OpportunityAnalyzer: Chronic Lymphocytic Leukemia - Opportunity Analysis and Forecasts to 2018

OpportunityAnalyzer: Chronic Lymphocytic Leukemia - Opportunity Analysis and Forecasts to 2018

$7,995.00

Publication ID
GDA06148774
Publication Date
June 30, 2014
Pages
153
Regions Covered
Publisher
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.
 

Highlights

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?
 

Key Findings

  • 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 GlobalData’s assessment, idelalisib’s 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.
 

Scope

  • 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.

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
6.2 Product Profiles - Major Brands 52
6.2.1 Rituxan/MabThera (rituximab) 52
6.2.2 Arzerra (ofatumumab) 56
6.2.3 Campath (alemtuzumab) 60
6.2.4 Treanda/Levact (bendamustine) 63
6.2.5 Gazyva/Gazyvaro (obinutuzumab) 66
6.2.6 Imbruvica (ibrutinib) 69

7 Unmet Needs Assessment and Oppportunity Analysis 75

7.1 Overview 75
7.2 Unmet Needs Analysis 76
7.2.1 Unmet Need: Therapies that are tolerable for elderly, unfit patients 76
7.2.2 Unmet Need: Efficacious Therapies for High-Risk 17p Deletion Patients 77
7.2.3 Unmet Need: Safe and Efficacious Therapeutic Options for Relapsed/Refractory Patients 78
7.2.4 Unmet Need: Prognostic Markers to Determine the Best Treatment Strategy 79
7.2.5 Unmet Need: Clinical Trials Designed to Reflect the Average CLL Patient 80
7.3 Opportunity Analysis 80
7.3.1 Opportunity: Development of Better Tolerated Therapies 80
7.3.2 Opportunity: Development of Combination Therapy 81
7.3.3 Opportunity: Increasing the Cost-Effectiveness of New Therapies 81
7.3.4 Opportunity: Development of a Prognostic Index 82
7.3.5 Opportunity: Identification of Patients Who Could Benefit from Early Treatment 83

8 R&D Strategies 84

8.1 Overview 84
8.1.1 Moving Towards a Chemotherapy-Free Future 84
8.1.2 Targeting the High-Risk 17p Deletion Population 85
8.1.3 Targeting the B-Cell Receptor Signaling Pathway in CLL 85
8.1.4 Combination Therapy 87
8.1.5 Oral Formulations 88
8.2 Clinical Trial Design 89
8.2.1 Re-Assessing Treatment Outcome Criteria to Support the Development of New Agents to Treat CLL 89
8.2.2 Evaluating CLL Clinical Trial Endpoints 90
8.2.3 Selecting Suitable Comparator Arms and Combinations 91
8.2.4 Current Clinical Trial Design 93

9 Pipeline Assessment 95

9.1 Overview 95
9.2 Promising Drugs in Clinical Development 96
9.2.1 Idelalisib (GS-1101, CAL-101) 96
9.2.2 IPI-145 101
9.2.3 ABT-199 104
9.3 Innovative Early-Stage Approaches 108
9.3.1 CTL019 109
9.3.2 Otlertuzumab (TRU-016) 110
9.3.3 Afuresertib 111
9.3.4 GS-9973 112
9.3.5 NOX-A12 113

10 Pipeline Valuation Analysis 114

10.1 Clinical Benchmark of Key Pipeline Drugs 114
10.2 Commercial Benchmark of Key Pipeline Drugs 117
10.3 Competitive Assessment 118
10.4 Top-Line Five-Year Forecast 120
10.4.1 US 123
10.4.2 5EU 123

11 Appendix 124

11.1 Bibliography 124
11.2 Abbreviations 138
11.3 Methodology 142
11.4 Forecasting Methodology 142
11.4.1 Diagnosed CLL Patients 142
11.4.2 Percentage of Drug-Treated Patients 143
11.4.3 Drugs Included in Each Therapeutic Class 143
11.4.4 Launch and Patent Expiry Dates 144
11.4.5 General Pricing Assumptions 144
11.4.6 Individual Drug Assumptions 145
11.4.7 Generic Erosion 147
11.4.8 Pricing of Pipeline Agents 147
11.5 Physicians and Specialists Included in This Study 148
11.6 About the Authors 149
11.6.1 Authors 149
11.6.2 Epidemiologist 150
11.6.3 Global Head of Healthcare 151
11.7 About GlobalData 152
11.8 Disclaimer 152
 

