Triple-Negative Breast Cancer Market Analysis 2034 - Competitive Landscape, Clinical Trials, Market Share, Therapies, Prevalence, and Key Players by DelveInsight

Leading triple-negative breast cancer companies such as G1 Therapeutics, Daiichi Sankyo, AstraZeneca, Zenith Epigenetics, Pfizer, OncoPep, Tesaro, Inc., NBE-Therapeutics AG, A&G Pharmaceutical Inc., Ayala Pharmaceuticals, Inc., Phoenix Molecular Designs, and others.
The triple negative breast cancer (TNBC) market size is estimated to reach ~USD 7 billion by 2034, registering a CAGR of 4.70% from 2025 to 2034, according to a new report by DelveInsight, a pharmaceutical market research firm. Rising incidence of TNBC and expanding adoption of innovative immunotherapies and targeted treatments are the primary factors propelling market growth. Moreover, increasing advancements in antibody-drug conjugates (ADCs), checkpoint inhibitors, and PARP inhibitors by pharma companies including AstraZeneca, Daiichi Sankyo, OBI Pharma, Astellas Pharma, Pfizer, BioNTech, Galera Therapeutics, Merck, Roche, and Gilead Sciences, among others, are driving the expansion of the TNBC market.

DelveInsight's "Triple-Negative Breast Cancer Market Insights, Epidemiology, and Market Forecast - 2034" report offers a comprehensive analysis of TNBC across the US, EU5, and Japan. It examines disease epidemiology, current and emerging treatment approaches, and market trends from 2020 to 2034. The report provides insights into therapy market share, forecasted market growth, clinical practices, and treatment algorithms. Additionally, it highlights key market drivers, barriers, and unmet needs, helping identify future commercial opportunities and assess the potential of developing therapies in the TNBC market.

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The robust TNBC clinical pipeline demonstrating positive clinical results is a major factor driving the therapeutic market. In April 2025, Gilead Sciences reported positive results from the Phase 3 ASCENT-04/KEYNOTE-D19 study, showing that the combination of TRODELVY (sacituzumab govitecan-hziy) and KEYTRUDA (pembrolizumab) significantly improved progression-free survival in patients with metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1 (CPS greater than or equal to 10), compared to chemotherapy and KEYTRUDA alone.

The growing TNBC prevalence globally is further fueling the TNBC market growth, as TNBC accounts for approximately 15-20% of all breast cancer cases worldwide. In 2023, there were approximately 100K incident cases of TNBC in the seven major markets (7MM). Among these 7MM, the United States has the highest incidence, with about 45K cases. Among EU4 countries and the UK, Germany reported the highest incidence with approximately 11K, followed by France.

Furthermore, innovative treatment developments and regulatory approvals are playing a crucial role in boosting market growth by expanding treatment options and improving patient outcomes. KEYTRUDA (pembrolizumab), approved in combination with chemotherapy for early-stage TNBC as well as PD-L1-positive locally recurrent or metastatic TNBC, holds Priority Review and Breakthrough Designation. Additionally, TRODELVY (sacituzumab govitecan-hziy), a TROP-2-directed ADC, is approved for metastatic TNBC patients who have received prior treatment and holds Priority Review, Breakthrough Designation, and Fast Track Designation from the FDA.

Moreover, rising investments in precision oncology and biomarker-driven therapies are providing lucrative opportunities for key TNBC companies. The current treatment landscape includes standard options like chemotherapy, immunotherapy, targeted therapy, surgery, and radiation therapy. KEYTRUDA in combination with chemotherapy, PARP inhibitors like TALZENNA (talazoparib) for BRCA-mutated TNBC, and TRODELVY for recurrent or refractory metastatic TNBC represent the current therapeutic arsenal.

