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

SKU ID :GBI-10669116 | Published Date: 03-Oct-2017 | No. of pages: 72
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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