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癌の診断および治療のためのバイオマーカー技術プラットフォーム

Biomarker Technology Platforms for Cancer Diagnoses and Therapies

発行 TriMark Publications 商品コード 214200
出版日 ページ情報 英文 399 Pages
納期: 即日から翌営業日
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癌の診断および治療のためのバイオマーカー技術プラットフォーム Biomarker Technology Platforms for Cancer Diagnoses and Therapies
出版日: 2014年07月01日 ページ情報: 英文 399 Pages
概要

癌の予防、治療および治癒に対する優れた治療法が開発されるまでは、早期の発見と診断がこの疾患による死亡率を減少させる最良の手段です。肺癌、乳癌、結腸癌、前立腺癌などの主な固形癌における長期生存率は、転移が発生すると急激に低下します。乳癌、結腸癌、卵巣癌、肺癌などの早期発見とスクリーニング検査には、バイオマーカーの開発が重要となります。

当レポートでは、癌バイオマーカーの技術動向と新たなバイオマーカーによる診断技術、市場機会と世界の収益動向などについて分析を行っており、概略下記の内容でお届けいたします。

第1章 概要

第2章 癌における生物学と診断業界のイントロダクション

  • バイオマーカー
  • バイオマーカーによる癌の検出と治療
  • 次世代DNAシークエンシングおよびバイオマーカー探索

第3章 癌バイオマーカー市場の分析

  • 本章の範囲
  • バイオマーカーの総市場における市場機会と分類
  • 商用アプリケーションにおける潜在的癌バイオマーカー
  • 組織の起源別の癌バイオマーカー市場見通し
  • 癌バイオマーカーの開発者における課題
  • 癌バイオマーカー製品におけるアンメットニーズ
  • 癌の非遺伝的バイオマーカー
  • 癌の分子診断検
  • 市場機会

第4章 癌バイオマーカーの主な臨床アプリケーション

  • 発売済み製品とパイプライン
  • CYP2C9ファーマコゲノミクスおよび個別化医療の役割
  • 個別化乳癌治療
  • 個別化NSCLC治療
  • AmpliChipベースの個別化医療

第5章 乳癌

  • 乳癌の概要
  • 罹患率および死亡率
  • BRCA1およびBRCA2遺伝子
  • エストロゲン受容体と乳癌
  • HER2遺伝子およびタンパク質
  • ハーセプチン治療
  • 補助化学療法のための腫瘍アッセイ
  • 乳癌の理解のためのゲノミクスの利用
  • 遺伝子分析ソリューション
  • 遺伝子発現マイクロアレイと再発予測
  • Oncotype DXの経済的利点
  • Oncotype DXの臨床的有用性の増大
  • 第2世代Oncotype DX
  • MammaPrint
  • Rotterdam Signature 76-Panel
  • マイクロアレイ技術のサマリー
  • 質量分析法ベースのアプローチ
  • 見通し
  • 将来展望
  • 乳癌プログラム(NMP66)
  • Myriad Genetics
  • ヤンセン診断法;LLC GeneSearch 乳リンパ節
  • OncoVue癌リスク検査
  • 乳癌用調査バイオマーカー
  • 乳癌予防のためのプロテインバイオマーカー
  • ドキソルビシンによる乳癌治療のバイオマーカー予後診断

第6章 卵巣癌

  • 罹患率
  • 血清マーカー
  • バイオマーカー
  • 卵巣癌用血清プロテインバイオマーカー
  • 卵巣癌のトリアージ検査

第7章 前立腺癌

  • 概要
  • 罹患率
  • 前立腺癌に含まれる遺伝子
  • アンドロゲン非依存性
  • 前立腺癌における遺伝子市場
  • 前立腺バイオマーカーのマイクロアレイ遺伝子同定
  • GEArray DNAマイクロアレイ
  • Vermillionの癌診断プログラム
  • ヘプシン
  • Gen-ProbeのPCA3アッセイ
  • 早期の前立腺癌抗原-2(EPCA-2)
  • 前立腺癌の最新の発見方法
  • 質量分析法
  • サマリー

第8章 膀胱癌

  • 概要
  • 罹患率および死亡率
  • 進行および再発
  • 膀胱癌検査
  • UroVysion 膀胱癌キット
  • The oncoFISH Bladder (Ikoniscope)
  • 核マトリクスタンパク質市場
  • ImmunoCyt™/uCyt+™
  • 膀胱癌市場
  • 市場分布
  • 償還

第9章 結腸直腸癌

  • 概要
  • 罹患率および死亡率
  • 結腸直腸癌のスクリーニング
  • Almac DiagnosticsのDSA
  • 結腸直腸癌プログラム(NMP35)
  • Myriad GeneticsのColaris APリスクアセスメント
  • サマリー

第10章 癌診断検査の革命のための遺伝子診断

  • 概要
  • AMAS検査
  • 主要市場におけるCorixaの抗体
  • Cytovision
  • Ariol System
  • Mammaglobinタンパク質発現
  • L523SまたはKOC RNA結合タンパク質
  • EDPバイオテクノロジーからのCA1-18

第11章 白血病バイオマーカー

  • 概要
  • 罹患率および死亡率
  • 進行および再発

第12章 肺癌

  • 概要
  • 罹患率および死亡率
  • 肺癌診断検査

第13章 癌バイオマーカーディスカバリーのための実現技術

  • ACIS
  • DNAのメチル化
  • プロテオミクス
  • 癌バイオマーカーとしての分泌タンパク質
  • 潜在腫瘍マーカーとしての非コードRNA
  • 結腸直腸癌発見のためのTIMP-1免疫学測定の構築
  • 自動顕微鏡ベースの分析システムの開発企業
  • 腫瘍細胞隔離のための研究製品の開発企業
  • 腫瘍細胞を特徴付けるための蛍光標識抗体を提供する企業
  • PerkinElmerのハイスループットプラットフォーム

