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Companion Diagnostics

Companion Diagnostics

This report analyzes the worldwide markets for Companion Diagnostics in US$ Thousand. The report provides separate comprehensive analytics for the US, Japan, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2008 through 2017. The report profiles 101 companies including many key and niche players such as Abbott Laboratories, Abbott Molecular, bioMérieux, Clarient Inc., LabCorp, Merck & Co. Inc., Myriad Genetics, Inc., Power3 Medical Products, Inc., QIAGEN NV, Roche Diagnostics Corp., and Theranostics Health. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

  • 1.INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
    • Study Reliability and Reporting Limitations
    • Disclaimers
    • Data Interpretation & Reporting Level
    • Quantitative Techniques & Analytics
    • Product Definitions and Scope of Study
  • 2.INDUSTRY OVERVIEW
    • Companion Diagnostics: Leading the Way to Personalized Medicine
    • Roche's Got an Edge Over its Counterparts
    • Select Popular Drugs with Companion Diagnostics
    • International Regulatory Agencies Doing their Part for Companion Diagnostics
    • Current and Future Analysis
  • 3.MARKET TRENDS
    • Companion Diagnostics: Challenging the One-Size-Fits- All Approach of the Pharmaceutical Industry
    • Companion Diagnostics Make Way for Personalized Medicine
    • Companion Diagnostics: Broader Scope and Applications Aplenty
    • Diagnostics Companies to Receive their Due Share
    • Diagnostics to Benefit at Large from Companion Diagnostics
    • Factors Fuelling the Growth of Companion Diagnostics
    • Companion Diagnostics to Play a Decisive Role in the Commercial Success of Drugs in Future
    • Companion Diagnostics Augur Well for Pharmaceutical Companies with Diagnostics Capabilities
    • Market to Witness Increasing Pharmaceutical and Diagnostic Deals
    • Select Deals between Pharmaceutical and Diagnostics Companies (2007-2011)
    • Select Companion Diagnostics Alliances (2008): By Company and Corresponding Collaborator
    • Drive Towards Individualized Medicine to Remain a Major Market Driver
    • Enter Companion Diagnostics
    • Role of Biomarkers in Companion Diagnostics
    • Regulatory Scenario in Leading Global Markets
    • Differences between Companion Diagnostics and Laboratory Diagnostic Tests (LDTs)
    • Drugs with Companion Diagnostics: Labeling Approach based on Risk Involved
    • Drugs Requiring Companion Diagnostics Tests as Mandated by the FDA
    • Drugs Requiring Companion Diagnostics Tests as Mandated by the EMEA
    • What is Expected of the FDA Henceforth?
    • Companion Diagnostics: What Various Stakeholders Expect?
    • Pharmaceutical Company (Drug Manufacturer)
    • Diagnostic Company (Companion Diagnostic Manufacturer)
    • Patients
    • Physician/Healthcare Professional
    • Payer
    • Revised Payer Strategy: Need of the Hour
    • Competitive Scenario
  • 4.PRODUCT OVERVIEW
    • Diagnostics in Personalized Medicine
    • Genetic Tests
    • Companion Diagnostics
    • Companion Diagnostics: What Makes them Work
    • Techniques Used in Companion Diagnostics
    • PCR Technology Proves to be of Significant Use in Companion Diagnostics
    • QuantaLife ddPCR™ System: A Breakthrough Innovation in the Field of Companion Diagnostics
    • Biomarkers as Companion Diagnostics
    • Herceptin and Vilazodone -References for Success of Biomarker Based Approach
    • Applications of Companion Diagnostics at a Glance
    • Role of Companion Diagnostics in the Drug Development Process
    • Companion Diagnostics in Clinical Trials
    • Companion Diagnostics in Select Therapeutic Areas
    • Companion Diagnostics in Oncology
    • Select Companion Diagnostics in Cancer
