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 updates
      • Q2 2022
        • May 2022
        • April 2022
      • Q1 2022
        • March 2022
        • February 2022
        • January 2022
      • Q4 2021
        • November 2021
      • Q3 2021
        • August 2021
        • July 2021
      • Q2 2021
        • June 2021
        • May 2021
        • April 2021
    • Key findings
      • Key findings on breast cancer
        • June 2021
        • May 2021
        • April 2021
    • Market outlook
      • Key findings
        • Market share of breast cancer drug classes: 2020
        • Market share of breast cancer drug classes: 2030
        • Drug-treatable population share and major-market sales share in breast cancer: 2020
        • Drug-treatable population share and major-market sales share in breast cancer: 2030
        • 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 tends
        • Patient-share dynamics of key branded agents in (neo)adjuvant HR-Positive / HER2-negative breast cancer in the United States: 2020-2030
        • Patient-share dynamics of key agents in (neo)adjuvant HR-Positive / HER2-positive breast cancer in the United States: 2020-2030
        • Patient-share dynamics of key agents in (neo)adjuvant triple-negative breast cancer in the United States: 2020-2030
        • Patient-share dynamics of key agents for first-line HR-Positive / HER2-negative breast cancer in the United States: 2020-2030
        • Patient-share dynamics of key agents in first-line HER2-positive breast cancer in the United States: 2020-2030
        • Patient-share dynamics of key agents for first-line triple-negative breast cancer in the United States: 2020-2030
        • Patient-share dynamics of key agents for first-line triple-negative breast cancer in Germany: 2020-2030
        • Patient-share dynamics of key agents in second-line HR-Positive / HER2-negative breast cancer in the United States: 2020-2030
        • Patient-share dynamics of key agents in third-line HR-Positive / HER2-negative breast cancer in the United States: 2020-2030
        • Patient-share dynamics of key agents in second-line HER2-positive breast cancer in the United States: 2020-2030
        • Patient-share dynamics of key agents in third-line HER2-positive breast cancer in the United States: 2020-2030
        • Patient-share dynamics of key agents in second-line triple-negative breast cancer in the United States: 2020-2030
        • Patient-share dynamics of key agents in third-line triple-negative breast cancer in the United States: 2020-2030
    • 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
          • 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
            • Sources used for diagnosed incidence of breast cancer
            • Diagnosed incident cases of breast cancer in the major pharmaceutical markets: 2020-2030
            • Disease definition
            • Methods
            • Sources used for molecular subtype of breast cancer
            • Diagnosed incident cases of breast cancer by molecular subtype: 2020-2030
            • Disease definition
            • Methods
            • Sources used for stage distribution of breast cancer
            • Diagnosed incident cases of breast cancer (all subtypes) by stage at diagnosis: 2020-2030
            • Diagnosed incident cases of HR-positive / HER2-negative breast cancer by stage at diagnosis: 2020-2030
            • Diagnosed Incident Cases of HR-Positive / HER2-Positive Breast Cancer by Stage at Diagnosis: 2020-2030
            • Diagnosed incident cases of HR-negative / HER2-positive breast cancer by stage at diagnosis: 2020-2030
            • Diagnosed incident cases of HR-negative / HER2-negative breast cancer by stage at diagnosis: 2020-2030
            • Disease definition
            • Methods
            • Sources used for menopausal status of breast cancer
            • Diagnosed incident cases of hormonal (HR-positive) breast cancer by menopausal status: 2020-2030
            • Breast cancer patient flow
            • Drug-treatable cases of HER2-positive (HR-positive and -negative) breast cancer in the major pharmaceutical markets: 2020-2030
            • Drug-treatable cases of HR-positive / HER2-negative breast cancer in the major pharmaceutical markets: 2020-2030
            • Drug-treatable cases of HR-negative / HER2-negative (triple-negative) breast cancer in the major pharmaceutical markets: 2020-2030
            • Sources used for drug-treated breast cancer populations
            • Drug-treated cases of breast cancer in the major pharmaceutical markets: 2020-2030
            • Drug-treated cases of HER2-positive (HR-positive and -negative) breast cancer in the major pharmaceutical markets: 2020-2030
            • Drug-treated cases of HR-positive / HER2-negative breast cancer in the major pharmaceutical markets: 2020-2030
            • Drug-treated cases of HR-negative / HER2-negative (triple-negative) breast cancer in the major pharmaceutical markets: 2020-2030
        • 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
              • 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
              • 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
              • 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
              • 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
          • Drug pipeline
            • Pipeline
            • Regulatory Milestones
          • 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
                • 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 Zejula for the treatment of breast cancer
                • Key ongoing clinical trials of Zejula in the treatment of breast cancer
                • Analysis of the clinical development program for Zejula
                • Expert insight: Zejula
                • Expectations for market authorization and sales opportunity of Zejula 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
                • Key results from select clinical trials investigating inavolisib for the treatment of breast cancer
                • Key ongoing clinical trials of inavolisib in the treatment of breast cancer
                • Analysis of the clinical development program for inavolisib
                • Expert insight: inavolisib
                • Expectations for market authorization and sales opportunity of inavolisib 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 Cosela for the treatment of breast cancer
                • Key ongoing clinical trials of Cosela in the treatment of breast cancer
                • Analysis of the clinical development program for Cosela
                • 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 / 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 GLSI-100 for the treatment of breast cancer
                • Key ongoing clinical trials of GLSI-100 in the treatment of breast cancer
                • Analysis of the clinical development program for GLSI-100
                • Expectations for market authorization and sales opportunity of GLSI-100 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
                • Expert insight: 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
                • Expert insight: 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
                • Expert insight: camizestrant
                • Expectations for market authorization and sales opportunity of camizestrant in breast cancer
                • Key results from select clinical trials investigating LY3484356 for the treatment of breast cancer
                • Key ongoing clinical trials of LY3484356 in the treatment of breast cancer
                • Analysis of the clinical development program for LY3484356
                • Expert insight: LY3484356
                • Expectations for market authorization and sales opportunity of LY3484356 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
                • 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
                • Key ongoing clinical trials of datopotamab deruxtecan in the treatment of breast cancer
                • Analysis of the clinical development program for datopotamab deruxtecan
                • Expectations for market authorization and sales opportunity of datopotamab deruxtecan 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
              • Breast cancer bibliography