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Opportunity Analyzer: B-Cell Non-Hodgkin’s Lymphoma (NHL) - Opportunity Analysis and Forecasts to 2024

Summary

Non-Hodgkin’s lymphoma (NHL) comprises a heterogeneous group of lymphoproliferative malignancies that arise in the B cells, T cells, or natural killer (NK) cells within the lymphoid tissue, such as the lymph nodes, bone marrow, thymus, and spleen. NHLs are further categorized into indolent or aggressive prognostic subtypes, which further influence the outcomes and treatment decisions. Patients diagnosed with indolent NHLs (follicular lymphoma [FL] or marginal zone lymphoma [MZL]) can achieve a median survival of 10 to 20 years, and relative 10-year survival rates of over 60%. However, patients with aggressive NHLs (diffuse large B-cell lymphoma [DLBCL] or mantle cell lymphoma [MCL]) can generally expect lower median survival rates, with the relative 10-year survival reported to be less than 50%.

For the purposes of this report, GlobalData focuses on the four most prevalent B-cell NHL subtypes: FL, MZL, DLBCL and MCL. The global market is defined to include sales of drugs aimed at treatment of those four subtypes in patients 30 years and older across the 7MM, which is comprised of the US, 5EU (France, Germany, Italy, Spain, and the UK), and Japan. The forecast includes the sale of agents in first-line, relapsed/refractory, and maintenance settings. GlobalData anticipates a major driver of market growth to be the steady increase in uptake of Imbruvica to treat MCL, and its anticipated expansion into FL, MZL, and DLBCL treatment settings over the forecast period.

Highlights

Key Questions Answered

- Based on interviews with key opinion leaders (KOLs), GlobalData has identified the major unmet needs in the NHL marketplace. Will the leading pipeline agents fulfil these unmet needs during the forecast period (2014-2024)?
- What research and development (R&D) strategies will companies leverage to compete in the future NHL marketplace?
- Which pipeline products are poised to make a major clinical and commercial impact?
- What clinical and commercial factors are likely to influence NHL drug uptake in the US and 5EU (France, Germany, Italy, Spain, and the UK) and Japan (7MM)?

Key Findings

- GlobalData projects the NHL market in the 7MM to experience modest growth from approximately $4.82bn in 2014 to a little under $5.5bn in 2024, at a compound annual growth rate (CAGR) of 1.0%. This growth will be fueled by the launch of the premium-priced drug Imbruvica in the DLBCL first-line and relapsed/refractory settings. In addition Revlimid is expected to launch in multiple indications across indolent and aggressive NHL, along with Zydelig, Gazyva, and other novel pipeline products.
- Primary and secondary research indicates that Imbruvica and Revlimid will experience rapid uptake due to high KOL enthusiasm and promising clinical efficacy results reported thus far. Furthermore, the ability to combine these agents with standard backbone therapies will aid in their uptake.
- GlobalData anticipates the launch of generic bendamustine and generic lenalidomide, along with biosimilar rituximab, at various times in the different markets during the forecast period. The arrival of those products, in combination with the stringent pricing and reimbursement criteria in the 5EU, will act as major barriers to global NHL market growth.

Scope

- Overview of NHL, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options.
- Topline NHL drug market revenue from 2014-2024. Annual cost of therapy (ACOT) and major product sales in first-line, relapsed/refractory, and maintenance treatment settings during the forecast period are included.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, opportunities, and R&D strategies for the NHL 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 products. An interactive clinical and commercial analyzer tool is available.
- Analysis of the current and future market competition in the global NHL 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 NHL therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the NHL 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.

