CONTENTS

8 FORECAST: BLADDER CANCER (Published on 04 July 2017)

8 OVERVIEW

9 EXECUTIVE SUMMARY

10 MARKET OVERVIEW AND TRENDS

22 MARKET DEFINITION AND METHODOLOGY

28 BAVENCIO (AVELUMAB)

33 CYRAMZA (RAMUCIRUMAB)

38 ERDAFITINIB

43 IMFINZI (DURVALUMAB)

48 KEYTRUDA (PEMBROLIZUMAB)

53 OPDIVO (NIVOLUMAB)

58 TECENTRIQ (ATEZOLIZUMAB)

63 PRIMARY RESEARCH METHODOLOGY

65 TREATMENT: BLADDER CANCER (Published on 05 June 2017)

65 OVERVIEW

66 EXECUTIVE SUMMARY

67 PRIMARY RESEARCH METHODOLOGY

69 DISEASE DEFINITION AND DIAGNOSIS

76 PATIENT SEGMENTATION

79 CURRENT TREATMENT OPTIONS

84 PRESCRIBING TRENDS

102 EPIDEMIOLOGY: BLADDER CANCER (Published on 19 July 2018)

102 OVERVIEW

104 DISEASE BACKGROUND

107 METHODOLOGY

116 FORECAST

121 BIBLIOGRAPHY

124 MARKETED DRUGS: BLADDER CANCER (Published on 04 July 2017)

124 OVERVIEW

125 EXECUTIVE SUMMARY

126 PRODUCT OVERVIEW

127 PRODUCT PROFILE: BAVENCIO

136 PRODUCT PROFILE: IMFINZI

146 PRODUCT PROFILE: KEYTRUDA

157 PRODUCT PROFILE: OPDIVO

167 PRODUCT PROFILE: TECENTRIQ

179 PIPELINE: BLADDER CANCER (Published on 04 July 2017)

179 OVERVIEW

180 EXECUTIVE SUMMARY

181 CLINICAL PIPELINE OVERVIEW

182 CLINICAL TRIAL DESIGN

185 KEY PIPELINE INTRAVESICAL THERAPIES

190 ADDITIONAL PHARMA INTELLIGENCE PIPELINE RESOURCES

191 PRODUCT PROFILE (LATE STAGE): ERDAFITINIB

LIST OF FIGURES
11 Figure 1: Bladder cancer market value in the US, Japan, and five major EU markets, by country, 2016-25

14 Figure 2: Bladder cancer market value in the US, Japan, and five major EU markets, by drug class, 2016-25

16 Figure 3: Sales of PD-1/PD-L1 inhibitors for bladder cancer in the US, Japan, and five major EU markets, by brand, 2016-25

19 Figure 4: Sales of Cyramza and erdafitinib for bladder cancer in the US, Japan, and five major EU markets, by brand, 2016-25

23 Figure 5: Patient-based forecast methodology for bladder cancer

25 Figure 6: Price sources and calculations, by country

29 Figure 7: Bavencio sales for bladder cancer in the US, Japan, and five major EU markets, by country, 2016-25

34 Figure 8: Cyramza sales for bladder cancer in the US, Japan, and five major EU markets, by country, 2016-25

39 Figure 9: Erdafitinib sales for bladder cancer in the US, Japan, and five major EU markets, by country, 2016-25

44 Figure 10: Imfinzi sales for bladder cancer in the US, Japan, and five major EU markets, by country, 2016-25

49 Figure 11: Keytruda sales for bladder cancer in the US, Japan, and five major EU markets, by country, 2016-25

54 Figure 12: Opdivo sales for bladder cancer in the US, Japan, and five major EU markets, by country, 2016-25

59 Figure 13: Tecentriq sales for bladder cancer in the US, Japan, and five major EU markets, by country, 2016-25

77 Figure 14: Distribution of bladder cancer patients across the US, Japan, and five major EU markets, by stage and country

84 Figure 15: Percentage of NMIBC patients who receive each type of treatment, by country

86 Figure 16: Top three intravesical therapies for NMIBC, by country

87 Figure 17: Percentage of MIBC patients who receive each type of treatment, by country

88 Figure 18: MIBC patients treated with cystectomy and systemic therapy who receive adjuvant chemotherapy, neoadjuvant chemotherapy, or both, by country

