Executive Summary
GBI Research, the leading business intelligence provider, has released its latest research “Comparative Analysis of Late Stage Pipeline Molecules in Major Indications - Oncology Pipeline Leads with Most Promising Molecules in Late Stage Development”. It provides a comprehensive analysis of the late stage pipeline molecules in 14 key indications from nine major therapy areas. The report provides in-depth coverage of the pipeline activity in the major indications, giving a wide view on the changing focus of the therapeutic landscape. Each chapter deals exhaustively with one indication, giving: an overview of the opportunity and unmet need in the market; a strategic pipeline assessment that covered the distribution of the pipeline according to their mechanism of action and class of drug, whether first-in-class, me-too, or generic or product extension; and a comparative analysis of key late stage pipeline molecules based on the major characteristics of targeted unmet need, mechanism of action, efficacy and safety. Furthermore, the report provides profiles of the promising drugs under clinical development.
This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts.
Oncology, Metabolic Disorders and CNS Command Robust Late Stage Pipeline
The therapy areas that command the largest number of molecules in the late stage pipeline are - oncology, metabolic disorders and central nervous system disorders. Oncology accounts for the majority of pipeline activity, with 37% of the entire pipeline. The focus on oncology to develop novel anti-cancer drugs is driven partly by patients’ constant need to switch treatments due to the side effects of heavy chemotherapy. Several companies, including Pfizer, Sanofi-aventis, Bristol-Myers Squibb (BMS) and Amgen are developing protein-based therapeutics since they do not carry the adverse effects associated with intense chemotherapy.
Comparative Analysis of Late Stage Pipeline Molecules in Major Indications, by Therapy Area, 2011
Source: GBI Research, Company Websites, Clinicaltrials.gov
Kinase Inhibitors - Most Important First-in-class Drug
Tyrosine kinase inhibitors are one of the most prominent developing classes of drug undergoing Phase II and Phase III evaluation; they account for approximately 40% of the Phase III promising molecules in oncology, followed by therapeutic vaccines, mammalian target of rapamycin (mTOR) inhibitors and Cytochrome P450 inhibitors among others. Specific inhibitors of tyrosine kinases are extremely advantageous and provide more promise against monoclonal antibodies since they are targeted at the tyrosine kinase activity of receptor tyrosine kinase (RTK). Inhibition of the activity of receptor and other tyrosine kinases represents a rational strategy to stop the functions of cells that rely on these pathways for survival. Non-cancer applications of kinase inhibitors are seen across diseases such as autoimmune diseases, restenosis, diabetes and other disorders.
Type 2 Diabetes Pipeline Inundated With Me-too Drugs
Type 2 diabetes has the highest number of me-too drugs among all the indications analyzed with 174 such products in the pipeline accounting for 69% of the entire pipeline. Me-too drugs largely duplicate the action of existing drugs and diminish the incentives for innovation in pioneering drugs without adding therapeutic value. However, the more differentiated me-too drugs are from pioneering drugs, the greater their potential benefits. In the case of type 2 diabetes, these me-too drugs are anticipated to provide better efficacy and safety profiles. Several glitazones and glucagon-like peptide-1 (GLP-1) analogues are me-too drugs in the pipeline.
Abstract
Comparative Analysis of Late Stage Pipeline Molecules in Major Indications - Oncology Pipeline Leads with Most Promising Molecules in Late Stage Development
Summary
GBI Research, a leading business intelligence provider, has released its latest research “Comparative Analysis of Late Stage Pipeline Molecules in Major Indications - Oncology Pipeline Leads with Most Promising Molecules in Late Stage Development”, which provides insights into the unmet needs targeted by late stage pipeline molecules across major therapy areas. The report examines the safety, efficacy parameters of molecules in development. The report includes insights into the R&D pipeline various therapy areas and identifies potential blockbusters.
In-depth analysis of the report is based on propriety databases, primary and secondary research and in-house analysis by GBI Research’s team of experts.
Scope
The scope of this report includes -
• Profiles of promising late stage pipeline molecules across various therapy areas
• Analysis of safety, efficacy, mechanism of actions of major pipeline drugs targeted at major therapy areas
• Comparison of late stage drugs based on safety, efficacy, mechanism of action, unmet need targeted and stage of disease targeted
Reasons To Buy
The report will enhance your decision making capability. It will allow you to -
• Build effective strategies to launch their pipeline products by identifying geographies with high potential for growth.
