The Global Immuno-oncology Therapeutics Market—Checkpoint Inhibitors

The Next Generation of Cancer Therapies

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Immuno-oncology is based on the premise that tumors escape detection by the immune system, contributing to their growth and progression. Checkpoint inhibitor pathways act as the checks and balances that allow T-cells to recognize foreign substances or tumors. This global study looks at the immune-oncology therapeutics pipeline for checkpoint inhibitors in the drug classes CTLA-4, PD-1/PD-L1, LAG-3, and TIM-3, identifying companies and products in development, dollars spent at each phase (preclinical through launch), cost and reimbursement implications to payers, challenges to commercialization, and opportunities for pharmaceutical, biotech, or diagnostic companies as oncology treatment algorithms evolve. The study period is 2011 to 2020.

Table of Contents

Executive Summary—Checkpoint InhibitorsScope and SegmentationKey Questions this Study will AnswerKey TakeawaysMarket SnapshotMarket Snapshot (continued)8 Big Market Themes for Checkpoint InhibitorsA Vibrant EcosystemParadigm Expansion to Solid Tumor Cancer TherapiesRegional Launch HighlightsGame-changing CompaniesSignificant Investor FundingKey 2016 Predictions—Checkpoint Inhibitor MarketDisruptive Pipeline AnalysisKey Methodology and ScopeCheckpoint Inhibitor Drug ClassesTimeline of Checkpoint Product ApprovalsCompetitive Landscape—Target Segments, Count of Marketed and Pipeline ProductsCheckpoint Segmentation by SubtypeCompetitive Landscape—Target Product Counts by PhaseCompetitive LandscapeCheckpoint Pipelines by Company, Target, and PhaseCheckpoint Pipelines by Company, Target, and Phase (continued)Checkpoint Pipelines by Company, Target, and Phase (continued)Checkpoint Pipelines by Company, Target, and Phase (continued)Checkpoint Target SegmentationCompetitive Landscape—CTLA-4/CAIX/GITR Segment, Products in DevelopmentCompetitive Landscape—PD-1/PD-L1 (programmed death 1-receptor) Competitive Landscape—LAG-3 (lymphocyte activating gene 3)Competitive Landscape—TIM-3 (T-cell immunoglobin and mucin domain 3)Product Dashboards of Leading Checkpoint InhibitorsPD-1 Product Dashboard—Keytruda® (Pembrolizumab): Merck & Co. (Marketed) PD-1 Product Dashboard—Opdivo® (Nivolumab): Bristol-Myers Squibb/Ono (Marketed)CTLA-4 Product Dashboard—Yervoy® (ipilimumab): Bristol-Myers Squibb (Marketed) PD-L1 Product Dashboard—Tecentriq® (Atezolizumab): Roche (Marketed) Key Companies and Products to Watch by TargetCompetitive Overview of Established CompaniesCheckpoint Inhibitors—PD-1/PD-L1PD-L1 Product Dashboard—Avelumab (MSB0010718C): Merck KGaA (Phase III)PD-L1 Product Dashboard—Durvalumab (MEDI-4736): AstraZeneca / MedImmune (Phase III)Checkpoint Inhibitors—CTLA-4CTLA-4 Product Dashboard—Tremelimumab (MEDI-1123): AstraZeneca (Phase III)Opportunities in Combination TherapiesImmuno-oncology Combination TherapiesCheckpoint Combination Clinical Trials by IndicationImmuno-oncology Checkpoint Phase III Trials to WatchImmuno-oncology Checkpoint Phase III Trials To Watch (continued)Disruptive Technologies and Advances in this FieldCommercialization Analysis Market OpportunitiesPotential Game-changing TherapiesOverall Environmental Impact FactorsCheckpoint Product Patent ExpirationsCommercialization Analysis—BiomarkersBiomarker ChallengesCommercialization Analysis—Cost ConsiderationsOpportunities in this Market—Escalating Drug CostsCheckpoint Inhibitor Payer EnvironmentJ-Codes, Annual Costs, and US PayersReimbursement Pathway—On-label Reimbursement PathReimbursement Pathway—Off-Label, MedicareReimbursement