Western European Companion Diagnostics Market

Regulatory Hurdles and LDTs Stall the Global and European Market for Companion Diagnostics

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The research service aims to give a global outlook of the companion diagnostic market landscape, with a specific focus on Western European countries. The segments related to oncology discussed in this study include breast cancer, lung cancer, colorectal cancer and other cancers, and non-oncology related infectious disease, CNS, and cardiovascular. The forecasts are based on test volumes for these cancers and disease types. Effective analysis of the reimbursement pathway in Germany, the United Kingdom, France, Italy, Spain, Scandinavia, and Benelux, coupled with regulatory approval in Europe, is discussed. A comparative assessment of regulatory scenarios has been performed to assess easy-target markets.

Table of Contents

Executive SummaryKey FindingsKey Findings (continued)Scope and SegmentationKey Questions This Study Will AnswerMarket Engineering MeasurementsCEO’s PerspectiveKey Companies to WatchExecutive Summary—3 Big PredictionsMarket OverviewMarket Background Market Background (continued)Market Background (continued)Market Background (continued)Market SegmentationOverall Market PerspectiveDefining Healthcare Trends in the FutureEuropean Regulatory OverviewRegulatory Overview—EuropeRegulatory Overview—Europe (continued)Future IVD Regulation in EuropeRole of EMADrug Labels Requiring Biomarker Testing by the EMAComparison of FDA and CE MarkingComparative Analysis of the United States, Europe, and China Global Regulatory OutlookCompetitive PlaybookNew Market OpportunitiesNew Market Opportunities (continued)New Market Opportunities (continued)Current Participant Strategies DiscussionCurrent Participant Strategies Discussion (continued)Unmet Needs DiscussionUnmet Needs Discussion (continued)Drivers and Restraints—Total Companion Diagnostics MarketMarket DriversMarket RestraintsMarket Impact of Top TrendsForecasts and Trends—Total Companion Diagnostics MarketMarket Engineering MeasurementsSnapshot of the European Companion Diagnostics MarketImportant Market CharacteristicsForecast AssumptionsTotal Companion Diagnostics Market—Revenue ForecastTotal Companion Diagnostics Market—Revenue Forecast by Disease FocusRevenue Forecast Discussion Revenue Forecast Discussion (continued) PEST AnalysisPEST Analysis (continued)Breast Cancer TestingRevenue Forecast for Breast Cancer Testing Revenue Forecast for Breast Cancer Testing DiscussionLung Cancer TestingRevenue Forecast for Lung Cancer Testing Revenue Forecast for Lung Cancer Testing DiscussionColorectal Cancer and Other Cancers TestingRevenue Forecast for Colorectal Cancer TestingRevenue Forecast for Other Cancers TestingRevenue Forecast for Colorectal Cancer and Other Cancers Testing DiscussionInfectious Disease, CNS, and Cardiovascular TestingRevenue Forecast for Infectious Disease, CNS, and Cardiovascular TestingRevenue Forecast for Infectious Disease, CNS, and Cardiovascular Testing DiscussionRevenue Forecast DiscussionRevenue Forecast Discussion (continued)Competitive EnvironmentCompetitive EnvironmentCompetitive Environment (continued)Product AnalysisProduct Analysis (continued) Top CompetitorsTop Competitors (continued)Market Share by TierMarket Share by Tier (continued)Merger, Acquisition, and Partnership AssessmentMerger, Acquisition, and Partnership Assessment (continued)Companion Diagnostic PartnersCompanion Diagnostic Partners (continued)Therapy Areas for Companion Diagnostic PartnershipsTypes of Companion Diagnostic PartnershipsGlobal Reach of Companion Diagnostic PartnershipEuropean Reimbursement LandscapeIntroductionReimbursement Systems Overview CDx Penetration Across Western EuropeGermany—Reimbursement OverviewGermany—Personalized Medicine OverviewGermany—Personalized Medicine Overview (continued)Germany—Overview of ReimbursementFrance—Reimbursement OverviewFrance—Personalized Medicine OverviewFrance—Personalized Medicine Overview (continued)France—Overview of ReimbursementFrance—Overview of Reimbursement (continued)The United Kingdom—Reimbursement OverviewThe United Kingdom—Personalized Medicine OverviewThe United Kingdom—Personalized Medicine Overview (continued)The United Kingdom—Overview of ReimbursementItaly—Reimbursement OverviewItaly—Personalized Medicine OverviewItaly—Personalized Medicine Overview (continued)Italy—Personalized Medicine Overview (continued)Italy—Overview of ReimbursementItaly—Overview of Reimbursement (continued)Spain—Reimbursement OverviewSpain—Personalized Medicine OverviewSpain—Healthcare Payment SystemSpain—Pricing and ReimbursementSpain—Pricing and Reimbursement (continued)Scandinavia—Reimbursement OverviewScandinavia—Personalized Medicine OverviewScandinavia—Personalized Medicine Overview (continued)Scandinavia—Reimbursement OverviewScandinavia—Reimbursement Overview (continued)Benelux—Reimbursement OverviewBenelux—Personalized Medicine OverviewThe Netherlands—Personalized Medicine OverviewThe Netherlands—Reimbursement OverviewThe Netherlands—Reimbursement Overview (continued)Belgium—Personalized Medicine OverviewBelgium—Reimbursement OverviewBelgium—Reimbursement Overview (continued)The Last WordThe Last Word—3 Big PredictionsThe Last Word—DiscussionThe Last Word—Discussion (continued)The Last Word—Discussion (continued)The Last Word—Discussion (continued)The Last Word—Discussion (continued)Legal DisclaimerAppendixEurope—Drivers ExplainedEurope—Drivers Explained (continued)Europe—Drivers Explained (continued)Europe—Restraints ExplainedEurope—Restraints Explained (continued)Europe—Restraints Explained (continued)Europe—Restraints Explained (continued)Europe—Restraints Explained (continued)Europe—Restraints Explained (continued)Europe—Restraints Explained (continued)Europe—Restraints Explained (continued)Decision Support DatabaseDecision Support Database (continued)Decision Support Database (continued)Decision Support Database (continued)Decision Support Database (continued)Associated MultimediaMarket Engineering MethodologyLearn More—Next Steps




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