第14章 コンパニオン診断としての癌治療と共同開発されたバイオマーカー検査

  • 概要
  • コンパニオン診断
  • 結腸直腸癌およびCamptostar向けEGFR
  • EGFR ExpressおよびErbitux
  • Myriadの IVDMIA 技術に基づいたコンパニオン
  • チロシンキナーゼ阻害薬のコンパニオン:Erlotinib/Gefitinib
  • コンパニオン診断の発展因子と障壁
  • 治療標的特定のための製薬会社とのパートナーシップ
  • コンパニオン診断の将来の発展

第15章 コンパニオン診断とカスタムメイド医療:生物学、アプローチ、パイプラインおよび規制動向

第16章 業界内のビジネス動向

第17章 新たな技術プラットフォームで癌診断市場に参入する企業

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目次
Product Code: TMRBIOM14-0701

Until superior therapeutic treatments are developed to prevent, treat and cure cancer, the best means of reducing mortality and morbidity in a disease this complex is early detection and diagnosis. In the major solid cancer types such as lung, breast, colon and prostate, long-term survival rates drop precipitously once metastatis has occurred. The case is clear for development of biomarkers for early detection and screening tests for diseases such as breast, colon, ovarian and lung cancer. In addition, diagnostic measurement of cancer disease progression is essential to successful disease management. For these reasons, development of new and effective biomarkers for cancer detection and diagnosis is central to the cancer problem. The use of nucleic acid biomarker diagnostics have begun to answer these questions. Protein biomarkers are also useful. The purpose of this TriMark Publications report is to describe the specific segment of the cancer diagnostics market which develops new biomarker technology platforms for diagnosing and treating cancer. Biomarkers are useful in following the course of cancer and evaluating which therapeutic regimes are most effective for a particular type of cancer, as well as determining long-term susceptibility to cancer or recurrence. This study particularly examines those clinical measurement devices, and their reagents and supplies, which are meant to be used in hospitals, clinics, commercial laboratories and doctor's offices to diagnose and monitor cancer. The examination also provides an in-depth discussion of the application of biomarkers in developing novel targeted cancer therapeutics, their predication response and efficacy, as well as their use in diagnosis of cancer.

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 Cancer Biology and the Diagnostic Industry

  • 2.1 Biomarkers
    • 2.1.1 The Biomarker Market for Cancer and Key Sectors
      • 2.1.1.1 The Sector
      • 2.1.1.2 The Critical Path Opportunities
      • 2.1.1.3 Capital Markets
      • 2.1.1.4 Molecular Diagnostics Technology Platforms
  • 2.2 Cancer Detection and Treatment Using Biomarkers as a Guide
    • 2.2.1 The Problem
  • 2.3 Next Generation Sequencing and Biomarker Discovery
    • 2.3.1 Second-Generation Sequencing
    • 2.3.2 Whole Genome Sequencing (WGS)
    • 2.3.3 Epigenomics
    • 2.3.4 Bioinformatics and Next Generation Sequencing
    • 2.3.5 Third Next Generation Sequencing

3. Market Analysis of the Cancer Biomarkers Space

  • 3.1 Scope of This Chapter
  • 3.2 The Overall Market Opportunity and Segmentation of the Total Cancer Biomarkers Marketplace
  • 3.3 Potential Cancer Biomarker Commercial Applications
    • 3.3.1 Market for Routine Tumor Markers
    • 3.3.2 PSA Testing Market Size
    • 3.3.3 Market Size and Forecasts for Companion Diagnostic Tests for Cancer Therapeutics
    • 3.3.4 SWOT Analysis of the Major Cancer Biomarker Market Segments
      • 3.3.4.1 Traditional Serum Cancer Biomarkers
      • 3.3.4.2 Proteomic Cancer Biomarkers
      • 3.3.4.3 Companion Diagnostic Cancer Biomarkers
  • 3.4 Cancer Biomarker Market Estimates by Tissue of Origin
    • 3.4.1 Colorectal
    • 3.4.2 Prostate
    • 3.4.3 Lung
    • 3.4.4 Breast
    • 3.4.5 Ovarian
  • 3.5 Challenges Facing Cancer Biomarker Developers
  • 3.6 Unmet Product Needs in the Cancer Biomarkers Space
  • 3.7 Epigenic Markers for Cancer
  • 3.8 Molecular Diagnostics Testing for Cancer
  • 3.9 Market Opportunities
    • 3.9.1 Industry Overview
    • 3.9.2 Medical Indications and Medically Useful Information
    • 3.9.3 Research Market
    • 3.9.4 Competition
    • 3.9.5 Diagnostic Services
    • 3.9.6 Clinical Image Analysis
    • 3.9.7 Research Imaging Market
    • 3.9.8 Genomic Disease Management and In Vitro Diagnostic Multivariate Index Assays (IVDMIA)
    • 3.9.9 Predictive Expression Profiles

4. Major Clinical Applications of Cancer Biomarkers

  • 4.1 Launched Products and Pipeline
  • 4.2 Launched Products and Pipeline
  • 4.3 CYP2C9 Pharmacogenetics and Role in Personalized Medicine
  • 4.4 Personalized Breast Cancer Therapy
  • 4.5 Personalized NSCLC Therapy
  • 4.6 AmpliChip-Based Personalized Medicine

