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

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)?

Companies mentioned

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

List of Tables

Table 1: Non-Hodgkin’s Lymphoma Subtypes

Table 2: Symptoms of Non-Hodgkin’s Lymphoma

Table 3: The Ann Arbor Staging System and the Cotswold Modifications for NHL

Table 4: Molecular Characteristics of Non-Hodgkin’s Lymphoma (2008 WHO Classification)

Table 5: Treatment Guidelines for Non-Hodgkin’s Lymphoma in the 7MM

Table 6: Risk Factors and Comorbidities for NHL

Table 7: US, Age- and Sex-Specific Incidence of B-Cell NHL During 2001–2010

Table 8: 7MM, Sources of B-Cell NHL Incidence Data

Table 9: 7MM, Incident Cases of Follicular Lymphoma, Ages =30 Years, Both Sexes, N, Selected Years 2014–2024

Table 10: 7MM, Age-Specific Incident Cases of Follicular Lymphoma, Both Sexes, N (Row %), 2014

Table 11: 7MM, Sex-Specific Incident Cases of Follicular Lymphoma, Ages =30 Years, N (Row %), 2014

Table 12: 7MM, Incident Cases of Marginal Zone Lymphoma, Ages =30 Years, Both Sexes, N, Selected Years 2014–2024

Table 13: 7MM, Age-Specific Incident Cases of Marginal Zone Lymphoma, Both Sexes, N (Row %), 2014

Table 14: 7MM, Sex-Specific Incident Cases of Marginal Zone Lymphoma, Ages =30 Years, N (Row %), 2014

Table 15: 7MM, Incident Cases of DLBCL, Ages =30 Years, Both Sexes, N, Selected Years, 2014–2024

Table 16: 7MM, Age-Specific Incident Cases of DLBCL, Both Sexes, N (Row %), 2014

Table 17: 7MM, Sex-Specific Incident Cases of DLBCL, Ages =30 Years, N (Row %), 2014

Table 18: 7MM, Incident Cases of Mantle Cell Lymphoma, Ages =30 Years, Both Sexes, N, Selected Years 2014–2024

Table 19: 7MM, Age-Specific Incident Cases of Mantle Cell Lymphoma, Both Sexes, N (Row %), 2014

Table 20: 7MM, Sex-Specific Incident Cases of Mantle Cell Lymphoma, Ages =30 Years, N (Row %), 2014

Table 21: Leading Treatments for NHL Patients in the 7MM

Table 22: Product Profile – Imbruvica

Table 23: Efficacy of Imbruvica in MCL

Table 24: Efficacy of Imbruvica in FL

Table 25: Efficacy of Imbruvica in DLBCL

Table 26: Safety of Imbruvica in MCL

Table 27: Imbruvica SWOT Analysis, 2015

Table 28: Product Profile – Revlimid

Table 29: Efficacy of Revlimid in MCL

Table 30: Efficacy of Revlimid in DLBCL

Table 31: Efficacy of Revlimid in DLBCL

Table 32: Safety of Revlimid

Table 33: Revlimid SWOT Analysis, 2015

Table 34: Product Profile – Rituxan

Table 35: Efficacy of Rituxan

Table 36: Safety of Rituxan

Table 37: Rituxan SWOT Analysis, 2015

Table 38: Product Profile – Treanda

Table 39: Efficacy of Treanda

Table 40: Safety of Treanda

Table 41: Treanda SWOT Analysis, 2015

Table 42: Product Profile – Velcade

Table 43: Efficacy of Velcade

Table 44: Safety of Velcade

Table 45: Velcade SWOT Analysis, 2015

Table 46: Product Profile – Zevalin

Table 47: Efficacy of Zevalin

Table 48: Safety of Zevalin

Table 49: Zevalin SWOT Analysis, 2015

Table 50: Product Profile – Zydelig

Table 51: Efficacy of Zydelig

Table 52: Safety of Zydelig

Table 53: Zydelig SWOT Analysis, 2015

Table 54: Overall Unmet Needs – Current Level of Attainment

Table 55: Key Products in the Present and Future B-Cell NHL Market, 2015

Table 56: Design of Current Registration Trials in Indolent B-Cell NHL

Table 57: Design of Current Registration Trials in Aggressive B-Cell NHL

Table 58: Non-Hodgkin’s Lymphoma – Late-Stage Pipeline, 2015

Table 59: Product Profile – Afinitor

Table 60: Efficacy of Afinitor in DLBCL

Table 61: Safety of Afinitor in DLBCL

Table 62: Afinitor SWOT Analysis, 2015

Table 63: Product Profile – Arzerra

Table 64: Efficacy of Arzerra in FL

Table 65: Safety of Arzerra in FL

Table 66: Arzerra SWOT Analysis, 2015

Table 67: Product Profile – Copanlisib

Table 68: Efficacy of Copanlisib

Table 69: Safety of Copanlisib

Table 70: Copanlisib SWOT Analysis, 2015

Table 71: Product Profile – Duvelisib

Table 72: Efficacy of Duvelisib

Table 73: Safety of Duvelisib

Table 74: Duvelisib SWOT Analysis, 2015

Table 75: Product Profile – Gazyva

Table 76: Efficacy of Gazyva in Indolent NHL

Table 77: Efficacy of Gazyva in DLBCL

Table 78: Safety of Gazyva

Table 79: Safety of Gazyva in DLBCL

Table 80: Gazyva SWOT Analysis, 2015

Table 81: Product Profile – Opdivo

Table 82: Efficacy of Opdivo

Table 83: Safety of Opdivo

Table 84: Opdivo SWOT Analysis, 2015

Table 85: Early-Stage Pipeline Products in Non-Hodgkin’s Lymphoma

Table 86: Clinical Benchmarking of Key Marketed and Pipeline Drugs – Indolent NHL, First-Line Therapies, 2015

