B-Cell Non-Hodgkin’s Lymphoma (NHL): Opportunity Analysis and Forecasts to 2027

Non-Hodgkin’s lymphoma (NHL) comprises a heterogeneous group of proliferative 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. B-cell lymphomas comprise approximately 85% of all NHL cases diagnosed in the US, and are a diverse group of blood cancers that arise in the B-cells. This report focuses on the four NHL subtypes that represent the greatest commercial opportunities for drug developers during the forecast period: Diffuse large B-cell lymphoma (DLBCL), Follicular lymphoma (FL), Marginal zone lymphoma (MZL) and Mantle cell lymphoma (MCL).

The introduction of Roche’s Rituxan/MabThera (rituximab) in the late 1990s revolutionized NHL therapy, and the market is now dominated by Rituxan. However, NHL patients frequently become refractory to Rituxan therapy or relapse after responding to the first-line treatment, which has spurred R&D efforts to address therapeutic options for relapsed/refractory (R/R) patients after first-line Rituxan-based therapy.

GlobalData valued the B-cell NHL (FL,MZL,DLBCL and MCL) market at $5.7B in 2017 in the 7MM (US, France, Germany, Italy, Spain, UK and Japan) and expects the market to increase to $9.2B in 2027 at a Compound Annual Growth Rate (CAGR) of 4.9%. Growth will be driven by the rise of chimeric antigen receptor (CAR)-T cell therapies, the launch of six pipeline agents, and the label expansion of currently marketed therapies across the B-cell NHL subtypes. However, growth will be tempered by the biosimilar and generic erosions of Rituxan, Treanda, Gazyva, Revlimid, Imbruvica, Zydelig, Velcade, and Torisel.

Key Questions Answered

Which pipeline agents are the most promising and expected to launch in the 7MM? What are the forecasted sales of these agents and what will be their impact in the B-cell NHL market?

What are the main unmet needs in B-cell NHL , which pipeline drugs will fulfill these needs, and to what extent?

What are the current research and development (R&D) strategies being explored and how can developers incorporate these methods into their business strategy?

Key Opinions Leaders (KOLs) insights across the 7MM, relating to the current treatment options and opinions on the late and early stage pipeline agents.

Scope

Overview of B-cell NHL (FL, MZL, DLBCL and MCL), including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.

Annualized CLL therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in seven geographic regions, forecast from 2017 to 2027. Forecast model includes previously diagnosed and newly diagnosed patients.

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: comprehensive data assessing emerging trends and mechanisms of action under development for B-cell NHL . The most promising candidates in late-stage development are profiled.

Analysis of the current and future market competition in the global B-cell 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

Growth will be driven by the rise of CAR-T cell therapies, the launch of six pipeline agents, and the label expansion of currently marketed therapies across the B-cell NHL subtypes.

Lisocabtagene maraleucel, ublituximab + umbralisib and Polivy are the three pipeline/upcoming therapies expected to generate the highest sales for B-cell NHL from 2017-2027.

Several unmet needs still remain in B-cell NHL, and while it is unlikely that they will be fully met within the forecast period, progress will be made on many of those needs.

The growth of the B-cell NHL market will be tempered by the patent expiry of leading brands, including Rituxan, Treanda, Gazyva, Revlimid, Imbruvica, Zydelig, and Velcade, and subsequent biosimilar/generic erosion

Lack of, or delayed, clinical development in Japan, will result in marketing approval of only a subset of the pipeline candidates in that region during the forecast period

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 B-cell NHL market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global B-cell 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.

Companies mentioned

AbbVie

Acerta Pharma BV

Amgen

Astellas Pharma

AstraZeneca

Bayer

Biogen Inc.

Cabaret Biotech Ltd

Calistoga

Celgene

Celltrion

Chugai

Denovo Biopharma LLC

Eagle Pharmaceuticals Inc.

Eisai ...

AbbVie

Acerta Pharma BV

Amgen

Astellas Pharma

AstraZeneca

Bayer

Biogen Inc.

Cabaret Biotech Ltd

Calistoga

Celgene

Celltrion

Chugai

Denovo Biopharma LLC

Eagle Pharmaceuticals Inc.

