Triple Negative Breast Cancer Market

Key Highlights

• The disease epidemiology covered in the report provides historical as well as forecasted Triple Negative Breast Cancer epidemiology scenario in the 7MM covering the United States, EU4 countries (Germany, Spain, Italy, and France), the United Kingdom and Japan from 2019 to 2032.

• Triple Negative Breast Cancer epidemiology is segmented as Total Triple Negative Breast Cancer Incident Cases, Triple Negative Breast Cancer Gene mutation-specific, Triple Negative Breast Cancer Stage-specific cases, and Diagnosed and Treatable cases of Triple Negative Breast Cancer] in the Triple Negative Breast Cancer market report.

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DelveInsight's "Triple Negative Breast Cancer Market Insights, Epidemiology, and Market Forecast — 2032" report delivers an in-depth understanding of the Triple Negative Breast Cancer, historical and forecasted epidemiology as well as the Triple Negative Breast Cancer market trends in the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan.

The Triple Negative Breast Cancer market report provides current treatment practices, emerging drugs, Triple Negative Breast Cancer market share of the individual therapies, current and forecasted Triple Negative Breast Cancer market Size from 2019 to 2032 segmented by seven major markets. The Report also covers current Triple Negative Breast Cancer treatment practice/algorithm, and unmet medical needs to curate best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain), and the United Kingdom
• Japan

Study Period: 2019-2032

Triple Negative Breast Cancer Market Disease Understanding and Treatment Algorithm

The DelveInsight’s Triple Negative Breast Cancer market report gives a thorough understanding of Triple Negative Breast Cancer by including details such as disease definition, symptoms, causes, pathophysiology, diagnosis, and treatment. Triple Negative Breast Cancer is defined as a tumor where the estrogen and progesterone (ER/PR) are negative, as assessed by immunohistochemistry (IHC), and there is a lack of overexpression of HER2, as assessed by immunohistochemistry (IHC), or the absence of its gene amplification, as assessed by fluorescence in situ hybridization technique. The epidemiological risk factor profiles also vary between TRIPLE NEGATIVE BREAST CANCER (ER-PR-HER2-) and other breast cancers.

TRIPLE NEGATIVE BREAST CANCERs are frequently identified as hyper dense masses without associated calcifications. The majority of TRIPLE NEGATIVE BREAST CANCERs are histologically classified as high-grade, invasive, ductal carcinomas of no special type with basal-like features. Central necrosis, pushing tumor borders, a conspicuous lymphocytic infiltrate, and fibrosis are common histologic features.

Triple Negative Breast Cancer Diagnosis

A triple-negative breast cancer diagnosis is not based on any specific symptoms, but on an assessment of cells from a biopsy, which are checked for estrogen, progesterone, and HER2 receptors to determine a person's breast cancer subtype. Triple-negative breast cancers: tend to be more advanced when diagnosed and more aggressive than ER-/PR-positive cancers; disproportionately affect Black and Hispanic women as well as younger women; and are the most commonly diagnosed breast cancer in women with inherited mutations in the BRCA1 gene.

Triple Negative Breast Cancer Treatment

Triple-negative breast cancer treatment is particularly complicated because there is no obvious drug target, as there is for ER/PR-positive or HER2-positive breast cancer. Currently, the standard treatments for TRIPLE NEGATIVE BREAST CANCER are surgery, chemotherapy, and radiation. But that is changing. As we learn more about the biology of this particularly complex form of breast cancer, it is clear that TRIPLE NEGATIVE BREAST CANCER is not a single disease but a group of breast cancers with distinct molecular and clinicopathological characteristics. In fact, TRIPLE NEGATIVE BREAST CANCER can be classified into several distinct molecular subtypes based on gene expression profiles. This has important implications for prognosis and triple-negative breast cancer treatments.

Triple Negative Breast Cancer Epidemiology

The Triple Negative Breast Cancer epidemiology section provides insights about 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. This part of the report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Key Findings

• The disease epidemiology covered in the report provides historical as well as forecasted Triple Negative Breast Cancer epidemiology scenario in the 7MM covering the United States, EU4 countries (Germany, Spain, Italy, and France), the United Kingdom and Japan from 2019 to 2032.

• The disease epidemiology covered in the report provides historical as well as forecasted Triple Negative Breast Cancer epidemiology [segmented as Total Incident Cases of Triple Negative Breast Cancer, Gene mutation-specific cases of Triple Negative Breast Cancer, Stage-specific cases of Triple Negative Breast Cancer, and Diagnosed and Treatable cases of Triple Negative Breast Cancer] in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom and Japan from 2019 to 2032.

