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市場調查報告書

癌症檢驗的分子診斷

Molecular Diagnostics in Cancer Testing

出版商 TriMark Publications 商品編碼 203890
出版日期 內容資訊 英文 201 Pages
商品交期: 最快1-2個工作天內
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癌症檢驗的分子診斷 Molecular Diagnostics in Cancer Testing
出版日期: 2016年06月06日 內容資訊: 英文 201 Pages
簡介

分子診斷是急速進化的領域,新的技術和應用相繼登場。包含分子診斷的技術、第1代放大、DNA探針、螢光原位雜合技術 (FISH)、第2代的生物晶片微流體、下一代的信號檢測、生物感應器、分子標籤、使用微陣列的基因表達譜等。這些技術對發現癌症的治療分子、癌症患者的篩檢和診斷、分類、藥物治療的最佳化有大幅貢獻。

本報告提供作為分子診斷的體外診斷領域之相關詳細分析,癌症的偵測和治療所採用的分子診斷市場規模與成長趨勢等資料彙整,並將其結果為您概述為以下內容。

第1章 概要

第2章 分子診斷的簡介

  • 分子診斷的機會創造
  • 人類基因體計劃帶給分子診斷的影響
  • 分子及臨床診斷相關考察
  • 後基因組時代的分子診斷
  • 分子診斷技術的進步
  • 寡核苷酸陣列平台
  • 新興癌症個人化醫療市場
    • 預測的癌症分子診斷
  • 藥物開發的伴同性檢驗
  • 分子診斷企業的機會
  • 液態切片
  • 資料分析
  • 公司內部/商用試驗
  • 癌症的多重遺傳基因面板檢驗

第3章 癌症診斷的分子檢驗市場

  • 市場概要
    • 市場概要
    • 進行癌症檢驗的分子診斷的研究所
    • 競爭環境
    • 癌症檢驗的銷售額與行銷策略

第4章 癌症的分子診斷檢驗

  • 癌症診斷檢驗
    • 癌症的治療策略
    • 癌症的治療
    • 為了了解癌症的基因學利用
    • 分子診斷工具解決方案
    • 基因表現分析技術
  • 乳癌
    • 乳癌概要
    • 乳癌的分子診斷化驗
    • 競爭結構與市場佔有率分析
    • 推動及阻礙市場要素
    • 乳癌的分子診斷檢驗分析市場及技術
  • 大腸癌的分子診斷市場
    • 大腸癌概要
    • 大腸癌的分子診斷化驗
    • 競爭結構與市場佔有率分析
    • 有關大腸癌的分子檢驗的新指南前列腺癌的分子診斷市場
    • 分子篩檢分析
    • 直腸結腸切片檢查後實施的分子化驗
    • 競爭結構與市場佔有率分析
    • 推動及阻礙市場要素
    • 前列腺癌的分子診斷檢驗的審定市場與技術趨勢
  • 卵巢癌
    • 卵巢癌的發病率
    • 卵巢癌檢驗市場主要企業
  • 肺癌
    • 肺癌的發病率
    • 藥理基因學和癌症
    • 肺癌的分子診斷化驗
    • 競爭空間
  • 黑色素瘤
    • bioMerieux
    • Roche
    • Myriad
    • Trovagene
  • 其他癌症的分子診斷化驗
    • Accugenomics
    • Ambry Genetics
    • Asuragen
    • DiaSorin
  • 多發性癌症檢驗面板
  • 潛在的市場新加入廠商

第5章 商務

  • 技術、市場趨勢
  • M&A活動
  • 聯盟
  • SWOT分析
    • 產業課題和策略性建議
    • 分子診斷產品的實用化
  • 智慧財產權

第6章 償付與申請

  • 概要
  • 償付手法的趨勢
  • 患者照護償與付
  • 收益方面的威脅
  • 申請

第7章 政府的法規

第8章 企業簡介 (41家)

附錄1:分子診斷相關的用語定義

附錄2:標準的癌症診斷面板

圖表一覽

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目錄
Product Code: TMRMDC16-0601