Table 87: Clinical Benchmarking of Key Marketed and Pipeline Drugs – Indolent NHL, Relapsed/Refractory Therapies, 2015

Table 88: Clinical Benchmarking of Key Marketed and Pipeline Drugs – Indolent NHL, Consolidation/Maintenance Therapies, 2015

Table 89: Clinical Benchmarking of Key Marketed and Pipeline Drugs – Aggressive NHL, First-Line Therapies, 2015

Table 90: Clinical Benchmarking of Key Marketed and Pipeline Drugs – Aggressive NHL, Relapsed/Refractory Therapies, 2015

Table 91: Clinical Benchmarking of Key Marketed and Pipeline Drugs – Aggressive NHL, Consolidation/Maintenance Therapies, 2015

Table 92: Commercial Benchmarking of Key Marketed and Pipeline Drugs – NHL, 2015

Table 93: Commercial Benchmarking of Key Marketed and Pipeline Drugs – NHL, 2015 (continued from Table 93)

Table 94: Top-Line Sales Forecasts ($bn) for NHL, 2014–2024

Table 95: Key Events Impacting Sales for NHL in the 7MM, 2014–2024

Table 96: NHL Market in the US and 5EU – Drivers and Barriers, 2015

Table 97: NHL Patient Population Segmentations in the 7MM – Secondary Sources

Table 98: Patient Populations Targeted by NHL Marketed and Pipeline Drug Developers

Table 99: NHL Marketed and Pipeline Products Broken Down by Therapeutic Class

Table 100: Key Branded Drug Key Launch Dates and Patent Expiries for NHL in the 7MM

Table 101: Key Generic and Biosimilar Entry Dates for NHL in the 7MM

Table 102: High-Prescribing Physicians Surveyed by Country

List of Figures

Figure 1: Common Follicular Lymphoma Drug Treatment Options by Line of Therapy in the 7MM, 2015

Figure 2: Common Marginal Zone Lymphoma Drug Treatment Options by Line of Therapy in the 7MM, 2015

Figure 3: Common Diffuse Large B-Cell Lymphoma Drug Treatment Options by Line of Therapy in the 7MM, 2015

Figure 4: Common Mantle Cell Lymphoma Drug Treatment Options by Line of Therapy in the 7MM, 2015

Figure 5: 7MM, Incident Cases of Follicular Lymphoma, Ages =30 Years, Both Sexes, N, 2014–2024

Figure 6: 7MM, Age-Specific Incident Cases of Follicular Lymphoma, Ages =30 Years, Both Sexes, N, 2014

Figure 7: 7MM, Sex-Specific Incident Cases of Follicular Lymphoma, Ages =30 Years, N, 2014

Figure 8: 7MM, Age-Standardized Incidence of Follicular Lymphoma (Cases per 100,000 Population), Ages =30 Years, by Sex, 2014

Figure 9: 7MM, Incident Cases of Marginal Zone Lymphoma, Ages =30 Years, Both Sexes, N, 2014–2024

Figure 10: 7MM, Age-Specific Incident Cases of Marginal Zone Lymphoma, Ages =30 Years, Both Sexes, N, 2014

Figure 11: 7MM, Sex-Specific Incident Cases of Marginal Zone Lymphoma, Ages =30 Years, N, 2014

Figure 12: 7MM, Age-Standardized Incidence of Marginal Zone Lymphoma (Cases per 100,000 Population), Ages =30 Years, by Sex, 2014

Figure 13: 7MM, Incident Cases of DLBCL, Ages =30 Years, Both Sexes, N, 2014–2024

Figure 14: 7MM, Age-Specific Incident Cases of DLBCL, Ages =30 Years, Both Sexes, N, 2014

Figure 15: 7MM, Sex-Specific Incident Cases of DLBCL, Ages =30 Years, N, 2014

Figure 16: 7MM, Age-Standardized Incidence of DLBCL (Cases per 100,000 Population), Ages =30 Years, by Sex, 2014

Figure 17: 7MM, Incident Cases of Mantle Cell Lymphoma, Ages =30 Years, Both Sexes, N, 2014–2024

Figure 18: 7MM, Age-Specific Incident Cases of Mantle Cell Lymphoma, Both Sexes, N, 2014

Figure 19: 7MM, Sex-Specific Incident Cases of Mantle Cell Lymphoma, Ages =30 Years, N, 2014

Figure 20: 7MM, Age-Standardized Incidence of Mantle Cell Lymphoma (Cases per 100,000 Population), Ages =30 Years, by Sex, 2014

Figure 21: Imbruvica – Ongoing Clinical Trials in B-Cell NHL

Figure 22: Revlimid – Ongoing Clinical Trials in B-Cell NHL

Figure 23: Velcade – Ongoing Clinical Trials in B-Cell NHL

Figure 24: Zydelig – Ongoing Clinical Trials in B-Cell NHL

Figure 25: Afinitor – Phase III Trial in Aggressive B-Cell NHL

Figure 26: Arzerra – Phase II and III Trials in Indolent and Aggressive NHL

Figure 27: Copanlisib – Phase II and III Trials in Indolent and Aggressive NHL

Figure 28: Duvelisib – Phase II and III Trials in Indolent NHL

Figure 29: Gazyva – Phase II and III Trials in Indolent and Aggressive NHL

Figure 30: Opdivo – Phase II Trials in Indolent and Aggressive NHL

Figure 31: Competitive Assessment of the Key Marketed and Late-Stage Pipeline Agents in Indolent NHL, 2014-2024

Figure 32: Competitive Assessment of the Key Marketed and Late-Stage Pipeline Agents in Aggressive NHL, 2014-2024

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