5. Breast Cancer

  • 5.1 Overview of Breast Cancer Disease
  • 5.2 Incidence and Mortality Rates
    • 5.2.1 Incidence Rates
    • 5.2.2 Mortality Rates
  • 5.3 BRCA1 and BRCA2 Genes
    • 5.3.1 Types of Genetic Testing Available for Breast Cancer
      • 5.3.1.1 DNA Sequencing
      • 5.3.1.2 Multi-Site Analysis
      • 5.3.1.3 Single-Site Analysis
    • 5.3.2 BRCA Test Results
      • 5.3.2.1 What Does a Positive BRCA1 or BRCA2 Test Result Mean
      • 5.3.2.2 What does a Negative BRCA1 or BRCA2 Test Result Mean
      • 5.3.2.3 What does an Ambiguous BRCA1 or BRCA2 Test Result Mean
      • 5.3.2.4 What are the Options for a Person who Tests Positive
    • 5.3.3 What are Some of the Benefits of Genetic Testing for Breast Cancer Risk
    • 5.3.4 What are Some of the Risks of Genetic Testing for Breast and Ovarian Cancer Risk
  • 5.4 Estrogen Receptors and Breast Cancer
    • 5.4.1 Expression and Prognostic Value of ER
    • 5.4.2 Progesterone Receptors and Breast Cancer
    • 5.4.3 ER and PR Predict Response to Endocrine Therapy
  • 5.5 HER2 Gene and Protein
    • 5.5.1 HER2 Tests
      • 5.5.1.1 IHC Test
      • 5.5.1.2 FISH Test
      • 5.5.1.3 Questions About Testing
      • 5.5.1.4 HER2 Tumor Status
  • 5.6 Herceptin Treatment
  • 5.7 Tumor Assays for Adjuvant Chemotherapy
  • 5.8 Use of Genomics to Understand Breast Cancer
  • 5.9 Genetic Analysis Solution
    • 5.9.1 The Use of Proteomics in Breast Cancer
    • 5.9.2 Tissue Microarrays
    • 5.9.3 Protein Microarrays
  • 5.10 Gene Expression Microarrays and Recurrence Prediction
    • 5.10.1 Oncotype DX
    • 5.10.2 Oncotype DX for Breast Cancer
    • 5.10.3 Risk Assessment
    • 5.10.4 Use of Chemotherapy
    • 5.10.5 Utility of the Oncotype DX Test
    • 5.10.6 Clinical Development and Validation of Oncotype DX
      • 5.10.6.1 Clinical Development of the Oncotype DX Recurrence Score
      • 5.10.6.2 Clinical Validation of Prediction of Recurrence and Survival in N-, ER+ Patients Treated with Tamoxifen
      • 5.10.6.3 Oncotype DX Predicts the Likelihood of Recurrence
      • 5.10.6.4 Oncotype DX Predicts the Likelihood of Breast Cancer Survival in a Community Hospital Setting 1
      • 5.10.6.5 Oncotype DX Predicts both Prognosis and Tamoxifen Benefit
  • 5.11 Economic Benefits of Oncotype DX
  • 5.12 Increased Clinical Utility of Oncotype DX
  • 5.13 Second Generation Oncotype DX
    • 5.13.1 Recurrence and Benefit Test for N-, ER- Breast Cancer
    • 5.13.2 Taxane Benefit Test
  • 5.14 MammaPrint
  • 5.15 Rotterdam Signature 76-Panel
  • 5.16 Summary of Microarray Technologies
  • 5.17 Mass Spectrometry-Based Approaches
    • 5.17.1 Gel-Based Approaches
    • 5.17.2 Non-Gel-Based Approaches
      • 5.17.2.1 SELDI-TOF MS
      • 5.17.2.2 SELDI and Prognosis
      • 5.17.2.3 SELDI and Treatment Monitoring
  • 5.18 Outlook
  • 5.19 Future Perspectives
  • 5.20 Breast Cancer Program (NMP66)
  • 5.21 Myriad Genetics
  • 5.22 Janssen Diagnostics, LLC GeneSearch Breast Lymph Node
  • 5.23 OncoVue® Cancer Risk Test (InterGenetics, Inc.)
  • 5.24 Research Biomarkers for Breast Cancer
  • 5.25 Protein Biomarkers for Breast Cancer Prevention
  • 5.26 Biomarker Prognosis of Breast Cancer Treated with Doxorubicin

6. Ovarian Cancer

  • 6.1 Incidence Rates
    • 6.1.1 Incidence Rates
    • 6.1.2 Mortality Rates
  • 6.2 Serum Markers
  • 6.3 Biomarkers
    • 6.3.1 Strategies for Discovering New Cancer Biomarkers
  • 6.4 Serum Protein Biomarkers for Ovarian Cancer
    • 6.4.1 Clinical Proteomics
  • 6.5 Ovarian Cancer Triage Testing
    • 6.5.1 Vermillion's Ovarian Cancer Triage Diagnostic Program

7. Prostate Cancer

  • 7.1 Overview
    • 7.1.1 Incidence Rates
    • 7.1.2 Mortality Rates
    • 7.1.3 Prostate Cancer Progression and Recurrence Test
    • 7.1.4 Current Market Size
  • 7.2 Genes Involved in Prostate Cancer
  • 7.3 Androgen Independence
  • 7.4 Gene Markers in Prostate Cancer
  • 7.5 Microarray Gene Identification of Prostate Biomarkers
  • 7.6 GEArray DNA Microarrays
  • 7.7 Vermillion's Cancer Diagnostic Program
  • 7.8 Hepsin
  • 7.9 Hologic Gen-Probe's PCA3 Assay
  • 7.10 Early Prostate Cancer Antigen-2 (EPCA-2)
  • 7.11 New and Novel Methods for Detection of Prostate Cancer
  • 7.12 Mass Spectrometry
  • 7.13 Summary

8. Bladder Cancer

  • 8.1 Overview
  • 8.2 Incidence and Mortality Rates
    • 8.2.1 Incidence Rates
    • 8.2.2 Mortality Rates
  • 8.3 Progression and Recurrence
    • 8.3.1 Bladder Cancer Risk Factors
    • 8.3.2 Bladder Cancer Symptoms
  • 8.4 Bladder Cancer Tests
  • 8.5 UroVysion Bladder Cancer Kit (Abbott Molecular)
  • 8.6 The oncoFISH Bladder (Ikonisys)
    • 8.6.1 The CellOptics Platform (Ikonisys)
    • 8.6.2 Cell Staining and Genetic Characterization
    • 8.6.3 Ikoniscope/IkoniLAN Automated Microscopy
  • 8.7 Nuclear Matrix Protein Markers
  • 8.8 ImmunoCyt/uCyt+
  • 8.9 Bladder Cancer Market
    • 8.9.1 Urologist Market
    • 8.9.2 Clinical Lab Market
    • 8.9.3 Primary Care Market
    • 8.9.4 Private and Public Sector Markets
    • 8.9.5 POC Market
    • 8.9.6 Market Distribution
    • 8.9.7 Reimbursement

