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PharmaPoint: Chronic Myeloid Leukemia (CML) - Global Drug Forecast and Market Analysis to 2022

Published By :

GlobalData

Published Date : May 2013

Category :

Oncology

No. of Pages : 211 Pages

PharmaPoint: Chronic Myeloid Leukemia (CML) - Global Drug Forecast and Market Analysis to 2022

Summary

Chronic myeloid leukemia (CML) is a rare myeloproliferative blood cancer that is characterized by the presence of the BCR-ABL fusion protein. The stage of CML is classified as chronic, accelerated or blast phase, ranging from least to most severe. Multiple BCR-ABL tyrosine kinase inhibitors (TKIs) are approved, and are the standard of care for CML. TKIs have transformed most cases of the disease into a manageable, chronic condition. As a result, patients survival rates and the prevalence of CML are increasing, placing a growing burden on global healthcare systems

Highlights

Key Questions Answered

- How will the CML market size and composition change over the forecast period?
- How will the TKIs be used differently in lines of therapy and in different patient segments?
- The unmet needs of many CML patients are relatively low. What remaining needs exist, and what qualities must potential new market entrants have to compete in this space?
- Will the entry of generic imatinib influence physician prescribing patterns? Why or why not?
- What are the strengths and weaknesses of Gleevec, Tasigna, Sprycel, Bosulif, Iclusig and Synribo, and how do they stack up against one another? Which will have the greatest commercial success over the forecast period?
- Do key opinion leaders believe that discontinuation of TKI therapy is feasible? For which patients?

Key Findings

- Global pressure to cut healthcare expenditure will influence physicians prescribing patterns.
- Once launched, generic imatinib will be the most commonly prescribed first line therapy for chronic phase patients, the largest and most lucrative segment. This availability of generics will be the single greatest factor in the decline of the CML therapeutics market from 2012-2022.
- Of the recent market entrants Bosulif and Iclusig, Iclusig will be more commercially successful. It is a favorite of KOLs because of its potent efficacy, particularly in patients with the T315I mutation. However, the uptake of both drugs will be restricted due to high prices and concerns about long-term side effects.
- There is still significant unmet need for safe and effective therapies that can control CML in the accelerated and blast phases.

Scope

- Overview of CML, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized CML therapeutics market revenue, annual cost of therapy and treatment usage pattern data by patient segment forecast from 2012 to 2022.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the CML therapeutics market
- Pipeline analysis: The CML pipeline is exceptionally weak, due to the relatively low level of unmet need. Innovative early-stage projects are highlighted, supplemented with KOL opinions about the validity of new targets.
- Analysis of the current and future market competition in the global CML market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

- Develop business strategies by understanding the trends shaping and driving the global CML therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global CML therapeutics market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Forecast drug sales in the global CML therapeutics market from 2012-2022.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies.
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