Pathway—Off-Label, Commercial PayersReimbursement Pathway—Off-Label, Commercial Payers (continued)A Snapshot of Global Drug Price Control Methods Pitfalls to AvoidCommercialization Analysis—Key Companies and Products to WatchCompanies to WatchCompanies to Watch (continued)Checkpoint Inhibitor Forecast Sales Total—2020 ($20.5B)Actual Sales by ProductCommercialization Analysis—Funding ConsiderationsInvestors Pour in Significant Funds Checkpoint Milestones2015 Deal and Financing—CTLA-4 Receptor Gene Therapy2015 Deal and Financing Summary—PD-1/PD-L12015 Deal and Financing Summary—PD-1/PD-L1 (continued)2015 Deal and Financing Summary—PD-1/PD-L1 (continued)2015 Deal and Financing Summary—PD-1/PD-L1 (continued)2015 Deal and Financing Summary—PD-1/PD-L1 (continued)2015 Deal and Financing Summary—PD-1/PD-L1 (continued)2015 Deal and Financing Summary—PD-1/PD-L1 (continued)2015 Deal and Financing Summary—LAG-32015 Deal and Financing Summary—LAG-3 (continued)2015 Deal and Financing Summary—LAG-3 (continued)2015 Deal and Financing Summary—TIM-3Conclusion and Take Home PointsKey ConclusionsGrowth Opportunities in 4 Checkpoint Inhibitor SegmentsNew Market Opportunities—Checkpoint InhibitorsThe Last Word—3 Big PredictionsLegal DisclaimerAppendix—Checkpoint Inhibitors Development Pipeline SummariesPipeline Analysis—CTLA-4/CAIX/GITR Segment, Products in DevelopmentPipeline Analysis—CTLA-4/CAIX/GITR Segment, Products in Development (continued)Pipeline Analysis—CTLA-4/CAIX/GITR Segment, Products in Development (continued)Pipeline Analysis—CTLA-4/CAIX/GITR Segment, Products in Development (continued)Pipeline Analysis—CTLA-4/CAIX/GITR Segment, Products in Development (continued)Pipeline Analysis—LAG-3 Products in DevelopmentPipeline Analysis—LAG-3 Products in Development (continued)Pipeline Analysis—LAG-3 Products in Development (continued)Pipeline Analysis—PD-1/PD-L1 Segment, Products in DevelopmentPipeline Analysis—PD-1/PD-L1 Segment, Products in Development (continued)Pipeline Analysis—PD-1/PD-L1 Segment, Products in Development (continued)Pipeline Analysis—PD-1/PD-L1 Segment, Products in Development (continued)Pipeline Analysis—PD-1/PD-L1 Segment, Products in Development (continued)Pipeline Analysis—PD-1/PD-L1 Segment, Products in Development (continued)Pipeline Analysis—PD-1/PD-L1 Segment, Products in Development (continued)Pipeline Analysis—PD-1/PD-L1 Segment, Products in Development (continued)Pipeline Analysis—PD-1/PD-L1 Segment, Products in Development (continued)Pipeline Analysis—PD-1/PD-L1 Segment, Products in Development (continued)Pipeline Analysis—PD-1/PD-L1 Segment, Products in Development (continued)Pipeline Analysis—PD-1/PD-L1 Segment, Products in Development (continued)Pipeline Analysis—PD-1/PD-L1 Segment, Products in Development (continued)Pipeline Analysis—PD-1/PD-L1 Segment, Products in Development (continued)Pipeline Analysis—PD-1/PD-L1 Segment, Products in Development (continued)Pipeline Analysis—PD-1/PD-L1 Segment, Products in Development (continued)Pipeline Analysis—PD-1/PD-L1 Segment, Products in Development (continued)Pipeline Analysis—TIM-3 (T-cell immunoglobin and mucin domain 3) Segment, Products in DevelopmentPipeline Analysis—TIM-3 (T-cell immunoglobin and mucin domain 3) Segment, Products in Development (continued)Pipeline Analysis—TIM-3 (T-cell immunoglobin and mucin domain 3) Segment, Products in Development (continued)The Frost & Sullivan StoryThe Frost & Sullivan StoryValue Proposition: Future of Your Company & CareerGlobal PerspectiveIndustry Convergence360º Research PerspectiveImplementation Excellence




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