表紙
市場調査レポート

MediPoint:腫瘍向けコンパニオン診断検査 - 米国市場の分析と予測

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

発行 GlobalData 商品コード 303983
出版日 ページ情報 英文 423 Pages
即納可能
価格
本日の銀行送金レート: 1USD=102.18円で換算しております。
Back to Top
MediPoint:腫瘍向けコンパニオン診断検査 - 米国市場の分析と予測 MediPoint: Companion Diagnostic Tests in Oncology - US Analysis and Market Forecasts
出版日: 2014年05月21日 ページ情報: 英文 423 Pages
概要

腫瘍向けコンパニオン診断市場では、非小細胞肺がん(NSCLC)における遺伝子変異の検査が注目されています。免疫組織化学(IHC)検査の典型であるヒト上皮成長因子受容体2(HER2)検査については実施件数は多いものの、NSCLCのコンパニオン診断検査は価格が高額な分子検査であり、そのため2014年には売上高において米国市場の67%を占める事になるでしょう。

当レポートでは、米国の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、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活用
  • 検査の動向
    • 概要
    • 乳がん
    • 大腸がん
    • メラノーマ
    • 非小細胞肺がん
  • 市場アクセス
    • 概要
    • 規制
    • 医療費償還
  • 規制上の課題とリコール
  • コンパニオン診断検査への医療費償還
  • 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
    • 米国
  • 第10章 付録

図表一覧

目次
Product Code: GDME1100CFR

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.

The major feature of the companion diagnostic testing market is the current domination of tests for mutations important in the prognosis and diagnosis of non-small cell lung cancer (NSCLC), with the two market leaders being Roche and Qiagen. According to GlobalData's forecast, in 2014, NSCLC companion diagnostic tests account for 67% of the US market by value. While more human epidermal growth factor receptor 2 (HER2) tests are carried out, because the NSCLC tests have been principally more expensive molecular tests, rather than the cheaper immunohistochemistry (IHC) test that typifies HER2 testing, the value of the NSCLC market is considerably higher.

Scope

  • An overview of companion diagnostic, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
  • Annualized US 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 US companion diagnostic market.
  • Realize device preferences of physicians who have performed the tests already.
  • Access market sizing, forecasts and quantified growth opportunities in US 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 US 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. Overview
    • 3.6.2. Breast Cancer Companion Diagnostic Tests
    • 3.6.3. Colorectal Cancer Companion Diagnostic Tests
    • 3.6.4. Melanoma Companion Diagnostic Tests
    • 3.6.5. Non-Small Cell Lung Cancer Companion Diagnostic Tests
  • 3.7. Market Access
    • 3.7.1. Overview
    • 3.7.2. Regulation
    • 3.7.3. 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
  • 3.10. 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. US

