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Gleevec (Chronic Myeloid Leukemia) - Forecast and Market Analysis to 2022

Published By :

GlobalData

Published Date : May 2013

Category :

Oncology

No. of Pages : 53 Pages


Gleevec (Chronic Myeloid Leukemia) Forecast and Market Analysis to 2022

Summary

GlobalData has released its new PharmaPoint Drug Evaluation report, Gleevec (Chronic Myeloid Leukemia) 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. 

Novartis Gleevec (imatinib mesylate) was the first BCR-ABL TKI approved for CML. Gleevec was first approved in the US and the 5EU in 2001 for Ph+ CML patients in blast phase, accelerated phase, or chronic phase after they had failed IFN-a therapy, with approval as a first-line therapy in newly diagnosed CP-CML patients following shortly thereafter, in 2002 (Gleevec Prescribing Information, 2012). In Japan, Gleevec was initially approved for all CML patients in 2001, with no prerequisite for prior therapy with IFN-a (Initial Patient Target Achieved for Glivec within 3 Months, 2002). Gleevecs approval completely changed the competitive landscape of CML, quickly replacing older therapies like IFN-a to become the gold-standard first-line treatment for adults and children with CML.

Scope

  • Overview of CML, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
  • Detailed information on Gleevec including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for Gleevec for the top seven countries from 2012 to 2022.
  • Sales information covered for the US, France, Germany, Italy, Spain, the UK and Japan

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 Gleevec performance
  • Obtain sales forecast for Gleevec from 2012-2022 in top seven countries (the US, France, Germany, Italy, Spain, the UK and Japan)
Table of Contents

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 7

2 Introduction 8
2.1 Catalyst 8
2.2 Related Reports 8

3 Disease Overview 10
3.1 Etiology and Pathophysiology 10
3.1.1 Etiology 10
3.1.2 Pathophysiology 11
3.1.3 Clinical Staging 13
3.1.4 Prognosis 14
3.1.5 Quality of Life 15
3.2 Symptoms 16

4 Disease Management 17
4.1 Global Trends 17
4.1.1 Treatment Overview 17
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

5 Competitive Assessment 28
5.1 Overview 28
5.2 Strategic Competitor Assessment 29

6 Product Profile - Gleevec (imatinib) 32
6.1 Overview 32
6.2 Efficacy 33
6.3 Safety 35
6.4 SWOT Analysis 36
6.5 Forecast 37

7 Appendix 38
7.1 Bibliography 38
7.2 Abbreviations 40
7.3 Methodology 42
7.4 Forecasting Methodology 42
7.4.1 Diagnosed CML patients 42
7.4.2 Drug-treated Patients on X Line of Therapy 43
7.4.3 General Pricing Assumptions 43
7.4.4 Compliance Assumptions for Oral TKIs 45
7.4.5 Individual Drug Assumptions 46
7.4.6 Generic Erosion 46
7.4.7 Pricing of New Market Entrants 46
7.5 Physicians and Specialists Included in this Study 47
7.6 Survey of High Prescribing Physicians 48
7.7 About the Authors 49
7.7.1 Authors 49
7.7.2 Epidemiologists 50
7.7.3 Global Director of Epidemiology and Clinical Trials Analysis 51
7.7.4 Global Head of Healthcare 52
7.8 About GlobalData 53
7.9 Contact Us 53
7.10 Disclaimer 53

List of Table


Table 1: The Staging of CML as Defined by Commonly Used Staging Systems 13
Table 2: Prognostic Scoring Systems for CML 15
Table 3: Common Symptoms of CML by Disease Phase 16
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 19
Table 6: Suggested Treatments for CML Patients with Selected BCR-ABL Kinase Domain Mutations 22
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: Global Sales Forecasts ($m) for Gleevec in CML, 20122022 37
Table 13: Physicians Surveyed, by Country 48

List of Chart


Figure 1: Translocation of Chromosomes 9 and 22 10
Figure 2: Comparison of Normal and Leukemia Blood Cells 11

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