Locally Advanced or Metastatic ER+/HER2- Breast Cancer – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Locally Advanced or Metastatic ER+ or HER2- Breast Cancer Market Outlook and Forecast

Locally Advanced or Metastatic ER+/HER2- Breast Cancer – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Published Date : 2023-12-28

Updated On : 2024-10-23

Pages : 159

Locally Advanced or Metastatic ER+/HER2- Breast Cancer Market Outlook

Thelansis’s “Locally Advanced or Metastatic ER+/HER2- Breast Cancer Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Locally Advanced or Metastatic ER+/HER2- Breast Cancer treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Locally Advanced or Metastatic ER+/HER2- Breast Cancer Overview

Human epidermal growth factor receptor 2 (HER2)–positive breast cancer accounts for approximately 15% to 20% of all breast cancer cases. Around 60–70% of HER2-positive breast cancer cases exhibit co-expression of hormone receptors (HRs). This co-expression influences the response to both anti-HER2–directed and endocrine therapy, primarily due to the "crosstalk" between the estrogen receptor (ER) and HER2 pathways. Historically, the HER2-positive breast cancer subtype was linked to heightened risks of systemic and brain metastases and poor overall survival. However, introducing trastuzumab has significantly improved outcomes for HER2-positive patients, aligning them with those of patients with luminal tumors. Presently, the recommended initial treatment for HER2-positive metastatic breast cancer involves dual HER2 antibody therapy using pertuzumab/trastuzumab alongside a taxane. Following disease progression, trastuzumab emtansine (T-DM1) becomes the standard of care. Lapatinib, which inhibits HER2 and epidermal growth factor receptor type 1 (EGFR1), was the first FDA-approved tyrosine kinase inhibitor (TKI) for HER2-positive metastatic breast cancer treatment.

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2023-2033

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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Locally Advanced or Metastatic ER+/HER2- Breast Cancer Competitive Landscape

S. no Asset Company Stage
1 Lasofoxifene and abemaciclib Sermonix Pharmaceuticals Inc. Phase 3
2 Vepdegestrant (ARV-471) Arvinas, Inc. and Pfizer Phase 1
3 AC699 Accutar Biotechnology Inc Phase 1
4 RYZ101 RayzeBio, Inc. Phase 1/2
5 FWD1802 Forward Pharmaceuticals Co., Ltd. Phase 1
6 EP0062 Ellipses Pharma Phase 1/2
7 Giredestrant and Exemestane Genentech, Inc. Phase 3
8 H3B-6545 Eisai Inc. Phase 1/2
9 SIM0270 Jiangsu Simcere Pharmaceutical Co., Ltd. Phase 3
10 Ribociclib and Goserelin Acetate Novartis Pharmaceuticals Phase 2

Continued...

KOLs across 8 MM market from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs.

COUNTRY No. Of KOLs
USA 17
GERMANY 4
UK 4
SPAIN 3
FRANCE 2
ITALY 3
JAPAN 3
CHINA 4

Locally Advanced or Metastatic ER+/HER2- Breast Cancer Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

Data Inputs with sourcing, Market Event, Product Event, Country specific Forecast Model, Market uptake and patient share uptake, Attribute Analysis, Analog Analysis, Disease burden, and pricing scenario, Summary, and Insights.

Locally Advanced or Metastatic ER+ or HER2- Breast Cancer Market Forecast

1.  Locally Advanced or Metastatic ER+/HER2- Breast Cancer – Key Findings Summary

         1.1.    Clinical findings
                     1.1.1. Disease overview
                     1.1.2. Therapeutic practices
                     1.1.3. Future outlook
         1.2.    Commercial findings
                     1.2.1. Locally Advanced or Metastatic ER+/HER2- Breast Cancer market scenario 2023
                     1.2.2. Locally Advanced or Metastatic ER+/HER2- Breast Cancer market scenario 2028
                     1.2.3. Locally Advanced or Metastatic ER+/HER2- Breast Cancer market scenario 2033

2. Locally Advanced or Metastatic ER+/HER2- Breast Cancer Overview

         2.1.    Disease Introduction
         2.2.    Pathophysiology
         2.3.    Signs and Symptoms
         2.4.    Risk Factors
         2.5.    Etiology
         2.6.    Classification
         2.7.    Pathogenesis
         2.8.    Diagnosis
         2.9.    Complications
         2.10. Treatment Algorithm
                     2.10.1.    Treatment in US (guidelines)
                     2.10.2.    Treatment in EU-5 (guidelines)
                     2.10.3.    Treatment in Japan (guidelines)
                     2.10.4.    Treatment in China (guidelines)
         2.11. Treatment Goals for Locally Advanced or Metastatic ER+/HER2- Breast Cancer
         2.12. Referral Patterns
                     2.12.1.    Referral Scenario in US
                     2.12.2.    Referral Scenario in EU-5
                     2.12.3.    Referral Scenario in Japan
                     2.12.4.    Referral Scenario in China
         2.13. Locally Advanced or Metastatic ER+/HER2- Breast Cancer Prognosis
         2.14. Healthcare burden
                     2.14.1.    Healthcare burden in US
                     2.14.2.    Healthcare burden in EU-5
                     2.14.3.    Healthcare burden in Japan
                     2.14.4.    Healthcare burden in China
         2.15.  Unmet Needs in Locally Advanced or Metastatic ER+/HER2- Breast Cancer management
         2.16.  Market Opportunity for Locally Advanced or Metastatic ER+/HER2- Breast Cancer
         2.17. KOL Comments on current and upcoming/expected treatment practices in Locally Advanced or Metastatic ER+/HER2- Breast Cancer

