Table of Contents (Forecast, Treatment, Epidemiology Datapacks included)

9 FORECAST: ACUTE LYMPHOBLASTIC LEUKEMIA (Published on 14 April 2016)

9 OVERVIEW

10 EXECUTIVE SUMMARY

11 MARKET OVERVIEW AND TRENDS

18 MARKET DEFINITION AND METHODOLOGY

23 BLINCYTO (BLINATUMOMAB)

26 CTL019

29 GLEEVEC (IMATINIB)

32 ICLUSIG (PONATINIB)

35 INOTUZUMAB OZOGAMICIN

38 JCAR015

41 MARQIBO (VINCRISTINE)

44 SPRYCEL (DASATINIB)

47 PRIMARY RESEARCH METHODOLOGY

49 TREATMENT: ACUTE LYMPHOBLASTIC LEUKEMIA (Published on 02 March 2016)

49 OVERVIEW

50 EXECUTIVE SUMMARY

51 PRIMARY RESEARCH METHODOLOGY

53 DISEASE DEFINITION AND DIAGNOSIS

56 PATIENT SEGMENTATION

57 COUNTRY TREATMENT TREES

58 CURRENT TREATMENT OPTIONS

63 PRESCRIBING TRENDS

78 FUTURE TREATMENT

79 EPIDEMIOLOGY: ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) (Published on 05 July 2018)

79 OVERVIEW

80 DISEASE BACKGROUND

83 METHODOLOGY

99 FORECAST

102 BIBLIOGRAPHY

105 MARKETED DRUGS: ACUTE LYMPHOBLASTIC LEUKEMIA (Published on 13 April 2016)

105 OVERVIEW

106 EXECUTIVE SUMMARY

107 PRODUCT OVERVIEW

109 PRODUCT PROFILE: BLINCYTO

119 PRODUCT PROFILE: GLEEVEC

125 PRODUCT PROFILE: ICLUSIG

132 PRODUCT PROFILE: SPRYCEL

139 PIPELINE: ACUTE LYMPHOBLASTIC LEUKEMIA (Published on 31 August 2017)

139 OVERVIEW

140 EXECUTIVE SUMMARY

141 CLINICAL PIPELINE OVERVIEW

146 LATEST ANALYST OPINION

148 APPENDIX

149 ADDITIONAL PHARMA INTELLIGENCE PIPELINE RESOURCES

150 PRODUCT PROFILE (LATE STAGE): CTL019

158 PRODUCT PROFILE (LATE STAGE): JCAR015

165 PRODUCT PROFILE (LATE STAGE): INOTUZUMAB OZOGAMICIN

LIST OF FIGURES
12 Figure 1: Total sales for acute lymphoblastic leukemia across the US, Japan, and five major EU markets, by country, 2015-24

13 Figure 2: Total branded tyrosine kinase inhibitor sales for acute lymphoblastic leukemia across the US, Japan, and five major EU markets, by country, 2015-24

14 Figure 3: Gleevec sales for acute lymphoblastic leukemia compared to imatinib generics sales across the US, Japan, and five major EU markets, 2015-24

15 Figure 4: Combined CAR-T therapy revenues for acute lymphoblastic leukemia across the US, Japan, and five major EU markets, by country, 2015-24

16 Figure 5: Sales of therapies approved for the treatment of Ph-negative acute lymphoblastic leukemia across the US, Japan, and five major EU markets, 2015-24

19 Figure 6: Patient-based forecast methodology for acute lymphoblastic leukemia

20 Figure 7: Price sources and calculations, by country

24 Figure 8: Blincyto sales for acute lymphoblastic leukemia across the US, Japan, and five major EU markets, by country, 2015-24

27 Figure 9: CTL019 sales for acute lymphoblastic leukemia across the US, Japan, and five major EU markets, by country, 2015-24

30 Figure 10: Gleevec sales for acute lymphoblastic leukemia across the US, Japan, and five major EU markets, by country, 2015-24

33 Figure 11: Iclusig sales for acute lymphoblastic leukemia across the US, Japan, and five major EU markets, by country, 2015-24

36 Figure 12: Inotuzumab ozogamicin sales for acute lymphoblastic leukemia across the US, Japan, and five major EU markets, by country, 2015-24

39 Figure 13: JCAR015 sales for acute lymphoblastic leukemia across the US, Japan, and five major EU markets, by country, 2015-24

42 Figure 14: Marqibo sales for acute lymphoblastic leukemia across the US, Japan, and five major EU markets, by country, 2015-24

