Triple Negative Breast Cancer (TNBC) - Market Insight, Epidemiology And Market Forecast - 2032

Key Highlights

• Breast cancer is a genetically and clinically heterogeneous disease with multiple subtypes. The classification of these subtypes has evolved over the years. The most common and widely accepted classification of breast cancer is from an immunohistochemical perspective, based on the expression of the following hormone receptors: estrogen (ER), progesterone (PR), and human epidermal growth factor (HER2)
• TNBC's distinct immune microenvironment, which includes high levels of vascular endothelial growth factors, tumor-infiltrating lymphocytes (TILs), tumor-associated macrophages (TAMs), and other molecules that promote tumor cell growth and migration, plays a dual role in the occurrence, growth, and metastasis of the disease.
• TNBC risk factors have been classified as either non-modifiable or modifiable. Age, sex, genetic mutations, genetic history, breast tissue density, and others are non-modifiable risk variables. Modifiable risk factors include medicines, BMI, inadequate vitamin supplements, chemical and drug exposure, and so on.
• TNBC can manifest as a higher-grade malignancy at first and have a more aggressive clinical course than other kinds of breast cancer. In addition, the rate of distant metastatic disease is greater, and the mean time to distant metastatic disease is shorter. Because of the absence of endocrine receptor expression, interventions are restricted. TNBC has a worse prognosis and greater mortality with residual illness than non-TNBC because of its aggressive course, high rates of recurrence, and limited therapy alternatives.
• Approximately half of the breast cancers, historically categorized as human epidermal growth factor receptor 2 (HER2)-negative, have low expression of HER2, defined as an immunohistochemical (IHC) score of 1+ or 2+ with negative in situ hybridization. The current clinical definition of HER2-low BC used in clinical practice and ongoing clinical trials relies on the standard IHC and ISH approach; thus, tumors with a low level of HER2 expression (defined as a HER2 IHC score of 1+ or 2+) and no detectable ERBB2 amplification fall into this category.
• Regarding the epidemiology of TNBC, it was found that the United States accounted for ~42% of the total cases of TNBC in the 7MM.
• The market size captured by the United States was found to be the largest among the 7MM countries. It was found that the United States accounted for ~61% of the total market size captured by the 7MM region.
• The term “triple negative breast cancer diagnosis” is somewhat misnomer. Rather than being an official medical diagnosis, TNBC refers to the cellular makeup of certain breast cancers, which can influence a patient's prognosis. The pathology for these cancers usually shows that the cancer cells tested negatively for three specific hormone receptors: estrogen, progesterone, and HER-2/neu.
• In contrast to hormone receptor (ER/PR)-positive and HER2-positive breast cancers, there are few FDA-approved targeted therapies for triple-negative breast cancer. Historically, chemotherapy has been the main systemic treatment, especially for patients with metastatic disease; although TNBC tends to respond well to chemo initially, recurrences are frequent.
• The recent approval of various immune checkpoint inhibitors (like pembrolizumab) and targeted therapies (like olaparib and talazoparib) has led to a dynamic shift in the treatment landscape, with their increased usage across various lines of therapy, leading to significant improvement in treatment outcomes and patient prognosis.
• The emerging pipeline for TNBC patients consists of early-stage and late-stage drugs in various lines of therapy. As per the publisher's estimates, the potential drugs that can significantly change in the market during the forecast period include COSELA, Capivasertib, Datopotamab Deruxtecan (Dato-DXd), ZEN003694 and TAVO (tavokinogene telseplasmid) being administered in various combinations. These drugs are in different stages of clinical development.

Report Summary

• The report covers a segment of key events describing the latest developments from a treatment point of view, including designations, collaboration, and agreements, etc., as well as a descriptive overview of Triple Negative Breast Cancer (TNBC), explaining the definition of Triple Negative Breast Cancer (TNBC), types and risk factors involved in Triple Negative Breast Cancer (TNBC), pathophysiology, and the treatment of Triple Negative Breast Cancer (TNBC).
• The report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage (Phase III and Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
• The report also encompasses a comprehensive analysis of the Triple Negative Breast Cancer (TNBC) market, thoroughly examining its historical and projected market size (2019-2032). It also includes the market share of therapies, along with detailed assumptions and the underlying rationale for methodology. The report also includes the drug outreach coverage in the 7MM region.
• The report includes qualitative insights that provide an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM Triple Negative Breast Cancer (TNBC) market.

Market

Various key players are currently leading the treatment landscape of TNBC, such as G1 Therapeutics, AstraZeneca, Zenith Epigenetics, etc. The details of the country and therapywise market size have been provided below.

• In 2022, the United States accounted for the largest market size among the 7MM countries, making ~61% of the total market size of the 7MM.
• Among the 7MM countries, Spain had the least market size in 2022, accounting for ~3% of the market size in the 7MM region.
• In the EU4 region, Germany accounted for the largest market size, making up ~29% of the total market size of the EU4 region.
• The market size has also been segregated linewise. In 2022, among the therapies being administered to first-line patients, KEYTRUDA (pembrolizumab) + paclitaxel/nab-paclitaxel/gemcitabine + carboplatin combination garnered the largest market share in the 7MM region.