Key Takeaways from the Triple-Negative Breast Cancer Market Report

* According to DelveInsight's analysis, the Triple-Negative Breast Cancer market across the 7 Major Markets (7MM) generated approximately USD 4.2 billion in revenue in 2023. Based on current statistics and market trends, the Triple-Negative Breast Cancer market is expected to witness steady growth, projecting a compound annual growth rate (CAGR) of 4.7% during the forecast period from 2025 to 2034.
* In May 2025, Lantern Pharma Inc. (Nasdaq: LTRN), an artificial intelligence company developing targeted and transformative cancer therapies using its proprietary AI platform, RADR Registered , today announced that it has received clearance of its Investigational New Drug Application (IND) from the U.S. Food and Drug Administration (FDA) for a Phase 1b/2 clinical trial for LP-184 in Triple Negative Breast Cancer. This achievement builds on the previous regulatory momentum including Orphan Drug Designation in 2023 and Fast Track Designation in 2024.
* In April 2025, Gilead Sciences, Inc. (Nasdaq: GILD) today announced positive topline results from the Phase 3 ASCENT-04/KEYNOTE-D19 study, demonstrating that Trodelvy Registered (sacituzumab govitecan-hziy) plus Keytruda Registered (pembrolizumab) significantly improved progression-free survival (PFS) compared to Keytruda and chemotherapy in patients with inoperable (unresectable) locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1 (CPS greater than or equal to 10). The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in PFS.
* In January 2025, the FDA approved DATROWAY, a promising antibody-drug conjugate developed by AstraZeneca (LON: AZN) and Daiichi Sankyo (TYO: 4568) for previously treated metastatic hormone receptor-positive (HR+), HER2-negative breast cancer, based on the TROPION-Breast01 Phase III trial demonstrating a statistically significant improvement in progression-free survival (PFS) compared to chemotherapy. Additionally, a Phase III global study (TROPION-Breast04) is ongoing, evaluating neoadjuvant DATROWAY combined with durvalumab versus pembrolizumab plus chemotherapy in untreated TNBC and hormone receptor-low/HER2-negative breast cancer, aiming to establish new standards in early-stage treatment.
* In 2023, KEYTRUDA contributed the largest in the first-line treatment of TNBC, while TRODELVY contributed the maximum in the second-line and third-line and above in the 7MM.
* Breast cancer is the most common cancer among adults and affects more than 2.3 million people each year globally.
* Triple-negative breast cancer is the most malignant subtype of breast cancer, which accounts for 15-20% of incident breast cancers.
* As per DelveInsight analysts, the total incident cases of TNBC in 7MM were estimated to be around 102K in 2023.
* Leading triple-negative breast cancer companies such as G1 Therapeutics, Daiichi Sankyo, AstraZeneca, Zenith Epigenetics, Pfizer, OncoPep, Tesaro, Inc., NBE-Therapeutics AG, A&G Pharmaceutical Inc., Ayala Pharmaceuticals, Inc., Phoenix Molecular Designs, and others are developing novel triple-negative breast cancer drugs that can be available in the triple-negative breast cancer market in the coming years.
* Some key therapies for triple-negative breast cancer treatment include COSELA (trilacicilib), Datopotamab Deruxtecan (Dato-DXd), Capivasertib, ZEN003694, PVX-410, Niraparib, NBE-002, AG-01, AL101, PMD-026, and others.
* In February 2024, G1 Therapeutics announced that the independent Data Monitoring Committee (DMC) recommended continuing the Phase 3 trial (PRESERVE 2) of trilaciclib combined with gemcitabine and carboplatin for first-line treatment of mTNBC to its final analysis. The analysis, focusing on Overall Survival (OS) in the intent-to-treat (ITT) population, is expected in Q3 2024. The DMC found no safety concerns and didn't suggest study modifications. G1 remains blinded to data, as early stopping criteria weren't met during interim analysis.

Triple Negative Breast Cancer Overview

Triple-Negative Breast Cancer (TNBC) is an aggressive subtype of breast cancer characterized by the absence of estrogen receptors (ER), progesterone receptors (PR), and HER2 protein expression. Because it lacks these common targets, TNBC does not respond to hormonal or HER2-targeted therapies, limiting treatment options to chemotherapy, immunotherapy, and emerging targeted agents. TNBC tends to grow and spread faster than other breast cancers, with a higher likelihood of recurrence within the first few years after diagnosis. It is more commonly seen in younger women and certain ethnic populations. Ongoing research focuses on improving early detection and developing more effective, personalized treatment strategies.

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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 individual seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders.

The triple-negative breast cancer market reportproffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:

* Total Incident Cases of Triple-negative Breast Cancer
* Stage-specific Cases of Triple-negative Breast Cancer
* Subtype-specific Cases of Triple-negative Breast Cancer
* Age-specific Cases of Metastatic Triple-negative Breast Cancer
* Gene Mutation-specific Cases of Triple-negative Breast Cancer
* Line Wise Treated Cases of Metastatic Triple-negative Breast Cancer

Key Triple-Negative Breast Cancer Therapies and Companies

* COSELA (trilacicilib): G1 Therapeutics
* Datopotamab Deruxtecan (Dato-DXd): AstraZeneca/Daiichi Sankyo
* Capivasertib: AstraZeneca
* ZEN003694: Zenith Epigenetics/Pfizer
* PVX-410: OncoPep
* Niraparib: Tesaro, Inc.
* NBE-002: NBE-Therapeutics AG
* AG-01: A&G Pharmaceutical Inc.
* AL101: Ayala Pharmaceuticals, Inc.
* PMD-026: Phoenix Molecular Designs

