전이성 HER2 양성 유방암 : 시장 인사이트, 역학, 시장 예측(2034년)

Metastatic HER2 positive Breast Cancer Market

Recent advancements in HER2 treatments have enhanced HER2-positive breast cancer management, yet relapse remains a primary challenge due to disease heterogeneity and drug resistance mechanisms.

The approval of HERCEPTIN marked a turning point in HER2-positive breast cancer treatment. HERCEPTIN was the first targeted treatment for a solid tumor and the first drug to be paired with a companion diagnostic.

Despite the effectiveness of trastuzumab in combination with chemotherapy, a substantial portion (30-50%) of treatment-naive HER2-positive metastatic breast cancer patients do not respond well initially, indicating resistance to trastuzumab. This underscores its limitations and the need for ongoing research to tackle resistance issues with novel therapies.

PERJETA is often used alongside trastuzumab and chemotherapy; pertuzumab's approval marked a significant milestone. The combination of trastuzumab and pertuzumab has become a standard of care for neoadjuvant and metastatic front-line settings.

The development of ADCs represents a breakthrough in treating metastatic breast cancer, particularly in HER2-positive breast cancer. Among these, KADCYLA was the first to gain FDA approval for breast cancer treatment.

Anti-HER2 therapies, such as HERCEPTIN, PERJETA, KADCYLA, ENHERTU, and others, have changed the treatment paradigm of HER2-positive cancers, which were previously associated with more aggressive disease and poorer outcomes.

Seagen's comprehensive TUKYSA development plan includes a Phase II trial (HER2CLIMB-04) combining TUKYSA with ENHERTU for second-line HER2-positive breast cancer and a Phase III trial (HER2CLIMB-05) evaluating TUKYSA with HERCEPTIN and Roche's PERJETA as a first-line maintenance regimen.

Both TUKYSA and KADCYLA are HER2-targeted agents, and both are under pressure from AstraZeneca and Daiichi Sankyo's ADC ENHERTU, which has handily beaten KADCYLA in a head-to-head trial.

Companies like Byondis, Hoffmann-La Roche, Ambrx, and Zymeworks/Jazz Pharmaceuticals actively engage in mid and late-stage research and development efforts for HER2-positive breast cancer. The pipeline of HER2-positive breast cancer possesses few potential drugs.

ARX788 may potentially become the ADC of choice for post-ENHERTU patients with its unique ADC structure.

As promising novel anti-HER2 treatments emerge, the field will continue to revolutionize, with guidelines beginning to include novel treatment options in the third-line setting and thereafter.

In 2023, the United States accounted for the maximum share of the total market of HER2-positive breast cancer in the 7MM was around 60%.

DelveInsight's "Metastatic HER2-positive Breast Cancer Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of the HER2-positive breast cancer, historical and forecasted epidemiology as well as the HER2-positive breast cancer market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The Metastatic HER2-positive breast cancer market report provides current treatment practices, emerging drugs, HER2-positive breast cancer market share of the individual therapies, and current and forecasted HER2-positive breast cancer market size from 2020 to 2034, segmented by seven major markets. The report also covers current HER2-positive breast cancer treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan
• Study Period: 2020-2034

Metastatic HER2-positive Breast Cancer Disease Understanding and Treatment Algorithm

HER2-positive Breast Cancer Overview

Breast cancer initiates when abnormal cancerous cells in the breast grow and proliferate, creating a tumor. It usually starts in the ducts or lobules of the breast.

Some breast cancers depend on the human epidermal growth factor receptor 2 (HER2) gene to grow. These cancers are called HER2+ and have many copies of the HER2 gene or high levels of the HER2 protein. These proteins are also called "receptors." The HER2 gene makes the HER2 protein found in cancer cells and is important for tumor cell growth. Human epidermal growth factor receptor-2 positive (HER2+) is breast cancer that tests positive for the HER2 protein. HER2+ breast cancer grows faster and is more likely to spread and return than human epidermal growth factor receptor-2 negative (HER2-) breast cancer. Patients' HER2 status is determined by whether breast cancer tests are positive or negative for the HER2 protein.

