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

Pages: 0 Published: April 01, 2013 Report Code: GDHC103PIDR

  • Overview
  • Key Players
  • Contents
  • Tables
  • Figures
  • Listen
    Text to Speech

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

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.

Key Highlights

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 Players

Novartis

Bristol Myers Squibb

Ariad Pharmaceuticals

Pfizer

Teva/Cephalon

Hospira

Prism Pharma

Incyte Pharmaceuticals

Bio-Path Holdings

Stragen

Otsuka

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.1.3Clinical Staging

3.1.4Prognosis

3.1.5Quality of Life

3.2Symptoms

4Epidemiology

4.1Risk Factors and Co-morbidities

4.1.1Exposure to ionizing radiation may not lead to the development of CML

4.1.2Obesity and weight gain in adulthood play important roles in CML risk

4.2Global and Historical Trends

4.2.1Incidence

4.2.2Prevalence and Survival

4.2.3Mortality

4.3Forecast Methodology

4.3.1Sources Used

4.3.2Forecast Assumptions and Methods, Incident Cases

4.3.3Forecast Assumptions and Methods, Prevalent Cases

4.3.4Sources Not Used

4.4Epidemiological Forecast of Chronic Myeloid Leukemia (2012–2022)

4.4.1Incident Cases of Chronic Myeloid Leukemia

4.4.2Incident Cases of Chronic Myeloid Leukemia by Age Group

4.4.3Incident Cases of Chronic Myeloid Leukemia by Sex

4.4.4Age-Standardized Incidence Rates of Chronic Myeloid Leukemia

4.4.5Incident Cases of Chronic Myeloid Leukemia with Ph+

4.4.6Incident Cases of Chronic Myeloid Leukemia by Phase at Diagnosis

4.4.7Prevalent Cases of Chronic Myeloid Leukemia

4.5Discussion

4.5.1Epidemiological Forecast Insight

4.5.2Limitations of the Analysis

4.5.3Strengths of the Analysis

5Disease Management

5.1Global Trends

5.1.1Treatment Overview

5.1.2Diagnostic Tests

5.1.3Genetic Testing

5.1.4Monitoring Patient Response to Treatment

5.1.5Future Directions: Discontinuation Therapy

5.2US

5.2.1Diagnosis and Monitoring

5.2.2Clinical Practice

5.2.3Genetic Testing

5.3France

5.3.1Diagnosis and Monitoring

5.3.2Clinical Practice

5.3.3Genetic Testing

5.4Germany

5.4.1Diagnosis and Monitoring

5.4.2Clinical Practice

5.4.3Genetic Testing

5.5Italy

5.5.1Diagnosis and Monitoring

5.5.2Clinical Practice

5.5.3Genetic Testing

5.6Spain

5.6.1Diagnosis and Monitoring

5.6.2Clinical Treatment

5.6.3Genetic Testing

5.7UK

5.7.1Diagnosis and Monitoring

5.7.2Clinical Treatment

5.7.3Genetic Testing

5.8Japan

5.8.1Diagnosis and Monitoring

5.8.2Clinical Treatment

5.8.3Genetic Testing

6Competitive Assessment

6.1Overview

6.2Strategic Competitor Assessment

6.3Product Profiles- Major Brands

6.3.1Gleevec (imatinib)

6.3.2Sprycel (dasatinib)

6.3.3Tasigna (nilotinib)

6.3.4Bosulif (bosutinib)

6.3.5Iclusig (ponatinib)

6.3.6Synribo (omacetaxine mepesuccinate)

6.3.7Minor Therapeutic Classes

7Opportunity and Unmet Need

7.1Overview

7.2Unmet Need: A Drug that Can Cure CML

7.3Unmet Need: Lower Annual Cost of Therapy

7.4Unmet Need: Treatments for Patients Who Have Primary Resistance to or are Refractory to TKIs

