慢性骨髄性白血病：世界市場（医薬品市場予測及び分析～2022）...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 7
1.1 List of Tables 13
1.2 List of Figures 16
2 Introduction 18
2.1 Catalyst 18
2.2 Related Reports 18
2.3 Upcoming Related Reports 18
3 Disease Overview 19
3.1 Etiology and Pathophysiology 19
3.1.1 Etiology 19
3.1.2 Pathophysiology 20
3.1.3 Clinical Staging 22
3.1.4 Prognosis 23
3.1.5 Quality of Life 24
3.2 Symptoms 24
4 Epidemiology 26
4.1 Risk Factors and Co-morbidities 26
4.1.1 Exposure to ionizing radiation may not lead to the development of CML 26
4.1.2 Obesity and weight gain in adulthood play important roles in CML risk 27
4.2 Global and Historical Trends 27
4.2.1 Incidence 27
4.2.2 Prevalence and Survival 29
4.2.3 Mortality 29
4.3 Forecast Methodology 30
4.3.1 Sources Used 31
4.3.2 Forecast Assumptions and Methods, Incident Cases 33
4.3.3 Forecast Assumptions and Methods, Prevalent Cases 35
4.3.4 Sources Not Used 35
4.4 Epidemiological Forecast of Chronic Myeloid Leukemia (2012-2022) 36
4.4.1 Incident Cases of Chronic Myeloid Leukemia 36
4.4.2 Incident Cases of Chronic Myeloid Leukemia by Age Group 38
4.4.3 Incident Cases of Chronic Myeloid Leukemia by Sex 39
4.4.4 Age-Standardized Incidence Rates of Chronic Myeloid Leukemia 40
4.4.5 Incident Cases of Chronic Myeloid Leukemia with Ph+ 41
4.4.6 Incident Cases of Chronic Myeloid Leukemia by Phase at Diagnosis 42
4.4.7 Prevalent Cases of Chronic Myeloid Leukemia 43
4.5 Discussion 47
4.5.1 Epidemiological Forecast Insight 47
4.5.2 Limitations of the Analysis 48
4.5.3 Strengths of the Analysis 49
5 Disease Management 50
5.1 Global Trends 50
5.1.1 Treatment Overview 50
5.1.2 Diagnostic Tests 52
5.1.3 Genetic Testing 53
5.1.4 Monitoring Patient Response to Treatment 55
5.1.5 Future Directions: Discontinuation Therapy 58
5.2 US 59
5.2.1 Diagnosis and Monitoring 59
5.2.2 Clinical Practice 60
5.2.3 Genetic Testing 61
5.3 France 62
5.3.1 Diagnosis and Monitoring 62
5.3.2 Clinical Practice 62
5.3.3 Genetic Testing 63
5.4 Germany 64
5.4.1 Diagnosis and Monitoring 64
5.4.2 Clinical Practice 64
5.4.3 Genetic Testing 66
5.5 Italy 66
5.5.1 Diagnosis and Monitoring 66
5.5.2 Clinical Practice 66
5.5.3 Genetic Testing 68
5.6 Spain 68
5.6.1 Diagnosis and Monitoring 68
5.6.2 Clinical Treatment 68
5.6.3 Genetic Testing 70
5.7 UK 70
5.7.1 Diagnosis and Monitoring 70
5.7.2 Clinical Treatment 71
5.7.3 Genetic Testing 72
5.8 Japan 73
5.8.1 Diagnosis and Monitoring 73
5.8.2 Clinical Treatment 73
5.8.3 Genetic Testing 74
6 Competitive Assessment 75
6.1 Overview 75
6.2 Strategic Competitor Assessment 75
6.3 Product Profiles- Major Brands 78
6.3.1 Gleevec (imatinib) 78
6.3.2 Sprycel (dasatinib) 83
6.3.3 Tasigna (nilotinib) 90
6.3.4 Bosulif (bosutinib) 96
6.3.5 Iclusig (ponatinib) 102
6.3.6 Synribo (omacetaxine mepesuccinate) 107
6.3.7 Minor Therapeutic Classes 112
7 Opportunity and Unmet Need 114
7.1 Overview 114
7.2 Unmet Need: A Drug that Can Cure CML 115