Metastatic HER2-positive Breast Cancer Diagnosis

Various tests such as tumor mutation testing: MSI-H/dMMR mutation, PD-1, and PD-L1 testing, FISH (Fluorescence in Situ Hybridization), Immunohistochemistry (IHC), Next-generation sequencing, Polymerase chain reaction, and genetic risk testing: BRCA tests are employed to determine the presence of HER2-positive breast cancer. The appearance of results in the report will vary based on the specific test conducted. Two widely used tests are the IHC test (Immunohistochemistry) and the FISH test (Fluorescence in Situ Hybridization).

It is important to know which HER2 test the patient had. Generally, only cancers that test IHC 3+ or FISH positive respond to the medicines that target HER2-positive breast cancers. An IHC 2+ test result is called borderline. If the patient has an IHC 2+ result, ask to retest the tissue with the FISH test.

Metastatic HER2-positive Breast Cancer Treatment

Metastatic breast cancer is primarily treated with targeted therapy and hormonal therapy. First-line treatment choice depends on receptor status, including estrogen, progesterone, and HER2 receptors. In cases where both HER2 and estrogen receptors are positive, initial treatment may involve hormonal therapy, HER2-targeted therapy, or a combination of both.

Anti-HER2 therapies (also called HER2 inhibitors or HER2-targeted therapies) are a class of medicines used to treat all stages of HER2-positive breast cancer, from early-stage to metastatic. HERCEPTIN (trastuzumab) treats early-stage and advanced HER2-positive breast cancer and can be given with chemotherapy and sometimes another targeted therapy called PERJETA (pertuzumab). Antibody-drug conjugates such as ENHERTU, KADCYLA, and PHESGO can treat unresectable or metastatic HER2-positive breast cancer. Another therapy, NERLYNX, combines chemotherapy to treat advanced-stage and metastatic HER2-positive breast cancer. Apart from this, TUKYSA (tucatinib) treats metastatic or locally advanced HER2-positive breast cancer that cannot be completely removed with surgery after the cancer has been treated with at least one anti-HER2 medicine.

Metastatic HER2-positive Breast Cancer Epidemiology

• The HER2-positive breast cancer epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incidence of breast cancer, total incident cases of HER2-positive breast cancer, hormonal status of HER2-positive breast cancer, age-specific cases of HER2-positive breast cancer, stage-specific cases of HER2-positive breast cancer, and Treatment-eligible Cases of HER2-positive Breast Cancer in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
• According to the estimates, the total incident population of HER2-positive breast cancer in the seven major markets was nearly 102,000 cases in 2023. The cases in the 7MM are expected to increase during the forecast period, i.e., 2024-2034.
• The HR+/HER2+ breast cases were highest in the United States, accounting for ~32,000 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 2023.
• Among EU4 and the UK, Germany had the maximum total incident cases of HER2-positive breast cancer, with ~11,000 cases in 2023, 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 ~6,000 cases in 2023.
• Metastatic HER2-positive Breast Cancer Cases by Age in the United States in 2023

Table of Contents

1 Key Insights

2 Report Introduction

3 Metastatic HER2-positive Breast Cancer Market Overview at a Glance

• 3.1 Market Share by Class (%) Distribution of HER2-positive Breast Cancer in 2023
• 3.2 Market Share by Class (%) Distribution of HER2-positive Breast Cancer in 2034

