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

  • ID: 3646795
  • Drug Pipelines
  • 282 pages
  • GlobalData
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B-Cell Non-Hodgkin’s Lymphoma Treatment Market Will Stutter to $5.45 Billion by 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 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, we focus 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. We anticipate 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.
- We anticipate 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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1.1 List of Tables

1.2 List of Figures

2 Introduction

2.1 Catalyst

2.2 Related Reports

3 Disease Overview

3.1 Etiology and Pathophysiology

3.1.1 Pathophysiology of Indolent and Aggressive B-Cell NHL

3.2 Symptoms

4 Disease Management

4.1 Diagnosis

4.2 Diagnostic Classification

4.2.1 Follicular Lymphoma

4.2.2 Marginal Zone Lymphoma

4.2.3 Diffuse Large B-Cell Lymphoma

4.2.4 Mantle Cell Lymphoma

4.3 Treatment Overview

4.3.1 Follicular Lymphoma

4.3.2 Marginal Zone Lymphoma

4.3.3 Diffuse Large B-Cell Lymphoma

4.3.4 Mantle Cell Lymphoma

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global Trends

5.3.1 US

5.3.2 5EU

5.3.3 Japan

5.4 Forecast Methodology

5.4.1 Sources Used

5.4.2 Sources Not Used

5.4.3 Forecast Assumptions and Methods

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

5.5.1 Follicular Lymphoma

5.5.2 Marginal Zone Lymphoma

5.5.3 Diffuse Large B-Cell Lymphoma

5.5.4 Mantle Cell Lymphoma

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of the Analysis

5.6.3 Strengths of the Analysis

6 Current Treatment Options

6.1 Overview

6.2 Product Profiles - Major Brands

6.2.1 Imbruvica (ibrutinib)

6.2.2 Revlimid (lenalidomide)

6.2.3 Rituxan (rituximab)

6.2.4 Treanda (bendamustine)

6.2.5 Velcade (bortezomib)

6.2.6 Zevalin (ibritumomab tiuxetan)

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

7 Unmet Needs Assessment and Opportunity Analysis

7.1 Overview

7.2 Unmet Needs Analysis

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

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

7.2.3 Unmet Need: Prolonged Survival Rates for MCL Patients

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

7.2.5 Unmet Need: Predictive and Prognostic Molecular Biomarkers

7.3 Opportunity Analysis

7.3.1 Opportunity: More Cost-Effective Therapies

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

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

7.3.4 Opportunity: Development of Novel Therapies for NHL Patients

8 Research and Development Strategies

8.1 Overview

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

8.1.2 Inhibiting New Targets in Relapsed/Refractory NHL Patients

8.1.3 Novel Approaches to NHL Treatment

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

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

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

8.1.7 Introducing New Routes of Drug Delivery to Improve Patient Convenience

8.2 Clinical Trial Design

8.2.1 Indolent and Aggressive B-Cell NHL

8.2.2 Clinical Endpoints

8.2.3 Comparator Arms

9 Pipeline Assessment

9.1 Overview

9.2 Promising Drugs in Clinical Development

9.2.1 Afinitor (everolimus)

9.2.2 Arzerra (ofatumumab)

9.2.3 Copanlisib (BAY 80-6946)

9.2.4 Duvelisib (IPI-145)

9.2.5 Gazyva (obinutuxumab)

9.2.6 Opdivo (nivolumab)

9.3 Innovative Early-Stage Approaches

9.3.1 Adcetris (brentuximab vedotin)

9.3.2 Blinatumomab (AMG-103)

9.3.3 CUDC-907

9.3.4 Daratumumab

9.3.5 Kyprolis (carfilzomib)

9.3.6 Y-90 Epratuzumab

9.3.7 Chimeric Antigen Receptor T-Cell Therapies

10 Pipeline Valuation Analysis

10.1 Clinical Benchmarking of Key Pipeline Drugs

10.1.1 Indolent NHL

10.1.2 Aggressive NHL

10.2 Commercial Benchmarking of Key Pipeline Drugs

10.3 Competitive Assessment

10.4 Top-Line, 10-Year Forecast

10.4.1 US

10.4.2 5EU

10.4.3 Japan

11 Appendix

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

11.4 Forecasting Methodology

11.4.1 NHL Patient Population Segmentation

11.4.2 Percentage of Drug-Treated Patients

11.4.3 Drugs Included in Each Therapeutic Class

11.4.4 Launch and Patent Expiry Dates

11.4.5 General Pricing Assumptions

11.4.6 Individual Drug Assumptions

11.4.7 Generic and Biosimilar Erosion

11.5 Primary Research

11.5.1 Physicians and Specialists Included in This Study

11.5.2 Online Survey of High Prescribing Physicians

11.6 About the Authors

11.6.1 Analyst

11.6.2 Epidemiologist

11.6.3 Therapy Area Director

11.6.4 Global Director of Therapy Analysis and Epidemiology

11.6.5 Global Head of Healthcare

11.7 About Us

11.8 Disclaimer

1.1 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

1.2 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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