New York, USA, Feb. 27, 2025 (GLOBE NEWSWIRE) -- Breast Cancer Market Sees Rapid Growth — Key Insights and Forecasts of Different Breast Cancers for the Coming 10 Years | DelveInsight
The breast cancer market has experienced robust growth, fueled by increased awareness and early detection efforts. Advances in diagnostic and treatment technologies have opened new avenues for personalized therapies. Strategic partnerships and significant investments in research are further driving innovation and market expansion.
Breast cancer remains one of the most prevalent cancers worldwide, affecting millions of women and a smaller proportion of men. It is a heterogeneous disease classified into different subtypes based on hormone receptor (HR) status and HER2 expression, including HR-positive/HER2-negative, HER2-positive, and triple-negative breast cancer (TNBC). Early detection through mammography, genetic screening for high-risk patients (e.g., BRCA mutations), and advances in treatment have significantly improved survival rates. However, metastatic breast cancer (MBC) remains a major challenge, with a high likelihood of recurrence and drug resistance.
The current treatment landscape for breast cancer includes chemotherapy, hormonal therapies, targeted therapies, and immunotherapies, depending on the subtype. For HR-positive breast cancer, endocrine therapies such as tamoxifen and aromatase inhibitors remain the standard of care, often combined with CDK4/6 inhibitors like palbociclib, ribociclib, and abemaciclib. HER2-positive breast cancer is effectively treated with HER2-targeted therapies, including trastuzumab, pertuzumab, and the ADCs trastuzumab emtansine (T-DM1) and trastuzumab deruxtecan (T-DXd). TNBC, historically difficult to treat, has seen the approval of immune checkpoint inhibitors such as pembrolizumab in combination with chemotherapy and ADCs like sacituzumab govitecan. PARP inhibitors (e.g., olaparib, talazoparib) are also used for BRCA-mutant cases.
The breast cancer therapeutics market is expanding rapidly, driven by the increasing incidence of the disease, advancements in precision medicine, and the development of novel therapies. The emergence of biosimilars for drugs like trastuzumab and bevacizumab is also influencing pricing dynamics and market access. Additionally, pharma companies are investing heavily in next-generation therapies, including bispecific antibodies, novel ADCs, and personalized mRNA vaccines, to address resistance mechanisms and improve patient outcomes.
Despite these advancements, challenges such as high treatment costs, disparities in access to care, and the need for better biomarkers remain. The future of breast cancer treatment is likely to be shaped by the integration of artificial intelligence in diagnostics, liquid biopsies for early detection, and the evolution of combination therapies to overcome resistance. The competitive landscape remains dynamic, with ongoing clinical trials and regulatory approvals expected to further diversify the treatment options available to patients.
Discover more about the breast cancer market in detail @ Breast Cancer Market Report
DelveInsight has expertise in the oncology market, and an experienced team handles the oncology domain proficiently. DelveInsight has recently released a series of epidemiology-based market reports on different types of breast cancers including Metastatic HR+/HER2− Breast Cancer, Benign Breast Disease and Early Breast Cancer, ESR1 Mutated Metastatic Breast Cancer, Metastatic HER2-positive Breast Cancer, and Triple-Negative Breast Cancer. These reports include a comprehensive understanding of current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Additionally, the reports feature an examination of prominent companies working with their lead candidates in different stages of clinical development. Let’s dive deep into the market assessment of these breast cancer types individually.
Metastatic HR+/HER2− Breast Cancer Market
HR+/HER2- breast cancer is the most prevalent subtype of breast cancer, characterized by the presence of hormone receptors for estrogen and progesterone while lacking HER2 overexpression. This subtype generally has a favorable prognosis and is commonly treated with hormone therapy to inhibit hormone-driven tumor growth.