4 Executive Summary of HER2-positive Breast Cancer

5 Key Events

6 Epidemiology and Market Methodology

7 Disease Background and Overview

• 7.1 Introduction
• 7.2 Types of Breast Cancer
  • 7.2.1 Subtypes of Breast Cancer
  • 7.2.2 Molecular Subtypes of Breast Cancer
• 7.3 HER2 Protein
• 7.4 HER2-positive Breast Cancer
• 7.5 Symptoms of HER2-positive Breast Cancer
• 7.6 Risk Factors of HER2-positive Breast Cancer
• 7.7 Signaling Pathway
• 7.8 Diagnosis and Testing for HER2 Status
  • 7.8.1 Biomarker Testing
    • 7.8.1.1 Tumor Markers
• 7.9 Diagnosis Guidelines
  • 7.9.1 ASCO Guidelines
• 7.1 Factors Affecting the Response and Resistance to HER2- and HR-Targeted Therapies
  • 7.10.1 HER2 Itself
  • 7.10.2 Hormone Receptors
  • 7.10.3 PI3K/AKT/mTOR Pathway
  • 7.10.4 Immune-related
• 7.11 Treatment and Management
  • 7.11.1 Targeted Therapy for HER2-positive Breast Cancer
    • 7.11.1.1 Monoclonal Antibodies
    • 7.11.1.2 Antibody-drug Conjugates
    • 7.11.1.3 Tyrosine Kinase Inhibitors
  • 7.11.2 Management of HER2-positive Early Breast Cancer in Italy
    • 7.11.2.1 Neoadjuvant Therapy of HER2+ Breast Cancer
    • 7.11.2.2 Adjuvant Therapy of HER2+ Breast Cancer
• 7.12 Treatment Algorithm for HER2-positive Breast Cancer
• 7.13 Treatment Guidelines
  • 7.13.1 ASCO Guideline for Patients with HER2-positive Breast Cancer
  • 7.13.2 ESMO Guideline (2022)
  • 7.13.3 G-BA Updates on Disease Management Programs (DMP) for Women with Breast Cancer
  • 7.13.4 NCCN Guidelines for Breast Cancer (2023)
    • 7.13.4.1 Systemic Treatment of Recurrent Unresectable (Local or Regional) or Stage IV (M1) Disease: ER- and/or PR-positive; HER2-positive
    • 7.13.4.2 Systemic Treatment of Recurrent Unresectable (Local or Regional) or Stage IV (M1) Disease: ER- and/or PR-negative; HER2-positive
    • 7.13.4.3 Systemic Therapy Regimens For Recurrent Unresectable (Local or Regional) or Stage IV (M1) Disease
    • 7.13.4.4 NCCN-recommended HER-targeted Therapy
• 7.14 Screening Recommendations for Breast Cancer in the 7MM
  • 7.14.1 Summary of Breast Cancer Screening Recommendations for Women at Average Risk in the United States
  • 7.14.2 American Cancer Society (ACS) Recommendations for the Early Detection of Breast Cancer
  • 7.14.3 Recommendations Made by the USPSTF (US Preventive Service Task Force): 2016
  • 7.14.4 Breast Cancer Screening in Germany
    • 7.14.4.1 IQWiG Recommendation: Mammography Screening Program
  • 7.14.5 European Commission Initiative on Breast Cancer (ECIBC) Guidelines for Screening Ages (2022)
  • 7.14.6 The Italian Group Recommendation for Mammography
  • 7.14.7 Screening Recommendation in France
  • 7.14.8 Breast Cancer Screening in Spain
  • 7.14.9 NHS Breast Screening Program
  • 7.14.10 Screening Recommendation in Japan
    • 7.14.10.1 The Japanese Society of Gynecologic Oncology (JSGO)