Molecular diagnostics is a rapidly-advancing area of research and medicine, with new technologies and applications being continually added. The technologies that come under the umbrella of molecular diagnostics include first-generation amplification, DNA probes, fluorescent in-situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors and molecular labels, and gene expression profiling using microarrays. These technologies are improving the discovery of therapeutic molecules for cancer, the screening, diagnosis and classification of cancer patients, and the optimization of drug therapy. This TriMark Publications report describes the specific segment of the in vitro diagnostics (IVD) market known as molecular diagnostics (MD), with a specialization in the MD tests for cancer. In the current medical diagnostics market, molecular diagnostics for cancer testing offers one of the brightest areas for growth and innovation. The confluence of breakthroughs in genomics, proteomics, and the development of microarray devices to measure analytes in the blood and various body tissues, has led to this revolutionary market segment offering the power of advanced analytical techniques to the diagnosis and treatment of cancer. This report analyzes the size and growth of the molecular diagnostics market in its applications for cancer detection and therapy, examining the factors that influence the various market segments and the dollar volume of sales, both in the United States and worldwide.

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

  • 2.1 Opening of Opportunities in Molecular Diagnostics
  • 2.2 Impact of the Human Genome Project on Molecular Diagnostics
  • 2.3 Considerations for Molecular and Clinical Diagnostics
  • 2.4 Molecular Diagnostics in the Post-Genomic Era
  • 2.5 Advances in Molecular Diagnostics Technologies
    • 2.5.1 Molecular Methods to Detect Genetic Variants in Cancer
      • 2.5.1.1 Allele-Specific PCR
      • 2.5.1.2 Sanger Dideoxy Sequencing
      • 2.5.1.3 Pyrosequencing
      • 2.5.1.4 Mass Spectrometry
      • 2.5.1.5 Single Base Extension Assay
      • 2.5.1.6 Multiplex Ligation-Dependent Probe Amplification (MLPA)
      • 2.5.1.7 Fluorescence In Situ Hybridization (FISH)
      • 2.5.1.8 Next Generation Sequencing
        • 2.5.1.8.1 Next-Generation Sequencing-Custom Panels, Amplicon Capture
        • 2.5.1.8.2 Next-Generation Sequencing-Custom Panels, Hybridization Capture
        • 2.5.1.8.3 Next-Generation Sequencing-Whole Exome Sequencing
        • 2.5.1.8.4 Next-Generation Sequencing-Whole Genome Sequencing
      • 2.5.1.9 Digital Droplet PCR (ddPCR)
    • 2.5.2 Clinical Applications of Next-generation Sequencing
  • 2.6 Oligonucleotide Array Platforms
  • 2.7 Emerging Cancer Personalized Medicine Market
  • 2.7.1 Predictive Cancer Molecular Diagnostics
  • 2.8 Companion Diagnostics
  • 2.9 Opportunities for Molecular Diagnostic Companies
  • 2.10 Liquid Biopsies
  • 2.11 Data Analysis
  • 2.12 In-house vs. Commercial Testing
  • 2.13 Multi-Gene Cancer Panels

3. Cancer Diagnostics Molecular Testing Market

  • 3.1 Market Description
    • 3.1.1 Market Overview for Molecular Diagnostics in Cancer Testing
    • 3.1.2 Laboratories Performing Molecular Diagnostics for Cancer Testing
    • 3.1.3 Competitive Landscape
      • 3.1.3.1 Pure Play Specialty Companies Performing Tumor MDx Analysis
      • 3.1.3.2 Mixed Specialty Cancer Diagnostic Labs
      • 3.1.3.3 General Clinical Reference Laboratories
      • 3.1.3.4 Diagnostic Device and Reagent Developers
      • 3.1.3.5 Companion Diagnostics Development in Partnership with a Pharmaceutical Company
    • 3.1.4 Sales and Marketing Strategies for Cancer Tests
      • 3.1.4.1 North American Market
      • 3.1.4.2 International Markets

