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MediPoint:腫瘍向けコンパニオン診断検査 - 世界市場の分析と予測

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

発行 GlobalData 商品コード 301411
出版日 ページ情報 英文 592 Pages
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MediPoint:腫瘍向けコンパニオン診断検査 - 世界市場の分析と予測 MediPoint: Companion Diagnostic Tests in Oncology - Global Analysis and Market Forecasts
出版日: 2014年05月05日 ページ情報: 英文 592 Pages
概要

がん治療向けのコンパニオン診断検査の世界市場の今後の年平均成長率(CAGR)は4.9%に達する、と予想されています。米国・欧州などの先進国では成長率が低迷する一方、中国・ブラジルの市場成長率は世界最大となる見通しです。疾患別では、現在は乳がん関連のHER2検査が市場の大半を占めていますが、まもなく非小細胞肺がんのコンパニオン診断検査(大半がEGFR(上皮増殖因子受容体)の突然変異状況向け)が追い抜くものと思われます。米国・欧州のコンパニオン診断検査の市場成長は、診断ガイドラインの受容や、検査への医療費償還の安定化に大きく依存しています。一方、途上国での市場成長は、患者側の研究室検査へのアクセスや、専門の病理解析サービスの成長に依存しています。

当レポートでは、全世界の腫瘍向けコンパニオン診断検査の市場について分析し、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、世界全体および主要10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て、その結果を概略以下の構成でお届けします。

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
    • 乳癌
    • 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活用
  • 検査の動向(主要10ヶ国の場合)
  • 市場アクセス(主要国・地域の場合)
  • 規制上の課題とリコール(計5件)
  • コンパニオン診断検査への医療費償還
    • 米国・欧州・アジア太平洋地域・南米の事例
  • 企業合併・買収(M&A)/パートナーシップ:主要動向
  • 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
    • 乳癌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
    • 乳癌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
    • 乳癌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
    • 10大市場の概況
    • 米国
    • フランス
    • ドイツ
    • イタリア
    • スペイン
    • 英国
    • 日本
    • ブラジル
    • 中国
    • インド

第10章 付録

図表一覧

目次
Product Code: GDME0189MAR

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.

Highlights

Key Questions Answered

  • Global cancer incidence is expected to rise. (Q).What role will companion diagnostic tests for play in the forecast period to tackle this global issue? (Q).How many procedures of companion diagnostic tests will be performed in the ten major markets covered in the report?
  • What are the reasons to develop a Companion Diagnostic Test. (Q).What motivates companies to develop a companion diagnostic; physician demand or legislative requirement?
  • What strategies are adopted in developing a new companion diagnostics test. (Q).When and how is a companion diagnostic test developed? (Q).Who are the stakeholders? (Q).What are the relationships between Big Pharma and Diagnostic test developers?
  • (Q).What technologies underpin companion diagnostic tests?. (Q).What are the common technologies used? Which are the most in demand, across all tests. (Q).What are the emerging technologies?
  • What Companion Diagnostic tests are available in breast cancer, colorectal cancer, melanoma and non-small cell lung cancer. (Q).Which are the leading tests? (Q).How are the tests performed
  • Where are companion diagnostics offered. (Q).What disease is likely to see the most demand for Companion diagnostics, which the least? (Q).Which countries are likely to adopt companion diagnostic tests?
  • What do physicians think of currently offered companion. (Q).What are the perceived strengths, weaknesses? (Q).What are the unmet needs?

Key Findings

  • The Companion Diagnostic test market for the 4 named cancers will grow at a CAGR of 4.9% over the forecast period. Developed regions, like US and EU showing lowest growth rates. While China and Brazil showing maximum growth rates.
  • Breast cancer HER2 testing dominates in terms of volume, but has been overtaken in terms of value by non-small cell lung cancer companion diagnostic testing, mostly for EGFR mutation status.
  • The market growth for companion diagnostic testing in the US and EU is heavily dependent on the acceptance into diagnostic guidelines and the stabilisation of test reimbursement. Growth in developing economies is dependant upon patient access to laboratory testing and growth of professional pathology services

