Assays for HIV Viral Load Testing
  • Table 5.10: HIV Resistance Testing Recommendations
  • Table 5.11: Commercially Available Molecular Diagnostic Products for HIV Assay
  • Table 5.12: Lower Detection Limits of HBV DNA Assays
  • Table 5.13: Summary of Molecular Diagnostic Assays for Testing HBV
  • Table 5.14: Recommendations for HCV Diagnostic Testing
  • Table 5.15: Commercially Available Molecular Diagnostic Products for HCV Assay
  • Table 5.16: Major Companies Marketing HCV Molecular Diagnostic Tests: Market Size and Share, 2012
  • Table 5.17: Commercially Available Molecular Diagnostic Products for Influenza Assay
  • Table 5.18: Major Companies Marketing Chlamydia/Gonorrhea Molecular Diagnostic Tests: Market Size and Share, 2012
  • Table 5.19: Commercially Available Molecular Diagnostic Products for Chlamydia Assay
  • Table 5.20: Commercially Available Molecular Diagnostic Products for Gonorrhea Assay
  • Table 5.21: Commercially Available Molecular Diagnostic Assays for Testing TB
  • Table 5.22: Comparative U.S. Claim Charges for TB Testing by Type, 2012
  • Table 5.23: Global Testing for TB by Testing Type, 2012
  • Table 5.24: Global Testing for TB by Testing Reason, 2012
  • Table 5.25: Commercially Available Molecular Diagnostic Products for MRSA Assay
  • Table 5.26: Major Companies Marketing MRSA Molecular Diagnostic Tests: Market Size and Share, 2012
  • Table 5.27: Commercially Available Molecular Diagnostic Products for VRE Assay
  • Table 5.28 Major Companies Marketing VRE Molecular Diagnostic Tests: Market Size and Share, 2012
  • Table 5.29: Transmission-related Disease Screening from Blood Donor Pools
  • Table 5.30: Principal Blood Screening Products of Hologic Gen-Probe for HIV Assay
  • Table 5.31: Major Companies Marketing Blood Screening Molecular Diagnostic Tests: Market Size and Share, 2012
  • Table 5.32: Qiagen's Digene HC2 High-risk HPV DNA Test
  • Table 5.33: Commercially Available Molecular Diagnostic Products for HPV Assay
  • Table 5.34: Major Companies Marketing HPV Molecular Diagnostic Tests: Market Size and Share, 2012
  • Table 6.1: Companies Marketing Products in the Cancer Molecular Diagnostics Sector
  • Table 6.2: Key Elements for Business Competition in Gene Expression Profiling for Cancer
  • Table 6.3: Key Elements for Future Success in the Gene Profiling for Cancer Segment
  • Table 6.4: Breast Cancer Overview
  • Table 6.5: Overview of ER/PR Testing and Response to Therapy
  • Table 6.6: Key Players in the Breast Cancer Molecular Diagnostic Space
  • Table 6.7: Commercially Available Molecular Diagnostic Products for Breast Cancer Assay
  • Table 6.8: Summary of Strengths, Weaknesses, Opportunities and Threats of the Breast Cancer Molecular Diagnostic Market
  • Table 6.9: Clinical Utility and Health Economic Benefits of Oncotype DX
  • Table 6.10: Oncotype DX Overview
  • Table 6.11: Comparison of Agendia vs. Genomic Health Breast Cancer Tests
  • Table 6.12: Overview of HER2/neu and Herceptin
  • Table 6.13: MammaPrint: Key Features
  • Table 6.14: Oncogene Science Biomarker Group Reagents
  • Table 6.15: Major Laboratory Testing Companies Marketing Breast Cancer Molecular Diagnostic Tests, 2012
  • Table 6.16: Global Market for Breast Cancer Molecular Diagnostic Testing, 2005-2012
  • Table 6.17: U.S. Market for Breast Cancer Molecular Diagnostic Testing, 2005-2012
  • Table 6.18: Global Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2013-2018
  • Table 6.19: U.S. Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2013-2018
  • Table 6.20: Breast Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact
  • Table 6.21: Breast Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact
  • Table 6.22: Colorectal Cancer Overview
  • Table 6.23: KRAS Mutation Assay
  • Table 6.24: KRAS Assays by Analytical Type
  • Table 6.25: KRAS Mutation Analysis Summary
  • Table 6.26: DxS KRAS Mutation Test Summary
  • Table 6.27: KRAS and BRAF in Clinical Use
  • Table 6.28: Product Development Opportunities in Cancer Tumor Types, 2008
  • Table 6.29: Key Players in the Colorectal Cancer Molecular Diagnostic Space
  • Table 6.30: ArcticDx Genetic Test, Colo Risk
  • Table 6.31: NexCourse CRC Test Offering and Treatment Direction
  • Table 6.32: Global Market for Molecular Diagnostic Colon Cancer Testing, 2005-2012
  • Table 6.33: U.S. Market for Molecular Diagnostic Colon Cancer Testing, 2005-2012
  • Table 6.34: Global Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2013-2018
  • Table 6.35: U.S. Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2010-2018
  • Table 6.36: Colon Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact
  • Table 6.37: Colon Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact
  • Table 6.38: Summary of Strengths, Weaknesses, Opportunities and Threats of the Colon Cancer Market
  • Table 6.39: Stages in Prostate Cancer Discovery and Diagnosis
  • Table 6.40: Corporate Players Entering the Prostate Cancer Molecular Diagnostic Space
  • Table 6.41: Gen-Probe Genetic Testing Product Line
  • Table 6.42: Prostate Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact
  • Table 6.43: Prostate Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact
  • Table 6.44: Summary of Strengths, Weaknesses, Opportunities and Threats of the Prostate Cancer Molecular Diagnostic Market
  • Table 6.45: Players in the Bladder Cancer Molecular Diagnostic Space
  • Table 6.46: Lung Cancer Survival Rates
  • Table 6.47: Lung Cancer Facts
  • Table 6.48: Lung Cancer Predictive and Prognostic Markers
  • Table 6.49: Potential of Cancer Biomarkers in Drug Delivery and Development
  • Table 6.50: Barriers to Adoption of Biomarkers in Clinical Use
  • Table 7.1: Common Genetic Disorders
  • Table 7.2: HLA Allele Nomenclature
  • Table 7.3: Comparison of HLA Typing Methods
  • Table 7.4: Diagnostic Companies with Existing Pharma Relationships (market caps under $5 Billion)
  • Table 7.5: Use of Cancer Biomarkers in Drug Development
  • Table 7.6: Utility of Biomarkers as Companion Diagnostics to Drug Development
  • Table 7.7: Competitors in the Field of Forensic Testing
  • Table 7.8: Competitors in the Field of Identity, Family and Paternity Testing
  • Table 7.9: Comparison of Current Genetic Testing Protocols and Potential Use of Whole Genome Sequencing
  • Table 7.10: Commercial CF-Screening Products
  • Table 7.11: CF Screening Technology Summary
  • Table 8.1: Molecular Diagnostics Methods for Detection of Salmonella in Food
  • Table 9.1: Barriers for Biologics Warfare Monitoring Systems
  • Table 9.2: Technical Problems for PCR Assays for Pathogen Genotyping and Detection
  • Table 9.3: Biological Warfare Agents Identified by PCR Methods
  • Table 9.4: Companies Developing Detection Devices for Biological Warfare Agents
  • Table 10.1: Regulatory Rules that Affect the Ability of a Diagnostic Testing Reagent Company to Conduct Business
  • Table 10.2: Strengths of the 510k Process
  • Table 10.3: Drawbacks of the 510k Process
  • Table 10.4: Focus Areas for the FDA Critical Path Initiative
  • Table 11.1: Factors Determining Third-Party Payment for Molecular Diagnostic Tests
  • Table 11.2: CPT Codes for Molecular Diagnostic Infectious Disease Testing
  • Table 11.3: New CPT Codes for Respiratory Virus Detection
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