HER2-Positive Breast Cancer Drug Market 2032: Clinical Trials, EMA, PDMA, FDA Approvals, Medication, Statistics, Revenue, Therapies and Companies by DelveInsight

(New York, USA) DelveInsight's "HER2-Positive Breast Cancer Market Insights, Epidemiology, and Market Forecast-2032" report delivers an in-depth understanding of 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 report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted HER2-Positive Breast Cancer market size from 2019 to 2032, segmented by seven major markets. The Report also covers current HER2-Positive Breast Cancer treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the HER2-Positive Breast Cancer market.

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Some facts of the HER2-Positive Breast Cancer Market Report are:
• The US currently dominates the HER2-positive breast cancer market, accounting for USD 1.6 billion in 2023. Furthermore, the total market size in EU4 and the UK exceeded USD 800 million in 2023, with projections indicating substantial growth through 2032.
• DelveInsight's epidemiological analysis, total HER2-positive breast cancer incident cases in the 7MM were more than 100K in 2023, with this figure expected to rise throughout the forecast period (2019-2032).
• In March 2025, the FDA granted orphan drug designation to Nerlynx® (neratinib) for breast cancer patients with brain metastases. Neratinib is a tyrosine kinase inhibitor approved for extended adjuvant treatment of HER2-positive breast cancer after trastuzumab therapy.
• In February 2025, Shanghai Henlius Biotech announced that the U.S. FDA has accepted its biologics license application for HLX11, a biosimilar to Perjeta® (pertuzumab). This marks a significant step in expanding the company's U.S. presence in treating HER2-positive breast cancer, following successful Phase 3 trials and a global commercialization agreement with Organon.
• In January 2025, ENHERTU was approved as the first HER2-directed therapy for patients with HER2-low or HER2-ultralow metastatic breast cancer.
• Leading HER2-Positive Breast Cancer companies working in the market are Novartis, Byondis, Pfizer, Merck Sharp & Dohme, Seagen, Alphamab Oncology, Zymeworks, ALX Oncology, Eli Lilly and Company, AstraZeneca, F. Hoffmann-La Roche Ltd., Merck & Co., Inc., Bayer AG, GlaxoSmithKline plc., Takeda Pharmaceutical Company Limited, Novartis AG, Teva Pharmaceuticals Industries Ltd., Baxter, Mylan N.V., Fresenius Kabi AG and Many Others.
• Key HER2-Positive Breast Cancer Therapies expected to launch in the market are HERCEPTIN (trastuzumab), PERJETA (pertuzumab), BYL719 (alpelisib), SYD985 (Trastuzumab duocarmazine), and Others, and Others
• The market growth of HER2+ Breast Cancer may offset by failures and/or discontinuation of the emerging therapies, unaffordable pricing, market access and reimbursement issues, and a scarcity of healthcare specialists.

HER2-Positive Breast Cancer Overview
HER2-Positive Breast Cancer is an aggressive subtype of breast cancer characterized by the overexpression of the human epidermal growth factor receptor 2 (HER2) protein. HER2-Positive Breast Cancer accounts for approximately 15-20% of all breast cancer cases and tends to grow and spread faster than HER2-negative types. HER2-Positive Breast Cancer diagnosis is confirmed through tests like immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). HER2-Positive Breast Cancer treatment typically includes targeted therapies such as trastuzumab (Herceptin), pertuzumab, T-DM1, and newer agents like trastuzumab deruxtecan.

HER2-Positive Breast Cancer patients benefit significantly from early detection and personalized treatment plans. HER2-Positive Breast Cancer prognosis has improved in recent years due to advancements in targeted therapy and precision medicine. HER2-Positive Breast Cancer clinical trials continue to explore novel drug combinations and treatment strategies to further enhance survival outcomes. HER2-Positive Breast Cancer management may also involve surgery, chemotherapy, radiation therapy, and hormonal therapy depending on the stage and receptor status.

HER2-Positive Breast Cancer research focuses on overcoming resistance mechanisms and minimizing side effects. HER2-Positive Breast Cancer awareness is vital for early screening and better patient outcomes. HER2-Positive Breast Cancer support groups and educational resources play a crucial role in patient care and recovery.

Learn more about HER2-Positive Breast Cancer treatment algorithms in different geographies, and patient journeys. Contact to receive a sample @ https://www.delveinsight.com/sample-request/her2-positive-breast-cancer-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

HER2-Positive Breast Cancer Market

The HER2-Positive Breast Cancer market outlook of the report helps to build a detailed comprehension of the historical, current, and forecasted HER2-Positive Breast Cancer market trends by analyzing the impact of current HER2-Positive Breast Cancer therapies on the market and unmet needs, and drivers, barriers, and demand for better technology.

This segment gives a thorough detail of the HER2-Positive Breast Cancer market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated HER2-Positive Breast Cancer market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

The current HER2-positive breast cancer treatment landscape has evolved significantly with the development of targeted therapies that have transformed patient outcomes. Monoclonal antibodies like HERCEPTIN (Roche and Genentech) and PERJETA (Roche) form the backbone of treatment.

