OpportunityAnalyzer: Non-Hodgkins B-Cell Lymphoma Opportunity Analysis and Forecast to 2018 Released On 3rd September 2014
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 JSB Market Research Pvt. Ltd.
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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-tomarket 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 secondgeneration 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. JSB Market Research Pvt. Ltd.
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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 Bcell 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. JSB Market Research Pvt. Ltd.
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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 1.1 List of Tables 13 1.2 List of Figures 15 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 JSB Market Research Pvt. Ltd.
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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 JSB Market Research Pvt. Ltd.
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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 R&D 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 JSB Market Research Pvt. Ltd.
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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 JSB Market Research Pvt. Ltd.
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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 JSB Market Research Pvt. Ltd.
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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 JSB Market Research Pvt. Ltd.
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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
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 JSB Market Research Pvt. Ltd.
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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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