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Chronic Kidney Disease (CKD) induced Hyperparathyroidism (HPT), Hyperphosphatemia (HP), and Hyperkalemia (HK) - Global Drug Forecast and Market Analysis to 2030

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    Report

  • 122 Pages
  • April 2021
  • Region: Global
  • GlobalData
  • ID: 5323667
CKD is a chronic condition in which patients suffer from an irreversible and progressive loss in renal function over many months or years, ultimately resulting in end-stage renal disease and the requirement for renal replacement therapy. CKD manifests when both kidneys are damaged sufficiently to hinder the removal of metabolic products from the body and the ability to provide mineral balance. The Centers for Disease Control and Prevention states that approximately 96% of people with kidney damage or mild to moderate reduced kidney function are oblivious to having CKD.

The global CKD-HPT, HP & HK market 2020 sales is estimated at approximately2.8B across the 7MM, encompassing the US, the five major European countries (5EU: France, Germany, Italy, Spain, and UK), and Japan. By 2030, The publisher expects the overall market to grow at a moderate compound annual growth rate (CAGR) of 6.9% to reach sales of5.5B over the 10-year period. Sales figures were forecast for both branded and generic drugs, from 2020 base year to 2030. The total market size for the 7MM (the “global market”) in 2020 was2.8B, with1.9 attributed to HPT,846M to HP, and93M to HK. The publisher expects that the total combined HPT, HP, and HK drug market will grow at a Compound Annual Growth Rate (CAGR) of 6.9% over the 10-year forecast period, resulting in a market value of5.5 by 2030.

Over the 10-year forecast period, the CKD market is expected to grow at a compound annual growth rate (CAGR) of 6.9%, reaching around5.5B in 2030. The major driver for this growth will be the increased use of drugs from different classes in combination with each other, which will lead to increased treatment costs. According to KOLs, combination therapy will become a mainstay in CKD treatment during the forecast period. This, in turn, will be the major driver of the market, despite the patent expirations of most currently marketed drugs and generic erosion.

Overall, the greatest unmet need in the CKD space is for novel drugs with curative or disease-stabilizing properties. The currently available drugs work in delaying disease progression. However, there is no marketed drug that addresses the underlying disease mechanism.

Key Questions Answered

Despite the existence of numerous well-established treatment options in the CKD-HPT, HP &HK space, a few-yet significant-unmet needs remain.
  • Which unmet needs are the most pressing in the 7MM
  • Where should pharmaceutical companies focus drug development efforts in order to become a significant player in the space

The CKD-HPT, HP &HK market hasn’t seen novel drug launches, though, clinical development activity has picked up.
  • What are the most promising late-stage candidates and how much they expected to generate over the forecast period
  • What do KOLs say about their clinical and commercial positioning

Although there is currently no cure for CKD-HPT, HP &HK, small companies are developing drugs to target new pathways.
  • Which have been historically the companies leading the way
  • What new companies are emerging in the space

Key Highlights
  • The proportion of people at risk of developing CKD-HPT, HP & HK expected to increase over the 10-year forecast period due to the growing disease prevalence
  • The potential launch of 5 late-stage pipeline agents will increase the number of patients who can be offered pharmacological treatment options. In addition, three of these drugs in late-stage development are expected to have a high annual cost of therapy (ACOT), a factor that will contribute to notable profitability
  • Despite multiple therapies currently available to CKD-HPT,HP & HK patients, there is still a high level of unmet need within the treatment space. The most recognizable is the need for novel therapies targeting new mechanisms and improving access to novel therapies

Scope
  • Overview of Chronic Kidney Disease - HPT, HP & HK including epidemiology, disease etiology and management
  • Topline CKD-HPT, HP & HK drugs market revenue, annual cost of therapy, and anticipated sales for major late-stage pipeline drugs
  • Key topics covered include assessment of current and pipeline therapies, unmet needs, current and future players and market outlook for the US, 5U and Japan over the 10-year forecast period
  • Pipeline analysis: Emerging novel trends under development, and detailed analysis of late-stage pipeline drugs
  • Analysis of the current and future market competition in the global CKD-HPT, HP & HK therapeutics market. Insightful review of the key industry drivers, restraints and challenges

Reasons to Buy this Report

The report will enable you to:
  • Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines
  • Develop business strategies by understanding the trends shaping and driving the global CKD-HPT, HP & HK therapeutics market
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global CKD-HPT, HP & HK market in the future
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing 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 CKD-HPT, HP& HK therapeutics market from 2020-2030
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

1. Chronic Kidney Disease-HPT, HP, and HK: Executive Summary
1.1 Combined Sales for CKD-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia to Increase by 2030
1.2 Novel Therapies Finally Begin to Address Long-Standing Key Unmet Needs
1.3 A Continued Focus on Improving the Compliance and Safety of Phosphate Binder Drugs
1.4 Tenapanor’s Novel Mechanism of Action Is Expected to Address Needs of Patients with Hyperphosphatemia
1.5 What Do Physicians Think?
2. Introduction
2.1 Catalyst
2.2 Related Reports
2.3 Upcoming Reports
3. Disease Overview
3.1 Etiology and Pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.2 Classification or Staging Systems
4. Epidemiology
4.1 Disease Background
4.2 Risk Factors and Comorbidities
4.3 Global and Historical Trends
4.4 7MM Forecast Methodology
4.4.1 Sources
4.4.2 Forecast Assumptions and Methods
4.4.3 Forecast Assumptions and Methods: Diagnosed Prevalent Cases of CKD - 7MM
4.4.4 Forecast Assumptions and Methods: Total Prevalent Cases of CKD
4.4.5 Forecast Assumptions and Methods: Diagnosed and Total Prevalent Cases of CKD by Stage
4.4.6 Diagnosed Prevalent Cases of CKD Based on Dialysis Dependence
4.4.7 Diagnosed Prevalent Cases of CKD with Hyperparathyroidism Among Dialysis-Dependent and Non-Dialysis-Dependent CKD Cases
4.4.8 Diagnosed Prevalent Cases of CKD with Hyperphosphatemia Among Dialysis Dependent and Non-dialysis Dependent CKD Cases
4.4.9 Diagnosed Prevalent Cases of CKD with Hyperkalemia Among Dialysis-Dependent and Non-Dialysis-Dependent CKD Cases
4.5 Epidemiological Forecast for Chronic Kidney Disease Hyperparathyroidism, Hyperphosphatemia and Hyperkalemia (2020-2030)
4.5.1 Diagnosed Prevalent Cases of CKD
4.5.2 Age-Specific Diagnosed Prevalent Cases of CKD
4.5.3 Sex-Specific Diagnosed Prevalent Cases of CKD
4.5.4 Diagnosed Prevalent Cases of CKD by Stage
4.5.5 Diagnosed Prevalent Cases of CKD Based on Dialysis Dependence
4.5.6 Diagnosed Prevalent Cases of CKD with Hyperparathyroidism Among Dialysis-Dependent and Non-dialysis-Dependent CKD Cases
4.5.7 Diagnosed Prevalent Cases of CKD with Hyperphosphatemia Among Dialysis-Dependent and Non-Dialysis-Dependent CKD Cases
4.5.8 Diagnosed Prevalent Cases of CKD With Hyperkalemia Among Dialysis-Dependent and Non-Dialysis-Dependent CKD Cases
4.5.9 Total Prevalent Cases of CKD
4.5.10 Age-Specific Total Prevalent Cases of CKD
4.5.11 Sex-Specific Total Prevalent Cases of CKD
4.5.12 Total Prevalent Cases of CKD by Stage
4.6 Discussion
4.6.1 Epidemiological Forecast Insight
4.6.2 COVID-19 Impact
4.6.3 Limitations of the Analysis
4.6.4 Strengths of the Analysis
5. Disease Management
5.1 Diagnosis and Treatment Overview
5.2 KOL Insights on Disease Management
5.2.1 US
5.2.2 5EU
5.2.3 Japan
6. Competitive Assessment
6.1 Overview
7. Unmet Needs and Opportunity Assessment
7.1 Overview
7.2 Getting Patients with Hyperphosphatemia to Adhere to Treatments
7.3 Improved Compliance
7.4 Optimal Management of Hyperkalemia Treatments
7.5 Drug Cost and Market Access
8. R&D Strategies
8.1 Overview
8.1.1 Deal-Making Trends
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 Remain
8.2 Clinical Trials 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
10. Pipeline Valuation Analysis
10.1 Overview
10.2 Competitive Assessment
11. Current and Future Players
11.1 Overview
11.2 Amgen Portfolio Assessment, 2021
11.3 AstraZeneca Portfolio Assessment, 2021
11.4 Vifor Pharma Portfolio Assessment, 2021
11.5 OPKO Portfolio Assessment, 2021
11.6 Akebia Therapeutics Portfolio Assessment, 2021
11.7 Ardelyx Portfolio Assessment, 2021
11.8 Shield Therapeutics Portfolio Assessment, 2021
11.9 Unicycive Therapeutics Portfolio Assessment, 2021
11.10 Kyowa Kirin Portfolio Assessment, 2021
12. Market Outlook
12.1 Global Markets
12.1.1 Forecast
12.1.2 Drivers and Barriers - Global Issues
12.2 US
12.2.1 Forecast
12.2.2 Key Events
12.2.3 Drivers and Barriers
12.3 5EU
12.3.1 Forecast
12.3.2 Key Events
12.3.3 Drivers and Barriers
12.4 Japan
12.4.1 Forecast
12.4.2 Key Events
12.4.3 Drivers and Barriers
13. Appendix
List of Tables
Table 1: Chronic Kidney Disease-HPT, HP, and HK: Key Metrics in the 7MM
Table 2: Degree of HK
Table 3: Stages of CKD
Table 4: KDIGO Classification of CKD
Table 5: Risk Factors and Comorbidities for CKD
Table 6: Common Diagnostic Tests for CKD and Associated Comorbidities
Table 7: Treatment Guidelines for CKD, HPT
Table 8: Amgen’s CKD-HPT, HP, and HK Portfolio Assessment, 2021
Table 9: AstraZeneca’s CKD-HPT, HP, and HK Portfolio Assessment, 2021
Table 10: Vifor’s CKD-HPT, HP, and HK Portfolio Assessment, 2021
Table 11: OPKO’s CKD-HPT, HP, and HK Portfolio Assessment, 2021
Table 12: Akebia’s CKD-HPT, HP, and HK Portfolio Assessment, 2021
Table 13: Ardelyx’s CKD-HPT, HP, and HK Portfolio Assessment, 2021
Table 14: Shield’s CKD-HPT, HP, and HK Portfolio Assessment, 2021
Table 15: Unicycive’s CKD-HPT, HP, and HK Portfolio Assessment, 2021
Table 16: Kyowa’s CKD-HPT, HP, and HK Portfolio Assessment, 2021
Table 17: HPT, HP, and HK Market - Global Drivers and Barriers, 2020-2030
Table 18: Key Events Impacting Sales for Disease HPT, HP, and HK in the US, 2020-2030
Table 19: HPT, HP, and HK Market - Drivers and Barriers in the US, 2020-2030
Table 20: Key Events Impacting Sales for HPT, HP, and HK in the 5EU, 2020-2030
Table 21: HPT, HP, and HK Market - Drivers and Barriers in the 5EU, 2020-2030
Table 22: Key Events Impacting Sales for HPT, HP, and HK in Japan, 2020-2030
Table 23: HPT, HP, and HK Market - Drivers and Barriers in Japan, 2020-2030
Table 24: Key Launch Dates for HPT, HP, and HK
Table 25: Key Patent Expiration Dates for HPT, HP, and HK
Table 26: High-Prescribing Physicians (non-KOLs) Surveyed, By Country
List of Figures
Figure 1: Global Sales Forecast by Country for CKD-Induced HPT, HP, and HK in 2020 and 2030
Figure 2: Analysis of the Company Portfolio Gap in CKD-HPT, HP, and HK During the Forecast Period
Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that the Publisher Expects to Be Licensed for the Treatment of HPT, HP, and HK During the Forecast Period
Figure 4: The Pathogenesis of HPT
Figure 5: 7MM, Diagnosed Prevalence of CKD, Men and Women, %, Ages =18 Years, 2020
Figure 6: 7MM, Total Prevalence of CKD, Men and Women, %, Ages =18 Years, 2020
Figure 7: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of CKD
Figure 8: 7MM, Sources Used to Forecast the Diagnosed and Total Prevalent Cases of CKD by Stage
Figure 9: 7MM, Sources Used and Not Used to Forecast the Diagnosed Prevalent Cases of CKD Based on Dialysis Dependence
Figure 10: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of CKD with Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia Among Dialysis-Dependent and Non-dialysis-Dependent CKD Cases
Figure 11: 7MM, Sources Used and Not Used to Forecast the Total Prevalent Cases of CKD
Figure 12: 7MM, Diagnosed Prevalent Cases of CKD, N, Both Sexes, Ages =18 Years, 2020
Figure 13: 7MM, Diagnosed Prevalent Cases of CKD by Age, N, Both Sexes, 2020
Figure 14: 7MM, Diagnosed Prevalent Cases of CKD by Sex, N, Ages =18 Years, 2020
Figure 15: 7MM, Diagnosed Prevalent Cases of CKD by Stage, N, Both Sexes, Ages =18 Years, 2020
Figure 16: 7MM, Diagnosed Prevalent Cases of CKD Based on Dialysis Dependence, N, Both Sexes, Ages =18 Years, 2020
Figure 17: 7MM, Diagnosed Prevalent Cases of CKD with Hyperparathyroidism, N, Both Sexes, Ages =18 Years, 2020
Figure 18: 7MM, Diagnosed Prevalent Cases of CKD With Hyperphosphatemia, N, Both Sexes, Ages =18 Years, 2020
Figure 19: 7MM, Diagnosed Prevalent Cases of CKD with Hyperkalemia, N, Both Sexes, =18 Years, 2020
Figure 20: 7MM, Total Prevalent Cases of CKD, N, Both Sexes, Ages =18 Years, 2020
Figure 21: 7MM, Diagnosed Total Cases of CKD by Age, N, Both Sexes, 2020
Figure 22: 7MM, Total Prevalent Cases of CKD by Sex, N, Ages =18 Years, 2020
Figure 23: 7MM, Total Prevalent Cases of CKD by Stage, N, Both Sexes, Ages =18 Years, 2020
Figure 24: Commonly Used Approach for Hyperphosphatemia Management in CKD-MBD
Figure 25: Unmet Needs and Opportunities in CKD
Figure 26: Overview of the Development Pipeline in CKD-Induced HPT, HP, and HK
Figure 27: Key Late-Stage Trials for the Promising Pipeline Agents that the Publisher Expects to Be Licensed for HPT, HP, and HK in the 7MM During the Forecast Period
Figure 28: Competitive Assessment of the Late-Stage Pipeline Agents that the Publisher Expects to Be Licensed for the Treatment of HPT, HP, and HK During the Forecast Period
Figure 29: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standard of Care (SOC), Phosphate Binders/NHE3 Inhibitor
Figure 30: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standard of Care (SOC), Calcimimetics
Figure 31: Analysis of the Company Portfolio Gap in HPT, HP, and HK During the Forecast Period
Figure 32: Global (7MM) Sales Forecast by Country for HPT, HP, and HK in 2020 and 2030
Figure 33: Sales Forecast by Class for HPT, HP, and HK in the US in 2020 and 2030
Figure 34: Sales Forecast by Class for HPT, HP, and HK in the 5EU in 2020 and 2030
Figure 35: Sales Forecast by Class for HPT, HP, and HK in Japan in 2020 and 2030

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Amgen
  • AstraZeneca
  • Vifor Pharma
  • OPKO Health
  • Akebia Therapeutics
  • Ardelyx
  • Shield Therapeutics
  • Unicycive Therapeutics