Scope

  • Overview of companion diagnostic tests in oncology, including core technologies, estimated procedure trends and disease overview.
  • Current and Future Players Companies involved in the space with portfolio assessment and SWOT analysis.
  • Pipeline analysis: Late-stage pipeline products with SWOT analysis and physician perception
  • Other Key topics covered include identification of unmet needs, implications on the companion diagnostic market and how they may be overcome in the near future
  • Analysis of the market opportunities in addition to Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications

Reasons to buy

  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline
  • Develop business strategies by understanding the trends shaping and driving the companion diagnostic cancer test market
  • Drive revenues by understanding the key trends, innovative products and technologies, and companies likely to impact the cancer companion diagnostic test market in the future
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships

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. US
    • 3.6.2. France
    • 3.6.3. Germany
    • 3.6.4. Italy
    • 3.6.5. Spain
    • 3.6.6. UK
    • 3.6.7. Japan
    • 3.6.8. Brazil
    • 3.6.9. China
    • 3.6.10. India
  • 3.7. Market Access
    • 3.7.1. Overview
    • 3.7.2. US
    • 3.7.3. 5EU
    • 3.7.4. Japan
    • 3.7.5. Brazil
    • 3.7.6. China
    • 3.7.7. India
  • 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. US
    • 3.9.2. Europe
    • 3.9.3. APAC
    • 3.9.4. South America
  • 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. 10 Major Markets Overview
    • 9.2.2. US
    • 9.2.3. France
    • 9.2.4. Germany
    • 9.2.5. Italy
    • 9.2.6. Spain
    • 9.2.7. UK
    • 9.2.8. Japan
    • 9.2.9. Brazil
    • 9.2.10. China
    • 9.2.11. India

