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

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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.

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.

Key Highlights

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)?

Pharmacyclics
AbbVie
Janssen
Celgene
Takeda/Millennium
Gilead
Novartis
Bayer
Infinity
Roche
Bristol-Myers Squibb
Seattle Genetics
Amgen
Curis
Genmab
Onyx
Immunomedics
Juno
Kite
Genentech
Biogen
Astellas
Spectrum
Chugai
MedImmune

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Pathophysiology of Indolent and Aggressive B-Cell NHL

3.2Symptoms

4Disease Management

4.1Diagnosis

4.2Diagnostic Classification

4.2.1Follicular Lymphoma

4.2.2Marginal Zone Lymphoma

4.2.3Diffuse Large B-Cell Lymphoma

4.2.4Mantle Cell Lymphoma

4.3Treatment Overview

4.3.1Follicular Lymphoma

4.3.2Marginal Zone Lymphoma

4.3.3Diffuse Large B-Cell Lymphoma

4.3.4Mantle Cell Lymphoma

5Epidemiology

5.1Disease Background

5.2Risk Factors and Comorbidities

5.3Global Trends

5.3.1US

5.3.25EU

5.3.3Japan

5.4Forecast Methodology

5.4.1Sources Used

5.4.2Sources Not Used

5.4.3Forecast Assumptions and Methods

5.5Epidemiological Forecast for B-Cell NHL (2014–2024)

5.5.1Follicular Lymphoma

5.5.2Marginal Zone Lymphoma

5.5.3Diffuse Large B-Cell Lymphoma

5.5.4Mantle Cell Lymphoma

5.6Discussion

5.6.1Epidemiological Forecast Insight

5.6.2Limitations of the Analysis

5.6.3Strengths of the Analysis

6Current Treatment Options

6.1Overview

6.2Product Profiles – Major Brands

6.2.1Imbruvica (ibrutinib)

6.2.2Revlimid (lenalidomide)

6.2.3Rituxan (rituximab)

6.2.4Treanda (bendamustine)

6.2.5Velcade (bortezomib)

6.2.6Zevalin (ibritumomab tiuxetan)

6.2.7Zydelig (idelalisib, GS-1101, CAL-101)

7Unmet Needs Assessment and Opportunity Analysis

7.1Overview

7.2Unmet Needs Analysis

7.2.1Unmet Need: Therapies That Prolong OS or PFS and Delay Relapse in Indolent NHL Patients

7.2.2Unmet Need: Safe and More Tolerable Front-Line Agents for Indolent NHL Patients

7.2.3Unmet Need: Prolonged Survival Rates for MCL Patients

7.2.4Unmet Need: Improved Cure Rate and Survival for DLBCL Patients after Front-Line Therapy

7.2.5Unmet Need: Predictive and Prognostic Molecular Biomarkers

7.3Opportunity Analysis

7.3.1Opportunity: More Cost-Effective Therapies

7.3.2Opportunity: Improved Consolidation/Maintenance Therapies for Follicular NHL Patients

7.3.3Opportunity: Novel Agents for Front-Line DLBCL and MCL Therapy

7.3.4Opportunity: Development of Novel Therapies for NHL Patients

8Research and Development Strategies

8.1Overview

8.1.1Targeting Multiple NHL Subtypes and Lines of Therapy to Capture the Greatest Patient Share

8.1.2Inhibiting New Targets in Relapsed/Refractory NHL Patients

8.1.3Novel Approaches to NHL Treatment

8.1.4Developing Novel Drugs in Combination with Rituxan to Replace Chemoimmunotherapy Regimens

8.1.5Developing Second-Generation Therapies to Replace the Established Standards of Care at the End of Patent Life

8.1.6Companies Collaborating on Investigator-Sponsored, Early-Stage Trials to Minimize Up-Front Risk

8.1.7Introducing New Routes of Drug Delivery to Improve Patient Convenience

8.2Clinical Trial Design

8.2.1Indolent and Aggressive B-Cell NHL

8.2.2Clinical Endpoints

8.2.3Comparator Arms

9Pipeline Assessment

9.1Overview

9.2Promising Drugs in Clinical Development

9.2.1Afinitor (everolimus)

9.2.2Arzerra (ofatumumab)

9.2.3Copanlisib (BAY 80-6946)

9.2.4Duvelisib (IPI-145)

9.2.5Gazyva (obinutuxumab)

9.2.6Opdivo (nivolumab)

9.3Innovative Early-Stage Approaches

9.3.1Adcetris (brentuximab vedotin)

9.3.2Blinatumomab (AMG-103)

9.3.3CUDC-907

9.3.4Daratumumab

9.3.5Kyprolis (carfilzomib)

9.3.6Y-90 Epratuzumab

9.3.7Chimeric Antigen Receptor T-Cell Therapies

10Pipeline Valuation Analysis

10.1Clinical Benchmarking of Key Pipeline Drugs

10.1.1Indolent NHL

10.1.2Aggressive NHL

10.2Commercial Benchmarking of Key Pipeline Drugs

10.3Competitive Assessment

10.4Top-Line, 10-Year Forecast

10.4.1US

10.4.25EU

10.4.3Japan

11Appendix

11.1Bibliography

11.2Abbreviations

11.3Methodology

11.4Forecasting Methodology

11.4.1NHL Patient Population Segmentation

11.4.2Percentage of Drug-Treated Patients

11.4.3Drugs Included in Each Therapeutic Class

11.4.4Launch and Patent Expiry Dates

11.4.5General Pricing Assumptions

11.4.6Individual Drug Assumptions

11.4.7Generic and Biosimilar Erosion

11.5Primary Research

11.5.1Physicians and Specialists Included in This Study

11.5.2Online Survey of High Prescribing Physicians

11.6About the Authors

11.6.1Analyst

11.6.2Epidemiologist

11.6.3Therapy Area Director

11.6.4Global Director of Therapy Analysis and Epidemiology

11.6.5Global Head of Healthcare

11.7About GlobalData

11.8Disclaimer

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