    • Oncotype DX®
    • Quantitative Recurrence Score
    • Early Development and Clinical Trials
    • Oncotype DX: Early Development and Outcomes by Trial Studies
    • Ongoing Trial
    • Oncotype DX Test in Oncology: Stage of Intervention in Adjuvant Treatment Decision
    • Eligibility
    • The Test Procedure
    • Result Interpretation
    • Reimbursement for Oncotype DX
    • Molecular Grade Index (MGISM) (bioTheranostics)
    • Breast Cancer IndexSM (bioTheranostics)
    • KRAS Testing
    • The Test Procedure
    • HER2 Testing for Herceptin Treatment in Breast Cancer
    • Assays Used for HER2 Testing
    • MammaPrint
    • Validation
    • Ongoing Clinical Trials
    • I-SPY Trials
    • HER-2/neu Blood Test
    • Mammostrat
    • CupPrint Test to Aid Cancer Treatment
    • The EGFRx™ Assay to Aid Cancer Treatment
    • c-Kit pharmDx Assay to Aid Cancer Treatment (DakoCytomation)
    • TheraGuide 5-FU™
    • Select Drugs and Companion Diagnostic Tests by Companies and FDA Status (Oncology): 2009
    • Companion Diagnostics in Inflammatory
    • PROMETHEUS® IBD Serology 7 for Irritable Bowel Disease
    • Companion Diagnostics in Infectious Diseases
    • Trofile™ Assay (Monogram Biosciences) to Aid in HIV Treatment
    • Select Drug and Companion Diagnostic Tests by Companies and FDA Status (Infectious Diseases): 2009
    • Companion Diagnostics In Drug Metabolism
    • AmpliChip® CYP450 Test
    • HILOmet PhyzioType™ System (Genomas)
    • Warfarin Sensitivity Test
    • Select Drugs and Companion Diagnostic Tests by Companies and FDA Status (Other Diseases)
    • Select Drugs with Companion Diagnostics Labeling
    • An Account of Companion Diagnostics Companies in the CNS Arena
  • 5.RECENT INDUSTRY ACTIVITY
    • LabCorp to Take Over Clearstone Central Laboratories
    • Nanosphere Seeks FDA Approval for Plavix Metabolism Assay and Troponin I Assay
    • Thermo Fisher to Take Over Phadia
    • Sanofi-Aventis Takes Over Genzyme Corp.
    • Ariad Partners with MolecularMD for Companion Diagnostics Development
    • CompanDX and CRL Join Forces to Develop Companion Diagnostics and Biomarkers
    • CST Grants Ventana Non-Exclusive Global License Related to Tissue-based IVD Testing
    • Luminex Partners with Partners HealthCare for Development of New Molecular Assays
    • Unilabs and Biogen to Offer Novel Companion Diagnostics Assay
    • Proteome Sciences and Buck Institute to Develop Biomarker Assay to Aid Breast Cancer Treatment
    • Myriad Genetics Takes Over Rules-Based Medicine
    • Roche to Develop Companion Diagnostics for Merck's Oncology Pipeline Drugs
    • Biodesix Obtains NY State Certification Under the Clinical Laboratory Evaluation Program
    • ExonHit Therapeutics is Now Exonhit
    • bioTheranostics Presents Outcome of Clinical Studies on Breast Cancer Index® and CancerTYPE ID® Tests
    • Pharmigene Collaborates with 50 Taiwanese Hospitals, Provides Novel Companion Diagnostics Test
    • Morphotek and Biocare Medical Join Forces to Develop Diagnostic Kits for Detecting FRA+ Cancer Patients
    • Seegene and Samsung Combine Forces for Molecular Diagnostics Test Development in Cancer
    • Clovis Oncology and Roche to Develop Companion Diagnostics for NSCLC
    • MDxHealth Demonstrates Successful Clinical Utility of Predict MDx
    • Pharmigene and University of Washington to Implement a Licensing Deal48
    • Caliper forms Alliance with Seegene to Expand Diagnostic Tests Portfolio
    • Ventana Obtains FDA Approval for INFORM HER2 Assay for Breast Cancer
    • Celgene to Use Foundation Medicine's Companion Diagnostic Test for Ongoing Drug Trials in Oncology
    • Roche to Co-develop Cancer Biomarkers with Evotec
    • Quest Diagnostics Takes Over Celera Corp.
    • Forest Laboratories Takes Over Clinical Data, Inc.
