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



Summary



GlobalData has released its new Country report, “PharmaPoint: Chronic Myeloid Leukemia (CML) - United States Drug Forecast and Market Analysis to 2022”. 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

This decline will be driven by the launch of generic imatinib in 2015 and generic dasatinib in 2020; the increased uptake of higher-priced therapies like Bosulif and Iclusig will not be able to fully counteract the generic erosion of these two market-leading drugs. Aside from Synribo, which was launched in 2012, the US market consists exclusively of BCR-ABL TKIs; the TKIs will remain the dominant therapeutic class over the forecast period due to their convenience and excellent efficacy and safety profiles.



Scope


- Overview of the CML including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on the key drugs in the US including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the US from 2012-2022.
- Analysis of the impact of key events as well the drivers and restraints affecting the US CML market.



Reasons to buy


- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of the competition by understanding the changing competitive landscape for CML
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
- Make more informed business decisions from insightful and in-depth analysis of drug performance
- Obtain sales forecast for drugs from 2012-2022 in the US

Table Of Contents

Table of Contents

1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 8
2 Introduction 9
2.1 Catalyst 9
2.2 Related Reports 9
3 Disease Overview 11
3.1 Etiology and Pathophysiology 11
3.1.1 Etiology 11
3.1.2 Pathophysiology 12
3.1.3 Clinical Staging 14
3.1.4 Prognosis 15
3.1.5 Quality of Life 16
3.2 Symptoms 16
4 Disease Management 18
4.1 Global Trends 18
4.1.1 Treatment Overview 18
4.1.2 Diagnostic Tests 20
4.1.3 Genetic Testing 21
4.1.4 Monitoring Patient Response to Treatment 23
4.1.5 Future Directions: Discontinuation Therapy 26
4.2 US 27
4.2.1 Diagnosis and Monitoring 27
4.2.2 Clinical Practice 28
4.2.3 Genetic Testing 29
5 Competitive Assessment 30
5.1 Overview 30
5.2 Strategic Competitor Assessment 30
5.3 Product Profiles- Major Brands 33
5.3.1 Gleevec (imatinib) 33
5.3.2 Sprycel (dasatinib) 38
5.3.3 Tasigna (nilotinib) 43
5.3.4 Bosulif (bosutinib) 48
5.3.5 Iclusig (ponatinib) 53
5.3.6 Synribo (omacetaxine mepesuccinate) 57
5.3.7 Minor Therapeutic Classes 61
6 Opportunity and Unmet Need 63
6.1 Overview 63
6.2 Unmet Need: A Drug that Can Cure CML 64
6.3 Unmet Need: Lower Annual Cost of Therapy 65
6.4 Unmet Need: Treatments for Patients Who Have Primary Resistance to or are Refractory to TKIs 66
6.5 Unmet Need: More Efficacious Treatments for AP and BP CML 66
6.6 Unmet Need: Therapies with Fewer Chronic Side Effects 67
6.7 Unmet Need: Better Compliance from Patients on Long-Term Oral Therapy 67
6.8 Unmet Need: Methods of Determining the Optimal Therapy for a Patient 68
6.9 Opportunity: Exploration into Discontinuation Therapy 68
6.10 Opportunity: Companion Devices to Enhance Patient Adherence to Oral Therapy 69
6.11 Opportunity: Therapies with BCR-ABL Independent MOAs 69
6.12 Opportunity: Extended-Release Formulations of TKIs 70
6.13 Opportunity: Biomarkers to Identify the Optimal Therapy for a Given Patient 70
7 Pipeline Assessment 71
7.1 Overview 71
7.2 Innovative Early-Stage Approaches 72
7.2.1 Project 1: The Wnt Signaling Pathway 73
7.2.2 Project 2: Jak2 Inhibitors 74
7.2.3 Project 3: Grb-2 75
7.2.4 Case Study: Smoothened Inhibitors 75
8 Market Outlook 77
8.1 United States 77
8.1.1 Forecast 77
8.1.2 Key Events 80
8.1.3 Drivers and Barriers 80
9 Appendix 83
9.1 Bibliography 83
9.2 Abbreviations 89
9.3 Methodology 92
9.4 Forecasting Methodology 92
9.4.1 Diagnosed CML patients 92
9.4.2 Drug-treated Patients on X Line of Therapy 93
9.4.3 Drugs Included in Each Therapeutic Class 93
9.4.4 Launch and Patent Expiry Dates 94
9.4.5 General Pricing Assumptions 94
9.4.6 Compliance Assumptions for Oral TKIs 95
9.4.7 Individual Drug Assumptions 95
9.4.8 Generic Erosion 97
9.5 Physicians and Specialists Included in this Study 98
9.6 Survey of High Prescribing Physicians 99
9.7 About the Authors 100
9.7.1 Authors 100
9.7.2 Epidemiologists 101
9.7.3 Global Director of Epidemiology and Clinical Trials Analysis 102
9.7.4 Global Head of Healthcare 103
9.8 About GlobalData 104
9.9 Contact Us 104
9.10 Disclaimer 104



List of Tables

Table 1: The Staging of CML as Defined by Commonly Used Staging Systems 14
Table 2: Prognostic Scoring Systems for CML 15
Table 3: Common Symptoms of CML by Disease Phase 17
Table 4: Most Commonly Followed Treatment Guidelines for CML 19
Table 5: Most Prescribed First-Line Therapies for CP, AP and BP CML in the Global Markets, 2013 20
Table 6: Suggested Treatments for CML Patients with Selected BCR-ABL Kinase Domain Mutations 23
Table 7: CML Response Types, Criteria, and Corresponding Tests 24
Table 8: Leading Treatments for Chronic Myeloid Leukemia, 2013 32
Table 9: Product Profile - Gleevec 34
Table 10: Hematologic and Cytogenetic Reponses to Gleevec in Newly Diagnosed CML Patients 36
Table 11: Gleevec SWOT Analysis, 2013 37
Table 12: Product Profile - Sprycel 39
Table 13: Hematologic and Cytogenetic Reponses to Sprycel in Imatinib Resistant or Intolerant Advanced Phase CML 40
Table 14: Sprycel SWOT Analysis, 2013 42
Table 15: Product Profile - Tasigna 44
Table 16: Molecular and Cytogenetic Responses of Tasigna Compared with Gleevec in Newly Diagnosed Ph+ CML in CP 45
Table 17: Tasigna SWOT Analysis, 2013 47
Table 18: Product Profile - Bosulif 49
Table 19: Bosulif SWOT Analysis, 2013 52
Table 20: Product Profile - Iclusig 54
Table 21: Iclusig SWOT Analysis, 2013 57
Table 22: Product Profile - Synribo 59
Table 23: Synribo SWOT Analysis, 2013 61
Table 24: Summary of Minor Therapeutic Classes, 2013 62
Table 25: Overall Unmet Needs - Current Level of Attainment 64
Table 26: Early-stage Pipeline Projects in CML 73
Table 27: Global Sales Forecasts ($m) for CML in the US, 2012-2022 78
Table 28: Key Events Impacting Sales of CML Therapeutics in the United States, 2013 80
Table 29: CML Market in the United States - Drivers and Barriers, 2013 80
Table 30: Key Launch Dates 94
Table 31: Key Patent Expiries 94
Table 32: Physicians Surveyed, by Country 99



List of Figures

Figure 1: Translocation of Chromosomes 9 and 22 12
Figure 2: Comparison of Normal and Leukemia Blood Cells 13
Figure 3: Sales for CML Therapeutics in the United States by Brand, 2012-2022 79

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