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OpportunityAnalyzer: Non-Hodgkin’s B-Cell Lymphoma - Opportunity Analysis and Forecast to 2018

Summary

The competitive landscape in the B-cell NHL markets in the US, France, Italy, Germany, Spain and the UK is poised to undergo a dramatic shift during the forecast period. Disease management of the four largest B-cell NHL indications, which includes Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), and Mantle Cell Lymphoma (MCL), currently revolves around multiple rounds of Rituxan-based chemotherapy. Although patients can achieve durable remissions to induction therapy, those patients who relapse after primary treatment have poor prognosis and high unmet needs. Several promising pipeline agents are set to have a dramatic impact on treatment of these relapsed/refractory patients over the forecast period: Pharmacyclics’/Janssen’s Imbruvica, which was approved for relapsed/refractory MCL patients in November 2013, Gilead’s Zydelig, which was approved for relapsed/refractory FL patients in July 2014, and Roche’s Gazyva, which will launch in 2015.

Highlights

Key Questions Answered

- How will the launch of Imbruvica and Zydelig impact the treatment landscape of relapsed/refractory MCL and FL patients?
- How will the launch of Gazyva and the subcutaneous formulation of MabThera help Roche protect their hematology franchise from biosimilar rituximab competition in the 5EU?
- The new agents will launch first in one B-cell indication before seeking label expansion into broader NHL patient populations. How will companies expand their hematology candidates beyond their initial approvals?
- Pharmacyclics has set a high pricing bar with a high ACOT for Imbruvica. How will this pricing strategy affect pricing of other pipeline agents, and will this be a barrier to entry in cost-conscious EU markets?
- The new agents address significant unmet needs in the relapsed/refractory NHL population. What remaining opportunity will remain after their launch?

Key Findings

- Imbruvica will gain significant patient share in the relapsed/refractory MCL market before expanding into the r/r FL setting. However, Zydelig’s time-to-market advantage as well as potentially superior clinical profile in FL patients will result in Zydelig maintaining the market lead in these patients.
- There is significant opportunity for the new agents Imbruvica and Zydelig, which are delivered orally and would greatly increase patient convenience in addition to providing superior clinical benefit over chemoimmunotherapy regimens.
- Physicians in the US and 5EU are eager to eventually transition their patients onto chemo-free combination regimens, and the new oral agents in combination with Rituxan or Gazyva have the potential to address this need in the first line.
- The loss of patent protection in 2013 for the gold-standard CD20 antibody MabThera (Rituxan) will have a significant impact on market growth in the 5EU, as biosimilar competition is expected beginning in 2018. By launching the second-generation CD20 antibody Gazyva, as well as a subcutaneous formulation of MabThera that greatly increases patient convenience, Roche will effectively maintain significant NHL patient share over biosimilar competitors in 2018.
- Many relapsed/refractory NHL patients seek treatment in clinical trials, due to the low clinical efficacy conferred by available chemoimmunotherapy regimens after failure of first-line treatment. As the pipeline agents gain approval and enter the market, GlobalData anticipates that trial registration will decrease, contributing to overall market growth in the US and 5EU as more patients opt to receive treatment outside of the clinical trial setting.

Scope

- Overview of B-cell NHL, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines for DLBCL, FL, MZL and MCL.
- Annualized B-cell NHL (including DLBCL. FL. MZL and MCL) therapeutics market revenue, annual cost of therapy and patient share in the first-line and relapsed/refractory setting (as well as consolidation/maintenance for FL patients) forecast from 2013 to 2018.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the B-cell NHL therapeutics market
- Pipeline analysis: The B-cell NHL pipeline is relatively small, but dominated by high profile novel therapies with the potential to be significant game changers.
- Analysis of the current and future market competition in the global B-cell NHL markets, including insightful review of the key industry drivers, barriers and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

- Develop business strategies by understanding the trends shaping and driving the B-cell NHL therapeutics markets in the US and 5EU.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global NHL therapeutics market in 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.
- Forecast drug sales in the global B-cell NHL therapeutics market from 2013-2018.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies.