Triple Negative Breast Cancer (TNBC) Drug Chapters

The section dedicated to drugs in the Triple Negative Breast Cancer (TNBC) report provides an in-depth evaluation of both the marketed drugs and late-stage pipeline drugs (Phase III and Phase II) related to TNBC. Among the FDA-approved treatments are LYNPARZA (olaparib), TALZENNA (talazoparib), KEYTRUDA (pembrolizumab), and others. There are several emerging therapies, and detailed coverage of the same has been provided in the report.

The drug chapters section provides valuable information on various aspects related to clinical trials of TNBC, including specific details, such as the pharmacological mechanisms of the drugs involved, agreements and partnerships, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases related to drugs targeting TNBC.

Marketed Therapies

LYNPARZA (olaparib)

LYNPARZA (olaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor. LYNPARZA is indicated for the treatment of adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with prior endocrine therapy or be considered inappropriate for endocrine therapy.

TALZENNA (talazoparib)

Talazoparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1 and PARP2, which play a role in DNA repair. TALZENNA is indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.

Triple Negative Breast Cancer (TNBC) Market Outlook

Unlike other forms of breast cancer, TNBC does not respond with hormonal or HER2-targeted treatment. Hence, for a long time, systemic chemotherapy has remained the mainstay treatment for metastatic TNBC. Even for resectable/non-metastatic disease, chemotherapy and surgery in neoadjuvant or adjuvant therapy have been widely used.

But the recent approval of various immune checkpoint inhibitors (like pembrolizumab) and targeted therapies (like olaparib and talazoparib) has led to a dynamic shift in the treatment landscape, with their increased usage across various lines of therapy, leading to significant improvement in treatment outcomes and patient prognosis.

In patients with localized TNBC, dose-dense doxorubicin-cyclophosphamide, and paclitaxel were the standard neoadjuvant chemotherapy backbone until 2021. With the approval of neoadjuvant pembrolizumab, chemotherapy with immunotherapy is the new standard of care for localized TNBC.

Before these recent developments, taxane-based chemotherapies have remained the standard of care for metastatic disease, specifically in first-line treatment. However, with their recent approvals, immune checkpoint inhibitors like pembrolizumab and atezolizumab have established their effectiveness when combined with taxane-based chemotherapies; however, their usage is limited to patients with high levels of PD-L1 expression. Due to their superior results, they remain the most preferred form of treatment in the first-line setting.

The TNBC market is witnessing significant growth and evolution due to increased awareness, technological advancements, therapeutic advancements, and integration into clinical trials. However, challenges related to cost, access, and market competition remain important considerations for TNBC, keeping the dynamic market scenario in mind.

Drug Class Insights

Treatment for triple-negative breast cancer (TNBC) is more difficult since there is no apparent therapeutic target, as there is for ER/PR-positive or HER2-positive breast cancer. TNBC is treated with surgery, chemotherapy, and radiation.

The second most preferred form of treatment are poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors LYNPARZA (olaparib) and TALZENNA (talazoparib); their usage is preferred in patients with germline BRCA1/2 mutations. Platinum-based chemotherapies are also used at times in the first-line treatment setting, but their usage is highly debated among physicians, as they tend to have very severe adverse effects and do not have that good of treatment outcome (PFS) either.

For patients with recurrent/refractory metastatic TNBC (mTNBC), the antibody-drug conjugate TRODELVY (sacituzumab govitecan-hziy) has emerged as an effective treatment option, in the second-line of the treatment. It targets Trop-2, which is present in most patients with triple-negative disease.

Triple Negative Breast Cancer (TNBC) Disease Understanding and Treatment

Triple Negative Breast Cancer (TNBC) Overview

Triple-negative breast cancer (TNBC) encompasses a heterogeneous group of fundamentally different diseases with different histologic, genomic, and immunologic profiles, which are aggregated under this term because of their lack of estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 expressions. Massively parallel sequencing and other omics technologies have demonstrated the level of heterogeneity in TNBCs and shed light on the pathogenesis of this therapeutically challenging entity in breast cancer.

Triple Negative Breast Cancer (TNBC) diagnosis

The phrase “triple negative breast cancer (TNBC) diagnosis” is a bit misleading. TNBC refers to the cellular composition of some breast tumors, which might impact a patient's prognosis rather than an official medical diagnosis. Pathology for these malignancies typically reveals that the cancer cells tested negative for three hormone receptors: estrogen, progesterone, and HER-2/neu. The first step in developing an effective treatment strategy is to confirm any breast cancer diagnosis. A triple negative test result means these hormones will not promote cancer development. Another problem is that standard breast cancer hormone treatment, such as tamoxifen or aromatase inhibitors, is unsuccessful in treating these tumors.

Further details related to country-based variations are provided in the report.

Triple Negative Breast Cancer (TNBC) Treatment

Triple-negative breast cancer (TNBC) represents a small but aggressive subtype of breast cancer with high mortality, partly because many cancers become metastatic. Relapse is common in TNBC, including for women with localized disease. TNBCs test negative for progesterone, estrogen receptors, and excess HER2 protein. For these reasons, this cancer type is not responsive to hormonal or HER2-targeted therapies.

