Metastatic HER2 positive Breast Cancer Treatment Market Size in 7MM is expected to grow at a decent CAGR by 2034, estimates DelveInsight

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.

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Key Takeaways from the Metastatic HER2 positive Breast Cancer Market Report
• In May 2025, Jazz Pharmaceuticals announced a study is to compare the efficacy of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy. The secondary objectives of the study will include further comparing the efficacy, safety and tolerability, patient-reported tolerability, and patient-reported physical functioning of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy. The pharmacokinetics and immunogenicity of zanidatamab in combination with chemotherapy will also be evaluated.
• In May 2025, Puma Biotechnology Inc. announced a phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy.
• In May 2025, CSPC ZhongQi Pharmaceutical Technology Co., Ltd. conducted a study is a multicenter, open, non-randomized phase II clinical trial consisting of a safety introduction phase followed by a single-arm phase 2 phase. This phase II trial enrolled patients with HR+/HER2- advanced breast cancer who had failed aromatase inhibitor (AI)/fulvestrant ± CDK4/6i. Pts failing prior AI ± CDK4/6i received nab-Sirolimus + fulvestrant, while those failing fulvestrant ± CDK4/6i received nab-Sirolimus + AI.
• 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.
• The leading Metastatic HER2 positive Breast Cancer Companies such as Novartis, Byondis, Pfizer, Merck Sharp & Dohme, Seagen, Alphamab Oncology, Zymeworks/ALX Oncology and Roche and others.
• Promising Metastatic HER2 positive Breast Cancer Pipeline Therapies such as HERCEPTIN (trastuzumab), PERJETA (pertuzumab), BYL719 (alpelisib), SYD985 (Trastuzumab duocarmazine), and others.

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Metastatic HER2 positive Breast Cancer Epidemiology Segmentation in the 7MM
• 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
• Treatment-eligible Cases of HER2-positive Breast Cancer

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Metastatic HER2 positive Breast Cancer Marketed Drugs
• ENHERTU (fam-trastuzumab deruxtecan-nxk): Daiichi Sankyo/AstraZeneca
ENHERTU is a HER2-directed ADC. Designed using Daiichi Sankyo's proprietary DXd ADC technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca's ADC scientific platform. ENHERTU comprises a HER2 monoclonal antibody attached to topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker. In December 2019, the FDA approved ENHERTU for treating adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. This indication was approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. In January 2021, ENHRTU got FDA approval in a second-line setting.

• KADCYLA (ado-trastuzumab emtansine): Roche/Chugai
KADCYLA is an antibody-drug conjugate. It comprises the anit-HER2 humanized monoclonal antibody, trastuzumab, and a chemotherapeutic drug, DM1, attached using a stable linker. In February 2013, the FDA approved KADCYLA for treating people with HER2-positive metastatic breast cancer who have received prior treatment with HERCEPTIN (trastuzumab) and taxane chemotherapy. KADCYLA became the standard of care in the second-line setting with a significant market share; however, after approval in the second line, ENHERTU has replaced KADCYLA and became the standard of care in the second-line. In 2019, KADCYLA got approval for early breast cancer, giving Roche a much-needed booster.

Metastatic HER2 positive Breast Cancer Emerging Drugs
• ARX788: Ambrx
ARX788, an anti-HER2 ADC, is currently being investigated in multiple clinical trials for the treatment of breast cancer, gastric/gastroesophageal junction (GEJ) cancer, and other solid tumors, including ongoing Phase II/III clinical trials for the treatment of HER2-positive metastatic breast cancer and gastric cancer.

• Zanidatamab: Zymeworks/Jazz Pharmaceuticals
Zanidatamab is an investigational bispecific antibody based on Zymeworks' Azymetric platform that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. Zymeworks, along with collaborators Jazz and BeiGene, are developing zanidatamab in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Currently, the drug is being evaluated in a Phase II clinical trial for treating HER2-positive breast cancer.

To learn more about Metastatic HER2 positive Breast Cancer Treatment guidelines, visit @ Metastatic HER2 positive Breast Cancer Treatment Market Landscape- https://www.delveinsight.com/sample-request/metastatic-her2-positive-breast-cancer-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Metastatic HER2 positive Breast Cancer Companies
Novartis, Byondis, Pfizer, Merck Sharp & Dohme, Seagen, Alphamab Oncology, Zymeworks/ALX Oncology and Roche and others.

Metastatic HER2 positive Breast Cancer Market Outlook
Numerous treatment options for HER2-positive breast cancer are available, falling into pharmacological and nonpharmacological categories. 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. Patients with metastatic HER2+ breast cancer were traditionally treated with conventional chemotherapy regimens until trastuzumab became available. Roche responded actively to the rise of biosimilars by introducing a subcutaneous (SC) formulation of HERCEPTIN in the EU in 2013 and the US in 2019, despite the availability of biosimilars. In continuing efforts of Roche to extend the HER2 franchise, Roche's first ADC, KADCYLA, received approval from the FDA in 2013 for HER2-positive metastatic breast cancer treatment after prior treatment with Roche's own HERCEPTIN and chemotherapy. The second ADC to gain approval from the FDA and EMA is ENHERTU (trastuzumab deruxtecan). This achievement could disrupt the second-line treatment landscape and be a game-changer for AstraZeneca and Daiichi.

Learn more about the FDA-approved drugs for Metastatic HER2 positive Breast Cancer @ Drugs for Metastatic HER2 positive Breast Cancer Treatment- https://www.delveinsight.com/sample-request/metastatic-her2-positive-breast-cancer-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Scope of the Metastatic HER2 positive Breast Cancer Market Report
• Coverage- 7MM
• Study Period- 2020-2034
• Metastatic HER2 positive Breast Cancer Companies- Novartis, Byondis, Pfizer, Merck Sharp & Dohme, Seagen, Alphamab Oncology, Zymeworks/ALX Oncology and Roche and others.
• Metastatic HER2 positive Breast Cancer Pipeline Therapies- HERCEPTIN (trastuzumab), PERJETA (pertuzumab), BYL719 (alpelisib), SYD985 (Trastuzumab duocarmazine), and others.
• Metastatic HER2 positive Breast Cancer Market Dynamics: Metastatic HER2 positive Breast Cancer Market Drivers and Barriers
• Metastatic HER2 positive Breast Cancer Market Access and Reimbursement, Unmet Needs and Future Perspectives

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Table of Content
1 Key Insights
2 Report Introduction
3 Metastatic HER2-positive Breast Cancer Market Overview at a Glance
4 Executive Summary of HER2-positive Breast Cancer
5 Key Events
6 Epidemiology and Market Methodology
7 Disease Background and Overview
8 Epidemiology and Patient Population
9 Patient Journey
10 Key Endpoints in HER2-positive Breast Cancer
11 Marketed Drugs
12 Emerging Drugs
13 HER2-positive Breast Cancer: 7MM Market Analysis
14 HER2-positive Breast Cancer Market Access and Reimbursement
15 Unmet Needs
16 SWOT Analysis
17 KOL Views
18 Appendix
19 DelveInsight Capabilities
20 Disclaimer
21 About DelveInsight

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