Breast Cancer Drugs Market 2032: Clinical Trials, EMA, PDMA, FDA Approvals, Medication, Statistics, Revenue, Therapies and Companies by DelveInsight

(Albany, USA) DelveInsight's "Breast Cancer Market Insights, Epidemiology, and Market Forecast-2032" report delivers an in-depth understanding of Breast Cancer, historical and forecasted epidemiology as well as the Breast Cancer market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

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

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Some facts of the Breast Cancer Market Report are:
• According to DelveInsight, Breast Cancer market size is expected to grow at a decent CAGR by 2032.
• The total market size of ER+/HER2- Breast Cancer in adjuvant/neoadjuvant setting in 2022 was around USD 870 million, and is projected to increase during the forecast period (2023-2032).
• Leading Breast Cancer companies working in the market are Veru, Sanofi, Roche, AstraZeneca, Eli Lilly, EQRx, Gilead, Sermonix Pharmaceuticals, Evgen Pharma, Tyme, Genentech, DaiichiSankyo, Pfizer Inc., AstraZeneca, Novartis AG, Merck, Sanofi, Bristol-Myers Squibb, Eisai, Mylan N.V., Teva Pharmaceutical, Kyowa Kirin Co., Ltd., MacroGenics, Inc., Gilead Sciences, Takeda Pharmaceutical Company Limited, and AbbVie Inc. and others.
• Key Breast Cancer Therapies expected to launch in the market are Camizestrant (AZD9833), Lasofoxifene, IBRANCE (palbociclib), LYNPARZA (olaparib), and others.
• In March 2025, the FDA granted orphan drug status to Nerlynx® (neratinib) for treating breast cancer patients with brain metastases. Neratinib, a tyrosine kinase inhibitor, is already approved for the extended adjuvant treatment of HER2-positive breast cancer following trastuzumab therapy.
• Also in March 2025, IceCure Medical Ltd. reported ongoing discussions with the FDA regarding its De Novo marketing application for ProSense®, aimed at treating early-stage, low-risk breast cancer patients receiving endocrine therapy. IceCure specializes in minimally invasive cryoablation technology that eradicates tumors through freezing, providing a non-surgical treatment option.
• In February 2025, Lumitron Technologies, Inc. received the FDA's "Breakthrough Device" designation for its HyperVIEWTM X-Ray system. This system leverages the K-Edge subtraction method for enhanced contrast imaging in breast cancer diagnosis and incorporates Lumitron's proprietary distributed charge laser-Compton technology, delivering imaging resolution 100 times greater and significantly safer than conventional X-rays.
• In January 2025, the FDA approved Datroway, a targeted therapy developed by AstraZeneca and Daiichi Sankyo, for patients with advanced breast cancer who have undergone prior treatment.
• 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.
• 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.
• In November 2023, Pfizer announces that its new breast cancer drug, palbociclib, has been approved by the FDA for the treatment of patients with HER2-positive metastatic breast cancer. Palbociclib is a CDK4/6 inhibitor that works by blocking the growth and spread of cancer cells.Merck announces that its new breast cancer drug, pembrolizumab, has been approved by the FDA for the treatment of patients with triple-negative breast cancer (TNBC). Pembrolizumab is an immunotherapy drug that works by boosting the body's immune system to fight cancer cells. Roche announces that its new breast cancer drug, tucatinib, has been approved by the FDA for the treatment of patients with HER2-positive advanced or metastatic breast cancer. Tucatinib is a TKI that works by blocking the HER2 protein, which is involved in the growth and spread of cancer cells.

Breast Cancer Overview
Breast cancer forms when cells in the breast mutate and grow uncontrollably. It is the most common cancer among women globally. While it primarily affects women, men can also develop breast cancer, though it's rare. Risk factors include age, family history, genetic mutations (such as BRCA1 and BRCA2), hormonal factors (late menopause, hormone replacement therapy), obesity, alcohol consumption, and radiation exposure. Symptoms may include a lump in the breast, changes in breast size or shape, dimpling of the breast skin, discharge, or inversion. Diagnosis involves mammograms, ultrasounds, MRIs, and biopsies. Treatment options vary based on the stage and type of cancer but may include surgery, chemotherapy, radiation therapy, hormone therapy, targeted therapy, or a combination. Early detection through screening and advancements in treatment have significantly improved survival rates and quality of life for those with breast cancer.

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Breast Cancer Market
The Breast Cancer market outlook of the report helps to build a detailed comprehension of the historical, current, and forecasted Breast Cancer market trends by analyzing the impact of current Breast Cancer therapies on the market and unmet needs, and drivers, barriers, and demand for better technology.