9. Colorectal Cancer

  • 9.1 Overview
  • 9.2 Incidence and Mortality Rates
    • 9.2.1 Incidence Rates
    • 9.2.2 Mortality Rates
    • 9.2.3 Progression and Recurrence
  • 9.3 Screening for CRC
    • 9.3.1 Stool-Based DNA Screening
  • 9.4 Almac Diagnostics DSA
  • 9.5 Colon Cancer Program (NMP35)
  • 9.6 Myriad Genetics COLARIS AP Risk Assessment
  • 9.7 Summary

10. Genetic Diagnostics Set to Revolutionize Cancer Diagnostic Testing

  • 10.1 Overview
    • 10.1.1 Clinicians' Need for More Information with Regard to Therapeutic Treatment Drives Demand for Pharmacogenomic Testing
    • 10.1.2 Predictive Medicine Shows Potential for Genetic Diagnostics
    • 10.1.3 Different Rates of Growth
    • 10.1.4 Effective Competitive Strategies
    • 10.1.5 Improvements in Marketing Effectiveness
    • 10.1.6 Emerging Technologies Imply Start of a New Era and Offer Tremendous Growth Opportunities
    • 10.1.7 Increased Market Share
    • 10.1.8 Technologies Used in Genetic Testing
  • 10.2 AMAS Test
  • 10.3 Corixa (now GSK) Antibodies as Tumor Markers
  • 10.4 CytoVision
  • 10.5 Ariol System
  • 10.6 Mammaglobin Protein Expression
  • 10.7 L523S or KOC RNA Binding Protein
  • 10.8 CA1-18 from EDP Biotech Corporation

11. Leukemia Biomarkers

  • 11.1 Overview
  • 11.2 Incidence and Mortality Rates
    • 11.2.1 Incidence Rates
    • 11.2.2 Mortality Rates
  • 11.3 Progression and Recurrence

12. Lung Cancer

  • 12.1 Introduction
  • 12.2 Incidence and Mortality Rates
    • 12.2.1 Incidence Rates
    • 12.2.2 Mortality Rates
  • 12.3 Lung Cancer Diagnostic Tests

13. Enabling Technologies for Oncology Biomarker Discovery

  • 13.1 Automated Cellular Imaging System (ACIS III)
    • 13.1.1 ACIS for HER2 Protein Expression Testing
    • 13.1.2 ACIS for ER Protein Expression Testing
    • 13.1.3 ACIS for PR Protein Expression Testing
    • 13.1.4 ACIS for Cell Proliferation Expression
    • 13.1.5 ACIS for Protein Expression
    • 13.1.6 ACIS for Protein Micrometastases in Bone Marrow
    • 13.1.7 ACIS for Protein Micrometastases in Tissue
    • 13.1.8 ACIS for TMA
    • 13.1.9 ACIS for DNA Ploidy
    • 13.1.10 ACIS for HPV
  • 13.2 DNA Methylation
    • 13.2.1 Differential Methylation Hybridization (DMH)
    • 13.2.2 MIRA-Assisted Microarrays for DNA Methylation Analysis and Cancer Diagnosis
  • 13.3 Proteomics
    • 13.3.1 Proteomics Technologies for Cancer Marker Discovery
    • 13.3.2 Validation of Candidate Biomarkers
    • 13.3.3 Requirements Bringing a New Marker into the Market
    • 13.3.4 Value Chain in the Development of New Cancer Biomarkers
  • 13.4 Secreted Proteins as Cancer Biomarkers
    • 13.4.1 Markers of Known Tissue Origin
    • 13.4.2 Secreted Proteins as Low Abundance Markers
    • 13.4.3 Secreted Proteins in Tissue and Blood
  • 13.5 Non-coding RNAs as Potential Tumor Markers
    • 13.5.1 miRNA Meets Microarray
    • 13.5.2 Mimetics and Inhibitors
    • 13.5.3 Clinical Patterns in Cancer
  • 13.6 Architect TIMP-1 (Tissue Inhibitor of Metalloproteinases-1) Immunoassay for CRC Detection
  • 13.7 Companies Developing Automated Microscope-Based Analysis Systems
  • 13.8 Companies Developing Research Products for Tumor Cell Isolation
  • 13.9 Companies Supplying Fluorescently Labeled Antibodies to Characterize Tumor Cells
  • 13.10 PerkinElmer High-Throughput Platforms: AlphaScreen, AequoScreen, DELFIA and LANCE Technologies

14. Biomarker Tests Co-Developed with Cancer Therapeutics as Companion Diagnostics

  • 14.1 Sector Overview
  • 14.2 Companion Diagnostics
  • 14.3 EGFR for CRC and Camptostar (Irinotecan)
    • 14.3.1 Companion Diagnostic Test Developed for UGT1A1 for Irinotecan
    • 14.3.2 Companion Diagnostic Test Developed for Bristol-Myers' SPRYCEL
    • 14.3.3 EGFR Express and Erbitux (Cetuximab)
  • 14.4 Companions Based on Myriad's IVDMIA Technology
    • 14.4.1 Myriad's TheraGuide 5-Fluorouracil (5-FU)
    • 14.4.2 BRACAnalysis Test
  • 14.5 Companions for Tyrosine Kinase Inhibitors: Erlotinib and Gefitinib
    • 14.5.1 TheraScreen: EGFR29
    • 14.5.2 The K-RAS Mutation Detection Kit
  • 14.8 Drivers and Barriers to Companion Diagnostics
  • 14.9 Partnerships with Pharma Companies to Identify Therapeutic Targets
  • 14.10 Future Developments for Companion Diagnostics