Table Of Contents

OpportunityAnalyzer: Non-Hodgkin’s B-Cell Lymphoma - Opportunity Analysis and Forecast to 2018
1 Table of Contents

2 Introduction 17
2.1 Catalyst 17
2.2 Related Reports 17
2.3 Upcoming Related Reports 17
3 Disease Overview 18
3.1 Etiology and Pathophysiology 18
3.1.1 Pathophysiology of Indolent and Aggressive B-Cell NHL 19
3.2 Symptoms 23
4 Disease Management 24
4.1 Diagnosis 24
4.1.1 Diagnostic Classification 25
4.2 Treatment Overview 27
5 Epidemiology 33
5.1 Disease Background 33
5.2 Risk Factors and Comorbidities 33
5.3 Global Trends 35
5.3.1 US 36
5.3.2 US 36
5.3.3 5EU 37
5.4 Forecast Methodology 40
5.4.1 Sources Used 42
5.4.2 Forecast Assumptions and Methods 44
5.4.3 Age-Standardized Incidence Rates 48
5.5 Epidemiological Forecast for B-Cell NHL (2013-2023) 48
5.5.1 Follicular Lymphoma 48
5.5.2 Marginal Zone Lymphoma 54
5.5.3 DLBCL 59
5.5.4 Mantle Cell Lymphoma 64
5.6 Discussion 71
5.6.1 Epidemiological Forecast Insight 71
5.6.2 Limitations of the Analysis 72
5.6.3 Strengths of the Analysis 73
6 Current Treatment Options 74
6.1 Overview 74
6.2 Product Profiles - Major Brands, Follicular Lymphoma 76
6.2.1 Imbruvica (ibrutinib) 76
6.2.2 Revlimid (lenalidomide) 80
6.2.3 Rituxan/MabThera (rituximab) 85
6.2.4 Treanda (bendamustine) 91
6.2.5 Velcade (bortezomib) 93
6.2.6 Zevalin (ibritumomab tiuxetan) 96
6.2.7 Zydelig (idelalisib, GS-1101, CAL-101) 100
7 Unmet Needs Assessment and Opportunity Analysis 104
7.1 Overview 104
7.2 Unmet Needs Analysis 104
7.2.1 Unmet Need: Safe and Tolerable Front-Line Agents for Indolent NHL Patients that Prolong OS and Delay Relapse 104
7.2.2 Unmet Need: Prolonged Survival Rates for Mantle Cell Patients 105
7.2.3 Unmet Need: Improved Cure Rate for DLBCL Patients after Front-Line Therapy 105
7.2.4 Unmet Need: Predictive and Prognostic Molecular Biomarkers 106
7.3 Opportunity Analysis 107
7.3.1 Opportunity: More Cost-Effective Therapies 107
7.3.2 Opportunity: Better Consolidation/Maintenance Therapies for Follicular Patients 107
7.3.3 Novel Agents for Front-Line DLBCL and Mantle Cell Lymphoma Therapy 108
8 RandD Strategies 109
8.1 Overview 109
8.1.1 Targeting Multiple NHL Subtypes and Lines of Therapy to Capture Greatest Patient Share 110
8.1.2 Inhibiting New Targets in Relapsed/Refractory NHL Patients 111
8.1.3 Developing Novel Drugs in Combination with Rituxan/MabThera to Replace Chemoimmunotherapy Regimens 112
8.1.4 Franchise Management through Developing Novel Second-Generation Therapies to Replace Established Standards of Care at the End of Their Patent Life 112
8.1.5 Small Biotechs Collaborating on Investigator-Sponsored Early-Stage Trials to De-Risk Later-Stage Studies 113
8.1.6 Introducing New Routes of Drug Delivery to Improve Patient Convenience 114
8.2 Clinical Trial Design 115
8.2.1 Indolent B-Cell NHL 115
8.2.2 Aggressive B-Cell NHL 117
8.2.3 Clinical Endpoints 118
8.2.4 Comparator Arms 119
9 Pipeline Assessment 121
9.1 Overview 121
9.2 Promising Drugs in Clinical Development 121
9.2.1 Arzerra (ofatumumab) 122
9.2.2 Gazyva (obinutuzumab) 125
9.3 Innovative Early-Stage Approaches 130
9.3.1 Adcetris (brentuximab vedotin) 132
9.3.2 Alisertib (MLN8237) 132
9.3.3 Blinatumomab (AMG-101) 133
9.3.4 Copanlisib (BAY 80-6946) 133
9.3.5 Y-90 Epratuzumab 134
9.3.6 Chimeric Antigen Receptor T-Cell Therapies 135
10 Pipeline Valuation Analysis 136
10.1 Clinical Benchmark of Key Pipeline Drugs 136
10.2 Commercial Benchmark of Key Pipeline Drugs 139
10.3 Competitive Assessment 140
10.4 Top Line Five Year Forecast 142
10.4.1 US 144
10.4.2 5EU 145
11 Appendix 146
11.1 Bibliography 146
11.2 Abbreviations 162
11.3 Methodology 168
11.4 Forecasting Methodology 168
11.4.1 Diagnosed NHL patients 168
11.4.2 Percent Drug-Treated Patients 168
11.4.3 Drugs Included in Each Therapeutic Class 169
11.4.4 Launch and Patent Expiry Dates 169
11.4.5 General Pricing Assumptions 170
11.4.6 Individual Drug Assumptions 170
11.4.7 Generic Erosion 173
11.4.8 Pricing of Pipeline agents 173
11.5 Physicians and Specialists Included in This Study 174
11.6 Survey of Prescribing Physicians 174
11.7 About the Authors 175
11.7.1 Authors 175
11.7.2 Epidemiologist 176
11.7.3 Global Head of Healthcare 176
11.8 About GlobalData 177
11.9 Disclaimer 177

