Breast Cancer – Landscape & Forecast – Disease Landscape & Forecast

The high incidence, long treatment duration, and multiple lines of therapy in the treatment of breast cancer represent strong commercial opportunity for drug development. The CDK4/6 inhibitors (Pfizer’s Ibrance, Novartis’s Kisqali, and Eli Lilly’s Verzenio/Verzenios) are contributing greatly to treatment options for HR-positive/HER2-negative disease, a trend that will continue through 2031. The current treatments and clinical pipeline for HER2-positive breast cancer are dynamic as options expand with the launch of novel HER2-targeting agents (Daiichi Sankyo / AstraZeneca’s Enhertu, Seagen / Pfizer’s Tukysa, and MacroGenics’ Margenza), sales of which will offset the launch of generics and biosimilars. The approval of PARP inhibitors (AstraZeneca / Merck & Co.’s Lynparza, Pfizer’s Talzenna), immune checkpoint inhibitors (Roche / Genentech / Chugai’s Tecentriq, Merck & Co.’s Keytruda), and TROP2-targeted agents (Gilead’s Trodelvy) will further diversify treatment of triple-negative breast cancer.

QUESTIONS ANSWERED

  • What is the size of clinically and commercially relevant drug-treatable breast cancer populations, and how will drug-treatment rates change over time?
  • What is the expected market impact of recent drug approvals, such as Trodelvy, Keytruda, Piqray, Enhertu, and Tukysa, on the various subpopulations in 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 key drivers and constraints will affect the breast cancer therapy market over the forecast period?

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 features continuous updates to provide timely insights and analyses as meaningful indication-specific news and events unfold.

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 Clarivate 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 2030, segmented by brands / biosimilars / generics and market-relevant drug-treatable populations.
  • Emerging therapies: Phase III/PR: 18 drugs; coverage of select Phase I and II products.

