Chronic lymphocytic leukemia (CLL), the most common form of adult leukemia, is caused by the uncontrolled proliferation of B lymphocytes (a type of white blood cell) in the bone marrow, blood and lymphoid tissues. This report focuses on the current treatment landscape, unmet needs, pipeline and commercial opportunity in the CLL market with coverage of both the first-line and relapsed/refractory settings. While the current standard of care consists of chemoimmunotherapy, CLL disease management is poised for dramatic changes, particularly in the treatment of relapsed/refractory and elderly patients, as four new drugs (Gazyva, Imbruvica, idelalisib and IPI-145) will launch during the forecast period. As they address large unmet needs, GlobalData expects these premium-priced new drugs will have rapid uptake driving the overall CLL market and contributing to over 70% of total market sales by 2018.
Key Questions Answered
- Which CLL patients have the greatest unmet needs and how well will these needs be addressed by the new agents?
- How will CLL disease management change as new agents enter the market?
- What are the R&D and clinical trial design strategies pursued by companies in the CLL space?
- What are the most promising late-stage pipeline agents for CLL? How do their clinical and commercial attributes compare to one another and the current standards of care?
- What opportunities will remain for future players following the launch of these pipeline agents?
- What exciting, innovative approaches are being investigated in the early-stage CLL pipeline?
- The CLL market, in the 6MM is forecasted to rapidly increase from $1.4bn in 2013 to $3.3bn in 2018, at a CAGR of 18.8%. This growth will be driven by the launch and adoption of four new premium-priced drugs during the forecast period, including Gazyva, Imbruvica, idelalisib and IPI-145.
- GlobalData expects there will be rapid uptake of the new agents in the relapsed/refractory setting, particularly in those patients who do not have a good response to first-line treatment. In the first-line setting, GlobalData foresees a slower uptake of the new agents, particularly among fit patients who can enjoy lengthy and deep remissions from the current standard of care chemoimmunotherapy-based regimens.
- Among the new agents, GlobalData expects Imbruvica and idelalisib will dominate patient share and will account for more than 60% of all total sales in 2018 and drive 100% of total market growth. However, in GlobalDatas assessment, idelalisibs use in combination with Rituxan and its overall stronger clinical development program will help it emerge as the market leader in the relapsed/refractory setting by 2018.
- Key countries covered: US, France, Germany, Italy, Spain, and UK
- Overview of CLL, including epidemiology, etiology, pathophysiology, clinical staging, symptoms, quality of life, and disease management.
- Topline CLL therapeutics market revenue from 2013-2018. Annual cost of therapy, and major marketed and pipeline drug sales in this forecast period are included.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, and clinical trial design for the CLL market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline drugs. An interactive clinical and commercial analyzer tool is available.
- Analysis of the current and future market competition in the 6MM CLL therapeutics 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
- 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 6MM CLL market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the 6MM CLL therapeutics market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing 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.
Table of Contents
1 Table of Contents
1 Table of Contents 8
1.1 List of Tables 12
1.2 List of Figures 15
2 Introduction 16
2.1 Catalyst 16
2.2 Related Reports 16
2.3 Upcoming Related Reports 17
3 Disease Overview 18
3.1 Etiology 18
3.2 Pathophysiology 18
3.3 Staging and Prognostic Markers 19
3.3.1 Rai and Binet Staging System 19
3.3.2 Chromosomal Abnormalities and Other Prognostic Markers 20
3.4 Symptoms 21
3.5 Quality of Life 22
4 Disease Management 23
4.1 Diagnosis 23
4.2 Treatment Overview 23
4.2.1 First-Line Treatment 25
4.2.2 Second-Line Treatment and Beyond 26
4.3 Response Criteria for Evaluating the Treatment Outcome 26
5 Epidemiology 28
5.1 Disease Background 28
5.2 Risk Factors and Comorbidities 29
5.3 Global Trends 31
5.3.1 Incidence 31
5.3.2 Survival from CLL - US and 5EU 34
5.4 Forecast Methodology 34
5.4.1 Sources Used 36
5.4.2 Sources Not Used 38
5.4.3 Forecast Assumptions and Methods, Diagnosed Incident Cases 38
5.4.4 Forecast Assumptions and Methods, 5-Year Diagnosed Prevalent Cases 40
5.4.5 Forecast Assumptions and Methods, Rai Stage at Diagnosis 40
5.5 Epidemiological Forecast for CLL (2013-2023) 41
5.5.1 Diagnosed Incident Cases of CLL 41
5.5.2 Age-Specific Diagnosed Incident Cases of CLL 42
5.5.3 Sex-Specific Diagnosed Incident Cases of CLL 44
5.5.4 Age-Standardized Diagnosed Incidence of CLL 45
5.5.5 5-Year Diagnosed Prevalent Cases of CLL 46
5.5.6 Diagnosed Incident Cases of CLL by Rai Stage at Diagnosis 48
5.6 Discussion 48
5.6.1 Epidemiological Forecast Insight 48
5.6.2 Limitations of the Analysis 49
5.6.3 Strengths of the Analysis 50
6 Current Treatment Options 51
6.1 Overview 51
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