CONTENTS

9 FORECAST: DIABETIC NEPHROPATHY (Published on 17 February 2017)
9 EXECUTIVE SUMMARY
11 MARKET OVERVIEW AND TRENDS
24 MARKET DEFINITION AND METHODOLOGY
29 ATRASENTAN
32 FARXIGA (DAPAGLIFLOZIN) FRANCHISE
35 FINERENONE
38 INVOKANA (CANAGLIFLOZIN) FRANCHISE
41 JARDIANCE (EMPAGLIFLOZIN) FRANCHISE
44 PRIMARY RESEARCH METHODOLOGY
46 TREATMENT: DIABETIC NEPHROPATHY (Published on 05 February 2018)
46 EXECUTIVE SUMMARY
48 PRIMARY RESEARCH METHODOLOGY
50 DISEASE DEFINITION AND DIAGNOSIS
57 PATIENT SEGMENTATION
58 GUIDELINE RECOMMENDATIONS
68 PRESCRIBING TRENDS
89 EPIDEMIOLOGY: DIABETIC NEPHROPATHY (Published on 05 February 2018)
89 EXECUTIVE SUMMARY
91 DISEASE BACKGROUND
93 METHODOLOGY
103 FORECAST
108 BIBLIOGRAPHY
111 APPENDIX: ADDITIONAL SOURCES
112 MARKETED DRUGS: DIABETIC NEPHROPATHY (Published on 02 February 2018)
112 EXECUTIVE SUMMARY
113 ACE INHIBITORS
118 ANGIOTENSIN II RECEPTOR BLOCKERS
125 PIPELINE: DIABETIC NEPHROPATHY (Published on 02 February 2018)
125 EXECUTIVE SUMMARY
128 CLINICAL PIPELINE OVERVIEW
129 TARGET PRODUCT PROFILE
135 CLINICAL TRIAL DESIGN
138 PRODUCT PROFILE (LATE STAGE): FARXIGA
153 PRODUCT PROFILE (LATE STAGE): INVOKANA
167 PRODUCT PROFILE (LATE STAGE): JARDIANCE
179 PRODUCT PROFILE (LATE STAGE): ATRASENTAN
192 PRODUCT PROFILE (LATE STAGE): FINERENONE

LIST OF FIGURES
11 Figure 1: Diabetic nephropathy novel treatment market sales across the US, Japan, and five major EU markets, by country, 2016-25
16 Figure 2: Diabetic nephropathy sales of specific drug franchises across the US, Japan, and five major EU markets, 2025
20 Figure 3: Diabetic nephropathy novel treatment market sales in the US, 2016-25
21 Figure 4: Diabetic nephropathy novel treatment market sales in the five major EU markets, by country, 2016-25
26 Figure 5: Methodology flow for diabetic nephropathy
27 Figure 6: Price sources and calculations, by country
30 Figure 7: Atrasentan sales for diabetic nephropathy across the US, Japan, and five major EU markets, by country, 2016-25
33 Figure 8: Farxiga franchise sales for diabetic nephropathy across the US, Japan, and five major EU markets, by country, 2016-25
36 Figure 9: Finerenone sales for diabetic nephropathy across the US, Japan, and five major EU markets, by country 2016-25
39 Figure 10: Invokana franchise sales for diabetic nephropathy across the US, Japan, and five major EU markets, by country, 2016-25
42 Figure 11: Jardiance franchise sales for diabetic nephropathy across the US, Japan, and five major EU markets, by country, 2016-25
53 Figure 12: Percentage of incident end-stage renal disease patients with diabetes as the primary cause
57 Figure 13: Patient segmentation by albuminuria and glomerular filtration rate, with US prevalence and risk of kidney outcomes
70 Figure 14: Type 2 diabetic patients receiving antihypertensives for treatment of diabetic nephropathy according to stage of renal impairment, by country
71 Figure 15: Type 2 diabetic patients receiving RAAS inhibitors for treatment of diabetic nephropathy according to stage of renal impairment, by country
72 Figure 16: Usage of ACE inhibitors, ARBs, and renin inhibitors for diabetic nephropathy, as a percentage of antihypertensives, among type 2 diabetics, by country
73 Figure 17: Antihypertensive monotherapy versus combination therapy used to treat diabetic nephropathy in type 1 and type 2 diabetics, by country
74 Figure 18: Antihypertensive monotherapy vs combination therapy used to treat diabetic nephropathy in type 2 diabetics, b renal impairment stage and country
75 Figure 19: Percentage of type 2 diabetic patients receiving antidiabetics according to stage of renal impairment, by country
76 Figure 20: Percentage of type 2 diabetic patients receiving metformin/selected fixed-dose combinations according to stage of renal impairment, by country
77 Figure 21: Percentage of type 2 diabetic patients receiving DPP-IV inhibitors (including metformin fixed-dose combinations), by stage of renal impairment and country
78 Figure 22: Ratio of prescribing of Januvia and Tradjenta in each stage of renal impairment compared to prescribing in patients without diabetic nephropathy, by country
79 Figure 23: Percentage of type 2 diabetic patients receiving SGLT-2 inhibitors (excluding fixed-dose combinations) according to stage of renal impairment, by country
81 Figure 24: Percentage of type 2 diabetic patients receiving GLP-1 agonists and fixed-ratio combinations with insulin, by stage of renal impairment and country
82 Figure 25: Percentage of type 2 diabetic patients receiving any insulin according to stage of renal impairment, by country
83 Figure 26: Percentage of type 2 diabetic patients receiving any insulin according to stage of renal impairment, PCPs only, by country
84 Figure 27: Percentage of type 2 diabetic patients receiving sulfonylureas according to stage of renal impairment, by country
85 Figure 28: Compliance rates of type 2 diabetics with antidiabetic medications according to renal impairment stage, by country
107 Figure 29: Trends in total prevalent cases of diabetic nephropathy in the US, Japan, and five major EU markets, by country, 2017-37
143 Figure 30: Farxiga for diabetic nephropathy - SWOT analysis
144 Figure 31: Datamonitor Healthcare's drug assessment summary for Farxiga in diabetic nephropathy
145 Figure 32: Datamonitor Healthcare's drug assessment summary for Farxiga in diabetic nephropathy
157 Figure 33: Invokana for diabetic nephropathy - SWOT analysis
158 Figure 34: Datamonitor Healthcare's drug assessment summary for Invokana in diabetic nephropathy
159 Figure 35: Datamonitor Healthcare's drug assessment summary for Invokana in diabetic nephropathy
169 Figure 36: Jardiance for diabetic nephropathy - SWOT analysis
170 Figure 37: Datamonitor Healthcare's drug assessment summary for Jardiance in diabetic nephropathy
171 Figure 38: Datamonitor Healthcare's drug assessment summary for Jardiance in diabetic nephropathy
185 Figure 39: Atrasentan for diabetic nephropathy - SWOT analysis
186 Figure 40: Datamonitor Healthcare's drug assessment summary for atrasentan in diabetic nephropathy
187 Figure 41: Datamonitor Healthcare's drug assessment summary for atrasentan in diabetic nephropathy
199 Figure 42: Finerenone for diabetic nephropathy - SWOT analysis
200 Figure 43: Datamonitor Healthcare's drug assessment summary for finerenone in diabetic nephropathy
201 Figure 44: Datamonitor Healthcare's drug assessment summary for finerenone in diabetic nephropathy

