Triple Negative Breast Cancer Market Forecast 2034 - FDA Approvals, Clinical Trials, Market Size, Medication, Prevalence, Companies by DelveInsight

DelveInsight's "Triple Negative Breast Cancer Market Insights, Epidemiology, and Market Forecast-2034" report delivers an in-depth understanding of Triple Negative Breast Cancer, historical and forecasted epidemiology as well as the Triple Negative Breast Cancer market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan. The Triple Negative Breast Cancer market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Triple Negative Breast Cancer market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Triple Negative Breast Cancer 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 Cancer market.

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.

Get in-depth insights on market size, clinical trials, and emerging therapies across the 7MM. Download Now - https://www.delveinsight.com/report-store/triple-negative-breast-cancer-tnbc-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

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 ≥ 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.

Explore the latest FDA approvals, pipeline drugs, and treatment innovations shaping the TNBC market. View Sample Market Report: Triple Negative Breast Cancer Market Report - https://www.delveinsight.com/sample-request/triple-negative-breast-cancer-tnbc-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Some facts of the Triple Negative Breast Cancer Market Report are:
• According to DelveInsight, Triple Negative Breast Cancer market size is expected to grow at a CAGR of 4.7% by 2034.
• According to DelveInsight's analysis, the TNBC market in the 7MM was valued at approximately USD 4,200 million in 2023. Over the forecast period from 2025 to 2034, Triple Negative Breast Cancer market is projected to grow at a CAGR of 4.7%.
• Leading Triple Negative Breast Cancer companies working in the market are Johnson & Johnson Private Limited, Cipla Inc, Abbott, AbbVie Inc, Merck KGaA, Sun Pharmaceutical, Aurobindo Pharma, Lupin, Hikma Pharmaceuticals PLC, Amneal Pharmaceuticals LLC., Pfizer Inc, Mylan N.V., Novartis AG, Bristol-Myers Squibb Company, GSK plc, Bayer AG, AstraZeneca, Gilead Science, Infinity Pharmaceuticals, HiberCell, Immunomedics, HiberCell, CytoDyn, and Many Others.
• Higher Indulgence in Immunotherapy and Growing Demand for Hospitals are some of the factors driving the Triple Negative Breast Cancer Market growth.
• Leronlimab (Cytodyn) has also received fast track designation by the US FDA which clearly suggests the fast growth of TRIPLE NEGATIVE BREAST CANCER market in the forecast period (2025-2034).
• In September 2025, Merck Sharp & Dohme LLC announced results of a Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)
• In September 2025, Gilead Sciences announced results of a Phase 1/2, Open-label Study of Sacituzumab Govitecan Administered at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
• In August 2025, Astrazeneca announced results of a Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC.
• In May 2025, UTR Therapeutics Inc. announced it had submitted an Investigational New Drug (IND) application to the FDA for UTRxM1-18, an innovative therapy aimed at treating c-MYC driven cancers such as triple-negative breast, pancreatic, colorectal, and ovarian cancers. Built on its proprietary 3'UTR engineering platform, UTRxM1-18 works by selectively degrading cancer-specific transcripts while preserving healthy cells. Preclinical data demonstrated robust, dose-dependent antitumor activity across multiple cancer types, without any dose-limiting toxicities.
• Also in May 2025, Lantern Pharma Inc. disclosed it received FDA clearance for its IND to initiate a Phase 1b/2 clinical trial of LP-184 in triple-negative breast cancer. This regulatory milestone follows the company's prior achievements, including securing Orphan Drug Designation in 2023 and Fast Track Designation in 2024.
• In April 2025, Gilead Sciences shared positive outcomes from the Phase 3 ASCENT-04/KEYNOTE-D19 trial. The study revealed that combining Trodelvy® (sacituzumab govitecan-hziy) with Keytruda® (pembrolizumab) significantly extended progression-free survival in patients with metastatic triple-negative breast cancer (mTNBC) exhibiting PD-L1 expression (CPS ≥ 10), compared to treatment with chemotherapy plus Keytruda alone.

Triple Negative Breast Cancer Epidemiology

In 2023, breast cancer incident cases across the 7 major markets (7MM) totaled approximately 680,000. The United States recorded the highest number of Triple Negative Breast Cancer (TNBC) cases at around 45,000, with a projected annual growth rate of 1% through 2034. Within the EU4 and the UK, Germany led with about 11,000 TNBC cases, followed by France at 10,000 and Spain at 5,000.