3.       Epidemiology

         3.1.    Epidemiology Overview
         3.2.    Epidemiology by Geography
                     3.2.1. Locally Advanced or Metastatic ER+/HER2- Breast Cancer Epidemiology in US (2023-2033)
                             3.2.1.1.              Incidence of Locally Advanced or Metastatic ER+/HER2- Breast Cancer
                             3.2.1.2.              Diagnosed cases
                             3.2.1.3.              Treatable Patient Pool
                             3.2.1.4.              Epidemiology Trends
                     3.2.2. Locally Advanced or Metastatic ER+/HER2- Breast Cancer Epidemiology in EU-5 (2023-2033)
                             3.2.2.1.              Incidence of Locally Advanced or Metastatic ER+/HER2- Breast Cancer
                             3.2.2.2.              Diagnosed cases
                             3.2.2.3.              Treatable Patient Pool
                             3.2.2.4.              Epidemiology Trends
                     3.2.3. Locally Advanced or Metastatic ER+/HER2- Breast Cancer Epidemiology in Japan (2023-2033)
                             3.2.3.1.              Incidence of Locally Advanced or Metastatic ER+/HER2- Breast Cancer
                             3.2.3.2.              Diagnosed cases
                             3.2.3.3.              Treatable Patient Pool
                             3.2.3.4.              Epidemiology Trends
                     3.2.4. Locally Advanced or Metastatic ER+/HER2- Breast Cancer Epidemiology in China (2023-2033)
                             3.2.4.1.              Incidence of Locally Advanced or Metastatic ER+/HER2- Breast Cancer
                             3.2.4.2.              Diagnosed cases
                             3.2.4.3.              Treatable Patient Pool
                             3.2.4.4.              Epidemiology Trends
         3.3.    Epidemiology Trends (World-wide)

4.       Market Outlook

         4.1.    US Locally Advanced or Metastatic ER+/HER2- Breast Cancer Market Forecast 2023-2033
                     4.1.1. Market Progression (Futuristic)
                     4.1.2. Market Trends and Expectations
                             4.1.2.1.              Worst case scenario
                             4.1.2.2.              Base Case Scenario
                             4.1.2.3.              Best Case Scenario
                     4.1.3. Drivers and Barriers
         4.2.    UK Locally Advanced or Metastatic ER+/HER2- Breast Cancer Market Forecast 2023-2033
                     4.2.1. Market Progression (Futuristic)
                     4.2.2. Market Trends and Expectations
                             4.2.2.1.              Worst case scenario
                             4.2.2.2.              Base Case Scenario
                             4.2.2.3.              Best Case Scenario
                     4.2.3. Drivers and Barriers
         4.3.    France Locally Advanced or Metastatic ER+/HER2- Breast Cancer Market Forecast 2023-2033
                     4.3.1. Market Progression (Futuristic)
                     4.3.2. Market Trends and Expectations
                             4.3.2.1.              Worst case scenario
                             4.3.2.2.              Base Case Scenario
                             4.3.2.3.              Best Case Scenario
                     4.3.3. Drivers and Barriers
         4.4.    Germany Locally Advanced or Metastatic ER+/HER2- Breast Cancer Market Forecast 2023-2033
                     4.4.1. Market Progression (Futuristic)
                     4.4.2. Market Trends and Expectations
                             4.4.2.1.              Worst case scenario
                             4.4.2.2.              Base Case Scenario
                             4.4.2.3.              Best Case Scenario
                     4.4.3. Drivers and Barriers
         4.5.    Italy Locally Advanced or Metastatic ER+/HER2- Breast Cancer Market Forecast 2023-2033
                     4.5.1. Market Progression (Futuristic)
                     4.5.2. Market Trends and Expectations
                             4.5.2.1.              Worst case scenario
                             4.5.2.2.              Base Case Scenario
                             4.5.2.3.              Best Case Scenario
                     4.5.3. Drivers and Barriers
         4.6.    Spain Locally Advanced or Metastatic ER+/HER2- Breast Cancer Market Forecast 2023-2033
                     4.6.1. Market Progression (Futuristic)
                     4.6.2. Market Trends and Expectations
                             4.6.2.1.              Worst case scenario
                             4.6.2.2.              Base Case Scenario
                             4.6.2.3.              Best Case Scenario
                     4.6.3. Drivers and Barriers
         4.7.    Japan Locally Advanced or Metastatic ER+/HER2- Breast Cancer Market Forecast 2023-2033
                     4.7.1. Market Progression (Futuristic)
                     4.7.2. Market Trends and Expectations
                             4.7.2.1.              Worst case scenario
                             4.7.2.2.              Base Case Scenario
                             4.7.2.3.              Best Case Scenario
                     4.7.3. Drivers and Barriers
         4.8.    China Locally Advanced or Metastatic ER+/HER2- Breast Cancer Market Forecast 2023-2033
                     4.8.1. Market Progression (Futuristic)
                     4.8.2. Market Trends and Expectations
                             4.8.2.1.              Worst case scenario
                             4.8.2.2.              Base Case Scenario
                             4.8.2.3.              Best Case Scenario
                     4.8.3. Drivers and Barriers
         4.9.    Key Expected Milestones (world-wide) Impacting the Market

