HER-2 Positive Breast Cancer Market
By Therapy Type;
Chemotherapy, Targeted Therapy Immunotherapy, and OthersBy Distribution Channel;
Hospital Pharmacy, Online Pharmacy, and Retail PharmacyBy Administration Route;
Oral and ParenteralBy End User;
Hospitals, Homecare, Speciality Centres, and OthersBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America - Report Timeline (2021 - 2031)Introduction
Global HER-2 Positive Breast Cancer Market (USD Million), 2021 - 2031
In the year 2024, the Global HER-2 Positive Breast Cancer Market was valued at USD 10,415.51 million. The size of this market is expected to increase to USD 14,126.66 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 4.5%.
HER-2 Positive Breast Cancer Market
*Market size in USD million
CAGR 4.5 %
Study Period | 2025 - 2031 |
---|---|
Base Year | 2024 |
CAGR (%) | 4.5 % |
Market Size (2024) | USD 10,415.51 Million |
Market Size (2031) | USD 14,126.66 Million |
Market Concentration | High |
Report Pages | 322 |
Major Players
- Celgene
- F. Hoffmann-La Roche
- GlaxoSmithKline
- Novartis
- Sanofi
- Herceptin
- Kadcyla
- Perjeta
- Tykerb.
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
HER-2 Positive Breast Cancer Market
Fragmented - Highly competitive market without dominant players
Breast cancer, a significant health concern worldwide, encompasses various subtypes. Among them, HER-2 positive breast cancer stands out as a distinct subtype characterized by overexpression of the human epidermal growth factor receptor 2 (HER-2). This subtype represents a formidable challenge in oncology due to its aggressive nature and potential for metastasis.
The advent of targeted therapies has revolutionized the management of HER-2 positive breast cancer, offering patients more effective treatment options and improved outcomes. Drugs such as trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1) have become cornerstone therapies, demonstrating remarkable efficacy in both early and metastatic settings.
Despite the advancements in treatment, challenges persist in the global landscape of HER-2 positive breast cancer management. Access to innovative therapies remains unequal across regions, presenting disparities in patient outcomes. Moreover, resistance to existing targeted agents and the emergence of new therapeutic modalities underscore the need for ongoing research and development efforts to address the evolving needs of patients with HER-2 positive breast cancer.
Global HER-2 Positive Breast Cancer Market Recent Developments
-
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 Market Segment Analysis
In this report, the HER-2 Positive Breast Cancer Market has been segmented by Therapy Type, Molecule Type, Administration Route,End User and Geography.
HER-2 Positive Breast Cancer Market, Segmentation by Therapy Type
The HER-2 Positive Breast Cancer Market has been segmented by Therapy Type into Chemotherapy, Targeted Therapy and Hormone Therapy.
Chemotherapy
Chemotherapy remains a widely used treatment option for HER-2 positive breast cancer, especially in cases with aggressive tumor growth. It works by targeting rapidly dividing cancer cells and can be used alone or in combination with other therapies. Studies indicate that around 40-50% of HER-2 positive patients receive chemotherapy as part of their treatment plan. While effective, chemotherapy is often associated with side effects such as nausea, fatigue, and hair loss, which are important considerations in patient care.
Targeted Therapy
Targeted therapies have revolutionized the treatment of HER-2 positive breast cancer by specifically attacking cancer cells that overexpress the HER-2 protein. Monoclonal antibodies and tyrosine kinase inhibitors are common examples, improving survival rates significantly. Approximately 60-70% of patients benefit from targeted therapy either as a first-line treatment or in combination with chemotherapy. These therapies have shown to reduce tumor progression and enhance patient outcomes with comparatively fewer systemic side effects.
Hormone Therapy
Hormone therapy is used primarily for patients whose HER-2 positive tumors also express hormone receptors like estrogen or progesterone. By blocking hormone activity, these therapies can slow or stop tumor growth. Around 20-30% of HER-2 positive patients receive hormone therapy as a part of their treatment regimen. Hormone therapy is generally well-tolerated, providing an effective long-term treatment option with fewer acute adverse effects compared to chemotherapy.
HER-2 Positive Breast Cancer Market, Segmentation by Molecule Type
The HER-2 Positive Breast Cancer Market has been segmented by Molecule Type into Biologics and Small Molecules.
Biologics
Biologics have become a cornerstone in the management of HER-2 positive breast cancer due to their ability to precisely target the HER-2 protein. This category includes monoclonal antibodies and antibody-drug conjugates, which have demonstrated significant reductions in tumor growth. Currently, 55-65% of HER-2 positive patients receive biologics as either standalone therapy or alongside chemotherapy. Their use is linked to better survival outcomes and generally lower incidence of severe side effects, enhancing the overall quality of patient care.