    • Source MDx Announces Assets Liquidation
    • bioMérieux and Ipsen Team Up
    • Invivoscribe Inks Agreement with Novartis
    • Novartis to Acquire Genoptix
    • TcLand Receives Funding for Rheumatoid Arthritis
    • WILEX to Take Over Siemens' Oncogene Science Business
    • Aeterna Zentaris to Partner with Almac for Cancer Therapeutic and Companion Diagnostic Development
    • Bayer Partners with Prometheus for Companion Diagnostics Development in Cancer Treatment
    • Genzyme Extends DxS' License for EGFR Diagnostics to Canada and the US
    • Almac Joins Forces with Merck and MRC Companion Diagnostics Development for Erbitux
    • bioMérieux Partners with GSK to Co-develop New Companion Diagnostics Test to aid Cancer Treatment
    • Power3 Medical Reports Novel Clinical Findings
    • Genetic Technologies Purchases Assets of Perlegen Sciences
    • Caliper Life Sciences Acquires Cambridge Research & Instrumentation
    • Flagship Partners with HistologiX to Provide Companion Diagnostics in Europe
    • MDxHealth Establishes New Business Division, MDxHealth PharmacoDx
    • Compendia and AltheaDx Enter into Partnership Deal to Consolidate Bioinformatics Services
    • Roche Bags License from Genzyme, Plans to Develop Tarceva with OSI
    • Dako Denmark Forms Alliance with Quintiles
    • Sirius Genomics and Golden Helix to Jointly Develop Companion Diagnostics
    • Sirius Genomics to Receive Funding from NRC-IRAP
    • Ventana Inks Agreement with Transgene to Develop Novel Assay
    • Array BioPharma Partners with Signal Genetics to Develop Multiple Myeloma Program
    • Aterovax Collaborates with Biomnis
    • QIAGEN Inks Distribution Agreement with Roche Molecular Systems
    • Clovis Enters Agreement with Ventana for Developing Companion Diagnostic Test US
    • Roche Molecular Systems Collaborates with Merck Sharp & Dohme
    • Debiopharm Group™ Inks Companion Diagnostic Development Agreement with Biocartis
    • GSK and Abbott to Collaborate for Diagnostic Test Development
    • QIAGEN Acquires PI3K Biomarker Exclusive Licence from Johns Hopkins University
    • QIAGEN Inks Agreement with Pfizer for Developing Novel Companion Diagnostic Test
    • AstraZeneca Inks Agreement with Dako for Development of Oncology Companion Diagnostics
    • Horizon Discovery Establishes Horizon Dx
    • MDxHealth to Ink Partnership Agreement with Pfizer, Cancer Research Technology and Newcastle University
    • OncoMethylome Enters Into Agreement with Glaxo SmithKline Biologicals
    • AVEO Pharmaceuticals Obtains Patents for Companion Diagnostic Tests
    • Dako Denmark Introduces HER2 CISH pharmDxTM Kit
  • 20/20 GeneSystems Introduces L-IHC Technology
    • Lab21 Introduces Companion Diagnostic for HIV
    • Saladax Receives $8 million for MyCare™ Expansion
    • Avacta Group Enters into Partnership with Takeda
    • TcLand Signs Agreement with Inserm
    • Sequenom Obtains License to Develop and Market Predictive Diagnostic Test for Genetic Predisposition of AMD
    • Kalgene Inks Agreement with Affomix for Development of Therapeutics and Companion Diagnostics
    • DxS Enters into Collaboration Agreement with ImClone Systems and Bristol-Myers Squibb
    • Psynova Neurotech Teams Up with Roche for Schizophrenia Treatment Development
    • QIAGEN Takes Over DxS
    • Eli Lilly Inks Agreement with Almac
    • Pfizer and Abbott Collaborate for Molecular Diagnostic Test Development
    • Dako Denmark Inks Agreement with Genentech
    • Novartis International Seeks Approval for Prexige
    • LabCorp Acquires Monogram Biosciences
    • AstraZeneca Collaborates with DxS
    • Exosome Diagnostics to Collaborate with DxS
    • Boehringer Ingelheim Inks Agreement with DxS
    • Novartis Extends Collaboration with Gen-Probe
    • Dako and OSI Pharmaceuticals Enter into Collaboration
    • Horizon and DxS Collaborates for New Companion Diagnostic Tests
    • Asuragen and Biogen Idec Ink Agreement for Developing Novel Companion Diagnostic
    • DxS' TheraScreen® K-RAS Companion Diagnostic Obtains Canadian Approval Canada; 13 Jul 2009
    • Roche Declares the Results of a Phase I Study on PLX4032
    • Gen-Probe to Take Over Tepnel
    • IPSOGEN Introduces MapQuant Dx™ HER2 test in Europe
    • LabCorp® and Vanda to Co-Develop Several Diagnostic Tests for Pharmacogenetic Markers