According to DelveInsight’s estimates, approximately 211,000 new cases of HR+/HER2− breast cancer were reported in the US in 2024. Over the past decade, endocrine therapy has been the standard treatment for HR+/HER2− breast cancer, including cases with visceral involvement. Currently, the preferred treatment approach combines aromatase inhibitors or fulvestrant with CDK4/6 inhibitors as part of endocrine therapy.
The introduction and approval of CDK4/6 inhibitors have significantly changed the treatment landscape for HR+/HER2− breast cancer. At present, three selective CDK4/6 inhibitors—ENHERTU, DATROWAY, IBRANCE, KISQALI, and VERZENIO—are used in combination with endocrine therapy. In November 2023, the FDA approved TRUQAP (capivasertib) alongside FASLODEX for patients with advanced HR+/HER2− breast cancer exhibiting specific biomarker alterations (PIK3CA, AKT1, or PTEN).
The NCCN Guidelines designated KISQALI as the only Category 1 Preferred CDK4/6 inhibitor for first-line treatment in combination with an aromatase inhibitor, reinforcing its market position in the U.S. This led to KISQALI reclaiming its lost market share, with its U.S. revenue contribution rebounding to 50%, a significant recovery from its decline to 46% in 2020, 36% in 2021, and 38% in 2022.
In January 2025, the FDA approved DATROWAY for patients with unresectable or metastatic HR+, HER2- breast cancer (IHC 0, IHC 1+, or IHC 2+/ISH-) who had previously undergone endocrine-based therapy and chemotherapy. Additionally, ENHERTU received approval for patients with unresectable or metastatic HR+, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer that had progressed following at least one endocrine therapy in the metastatic setting.
Also, in January 2025, Roche announced positive topline results from its Phase III INAVO120 trial, evaluating ITOVEBI in combination with IBRANCE and fulvestrant for patients with PIK3CA-mutated HR+/HER2−, endocrine-resistant, locally advanced, or metastatic breast cancer.
Key players in the HR+/HER2− breast cancer market include Pfizer, Novartis, Stemline Therapeutics, Olema Pharmaceuticals, Arvinas, Immutep, AstraZeneca, Roche/Genentech, Evexta Bio, EQRx, Sermonix Pharmaceuticals, Celcuity, Veru Pharma, Evgen Pharma, Eli Lilly, Biotheryx, and others.
Among the 7MM, the US held the largest market share for HR+/HER2− breast cancer, generating approximately USD 7.5 billion in revenue in 2023. The market is expected to grow significantly over the forecast period (2025-2034), driven by the introduction of several novel therapeutic classes.
For a comprehensive view of the metastatic HR+/HER2− breast cancer market, check out the Metastatic HR+/HER2− Breast Cancer Market Assessment
Benign Breast Disease and Early Breast Cancer Market
Benign breast disease encompasses a range of non-cancerous lesions often detected through clinical examination, routine imaging, self-examination by the patient, or due to breast pain (mastalgia). Once appropriate imaging and necessary biopsies confirm a benign diagnosis, management focuses on symptom relief and patient education, without the need for additional surgical intervention. These benign conditions are more prevalent in younger individuals, typically emerging in the second decade of life and peaking between ages 40 and 50.
Early-stage breast cancer refers to cancer that has not spread beyond the breast or the nearby lymph nodes in the armpit on the same side of the body, with no metastasis to other organs. The number staging system categorizes breast cancer into different stages, with early breast cancer classified as Stage 0, Stage I, and Stage II.
In 2023, the estimated number of incident cases of benign breast disease and early breast cancer across the 7MM was 2.9 million and 544,200, respectively. These numbers are expected to rise over the forecast period. The United States accounted for the largest share of these cases, representing around 49% of the total 7MM incidence, followed by the EU4 (France, Germany, Italy, and Spain), the UK, and Japan.
The current treatment landscape is segmented based on commonly used therapeutic approaches across the 7MM, with minor regional variations in intervention patterns. Surgical procedures such as lumpectomy, mastectomy, minimally invasive techniques, and surgical excision are key treatment options for benign breast disease. The total market size for benign breast disease and early breast cancer in the 7MM was valued at USD 8.8 billion in 2023, with projections indicating growth throughout the forecast period.