Japan showed the highest occurrence in Stage II TNBC (6,000 cases), with additional cases across Stage I (3,000), Stage III (4,000), and Stage IV (700). BRCA1-mutated TNBC was the most prevalent gene mutation subtype in EU4 and the UK, accounting for roughly 3,800 cases.

Age-wise, France reported the highest burden among individuals under 45 (3,200 cases). In Italy, Stage II TNBC also dominated with 4,000 cases. Germany's treatment distribution in 2023 included 8,000 cases in neoadjuvant/adjuvant settings and progressively fewer in later lines of therapy, with all segments expected to rise by 2034.

Triple Negative Breast Cancer Epidemiology Segmentation:
• 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

Understand epidemiology, treatment practices, and competitive dynamics to guide your TNBC strategy - https://www.delveinsight.com/report-store/triple-negative-breast-cancer-tnbc-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Triple Negative Breast Cancer Drugs Analysis
DATROWAY (Datopotamab Deruxtecan) - AstraZeneca/Daiichi Sankyo
DATROWAY is an investigational antibody-drug conjugate (ADC) for TNBC, being tested as monotherapy and with IMFINZI across neoadjuvant, adjuvant, and metastatic settings. Phase III trials, including a combination with durvalumab launched in December 2023, aim to provide data by 2026 to advance TNBC treatment.

Adagloxad Simolenin - OBI Pharma
This therapeutic cancer vaccine targets the tumor-associated Globo H antigen, stimulating immune responses against cancer cells. Licensed from Merck, Phase III trials in high-risk, early-stage TNBC have shown safety and promising immune activity, with a positive DSMB review in January 2024 supporting continuation.

PADCEV (Enfortumab vedotin) - Astellas/Pfizer
PADCEV is an ADC that targets Nectin-4 on tumors and delivers a cytotoxic payload (MMAE). Administered intravenously, it induces cancer cell apoptosis. Currently in Phase II, it is being tested with pembrolizumab for locally advanced or metastatic TNBC and other solid tumors, offering options for treatment-resistant cases.

Triple Negative Breast Cancer Market Segmentation
Triple Negative Breast Cancer Treatment
• Surgery (Lumpectomy, Mastectomy)
• Chemotherapy
• Radiation therapy
• Immunotherapy
• Targeted therapy (PARP inhibitors, ADCs)

TNBC Drug Class Analysis
• PD-1/PD-L1 Inhibitors
• PARP Inhibitors
• Antibody-Drug Conjugates (ADCs)

TNBC End-User Outlook (Revenue, USD Million, 2025 - 2034)
• Hospitals and Specialty Clinics
• Cancer Treatment Centers
• Others

TNBC Regional Outlook (Revenue, USD Million, 2025 - 2034)
• The U.S.
• Europe (Germany, France, Italy, Spain, the UK)
• Asia Pacific (Japan)

Analyze market trends, key players, and strategic insights to identify opportunities in the TNBC market. Request Your Free Sample - https://www.delveinsight.com/sample-request/triple-negative-breast-cancer-tnbc-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

List of Key Players in the TNBC Market
• Merck
• Roche
• AstraZeneca
• Pfizer
• Gilead Sciences
• Daiichi Sankyo
• OBI Pharma
• Astellas Pharma
• BioNTech
• Galera Therapeutics, and others.
The TNBC market is experiencing steady growth driven by technological advancements in targeted therapy, increasing disease prevalence, and expanding pipeline of innovative treatments. The overall market is projected to grow significantly, driven by increasing biomarker testing, better patient selection, and continued advancements in ADCs, checkpoint inhibitors, PARP inhibitors, and novel immune-based approaches.

The comprehensive DelveInsight's Triple Negative Breast Cancer Market Report provides pharmaceutical executives with the detailed market intelligence, competitive analysis, and strategic insights necessary to navigate this complex and rapidly evolving therapeutic landscape - https://www.delveinsight.com/sample-request/triple-negative-breast-cancer-tnbc-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Contact Us:
Ankit Nigam
Manager Marketing
info@delveinsight.com
+14699457679

About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

This release was published on openPR.