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United States KISQALI Drug Insight and Market Forecast - 2032

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    Drug Pipelines

  • 30 Pages
  • January 2023
  • Region: United States
  • DelveInsight
  • ID: 5135474
“KISQALI Drug Insight and Market Forecast - 2032” report provides comprehensive insights about KISQALI for ER +ve HER2-ve Breast Cancer in the United States. A detailed picture of the KISQALI for ER+ve HER2-ve Breast Cancer in the United States for the study period 2019-2032 is provided in this report along with a detailed description of the KISQALI for ER+ve HER2-ve Breast Cancer. The report provides insight about mechanism of action, dosage and administration, as well as research and development activity including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the KISQALI market forecast, analysis for ER+ve HER2-ve Breast Cancer in the United States, descriptive analysis such as SWOT, analyst views, comprehensive overview of market competitors, and brief about other emerging therapies in ER+ve HER2-ve Breast Cancer.

Drug Summary

KISQALI (Ribociclib; LEE011) is a kinase inhibitor indicated for the treatment of adult patients with HR+, HER2− advanced or metastatic cancer in combination with:
  • An aromatase inhibitor as initial endocrine-based therapy
  • Fulvestrant as first-line endocrine therapy or as maintenance therapy after disease progression on endocrine therapy in postmenopausal women or men
  • Dosage and Administration
The recommended dose of KISQALI is 600 mg (three 200 mg film-coated tablets) taken orally, once daily for 21 consecutive days, followed by 7 days off treatment resulting in a complete cycle of 28 days. KISQALI can be taken with or without food. When given with KISQALI, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, 29, and once monthly thereafter.
  • Mechanism of Action
KISQALI is a cyclin-dependent kinase (CDK4/6 inhibitor). These kinases are activated upon binding to D-cyclins and play a vital role in signaling pathways that lead to cell cycle progression and cellular proliferation. The cyclin D-CDK4/6 complex regulates cell cycle progression through phosphorylation of the retinoblastoma protein (pRb).

A combination of ribociclib and antiestrogen (e.g., letrozole) resulted in increased tumor growth inhibition compared to each drug alone. Additionally, the combination of ribociclib and fulvestrant resulted in tumor growth inhibition in ER+ breast cancer.

Scope of the Report

The report provides insights into:

  • A comprehensive product overview including the KISQALI description, mechanism of action, dosage and administration, research and development activities in ER+ve HER2-ve Breast Cancer.
  • Elaborated details on KISQALI regulatory milestones and other development activities have been provided in this report.
  • The report also highlights the KISQALI research and development activity in ER+ve HER2-ve Breast Cancer in detail across the United States.
  • The report also covers the patents information with expiry timeline around KISQALI.
  • The report contains forecasted sales of KISQALI for ER+ve HER2-ve Breast Cancer till 2032.
  • Comprehensive coverage of the late-stage emerging therapies for ER+ve HER2-ve Breast Cancer.
  • The report also features the SWOT analysis with analyst views for KISQALI in ER+ve HER2-ve Breast Cancer.

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by the research team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

KISQALI Analytical Perspective

In-depth KISQALI Market Assessment

This report provides a detailed market assessment of KISQALI in ER+ve HER2-ve Breast Cancer in the United States. This segment of the report provides forecasted sales data from 2023 to 2032.

KISQALI Clinical Assessment

The report provides the clinical trials information of KISQALI in ER+ve HER2-ve Breast Cancer covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights

  • In the coming years, the market scenario for ER+ve HER2-ve Breast Cancer is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
  • The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence KISQALI dominance.
  • Other emerging products for ER+ve HER2-ve Breast Cancer are expected to give tough market competition to KISQALI and launch of late-stage emerging therapies in the near future will significantly impact the market.
  • A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of KISQALI in ER+ve HER2-ve Breast Cancer.
  • This in-depth analysis of the forecasted sales data from 2023 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the KISQALI in ER+ve HER2-ve Breast Cancer.  

Key Questions Answered

  • What is the product type, route of administration and mechanism of action of KISQALI?
  • What is the clinical trial status of the study related to KISQALI in ER+ve HER2-ve Breast Cancer and study completion date?
  • What are the key collaborations, mergers and acquisitions, licensing and other activities related to the KISQALI development?
  • What are the key designations that have been granted to KISQALI for ER+ve HER2-ve Breast Cancer?
  • What is the forecasted market scenario of KISQALI for ER+ve HER2-ve Breast Cancer?
  • What are the forecasted sales of KISQALI in the United States?
  • What are the other emerging products available in ER+ve HER2-ve Breast Cancer and how are they giving competition to KISQALI for ER+ve HER2-ve Breast Cancer?
  • Which are the late-stage emerging therapies under development for the treatment of ER+ve HER2-ve Breast Cancer?


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Table of Contents

1. Report Introduction

2. KISQALI Overview in ER+ve HER2-ve Breast Cancer
2.1. Product Detail
2.2. Clinical Development
2.2.1. Clinical studies
2.2.2. Clinical trials information
2.3. Regulatory milestones
2.4. Other Developmental Activities
2.5. Product Profile

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies)

5 KISQALI Market Assessment
5.1. Market Outlook of KISQALI in ER+ve HER2-ve Breast Cancer
5.2. US Market Analysis
5.2.1. Market size of KISQALI in the United States for ER+ve HER2-ve Breast Cancer

6. SWOT Analysis

7. Analysts’ Views

8. Appendix
8.1. Bibliography
8.2. Report Methodology

9. Publisher Capabilities

10. Disclaimer

11. About the Publisher

12. Report Purchase Options

List of Tables
Table 1: KISQALI , Clinical Trial Description, 2023
Table 2: KISQALI : General Description
Table 3: Competitive Landscape (Marketed Therapies)
Table 4: Competitive Landscape (Late -stage Emerging Therapies)
Table 5: KISQALI Market Size in the US, in USD million (2019-2032)

List of Figures
Figure 1: KISQALI Market Size in the United States, USD million (2019-2032)