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

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 approximately $2.8B across the 7MM, encompassing the US, the five major European countries (5EU: France, Germany, Italy, Spain, and UK), and Japan. By 2030, GlobalData expects the overall market to grow at a moderate compound annual growth rate (CAGR) of 6.9% to reach sales of $5.5B 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 was $2.8B, with $1.9 attributed to HPT, $846M to HP, and $93M to HK. GlobalData 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 of $5.5 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 around $5.5B 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?

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.

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.

Reasons to buy

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.

Companies mentioned

Amgen

AstraZeneca

Vifor Pharma

OPKO Health

Akebia Therapeutics

Ardelyx

Shield Therapeutics

Unicycive Therapeutics

Table of Contents

| About GlobalData

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

13.1 Bibliography

13.2 Abbreviations

13.3 Methodology

13.3.1 Forecasting Methodology

13.3.2 Diagnosed Patients

13.3.3 Percent Drug-Treated Patients

13.3.4 Drugs Included in Each Therapeutics Class

13.3.5 Launch and Patent Expiry Dates

13.3.6 General Pricing Assumptions

13.3.7 Individual Drug Assumptions

13.3.8 Generic Erosion

13.3.9 Pricing of Pipeline Agents

13.4 Primary Research – KOLs and Payers Interviewed for This Report

13.4.1 KOLs

13.4.2 Payers

13.5 Primary Research – Prescriber Survey

13.6 About the Authors

13.6.1 Analyst

13.6.2 Associate Therapy Area Director

13.6.3 Therapy Area Director

13.6.4 Epidemiologist

13.6.5 Managing Epidemiologist

13.6.6 Global Director of Therapy Analysis and Epidemiology

13.6.7 Global Head and EVP of Healthcare Operations and Strategy

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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 GlobalData 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 GlobalData 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 GlobalData 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

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