15. Companion Diagnostics and Personalized Medicine: Biology, Approaches, Pipeline and Regulatory Trends

  • 15.1 Scope of This Chapter
  • 15.2 Introduction to Companion Diagnostics and Personalized Medicine
    • 15.2.1 Stakeholders in Companion Diagnostics
    • 15.2.2 Development of Stakeholders' Business Models for Companion Diagnostics for Personalized Medicine
      • 15.2.2.1 Pharmaceutical Company Business Models for Developing Companion Diagnostics Products
      • 15.2.2.2 Diagnostic Company Business Models for Developing Companion Diagnostics Products
      • 15.2.2.3 Life Science Company Business Models for Developing Companion Diagnostics Products
      • 15.2.2.4 Pharmacy Benefit Management Company Business Models for Developing Companion Diagnostics Products
    • 15.2.3 Trends in Companion Diagnostic Deals
      • 15.2.3.1 Market Size of Companion Diagnostics
    • 15.2.4 Companion Diagnostics: Industry SWOT Analysis
    • 15.2.5 Challenges for Companion Diagnostics Development
    • 15.2.6 Timeline for Impact of Various Segments in Companion Diagnostics
    • 15.2.7 Use of Proteomics to Develop Individualized Tests
  • 15.3 The Compelling Case for Personalized Medicine
  • 15.4 Drug Metabolism and Implications for Companion Diagnostics and Personalized Medicine
  • 15.5 Examples of Personalized Medicine
  • 15.6 Personalized Medicine and Companion Diagnostics Testing Product Pipeline
  • 15.7 The Personalized Medicine Coalition
  • 15.8 Regulatory Trends and Guidelines in the Personalized Medicine Space
    • 15.8.1 The Changing Regulatory Landscape for Personalized Medicine
  • 15.9 Patenting Personalized Medicine
  • 15.10 The Leading Edge of Personalized Medicine: Specific Examples of Clinical Situations Where Personalized Medicine and Companion Diagnostics are Appropriate and Being Deployed
    • 15.10.1 EGFR Assay
    • 15.10.2 UGT1A1 Molecular Assay for Camptosar
    • 15.10.3 Response to Gleevec in Gastrointestinal Stromal Tumors
    • 15.10.4 LabCorp and Qiagen and Personalized Medicine for the treatment of Colorectal Cancer
    • 15.10.5 Labcorp and ARCA Discovery, Inc. and Personalized Medicine for Cardiovascular Disease
  • 15.11 Companion Diagnostics and Personalized Medicine: Qualitative and Quantitative Market Analysis
    • 15.11.1 Market Analysis of Molecular Diagnostics and Companion Diagnostics and Personalized Medicine
    • 15.11.2 Diagnostics vs. Pharmaceuticals
    • 15.11.3 Molecular Diagnostic Market
    • 15.11.4 Molecular Diagnostics Technology Platforms and their Impact on Personalized Medicine
  • 15.12 Snapshot of Companion Diagnostics Industry Structure
  • 15.13 The Case for Theranostics (Therapeutic/Companion Diagnostic)
  • 15.14 Personalized Medicine Market Analysis-Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters
  • 15.15 How the Market Segregates Today
  • 15.16 Timeline for Impact of Various Segments in Personalized Medicine
  • 15.17 Challenges for Personalized Therapeutics and Companion Diagnostics Development
  • 15.18 Macro Trends in Personalized Medicine
  • 15.19 Personalized Medicine and Companion Diagnostics: Industry SWOT Analysis

16. Business Trends in the Industry

  • 16.1 Industry Consolidation
  • 16.2 Breadth of Product Offering and Pricing
  • 16.3 Government Regulation of Medical Devices
    • 16.3.1 FDA Guidance on Drug Test Co-Development
  • 16.4 Strategic Business and Marketing Considerations
  • 16.5 Commercial Opportunities in Cancer Markers
    • 16.5.1 Licensing and Intellectual Property Constraints and how they will Impact New Product Development
  • 16.6 Moderators of Growth
    • 16.6.1 Roadblocks to Integrating Cancer Biomarkers into Clinical Practice
  • 16.7 Biotechnology Industry Trends
  • 16.8 Pharmaceutical Industry Trends
  • 16.9 Sales and Marketing Strategies for Tumor Marker Tests
    • 16.9.1 North American Market
    • 16.9.2 International Markets
      • 16.9.2.1 Europe
      • 16.9.2.2 Central and South America
      • 16.9.2.3 Asia-Pacific
  • 16.10 Product Commercialization
  • 16.11 Reimbursement
  • 16.12 Self Referral Rules
  • 16.13 Health Insurance Portability and Accountability Act
  • 16.14 Clinical Laboratory Improvement Amendments
  • 16.15 In Vitro Diagnostic Directive and Medical Device Regulations
  • 16.16 FDA's Quality System Regulation
  • 16.17 FDA's OIVD on IVDMIAs
  • 16.18 FDA Approval Process for Protein-Based Biomarkers
    • 16.18.1 Classification of Protein-Based Biomarker Assays as Medical Devices
    • 16.18.2 Clinical and Analytical Requirements for Biomarker Performance
    • 16.18.3 Approval Process Workflow
  • 16.19 Genetic Tests and Medical Records
    • 16.19.1 Laws Against Genetic Discrimination
  • 16.20 Medicare Reimbursement
    • 16.20.1 Medicare Spending Trends
  • 16.21 Global Drivers of Clinical Laboratory Testing
  • 16.22 Global Outlook for Cancer Biomarkers
    • 16.22.1 Which Companies are Utilizing Cutting-Edge Technologies to Develop, Validate and Implement Cancer Biomarkers for Clinical Use
    • 16.22.2 What Impediments Still Exist to Incorporating Promising Research into Clinical Practice
    • 16.22.3 Which Biomarkers Show the Most Promise for Approval
    • 16.22.4 How can Regulatory Oversight Drive Approval and Adoption of New Technologies
    • 16.22.5 Which Alliances Show the Greatest Synergy in Bringing Valid Biomarkers to Market
    • 16.22.6 Which Shared Technologies are Driving the Most Encouraging Development
    • 16.22.7 How Strategic Alliances and Interdisciplinary Involvement Drive Development and Implementation of Emerging Biomarker Technologies
  • 16.23 Oncology Biomarker Qualification Initiative
  • 16.24 FDA Critical Path
  • 16.25 FDA Criteria for a Valid Biomarker