Country Wise- Triple Negative Breast Cancer Epidemiology

This section provides a glimpse of the Triple Negative Breast Cancer epidemiology in the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan.

Triple Negative Breast Cancer Drug Chapters

The drug chapter segment of the Triple Negative Breast Cancer report encloses the detailed analysis of Triple Negative Breast Cancer marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Triple Negative Breast Cancer clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Triple Negative Breast Cancer Marketed Drugs

KEYTRUDA (pembrolizumab): Merck & Co

In July 2021, the US FDA approved KEYTRUDA for high-risk, early-stage, Triple Negative Breast Cancer in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. In November 2020, the US FDA approved Keytruda (pembrolizumab) in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic TRIPLE NEGATIVE BREAST CANCER whose tumors express PD-L1 as determined by an FDA-approved test.

TRODELVY (sacituzumab govitecan-hziy): Gilead Sciences

In April 2021, Gilead Sciences announced the full approval of Trodelvy (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic Triple Negative Breast Cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease. The approval was supported by data from the Phase III ASCENT study, in which the drug demonstrated statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death, extending median PFS to 4.8 months from 1.7 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; p < 0.0001). Trodelvy also extended median overall survival to 11.8 months versus 6.9 months (HR: 0.51; 95% CI: 0.41-0.62; p < 0.0001), representing a 49% reduction in the risk of death.

Note: Detailed Current therapies assessment will be provided in the full report of Triple Negative Breast Cancer

Triple Negative Breast Cancer Emerging Drugs

Infinity Pharmaceuticals is developing IPI-549 (Eganelisib), which is an investigational first-in-class, oral, immuno-oncology product candidate targeting tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition, thereby reducing pro-tumor macrophage function and increasing anti-tumor macrophage function. Currently, the drug is in Phase II stage of Triple Negative Breast Cancer clinical trial development for the treatment of patients with TRIPLE NEGATIVE BREAST CANCER (MARIO-3).In January 2022, the company announced in their corporate presentation that the updated data readout for MARIO-3 trial is anticipated in 2H 2022. In addition to that the company also anticipated to initiate MARIO-4 registration enabling study in frontline advanced/metastatic TRIPLE NEGATIVE BREAST CANCER by end of 2022. In December 2021, the company announced the updated data from the MARIO-3 study which demonstrated that 88.6% of evaluable 1L TRIPLE NEGATIVE BREAST CANCER Patients Achieved tumor Reduction In September 2020, the company announced that US FDA granted Fast Track designation for the drug in combination with a checkpoint inhibitor and chemotherapy for the treatment of patients with inoperable locally advanced or metastatic TRIPLE NEGATIVE BREAST CANCER. Furthermore, in collaboration with Arcus Biosciences, the company is evaluating a checkpoint inhibitor-free, novel combination regimen of eganelisib plus AB928 (dual adenosine receptor antagonist) plus Doxil in advanced TRIPLE NEGATIVE BREAST CANCER patients. Recently, in May 2022, the company anticipated that they will initiate the first eganelisib (MARIO-4) registration-enabling trial, in front-line metastatic TRIPLE NEGATIVE BREAST CANCER by year-end 2022.

HiberCell’s Imprime PGG is a novel innate immune activator that binds to the dectin-1 receptor and activates innate immunity, reprogramming the immunosuppressive tumor microenvironment to enhance antigen presentation, trigger T cell activation and ultimately enhance the immune response against tumors. A Phase II clinical studies of Imprime PGG in combination with checkpoint inhibition demonstrated compelling mechanistic proof-of-concept data including the activation of innate and adaptive immunity resulting in improved overall survival, overall response and disease control rates in mTRIPLE NEGATIVE BREAST CANCER. In the ongoing Phase II Triple Negative Breast Cancer clinical trial studies, Imprime PGG paired with the checkpoint inhibitor Keytruda resulted in encouraging benefits across all clinical measures in patients with metastatic breast cancer, including TRIPLE NEGATIVE BREAST CANCER. In January 2021, the company announced an agreement with Biodesix to further the development of an enzyme-linked immunosorbent assay (ELISA) as a companion diagnostic in future registrational trials in breast cancer for Imprime PGG programs.

Note: Detailed emerging therapies assessment will be provided in the full report of Triple Negative Breast Cancer

Triple Negative Breast Cancer Market Outlook

TRIPLE NEGATIVE BREAST CANCER is a type of breast cancer that does not express the estrogen and the progesterone receptors and the human epidermal growth factor receptor type 2 (HER2). Since there are no positive markers to reliably classify TRIPLE NEGATIVE BREAST CANCER, these tumors are not yet treated with targeted therapies. Perhaps for this reason they are the most aggressive form of breast carcinomas. The treatment paradigm for TRIPLE NEGATIVE BREAST CANCER generally includes a combination of conventional therapies such as surgery, radiation, and chemotherapy.

