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MediPoint:腫瘍向けコンパニオン診断検査 - EU市場の分析と予測

MediPoint: Companion Diagnostic Tests in Oncology - EU Analysis and Market Forecasts

発行 GlobalData 商品コード 303984
出版日 ページ情報 英文 489 Pages
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MediPoint:腫瘍向けコンパニオン診断検査 - EU市場の分析と予測 MediPoint: Companion Diagnostic Tests in Oncology - EU Analysis and Market Forecasts
出版日: 2014年05月21日 ページ情報: 英文 489 Pages
概要

EU5カ国におけるコンパニオン診断検査市場は、2012年には5320万ドルに達すると予測されています。主なEU諸国では、HER2・IHC検査はほぼ市場に浸透しており、主要な成長要因は乳がんの発生率の増加となっています。乳がんに対するIHC検査市場について、EU諸国の中ではスペインが最も高い成長を見せています。

当レポートでは、EUにおける腫瘍向けコンパニオン診断検査の市場について、疾患の概要や市場構造、現在のアンメットニーズ、主な市場促進・抑制要因、今後の市場機会、現在治験中の主要製品、主要5ヶ国における市場動向(過去3年間の実績値と今後7年間の予測値)、製品カテゴリー別の詳細動向、主要企業のプロファイルなどを調査し分析をまとめています。

第1章 目次

第2章 イントロダクション

第3章 産業概要

  • コンパニオン診断の登場
    • コンパニオン診断の定義
    • 医療の変化の側面
    • コンパニオン個別化診断の定義
  • 疾患への適用
    • 乳がん
    • 大腸がん
    • メラノーマ(黒色腫)
    • 非小細胞肺がん
  • コンパニオン診断技術
    • 免疫化学的手法
    • 核酸検査
    • 新たな手法
  • コンパニオン診断の発達
    • コンパニオン診断の経済的価値
    • コンパニオン診断検査の発展の時期
    • 戦略
    • パートナーの選定
    • バイオマーカーの発見
  • 臨床転帰
    • 疾患治療におけるコンパニオン診断の役割
    • コンパニオン診断検査の適用
  • 検査の動向
    • フランス
    • ドイツ
    • イタリア
    • スペイン
    • 英国
  • 市場アクセス
    • 規制
    • 医療費の償還
  • 規制上の課題とリコール(5件)
  • コンパニオン診断検査への医療費償還
    • 欧州
  • 企業合併・買収(M&A)/主なパートナーシップ
  • 経済的な影響
    • コンパニオン診断のコスト効率性(全体的および医療機関からの観点)
  • 市場促進要因
    • 医療面での圧力増大
    • 経済面での負の圧力
    • 新技術の利用可能性
    • FDA(米国食品医薬品局)の規制の改革
    • 医薬品開発プロセスの改善の必要性
    • がんの有病者数の増大
    • 標的治療の需要拡大
  • 市場阻害要因
    • 医療費償還の難しさ
    • 適応症の消失
    • バイオシミラー療法の出現
    • LDT(研究室で開発された検査法)との競合
    • 次世代型遺伝子シーケンシングの登場
    • 装置選択に際しての研究室の選択肢の少なさ
    • コンパニオン診断検査に対する患者の認知度の低さ
    • 新たなコンパニオン診断検査に対する医師側の抵抗

第4章 競合力の評価

  • 概要
  • 現在上市済みの製品で使用されている手法
    • 免疫組織化学
    • 蛍光in situハイブリダイゼーション
    • ポリメラーゼ連鎖反応
  • 競争力の分析
    • 乳がん向けコンパニオン診断検査
    • 大腸がん向けコンパニオン診断検査
    • メラノーマ向けコンパニオン診断検査
    • 非小細胞肺がん向けコンパニオン診断検査

第5章 アンメットニーズ

  • がん治療改善の必要性
  • 客観テストのニーズ
  • 高スループット検査のニーズ
  • 医療費償還の確実性
  • 検査に必要な体内組織の量と種類
  • 誰が検査対象となるのか?
  • 検査の正確性
  • 検査の複雑化とプロセス障害の増加

第6章 パイプライン製品

  • 概要
  • 開発段階別のパイプライン
  • パイプライン製品のプロファイル
    • 乳がん向けコンパニオン診断検査
    • 大腸がん向けコンパニオン診断検査
    • メラノーマ向けコンパニオン診断検査
    • 非小細胞肺がん向けコンパニオン診断検査

第7章 注目すべき治験

  • 概要
  • 特定の薬物療法とむすびついたコンパニオン診断検査のパイプライン製品を活用した、主な治験の情報

第8章 現在・将来の市場参入企業

  • 企業戦略の傾向
    • コンパニオン診断のビジネスモデル
  • 企業プロファイル
    • コンパニオン診断検査手法を開発している製薬/治療企業
    • (製薬企業と提携して)コンパニオン診断検査手法を開発している診断企業

