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

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OpportunityAnalyzer: 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...
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OpportunityAnalyzer: 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.

Additional Information

Additional Information

Publisher name GlobalData.
Format PDF
Page count 282
Publication date 1 Jan 2016
Table of contents 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

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