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United States PIQRAY Drug Insight and Market Forecast - 2032

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    Drug Pipelines

  • 30 Pages
  • January 2023
  • Region: United States
  • DelveInsight
  • ID: 5726023
“PIQRAY Drug Insight and Market Forecast - 2032” report provides comprehensive insights about PIQRAY for ER +ve HER2-ve Breast Cancer in the United States. A detailed picture of the PIQRAY 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 PIQRAY 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 PIQRAY 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

PIQRAY (BYL719; ALPESLIB) is an orally bioavailable, alpha-specific PI3K inhibitor developed by Novartis. In breast cancer cell lines harboring PIK3CA mutations, BYL719 has been shown to potentially inhibit the PI3K pathway and have antiproliferative effects. In addition, cancer cell lines with PIK3CA mutations were more sensitive to BYL719 than those without the mutation across a broad range of different cancers.
  • Dosage
The recommended dose of PIQRAY is 300 mg (two 150 mg film-coated tablets) taken orally, once daily, with food. This drug comes in three dosage forms: 50 mg, 150 mg, and 200 mg.
  • Mechanism of Action
Alpelisib is an inhibitor of phosphatidylinositol-3-kinase (PI3K), with inhibitory activity predominantly against PI3Kα. Gain-of-function mutations in the PI3K catalytic α- subunit gene (PIK3CA) activate PI3K and Akt signaling, resulting in cellular transformation and tumor formation in vitro and in vivo. In breast cancer cell lines, alpelisib inhibited the phosphorylation of PI3K downstream targets, including Akt, and showed activity in cell lines harboring a PIK3CA mutation. In vivo, alpelisib inhibited the PI3K/Akt signaling pathway and reduced tumor growth in xenograft models, including models of breast cancer. PI3K inhibition by alpelisib treatment has been shown to induce an increase in estrogen receptor (ER) transcription in breast cancer cells. The combination of alpelisib and fulvestrant demonstrated increased antitumor activity compared to either treatment alone in xenograft models derived from ER+, PIK3CA-mutated breast cancer cell lines.

Scope of the Report

The report provides insights into:

  • A comprehensive product overview including the PIQRAY description, mechanism of action, dosage and administration, research and development activities in ER+ve HER2-ve Breast Cancer.
  • Elaborated details on PIQRAY regulatory milestones and other development activities have been provided in this report.
  • The report also highlights the PIQRAY 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 PIQRAY.
  • The report contains forecasted sales of PIQRAY 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 PIQRAY 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.

PIQRAY Analytical Perspective

In-depth PIQRAY Market Assessment

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

PIQRAY Clinical Assessment

The report provides the clinical trials information of PIQRAY 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 PIQRAY dominance.
  • Other emerging products for ER+ve HER2-ve Breast Cancer are expected to give tough market competition to PIQRAY 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 PIQRAY 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 PIQRAY in ER+ve HER2-ve Breast Cancer.  

Key Questions Answered

  • What is the product type, route of administration and mechanism of action of PIQRAY?
  • What is the clinical trial status of the study related to PIQRAY 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 PIQRAY development?
  • What are the key designations that have been granted to PIQRAY for ER+ve HER2-ve Breast Cancer?
  • What is the forecasted market scenario of PIQRAY for ER+ve HER2-ve Breast Cancer?
  • What are the forecasted sales of PIQRAY 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 PIQRAY 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. PIQRAY 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 PIQRAY Market Assessment
5.1. Market Outlook of PIQRAY in ER+ve HER2-ve Breast Cancer
5.2. US Market Analysis
5.2.1. Market size of PIQRAY 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: PIQRAY , Clinical Trial Description, 2023
Table 2: PIQRAY : General Description
Table 3: Competitive Landscape (Marketed Therapies)
Table 4: Competitive Landscape (Late -stage Emerging Therapies)
Table 5: PIQRAY Market Size in the US, in USD million (2019-2032)

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