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PUBLISHER: DelveInsight | PRODUCT CODE: 2082639

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PUBLISHER: DelveInsight | PRODUCT CODE: 2082639

Metastatic HER2 Positive Breast Cancer - Epidemiology Forecast - 2036

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Metastatic HER2-positive Breast Cancer Insights and Trends

  • Human epidermal growth factor receptor-2 positive (HER2+) breast cancer indicates that the HER2 protein is detected in the cancer cells. This type of breast cancer exhibits a more rapid growth rate and a higher propensity to metastasize and recur compared to breast cancer that lacks the HER2 protein, known as HER2-negative (HER2-) breast cancer. A patient's HER2 status is determined by assessing whether breast cancer tests show a positive or negative presence of the HER2 protein.
  • HER2-positive breast cancer accounts for approximately 15-20% of all breast cancer cases, and over the years, it has witnessed significant advancements in treatment options.
  • In France the incidence of invasive breast cancer increased annually by ~0.8% in all age groups combined from 1990 to 2018.
  • In the US From the mid-2000s, invasive breast cancer in women has increased by approximately 0.5% each year. This is likely caused by an increase in excess body weight in women overall, as well as a drop in fertility rates and rising age for first births. However as per the reports from American cancer society breast cancer cases from have increased with a significant CAGR between 2022 to 2036.
  • The incidence of breast cancer in Germany is expected to rise in the future, primarily because of the aging population and shifts in reproductive patterns. These shifts encompass a greater number of women without children, delayed first-time motherhood, reduced breastfeeding rates, and modifications in lifestyle, encompassing dietary and exercise habits.

Metastatic HER2-positive Breast Cancer Epidemiology forecast in the US

  • 2025 Incident Cases of Metastatic HER2-positive Breast Cancer (The US): ~ 14,500
  • Metastatic HER2-positive Breast Cancer Growth Rate (2026-2036): ~ 1.5% CAGR

DelveInsight's 'Metastatic HER2-positive Breast Cancer - Epidemiology Forecast - 2036' report delivers an in-depth understanding of the metastatic HER2-positive breast cancer, historical and forecasted epidemiology of the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Metastatic HER2-positive Breast Cancer Understanding

HER2-positive Breast Cancer Overview and Diagnosis

Breast cancer develops when abnormal cells in the breast grow uncontrollably, usually beginning in the ducts or lobules and forming a tumor. Some breast cancers are driven by overexpression or amplification of the HER2 gene/protein; these are known as HER2-positive (HER2+) breast cancers. HER2+ breast cancer tends to grow faster and is more likely to spread or recur than HER2-negative disease.

HER2 status is determined through biomarker testing, most commonly using Immunohistochemistry (IHC) and Fluorescence in Situ Hybridization (FISH), although other tests such as NGS, PCR, PD-1/PD-L1, MSI-H/dMMR, and BRCA testing may also be used. In general, only tumors that are IHC 3+ or FISH-positive are considered HER2-positive and are likely to respond to HER2-targeted therapies. An IHC 2+ result is considered borderline and typically requires confirmatory FISH testing.

Metastatic HER2-positive Breast Cancer Epidemiology

Key Findings from Metastatic HER2-positive Breast Cancer Epidemiological Analysis and Forecast

  • According to the estimates, the total incident population of HER2-positive breast cancer in the 7MM was nearly 104,000 cases in 2025. The cases in the 7MM are expected to increase during the forecast period, i.e., 2025-2036.
  • The metastatic HER2+ breast cases were highest in the treatment eligible pool for HER2+ breast cancer in the US, accounting for ~14,500 cases.
  • According to the estimates, most cases of HER2-positive breast cancer occur in people between 40 and 60 in the United States, accounting for ~52% of total cases in 2025.
  • Among EU4 and the UK, Germany had the maximum total incident cases of HER2-positive breast cancer, with ~10,800 cases in 2025, while Spain accounted for the least number of cases.
  • In Japan, stage-specific cases of HER2-positive breast cancer were highest in Stage II, accounting for ~6,600 cases in 2025.

Scope of the Report:

  • The report covers a segment of a descriptive overview of metastatic HER2-positive breast cancer, explaining their causes, signs and symptoms, and pathogenesis.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression.

Report Insights

Metastatic HER2-positive Breast Cancer Patient Population Forecast

Report Key Strengths

  • Epidemiology-based (Epi-based) bottom-up forecasting
  • 11-year forecast
  • Patient Burden trends (by geography)

FAQs:

  • What are the disease risks, burdens, and unmet needs of metastatic HER2-positive breast cancer? What will be the growth opportunities across the 7MM concerning the patient population with metastatic HER2-positive breast cancer?
  • What is the historical and forecasted metastatic HER2-positive breast cancer patient pool in the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?