89 Figure 19: Top three regimens used in the neoadjuvant treatment of MIBC patients, by country

90 Figure 20: Top three regimens used in the adjuvant treatment of MIBC patients, by country

91 Figure 21: Percentage of Stage IV bladder cancer patients who receive each treatment type, by country

92 Figure 22: Top three regimens used in the first-line treatment of Stage IV bladder cancer patients, by country

94 Figure 23: Top three regimens used for second-line treatment of Stage IV bladder cancer patients, by country

96 Figure 24: Percentage of local relapse bladder cancer patients who receive each treatment type, by country

97 Figure 25: Top three regimens used for first-line treatment of local relapse bladder cancer, by country

98 Figure 26: Percentage of distant relapse bladder cancer patients who receive each treatment type, by country

99 Figure 27: Top three regimens used for first-line treatment of distant relapse bladder cancer, by country

120 Figure 28: Trends in incident cases of bladder cancer in the US, Japan, and five major EU markets, by country, 2017-37

131 Figure 29: Bavencio for urothelial bladder cancer - SWOT analysis

132 Figure 30: Datamonitor Healthcare's drug assessment summary for Bavencio in urothelial bladder cancer

133 Figure 31: Datamonitor Healthcare's drug assessment summary for Bavencio in urothelial bladder cancer

141 Figure 32: Imfinzi for urothelial bladder cancer - SWOT analysis

142 Figure 33: Datamonitor Healthcare's drug assessment summary for Imfinzi in urothelial bladder cancer

143 Figure 34: Datamonitor Healthcare's drug assessment summary for Imfinzi in urothelial bladder cancer

151 Figure 35: Keytruda for urothelial bladder cancer - SWOT analysis

152 Figure 36: Datamonitor Healthcare's drug assessment summary for Keytruda in urothelial bladder cancer

153 Figure 37: Datamonitor Healthcare's drug assessment summary for Keytruda in urothelial bladder cancer

161 Figure 38: Opdivo for urothelial bladder cancer - SWOT analysis

162 Figure 39: Datamonitor Healthcare's drug assessment summary for Opdivo in urothelial bladder cancer

163 Figure 40: Datamonitor Healthcare's drug assessment summary for Opdivo in urothelial bladder cancer

173 Figure 41: Tecentriq for urothelial bladder cancer - SWOT analysis

174 Figure 42: Datamonitor Healthcare's drug assessment summary for Tecentriq in urothelial bladder cancer

175 Figure 43: Datamonitor Healthcare's drug assessment summary for Tecentriq in urothelial bladder cancer

194 Figure 44: Erdafitinib for urothelial bladder cancer - SWOT analysis

195 Figure 45: Datamonitor Healthcare's drug assessment summary for erdafitinib in urothelial bladder cancer

196 Figure 46: Datamonitor Healthcare's drug assessment summary for erdafitinib in urothelial bladder cancer

LIST OF TABLES
12 Table 1: Bladder cancer market value in the US, Japan, and five major EU markets, by country ($m), 2016-25

15 Table 2: Bladder cancer market value in the US, Japan, and five major EU markets, by drug class ($m), 2016-25

17 Table 3: Sales of PD-1/PD-L1 inhibitors for bladder cancer in the US, Japan, and five major EU markets, by brand ($m), 2016-25

20 Table 4: Sales of Cyramza and erdafitinib for bladder cancer in the US, Japan, and five major EU markets, by brand ($m), 2016-25

22 Table 5: Summary of drug classes and molecules in Datamonitor Healthcare's bladder cancer forecast, 2016?25

25 Table 6: Exchange rates used for calculating prices

26 Table 7: Patent expiry dates for key marketed brands in bladder cancer in the US, Japan, and five major EU markets, 2016-25

27 Table 8: Estimated launch dates of key pipeline products and marketed brands in bladder cancer in the US, Japan, and five major EU markets, 2016-25