17. Companies Entering the Cancer Diagnostics Market with Novel Technology Platforms

  • 17.1 Abbott Diagnostics
  • 17.2 Affymetrix, Inc.
  • 17.3 Agendia BV
  • 17.4 Agensys, Inc. (Astellas Pharma US)
  • 17.5 Agilent Technologies
  • 17.6 Almac Group
  • 17.7 AMDL, Inc.
  • 17.8 Asuragen, Inc.
  • 17.9 Aureon Laboratories, Inc.
  • 17.10 Beckman Coulter, Inc.
  • 17.11 Biocode Hycel S.A.
  • 17.12 BioCurex, Inc.
  • 17.13 Biomarker Technologies, LLC
  • 17.14 Biomedical Diagnostics, LLC
  • 17.15 Biomerica, Inc.
  • 17.16 bioMérieux
  • 17.17 Biomira, Inc. (Oncothyreon, Inc.)
  • 17.18 Biomoda, Inc.
  • 17.19 Bruker Daltonics, Inc.
  • 17.20 Byk Gulden
  • 17.21 Cangen Biotechnologies, Inc.
  • 17.22 Caprion Proteomics
  • 17.23 Celera Diagnostics
  • 17.24 Cepheid
  • 17.25 Clarient, Inc. (GE Healthcare)
  • 17.26 Claros Diagnostics, Inc.
  • 17.27 Clinical Data, Inc.: PGxHealth and Cogenics
  • 17.28 Correlogic Systems, Inc.
  • 17.29 CytoCore, Inc. (Formerly Molecular Diagnostics, Inc.)
  • 17.30 Cytogen Corporation (now EUSA Pharma)
  • 17.31 Dako (Agilent Technologies)
  • 17.32 diaDexus, LLC
  • 17.33 DiagnoCure, Inc.
  • 17.34 DRG International, Inc.
  • 17.35 EDP Biotech Corporation
  • 17.36 Eisai Co., Ltd.
  • 17.37 Eli Lilly & Co.
  • 17.38 Epigenomics
  • 17.39 Exact Sciences Corporation
  • 17.40 Exagen Diagnostics, Inc.
  • 17.41 Exigon
  • 17.42 Gene Logic, Inc.
  • 17.43 Genesis Genomics, Inc. (Mitomics)
  • 17.44 GenMark Diagnostics
  • 17.45 Genomic Health, Inc.
  • 17.46 Gen-Probe, Inc. (now known as Hologic Gen-Probe)
  • 17.47 Health Discovery Corporation
  • 17.48 Ikonisys, Inc.
  • 17.49 Illumina
  • 17.50 Immunomedics, Inc.
  • 17.51 Incyte Pharmaceuticals, Inc.
  • 17.52 InterGenetics, Inc.
  • 17.53 Ipsogen (Qiagen Marseille)
  • 17.54 Janssen Diagnostics
  • 17.55 LabCorp
  • 17.56 Life Technologies Corporation (Thermo Fisher Scientific)
  • 17.57 Matritech, Inc. (Alere)
  • 17.58 Miraculins, Inc.
  • 17.59 Mitsubishi Kagaku Medical
  • 17.60 MolecularMD
  • 17.61 Myriad Genetics, Inc.
  • 17.62 NimbleGen Systems, Inc.
  • 17.63 Northwest Biotherapeutics, Inc.
  • 17.64 Oncotech, Inc. (Exiqon A/S)
  • 17.65 Oncothyreon, Inc. (Formerly known as Biomira)
  • 17.66 OPKO Health, Inc.
  • 17.67 Orion Genomics
  • 17.68 Oxford BioTherapeutics (Formerly Oxford Genome Sciences)
  • 17.69 Panacea Pharmaceuticals, Inc.
  • 17.70 Polymedco, Inc.
  • 17.71 Power3 Medical Products
  • 17.72 Qiagen N.V.
  • 17.73 Roche Molecular Diagnostics
  • 17.74 SensiGen, LLC (Sequenom Center for Molecular Medicine)
  • 17.75 Siemens Healthcare Diagnostics, Inc.
  • 17.76 Upstream Biosciences, Inc.
  • 17.77 Ventana Medical Systems, Inc. (Part of the Roche Group)
  • 17.78 Veridex, LLC (Janssen Diagnostics, LLC)
  • 17.79 Vermillion, Inc. (Formerly Ciphergen)

Appendix 1: Cancer Biomarker Centers of Research

Appendix 2: Myriad Patents on Genes BRCA-1 and BRCA-2

Appendix 3: Cancer Markers Currently in Common Clinical Use

Appendix 4: International Federation of Gynecology and Obstetrics (FIGO) Staging System for Primary Carcinoma of the Ovary

Appendix 5: FDA Guidance for Industry: Pharmacogenomic Data Submission

  • A5.1 Introduction
  • A5.2 Background
  • A5.3 Submission Policy
    • A5.3.1 General Principles
    • A5.3.2 Specific Uses of Pharmacogenomic Data in Drug Development and Labeling
    • A5.3.3 Benefits of Voluntary Submissions to Sponsors and FDA
  • A5.4 Submission of Pharmacogenomic Data
    • A5.4.1 Submission of Pharmacogenomic Data During the IND Phase
    • A5.4.2 Submission of Pharmacogenomic Data to a New NDA, BLA or Supplement
    • A5.4.3 Submission to a Previously Approved NDA or BLA
    • A5.4.4 Compliance with 21 CFR Part 58
    • A5.4.5 Submission of Voluntary Genomic Data from Application-Independent Research
  • A5.5 Format and Content of a VGDS
  • A5.6 Process for Submitting Pharmacogenomic Data
  • A5.7 Agency Review of VGDSs 390

