Report Overview

According to the World 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 developing new cancer drug treatments for effective management and treatment.

Key Takeaways

  • Major companies involved in breast cancer clinical trials include AstraZeneca, Daiichi Sankyo Co., Ltd., Hoffmann-La Roche, Merck KGaA, Pfizer, Inc., HiberCell, Inc., Neutec Pharma Limited, Eisai Inc. and Novartis Pharmaceuticals among others.
  • Inavolisib, Sacituzumab Tirumotecan, and DS-8201a are among notable breast cancer drugs presently under clinical trials.
  • In August 2022, Daiichi Sankyo’s fam-trastuzumab deruxtecan-nxki received U.S. FDA approval for treating unresectable or HER2+ metastatic breast cancer in patients. Such approvals signify an evolving regulatory landscape to bring effective and innovative solutions for patients.

Report Coverage

The Breast Cancer Drug Pipeline report by Expert Market Research gives comprehensive insights on the breast cancer drugs currently undergoing clinical trials. It covers various aspects related to the details of 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.

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.

Breast Cancer Drug Pipeline Outlook

Breast cancer begins inside the milk ducts of the breast, when the cells undergo continuous multiplication, leading to the occurrence of a tumor. These tumors can cause lumps or thickening and can be considered 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 therapies and medication classes, including targeted therapies, immunotherapies, and biosimilars, are available to treat different types of breast cancer. Surgery, chemotherapy, radiation, targeted therapy, hormone therapy, and immunotherapy are amongst the 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 drugs 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 report covers the pathophysiology and epidemiology, developing treatment, and the progress and future aspects of ongoing clinical trials of cancer in detail.

Breast Cancer – Drug Pipeline Therapeutic Assessment

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

By Phase

EMR’s 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

EMR’s pipeline assessment report covers 50+ drug analysis based on route of administration.

  • Oral
  • Parenteral
  • Others

Breast Cancer – Pipeline Assessment Segmentation, By Phases

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

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 analysis 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 EMR analysis, the parenteral route accounted for a major share of breast cancer clinical trials.

Breast Cancer Clinical Trials Assessment – Competitive Dynamics

The EMR report for breast cancer drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. Below is the list of a few players involved in pancreatic cancer clinical trials:

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

Breast Cancer – Pipeline 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 includes 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.

DS-8201a - Daiichi Sanky o Co., Ltd.

Developed by Daiichi Sankyo Co., Ltd., DS-8201a is currently being evaluated in a phase II study. A unique combination of an antibody and a drug, it is designed to slow down tumor growth.

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.

Scope of the Report Details
Drug Pipeline by Clinical Trial Phase
  • Late-Stage Products (Phase III and Phase IV)
  • Mid-Stage Products (Phase II)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products 
Route of Administration
  • Oral
  • Intravenous 
  • Subcutaneous
  • Parenteral
  • Topical
Drug Classes
  • Small Molecule
  • Polymer
  • Monoclonal Antibody
  • Peptides
  • Gene Therapy
Treatment Type
  • Chemotherapy
  • Immunotherapy
  • Hormone Therapy
  • Targeted Therapy
  • Others
Leading Sponsors Covered
  • AstraZeneca
  • Daiichi Sankyo Co., Ltd.
  • GlaxoSmithKline
  • Bayer AG
  • F. Hoffmann-La Roche
  • Novartis Pharmaceuticals
  • Seagen Inc.
  • Pfizer, Inc.
  • Merck KGaA
Geographies Covered
  • North America
  • Europe
  • Asia Pacific
  • Others

Key Questions Answered in the Breast Cancer – Pipeline Assessment Report

  • What is the current landscape of breast cancer pipeline drugs?
  • How many companies are developing breast cancer drugs?
  • How many phase III and phase IV drugs are currently present in breast cancer pipeline drugs?
  • Which companies/institutions are leading the breast cancer drug development?
  • What are the efficacy and safety profiles of breast cancer pipeline drugs?
  • What are the opportunities and challenges present in the breast cancer clinical pipeline landscape?
  • Which company is conducting the major trials for breast cancer drugs?
  • What are the geographies covered for clinical trials in breast cancer?
  • What are the clinical trial results of the drugs under development for breast cancer?
  • What are emerging trends in breast cancer clinical trials?

Related Reports

Global Breast Cancer Therapeutics Market

Global Breast Cancer Treatment Market

Global Breast Implants Market

Global Digital Breast Tomosynthesis Market

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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