The breast cancer market is rapidly evolving and presents new commercial opportunities for drug developers. CDK4/6 inhibitors (Pfizer’s Ibrance, Novartis’s Kisqali, and Eli Lilly’s Verzenio / Verzenios) are creating new dynamics in the metastatic HR-positive / HER2-negative treatment practice. In HER2-positive breast cancer, HER2-targeting drugs in development are forecast to enter the market, while sales of current HER2-targeting agents will be impacted as a result of competition, label expansions, biosimilar entries, and new trials leading to changes in treatment guidelines. Furthermore, the approval of PARP inhibitors (AstraZeneca / Merck & Co.’s Lynparza and Pfizer’s Talzenna), PD-1-targeting agents (Roche / Genentech / Chugai’s Tecentriq), PI3K inhibitors (Novartis’s Piqray), HER2-targeting agents (Daiichi Sankyo / AstraZeneca’s Enhertu, Seagen’s Tukysa, and Macrogenics’ Margenza), TROP2-targeting antibody-drug conjugates (Immunomedics’ Trodelvy), and the anticipated entry of other agents from these drug classes will diversify treatment options, especially for triple-negative breast cancer.

Questions answered

  • What is the size of the drug-treatable breast cancer population, and how will drug-treatment rates change over time?
  • What is the expected market impact of recent drug approvals, such as Tecentriq, Piqray, Enhertu, Tukysa, and Trodelvy on the various subpopulations of breast cancer?
  • What are the most promising agents in the pipeline, and how will they shape the future of the breast cancer market?
  • What are the drivers and constraints in the breast cancer market, and how will the market evolve over the forecast period?

Content Highlights

  • Geographies: United States, EU5, Japan
  • Primary Research: 19 country-specific interviews with thought-leading medical oncologists supported by survey data collected for this and other DRG research
  • Epidemiology: Incidence of breast cancer by country, segmented by HR and HER2 status, staging, and line of therapy
  • Forecast: 10-year, annualized, drug-level sales and patient share of key breast cancer therapies through 2029, segmented by brands / biosimilars / generics and market-relevant drug-treatable populations
  •  Emerging Therapies: Phase III/PR: 15 drugs; coverage of select Phase I and II products

Product Description

Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.