8 Epidemiology and Patient Population

• 8.1 Key Findings
• 8.2 Assumptions and Rationale
• 8.3 Total Incident Cases of Breast Cancer in the 7MM
• 8.4 Total Incident Cases of HER2-positive Breast Cancer in the 7MM
• 8.5 The United States
  • 8.5.1 Total Incidence of Breast Cancer in the United States
  • 8.5.2 Incidence of HER2-positive Breast Cancer in the United States
  • 8.5.3 Incidence of HER2-positive Breast Cancer Cases by Hormonal Status in the United States
  • 8.5.4 Stage-specific Incidence of HER2-positive Breast Cancer in the United States
  • 8.5.5 Age-specific Incidence of HER2-positive Breast Cancer in the United States
  • 8.5.6 Treatment-eligible Pool for HER2-positive Breast Cancer in the United States
• 8.6 EU4 and the UK
  • 8.6.1 Total Incidence of Breast Cancer in EU4 and the UK
  • 8.6.2 Incidence of HER2-positive Breast Cancer in EU4 and the UK
  • 8.6.3 Incidence of HER2-positive Breast Cancer Cases by Hormonal Status in EU4 and the UK
  • 8.6.4 Stage-specific Incidence of HER2-positive Breast Cancer in EU4 and the UK
  • 8.6.5 Age-specific Incidence of HER2-positive Breast Cancer in EU4 and the UK
  • 8.6.6 Treatment-eligible Pool for HER2-positive Breast Cancer in EU4 and the UK
• 8.7 Japan
  • 8.7.1 Total Incidence of Breast Cancer in Japan
  • 8.7.2 Incidence of HER2-positive Breast Cancer in Japan
  • 8.7.3 Incidence of HER2-positive Breast Cancer Cases by Hormonal Status in Japan
  • 8.7.4 Stage-specific Incidence of HER2-positive Breast Cancer in Japan
  • 8.7.5 Age-specific Incidence of HER2-positive Breast Cancer in Japan
  • 8.7.6 Treatment-eligible Pool for HER2-positive Breast Cancer in Japan

9 Patient Journey

10 Key Endpoints in HER2-positive Breast Cancer

11 Marketed Drugs

• 11.1 Key Competitors
• 11.2 HERCEPTIN (trastuzumab): Roche
  • 11.2.1 Product Description
  • 11.2.2 Regulatory Milestones
  • 11.2.3 Other Developmental Activities
  • 11.2.4 Safety and Efficacy
  • 11.2.5 Product Profile
• 11.3 HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk): Roche
  • 11.3.1 Product Profile
  • 11.3.2 Regulatory Milestones
  • 11.3.3 Safety and Efficacy
  • 11.3.4 Product Profile
• 11.4 ENHERTU (fam-trastuzumab deruxtecan-nxk): Daiichi Sankyo/AstraZeneca
  • 11.4.1 Product Description
  • 11.4.2 Regulatory Milestones
  • 11.4.3 Other Developmental Activities
  • 11.4.4 Current Pipeline Activity
    • 11.4.4.1 Clinical Trials Information
  • 11.4.5 Safety and Efficacy
  • 11.4.6 Product Profile
• 11.5 PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf): Roche/Chugai
  • 11.5.1 Product Description
  • 11.5.2 Regulatory Milestones
  • 11.5.3 Other Developmental Activities
  • 11.5.4 Safety and Efficacy
  • 11.5.5 Product Profile
• 11.6 KADCYLA (ado-trastuzumab emtansine): Roche/Chugai
  • 11.6.1 Product Description
  • 11.6.2 Regulatory Milestones
  • 11.6.3 Other Developmental Activities
  • 11.6.4 Current Pipeline Activity
    • 11.6.4.1 Clinical Trials Information
  • 11.6.5 Safety and Efficacy
  • 11.6.6 Product Profile
• 11.7 MARGENZA (margetuximab-cmkb): MacroGenics
  • 11.7.1 Product Description
  • 11.7.2 Regulatory Milestones
  • 11.7.3 Other Developmental Activities
  • 11.7.4 Current Pipeline Activity
    • 11.7.4.1 Clinical Trials Information
  • 11.7.5 Safety and Efficacy
  • 11.7.6 Product Profile
• 11.8 TUKYSA (tucatinib): Seagen
  • 11.8.1 Product Description
  • 11.8.2 Regulatory Milestones
  • 11.8.3 Other Developmental Activities
  • 11.8.4 Current Pipeline Activity
    • 11.8.4.1 Clinical Trials Information
  • 11.8.5 Safety and Efficacy
  • 11.8.6 Product Profile
• 11.9 NERLYNX (neratinib): Puma Biotechnology
  • 11.9.1 Product Description
  • 11.9.2 Regulatory Milestones
  • 11.9.3 Other Developmental Activities
  • 11.9.4 Current Pipeline Activity
    • 11.9.4.1 Clinical Trials Information
  • 11.9.5 Safety and Efficacy
  • 11.9.6 Product Profile
• 11.10 PERJETA (pertuzumab): Roche
  • 11.10.1 Product Description
  • 11.10.2 Regulatory Milestones
  • 11.10.3 Other Developmental Activities
  • 11.10.4 Safety and Efficacy
  • 11.10.5 Product Profile
• 11.11 TYKERB/TYVERB (lapatinib): Novartis
  • 11.11.1 Product Description
  • 11.11.2 Regulatory Milestones
  • 11.11.3 Other Developmental Activities
  • 11.11.4 Current Pipeline Activity
    • 11.11.4.1 Clinical Trials Information
  • 11.11.5 Safety and Efficacy
  • 11.11.6 Product Profile