• Exploit in-licensing and out-licensing opportunities by identifying products that might fill their portfolio gaps.
• Reinforce R&D pipelines by identifying new target mechanisms which can produce first-in-class molecules which are safer and more efficacious.
Table of Contents
1 Table of Contents
1 Table of Contents 3
1.1 List of Tables 6
1.2 List of Figures 7
2 Comparative Analysis of Late Stage Pipeline Molecules in Major Indications - Introduction 8
2.1 GBI Research Report Guidance 9
3 Comparative Analysis of Late Stage Pipeline Molecules in Major Indications - Oncology 10
3.1 Comparative Analysis of Late Stage Pipeline Molecules in NSCLC 10
3.1.1 Overview 10
3.1.2 Opportunity and Unmet Need 10
3.1.3 Strategic Pipeline Assessment 10
3.1.4 Comparative Analysis of Late Stage Pipeline Molecules Based on Major Characteristics 13
3.1.5 Promising Drugs under Clinical Development 15
3.1.6 Other Promising Drugs under Clinical Development 18
3.2 Comparative Analysis of Late Stage Pipeline Molecules in Colorectal Cancer 19
3.2.1 Overview 19
3.2.2 Opportunity and Unmet Need 19
3.2.3 Strategic Pipeline Assessment 21
3.2.4 Trends in Colorectal Cancer Pipeline 23
3.2.5 Comparative Analysis Based on Major Characteristics 24
3.2.6 Promising Drugs Under Clinical Development 25
3.3 Comparative Analysis of Late Stage Pipeline Molecules in Breast Cancer 31
3.3.1 Overview 31
3.3.2 Opportunity and Unmet Need 31
3.3.3 Strategic Pipeline Assessment 31
3.3.4 Comparative Analysis Based on Major Characteristics 34
3.3.5 Promising Drugs under Clinical Development 35
3.4 Comparative Analysis of Late Stage Pipeline Molecules in Prostate Cancer 37
3.4.1 Overview 37
3.4.2 Opportunity and Unmet Need 37
3.4.3 Strategic Pipeline Assessment 40
3.4.4 Trends in Prostate Cancer Pipeline 42
3.4.5 Comparative Analysis Based on Major Characteristics 43
3.4.6 Promising Drugs under Clinical Development 44
4 Comparative Analysis of Late Stage Pipeline Molecules in Major Indications - Metabolic Disorders 50
4.1 Comparative Analysis of Late Stage Pipeline Molecules in Type II Diabetes 50
4.1.1 Overview 50
4.1.2 Opportunity and Unmet Need 50
4.1.3 Strategic Pipeline Assessment 51
4.1.4 Comparative Analysis Based on Major Characteristics 53
4.1.5 Promising Drugs under Clinical Development 54
5 Comparative Analysis of Late Stage Pipeline Molecules in Major Indications - Respiratory Diseases 58
5.1 Comparative Analysis of Late Stage Pipeline Molecules in COPD 58
5.1.1 Overview 58
5.1.2 Opportunity and Unmet Need 58
5.1.3 Strategic Pipeline Assessment 59
5.1.4 Comparative Analysis Based on Major Characteristics 61
5.1.5 Promising Drugs under Clinical Development 62
6 Comparative Analysis of Late Stage Pipeline Molecules in Major Indications - Musculoskeletal 66
6.1 Comparative Analysis of Late Stage Pipeline Molecules in Rheumatoid Arthritis 66
6.1.1 Overview 66
6.1.2 Opportunity and Unmet Need 66
6.1.3 Strategic Pipeline Assessment 67
6.1.4 Comparative Analysis Based on Major Characteristics 69
6.1.5 Promising Drugs under Clinical Development 70
7 Comparative Analysis of Late Stage Pipeline Molecules in Major Indications - Central Nervous System 73
7.1 Comparative Analysis of Late Stage Pipeline Molecules in Epilepsy 73
7.1.1 Overview 73
7.1.2 Opportunity and Unmet Need 73
7.1.3 Strategic Pipeline Assessment 74
7.1.4 Comparative Analysis Based on Major Characteristics 76
7.1.5 Promising Drugs under Clinical Development 77
7.2 Comparative Analysis of Late Stage Pipeline Molecules in Multiple Sclerosis 82
7.2.1 Overview 82
7.2.2 Opportunity and Unmet Need 82
7.2.3 Strategic Pipeline Assessment 83
7.2.4 Comparative Analysis Based on Major Characteristics 85
7.2.5 Promising Drugs under Clinical Development 86