Currently, the therapeutic market of TRIPLE NEGATIVE BREAST CANCER accounts mainly for the systemic chemotherapies (either alone or in combination), such as Paclitaxel (Abraxane), Erbulin (Halaven), Carboplatin, Cisplatin, Docetaxel etc. These chemotherapies are being used off-label, as both first line as well as second line treatment of TRIPLE NEGATIVE BREAST CANCER patients, with variation in the dosing frequency and drug-combinations.

Chemotherapy includes Neoadjuvant or Adjuvant chemotherapy that remains a key component of systemic treatment in TRIPLE NEGATIVE BREAST CANCER, which is determined primarily by its Triple Negative Breast Cancer clinical trial or pathologic stage. Neoadjuvant and adjuvant chemotherapy are the standard systemic treatment for early TRIPLE NEGATIVE BREAST CANCER, and anthracycline and taxane-based chemotherapy regimens comprise the current standard of care. Neoadjuvant therapy is followed to get chemo before surgery, to help shrink the tumor so that surgical procedures are easy to conduct. While adjuvant therapy is followed after surgery in case of larger tumors or the involvement of the lymph nodes.

The next step in the treatment of Triple Negative Breast Cancer is Surgery, which includes removal of the entire breast i.e., mastectomy since the cancer is quite aggressive and results into high metastasis. This is generally followed if there are calcium deposits or other abnormal cells in the breast. Radiation is another option to treat triple breast cancer that helps in killing any cancer cells still left in the area. The goal is to stop the cancer from coming back and generally followed after surgery.

Apart from the above mentioned options, there are few drugs that are approved by the FDA for the treatment of TRIPLE NEGATIVE BREAST CANCER. In January 2018, Lynparza (Olaparib; AstraZeneca), a poly ADP ribose polymerase (PARP) inhibitor, became the first non-chemotherapy treatment for patients with an inherited BRCA mutation and HER2-negative metastatic breast cancer, to receive the US Food and Drug Administration (USFDA) approval. Although the drug is not specifically approved for TRIPLE NEGATIVE BREAST CANCER patients, it still provides a novel treatment option for TRIPLE NEGATIVE BREAST CANCER patients with BRCA mutation.

Upcoming therapies, such as, Tecentriq (Hoffman-La Roche), IPI-549 (Infinity Pharmaceuticals), GX-I7 + Keytruda , and others have the potential to create a significant positive shift in the TRIPLE NEGATIVE BREAST CANCER market size during the study period (2019–2032).

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 (2022–2032).

According to DelveInsight, Triple Negative Breast Cancer market in 7MM is expected to witness a major change in the study period 2019-2032.

Analyst Commentary

• The pipeline of Triple Negative Breast Cancer is very robust, many potential therapies are being investigated for the treatment of Triple Negative Breast Cancer, and it is safe to predict that the treatment space will experience a significant impact on the market during the forecast period.
• The expected introduction of emerging therapies with improved efficacy, more awareness initiatives programs, and further improvement in the diagnosis rate, are likely to boost the growth of the Triple Negative Breast Cancer market in the 7MM. Aside from that, the market size of Triple Negative Breast Cancer may flourish due to increased research and development, label-expansion of approved therapies into other epilepsy in this field.
• The market growth of Triple Negative Breast Cancer may be offset by failures and/or discontinuation of the emerging therapies, unaffordable pricing, market access and reimbursement issues, and a scarcity of healthcare specialists.

Triple Negative Breast Cancer Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the Triple Negative Breast Cancer market or expected to get launched in the market during the study period 2019-2032. The analysis covers Triple Negative Breast Cancer market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Note: Detailed emerging therapies assessment will be provided in the full report of Triple Negative Breast Cancer

Triple Negative Breast Cancer Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase II and Phase III stage. It also analyzes Triple Negative Breast Cancer key players involved in developing targeted therapeutics.

Triple Negative Breast Cancer Clinical Trial Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing, patent details and other information for Triple Negative Breast Cancer emerging therapies.