Table Of Contents

Opportunity Analyzer: B-Cell Non-Hodgkin’s Lymphoma (NHL) - Opportunity Analysis and Forecasts to 2024
1 Table of Contents
1 Table of Contents 10
1.1 List of Tables 15
1.2 List of Figures 20
2 Introduction 22
2.1 Catalyst 22
2.2 Related Reports 22
3 Disease Overview 23
3.1 Etiology and Pathophysiology 24
3.1.1 Pathophysiology of Indolent and Aggressive B-Cell NHL 24
3.2 Symptoms 28
4 Disease Management 29
4.1 Diagnosis 29
4.2 Diagnostic Classification 30
4.2.1 Follicular Lymphoma 31
4.2.2 Marginal Zone Lymphoma 32
4.2.3 Diffuse Large B-Cell Lymphoma 32
4.2.4 Mantle Cell Lymphoma 33
4.3 Treatment Overview 33
4.3.1 Follicular Lymphoma 33
4.3.2 Marginal Zone Lymphoma 36
4.3.3 Diffuse Large B-Cell Lymphoma 38
4.3.4 Mantle Cell Lymphoma 41
5 Epidemiology 44
5.1 Disease Background 44
5.2 Risk Factors and Comorbidities 44
5.3 Global Trends 46
5.3.1 US 47
5.3.2 5EU 48
5.3.3 Japan 51
5.4 Forecast Methodology 51
5.4.1 Sources Used 53
5.4.2 Sources Not Used 56
5.4.3 Forecast Assumptions and Methods 56
5.5 Epidemiological Forecast for B-Cell NHL (2014-2024) 60
5.5.1 Follicular Lymphoma 60
5.5.2 Marginal Zone Lymphoma 67
5.5.3 Diffuse Large B-Cell Lymphoma 74
5.5.4 Mantle Cell Lymphoma 81
5.6 Discussion 88
5.6.1 Epidemiological Forecast Insight 88
5.6.2 Limitations of the Analysis 89
5.6.3 Strengths of the Analysis 90
6 Current Treatment Options 91
6.1 Overview 91
6.2 Product Profiles - Major Brands 93
6.2.1 Imbruvica (ibrutinib) 93
6.2.2 Revlimid (lenalidomide) 101
6.2.3 Rituxan (rituximab) 107
6.2.4 Treanda (bendamustine) 112
6.2.5 Velcade (bortezomib) 116
6.2.6 Zevalin (ibritumomab tiuxetan) 120
6.2.7 Zydelig (idelalisib, GS-1101, CAL-101) 124
7 Unmet Needs Assessment and Opportunity Analysis 129
7.1 Overview 129
7.2 Unmet Needs Analysis 130
7.2.1 Unmet Need: Therapies That Prolong OS or PFS and Delay Relapse in Indolent NHL Patients 130
7.2.2 Unmet Need: Safe and More Tolerable Front-Line Agents for Indolent NHL Patients 131
7.2.3 Unmet Need: Prolonged Survival Rates for MCL Patients 132
7.2.4 Unmet Need: Improved Cure Rate and Survival for DLBCL Patients after Front-Line Therapy 133
7.2.5 Unmet Need: Predictive and Prognostic Molecular Biomarkers 134
7.3 Opportunity Analysis 136
7.3.1 Opportunity: More Cost-Effective Therapies 136
7.3.2 Opportunity: Improved Consolidation/Maintenance Therapies for Follicular NHL Patients 137
7.3.3 Opportunity: Novel Agents for Front-Line DLBCL and MCL Therapy 137
7.3.4 Opportunity: Development of Novel Therapies for NHL Patients 138
8 Research and Development Strategies 141
8.1 Overview 141
8.1.1 Targeting Multiple NHL Subtypes and Lines of Therapy to Capture the Greatest Patient Share 143
8.1.2 Inhibiting New Targets in Relapsed/Refractory NHL Patients 145
8.1.3 Novel Approaches to NHL Treatment 147
8.1.4 Developing Novel Drugs in Combination with Rituxan to Replace Chemoimmunotherapy Regimens 150
8.1.5 Developing Second-Generation Therapies to Replace the Established Standards of Care at the End of Patent Life 152
8.1.6 Companies Collaborating on Investigator-Sponsored, Early-Stage Trials to Minimize Up-Front Risk 154
8.1.7 Introducing New Routes of Drug Delivery to Improve Patient Convenience 155
8.2 Clinical Trial Design 157
8.2.1 Indolent and Aggressive B-Cell NHL 157
8.2.2 Clinical Endpoints 160
8.2.3 Comparator Arms 163
9 Pipeline Assessment 165
9.1 Overview 165
9.2 Promising Drugs in Clinical Development 166
9.2.1 Afinitor (everolimus) 166
9.2.2 Arzerra (ofatumumab) 170
9.2.3 Copanlisib (BAY 80-6946) 177
9.2.4 Duvelisib (IPI-145) 183
9.2.5 Gazyva (obinutuxumab) 187
9.2.6 Opdivo (nivolumab) 195
9.3 Innovative Early-Stage Approaches 200
9.3.1 Adcetris (brentuximab vedotin) 202
9.3.2 Blinatumomab (AMG-103) 203
9.3.3 CUDC-907 203
9.3.4 Daratumumab 204
9.3.5 Kyprolis (carfilzomib) 204
9.3.6 Y-90 Epratuzumab 205
9.3.7 Chimeric Antigen Receptor T-Cell Therapies 205
10 Pipeline Valuation Analysis 207
10.1 Clinical Benchmarking of Key Pipeline Drugs 207
10.1.1 Indolent NHL 208
10.1.2 Aggressive NHL 211
10.2 Commercial Benchmarking of Key Pipeline Drugs 214
10.3 Competitive Assessment 217
10.4 Top-Line, 10-Year Forecast 222
10.4.1 US 224
10.4.2 5EU 225
10.4.3 Japan 225
11 Appendix 227
11.1 Bibliography 227
11.2 Abbreviations 253
11.3 Methodology 261
11.4 Forecasting Methodology 261
11.4.1 NHL Patient Population Segmentation 261
11.4.2 Percentage of Drug-Treated Patients 262
11.4.3 Drugs Included in Each Therapeutic Class 264
11.4.4 Launch and Patent Expiry Dates 265
11.4.5 General Pricing Assumptions 265
11.4.6 Individual Drug Assumptions 266
11.4.7 Generic and Biosimilar Erosion 273
11.5 Primary Research 274
11.5.1 Physicians and Specialists Included in This Study 274
11.5.2 Online Survey of High Prescribing Physicians 277
11.6 About the Authors 278
11.6.1 Analyst 278
11.6.2 Epidemiologist 278
11.6.3 Therapy Area Director 279
11.6.4 Global Director of Therapy Analysis and Epidemiology 279
11.6.5 Global Head of Healthcare 280
11.7 About GlobalData 281
11.8 Disclaimer 281

