Summary
Anemia is a common complication of chronic kidney disease (CKD) that is most frequently attributed to insufficient synthesis of erythropoietin (EPO) due to kidney damage. CKD anemia is highly prevalent among CKD patients and its prevalence increases as CKD progresses, affecting more than half of patients in stage V. Over the last 20 years, the CKD anemia market has grown exponentially. Treatment of CKD anemia was significantly improved following the introduction of recombinant human EPO (rHuEPO), and ESAs have dominated the disease space as the standard of care.
The CKD anemia market is relatively well-established; many physicians believe that the existing therapies, namely ESAs, effectively control anemia for most patients. However, despite several options, there is still room for improvement and innovation within the space. The publisher has identified a variety of unmet needs. While ESAs have improved the treatment for patients with CKD anemia, their safety profiles are not ideal. As injectable ESAs often stimulate EPO to supraphysiologic levels, which subsequently associates their use with increased cardiovascular (CV) risks, safer treatment options for CKD anemia is currently the most significant unmet need for the condition.
Major drivers of growth in the CKD anemia market over the forecast period include: the launch and uptake of novel hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) drug class across all markets covered in the report will drive the growth of the CKD anemia market. The publisher expects this novel class of drugs, which includes several recently approved and late-stage candidates, to have steady uptake across the 8MM, as they are anticipated to address some of the main unmet needs in the space. Market growth will also be driven by the launch of several oral and IV iron products in addition markets.
The publisher expects the market to increase to $6.6B in 2029 at a Compound Annual Growth Rate (CAGR) of 3.4%. Furthermore, the China CKD anemia market is expected to experience the highest growth, increasing to $962M (14.6% of global market share) by 2029, at a CAGR of 9.9%. Sales in the other regions are also expected to increase by the end of the forecast period. This global growth is driven mainly by the anticipated approval and launch of HIF-PHIs but will likely be tempered by marked biosimilar erosion of several top-selling currently marketed branded erythropoiesis-stimulating agents (ESAs).
Key Highlights
- Despite therapies currently available to anemia in CKD patients, there is still room for improvement within the space. Global sentiment among KOLs included the growing need for safer treatment options, less burdensome drug administration, and the importance of novel therapies for patients resistant to ESA treatment.
- Although ESAs are forecast to remain the highest-grossing drug class at the end of the forecast period, this drug class has a negative CAGR of 2.9%. This decline in sales can be largely attributed the launch of HIF-PHIs and biosimilar competition.
- These market dynamics will occur against a backdrop of a moderate growth of global CKD anemia prevalent cases over the 10-year forecast period, with approximately 2.6 million drug treated cases across the 8MM in 2029.
Key Questions Answered
- Despite the existence well-established treatment options for treating CKD anemia, a few - yet significant - unmet needs remain.
- Which unmet needs are the most pressing in the 8MM?
- Where should pharmaceutical companies focus drug development efforts in order to become a significant player in the space?
- Sales in the CKD anemia market are dominated by the highly lucrative ESA class of drugs
- What factors will shape the competitive treatment landscape?
- Will ESAs maintain their strong market position?
- How much pressure will they face from new entrants?
Several HIF-PHIs have recently been marketed or are soon expected to gain their first approval among the 8MM -
- Which companies are leading the way with their own HIF-PHI?
- What do KOLs say about their clinical and commercial positioning?
- How are they expected to shape the future CKD anemia treatment paradigm?
Scope
- Overview of CKD anemia including epidemiology, disease etiology and management.
- Topline CKD anemia drugs market revenue (including ESAs and iron therapies), 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, Japan and China 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 angina pectoris therapeutics market. Insightful review of the key industry drivers, restraints and challenges.
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 angina pectoris therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global angina pectoris 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 anemia therapeutics market from 2019-2029.
- 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 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 CKD-Induced Anemia: Executive Summary
2.1 CKD Anemia Market to Experience Strong Growth from 2019-2029
2.2 Optimizing Treatment Safety and Ease of Administration Are Popular R&D Strategies
2.3 New Pipeline Products Will Help in Partially Addressing Some Unmet Needs
2.4 Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors Dominate the CKD Anemia Pipeline
