OpportunityAnalyzer: Late - Stage Chronic Kidney Disease - Opportunity Analysis and Forecasts to 2026

  • ID: 4497182
  • Drug Pipelines
  • 195 pages
  • GlobalData
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FEATURED COMPANIES

  • AbbVie
  • Ardelyx
  • Deltanoid
  • Keryx
  • Mitsubishi Tanabe
  • Relypsa
  • MORE
OpportunityAnalyzer: Late - Stage Chronic Kidney Disease - Opportunity Analysis and Forecasts to 2026

Summary

CKD-induced hyperparathyroidism (HPT), hyperphosphatemia (HP), and hyperkalemia (HK) therapeutics had sales of approximately $4.2B in 2016 across the seven major markets (7MM) covered in this report; i.e., the US, the five major European markets (5EU: France, Germany, Italy, Spain, and UK), and Japan. In the 2016 base year, around 62% of market share was attributed to HPT therapy sales, whereas HP and HK held around 38% and 0.1% of the market, respectively.

By 2026, the author expects the late-stage chronic kidney disease (CKD) market to grow at a strong Compound Annual Growth Rate (CAGR) of around 9.5%, reaching sales of about $10.5B by the end of the forecast period in 2026. In general, the US will contribute the most to CKD market growth, as it is forecast to grow at a CAGR of over 11%, from around $2.5B in 2016. Over the forecast period, the most prominent wave of sales increases will come from the launch of new HK agents and the calcimimetic, Parsabiv (etelcalcetide), which will counteract the loss of market exclusivity of its in-house predecessor, Sensipar (cinacalcet).

The major drivers of CKD market growth over the forecast period are:
- The launch of Amgen’s first intravenous (IV) calcimimetic, Parsabiv, in 2017
- The recent launch of Veltassa (patiromer sorbitex calcium) in the US in 2016
- The launch of Lokelma (sodium zirconium cyclosilicate) in all 7MM by 2019
- An increase in the global prevalence of HPT, HP, and HK
- The recent launch of Rayaldee (calcifediol ER) in the US in 2016
- Increased use of new iron-based phosphate binders, Velphoro (sucroferric oxyhydroxide) and Auryxia (ferric citrate)

The major barriers that will restrict the growth of the HPT market during the forecast period are:
- Amgen’s Sensipar losing market exclusivity in the US (2018), 5EU (2019), and Japan (2020)
- Generic erosion of key players in the phosphate binder space, such as Fosrenol (lanthanum carbonate), Renvela/Renagel (sevelamer), and Velphoro, over the forecast period

The report "OpportunityAnalyzer: Late - Stage Chronic Kidney Disease - Opportunity Analysis and Forecasts to 2026", provide:
- An overview of CKD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized Late-Stage CKD-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2016 and forecast for ten years to 2026.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the Late-Stage CKD-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia therapeutics market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
- Analysis of the current and future market competition in the global Late-Stage CKD-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Companies mentioned in this report: OPKO Health, Amgen, Vifor, ZS Pharma, AstraZeneca, AbbVie, Sanofi, Genzyme, Shire, Keryx, Relypsa, Mitsubishi Tanabe, Kyowa Hakko Kirin, Deltanoid, Shield Therapeutics, Ardelyx , Spectrum

Scope

- Overview of CKD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized Late-Stage CKD-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2016 and forecast for ten years to 2026.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the Late-Stage CKD-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia therapeutics market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
- Analysis of the current and future market competition in the global Late-Stage CKD-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to:
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global T2D therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global T2D therapeutics market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global T2D therapeutics market from 2016-2026.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
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Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • AbbVie
  • Ardelyx
  • Deltanoid
  • Keryx
  • Mitsubishi Tanabe
  • Relypsa
  • MORE
1 Table of Contents

2 Executive Summary
2.1 Combined Sales for CKD-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia to Double by 2026
2.2 A Continued Focus on Improving the Compliance and Safety of Phosphate Binder Drugs
2.3 Novel Therapies Finally Begin to Address Long-Standing Key Unmet Needs in Hyperkalemia
2.4 IV Calcimimetic, Parsabiv Expected to Revolutionize the Treatment of Dialysis-Dependent Hyperparathyroidism Patients
2.5 What Do Physicians Think?

