Current And Future Market Analysis Of Non-Hodgkins B-Cell Lymphoma Market 2018: Opportunity and Forecast

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About Non-Hodgkins B-Cell Lymphoma Market

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/Janssens Imbruvica, which was approved for relapsed/refractory MCL patients in November 2013, Gileads Zydelig, which was approved for relapsed/refractory FL patients in July 2014, and Roches Gazyva, which will launch in 2015.

Highlights

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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, Zydeligs 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.

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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.

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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

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