    • Theranostics Secures Exclusive License from NIH
    • Reckitt Benckiser Takes Over Adams Respiratory Therapeutics
    • National Jewish Health Signs Agreement with Laboratory Corporation of America Holdings
    • DxS Collaborates with Amgen to Provide A K-RAS Companion Diagnostic for Vectibix®
    • Dako Collaboration with Genentech on a New Companion Diagnostic
    • Celera Partners with Abbott for Identifying Pharmacogenomic Markers
    • Tethys Bioscience Acquires Lipomics Technologies
    • The Immune Tolerance Institute Collaborates with Beckman Coulter
    • Amgen and Lab21 Collaborate to Target Predictive Genetic Test For Bowel Cancer
    • LabCorp Acquires Tandem Labs
    • Roche to Acquire Ventana
    • Siemens Inks Non-Exclusive Deal with Laboratory Corporation of America® Holdings
    • GE and Eli Lilly Enter a Research Agreement
    • Agilent and Lipomics to Co-Develop Assays for Metabolic Diseases
    • Celerus Diagnostics Accomplishes Automated Rapid ISH™ (US)
    • Debiopharm GroupTM Inks Agreement with Biocartis
    • F. Hoffmann-La Roche Inks Agreement with Itamar Medical
    • Linkage Biosciences Enhance LinkSeqTM HLA Product Line
    • Asuragen and Merck Enter Collaboration to Develop NovelPharmacogenomic Tests
    • bioMérieux and Ipsen Team Up
    • LabCorp Partners with ARCA Discovery for Commercial Development of Companion Diagnostic Test for Heart Failure Drug
    • EPIDAUROS and Osmetech® Enter into Agreement
  • 6.FOCUS ON SELECT PLAYERS
    • Abbott Laboratories (US)
    • Abbott Molecular (US)
    • bioMérieux (France)
    • Clarient Inc. (US)
    • LabCorp (US)
    • Merck & Co. Inc. (US)
    • Myriad Genetics, Inc. (US)
    • Power3 Medical Products, Inc. (US)
    • QIAGEN NV (The Netherlands)
    • Qiagen: Companion Diagnostics Tests by Therapeutic Applications and Regulatory Status
    • Companion Diagnostics: Pipeline Biomarkers by Type of Cancer (April 2010)
    • Roche Diagnostics Corp. (US)
    • Virology and Oncology: Therapeutic Areas in Focus in Companion Diagnostics
    • Theranostics Health (USA)
  • 7.GLOBAL MARKET PERSPECTIVE
  • 8.THE UNITED STATES
    • A. Market Analysis
    • A Prelude
    • Companion Diagnostics: A Novel Paradigm in Prescribing Drugs
    • Need for Convergence of Pharmaceutical and Diagnostics Companies
    • Developing a Companion Diagnostic for Targeted Therapies Drives Companies into a Tight Spot
    • Companion Diagnostics from Early Stages of Drug Development
    • Development of Companion Diagnostics in Oncology: A Historic Review
    • Earlier Fruitful Attempts at Companion Diagnostics Development
    • Increasing Number of Deals, Collaborations, and Partnerships
    • Joint Development of Drugs and their Companion Diagnostics: An Upcoming Trend
    • Number of Companion Diagnostics being Developed Keeps Soaring
    • Majority of Companion Diagnostics have been Developed Independent of the Drug
    • Potential in Curbing Healthcare Costs to Drive Companion Diagnostics Adoption in the US
    • Companion Diagnostics Labeling: Tests Mandated by FDA
    • Companion Diagnostics Labeling: Tests Recommended by FDA
    • Companion Diagnostics 'For Informational Use' Tests
    • Strategic Corporate Developments
    • Key Players
    • Abbott Laboratories (US)
    • Abbott Molecular (US)
    • Clarient Inc. (US)
    • LabCorp (US)
    • Merck & Co. Inc. (US)
    • Myriad Genetics, Inc. (US)
    • Power3 Medical Products, Inc. (US)
    • Roche Diagnostics Corp. (US)
    • Virology and Oncology: Therapeutic Areas in Focus in Companion Diagnostics
    • Theranostics Health (USA)
    • B. Market Analytics
  • 9.JAPAN
    • A. Market Analysis
    • Current & Future Analysis
    • B. Market Analytics
  • 10.EUROPE
    • A. Market Analysis
    • Regulatory Scenario in Europe
    • Companion Diagnostics: Select European Players with Strong Biomarker Pipeline
    • Strategic Corporate development
    • QIAGEN NV (The Netherlands): A Key Player
    • B. Market Analytics
  • 10a.FRANCE
    • A. Market Analysis
    • Strategic Corporate Development
    • bioMérieux (France): A Key Player
    • B. Market Analytics
  • 10b.GERMANY
    • A. Market Analysis
    • Current & Future Analysis
    • B. Market Analytics
  • 10c.ITALY
    • A. Market Analysis
    • Current & Future Analysis
