The triple-negative breast cancer market is expected to grow due to rising incidence rates, increasing awareness, advancements in targeted therapies, ongoing clinical trials, improved diagnostics, and greater investment in research and development. Along with these, the launch of emerging therapies such as DATROWAY, PADCEV, BNT327/ PM8002, and others will fuel the TNBC market growth.
LAS VEGAS, July 29, 2025 /PRNewswire/ — DelveInsight’s Triple-Negative Breast Cancer Market Insights report includes a comprehensive understanding of current treatment practices, triple-negative breast cancer emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
Key Takeaways from the Triple-Negative Breast Cancer Market Report
- According to DelveInsight’s analysis, the market size for triple-negative breast cancer was found to be USD 4.5 billion in the 7MM in 2024.
- The United States accounted for the highest market size of TNBC, approximately 69% of the total market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- As per the estimates, among the current treatment options, KEYTRUDA (pembrolizumab) and chemotherapy held the largest TNBC treatment market share, generating approximately USD 2 billion in revenue in 2024 across the 7MM.
- In 2024, 7MM recorded approximately 104K new TNBC cases. With a projected CAGR of 0.7%, the number of cases is expected to gradually rise, leading to a higher disease burden by 2034.
- Leading triple-negative breast cancer companies developing emerging therapies, such as AstraZeneca, Daiichi Sankyo, Astellas Pharma, Pfizer, Galera Therapeutics, BioNTech, and others, are developing new TNBC treatment drugs that can be available in the triple-negative breast cancer market in the coming years.
- The promising triple-negative breast cancer therapies in the pipeline include DATROWAY (Datopotamab Deruxtecan), PADCEV (Enfortumab vedotin), Tilarginine, BNT327/PM8002, IMFINZI (Durvalumab), and others.
Discover the TNBC new treatment @ New Treatments for TNBC
Triple-Negative Breast Cancer Market Dynamics
The triple-negative breast cancer market dynamics are expected to change in the coming years. Combining chemotherapy, immunotherapy, and targeted therapies, such as TALZENNA and TRODELVY, offers enhanced disease control and expands treatment options for advanced-stage TNBC patients, while innovations in immune checkpoint inhibitors, therapeutic vaccines, and ongoing research into personalized approaches are transforming long-term management by boosting immune response, improving survival rates, and addressing the need for more effective, tailored solutions beyond first-line therapy
As potential therapies are being investigated for the treatment of triple-negative breast cancer, it is safe to predict that the treatment space will significantly impact the triple-negative breast cancer market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the triple-negative breast cancer market in the 7MM.
However, several factors may impede the growth of the triple-negative breast cancer market. TNBC is the most difficult breast cancer subtype to manage due to its aggressive nature, lack of targeted treatment options, and high rates of chemotherapy resistance, which contribute to frequent relapse, reduced treatment efficacy, and limited long-term remission, even when diagnosed early; this underscores the urgent need for innovative, effective therapies that not only improve outcomes and prevent disease progression but also minimize the significant side effects of current aggressive treatments like chemotherapy and immunotherapy, which severely impact patient quality of life.
Moreover, triple-negative breast cancer treatment poses a significant economic burden and disrupts patients’ overall well-being and QOL. Furthermore, the triple-negative breast cancer market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the triple-negative breast cancer market growth.
Triple-Negative Breast Cancer Treatment Market
Triple-negative breast cancer lacks expression of hormone receptors and HER2, rendering it unresponsive to endocrine and HER2-targeted therapies. Consequently, systemic chemotherapy has long been the mainstay of treatment, especially in metastatic settings. Management typically starts with neoadjuvant or adjuvant chemotherapy, progressing to first-line treatments in advanced stages. If the disease advances or shows inadequate response, additional lines of therapy are introduced. Immunotherapies, particularly PD-1/PD-L1 inhibitors, are increasingly being utilized in metastatic TNBC to boost the body’s immune defense against cancer cells.
In early-stage TNBC, the PD-1 inhibitor KEYTRUDA (pembrolizumab) has become a standard part of treatment. It is administered with neoadjuvant chemotherapy and then continued as adjuvant monotherapy. In PD-L1-positive patients (CPS ≥10), it is also used alongside chemotherapy for locally recurrent or metastatic disease. Targeted therapies are making headway as well, particularly for patients with BRCA mutations. In such cases, PARP inhibitors like LYNPARZA (olaparib) and TALZENNA (talazoparib) target defective DNA repair pathways. TRODELVY (sacituzumab govitecan), an antibody-drug conjugate (ADC) targeting TROP-2, is approved for relapsed or treatment-resistant metastatic TNBC. Although TECENTRIQ (atezolizumab) was withdrawn from the U.S. market after failing confirmatory trials, it is still available in Europe and Japan.
