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

Published By :

GlobalData

Published Date : Apr 2013

Category :

Oncology

No. of Pages : 99 Pages


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

Summary

GlobalData has released its new Country report, PharmaPoint: Chronic Myeloid Leukemia (CML) Japan 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.

Japan is the second-largest CML market of the 7MM, due to a high prevalence of CML, exceptionally high drug treatment rates and rapid uptake of premium-priced second-generation TKIs in the frontline CP-CML setting. This growth in sales in unique among the 7MM, and is due to the fact that generic erosion will impact Gleevec and Sprycel sales to a lesser extent than in the US and the 5EU. Throughout the forecast, Gleevec will weather generic erosion and increased competition from secondand third-generation TKIs to remain the patient-share leader.

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 Japan including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for the top drugs in Japan from 2012-2022.
  • Analysis of the impact of key events as well the drivers and restraints affecting Japan 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 Japan
Table of Contents

1 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 Japan 27
4.2.1 Diagnosis and Monitoring 27
4.2.2 Clinical Treatment 27
4.2.3 Genetic Testing 28

5 Competitive Assessment 29
5.1 Overview 29
5.2 Strategic Competitor Assessment 29
5.3 Product Profiles- Major Brands 32
5.3.1 Gleevec (imatinib) 32
5.3.2 Sprycel (dasatinib) 36
5.3.3 Tasigna (nilotinib) 42
5.3.4 Bosulif (bosutinib) 47
5.3.5 Iclusig (ponatinib) 52
5.3.6 Minor Therapeutic Classes 56

6 Opportunity and Unmet Need 58
6.1 Overview 58
6.2 Unmet Need: A Drug that Can Cure CML 59
6.3 Unmet Need: Lower Annual Cost of Therapy 60
6.4 Unmet Need: Treatments for Patients Who Have Primary Resistance to or are Refractory to TKIs 61
6.5 Unmet Need: More Efficacious Treatments for AP and BP CML 61
6.6 Unmet Need: Therapies with Fewer Chronic Side Effects 62
6.7 Unmet Need: Better Compliance from Patients on Long-Term Oral Therapy 62
6.8 Unmet Need: Methods of Determining the Optimal Therapy for a Patient 63
6.9 Opportunity: Exploration into Discontinuation Therapy 63
6.10 Opportunity: Companion Devices to Enhance Patient Adherence to Oral Therapy 64
6.11 Opportunity: Therapies with BCR-ABL Independent MOAs 64
6.12 Opportunity: Extended-Release Formulations of TKIs 65
6.13 Opportunity: Biomarkers to Identify the Optimal Therapy for a Given Patient 65

7 Pipeline Assessment 66
7.1 Overview 66
7.2 Innovative Early-Stage Approaches 66
7.2.1 Project 1: The Wnt Signaling Pathway 68
7.2.2 Project 2: Jak2 Inhibitors 69
7.2.3 Project 3: Grb-2 70
7.2.4 Case Study: Smoothened Inhibitors 70

8 Market Outlook 72
8.1 Japan 72
8.1.1 Forecast 73
8.1.2 Key Events 74
8.1.3 Drivers and Barriers 75

9 Appendix 78
9.1 Bibliography 78
9.2 Abbreviations 84
9.3 Methodology 87
9.4 Forecasting Methodology 87
9.4.1 Diagnosed CML patients 87
9.4.2 Drug-treated Patients on X Line of Therapy 88
9.4.3 Drugs Included in Each Therapeutic Class 88
9.4.4 Launch and Patent Expiry Dates 88
9.4.5 General Pricing Assumptions 89
9.4.6 Compliance Assumptions for Oral TKIs 90
9.4.7 Individual Drug Assumptions 90
9.4.8 Generic Erosion 92
9.4.9 Pricing of New Market Entrants 92
9.5 Physicians and Specialists Included in this Study 93
9.6 Survey of High Prescribing Physicians 94
9.7 About the Authors 95
9.7.1 Authors 95
9.7.2 Epidemiologists 96
9.7.3 Global Director of Epidemiology and Clinical Trials Analysis 97
9.7.4 Global Head of Healthcare 98
9.8 About GlobalData 99
9.9 Contact Us 99
9.10 Disclaimer 99

List of Table


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 31
Table 9: Product Profile Gleevec 33
Table 10: Hematologic and Cytogenetic Reponses to Gleevec in Newly Diagnosed CML Patients 34
Table 11: Gleevec SWOT Analysis, 2013 36
Table 12: Product Profile Sprycel 38
Table 13: Hematologic and Cytogenetic Reponses to Sprycel in Imatinib Resistant or Intolerant Advanced Phase CML 39
Table 14: Sprycel SWOT Analysis, 2013 41
Table 15: Product Profile Tasigna 43
Table 16: Molecular and Cytogenetic Responses of Tasigna Compared with Gleevec in Newly Diagnosed Ph+ CML in CP 44
Table 17: Tasigna SWOT Analysis, 2013 46
Table 18: Product Profile Bosulif 48
Table 19: Bosulif SWOT Analysis, 2013 51
Table 20: Product Profile Iclusig 53
Table 21: Iclusig SWOT Analysis, 2013 56
Table 22: Summary of Minor Therapeutic Classes, 2013 57
Table 23: Overall Unmet Needs Current Level of Attainment 59
Table 24: Early-stage Pipeline Projects in CML 68
Table 25: Sales Forecasts ($m) for CML Therapeutics in Japan, 20122022 73
Table 26: Key Events Impacting Sales of CML Therapeutics in Japan, 2013 74
Table 27: CML Market in Japan Drivers and Barriers, 2013 75
Table 28: Key Launch Dates 88
Table 29: Key Patent Expiries 88
Table 30: Physicians Surveyed, by Country 94

List of Chart


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 Japan by Brand, 20122022 74

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