PI3K Signaling Pathway Analysis: A Shifting Marketed and Pipeline Product Landscape, as Blockbusters Expire and Development Moves Towards Downstream Targets

PI3K Signaling Pathway Analysis: A Shifting Marketed and Pipeline Product Landscape, as Blockbusters Expire and Development Moves Towards Downstream Targets

PI3K Signaling Pathway Analysis: A Shifting Marketed and Pipeline Product Landscape, as Blockbusters Expire and Development Moves Towards Downstream Targets

Summary

Phosphoinositide 3-kinases (PI3K) are a family of lipid kinases that transduce signals from a range of growth factors and cytokines into intracellular messages by generating phospholipids. This in turn activates the serine/threonine kinase AKT (AKT), as well as other downstream effectors such as mammalian target of rapamycin (mTOR) and forkhead box O (FOXO).

The PI3K pathway is a critical signal transduction pathway and plays important roles in the regulation of many cellular processes including protein synthesis, cell-cycle progression and cell survival. Additionally, numerous diseases are known to be associated with dysregulated PI3K signaling. This is particularly the case for cancers, with the pathway being recognized as perhaps the most commonly activated signaling pathway in human cancer. However, PI3K signaling has also been associated with several other disease areas including disorders of the gastrointestinal, metabolic and central nervous systems.

Due to its wide-ranging role in numerous cellular processes and disease states, the PI3K signaling pathway has been extensively researched over recent decades and is widely recognized as a prime target for therapeutic intervention. Indeed, globally, 1,984 products that target components of the PI3K signaling network have gained market approval to date. These include a number of highly clinically and commercially successful therapies such as the blockbuster drugs Herceptin (trastuzumab), Avastin (bevacizumab) and Lantus (insulin glargine).

Despite this, PI3K signaling remains a focal point of drug discovery as many components of the pathway are yet to be targeted by currently available pharmaceuticals. There are 2,061 pipeline products in development that target components of the PI3K pathway, many of which act on first-in-class molecular targets.

The latest report, “PI3K Signaling Pathway Analysis” provides a comprehensive assessment of the marketed and pipeline products acting on various components of the phosphoinositide 3-kinase (PI3K) signaling network. The report discusses the significance of the PI3K pathway, including its role in disease, and provides a comprehensive overview of the PI3K marketed and pipeline landscapes. The report provides a breakdown of the following key signaling pathways within the PI3K network in terms of marketed and pipeline activity: PI3K/AKT/mTOR pathway, Ras/Raf/MEK/ERK pathway, cell survival pathways downstream of AKT, cell-cycle progression pathways downstream of AKT, metabolism pathways downstream of AKT and kinases downstream of phosphoinositide-dependent kinase-1 (PDK1).

An analysis of the marketed and pipeline activity across various nodes (defined as groups of molecules which have the same role in response to a stimulus) within each of these pathways is provided. An examination of the marketed and pipeline products acting on each of these pathways in terms of molecule type and therapy area, and, in the case of pipeline products, novelty and stage of development, provides further granularity. Additionally, detailed product profiles of key marketed products are provided, which incorporate clinical and commercial perspectives and include historical and forecast annual sales revenues. The report concludes with a discussion of promising late-stage pipeline products.

Scope

  • Which products that target components of the PI3K network are most commercially successful and which indications are these products approved for?
  • What is the range of molecule types that act on components of the PI3K network?
  • Which nodes across the various pathways are not currently targeted by marketed products and how many pipeline products act on these nodes?
  • What is the distribution of pipeline products by stage of development across various nodes?
  • Which late-stage pipeline products are projected to be the most commercially successful?
Reasons to buy
  • Appreciate the significance and complexity of the PI3K signaling network, with visual schematics of the overall network, as well as breakdowns of the key signaling pathways, by node.
  • Understand the current status of the PI3K marketed landscape, and the relative clinical and commercial success of currently marketed products.
  • Analyze the PI3K pipeline landscape and gain insight into the pipeline products that act on novel molecular targets within the PI3K network.