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: HER2 Testing in the US, 2011-2020
  • Table 13: Colorectal Cancer Companion Diagnostic (KRAS) Testing in the US, 2011-2020
  • Table 14: Melanoma Companion Diagnostic Testing (BRAF) in the US, 2011-2020
  • Table 15: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the US, 2011-2020
  • Table 16: Types of Genetic Tests Carried Out in France during 2009
  • Table 17: Biomarkers tested for in France
  • Table 18: Tumor Molecular Profiling in France in 2011 and 2012
  • Table 19: Breast Cancer Companion Diagnostic Testing (HER2) in France, 2011-2020
  • Table 20: KRAS Companion Diagnostic Testing in France, 2008-2012
  • Table 21: Colorectal Cancer Companion Diagnostic (KRAS) Testing in France, 2011-2020
  • Table 22: Melanoma Companion Diagnostic Testing (BRAF) in France, 2011-2020
  • Table 23: EGFR Companion Diagnostic Testing in France, 2008-2012
  • Table 24: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in France, 2011-2020
  • Table 25: Breast Cancer Companion Diagnostic Testing (HER2) in Germany, 2011-2020
  • Table 26: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Germany, 2011-2020
  • Table 27: Melanoma Companion Diagnostic Testing (BRAF) in Germany, 2011-2020
  • Table 28: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Germany, 2011-2020
  • Table 29: Breast Cancer Companion Diagnostic Testing (HER2) in Italy, 2011-2020
  • Table 30: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Italy, 2011-2020
  • Table 31: Melanoma Companion Diagnostic Testing (BRAF) in Italy, 2011-2020
  • Table 32: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Italy, 2011-2020
  • Table 33: Breast Cancer Companion Diagnostic Testing (HER2) in Spain, 2011-2020
  • Table 34: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Spain, 2011-2020
  • Table 35: Melanoma Companion Diagnostic Testing (BRAF) in Spain, 2011-2020
  • Table 36: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Spain, 2011-2020
  • Table 37: Tumor Molecular Profiling in UK in 2006 and 2007
  • Table 38: Breast Cancer Companion Diagnostic Testing (HER2) in the UK, 2011-2020
  • Table 39: Cost of Analysis of KRAS Laboratory-Developed Molecular Tests in the UK
  • Table 40: Colorectal Cancer Companion Diagnostic (KRAS) Testing in the UK, 2011-2020
  • Table 41: Melanoma Companion Diagnostic Testing (BRAF) in the UK, 2011-2020
  • Table 42: Lung Cancer EGFR Tests in the UK
  • Table 43: Cost of Analysis of NSCLC Laboratory-Developed Molecular Tests in the UK
  • Table 44: EGFR Method Selection in the UK, 2013
  • Table 45: Cost of EGFR Testing in the UK
  • Table 46: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the UK, 2011-2020
  • Table 47: HER2 Testing for Breast Cancer Patients in Japan
  • Table 48: Breast Cancer Companion Diagnostic Testing (HER2) in Japan, 2011-2020
  • Table 49: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Japan, 2011-2020
  • Table 50: Melanoma Companion Diagnostic Testing (BRAF) in Japan, 2011-2020
  • Table 51: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Japan, 2011-2020
  • Table 52: Breast Cancer Companion Diagnostic Testing (HER2) in Brazil, 2011-2020
  • Table 53: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Brazil, 2011-2020
  • Table 54: Melanoma Companion Diagnostic Testing (BRAF) in Brazil, 2011-2020
  • Table 55: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Brazil, 2011-2020
  • Table 56: Breast Cancer Companion Diagnostic Testing (HER2) in China, 2011-2020
  • Table 57: Colorectal Cancer Companion Diagnostic (KRAS) Testing in China, 2011-2020
  • Table 58: Melanoma Companion Diagnostic Testing (BRAF) in China, 2011-2020
  • Table 59: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in China, 2011-2020
  • Table 60: Breast Cancer Companion Diagnostic Testing (HER2) in India, 2011-2020