    • B. Market Analytics
  • 10d.THE UNITED KINGDOM
    • A. Market Analysis
    • Strategic Corporate Developments
    • B. Market Analytics
  • 10e.REST OF EUROPE
    • A. Market Analysis
    • Strategic Corporate Development
    • B. Market Analytics
  • 11.REST OF WORLD
    • A. Market Analysis
    • Strategic Corporate development
    • B. Market Analytics
    • Competitive Landscape
    • Total Companies Profiled: 101 (including Divisions/Subsidiaries - 115)
    • Region/CountryPlayers
    • The United States
    • Canada
    • Europe
    • France
    • Germany
    • The United Kingdom
    • Rest of Europe
    • Asia-Pacific (Excluding Japan)
    • Middle East
  • List of Tables
    • Table 1: Number of Companion Diagnostic Tests by Disease Area: 2004-2008 (includes corresponding Graph/Chart)
    • Table 2: Companion Diagnostics: Number of Partnership Deals by Select Global Players (includes corresponding Graph/Chart)
    • Table 3: Roche Diagnostics: Companion Diagnostics in Various Stages of Development (2009)
    • Table 4: World Recent Past Current & Future Analysis for Companion Diagnostics Market by Geographic Region - US, Japan, Europe, and Rest of World Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2008 through 2017 (includes corresponding Graph/Chart)
    • Table 5: World 10-Year Perspective for Companion Diagnostics by Geographic Region - Percentage Breakdown of Dollar Sales for US, Japan, Europe, and Rest of World for Years 2008, 2011 & 2017 (includes corresponding Graph/Chart)
    • Table 6: Roche Diagnostics: Companion Diagnostics in Various Stages of Development (2009)
    • Table 7: The US Recent Past, Current & Future Analysis for Companion Diagnostics Market - Analyzed by Annual Revenue Figures in US$ Thousand for Years 2008 through 2017 (includes corresponding Graph/Chart)
    • Table 8: Japanese Recent Past, Current & Future Analysis for Companion Diagnostics Market - Analyzed by Annual Revenue Figures in US$ Thousand for Years 2008 through 2017 (includes corresponding Graph/Chart)
    • Table 9: Molecular Diagnostics Tests: Percentage Share Breakdown by Function (includes corresponding Graph/Chart)
    • Table 10: Drug Development Pipeline with Biomarker (2009): By Therapeutic Area (Europe) (includes corresponding Graph/Chart)
    • Table 11: Pipeline Projects for Select Therapeutic Areas: Percentage Share of Pipeline Projects With or Without Biomarkers (2009) (includes corresponding Graph/Chart)
    • Table 12: European Recent Past, Current & Future Analysis for Companion Diagnostics by Geographic Region - France, Germany, Italy, UK and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2008 through 2017 (includes corresponding Graph/Chart)
    • Table 13: European 10-Year Perspective for Companion Diagnostics by Geographic Region - Percentage Breakdown of Dollar Sales for France, Germany, Italy, UK, and Rest of Europe for Years 2008, 2011 & 2017 (includes corresponding Graph/Chart)
    • Table 14: French Recent Past, Current & Future Analysis for Companion Diagnostics Market - Analyzed by Annual Revenue Figures in US$ Thousand for Years 2008 through 2017 (includes corresponding Graph/Chart)
    • Table 15: German Recent Past, Current & Future Analysis for Companion Diagnostics Market - Analyzed by Annual Revenue Figures in US$ Thousand for Years 2008 through 2017 (includes corresponding Graph/Chart)
    • Table 16: Italian Recent Past, Current & Future Analysis for Companion Diagnostics Market - Analyzed by Annual Revenue Figures in US$ Thousand for Years 2008 through 2017 (includes corresponding Graph/Chart)
    • Table 17: The UK Recent Past, Current & Future Analysis for Companion Diagnostics Market - Analyzed by Annual Revenue Figures in US$ Thousand for Years 2008 through 2017 (includes corresponding Graph/Chart)
    • Table 18: Rest of European Recent Past, Current & Future Analysis for Companion Diagnostics Market - Analyzed by Annual Revenue Figures in US$ Thousand for Years 2008 through 2017 (includes corresponding Graph/Chart)
    • Table 19: Rest of the World Recent Past, Current & Future Analysis for Companion Diagnostics Market - Analyzed by Annual Revenue Figures in US$ Thousand for Years 2008 through 2017 (includes corresponding Graph/Chart)
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