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Chronic Lymphocytic Leukemia: Opportunity Analysis and Forecasts to 2027

  • ID: 4755674
  • Report
  • 151 pages
  • GlobalData
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FEATURED COMPANIES

  • AbbVie
  • Bristol-Myers Squibb
  • Genmab
  • Incuron
  • Kite Pharma
  • Neon Therapeutics
  • MORE
Chronic Lymphocytic Leukemia: Opportunity Analysis and Forecasts to 2027

Summary

Chronic lymphocytic leukemia (CLL) is a form of cancer that originates from lymphocytes in the bone marrow and later invades the blood and/or lymphoid tissues. CLL treatment has been transformed since the novel oral targeted agents Imbruvica (ibrutinib), Zydelig (idelalisib), and Venclexta (venetoclax) were introduced to the market from 2014 onwards and challenged the prior dominance of chemoimmunotherapy regimens. During the forecast period, the global CLL market will welcome five new drugs-Calquence (acalabrutinib), zanubrutinib, umbralisib, ublituximab, and Revlimid (lenalidomide).

It is estimated that the value of the CLL market in the 7MM (US, France, Germany, Italy, Spain, UK, and Canada) in 2017 was $7.7B. Among these sales, 79.5% ($6.1B) were generated in the US, with the 5EU representing the next largest region by sales, with an estimated 18.5% ($1.4B). Canada contributed the smallest proportion of sales, at 2.0% ($157M) of the global CLL market. By 2027, the US is forecast to represent a similar proportion of the 7MM sales, at 79.6%. The 5EU and Canada will account for 18.3% and 2.0% of the 7MM CLL market, respectively.

It is projected that the CLL sales will rise to $9.2B in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Canada) by 2027, at a modest compound annual growth rate (CAGR) of 1.8%. In particular, US CLL market is expected to grow more rapidly than the 5EU or Canada, increasing to $7.4B by 2027, at a still-modest CAGR of 1.9%. Sales in the other regions are also expected to increase by the end of the forecast period, with the 5EU and Canada having a CAGR of 1.7% and 1.8%, respectively.

This is driven by increasing incidence, driven primarily by aging populations, label expansions into the first-line setting for AbbVie/Roche’s Venclexta, frontline approval of the combination of AbbVie/Johnson & Johnson’s Imbruvica + Venclexta, and the increasing use of combination therapies instead of monotherapies or chemoimmunotherapy regimens. Generic and biosimilar erosion of some of the mainstays of CLL treatment is also expected during the forecast period, particularly the use of generic ibrutinib and biosimilar rituximab will lead to a decline in sales. A lack of innovative drugs in the late-stage pipeline with novel mechanisms of action means that next-generation agents are not expected to generate significant sales.

The report "Chronic Lymphocytic Leukemia: Opportunity Analysis and Forecasts to 2027", answers the following key questions -
  • Which pipeline agents are the most promising and expected to launch in the 7MM? What are the forecasted sales of these agents and what will be their impact in the CLL market?
  • What are the main unmet needs in CLL, which pipeline drugs will fulfil these needs, and to what extent?
  • What are the current research and development (R&D) strategies being explored and how can developers incorporate these methods into their business strategy?
  • Key Opinions Leaders (KOLs) insights across the 7MM, relating to the current treatment options and opinions on the late and early stage pipeline agents
Companies mentioned: AbbVie, Acerta Pharma, ADC Therapeutics, Adlai Nortye Biopharma, Aptevo Therapeutics, ArQule, Asana BioSciences, Astellas, AstraZeneca, Bayer, BeiGene, Biogen Idec, BioInvent International, Boehringer Ingelheim, Boston Biomedical, Bristol-Myers Squibb, Celgene, Cellectar Biosciences, Celltrion, Celularity, Centaurus Biopharma, Cyclacel Pharmaceuticals, Dynavax Technologies, Eli Lilly, Esanex, Eureka Therapeutics, Genentech, Genmab, Genzyme, Gilead Sciences, GSK, Hoffmann-La Roche, Hybrigenics, Immunomedics, Incuron, Incyte, Innate Pharma, Innovative Cellular Therapeutics, Invectys, Johnson & Johnson, Juno Therapeutics, Karyopharm Therapeutics, Kiromic, Kite Pharma, LAM Therapeutics, Lundbeck, Mei Pharma, Merck & Co., Esanex, Eureka Therapeutics, Genentech, Genmab, Genzyme, Gilead Sciences, GSK, Hoffmann-La Roche, Hybrigenics, Immunomedics, Incuron, Incyte, Innate Pharma, Innovative Cellular Therapeutics, Invectys, Johnson & Johnson, Juno Therapeutics, Karyopharm Therapeutics, Kiromic, Kite Pharma, LAM Therapeutics, Lundbeck, Mei Pharma, Merck & Co., Millennium Pharmaceuticals, MingSight Pharmaceuticals, Miragen Therapeutics, Molecular Templates, MorphoSys, MundiPharma, Neon Therapeutics, Novartis, Oncternal Therapeutics, Pharmacyclics, Piqur Therapeutics, Portola Pharmaceuticals, Sanofi, Sunesis Pharmaceuticals, Surface Oncology, Teva, TG Therapeutics, Tolero Pharmaceuticals, Trillium Therapeutics, Verastem, Xencor, Zhejiang DTRM Biopharma, Ziopharm Oncology