Reasons to Buy:

  • Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • To understand key opinion leaders' perspectives around the diagnostic challenges to overcome barriers in the future.
  • Detailed insights on various factors hampering disease diagnosis and other existing diagnostic challenges.
Product Code: DIEI0688

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Metastatic HER2-positive Breast Cancer

4. Epidemiology Forecast Methodology

5. Disease Background and Overview of Metastatic HER2-positive Breast Cancer

  • 5.1. Introduction
  • 5.2. Types of Breast Cancer
    • 5.2.1. Subtypes of Breast Cancer
    • 5.2.2. Molecular Subtypes of Breast Cancer
  • 5.3. HER2 Protein
  • 5.4. HER2-positive Breast Cancer
  • 5.5. Symptoms of HER2-positive Breast Cancer
  • 5.6. Risk Factors of HER2-positive Breast Cancer
  • 5.7. Signaling Pathway
  • 5.8. Diagnosis and Testing for HER2 Status
    • 5.8.1. Biomarker Testing
      • 5.8.1.1. Tumor Markers
  • 5.9. Diagnosis Guidelines
    • 5.9.1. ASCO Guidelines
  • 5.1. Factors Affecting the Response and Resistance to HER2- and HR-Targeted Therapies
    • 5.10.1. HER2 Itself
    • 5.10.2. Hormone Receptors
    • 5.10.3. PI3K/AKT/mTOR Pathway
    • 5.10.4. Immune-related

6. Epidemiology and Patient Population of Metastatic HER2-positive Breast Cancer

  • 6.1. Key Findings
  • 6.2. Assumptions and Rationale
  • 6.3. Total Incident Cases of Breast Cancer in the 7MM
  • 6.4. Total Incident Cases of HER2-positive Breast Cancer in the 7MM
  • 6.5. The United States
    • 6.5.1. Total Incidence of Breast Cancer in the United States
    • 6.5.2. Incidence of HER2-positive Breast Cancer in the United States
    • 6.5.3. Incidence of HER2-positive Breast Cancer Cases by Hormonal Status in the United States
    • 6.5.4. Stage-specific Incidence of HER2-positive Breast Cancer in the United States
    • 6.5.5. Age-specific Incidence of HER2-positive Breast Cancer in the United States
    • 6.5.6. Line-wise Metastatic Cases of HER2-positive Breast Cancer in the United States
  • 6.6. EU4 and the UK
    • 6.6.1. Total Incidence of Breast Cancer in EU4 and the UK
    • 6.6.2. Incidence of HER2-positive Breast Cancer in EU4 and the UK
    • 6.6.3. Incidence of HER2-positive Breast Cancer Cases by Hormonal Status in EU4 and the UK
    • 6.6.4. Stage-specific Incidence of HER2-positive Breast Cancer in EU4 and the UK
    • 6.6.5. Age-specific Incidence of HER2-positive Breast Cancer in EU4 and the UK
    • 6.6.6. Line-wise Metastatic Cases of HER2-positive Breast Cancer in EU4 and the UK
  • 6.7. Japan
    • 6.7.1. Total Incidence of Breast Cancer in Japan
    • 6.7.2. Incidence of HER2-positive Breast Cancer in Japan
    • 6.7.3. Incidence of HER2-positive Breast Cancer Cases by Hormonal Status in Japan
    • 6.7.4. Stage-specific Incidence of HER2-positive Breast Cancer in Japan
    • 6.7.5. Age-specific Incidence of HER2-positive Breast Cancer in Japan
    • 6.7.6. Line-wise Metastatic Cases of HER2-positive Breast Cancer in Japan

