Table of Contents
1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 4
2 Executive Summary 6
2.1 Competitive Market Landscape Driven by Rising Prevalence 6
2.2 Large and Diverse Pipeline Dominated by Products Acting on G Protein Coupled Receptors (GPCR) and Protein Kinases 6
2.3 Strong Opportunities for Investment in First-in-Class Products 6
3 The Case for Innovation 7
3.1 Growing Opportunities for Biologic Products 7
3.2 Diversification of Molecular Targets 8
3.3 Innovative First-in-Class Product Developments Remain Attractive 8
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Innovation 9
3.5 Sustained Innovation in Type 2 Diabetes Mellitus 9
4 Clinical and Commercial Landscape 10
4.1 Overview of Type 2 Diabetes Mellitus 10
4.2 Disease Classification 10
4.2.1 Type 1 Diabetes Mellitus 10
4.2.2 Type 2 Diabetes Mellitus 11
4.2.3 Type 3 Diabetes Mellitus 11
4.2.4 LADA 11
4.2.5 MODY 11
4.2.6 Gestational 11
4.2.7 Pancreatic diabetes 11
4.2.8 Prediabetes 11
4.3 Symptoms 11
4.4 Diagnosis 12
4.5 Etiology 12
4.6 Pathophysiology 13
4.7 Comorbidities and Complications 14
4.8 Epidemiology 15
4.9 Treatment 16
4.9.1 Non-Insulin T2DM Therapies 17
4.9.2 Insulin-Based T2DM Therapies 19
4.10 Overview of Marketed Products 20
4.11 Unmet Need and Commercial Opportunities in T2DM 22
5 Assessment of Pipeline Product Innovation 23
5.1 Overview 23
5.2 Pipeline by Stage of Development and Molecule Type 23
5.3 Pipeline by Molecular Target 24
5.4 Comparative Distribution of Programs between the Market and Pipeline by Molecular Target Class 26
5.5 Comparative Distribution of First-in-Class and Non-First-in-Class Pipeline Programs by Molecular Target Class 27
5.6 Ratio of First-in-Class Programs to First-in-Class Molecular Targets within the Pipeline 28
5.7 List of All First-in-Class Pipeline Programs 30
6 Signaling Network, Disease Causation and Innovation Alignment 39
6.1 Complexity of Signaling Networks in Type 2 Diabetes Mellitus 39
6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration 39
6.3 First-in-Class Molecular Target Matrix Assessment 39
7 First-in-Class Molecular Target Evaluation 44
7.1 Pipeline Programs Targeting XXX 44
7.2 Pipeline Programs Targeting XXX 45
7.3 Pipeline Programs Targeting XXX 46
7.4 Pipeline Programs Targeting XXX 48
7.5 Pipeline Programs Targeting XXX 49
7.6 Pipeline Programs Targeting XXX 50
7.7 Pipeline Programs Targeting XXX 51
7.8 Pipeline Programs Targeting XXX 52
7.9 Pipeline Programs Targeting XXX 53
7.10 Conclusion 56
8 Strategic Consolidations 57
8.1 Industry-Wide First-in-Class Deals 57
8.2 Licensing Deals 58
8.2.1 Deals by Region, Value and Year 58
8.2.2 Deals by Stage of Development and Value 59
8.2.3 Deals by Molecule Type and Molecular Target 59
8.2.4 List of Deals with Disclosed Deal Values 60
8.3 Co-development Deals 62
8.3.1 Deals by Region, Value and Year 62
8.3.2 Deals by Stage of Development and Value 62
8.3.3 Deals by Molecule Type and Molecular Target 63
8.3.4 List of Deals with Disclosed Deal Values 64
8.4 First-in-Class Programs with and without Prior Licensing or Co-development Deal Involvement 65
9 Appendix 69
9.1 References 69
9.2 Abbreviations 74
9.3 Methodology 75
9.3.1 Data Integrity 75
9.3.2 Innovative and Meaningful Analytical Techniques and Frameworks 75
9.3.3 Evidence Based Analysis and Insight 75
9.4 Secondary Research 75
9.4.1 Market Analysis 76
9.4.2 Pipeline Analysis 76
9.4.3 Licensing and Co-development Deals 77
9.5 Contact Us 77
9.6 Disclaimer 77