Discover more about benign breast disease and early breast cancer in development @ Benign Breast Disease and Early Breast Cancer Clinical Trials
ESR1 Mutated Metastatic Breast Cancer Market
ESR1 mutations are most commonly acquired in advanced breast cancer patients treated with aromatase inhibitors, particularly in cases where cancer progresses despite prior sensitivity to this therapy. These mutations are less frequent in patients with intrinsic endocrine resistance.
ER-positive/HER2-negative breast cancer is the most prevalent subtype, accounting for approximately 70% of cases. Among patients with this subtype who receive endocrine therapy for metastatic disease, ESR1 mutations are frequently observed. In 2023, the total diagnosed prevalent cases of ESR1-mutated metastatic breast cancer across the 7MM were estimated at around 43,000.
Currently, ORSERDU is the only approved treatment specifically for ER-positive, HER2-negative tumors harboring ESR1 mutations. However, there remains a critical need for therapies that enhance survival and quality of life in metastatic breast cancer patients. Palazestrant demonstrates significant potential in addressing these needs, both as a monotherapy and in combination with existing standard treatments, supported by clinical evidence and ongoing research.
Several promising drugs are in the pipeline, including Camizestrant (AstraZeneca), Palazestrant (Olema Pharmaceuticals), ARV-471 (Arvinas), Lasofoxifene (Sermonix Pharmaceuticals), Giredestrant (Roche), Imlunestrant (LY3484356) (Eli Lilly), H3B-6545 (H3 Biomedicine/Eisai), and IBRANCE (palbociclib) (Pfizer), among others.
In 2023, the US had the largest market size for ESR1-mutated metastatic breast cancer within the 7MM, valued at approximately USD 820 million, with projections indicating continued growth through 2034. The anticipated introduction of new therapies, increased early patient screening, expanded treatment in secondary care, advancements in implementation strategies, and heightened awareness will drive the development of more effective treatment options. Nevertheless, an endocrine therapy capable of working effectively regardless of ESR1 mutation status would be highly beneficial.
To gain a deeper understanding of the ESR1 mutated metastatic breast cancer market, be sure to explore the ESR1 Mutated Metastatic Breast Cancer Market Outlook
Metastatic HER2-positive Breast Cancer Market
Breast cancer develops when abnormal cells in the breast multiply uncontrollably, forming a tumor. It typically originates in the breast’s ducts or lobules. Certain breast cancers rely on the human epidermal growth factor receptor 2 (HER2) gene for growth. These cancers, known as HER2-positive (HER2+), exhibit multiple copies of the HER2 gene or elevated levels of the HER2 protein, also called receptors. The HER2 gene produces this protein, which plays a crucial role in tumor cell growth.
In 2023, the estimated number of HER2-positive breast cancer cases across the seven major markets was approximately 102,000. The incidence of these cases is projected to rise between 2024 and 2034.
Various treatment options exist for HER2-positive breast cancer, categorized into pharmacological and nonpharmacological approaches. While advancements in HER2-targeted therapies have significantly improved disease management, challenges such as relapse persist due to tumor heterogeneity and drug resistance.
Historically, metastatic HER2+ breast cancer was treated with standard chemotherapy until trastuzumab became available. Roche responded to the rise of biosimilars by launching a subcutaneous (SC) version of HERCEPTIN in Europe (2013) and the US (2019). As part of its efforts to expand its HER2-targeted therapies, Roche introduced its first antibody-drug conjugate (ADC), KADCYLA, which received FDA approval in 2013 for treating HER2-positive metastatic breast cancer following prior HERCEPTIN and chemotherapy treatment.
The second ADC to gain FDA and EMA approval, ENHERTU (trastuzumab deruxtecan), represents a potential breakthrough, reshaping the second-line treatment landscape and providing a competitive edge for AstraZeneca and Daiichi Sankyo.