12 Emerging Drugs

• 12.1 Key Competition
• 12.2 SYD985 (trastuzumab duocarmazine): Byondis
  • 12.2.1 Product Description
  • 12.2.2 Other Developmental Activities
  • 12.2.3 Clinical Development
    • 12.2.3.1 Clinical Trial Information
  • 12.2.4 Safety and Efficacy
• 12.3 Giredestrant: Roche
  • 12.3.1 Product Description
  • 12.3.2 Clinical Development
    • 12.3.2.1 Clinical Trial Information
• 12.4 ARX788: Ambrx
  • 12.4.1 Product Description
  • 12.4.2 Other Developmental Activities
  • 12.4.3 Clinical Development
    • 12.4.3.1 Clinical Trial Information
  • 12.4.4 Safety and Efficacy
• 12.5 Zanidatamab: Zymeworks/Jazz Pharmaceuticals
  • 12.5.1 Product Description
  • 12.5.2 Other Developmental Activities
  • 12.5.3 Clinical Development
    • 12.5.3.1 Clinical Trials Information
  • 12.5.4 Safety and Efficacy
• 12.6 IBRANCE (palbociclib): Pfizer
  • 12.6.1 Product Description
  • 12.6.2 Other Developmental Activities
  • 12.6.3 Clinical Development
    • 12.6.3.1 Clinical Trial Information

13 HER2-positive Breast Cancer: 7MM Market Analysis

• 13.1 Key Findings
• 13.2 Market Outlook
• 13.3 Approval Timeline of HER2-positive Breast Cancer Drugs
  • 13.3.1 United States
  • 13.3.2 EU4 and the UK
  • 13.3.3 Japan
• 13.4 Conjoint Analysis
• 13.5 Key Market Forecast Assumptions
• 13.6 Total Market Size of HER2-positive Breast Cancer in the 7MM
• 13.7 United States Market Size
  • 13.7.1 Total Market Size of HER2-positive Breast Cancer in the United States
  • 13.7.2 Market Size of HER2-positive Breast Cancer by Therapies in the United States
• 13.8 EU4 and the UK Market Size
  • 13.8.1 Total Market Size of HER2-positive Breast Cancer in EU4 and the UK
  • 13.8.2 Market Size of HER2-positive Breast Cancer by Therapies in EU4 and the UK
• 13.9 Japan Market Size
  • 13.9.1 Total Market Size of HER2-positive Breast Cancer in Japan
  • 13.9.2 Market Size of HER2-positive Breast Cancer by Therapies in Japan

14 HER2-positive Breast Cancer Market Access and Reimbursement

• 14.1 HERCEPTIN (trastuzumab): Genentech
• 14.2 MARGENZA (margetuximab): MacroGenics
• 14.3 PHESGO (pertuzumab/trastuzumab/hyaluronidase): Genentech
• 14.4 TUKYSA (tucatinib): Seagen
• 14.5 NERLYNX (neratinib): Puma biotech
• 14.6 TYKERB (lapatinib): Novartis
• 14.7 PERJETA (pertuzumab): Roche
• 14.8 KADCYLA (trastuzumab emtansine): Roche/Chugai
• 14.9 ENHERTU (trastuzumab deruxtecan): Daiichi/AstraZeneca
• 14.1 Payer Coverage

15 Unmet Needs

16 SWOT Analysis

17 KOL Views

18 Appendix

• 18.1 Bibliography
• 18.2 Report Methodology

19 DelveInsight Capabilities

20 Disclaimer

21 About DelveInsight