1.1 List of Tables

Table 1: Rai and Binet Staging of CLL 20
Table 2: iwCLL Symptoms of Progressive CLL 22
Table 3: Definitions of the Response to Treatment of CLL 27
Table 4: CLL Clinical Stages at Diagnosis 29
Table 5: Risk Factors and Comorbidities for CLL 30
Table 6: Trends in the Age-Adjusted Incidence of CLL in the US, All Ages, 2003-2010 32
Table 7: Trends in the Age-Adjusted Incidence of CLL (Cases per 100,000 Population) in France, All Ages, 1980-2012 33
Table 8: Trends in the 5-Year Relative Survival (%) of CLL in the US and 5EU, Both Sexes, 1993-2009 34
Table 9: Sources of Epidemiological Data Used to Forecast the CLL Diagnosed Incident and Prevalent Cases, and the Rai Stage at Diagnosis 35
Table 10: 6MM, Diagnosed Incident Cases of CLL, Both Sexes, Ages ≥40 Years, N, 2013-2023 41
Table 11: 6MM, Age-Specific Diagnosed Incident Cases of CLL, Both Sexes, N (Row %), 2013 43
Table 12: 6MM, Sex-Specific Diagnosed Incident Cases of CLL, Ages ≥40 Years, N (Row %), 2013 44
Table 13: 6MM, 5-Year Diagnosed Prevalent Cases of CLL, Both Sexes, Ages ≥40 Years, N, 2013-2023 47
Table 14: Leading Treatments for CLL 52
Table 15: Product Profile - Rituxan 54
Table 16: Rituxan SWOT Analysis 56
Table 17: Product Profile - Arzerra 58
Table 18: Arzerra SWOT Analysis 60
Table 19: Product Profile - Campath 61
Table 20: Campath SWOT Analysis 62
Table 21: Product Profile - Treanda 64
Table 22: Treanda SWOT Analysis 65
Table 23: Product Profile - Gazyva 67
Table 24: Gazyva SWOT Analysis 69
Table 25: Product Profile - Imbruvica 72
Table 26: Imbruvica SWOT Analysis 74
Table 27: Overall Unmet Needs - Current Level of Attainment 76
Table 28: BCR Signaling Pathway Inhibitors in Clinical Development in CLL 87
Table 29: Design of Current Phase III Trials in CLL 93
Table 30: CLL - Late-Stage Pipeline, 2014 96
Table 31: Product Profile - Idelalisib (GS-1101, CAL-101) 99
Table 32: Idelalisib SWOT Analysis 101
Table 33: Product Profile - IPI-145 102
Table 34: IPI-145 SWOT Analysis 104
Table 35: Product Profile - ABT-199 106
Table 36: ABT-199 SWOT Analysis 108
Table 37: Early-Stage Pipeline Products in CLL 109
Table 38: Clinical Benchmark of Key Pipeline Drugs - First-Line CLL 115
Table 39: Clinical Benchmark of Key Pipeline Drugs - Relapsed/Refractory CLL 116
Table 40: Commercial Benchmark of Key Pipeline Drugs 117
Table 41: Top-Line Sales Forecasts ($) for CLL, 2013-2018 121
Table 42: Key Events Impacting Sales for CLL, 2013-2018 122
Table 43: CLL Market in the US and 5EU - Drivers and Barriers, 2013-2018 122
Table 44: Key Launch Dates 144
Table 45: Key Patent Expiries 144
 

1.2 List of Figures

Figure 1: Treatment Algorithm for CLL 24
Figure 2: 6MM, Diagnosed Incident Cases of CLL, Both Sexes, Ages ≥40 Years, N, 2013-2023 42
Figure 3: 6MM, Age-Specific Diagnosed Incident Cases of CLL, Both Sexes, N, 2013 43
Figure 4: 6MM, Sex-Specific Diagnosed Incident Cases of CLL, Ages ≥40 Years, N, 2013 45
Figure 5: 6MM, Age-Standardized Diagnosed Incidence of CLL (Cases per 100,000 Population), Ages ≥40 Years, by Sex, 2013 46
Figure 6: 6MM, 5-Year Diagnosed Prevalent Cases of CLL, Both Sexes, Ages ≥40 Years, N, 2013-2023 47
Figure 7: 6MM, Diagnosed Incident Cases of CLL by Rai Stage at Diagnosis, Ages ≥40 Years, N, 2013 48
Figure 8: Gazyva- Phase II and III Trials 68
Figure 9: Imbruvica - Phase II and III Trials 72
Figure 10: The BCR Signaling Pathway in CLL 86
Figure 11: The Evolving CLL Treatment Landscape 88
Figure 12: Idelalisib - Phase II and III Trials 97
Figure 13: IPI-145 - Phase Ib and III Trials 103
Figure 14: ABT-199 - Phase II and III Trials 106
Figure 15: Competitive Assessment of Key Marketed and Pipeline Drugs - First-Line CLL 119
Figure 16: Competitive Assessment of Key Marketed and Pipeline Drugs - Relapsed/Refractory CLL 120
Figure 17: Global Sales for CLL by Region (US and 5EU), 2013-2018 121
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