1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Role of PI3K in Disease
2.1.1 Oncology
2.1.2 Central Nervous System
2.1.3 Ulcerative Colitis
3 Marketed Products Landscape
3.1 Overview
3.2 Key Signaling Pathways within the PI3K Marketed Product Landscape
3.2.1 PI3K/AKT/mTOR Pathway
3.2.2 Ras/Raf/MEK/ERK Pathway
3.2.3 Cell Survival Pathways Downstream of AKT
3.2.4 Cell Cycle Progression Pathways Downstream of AKT
3.2.5 Kinases Downstream of PDK1
3.3 Key Marketed Products
4 Pipeline Products Landscape
4.1 Overview
4.2 Key Signaling Pathways within the PI3K Pipeline Product Landscape
4.2.1 PI3K/AKT/mTOR Pathway
4.2.2 Ras/Raf/MEK/ERK Pathway
4.2.3 Cell Survival Pathways Downstream of AKT
4.2.4 Cell Cycle Progression Pathways Downstream of AKT
4.2.5 Metabolism Pathways Downstream of AKT
4.2.6 Kinases Downstream of PDK1
4.2.7 Clinical-Stage Pipeline Products
4.2.8 List of All Pipeline Products
5 Appendix
5.1 References
5.2 Abbreviations
5.3 List of PI3K Pathway Nodes
5.4 About GBI Research
5.5 Disclaimer
1.1 List of Tables
Table 1: PI3K Marketed and Pipeline Landscape, Most Commercially Successful Marketed Products Acting on Components of the PI3K Pathway, 2017-2024
Table 2: PI3K Marketed and Pipeline Landscape, Most Commercially Successful Pipeline Products Acting on the PI3K Signaling Network, 2024
Table 3: PI3K Marketed and Pipeline Landscape, All Pipeline Products Acting on the PI3K Signaling Network, 2018
1.2 List of Figures
Figure 1: PI3K Marketed and Pipeline Landscape, Global, PI3K Signaling Network, 2018
Figure 2: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for the PI3K/AKT/mTOR Pathway, 2018
Figure 3: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for the PI3K/AKT/mTOR Pathway by Molecule Type, 2018
Figure 4: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for the PI3K/AKT/mTOR Pathway by Therapy Area, 2018
Figure 5: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for the Ras/Raf/MER/ERK Pathway, 2018
Figure 6: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for the Ras/Raf/MER/ERK Pathway by Molecule Type, 2018
Figure 7: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for the Ras/Raf/MER/ERK Pathway by Therapy Area, 2018
Figure 8: PI3K Marketed and Pipeline Landscape, Gloal, Marketed Activity for Cell Survival Pathways Downstream of AKT, 2018
Figure 9: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for Cell Survival Pathways Downstream of AKT by Molecule Type, 2018
Figure 10: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for Cell Survival Pathways Downstream of AKT by Therapy Area, 2018
Figure 11: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for Cell Cycle Progression Pathways Downstream of AKT, 2018
Figure 12: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for Cell Cycle Progression Pathways Downstream of AKT by Molecule Type, 2018
Figure 13: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for Cell Cycle Progression Pathways Downstream of AKT by Therapy Area, 2018
Figure 14: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for Kinases Downstream of PDK1, 2018
Figure 15: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for Kinases Downstream of PDK1 by Molecule Type, 2018
Figure 16: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for Kinases Downstream of PDK1 by Therapy Area, 2018
Figure 17: PI3K Marketed and Pipeline Landscape, Global, Historical and Forecast Annual Revenues for Herceptin ($bn), 2006-2024
Figure 18: PI3K Marketed and Pipeline Landscape, Global, Historical and Forecast Annual Revenues for Avastin ($bn), 2006-2024
Figure 19: PI3K Marketed and Pipeline Landscape, Global, Historical and Forecast Annual Revenues for Lantus (insulin glargine) ($bn), 2006-2024
Figure 20: PI3K Marketed and Pipeline Landscape, Global, Historical and Forecast Annual Revenues for Eylea (aflibercept) ($bn), 2011-2024
Figure 21: PI3K Marketed and Pipeline Landscape, Global, Historical and Forecast Annual Revenues for Ibrance (palbociclib) ($bn), 2015-2024
Figure 22: PI3K Marketed and Pipeline Landscape, Global, Historical and Forecast Annual Revenues for Novolog ($bn), 2006-2024
