Chronic Lymphocytic Leukemia: Opportunity Analysis and Forecasts to 2027

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Chronic Lymphocytic Leukemia: Executive Summary

2.1 Modest Growth in the CLL Market Expected from 2017–2027

2.2 Combinations of Targeted Drugs

2.3 Unmet Needs Exist in CLL, Particularly for Therapies of Fixed Duration as Well as More Efficacious Therapies for Patients with Adverse Prognostic Features

2.4 Commercial Opportunity for Therapies that Provide a Cure

2.5 Late-Stage Pipeline Agents to Have Low Impact on the Future CLL Treatment Landscape

2.6 What Do Physicians Think?

2.6.1 Defined Course of Treatment

2.6.2 Combination Therapies

2.6.3 Measuring Minimal Residual Disease Negativity

2.6.4 Therapies with Curative Potential

2.6.5 Chimeric Antigen Receptor-T Cell Therapy

2.6.6 PD-1/PD-L1 Checkpoint Inhibitors

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

4.2 Rai and Binet Staging Systems

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.4 Forecast Methodology

5.4.1 Sources Used

5.4.2 Forecast Assumptions and Methods – Population

5.4.3 Forecast Assumptions and Methods – Diagnosed Incident Cases of CLL

5.4.4 Diagnosed Incident Cases by Stage at Diagnosis (Rai Staging and Modified Rai Staging)

5.4.5 Diagnosed Incident Cases by Stage at Diagnosis (Binet Staging)

5.4.6 High-Risk Cytogenetics (11q Deletion, 13q Deletion, 17p Deletion, p53 mutation, CD38, ZAP70 and IGHV [Unmutated]) Among the Diagnosed Incident Cases of CLL

5.4.7 Forecast Assumptions and Methods – Diagnosed Prevalent Cases of CLL

5.5 Epidemiological Forecast for CLL (2017–2027)

5.5.1 Diagnosed Incident Cases of CLL

5.5.2 Age-Specific Diagnosed Incident Cases of CLL

5.5.3 Sex-Specific Diagnosed Incident Cases of CLL

5.5.4 Diagnosed Incident Cases of CLL by Rai Stage at Diagnosis

5.5.5 Diagnosed Incident Cases of CLL by Modified Rai Stage at Diagnosis

5.5.6 Diagnosed Incident Cases of CLL by Binet Stage at Diagnosis

5.5.7 Diagnosed Incident Cases of CLL by High-Risk Cytogenetics

5.5.8 Diagnosed Prevalent Cases of CLL

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of the Analysis

5.6.3 Strengths of the Analysis

6 Current Treatment Options

6.1 Overview

6.2 Treatment Algorithms

6.2.1 Young and Fit Patients (Without 17p Deletion/p53 Mutation)

6.2.2 Elderly and Fit or Young and Unfit Patients (Without 17p Deletion/p53 Mutation)

6.2.3 Elderly and Frail Patients (Without 17p Deletion/p53 Mutation)

6.2.4 Patients with High-Risk 17p Deletion and/or p53 Mutation

6.3 Marketed Therapies

6.3.1 Anti-CD20 Monoclonal Antibodies

6.3.2 Subcutaneous Rituxan

6.3.3 BCR Inhibitors

6.3.4 BCL-2 Inhibitor

6.4 Preferred Treatments Within the Seven Major Markets

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Unmet Need and Opportunity: Efficacious Therapies for High-Risk 17p Deletion Patients

7.3 Unmet Need and Opportunity: Therapies That Are of a Limited, Definite Duration of Treatment

7.4 Unmet Need and Opportunity: More Efficacious Treatment Options in First-Line Therapy for Elderly and Frail, or Young and Fit Patients