3 Introduction
3.1 Catalyst
3.2 Related Reports

4 Disease Overview
4.1 Etiology and Pathophysiology
4.1.1 Etiology
4.1.2 Pathophysiology
4.2 Symptoms
4.3 Diagnosis and Monitoring
4.4 Prognosis and Quality of Life

5 Epidemiology
5.1 Disease Background
5.2 Risk Factors and Comorbidities
5.3 Global and Historical Trends
5.4 Forecast Methodology
5.4.1 Sources
5.4.2 Forecast Assumptions and Methods
5.5 Epidemiological Forecast for CKD (2016-2026)
5.5.1 Total Prevalent Cases of CKD, Stages I-IV
5.5.2 Age-Specific Total Prevalent Cases of CKD, Stages I-IV
5.5.3 Sex-Specific Total Prevalent Cases of CKD, Stages I-IV
5.5.4 Total Prevalent Cases of CKD by Stage
5.5.5 Diagnosed Prevalent Cases of CKD, Stages I-V
5.5.6 Diagnosed Prevalent Cases of CKD by Stage
5.6 Discussion
5.6.1 Epidemiological Forecast Insight
5.6.2 Limitations of the Analysis
5.6.3 Strengths of the Analysis

6 Current Treatment Options
6.1 Overview
6.2 Treatment Guidelines and Leading Prescribed Drugs
6.2.1 Hyperparathyroidism and Hyperphosphatemia
6.2.2 Hyperkalaemia
6.3 Clinical Practice
6.3.1 Hyperparathyroidism and Hyperphosphatemia
6.3.2 Hyperkalemia
6.4 Calcimimetics
6.4.1 Sensipar (cinacalcet hydrochloride)
6.5 Vitamin D Sterols
6.5.1 Nutritional/Native Vitamin D
6.5.2 Vitamin D Receptor Agonists
6.6 Phosphate Binding Therapies
6.6.1 Overview
6.6.2 Calcium-Based Phosphate Binders
6.6.3 Aluminum-Containing Phosphate Binders
6.6.4 Magnesium-Containing Phosphate Binders
6.6.5 Renvela/Renagel (sevelamer carbonate/hydrochloride)
6.6.6 Fosrenol (lanthanum carbonate)
6.6.7 Velphoro (sucroferric oxyhydroxide)
6.6.8 Auryxia (ferric citrate)
6.7 Potassium Binding Therapies
6.7.1 Resins
6.7.2 Veltassa (patiromer sorbitex calcium)

7 Unmet Needs and Opportunity Assessment
7.1 Overview
7.2 Optimal Management of Phosphate in Hyperparathyroidism
7.2.1 Unmet Need
7.2.2 Gap Analysis
7.2.3 Opportunity
7.3 Novel Hyperkalemia Treatments
7.3.1 Unmet Need
7.3.2 Gap Analysis
7.3.3 Opportunity
7.4 Improved Compliance
7.4.1 Unmet Need
7.4.2 Gap Analysis
7.4.3 Opportunity
7.5 Drug Cost and Market Access
7.5.1 Unmet Need
7.5.2 Gap Analysis
7.5.3 Opportunity

8 R&D Strategies
8.1 Overview
8.1.1 Licensing and Alliances
8.1.2 Optimizing Treatment Safety and Compliance in Both the Pre-dialysis and Dialysis Setting
8.1.3 Development of Various Novel Phosphate Binders Continues as Unmet Needs Remian
8.2 Clinical Trial Design
8.2.1 Hyperparathyroidism
8.2.2 Hyperphosphatemia
8.2.3 Hyperkalemia

9 Pipeline Assessment
9.1 Overview
9.2 Promising Drugs in Clinical Development
9.2.1 Parsabiv (etelcalcetide hydrochloride)
9.2.2 Evocalcet
9.2.3 DP-001
9.2.4 PT20
9.2.5 Tenapanor hydrochloride
9.2.6 Alpharen (fermagate)
9.2.7 Lokelma (sodium zirconium cyclosilicate)
9.3 Innovative Early Stage Approaches
9.3.1 Renazorb (SPI-014)