1.1 List of Tables
Table 1: Non-Hodgkin's Lymphoma Subtypes 25
Table 2: Symptoms of Non-Hodgkin's Lymphoma 28
Table 3: The Ann Arbor Staging System and the Cotswold Modifications for NHL 30
Table 4: Molecular Characteristics of Non-Hodgkin's Lymphoma (2008 WHO Classification) 31
Table 5: Treatment Guidelines for Non-Hodgkin's Lymphoma in the 7MM 33
Table 6: Risk Factors and Comorbidities for NHL 46
Table 7: US, Age- and Sex-Specific Incidence of B-Cell NHL During 2001-2010 47
Table 8: 7MM, Sources of B-Cell NHL Incidence Data 52
Table 9: 7MM, Incident Cases of Follicular Lymphoma, Ages ?30 Years, Both Sexes, N, Selected Years 2014-2024 61
Table 10: 7MM, Age-Specific Incident Cases of Follicular Lymphoma, Both Sexes, N (Row %), 2014 63
Table 11: 7MM, Sex-Specific Incident Cases of Follicular Lymphoma, Ages ?30 Years, N (Row %), 2014 65
Table 12: 7MM, Incident Cases of Marginal Zone Lymphoma, Ages ?30 Years, Both Sexes, N, Selected Years 2014-2024 68
Table 13: 7MM, Age-Specific Incident Cases of Marginal Zone Lymphoma, Both Sexes, N (Row %), 2014 70
Table 14: 7MM, Sex-Specific Incident Cases of Marginal Zone Lymphoma, Ages ?30 Years, N (Row %), 2014 72
Table 15: 7MM, Incident Cases of DLBCL, Ages ?30 Years, Both Sexes, N, Selected Years, 2014-2024 75
Table 16: 7MM, Age-Specific Incident Cases of DLBCL, Both Sexes, N (Row %), 2014 77
Table 17: 7MM, Sex-Specific Incident Cases of DLBCL, Ages ?30 Years, N (Row %), 2014 79
Table 18: 7MM, Incident Cases of Mantle Cell Lymphoma, Ages ?30 Years, Both Sexes, N, Selected Years 2014-2024 82
Table 19: 7MM, Age-Specific Incident Cases of Mantle Cell Lymphoma, Both Sexes, N (Row %), 2014 84
Table 20: 7MM, Sex-Specific Incident Cases of Mantle Cell Lymphoma, Ages ?30 Years, N (Row %), 2014 86
Table 21: Leading Treatments for NHL Patients in the 7MM 92
Table 22: Product Profile - Imbruvica 95
Table 23: Efficacy of Imbruvica in MCL 97
Table 24: Efficacy of Imbruvica in FL 98
Table 25: Efficacy of Imbruvica in DLBCL 99
Table 26: Safety of Imbruvica in MCL 100
Table 27: Imbruvica SWOT Analysis, 2015 100
Table 28: Product Profile - Revlimid 102
Table 29: Efficacy of Revlimid in MCL 104
Table 30: Efficacy of Revlimid in DLBCL 105
Table 31: Efficacy of Revlimid in DLBCL 105
Table 32: Safety of Revlimid 106
Table 33: Revlimid SWOT Analysis, 2015 107
Table 34: Product Profile - Rituxan 110
Table 35: Efficacy of Rituxan 111
Table 36: Safety of Rituxan 112
Table 37: Rituxan SWOT Analysis, 2015 112
Table 38: Product Profile - Treanda 114
Table 39: Efficacy of Treanda 115
Table 40: Safety of Treanda 115
Table 41: Treanda SWOT Analysis, 2015 116
Table 42: Product Profile - Velcade 118
Table 43: Efficacy of Velcade 119
Table 44: Safety of Velcade 120
Table 45: Velcade SWOT Analysis, 2015 120
Table 46: Product Profile - Zevalin 122
Table 47: Efficacy of Zevalin 123
Table 48: Safety of Zevalin 124
Table 49: Zevalin SWOT Analysis, 2015 124
Table 50: Product Profile - Zydelig 126
Table 51: Efficacy of Zydelig 127
Table 52: Safety of Zydelig 128
Table 53: Zydelig SWOT Analysis, 2015 128
