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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

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


Kidneys are highly specialized organs that maintain a stable internal environment of the body - referred to as homeostasis - by selectively excreting, retaining and secreting various substances according to specific needs. The kidneys serve a pivotal role in a number of basic physiological functions, including blood pressure control, salt and water homeostasis, blood cell production, acid-base balance, and calcium homeostasis.

Renal diseases are typically classified as either chronic or acute. CKD is asymptomatic at the early stages and often undiagnosed (Dousdampanis et al., 2012). CKD often exists alongside other conditions such as cardiovascular disease (CVD), diabetes and certain autoimmune diseases such as lupus. The risk of developing CKD increases with age.

Symptoms of renal diseases differ slightly between indications. Renal diseases are typically asymptomatic until relatively advanced renal failure is present. Pain is not a common symptom due to the lack of pain receptors in the kidney, except in some renal diseases that involve the ureter or the renal capsule, such as nephrolithiasis (kidney stones). In the early stages of renal disease, patients may only experience abnormalities in urine output or a presence of red blood cells and/or protein in the urine. In later stages, systemic symptoms may manifest, as well as signs of lost renal function, such as edema, fluid overload, electrolyte abnormalities and anemia.

Majority of marketed products for renal diseases are small molecules, which account for more than 95% of all products. There are only a small number of other molecule types - such as monoclonal antibodies (mAb) and proteins - available in the market.

The pipeline is highly diverse in terms of molecule type. Unlike the marketed products, the pipeline contains a wide range of other molecule types, including proteins, mAbs, synthetic peptides, cell therapies and vaccines. While small molecules account for majority of the marketed products, they only account for about 60% of the pipeline. This is partly due to the relatively large proportion of biologics.

Drug development for renal diseases has significantly lagged behind other therapy areas, and very few novel therapies have been approved in the last decade. The marketed pharmacotherapeutic treatments for renal diseases typically focus on controlling the risk factors and complications of renal failure. Treatments include anti-hypertensive agents, hormones, antibiotics, and systemic immunosuppressants.

The report “Frontier Pharma: Renal Diseases - High Degree of Innovation and Diversity with Products Targeting Immune and Hormone Signaling Dominating the Pipeline for Chronic Kidney Disease” assesses first-in-class innovation in the renal diseases pipeline, highlighting key trends and emerging treatment classes.

