HER2 Positive Breast Cancer Treatment Market 2034: EMA, PDMA, FDA Approval, Clinical Trials, Medication, Prevalence, Revenue, Statistics and Companies by DelveInsight

(Albany, USA) DelveInsight's "HER2 Positive Breast Cancer Market Insights, Epidemiology, and Market Forecast-2034′′ report offers 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, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The HER2 Positive Breast Cancer market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage HER2 Positive Breast Cancer pipeline products will significantly revolutionize the HER2 Positive Breast Cancer market dynamics.

The HER2 Positive Breast Cancer market report covers emerging drugs, current treatment practices, market share of the individual therapies, and current & forecasted market size from 2020 to 2034. It also evaluates the current treatment practice/algorithm, market drivers & barriers, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

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Some of the key facts of the HER2 Positive Breast Cancer Market Report:
• The HER2 Positive Breast Cancer market size is anticipated to grow with a significant CAGR during the study period (2020-2034)
• In March 2025, The FDA awarded orphan drug designation to Nerlynx® (neratinib) for treating breast cancer patients with brain metastases. Neratinib, a tyrosine kinase inhibitor, is already approved for extended adjuvant therapy in HER2-positive breast cancer following trastuzumab treatment.
• In February 2025, Shanghai Henlius Biotech announced that the U.S. FDA has accepted its Biologics License Application (BLA) for HLX11, a biosimilar of Perjeta® (pertuzumab). This milestone strengthens the company's expansion into the U.S. market for HER2-positive breast cancer treatment, following positive Phase 3 trial results and a global commercialization deal with Organon.
• In September 2024, A study presented at the ESMO Congress revealed that AstraZeneca and Daiichi Sankyo's Enhertu offers benefits to women with HER2-positive breast cancer, including those with brain metastases. Findings from the DESTINY-Breast12 trial showed that 61.6% of patients with brain metastases remained progression-free after one year, with a central nervous system progression-free survival rate of 58.9%, regardless of whether the metastases were stable or progressing. These results highlight Enhertu's potential in effectively treating HER2-positive breast cancer with brain involvement.
• The rise in the number of incident cases, along with a rapidly evolving treatment landscape, are the Key driver of the market's growth
• Latest results from two phase III trials i.e. phase III DESTINYBREAST03 and phase III trial of antibody-drug conjugates targeting HER2 in patients with HER2-positive metastatic breast cancer may prove to be practice changing, as reported at the ESMO Congress 2021
• According to the American Cancer Society and National Cancer Institute, HER2 Positive Breast Cancers only constitute 14-15% of all female breast cancer cases
• According to NICE (National Institute for Health and Care Excellence), around 7000 people diagnosed each year in England with early breast cancer have HER2-positive disease
• Key HER2 Positive Breast Cancer Companies: AdaptVac, Voronoi, Dizal Pharmaceuticals, Alteogen, Inc, Precirix, BioInvent International, Miracogen Inc., Alphamab BioPharmaceuticals, CSPC ZhongQi Pharmaceutical Technology, Jiangsu HengRui Medicine Co., Ltd, Shanghai Henlius Biotech, Ambrx, Genentech, Innate Pharma, EirGenix, GeneQuantum Healthcare Co., Ltd., and others
• Key HER2 Positive Breast Cancer Therapies: ES2B C001, VRN 10, DZD1516, ALT-P7, CAM-H2, BI-1607+ trastuzumab, MRG002 Shanghai, KN-026 Jiangsu, DP 303c, SHR-A1811, HLX11, ARX 788, Inavolisib, Monalizumab, Pertuzumab, GQ1001, and others
• The HER2 Positive Breast Cancer epidemiology based on gender analyzed that HER2 Positive Breast Cancer is mainly found in females and males account for less than 1% of cases

HER2 Positive Breast Cancer Overview
HER2-positive breast cancer is a type of breast cancer where cancer cells have high levels of the human epidermal growth factor receptor 2 (HER2) protein. This protein promotes the growth of cancer cells, making HER2-positive breast cancer more aggressive than other types. It accounts for about 15-20% of breast cancer cases. However, targeted therapies like trastuzumab (Herceptin), pertuzumab, and trastuzumab deruxtecan (Enhertu) have significantly improved outcomes by specifically targeting the HER2 protein. Early detection and HER2 testing are essential for guiding treatment decisions.