Appendix 6: E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions

  • A6.1 Introduction
  • A6.2 Background
  • A6.3 Scope
  • A6.4 General Principles
  • A6.5 Structure of Biomarker Qualification Submissions

Glossary

INDEX OF FIGURES

  • Figure 3.1: Potential Market for Cancer Biomarkers
  • Figure 3.2: Segmentation of the Cancer Biomarkers Marketplace Based on Commercial Offerings-Products and Services
  • Figure 3.3: Geographical Distribution of Cancer Tumor Diagnostic Testing
  • Figure 3.4: Cancer Biomarkers Research Market, 2006-2016
  • Figure 3.5: Breast Cancer Biomarker Market Potential, 2010
  • Figure 3.6: Challenges in the Study or Utilization of Proteomic Cancer Biomarkers
  • Figure 3.7: Challenges in the Study or Utilization of Companion Diagnostic Cancer Biomarkers
  • Figure 3.8: Challenges in the Study or Utilization of Serum Cancer Markers
  • Figure 3.9: Top Unmet Needs in Commercial Products in the Cancer Biomarkers Space
  • Figure 5.1: Hybridization Process
  • Figure 5.2: FISH Test Procedure
  • Figure 5.3: Gene Expression Profiling
  • Figure 15.1: Strategic and Tactical Considerations for Co-Development of Companion Diagnostics
  • Figure 15.2: Global Market for Companion Diagnostics
  • Figure 15.3: Number of Companion Diagnostic Agreements, 2000-2013
  • Figure 15.4: Surface Binding Produces Phase Shifts that Increases the Diffraction Signal Intensity
  • Figure 15.5: Phase I and II Processes of Drug Metabolism
  • Figure 15.6: Human Phase I Enzymes
  • Figure 15.7: Human Phase II Enzymes
  • Figure 15.8: Hepatic Distribution of Human CYP450
  • Figure 15.9: Relative Contribution of CYP450 Enzymes to Drug Metabolism
  • Figure 15.10: Genetic Components Determine Drug Metabolism
  • Figure 15.11: From Genetic Content to Personalized Medicine
  • Figure 15.12: Remuneration for Diagnostics
  • Figure 15.13: Breakout of the Molecular Diagnostics Marketplace
  • Figure 15.14: Molecular Diagnostics Market Segmentation
  • Figure 15.15: Molecular Diagnostics Market Segmentation by Technology
  • Figure 15.16: Market Survey Respondent Demographics
  • Figure 15.17: Breakout of the Respondent Pool by Affiliation
  • Figure 15.18: Segmentation of the Personalized Medicine Market
  • Figure 15.19: Personalized Medicine Market Drivers
  • Figure 15.20: Challenges in the Personalized Medicine Space
  • Figure 16.1: Medicare Spending on Clinical Laboratory Services per Enrollee, 2003-2016