Reimbursement Scenario in Triple Negative Breast Cancer

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In a report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

KOL- Views

To keep up with current market trends, we take KOLs and SMEs ' opinions working in the Triple Negative Breast Cancer domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Triple Negative Breast Cancer market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform Competitive and Market Intelligence analysis of the Triple Negative Breast Cancer Market by using various Competitive Intelligence tools that include - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Triple Negative Breast Cancer Market Report

• The report covers the descriptive overview of Triple Negative Breast Cancer, explaining its causes, signs and symptoms, pathophysiology, diagnosis, and currently available therapies
• Comprehensive insight has been provided into the Triple Negative Breast Cancer epidemiology and treatment in the 7MM
• Additionally, an all-inclusive account of both the current and emerging therapies for Triple Negative Breast Cancer are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
• A detailed review of the Triple Negative Breast Cancer market; historical and forecasted is included in the report, covering drug outreach in the 7MM
• Detailed Patient Based Market Forecasting determines the trends shaping and driving the global Triple Negative Breast Cancer market

Triple Negative Breast Cancer Market Report Highlights

• In the coming years, the Triple Negative Breast Cancer market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
• The companies and academics are working to assess challenges and seek opportunities that could influence Triple Negative Breast Cancer R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
• Major players are involved in developing therapies for Triple Negative Breast Cancer. The launch of emerging therapies will significantly impact the Triple Negative Breast Cancer market
• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Triple Negative Breast Cancer
• Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed Triple Negative Breast Cancer clinical trial profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities

Triple Negative Breast Cancer Report Insights

• Patient Based Market Forecasting
• Therapeutic Approaches
• Triple Negative Breast Cancer Pipeline Analysis
• Triple Negative Breast Cancer Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Triple Negative Breast Cancer Report Key Strengths

• 11 Years Forecast
• 7MM Coverage
• Triple Negative Breast Cancer Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Triple Negative Breast Cancer Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness

Key Questions

Market Insights:

• What was the Triple Negative Breast Cancer drug class share (%) distribution in 2019 and how it would look like in 2032?
• What would be the Triple Negative Breast Cancer total market size as well as market size by therapies across the 7MM during the forecast period (2019-2032)?
• What are the key findings of the market across 7MM and which country will have the largest Triple Negative Breast Cancer market size during the forecast period (2019-2032)?
• At what CAGR, the Triple Negative Breast Cancer market is expected to grow by 7MM during the forecast period (2019-2032)?
• What would be the Triple Negative Breast Cancer market outlook across the 7MM during the forecast period (2019-2032)?
• What would be the Triple Negative Breast Cancer market growth till 2032, and what will be the resultant market Size in the year 2032?
• How would the unmet needs affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What are the disease risk, burden, and regional/ethnic differences of Triple Negative Breast Cancer?
• What are the key factors driving the epidemiology trend for seven major markets covering the United States, EU4 (Germany, Spain, France, and Italy), the UK, and Japan?
• What is the historical Triple Negative Breast Cancer patient pool in seven major markets covering the United States, EU4 (Germany, Spain, France, and Italy), the UK, and Japan?
• What would be the forecasted patient pool of Triple Negative Breast Cancer in seven major markets covering the United States, EU4 (Germany, Spain, France, and Italy), the UK, and Japan?
• Where will be the growth opportunities in the 7MM concerning the patient population about Triple Negative Breast Cancer?
• Out of all 7MM countries, which country would have the highest prevalent population of Triple Negative Breast Cancer during the forecast period (2019-2032)?
• At what CAGR the patient population is expected to grow by 7MM during the forecast period (2019-2032)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the Triple Negative Breast Cancer treatment in addition to the approved therapies?
• What are the current treatment guidelines for the treatment of Triple Negative Breast Cancer in the US, Europe, and Japan?
• What are the Triple Negative Breast Cancer marketed drugs and their respective MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, efficacy, etc.?
• How many companies are developing therapies for the treatment of Triple Negative Breast Cancer?
• How many therapies are in-development by each company for Triple Negative Breast Cancer treatment?
• How many are emerging therapies in mid-stage, and late stage of development for Triple Negative Breast Cancer treatment?
• What are the key collaborations (Industry - Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Triple Negative Breast Cancer therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Triple Negative Breast Cancer and its status?
• What are the current challenges faced in drug development?
• What are the key designations that have been granted for the emerging therapies for Triple Negative Breast Cancer?
• What are the global historical and forecasted markets of Triple Negative Breast Cancer?

Reasons to buy

• The Patient Based Market Forecasting analysis will help in developing business strategies by understanding trends shaping and driving the Triple Negative Breast Cancer market
• Organize sales and marketing efforts by identifying the best opportunities for Triple Negative Breast Cancer in the US, Europe (Germany, Spain, Italy, and France), the United Kingdom, and Japan
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors
• Organize sales and marketing efforts by identifying the best opportunities for the Triple Negative Breast Cancer market
• To understand the future market competition in the Triple Negative Breast Cancer market