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Frontier Pharma: Renal Diseases - High Degree of Innovation and Diversity with Products Targeting Immune and Hormone Signaling Dominating the Pipeline for Chronic Kidney Disease

Published By :

GBI Research

Published Date : Oct 2017

Category :

Pharmaceutical

No. of Pages : 72 Pages

Frontier Pharma: Renal Diseases - High Degree of Innovation and Diversity with Products Targeting Immune and Hormone Signaling Dominating the Pipeline for Chronic Kidney Disease

Summary

The renal diseases therapy area encompasses a range of diseases of the kidney, such as chronic kidney disease (CKD), acute kidney injury, diabetic nephropathy and focal segmental glomerulosclerosis. Renal diseases are becoming increasingly common due to the increased prevalence of hypertension and diabetes, two major causes of CKD. For most forms of renal diseases, early detection and management may slow down or prevent progression to renal failure and associated complications. However, many renal diseases are typically asymptomatic until they have progressed to end-stage renal disease (ESRD), which requires renal replacement therapies such as hemodialysis and renal transplantation, and is associated with substantial morbidity and mortality.

The marketed treatments of renal diseases typically focus on controlling the risk factors and complications of renal failure. Treatments include anti-hypertensive agents, hormones, antibiotics, and immunosuppressants. However, these treatments are often not wholly effective, as patients are still at risk of dying prematurely from cardiovascular disease or progressing to ESRD. Few new renal disease therapies have reached the market in the past decade, and with the rising prevalence, there is a high need for innovation and investment in the renal diseases therapy area.

The report assesses first-in-class innovation in the renal diseases pipeline, highlighting key trends and emerging treatment classes. There are 100 first-in-class products in development in this therapy area, which account for 39% of products in the overall pipeline for which there is a disclosed molecular target, and act upon 77 unique individual molecular targets. First-in-class innovation is concentrated heavily at the early drug development stages.

The first-in-class programs identified show considerable diversity, and the relatively high degree of innovation in the renal diseases therapy area makes for a promising development pipeline. It is clear that recent activity in this area has increased, partly owing to the growing recognition of the unmet medical need. Further investment in innovation would benefit the therapy area greatly, and likely prove a worthwhile investment, particularly for highly prevalent diseases such as CKD and diabetic nephropathy, for which there are a lack of effective pharmacotherapeutic options.

Scope

- With 365 products in active development, the pipeline is modestly sized. Does current pipeline innovation hold the potential to affect the future renal diseases market?
- There are 100 first-in-class products in the renal diseases pipeline. Which of these hold the greatest potential to improve future disease treatment with regard to their molecular target?
- The majority of first-in-class products were in development for indications involving inflammation. Which first-in-class targets are most promising, and how does the ratio of first-in-class targets to first-in-class products differ by stage of development and molecular target class?
- A significant number of first-in-class products have been identified with no prior involvement in deals. How do deal frequency and value compare between target families and molecule types, and which first-in-class programs have not yet been involved in a licensing or co-development deal?