4. Molecular Diagnostic Tests for Cancer

  • 4.1 Overview of Molecular Diagnostics for Cancer
    • 4.1.1 Cancer Statistics
    • 4.1.2 Treating Cancers
    • 4.1.3 Use of Genomics to Understand Cancer
    • 4.1.4 Molecular Diagnostic Tools Solutions
    • 4.1.5 Technology of Gene Expression Analysis
      • 4.1.5.1 Amplify and Detect Diminished Amounts of RNA Consistently
      • 4.1.5.2 Analyze Hundreds of Genes
      • 4.1.5.3 Employ Advanced Information Technology
  • 4.2 Breast Cancer Molecular Diagnostics
    • 4.2.1 Overview of Breast Cancer
    • 4.2.2 Breast Cancer Molecular Diagnostic Assays
      • 4.2.2.1 Ambry Genetics
      • 4.2.2.2 Agendia
        • 4.2.2.2.1 MammaPrint
      • 4.2.2.3 BGI
      • 4.2.2.4 Bioreference Labs
      • 4.2.2.5 BioTheronostics (part of BioMérieux)
        • 4.2.2.5.1 Breast Cancer Index
      • 4.2.2.6 Cancer Genetics, Inc. (CGI)
      • 4.2.2.7 Dako (part of Agilent Technologies)
      • 4.2.2.8 DiaSorin
      • 4.2.2.9 Fulgent Diagnostics
      • 4.2.2.10 Genetic Technologies Ltd.
      • 4.2.2.11 Genomic Health
        • 4.2.2.11.1 Oncotype DX
      • 4.2.2.12 Genoptix (part of Novartis)
      • 4.2.2.13 Invitae
      • 4.2.2.14 LabCorp
        • 4.2.2.14.1 BRCAssure® Tests
      • 4.2.2.15 Multiplicom
      • 4.2.2.16 Myriad Genetics
        • 4.2.2.16.1 BRACAnalysis®
        • 4.2.2.16.2 BART®
      • 4.2.2.17 Nanostring Technologies
        • 4.2.2.17.1 Prosigna
      • 4.2.2.18 Neogenomics
      • 4.2.2.19 Pathway Genomics
      • 4.2.2.20 Sophia Genetics
      • 4.2.2.21 Quest Diagnostics
        • 4.2.2.21.1 BRCAvantage Plus
      • 4.2.2.22 Ventana Medical Systems (Roche)
        • 4.2.2.22.1 HER2 Dual ISH DNA Probe Cocktail, INFORM
    • 4.2.3 Competitive Structure and Market Share Analysis
      • 4.2.3.1 Breast Cancer Molecular Diagnostic Testing Market Size
        • 4.2.3.1.1 Global Market
        • 4.2.3.1.2 U.S. Market
        • 4.2.3.1.3 European Market
    • 4.2.4 Market Drivers and Restraints
      • 4.2.4.1 Market Drivers
      • 4.2.4.2 Market Restraints
    • 4.2.5 Breast Cancer Molecular Diagnostic Testing Assay Market and Technology Trends
      • 4.2.5.1 Breast Cancer Molecular Diagnostic Testing Assay Market Trends
      • 4.2.5.2 Breast Cancer Molecular Diagnostic Testing Assay Technology Trends
      • 4.2.5.3 Breast Cancer Testing Assay Strategic Recommendations
  • 4.3 Colorectal Cancer Molecular Diagnostics Market
    • 4.3.1 Overview of Colorectal Cancer
    • 4.3.2 Colon Cancer Molecular Diagnostic Assays
      • 4.3.2.1 BRAF
      • 4.3.2.2 KRAS
      • 4.3.2.3 mSEPT9
      • 4.3.2.4 Screening Assays
        • 4.3.2.4.1 Overview of Stool-based DNA Assays
      • 4.3.2.5 Abbott
        • 4.3.2.5.1 Abbott RealTime KRAS Amplification Reagent Kit
        • 4.3.2.5.2 RealTime mS9 Colorectal Cancer
      • 4.3.2.6 Agendia
        • 4.3.2.6.1 ColoPrint