LIST OF TABLES
13 Table 1: Patient self-reported cardiovascular disease in the diabetic nephropathy and general diabetes populations in the US
24 Table 2: Summary of drug classes and molecules included in the diabetic nephropathy patient-based forecast
25 Table 3: Patent expiries occurring in diabetic nephropathy during the forecast period, 2016-25
28 Table 4: Exchange rates used for calculating prices
31 Table 5: Atrasentan sales for diabetic nephropathy across the US, Japan, and five major EU markets, by country ($m), 2016-25
34 Table 6: Farxiga franchise sales for diabetic nephropathy across the US, Japan, and five major EU markets, by country ($m), 2016-25
37 Table 7: Finerenone sales for diabetic nephropathy across the US, Japan, and five major EU markets, by country ($m), 2016-25
40 Table 8: Invokana franchise sales for diabetic nephropathy across the US, Japan, and five major EU markets, by country ($m), 2016-25
43 Table 9: Jardiance franchise sales for diabetic nephropathy across the US, Japan, and five major EU markets, by country ($m), 2016-25
44 Table 10: Diabetologists, endocrinologists, and nephrologists surveyed for the diabetic nephropathy primary research study, 2016
48 Table 11: Primary care physicians, diabetologists, and endocrinologists surveyed for the diabetic nephropathy primary research study, 2017
59 Table 12: Guideline recommendations for blood pressure and glycemic control - kidney organizations
62 Table 13: Guideline recommendations for blood pressure and glycemic control - diabetes organizations
64 Table 14: Risk of cardiovascular death and end-stage renal disease according to albuminuria and eGFR (% per year)
69 Table 15: Proportion of US patients with diabetic nephropathy who are treated with antihypertensives/RAAS inhibitors, by renal stage
94 Table 16: Sources used for diabetic nephropathy analysis in the US, Japan, and five major EU markets, by country
101 Table 17: Age-standardized diabetic nephropathy prevalence proportions, by country
102 Table 18: Segmentation of diabetic nephropathy into chronic kidney disease stage
104 Table 19: Total prevalent cases of diabetic nephropathy in the US, Japan, and five major EU markets, by country, 2017-37
114 Table 20: ACE inhibitors class overview
119 Table 21: ARBs class overview
120 Table 22: Major ARB trials in type 2 diabetic nephropathy patients with severe albuminuria
128 Table 23: Phase III pipeline products in development for diabetic nephropathy
130 Table 24: Cozaar drug profile
132 Table 25: Cozaar pivotal trial data in diabetic nephropathy
139 Table 26: Farxiga drug profile
140 Table 27: Farxiga Phase III trial in chronic kidney disease, including diabetic nephropathy
141 Table 28: Farxiga Phase III trial in type 2 diabetes with cardiovascular disease or multiple risk factors (includes diabetic nephropathy patients)
142 Table 29: Farxiga Phase II/III trial on UACR and glycemic control in diabetic nephropathy
154 Table 30: Invokana drug profile
156 Table 31: Invokana Phase III trial in diabetic nephropathy
168 Table 32: Jardiance drug profile
180 Table 33: Atrasentan drug profile
182 Table 34: Atrasentan Phase III trial in diabetic nephropathy
184 Table 35: Atrasentan Phase IIb pooled results of 12-week studies in diabetic nephropathy
193 Table 36: Finerenone drug profile
194 Table 37: Finerenone Phase III trials in diabetic nephropathy
197 Table 38: Finerenone Phase IIb (ARTS-DN) results in diabetic nephropathy