7.3 Comparative Analysis of Late Stage Pipeline Molecules in Major Depressive Disorder 88
7.3.1 Overview 88
7.3.2 Opportunity and Unmet Need 88
7.3.3 Strategic Pipeline Assessment 89
7.3.4 Comparative Analysis Based on Major Characteristics 91
7.3.5 Promising Drugs under Clinical Development 92
8 Comparative Analysis of Late Stage Pipeline Molecules in Major Indications - Immunology 94
8.1 Comparative Analysis of Late Stage Pipeline Molecules in Crohn’s Disease 94
8.1.1 Overview 94
8.1.2 Opportunity and Unmet Need 94
8.1.3 Strategic Pipeline Assessment 95
8.1.4 Comparative Analysis Based on Major Characteristics 97
8.1.5 Promising Drugs under Clinical Development 98
9 Comparative Analysis of Late Stage Pipeline Molecules in Major Indications - Cardiovascular 102
9.1 Comparative Analysis of Late Stage Pipeline Molecules in Hypertension 102
9.1.1 Overview 102
9.1.2 Opportunity and Unmet Need 102
9.1.3 Strategic Pipeline Assessment 103
9.1.4 Comparative Analysis Based on Major Characteristics 105
9.1.5 Promising Drugs under Clinical Development 106
10 Comparative Analysis of Late Stage Pipeline Molecules in Major Indications - Infectious Disease 107
10.1 Comparative Analysis of Late Stage Pipeline Molecules in HIV/ AIDS 107
10.1.1 Overview 107
10.1.2 Opportunity and Unmet Need 107
10.1.3 Strategic Pipeline Assessment 108
10.1.4 Comparative Analysis Based on Major Characteristics 110
10.1.5 Promising Drugs under Clinical Development 111
11 Comparative Analysis of Late Stage Pipeline Molecules in Major Indications - Gastrointestinal Diseases 117
11.1 Comparative Analysis of Late Stage Pipeline Molecules in Ulcerative Colitis 117
11.1.1 Overview 117
11.1.2 Opportunity and Unmet Need 117
11.1.3 Strategic Pipeline Assessment 118
11.1.4 Comparative Analysis Based on Major Characteristics 120
11.1.5 Promising Drugs under Clinical Development 121
12 Comparative Analysis of Late Stage Pipeline Molecules in Major Indications - Conclusion 123
12.1 Oncology Pipeline Holds Most Prominence for Market Players 123
12.2 Colorectal Cancer Most Noteworthy Indications With Respect To Phase III Activity 124
12.3 An Average Of 50% Unmet Need Common in Oncology Therapeutics Followed By RA 125
12.4 Kinase Inhibitors - Most Important First-In-class Drug 126
12.5 Receptor Tyrosine Kinase and Vaccines Are Major Promising Class Based On Sales Forecast for Oncology 127
13 Comparative Analysis of Late Stage Pipeline Molecules in Major Indications - Appendix 128
13.1 Marketed Definitions 128
13.2 Abbreviations 128
13.3 Research Methodology 130
13.3.1 Coverage 130
13.3.2 Secondary Research 130
13.3.3 Primary Research 131
13.3.4 Expert Panel Validation 131
13.4 Contact Us 131
13.5 Disclaimer 131
13.6 Sources 132
List of Tables
1.1 List of Tables
Table 1: Comparative Analysis of Late Stage Pipeline Molecules in NSCLC, Based on Major Characteristics 13
Table 2: Comparative Analysis of Late Stage Pipeline Molecules in NSCLC, Other Promising Candidates in Late Stage Pipeline, 2011 18
Table 3: Comparative Analysis of Late Stage Pipeline Molecules in Colorectal Cancer, Based on Major Characteristics 24
Table 4: Comparative Analysis of Late Stage Pipeline Molecules in Breast Cancer, Based on Major Characteristics 34
Table 5: Comparative Analysis of Late Stage Pipeline Molecules in Prostate Cancer, Based on Major Characteristics 43
Table 6: Comparative Analysis of Late Stage Pipeline Molecules in Type 2 Diabetes, Based on Major Characteristics 53
Table 7: Comparative Analysis of Late Stage Pipeline Molecules in COPD, Based on Major Characteristics 61
Table 8: Comparative Analysis of Late Stage Pipeline Molecules in Rheumatoid Arthritis, Based on Major Characteristics 69