Table of contents

  • Breast Cancer - Landscape & Forecast - Disease Landscape & Forecast
    • Key findings
      • Key Findings on Breast Cancer
    • Key updates
      • Q3 2023
        • July 2023
      • Q2 2023
        • May 2023
      • Q1 2023
        • February 2023
      • Q4 2022
        • December 2022
        • October 2022
    • Market outlook
      • Key findings
        • Market share of breast cancer drug classes: 2021
        • Market share of breast cancer drug classes: 2031
        • Drug-treatable population share and major-market sales share in breast cancer: 2021
        • Drug-treatable population share and major-market sales share in breast cancer: 2031
        • Population positioning of current therapies in breast cancer
        • Population positioning of emerging 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 regimens in (neo)adjuvant HR-Positive / HER2-negative breast cancer in the United States: 2021-2031
        • Patient-share dynamics of key regimens in (neo)adjuvant HR-Positive / HER2-positive breast cancer in the United States: 2021-2031
        • Patient-share dynamics of key regimens in (neo)adjuvant triple-negative breast cancer in the United States: 2021-2031
        • Patient-share dynamics of key regimens for first-line HR-positive / HER2-negative breast cancer in the United States: 2021-2031
        • Patient-share dynamics of key regimens in first-line HER2-positive breast cancer in the United States: 2021-2031
        • Patient-share dynamics of key regimens for first-line triple-negative breast cancer in the United States: 2021-2031
        • Patient-share dynamics of key regimens in second-line HR-positive / HER2-negative breast cancer in the United States: 2021-2031
        • Patient-share dynamics of key regimens in third-line HR-positive / HER2-negative breast cancer in the United States: 2021-2031
        • Patient-share dynamics of key regimens in second-line HER2-positive breast cancer in the United States: 2021-2031
        • Patient-share dynamics of key regimens in third-line HER2-positive breast cancer in the United States: 2021-2031
        • Patient-share dynamics of key regimens in second-line triple-negative breast cancer in the United States: 2021-2031
        • Patient-share dynamics of key regimens in third-line triple-negative breast cancer in the United States: 2021-2031
    • Forecast
      • Market forecast downloads
      • Market forecast assumptions
      • Market forecast dashboard
    • Etiology and pathophysiology
      • Disease overview
        • Etiology
          • 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
            • AJCC anatomic stage groups for breast cancer
            • AJCC clinical prognostic stage for breast cancer
            • AJCC pathologic prognostic stage for 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
            • Immune checkpoint activation and pathways
        • Epidemiology
          • Key findings
            • Epidemiology populations
              • Disease definition, methods, and sources used
              • Diagnosed incident cases of breast cancer in the major pharmaceutical markets: 2022-2032
              • Disease definition, methods, and sources used
              • Diagnosed incident cases of breast cancer by molecular subtype: 2022-2032
              • Disease definition, methods, and sources used
              • Diagnosed incident cases of breast cancer (all subtypes) by stage at diagnosis: 2022-2032
              • Diagnosed incident cases of HR-positive / HER2-negative breast cancer by stage at diagnosis: 2022-2032
              • Diagnosed incident cases of HR-Positive / HER2-Positive Breast Cancer by Stage at Diagnosis: 2022-2032
              • Diagnosed incident cases of HR-negative / HER2-positive breast cancer by stage at diagnosis: 2022-2032
              • Diagnosed incident cases of HR-negative / HER2-negative breast cancer by stage at diagnosis: 2022-2032
              • Disease definition, methods, and sources used
              • Diagnosed incident cases of hormonal (HR-positive) breast cancer by menopausal status: 2022-2032
              • Breast cancer patient flow
              • Drug-treatable cases of HER2-positive (HR-positive and -negative) breast cancer in the major pharmaceutical markets: 2021-2031
              • Drug-treatable cases of HR-positive / HER2-negative breast cancer in the major pharmaceutical markets: 2021-2031
              • Drug-treatable cases of HR-negative / HER2-negative (triple-negative) breast cancer in the major pharmaceutical markets: 2021-2031
              • Sources used for drug-treated breast cancer populations
              • Drug-treated cases of breast cancer in the major pharmaceutical markets: 2021-2031
              • Drug-treated cases of HER2-positive (HR-positive and -negative) breast cancer in the major pharmaceutical markets: 2021-2031
              • Drug-treated cases of HR-positive / HER2-negative breast cancer in the major pharmaceutical markets: 2021-2031
              • Drug-treated cases of HR-negative / HER2-negative (triple-negative) breast cancer in the major pharmaceutical markets: 2021-2031
          • 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
                • Trastuzumab
                • Key results from select clinical trials investigating trastuzumab for the treatment of breast cancer
                • Expert insight: trastuzumab
                • Key results from select clinical trials investigating Perjeta for 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
                • 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
                • 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
                • 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 Orserdu for the treatment of breast cancer
                • Ongoing clinical development of Orserdu
                • Key ongoing clinical trials of Lynparza in the treatment of breast cancer
                • Expert insight: Orserdu
                • 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
                • 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
                • 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
                • 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
              • Expert insight: unmet need in breast cancer
            • Drug pipeline
              • Pipeline
              • Regulatory milestones
              • Indication Comparison
            • Emerging therapies
              • Key findings
                • Key emerging therapies
                  • Key therapies in development for breast cancer
