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
- Q1 2023
- February 2023
- Q4 2022
- December 2022
- October 2022
- Q2 2022
- June 2022
- May 2022
- April 2022
- Q1 2022
- March 2022
- February 2022
- Q1 2023
- 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 tends
- 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
- Key findings
- 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
- Disease overview
- Epidemiology
- Key findings
- Epidemiology populations
- Disease definition
- Methods and Sources Used
- Diagnosed incident cases of breast cancer in the major pharmaceutical markets: 2021-2031
- Disease definition
- Methods and Sources Used
- Diagnosed incident cases of breast cancer by molecular subtype: 2021-2031
- Disease definition
- Methods and Sources Used
- Diagnosed incident cases of breast cancer (all subtypes) by stage at diagnosis: 2021-2031
- Diagnosed incident cases of HR-positive / HER2-negative breast cancer by stage at diagnosis: 2021-2031
- Diagnosed Incident Cases of HR-Positive / HER2-Positive Breast Cancer by Stage at Diagnosis: 2021-2031
- Diagnosed incident cases of HR-negative / HER2-positive breast cancer by stage at diagnosis: 2021-2031
- Diagnosed incident cases of HR-negative / HER2-negative breast cancer by stage at diagnosis: 2021-2031
- Disease definition
- Methods and Sources Used
- Diagnosed incident cases of hormonal (HR-positive) breast cancer by menopausal status: 2021-2031
- 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
- 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
- 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
- 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
- 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
- Key results from select clinical trials investigating Zejula for the treatment of breast cancer
- Analysis of the clinical development program for Zejula
- Key ongoing clinical trials of Zejula in the treatment of breast cancer
- 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
- 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
- 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
- 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
- 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
- Abbreviations
- Breast cancer bibliography
- Key findings
Kiran Bountra, M.Res., Ph.D., Senior Healthcare Research & Data Analyst, Oncology. Dr. Bountra has a background in the biotechnology sector, specializing in target validation and small-molecule drug discovery. Before joining Clarivate, he worked as a senior scientist at OMass Therapeutics, with a focus on basal cell carcinoma and epilepsy programs. Previously, he trained as a structural biologist, researching the mechanisms of transport proteins involved in drug resistance. He holds a Ph.D. in biochemistry from Imperial College London.
Harinder Kumar, B.D.S., M.P.H., is an associate epidemiologist at Clarivate. His areas of interest are cancer and psychiatric epidemiology. Previously, Dr. Kumar worked with the government of Punjab, National Health Mission, India. He received his M.P.H. from the Tata Institute of Social Sciences in Mumbai. He holds a B.D.S. in dentistry from the National Dental College and Hospital in Punjab.