Reasons to buy

- Understand the current clinical and commercial landscape. It includes a comprehensive study of disease pathogenesis, diagnosis, prognosis and the treatment options available.
- Visualize the composition of the renal diseases market in terms of dominant molecule types and targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge allows a competitive understanding of gaps in the current market.
- Analyze the renal diseases pipeline and stratify by stage of development, molecule type and molecular target. There are strong signs in the pipeline that the industry is seeking novel approaches to treating renal diseases to overcome the level of unmet need.
- Assess the therapeutic potential of first-in-class targets. Using proprietary matrices, first-in-class products have been assessed and ranked according to clinical potential. The matrices have been split into three categories: renal failure, glomerulonephritides, and renal scarring. Promising targets have been reviewed in greater detail.
- Identify commercial opportunities in the renal diseases deals landscape by analyzing trends in licensing and co-development deals, and producing a list of first-in-class therapies with no prior involvement in licensing or co-development deals
1 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 Unmet Need and Limited Treatment Options Despite Rising Prevalence 5
2.2 Increasing Number of Pipeline Biologics 5
2.3 Significant Degree of First-in-Class Innovation 5
2.4 Low Deal Volume but Large Proportion of High-Value Deals 6
3 The Case for Innovation 7
3.1 Growing Opportunities for Biologic Products 8
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 Product Innovation 9
3.5 Sustained Innovation 9
3.6 GBI Research Report Guidance 10
4 Clinical and Commercial Landscape 11
4.1 Disease Overview 11
4.2 Symptoms 12
4.2.1 Acute Kidney Injury 12
4.2.2 Chronic Kidney Disease 12
4.3 Diagnosis 12
4.3.1 Acute Kidney Injury 12
4.3.2 Chronic Kidney Disease 13
4.4 Etiology and Pathophysiology 13
4.4.1 Renal Anatomy and Physiology 14
4.4.2 Pathophysiological Processes of Renal Diseases 14
4.4.3 Renal Diseases 16
4.5 Epidemiology 18
4.6 Co-morbidities and Complications 19
4.6.1 Anemia 19
4.6.2 Diabetes 19
4.6.3 Cardiovascular Disease 19
4.6.4 Mineral and Bone Disorders 20
4.7 Treatment Options 20
4.7.1 Angiotensin Converting Enzyme Inhibitors 20
4.7.2 Angiotensin II Receptor Blockers 21
4.7.3 Erythropoietin-Stimulating Agents 21
4.7.4 Systemic Immunosuppressants 21
4.7.5 Dialysis 21
4.8 Overview of Marketed Products 22
4.9 Current Unmet Needs 23
5 Assessment of Pipeline Product Innovation 25
5.1 Pipeline by Stage of Development, Molecule Type and Molecular Target 25
5.2 First-in-Class Programs Targeting Novel Molecular Targets 29
6 Renal Diseases Signaling Network, Disease Causation and Innovation Alignment 36
6.1 Complexity of Signaling Networks 36
6.2 Signaling Pathways and First-in-Class Molecular Target Integration 36
6.3 First-in-Class Matrix Assessment 36
7 First-in-Class Target and Pipeline Program Evaluation 39
7.1 Pipeline Programs Targeting Complement Factor D 39
7.2 Pipeline Programs Targeting Midkine 41
7.3 Pipeline Programs Targeting Galectin-3 43
7.4 Pipeline Programs Targeting Connective Tissue Growth Factor 45
7.5 Pipeline Programs Targeting CX3C Chemokine Receptor 1 47
7.6 Pipeline Programs Targeting C-C Chemokine Receptor Type 2 48
7.7 Pipeline Programs Targeting Lysyl Oxidase and Lysyl Oxidase Homolog 2 50
7.8 Pipeline Programs Targeting Tumor Necrosis Factor Receptor Superfamily Member 5 52
7.9 Conclusion 54
8 Strategic Consolidations 55
8.1 Industry-Wide First-in-Class Deals 55
8.2 Licensing Deals 56
8.2.1 Deals by Region, Year and Value 57
8.2.2 Deals by Stage of Development and Value 58
8.2.3 Deals by Molecule Type and Value 58
8.2.4 Deals by Molecular Target and Value 59
8.2.5 List of Deals with Disclosed Deal Values 59
8.3 Co-development Deals 60
8.3.1 Deals by Region, Year and Value 60
8.3.2 Deals by Stage of Development and Value 60
8.3.3 Deals by Molecule Type and Value 61
8.3.4 Deals by Molecular Target and Value 61
8.3.5 List of Deals with Disclosed Deal Values 62
8.4 List of First-in-Class Pipeline Products with and Without Prior Deal Involvement 63
9 Appendix 66
9.1 Abbreviations 66
9.2 Disease List 66
9.3 References 67
9.4 Research Methodology 70
9.4.1 Data integrity 71
9.4.2 Innovative and meaningful analytical techniques and frameworks 71
9.4.3 Evidence based analysis and insight 71
9.5 Secondary Research 71
9.5.1 Market Analysis 71
9.5.2 Pipeline Analysis 71
9.5.3 Licensing and Co-development Deals 72
9.6 Contact Us 72
9.7 Disclaimer 72

1.1 List of Tables
Table 1: Renal Diseases, Global, AKI Stages, 2017 13
Table 2: Renal Diseases, Global, CKD Stages, 2017 13
Table 3: Renal Diseases, Global, AKI Types, 2017 17
Table 4: Renal Diseases, Global, Epidemiology of Renal Diseases, 2016 19
Table 5: Renal Diseases, Global, Key Features of Complement Factor D, 2017 40
Table 6: Renal Diseases, Global, Pipeline Programs Targeting Complement Factor D, 2017 41
Table 7: Renal Diseases, Global, Key Features of Midkine, 2017 42
Table 8: Renal Diseases, Global, Pipeline Programs Targeting Midkine, 2017 43
Table 9: Renal Diseases, Global, Key Features of Galectin-3, 2017 44
Table 10: Renal Diseases, Global, Pipeline Programs Targeting Galectin-3, 2017 45
Table 11: Renal Diseases Global, Key Features of Connective Tissue Growth Factor, 2017 46
Table 12: Renal Diseases, Global, Pipeline Programs Targeting Connective Tissue Growth Factor, 2017 47
Table 13: Renal Diseases, Global, Key Features of CX3C Chemokine Receptor 1, 2017 48
Table 14: Renal Diseases, Global, Pipeline Programs Targeting CX3C Chemokine Receptor 1, 2017 48
Table 15: Renal Diseases, Global, Key Features of C-C Chemokine Receptor Type 2, 2017 49
Table 16: Renal Diseases, Global, Pipeline Programs Targeting C-C Chemokine Receptor Type 2, 2017 50
Table 17: Renal Diseases, Global, Key Features of Lysyl Oxidase, 2017 51
Table 18: Renal Diseases, Global, Key Features of Lysyl Oxidase Homolog 2, 2017 51
Table 19: Renal Diseases, Global, Pipeline Programs Targeting Lysyl Oxidase, 2017 52
Table 20: Renal Diseases, Global, Pipeline Programs Targeting Lysyl Oxidase Homolog 2, 2017 52
Table 21: Renal Diseases, Global, Key Features of Tumor Necrosis Factor Receptor Superfamily Member 5, 2017 53
Table 22: Renal Diseases, Global, Pipeline Programs Targeting Tumor Necrosis Factor Receptor Superfamily Member 5, 2017 53