10 Pipeline Valuation Analysis
10.1 Clinical Benchmark of Key Pipeline Drugs
10.2 Commercial Benchmark of Key Pipeline Drugs
10.3 Competitive Assessment
10.4 Top-Line 10-Year Forecast
10.4.1 US
10.4.2 5EU
10.4.3 Japan

11 Appendix
11.1 Bibliography
11.2 Abbreviations
11.3 Methodology
11.3.1 Forecasting Methodology
11.3.2 Diagnosed Patients
11.3.3 Percent Drug-Treated Patients
11.3.4 Drugs Included in Each Therapeutic Class
11.3.5 Launch and Patent Expiry Dates
11.3.6 General Pricing Assumptions
11.3.7 Individual Drug Assumptions
11.3.8 Generic Erosion
11.3.9 Pricing of Pipeline Agents
11.4 Primary Research - KOLs Interviewed for This Report
11.5 Primary Research - Prescriber Survey
11.6 About the Authors
11.6.1 Managing Analyst
11.6.2 Analyst
11.6.3 Therapy Area Director
11.6.4 Epidemiologist
11.6.5 Director of Epidemiology
11.6.6 Global Director of Therapy Analysis and Epidemiology
11.6.7 Global Head of Healthcare
11.7 About
11.8 Contact
11.9 Disclaimer

List of Tables
Table 1: Late-Stage Chronic Kidney Disease-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia, Key Metrics in the 7MM
Table 2: Stages of CKD
Table 3: Common Comorbidities of CKD and ESRD
Table 4: Degree of HK
Table 5: Factors Influencing Renal Potassium Excretion
Table 6: Factors Influencing Potassium Plasma Levels
Table 7: Symptoms of CKD
Table 8: Main Conditions Associated with HPT
Table 9: Common Diagnostic Tests for CKD and Associated Comorbidities
Table 10: Common Monitoring Procedures for HPT patients.
Table 11: Recommended Phosphate Maintenance Levels for CKD Patients
Table 12: Cardiac Monitoring Recommendations in HK Patients
Table 13: ECG Changes Indicative of Increasing Serum Potassium Levels
Table 14: Acute versus Chronic HK
Table 15: KDIGO Classification of CKD
Table 16: Risk Factors and Comorbidities for CKD
Table 17: 7MM, Total Prevalent Cases of CKD, Stages I-IV, Both Sexes, Ages =20 Years, N, Selected Years from 2016-2026
Table 18: 7MM, Diagnosed Prevalent Cases of CKD, Stages I-V, Both Sexes, Ages =20 Years, N, Selected Years from 2016-2026
Table 19: Treatment Guidelines for CKD, HPT
Table 20: Leading Treatments for HPT and HP, 2016
Table 21: Treatment Guidelines for CKD, HPT
Table 22: Interventions for the treatment of acute or chronic HK
Table 23: Product Profile - Sensipar
Table 24: Sensipar SWOT Analysis
Table 25: Nutritional Vitamin D Sterols
Table 26: Product Profile - Rayaldee
Table 27: Rayaldee SWOT Analysis
Table 28: Common VDRAs
Table 29: Product Profile - VDRAs
Table 30: Paricalcitol SWOT Analysis
Table 31: Product Profile - Sevelamer
Table 32: Sevelamer SWOT Analysis
Table 33: Product Profile - Fosrenol
Table 34: Fosrenol SWOT Analysis
Table 35: Product Profile - Velphoro
Table 36: Velphoro SWOT Analysis
Table 37: Product Profile - Auryxia
Table 38: Auryxia SWOT Analysis
Table 39: Product Profile - Resins
Table 40: Auryxia SWOT Sodium polystyrene sulfonate
Table 41: Product Profile - Veltassa
Table 42: Veltassa SWOT Analysis
Table 43: Key Late-Stage Pipeline Agents for HPT
Table 44: Product Profile - Parsabiv
Table 45: Etelcalcetide SWOT Analysis
Table 46: Product Profile - Evocalcet
Table 47: Evocalcet SWOT Analysis
Table 48: Product Profile - DP-001
Table 49: DP-001 SWOT Analysis
Table 50: Product Profile - PT20
Table 51: PT20 SWOT Analysis
Table 52: Product Profile - Tenpanor
Table 53: Tenapanor SWOT Analysis
Table 54: Product Profile - Alpharen
Table 55: Alpharen SWOT Analysis
Table 56: Product Profile - Lokelma
Table 57: Lokelma SWOT Analysis
Table 58: Early Stage Pipeline Products for HPT, HP, and HK.
Table 59: Clinical Benchmarking of Key Marketed & Pipeline Products (Phosphate binders)
Table 60: Clinical Benchmarking of Key Marketed and Pipeline Products (calcimimetics)
Table 61: Clinical Benchmarking of Key Marketed and Pipeline Products (Vitamin D sterols)
Table 62: Clinical Benchmarking of Key Marketed and Pipeline Products (potassium binders)
Table 63: Commercial Benchmarking of Key Marketed & Pipeline Products (Phosphate binders)
Table 64: Commercial Benchmarking of Key Marketed & Pipeline Products (calcimimetics)
Table 65: Clinical Benchmarking of Key Marketed and Pipeline Products (Vitamin D sterols)
Table 66: Commercial benchmarking of SOC and newly launched/pipeline potassium binders.
Table 67: Key Events Impacting Sales for HPT, HP, and HK, 2016-2026
Table 68: HPT Market - Global Drivers and Barriers, 2016?2026
Table 69: Key Launch Dates for HPT, HP, and HK
Table 70: Key Patent Expirations for HPT, HP, and HK
Table 71: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country

