Summary

The triple-negative breast cancer market reached a value of US$ 490.5 Million across the top 7 markets (US, EU4, UK, and Japan) in 2023. Looking forward, IMARC Group expects the top 7 markets to reach US$ 773.2 Million by 2034, exhibiting a growth rate (CAGR) of 4.22% during 2024-2034.

The triple-negative breast cancer market has been comprehensively analyzed in IMARC's new report titled "Triple-negative Breast Cancer Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2024-2034". Triple-negative breast cancer (TNBC) is a specific type of cancer that tests negative for three major receptors, the hormones estrogen and progesterone, as well as a protein known as human epidermal growth factor receptor 2 (HER2). It is much more malignant than the rest of the cancers and is recognized for being challenging to treat. The symptoms of TNBC are similar to those of other types of breast cancer. The earliest and most typical sign is the formation of a new lump or nodule, which is painless. Other symptoms usually involve swelling in the whole breast, an occurrence of a dimply or saggy outer layer of skin, pain in the breast or the nipple, a discharge in the nipple that might seem to resemble breast milk, reversing nipples, the skin around the nipple or the breast appearing to be dry and brittle, etc. In addition, swollen lymph nodes may often develop in the patient if the breast cancer has migrated to the lymph nodes under the arm or surrounding the collar bone. To diagnose this condition, the clinician will first perform mammography to analyze any appearance of a mass or tumor in the breast. This is followed by a biopsy, during which a tiny part of the breast tissue is extracted and evaluated to determine the subtype of the underlying cancer. The doctor may perform several other tests on the patient, including MRIs, ultrasound scans, computational tomography scans, and positron emission tomography (PET) scans.

The increasing prevalence of breast cancer in women who are under the age of 40 and the growing frequency of reoccurrences of the ailment are primarily driving the triple-negative breast cancer market. In addition to this, the introduction of advanced biopsy techniques that aid in several aspects of breast cancer management, including prognosis prediction, early relapse detection, longitudinal monitoring of disease progress and response to treatment, etc., is further creating a positive outlook for the market. Moreover, the emergence of nanotechnology as an efficient tool in the clinical management of the disease is also bolstering the market growth. The use of nanoparticles facilitates the delivery of drugs and agents to tumor sites in a systematic and efficient manner. Besides this, the ongoing advancements in oncology therapeutics have shifted focus towards an outcome-based approach to cancer care, with a rising emphasis on combination drugs and innovative therapeutic modalities, thereby propelling the global market. Additionally, several key players are making significant investments in developing precise and high-resolution prognostic molecular biomarkers to stratify and distinguish high-risk residual TNBC tumors from low-risk ones. This, in turn, is further acting as another growth-inducing factor. Apart from this, numerous biotechnological developments, including the classification of TNBC into distinct subtypes based on mRNA expression profiles and unique tumor signatures, for generating relevant information about the actionable therapeutic targets, molecular drivers, and effective therapy selection are expected to drive the triple-negative breast cancer market in the coming years.

IMARC Group's new report provides an exhaustive analysis of the triple-negative breast cancer market in the United States, EU4 (Germany, Spain, Italy, and France), United Kingdom, and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report, the United States has the largest patient pool for triple-negative breast cancer and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario, unmet medical needs, etc., have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the triple-negative breast cancer market in any manner.

Recent Developments:
In February 2024, a pre-clinical study conducted by the University of Adelaide revealed that CDDD11-8 can successfully inhibit the growth of triple-negative breast cancer without any toxic side effects. This therapeutic candidate is designed to be taken orally, and acts by targeting a specific protein in the cancerous tumor called CDK9, which speeds up cell growth.
In December 2023, Anixa Biosciences, Inc. announced new and updated positive results from the Phase 1 clinical trial of its breast cancer vaccine. The trial is being conducted in collaboration with Cleveland Clinic and supported by a grant from the U.S. Department of Defense. This vaccine is designed to direct the immune system to destroy TNBC cancer cells in patients.
In May 2023, Shanghai Junshi Biosciences Co., Ltd disclosed that the National Medical Products Administration (“NMPA”) had authorized the supplemental new drug application (“sNDA”) for the company’s anti-PD-1 monoclonal antibody, toripalimab. This antibody is used in conjunction with albumin-bound paclitaxel to treat PD-L1 positive (CPS ≥ 1) untreated metastatic or recurrent metastatic triple-negative breast cancer.