  • Table 61: Colorectal Cancer Companion Diagnostic (KRAS) Testing in India, 2011-2020
  • Table 62: Melanoma Companion Diagnostic Testing (BRAF) in India, 2011-2020
  • Table 63: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in India, 2011-2020
  • Table 64: FDA Medical Device Classifications
  • Table 65: US Reimbursement Policies for FDA- and Non-FDA-Approved Molecular Tests
  • Table 66: EU Medical Device Classifications and Conformance Requirements
  • Table 67: EU Medical Device Essential Requirements
  • Table 68: Differences Between US FDA Approval and EU CE-Marking
  • Table 69: Healthcare Systems in China
  • Table 70: Healthcare Principles in China
  • Table 71: Timetable to Approve New Medical Devices in France
  • Table 72: Access Opportunities for New Companion Diagnostic Tests in Europe
  • Table 73: Estimate of the Unmet Clinical Need in the UK for the Main Molecular Tests in Solid Tumors
  • Table 74: Tariffs for Companion Diagnostic and Related Tests at the Tata Memorial Hospital
  • Table 75: Key Mergers and Acquisitions during 2013-2014
  • Table 76: Partnerships during 2013-2014
  • Table 77: Impact of Companion Diagnostics on Cancer Treatment Costs in France
  • Table 78: Effectiveness of Disease Therapies
  • Table 79: HER2 FISH/iQFISH PharmDx Product Profile
  • Table 80: Common Reasons for HER2 FISH Failure
  • Table 81: HER2 FISH PharmDx/HER2 iQFISH PharmDx SWOT Analysis
  • Table 82: HercepTest Product Profile
  • Table 83: HercepTest Scoring Algorithm
  • Table 84: HercepTest SWOT Analysis
  • Table 85: HER2 CISH PharmDx Product Profile
  • Table 86: HER2 CISH PharmDx SWOT Analysis
  • Table 87: SPOT-Light HER2 CISH Kit Product Profile
  • Table 88: SPOT-Light HER2 CISH Kit SWOT Analysis
  • Table 89: Leica Bond Oracle HER2 IHC System Product Profile
  • Table 90: Leica Bond Oracle HER2 IHC System Test Algorithm
  • Table 91: Leica Bond Oracle HER2 IHC System SWOT Analysis
  • Table 92: Biogenex INSITE HER2/Neu Product Profile
  • Table 93: Biogenex INSITE HER2/Neu SWOT Analysis
  • Table 94: Abbott Pathvysion HER-2 DNA Probe Kit Product Profile
  • Table 95: Abbott Pathvysion HER-2 DNA Probe Kit SWOT Analysis
  • Table 96: Ventana INFORM HER2 Dual ISH Assay Product Profile
  • Table 97: Ventana INFORM HER2 Dual ISH Assay SWOT Analysis
  • Table 98: Pathway HER2/Neu IHC Product Profile
  • Table 99: Pathway HER2/Neu IHC SWOT Analysis
  • Table 100: HerMark Product Profile
  • Table 101: HerMark SWOT Analysis
  • Table 102: Therascreen KRAS RGQ Product Profile
  • Table 103: Therascreen KRAS RGQ SWOT Analysis
  • Table 104: Cobas KRAS Mutation Test Product Profile
  • Table 105: Cobas KRAS Mutation Test SWOT Analysis
  • Table 106: EGFR PharmDx Kit Product Profile
  • Table 107: EGFR PharmDx Kit SWOT Analysis
  • Table 108: THxID BRAF Product Profile
  • Table 109: Effect of Melanin on the THxID BRAF PCR Test
  • Table 110: THxID BRAF SWOT Analysis
  • Table 111: Cobas 4800 BRAF V600 Mutation Test - Melanoma Product Profile
  • Table 112: Interpretation of Cobas BRAF V600 Mutation Test - Melanoma
  • Table 113: Cobas 4800 BRAF V600 Mutation Test - Melanoma SWOT Analysis
  • Table 114: Vysis ALK Break Apart FISH Probe Kit Product Profile
  • Table 115: Abbott Vysis ALK Break Apart FISH Probe Kit SWOT Analysis
  • Table 116: Amoy-Dx EML4-ALK Fusion Gene Detection Kit Product Profile
  • Table 117: Amoy-Dx EML4-ALK Fusion Gene Detection Kit SWOT Analysis
  • Table 118: Therascreen EGFR RGQ PCR Kit Product Profile
  • Table 119: Therascreen EGFR RGQ PCR Kit SWOT Analysis
  • Table 120: ALK IHC Test Product Profile
  • Table 121: ALK IHC Test SWOT Analysis
  • Table 122: Cobas EGFR Mutation Test Product Profile
  • Table 123: Cobas EGFR Mutation Test SWOT Analysis
  • Table 124: Companion Diagnostic Tests Pipeline, 2014
  • Table 125: Neuvax Companion Diagnostic Assay Product Profile
  • Table 126: Neuvax Companion Diagnostic Assay Product SWOT Analysis