Scope
  • Overview of CLL, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
  • Annualized CLL therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in seven geographic regions, forecast from 2017 to 2027.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the CLL therapeutics market.
  • Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for CLL. The most promising candidates in late-stage development are profiled.
  • Analysis of the current and future market competition in the global CLL market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Reasons to buy

The report will enable you to -
  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the global CLL market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global CLL market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
Note: Product cover images may vary from those shown
2 of 3

FEATURED COMPANIES

  • AbbVie
  • Bristol-Myers Squibb
  • Genmab
  • Incuron
  • Kite Pharma
  • Neon Therapeutics
  • MORE
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
11.8 Contact Us
11.9 Disclaimer

List of Tables
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

List of Figures
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 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
Note: Product cover images may vary from those shown
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  • AbbVie
  • Acerta Pharma
  • ADC Therapeutics
  • Adlai Nortye Biopharma
  • Aptevo Therapeutics
  • ArQule
  • Asana BioSciences
  • Astellas
  • AstraZeneca
  • Bayer
  • BeiGene
  • Biogen Idec
  • BioInvent International
  • Boehringer Ingelheim
  • Boston Biomedical
  • Bristol-Myers Squibb
  • Celgene
  • Cellectar Biosciences
  • Celltrion
  • Celularity
  • Centaurus Biopharma
  • Cyclacel Pharmaceuticals
  • Dynavax Technologies
  • Eli Lilly
  • Esanex
  • Eureka Therapeutics
  • Genentech
  • Genmab
  • Genzyme
  • Gilead Sciences
  • GSK
  • Hoffmann-La Roche
  • Hybrigenics
  • Immunomedics
  • Incuron
  • Incyte
  • Innate Pharma
  • Innovative Cellular Therapeutics
  • Invectys
  • Johnson & Johnson
  • Juno Therapeutics
  • Karyopharm Therapeutics
  • Kiromic
  • Kite Pharma
  • LAM Therapeutics
  • Lundbeck
  • Mei Pharma
  • Merck & Co.
  • Esanex
  • Eureka Therapeutics
  • Genentech
  • Genmab
  • Genzyme
  • Gilead Sciences
  • GSK
  • Hoffmann-La Roche
  • Hybrigenics
  • Immunomedics
  • Incuron
  • Incyte
  • Innate Pharma
  • Innovative Cellular Therapeutics
  • Invectys
  • Johnson & Johnson
  • Juno Therapeutics
  • Karyopharm Therapeutics
  • Kiromic
  • Kite Pharma
  • LAM Therapeutics
  • Lundbeck
  • Mei Pharma
  • Merck & Co.
  • Millennium Pharmaceuticals
  • MingSight Pharmaceuticals
  • Miragen Therapeutics
  • Molecular Templates
  • MorphoSys
  • MundiPharma
  • Neon Therapeutics
  • Novartis
  • Oncternal Therapeutics
  • Pharmacyclics
  • Piqur Therapeutics
  • Portola Pharmaceuticals
  • Sanofi
  • Sunesis Pharmaceuticals
  • Surface Oncology
  • Teva
  • TG Therapeutics
  • Tolero Pharmaceuticals
  • Trillium Therapeutics
  • Verastem
  • Xencor
  • Zhejiang DTRM Biopharma
  • Ziopharm Oncology
Note: Product cover images may vary from those shown
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