Table 9: Comparative Analysis of Late Stage Pipeline Molecules in Epilepsy, Based on Major Characteristics 76
Table 10: Comparative Analysis of Late Stage Pipeline Molecules in Multiple Sclerosis, Based on Major Characteristics 85
Table 11: Comparative Analysis of Late Stage Pipeline Molecules in Major Depressive Disorder, Based on Major Characteristics 91
Table 12: Comparative Analysis of Late Stage Pipeline Molecules in Crohn’s Disease, Based on Major Characteristics 97
Table 13: Comparative Analysis of Late Stage Pipeline Molecules in Hypertension, Based on Major Characteristics 105
Table 14: Comparative Analysis of Late Stage Pipeline Molecules in HIV/AIDS, Based on Major Characteristics 110
Table 15: Comparative Analysis of Late Stage Pipeline Molecules in Ulcerative Colitis, Based on Major Characteristics 120
List of Figures
1.2 List of Figures
Figure 1: NSCLC Pipeline, Global, Mechanism of Action, 2010 11
Figure 2: NSCLC Pipeline, Global, Technology Analytics Framework, 2010 12
Figure 3: Colorectal Cancer Pipeline, Global, Mechanism of Action, 2010 21
Figure 4: Colorectal Cancer Pipeline, Global, Technology Trends Analytic Framework, 2010 22
Figure 5: Breast Cancer Pipeline, Global, Mechanism of Action, 2010 32
Figure 6: Breast Cancer Pipeline, Global, Technology Trends Analytic Framework, 2010 33
Figure 7: Prostate Cancer Pipeline, Global, Mechanism of Action, 2010 40
Figure 8: Prostate Cancer Pipeline, Global, Technology Trends Analytic Framework, 2010 41
Figure 9: Type 2 Diabetes Pipeline, Global, Mechanism of Action, 2010 51
Figure 10: Type 2 Diabetes Pipeline, Global, Technology Trends Analytic Framework, 2010 52
Figure 11: COPD Pipeline, Global, Mechanism of Action, 2010 59
Figure 12: COPD Pipeline, Global, Technology Trends Analytic Framework, 2010 60
Figure 13: Rheumatoid Arthritis Pipeline, Global, Mechanism of Action, 2010 67
Figure 14: Rheumatoid Arthritis Pipeline, Global, Technology Trends Analytic Framework, 2010 68
Figure 15: Epilepsy Pipeline, Global, Mechanism of Action, 2010 74
Figure 16: Epilepsy Pipeline, Global, Technology Trends Analytic Framework, 2010 75
Figure 17: Multiple Sclerosis Pipeline, Global, Mechanism of Action, 2010 83
Figure 18: Multiple Sclerosis Pipeline, Global, Technology Trends Analytic Framework, 2009 84
Figure 19: Major Depressive Disorder Pipeline, Global, Mechanism of Action, 2010 89
Figure 20: Major Depressive Disorder Pipeline, Technology Trends Analytic Framework, 2011 90
Figure 21: Crohn’s Disease Pipeline, Global, Mechanism of Action, 2010 95
Figure 22: Crohn’s Disease Pipeline, Global, Technology Trends Analytic Framework, 2010 96
Figure 23: Anti-hypertension Pipeline, Global, Mechanism of Action, 2010 103
Figure 24: Anti Hypertension Pipeline, Global, Technology Trends Analytic Framework, 2010 104
Figure 25: HIV/AIDS Pipeline, Global, Mechanism of Action, 2010 108
Figure 26: HIV/ AIDS Pipeline, Global, Technology Trends Analytic Framework, 2010 109
Figure 27: Ulcerative Colitis Pipeline, Global, Mechanism of Action, 2010 118
Figure 28: Ulcerative Colitis Pipeline, Global, Technology Trends Analytic Framework, 2009 119
Figure 29: Comparative Analysis of Late Stage Pipeline Molecules in Major Indications, by Therapy Area, 2011 123
Figure 30: Comparative Analysis of Late Stage Pipeline Molecules in Major Indications, by Phase, 2011 124
Figure 31: Comparative Analysis of Late Stage Pipeline Molecules in Major Indications, Unmet Needs in % and $m, 2009 125
Figure 32: Comparative Analysis of Late Stage Pipeline Molecules in Major Indications, Technology Trends, 2011 126
Figure 33: Comparative Analysis of Late Stage Pipeline Molecules in Major Indications, Sales Forecast of Some Key Late Stage Pipeline Drugs in Oncology, ($m), 2017 127