7.5 Unmet Need and Opportunity: Prognostic Markers That Determine the Optimal Treatment Strategy

7.6 Unmet Need and Opportunity: Identification of Patients Who Could Benefit from Early Treatment

8 R&D Strategies

8.1 Overview

8.1.1 Targeting the High-Risk 17p Deletion Population

8.1.2 Targeting Other B-Cell Receptor Proteins

8.1.3 Combination Therapies

8.2 Clinical Trials Design

8.2.1 Ongoing Late-Stage Clinical Trials of Marketed and Pipeline Drugs

8.2.2 Evaluating CLL Clinical Trial Endpoints

8.2.3 Selecting Suitable Comparator Arms

9 Pipeline Assessment

9.1 Overview

9.1.1 Umbralisib and Ublituximab

9.1.2 Calquence and Zanubrutinib

9.1.3 Revlimid

9.2 Innovative Early-Stage Approaches

9.2.1 PD-1/PD-L1 Checkpoint Inhibitors

9.2.2 Chimeric Antigen Receptor T Cell Therapy

9.2.3 Other Innovative Approaches

9.3 Summary of Products in Development for CLL

10 Pipeline Valuation Analysis

10.1 Clinical Benchmark of Key Pipeline Drugs

10.2 Commercial Benchmark of Key Pipeline Drugs

10.3 Competitive Assessment

10.4 Top-Line 10-Year Forecast

10.4.1 US

10.4.2 5EU

10.4.3 Canada

11 Appendix

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

11.3.1 Forecasting Methodology

11.3.2 Diagnosed Patients

11.3.3 Percent Drug-Treated Patients

11.3.4 Drugs Included in Each Therapeutic Class

11.3.5 Launch and Patent Expiry Dates

11.3.6 General Pricing Assumptions

11.3.7 Individual Drug Assumptions

11.3.8 Generic/Biosimilar Erosion

11.3.9 Pricing of Pipeline Agents

11.4 Primary Research – Key Opinion Leaders Interviewed for This Report

11.4.1 KOLs

11.5 Primary Research – Prescriber Survey

11.6 About the Authors

11.6.1 Analyst

11.6.2 Managing Analyst

11.6.3 Therapy Area Directors

11.6.4 Epidemiologist

11.6.5 Epidemiologist Reviewers

11.6.6 Global Director of Therapy Analysis and Epidemiology

11.6.7 Global Head and EVP of Healthcare Operations and Strategy

11.7 About GlobalData

11.8 Contact Us

11.9 Disclaimer

Table 1: Chronic Lymphocytic Leukemia: Key Metrics in the Seven Major Markets

Table 2: iwCLL Symptoms of Progressive CLL

Table 3: Rai and Binet Staging of CLL

Table 4: Risk Factors and Comorbid Conditions Associated with CLL

Table 5: 7MM, Diagnosed Incident Cases of CLL by High-Risk Cytogenetics, Both Sexes, Ages ≥18 Years, N, 2017

Table 6: Treatment Guidelines for CLL

Table 7: Current Leading Treatments for CLL

Table 8: Comparison of CurrentA Phase III Trials Involving Drugs Marketed in CLL

Table 9: Comparison of Current Phase III Trials Involving Drugs in the Pipeline for CLL

Table 10: Comparison of Therapeutic Classes in Development for CLL, 2017–2027

Table 11: Innovative Early-Stage Approaches for CLL, 2018

Table 12: Drugs in Development for CLL, 2018

Table 13: Clinical Benchmark of Key Pipeline Drugs – CLL

Table 14: Commercial Benchmark of Key Pipeline Drugs – CLL

Table 15: Top-Line Sales Forecasts ($M) for CLL, 2017–2027

Table 16: Key Events Impacting Sales in 7MM for CLL, 2017–2027

Table 17: CLL Market – Global Drivers and Barriers, 2017–2027

Table 18: Sales Forecast ($M) for CLL in the US, 2017–2027

Table 19: Sales Forecast ($M) for CLL in the 5EU, 2017–2027

Table 20: Sales Forecast ($M) for CLL in Canada, 2017–2027

Table 21: Key Projected Launch Dates for CLL

Table 22: Key Historical and Projected Patent Expiry Dates for CLL

Table 23: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country

Figure 1: Global (7MM) Sales Forecast for CLL by Country/Region in 2017 and 2027

Figure 2: Competitive Assessment of Marketed and Pipeline Drugs in CLL Benchmarked Against the Standards of Care Rituxan and Imbruvica