      • 4.3.2.7 Ambry Genetics
        • 4.3.2.7.1 ColoNext
      • 4.3.2.8 Bioreference Labs
      • 4.3.2.9 Cancer Genetics, Inc.
      • 4.3.2.10 Epigenomics
        • 4.3.2.10.1 Epi proColon
      • 4.3.2.11 Exact Sciences
        • 4.3.2.11.1 Cologuard
      • 4.3.2.12 Fulgent Diagnostics
      • 4.3.2.13 Genomic Health
        • 4.3.2.13.1 Oncotype DX colon
      • 4.3.2.14 Genomictree
      • 4.3.2.15 Genoptix (part of Novartis)
      • 4.3.2.16 Invitae
      • 4.3.2.17 LabCorp
      • 4.3.2.18 Myriad Genetics
        • 4.3.2.18.1 COLARIS
        • 4.3.2.18.2 COLARIS AP
      • 4.3.2.19 Neogenomics
      • 4.3.2.20 Novigenix
        • 4.3.2.20.1 Colox
      • 4.3.2.21 Pathway Genomics
        • 4.3.2.21.1 ColoTrue
      • 4.3.2.22 Qiagen
        • 4.3.2.22.1 therascreen KRAS RGQ PCR Kit
      • 4.3.2.23 Quest Diagnostics
        • 4.3.2.23.1 ColoVantage
      • 4.3.2.24 Roche
        • 4.3.2.24.1 cobas® KRAS Mutation Test
      • 4.3.2.25 Trovagene
        • 4.3.2.25.1 PCM KRAS Mutation Detection Test
    • 4.3.3 Competitive Structure and Market Share Analysis
      • 4.3.3.1 Colorectal Cancer Molecular Diagnostic Testing Market Size
      • 4.3.3.2 Market Drivers and Restraints
        • 4.3.3.2.1 Market Drivers
        • 4.3.3.2.2 Market Restraints
      • 4.3.3.3 Colon Cancer Molecular Diagnostic Testing Assay Market and Technology Trends
        • 4.3.3.3.1 Colon Cancer Molecular Diagnostic Testing Assay Market Trends
        • 4.3.3.3.2 Colon Cancer Molecular Diagnostic Testing Assay Technology Trends
        • 4.3.3.3.3 Colon Cancer Molecular Diagnostic Testing Assay Strategic Recommendations
    • 4.3.4 New Guidelines for Colorectal Cancer Molecular Testing
  • 4.4 Prostate Cancer Molecular Diagnostics Market
    • 4.4.1 Molecular Screening Assays for Prostate Cancer
      • 4.4.1.1 Hologic
        • 4.4.1.1.1 PROGENSA PCA3 Assay
      • 4.4.1.2 Bostwick Laboratories
        • 4.4.1.2.1 PCA3Plus
      • 4.4.1.3 Overview of PCA3
      • 4.4.1.4 MDx Health
        • 4.4.1.4.1 SelectMDx for Prostate Cancer
      • 4.4.1.5 Invitae
        • 4.4.1.5.1 Invitae Prostate Cancer Panel
      • 4.4.1.6 Neogenomics
        • 4.4.1.6.1 NeoLAB Prostate
    • 4.4.2 Molecular Assays Performed After Colorectal Biopsy
      • 4.4.2.1 Myriad Genetics
        • 4.4.2.1.1 Prolaris
      • 4.4.2.2 Genomic Health
        • 4.4.2.2.1 Oncotype DX Genomic Prostrate Score
      • 4.4.2.3 MDxHealth (ConfirmMDx)
      • 4.4.2.4 Bostwick Laboratories (ProstaVysion)
      • 4.4.3.5 MDNA Life Sciences
        • 4.4.3.5.1 Prostate Core Mitomic Test
      • 4.4.2.6 GenomeDx
        • 4.4.2.6.1 Decipher
    • 4.4.3 Competitive Structure and Market Share Analysis
    • 4.4.4 Market Drivers and Restraints
      • 4.4.4.1 Market Drivers
      • 4.4.4.2 Market Restraints
    • 4.4.5 Prostate Cancer Molecular Diagnostic Testing Assay Market and Technology Trends