7.5Unmet Need: More Efficacious Treatments for AP and BP CML

7.6Unmet Need: Therapies with Fewer Chronic Side Effects

7.7Unmet Need: Better Compliance from Patients on Long-Term Oral Therapy

7.8Unmet Need: Methods of Determining the Optimal Therapy for a Patient

7.9Opportunity: Exploration into Discontinuation Therapy

7.10Opportunity: Companion Devices to Enhance Patient Adherence to Oral Therapy

7.11Opportunity: Therapies with BCR-ABL Independent MOAs

7.12Opportunity: Extended-Release Formulations of TKIs

7.13Opportunity: Biomarkers to Identify the Optimal Therapy for a Given Patient

8Pipeline Assessment

8.1Overview

8.2Clinical Trial Mapping

8.2.1Clinical Trials by Country

8.3Clinical Trials by Phase and Trial Status

8.4Innovative Early-Stage Approaches

8.4.1Project 1: The Wnt Signaling Pathway

8.4.2Project 2: Jak2 Inhibitors

8.4.3Project 3: Grb-2

8.4.4Case Study: Smoothened Inhibitors

9Current and Future Players

9.1Overview

9.2Trends in Corporate Strategy

9.3Company Profiles

9.3.1Novartis

9.3.2BMS

9.3.3Ariad

9.3.4Pfizer

10Market Outlook

10.1Global Markets

10.1.1Forecast

10.1.2Drivers and Barriers – Global Issues

10.2US

10.2.1Forecast

10.2.2Key Events

10.2.3Drivers and Barriers

10.3France

10.3.1Forecast

10.3.2Key Events

10.3.3Drivers and Barriers

10.4Germany

10.4.1Forecast

10.4.2Key Events

10.4.3Drivers and Barriers

10.5Italy

10.5.1Forecast

10.5.2Key Events

10.5.3Drivers and Barriers

10.6Spain

10.6.1Forecast

10.6.2Key Events

10.6.3Drivers and Barriers

10.7UK

10.7.1Forecast

10.7.2Key Events

10.7.3Drivers and Barriers

10.8Japan

10.8.1Forecast

10.8.2Key Events

10.8.3Drivers and Barriers

11Appendix

11.1Bibliography

11.2Abbreviations

11.3Methodology

11.4Forecasting Methodology

11.4.1Diagnosed CML patients

11.4.2Drug-treated Patients on X Line of Therapy

11.4.3Drugs Included in Each Therapeutic Class

11.4.4Launch and Patent Expiry Dates

11.4.5General Pricing Assumptions

11.4.6Compliance Assumptions for Oral TKIs

11.4.7Individual Drug Assumptions

11.4.8Generic Erosion

11.4.9Pricing of New Market Entrants

11.5Physicians and Specialists Included in this Study

11.6Survey of High Prescribing Physicians

11.7About the Authors

11.7.1Authors

11.7.2Epidemiologists

11.7.3Global Director of Epidemiology and Clinical Trials Analysis

11.7.4Global Head of Healthcare

11.8 About GlobalData

11.9 Contact Us

11.10 Disclaimer

List of Tables

Table 1: The Staging of CML as Defined by Commonly Used Staging Systems

Table 2: Prognostic Scoring Systems for CML

Table 3: Common Symptoms of CML by Disease Phase

Table 4: Reported Incidence of Chronic Myeloid Leukemia for the US, EU, and Japan

Table 5: US and Japan, Annual Percentage Change (APC) in CML Mortality Rates, by Sex, All Ages, %, 1993–2008

Table 6: 7MM, Sources of CML Incidence and Prevalence Data

Table 7: 7MM, Incident Cases of Chronic Myeloid Leukemia, All Ages, Men and Women, N, 2012–2022

Table 8: 7MM, Incident Cases of CML, by Age Group, Men and Women, N, 2012

Table 9: 7MM, Incident Cases of CML, by Sex, All Ages, N (Row %), 2012

Table 10: 7MM, Incident Cases of CML, by Ph+, Men and Women, All Ages, N, 2012

Table 11: 7MM, Incident Cases of CML, by Phase at Diagnosis, Men and Women, All Ages, N, 2012

Table 12: 7MM, Five- and 10-Year Prevalent Cases of Chronic Myeloid Leukemia, All Ages, Men and Women, N, 2012–2022

Table 13: Most Commonly Followed Treatment Guidelines for CML

Table 14: Most Prescribed First-Line Therapies for CP, AP and BP CML in the Global Markets, 2013

Table 15: Suggested Treatments for CML Patients with Selected BCR-ABL Kinase Domain Mutations

Table 16: CML Response Types, Criteria, and Corresponding Tests

Table 17: Leading Treatments for Chronic Myeloid Leukemia, 2013

Table 18: Product Profile – Gleevec

Table 19: Hematologic and Cytogenetic Reponses to Gleevec in Newly Diagnosed CML Patients

Table 20: Gleevec SWOT Analysis, 2013

Table 21: Global Sales Forecasts ($m) for Gleevec in CML, 2012–2022

Table 22: Product Profile – Sprycel

Table 23: Hematologic and Cytogenetic Reponses to Sprycel in Imatinib Resistant or Intolerant Advanced Phase CML

Table 24: Sprycel SWOT Analysis, 2013

Table 25: Global Sales Forecasts ($m) for Sprycel in CML, 2012–2022

Table 26: Product Profile – Tasigna

Table 27: Molecular and Cytogenetic Responses of Tasigna Compared with Gleevec in Newly Diagnosed Ph+ CML in CP