Table of contents

  • Breast Cancer - Landscape & Forecast - Disease Landscape & Forecast
    • Key Updates
      • Q1 2021
        • March 2021
        • February 2021
        • January 2021
      • Q4 2020
        • December 2020
      • Q3 2020
        • August 2020
      • Q2 2020
        • May 2020
      • Q1 2020
        • March 2020
    • Key Findings
      • Breast Cancer – Key Findings – March 2021
        • March 2020
    • Market Outlook
      • Key Findings
        • Market Share of Breast Cancer Drug Classes: 2019
        • Market Share of Breast Cancer Drug Classes: 2029
        • Drug-Treatable Population Share and Major-Market Sales Share in Breast Cancer: 2019
        • Drug-Treatable Population Share and Major-Market Sales Share in Breast Cancer: 2029
        • Population Positioning of Therapies in Breast Cancer
        • SWOT Analysis
      • Market Drivers and Constraints
        • What Factors Are Driving the Market for Breast Cancer?
        • What Factors Are Constraining the Market for Breast Cancer?
      • Segment-Specific Trends
        • Patient Share Dynamics of Key Branded Agents in (Neo)Adjuvant HR-Positive / HER2-Negative Breast Cancer in the United States: 2019-2029
        • Patient Share Dynamics of Key Agents in (Neo)Adjuvant HR-Positive / HER2-Positive Breast Cancer in the United States: 2019-2029
        • Patient Share Dynamics of Key Agents in (Neo)Adjuvant Triple-Negative Breast Cancer in the United States: 2019-2029
        • Patient-Share Dynamics of Key Agents for First-Line HR-Positive / HER2-Negative Breast Cancer in the United States: 2019-2029
        • Patient-Share Dynamics of Key Agents in First-Line HER2-Positive Breast Cancer in the United States: 2019-2029
        • Patient-Share Dynamics of Key Agents for First-Line Triple-Negative Breast Cancer in the United States: 2019-2029
        • Patient-Share Dynamics of Key Agents for First-Line Triple-Negative Breast Cancer in Germany: 2019-2029
        • Patient-Share Dynamics of Key Agents in Second-Line HR-Positive / HER2-Negative Breast Cancer in the United States: 2019-2029
        • Patient-Share Dynamics of Key Agents in Third-Line HR-Positive / HER2-Negative Breast Cancer in the United States: 2019-2029
        • Patient-Share Dynamics of Key Agents in Second-Line HER2-Positive Breast Cancer in the United States: 2019-2029
        • Patient-Share Dynamics of Key Agents in Third-Line HER2-Positive Breast Cancer in the United States: 2019-2029
        • Patient-Share Dynamics of Key Agents in Third-Line Triple-Negative Breast Cancer in the United States: 2019-2029
    • Forecast
      • Market Forecast Downloads
      • Market Forecast Assumptions
      • Market Forecast Dashboard
    • Etiology and Pathophysiology
      • Disease Overview
        • Disease Pathophysiology
          • Prognostic Biomarkers
          • Patterns of Metastasis
          • Patterns of Metastatic Spread in Breast Cancer
        • Staging and Classification
          • Staging of Breast Cancer
          • Definitions of TNM Staging Classifications of Breast Cancer
          • TNM Staging System for Classification of Breast Cancer
        • Prognostic Gene Expression Signatures
          • Oncotype DX
          • MammaPrint
          • Breast Cancer Index
        • Key Pathways and Drug Targets
          • Key Pathways and Drug Targets for Breast Cancer
          • Schematic Diagram of the PI3K/AKT/mTOR Pathway
          • PARP Inhibition: Mechanism of Action
          • Mechanism by Which Bone Metastasis Occurs in Breast Cancer
          • Immune Checkpoint Activation and Pathways
      • Epidemiology
        • Key Findings
          • Epidemiology Populations
            • Disease Definition
            • Methods
            • Sources Used for Diagnosed Incidence of Breast Cancer
            • Diagnosed Incident Cases of Breast Cancer in the Major Pharmaceutical Markets: 2019-2029
            • Disease Definition
            • Methods
            • Sources Used for Molecular Subtype of Breast Cancer
            • Diagnosed Incident Cases of Breast Cancer by Molecular Subtype: 2019-2029
            • Disease Definition
            • Methods
            • Sources Used for Stage Distribution of Breast Cancer
            • Diagnosed Incident Cases of Breast Cancer (All Subtypes) by Stage at Diagnosis: 2019-2029
            • Diagnosed Incident Cases of HR-Positive / HER2-Negative Breast Cancer by Stage at Diagnosis: 2019-2029