List of Table

lysis, 2013 88
Table 25: Global Sales Forecasts ($m) for Sprycel in CML, 2012-2022 90
Table 26: Product Profile - Tasigna 91
Table 27: Molecular and Cytogenetic Responses of Tasigna Compared with Gleevec in Newly Diagnosed Ph+ CML in CP 92
Table 28: Tasigna SWOT Analysis, 2013 94
Table 29: Global Sales Forecasts ($m) for Tasigna in CML, 2012-2022 95
Table 30: Product Profile - Bosulif 97
Table 31: Bosulif SWOT Analysis, 2013 100
Table 32: Global Sales Forecasts ($m) for Bosulif in CML, 2012-2022 101
Table 33: Product Profile - Iclusig 103
Table 34: Iclusig SWOT Analysis, 2013 106
Table 35: Global Sales Forecasts ($m) for Iclusig in CML, 2012-2022 107
Table 36: Product Profile - Synribo 109
Table 37: Synribo SWOT Analysis, 2013 111
Table 38: Global Sales Forecasts ($m) for Synribo in CML, 2012-2022 112
Table 39: Summary of Minor Therapeutic Classes, 2013 113
Table 40: Overall Unmet Needs - Current Level of Attainment 115
Table 41: CML - Clinical Trials by Phase and Status, 2013 124
Table 42: Early-stage Pipeline Projects in CML 126
Table 43: Key Companies in the CML Market, 2013 131
Table 44: Novartis CML Portfolio Assessment, 2013 135
Table 45: Novartis SWOT Analysis, 2013 135
Table 46: BMS CML Portfolio Assessment, 2013 137
Table 47: BMS SWOT Analysis, 2013 138
Table 48: Ariads CML Portfolio Assessment, 2013 140
Table 49: Ariad SWOT Analysis, 2013 141
Table 50: Pfizers CML Portfolio Assessment, 2013 142
Table 51: Pfizer SWOT Analysis, 2013 143
Table 52: Global Sales Forecasts ($m) for CML, 2012-2022 145
Table 53: Chronic Myeloid Leukemia Market - Drivers and Barriers, 2013 146
Table 54: Global Sales Forecasts ($m) for CML in the US, 2012-2022 150
Table 55: Key Events Impacting Sales of CML Therapeutics in the United States, 2013 152
Table 56: CML Market in the United States - Drivers and Barriers, 2013 152
Table 57: Sales Forecasts ($m) for CML Therapeutics in France, 2012-2022 156
Table 58: Key Events Impacting Sales of CML Therapeutics in France, 2013 158
Table 59: CML Market in France - Drivers and Barriers, 2013 158
Table 60: Sales Forecasts ($m) for CML Therapeutics in Germany, 2012-2022 161
Table 61: Key Events Impacting Sales of CML Therapeutics in Germany, 2013 162
Table 62: CML Market in Germany - Drivers and Barriers, 2013 162
Table 63: Sales Forecasts ($m) for CML Therapeutics in Italy, 2012-2022 165
Table 64: Key Events Impacting Sales of CML Therapeutics in Italy, 2013 166
Table 65: CML Market in Italy - Drivers and Barriers, 2013 166
Table 66: Sales Forecasts ($m) for CML Therapeutics in Spain, 2012-2022 169
Table 67: Key Events Impacting Sales of CML Therapeutics in Spain, 2013 170
Table 68: CML Market in Spain - Drivers and Barriers, 2013 170
Table 69: Sales Forecasts ($m) for CML Therapeutics in the United Kingdom, 2012-2022 174
Table 70: Key Events Impacting Sales of CML Therapeutics in the UK, 2013 175
Table 71: CML Market in the UK - Drivers and Barriers, 2013 175
Table 72: Sales Forecasts ($m) for CML Therapeutics in Japan, 2012-2022 179
Table 73: Key Events Impacting Sales of CML Therapeutics in Japan, 2013 181
Table 74: CML Market in Japan - Drivers and Barriers, 2013 181
Table 75: Key Launch Dates 197
Table 76: Key Patent Expiries 197
Table 77: Physicians Surveyed, by Country 206

List of Chart

1.2 List of Figures
Figure 1: Translocation of Chromosomes 9 and 22 20
Figure 2: Comparison of Normal and Leukemia Blood Cells 21
Figure 3: 7MM, Incident Cases of Chronic Myeloid Leukemia, All Ages, Men and Women, N, 2012-2022 37
Figure 4: 7MM, Incident Cases of Chronic Myeloid Leukemia, by Age Group, Men and Women, N, 2012 39
Figure 5: 7MM, Incident Cases of Chronic Myeloid Leukemia, All Ages, By Sex , N, 2012 40
Figure 6: 7MM, Age-Standardized Incidence of Chronic Myeloid Leukemia, All Ages, Men and Women, Cases per 100,000 People, 2012 41
Figure 7: 7MM, Incident Cases of Chronic Myeloid Leukemia, by Phase at Diagnosis, All Ages, Men and Women, N, 2012 43
Figure 8: 7MM, Five-Year Prevalent Cases of Chronic Myeloid Leukemia, All Ages, Men and Women, N, 2012-2022 46
Figure 9: 7MM, 10-Year Prevalent Cases of Chronic Myeloid Leukemia, All Ages, Men and Women, N, 2012-2022 46
Figure 10: CML Therapeutics - Clinical Trials by Country, 2013 123
Figure 11: Company Portfolio Gap Analysis in CML, 2013-2022 131
Figure 12: Global Sales for CML Therapeutics by Region, 2012-2022 145
Figure 13: Sales for CML Therapeutics in the United States by Brand, 2012-2022 151
Figure 14: Sales for CML in France by Brand, 2012-2022 157
Figure 15: Sales for CML Therapeutics in Germany by Brand, 2012-2022 161
Figure 16: Sales for CML in Italy by Brand, 2012-2022 165
Figure 17: Sales for CML Therapeutics in Spain by Brand, 2012-2022 169
Figure 18: Sales for CML Therapeutics in the UK by Brand, 2012-2022 174
Figure 19: Sales for CML Therapeutics in Japan by Brand, 2012-2022 180

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