2.5 What Do Physicians Think?
3 Introduction
3.1 Catalyst
3.2 Related Reports
3.3 Upcoming Related Reports
4 Disease Overview
4.1 Etiology and Pathophysiology
4.1.1 Etiology
4.1.2 Pathophysiology
4.2 Classification or Staging Systems
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
5.4.3 Diagnosed Prevalent Cases of CKD Anemia and Diagnosed Prevalent Cases of CKD Anemia by Stage
5.4.4 Diagnosed Prevalent Cases of CKD Anemia Based on Dialysis Dependency
5.4.5 Diagnosed Prevalent Cases of CKD Anemia Based on Cause of Anemia
5.5 Epidemiological Forecast for CKD Anemia (2019-2029)
5.5.1 Diagnosed Prevalent Cases of CKD Anemia
5.5.2 Age-Specific Diagnosed Prevalent Cases of CKD Anemia
5.5.3 Sex-Specific Diagnosed Prevalent Cases of CKD Anemia
5.5.4 Diagnosed Prevalent Cases of CKD Anemia by Stage
5.5.5 Diagnosed Prevalent Cases of CKD Anemia Based on Dialysis Dependency
5.5.6 Diagnosed Prevalent Cases of CKD Anemia Based on Cause of Anemia
5.6 Discussion
5.6.1 Epidemiological Forecast Insight
5.6.2 Coronavirus Disease 2019 Impact
5.6.3 Limitations of the Analysis
5.6.4 Strengths of the Analysis
6 Disease Management
6.1 Diagnosis and Treatment Overview
6.1.1 Erythropoiesis-stimulating agents (ESAs).
6.1.2 Iron Supplementation
6.2 US
6.3 5EU
6.4 Japan
6.5 China
7 Competitive Assessment
7.1 Overview
8 Unmet Needs and Opportunity Assessment
8.1 Overview
8.2 Safer Therapies that Avoid Overshooting Hb Targets
8.3 Alternative Therapies for Patients Resistant to ESAs
8.4 Therapies with Improved Route of Administration
8.5 Further Defining Appropriate Target Hb Levels
9 Pipeline Assessment
9.1 Overview
9.2 Promising Drugs in Clinical Development
9.2.1 Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors (HIF-PHI)
10 Current and Future Players
10.1 Overview
10.2 Trends in Corporate Strategy
10.3 Amgen
10.4 Johnson & Johnson
10.5 Roche
10.6 Pfizer
10.7 Vifor Pharma
10.8 FibroGen
10.9 Akebia
10.10 AMAG Pharmaceuticals
10.11 Shield Therapeutics
10.12 Rockwell
10.13 GlaxoSmithKline
10.14 Bayer
10.15 JCR Pharmaceuticals
11 Market Outlook
11.1 Global Markets
11.1.1 Forecast
11.1.2 Drivers and Barriers - Global Issues
11.2 US
11.2.1 Forecast
11.2.2 Key Events
11.2.3 Drivers and Barriers
11.3 5EU
11.3.1 Forecast
11.3.2 Key Events
11.3.3 Drivers and Barriers
11.4 Japan
11.4.1 Forecast
11.4.2 Key Events
11.4.3 Drivers and Barriers
11.5 China
11.5.1 Forecast
11.5.2 Key Events
11.5.3 Drivers and Barriers
12 Appendix
List of Tables
Table 1: CKD Anemia: Key Metrics in the 8MM
Table 2: Stages of CKD
Table 3: Risk Factors and Comorbidities for CKD Anemia
Table 4: Treatment Guidelines for CKD Anemia
Table 5: Country Profile - US
Table 6: Country Profile - 5EU
Table 7: Country Profile - Japan
Table 8: Country Profile - China
Table 9: Leading ESA Treatments in CKD Anemia, 2021
Table 10: Amgen’s CKD Anemia Portfolio Assessment, 2021
Table 11: J&J’s CKD Anemia Portfolio Assessment, 2021
Table 12: Roche’s CKD Anemia Portfolio Assessment, 2021
Table 13: Pfizer’s CKD Anemia Portfolio Assessment, 2021
Table 14: Vifor Pharma’s Portfolio Assessment
Table 15: FibroGen’s CKD Anemia Portfolio Assessment, 2021
Table 16: Akebia’s CKD Anemia Portfolio Assessment, 2021
Table 17: AMAG’s CKD Anemia Portfolio Assessment, 2021
Table 18: Shield Therapeutics CKD Anemia Portfolio Assessment, 2021
Table 19: Rockwell CKD Anemia Portfolio Assessment, 2021
Table 20: GlaxoSmithKline’s CKD Anemia Portfolio Assessment, 2021
Table 21: Bayer’s CKD Anemia Portfolio Assessment, 2021
Table 22: JCR Pharmaceuticals’ CKD Anemia Portfolio Assessment, 2021
Table 23: CKD Anemia Market - Global Drivers and Barriers, 2019-2029