Table 54: Overall Unmet Needs - Current Level of Attainment 130
Table 55: Key Products in the Present and Future B-Cell NHL Market, 2015 142
Table 56: Design of Current Registration Trials in Indolent B-Cell NHL 157
Table 57: Design of Current Registration Trials in Aggressive B-Cell NHL 159
Table 58: Non-Hodgkin's Lymphoma - Late-Stage Pipeline, 2015 166
Table 59: Product Profile - Afinitor 168
Table 60: Efficacy of Afinitor in DLBCL 169
Table 61: Safety of Afinitor in DLBCL 170
Table 62: Afinitor SWOT Analysis, 2015 170
Table 63: Product Profile - Arzerra 173
Table 64: Efficacy of Arzerra in FL 175
Table 65: Safety of Arzerra in FL 176
Table 66: Arzerra SWOT Analysis, 2015 177
Table 67: Product Profile - Copanlisib 179
Table 68: Efficacy of Copanlisib 181
Table 69: Safety of Copanlisib 182
Table 70: Copanlisib SWOT Analysis, 2015 182
Table 71: Product Profile - Duvelisib 184
Table 72: Efficacy of Duvelisib 185
Table 73: Safety of Duvelisib 186
Table 74: Duvelisib SWOT Analysis, 2015 186
Table 75: Product Profile - Gazyva 189
Table 76: Efficacy of Gazyva in Indolent NHL 191
Table 77: Efficacy of Gazyva in DLBCL 192
Table 78: Safety of Gazyva 193
Table 79: Safety of Gazyva in DLBCL 194
Table 80: Gazyva SWOT Analysis, 2015 195
Table 81: Product Profile - Opdivo 197
Table 82: Efficacy of Opdivo 198
Table 83: Safety of Opdivo 199
Table 84: Opdivo SWOT Analysis, 2015 199
Table 85: Early-Stage Pipeline Products in Non-Hodgkin's Lymphoma 201
Table 86: Clinical Benchmarking of Key Marketed and Pipeline Drugs - Indolent NHL, First-Line Therapies, 2015 208
Table 87: Clinical Benchmarking of Key Marketed and Pipeline Drugs - Indolent NHL, Relapsed/Refractory Therapies, 2015 210
Table 88: Clinical Benchmarking of Key Marketed and Pipeline Drugs - Indolent NHL, Consolidation/Maintenance Therapies, 2015 211
Table 89: Clinical Benchmarking of Key Marketed and Pipeline Drugs - Aggressive NHL, First-Line Therapies, 2015 212
Table 90: Clinical Benchmarking of Key Marketed and Pipeline Drugs - Aggressive NHL, Relapsed/Refractory Therapies, 2015 213
Table 91: Clinical Benchmarking of Key Marketed and Pipeline Drugs - Aggressive NHL, Consolidation/Maintenance Therapies, 2015 214
Table 92: Commercial Benchmarking of Key Marketed and Pipeline Drugs - NHL, 2015 216
Table 93: Commercial Benchmarking of Key Marketed and Pipeline Drugs - NHL, 2015 (continued from Table 93) 217
Table 94: Top-Line Sales Forecasts ($bn) for NHL, 2014-2024 222
Table 95: Key Events Impacting Sales for NHL in the 7MM, 2014-2024 223
Table 96: NHL Market in the US and 5EU - Drivers and Barriers, 2015 224
Table 97: NHL Patient Population Segmentations in the 7MM - Secondary Sources 262
Table 98: Patient Populations Targeted by NHL Marketed and Pipeline Drug Developers 263
Table 99: NHL Marketed and Pipeline Products Broken Down by Therapeutic Class 264
Table 100: Key Branded Drug Key Launch Dates and Patent Expiries for NHL in the 7MM 265
Table 101: Key Generic and Biosimilar Entry Dates for NHL in the 7MM 273
Table 102: High-Prescribing Physicians Surveyed by Country 277