第9章 市場の将来展望

  • 市場分野別
    • 乳がん向けコンパニオン診断検査
    • 大腸がん向けコンパニオン診断検査
    • メラノーマ向けコンパニオン診断検査
    • 非小細胞肺がん向けコンパニオン診断検査
    • 手法
  • 地域別
    • 概要
    • フランス
    • ドイツ
    • イタリア
    • スペイン
    • 英国
  • 第10章 付録

図表一覧

目次
Product Code: GDME1101CFR

A companion diagnostic test is defined as an in vitro diagnostic device or an imaging tool whose use allows the safe application of a therapy. In-vitro Companion Diagnostic tests measure the expression or presence of a specific biomarker that is linked to a disease condition or therapy. This report provides an analysis of the companion diagnostic market for four major cancers in the US, the 5EU (France, Germany, Italy, Spain, and UK), Brazil, and the some of the Asia-Pacific (APAC) regions (Japan, China, and India), and identifies the unmet needs in this companion diagnostics market. This report analyses companion diagnostic tests used in breast, colorectal, melanoma and non-small cell lung cancer. This report also discusses physician attitudes towards current companion diagnostic tests, and the future of companion diagnostic tests. This report focuses on the major test kits that are supplied to pathology laboratories.

GlobalData estimates the 5EU companion diagnostic test market, for breast cancer companion diagnostic tests, principally HER2 tests, to have been worth $53.2m in 2012. In the major EU, uptake of the HER2 IHC test is near saturation, and most growth will come from increases in breast cancer incidence. Within the EU, Spain shows the highest growth in breast cancer IHC tests.

Scope

  • An overview of companion diagnostic, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
  • Annualized EU companion diagnostic market revenue and future forecasts from 2011 to 2013, forecast for 7 years to 2020.
  • Investigation of current and future market competition for companion diagnostic.
  • Insightful review of the key industry drivers, restraints and challenges as well as predicted impact of key events.
  • Competitor assessment including device approval analysis and device sales forecasts.
  • Marketed and pipeline product profiles covering efficiency, safety, clinical study details, device approvals, product positioning and device sales forecast.
  • Analysis of unmet needs within the market and opportunities for future players.
  • Technology trends evaluation to assess strength of pipeline.
  • An overview of all devices in development including clinical study details, design and material selection considerations, efficacy reports, and device approval timelines.
  • Company profiles including business description, financial overview and SWOT analysis.
  • Coverage of key market players.
  • Strategic assessment of the companion diagnostic sector through market impact analysis, future market scenario and company analysis.
  • Direct quotes from Key Opinion Leaders (KOL) as well as doctors

Reasons to buy

  • Understand the trends shaping and driving the EU companion diagnostic market.
  • Realize device preferences of physicians who have performed the tests already.
  • Access market sizing, forecasts and quantified growth opportunities in EU companion diagnostic market through 2018.
  • Quantify candidate patient populations to better design product pricing & launch plans.
  • Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.
  • Perform benchmarking analysis of growth opportunities against currently marketed products.
  • Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
  • Take a comprehensive look at the market's device pipeline and identify promising, paradigm-shifting products.
  • Create an effective counter-strategy to gain a competitive advantage against those currently in the market.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for growth.
  • What's the next big thing in EU companion diagnostic market landscape? Identify, understand and capitalize.

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Catalyst
  • 2.2. Related Reports

3. Industry Overview

  • 3.1. Emergence of Companion Diagnostics
    • 3.1.1. Definition of Companion Diagnostics
    • 3.1.2. Changing Face of Medicine
    • 3.1.3. Definitions of Companion and Personalized Diagnostics
  • 3.2. Disease Applications
    • 3.2.1. Breast Cancer
    • 3.2.2. Colorectal Cancer
    • 3.2.3. Melanoma
    • 3.2.4. Non-Small Cell Lung Cancer
  • 3.3. Companion Diagnostics Technologies
    • 3.3.1. Immunochemical Techniques
    • 3.3.2. Nucleic Acid Testing
    • 3.3.3. Emerging Technologies
  • 3.4. Companion Diagnostics Development
    • 3.4.1. Economic Value of a Companion Diagnostic
    • 3.4.2. When to Develop a Companion Diagnostic Test
    • 3.4.3. Strategy
    • 3.4.4. Selection of Partner
    • 3.4.5. Biomarker Discovery
  • 3.5. Clinical Outcomes
    • 3.5.1. Role of Companion Diagnostics in Disease Treatment
    • 3.5.2. Companion Diagnostic Test Applications
  • 3.6. Testing Trends
    • 3.6.1. France
    • 3.6.2. Germany
    • 3.6.3. Italy
    • 3.6.4. Spain
    • 3.6.5. UK
  • 3.7. Market Access
    • 3.7.1. Regulation
    • 3.7.2. Reimbursement
  • 3.8. Regulatory Issues and Recalls
    • 3.8.1. Dako FDA Warning Letter
    • 3.8.2. HercepTest Recall
    • 3.8.3. Cobas KRAS Test Recall
    • 3.8.4. Cobas BRF V600E Test Recall
    • 3.8.5. Leica Bond HER2 IHC System
  • 3.9. Reimbursement of Companion Diagnostic Tests
    • 3.9.1. Europe
  • 3.10. M&A, Key Partnerships
    • 3.10.1. Significant Mergers and Acquisitions
    • 3.10.2. Recent Partnerships
  • 3.11. Economic Impact
    • 3.11.1. Cost Effectiveness of Companion Diagnostics
    • 3.11.2. Cost Effectiveness of Companion Diagnostics: Healthcare Provider Perspective
  • 3.12. Market Drivers
    • 3.12.1. Driver: Increasing Healthcare Pressures
    • 3.12.2. Driver: Adverse Economic Pressures
    • 3.12.3. Driver: Availability of New Technologies
    • 3.12.4. Driver: FDA Regulatory Changes
    • 3.12.5. Driver: Need to Improve Drug Development Processes
    • 3.12.6. Driver: Increasing Cancer Incidence
    • 3.12.7. Driver: Accelerating Demand for Targeted Therapies
  • 3.13. Market Barriers
    • 3.13.1. Barrier: Reimbursement Difficulties
    • 3.13.2. Barrier: Loss of Indication
    • 3.13.3. Barrier: Emergence of Biosimilar Therapies
    • 3.13.4. Barrier: Competition with Laboratory-Developed Tests
    • 3.13.5. Barrier: Emergence of Next-Generation Gene Sequencing
    • 3.13.6. Barrier: Lack of Laboratory Choice in Instrument Selection
    • 3.13.7. Barrier: Lack of Patient Awareness about Companion Diagnostic Tests
    • 3.13.8. Barrier: Physician Resistance to New Companion Diagnostic Tests

4. Competitive Assessment

  • 4.1. Overview
  • 4.2. Techniques in Use by Currently Marketed Products
    • 4.2.1. Immunohistochemistry
    • 4.2.2. Fluorescence In Situ Hybridization
    • 4.2.3. Polymerase Chain Reaction
  • 4.3. Competitive Analysis
    • 4.3.1. Breast Cancer Companion Diagnostic Tests
    • 4.3.2. Colorectal Cancer Companion Diagnostic Tests
    • 4.3.3. Melanoma Companion Diagnostic Tests
    • 4.3.4. Non-Small Cell Lung Cancer Companion Diagnostic Tests

5. Unmet Needs

  • 5.1. Need for Improved Cancer Treatments
  • 5.2. Need for Objective Tests
  • 5.3. Need for High-Throughput Tests
  • 5.4. Certainty of Reimbursement
  • 5.5. Amount and Type of Tissue Needed for Test
  • 5.6. Who Should be Tested?
  • 5.7. Test Accuracy
  • 5.8. Increasing Test Complexity and Increased Process Failure

6. Pipeline Products

  • 6.1. Overview
  • 6.2. Pipeline by Phase of Development
  • 6.3. Pipeline Product Profiles
    • 6.3.1. Breast Cancer Companion Diagnostic Tests
    • 6.3.2. Colorectal Cancer Companion Diagnostic Tests
    • 6.3.3. Melanoma Companion Diagnostic Tests
    • 6.3.4. Non-Small Cell Lung Cancer Companion Diagnostic Tests

7. Clinical Trials to Watch

  • 7.1. Overview
  • 7.2. Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug Therapies

8. Current and Future Players

  • 8.1. Trends in Corporate Strategy
    • 8.1.1. Companion Diagnostics Business Models
  • 8.2. Company Profiles
    • 8.2.1. Pharmaceutical/Therapy Companies Developing Companion Diagnostic Tests
    • 8.2.2. Diagnostics Companies Developing Companion Diagnostic Tests (in Partnership with Pharmaceutical Companies)

9. Market Outlooks

  • 9.1. By Market Segment
    • 9.1.1. Breast Cancer Companion Diagnostic Tests
    • 9.1.2. Colorectal Cancer Companion Diagnostic Tests
    • 9.1.3. Melanoma Companion Diagnostic Tests
    • 9.1.4. Non-Small Cell Lung Cancer Companion Diagnostic Tests
    • 9.1.5. Technique
  • 9.2. By Geography
    • 9.2.1. Overview
    • 9.2.2. France
    • 9.2.3. Germany
    • 9.2.4. Italy
    • 9.2.5. Spain
    • 9.2.6 UK