Taxane-based chemotherapy continues to be a cornerstone of TNBC treatment and is often combined with immune checkpoint inhibitors in PD-L1-positive cases. Platinum-based chemotherapy, though occasionally used, has shown mixed results due to concerns over toxicity and limited benefit. Despite therapeutic progress, TNBC remains a particularly aggressive subtype, underscoring the urgent need for continued innovation.
Overall, current treatments frequently fall short of achieving lasting disease control, highlighting the pressing demand for novel therapies that can improve long-term outcomes and survival for TNBC patients.
To know more about FDA-approved drugs for TNBC, visit @ Approved TNBC Treatment
Triple-Negative Breast Cancer Pipeline Therapies and Key Companies
Some of the drugs in the pipeline include DATROWAY [(Datopotamab Deruxtecan), AstraZeneca and Daiichi Sankyo], IMFINZI [(Durvalumab), AstraZeneca], PADCEV [(Enfortumab vedotin), Astellas Pharma and Pfizer], Tilarginine [(L-NMMA), Galera Therapeutics], and others.
Datopotamab deruxtecan (Dato-DXd), also known as DATROWAY, is an experimental antibody-drug conjugate (ADC) being evaluated for the treatment of triple-negative breast cancer, both as a standalone therapy and in combination with IMFINZI (durvalumab). The therapy is aimed at high-risk TNBC patients, including those who are PD-L1-positive. Results from pivotal Phase III trials are expected in 2025, with more comprehensive findings anticipated by 2026, potentially influencing future treatment approaches for TNBC.
Currently in Phase III development for TNBC, Dato-DXd is part of a global collaboration between AstraZeneca and Daiichi Sankyo, initiated in July 2020. Under this partnership, Daiichi Sankyo retains exclusive rights in Japan and oversees manufacturing and supply, while both companies are co-developing the drug across several cancer types globally.
Tilarginine (L-NMMA), a broad nitric oxide synthase (NOS) inhibitor, is under Phase II investigation for metaplastic breast cancer (MpBC) in combination with alpelisib and nab-paclitaxel in HER2-negative metastatic or locally advanced settings. It is also being explored with a taxane in Phase II trials for patients with metastatic or locally advanced TNBC. In December 2024, Galera Therapeutics acquired Nova Pharmaceuticals.
IMFINZI (durvalumab), an FDA-approved PD-L1 inhibitor developed by AstraZeneca for other cancers, works by blocking PD-L1 to enhance immune system recognition and destruction of tumor cells. It is currently undergoing Phase I/II studies in combination with paclitaxel and other novel therapies as a first-line option for metastatic TNBC (mTNBC), with key data expected by late 2025.
Notably, the BEGONIA trial (October 2023) reported durable and significant tumor responses from the combination of datopotamab deruxtecan and IMFINZI when used as a first-line treatment for patients with mTNBC, along with a favorable safety profile.
The anticipated launch of these emerging therapies are poised to transform the triple-negative breast cancer market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the triple-negative breast cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
Discover more about triple-negative breast cancer drugs in development @ Triple-Negative Breast Cancer Clinical Trials
Recent Developments in the Triple-Negative Breast Cancer Market
- In May 2025, Gilead Sciences, Inc. reported that TRODELVY (sacituzumab govitecan-hziy) combined with KEYTRUDA (pembrolizumab) lowered the risk of disease progression or death by 35% (hazard ratio: 0.65) compared to the standard treatment of Keytruda plus chemotherapy as a first-line therapy for patients with PD-L1–positive (CPS ≥10) metastatic triple-negative breast cancer (TNBC).
- In May 2025, Gilead Sciences, Inc. reported positive topline results from the Phase 3 ASCENT-03 trial evaluating TRODELVY (sacituzumab govitecan-hziy). The study achieved its primary goal by showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy in patients with first-line metastatic triple-negative breast cancer (mTNBC) who are not eligible for PD-1/PD-L1 inhibitors, either due to being PD-L1 negative or otherwise unsuitable for immunotherapy.