1.1 List of Tables

Table 1: Non-Hodgkin's Lymphomas 20
Table 2: Symptoms of Non-Hodgkin's Lymphoma 23
Table 3: The Ann Arbor Staging Criteria for NHL (Cotswolds Modification) 24
Table 4: Molecular Characteristics of Non-Hodgkin's Lymphoma (2008 WHO Classification) 27
Table 5: Treatment Guidelines for Non-Hodgkin's Lymphoma 27
Table 6: Risk Factors and Comorbidities for NHL 35
Table 7: US, Age- and Sex-Specific Incidence of B-Cell NHL during 2001-2010 37
Table 8: 6MM, Sources of B-Cell NHL Incidence Data 41
Table 9: 6MM, Incident Cases of Follicular Lymphoma, Ages ?30 Years, Both Sexes, N, Selected Years 2013-2023 49
Table 10: 6MM, Age-Specific Incident Cases of Follicular Lymphoma, Both Sexes, N (Row %), 2013 50
Table 11: 6MM, Sex-Specific Incident Cases of Follicular Lymphoma, Ages ?30 Years, N (Row %), 2013 52
Table 12: 6MM, Incident Cases of Marginal Zone Lymphoma, Ages ?30 Years, Both Sexes, N, Selected Years 2013-2023 55
Table 13: 6MM, Age-Specific Incident Cases of Marginal Zone Lymphoma, Both Sexes, N (Row %), 2013 56
Table 14: 6MM, Sex-Specific Incident Cases of Marginal Zone Lymphoma, Ages ?30 Years, N (Row %), 2013 58
Table 15: 6MM, Incident Cases of DLBCL, Ages ?30 Years, Both Sexes, N, Selected Years 2013-2023 60
Table 16: 6MM, Age-Specific Incident Cases of DLBCL, Both Sexes, N (Row %), 2013 61
Table 17: 6MM, Sex-Specific Incident Cases of DLBCL, Ages ?30 Years, N (Row %), 2013 63
Table 18: 6MM, Incident Cases of Mantle Cell Lymphoma, Ages ?30 Years, Both Sexes, N, Selected Years 2013-2023 65
Table 19: 6MM, Age-Specific Incident Cases of Mantle Cell Lymphoma, Both Sexes, N (Row %), 2013 67
Table 20: 6MM, Sex-Specific Incident Cases of Mantle Cell Lymphoma, Ages ?30 Years, N (Row %), 2013 69
Table 21: Leading Treatments for NHL 75
Table 22: Product Profile - Imbruvica (ibrutinib) 77
Table 23: Imbruvica SWOT Analysis, 2013 80
Table 24: Product Profile - Revlimid (lenalidomide) 82
Table 25: Revlimid SWOT Analysis, 2013 85
Table 26: Product Profile - Rituxan (rituximab) 88
Table 27: Rituxan SWOT Analysis, 2013 90
Table 28: Product Profile - Treanda (bendamustine) 92
Table 29: Treanda SWOT Analysis, 2013 93
Table 30: Product Profile - Velcade (bortezomib) 95
Table 31: Velcade SWOT Analysis, 2013 96
Table 32: Product Profile - Zevalin (ibritumomab tiuxetan) 98
Table 33: Zevalin SWOT Analysis, 2013 100
Table 34: Product Profile - Zydelig (idelalisib) 101
Table 35: Zydelig SWOT Analysis, 2013 103
Table 36: Overall Unmet Needs - Current Level of Attainment 104
Table 37: Design of Current Registrational Trials in indolent NHL 115
Table 38: Design of Current Registrational Trials in Aggressive NHL 117
Table 39: Non-Hodgkin's Lymphoma - Phase III Pipeline, 2013 121
Table 40: Product Profile - Arzerra (ofatumumab) 123
Table 41: Arzerra SWOT Analysis, 2013 125
Table 42: Product Profile - Gazyva (obinutuzumab) 127
Table 43: Gazyva SWOT Analysis, 2013 129
Table 44: Early-Stage Pipeline Products in Non-Hodgkin's Lymphoma 131
Table 45: Clinical Benchmark of Key Marketed and Pipeline Drugs - Indolent NHL, Relapsed/Refractory Therapies 138
Table 46: Clinical Benchmark of Key Marketed and Pipeline Drugs - Aggressive NHL, Relapsed/Refractory Therapies 139
Table 47: Commercial Benchmark of Key Marketed and Pipeline Drugs 140
Table 48: Top Line Sales Forecasts ($bn) for NHL, 2013-2018 143
Table 49: Key Events Impacting Sales for NHL in the US and 5EU, 2013 143
Table 50: NHL Market in the US and 5EU - Drivers and Barriers, 2013 144
Table 51: Key Branded Drug Launch Dates 169
Table 52: Key Patent/Exclusivity Expiries 170
Table 53: Physicians Surveyed by Country 174

