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

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Non-Hodgkins 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.

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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.

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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

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