- In December 2024, Galera Therapeutics completed the acquisition of Nova Pharmaceuticals.
Triple-Negative Breast Cancer Overview
Triple-negative breast cancer is a particularly aggressive and diverse form of breast cancer that lacks expression of estrogen receptors (ER), progesterone receptors (PR), and HER2. It accounts for a substantial share of breast cancer cases and is associated with fast disease progression, high chances of recurrence, and unfavorable outcomes. TNBC tends to occur more frequently in younger women, individuals of African American descent, and those with BRCA1 gene mutations.
The risk factors for TNBC are divided into two categories: non-modifiable factors, such as age, gender, genetic mutations, family history, and breast density, and modifiable ones, which include obesity, exposure to certain chemicals, and specific drug use. Due to its aggressive behavior and absence of hormone receptors, TNBC is particularly difficult to treat, highlighting the need for continuous research to enhance therapeutic approaches and patient survival.
Diagnosis typically involves imaging tools like mammography, ultrasound, and MRI, followed by tissue sampling techniques including core needle biopsy, fine needle aspiration, or surgical biopsy. TNBC tumors are often high-grade and poorly differentiated, and the disease is staged using the TNM system, which evaluates tumor size, lymph node involvement, and the extent of metastasis.
Triple-Negative Breast Cancer Epidemiology Segmentation
The triple-negative breast cancer epidemiology section provides insights into the historical and current triple-negative breast cancer patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.
The triple-negative breast cancer market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:
- Total Incident Cases of Breast Cancer
- Total Incident Cases of TNBC
- Gene Mutation-specific Incident Cases of TNBC
- Stage-specific Incident Cases of TNBC
- Age-specific Incident Cases of TNBC
- Line-wise Treated Incident Cases of TNBC
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Triple-Negative Breast Cancer Market Report Metrics |
Details |
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Study Period |
2020–2034 |
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Coverage |
7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. |
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Triple-Negative Breast Cancer Market CAGR |
4.7 % |
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Triple-Negative Breast Cancer Market Size in 2024 |
USD 4.5 Billion |
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Key Triple-Negative Breast Cancer Companies |
AstraZeneca, Daiichi Sankyo, Astellas Pharma, Pfizer, Galera Therapeutics, BioNTech, Merck, Gilead Sciences, Roche, Genentech, and others |
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Key Triple-Negative Breast Cancer Therapies |
DATROWAY (Datopotamab Deruxtecan), PADCEV (Enfortumab vedotin), Tilarginine, BNT327/PM8002, IMFINZI (Durvalumab), KEYTRUDA, TRODELVY, TALZENNA, LYNPARZA, TECENTRIQ, and others |
Scope of the Triple-Negative Breast Cancer Market Report
- Therapeutic Assessment: Triple-Negative Breast Cancer current marketed and emerging therapies
- Triple-Negative Breast Cancer Market Dynamics: Key Market Forecast Assumptions of Emerging Triple-Negative Breast Cancer Drugs and Market Outlook
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL’s views, Analyst’s views, Triple-Negative Breast Cancer Market Access and Reimbursement
Download the report to understand which factors are driving triple-negative breast cancer market trends @ Triple-Negative Breast Cancer Market Forecast
Table of Contents
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1 |
Key Insights |
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2 |
Report Introduction |
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3 |
TNBC Market Overview at a Glance |
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3.1 |
Market Share (%) Distribution of TNBC by Therapies in the 7MM in 2020 |
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3.2 |
Market Share (%) Distribution of TNBC by Therapies in the 7MM in 2034 |
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4 |
Executive Summary |
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5 |
Key Events |
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6 |
Disease Background and Overview |
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6.1 |
Introduction |
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6.2 |
Various Subtypes of Breast Cancer Based on Immunohistochemical Expression |
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6.3 |
TNBC Overview |
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6.3.1 |
Intrinsic Molecular Subtypes in TNBC |
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6.3.2 |
Characteristics of Tumor Microenvironment in TNBC |
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6.3.3 |
Potential Risk Factors |
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6.3.4 |
Clinical Presentation |
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6.3.5 |
Characterization of HER2-low Breast Cancers |
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6.4 |
Diagnosis |
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6.4.1 |
Staging |
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6.4.2 |
Grading |
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6.4.3 |
Clinical Prognostic Stage |
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6.4.4 |
Pathological Prognostic Stage |
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6.4.5 |
American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer |
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6.4.6 |
Recommendations for HER2 Testing in Breast Cancer: American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Clinical Practice Guideline Update |
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6.4.7 |
Diagnostic Algorithm |
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6.5 |
Treatment and Management |
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6.5.1 |
NCCN Clinical Practice Guidelines in Oncology for Breast Cancer |
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6.5.2 |