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: FDA Medical Device Classifications
  • Table 17: US Reimbursement Policies for FDA- and Non-FDA-Approved Molecular Tests
  • Table 18: Key Mergers and Acquisitions during 2013-2014
  • Table 19: Partnerships during 2013-2014
  • Table 20: Impact of Companion Diagnostics on Cancer Treatment Costs in France
  • Table 21: Effectiveness of Disease Therapies
  • Table 22: HER2 FISH/iQFISH PharmDx Product Profile
  • Table 23: Common Reasons for HER2 FISH Failure
  • Table 24: HER2 FISH PharmDx/HER2 iQFISH PharmDx SWOT Analysis
  • Table 25: HercepTest Product Profile
  • Table 26: HercepTest Scoring Algorithm
  • Table 27: HercepTest SWOT Analysis
  • Table 28: HER2 CISH PharmDx Product Profile
  • Table 29: HER2 CISH PharmDx SWOT Analysis
  • Table 30: SPOT-Light HER2 CISH Kit Product Profile
  • Table 31: SPOT-Light HER2 CISH Kit SWOT Analysis
  • Table 32: Leica Bond Oracle HER2 IHC System Product Profile
  • Table 33: Leica Bond Oracle HER2 IHC System Test Algorithm
  • Table 34: Leica Bond Oracle HER2 IHC System SWOT Analysis
  • Table 35: Biogenex INSITE HER2/Neu Product Profile
  • Table 36: Biogenex INSITE HER2/Neu SWOT Analysis
  • Table 37: Abbott Pathvysion HER-2 DNA Probe Kit Product Profile
  • Table 38: Abbott Pathvysion HER-2 DNA Probe Kit SWOT Analysis
  • Table 39: Ventana INFORM HER2 Dual ISH Assay Product Profile
  • Table 40: Ventana INFORM HER2 Dual ISH Assay SWOT Analysis
  • Table 41: Pathway HER2/Neu IHC Product Profile
  • Table 42: Pathway HER2/Neu IHC SWOT Analysis
  • Table 43: HerMark Product Profile
  • Table 44: HerMark SWOT Analysis
  • Table 45: Therascreen KRAS RGQ Product Profile
  • Table 46: Therascreen KRAS RGQ SWOT Analysis
  • Table 47: Cobas KRAS Mutation Test Product Profile
  • Table 48: Cobas KRAS Mutation Test SWOT Analysis
  • Table 49: EGFR PharmDx Kit Product Profile
  • Table 50: EGFR PharmDx Kit SWOT Analysis
  • Table 51: THxID BRAF Product Profile
  • Table 52: Effect of Melanin on the THxID BRAF PCR Test
  • Table 53: THxID BRAF SWOT Analysis
  • Table 54: Cobas 4800 BRAF V600 Mutation Test - Melanoma Product Profile
  • Table 55: Interpretation of Cobas BRAF V600 Mutation Test - Melanoma
  • Table 56: Cobas 4800 BRAF V600 Mutation Test - Melanoma SWOT Analysis
  • Table 57: Vysis ALK Break Apart FISH Probe Kit Product Profile
  • Table 58: Abbott Vysis ALK Break Apart FISH Probe Kit SWOT Analysis
  • Table 59: Amoy-Dx EML4-ALK Fusion Gene Detection Kit Product Profile
  • Table 60: Amoy-Dx EML4-ALK Fusion Gene Detection Kit SWOT Analysis
  • Table 61: Therascreen EGFR RGQ PCR Kit Product Profile
  • Table 62: Therascreen EGFR RGQ PCR Kit SWOT Analysis
  • Table 63: ALK IHC Test Product Profile
  • Table 64: ALK IHC Test SWOT Analysis
  • Table 65: Cobas EGFR Mutation Test Product Profile
  • Table 66: Cobas EGFR Mutation Test SWOT Analysis
  • Table 67: Companion Diagnostic Tests Pipeline, 2014
  • Table 68: Neuvax Companion Diagnostic Assay Product Profile
  • Table 69: Neuvax Companion Diagnostic Assay Product SWOT Analysis
  • Table 70: Companion Diagnostic Test - Palbociclib Product Profile
  • Table 71: Companion Diagnostic Test - Palbociclib SWOT Analysis
  • Table 72: Companion Diagnostic Test - Breast Cancer Product Profile
  • Table 73: Companion Diagnostic Test - Breast Cancer SWOT Analysis
  • Table 74: Onapristone Companion Diagnostic Assay Product Profile
  • Table 75: Onapristone Companion Diagnostic Assay SWOT Analysis
  • Table 76: Aromatase Inhibitor Biomarker - Companion Diagnostic Test Product Profile
  • Table 77: Aromatase Inhibitor Biomarker - Companion Diagnostic Test SWOT Analysis
  • Table 78: BRAF Companion Diagnostic Assay - Colon Cancer Product Profile
  • Table 79: BRAF Companion Diagnostic Assay - Colon Cancer SWOT Analysis
  • Table 80: KRAS Companion Diagnostic Assay - Colon Cancer Product Profile
  • Table 81: KRAS Companion Diagnostic Assay - Colon Cancer SWOT Analysis
  • Table 82: PIK3CA Companion Diagnostic Assay - Colorectal Cancer Product Profile