            • Diagnosed Incident Cases of HR-Positive / HER2-Positive Breast Cancer by Stage at Diagnosis: 2019-2029
            • Diagnosed Incident Cases of HR-Negative / HER2-Positive Breast Cancer by Stage at Diagnosis: 2019-2029
            • Diagnosed Incident Cases of HR-Negative / HER2-Negative Breast Cancer by Stage at Diagnosis: 2019-2029
            • Disease Definition
            • Methods
            • Sources Used for Menopausal Status of Breast Cancer
            • Diagnosed Incident Cases of Hormonal (HR-Positive) Breast Cancer by Menopausal Status: 2019-2029
            • Breast Cancer Patient Flow
            • Drug-Treatable Cases of HER2-Positive (HR-Positive and -Negative) Breast Cancer in the Major Pharmaceutical Markets: 2019-2029
            • Drug-Treatable Cases of HR-Positive / HER2-Negative Breast Cancer in the Major Pharmaceutical Markets: 2019-2029
            • Drug-Treatable Cases of HR-Negative / HER2-Negative (Triple-Negative) Breast Cancer in the Major Pharmaceutical Markets: 2019-2029
            • Sources Used for Drug-Treated Breast Cancer Populations
            • Drug-Treated Cases of Breast Cancer in the Major Pharmaceutical Markets: 2019-2029
            • Drug-Treated Cases of HER2-Positive (HR-Positive and -Negative) Breast Cancer in the Major Pharmaceutical Markets: 2019-2029
            • Drug-Treated Cases of HR-Positive / HER2-Negative Breast Cancer in the Major Pharmaceutical Markets: 2019-2029
            • Drug-Treated Cases of HR-Negative / HER2-Negative (Triple-Negative) Breast Cancer in the Major Pharmaceutical Markets: 2019-2029
        • Current Treatment
          • Key Findings
            • Treatment Goals
              • Key Endpoints Used in Clinical Trials for Breast Cancer
            • Key Current Therapies
              • Overview
              • Mechanism of Action of Key Current Drug Classes Used for Breast Cancer
              • Current Treatments Used for Breast Cancer
              • Market Events Impacting the Use of Key Current Therapies for Breast Cancer
              • Key Results from Select Clinical Trials Investigating Trastuzumab for the Treatment of Breast Cancer
              • Ongoing Clinical Development of Trastuzumab
              • Expert Insight: Trastuzumab
              • Key Results from Select Clinical Trials Investigating Perjeta for the Treatment of Breast Cancer
              • Ongoing Clinical Development of Perjeta
              • Key Ongoing Clinical Trials of Perjeta in the Treatment of Breast Cancer
              • Expert Insight: Perjeta
              • Key Results from Select Clinical Trials Investigating Kadcyla for the Treatment of Breast Cancer
              • Ongoing Clinical Development of Kadcyla
              • Key Ongoing Clinical Trials of Kadcyla in the Treatment of Breast Cancer
              • Expert Insight: Kadcyla
              • Key Results from Select Clinical Trials Investigating Tykerb / Tyverb for the Treatment of Breast Cancer
              • Expert Insight: Tykerb / Tyverb
              • Key Results from Select Clinical Trials Investigating Nerlynx for the Treatment of Breast Cancer
              • Ongoing Clinical Development of Nerlynx
              • Key Ongoing Clinical Trials of Nerlynx in the Treatment of Breast Cancer
              • Expert Insight: Nerlynx
              • Key Results from Select Clinical Trials Investigating Enhertu for the Treatment of Breast Cancer
              • Ongoing Clinical Development of Enhertu
              • Key Ongoing Clinical Trials of Enhertu in the Treatment of Breast Cancer
              • Expert Insight: Enhertu
              • Tukysa
              • Key Results from Select Clinical Trials Investigating Tukysa for the Treatment of Breast Cancer
              • Ongoing Clinical Development of Tukysa
              • Key Ongoing Clinical Trials of Tukysa in the Treatment of Breast Cancer
              • Expert Insight: Tukysa
              • Key Results from Select Clinical Trials Investigating Margenza for the Treatment of Breast Cancer
              • Ongoing Clinical Development of Margenza
              • Key Ongoing Clinical Trials of Margenza in the Treatment of Breast Cancer
              • Expert Insight: Margenza
              • Key Results from Select Clinical Trials Investigating Ibrance for the Treatment of Breast Cancer
              • Ongoing Clinical Development of Ibrance
              • Key Ongoing Clinical Trials of Ibrance in the Treatment of Breast Cancer