      • 4.4.5.1 Prostate Cancer Molecular Diagnostic Testing Assay Market Trends
      • 4.4.5.2 Prostate Cancer Molecular Diagnostic Testing Assay Technology Trends
  • 4.5 Ovarian Cancer
    • 4.5.1 Incidence of Ovarian Cancer
    • 4.5.2 Key Players in Ovarian Testing Market
      • 4.5.2.1 Ambry Genetics
      • 4.5.2.2 Myriad Genetics
      • 4.5.2.3 Market Drivers and Restraints
        • 4.5.2.3.1 Market Drivers
        • 4.5.2.3.2 Market Restraints
  • 4.6 Lung Cancer
    • 4.6.1 Incidence of Lung Cancer
    • 4.6.2 Pharmacogenomics and Cancer
    • 4.6.3 Lung Cancer Molecular Diagnostics Assays
      • 4.6.3.1 Genoptix (a Novartis company)
        • 4.6.3.1.1 NexCourse NSCLC
      • 4.6.3.2 Qiagen
        • 4.6.3.2.1 therascreen EGFR RGQ PCR Kit
      • 4.6.3.3 Roche
        • 4.6.3.3.1 cobas® EGFR Mutation Test v2
      • 4.6.3.4 Epigenomics
        • 4.6.3.4.1 Epi proLung® BL Reflex Assay
      • 4.6.3.5 Myriad Genetics
        • 4.6.3.5.1 myPlan™ Lung Cancer
      • 4.6.3.6 Quest Diagnostics
        • 4.6.3.6.1 Lung Cancer Mutation Panel
      • 4.6.3.7 Rosetta Genomics
        • 4.6.3.7.1 OncoGxLung
      • 4.6.3.8 Trovagene
        • 4.6.3.8.1 PCM EGFR Mutation Detection Test
      • 4.6.3.9 Veracyte, Inc.
        • 4.6.3.9.1 Percepta
      • 4.6.3.10 Accugenomics
        • 4.6.3.10.1 Lung Cancer Risk Test (LCRT-AGX)
    • 4.6.4 Competitive Space
  • 4.7 Melanoma
    • 4.7.1 bioMérieux
      • 4.7.1.1 THxID™ BRAF
    • 4.7.2 Roche
      • 4.7.2.1 cobas®
    • 4.7.3 Myriad
      • 4.7.3.1 myPath™ Melanoma
    • 4.7.4 Trovagene
      • 4.7.4.1 PCM BRAF Mutation Detection Test
  • 4.8 Molecular Diagnostic Assays for Other Types of Cancers
    • 4.8.1 Accugenomics
      • 4.8.1.1 Standardized BCR-ABL Molecular Diagnostics Test
    • 4.8.2 Ambry Genetics
      • 4.8.2.1 PancNext
      • 4.8.2.2 PGLNext
      • 4.8.2.3 RenalNext
    • 4.8.3 Asuragen
      • 4.8.3.1 QuantideX® qPCR BCR-ABL IS Kit
    • 4.8.4 DiaSorin
      • 4.8.4.1 PML-RARA Detection bcr1,3 and Discrimination bcr2
  • 4.9 Panels Testing Multiple Cancers
    • 4.9.1 Ambry Genetics
      • 4.9.1.1 CancerNext
      • 4.9.1.2 CancerNext-Expanded
    • 4.9.2 Biotheranostics
      • 4.9.2.1 CancerTYPE ID
    • 4.9.3 Cancer Genetics, Inc. (CGI)
    • 4.9.4 Color Genomics
      • 4.9.4.1 Color Test
    • 4.9.5 Counsyl Labs
    • 4.9.6 Guardant Health
    • 4.9.7 Multiplicom
      • 4.9.7.1 SOMATIC 1 MASTR™ Plus Dx
    • 4.9.8 Myriad Genetics
      • 4.9.8.1 myRisk™ Hereditary Cancer
    • 4.9.9 Pathway Genomics
      • 4.9.9.1 CancerIntercept™ Detect
    • 4.9.10 Quest Diagnostics
      • 4.9.10.1 OncoVantage® Solid Tumor Mutation Analysis
    • 4.9.11 Rosetta Genomics
      • 4.9.11.1 OncoGxOne™
  • 4.10 Potential new Entrants to the Market
    • 4.10.1 Illumina
    • 4.10.2 Metabiomics
    • 4.10.3 Orion Genomics
    • 4.10.4 Siemens
    • 4.10.5 VolitionRx