This segment gives a thorough detail of the Breast Cancer market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated Breast Cancer market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

The Breast Cancer market is propelled by several significant drivers, including the rising global incidence of breast cancer, increasing awareness through screening programs, and the growing adoption of personalized medicine. Breast Cancer market growth is further supported by advancements in diagnostic technologies such as liquid biopsies, molecular imaging, and AI-based pathology, which enable early detection and more accurate diagnosis. The Breast Cancer market also benefits from a robust pipeline of targeted therapies, including HER2 inhibitors, PARP inhibitors, and antibody-drug conjugates, which offer improved outcomes and reduced side effects.
Additionally, strong investments from both public and private sectors in oncology research further stimulate innovation and market expansion. However, the Breast Cancer market faces several barriers, such as the high cost of treatment and diagnostics, which limits accessibility, particularly in low- and middle-income countries. Breast Cancer market challenges also include disparities in healthcare infrastructure, late-stage diagnosis in underserved populations, and the complex regulatory landscape for new drug approvals. Moreover, resistance to existing therapies and side effects associated with long-term treatment pose ongoing concerns. Despite these obstacles, the Breast Cancer market continues to show resilience and growth, driven by technological advances, supportive healthcare policies, and a rising focus on patient-centric care.
According to DelveInsight, the Breast Cancer market in 7MM is expected to witness a major change in the study period 2019-2032.

Breast Cancer Epidemiology
The Breast Cancer epidemiology section provides insights into the historical and current Breast Cancer patient pool and forecasted trends for seven individual 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 Breast Cancer market report also provides the diagnosed patient pool, trends, and assumptions.

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Breast Cancer Drugs Uptake
This section focuses on the uptake rate of the potential Breast Cancer drugs recently launched in the Breast Cancer market or expected to be launched in 2019-2032. The analysis covers the Breast Cancer market uptake by drugs, patient uptake by therapies, and sales of each drug.
Breast Cancer Drugs Uptake helps in understanding the drugs with the most rapid uptake and the reasons behind the maximal use of new drugs and allows the comparison of the drugs based on Breast Cancer market share and size, which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Breast Cancer Pipeline Development Activities
The Breast Cancer report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses Breast Cancer key players involved in developing targeted therapeutics.

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Breast Cancer Therapeutics Assessment
Major key companies are working proactively in the Breast Cancer Therapeutics market to develop novel therapies which will drive the Breast Cancer treatment markets in the upcoming years are Veru Inc. (NASDAQ: VERU), Sanofi (EPA: SAN), Roche Holding AG (SWX: ROG), AstraZeneca (LSE: AZN), Eli Lilly and Company (NYSE: LLY), EQRx, Inc. (NASDAQ: EQRX), Gilead Sciences, Inc. (NASDAQ: GILD), Sermonix Pharmaceuticals (Privately Held), Evgen Pharma plc (LSE: EVG), Tyme Technologies, Inc. (NASDAQ: TYME), Genentech (Subsidiary of Roche Holding AG), Daiichi Sankyo Company, Limited (TYO: 4568), Pfizer Inc. (NYSE: PFE), Novartis AG (SWX: NOVN), Merck & Co., Inc. (NYSE: MRK), Bristol-Myers Squibb Company (NYSE: BMY), Eisai Co., Ltd. (TYO: 4523), Mylan N.V. (now part of Viatris Inc., NASDAQ: VTRS), Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), Kyowa Kirin Co., Ltd. (TYO: 4151), MacroGenics, Inc. (NASDAQ: MGNX), Takeda Pharmaceutical Company Limited (TYO: 4502), AbbVie Inc. (NYSE: ABBV), and others.

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Breast Cancer Report Key Insights
1. Breast Cancer Patient Population
2. Breast Cancer Market Size and Trends
3. Key Cross Competition in the Breast Cancer Market
4. Breast Cancer Market Dynamics (Key Drivers and Barriers)
5. Breast Cancer Market Opportunities
6. Breast Cancer Therapeutic Approaches
7. Breast Cancer Pipeline Analysis
8. Breast Cancer Current Treatment Practices/Algorithm
9. Impact of Emerging Therapies on the Breast Cancer Market

Table of Contents
1. Key Insights
2. Executive Summary
3. Breast Cancer Competitive Intelligence Analysis
4. Breast Cancer Market Overview at a Glance
5. Breast Cancer Disease Background and Overview
6. Breast Cancer Patient Journey
7. Breast Cancer Epidemiology and Patient Population
8. Breast Cancer Treatment Algorithm, Current Treatment, and Medical Practices
9. Breast Cancer Unmet Needs
10. Key Endpoints of Breast Cancer Treatment
11. Breast Cancer Marketed Products
12. Breast Cancer Emerging Therapies
13. Breast Cancer Seven Major Market Analysis
14. Attribute Analysis
15. Breast Cancer Market Outlook (7 major markets)
16. Breast Cancer Access and Reimbursement Overview
17. KOL Views on the Breast Cancer Market
18. Breast Cancer Market Drivers
19. Breast Cancer Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer

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