7.3 Unmet Need: Lower Annual Cost of Therapy 116
7.4 Unmet Need: Treatments for Patients Who Have Primary Resistance to or are Refractory to TKIs 117
7.5 Unmet Need: More Efficacious Treatments for AP and BP CML 117
7.6 Unmet Need: Therapies with Fewer Chronic Side Effects 118
7.7 Unmet Need: Better Compliance from Patients on Long-Term Oral Therapy 118
7.8 Unmet Need: Methods of Determining the Optimal Therapy for a Patient 119
7.9 Opportunity: Exploration into Discontinuation Therapy 119
7.10 Opportunity: Companion Devices to Enhance Patient Adherence to Oral Therapy 120
7.11 Opportunity: Therapies with BCR-ABL Independent MOAs 120
7.12 Opportunity: Extended-Release Formulations of TKIs 121
7.13 Opportunity: Biomarkers to Identify the Optimal Therapy for a Given Patient 121
8 Pipeline Assessment 122
8.1 Overview 122
8.2 Clinical Trial Mapping 123
8.2.1 Clinical Trials by Country 123
8.3 Clinical Trials by Phase and Trial Status 124
8.4 Innovative Early-Stage Approaches 125
8.4.1 Project 1: The Wnt Signaling Pathway 126
8.4.2 Project 2: Jak2 Inhibitors 127
8.4.3 Project 3: Grb-2 128
8.4.4 Case Study: Smoothened Inhibitors 128
9 Current and Future Players 130
9.1 Overview 130
9.2 Trends in Corporate Strategy 132
9.3 Company Profiles 133
9.3.1 Novartis 133
9.3.2 BMS 136
9.3.3 Ariad 138
9.3.4 Pfizer 141
10 Market Outlook 144
10.1 Global Markets 144
10.1.1 Forecast 144
10.1.2 Drivers and Barriers – Global Issues 146
10.2 US 149
10.2.1 Forecast 149
10.2.2 Key Events 152
10.2.3 Drivers and Barriers 152
10.3 France 155
10.3.1 Forecast 155
10.3.2 Key Events 158
10.3.3 Drivers and Barriers 158
10.4 Germany 160
10.4.1 Forecast 161
10.4.2 Key Events 162
10.4.3 Drivers and Barriers 162
10.5 Italy 164
10.5.1 Forecast 165
10.5.2 Key Events 166
10.5.3 Drivers and Barriers 166
10.6 Spain 168
10.6.1 Forecast 169
10.6.2 Key Events 170
10.6.3 Drivers and Barriers 170
10.7 UK 172
10.7.1 Forecast 174
10.7.2 Key Events 175
10.7.3 Drivers and Barriers 175
10.8 Japan 178
10.8.1 Forecast 179
10.8.2 Key Events 181
10.8.3 Drivers and Barriers 181
11 Appendix 184
11.1 Bibliography 184
11.2 Abbreviations 194
11.3 Methodology 196
11.4 Forecasting Methodology 196
11.4.1 Diagnosed CML patients 196
11.4.2 Drug-treated Patients on X Line of Therapy 197
11.4.3 Drugs Included in Each Therapeutic Class 197
11.4.4 Launch and Patent Expiry Dates 197
11.4.5 General Pricing Assumptions 198
11.4.6 Compliance Assumptions for Oral TKIs 200
11.4.7 Individual Drug Assumptions 201
11.4.8 Generic Erosion 204
11.4.9 Pricing of New Market Entrants 204
11.5 Physicians and Specialists Included in this Study 205
11.6 Survey of High Prescribing Physicians 206
11.7 About the Authors 207
11.7.1 Authors 207
11.7.2 Epidemiologists 208
11.7.3 Global Director of Epidemiology and Clinical Trials Analysis 209
11.7.4 Global Head of Healthcare 210
11.8 About GlobalData 211
11.9 Contact Us 211
11.10 Disclaimer 211