45 Figure 15: Sprycel sales for acute lymphoblastic leukemia across the US, Japan, and five major EU markets, by country, 2015-24

56 Figure 16: Segmentation by age and Ph status of patients with acute lymphoblastic leukemia, by country

60 Figure 17: Proportion of Ph+ AYA (15-39 years) acute lymphoblastic leukemia patients at each stage of therapy, by country

61 Figure 18: Proportion of Ph+ adult (?40 years) acute lymphoblastic leukemia patients at each stage of therapy, by country

64 Figure 19: Percentage of Ph+ AYA acute lymphoblastic leukemia patients receiving each type of induction treatment regimen, by country

65 Figure 20: Percentage of Ph+ adult acute lymphoblastic leukemia patients receiving each type of induction treatment regimen, by country

66 Figure 21: Proportion of Ph+ acute lymphoblastic leukemia patients receiving stem cell transplant following complete response to induction therapy, by country

67 Figure 22: Percentage uptake of TKIs for post-stem cell transplant therapy in Ph+ AYA acute lymphoblastic leukemia patients, by country

68 Figure 23: Percentage uptake of TKIs for post-stem cell transplant therapy in Ph+ adult acute lymphoblastic leukemia patients, by country

69 Figure 24: Percentage of Ph+ AYA acute lymphoblastic leukemia patients receiving each type of consolidation treatment regimen, by country

70 Figure 25: Percentage of Ph+ adult acute lymphoblastic leukemia patients receiving each type of consolidation treatment regimen, by country

71 Figure 26: Percentage of Ph+ AYA acute lymphoblastic leukemia patients receiving each type of maintenance treatment regimen, by country

72 Figure 27: Percentage of Ph+ adult acute lymphoblastic leukemia patients receiving each type of maintenance treatment regimen, by country

74 Figure 28: Top three treatment regimens for relapse/refractory therapy in Ph+ AYA acute lymphoblastic leukemia patients, by country

75 Figure 29: Top three treatment regimens for relapse/refractory therapy in Ph+ adult acute lymphoblastic leukemia patients, by country

101 Figure 30: Trends in incident cases of ALL in the US, Japan, and five major EU markets, by country, 2017-37

108 Figure 31: Datamonitor Healthcare's drug assessment summary for marketed and late-stage pipeline drugs in acute lymphoblastic leukemia

113 Figure 32: Blincyto - SWOT analysis in acute lymphoblastic leukemia

114 Figure 33: Datamonitor Healthcare's drug assessment summary for Blincyto in acute lymphoblastic leukemia

115 Figure 34: Datamonitor Healthcare's drug assessment summary for Blincyto in acute lymphoblastic leukemia

121 Figure 35: Gleevec - SWOT analysis in acute lymphoblastic leukemia

122 Figure 36: Datamonitor Healthcare's drug assessment summary for Gleevec in acute lymphoblastic leukemia

123 Figure 37: Datamonitor Healthcare's drug assessment summary for Gleevec in acute lymphoblastic leukemia

128 Figure 38: Iclusig - SWOT analysis in acute lymphoblastic leukemia

129 Figure 39: Datamonitor Healthcare's drug assessment summary for Iclusig in acute lymphoblastic leukemia

130 Figure 40: Datamonitor Healthcare's drug assessment summary for Iclusig in acute lymphoblastic leukemia

135 Figure 41: Sprycel - SWOT analysis in acute lymphoblastic leukemia

136 Figure 42: Datamonitor Healthcare's drug assessment summary for Sprycel in acute lymphoblastic leukemia

137 Figure 43: Datamonitor Healthcare's drug assessment summary for Sprycel in acute lymphoblastic leukemia

153 Figure 44: SWOT analysis - CTL019 for acute lymphoblastic leukemia

154 Figure 45: Datamonitor Healthcare's drug assessment summary for CTL019 in acute lymphoblastic leukemia

155 Figure 46: Datamonitor Healthcare's drug assessment summary for CTL019 in acute lymphoblastic leukemia

156 Figure 47: Overview of CTL019 technology

161 Figure 48: SWOT analysis - JCAR015 for acute lymphoblastic leukemia

162 Figure 49: Datamonitor Healthcare's drug assessment summary for JCAR015 in acute lymphoblastic leukemia

163 Figure 50: Datamonitor Healthcare's drug assessment summary for JCAR015 in acute lymphoblastic leukemia

170 Figure 51: SWOT analysis - inotuzumab ozogamicin for acute lymphoblastic leukemia

171 Figure 52: Datamonitor Healthcare's drug assessment summary for inotuzumab ozogamicin in acute lymphoblastic leukemia