List of Figures
Figure 1: Global Sales Forecast by Country in 2016 and 2026
Figure 2: Global Sales Forecast by CKD-Induced HPT, HP, and HK in 2016 and 2026
Figure 3: The Pathogenesis of HPT
Figure 4: The Pathogenesis of HK
Figure 5: 7MM, Age-Standardized Total Prevalence of CKD, Stages I-IV, Ages =20 Years, 2016
Figure 6: 7MM, Sources Used to Forecast the Total Prevalent Cases of CKD Stages I-IV
Figure 7: 7MM, Sources Used to Forecast the Total Prevalent Cases of CKD by Stage
Figure 8: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of CKD Stages I-IV
Figure 9: 7MM, Sources Used to Forecast the Number of CKD Cases on Dialysis
Figure 10: 7MM, Sources Used to Forecast the Number of New Kidney Transplants
Figure 11: 7MM, Age-Specific Total Prevalent Cases of CKD, Stages I-IV, Both Sexes, Ages =20 Years, N, 2016
Figure 12: 7MM, Sex-Specific Total Prevalent Cases of CKD, Stages I-IV, Both Sexes, Ages =20 Years, N, 2016
Figure 13: 7MM, Total Prevalent Cases of CKD by Stage, Both Sexes, Ages =20 Years, N, 2016
Figure 14: 7MM, Diagnosed Prevalent Cases of CKD by Stage, Both Sexes, Ages =20 Years, N, 2016
Figure 15: Unmet Need and Opportunity in CKD
Figure 16: Overview of the Development Pipeline in CKD-Induced HPT, HP, and HK
Figure 17: Competitive Assessment of Key Pipeline Phosphate Binders
Figure 18: Competitive Assessment of Key Pipeline Calcimimetics
Figure 19: Competitive Assessment of Key Pipeline Vitamin D Sterols
Figure 20: Competitive Assessment of Key Pipeline Potassium Binders
Figure 21: Global Sales Forecast by Country in 2016 and 2026
Figure 22: Global Sales Forecast by CKD-Induced HPT, HP, and HK in 2016 and 2026
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  • OPKO Health
  • Amgen
  • Vifor
  • ZS Pharma
  • AstraZeneca
  • AbbVie
  • Sanofi
  • Genzyme
  • Shire
  • Keryx
  • Relypsa
  • Mitsubishi Tanabe
  • Kyowa Hakko Kirin
  • Deltanoid
  • Shield Therapeutics
  • Ardelyx
  • Spectrum
Note: Product cover images may vary from those shown
5 of 4
Note: Product cover images may vary from those shown
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