Key Highlights:
Triple-negative breast cancer represents 10–15 % of all breast cancers and has a low survival rate of less than 5 years.
A maximum of fifty percent of patients diagnosed with early-stage triple-negative breast cancer (stages I to III) develop disease recurrence, and 37% die within the first 5 years of surgery.
It is estimated that 2.6 million new breast cancer cases will occur in 2030, representing an 18 % increase from 2020 globally.
According to studies, Black women are more prone than white women to acquire triple-negative breast cancer, as do women under the age of 40 compared to those aged between 50-64 years.
Around 70%-80% of the breast cancers that develop in women with mutations in the BRCA1 genes are triple-negative breast cancer.

Drugs:
TRODELVY (sacituzumab govitecan) is a prescription medication used to treat women with triple-negative breast cancer (negative for progesterone and estrogen hormone receptors and HER2) that has spread to various other parts of the body (metastatic) or cannot be removed surgically, and who have undergone two or more prior treatments, including at least one for metastatic disease. Sacituzumab govitecan is a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate, which targets the Trop-2 receptor that helps cancer grow, divide, and spread.

Toripalimab is an anti-PD-1 monoclonal antibody used for treating advanced triple-negative breast cancer. It promotes the immune system’s ability to attack and kill tumor cells by blocking PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function).

Mirvetuximab soravtansine is under clinical study by ImmunoGen for triple-negative breast cancer. It is formulated as an intravenous (IV) solution.The drug candidate is an immunoconjugate consisting of the humanized monoclonal antibody that selectively binds to folate receptor 1 (FOLR1).


Time Period of the Study

Base Year: 2023
Historical Period: 2018-2023
Market Forecast: 2024-2034

Countries Covered

United States
Germany
France
United Kingdom
Italy
Spain
Japan

Analysis Covered Across Each Country

Historical, current, and future epidemiology scenario
Historical, current, and future performance of the Triple-negative breast cancer market
Historical, current, and future performance of various therapeutic categories in the market
Sales of various drugs across the Triple-negative breast cancer market
Reimbursement scenario in the market
In-market and pipeline drugs

Competitive Landscape:
This report also provides a detailed analysis of the current Triple-negative breast cancer marketed drugs and late-stage pipeline drugs.

In-Market Drugs

Drug Overview
Mechanism of Action
Regulatory Status
Clinical Trial Results
Drug Uptake and Market Performance

Late-Stage Pipeline Drugs

Drug Overview
Mechanism of Action
Regulatory Status
Clinical Trial Results
Drug Uptake and Market Performance

*Kindly note that the drugs in the above table only represent a partial list of marketed/pipeline drugs, and the complete list has been provided in the report.


Key Questions Answered in this Report:
Market Insights

How has the Triple-negative breast cancer market performed so far and how will it perform in the coming years?
What are the markets shares of various therapeutic segments in 2023 and how are they expected to perform till 2034?
What was the country-wise size of the Triple-negative breast cancer market across the seven major markets in 2023 and what will it look like in 2034?
What is the growth rate of the Triple-negative breast cancer market across the seven major markets and what will be the expected growth over the next ten years?
What are the key unmet needs in the market?

Epidemiology Insights

What is the number of prevalent cases (2018-2034) of Triple-negative breast cancer across the seven major markets?
What is the number of prevalent cases (2018-2034) of Triple-negative breast cancer by age across the seven major markets?
What is the number of prevalent cases (2018-2034) of Triple-negative breast cancer by gender across the seven major markets?
How many patients are diagnosed (2018-2034) with Triple-negative breast cancer across the seven major markets?
What is the size of the Triple-negative breast cancer patient pool (2018-2023) across the seven major markets?
What would be the forecasted patient pool (2024-2034) across the seven major markets?
What are the key factors driving the epidemiological trend of Triple-negative breast cancer?
What will be the growth rate of patients across the seven major markets?