  • Table 83: PIK3CA Companion Diagnostic Assay - Colorectal Cancer SWOT Analysis
  • Table 84: Vectibix Companion Diagnostic Product Profile
  • Table 85: Vectibix Companion Diagnostic SWOT Analysis
  • Table 86: MAGE-A3 Companion Skin Cancer Assay Product Profile
  • Table 87: MAGE-A3 Companion Skin Cancer Assay SWOT Analysis
  • Table 88: GNAQ/GNA11 Companion Diagnostic Assays - Melanoma Product Profile
  • Table 89: GNAQ/GNA11 Companion Diagnostic Assays - Melanoma SWOT Analysis
  • Table 90: Companion Diagnostic Test - Melanoma Cancer Product Profile
  • Table 91: Companion Diagnostic Test - Melanoma Cancer SWOT Analysis
  • Table 92: KRAS Companion Diagnostic Assay - Melanoma Product Profile
  • Table 93: KRAS Companion Diagnostic Assay - Melanoma SWOT Analysis
  • Table 94: Companion Diagnostic Test - Melanoma Product Profile
  • Table 95: Companion Diagnostic Test - Melanoma SWOT Analysis
  • Table 96: BRAF Companion Diagnostic Assay - Lung Cancer Product Profile
  • Table 97: BRAF Companion Diagnostic Assay - Lung Cancer SWOT Analysis
  • Table 98: KRAS Companion Diagnostic Assay - Lung Cancer Product Profile
  • Table 99: KRAS Companion Diagnostic Assay - Lung Cancer SWOT Analysis
  • Table 100: MET Companion Diagnostic Assay - Lung Cancer Product Profile
  • Table 101: MET Companion Diagnostic Assay - Lung Cancer SWOT Analysis
  • Table 102: PIK3CA Companion Diagnostic Assay - Lung Cancer Product Profile
  • Table 103: PIK3CA Companion Diagnostic Assay - Lung Cancer SWOT Analysis
  • Table 104: Companion Diagnostic Device - Lung Cancer Product Profile
  • Table 105: Companion Diagnostic Device - Lung Cancer SWOT Analysis
  • Table 106: Companion Diagnostic Test - Crizotinib Product Profile
  • Table 107: Companion Diagnostic Test - Crizotinib SWOT Analysis
  • Table 108: Companion Diagnostic Test - Dacomitinib Product Profile
  • Table 109: Companion Diagnostic Test - Dacomitinib SWOT Analysis
  • Table 110: T790M Mutation Companion Diagnostic Test Product Profile
  • Table 111: T790M Mutation Companion Diagnostic Test SWOT Analysis
  • Table 112: Entinostat Companion Diagnostic Assay Product Profile
  • Table 113: Entinostat Companion Diagnostic Assay SWOT Analysis
  • Table 114: MUC1 Expression Companion Diagnostic Test Product Profile
  • Table 115: MUC1 Expression Companion Diagnostic Test SWOT Analysis
  • Table 116: Companion Diagnostic Assay - NSCLC Product Profile
  • Table 117: Companion Diagnostic Assay - NSCLC SWOT Analysis
  • Table 118: Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug Therapies.
  • Table 119: Company Profile - Amgen
  • Table 120: Amgen's Key Products
  • Table 121: Selected Amgen Anti-Cancer Therapies Currently in Clinical Trials
  • Table 122: Amgen SWOT Analysis
  • Table 123: Company Profile - Arno Therapeutics
  • Table 124: Selected Arno Therapeutics Anti-Cancer Therapies Currently in Clinical Trials
  • Table 125: Arno Therapeutics SWOT Analysis
  • Table 126: Company Profile - AstraZeneca
  • Table 127: Key Events in the Development of AstraZeneca's Drug Portfolio Since 2011
  • Table 128: Key Project Terminations by AstraZeneca Since 2008
  • Table 129: AstraZeneca SWOT Analysis
  • Table 130: Company Profile - Bristol-Myers Squibb
  • Table 131: Recent Key Product Approvals from Bristol-Myers Squibb
  • Table 132: Recent Key BMS Partnerships and Agreements
  • Table 133: Bristol-Myers Squibb SWOT Analysis
  • Table 134: Company Profile - Clovis Oncology
  • Table 135: Clovis Oncology's Key Products
  • Table 136: Clovis Oncology SWOT Analysis
  • Table 137: Company Profile - Eli Lilly and Company
  • Table 138: Eli Lilly and Company SWOT Analysis
  • Table 139: Company Profile - Genentech
  • Table 140: Selected Genentech Marketed Products
  • Table 141: Genentech SWOT Analysis
  • Table 142: Company Profile - Pfizer
  • Table 143: Pfizer SWOT Analysis
  • Table 144: Company Profile - Syndax Pharmaceuticals
  • Table 145: Syndax Pharmaceuticals SWOT Analysis
