PI3K Signaling Pathway Analysis: A Shifting Marketed and Pipeline Product Landscape, as Blockbusters Expire and Development Moves Towards Downstream Targets
Summary
GBI Research's latest report, PI3K Signaling Pathway Analysis: A Shifting Marketed and Pipeline Product Landscape, as Blockbusters Expire and Development Moves Towards Downstream Targets, provides a comprehensive assessment of the marketed and pipeline products acting on various components of the phosphoinositide 3-kinase (PI3K) signaling network.
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. Consequently, the PI3K signaling pathway has been extensively researched over recent decades and is widely recognized as a prime target for therapeutic intervention. Indeed, globally, 2,129 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 2,067 pipeline products in development that target components of the PI3K pathway, many of which act on first-in-class molecular targets.
The following 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 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.
PI3K Signaling Pathway Analysis: A Shifting Marketed and Pipeline Product Landscape, as Blockbusters Expire and Development Moves Towards Downstream Targets
1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 4
1.2 List of Figures 5
2 Introduction 7
2.1 Role of PI3K in Disease 9
2.1.1 Oncology 9
2.1.2 Central Nervous System 11
2.1.3 Ulcerative Colitis 12
3 Marketed Products Landscape 14
3.1 Overview 14
3.2 Key Signaling Pathways within the PI3K Marketed Product Landscape 14
3.2.1 PI3K/AKT/mTOR Pathway 14
3.2.2 Ras/Raf/MEK/ERK Pathway 18
3.2.3 Cell Survival Pathways Downstream of AKT 19
3.2.4 Cell Cycle Progression Pathways Downstream of AKT 22
3.2.5 Kinases Downstream of PDK1 24
3.3 Key Marketed Products 25
4 Pipeline Products Landscape 44
4.1 Overview 44
4.2 Key Signaling Pathways within the PI3K Pipeline Product Landscape 44
4.2.1 PI3K/AKT/mTOR Pathway 44
4.2.2 Ras/Raf/MEK/ERK Pathway 49
4.2.3 Cell Survival Pathways Downstream of AKT 52
4.2.4 Cell Cycle Progression Pathways Downstream of AKT 57
4.2.5 Metabolism Pathways Downstream of AKT 61
4.2.6 Kinases Downstream of PDK1 65
4.2.7 Clinical-Stage Pipeline Products 68
4.2.8 List of All Pipeline Products 81
5 Appendix 255
5.1 References 255
5.2 Abbreviations 258
5.3 List of PI3K Pathway Nodes 261
5.4 About GBI Research 265
5.5 Disclaimer 265
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 36
Table 2: PI3K Marketed and Pipeline Landscape, Most Commercially Successful Pipeline Products Acting on the PI3K Signaling Network, 2024 69
Table 3: PI3K Marketed and Pipeline Landscape, All Pipeline Products Acting on the PI3K Signaling Network, 2018 81
1.2 List of Figures
Figure 1: PI3K Marketed and Pipeline Landscape, Global, PI3K Signaling Network, 2018 7
Figure 2: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for the PI3K/AKT/mTOR Pathway, 2018 15
Figure 3: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for the PI3K/AKT/mTOR Pathway by Molecule Type, 2018 16
Figure 4: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for the PI3K/AKT/mTOR Pathway by Therapy Area, 2018 17
Figure 5: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for the Ras/Raf/MER/ERK Pathway, 2018 18
Figure 6: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for the Ras/Raf/MER/ERK Pathway by Molecule Type, 2018 18
Figure 7: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for the Ras/Raf/MER/ERK Pathway by Therapy Area, 2018 19
Figure 8: PI3K Marketed and Pipeline Landscape, Gloal, Marketed Activity for Cell Survival Pathways Downstream of AKT, 2018 20
Figure 9: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for Cell Survival Pathways Downstream of AKT by Molecule Type, 2018 20
Figure 10: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for Cell Survival Pathways Downstream of AKT by Therapy Area, 2018 21
Figure 11: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for Cell Cycle Progression Pathways Downstream of AKT, 2018 22
Figure 12: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for Cell Cycle Progression Pathways Downstream of AKT by Molecule Type, 2018 23
Figure 13: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for Cell Cycle Progression Pathways Downstream of AKT by Therapy Area, 2018 23
Figure 14: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for Kinases Downstream of PDK1, 2018 24
Figure 15: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for Kinases Downstream of PDK1 by Molecule Type, 2018 24
Figure 16: PI3K Marketed and Pipeline Landscape, Global, Marketed Activity for Kinases Downstream of PDK1 by Therapy Area, 2018 25
Figure 17: PI3K Marketed and Pipeline Landscape, Global, Historical and Forecast Annual Revenues for Herceptin ($bn), 2006-2024 26
Figure 18: PI3K Marketed and Pipeline Landscape, Global, Historical and Forecast Annual Revenues for Avastin ($bn), 2006-2024 27