  • Table 127: Companion Diagnostic Test - Palbociclib Product Profile
  • Table 128: Companion Diagnostic Test - Palbociclib SWOT Analysis
  • Table 129: Companion Diagnostic Test - Breast Cancer Product Profile
  • Table 130: Companion Diagnostic Test - Breast Cancer SWOT Analysis
  • Table 131: Onapristone Companion Diagnostic Assay Product Profile
  • Table 132: Onapristone Companion Diagnostic Assay SWOT Analysis
  • Table 133: Aromatase Inhibitor Biomarker - Companion Diagnostic Test Product Profile
  • Table 134: Aromatase Inhibitor Biomarker - Companion Diagnostic Test SWOT Analysis
  • Table 135: BRAF Companion Diagnostic Assay - Colon Cancer Product Profile
  • Table 136: BRAF Companion Diagnostic Assay - Colon Cancer SWOT Analysis
  • Table 137: KRAS Companion Diagnostic Assay - Colon Cancer Product Profile
  • Table 138: KRAS Companion Diagnostic Assay - Colon Cancer SWOT Analysis
  • Table 139: PIK3CA Companion Diagnostic Assay - Colorectal Cancer Product Profile
  • Table 140: PIK3CA Companion Diagnostic Assay - Colorectal Cancer SWOT Analysis
  • Table 141: Vectibix Companion Diagnostic Product Profile
  • Table 142: Vectibix Companion Diagnostic SWOT Analysis
  • Table 143: MAGE-A3 Companion Skin Cancer Assay Product Profile
  • Table 144: MAGE-A3 Companion Skin Cancer Assay SWOT Analysis
  • Table 145: GNAQ/GNA11 Companion Diagnostic Assays - Melanoma Product Profile
  • Table 146: GNAQ/GNA11 Companion Diagnostic Assays - Melanoma SWOT Analysis
  • Table 147: Companion Diagnostic Test - Melanoma Cancer Product Profile
  • Table 148: Companion Diagnostic Test - Melanoma Cancer SWOT Analysis
  • Table 149: KRAS Companion Diagnostic Assay - Melanoma Product Profile
  • Table 150: KRAS Companion Diagnostic Assay - Melanoma SWOT Analysis
  • Table 151: Companion Diagnostic Test - Melanoma Product Profile
  • Table 152: Companion Diagnostic Test - Melanoma SWOT Analysis
  • Table 153: BRAF Companion Diagnostic Assay - Lung Cancer Product Profile
  • Table 154: BRAF Companion Diagnostic Assay - Lung Cancer SWOT Analysis
  • Table 155: KRAS Companion Diagnostic Assay - Lung Cancer Product Profile
  • Table 156: KRAS Companion Diagnostic Assay - Lung Cancer SWOT Analysis
  • Table 157: MET Companion Diagnostic Assay - Lung Cancer Product Profile
  • Table 158: MET Companion Diagnostic Assay - Lung Cancer SWOT Analysis
  • Table 159: PIK3CA Companion Diagnostic Assay - Lung Cancer Product Profile
  • Table 160: PIK3CA Companion Diagnostic Assay - Lung Cancer SWOT Analysis
  • Table 161: Companion Diagnostic Device - Lung Cancer Product Profile
  • Table 162: Companion Diagnostic Device - Lung Cancer SWOT Analysis
  • Table 163: Companion Diagnostic Test - Crizotinib Product Profile
  • Table 164: Companion Diagnostic Test - Crizotinib SWOT Analysis
  • Table 165: Companion Diagnostic Test - Dacomitinib Product Profile
  • Table 166: Companion Diagnostic Test - Dacomitinib SWOT Analysis
  • Table 167: T790M Mutation Companion Diagnostic Test Product Profile
  • Table 168: T790M Mutation Companion Diagnostic Test SWOT Analysis
  • Table 169: Entinostat Companion Diagnostic Assay Product Profile
  • Table 170: Entinostat Companion Diagnostic Assay SWOT Analysis
  • Table 171: MUC1 Expression Companion Diagnostic Test Product Profile
  • Table 172: MUC1 Expression Companion Diagnostic Test SWOT Analysis
  • Table 173: Companion Diagnostic Assay - NSCLC Product Profile
  • Table 174: Companion Diagnostic Assay - NSCLC SWOT Analysis
  • Table 175: Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug Therapies.
  • Table 176: Company Profile - Amgen
  • Table 177: Amgen's Key Products
  • Table 178: Selected Amgen Anti-Cancer Therapies Currently in Clinical Trials
  • Table 179: Amgen SWOT Analysis
  • Table 180: Company Profile - Arno Therapeutics