Triple-negative Breast Cancer: Current Treatment Scenario, Marketed Drugs and Emerging Therapies

What are the current marketed drugs and what are their market performance?
What are the key pipeline drugs and how are they expected to perform in the coming years?
How safe are the current marketed drugs and what are their efficacies?
How safe are the late-stage pipeline drugs and what are their efficacies?
What are the current treatment guidelines for Triple-negative breast cancer drugs across the seven major markets?
Who are the key companies in the market and what are their market shares?
What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the Triple-negative breast cancer market?
What are the key regulatory events related to the Triple-negative breast cancer market?
What is the structure of clinical trial landscape by status related to the Triple-negative breast cancer market?
What is the structure of clinical trial landscape by phase related to the Triple-negative breast cancer market?
What is the structure of clinical trial landscape by route of administration related to the Triple-negative breast cancer market?

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Table of Contents

1 Preface

2 Scope and Methodology
2.1 Objectives of the Study
2.2 Stakeholders
2.3 Data Sources
2.3.1 Primary Sources
2.3.2 Secondary Sources
2.4 Market Estimation
2.4.1 Bottom-Up Approach
2.4.2 Top-Down Approach
2.5 Forecasting Methodology

3 Executive Summary

4 Triple-negative Breast Cancer - Introduction
4.1 Overview
4.2 Regulatory Process
4.3 Epidemiology (2018-2023) and Forecast (2024-2034)
4.4 Market Overview (2018-2023) and Forecast (2024-2034)
4.5 Competitive Intelligence

5 Triple-negative Breast Cancer - Disease Overview
5.1 Introduction
5.2 Symptoms and Diagnosis
5.3 Pathophysiology
5.4 Causes and Risk Factors
5.5 Treatment

6 Patient Journey

7 Triple-negative Breast Cancer - Epidemiology and Patient Population
7.1 Epidemiology - Key Insights
7.2 Epidemiology Scenario - Top 7 Markets
7.2.1 Epidemiology Scenario (2018-2023)
7.2.2 Epidemiology Forecast (2024-2034)
7.2.3 Epidemiology by Age (​2018-2034​)
7.2.4 Epidemiology by Gender (​2018-2034​)
7.2.5 Diagnosed Cases (​2018-2034​)
7.2.6 Patient Pool/Treated Cases (​2018-2034​)
7.3 Epidemiology Scenario - United States
7.3.1 Epidemiology Scenario (2018-2023)
7.3.2 Epidemiology Forecast (2024-2034)
7.3.3 Epidemiology by Age (​2018-2034​)
7.3.4 Epidemiology by Gender (​2018-2034​)
7.3.5 Diagnosed Cases (​2018-2034​)
7.3.6 Patient Pool/Treated Cases (​2018-2034​)
7.4 Epidemiology Scenario - Germany
7.4.1 Epidemiology Scenario (2018-2023)
7.4.2 Epidemiology Forecast (2024-2034)
7.4.3 Epidemiology by Age (​2018-2034​)
7.4.4 Epidemiology by Gender (​2018-2034​)
7.4.5 Diagnosed Cases (​2018-2034​)
7.4.6 Patient Pool/Treated Cases (​2018-2034​)
7.5 Epidemiology Scenario - France
7.5.1 Epidemiology Scenario (2018-2023)
7.5.2 Epidemiology Forecast (2024-2034)
7.5.3 Epidemiology by Age (​2018-2034​)
7.5.4 Epidemiology by Gender (​2018-2034​)
7.5.5 Diagnosed Cases (​2018-2034​)
7.5.6 Patient Pool/Treated Cases (​2018-2034​)
7.6 Epidemiology Scenario - United Kingdom
7.6.1 Epidemiology Scenario (2018-2023)
7.6.2 Epidemiology Forecast (2024-2034)
7.6.3 Epidemiology by Age (​2018-2034​)
7.6.4 Epidemiology by Gender (​2018-2034​)
7.6.5 Diagnosed Cases (​2018-2034​)
7.6.6 Patient Pool/Treated Cases (​2018-2034​)
7.7 Epidemiology Scenario - Italy
7.7.1 Epidemiology Scenario (2018-2023)
7.7.2 Epidemiology Forecast (2024-2034)
7.7.3 Epidemiology by Age (​2018-2034​)
7.7.4 Epidemiology by Gender (​2018-2034​)
7.7.5 Diagnosed Cases (​2018-2034​)
7.7.6 Patient Pool/Treated Cases (​2018-2034​)
7.8 Epidemiology Scenario - Spain
7.8.1 Epidemiology Scenario (2018-2023)
7.8.2 Epidemiology Forecast (2024-2034)
7.8.3 Epidemiology by Age (​2018-2034​)
7.8.4 Epidemiology by Gender (​2018-2034​)
7.8.5 Diagnosed Cases (​2018-2034​)
7.8.6 Patient Pool/Treated Cases (​2018-2034​)
7.9 Epidemiology Scenario - Japan
7.9.1 Epidemiology Scenario (2018-2023)
7.9.2 Epidemiology Forecast (2024-2034)
7.9.3 Epidemiology by Age (​2018-2034​)
7.9.4 Epidemiology by Gender (​2018-2034​)
7.9.5 Diagnosed Cases (​2018-2034​)
7.9.6 Patient Pool/Treated Cases (​2018-2034​)

