Metastatic HER2 positive Breast Cancer Market: Analysis of Epidemiology, Pipeline Products, and Key Companies Working, DelveInsight | Byondis, Hoffmann-La Roche, Ambrx, and Zymeworks/Jazz Pharmaceuticals

Metastatic HER2 positive Breast Cancer emerging therapies such as HERCEPTIN, PERJETA, KADCYLA, ENHERTU, and others are expected to boost the Metastatic HER2 positive Breast Cancer Market in the upcoming years.

DelveInsight has launched a new report on "Metastatic HER2 positive Breast Cancer - Market Insights, Epidemiology, and Market Forecast-2034" that delivers an in-depth understanding of the Metastatic HER2 positive Breast Cancer, historical and forecasted epidemiology as well as the Metastatic HER2 positive Breast Cancer market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

Download our free metastatic her2 positive breast cancer market sample report @ https://www.delveinsight.com/report-store/metastatic-her2-positive-breast-cancer-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=kpr

Some of the key facts of the Metastatic HER2 positive Breast Cancer Market Report:

Recent advancements in HER2-targeted therapies have significantly improved the management of HER2-positive breast cancer. However, relapse remains a major challenge due to disease heterogeneity and mechanisms of drug resistance.
In 2023, the estimated total number of incident HER2-positive breast cancer cases across the seven major markets (7MM) was approximately 102,000. This number is expected to rise throughout the forecast period from 2024 to 2034.
In February 2025, the FDA approved a label expansion for the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to assist in identifying patients with hormone receptor-positive, HER2-ultralow metastatic breast cancer who may be eligible for treatment with fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu).
The highest number of HR+/HER2+ breast cancer cases was reported in the United States, with around 32,000 cases.
In the U.S., the majority of HER2-positive breast cancer cases were observed in individuals aged 40 to 60, making up roughly 52% of the total cases in 2023.
The approval of HERCEPTIN marked a pivotal moment in HER2-positive breast cancer treatment, as it was the first targeted therapy for a solid tumor and the first drug to be paired with a companion diagnostic. Despite the effectiveness of trastuzumab in combination with chemotherapy, 30-50% of treatment-naïve patients with HER2-positive metastatic breast cancer exhibit primary resistance, highlighting the need for continued research into overcoming resistance with novel therapies.
PERJETA is commonly used alongside trastuzumab and chemotherapy, and its approval was a significant milestone. The combination of trastuzumab and pertuzumab has become a standard of care in both neoadjuvant and metastatic first-line settings.
The development of antibody-drug conjugates (ADCs) has been a breakthrough in treating metastatic breast cancer, particularly in HER2-positive cases. Among these, KADCYLA was the first ADC to receive FDA approval for breast cancer treatment. Anti-HER2 therapies, including HERCEPTIN, PERJETA, KADCYLA, ENHERTU, and others, have transformed the treatment landscape for HER2-positive cancers, which were previously associated with aggressive disease and poor outcomes.
Seagen's extensive TUKYSA development program includes a Phase II trial (HER2CLIMB-04) evaluating TUKYSA in combination with ENHERTU for second-line HER2-positive breast cancer and a Phase III trial (HER2CLIMB-05) assessing TUKYSA alongside HERCEPTIN and Roche's PERJETA as a first-line maintenance regimen.
In the current market, the combination therapy of trastuzumab, PERJETA, and chemotherapy held the largest share, generating approximately USD 470 million in the US in 2023.
Both TUKYSA and KADCYLA are HER2-targeted therapies, but they face increasing competition from AstraZeneca and Daiichi Sankyo's ADC ENHERTU, which demonstrated superior efficacy over KADCYLA in a direct comparison.
Companies such as Byondis, Hoffmann-La Roche, Ambrx, and Zymeworks/Jazz Pharmaceuticals are actively engaged in mid- and late-stage research and development for HER2-positive breast cancer. Despite ongoing efforts, the HER2-positive breast cancer pipeline has a limited number of potential breakthrough drugs. ARX788, with its distinct ADC structure, could emerge as the preferred ADC option for patients who have progressed after ENHERTU.
As innovative anti-HER2 therapies continue to emerge, the treatment landscape is evolving, with guidelines beginning to incorporate novel treatment options in third-line and later settings.
In 2023, the United States held the largest market share for HER2-positive breast cancer in the 7MM (seven major markets), accounting for approximately 60% of the total market.
Key Metastatic HER2 positive Breast Cancer companies such as Byondis, Hoffmann-La Roche, Ambrx, and Zymeworks/Jazz Pharmaceuticals, and others are evaluating new drugs for Metastatic HER2 positive Breast Cancer to improve the treatment landscape.
Promising Metastatic HER2 positive Breast Cancer pipeline therapies in various stages of development include HERCEPTIN, PERJETA, KADCYLA, ENHERTU, and others.
Key benefits of the Metastatic HER2 positive Breast Cancer market report:
Metastatic HER2 positive Breast Cancer market report covers a descriptive overview and comprehensive insight of the Metastatic HER2 positive Breast Cancer Epidemiology and Metastatic HER2 positive Breast Cancer market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan.)
The Metastatic HER2 positive Breast Cancer market report provides insights on the current and emerging therapies.
Metastatic HER2 positive Breast Cancer market report provides a global historical and forecasted market covering drug outreach in 7MM.
The Metastatic HER2 positive Breast Cancer market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Metastatic HER2 positive Breast Cancer market.