5. Business

  • 5.1 Technology and Market Trends
    • 5.1.1 Technology Trends
    • 5.1.2 Market Trends
  • 5.2 M&A Activity
  • 5.3 Partnerships
  • 5.4 Summary of Market Strengths, Weaknesses, Opportunities and Threats
    • 5.4.1 Industry Challenges and Strategic Recommendations
    • 5.4.2 Commercialization of Molecular Diagnostic Products
  • 5.5 Intellectual Property Rights
    • 5.5.1 BRCA1 and BRCA2 Gene Patents
    • 5.5.2 Current Patent Disputes

6. Reimbursement and Billing

  • 6.1 Overview
  • 6.2 Trends in Reimbursement Practice
    • 6.2.1 Medicare Reimbursement
    • 6.2.2 Analysis of ROI for MDx Tests for Cancer Using Medicare Reimbursement Rules
  • 6.3 Trends in Patient Care and Reimbursement
  • 6.4 Revenue Threats
    • 6.4.1 Three Areas for Denial of Claims by Biomarkers
  • 6.5 Billing
    • 6.5.1 Medicare Billing Procedures
    • 6.5.2 Medicare CPT Coding Rules for Cancer Biomarkers

7. Government Regulation

  • 7.1 U.S. Food and Drug Administration
  • 7.2 CLIA Regulations
  • 7.3 Clinical Laboratory Improvement Act
  • 7.4 State Licensing for Service Laboratories
  • 7.5 510(k) Clearance
  • 7.6 Pre-Market Approval
  • 7.7 ASRs
  • 7.8 What Regulatory Guidance is Needed for Companion Biomarkers?
  • 7.9 U.S. Patent and Trademark Office
  • 7.10 IRB Approval in Clinical Trials
  • 7.11 Microarray Quality Control
  • 7.12 ER and PR Proficiency Testing

8. Company Profiles

  • 8.1 Abbott Molecular Diagnostics
  • 8.2 AccuGenomics, Inc.
  • 8.3 Agendia
  • 8.4 Ambry Genetics
  • 8.5 Asuragen
  • 8.6 BGI
  • 8.7 Biodesix
  • 8.8 bioMérieux
  • 8.9 Bioreference Labs
  • 8.10 bioTheranostics
  • 8.11 Cancer Genetics, Inc.
  • 8.12 Counsyl
  • 8.13 Dako (an Agilent Technologies company)
  • 8.14 DiaSorin
  • 8.15 Epigenomics
  • 8.16 Exact Sciences Corporation
  • 8.17 Exiqon
  • 8.18 Flatiron Health
  • 8.19 Fulgent Diagnostics
  • 8.20 Genomic Health, Inc.
  • 8.21 Genomictree
  • 8.22 Genoptix, Inc. (Novartis)
  • 8.23 HTG Molecular Diagnostics
  • 8.24 Guardant Health
  • 8.25 Hologic
  • 8.26 Illumina
  • 8.27 Invitae
  • 9.28 LabCorp
  • 8.29 MDxHealth
  • 8.30 Myriad Genetics, Inc.
  • 8.31 Nanostring
  • 8.32 Neogenomics
  • 8.33 Nuvera Biosciences
  • 8.34 Orion Genomics
  • 8.35 Pathway Genomics
  • 8.36 Qiagen
  • 8.37 Quest Diagnostics
  • 8.38 Roche Molecular Systems
  • 8.39 Rosetta Genomics Ltd.
  • 8.40 Sophia Genetics
  • 8.41 Trovagene