8 Triple-negative Breast Cancer - Treatment Algorithm, Guidelines, and Medical Practices
8.1 Guidelines, Management and Treatment
8.2 Treatment Algorithm

9 Triple-negative Breast Cancer - Unmet Needs

10 Triple-negative Breast Cancer - Key Endpoints of Treatment

11 Triple-negative Breast Cancer - Marketed Products
11.1 List of Triple-negative Breast Cancer Marketed Drugs Across the Top 7 Markets
11.1.1 Sacituzumab govitecan - Everest Medicines/Immunomedics
11.1.1.1 Drug Overview
11.1.1.2 Mechanism of Action
11.1.1.3 Regulatory Status
11.1.1.4 Clinical Trial Results
11.1.1.5 Sales Across Major Markets

Kindly note that the above only represents a partial list of marketed drugs, and the complete list has been provided in the report.

12 Triple-negative Breast Cancer - Pipeline Drugs
12.1 List of Triple-negative Breast Cancer Pipeline Drugs Across the Top 7 Markets
12.1.1 Toripalimab - Shanghai Junshi Biosciences
12.1.1.1 Drug Overview
12.1.1.2 Mechanism of Action
12.1.1.3 Clinical Trial Results
12.1.1.4 Safety and Efficacy
12.1.1.5 Regulatory Status
12.1.2 Durvalumab - Celgene/MedImmune
12.1.2.1 Drug Overview
12.1.2.2 Mechanism of Action
12.1.2.3 Clinical Trial Results
12.1.2.4 Safety and Efficacy
12.1.2.5 Regulatory Status
12.1.3 Mirvetuximab soravtansine - ImmunoGen
12.1.3.1 Drug Overview
12.1.3.2 Mechanism of Action
12.1.3.3 Clinical Trial Results
12.1.3.4 Safety and Efficacy
12.1.3.5 Regulatory Status
12.1.4 Alpelisib - Novartis Oncology
12.1.4.1 Drug Overview
12.1.4.2 Mechanism of Action
12.1.4.3 Clinical Trial Results
12.1.4.4 Safety and Efficacy
12.1.4.5 Regulatory Status
12.1.5 Darolutamide - Bayer HealthCare/Orion
12.1.5.1 Drug Overview
12.1.5.2 Mechanism of Action
12.1.5.3 Clinical Trial Results
12.1.5.4 Safety and Efficacy
12.1.5.5 Regulatory Status

Kindly note that the above only represents a partial list of pipeline drugs, and the complete list has been provided in the report.

