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

Summary

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

After it enters the market in 2016, generic imatinib will displace Gleevec as the most commonly prescribed first-line therapy for CP-CML patients. Historically, the German market is receptive to generics, and GlobalDatas primary research indicates that the availability of a lower-priced generic will offset the uptake of the stronger second-generation TKIs. Generic imatinib will also overtake Gleevec as the leading first-line therapy prescribed for the AP/BP-CML patient segment. Since these are higher-risk patients, however, generic imatinib will be prescribed only slightly more frequently than second-generation TKIs.

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 Germany including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for the top drugs in Germany from 2012-2022.
  • Analysis of the impact of key events as well the drivers and restraints affecting Germany 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 Germany
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 Reprts 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 Germany 27
4.2.1 Diagnosis and Monitoring 27
4.2.2 Clinical Practice 27
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 Minor Therapeutic Classes 57

6 Opportunity and Unmet Need 59
6.1 Overview 59
6.2 Unmet Need: A Drug that Can Cure CML 60
6.3 Unmet Need: Lower Annual Cost of Therapy 61
6.4 Unmet Need: Treatments for Patients Who Have Primary Resistance to or are Refractory to TKIs 62
6.5 Unmet Need: More Efficacious Treatments for AP and BP CML 62
6.6 Unmet Need: Therapies with Fewer Chronic Side Effects 63
6.7 Unmet Need: Better Compliance from Patients on Long-Term Oral Therapy 63
6.8 Unmet Need: Methods of Determining the Optimal Therapy for a Patient 64
6.9 Opportunity: Exploration into Discontinuation Therapy 64
6.10 Opportunity: Companion Devices to Enhance Patient Adherence to Oral Therapy 65
6.11 Opportunity: Therapies with BCR-ABL Independent MOAs 65
6.12 Opportunity: Extended-Release Formulations of TKIs 66
6.13 Opportunity: Biomarkers to Identify the Optimal Therapy for a Given Patient 66

7 Pipeline Assessment 67
7.1 Overview 67
7.2 Innovative Early-Stage Approaches 68
7.2.1 Project 1: The Wnt Signaling Pathway 69
7.2.2 Project 2: Jak2 Inhibitors 70
7.2.3 Project 3: Grb-2 71
7.2.4 Case Study: Smoothened Inhibitors 71

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

9 Appendix 77
9.1 Bibliography 77
9.2 Abbreviations 83
9.3 Methodology 86
9.4 Forecasting Methodology 86
9.4.1 Diagnosed CML patients 86
9.4.2 Drug-treated Patients on X Line of Therapy 87
9.4.3 Drugs Included in Each Therapeutic Class 87
9.4.4 Launch and Patent Expiry Dates 87
9.4.5 General Pricing Assumptions 88
9.4.6 Compliance Assumptions for Oral TKIs 89
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 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: Summary of Minor Therapeutic Classes, 2013 58
Table 23: Overall Unmet Needs Current Level of Attainment 60
Table 24: Early-stage Pipeline Projects in CML 68
Table 25: Sales Forecasts ($m) for CML Therapeutics in Germany, 20122022 74
Table 26: Key Events Impacting Sales of CML Therapeutics in Germany, 2013 75
Table 27: CML Market in Germany Drivers and Barriers, 2013 75
Table 28: Key Launch Dates 87
Table 29: Key Patent Expiries 87
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 Germany by Brand, 20122022 74

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