Appendix 1: Definition of Terms for Molecular Diagnostics

Appendix 2: Standard Cancer Therapeutic Panels

INDEX OF FIGURES

  • Figure 2.1: Finding Genes with Microassays
  • Figure 2.2: Use of Microassays for Studying Gene Expression
  • Figure 2.3: Finding New Drugs with Microarrays
  • Figure 2.4: Using DNA Microarrays to Compare Cancer and Normal Cells
  • Figure 2.5: Microarrays for Prediction of Survival in Cancer
  • Figure 2.6: ddPCR Using a Single Color Probe
  • Figure 2.7: ddPCR Using Two Probe Colors
  • Figure 2.8: BEAMing Method of ctDNA Detection
  • Figure 2.9: Using Gene Expression Patterns to Chose Treatment
  • Figure 3.1: Molecular Diagnostic Markets for Cancer Testing Globally, 2015
  • Figure 3.2: Molecular Diagnostic Markets for Cancer Testing in the U.S., 2015
  • Figure 3.3: Market Share for Key Companies in the Global Molecular Diagnostics Cancer Testing Market
  • Figure 3.4: Market Growth and Evolution of MDx Cancer Biomarkers
  • 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: Action of Herceptin in Breast Cancer Patients
  • Figure 4.4: Analysis of Cancer Tissue by Microarray
  • Figure 4.5: HNPCC Mutation Increases Risk of Cancer
  • Figure 4.6: APC Mutation Increases Risk of Cancer
  • Figure 4.7: Prostate-Specific Membrane Antigen
  • Figure 4.8: PCA3 Score Nomogram
  • Figure 4.9: Ovarian Cancer Types
  • Figure 4.10: Targets for Therapy-Mutations Associated with Lung Cancer
  • Figure 4.11: Molecular Subsets of Lung Cancer
  • Figure 5.1: FDA Co-Developed Products as a Model for Collaboration