Figure 23: PI3K Marketed and Pipeline Landscape, Global, Historical and Forecast Annual Revenues for Humalog ($bn), 2006-2024
Figure 24: PI3K Marketed and Pipeline Landscape, Global, Historical and Forecast Annual Revenues for Perjeta ($bn), 2012-2024
Figure 25: PI3K Marketed and Pipeline Landscape, Global, Historical and Forecast Annual Revenues for Avonex ($bn), 2006-2024
Figure 26: PI3K Marketed and Pipeline Landscape, Global, Historical and Forecast Annual Revenues for Levemir (insulin detemir) ($bn), 2006-2023
Figure 27: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the PI3K/AKT/mTOR Pathway, 2018
Figure 28: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the PI3K/AKT/mTOR Pathway by Novelty, 2018
Figure 29: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the PI3K/AKT/mTOR Pathway by Stage of Development, 2018
Figure 30: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the PI3K/AKT/mTOR Pathway by Molecule Type, 2018
Figure 31: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the PI3K/AKT/mTOR Pathway by Therapy Area, 2018
Figure 32: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the Ras/Raf/MEK/ERK Pathway, 2018
Figure 33: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the Ras/Raf/MEK/ERK Pathway by Novelty, 2018
Figure 34: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the Ras/Raf/MEK/ERK Pathway by Stage of Development, 2018
Figure 35: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the Ras/Raf/MEK/ERK Pathway by Molecule Type, 2018
Figure 36: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the Ras/Raf/MEK/ERK Pathway by Therapy Area, 2018
Figure 37: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the Cell Survival Pathways Downstream of AKT, 2018
Figure 38: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the Cell Survival Pathways Downstream of AKT by Novelty, 2018
Figure 39: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the Cell Survival Pathways Downstream of AKT by Stage of Development, 2018
Figure 40: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the Cell Survival Pathways Downstream of AKT by Molecule Type, 2018
Figure 41: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the Cell Survival Pathways Downstream of AKT by Therapy Area, 2018
Figure 42: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Cell-Cycle Progression Pathways Downstream of AKT, 2018
Figure 43: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Cell-Cycle Progression Pathways Downstream of AKT by Novelty, 2018
Figure 44: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Cell-Cycle Progression Pathways Downstream of AKT by Stage of Development, 2018
Figure 45: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Cell-Cycle Progression Pathways Downstream of AKT by Molecule Type, 2018
Figure 46: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Cell-Cycle Progression Pathways Downstream of AKT by Therapy Area, 2018
Figure 47: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Metabolism Pathways Downstream of AKT, 2018
Figure 48: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity Metabolism Pathways Downstream of AKT by Novelty, 2018
Figure 49: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Metabolism Pathways Downstream of AKT by Stage of Development, 2018
Figure 50: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Metabolism Pathways Downstream of AKT by Molecule Type, 2018
Figure 51: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Metabolism Pathways Downstream of AKT by Therapy Area, 2018
Figure 52: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Kinases Downstream of PDK1, 2018
Figure 53: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Kinases Downstream of PDK1 by Novelty, 2018
Figure 54: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Kinases Downstream of PDK1 by Stage of Development, 2018
Figure 55: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Kinases Downstream of PDK1 by Molecule Type, 2018
Figure 56: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Kinases Downstream of PDK1 by Therapy Area, 2018

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