The breast cancer therapy 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 are in development and will enter the market, and sales of current HER2-targeting agents will be impacted as a result of the 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 therapy 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.
SOLUTION ENHANCEMENT
Disease Landscape & Forecast will feature continuous updates in 2021 to provide timely insights and analyses as meaningful indication-specific news and events unfold.
Table of contents
- Breast Cancer - Landscape & Forecast - Disease Landscape & Forecast
- Key Updates
- Q3 2021
- July 2021
- Q2 2021
- June 2021
- May 2021
- April 2021
- Q1 2021
- March 2021
- February 2021
- January 2021
- Q4 2020
- December 2020
- Q3 2020
- August 2020
- Q3 2021
- Key Findings
- Breast Cancer – Key Findings – July 2021
- August 2020
- Breast Cancer – Key Findings – July 2021
- 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 Second-Line Triple-Negative 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
- Key Findings
- 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
- Disease Overview
- 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
- Key Findings
- 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
- Key Findings
- 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 Trilaciclib for the Treatment of Breast Cancer
- Key Ongoing Clinical Trials of Trilaciclib in the Treatment of Breast Cancer
- Analysis of the Clinical Development Program for Trilaciclib
- Expectations for Market Authorization and Sales Opportunity of Trilaciclib 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 Camizestrant for the Treatment of Breast Cancer
- Key Ongoing Clinical Trials of Camizestrant in the Treatment of Breast Cancer
- Analysis of the Clinical Development Program for Camizestrant
- Expectations for Market Authorization and Sales Opportunity of Camizestrant 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
- Key Results from Select Clinical Trials Investigating Enobosarm for the Treatment of Breast Cancer
- Key Ongoing Clinical Trials of Enobosarm in the Treatment of Breast Cancer
- Analysis of the Clinical Development Program for Enobosarm
- Expectations for Market Authorization and Sales Opportunity of Enobosarm in Breast Cancer
- Early-Phase Pipeline Analysis
- Select Compounds in Early-Phase Development for Breast Cancer
- Key Findings
- Access and Reimbursement Overview
- Region-Specific Reimbursement Practices
- General Reimbursement Environment: United States
- General Reimbursement Environment: EU5
- General Reimbursement Environment: Japan
- Region-Specific Reimbursement Practices
- Appendix
- Key Abbreviations Related to Breast Cancer
- Brands, Marketers, and Generic Availability of Key Therapies for Breast Cancer by Market
- Breast Cancer Bibliography
- Key Updates
Author(s): Carolina do Pazo, M.Sc.; Alexandre Vo Dupuy, Pharm.D., M.Sc.
Carolina do Pazo, M.Sc., is a senior analyst on the Oncology team at Clarivate. She has authored content on breast cancer, SCCHN, ovarian cancer, 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 principal epidemiologist at Clarivate. Previously, 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.