Global HER-2 Positive Breast Cancer Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

• The U.S. FDA granted accelerated approval to Enhertu for HER2-positive breast cancer patients who had progressed after two or more prior anti-HER2 therapies. In a clinical trial, Enhertu demonstrated a 60.3% overall response rate with a median duration of response of 14.8 months. However, the drug comes with warnings for serious side effects like interstitial lung disease (ILD) and embryo-fetal toxicity​

• This pivotal clinical trial demonstrated that Enhertu (T-DXd) showed superior efficacy over the previous standard treatment, Kadcyla (T-DM1), in HER2-positive metastatic breast cancer. The study found that T-DXd significantly improved progression-free survival and showed a higher response rate, although it also brought concerns about lung inflammation (ILD). Researchers are exploring its potential in earlier-stage cancers and for other HER2-driven cancers.

HER-2 positive breast cancer represents a distinct subtype characterized by overexpression of the human epidermal growth factor receptor 2 (HER-2). In recent years, the market for HER-2 positive breast cancer treatments has seen significant growth owing to advancements in targeted therapies. One prominent segment within this market comprises HER-2 targeted therapies, such as trastuzumab and pertuzumab, which have revolutionized treatment outcomes for patients. These drugs work by specifically targeting the HER-2 protein, thereby inhibiting cancer cell growth and improving survival rates.

Another key segment in the HER-2 positive breast cancer market is diagnostics. Accurate and timely diagnosis is crucial for effective treatment planning. Diagnostic tests such as immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) are commonly used to determine HER-2 status in breast cancer patients. The development of more sensitive and specific diagnostic tools has enhanced the ability to identify patients who may benefit from HER-2 targeted therapies, thereby driving demand for these diagnostic tests.

The market for supportive care in HER-2 positive breast cancer constitutes an essential segment. Patients undergoing HER-2 targeted therapies may experience side effects such as cardiotoxicity and infusion-related reactions. As a result, supportive care medications and interventions play a vital role in managing these adverse effects and improving patients' quality of life. Additionally, supportive care encompasses psychological support, nutritional guidance, and symptom management, addressing the holistic needs of patients navigating through their treatment journey. In conclusion, the HER-2 positive breast cancer market comprises several key segments, including targeted therapies, diagnostics, and supportive care, all of which contribute to improving patient outcomes and quality of life.

Global HER-2 Positive Breast Cancer Segment Analysis

In this report, the Global HER-2 Positive Breast Cancer Market has been segmented by Therapy Type, Molecule Type, Administration Route and Geography.

Global HER-2 Positive Breast Cancer Market, Segmentation by Therapy Type

The Global HER-2 Positive Breast Cancer Market has been segmented by Therapy Type into Chemotherapy, Targeted Therapy and Hormone Therapy.

HER-2 positive breast cancer is a subtype characterized by the overexpression of human epidermal growth factor receptor 2 (HER-2), which drives tumor growth and progression. The treatment landscape for HER-2 positive breast cancer is diverse, comprising various therapeutic approaches aimed at targeting HER-2 signaling pathways. One crucial segmentation within this market is based on therapy type, which includes targeted therapies, chemotherapy, and hormonal therapies.

Targeted therapies represent a cornerstone in the management of HER-2 positive breast cancer. These therapies specifically target the HER-2 protein or its signaling pathways, thereby inhibiting tumor growth. Monoclonal antibodies such as trastuzumab and pertuzumab, which block HER-2 receptors, have shown significant efficacy in both early and advanced stages of HER-2 positive breast cancer. Additionally, small molecule tyrosine kinase inhibitors like lapatinib further complement targeted therapy options by inhibiting HER-2 receptor signaling intracellularly.

Chemotherapy remains a vital component of treatment for HER-2 positive breast cancer, particularly in combination with targeted therapies or as neoadjuvant and adjuvant therapy. Anthracyclines, taxanes, and platinum-based agents are commonly used chemotherapeutic agents either alone or in combination regimens to achieve tumor shrinkage and improve overall survival outcomes. Chemotherapy is often administered in conjunction with targeted therapies to enhance treatment response and reduce the risk of disease recurrence.

Global HER-2 Positive Breast Cancer Market, Segmentation by Molecule Type

The Global HER-2 Positive Breast Cancer Market has been segmented by Molecule Type into Biologics and Small Molecules.

Global HER-2 positive breast cancer market segmentation by molecule type reveals diverse therapeutic approaches aimed at targeting the HER-2 protein, a key driver of this aggressive form of breast cancer. Monoclonal antibodies (mAbs) represent a significant portion of treatment options, functioning by binding to HER-2 receptors and inhibiting downstream signaling pathways that promote cancer growth. Examples include trastuzumab and pertuzumab, both widely used in combination therapy regimens to enhance treatment efficacy.