Figure 3: Inhibition of the BCR Pathway by the BTK Antagonist Imbruvica and by the PI3Kδ Antagonist Zydelig

Figure 4: Inhibition of the BCL-2 Pathway by the BCL-2 Antagonist Venclexta

Figure 5: 7MM, Age-Standardized Diagnosed Incidence of CLL (Cases per 100,000 Population), Men, Ages ≥18 Years, 2017–2027

Figure 6: 7MM, Age-Standardized Diagnosed Incidence of CLL (Cases per 100,000 Population), Women, Ages ≥18 Years, 2017–2027

Figure 7: 7MM, Sources Used, Diagnosed Incident Cases of CLL

Figure 8: 7MM, Sources Used, Diagnosed Incident Cases of CLL by Stage at Diagnosis (Rai Staging and Modified Rai Staging)

Figure 9: 7MM, Sources Used, Diagnosed Incident Cases of CLL by Stage at Diagnosis (Binet Staging)

Figure 10: 7MM, Sources Used, 11q and 13q Deletion Among the Diagnosed Incident Cases of CLL

Figure 11: 7MM, Sources Used, 17p Deletion Among the Diagnosed Incident Cases of CLL

Figure 12: 7MM, Sources Used, TP53 Among the Diagnosed Incident Cases of CLL

Figure 13: 7MM, Sources Used, CD38 Among the Diagnosed Incident Cases of CLL

Figure 14: 7MM, Sources Used, ZAP70 Among the Diagnosed Incident Cases of CLL

Figure 15: 7MM, Sources Used, IGHV (Unmutated) Among the Diagnosed Incident Cases of CLL

Figure 16: 7MM, Sources Used, Diagnosed Prevalent Cases of CLL

Figure 17: 7MM, Diagnosed Incident Cases of CLL, Both Sexes, Ages ≥18 Years, N, 2017

Figure 18: 7MM, Age-Specific Diagnosed Incident Cases of CLL, Both Sexes, N, 2017

Figure 19: 7MM, Sex-Specific Diagnosed Incident Cases of CLL, Ages ≥18 Years, N, 2017

Figure 20: 7MM, Diagnosed Incident Cases of CLL by Rai Stage at Diagnosis, Both Sexes, Ages ≥18 Years, N, 2017

Figure 21: 7MM, Diagnosed Incident Cases of CLL by Modified Rai Stage at Diagnosis, Both Sexes, Ages ≥18 Years, N, 2017

Figure 22: 7MM, Diagnosed Incident Cases of CLL by Binet Stage at Diagnosis, Both Sexes, Ages ≥18 Years, N, 2017

Figure 23: 7MM, Diagnosed Prevalent Cases of CLL, Both Sexes, Ages ≥18 Years, N, 2017

Figure 24: Unmet Needs and Opportunities in CLL

Figure 25: Overview of the Development Pipeline in CLL

Figure 26: Key Phase III Trials for the Promising Pipeline Agents That GlobalData Expects to be Licensed for CLL in the 7MM During the Forecast Period

Figure 27: Competitive Assessment of Marketed and Pipeline Agents in CLL, 2017–2027

Figure 28: Top-Line Sales for CLL by Country/Region, 2017 and 2027

Figure 29: Global (7MM) Sales for CLL by Drug Class, 2017 and 2027

Figure 30: Sales for CLL by Drug Class in the US, 2017 and 2027

Figure 31: Sales for CLL by Drug Class in the 5EU, 2017 and 2027

Figure 32: Sales for CLL by Drug Class in Canada, 2017 and 2027