1.2 List of Figures
Figure 1: Common Follicular Lymphoma Drug Treatment Options by Line of Therapy in the 7MM, 2015 36
Figure 2: Common Marginal Zone Lymphoma Drug Treatment Options by Line of Therapy in the 7MM, 2015 38
Figure 3: Common Diffuse Large B-Cell Lymphoma Drug Treatment Options by Line of Therapy in the 7MM, 2015 41
Figure 4: Common Mantle Cell Lymphoma Drug Treatment Options by Line of Therapy in the 7MM, 2015 43
Figure 5: 7MM, Incident Cases of Follicular Lymphoma, Ages ?30 Years, Both Sexes, N, 2014-2024 62
Figure 6: 7MM, Age-Specific Incident Cases of Follicular Lymphoma, Ages ?30 Years, Both Sexes, N, 2014 64
Figure 7: 7MM, Sex-Specific Incident Cases of Follicular Lymphoma, Ages ?30 Years, N, 2014 66
Figure 8: 7MM, Age-Standardized Incidence of Follicular Lymphoma (Cases per 100,000 Population), Ages ?30 Years, by Sex, 2014 67
Figure 9: 7MM, Incident Cases of Marginal Zone Lymphoma, Ages ?30 Years, Both Sexes, N, 2014-2024 69
Figure 10: 7MM, Age-Specific Incident Cases of Marginal Zone Lymphoma, Ages ?30 Years, Both Sexes, N, 2014 71
Figure 11: 7MM, Sex-Specific Incident Cases of Marginal Zone Lymphoma, Ages ?30 Years, N, 2014 73
Figure 12: 7MM, Age-Standardized Incidence of Marginal Zone Lymphoma (Cases per 100,000 Population), Ages ?30 Years, by Sex, 2014 74
Figure 13: 7MM, Incident Cases of DLBCL, Ages ?30 Years, Both Sexes, N, 2014-2024 75
Figure 14: 7MM, Age-Specific Incident Cases of DLBCL, Ages ?30 Years, Both Sexes, N, 2014 78
Figure 15: 7MM, Sex-Specific Incident Cases of DLBCL, Ages ?30 Years, N, 2014 80
Figure 16: 7MM, Age-Standardized Incidence of DLBCL (Cases per 100,000 Population), Ages ?30 Years, by Sex, 2014 81
Figure 17: 7MM, Incident Cases of Mantle Cell Lymphoma, Ages ?30 Years, Both Sexes, N, 2014-2024 83
Figure 18: 7MM, Age-Specific Incident Cases of Mantle Cell Lymphoma, Both Sexes, N, 2014 85
Figure 19: 7MM, Sex-Specific Incident Cases of Mantle Cell Lymphoma, Ages ?30 Years, N, 2014 87
Figure 20: 7MM, Age-Standardized Incidence of Mantle Cell Lymphoma (Cases per 100,000 Population), Ages ?30 Years, by Sex, 2014 88
Figure 21: Imbruvica - Ongoing Clinical Trials in B-Cell NHL 96
Figure 22: Revlimid - Ongoing Clinical Trials in B-Cell NHL 103
Figure 23: Velcade - Ongoing Clinical Trials in B-Cell NHL 118
Figure 24: Zydelig - Ongoing Clinical Trials in B-Cell NHL 126
Figure 25: Afinitor - Phase III Trial in Aggressive B-Cell NHL 168
Figure 26: Arzerra - Phase II and III Trials in Indolent and Aggressive NHL 174
Figure 27: Copanlisib - Phase II and III Trials in Indolent and Aggressive NHL 180
Figure 28: Duvelisib - Phase II and III Trials in Indolent NHL 185
Figure 29: Gazyva - Phase II and III Trials in Indolent and Aggressive NHL 190
Figure 30: Opdivo - Phase II Trials in Indolent and Aggressive NHL 197
Figure 31: Competitive Assessment of the Key Marketed and Late-Stage Pipeline Agents in Indolent NHL, 2014-2024 220
Figure 32: Competitive Assessment of the Key Marketed and Late-Stage Pipeline Agents in Aggressive NHL, 2014-2024 221

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