ESMO Clinical Practice Guidelines for Diagnosis, Treatment, and Follow-up of Early Breast Cancer |
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6.5.3 |
ESMO Clinical Practice Guideline for the Diagnosis, Staging, and Treatment of Patients with Metastatic Breast Cancer |
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6.5.4 |
Japanese Breast Cancer Society (JBCS) Clinical Practice Guidelines for Breast Cancer – 2022 Update |
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6.5.5 |
Treatment Algorithm |
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7 |
Epidemiology and Market Forecast Methodology |
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8 |
Epidemiology and Patient Population |
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8.1 |
Key Findings |
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8.2 |
Assumptions and Rationale: 7MM |
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8.2.1 |
Incident Cases of Breast Cancer |
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8.2.2 |
Incident Cases of TNBC |
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8.2.3 |
Gene Mutation-specific Incident Cases of TNBC |
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8.2.4 |
Stage-specific Incident Cases of TNBC |
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8.2.5 |
Age-specific Incident Cases of TNBC |
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8.3 |
Total Incident Cases of Breast Cancer in the 7MM |
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8.4 |
Total Incident Cases of TNBC in the 7MM |
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8.5 |
The United States |
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8.6 |
EU4 and the UK |
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8.7 |
Japan |
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9 |
Patient Journey |
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10 |
Marketed Therapies |
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10.1 |
Key Cross Competition |
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10.2 |
KEYTRUDA (pembrolizumab): Merck |
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10.2.1 |
Product Description |
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10.2.2 |
Regulatory Milestone |
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10.2.3 |
Other Developmental Activities |
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10.2.4 |
Clinical Trials Information |
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10.2.5 |
Safety and Efficacy |
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10.3 |
TRODELVY (sacitzumab govitecan-hziy): Gilead Sciences |
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10.4 |
TALZENNA (talazoparib): Pfizer |
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10.5 |
LYNPARZA (olaparib): AstraZeneca/Merck |
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10.6 |
TECENTRIQ (atezolizumab): Roche/Genentech |
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To be continued in the report… |
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11 |
Emerging Drug Profiles |
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11.1 |
Key Cross Competition of Emerging Drugs |
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11.2 |
DATROWAY (Datopotamab Deruxtecan): AstraZeneca/Daiichi Sankyo |
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11.2.1 |
Drug Description |
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11.2.2 |
Other Developmental Activities |
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11.2.3 |
Clinical Trials Information |
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11.2.4 |
Safety and Efficacy |
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11.2.5 |
Analysts’ View |
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11.3 |
PADCEV (Enfortumab vedotin): Astellas Pharma/Pfizer |
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11.4 |
Tilarginine: Galera Therapeutics |
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11.5 |
BNT327/PM8002: BioNTech |
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11.6 |
IMFINZI (Durvalumab): AstraZeneca |
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To be continued in the report… |
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12 |
TNBC: Market Analysis |
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12.1 |
Key Findings |
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12.2 |
Market Outlook |
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12.3 |
Attribute Analysis |
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12.4 |
Key Market Forecast Assumptions |
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12.4.1 |
Cost Assumptions and Rebates |
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12.4.2 |
Pricing Trends |
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12.4.3 |
Analogue Assessment |
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12.4.4 |
Launch Year and Therapy Uptake |
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12.5 |
Total Market Size of TNBC in the 7MM |
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12.6 |
Market Size of TNBC by Therapies in the 7MM |
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12.7 |
Market Size of TNBC in the United States |
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12.8 |
Market Size of TNBC in EU4 and the UK |
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12.9 |
Market Size of TNBC in Japan |
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13 |
Key Opinion Leaders’ Views |
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14 |
Unmet Needs |
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15 |
SWOT Analysis |
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16 |
Market Access and Reimbursement |
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16.1 |
The United States |
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16.2 |
In EU4 and the UK |
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16.3 |
Japan |
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17 |
Acronyms and Abbreviations |
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18 |
Bibliography |
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19 |
Report Methodology |
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