CONTENTS
7 OVERVIEW
7 Latest key takeaways
10 DISEASE BACKGROUND
10 Definition
10 Patient segmentation
13 TREATMENT
13 Major treatment guidelines
19 KDIGO guidelines
21 JSDT guidelines
25 EPIDEMIOLOGY
25 Prevalence methodology
28 MARKETED DRUGS
38 PIPELINE DRUGS
44 KEY REGULATORY EVENTS
44 Japan Nods Include Global Firsts For Duvroq, Vafseo And First Local Biosimilar Humira
44 Roxadustat Among New Filings At EMA
44 Court Says FibroGen’s UK Roxadustat Patents Are Invalid
45 PROBABILITY OF SUCCESS
47 CLINICAL TRIAL LANDSCAPE
49 Sponsors by status
49 Sponsors by phase
50 Recent events
52 DRUG ASSESSMENT MODEL
52 Erythropoiesis-stimulating agents
54 Iron products
57 HIF-PH inhibitors
62 Expected Medicare dialysis reimbursement for HIF-PH inhibitors
63 MARKET DYNAMICS
66 FUTURE TRENDS
67 CONSENSUS FORECASTS
69 RECENT EVENTS AND ANALYST OPINION
69 Vadadustat for Anemia Due to Chronic Renal Failure, Dialysis-Independent (October 22, 2020)
70 Vadadustat for Anemia Due to Chronic Renal Failure, Dialysis-Independent (September 3, 2020)
73 Roxadustat for Anemia Due to Chronic Renal Failure, Dialysis-Independent (June 8, 2020)
75 Vadadustat for Anemia Due to Chronic Renal Failure, Dialysis-Dependent and Independent (May 5, 2020)
78 Roxadustat for Anemia Due to Chronic Renal Failure, Dialysis-Dependent and Independent (May 9, 2019)
82 KEY UPCOMING EVENTS
83 KEY OPINION LEADER INSIGHTS
83 ESAs
83 HIF stabilizers
84 Pricing and reimbursement
86 UNMET NEEDS
86 Rankings of unmet needs in anemia in CKD
89 BIBLIOGRAPHY
92 Prescription information
94 APPENDIX
LIST OF FIGURES
11 Figure 1: WHO definition of anemia and segmentation by severity
11 Figure 2: Japan – JSDT definition of anemia
12 Figure 3: Rates of the stages of anemia among adult CKD patients seen by nephrologists
15 Figure 4: CV outcomes in US prescribing information of ESAs
17 Figure 5: US dialysis patients: change in ESA usage and dosing, as well as Hb levels
20 Figure 6: KDIGO guidelines
22 Figure 7: JSDT guidelines
22 Figure 8: JSDT guidelines [continued]
23 Figure 9: JSDT guidelines [continued]
27 Figure 10: Trends in prevalent cases of anemia in CKD, 2018–27
38 Figure 11: Overview of pipeline drugs for anemia in CKD in the US
38 Figure 12: Pipeline drugs for anemia in CKD, by company
39 Figure 13: Pipeline drugs for anemia in CKD, by drug type
39 Figure 14: Pipeline drugs for anemia in CKD, by classification
45 Figure 15: Probability of success in the anemia in CKD, dialysis-dependent pipeline
46 Figure 16: Probability of success in the anemia in CKD, dialysis-independent pipeline
47 Figure 17: Clinical trials in anemia
47 Figure 18: Top 10 drugs for clinical trials in anemia
48 Figure 19: Top 10 companies for clinical trials in anemia
48 Figure 20: Trial locations in anemia
49 Figure 21: Anemia trials status
50 Figure 22: Anemia trials sponsors, by phase
52 Figure 23: Datamonitor Healthcare’s drug assessment summary for anemia in CKD
63 Figure 24: Market dynamics in anemia in CKD: erythropoiesis-stimulating agents
64 Figure 25: Market dynamics in anemia in CKD: iron products
65 Figure 26: Market dynamics in anemia in CKD: HIF-PH inhibitors
66 Figure 27: Future trends in anemia in CKD
70 Figure 28: Vadadustat for Anemia Due to Chronic Renal Failure, Dialysis-Independent (October 22, 2020)
73 Figure 29: Vadadustat for Anemia Due to Chronic Renal Failure, Dialysis-Independent (September 3, 2020)
75 Figure 30: Roxadustat for Anemia Due to Chronic Renal Failure, Dialysis-Independent (June 8, 2020)
78 Figure 31: Vadadustat for Anemia Due to Chronic Renal Failure, Dialysis-Dependent and -Independent (May 5, 2020)
81 Figure 32: Roxadustat for Anemia Due to Chronic Renal Failure, Dialysis-Dependent and -Independent (May 9, 2019)
82 Figure 33: Key upcoming events in anemia in CKD, dialysis-dependent
82 Figure 34: Key upcoming events in anemia in CKD, dialysis-independent
87 Figure 35: Average scores of unmet needs in the US (n=20)
88 Figure 36: Average scores of unmet needs in Europe (n=21)
LIST OF TABLES
17 Table 1: US non-dialysis CKD patients: percentage on ESAs
26 Table 2: Prevalent cases of anemia in CKD, 2018–27
29 Table 3: Marketed drugs for anemia in CKD, dialysis-dependent
34 Table 4: Marketed drugs for anemia in CKD, dialysis-independent
40 Table 5: Pipeline drugs for anemia in CKD, dialysis-dependent, in the US
42 Table 6: Pipeline drugs for anemia in CKD, dialysis-independent, in the US
67 Table 7: Historical global sales, by drug ($m), 2015–19
68 Table 8: Forecasted global sales, by drug ($m), 2020–24
69 Table 9: Vadadustat for Anemia Due to Chronic Renal Failure, Dialysis-Independent (October 22, 2020)
71 Table 10: Vadadustat for Anemia Due to Chronic Renal Failure, Dialysis-Independent (September 3, 2020)
73 Table 11: Roxadustat for Anemia Due to Chronic Renal Failure, Dialysis-Independent (June 8, 2020)
76 Table 12: Vadadustat for Anemia Due to Chronic Renal Failure, Dialysis-Dependent and Independent (May 5, 2020)
79 Table 13: Roxadustat for Anemia Due to Chronic Renal Failure, Dialysis-Dependent and Independent (May 9, 2019)
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