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HER2 Positive Breast Cancer Market
The dynamics of the HER2 Positive Breast Cancer market are anticipated to change in the coming years owing to the expected launch of emerging therapies and others during the forecast period 2024-2034

HER2 Positive Breast Cancer Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

HER2 Positive Breast Cancer Epidemiology Segmentation:
The HER2 Positive Breast Cancer market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:
• Total Prevalence of HER2 Positive Breast Cancer
• Prevalent Cases of HER2 Positive Breast Cancer by severity
• Gender-specific Prevalence of HER2 Positive Breast Cancer
• Diagnosed Cases of Episodic and Chronic HER2 Positive Breast Cancer

Download the report to understand which factors are driving HER2 Positive Breast Cancer epidemiology trends @ HER2 Positive Breast Cancer Epidemiological Insights
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HER2 Positive Breast Cancer Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the HER2 Positive Breast Cancer market or expected to get launched during the study period. The analysis covers HER2 Positive Breast Cancer market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the HER2 Positive Breast Cancer Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

HER2 Positive Breast Cancer Therapies and Key Companies
• ES2B C001: AdaptVac
• VRN 10: Voronoi
• DZD1516: Dizal Pharmaceuticals
• ALT-P7: Alteogen, Inc
• CAM-H2: Precirix
• BI-1607+ trastuzumab: BioInvent International
• MRG002 Shanghai: Miracogen Inc.
• KN-026 Jiangsu: Alphamab BioPharmaceuticals
• DP 303c: CSPC ZhongQi Pharmaceutical Technology
• SHR-A1811: Jiangsu HengRui Medicine Co., Ltd
• HLX11: Shanghai Henlius Biotech
• ARX 788: Ambrx
• Inavolisib: Genentech
• Monalizumab: Innate Pharma
• Pertuzumab: EirGenix
• GQ1001: GeneQuantum Healthcare Co., Ltd.

To know more about HER2 Positive Breast Cancer treatment, visit @ HER2 Positive Breast Cancer Medications
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HER2 Positive Breast Cancer Market Drivers
• Rising Incidence of Breast Cancer
• Advancements in Targeted Therapies
• Favorable Regulatory Support
• Increased Awareness and Screening
• Personalized Medicine Growth

HER2 Positive Breast Cancer Market Barriers
• High Cost of Therapy
• Therapy Resistance
• Limited Access to Advanced Treatments
• Complex R&D Requirements
• Patent Expirations

Scope of the 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 HER2 Positive Breast Cancer Companies: AdaptVac, Voronoi, Dizal Pharmaceuticals, Alteogen, Inc, Precirix, BioInvent International, Miracogen Inc., Alphamab BioPharmaceuticals, CSPC ZhongQi Pharmaceutical Technology, Jiangsu HengRui Medicine Co., Ltd, Shanghai Henlius Biotech, Ambrx, Genentech, Innate Pharma, EirGenix, GeneQuantum Healthcare Co., Ltd., and others
• Key HER2 Positive Breast Cancer Therapies: ES2B C001, VRN 10, DZD1516, ALT-P7, CAM-H2, BI-1607+ trastuzumab, MRG002 Shanghai, KN-026 Jiangsu, DP 303c, SHR-A1811, HLX11, ARX 788, Inavolisib, Monalizumab, Pertuzumab, GQ1001, and others
• HER2 Positive Breast Cancer Therapeutic Assessment: HER2 Positive Breast Cancer current marketed and HER2 Positive Breast Cancer emerging therapies
• HER2 Positive Breast Cancer Market Dynamics: HER2 Positive Breast Cancer market drivers and HER2 Positive Breast Cancer market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• HER2 Positive Breast Cancer Unmet Needs, KOL's views, Analyst's views, HER2 Positive Breast Cancer Market Access and Reimbursement

Discover more about therapies set to grab major HER2 Positive Breast Cancer market share @ HER2 Positive Breast Cancer Treatment Landscape
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Table of Contents
1. HER2 Positive Breast Cancer Market Report Introduction
2. Executive Summary for HER2 Positive Breast Cancer
3. SWOT analysis of HER2 Positive Breast Cancer
4. HER2 Positive Breast Cancer Patient Share (%) Overview at a Glance
5. HER2 Positive Breast Cancer Market Overview at a Glance
6. HER2 Positive Breast Cancer Disease Background and Overview
7. HER2 Positive Breast Cancer Epidemiology and Patient Population
8. Country-Specific Patient Population of HER2 Positive Breast Cancer
9. HER2 Positive Breast Cancer Current Treatment and Medical Practices
10. HER2 Positive Breast Cancer Unmet Needs
11. HER2 Positive Breast Cancer Emerging Therapies
12. HER2 Positive Breast Cancer Market Outlook
13. Country-Wise HER2 Positive Breast Cancer Market Analysis (2020-2034)
14. HER2 Positive Breast Cancer Market Access and Reimbursement of Therapies
15. HER2 Positive Breast Cancer Market Drivers
16. HER2 Positive Breast Cancer Market Barriers
17. HER2 Positive Breast Cancer Appendix
18. HER2 Positive Breast Cancer Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

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