7. Appendix

  • 7.1. Bibliography
  • 7.2. Report Methodology

8. DelveInsight Capabilities

9. Disclaimer

10. About DelveInsight

Product Code: DIEI0688

List of Tables

  • Table 1: Summary of HER2-Positive Breast Cancer Epidemiology (2022-2036)
  • Table 2: Intrinsic Subtype of Breast Cancer
  • Table 3: Total Incident Cases of Breast Cancer in the 7MM (2022-2036)
  • Table 4: Total Incident Cases of HER2-positive Breast Cancer in the 7MM (2022-2036)
  • Table 9: Total Incidence of Breast Cancer in the United States (2022-2036)
  • Table 10: Incidence of HER2-positive Breast Cancer in the United States (2022-2036)
  • Table 11: Incidence of HER2-positive Breast Cancer Cases by Hormonal Status in the United States (2022-2036)
  • Table 12: Stage-specific Incidence of HER2-positive Breast Cancer in the United States (2022-2036)
  • Table 13: Age-specific Incidence of HER2-positive Breast Cancer in the United States (2022-2036)
  • Table 14: Line-wise Metastatic Cases of HER2-positive Breast Cancer in the United States (2022-2036)
  • Table 15: Incidence of HER2-positive Breast Cancer in EU4 and the UK (2022-2036)
  • Table 16: Incidence of HER2-positive Breast Cancer Cases by Hormonal Status in EU4 and the UK (2022-2036)
  • Table 17: Stage-specific Incidence of HER2-positive Breast Cancer in EU4 and the UK (2022-2036)
  • Table 18: Age-specific Incidence of HER2-positive Breast Cancer in EU4 and the UK (2022-2036)
  • Table 19: Line-wise Metastatic Cases of HER2-positive Breast Cancer in EU4 and the UK (2022-2036)
  • Table 20: Total Incidence of Breast Cancer in Japan (2022-2036)
  • Table 21: Incidence of HER2-positive Breast Cancer in Japan (2022-2036)
  • Table 22: Incidence of HER2-positive Breast Cancer Cases by Hormonal Status in Japan (2022-2036)
  • Table 23: Stage-specific Incidence of HER2-positive Breast Cancer in Japan (2022-2036)
  • Table 24: Age-specific Incidence of HER2-positive Breast Cancer in Japan (2022-2036)
  • Table 25: Line-wise Metastatic Cases of HER2-positive Breast Cancer in Japan (2022-2036)

List of Figures

  • Figure 1: Molecular Subtypes of Breast Cancer
  • Figure 2: Overview of Estrogen Receptor (ER) and HER2 Signaling Crosstalk
  • Figure 3: Algorithm for Evaluation of HER2 Protein Expression by Immunohistochemistry (IHC) Assay of the Invasive Component of a Breast Cancer Specimen
  • Figure 4: Algorithm for Evaluation of HER2 Gene Amplification by in situ Hybridization (ISH) Assay of the Invasive Component of a Breast Cancer Specimen Using a Single-signal (HER2 gene) Assay (single-probe ISH)
  • Figure 5: Algorithm for Evaluation of HER2 Gene Amplification by in situ hybridization (ISH) Assay of the Invasive Component of a Breast Cancer Specimen Using A Dual-signal (HER2 gene) Assay (dual-probe ISH)
  • Figure 6: Total Incident Cases of Breast Cancer in the 7MM (2022-2036)
  • Figure 7: Total Incident Cases of HER2-positive Breast Cancer in the 7MM (2022-2036)
  • Figure 8: Total Incidence of Breast Cancer in the United States (2022-2036)
  • Figure 9: Incidence of HER2-positive Breast Cancer in the United States (2022-2036)
  • Figure 10: Incidence of HER2-positive Breast Cancer Cases by Hormonal Status in the United States (2022-2036)
  • Figure 11: Stage-specific Incidence of HER2-positive Breast Cancer in the United States (2022-2036)
  • Figure 12: Age-specific Incidence of HER2-positive Breast Cancer in the United States (2022-2036)
  • Figure 13: Line-wise Metastatic Cases of HER2-positive Breast Cancer in the United States (2022-2036)
  • Figure 14: Total Incidence of Breast Cancer in EU4 and the UK (2022-2036)
  • Figure 15: Incidence of HER2-positive Breast Cancer in EU4 and the UK (2022-2036)
  • Figure 16: Incidence of HER2-positive Breast Cancer Cases by Hormonal Status in EU4 and the UK (2022-2036)
  • Figure 17: Stage-specific Incidence of HER2-positive Breast Cancer in EU4 and the UK (2022-2036)
  • Figure 18: Age-specific Incidence of HER2-positive Breast Cancer in EU4 and the UK (2022-2036)
  • Figure 19: Line-wise Metastatic Cases of HER2-positive Breast Cancer in EU4 and the UK (2022-2036)
  • Figure 20: Total Incidence of Breast Cancer in Japan (2022-2036)
  • Figure 21: Incidence of HER2-positive Breast Cancer in Japan (2022-2036)
  • Figure 22: Incidence of HER2-positive Breast Cancer Cases by Hormonal Status in Japan (2022-2036)
  • Figure 23: Stage-specific Incidence of HER2-positive Breast Cancer in Japan (2022-2036)
  • Figure 24: Age-specific Incidence of HER2-positive Breast Cancer in Japan (2022-2036)
  • Figure 25: Line-wise Metastatic Cases of HER2-positive Breast Cancer in Japan (2022-2036)
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