Specifically, this report outlines -

  • Analysis of 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.
  • 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.
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
1.1 List of Tables
1.2 List of Figures
2 Executive Summary
2.1 Unmet Need and Limited Treatment Options Despite Rising Prevalence
2.2 Increasing Number of Pipeline Biologics
2.3 Significant Degree of First-in-Class Innovation
2.4 Low Deal Volume but Large Proportion of High-Value Deals
3 The Case for Innovation
3.1 Growing Opportunities for Biologic Products
3.2 Diversification of Molecular Targets
3.3 Innovative First-in-Class Product Developments Remain Attractive
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation
3.5 Sustained Innovation
3.6 GBI Research Report Guidance
4 Clinical and Commercial Landscape
4.1 Disease Overview
4.2 Symptoms
4.2.1 Acute Kidney Injury
4.2.2 Chronic Kidney Disease
4.3 Diagnosis
4.3.1 Acute Kidney Injury
4.3.2 Chronic Kidney Disease
4.4 Etiology and Pathophysiology
4.4.1 Renal Anatomy and Physiology
4.4.2 Pathophysiological Processes of Renal Diseases
4.4.3 Renal Diseases
4.5 Epidemiology
4.6 Co-morbidities and Complications
4.6.1 Anemia
4.6.2 Diabetes
4.6.3 Cardiovascular Disease
4.6.4 Mineral and Bone Disorders
4.7 Treatment Options
4.7.1 Angiotensin Converting Enzyme Inhibitors
4.7.2 Angiotensin II Receptor Blockers
4.7.3 Erythropoietin-Stimulating Agents
4.7.4 Systemic Immunosuppressants
4.7.5 Dialysis
4.8 Overview of Marketed Products
4.9 Current Unmet Needs
5 Assessment of Pipeline Product Innovation
5.1 Pipeline by Stage of Development, Molecule Type and Molecular Target
5.2 First-in-Class Programs Targeting Novel Molecular Targets
6 Renal Diseases Signaling Network, Disease Causation and Innovation Alignment
6.1 Complexity of Signaling Networks
6.2 Signaling Pathways and First-in-Class Molecular Target Integration
6.3 First-in-Class Matrix Assessment
7 First-in-Class Target and Pipeline Program Evaluation
7.1 Pipeline Programs Targeting Complement Factor D
7.2 Pipeline Programs Targeting Midkine
7.3 Pipeline Programs Targeting Galectin-3
7.4 Pipeline Programs Targeting Connective Tissue Growth Factor
7.5 Pipeline Programs Targeting CX3C Chemokine Receptor 1
7.6 Pipeline Programs Targeting C-C Chemokine Receptor Type 2
7.7 Pipeline Programs Targeting Lysyl Oxidase and Lysyl Oxidase Homolog 2
7.8 Pipeline Programs Targeting Tumor Necrosis Factor Receptor Superfamily Member 5
7.9 Conclusion
8 Strategic Consolidations
8.1 Industry-Wide First-in-Class Deals
8.2 Licensing Deals
8.2.1 Deals by Region, Year and Value
8.2.2 Deals by Stage of Development and Value
8.2.3 Deals by Molecule Type and Value
8.2.4 Deals by Molecular Target and Value
8.2.5 List of Deals with Disclosed Deal Values
8.3 Co-development Deals
8.3.1 Deals by Region, Year and Value
8.3.2 Deals by Stage of Development and Value
8.3.3 Deals by Molecule Type and Value
8.3.4 Deals by Molecular Target and Value
8.3.5 List of Deals with Disclosed Deal Values
8.4 List of First-in-Class Pipeline Products with and Without Prior Deal Involvement
9 Appendix
9.1 Abbreviations
9.2 Disease List
9.3 References
9.4 Research Methodology
9.4.1 Data integrity
9.4.2 Innovative and meaningful analytical techniques and frameworks
9.4.3 Evidence based analysis and insight
9.5 Secondary Research
9.5.1 Market Analysis
9.5.2 Pipeline Analysis
9.5.3 Licensing and Co-development Deals
9.6 Contact Us
9.7 Disclaimer
List of Tables
Table 1: Renal Diseases, Global, AKI Stages, 2017
Table 2: Renal Diseases, Global, CKD Stages, 2017
Table 3: Renal Diseases, Global, AKI Types, 2017
Table 4: Renal Diseases, Global, Epidemiology of Renal Diseases, 2016
Table 5: Renal Diseases, Global, Key Features of Complement Factor D, 2017
Table 6: Renal Diseases, Global, Pipeline Programs Targeting Complement Factor D, 2017
Table 7: Renal Diseases, Global, Key Features of Midkine, 2017
Table 8: Renal Diseases, Global, Pipeline Programs Targeting Midkine, 2017
Table 9: Renal Diseases, Global, Key Features of Galectin-3, 2017
Table 10: Renal Diseases, Global, Pipeline Programs Targeting Galectin-3, 2017
Table 11: Renal Diseases Global, Key Features of Connective Tissue Growth Factor, 2017
Table 12: Renal Diseases, Global, Pipeline Programs Targeting Connective Tissue Growth Factor, 2017
Table 13: Renal Diseases, Global, Key Features of CX3C Chemokine Receptor 1, 2017
Table 14: Renal Diseases, Global, Pipeline Programs Targeting CX3C Chemokine Receptor 1, 2017
Table 15: Renal Diseases, Global, Key Features of C-C Chemokine Receptor Type 2, 2017
Table 16: Renal Diseases, Global, Pipeline Programs Targeting C-C Chemokine Receptor Type 2, 2017
Table 17: Renal Diseases, Global, Key Features of Lysyl Oxidase, 2017
Table 18: Renal Diseases, Global, Key Features of Lysyl Oxidase Homolog 2, 2017
Table 19: Renal Diseases, Global, Pipeline Programs Targeting Lysyl Oxidase, 2017
Table 20: Renal Diseases, Global, Pipeline Programs Targeting Lysyl Oxidase Homolog 2, 2017
Table 21: Renal Diseases, Global, Key Features of Tumor Necrosis Factor Receptor Superfamily Member 5, 2017
Table 22: Renal Diseases, Global, Pipeline Programs Targeting Tumor Necrosis Factor Receptor Superfamily Member 5, 2017
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)

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