  • Table 146: Company Profile - Abbott Laboratories
  • Table 147: Abbott's Key Product Areas
  • Table 148: Abbott Laboratories SWOT Analysis, 2013
  • Table 149: Company Profile - Amoy Diagnostics
  • Table 150: Amoy Diagnostics SWOT Analysis, 2013
  • Table 151: Company Profile - Biogenex Laboratories
  • Table 152: Biogenex Laboratories SWOT Analysis, 2013
  • Table 153: Company Profile - BioMerieux
  • Table 154: BioMerieux SWOT Analysis, 2013
  • Table 155: Company Profile - Dako (Agilent Technologies)
  • Table 156: Dako/Agilent Technologies SWOT Analysis
  • Table 157: Company Profile - Illumina
  • Table 158: Illumina Product Areas
  • Table 159: Illumina SWOT Analysis
  • Table 160: Company Profile - Leica Biosystems (Danaher)
  • Table 161: Leica Biosystems/Danaher SWOT Analysis
  • Table 162: Company Profile - Life Technologies (Thermo Fisher Scientific)
  • Table 163: Life Technologies SWOT Analysis
  • Table 164: Company Profile - MolecularMD
  • Table 165: MolecularMD SWOT Analysis
  • Table 166: Company Profile - Myriad Genetics
  • Table 167: Myriad Genetics Major Product Areas
  • Table 168: Myriad Genetics SWOT Analysis
  • Table 169: Company Profile - Qiagen
  • Table 170: Qiagen Major Product Areas
  • Table 171: Qiagen SWOT Analysis
  • Table 172: Company Profile - Roche Diagnostics
  • Table 173: Roche SWOT Analysis
  • Table 174: Company Profile - Siemens Healthcare
  • Table 175: Siemens Healthcare SWOT Analysis
  • Table 176: Company Profile - Ventana Medical Systems
  • Table 177: Ventana Medical Systems SWOT Analysis
  • Table 178: US Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011-2020
  • Table 179: US Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011-2020
  • Table 180: USl Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011-2020
  • Table 181: US Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011-2020
  • Table 182: US Sales Forecast for IHC and Molecular Tests ($m), 2011-2020
  • Table 183: Major Events Affecting the Companion Diagnostic Test Market
  • Table 184: Sales Forecast for Companion Diagnostic Tests ($m) in the US, 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: Healthcare Coverage Frameworks
  • Figure 19: Multiple Partnerships in Companion Diagnostics during 2013-2014
  • Figure 20: Building a Companion Diagnostics Business: Forming Multiple Partnerships
  • Figure 21: Increasing Medicare Cost of Treatment
  • Figure 22: Growth of Drug Therapy Expenditure in France, 2004-2009
  • Figure 23: Share of Targeted Therapies of Anti-Cancer Drug Costs in France
  • Figure 24: Increase in Approvals of Biologic (Targeted) Therapies
  • Figure 25: EGFR PharmDx Test Adoption Curve
  • Figure 26: Probe Arrangement in the Vysis ALK Break Apart FISH Probe Kit
  • Figure 27: Scorpion Primers
  • Figure 28: Increase in High- and Moderate-Complexity Molecular Tests
  • Figure 29: Reasons for Companion Diagnostic Test Failure
  • Figure 30: Female Breast Cancer Treatment Patterns by Stage, 2008
  • Figure 31: Colon Cancer Treatment Patterns by Stage, 2008
  • Figure 32: Lung Cancer Treatment Patterns by Stage, 2008
  • Figure 33: Expected Companion Diagnostic Test Pipeline, US Approvals, 2014-2019
  • Figure 34: Sponsors of Clinical Trials for Targeted Cancer Therapies
  • Figure 35: Sponsors of Clinical Trials for Targeted Cancer Therapies Based on Mutational Status
  • Figure 36: Sponsors of Clinical Trials for Targeted Cancer Therapies, by Phase
  • Figure 37: US Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011-2020
  • Figure 38: US Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011-2020
  • Figure 39: US Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011-2020
  • Figure 40: US Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011-2020
  • Figure 41: US Sales Forecast for IHC and Molecular Tests ($m), 2011-2020
  • Figure 42: Global Market Share of Molecular Tests and Immunohistochemistry Tests in 2012 and 2020
  • Figure 43: Sales Forecast for Companion Diagnostic Tests ($m) in the US, 2011-2020
Back to Top