30 Table 9: Bavencio sales for bladder cancer in the US, Japan, and five major EU markets, by country ($m), 2016-25

32 Table 10: Bavencio patient numbers for bladder cancer in the US, Japan, and five major EU markets, by country, 2016-25

35 Table 11: Cyramza sales for bladder cancer in the US, Japan, and five major EU markets, by country ($m), 2016-25

37 Table 12: Cyramza patient numbers for bladder cancer in the US, Japan, and five major EU markets, by country, 2016-25

40 Table 13: Erdafitinib sales for bladder cancer in the US, Japan, and five major EU markets, by country ($m), 2016-25

42 Table 14: Erdafitinib patient numbers for bladder cancer in the US, Japan, and five major EU markets, by country, 2016-25

45 Table 15: Imfinzi sales for bladder cancer in the US, Japan, and five major EU markets, by country ($m), 2016-25

47 Table 16: Imfinzi patient numbers for bladder cancer in the US, Japan, and five major EU markets, by country, 2016-25

50 Table 17: Keytruda sales for bladder cancer in the US, Japan, and five major EU markets, by country ($m), 2016-25

52 Table 18: Keytruda patient numbers for bladder cancer in the US, Japan, and five major EU markets, by country, 2016-25

55 Table 19: Opdivo sales for bladder cancer in the US, Japan, and five major EU markets, by country ($m), 2016-25

57 Table 20: Opdivo patient numbers for bladder cancer in the US, Japan, and five major EU markets, by country, 2016-25

60 Table 21: Tecentriq sales for bladder cancer in the US, Japan, and five major EU markets, by country ($m), 2016-25

62 Table 22: Tecentriq patient numbers for bladder cancer in the US, Japan, and five major EU markets, by country, 2016-25

63 Table 23: Medical oncologists and urologists surveyed for the urothelial bladder cancer primary research study, 2016

67 Table 24: Medical oncologists and urologists surveyed for the urothelial bladder cancer primary research study, 2016

72 Table 25: Bladder cancer five-year survival rates in the US, by stage at diagnosis

76 Table 26: TNM classification of bladder cancer, by stage at diagnosis

80 Table 27: Leading treatments for bladder cancer

105 Table 28: T staging within the TNM classification of bladder cancer

108 Table 29: International Classification of Diseases topography codes for bladder cancer

111 Table 30: Cancer registry databases used as a source of bladder cancer incidence data, by country

114 Table 31: Sources of survival data used to estimate bladder cancer prevalence, by country

115 Table 32: Validation of forecast estimates against benchmark estimates, by country

117 Table 33: Incident cases of bladder cancer in the US, Japan, and five major EU markets, by country, 2017-37

126 Table 34: Key marketed products for bladder cancer

128 Table 35: Bavencio drug profile

129 Table 36: Bavencio pivotal trial data in urothelial bladder cancer

130 Table 37: Bavencio ongoing late-phase trials in urothelial bladder cancer

137 Table 38: Imfinzi drug profile

138 Table 39: Imfinzi pivotal trial data in urothelial bladder cancer

139 Table 40: Imfinzi ongoing late-phase trials in urothelial bladder cancer

147 Table 41: Keytruda drug profile

148 Table 42: Keytruda pivotal trial data in urothelial bladder cancer

149 Table 43: Keytruda ongoing late-phase trials in urothelial bladder cancer

150 Table 44: Keytruda early-phase data in urothelial bladder cancer

158 Table 45: Opdivo drug profile

159 Table 46: Opdivo pivotal trial data in urothelial bladder cancer

160 Table 47: Opdivo ongoing late-phase trials in urothelial bladder cancer

168 Table 48: Tecentriq drug profile

170 Table 49: Tecentriq pivotal trial data in urothelial bladder cancer

171 Table 50: Tecentriq ongoing late-phase trials in urothelial bladder cancer

181 Table 51: Late-phase pipeline products in development for urothelial bladder cancer

186 Table 52: BC-819 drug profile

187 Table 53: Instiladrin drug profile

188 Table 54: Vicinium drug profile

192 Table 55: Erdafitinib drug profile

193 Table 56: Key erdafitinib Phase II trial in urothelial bladder cancer
193 Table 57: Erdafitinib early-phase data in urothelial bladder cancer