1.2 List of Figures
Figure 1: Renal Diseases, US, Innovation Trends in Product Approvals, 1987-2014 7
Figure 2: Renal Diseases, US, Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006-2013 9
Figure 3: Renal Diseases, Global, Marketed Products by Molecule Type, 2017 22
Figure 4: Renal Diseases, Global, Marketed Products by Molecular Target, 2017 23
Figure 5: Renal Diseases, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2017 25
Figure 6: Renal Diseases, Global, Pipeline by Stage of Development and Molecule Type, 2017 26
Figure 7: Renal Diseases, Global, Renal Failure, Glomerulonephritides and Renal Scarring Pipelines by Stage of Development and Molecule Type, 2017 27
Figure 8: Renal Diseases, Global, Pipeline by Molecular Target, 2017 28
Figure 9: Renal Diseases, Global, Renal Failure, Glomerulonephritides and Renal Scarring Pipelines by Molecular Target, 2017 29
Figure 10: Renal Diseases, Global, Distribution of Pipeline First-in-Class and Non-First-in-Class Products by Stage of Development and Molecular Target, 2017 30
Figure 11: Renal Diseases, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Products by Stage of Development (%), 2017 30
Figure 12: Renal Diseases, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Products by Molecular Target (%), 2017 31
Figure 13: Renal Diseases, Global, Ratio of First-in-Class Products to First-in-Class Targets by Stage of Development, 2017 31
Figure 14: Renal Diseases, Global, Ratio of First-in-Class Products to First-in-Class Targets by Molecular Target, 2017 32
Figure 15: Renal Diseases, Global, Pipeline Products, 2017 (Part 1) 32
Figure 16: Renal Diseases, Global, Pipeline Products, 2017 (Part 2) 33
Figure 17: Renal Diseases, Global, Pipeline Products, 2017 (Part 3) 33
Figure 18: Renal Diseases, Global, Pipeline Products, 2017 (Part 4) 34
Figure 19: Renal Diseases, Global, Pipeline Products, 2017 (Part 5) 34
Figure 20: Renal Disease, Global, Pipeline Products, 2017 (Part 6) 35
Figure 21: Renal Diseases, Global, Pipeline Products, 2017 (Part 7) 35
Figure 22: Renal Diseases, Global, First-in-Class Matrix Assessment (Renal Failure), 2017 37
Figure 23: Renal Diseases, Global, First-in-Class Matrix Assessment (Glomerulonephritides), 2017 37
Figure 24: Renal Diseases, Global, First-in-Class Matrix Assessment (Renal Scarring), 2017 38
Figure 25: Renal Diseases, Global, Licensing Deals by Stage of Development, 2006-2015 55
Figure 26: Renal Diseases, Global, Industry-Wide Licensing Deals by Deal Value, Upfront Payment Value, Stage of Development and First-in-Class Status ($m), 2006-2015 56
Figure 27: Renal Diseases, Global, Licensing Deals by Region, Value and Year, 2006-2017 57
Figure 28: Renal Diseases, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2017 58
Figure 29: Renal Diseases, Global, Licensing Deals by Molecule Type, 2006-2017 58
Figure 30: Renal Diseases, Global, Licensing Deals by Molecular Target, 2006-2017 59
Figure 31: Renal Diseases, Global, Licensing Deals with Disclosed Deal Values, 2006-2017 59
Figure 32: Renal Diseases, Global, Co-development Deals by Region, Value and Year, 2006-2017 60
Figure 33: Renal Diseases, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2017 61
Figure 34: Renal Diseases, Global, Co-development Deals by Molecule Type, 2006-2017 61
Figure 35: Renal Diseases, Global, Co-development Deals by Molecular Target, 2006-2017 62
Figure 36: Renal Diseases, Global, Co-development Deals with Disclosed Deal Values, 2006-2017 62
Figure 37: Renal Diseases, Global, First-in-class Programs in Active Development Involved in Previous Deals, 2017 63
Figure 38: Renal Diseases, Global, First-in-class Programs in Active Development Without Recorded Prior Deal Involvement, 2017 (Part 1) 64
Figure 39: Renal Diseases, Global, First-in-class Programs in Active Development Without Recorded Prior Deal Involvement, 2017 (Part 2) 65

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