Figure 19: PI3K Marketed and Pipeline Landscape, Global, Historical and Forecast Annual Revenues for Lantus (insulin glargine) ($bn), 2006-2024 28
Figure 20: PI3K Marketed and Pipeline Landscape, Global, Historical and Forecast Annual Revenues for Eylea (aflibercept) ($bn), 2011-2024 29
Figure 21: PI3K Marketed and Pipeline Landscape, Global, Historical and Forecast Annual Revenues for Ibrance (palbociclib) ($bn), 2015-2024 30
Figure 22: PI3K Marketed and Pipeline Landscape, Global, Historical and Forecast Annual Revenues for Novolog ($bn), 2006-2024 31
Figure 23: PI3K Marketed and Pipeline Landscape, Global, Historical and Forecast Annual Revenues for Humalog ($bn), 2006-2024 32
Figure 24: PI3K Marketed and Pipeline Landscape, Global, Historical and Forecast Annual Revenues for Perjeta ($bn), 2012-2024 33
Figure 25: PI3K Marketed and Pipeline Landscape, Global, Historical and Forecast Annual Revenues for Avonex ($bn), 2006-2024 34
Figure 26: PI3K Marketed and Pipeline Landscape, Global, Historical and Forecast Annual Revenues for Levemir (insulin detemir) ($bn), 2006-2023 35
Figure 27: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the PI3K/AKT/mTOR Pathway, 2018 44
Figure 28: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the PI3K/AKT/mTOR Pathway by Novelty, 2018 46
Figure 29: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the PI3K/AKT/mTOR Pathway by Stage of Development, 2018 47
Figure 30: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the PI3K/AKT/mTOR Pathway by Molecule Type, 2018 48
Figure 31: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the PI3K/AKT/mTOR Pathway by Therapy Area, 2018 49
Figure 32: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the Ras/Raf/MEK/ERK Pathway, 2018 49
Figure 33: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the Ras/Raf/MEK/ERK Pathway by Novelty, 2018 50
Figure 34: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the Ras/Raf/MEK/ERK Pathway by Stage of Development, 2018 50
Figure 35: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the Ras/Raf/MEK/ERK Pathway by Molecule Type, 2018 51
Figure 36: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the Ras/Raf/MEK/ERK Pathway by Therapy Area, 2018 52
Figure 37: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the Cell Survival Pathways Downstream of AKT, 2018 53
Figure 38: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the Cell Survival Pathways Downstream of AKT by Novelty, 2018 54
Figure 39: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the Cell Survival Pathways Downstream of AKT by Stage of Development, 2018 55
Figure 40: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the Cell Survival Pathways Downstream of AKT by Molecule Type, 2018 56
Figure 41: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for the Cell Survival Pathways Downstream of AKT by Therapy Area, 2018 57
Figure 42: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Cell-Cycle Progression Pathways Downstream of AKT, 2018 58
Figure 43: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Cell-Cycle Progression Pathways Downstream of AKT by Novelty, 2018 58
Figure 44: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Cell-Cycle Progression Pathways Downstream of AKT by Stage of Development, 2018 59
Figure 45: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Cell-Cycle Progression Pathways Downstream of AKT by Molecule Type, 2018 60
Figure 46: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Cell-Cycle Progression Pathways Downstream of AKT by Therapy Area, 2018 61
Figure 47: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Metabolism Pathways Downstream of AKT, 2018 62
Figure 48: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity Metabolism Pathways Downstream of AKT by Novelty, 2018 62
Figure 49: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Metabolism Pathways Downstream of AKT by Stage of Development, 2018 63
Figure 50: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Metabolism Pathways Downstream of AKT by Molecule Type, 2018 64
Figure 51: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Metabolism Pathways Downstream of AKT by Therapy Area, 2018 65
Figure 52: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Kinases Downstream of PDK1, 2018 65
Figure 53: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Kinases Downstream of PDK1 by Novelty, 2018 66
Figure 54: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Kinases Downstream of PDK1 by Stage of Development, 2018 66
Figure 55: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Kinases Downstream of PDK1 by Molecule Type, 2018 67
Figure 56: PI3K Marketed and Pipeline Landscape, Global, Pipeline Activity for Kinases Downstream of PDK1 by Therapy Area, 2018 68
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