慢性リンパ性白血病（CLL）：グローバル製薬市場機会分析と予測...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 8
1.1 List of Tables 12
1.2 List of Figures 15
2 Introduction 16
2.1 Catalyst 16
2.2 Related Reports 16
2.3 Upcoming Related Reports 17
3 Disease Overview 18
3.1 Etiology 18
3.2 Pathophysiology 18
3.3 Staging and Prognostic Markers 19
3.3.1 Rai and Binet Staging System 19
3.3.2 Chromosomal Abnormalities and Other Prognostic Markers 20
3.4 Symptoms 21
3.5 Quality of Life 22
4 Disease Management 23
4.1 Diagnosis 23
4.2 Treatment Overview 23
4.2.1 First-Line Treatment 25
4.2.2 Second-Line Treatment and Beyond 26
4.3 Response Criteria for Evaluating the Treatment Outcome 26
5 Epidemiology 28
5.1 Disease Background 28
5.2 Risk Factors and Comorbidities 29
5.3 Global Trends 31
5.3.1 Incidence 31
5.3.2 Survival from CLL – US and 5EU 34
5.4 Forecast Methodology 34
5.4.1 Sources Used 36
5.4.2 Sources Not Used 38
5.4.3 Forecast Assumptions and Methods, Diagnosed Incident Cases 38
5.4.4 Forecast Assumptions and Methods, 5-Year Diagnosed Prevalent Cases 40
5.4.5 Forecast Assumptions and Methods, Rai Stage at Diagnosis 40
5.5 Epidemiological Forecast for CLL (2013-2023) 41
5.5.1 Diagnosed Incident Cases of CLL 41
5.5.2 Age-Specific Diagnosed Incident Cases of CLL 42
5.5.3 Sex-Specific Diagnosed Incident Cases of CLL 44
5.5.4 Age-Standardized Diagnosed Incidence of CLL 45
5.5.5 5-Year Diagnosed Prevalent Cases of CLL 46
5.5.6 Diagnosed Incident Cases of CLL by Rai Stage at Diagnosis 48
5.6 Discussion 48
5.6.1 Epidemiological Forecast Insight 48
5.6.2 Limitations of the Analysis 49
5.6.3 Strengths of the Analysis 50
6 Current Treatment Options 51
6.1 Overview 51
6.2 Product Profiles – Major Brands 52
6.2.1 Rituxan/MabThera (rituximab) 52
6.2.2 Arzerra (ofatumumab) 56
6.2.3 Campath (alemtuzumab) 60
6.2.4 Treanda/Levact (bendamustine) 63
6.2.5 Gazyva/Gazyvaro (obinutuzumab) 66
6.2.6 Imbruvica (ibrutinib) 69
7 Unmet Needs Assessment and Oppportunity Analysis 75
7.1 Overview 75
7.2 Unmet Needs Analysis 76
7.2.1 Unmet Need: Therapies that are tolerable for elderly, unfit patients 76
7.2.2 Unmet Need: Efficacious Therapies for High-Risk 17p Deletion Patients 77
7.2.3 Unmet Need: Safe and Efficacious Therapeutic Options for Relapsed/Refractory Patients 78
7.2.4 Unmet Need: Prognostic Markers to Determine the Best Treatment Strategy 79
7.2.5 Unmet Need: Clinical Trials Designed to Reflect the Average CLL Patient 80
7.3 Opportunity Analysis 80
7.3.1 Opportunity: Development of Better Tolerated Therapies 80
7.3.2 Opportunity: Development of Combination Therapy 81
7.3.3 Opportunity: Increasing the Cost-Effectiveness of New Therapies 81
7.3.4 Opportunity: Development of a Prognostic Index 82
7.3.5 Opportunity: Identification of Patients Who Could Benefit from Early Treatment 83
8 R&D Strategies 84
8.1 Overview 84
8.1.1 Moving Towards a Chemotherapy-Free Future 84
8.1.2 Targeting the High-Risk 17p Deletion Population 85
8.1.3 Targeting the B-Cell Receptor Signaling Pathway in CLL 85
8.1.4 Combination Therapy 87
8.1.5 Oral Formulations 88
8.2 Clinical Trial Design 89
8.2.1 Re-Assessing Treatment Outcome Criteria to Support the Development of New Agents to Treat CLL 89
8.2.2 Evaluating CLL Clinical Trial Endpoints 90
8.2.3 Selecting Suitable Comparator Arms and Combinations 91
8.2.4 Current Clinical Trial Design 93
9 Pipeline Assessment 95
9.1 Overview 95
9.2 Promising Drugs in Clinical Development 96
9.2.1 Idelalisib (GS-1101, CAL-101) 96
9.2.2 IPI-145 101
9.2.3 ABT-199 104
9.3 Innovative Early-Stage Approaches 108
9.3.1 CTL019 109
9.3.2 Otlertuzumab (TRU-016) 110
9.3.3 Afuresertib 111
9.3.4 GS-9973 112
9.3.5 NOX-A12 113
10 Pipeline Valuation Analysis 114
10.1 Clinical Benchmark of Key Pipeline Drugs 114
10.2 Commercial Benchmark of Key Pipeline Drugs 117
10.3 Competitive Assessment 118
10.4 Top-Line Five-Year Forecast 120
10.4.1 US 123
10.4.2 5EU 123
11 Appendix 124
11.1 Bibliography 124
11.2 Abbreviations 138
11.3 Methodology 142
11.4 Forecasting Methodology 142
11.4.1 Diagnosed CLL Patients 142
11.4.2 Percentage of Drug-Treated Patients 143
11.4.3 Drugs Included in Each Therapeutic Class 143
11.4.4 Launch and Patent Expiry Dates 144
11.4.5 General Pricing Assumptions 144
11.4.6 Individual Drug Assumptions 145
11.4.7 Generic Erosion 147
11.4.8 Pricing of Pipeline Agents 147
11.5 Physicians and Specialists Included in This Study 148
11.6 About the Authors 149
11.6.1 Authors 149
11.6.2 Epidemiologist 150
11.6.3 Global Head of Healthcare 151
11.7 About GlobalData 152
11.8 Disclaimer 152