              • Expert Insight: Ibrance
              • Key Results from Select Clinical Trials Investigating Kisqali for the Treatment of Breast Cancer
              • Ongoing Clinical Development of Kisqali
              • Key Ongoing Clinical Trials of Kisqali in the Treatment of Breast Cancer
              • Expert Insight: Kisqali
              • Key Results from Select Clinical Trials Investigating Verzenio / Verzenios for the Treatment of Breast Cancer
              • Ongoing Clinical Development of Verzenio / Verzenios
              • Key Ongoing Clinical Trials of Verzenio / Verzenios in the Treatment of Breast Cancer
              • Expert Insight: Verzenio / Verzenios
              • Key Results from Select Clinical Trials Investigating Everolimus for the Treatment of Breast Cancer
              • Ongoing Clinical Development of Everolimus
              • Key Ongoing Clinical Trials of Everolimus in the Treatment of Breast Cancer
              • Expert Insight: Everolimus
              • Key Results from Select Clinical Trials Investigating Bevacizumab for the Treatment of Breast Cancer
              • Expert Insight: Bevacizumab
              • Key Results from Select Clinical Trials Investigating Abraxane for the Treatment of Breast Cancer
              • Expert Insight: Abraxane
              • Key Results from Select Clinical Trials Investigating Halaven for the Treatment of Breast Cancer
              • Expert Insight: Halaven
              • Key Results from Select Clinical Trials Investigating Fulvestrant for the Treatment of Breast Cancer
              • Expert Insight: Fulvestrant
              • Key Results from Select Clinical Trials Investigating Lynparza for the Treatment of Breast Cancer
              • Ongoing Clinical Development of Lynparza
              • Key Ongoing Clinical Trials of Lynparza in the Treatment of Breast Cancer
              • Expert Insight: Lynparza
              • Key Results from Select Clinical Trials Investigating Talzenna for the Treatment of Breast Cancer
              • Ongoing Clinical Development for Talzenna
              • Key Ongoing Clinical Trials of Talzenna in Breast Cancer
              • Expert Insight: Talzenna
              • Key Results from Select Clinical Trials Investigating Tecentriq for the Treatment of Breast Cancer
              • Ongoing Clinical Development for Tecentriq
              • Key Ongoing Clinical Trials of Tecentriq in the Treatment of Breast Cancer
              • Expert Insight: Tecentriq
              • Key Results from Select Clinical Trials Investigating Keytruda for the Treatment of Breast Cancer
              • Ongoing Clinical Development for Keytruda
              • Key Ongoing Clinical Trials of Keytruda in the Treatment of Breast Cancer
              • Expert Insight: Keytruda
              • Key Results from Select Clinical Trials Investigating Piqray for the Treatment of Breast Cancer
              • Ongoing Clinical Development for Piqray
              • Key Ongoing Clinical Trials of Piqray in the Treatment of Breast Cancer
              • Expert Insight: Piqray
              • Trodelvy
              • Key Results from Select Clinical Trials Investigating Trodelvy for the Treatment of Breast Cancer
              • Ongoing Clinical Development of Trodelvy
              • Key Ongoing Clinical Trials of Trodelvy in the Treatment of Breast Cancer
              • Expert Insight: Trodelvy
            • Medical Practice
              • Neoadjuvant Treatment of Stage II/III Breast Cancer
              • Adjuvant Treatment of Stage I-III Breast Cancer
              • First-Line Treatment of Advanced / Metastatic Breast Cancer
              • Second- and Subsequent-Line Treatment of Advanced / Metastatic Breast Cancer
              • Country-Specific Breast Cancer Treatment Guidelines
              • Patient Characteristics Influencing Drug Selection in Breast Cancer
              • Treatment Decision Tree for Early-Stage Breast Cancer: United States
              • Treatment Decision Tree for Metastatic Breast Cancer: United States
              • Treatment Decision Tree for Early-Stage Breast Cancer: Europe
              • Treatment Decision Tree for Metastatic Breast Cancer: Europe
              • Treatment Decision Tree for Early-Stage Breast Cancer: Japan
              • Treatment Decision Tree for Metastatic Breast Cancer: Japan
          • Unmet Need Overview