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Metastatic HER2 positive Breast Cancer Overview

Breast cancer begins when abnormal cancerous cells in the breast multiply uncontrollably, forming a tumor. It typically originates in the breast's ducts or lobules.

Certain types of breast cancer rely on the human epidermal growth factor receptor 2 (HER2) gene for growth. These cancers, known as HER2-positive (HER2+), have an excessive number of HER2 gene copies or elevated levels of the HER2 protein, also referred to as receptors. The HER2 gene produces the HER2 protein, which plays a crucial role in tumor cell proliferation.

HER2+ breast cancer is characterized by the presence of the HER2 protein and tends to grow more aggressively, spread more rapidly, and have a higher likelihood of recurrence compared to HER2-negative (HER2-) breast cancer. A patient's HER2 status is determined by diagnostic tests that identify the presence or absence of the HER2 protein in breast cancer cells.

Metastatic HER2 positive Breast Cancer Market Outlook

A wide range of treatment options is available for HER2-positive breast cancer, categorized into pharmacological and nonpharmacological approaches. While recent advancements in HER2-targeted therapies have improved disease management, relapse remains a significant challenge due to tumor heterogeneity and drug resistance mechanisms.

Historically, patients with metastatic HER2-positive breast cancer were treated with conventional chemotherapy regimens until the introduction of trastuzumab. To counter the rise of biosimilars, Roche launched a subcutaneous (SC) formulation of HERCEPTIN in the EU in 2013 and later in the US in 2019. As part of its strategy to expand its HER2 treatment portfolio, Roche developed KADCYLA, its first antibody-drug conjugate (ADC), which received FDA approval in 2013 for HER2-positive metastatic breast cancer following prior treatment with HERCEPTIN and chemotherapy. The second ADC to receive FDA and EMA approval was ENHERTU (trastuzumab deruxtecan), a breakthrough therapy that has the potential to reshape the second-line treatment landscape, marking a significant milestone for AstraZeneca and Daiichi Sankyo.

Another emerging therapy, SYD985, is progressing in the competitive market, with a Biologics License Application (BLA) filed in both the US and EU. Several pharmaceutical companies, including Pfizer, Roche, Spectrum Pharmaceuticals, Hoffmann-La Roche, Eli Lilly and Company, and Ambrx, are actively engaged in mid- and late-stage research and development for HER2-positive breast cancer treatments. The HER2-positive breast cancer therapeutics market is expected to expand throughout the forecast period.

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Metastatic HER2 positive Breast Cancer Marketed Drugs:
ENHERTU (fam-trastuzumab deruxtecan-nxk): Daiichi Sankyo/AstraZeneca
KADCYLA (ado-trastuzumab emtansine): Roche/Chugai
Metastatic HER2 positive Breast Cancer Emerging Drugs:
ARX788: Ambrx
Zanidatamab: Zymeworks/Jazz Pharmaceuticals
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Scope of the Metastatic HER2 positive Breast Cancer Market Report

Study Period: 2020-2034
Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
Key Metastatic HER2 positive Breast Cancer Companies: Byondis, Hoffmann-La Roche, Ambrx, and Zymeworks/Jazz Pharmaceuticals, and others
Key Metastatic HER2 positive Breast Cancer Therapies: HERCEPTIN, PERJETA, KADCYLA, ENHERTU, and others
Metastatic HER2 positive Breast Cancer Therapeutic Assessment: Metastatic HER2 positive Breast Cancer current marketed and Metastatic HER2 positive Breast Cancer emerging therapies
Metastatic HER2 positive Breast Cancer Market Dynamics: Metastatic HER2 positive Breast Cancer market drivers and Metastatic HER2 positive Breast Cancer market barriers
Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
Metastatic HER2 positive Breast Cancer Unmet Needs, KOL's views, Analyst's views, Metastatic HER2 positive Breast Cancer Market Access and Reimbursement

Table of Contents

1. Report Introduction
2. Executive Summary
3. SWOT analysis
4. Metastatic HER2 positive Breast Cancer Patient Share (%) Overview at a Glance
5. Metastatic HER2 positive Breast Cancer Market Overview at a Glance
6. Metastatic HER2 positive Breast Cancer Disease Background and Overview
7. Metastatic HER2 positive Breast Cancer Epidemiology and Patient Population
8. Country-Specific Patient Population of Metastatic HER2 positive Breast Cancer
9. Metastatic HER2 positive Breast Cancer Current Treatment and Medical Practices
10. Unmet Needs
11. Metastatic HER2 positive Breast Cancer Emerging Therapies
12. Metastatic HER2 positive Breast Cancer Market Outlook
13. Country-Wise Metastatic HER2 positive Breast Cancer Market Analysis (2020-2034)
14. Market Access and Reimbursement of Therapies
15. Market drivers
16. Market barriers
17. Appendix
18. Metastatic HER2 positive Breast Cancer Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

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Related Reports:

Metastatic HER2 positive Breast Cancer Pipeline Insights, DelveInsight

"Metastatic HER2 positive Breast Cancer Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Metastatic HER2 positive Breast Cancer market. A detailed picture of the Metastatic HER2 positive Breast Cancer pipeline landscape is provided, which includes the disease overview and Metastatic HER2 positive Breast Cancer treatment guidelines.

Contact Info:

Kritika Rehani, Team Leader Marketing & Branding
krehani@delveinsight.com
info@delveinsight.com
www.delveinsight.com
+14699457679

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

This release was published on openPR.