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.
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
Kiran Bountra
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
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.