Chronic Myeloid Leukemia (CML) – United Kingdom Drug Forecast and Market Analysis to 2022

Pages: 95 Published: April 01, 2013 Report Code: GDHC1087CFR

GlobalData has released its new Country report, “Chronic Myeloid Leukemia (CML) – United Kingdom 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

The UK has the second lowest prevalence of CML, and is currently the smallest CML market of the 7MM. Although an increasing prevalence of CML and the launch of Bosulif and Iclusig will act as driving forces of market growth, it will not be enough to compensate for erosion of Gleevec and Sprycel sales once their generic equivalents hit the market.


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 UK including product description, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for the top drugs in the UK from 2012-2022.

Analysis of the impact of key events as well the drivers and restraints affecting the UK 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 UK

Table of Contents

1Table of Contents1

1.1List of Tables3

1.2List of Figures3

2Executive Summary4

2.1Sales for CML in UK4

2.2What Do the Physicians Think?5



3.2Related Reports7

3.3Upcoming Related Reports8

4Disease Overview8

4.1Etiology and Pathophysiology8



4.1.3Clinical Staging10


4.1.5Quality of Life12


5Disease Management15

5.1Global Trends15

5.1.1Treatment Overview15

5.1.2Diagnostic Tests17

5.1.3Genetic Testing18

5.1.4Monitoring Patient Response to Treatment20

5.1.5Future Directions: Discontinuation Therapy23


5.2.1Diagnosis and Monitoring23

5.2.2Clinical Treatment24

5.2.3Genetic Testing25

6Competitive Assessment25


6.2Strategic Competitor Assessment26

6.3Product Profiles- Major Brands29

6.3.1Gleevec (imatinib)29

6.3.2Sprycel (dasatinib)33

6.3.3Tasigna (nilotinib)39

6.3.4Bosulif (bosutinib)44

6.3.5Iclusig (ponatinib)49

6.3.6Minor Therapeutic Classes53

7Opportunity and Unmet Need55


7.2Unmet Need: A Drug that Can Cure CML56

7.3Unmet Need: Lower Annual Cost of Therapy57

7.4Unmet Need: Treatments for Patients Who Have Primary Resistance to or are Refractory to TKIs58

7.5Unmet Need: More Efficacious Treatments for AP and BP CML58

7.6Unmet Need: Therapies with Fewer Chronic Side Effects59

7.7Unmet Need: Better Compliance from Patients on Long-Term Oral Therapy59

7.8Unmet Need: Methods of Determining the Optimal Therapy for a Patient60

7.9Opportunity: Exploration into Discontinuation Therapy60

7.10Opportunity: Companion Devices to Enhance Patient Adherence to Oral Therapy61

7.11Opportunity: Therapies with BCR-ABL Independent MOAs61

7.12Opportunity: Extended-Release Formulations of TKIs61

7.13Opportunity: Biomarkers to Identify the Optimal Therapy for a Given Patient62

8Pipeline Assessment62


8.2Innovative Early-Stage Approaches63

8.2.1Project 1: The Wnt Signaling Pathway65

8.2.2Project 2: Jak2 Inhibitors66

8.2.3Project 3: Grb-267

8.2.4Case Study: Smoothened Inhibitors68

9Market Outlook68



9.1.2Key Events71

9.1.3Drivers and Barriers72





10.4Forecasting Methodology83

10.4.1Diagnosed CML patients83

10.4.2Drug-treated Patients on X Line of Therapy83

10.4.3Drugs Included in Each Therapeutic Class83

10.4.4Launch and Patent Expiry Dates84

10.4.5General Pricing Assumptions85

10.4.6Compliance Assumptions for Oral TKIs85

10.4.7Individual Drug Assumptions86

10.4.8Generic Erosion88

10.4.9Pricing of New Market Entrants88

10.5Physicians and Specialists Included in this Study89

10.6Survey of High Prescribing Physicians89

10.7About the Authors91



10.7.3Global Director of Epidemiology and Clinical Trials Analysis93

10.7.4Global Head of Healthcare94

10.8About GlobalData95

10.9Contact Us95


List of Tables

Table 1: The Staging of CML as Defined by Commonly Used Staging Systems11

Table 2: Prognostic Scoring Systems for CML12

Table 3: Common Symptoms of CML by Disease Phase14

Table 4: Most Commonly Followed Treatment Guidelines for CML16

Table 5: Most Prescribed First-Line Therapies for CP, AP and BP CML in the Global Markets, 201317

Table 6: Suggested Treatments for CML Patients with Selected BCR-ABL Kinase Domain Mutations19

Table 7: CML Response Types, Criteria, and Corresponding Tests20

Table 8: Leading Treatments for Chronic Myeloid Leukemia, 201328

Table 9: Product Profile – Gleevec29

Table 10: Hematologic and Cytogenetic Reponses to Gleevec in Newly Diagnosed CML Patients31

Table 11: Gleevec SWOT Analysis, 201333

Table 12: Product Profile – Sprycel35

Table 13: Hematologic and Cytogenetic Reponses to Sprycel in Imatinib Resistant or Intolerant Advanced Phase CML35

Table 14: Sprycel SWOT Analysis, 201338

Table 15: Product Profile – Tasigna39

Table 16: Molecular and Cytogenetic Responses of Tasigna Compared with Gleevec in Newly Diagnosed Ph+ CML in CP40

Table 17: Tasigna SWOT Analysis, 201343

Table 18: Product Profile – Bosulif45

Table 19: Bosulif SWOT Analysis, 201348

Table 20: Product Profile – Iclusig50

Table 21: Iclusig SWOT Analysis, 201353

Table 22: Summary of Minor Therapeutic Classes, 201353

Table 23: Overall Unmet Needs – Current Level of Attainment56

Table 24: Early-stage Pipeline Projects in CML64

Table 25: Sales Forecasts ($m) for CML Therapeutics in the United Kingdom, 2012–202270

Table 26: Key Events Impacting Sales of CML Therapeutics in the UK, 201371

Table 27: CML Market in the UK – Drivers and Barriers, 201372

Table 28: Key Launch Dates84

Table 29: Key Patent Expiries84

Table 30: Physicians Surveyed, by Country89

List of Figures

Figure 1: Sales for CML Therapeutics in the UK by Brand, 2012–20225

Figure 2: Translocation of Chromosomes 9 and 229

Figure 3: Comparison of Normal and Leukemia Blood Cells10

Figure 4: Sales for CML Therapeutics in the UK by Brand, 2012–202271


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