Table 28: Tasigna SWOT Analysis, 2013

Table 29: Global Sales Forecasts ($m) for Tasigna in CML, 2012–2022

Table 30: Product Profile – Bosulif

Table 31: Bosulif SWOT Analysis, 2013

Table 32: Global Sales Forecasts ($m) for Bosulif in CML, 2012–2022

Table 33: Product Profile – Iclusig

Table 34: Iclusig SWOT Analysis, 2013

Table 35: Global Sales Forecasts ($m) for Iclusig in CML, 2012–2022

Table 36: Product Profile – Synribo

Table 37: Synribo SWOT Analysis, 2013

Table 38: Global Sales Forecasts ($m) for Synribo in CML, 2012–2022

Table 39: Summary of Minor Therapeutic Classes, 2013

Table 40: Overall Unmet Needs – Current Level of Attainment

Table 41: CML – Clinical Trials by Phase and Status, 2013

Table 42: Early-stage Pipeline Projects in CML

Table 43: Key Companies in the CML Market, 2013

Table 44: Novartis’ CML Portfolio Assessment, 2013

Table 45: Novartis SWOT Analysis, 2013

Table 46: BMS’ CML Portfolio Assessment, 2013

Table 47: BMS SWOT Analysis, 2013

Table 48: Ariad’s CML Portfolio Assessment, 2013

Table 49: Ariad SWOT Analysis, 2013

Table 50: Pfizer’s CML Portfolio Assessment, 2013

Table 51: Pfizer SWOT Analysis, 2013

Table 52: Global Sales Forecasts ($m) for CML, 2012–2022

Table 53: Chronic Myeloid Leukemia Market – Drivers and Barriers, 2013

Table 54: Global Sales Forecasts ($m) for CML in the US, 2012–2022

Table 55: Key Events Impacting Sales of CML Therapeutics in the United States, 2013

Table 56: CML Market in the United States – Drivers and Barriers, 2013

Table 57: Sales Forecasts ($m) for CML Therapeutics in France, 2012–2022

Table 58: Key Events Impacting Sales of CML Therapeutics in France, 2013

Table 59: CML Market in France – Drivers and Barriers, 2013

Table 60: Sales Forecasts ($m) for CML Therapeutics in Germany, 2012–2022

Table 61: Key Events Impacting Sales of CML Therapeutics in Germany, 2013

Table 62: CML Market in Germany – Drivers and Barriers, 2013

Table 63: Sales Forecasts ($m) for CML Therapeutics in Italy, 2012–2022

Table 64: Key Events Impacting Sales of CML Therapeutics in Italy, 2013

Table 65: CML Market in Italy – Drivers and Barriers, 2013

Table 66: Sales Forecasts ($m) for CML Therapeutics in Spain, 2012–2022

Table 67: Key Events Impacting Sales of CML Therapeutics in Spain, 2013

Table 68: CML Market in Spain – Drivers and Barriers, 2013

Table 69: Sales Forecasts ($m) for CML Therapeutics in the United Kingdom, 2012–2022

Table 70: Key Events Impacting Sales of CML Therapeutics in the UK, 2013

Table 71: CML Market in the UK – Drivers and Barriers, 2013

Table 72: Sales Forecasts ($m) for CML Therapeutics in Japan, 2012–2022

Table 73: Key Events Impacting Sales of CML Therapeutics in Japan, 2013

Table 74: CML Market in Japan – Drivers and Barriers, 2013

Table 75: Key Launch Dates

Table 76: Key Patent Expiries

Table 77: Physicians Surveyed, by Country

List of Figures

Figure 1: Translocation of Chromosomes 9 and 22

Figure 2: Comparison of Normal and Leukemia Blood Cells

Figure 3: 7MM, Incident Cases of Chronic Myeloid Leukemia, All Ages, Men and Women, N, 2012–2022

Figure 4: 7MM, Incident Cases of Chronic Myeloid Leukemia, by Age Group, Men and Women, N, 2012

Figure 5: 7MM, Incident Cases of Chronic Myeloid Leukemia, All Ages, By Sex , N, 2012

Figure 6: 7MM, Age-Standardized Incidence of Chronic Myeloid Leukemia, All Ages, Men and Women, Cases per 100,000 People, 2012

Figure 7: 7MM, Incident Cases of Chronic Myeloid Leukemia, by Phase at Diagnosis, All Ages, Men and Women, N, 2012

Figure 8: 7MM, Five-Year Prevalent Cases of Chronic Myeloid Leukemia, All Ages, Men and Women, N, 2012–2022

Figure 9: 7MM, 10-Year Prevalent Cases of Chronic Myeloid Leukemia, All Ages, Men and Women, N, 2012–2022

Figure 10: CML Therapeutics – Clinical Trials by Country, 2013

Figure 11: Company Portfolio Gap Analysis in CML, 2013–2022

Figure 12: Global Sales for CML Therapeutics by Region, 2012–2022

Figure 13: Sales for CML Therapeutics in the United States by Brand, 2012–2022

Figure 14: Sales for CML in France by Brand, 2012–2022

Figure 15: Sales for CML Therapeutics in Germany by Brand, 2012–2022

Figure 16: Sales for CML in Italy by Brand, 2012–2022

Figure 17: Sales for CML Therapeutics in Spain by Brand, 2012–2022

Figure 18: Sales for CML Therapeutics in the UK by Brand, 2012–2022

Figure 19: Sales for CML Therapeutics in Japan by Brand, 2012–2022

$10995

Can be used by individual purchaser only

$32985

Can be shared globally by unlimited users within the purchasing corporation e.g. all employees of a single company

Get in touch to find out about multi-purchase discounts

reportstore@globaldata.com
Tel +44 (0) 20 7947 2960

GDPR + CCPA Compliant

Personal and transaction information are kept safe from unauthorised use.

Recently Viewed Reports

Looking to stay on top of industry & market trends?

Sign up to receive regular alerts for our latest analysis and reports. No matter your industry focus, you can keep your finger on the pulse with our timely updates.