INDEX OF TABLES

  • Table 2.1: Types of Molecular Tests and Types of Genetic Variants Detected
  • Table 2.2: Use of Cancer Biomarkers to Enhance Patient Care
  • Table 2.3: Targeted Drug Therapies for Cancers
  • Table 2.4: Select Genes and Cancer Risk
  • Table 2.5: Use of Cancer Biomarkers in Drug Development
  • Table 2.6: Utility of Biomarkers as Companion Diagnostics to Drug Development
  • Table 2.7: FDA Approved Companion Diagnostics
  • Table 2.8: Recommended Databases for Interpreting Somatic Mutation Results in Cancer
  • Table 3.1: Specific Diagnostic Products Categories Comprising the Cancer Diagnostic Market
  • Table 3.2: Global Market for Molecular Diagnostics Cancer Testing, 2012-2021
  • Table 3.3: U.S. Market for Molecular Diagnostics Cancer Testing, 2012-2021
  • Table 3.4: Molecular Diagnostic Markets for Cancer Testing, 2015
  • Table 3.5: Key Companies in the Global Molecular Diagnostics Cancer Testing Market
  • Table 3.6: Highlights of the Cancer Diagnostic Testing Segment
  • Table 3.7: Highlights of Certified Clinical Labs Specializing in Cancer Genetics and Molecular Diagnostic Services
  • Table 3.8: Business Factors Influencing Advanced Oncology Testing Services
  • Table 3.9: Strategies for Marketing Cancer Diagnostic Products
  • Table 3.10: Key Elements of MDx Diagnostic Companies Marketing Plan
  • Table 4.1: FDA Approved Cancer Tests
  • Table 4.2: Estimates for the Leading Sites of New Cancer Cases in the U.S. by Gender, 2016
  • Table 4.3: Estimates for the Leading Sites of Cancer Deaths in the U.S. by Gender, 2016
  • Table 4.4: Molecular Diagnostic Technologies
  • Table 4.5: Breast Cancer Overview
  • Table 4.6: Overview of HER2/neu and Herceptin
  • Table 4.7: Key Players in the Breast Cancer Molecular Diagnostic Space
  • Table 4.8: FDA-Approved Breast Cancer Molecular Diagnostic Tests on the Market
  • Table 4.9: MammaPrint: Key Features
  • Table 4.10: Clinical Utility and Health Economic Benefits of Oncotype DX
  • Table 4.11: Oncotype DX Overview
  • Table 4.12: Major Laboratory Testing Companies Marketing Breast Cancer Molecular Diagnostic Tests, 2015
  • Table 4.13: Global Market for Breast Cancer Molecular Diagnostic Testing, 2012-2021
  • Table 4.14: U.S. Market for Breast Cancer Molecular Diagnostic Testing, 2012-2021
  • Table 4.15: Breast Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact
  • Table 4.16: Breast Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact
  • Table 4.17: Summary of Strengths, Weaknesses, Opportunities and Threats of the Breast Cancer Molecular Diagnostic Market
  • Table 4.18: Colorectal Cancer Overview
  • Table 4.19: Key Players in the Breast Cancer Molecular Diagnostic Space
  • Table 4.20: FDA-Approved and/or CE-marked Colorectal Cancer Molecular Diagnostic Tests on the Market
  • Table 4.21: KRAS Assays by Analytical Type
  • Table 4.22: KRAS Mutation Analysis Summary
  • Table 4.23: KRAS and BRAF in Clinical Use
  • Table 4.24: Key Players in the Colorectal Cancer Molecular Diagnostic Space
  • Table 4.25: NexCourse CRC Test Offering and Treatment Direction
  • Table 4.26: Global Market for Molecular Diagnostic Colon Cancer Testing, 2012-2021
  • Table 4.27: U.S. Market for Molecular Diagnostic Colon Cancer Testing, 2012-2021
  • Table 4.28: Colon Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact
  • Table 4.29: Colon Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact
  • Table 4.30: Summary of Strengths, Weaknesses, Opportunities and Threats of the Colon Cancer Market
  • Table 4.31: Stages in Prostate Cancer Discovery and Diagnosis
  • Table 4.32: Corporate Players in the Prostate Cancer Molecular Diagnostic Space
  • Table 4.33: Prostate Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact
  • Table 4.34: Prostate Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of pact
  • Table 4.35: Summary of Strengths, Weaknesses, Opportunities and Threats of the Prostate Cancer Molecular Diagnostic Market
  • Table 4.36: Ovarian Cancer Molecular Diagnostic Testing Market: Market Drivers in Order of Impact
  • Table 4.37: Ovarian Cancer Molecular Diagnostic Testing Market: Market Restraints in Order of Impact
  • Table 4.38: Lung Cancer Survival Rates
  • Table 4.39: Lung Cancer Facts
  • Table 4.40: Pharmacogenetic Markers for Select Cancer Drugs
  • Table 4.41: Potential of Cancer Biomarkers in Drug Delivery and Development
  • Table 5.1: Technology Trends in Cancer Testing
  • Table 5.2: Trends in Theranostics
  • Table 5.3: Market Trends in Cancer Testing
  • Table 5.4: Molecular Diagnostics Cancer Market: Market Drivers Ranked in Order of Impact
  • Table 5.5: Molecular Diagnostics Cancer Market: Market Restraints Ranked in Order of Impact
  • Table 5.6: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of Care Market
  • Table 5.7: Molecular Diagnostics Cancer Market: Strategic Recommendations on Molecular Diagnostic Sector Business Functions
  • Table 5.8: Total U.S. Molecular Diagnostics Cancer Market: Impact of Top Industry Challenges
  • Table 5.9: Key Elements for Business Competition in Gene Expression Profiling for Cancer
  • Table 6.1: Factors Determining Third-Party Payment for Advanced Cancer Tests
  • Table 7.1: Rules that Affect the Ability of a Cancer Diagnostic Service Lab to Conduct Business
  • Table 7.2: Focus Areas for the FDA Critical Path Initiative
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