Triple-Negative Breast Cancer Therapeutics Market 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Medication, Statistics, Revenue, NICE Approvals, Therapies and Companies by DelveInsight

(Albany, USA) DelveInsight's "Triple-Negative Breast Cancers Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of TNBC, historical and forecasted epidemiology, as well as the TNBC market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The Triple-Negative Breast Cancers market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Triple-Negative Breast Cancers market size from 2020 to 2034 segmented by seven major markets. The Report also covers current Triple-Negative Breast Cancers treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Triple-Negative Breast Cancers market.

Discover Key Insights into the Triple-Negative Breast Cancer Market with DelveInsight's In-Depth Report @ Triple-Negative Breast Cancer Market Size- https://www.delveinsight.com/report-store/triple-negative-breast-cancer-tnbc-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

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®, 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® (sacituzumab govitecan-hziy) plus Keytruda® (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 ≥ 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 form of breast cancer that lacks estrogen receptors, progesterone receptors, and HER2 protein expression, making it difficult to treat with hormonal or targeted therapies. Triple-Negative Breast Cancer commonly affects younger women and is more prevalent among African American and Hispanic populations. Triple-Negative Breast Cancer often presents as a high-grade tumor with a faster growth rate and greater risk of recurrence compared to other breast cancer subtypes. Triple-Negative Breast Cancer is usually diagnosed through imaging tests and confirmed via biopsy and immunohistochemistry.
Triple-Negative Breast Cancer treatment options typically include surgery, chemotherapy, and radiation therapy, but Triple-Negative Breast Cancer lacks the benefit of hormone therapy and HER2-targeted drugs. Triple-Negative Breast Cancer research is focusing on immunotherapy, PARP inhibitors, and clinical trials for targeted therapies. Triple-Negative Breast Cancer survival rates vary depending on the stage at diagnosis, with early detection improving outcomes. Triple-Negative Breast Cancer awareness and genetic counseling, especially for BRCA1 mutations, play a crucial role in prevention and early intervention.
Triple-Negative Breast Cancer remains a critical area of study in oncology due to its unique biology and limited treatment options. Triple-Negative Breast Cancer patients benefit from specialized care and participation in clinical research.

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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 report proffers 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

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Triple-Negative Breast Cancer Treatment Market
There are several FDA-approved targeted therapies for triple-negative breast cancer. Traditionally, chemotherapy has been the primary systemic treatment, particularly for patients with metastatic disease. Although TNBC generally responds well to chemotherapy at first, recurrences are common.
If TNBC recurs locally, cannot be surgically removed, and expresses the PD-L1 protein, a combination of immunotherapy using the drug KEYTRUDA (pembrolizumab) and chemotherapy may be considered.
In November 2020, the US FDA approved KEYTRUDA, an anti-PD-1 therapy developed by Merck, to be used alongside chemotherapy for patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) that shows PD-L1 expression.
Other treatment options may also be available depending on the specific circumstances. If the cancer reoccurs in other areas of the body, treatment options may include chemotherapy or the antibody-drug conjugate TRODELVY (sacituzumab govitecan).
TRODELVY (sacituzumab govitecan-hziy) is a conjugate that combines an antibody targeting Trop-2 with a topoisomerase inhibitor. The FDA approved TRODELVY in April 2021 as the first therapy for metastatic triple-negative breast cancer. It is marketed by Gilead Sciences.
TALZENNA (talazoparib), developed by Pfizer, is a drug that inhibits poly (ADP-ribose) polymerase (PARP) enzymes, specifically PARP1 and PARP2, which are involved in DNA repair. The U.S. FDA approved it in October 2018. TECENTRIQ (atezolizumab) received provisional approval for metastatic triple-negative breast cancer due to favorable outcomes from the IMpassion 130 trial. However, the results from the IMpassion 131 trial did not support these conclusions, prompting Roche to withdraw the application for full registration after discussions with the Therapeutic Goods Administration (TGA).

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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

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

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