172 Figure 53: Datamonitor Healthcare's drug assessment summary for inotuzumab ozogamicin in acute lymphoblastic leukemia

LIST OF TABLES
18 Table 1: Summary of drug classes and molecules in Datamonitor Healthcare's acute lymphoblastic leukemia patient-based forecast

21 Table 2: Exchange rates used for calculating prices

21 Table 3: Patent expiry dates for key marketed brands in acute lymphoblastic leukemia in the US, Japan, and five major EU markets, 2015-24

22 Table 4: Estimated approval dates of key late-stage pipeline products in acute lymphoblastic leukemia in the US, Japan, and five major EU markets, 2015-24

25 Table 5: Blincyto sales for acute lymphoblastic leukemia across the US, Japan, and five major EU markets, by country ($m), 2015-24

28 Table 6: CTL019 sales for acute lymphoblastic leukemia across the US, Japan, and five major EU markets, by country ($m), 2015-24

31 Table 7: Gleevec sales for acute lymphoblastic leukemia across the US, Japan, and five major EU markets, by country ($m), 2015-24

34 Table 8: Iclusig sales for acute lymphoblastic leukemia across the US, Japan, and five major EU markets, by country ($m), 2015-24

37 Table 9: Inotuzumab ozogamicin sales for acute lymphoblastic leukemia across the US, Japan, and five major EU markets, by country ($m), 2015-24

40 Table 10: JCAR015 sales for acute lymphoblastic leukemia across the US, Japan, and five major EU markets, by country ($m), 2015-24

43 Table 11: Marqibo sales for acute lymphoblastic leukemia across the US, Japan, and five major EU markets, by country ($m), 2015-24

46 Table 12: Sprycel sales for acute lymphoblastic leukemia across the US, Japan, and five major EU markets, by country ($m), 2015-24

47 Table 13: Hematologists surveyed for the acute lymphoblastic leukemia primary research study, 2015

51 Table 14: Hematologists surveyed for the acute lymphoblastic leukemia primary research study, 2015

59 Table 15: Approved TKIs indicated for the treatment of adults with acute lymphoblastic leukemia

81 Table 16: WHO classification of ALL

87 Table 17: Cancer registry databases used as a source of ALL incidence data, by country

90 Table 18: Forecasting methodology for ALL incidence, by country and age group

93 Table 19: Proportions and sources used to segment incident ALL cases by immunophenotype

96 Table 20: Proportions used to segment incident ALL cases by chromosomal and molecular abnormality

98 Table 21: Sources of survival data used to estimate B-cell ALL prevalence, by country

100 Table 22: Incident cases of ALL in the US, Japan, and five major EU markets, by country, 2017-37

107 Table 23: Key marketed drugs for acute lymphoblastic leukemia

107 Table 24: Key marketed drugs for acute lymphoblastic leukemia, by approval date

110 Table 25: Blincyto drug profile

111 Table 26: Pivotal clinical trial data for Blincyto in acute lymphoblastic leukemia

112 Table 27: Blincyto ongoing late-phase clinical trials in acute lymphoblastic leukemia

120 Table 28: Gleevec drug profile

121 Table 29: Pivotal clinical trial data for Gleevec in acute lymphoblastic leukemia

126 Table 30: Iclusig drug profile

127 Table 31: Pivotal clinical trial data for Iclusig in acute lymphoblastic leukemia

133 Table 32: Sprycel drug profile

134 Table 33: Overview of pivotal trial data for Sprycel in acute lymphoblastic leukemia

141 Table 34: Phase III pipeline candidates under development for acute lymphoblastic leukemia

151 Table 35: CTL019 drug profile

152 Table 36: Overview of ongoing trials for CTL019 in acute lymphoblastic leukemia

152 Table 37: Overview of early-phase data for CTL019 in acute lymphoblastic leukemia

159 Table 38: JCAR015 drug profile

160 Table 39: Overview of ongoing trials for JCAR015 in acute lymphoblastic leukemia

160 Table 40: Overview of early-phase data for JCAR015 in acute lymphoblastic leukemia

166 Table 41: Inotuzumab ozogamicin drug profile for acute lymphoblastic leukemia
168 Table 42: Ongoing clinical trial development of inotuzumab ozogamicin in acute lymphoblastic leukemia