5.       Competitive Landscape

         5.1.    Pipeline Therapies Overview
                     5.1.1. Phase III Therapies
                                      5.1.1.1.                     Current Status
                                      5.1.1.2.                     Trial details, results
                                      5.1.1.3.                     Approval Timeline
                                      5.1.1.4.                     Likelihood of approval
                                      5.1.1.5.                     Expected Product Positioning
                             5.1.1.2.              All other Phase III Therapies …..
                             5.1.1.3.              Attribute Analysis of Phase III molecules
                     5.1.2.  Phase II and Phase I/II Therapies
                                      5.1.2.1.                     Current Status
                                      5.1.2.2.                     Trial details, results
                                      5.1.2.3.                     Approval Timelines
                     5.1.3. List of active Pre-clinical Therapies
                                      5.1.3.1.                     Status in Locally Advanced or Metastatic ER+/HER2- Breast Cancer
                                      5.1.3.2.                     Company positioning
                             5.1.3.2.              All other pre-clinical therapies
                     5.1.4. List of Inactive/discontinued assets
                             5.1.4.1.              Business impact of discontinuations on current pipeline
                     5.1.5. Potential winners from Locally Advanced or Metastatic ER+/HER2- Breast Cancer Pipeline
                             5.1.5.1.              Potential Blockbusters across the pipeline

6.       Regulatory/Approval Scenario

         6.1.    Regulatory/Approval Framework in US
                     6.1.1. Policy Framework
                     6.1.2. Payer Expectations
         6.2.    Regulatory/Approval Framework in UK
                     6.2.1. Policy Framework
                     6.2.2. Payer Expectations
         6.3.    Regulatory/Approval Framework in France
                     6.3.1. Policy Framework
                     6.3.2. Payer Expectations
         6.4.    Regulatory/Approval Framework in Germany
                     6.4.1. Policy Framework
                     6.4.2. Payer Expectations
         6.5.    Regulatory/Approval Framework in Italy
                     6.5.1. Policy Framework
                     6.5.2. Payer Expectations
         6.6.    Regulatory/Approval Framework in Spain
                     6.6.1. Policy Framework
                     6.6.2. Payer Expectations
         6.7.       Regulatory/Approval Framework in Japan
                     6.7.1. Policy Framework
                     6.7.2. Payer Expectations
         6.8.       Regulatory/Approval Framework in China
                     6.8.1. Policy Framework
                     6.8.2. Payer Expectations

7.       Clinical Trial Assessment – Current and Future Paradigm

         7.1.    Distribution of Primary Endpoints across trials
         7.2.    Distribution of Secondary Endpoints across trials
         7.3.    Evolution and acceptance of surrogate endpoints
         7.4.    Key Investigator initiated trials
         7.5.    Attrition analysis
                     7.5.1. Suspended/Discontinued Assets
                     7.5.2. Failed Trials, Reasons and Business Impact
                     7.5.3. Terminated Trials, Reasons and Business Impact
                     7.5.4. Withdrawn Trials, Reasons and Business Impact
         7.6.    Trial enrollment scenario and challenges
         7.7.    Clinical Trial Guidance (across geographies)

8.       Thelansis Commentary

         8.1.    Key Unmet needs in Locally Advanced or Metastatic ER+/HER2- Breast Cancer
         8.2.    Possible Best-case Clinical Trial Strategies
         8.3.    Possible Best Case Targeted Product Profile (TPP)
         8.4.    Possible Best-case Market positioning strategies
         8.5.    Possible Best-case Market Access Strategies
         8.6.    Possible Best-case LCM Strategies
         8.7.    Overall View on Locally Advanced or Metastatic ER+/HER2- Breast Cancer Market in Dollar Value

9.       Report Methodology

         9.1.    Secondary research
         9.2.    Primary research
         9.3.    Data collation
         9.4.    Insight Generation

10.   About Thelansis

         10.1.    Our Capabilities
         10.2.    Our Services
         10.3.    Our Contacts
         10.4.    Disclaimer