            • Current and Future Attainment of Unmet Needs in Breast Cancer
            • Top Unmet Needs in Breast Cancer: Current and Future Attainment
          • Emerging Therapies
            • Key Findings
              • Pipeline Trends in Breast Cancer
            • Key Emerging Therapies
              • Key Therapies in Development for Breast Cancer
              • Estimated Market Authorization Dates of Key Emerging Therapies for the Treatment of Breast Cancer
              • Key Results from Select Clinical Trials Investigating Veliparib for the Treatment of Breast Cancer
              • Key Ongoing Trials of Veliparib in the Treatment of Breast Cancer
              • Analysis of the Clinical Development Program for Veliparib
              • Expert Insight: Veliparib
              • Expectations for Market Authorization and Sales Opportunity of Veliparib in Breast Cancer
              • Key Results from Select Clinical Trials Investigating Ipatasertib for the Treatment of Breast Cancer
              • Key Ongoing Trials of Ipatasertib in the Treatment of Breast Cancer
              • Analysis of the Clinical Development Program for Ipatasertib
              • Expert Insight: Ipatasertib
              • Expectations for Market Authorization and Sales Opportunity of Ipatasertib in Breast Cancer
              • Key Results from Select Clinical Trials Investigating Capivasertib for the Treatment of Breast Cancer
              • Key Ongoing Trials of Capivasertib in the Treatment of Breast Cancer
              • Analysis of the Clinical Development Program for Capivasertib
              • Expert Insight: Capivasertib
              • Expectations for Market Authorization and Sales Opportunity of Capivasertib in Breast Cancer
              • GDC-0077
              • Key Results from Select Clinical Trials Investigating GDC-0077 for the Treatment of Breast Cancer
              • Key Ongoing Clinical Trials of GDC-0077 in the Treatment of Breast Cancer
              • Analysis of the Clinical Development Program for GDC-0077
              • Expert Insight: GDC-0077
              • Expectations for Market Authorization and Sales Opportunity of GDC-0077 in Breast Cancer
              • Key Results from Select Clinical Trials Investigating Bavencio for the Treatment of Breast Cancer
              • Key Ongoing Clinical Trials of Bavencio in the Treatment of Breast Cancer
              • Analysis of the Clinical Development Program for Bavencio
              • Expert Insight: Bavencio
              • Expectations for Market Authorization and Sales Opportunity of Bavencio in Breast Cancer
              • Key Results from Select Clinical Trials Investigating Opdivo for the Treatment of Breast Cancer
              • Key Ongoing Trials of Opdivo in the Treatment of Breast Cancer
              • Analysis of the Clinical Development Program for Opdivo
              • Expert Insight: Opdivo
              • Expectations for Market Authorization and Sales Opportunity of Opdivo in Breast Cancer
              • Key Results from Select Clinical Trials Investigating Trastuzumab Duocarmazine for the Treatment of Breast Cancer
              • Key Ongoing Trials of Trastuzumab Duocarmazine in the Treatment of Breast Cancer
              • Analysis of the Clinical Development Program for Trastuzumab Duocarmazine
              • Expert Insight: Trastuzumab Duocarmazine
              • Expectations for Market Authorization and Sales Opportunity of Trastuzumab Duocarmazine in Breast Cancer
              • Key Results from Select Clinical Trials Investigating Tesetaxel for the Treatment of Breast Cancer
              • Key Ongoing Clinical Trials of Tesetaxel in the Treatment of Breast Cancer
              • Analysis of the Clinical Development Program for Tesetaxel
              • Expert Insight: Tesetaxel
              • Expectations for Market Authorization and Sales Opportunity of Tesetaxel in Breast Cancer
              • Key Results from Select Clinical Trials Investigating Oraxol for the Treatment of Breast Cancer
              • Analysis of the Clinical Development Program for Oraxol
              • Expert Insight: Oraxol
              • Expectations for Market Authorization and Sales Opportunity of Oraxol in Breast Cancer
              • Key Results from Select Clinical Trials Investigating Adagloxad Simolenin / OBI-821 for the Treatment of Breast Cancer
              • Key Ongoing Trials of Adagloxad Simolenin / OBI-821 in the Treatment of Breast Cancer
