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Frontier Pharma: Type 2 Diabetes Mellitus - GPCRs and Protein Kinases Dominate Pipeline, with Most Promising First-in-Class Targets Demonstrating Potential Disease-Modifying Effects

Published By :

GBI Research

Published Date : Dec 2016

Category :

Pharmaceutical

No. of Pages : 88 Pages

Type 2 diabetes mellitus (T2DM) is a chronic, progressive and serious metabolic disorder characterized by hyperglycemia (high blood glucose levels) and associated with numerous complications and co-morbidities, including cardiovascular, renal and neurodegenerative diseases.

Global prevalence of the disease has risen rapidly in the past several decades, primarily as a result of rising obesity, a major risk factor for T2DM. This has resulted in a large and competitive market landscape, with a number of drugs competing with one another for different market segments, across multiple lines of therapy.

The emergence over the past decade of glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase 4 (DPP-4) inhibitors and sodium-glucose cotransporter 2 (SGLT-2) inhibitors has intensified competition. These new drug classes have been highly commercially successful and are now well established within the treatment algorithm.

In spite of these developments, there are still significant unmet needs for T2DM, and the rationale for investment in first-in-class innovation remains strong. First-in-class products account for a considerable proportion of the large T2DM pipeline, with a diverse range of first-in-class targets identified.

Scope

The escalating T2DM public healthcare need has resulted in a competitive market landscape

  • What is the pathophysiology of T2DM?
  • What are the common co-morbidities and complications?
  • How has the emergence of new drug classes in the past decade impacted the treatment algorithm? 
  • What are the most significant unmet needs within the market? 

The T2DM pipeline is large and innovative

  • Which molecule types and molecular targets are most prominent within the pipeline? 
  • Which first-in-class targets are most promising? 
  • How does the ratio of first-in-class targets to first-in-class products differ by stage of development and molecular target class? 

The T2DM deals landscape is highly active

  • Do T2DM products attract high deal values? 
  • Which molecule types and molecular targets dominate the deals landscape? 
  • Which first-in-class pipeline products have no prior involvement in licensing or co-development deals?

Reasons to buy

This report will allow you to 

  • Appreciate the current clinical and commercial landscapes by considering disease pathogenesis, etiology, epidemiology, symptoms, co-morbidities and complications, and treatment options. 
  • Identify leading products and companies within the market, as well as key unmet needs, in order to gain a competitive understanding of gaps in the current market.
  • Recognize innovative pipeline trends by analyzing therapies by stage of development, molecule type and molecular target.
  • Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix, all first-in-class targets in the T2DM pipeline have been assessed and ranked according to clinical potential. Promising early-stage targets have been further reviewed in greater detail.
  • Consider first-in-class pipeline products with no prior involvement in licensing and co-development deals that may represent potential investment opportunities.

Table of Contents
1 Table of Contents 2
1.1 List of Tables 3
1.2 List of Figures 3
2 Executive Summary 5
2.1 Large and Competitive Market Landscape Driven by Rising Prevalence 5
2.2 Investment in First-in-Class Innovation Remains Strong 5
2.3 Opportunities for Investment in First-in-Class Product Development are Considerable 5
3 The Case for Innovation 6
3.1 Growing Opportunities for Biologic Products 7
3.2 Diversification of Molecular Targets 7
3.3 Innovative First-in-Class Product Development Remains Attractive 7
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 8
3.5 Sustained Innovation 8
3.6 GBI Research Report Guidance 8
4 Clinical and Commercial Landscape 10
4.1 Disease Overview 10
4.2 Classification of Diabetes Mellitus 10
4.3 Symptoms 11
4.4 Epidemiology 11
4.5 Etiology 12
4.6 Pathophysiology 12
4.7 Co-morbidities and Complications 14
4.8 Management and Treatment of Type 2 Diabetes Mellitus 16
4.8.1 Non-insulin T2DM Therapies 17
4.9 Insulin-Based T2DM Therapies 20
4.10 Overview of Marketed Products in Type 2 Diabetes 21
4.11 Unmet Need and Commercial Opportunities in T2DM 24
5 Assessment of Pipeline Product Innovation 25
5.1 Pipeline by Stage of Development, Molecule Type and Molecular Target 25
5.2 Comparative Distribution of Programs between the Market and Pipeline by Molecular Target Class 29
5.3 First-in-Class Programs by Molecular Target Category 29
6 Type 2 Diabetes Mellitus Signaling Network, Disease Causation and Innovation Alignment 48
6.1 Complexity of Signaling Networks 48
6.2 Signaling Pathways and First-in-Class Molecular Target Integration 48
6.3 First-in-Class Matrix Assessment 48
7 First-in-Class Target and Pipeline Program Evaluation 54
7.1 Pipeline Programs Targeting Insulin Receptor Substrate 1 and Insulin Receptor Substrate 2 54
7.2 Pipeline Programs Targeting G-Protein Coupled Receptor Kinase 5 (GRK5) 56
7.3 Pipeline Programs Targeting Type 2 Angiotensin II Receptor 57
7.4 Pipeline Programs Targeting Islet Amyloid Polypeptide (IAPP) 58
7.5 Pipeline Programs Targeting Nacht LRR and PYD Domains Containing Protein 3 60
7.6 Pipeline Programs Targeting Peroxisome Proliferator Activated Receptor Gamma Coactivator 1 Alpha (PPARGC1A) 61
7.7 Pipeline Programs Targeting Glucagon 62
7.8 Pipeline Programs Targeting Alpha Synuclein 64
7.9 Pipeline Programs Targeting Microtubule Associated Protein Tau 65
8 Strategic Consolidations 67
8.1 Industry-Wide First-in-Class Deals 67
8.2 Licensing Deals 68
8.3 Co-development Deals 71
8.4 First-in-Class Programs Not Involved in Licensing or Co-development Deals 74
9 Appendix 80
9.1 References 80
9.2 Abbreviations 85
9.3 Research Methodology 86
9.4 Secondary Research 86
9.4.1 Market Analysis 86
9.4.2 Pipeline Analysis 86
9.4.3 First-in-Class Matrix Assessment 87
9.4.4 First-in-Class Target Profiles 87
9.4.5 Licensing and Co-development Deals 87
9.5 Contact Us 87
9.6 Disclaimer 87