Evaluate pipeline strength and market positioning across the 7MM. Benchmark Leading TNBC Companies & Emerging Therapies [https://www.delveinsight.com/report-store/triple-negative-breast-cancer-tnbc-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Triple Negative Breast Cancer Market Report Highlights

* To keep up with current market trends, DelveInsight takes KOLs and SME's opinions working in the domain through primary research to fill the data gaps and validate our secondary research.
* The epidemiology chapter provides historical as well as forecasted epidemiology segmented by total incident cases of breast cancer, total incident cases of TNBC, gene mutation-specific cases of TNBC, stage-specific cases of TNBC, age-specific cases of TNBC, and line-wise treated incident cases of TNBC, in the 7MM.
* The report provides an edge to pharma executives by understanding the market trends through SWOT analysis and expert insights, patient journey, and treatment preferences that help in shaping and driving the 7MM Triple Negative Breast Cancer market.
* The report further contains an all-inclusive account of both the current and emerging therapies, along with the elaborate profiles of late-stage and prominent therapies, that will have an impact on the current treatment landscape.

Triple-Negative Breast Cancer Market Dynamics

The triple-negative breast cancer market dynamics are marked by a complex interplay of challenges and opportunities. Recent approvals of PD-1/PD-L1 and PARP inhibitors in frontline treatment have significantly improved patient prognosis, while the entry of the new ADC TRODELVY into the market has provided an effective treatment option for those progressing from prior lines of therapy; additionally, the identification and effective targeting of new potentially targetable biomarkers by novel molecules could enhance outcomes for patients with low expression of known targetable biomarkers, such as PD-L1 and germline BRCA1/2 mutations, and ongoing research into TNBC is expected to lead to subclassification, ultimately improving treatment allocation and patient prognosis.

Furthermore, many potential therapies are being investigated for the treatment of TNBC, and it is safe to predict that the treatment space will significantly impact the TNBC 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 TNBC market in the 7MM.

However, several factors may impede the growth of the TNBC market. There is a lack of appropriate treatment options for patients with low PD-L1 expression and no germline BRCA1/2 mutations, compounded by common diagnosis delays in TNBC, where most patients are diagnosed at advanced stages; while many physicians wish to consider earlier use of more efficacious treatments to prevent patients from succumbing to disease before accessing later lines of therapy, this often conflicts with payers due to the higher costs associated, making the challenge for any upcoming drug in this market to either demonstrate significant improvements in safety and efficacy or to be offered at a lower cost, as evidenced by TRODELVY's established effectiveness in later lines of treatment.

Moreover, TNBC treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the TNBC 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 TNBC market growth.

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Scope of the Triple-Negative Breast Cancer Market Report

* Study Period: 2020-2034
* Coverage: 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]
* Triple-Negative Breast Cancer Market Size in 2023: USD 1.5 Billion
* Key Triple-Negative Breast Cancer Companies: G1 Therapeutics (NASDAQ: GTHX), Daiichi Sankyo (TYO: 4568), AstraZeneca (LSE: AZN), Pfizer (NYSE: PFE), Ayala Pharmaceuticals, Inc. (NASDAQ: AYLA), Zenith Epigenetics, OncoPep, Tesaro, Inc. (Acquired by GlaxoSmithKline - LSE: GSK), NBE-Therapeutics AG (Acquired by Boehringer Ingelheim), A&G Pharmaceutical Inc., Phoenix Molecular Designs, and others.
* Key Triple-Negative Breast Cancer Therapies: Imprime PGG , TECENTRIQ, IPI-549, Leronlimab (PRO 140), MDNA11, LY3023414, Niraparib, Pembrolizumab, Sacituzumab Govitecan, NBE-002, L-NMMA, ASTX727, AG-01, ZEN003694, AL101, PMD-026, CDX-1140, and others
* Therapeutic Assessment: Triple-Negative Breast Cancer current marketed and emerging therapies
* Triple-Negative Breast Cancer Market Dynamics: Key Market Forecast Assumptions of Emerging TNBC 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

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Table of Contents

1. Triple-Negative Breast Cancer Market Key Insights

2. Triple-Negative Breast Cancer Market Report Introduction

3. Triple-Negative Breast Cancer Market Overview at a Glance

4. Triple-Negative Breast Cancer Market Executive Summary

5. Disease Background and Overview

6. Triple-Negative Breast Cancer Treatment and Management

7. Triple-Negative Breast Cancer Epidemiology and Patient Population

8. Patient Journey

9. Triple-Negative Breast Cancer Marketed Drugs

10. Triple-Negative Breast Cancer Emerging Drugs

11. Seven Major Triple-Negative Breast Cancer Market Analysis

12. Triple-Negative Breast Cancer Market Outlook

13. Potential of Current and Emerging Therapies

14. KOL Views

15. Unmet Needs

16. SWOT Analysis

17. Appendix

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

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