Small Molecules
Small molecules are synthetic drugs that inhibit key intracellular pathways driving HER-2 positive breast cancer. Tyrosine kinase inhibitors are a prominent example, effectively preventing tumor proliferation and disease progression. Roughly 30-40% of patients benefit from small molecule therapy, often combined with other treatments. These drugs offer convenient oral administration and a strong tolerability profile, making them an attractive option for long-term management.
HER-2 Positive Breast Cancer Market, Segmentation by Administration Route
The HER-2 Positive Breast Cancer Market has been segmented by Administration Route into Oral and Parenteral.
Oral
Oral administration is favored for its convenience, allowing patients to take HER-2 positive breast cancer treatments at home, thereby improving treatment adherence and overall quality of life. This method is commonly used for small molecule drugs, including tyrosine kinase inhibitors, covering roughly 35-45% of the patient population. Oral therapies support flexible dosing and effective tumor suppression, though monitoring for gastrointestinal effects and drug interactions is essential for safety.
Parenteral
Parenteral administration delivers therapy via intravenous or subcutaneous routes and is widely used for biologics like monoclonal antibodies. Approximately 55-65% of HER-2 positive patients receive parenteral treatments, which ensure precise dosing control, high bioavailability, and rapid therapeutic effect. While highly effective, parenteral therapies require clinical supervision and careful management of potential infusion-related reactions.
HER-2 Positive Breast Cancer Market, Segmentation by End User
The HER-2 Positive Breast Cancer Market has been segmented End User into Hospitals, Homecare, Speciality Centres, and Others
Hospitals
Hospitals serve as the primary end users for HER-2 positive breast cancer therapies, providing a full range of treatments, including chemotherapy, targeted therapy, and biologics. Around 50-60% of patients receive care in hospital settings due to access to advanced diagnostics and experienced oncologists. Hospitals ensure controlled treatment administration, continuous monitoring, and prompt management of side effects, delivering high-quality patient care.
Homecare
Homecare services are gaining popularity for HER-2 positive patients, especially for oral therapies and long-term maintenance. Approximately 15-20% of patients receive treatment at home, enjoying comfort and convenience while minimizing hospital visits. Homecare supports treatment adherence, patient comfort, and reduced healthcare costs, although careful monitoring is essential for safe therapy.
Specialty Centres
Specialty centres provide focused cancer care with access to targeted therapies, hormone treatments, and biologics under expert supervision. Roughly 20-25% of patients are treated in these centers, benefiting from advanced diagnostics, personalized treatment plans, and clinical trial opportunities. These centers optimize outcomes through expert guidance and specialized care.
Others
The Others category includes outpatient clinics, research institutes, and smaller healthcare facilities offering HER-2 positive treatments. About 5-10% of patients are treated in these settings, catering to niche needs such as experimental therapies or supportive care. This segment highlights flexibility, patient convenience, and research-driven treatment approaches.
HER-2 Positive Breast Cancer Market, Segmentation by Geography
In this report, the 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.
Regions and Countries Analyzed in this Report
HER-2 Positive Breast Cancer Market Share (%), by Geographical Region
North America
North America leads the HER-2 positive breast cancer market with advanced healthcare infrastructure, high adoption of targeted therapies, and strong patient awareness. The region contributes approximately 35-40% of the global market. Access to cutting-edge diagnostics, research initiatives, and favorable reimbursement policies ensures widespread treatment accessibility.
Europe
Europe represents a significant share of the HER-2 positive breast cancer market, with around 25-30% of global patients. Countries such as Germany, France, and the UK are at the forefront of biologics adoption and specialty cancer care. Strong healthcare policies, early diagnosis programs, and increasing patient awareness are key drivers in this region.
Asia Pacific
The Asia Pacific region is experiencing rapid growth in the HER-2 positive breast cancer market, accounting for approximately 20-25% of global patients. Expansion of hospital networks, improved access to advanced therapies, and rising patient awareness are accelerating market growth, particularly in China, India, and Japan.
Middle East and Africa
The Middle East and Africa market contributes around 5-7% of the global HER-2 positive breast cancer market. Growth is fueled by increased healthcare investments, enhanced oncology services, and government-led early diagnosis initiatives. While access to advanced therapies remains limited in some areas, urban centers are progressively adopting targeted treatment protocols.
Latin America
Latin America holds approximately 8-10% of the global HER-2 positive breast cancer market. Growth is driven by rising cancer awareness, expansion of hospital and specialty care facilities, and increasing access to biologics and small molecule therapies. Improving diagnostic infrastructure and patient access to modern treatments is a key focus in this region.