  • Table 181: Selected Arno Therapeutics Anti-Cancer Therapies Currently in Clinical Trials
  • Table 182: Arno Therapeutics SWOT Analysis
  • Table 183: Company Profile - AstraZeneca
  • Table 184: Key Events in the Development of AstraZeneca's Drug Portfolio Since 2011
  • Table 185: Key Project Terminations by AstraZeneca Since 2008
  • Table 186: AstraZeneca SWOT Analysis
  • Table 187: Company Profile - Bristol-Myers Squibb
  • Table 188: Recent Key Product Approvals from Bristol-Myers Squibb
  • Table 189: Recent Key BMS Partnerships and Agreements
  • Table 190: Bristol-Myers Squibb SWOT Analysis
  • Table 191: Company Profile - Clovis Oncology
  • Table 192: Clovis Oncology's Key Products
  • Table 193: Clovis Oncology SWOT Analysis
  • Table 194: Company Profile - Eli Lilly and Company
  • Table 195: Eli Lilly and Company SWOT Analysis
  • Table 196: Company Profile - Genentech
  • Table 197: Selected Genentech Marketed Products
  • Table 198: Genentech SWOT Analysis
  • Table 199: Company Profile - Pfizer
  • Table 200: Pfizer SWOT Analysis
  • Table 201: Company Profile - Syndax Pharmaceuticals
  • Table 202: Syndax Pharmaceuticals SWOT Analysis
  • Table 203: Company Profile - Abbott Laboratories
  • Table 204: Abbott's Key Product Areas
  • Table 205: Abbott Laboratories SWOT Analysis, 2013
  • Table 206: Company Profile - Amoy Diagnostics
  • Table 207: Amoy Diagnostics SWOT Analysis, 2013
  • Table 208: Company Profile - Biogenex Laboratories
  • Table 209: Biogenex Laboratories SWOT Analysis, 2013
  • Table 210: Company Profile - BioMerieux
  • Table 211: BioMerieux SWOT Analysis, 2013
  • Table 212: Company Profile - Dako (Agilent Technologies)
  • Table 213: Dako/Agilent Technologies SWOT Analysis
  • Table 214: Company Profile - Illumina
  • Table 215: Illumina Product Areas
  • Table 216: Illumina SWOT Analysis
  • Table 217: Company Profile - Leica Biosystems (Danaher)
  • Table 218: Leica Biosystems/Danaher SWOT Analysis
  • Table 219: Company Profile - Life Technologies (Thermo Fisher Scientific)
  • Table 220: Life Technologies SWOT Analysis
  • Table 221: Company Profile - MolecularMD
  • Table 222: MolecularMD SWOT Analysis
  • Table 223: Company Profile - Myriad Genetics
  • Table 224: Myriad Genetics Major Product Areas
  • Table 225: Myriad Genetics SWOT Analysis
  • Table 226: Company Profile - Qiagen
  • Table 227: Qiagen Major Product Areas
  • Table 228: Qiagen SWOT Analysis
  • Table 229: Company Profile - Roche Diagnostics
  • Table 230: Roche SWOT Analysis
  • Table 231: Company Profile - Siemens Healthcare
  • Table 232: Siemens Healthcare SWOT Analysis
  • Table 233: Company Profile - Ventana Medical Systems
  • Table 234: Ventana Medical Systems SWOT Analysis
  • Table 235: Global Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011-2020
  • Table 236: Global Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011-2020
  • Table 237: Global Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011-2020
  • Table 238: Global Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011-2020
  • Table 239: Global Sales Forecast for IHC and Molecular Tests ($m), 2011-2020
  • Table 240: Major Events Affecting the Companion Diagnostic Test Market
  • Table 241: Global Sales Forecast for Companion Diagnostic Tests ($m), 2011-2020
  • Table 242: Sales Forecast for Companion Diagnostic Tests ($m) in the US, 2011-2020
  • Table 243: Sales Forecast for Companion Diagnostic Tests ($m) in France, 2011-2020
  • Table 244: Sales Forecast for Companion Diagnostic Tests ($m) in Germany, 2011-2020
  • Table 245: Sales Forecast for Companion Diagnostic Tests ($m) in Italy, 2011-2020
  • Table 246: Sales Forecast for Companion Diagnostic Tests ($m) in Spain, 2011-2020
  • Table 247: Sales Forecast for Companion Diagnostic Tests ($m) in the UK, 2011-2020
  • Table 248: Sales Forecast for Companion Diagnostic Tests ($m) in Japan, 2011-2020
  • Table 249: Sales Forecast for Companion Diagnostic Tests ($m) in Brazil, 2011-2020
  • Table 250: Sales Forecast for Companion Diagnostic Tests ($m) in China, 2011-2020
  • Table 251: Sales Forecast for Companion Diagnostic Tests ($m) in India, 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: Uptake of HER2 Testing among Invasive Breast Cancer Patients
  • Figure 14: HER2 Testing in the US, 2011-2020
  • Figure 15: Colorectal Cancer Companion Diagnostic (KRAS) Testing in the US, 2011-2020
  • Figure 16: Melanoma Companion Diagnostic Testing (BRAF) in the US, 2011-2020
  • Figure 17: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the US, 2011-2020
  • Figure 18: Breast Cancer Companion Diagnostic Testing (HER2) in France, 2011-2020
  • Figure 19: KRAS Testing in France 2008-2012
  • Figure 20: Colorectal Cancer Companion Diagnostic (KRAS) Testing in France, 2011-2020
  • Figure 21: Melanoma Companion Diagnostic Testing (BRAF) in France, 2011-2020
  • Figure 22: EGFR Testing in France, 2008-2012
  • Figure 23: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in France, 2011-2020
  • Figure 24: Breast Cancer Companion Diagnostic Testing (HER2) in Germany, 2011-2020
  • Figure 25: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Germany, 2011-2020
  • Figure 26: Melanoma Companion Diagnostic Testing (BRAF) in Germany, 2011-2020
  • Figure 27: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Germany, 2011-2020
  • Figure 28: Treatment Index: Italy versus Rest of EU in Use of Herceptin per Head of Population, 2002
  • Figure 29: Percentage of All Breast Cancer Patients Tested for HER2, Italy versus Rest of EU, 2002
  • Figure 30: Breast Cancer Companion Diagnostic Testing (HER2) in Italy, 2011-2020
  • Figure 31: Methods Used for KRAS Genotyping by the Centers Participating in the Italian Quality Assessment Scheme
  • Figure 32: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Italy, 2011-2020
  • Figure 33: Melanoma Companion Diagnostic Testing (BRAF) in Italy, 2011-2020
  • Figure 34: Methods Used for EGFR Genotyping by the Centers Participating in the Italian Quality Assessment Scheme in 2013
  • Figure 35: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Italy, 2011-2020
  • Figure 36: Breast Cancer Companion Diagnostic Testing (HER2) in Spain, 2011-2020
  • Figure 37: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Spain, 2011-2020
  • Figure 38: Melanoma Companion Diagnostic Testing (BRAF) in Spain, 2011-2020
  • Figure 39: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Spain, 2011-2020
  • Figure 40: UK HER2 Status Testing Algorithm
  • Figure 41: Breast Cancer Companion Diagnostic Testing (HER2) in the UK, 2011-2020
  • Figure 42: Colorectal Cancer Companion Diagnostic (KRAS) Testing in the UK, 2011-2020
  • Figure 43: Melanoma Companion Diagnostic Testing (BRAF) in the UK, 2011-2020
  • Figure 44: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the UK, 2011-2020
  • Figure 45: Breast Cancer Companion Diagnostic Testing (HER2) in Japan, 2011-2020
  • Figure 46: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Japan, 2011-2020
  • Figure 47: Melanoma Companion Diagnostic Testing (BRAF) in Japan, 2011-2020
  • Figure 48: EGFR Testing in Japan, 2006-2011
  • Figure 49: Japanese Lung Cancer Society Diagnostic Testing Algorithm
  • Figure 50: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Japan, 2011-2020
  • Figure 51: Breast Cancer Companion Diagnostic Testing (HER2) in Brazil, 2011-2020
  • Figure 52: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Brazil, 2011-2020
  • Figure 53: Melanoma Companion Diagnostic Testing (BRAF) in Brazil, 2011-2020
  • Figure 54: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Brazil, 2011-2020
  • Figure 55: Breast Cancer Companion Diagnostic Testing (HER2) in China, 2011-2020
  • Figure 56: Colorectal Cancer Companion Diagnostic (KRAS) Testing in China, 2011-2020