List of Table

Table 1: Type 2 Diabetes Mellitus, Global, Related Indications of T2DM First-in-Class Products, 2016 49
Table 2: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Insulin Receptor Substrate 1, 2016 55
Table 3: Type 2 Diabetes Mellitus, Global, Key Features of Insulin Receptor Substrate 1, 2016 55
Table 4: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Insulin Receptor Substrate 2, 2016 55
Table 5: Type 2 Diabetes Mellitus, Global, Key Features of Insulin Receptor Substrate 2, 2016 55
Table 6: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting G-Protein Coupled Receptor Kinase 5, 2016 56
Table 7: Type 2 Diabetes Mellitus, Global, Key Features of G-Protein Coupled Receptor Kinase 5, 2016 57
Table 8: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Type 2 Angiotensin II Receptor, 2016 58
Table 9: Type 2 Diabetes Mellitus, Global, Key Features of Type 2 Angiotensin II Receptor, 2016 58
Table 10: Type 2 Diabetes Mellitus, Global Pipeline Programs Targeting Islet Amyloid Polypeptide, 2016 59
Table 11: Type 2 Diabetes Mellitus, Global, Key Features of Islet Amyloid Polypeptide, 2016 59
Table 12: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Nacht LRR and PYD Domains Containing Protein 3, 2016 60
Table 13: Type 2 Diabetes Mellitus, Global, Key Features of Nacht LRR and PYD Domains Containing Protein 3, 2016 61
Table 14: Type 2 Diabetes Mellitus, Global Pipeline Programs Targeting Peroxisome Proliferator Activated Receptor Gamma Coactivator 1 Alpha, 2016 62
Table 15: Type 2 Diabetes Mellitus, Global, Key Features of Peroxisome Proliferator Activated Receptor Gamma Coactivator 1 Alpha, 2016 62
Table 16: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Glucagon, 2016 63
Table 17: Type 2 Diabetes Mellitus, Global, Key Features of Glucagon, 2016 63
Table 18: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Alpha Synuclein, 2016 65
Table 19: Type 2 Diabetes Mellitus Market, Global, Key Features of Alpha Synuclein, 2016 65
Table 20: Type 2 Diabetes Market, Global, Pipeline Programs Targeting Microtubule Associated Protein Tau, 2016 66
Table 21: Type 2 Diabetes Mellitus Market, Global, Key Features of Microtubule Associated Protein Tau, 2016 66