13. Triple-negative Breast Cancer - Attribute Analysis of Key Marketed and Pipeline Drugs

14. Triple-negative Breast Cancer – Clinical Trial Landscape
14.1 Drugs by Status
14.2 Drugs by Phase
14.3 Drugs by Route of Administration
14.4 Key Regulatory Events

15 Triple-negative Breast Cancer - Market Scenario
15.1 Market Scenario - Key Insights
15.2 Market Scenario - Top 7 Markets
15.2.1 Triple-negative Breast Cancer - Market Size
15.2.1.1 Market Size (2018-2023)
15.2.1.2 Market Forecast (2024-2034)
15.2.2 Triple-negative Breast Cancer - Market Size by Therapies
15.2.2.1 Market Size by Therapies (2018-2023)
15.2.2.2 Market Forecast by Therapies (2024-2034)
15.3 Market Scenario - United States
15.3.1 Triple-negative Breast Cancer - Market Size
15.3.1.1 Market Size (2018-2023)
15.3.1.2 Market Forecast (2024-2034)
15.3.2 Triple-negative Breast Cancer - Market Size by Therapies
15.3.2.1 Market Size by Therapies (2018-2023)
15.3.2.2 Market Forecast by Therapies (2024-2034)
15.3.3 Triple-negative Breast Cancer - Access and Reimbursement Overview
15.4 Market Scenario - Germany
15.4.1 Triple-negative Breast Cancer - Market Size
15.4.1.1 Market Size (2018-2023)
15.4.1.2 Market Forecast (2024-2034)
15.4.2 Triple-negative Breast Cancer - Market Size by Therapies
15.4.2.1 Market Size by Therapies (2018-2023)
15.4.2.2 Market Forecast by Therapies (2024-2034)
15.4.3 Triple-negative Breast Cancer - Access and Reimbursement Overview
15.5 Market Scenario - France
15.5.1 Triple-negative Breast Cancer - Market Size
15.5.1.1 Market Size (2018-2023)
15.5.1.2 Market Forecast (2024-2034)
15.5.2 Triple-negative Breast Cancer - Market Size by Therapies
15.5.2.1 Market Size by Therapies (2018-2023)
15.5.2.2 Market Forecast by Therapies (2024-2034)
15.5.3 Triple-negative Breast Cancer - Access and Reimbursement Overview
15.6 Market Scenario - United Kingdom
15.6.1 Triple-negative Breast Cancer - Market Size
15.6.1.1 Market Size (2018-2023)
15.6.1.2 Market Forecast (2024-2034)
15.6.2 Triple-negative Breast Cancer - Market Size by Therapies
15.6.2.1 Market Size by Therapies (2018-2023)
15.6.2.2 Market Forecast by Therapies (2024-2034)
15.6.3 Triple-negative Breast Cancer - Access and Reimbursement Overview
15.7 Market Scenario - Italy
15.7.1 Triple-negative Breast Cancer - Market Size
15.7.1.1 Market Size (2018-2023)
15.7.1.2 Market Forecast (2024-2034)
15.7.2 Triple-negative Breast Cancer - Market Size by Therapies
15.7.2.1 Market Size by Therapies (2018-2023)
15.7.2.2 Market Forecast by Therapies (2024-2034)
15.7.3 Triple-negative Breast Cancer - Access and Reimbursement Overview
15.8 Market Scenario - Spain
15.8.1 Triple-negative Breast Cancer - Market Size
15.8.1.1 Market Size (2018-2023)
15.8.1.2 Market Forecast (2024-2034)
15.8.2 Triple-negative Breast Cancer - Market Size by Therapies
15.8.2.1 Market Size by Therapies (2018-2023)
15.8.2.2 Market Forecast by Therapies (2024-2034)
15.8.3 Triple-negative Breast Cancer - Access and Reimbursement Overview
15.9 Market Scenario - Japan
15.9.1 Triple-negative Breast Cancer - Market Size
15.9.1.1 Market Size (2018-2023)
15.9.1.2 Market Forecast (2024-2034)
15.9.2 Triple-negative Breast Cancer - Market Size by Therapies
15.9.2.1 Market Size by Therapies (2018-2023)
15.9.2.2 Market Forecast by Therapies (2024-2034)
15.9.3 Triple-negative Breast Cancer - Access and Reimbursement Overview

16 Triple-negative Breast Cancer - Recent Events and Inputs From Key Opinion Leaders

17 Triple-negative Breast Cancer Market - SWOT Analysis
17.1 Strengths
17.2 Weaknesses
17.3 Opportunities
17.4 Threats

18 Triple-negative Breast Cancer Market – Strategic Recommendations

19 Appendix