Several pharmaceutical companies, including Pfizer, Roche, Spectrum Pharmaceuticals, Hoffmann-La Roche, Eli Lilly, and Ambrx, are actively engaged in mid- and late-stage research and development for HER2-positive breast cancer treatments. The HER2-positive breast cancer therapeutics market is expected to expand in the coming years.
In the United States, the market for HER2-positive breast cancer therapies was valued at over USD 1.6 billion in 2023 and is projected to grow further by 2034. As new and promising anti-HER2 treatments emerge, the field will continue to evolve, with updated clinical guidelines incorporating novel therapies into third-line and subsequent treatment strategies.
Explore in-depth for a comprehensive understanding of the Metastatic HER2-positive Breast Cancer Clinical Trials
Triple-Negative Breast Cancer Market
Triple-negative breast cancer (TNBC) is an aggressive and diverse subtype of breast cancer, distinguished by the absence of estrogen receptors (ER), progesterone receptors (PR), and human epidermal growth factor receptor 2 (HER2). It accounts for a significant proportion of breast cancer cases and is associated with rapid progression, high recurrence rates, and poor prognosis. TNBC is more frequently diagnosed in younger women, African American individuals, and those with BRCA1 gene mutations. According to DelveInsight's estimates, approximately 102,000 new TNBC cases were reported in the 7MM in 2023, with the United States contributing 44% of these cases.
The standard treatment strategy typically begins with neoadjuvant or adjuvant therapy, followed by first-line treatment for advanced cases. If the disease progresses or fails to respond sufficiently, second-line and subsequent therapies are considered. Immunotherapy, particularly PD-1/PD-L1 inhibitors, is increasingly utilized in metastatic TNBC to strengthen the immune system's response against tumors.
For early-stage TNBC, KEYTRUDA (Pembrolizumab), a PD-1 inhibitor, has become a standard therapy when combined with neoadjuvant chemotherapy and continued as adjuvant monotherapy. It is also used alongside chemotherapy for locally recurrent or metastatic PD-L1-positive TNBC (CPS ≥10). Targeted therapies have gained prominence, particularly for BRCA-mutated TNBC, with PARP inhibitors like LYNPARZA (Olaparib) and TALZENNA (Talazoparib) leveraging defective DNA repair mechanisms. TRODELVY (Sacituzumab govitecan), a TROP-2-directed antibody-drug conjugate (ADC), is prescribed for recurrent or treatment-resistant metastatic TNBC. Meanwhile, TECENTRIQ (Atezolizumab) was withdrawn from the US market following unsuccessful confirmatory trials but remains available in Europe and Japan.
Taxane-based chemotherapy remains the cornerstone of treatment, often combined with immune checkpoint inhibitors for PD-L1-positive cases. Platinum-based chemotherapy is sometimes used but remains controversial due to severe side effects and limited efficacy. Despite progress, TNBC continues to present significant challenges, emphasizing the need for further research to improve treatment options and patient survival.
There is a pressing demand for novel therapies, as existing treatments often fail to provide long-term disease control. The development of innovative drugs holds promise for enhancing patient outcomes. Several potential therapies are currently in the pipeline, including DATROWAY (Datopotamab Deruxtecan) (AstraZeneca/Daiichi Sankyo), Adagloxad Simolenin (OBI Pharma), PADCEV (Enfortumab vedotin) (Astellas Pharma/Pfizer), BNT327/PM8002 (BioNTech), Tilarginine (Galera Therapeutics), and others.
DelveInsight’s analysis estimates that the TNBC market in the 7MM was valued at USD 4.2 billion in 2023. Between 2025 and 2034, the market is projected to expand at a CAGR of 4.7%, driven by the introduction of novel therapies.
To access a complete analysis of the TNBC market, visit Triple-Negative Breast Cancer Market Assessment
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