                  • Estimated market authorization dates of key emerging therapies for breast cancer
                  • Key results from select clinical trials investigating veliparib for 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
                  • Capivasertib
                  • Key results from select clinical trials investigating capivasertib for the treatment of breast cancer
                  • Analysis of the clinical development program for capivasertib
                  • Key ongoing trials of capivasertib in the treatment of breast cancer
                  • Expert insight: capivasertib
                  • Expectations for market authorization and sales opportunity of capivasertib in breast cancer
                  • Key results from select clinical trials investigating inavolisib for the treatment of breast cancer
                  • Analysis of the clinical development program for inavolisib
                  • Key ongoing clinical trials of inavolisib in the treatment of breast cancer
                  • Expert insight: inavolisib
                  • Expectations for market authorization and sales opportunity of inavolisib in breast cancer
                  • Gedatolisib
                  • Key results from select clinical trials investigating gedatolisib for the treatment of breast cancer
                  • Analysis of the clinical development program for gedatolisib
                  • Key ongoing trials of gedatolisib in the treatment of breast cancer
                  • Expectations for market authorization and sales opportunity of gedatolisib in breast cancer
                  • Key results from select clinical trials investigating Bavencio for the treatment of breast cancer
                  • Analysis of the clinical development program for Bavencio
                  • Key ongoing clinical trials of Bavencio in the treatment of breast cancer
                  • 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
                  • Analysis of the clinical development program for Opdivo
                  • Key ongoing trials of Opdivo in the treatment of breast cancer
                  • 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
                  • 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 Cosela for the treatment of breast cancer
                  • Analysis of the clinical development program for Cosela
                  • Key ongoing clinical trials of Cosela in the treatment of breast cancer
                  • Expert insight: Cosela
                  • Expectations for market authorization and sales opportunity of Cosela 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 for the treatment of breast cancer
                  • Analysis of the clinical development program for adagloxad simolenin
                  • Key ongoing trials of adagloxad simolenin in the treatment of breast cancer
                  • Expert insight: adagloxad simolenin
                  • Expectations for market authorization and sales opportunity of adagloxad simolenin in breast cancer
                  • Key results from select clinical trials investigating GLSI-100 for the treatment of breast cancer
                  • Analysis of the clinical development program for GLSI-100
                  • Key ongoing clinical trials of GLSI-100 in the treatment of breast cancer
                  • Expert insight: GLSI-100
                  • Expectations for market authorization and sales opportunity of GLSI-100 in breast cancer
                  • Key results from select clinical trials investigating giredestrant for the treatment of breast cancer
                  • Analysis of the clinical development program for giredestrant
                  • Key ongoing clinical trials of giredestrant in the treatment of breast cancer
                  • Expert insight: giredestrant
                  • Expectations for market authorization and sales opportunity of giredestrant in breast cancer
                  • Key results from select clinical trials investigating camizestrant for the treatment of breast cancer
                  • Analysis of the clinical development program for camizestrant
                  • Key ongoing clinical trials of camizestrant in the treatment of breast cancer
                  • Expert insight: camizestrant
                  • Expectations for market authorization and sales opportunity of camizestrant in breast cancer
                  • Key results from select clinical trials investigating imlunestrant (LY3484356) for the treatment of breast cancer
                  • Analysis of the clinical development program for imlunestrant (LY3484356)
                  • Key ongoing clinical trials of imlunestrant (LY3484356) in the treatment of breast cancer
                  • Expert insight: Imlunestrant (LY3484356)
                  • Expectations for market authorization and sales opportunity of imlunestrant (LY3484356) in breast cancer
                  • Key results from select clinical trials investigating lasofoxifene for the treatment of breast cancer
                  • Key ongoing clinical trials of lasofoxifene in the treatment of breast cancer
                  • 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
                  • Analysis of the clinical development program for enobosarm
                  • Key ongoing clinical trials of enobosarm in the treatment of breast cancer
                  • Expert insight: enobosarm
                  • Expectations for market authorization and sales opportunity of enobosarm in breast cancer
                  • Key results from select clinical trials investigating datopotamab deruxtecan for the treatment of breast cancer
                  • Analysis of the clinical development program for datopotamab deruxtecan
                  • Key ongoing clinical trials of datopotamab deruxtecan in the treatment of breast cancer
                  • Expert insights: datopotamab deruxtecan
                  • Expectations for market authorization and sales opportunity of datopotamab deruxtecan in breast cancer
                  • Key results from select clinical trials investigating ARV-471 for the treatment of breast cancer
                  • Analysis of the clinical development program for ARV-471
                  • Key ongoing clinical trials of ARV-471 in the treatment of breast cancer
                  • Expectations for market authorization and sales opportunity of ARV-471 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
                • Abbreviations
                • Breast cancer bibliography

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