In contrast to hormone receptor (ER/PR)-positive and HER2-positive breast cancers, there are few FDA-approved targeted therapies for triple-negative breast cancer. Historically, chemotherapy has been the main systemic treatment, especially for patients with metastatic disease; although TNBC tends to respond well to chemo initially, recurrences are frequent.

Patients have a worse prognosis with fewer treatment options than other breast cancer subtypes, and TNBC is more resistant to conventional treatment. Overall survival rates for TNBC patients with advanced or Stage IV disease is approximately 12 months compared to 36 months for those with ER-positive/PR-positive/HER2-negative disease.

But, of late, this pattern of treatment and survival is changing, as with an increased understanding of the disease's pathophysiology, TNBC is classified into several distinct molecular subtypes based on gene expression profiles rather than being considered a single disease. Following these developments, accompanied by newer therapies being recently approved, there has been improvement in the prognosis of patients.

Further details related to treatment and management are provided in the report.

Triple Negative Breast Cancer (TNBC) Epidemiology

The Triple Negative Breast Cancer (TNBC) epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Incident Cases of Triple Negative Breast Cancer (TNBC), Subtype-specific Cases of Triple Negative Breast Cancer (TNBC), Gene Mutation-specific Cases of Triple Negative Breast Cancer (TNBC), Stage-specific Cases of Triple Negative Breast Cancer (TNBC), Age-specific Cases of Triple Negative Breast Cancer (TNBC) and Line wise Treated Cases of Triple Negative Breast Cancer (TNBC) in the 7MM covering the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2019 to 2032.

• The total incident cases of TNBC in the United States comprised ~43,000 cases in 2022. These cases are expected to increase by 2032.
• Among the EU4 countries, Germany accounted for the highest number of incident cases of TNBC, i.e., ~10,750 cases in 2022. Whereas Spain accounted for the least number of cases, i.e., ~5,200 cases in 2022.
• In Japan, as per subtype-specific classification, the HER2-negative cases were found to be the highest in number, ~8,400 cases, in 2022.
• As per gene mutation-specific cases, the BRCA1 cases were found to be the highest in number, i.e., ~730 cases in 2022, in the UK.

KOL Views

To stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.

We have reached out to industry experts to gather insights on various aspects related to Triple Negative Breast Cancer (TNBC), including the evolving treatment landscape, patients' reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.

The team of analysts connected with more than 10 KOLs across the 7MM. We contacted institutions such as the National Cancer Center Hospital, University of Messina, Icahn School of Medicine, and Tufts Medical Center, among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the Triple Negative Breast Cancer (TNBC) market, which will assist our clients in analyzing the overall epidemiology and market scenario.

Qualitative Analysis

We conduct qualitative and market intelligence analysis by employing the SWOT analysis approach. Within the SWOT analysis framework, we assess the strengths, weaknesses, opportunities, and threats pertaining to various aspects such as disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies. This analysis provides a comprehensive evaluation of the current situation and helps identify areas of advantage, areas for improvement, potential opportunities, and potential challenges in the specified domains.

Market Access and Reimbursement

Cancer treatments are funded in several countries through public reimbursement programs. This type of support promotes equitable access for people by removing direct fees from patients. The escalating prices of cancer medications have compelled several nations to seek cost-cutting measures.

Cancer drugs are highly specialized medicines with limited authorized indications, frequently specific to one or a combination of tumor sites, chemotherapy regimens, and treatment sequences. Typically, public payers limit reimbursement to certain specific conditions.

Patients with Medicare may or may not have to pay a portion of the cost of KEYTRUDA (pembrolizumab) based on their insurance plan. For example, with a Medicare Advantage plan, 41% of patients had no out-of-pocket costs for the 200 mg dose of KEYTRUDA. Roughly 80% of patients are responsible for a portion of the cost paid between USD 0 and USD 925 per infusion after meeting their deductible. Most patients with Medicaid typically pay USD 4-8 per KEYTRUDA infusion. The copay part, which needs to be paid by the patient, ranges from USD 12,045.

Further details related to reimbursement will be provided in the report.

Triple Negative Breast Cancer (TNBC) Report Insights

• Patient Population
• Therapeutic Approaches
• Triple Negative Breast Cancer (TNBC) Market Size and Trends
• Existing Market Opportunity

Triple Negative Breast Cancer (TNBC) Report Key Strengths

• Ten-year Forecast
• The 7MM Coverage
• Triple Negative Breast Cancer (TNBC) Epidemiology Segmentation
• Key Cross Competition

Triple Negative Breast Cancer (TNBC) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Market Attractiveness
• Qualitative Analysis (SWOT)

Key Questions Answered

• Would there be any changes observed in the current treatment approach?
• Will there be any improvements in Triple Negative Breast Cancer (TNBC) management recommendations?
• Would technical advances pave the way for future therapies for Triple Negative Breast Cancer (TNBC)?
• How would the emerging therapies fare against the already established approved treatment regimens?