10. Appendix

  • 10.1. Bibliography
  • 10.2. Abbreviations
  • 10.3. Report Methodology
    • 10.3.1. Coverage
    • 10.3.2. Secondary Research
    • 10.3.3. Forecasting Methodology
  • 10.4. Physicians Included in this Study
  • 10.5. About the Authors
    • 10.5.1. Andrew Thompson, Ph.D., Senior Analyst, In Vitro Diagnostics
    • 10.5.2. Derek Archila, MBA, Lead Analyst, Medical Devices
    • 10.5.3. Bonnie Bain, PhD, Global Head of Healthcare
  • 10.6. Disclaimer

List of Tables

  • Table 1: Possible Companion Diagnostic Test Platforms
  • Table 2: Specific Breast Cancer Types Associated with Inherited Disorders
  • Table 3: Specific Mutations Associated with Non-Small Cell Lung Cancer
  • Table 4: Weaknesses of ELISA Technique
  • Table 5: Key Stages of PCR Gene Test
  • Table 6: Key Principles Guiding Companion Diagnostic Test Development
  • Table 7: Companion Diagnostic Test Development Partner Selection
  • Table 8: Biomarker Discovery
  • Table 9: Disease Diagnosis, Treatment, and Monitoring
  • Table 10: Application of Companion Diagnostic Tests
  • Table 11: Major Biomarkers currently measured in Cancer Companion Diagnostic Tests
  • Table 12: Types of Genetic Tests Carried Out in France during 2009
  • Table 13: Biomarkers tested for in France
  • Table 14: Tumor Molecular Profiling in France in 2011 and 2012
  • Table 15: Breast Cancer Companion Diagnostic Testing (HER2) in France, 2011-2020
  • Table 16: KRAS Companion Diagnostic Testing in France, 2008-2012
  • Table 17: Colorectal Cancer Companion Diagnostic (KRAS) Testing in France, 2011-2020
  • Table 18: Melanoma Companion Diagnostic Testing (BRAF) in France, 2011-2020
  • Table 19: EGFR Companion Diagnostic Testing in France, 2008-2012
  • Table 20: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in France, 2011-2020
  • Table 21: Breast Cancer Companion Diagnostic Testing (HER2) in Germany, 2011-2020
  • Table 22: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Germany, 2011-2020
  • Table 23: Melanoma Companion Diagnostic Testing (BRAF) in Germany, 2011-2020
  • Table 24: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Germany, 2011-2020
  • Table 25: Breast Cancer Companion Diagnostic Testing (HER2) in Italy, 2011-2020
  • Table 26: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Italy, 2011-2020
  • Table 27: Melanoma Companion Diagnostic Testing (BRAF) in Italy, 2011-2020
  • Table 28: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Italy, 2011-2020
  • Table 29: Breast Cancer Companion Diagnostic Testing (HER2) in Spain, 2011-2020
  • Table 30: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Spain, 2011-2020
  • Table 31: Melanoma Companion Diagnostic Testing (BRAF) in Spain, 2011-2020
  • Table 32: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Spain, 2011-2020
  • Table 33: Tumor Molecular Profiling in UK in 2006 and 2007
  • Table 34: Breast Cancer Companion Diagnostic Testing (HER2) in the UK, 2011-2020
  • Table 35: Cost of Analysis of KRAS Laboratory-Developed Molecular Tests in the UK
  • Table 36: Colorectal Cancer Companion Diagnostic (KRAS) Testing in the UK, 2011-2020
  • Table 37: Melanoma Companion Diagnostic Testing (BRAF) in the UK, 2011-2020
  • Table 38: Lung Cancer EGFR Tests in the UK
  • Table 39: Cost of Analysis of NSCLC Laboratory-Developed Molecular Tests in the UK
  • Table 40: EGFR Method Selection in the UK, 2013
  • Table 41: Cost of EGFR Testing in the UK
  • Table 42: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the UK, 2011-2020
  • Table 43: EU Medical Device Classifications and Conformance Requirements