              • Analysis of the Clinical Development Program for Adagloxad Simolenin / OBI-821
              • Expert Insight: Adagloxad Simolenin / OBI-821
              • Expectations for Market Authorization and Sales Opportunity of Adagloxad Simolenin / OBI-821 in Breast Cancer
              • Key Results from Select Clinical Trials Investigating Balixafortide for the Treatment of Breast Cancer
              • Key Ongoing Trials of Balixafortide in the Treatment of Breast Cancer
              • Analysis of the Clinical Development Program for Balixafortide
              • Expert Insight: Balixafortide
              • Expectations for Market Authorization and Sales Opportunity of Balixafortide in Breast Cancer
              • Key Results from Select Clinical Trials Investigating Elacestrant for the Treatment of Breast Cancer
              • Key Ongoing Trials of Elacestrant in the Treatment of Breast Cancer
              • Analysis of the Clinical Development Program for Elacestrant
              • Expert Insight: Elacestrant
              • Expectations for Market Authorization and Sales Opportunity of Elacestrant in Breast Cancer
              • Key Results from Select Clinical Trials Investigating Giredestrant for the Treatment of Breast Cancer
              • Key Ongoing Clinical Trials of Giredestrant in the Treatment of Breast Cancer
              • Analysis of the Clinical Development Program for Giredestrant
              • Expectations for Market Authorization and Sales Opportunity of Giredestrant in Breast Cancer
              • Key Results from Select Clinical Trials Investigating Amcenestrant for the Treatment of Breast Cancer
              • Key Ongoing Clinical Trials of Amcenestrant in the Treatment of Breast Cancer
              • Analysis of the Clinical Development Program for Amcenestrant
              • Expectations for Market Authorization and Sales Opportunity of Amcenestrant in Breast Cancer
              • Key Results from Select Clinical Trials Investigating AZD9833 for the Treatment of Breast Cancer
              • Key Ongoing Clinical Trials of AZD9833 in the Treatment of Breast Cancer
              • Analysis of the Clinical Development Program for AZD9833
              • Expectations for Market Authorization and Sales Opportunity of AZD9833 in Breast Cancer
              • Key Ongoing Trials of Lasofoxifene in the Treatment of Breast Cancer
              • Analysis of the Clinical Development Program for Lasofoxifene
              • Expert Insight: Lasofoxifene
              • Expectations for Market Authorization and Sales Opportunity of Lasofoxifene in Breast Cancer
            • Early-Phase Pipeline Analysis
              • Select Compounds in Early-Phase Development for Breast Cancer
          • Access and Reimbursement Overview
            • Region-Specific Reimbursement Practices
              • General Reimbursement Environment: United States
              • General Reimbursement Environment: EU5
              • General Reimbursement Environment: Japan
          • Appendix
            • Key Abbreviations Related to Breast Cancer
            • Brands, Marketers, and Generic Availability of Key Therapies for Breast Cancer by Market
            • Breast Cancer Bibliography

        Author(s): Carolina do Pazo, M.Sc.; Alexandre Vo Dupuy, Pharm.D., M.Sc.

        Carolina do Pazo, M.Sc., is an analyst on the Oncology team at DRG, part of Clarivate. She has authored content on ovarian and prostate cancer. Previously, she was a research scientist at the Institut Pasteur de Montevideo, where she analyzed the aging process of yeast cells, and she was part of a project between Indiana University and the Universidad ORT that analyzed the production of nanohybrids for drug delivery system applications. As a Chevening Scholar, Ms. Do Pazo completed an M.Sc. in biotechnology, bioprocessing, and business management with distinction at the University of Warwick. She also earned her first-class M.Eng. in biotechnology from the Universidad ORT.

        Alexandre Vo Dupuy, M.Sc., Pharm.D., is a senior epidemiologist at DRG, part of Clarivate. Prior to joining DRG, he worked in the fields of consulting and real-world evidence and at a major pharmaceutical company. He obtained his doctor of pharmacy from Descartes University in Paris and his master’s degree in pharmacoepidemiology from the University of Bordeaux.


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