1.2 List of Figures

Figure 1: 6MM, Incident Cases of Follicular Lymphoma, Ages ?30 Years, Both Sexes, N, 2013-2023 49
Figure 2: 6MM, Age-Specific Incident Cases of Follicular Lymphoma, Both Sexes, N, 2013 51
Figure 3: 6MM, Sex-Specific Incident Cases of Follicular Lymphoma, Ages ?30 Years, N, 2013 53
Figure 4: 6MM, Age-Standardized Incidence of Follicular Lymphoma (Cases per 100,000 Population), Ages ?30 Years, 2013 54
Figure 5: 6MM, Incident Cases of Marginal Zone Lymphoma, Ages ?30 Years, Both Sexes, N, 2013-2023 55
Figure 6: 6MM, Age-Specific Incident Cases of Marginal Zone Lymphoma, Both Sexes, N, 2013 57
Figure 7: 6MM, Sex-Specific Incident Cases of Marginal Zone Lymphoma, Ages ?30 Years, N, 2013 58
Figure 8: 6MM, Age-Standardized Incidence of Marginal Zone Lymphoma (Cases per 100,000 Population), Ages ?30 Years, 2013 59
Figure 9: 6MM, Incident Cases of DLBCL, Ages ?30 Years, Both Sexes, N, 2013-2023 60
Figure 10: 6MM, Age-Specific Incident Cases of DLBCL, Both Sexes, N, 2013 62
Figure 11: 6MM, Sex-Specific Incident Cases of DLBCL, Ages ?30 Years, N, 2013 63
Figure 12:6MM, Age-Standardized Incidence of DLBCL (Cases per 100,000 Population), Ages ?30 Years, 2013 64
Figure 13:6MM, Incident Cases of Mantle Cell Lymphoma, Ages ?30 Years, Both Sexes, N, 2013-2023 66
Figure 14: 6MM, Age-Specific Incident Cases of Mantle Cell Lymphoma, Both Sexes, N, 2013 68
Figure 15: 6MM, Sex-Specific Incident Cases of Mantle Cell Lymphoma, Ages ?30 Years, N, 2013 70
Figure 16:6MM, Age-Standardized Incidence of Mantle Cell Lymphoma (Cases per 100,000 Population), Ages ?30 Years, 2013 71
Figure 17: Imbruvica - Phase II and III Trials in Indolent and Aggressive NHL 78
Figure 18: Revlimid - Phase II and III Trials in Indolent and Aggressive NHL 83
Figure 19: Velcade - Phase II and III Trials in Indolent and Aggressive NHL 95
Figure 20: Zevalin - Phase II and III Trials in Indolent and Aggressive NHL 98
Figure 21: Zydelig - Phase II and III Trials 102
Figure 22: Arzerra - Phase II and III Trials in Indolent and Aggressive NHL 123
Figure 23: Gazyva - Phase II and III Trials in Indolent and Aggressive NHL 128
Figure 24:Competitive Assessment of Key Marketed and Pipeline Drugs - Indolent NHL, Relapsed/Refractory Therapies, 2013-2018 141
Figure 25:Competitive Assessment of Key Marketed and Pipeline Drugs - Aggressive NHL, Relapsed/Refractory Therapies, 2013-2018 142

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