  • Table 44: EU Medical Device Essential Requirements
  • Table 45: Differences Between US FDA Approval and EU CE-Marking
  • Table 46: Timetable to Approve New Medical Devices in France
  • Table 47: Access Opportunities for New Companion Diagnostic Tests in Europe
  • Table 48: Estimate of the Unmet Clinical Need in the UK for the Main Molecular Tests in Solid Tumors
  • Table 49: Key Mergers and Acquisitions during 2013-2014
  • Table 50: Partnerships during 2013-2014
  • Table 51: Impact of Companion Diagnostics on Cancer Treatment Costs in France
  • Table 52: Effectiveness of Disease Therapies
  • Table 53: HER2 FISH/iQFISH PharmDx Product Profile
  • Table 54: Common Reasons for HER2 FISH Failure
  • Table 55: HER2 FISH PharmDx/HER2 iQFISH PharmDx SWOT Analysis
  • Table 56: HercepTest Product Profile
  • Table 57: HercepTest Scoring Algorithm
  • Table 58: HercepTest SWOT Analysis
  • Table 59: HER2 CISH PharmDx Product Profile
  • Table 60: HER2 CISH PharmDx SWOT Analysis
  • Table 61: SPOT-Light HER2 CISH Kit Product Profile
  • Table 62: SPOT-Light HER2 CISH Kit SWOT Analysis
  • Table 63: Leica Bond Oracle HER2 IHC System Product Profile
  • Table 64: Leica Bond Oracle HER2 IHC System Test Algorithm
  • Table 65: Leica Bond Oracle HER2 IHC System SWOT Analysis
  • Table 66: Biogenex INSITE HER2/Neu Product Profile
  • Table 67: Biogenex INSITE HER2/Neu SWOT Analysis
  • Table 68: Abbott Pathvysion HER-2 DNA Probe Kit Product Profile
  • Table 69: Abbott Pathvysion HER-2 DNA Probe Kit SWOT Analysis
  • Table 70: Ventana INFORM HER2 Dual ISH Assay Product Profile
  • Table 71: Ventana INFORM HER2 Dual ISH Assay SWOT Analysis
  • Table 72: Pathway HER2/Neu IHC Product Profile
  • Table 73: Pathway HER2/Neu IHC SWOT Analysis
  • Table 74: HerMark Product Profile
  • Table 75: HerMark SWOT Analysis
  • Table 76: Therascreen KRAS RGQ Product Profile
  • Table 77: Therascreen KRAS RGQ SWOT Analysis
  • Table 78: Cobas KRAS Mutation Test Product Profile
  • Table 79: Cobas KRAS Mutation Test SWOT Analysis
  • Table 80: EGFR PharmDx Kit Product Profile
  • Table 81: EGFR PharmDx Kit SWOT Analysis
  • Table 82: THxID BRAF Product Profile
  • Table 83: Effect of Melanin on the THxID BRAF PCR Test
  • Table 84: THxID BRAF SWOT Analysis
  • Table 85: Cobas 4800 BRAF V600 Mutation Test - Melanoma Product Profile
  • Table 86: Interpretation of Cobas BRAF V600 Mutation Test - Melanoma
  • Table 87: Cobas 4800 BRAF V600 Mutation Test - Melanoma SWOT Analysis
  • Table 88: Vysis ALK Break Apart FISH Probe Kit Product Profile
  • Table 89: Abbott Vysis ALK Break Apart FISH Probe Kit SWOT Analysis
  • Table 90: Amoy-Dx EML4-ALK Fusion Gene Detection Kit Product Profile
  • Table 91: Amoy-Dx EML4-ALK Fusion Gene Detection Kit SWOT Analysis
  • Table 92: Therascreen EGFR RGQ PCR Kit Product Profile
  • Table 93: Therascreen EGFR RGQ PCR Kit SWOT Analysis
  • Table 94: ALK IHC Test Product Profile
  • Table 95: ALK IHC Test SWOT Analysis
  • Table 96: Cobas EGFR Mutation Test Product Profile
  • Table 97: Cobas EGFR Mutation Test SWOT Analysis
  • Table 98: Companion Diagnostic Tests Pipeline, 2014
  • Table 99: Neuvax Companion Diagnostic Assay Product Profile
  • Table 100: Neuvax Companion Diagnostic Assay Product SWOT Analysis
  • Table 101: Companion Diagnostic Test - Palbociclib Product Profile
  • Table 102: Companion Diagnostic Test - Palbociclib SWOT Analysis
  • Table 103: Companion Diagnostic Test - Breast Cancer Product Profile
  • Table 104: Companion Diagnostic Test - Breast Cancer SWOT Analysis