  • Figure 57: Melanoma Companion Diagnostic Testing (BRAF) in China, 2011-2020
  • Figure 58: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in China, 2011-2020
  • Figure 59: Breast Cancer Companion Diagnostic Testing (HER2) in India, 2011-2020
  • Figure 60: Colorectal Cancer Companion Diagnostic (KRAS) Testing in India, 2011-2020
  • Figure 61: Melanoma Companion Diagnostic Testing (BRAF) in India, 2011-2020
  • Figure 62: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in India, 2011-2020
  • Figure 63: EU Medical Device Approval and Post-Market Surveillance Process
  • Figure 64: Healthcare Coverage Frameworks
  • Figure 65: German Reimbursement Establishment Process
  • Figure 66: Increase in EGFR Testing at AstraZeneca-Funded Test Centers in the UK
  • Figure 67: UK Regional Access to Cancer Diagnostic Testing
  • Figure 68: Registration of Domestic and Imported Medical Devices in China
  • Figure 69: Multiple Partnerships in Companion Diagnostics during 2013-2014
  • Figure 70: Building a Companion Diagnostics Business: Forming Multiple Partnerships
  • Figure 71: Increasing Medicare Cost of Treatment
  • Figure 72: Growth of Drug Therapy Expenditure in France, 2004-2009
  • Figure 73: Share of Targeted Therapies of Anti-Cancer Drug Costs in France
  • Figure 74: Increase in Approvals of Biologic (Targeted) Therapies
  • Figure 75: EGFR PharmDx Test Adoption Curve
  • Figure 76: Probe Arrangement in the Vysis ALK Break Apart FISH Probe Kit
  • Figure 77: Scorpion Primers
  • Figure 78: Increase in High- and Moderate-Complexity Molecular Tests
  • Figure 79: Reasons for Companion Diagnostic Test Failure
  • Figure 80: Female Breast Cancer Treatment Patterns by Stage, 2008
  • Figure 81: Colon Cancer Treatment Patterns by Stage, 2008
  • Figure 82: Lung Cancer Treatment Patterns by Stage, 2008
  • Figure 83: Expected Companion Diagnostic Test Pipeline, US Approvals, 2014-2019
  • Figure 84: Sponsors of Clinical Trials for Targeted Cancer Therapies
  • Figure 85: Sponsors of Clinical Trials for Targeted Cancer Therapies Based on Mutational Status
  • Figure 86: Sponsors of Clinical Trials for Targeted Cancer Therapies, by Phase
  • Figure 87: Global Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011-2020
  • Figure 88: Global Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011-2020
  • Figure 89: Global Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011-2020
  • Figure 90: Global Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011-2020
  • Figure 91: Uptake in ALK Mutation IHC and FISH Testing in France, 2011-2020
  • Figure 92: Uptake of ALK Mutation IHC and FISH Testing in Germany 2011-2020
  • Figure 93: Global Sales Forecast for IHC and Molecular Tests ($m), 2011-2020
  • Figure 94: Global Market Share of Molecular Tests and Immunohistochemistry Tests in 2012 and 2020
  • Figure 95: Global Sales Forecast for Companion Diagnostic Tests ($m), 2011-2020
  • Figure 96: Sales Forecast for Companion Diagnostic Tests ($m) in the US, 2011-2020
  • Figure 97: Sales Forecast for Companion Diagnostic Tests ($m) in France, 2011-2020
  • Figure 98: Sales Forecast for Companion Diagnostic Tests ($m) in Germany, 2011-2020
  • Figure 99: Sales Forecast for Companion Diagnostic Tests ($m) in Italy, 2011-2020
  • Figure 100: Sales Forecast for Companion Diagnostic Tests ($m) in Spain, 2011-2020
  • Figure 101: Sales Forecast for Companion Diagnostic Tests ($m) in the UK, 2011-2020
  • Figure 102: Sales Forecast for Companion Diagnostic Tests ($m) in Japan, 2011-2020
  • Figure 103: Sales Forecast for Companion Diagnostic Tests ($m) in Brazil, 2011-2020
  • Figure 104: Sales Forecast for Companion Diagnostic Tests ($m) in China, 2011-2020
  • Figure 105: Sales Forecast for Companion Diagnostic Tests ($m) in India, 2011-2020
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