List of Chart

Figure 1: Type 2 Diabetes Mellitus, Global, Innovation Trends in Product Approvals Across the Pharmaceutical Market, 1987-2014 6
Figure 2: Type 2 Diabetes Mellitus, Global, Post-Marketing-Approval Sales Performance of First-in-Class and Non-First-in-Class Products Across Pharmaceutical Industry ($m), 2006-2013 8
Figure 3: Type 2 Diabetes Mellitus, Global, Marketed Products by Molecule Type, 2016 22
Figure 4: Type 2 Diabetes Mellitus, Global, Marketed Products by Molecular Target, 2016 23
Figure 5: Type 2 Diabetes Mellitus, Global, Pipeline Size by Therapy Area, 2016 25
Figure 6: Type 2 Diabetes Mellitus, Global, Pipeline by Stage of Development and Molecule Type, 2016 26
Figure 7: Type 2 Diabetes Mellitus, Global, Pipeline by Molecular Target and Stage of Development, 2016 27
Figure 8: Type 2 Diabetes Mellitus, Global, Pipeline Breakdown of GPCR and Protein Kinase Molecular Target, 2016 28
Figure 9: Type 2 Diabetes Mellitus, Global, Distribution of Pipeline and Marketed Products by Molecular Target Class, 2016 29
Figure 10: Type 2 Diabetes Mellitus, Global, Distribution of Pipeline Products by First-in-Class Status and Molecular Target Class, 2016 31
Figure 11: Type 2 Diabetes Mellitus, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Products by Stage of Development, 2016 32
Figure 12: Type 2 Diabetes Mellitus, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Products by Molecular Target Class, 2016 32
Figure 13: Type 2 Diabetes Mellitus, Global, Ratio of First-in-Class Targets to First-in-Class Products by Stage of Development, 2016 33
Figure 14: Type 2 Diabetes Mellitus, Global, Ratio of First-in-Class Targets to First-in-Class Products by Molecular Target, 2016 33
Figure 15: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 1) 34
Figure 16: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 2) 35
Figure 17: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 3) 36
Figure 18: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 4) 37
Figure 19: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 5) 38
Figure 20: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 6) 39
Figure 21: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 7) 40
Figure 22: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 8) 41
Figure 23: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 9) 42
Figure 24: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 10) 43
Figure 25: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 11) 44
Figure 26: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 12) 45
Figure 27: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 13) 46
Figure 28: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 14) 47
Figure 29: Type 2 Diabetes Mellitus, Global, First-in-Class Molecular Target Analysis Matrix Part 1, 2016 50
Figure 30: Type 2 Diabetes Mellitus, Global, First-in-Class Molecular Target Analysis Matrix Part 2, 2016 51
Figure 31: Type 2 Diabetes Mellitus, Global, First-in-Class Molecular Target Analysis Matrix Part 3, 2016 52
Figure 32: Type 2 Diabetes Mellitus, Global, First-in-Class Molecular Target Analysis Matrix Part 4, 2016 53
Figure 33: Type 2 Diabetes Mellitus, Global, Industry-Wide Licensing Deals by Stage of Development, 2006-2016 67
Figure 34: Type 2 Diabetes Mellitus, Global, Industry-Wide Licensing Deals by Deal Value, Upfront Payment Value, Stage of Development and First-in-Class Status ($m), 2006-2014 68
Figure 35: Type 2 Diabetes Mellitus, Global, Licensing Deals by Region, Value and Year, 2006-2016 69
Figure 36: Type 2 Diabetes Mellitus, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2016 70
Figure 37: Type 2 Diabetes Mellitus, Global, Number and Aggregate Deal Value of Licensing Deals by Molecule Type, 2006-2016 71
Figure 38: Type 2 Diabetes Mellitus, Global, Frequency and Aggregate Deal Value of Licensing Deals by Molecular Target, 2006-2016 71
Figure 39: Type 2 Diabetes Mellitus, Global, Co-development Deals by Region and Deal Value and Year, 2006-2016 72
Figure 40: Type 2 Diabetes Mellitus, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2016 73
Figure 41: Type 2 Diabetes Mellitus, Global, Number and Aggregate Deal Value of Co-development Deals by Molecule Type, 2006-2016 73
Figure 42: Type 2 Diabetes Mellitus, Global, Frequency and Aggregate Deal Value of Co-development Deals by Molecular Target, 2006-2016 74
Figure 43: Type 2 Diabetes Mellitus, Global, Deal Involvement of First-in-Class Programs, 2016 (part 1) 75
Figure 44: Type 2 Diabetes Mellitus, Global, Deal Involvement of First-in-Class Programs, 2016 (part 2) 76
Figure 45: Type 2 Diabetes Mellitus, Global, Deal Involvement of First-in-Class Programs, 2016 (part 3) 77
Figure 46: Type 2 Diabetes Mellitus, Global, Deal Involvement of First-in-Class Programs, 2016 (part 4) 78
Figure 47: Type 2 Diabetes Mellitus, Global, Deal Involvement of First-in-Class Programs, 2016 (part 5) 79

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