INDEX OF TABLES

  • Table 2.1: Cancer Biomarker Stakeholders
  • Table 3.1: Characteristics of Different Cancer Biomarker Types and Associated Market Opportunities
  • Table 3.2: Segmentation of the Cancer Biomarker Market by Type/Lineage of Cancer Biomarkers and Market Size
  • Table 3.3: In Vitro Cancer Marker Market Segments Worldwide, 2007-2012
  • Table 3.4: Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2009-2019
  • Table 3.5: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2009-2019
  • Table 3.6: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2009-2019
  • Table 3.7: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2009-2019
  • Table 3.8: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2009-2019
  • Table 3.9: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2009-2019
  • Table 3.10: Global Distribution of IVD Cancer Tumor Marker Diagnostic Testing, 2013
  • Table 3.11: Estimated Market Share of Major Competitors in U.S. Cancer Tumor Marker Diagnostics Market
  • Table 3.12: Major Presence in Cancer Tumor Marker Diagnostics Markets
  • Table 3.13: Worldwide CEA Sales, 2009-2019
  • Table 3.14: U.S. CEA Sales, 2009-2019
  • Table 3.15: Japan CEA Sales, 2009-2019
  • Table 3.16: Europe CEA Sales, 2009-2019
  • Table 3.17: Rest of the World CEA Sales, 2009-2019
  • Table 3.18: Worldwide PSA Sales 2009-2019
  • Table 3.19: U.S. PSA Sales 2009-2019
  • Table 3.20: Cancer Biomarkers Research Market Forecast, 2006-2016
  • Table 3.21: Cancer Biomarker Market Estimates by Tissue of Origin
  • Table 3.22: Companies Developing New Proteomic Cancer Biomarker Technology Platforms
  • Table 3.23: Uses of Molecular Diagnostics in Detection and Management of Cancer
  • Table 3.24: U.S. Cancer Diagnostic Testing Market Size, 2005-2016
  • Table 3.25: Market Opportunities for Cancer Biomarker Technology Platforms
  • Table 4.1: Use of Biomarkers in Clinical Use
  • Table 4.2: Use of Biomarkers in Cancer Research
  • Table 4.3: Currently Approved Targeted Therapies for Solid Malignancies and Their Molecular Targets
  • Table 4.4: Tumor Biomarkers Currently in Common Use
  • Table 4.5: Clinically Relevant Biomarkers
  • Table 4.6: Biomarkers for Monitoring Therapeutic Effectiveness and Resistance
  • Table 4.7: Biomarkers for Dose Response of Therapy
  • Table 4.8: Decision on Optimal Duration of Therapy
  • Table 5.1: Estimated New Female Breast Cancer Cases and Deaths by Age in the U.S., 2013
  • Table 5.2: BRCA Development Model
  • Table 5.3: BRCA Test Development and Commercialization
  • Table 5.4: BRACAnalysis
  • Table 5.5: Revenue for BRACAnalysis Risk Assessment Test, 2002-2013
  • Table 5.6: Key Players in the Breast Cancer Molecular Diagnostic Space
  • Table 5.7 Companies Offering IVDMIA Microarray Breast Cancer Biomarker Analysis
  • Table 5.8: GEArray DNA Microarrays and RT2 Profiler PCR Arrays
  • Table 5.9: Product Development Opportunities in Breast Cancer
  • Table 5.10: Concentration of Some Abundant Proteins, New Cancer Biomarkers Identified by SELDI-TOF and Classical Cancer Biomarkers in Serum
  • Table 5.11: Questions Related to Diagnostic SELDI-TOF Technology
  • Table 6.1: Worldwide CA-125 Sales, 2001-2018
  • Table 6.2: U.S. CA-125 Sales, 2001-2018
  • Table 6.3: Some Clinically Established Cancer Serum Markers Currently in Use for Cancer
  • Table 6.4: Pathophysiology of Ovarian Cancer and Characterization of Ovarian Epithelial Tumors
  • Table 7.1: Worldwide PSA Sales, 2000-2018
  • Table 7.2: U.S. PSA Sales, 2000-2018
  • Table 7.3: Molecular Gene Markers for Prostate Cancer
  • Table 8.1: Worldwide Bladder Cancer Marker Sales, 2001-2018
  • Table 8.2: U.S. Bladder Cancer Marker Sales, 2001-2018
  • Table 8.3: Worldwide NMP22 Sales, 2001-2018
  • Table 8.4: Summary of Matritech's Product Development Programs
  • Table 8.5: Opportunities for Bladder Cancer Biomarkers
  • Table 9.1: TNM Staging for CRC
  • Table 10.1: Genetic Diagnostics Market, 2004-2018
  • Table 13.1: Genomic and Proteomic Technologies
  • Table 14.1: Potential Benefits of Biomarkers as Companion Diagnostics
  • Table 14.2: Utility of Biomarker as Companion Diagnostics to Drug Development
  • Table 14.3: Device Submission Elements for the FDA
  • Table 14.4: Summary of Biomarker Use in the Commercialization of Novel Oncology Pharmacotherapeutics
  • Table 14.5: Pharmacoeconomic Challenges to the Implementation of Biomarkers as Companion Diagnostic Tests
  • Table 15.1: FDA Approved Companion Diagnostic Devices: In Vitro and Imaging Tools
  • Table 15.2: Personalized Medicine Industry SWOT Analysis
  • Table 15.3: Hurdles to Personalized Medicine and Companion Diagnostics Development
  • Table 15.4: Timeline of Impact in Areas of Personalized Medicine
  • Table 15.5: Impact of Personalized Medicine on Various Therapeutic Areas
  • Table 15.6: Percentage of Non-Responders in Various Drug Classes
  • Table 15.7: High Profile Drug Withdrawals from the Marketplace
  • Table 15.8: Drug Metabolism Drives Drug Efficacy/Toxicity
  • Table 15.9: Population Frequency of the Various Cytochromes
  • Table 15.10: Selected List of Personalized Medicine Tests
  • Table 15.11: Personalized Medicine and Companion Diagnostics Product Pipeline
  • Table 15.12: Marketed Personalized Therapies, 2013
  • Table 15.13: Members of the Personalized Medicine Coalition
  • Table 15.14: Various Molecular Diagnostics Technologies: Timeline for Impact
  • Table 15.15: Various Molecular Diagnostics Technologies: Impact on Different Therapeutic Areas in Personalized Medicine
  • Table 15.16: Technical Challenges in the Deployment for Personalized Medicine
  • Table 15.17: Classification of Diagnostics by Risk
  • Table 15.18: Areas in Personalized Medicine-Timeline of Impact
  • Table 15.19: Impact of Personalized Medicine on Various Therapeutic Areas
  • Table 15.20: Hurdles in Personalized Medicine and Companion Diagnostics Development in Various Therapeutic Areas
  • Table 15.21: Market Opportunities in Personalized Medicine
  • Table 15.22: Challenges for Market Adoption of the Various Personalized Medicine Tests
  • Table 15.23: Personalized Medicine Industry SWOT
  • Table 16.1: List and Discounted Prices for Abbott Tumor Marker Tests
  • Table 16.2: Increases in Total Allowed Charges for Laboratory Services per Enrollee, 2000-2016
  • Table 16.3: Incurred Reimbursement Amounts per Fee-for-Service for Laboratory Services per Enrollee, 2003-2016
  • Table 16.4: Medicare Part B Benefit Payments, 2003-2016
  • Table 17.1: Major GeneChip Instrument Products
  • Table 17.2: Major GeneChip Array and Reagent Products
  • Table 17.3: Gene Titan Products
  • Table 17.4: Gene Atlas Products
  • Table 17.5: Gene Atlas Products
  • Table 17.6: Opportunities for Biomarkers in Cancer Diagnosis and Treatment
  • Table 17.7: Tumor Diagnosis Immunoassay
  • Table 17.8: Tumor Diagnosis Radioimmunoassay
  • Table 17.9: Myriad Molecular Diagnostic Revenues, 2012 and 2013
  • Table 17.10: Roche Group Financial Figures-Net Sales by Business Sector, 2008-2013
  • Table 17.11: Roche Group Diagnostics Division-Net Sales by Geographic Region, 2012 and 2013
  • Table 17.12: Roche Group Financial Figures-Net Sales by Diagnostics Sub-Division, 2008-2013
  • Table A1.1: Team Descriptions
  • Table A3.1: List of FDA-Approved Protein Tumor Markers Currently Used in Clinical Practice
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