The development of antibody-drug conjugates (ADCs), such as ENHERTU (Daiichi Sankyo and AstraZeneca) and KADCYLA (Roche), represents a breakthrough in treating metastatic breast cancer, particularly for HER2-positive subtypes. KADCYLA was the first ADC to gain FDA approval for breast cancer treatment, establishing itself as the standard of care in the second-line setting. In a trial in 2021, ENHERTU demonstrated superior efficacy compared to KADCYLA, establishing itself as the new standard of care in previously treated HER2-positive metastatic breast cancer.

Additionally, kinase inhibitors such as NERLYNX from Puma Biotechnology (NASDAQ: PBYI) and newer entries like MARGENZA from MacroGenics Inc. (NASDAQ: MGNX) provide options for patients who have progressed on earlier therapies.

According to DelveInsight, the HER2-Positive Breast Cancer market in 7MM is expected to witness a major change in the study period 2019-2032.

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HER2-Positive Breast Cancer Epidemiology

The HER2-Positive Breast Cancer epidemiology section provides insights into the historical and current HER2-Positive Breast Cancer patient pool and forecasted trends for seven individual major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the HER2-Positive Breast Cancer market report also provides the diagnosed patient pool, trends, and assumptions.

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HER2-Positive Breast Cancer Drugs Uptake

This section focuses on the uptake rate of the potential HER2-Positive Breast Cancer drugs recently launched in the HER2-Positive Breast Cancer market or expected to be launched in 2019-2032. The analysis covers the HER2-Positive Breast Cancer market uptake by drugs, patient uptake by therapies, and sales of each drug.

HER2-Positive Breast Cancer Drugs Uptake helps in understanding the drugs with the most rapid uptake and the reasons behind the maximal use of new drugs and allows the comparison of the drugs based on HER2-Positive Breast Cancer market share and size, which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

HER2-Positive Breast Cancer Pipeline Development Activities

The HER2-Positive Breast Cancer report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses HER2-Positive Breast Cancer key players involved in developing targeted therapeutics.

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HER2-Positive Breast Cancer Therapeutics Assessment

Major key companies are working proactively in the HER2-Positive Breast Cancer Therapeutics market to develop novel therapies which will drive the HER2-Positive Breast Cancer treatment markets in the upcoming years are Novartis (SWX: NOVN), Byondis, Pfizer (NYSE: PFE), Merck Sharp & Dohme (NYSE: MRK), Seagen (NASDAQ: SGEN), Alphamab Oncology (HKEX: 9966), Zymeworks (NASDAQ: ZYME), ALX Oncology (NASDAQ: ALXO), Eli Lilly and Company (NYSE: LLY), AstraZeneca (LSE: AZN), F. Hoffmann-La Roche Ltd. (SWX: RO), Merck & Co., Inc. (NYSE: MRK), Bayer AG (ETR: BAYN), GlaxoSmithKline plc. (LSE: GSK), Takeda Pharmaceutical Company Limited (TSE: 4502), Novartis AG (SWX: NOVN), Teva Pharmaceuticals Industries Ltd. (NYSE: TEVA), Baxter (NYSE: BAX), Mylan N.V. (NASDAQ: MYL), Fresenius Kabi AG, and others.

Learn more about the emerging HER2-Positive Breast Cancer therapies & key companies @ https://www.delveinsight.com/sample-request/her2-positive-breast-cancer-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

HER2-Positive Breast Cancer Report Key Insights

1. HER2-Positive Breast Cancer Patient Population
2. HER2-Positive Breast Cancer Market Size and Trends
3. Key Cross Competition in the HER2-Positive Breast Cancer Market
4. HER2-Positive Breast Cancer Market Dynamics (Key Drivers and Barriers)
5. HER2-Positive Breast Cancer Market Opportunities
6. HER2-Positive Breast Cancer Therapeutic Approaches
7. HER2-Positive Breast Cancer Pipeline Analysis
8. HER2-Positive Breast Cancer Current Treatment Practices/Algorithm
9. Impact of Emerging Therapies on the HER2-Positive Breast Cancer Market

Table of Contents

1. Key Insights
2. Executive Summary
3. HER2-Positive Breast Cancer Competitive Intelligence Analysis
4. HER2-Positive Breast Cancer Market Overview at a Glance
5. HER2-Positive Breast Cancer Disease Background and Overview
6. HER2-Positive Breast Cancer Patient Journey
7. HER2-Positive Breast Cancer Epidemiology and Patient Population
8. HER2-Positive Breast Cancer Treatment Algorithm, Current Treatment, and Medical Practices
9. HER2-Positive Breast Cancer Unmet Needs
10. Key Endpoints of HER2-Positive Breast Cancer Treatment
11. HER2-Positive Breast Cancer Marketed Products
12. HER2-Positive Breast Cancer Emerging Therapies
13. HER2-Positive Breast Cancer Seven Major Market Analysis
14. Attribute Analysis
15. HER2-Positive Breast Cancer Market Outlook (7 major markets)
16. HER2-Positive Breast Cancer Access and Reimbursement Overview
17. KOL Views on the HER2-Positive Breast Cancer Market
18. HER2-Positive Breast Cancer Market Drivers
19. HER2-Positive Breast Cancer Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer

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