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 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan].
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Key Takeaways from the Triple-Negative Breast Cancer Market Report
- As per DelveInsight analysis, the triple-negative breast cancer market size in the 7MM was ~USD 1.5 billion in 2023 and it is expected to grow positively at a significant CAGR during the study period (2020–2034).
- 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.
Discover which therapies are expected to grab the major triple-negative breast cancer market share @ Triple-Negative Breast Cancer Market Report
Triple-Negative Breast Cancer Overview
Triple-negative breast cancer (TNBC) is a breast cancer subtype distinguished by the lack of three important receptors: ER, PR, and (HER2. These receptors are vital for controlling the growth of normal breast cells, and their absence in TNBC complicates treatment compared to other breast cancer forms. While the precise causes of TNBC remain unclear, several risk factors have been identified. Genetic mutations, particularly in the BRCA1 gene, are significantly linked to a higher risk of developing TNBC. Other contributing factors may include family history, early onset of menstruation, late menopause, obesity, and specific racial or ethnic backgrounds.
The symptoms of TNBC resemble those of other breast cancer types and may include a lump in the breast or underarm, breast pain, alterations in breast size or shape, skin changes on the breast, and nipple discharge that is not related to breastfeeding. However, these symptoms are not unique to TNBC and can also occur in other conditions. Diagnosing triple-negative breast cancer typically involves a combination of approaches, including mammograms, ultrasounds, and MRI scans to detect abnormalities in breast tissue.
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
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
Learn more about the FDA-approved drugs for triple-negative breast cancer @ Drugs for Triple-Negative Breast Cancer Treatment
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.
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, Daiichi Sankyo, AstraZeneca, Zenith Epigenetics, Pfizer, OncoPep, Tesaro, Inc., NBE-Therapeutics AG, A&G Pharmaceutical Inc., Ayala Pharmaceuticals, 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
Discover more about triple-negative breast cancer drugs in development @ Triple-Negative Breast Cancer Clinical Trials
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
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