Another prominent category comprises tyrosine kinase inhibitors (TKIs), which work by blocking the tyrosine kinase activity of the HER-2 receptor, thereby impeding cell proliferation and survival signaling. Drugs like lapatinib fall into this class, often utilized either in combination with other HER-2 targeted therapies or as part of sequential treatment strategies. Additionally, antibody-drug conjugates (ADCs) represent an innovative approach combining the specificity of monoclonal antibodies with the cytotoxic potency of chemotherapy agents. ADCs such as ado-trastuzumab emtansine (T-DM1) deliver chemotherapy directly to HER-2 positive cancer cells, minimizing systemic toxicity while maximizing therapeutic benefit.

The segmentation by molecule type underscores the evolving landscape of HER-2 positive breast cancer treatment, characterized by the continual development of novel therapeutics aimed at improving patient outcomes and quality of life. These diverse molecular approaches not only reflect the complexity of HER-2 signaling pathways but also highlight the concerted efforts of pharmaceutical companies and researchers to address unmet medical needs in this challenging disease setting.

Global HER-2 Positive Breast Cancer Market, Segmentation by Administration Route

The Global HER-2 Positive Breast Cancer Market has been segmented by Administration Route into Oral and Parenteral.

In the realm of HER-2 positive breast cancer treatment, the segmentation by administration route plays a pivotal role in determining the efficacy and patient experience. One primary route of administration is oral medication, wherein patients take prescribed pills or capsules. This method offers convenience and flexibility, allowing patients to adhere to their treatment regimen more effectively. Oral medications for HER-2 positive breast cancer often include targeted therapies such as tyrosine kinase inhibitors or hormone therapies, offering a non-invasive option for managing the disease.

Another significant administration route is intravenous (IV) infusion, which involves delivering medications directly into the bloodstream through a vein. IV infusion is commonly utilized for chemotherapy drugs and certain targeted therapies in HER-2 positive breast cancer treatment. While this method may require hospital or clinic visits for administration, it allows for precise dosage control and immediate delivery of medications throughout the body. Additionally, healthcare professionals can monitor patients closely during IV infusion sessions, ensuring safety and efficacy.

Subcutaneous injection represents another administration route for HER-2 positive breast cancer treatment. This method involves injecting medications into the fatty layer of tissue beneath the skin, where they are gradually absorbed into the bloodstream. Subcutaneous injections are often preferred for certain targeted therapies and supportive care medications, offering a balance between convenience and effectiveness. Patients may receive subcutaneous injections at home or in a clinical setting, depending on the specific treatment protocol and healthcare provider's recommendations.

The segmentation of the HER-2 positive breast cancer market by administration route reflects the diverse approaches to treatment delivery and patient care. Each administration method presents unique benefits and considerations, allowing healthcare providers to tailor treatment plans to individual patient needs and preferences. By understanding the characteristics and implications of different administration routes, stakeholders can optimize therapeutic outcomes and enhance the overall management of HER-2 positive breast cancer.

Global HER-2 Positive Breast Cancer Market, Segmentation by Geography

In this report, the Global HER-2 Positive Breast Cancer Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Global HER-2 Positive Breast Cancer Market Share (%), by Geographical Region, 2024

In North America, the market for HER-2 positive breast cancer treatments continues to flourish, primarily driven by advanced healthcare infrastructure and substantial investments in research and development. The region boasts a high prevalence rate of HER-2 positive breast cancer cases, prompting pharmaceutical companies to focus on innovative therapies and targeted treatments. Additionally, favorable reimbursement policies and increasing awareness among patients further contribute to the growth of the market in North America.

In Europe, the landscape of HER-2 positive breast cancer treatment is marked by significant advancements in personalized medicine and molecular diagnostics. Countries across the region prioritize early detection and comprehensive treatment strategies, leading to a robust market for HER-2 targeted therapies and immunotherapies. Moreover, collaborative efforts between research institutions and pharmaceutical companies foster a conducive environment for the development of novel therapeutics, driving market expansion in Europe.

Across the Asia Pacific region, the HER-2 positive breast cancer market is witnessing rapid growth, propelled by rising incidences of breast cancer and improving healthcare infrastructure. Countries such as China, India, and Japan are at the forefront of market expansion, fueled by increasing investments in oncology research and clinical trials. Moreover, partnerships between multinational pharmaceutical companies and local healthcare providers facilitate access to innovative treatments, addressing the unmet medical needs of patients in the region.

This report provides an in depth analysis of various factors that impact the dynamics of Global HER-2 Positive Breast Cancer Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Key players in Global HER-2 Positive Breast Cancer Market include:

• Celgene
• F. Hoffmann-La Roche
• GlaxoSmithKline
• Novartis
• Sanofi
• Herceptin
• Kadcyla
• Perjeta
• Tykerb.

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis