Breast Cancer Drug Pipeline Analysis Report 2025

Breast cancer marks an abnormal breast cell growth that results in tumor development. According to the Wor ld Health Organization, breast cancer was the most common cancer in women in 2022. Around 2.3 million women were diagnosed with breast cancer and 670 000 deaths were registered in 2022. To tackle the rising mortality rates, various companies are committed to develop new breast cancer drug candidates across the region.

Report Coverage

The Breast Cancer Drug Pipeline report by the publisher gives comprehensive insights on the breast cancer therapeutic drugs currently undergoing clinical trials. It covers various aspects related to the details for each of these drugs under development. The report includes the analysis of over 100 pipeline drugs and 50+ companies . It will include an analysis based on efficacy and safety measure outcomes published for the trials including their adverse effects on breast cancer pipeline landscape.

The detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration and ongoing product development activities related to breast cancer are covered. Moreover, breast cancer collaborations and commercial assessments are offered, helping stakeholders to make informed decisions.

Breast Cancer Drug Pipeline Outlook

Breast cancer begins inside the milk ducts of the breast, when the cells undergo continuous multiplication, leading to occurrence of a tumor. These tumors can cause lumps or thickening and can be considered as the early signs of detection. Although the in-situ form is not life-threatening and can be detected at early stages, the global estimates demonstrate large inequities in the breast cancer burden. For instance, 1 in 12 women will be diagnosed with breast cancer in their lifetime in countries with a very high human development index (HDI).

Early signs of breast cancer include changes in the shape and size of the breast, redness, scaling, dimpling, or puckering in the skin, swelling, or a lump near or in the breast or underarm area. Common breast cancer screening tests include clinical breast exam, ultrasound, mammogram, MRI, and biopsy. Various types of breast cancer treatments and medication classes, including targeted therapies, immunotherapies, biosimilars, are available to treat different types of breast cancer. Surgery, chemotherapy, radiation, targeted therapy, hormone therapy, and immunotherapy are amongst standard treatments used for breast cancer.

Currently, several clinical trials are in progress to develop effective treatment alternatives for breast cancer, indicating a promising future for the treatment landscape. Some of the notable breast cancer drug candidates which are showing promising results in breast cancer treatment include PI3K/mTOR inhibitors, TROP2-directed antibody-drug conjugates (ADC), and a first-in-human trial assessing a cancer-killing oncolytic virus.

The American Society for Clinical Oncology (ASCO) Annual Meeting 2022 featured important presentations. In August 2022, the United States FDA approved fam-trastuzumab deruxtecan-nxki by Daiichi Sankyo Co, Ltd., for the treatment of patients with unresectable or HER2+ metastatic breast cancer. The drug is intended for patients who have received a prior anti-HER2-based regimen. Other notable approval was Olaparib developed by AstraZeneca. The drug is used for the treatment of adult patients with suspected deleterious germline BRCA-mutated HER2-high-risk early breast cancer.

The breast cancer pipeline insight covers the pathophysiology and epidemiology, developing treatment, and the progress and future aspects of ongoing clinical trials cancer in detail.

Breast Cancer - Drug Pipeline Therapeutic Assessment

This section of the report covers the analysis of breast cancer drug candidates based on various segmentations such as:

By Phase

The pipeline assessment report covers 50+ drug analysis based on phase.

• Late-Stage Products (Phase 3 and Phase 4)
• Mid-Stage Products (Phase 2)
• Early-Stage Products (Phase I)
• Preclinical and Discovery Stage Products

By Route of Administration

The breast cancer therapeutic assessment report covers 50+ drug analysis based on route of administration.

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Breast Cancer - Pipeline Assessment Segmentation, By Phases

The breast cancer pipeline analysis covers phase I, phase II, phase III, phase IV, and early phase drugs. The coverage includes in-depth analysis of each drug across these phases. According to analysis, phase II trials cover a major share of the total breast cancer clinical trials conducted.

DS-8201a is amongst notable phase II drugs, currently being developed by UNICANCER. The study is conducted to assess the efficacy of DS-8201a monotherapy in patients suffering from metastatic breast cancer.

Breast Cancer - Pipeline Assessment Segmentation, By Route of Administration

The route of administration categories covered under breast cancer pipeline report include oral, parenteral, and others. The report provides a comparative analysis of the route of administration for each drug in various phases of clinical trials. According to analysis, the parenteral route accounted for the major share of breast cancer clinical trials.

Breast Cancer Clinical Trials Assessment - Competitive Dynamics

The report for breast cancer drug pipeline analysis covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed breast cancer therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of few players involved in breast cancer clinical trials:

• AstraZeneca
• Daiichi Sankyo Co., Ltd.
• GlaxoSmithKline
• Bayer AG
• F. Hoffmann-La Roche
• Novartis Pharmaceuticals
• Seagen Inc.
• Pfizer, Inc.
• Merck KGaA
• Others

Breast Cancer - Emerging Drugs Profile

This section covers the detailed analysis of each drug under multiple phases including phase I, phase II, phase III, phase IV, and emerging drugs. Moreover, the section covers include product description, trial ID, study type, drug class, mode of administration, and recruitment status of breast cancer clinical trial drugs.

Inavolisib - Hoffmann-La Roche

Inavolisib is currently under phase III, sponsored by Hoffmann-La Roche. The study is being done to assess the safety and efficacy of Phesgo (trastuzumab, pertuzumab, and rHuPH20 injection) in participants with previously untreated HER2-positive advanced breast cancer.

Drug: Sagopilone - Bayer AG

Sagopilone is currently under phase II, sponsored by Bayer AG. The purpose of the study is to evaluate the efficacy of a breast cancer emerging drug called ZK-Epothilone (ZK-Epo) in patients with metastatic breast cancer.

Drug: DS-8201

a - Daiichi Sanky o Co., Ltd.
Developed by Daiichi Sankyo Co., Ltd., the drug is currently under phase II. The study is conducted to evaluate the safety and efficacy of combination of a drug and an antibody.

Drug: Sacituzumab Tirumotecan - Merck KGaA

This drug is currently under phase III and is developed by Merck KGaA. It is being studied to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab.

Key Questions Answered in the Breast Cancer - Pipeline Assessment Report

• What is the current landscape of breast cancer pipeline drugs?
• Which companies/institutions are developing breast cancer therapeutic drugs?
• How many phase II drugs are currently present in breast cancer pipeline drugs?
• Which company is leading the breast cancer pipeline development activities?
• What is the current breast cancer commercial assessment?
• What are the opportunities and challenges present in the breast cancer drug pipeline landscape?
• What is the efficacy and safety profile of breast cancer pipeline drugs?
• Which companies/institutions are involved in breast cancer collaborations aimed at providing enhanced therapeutic alternatives for patients?
• What are the geographies covered for clinical trials in breast cancer?

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