Market Trends
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
Drivers:
- Targeted Therapies Advancements
- Increased Awareness and Early Detection Initiatives
-
Growing Investment in Research and Development - The global market for HER-2 positive breast cancer is witnessing a surge in investment towards research and development initiatives. With an increasing understanding of the molecular mechanisms underlying HER-2 positive breast cancer, pharmaceutical companies and research institutions are directing significant resources into discovering novel therapeutic approaches and improving existing treatment modalities. This heightened investment is driven by the pressing need to address the challenges posed by HER-2 positive breast cancer, including resistance to current therapies and the desire to enhance patient outcomes through personalized medicine strategies.
The growing prevalence of HER-2 positive breast cancer worldwide has further fueled investment in research and development efforts. As the incidence of this aggressive form of breast cancer continues to rise, there is a corresponding urgency to develop more effective targeted therapies and diagnostic tools. Consequently, stakeholders across the healthcare industry are collaborating to accelerate the pace of innovation and bring promising treatments to market. This concerted investment in research and development reflects a commitment to improving the standard of care for patients with HER-2 positive breast cancer and ultimately reducing the global burden of this disease.
Restraints:
- High Treatment Costs
- Limited Access to Advanced Healthcare in Developing Regions
-
Resistance to HER-2 Targeted Therapies - While HER2-targeted therapies have revolutionized the treatment of HER2-positive breast cancer, a significant challenge lies in the emergence of drug resistance. This resistance can develop through various mechanisms, including tumor cells finding ways to bypass the targeted pathway or developing mutations in the HER2 gene itself. As a result, a proportion of patients eventually experience their cancer progressing despite initial therapy.
This resistance creates a roadblock in the HER2-positive breast cancer market. On one hand, the development of new and improved HER2-targeted therapies remains a key area of research, with the goal of overcoming existing resistance mechanisms. On the other hand, the presence of resistance also necessitates exploring alternative treatment options, such as immunotherapies or drugs targeting different cancer pathways, for patients who no longer respond to HER2-targeted drugs.
Opportunities:
- Emerging Markets Expansion
- Personalized Medicine and Biomarker Development
-
Innovative Treatment Approaches like Immunotherapy - The global HER-2 positive breast cancer market is projected to experience modest growth, driven by the development of innovative treatment approaches like immunotherapy. Immunotherapy harnesses the body's own immune system to fight cancer cells, offering a promising new avenue for treating HER-2 positive breast cancer. These novel therapies have the potential to improve treatment efficacy and reduce side effects compared to traditional chemotherapy options.
The influx of new drugs targeting the HER-2 protein, along with ongoing clinical trials for next-generation immunotherapies, is expected to invigorate the market. This expanding treatment landscape empowers physicians to tailor therapies to individual patient needs, potentially leading to improved clinical outcomes and a more positive prognosis for HER-2 positive breast cancer patients.
Competitive Landscape 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
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Therapy Type
- Market Snapshot, By Distribution Channel
- Market Snapshot, By Administration Route
- Market Snapshot, By End User
- Market Snapshot, By Region
- HER-2 Positive Breast Cancer Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Targeted Therapies Advancements
- Increased Awareness and Early Detection Initiatives
- Growing Investment in Research and Development
- Restraints
- High Treatment Costs
- Limited Access to Advanced Healthcare in Developing Regions
- Resistance to HER-2 Targeted Therapies
- Opportunities
- Emerging Markets Expansion
- Personalized Medicine and Biomarker Development
- Innovative Treatment Approaches like Immunotherapy
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- HER-2 Positive Breast Cancer Market, By Therapy Type, 2021 - 2031 (USD Million)
- Chemotherapy
- Targeted Therapy
- Immunotherapy
- Others
- HER-2 Positive Breast Cancer Market, By Distribution Channel, 2021 - 2031 (USD Million)
- Hospital Pharmacy
- Online Pharmacy
- etail Pharmacy
- HER-2 Positive Breast Cancer Market, By Administration Route, 2021 - 2031 (USD Million)
- Oral
- Parenteral
-
HER-2 Positive Breast Cancer Market, By End User, 2021 - 2031 (USD Million)
-
Hospitals
-
Homecare
-
Speciality Centres
-
Others
-
- HER-2 Positive Breast Cancer Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- HER-2 Positive Breast Cancer Market, By Therapy Type, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Celgene
- F. Hoffmann-La Roche
- GlaxoSmithKline
- Novartis
- Sanofi
- Herceptin
- Kadcyla
- Perjeta
- Tykerb.
- Company Profiles
- Analyst Views
- Future Outlook of the Market