  • Table 105: Onapristone Companion Diagnostic Assay Product Profile
  • Table 106: Onapristone Companion Diagnostic Assay SWOT Analysis
  • Table 107: Aromatase Inhibitor Biomarker - Companion Diagnostic Test Product Profile
  • Table 108: Aromatase Inhibitor Biomarker - Companion Diagnostic Test SWOT Analysis
  • Table 109: BRAF Companion Diagnostic Assay - Colon Cancer Product Profile
  • Table 110: BRAF Companion Diagnostic Assay - Colon Cancer SWOT Analysis
  • Table 111: KRAS Companion Diagnostic Assay - Colon Cancer Product Profile
  • Table 112: KRAS Companion Diagnostic Assay - Colon Cancer SWOT Analysis
  • Table 113: PIK3CA Companion Diagnostic Assay - Colorectal Cancer Product Profile
  • Table 114: PIK3CA Companion Diagnostic Assay - Colorectal Cancer SWOT Analysis
  • Table 115: Vectibix Companion Diagnostic Product Profile
  • Table 116: Vectibix Companion Diagnostic SWOT Analysis
  • Table 117: MAGE-A3 Companion Skin Cancer Assay Product Profile
  • Table 118: MAGE-A3 Companion Skin Cancer Assay SWOT Analysis
  • Table 119: GNAQ/GNA11 Companion Diagnostic Assays - Melanoma Product Profile
  • Table 120: GNAQ/GNA11 Companion Diagnostic Assays - Melanoma SWOT Analysis
  • Table 121: Companion Diagnostic Test - Melanoma Cancer Product Profile
  • Table 122: Companion Diagnostic Test - Melanoma Cancer SWOT Analysis
  • Table 123: KRAS Companion Diagnostic Assay - Melanoma Product Profile
  • Table 124: KRAS Companion Diagnostic Assay - Melanoma SWOT Analysis
  • Table 125: Companion Diagnostic Test - Melanoma Product Profile
  • Table 126: Companion Diagnostic Test - Melanoma SWOT Analysis
  • Table 127: BRAF Companion Diagnostic Assay - Lung Cancer Product Profile
  • Table 128: BRAF Companion Diagnostic Assay - Lung Cancer SWOT Analysis
  • Table 129: KRAS Companion Diagnostic Assay - Lung Cancer Product Profile
  • Table 130: KRAS Companion Diagnostic Assay - Lung Cancer SWOT Analysis
  • Table 131: MET Companion Diagnostic Assay - Lung Cancer Product Profile
  • Table 132: MET Companion Diagnostic Assay - Lung Cancer SWOT Analysis
  • Table 133: PIK3CA Companion Diagnostic Assay - Lung Cancer Product Profile
  • Table 134: PIK3CA Companion Diagnostic Assay - Lung Cancer SWOT Analysis
  • Table 135: Companion Diagnostic Device - Lung Cancer Product Profile
  • Table 136: Companion Diagnostic Device - Lung Cancer SWOT Analysis
  • Table 137: Companion Diagnostic Test - Crizotinib Product Profile
  • Table 138: Companion Diagnostic Test - Crizotinib SWOT Analysis
  • Table 139: Companion Diagnostic Test - Dacomitinib Product Profile
  • Table 140: Companion Diagnostic Test - Dacomitinib SWOT Analysis
  • Table 141: T790M Mutation Companion Diagnostic Test Product Profile
  • Table 142: T790M Mutation Companion Diagnostic Test SWOT Analysis
  • Table 143: Entinostat Companion Diagnostic Assay Product Profile
  • Table 144: Entinostat Companion Diagnostic Assay SWOT Analysis
  • Table 145: MUC1 Expression Companion Diagnostic Test Product Profile
  • Table 146: MUC1 Expression Companion Diagnostic Test SWOT Analysis
  • Table 147: Companion Diagnostic Assay - NSCLC Product Profile
  • Table 148: Companion Diagnostic Assay - NSCLC SWOT Analysis
  • Table 149: Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug Therapies.
  • Table 150: Company Profile - Amgen
  • Table 151: Amgen's Key Products
  • Table 152: Selected Amgen Anti-Cancer Therapies Currently in Clinical Trials
  • Table 153: Amgen SWOT Analysis
  • Table 154: Company Profile - Arno Therapeutics
  • Table 155: Selected Arno Therapeutics Anti-Cancer Therapies Currently in Clinical Trials
  • Table 156: Arno Therapeutics SWOT Analysis
  • Table 157: Company Profile - AstraZeneca
  • Table 158: Key Events in the Development of AstraZeneca's Drug Portfolio Since 2011
  • Table 159: Key Project Terminations by AstraZeneca Since 2008
  • Table 160: AstraZeneca SWOT Analysis
  • Table 161: Company Profile - Bristol-Myers Squibb
  • Table 162: Recent Key Product Approvals from Bristol-Myers Squibb
  • Table 163: Recent Key BMS Partnerships and Agreements
  • Table 164: Bristol-Myers Squibb SWOT Analysis
  • Table 165: Company Profile - Clovis Oncology
  • Table 166: Clovis Oncology's Key Products
  • Table 167: Clovis Oncology SWOT Analysis
  • Table 168: Company Profile - Eli Lilly and Company
  • Table 169: Eli Lilly and Company SWOT Analysis
  • Table 170: Company Profile - Genentech
  • Table 171: Selected Genentech Marketed Products
  • Table 172: Genentech SWOT Analysis
  • Table 173: Company Profile - Pfizer
  • Table 174: Pfizer SWOT Analysis
  • Table 175: Company Profile - Syndax Pharmaceuticals
  • Table 176: Syndax Pharmaceuticals SWOT Analysis
  • Table 177: Company Profile - Abbott Laboratories
  • Table 178: Abbott's Key Product Areas
  • Table 179: Abbott Laboratories SWOT Analysis, 2013
  • Table 180: Company Profile - Amoy Diagnostics
  • Table 181: Amoy Diagnostics SWOT Analysis, 2013
  • Table 182: Company Profile - Biogenex Laboratories
  • Table 183: Biogenex Laboratories SWOT Analysis, 2013
  • Table 184: Company Profile - BioMerieux
  • Table 185: BioMerieux SWOT Analysis, 2013
  • Table 186: Company Profile - Dako (Agilent Technologies)
  • Table 187: Dako/Agilent Technologies SWOT Analysis
  • Table 188: Company Profile - Illumina
  • Table 189: Illumina Product Areas
  • Table 190: Illumina SWOT Analysis
  • Table 191: Company Profile - Leica Biosystems (Danaher)
  • Table 192: Leica Biosystems/Danaher SWOT Analysis
  • Table 193: Company Profile - Life Technologies (Thermo Fisher Scientific)
  • Table 194: Life Technologies SWOT Analysis
  • Table 195: Company Profile - MolecularMD
  • Table 196: MolecularMD SWOT Analysis
  • Table 197: Company Profile - Myriad Genetics
  • Table 198: Myriad Genetics Major Product Areas
  • Table 199: Myriad Genetics SWOT Analysis
  • Table 200: Company Profile - Qiagen
  • Table 201: Qiagen Major Product Areas
  • Table 202: Qiagen SWOT Analysis
  • Table 203: Company Profile - Roche Diagnostics
  • Table 204: Roche SWOT Analysis
  • Table 205: Company Profile - Siemens Healthcare
  • Table 206: Siemens Healthcare SWOT Analysis
  • Table 207: Company Profile - Ventana Medical Systems
  • Table 208: Ventana Medical Systems SWOT Analysis
  • Table 209: 5EU Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011-2020
  • Table 210: 5EU Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011-2020
  • Table 211: 5EU Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011-2020
  • Table 212: 5EU Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011-2020
  • Table 213: 5EU Sales Forecast for IHC and Molecular Tests ($m), 2011-2020
  • Table 214: Major Events Affecting the Companion Diagnostic Test Market
  • Table 215: Sales Forecast for Companion Diagnostic Tests ($m) in France, 2011-2020
  • Table 216: Sales Forecast for Companion Diagnostic Tests ($m) in Germany, 2011-2020
  • Table 217: Sales Forecast for Companion Diagnostic Tests ($m) in Italy, 2011-2020
  • Table 218: Sales Forecast for Companion Diagnostic Tests ($m) in Spain, 2011-2020
  • Table 219: Sales Forecast for Companion Diagnostic Tests ($m) in the UK, 2011-2020

List of Figures

  • Figure 1: Genomic Sequencing Costs, 2001-2012
  • Figure 2: Use of Proteomics in Personalized Medicine
  • Figure 3: Incidence of Inherited Breast Cancer Mutations among Diagnosed Breast Cancer Patients
  • Figure 4: Basic FISH Process
  • Figure 5: Basic PCR Process
  • Figure 6: Impact of Sample Storage on PCR Outcome
  • Figure 7: Genomic Sequencing Costs, 2001-2012
  • Figure 8: Scientific and Economic Potential of Companion Diagnostics
  • Figure 9: Drug and Diagnostic Test Co-Development
  • Figure 10: Roche Lifecycle Algorithm for Co-Development of a Predictive Diagnostic
  • Figure 11: Key Development Drivers for Companion Diagnostic Tests
  • Figure 12: Qiagen Model to Build a JAK2 Companion Diagnostic Tests Business
  • Figure 13: Breast Cancer Companion Diagnostic Testing (HER2) in France, 2011-2020
  • Figure 14: KRAS Testing in France 2008-2012
  • Figure 15: Colorectal Cancer Companion Diagnostic (KRAS) Testing in France, 2011-2020
  • Figure 16: Melanoma Companion Diagnostic Testing (BRAF) in France, 2011-2020
  • Figure 17: EGFR Testing in France, 2008-2012
  • Figure 18: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in France, 2011-2020
  • Figure 19: Breast Cancer Companion Diagnostic Testing (HER2) in Germany, 2011-2020
  • Figure 20: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Germany, 2011-2020
  • Figure 21: Melanoma Companion Diagnostic Testing (BRAF) in Germany, 2011-2020
  • Figure 22: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Germany, 2011-2020
  • Figure 23: Treatment Index: Italy versus Rest of EU in Use of Herceptin per Head of Population, 2002
  • Figure 24: Percentage of All Breast Cancer Patients Tested for HER2, Italy versus Rest of EU, 2002
  • Figure 25: Breast Cancer Companion Diagnostic Testing (HER2) in Italy, 2011-2020
  • Figure 26: Methods Used for KRAS Genotyping by the Centers Participating in the Italian Quality Assessment Scheme
  • Figure 27: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Italy, 2011-2020
  • Figure 28: Melanoma Companion Diagnostic Testing (BRAF) in Italy, 2011-2020
  • Figure 29: Methods Used for EGFR Genotyping by the Centers Participating in the Italian Quality Assessment Scheme in 2013
  • Figure 30: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Italy, 2011-2020
  • Figure 31: Breast Cancer Companion Diagnostic Testing (HER2) in Spain, 2011-2020
  • Figure 32: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Spain, 2011-2020
  • Figure 33: Melanoma Companion Diagnostic Testing (BRAF) in Spain, 2011-2020
  • Figure 34: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Spain, 2011-2020
  • Figure 35: UK HER2 Status Testing Algorithm
  • Figure 36: Breast Cancer Companion Diagnostic Testing (HER2) in the UK, 2011-2020
  • Figure 37: Colorectal Cancer Companion Diagnostic (KRAS) Testing in the UK, 2011-2020
  • Figure 38: Melanoma Companion Diagnostic Testing (BRAF) in the UK, 2011-2020
  • Figure 39: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the UK, 2011-2020
  • Figure 40: EU Medical Device Approval and Post-Market Surveillance Process
  • Figure 41: German Reimbursement Establishment Process
  • Figure 42: Increase in EGFR Testing at AstraZeneca-Funded Test Centers in the UK
  • Figure 43: UK Regional Access to Cancer Diagnostic Testing
  • Figure 44: Multiple Partnerships in Companion Diagnostics during 2013-2014
  • Figure 45: Building a Companion Diagnostics Business: Forming Multiple Partnerships
  • Figure 46: Increasing Medicare Cost of Treatment
  • Figure 47: Growth of Drug Therapy Expenditure in France, 2004-2009
  • Figure 48: Share of Targeted Therapies of Anti-Cancer Drug Costs in France
  • Figure 49: Increase in Approvals of Biologic (Targeted) Therapies
  • Figure 50: EGFR PharmDx Test Adoption Curve
  • Figure 51: Probe Arrangement in the Vysis ALK Break Apart FISH Probe Kit
  • Figure 52: Scorpion Primers
  • Figure 53: Increase in High- and Moderate-Complexity Molecular Tests
  • Figure 54: Reasons for Companion Diagnostic Test Failure
  • Figure 55: Female Breast Cancer Treatment Patterns by Stage, 2008
  • Figure 56: Colon Cancer Treatment Patterns by Stage, 2008
  • Figure 57: Lung Cancer Treatment Patterns by Stage, 2008
  • Figure 58: Expected Companion Diagnostic Test Pipeline, US Approvals, 2014-2019
  • Figure 59: Sponsors of Clinical Trials for Targeted Cancer Therapies
  • Figure 60: Sponsors of Clinical Trials for Targeted Cancer Therapies Based on Mutational Status
  • Figure 61: Sponsors of Clinical Trials for Targeted Cancer Therapies, by Phase
  • Figure 62: 5EU Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011-2020
  • Figure 63: 5EU Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011-2020
  • Figure 64: 5EU Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011-2020
  • Figure 65: 5EU Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011-2020
  • Figure 66: Uptake in ALK Mutation IHC and FISH Testing in France, 2011-2020
  • Figure 67: Uptake of ALK Mutation IHC and FISH Testing in Germany 2011-2020
  • Figure 68: 5EU Sales Forecast for IHC and Molecular Tests ($m), 2011-2020
  • Figure 69: 5EU Market Share of Molecular Tests and Immunohistochemistry Tests in 2012 and 2020
  • Figure 70: Sales Forecast for Companion Diagnostic Tests ($m) in France, 2011-2020
  • Figure 71: Sales Forecast for Companion Diagnostic Tests ($m) in Germany, 2011-2020
  • Figure 72: Sales Forecast for Companion Diagnostic Tests ($m) in Italy, 2011-2020
  • Figure 73: Sales Forecast for Companion Diagnostic Tests ($m) in Spain, 2011-2020
  • Figure 74: Sales Forecast for Companion Diagnostic Tests ($m) in the UK, 2011-2020
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