Table 24: Key Events Impacting Sales for CKD Anemia in the US, 2019-2029
Table 25: CKD Anemia Market - Drivers and Barriers in the US, 2019-2029
Table 26: Key Events Impacting Sales for CKD Anemia in the 5EU, 2019-2029
Table 27: CKD Anemia Market - Drivers and Barriers in the 5EU, 2019-2029
Table 28: Key Events Impacting Sales for CKD Anemia in Japan, 2019-2029
Table 29: CKD Anemia Market - Drivers and Barriers in Japan, 2019-2029
Table 30: Key Events Impacting Sales for CKD Anemia in China, 2019-2029
Table 31: CKD Anemia Market - Drivers and Barriers in China, 2019-2029
Table 32: Key Historical and Projected Launch Dates for CKD Anemia
Table 33: Key Historical and Projected Patent Expiry Dates for CKD Anemia
Table 34: High-Prescribing Physicians (non-KOLs) Surveyed, By Country
List of Figures
Figure 1: Global Sales Forecast by Country for CKD Anemia in 2019 and 2029
Figure 2: Analysis of the Company Portfolio Gap in CKD Anemia During the Forecast Period
Figure 3: Competitive Assessment of the HIF-PHIs that the Publisher Expects to Be Licensed for the Treatment of CKD Anemia During the Forecast Period
Figure 4: Mechanisms of CKD Anemia
Figure 5: 8MM, Diagnosed Prevalence of CKD Anemia, Men and Women, %, Ages ≥18 Years, 2019
Figure 6: 8MM, Sources Used and Not Used to Forecast the Diagnosed Prevalent Cases of CKD Anemia, Diagnosed Prevalent Cases of CKD Anemia by Stage, and Diagnosed Prevalent Cases of CKD Anemia Based on Dialysis Dependence
Figure 7: 8MM, Sources Used to Forecast the Diagnosed Prevalent Cases of CKD Anemia Based on Cause of Anemia
Figure 8: 8MM, Diagnosed Prevalent Cases of CKD Anemia, N, Both Sexes, Ages ≥18 Years, 2019
Figure 9: 8MM, Diagnosed Prevalent Cases of CKD Anemia by Age, N, Both Sexes, 2019
Figure 10: 8MM, Diagnosed Prevalent Cases of CKD Anemia by Sex, N, Ages ≥18 Years, 2019
Figure 11: 8MM, Diagnosed Prevalent Cases of CKD Anemia by Stage, N, Both Sexes, Ages ≥18 Years, 2019
Figure 12: 8MM, Diagnosed Prevalent Cases of CKD Anemia Based on Dialysis Dependence, N, Both Sexes, Ages ≥18 Years, 2019
Figure 13: 8MM, Diagnosed Prevalent Cases of CKD Anemia Based on Cause of Anemia, N, Both Sexes, Ages ≥18 Years, 2019
Figure 14: Unmet Needs and Opportunities in CKD Anemia
Figure 15: Overview of the Development Pipeline in CKD Anemia
Figure 16: Key Phase III Trials for the HIF-PHIs that the Publisher Expects to be Licensed for CKD Anemia in the 8MM During the Forecast Period
Figure 17: Competitive Assessment of HIF-PHIs that the Publisher Expects to be Licensed for the Treatment of CKD Anemia During the Forecast Period
Figure 18: Physicians Reporting Degree of Negative Impact of PRO2TECT Trial Results on Vadadustat Future Clinical and Market Potential
Figure 19: Analysis of the Company Portfolio Gap in CKD Anemia During the Forecast Period
Figure 20: Global (8MM) Sales Forecast by Country for CKD Anemia in 2019 and 2029
Figure 21: Global (8MM) Sales Forecast by Class for CKD Anemia in 2019 and 2029
Figure 22: Sales Forecast by Class for CKD Anemia in the US in 2019 and 2029
Figure 23: Sales Forecast by Class for CKD Anemia in the 5EU in 2019 and 2029
Figure 24: Sales Forecast by Class for CKD Anemia in Japan in 2019 and 2029
Figure 25: Sales Forecast by Class for CKD Anemia in China in 2019 and 2029
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- AMAG Pharmaceuticals
- American Regent
- Amgen
- Astellas
- AstraZeneca
- Bayer
- FibroGen
- GlaxoSmithKline
- Johnson & Johnson
- Kyowa Kirin
- Mitsubishi Tanabe Pharma
- Norgine BV
- Pfizer
- Roche
- Rockwell Medical
- Shield Therapeutics
- Vifor Pharma