Eisai

EMD Serono

Genentech

Gilead

Idec Pharmaceuticals

Infinity Pharmaceuticals

Johnson & Johnson

Juno Therapeutics

Kite Pharma

Merck KGaA

Millennium Pharmaceuticals

MorphoSys

Mundipharma International

Napp Pharmaceuticals Ltd

Novartis

Pfizer

Pharmacyclics LLC

Roche

Sandoz

Spectrum Pharmaceuticals

Takeda

Teva Pharmaceuticals

TG Therapeutics Inc.

Verastem

Wyeth

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 B-Cell NHL: Executive Summary

2.1 The B-Cell NHL Market Is Expected to ...

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 B-Cell NHL: Executive Summary

2.1 The B-Cell NHL Market Is Expected to Grow to $9.2B in 2027

2.2 Combinations with Rituxan and Label Expansions Across B-Cell NHL Will Continue to Be the Prominent Strategies Utilized by Developers

2.3 Moderate Level of Overall Unmet Need, but Opportunities Remain in Specific Settings

2.4 Large Pipeline Composed of Therapies with Relatively High Potential

2.5 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology

4.1.1 FL

4.1.2 MZL

4.1.3 DLBCL

4.1.4 MCL

4.2 Pathophysiology

4.2.1 FL

4.2.2 MZL

4.2.3 DLBCL

4.2.4 MCL

4.3 Staging

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.3.1 US

5.3.2 5EU

5.3.3 Japan

5.4 Forecast Methodology

5.4.1 Sources

5.4.2 Forecast Assumptions and Methods

5.5 Epidemiological Forecast for B-Cell NHL (2017–2027)

5.5.1 Diagnosed Incident Cases of B-Cell NHL

5.5.2 Age-Specific Diagnosed Incident Cases of B-Cell NHL

5.5.3 Sex-Specific Diagnosed Incident Cases of B-Cell NHL

5.5.4 Diagnosed Incident Cases of DLBCL, FL, MZL, and MCL

5.5.5 Diagnosed Incident Cases of DLBCL by Cancer Staging

5.5.6 Diagnosed Incident Cases of FL by Cancer Staging

5.5.7 Diagnosed Incident Cases of MZL by Cancer Staging

5.5.8 Diagnosed Incident Cases of MCL by Cancer Staging

5.5.9 Diagnosed Incident Cases of FL by Grade

5.5.10 Diagnosed Prevalent Cases of B-Cell NHL

5.5.11 Diagnosed Prevalent Cases of DLBCL, FL, MZL, and MCL

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

6.1.1 Agents Used Across the Four Subtypes and Across Lines of Therapy

6.1.2 Rituxan Hycela, Rituximab Biosimilars, and Gazyva

6.1.3 Small Molecule Inhibitors in MCL, FL, and MZL

6.1.4 CAR-T Therapy in DLBCL

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Predictive and Prognostic Molecular Biomarkers

7.2.1 GCB and Non-GCB Histology in DLBCL

7.2.2 Patients Who Are Not Cured with 1L R-CHOP in DLBCL

7.2.3 The POD24 Group in FL

7.2.4 DGM1-Positive Patients in DLBCL

7.3 Improvement of Cure Rate and Better Therapies for DLBCL Patients Who Are Not Cured by 1L R-CHOP

7.4 Further Options in FL for Various Patient Subsets

7.5 Patients Refractory to/Relapsed after Treatment with Imbruvica in MCL

7.6 Clinical Research in MZL

8 R&D Strategies

8.1 Overview

8.1.1 Label Expansions to Additional NHL Subtypes and Lines of Therapy

8.1.2 Novel Mechanisms of Action

8.1.3 Exploration of Novel Combinations With and Without Rituxan

8.2 Clinical Trials Design

8.2.1 Ongoing Late-Stage Trials of Marketed and Pipeline Drugs

8.2.2 PFS is the Most Common Clinical Trial Endpoint

8.2.3 Comparator Arms

9 Pipeline Assessment

10 Pipeline Valuation Analysis

10.1 Clinical Benchmark of Key Pipeline and Marketed Drugs

10.1.1 iNHL

10.1.2 DLBCL

10.1.3 MCL

10.2 Commercial Benchmark of Key Pipeline Drugs

10.2.1 iNHL

10.2.2 DLBCL

10.2.3 MCL

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

11.3.1 Forecasting Methodology

11.3.2 Diagnosed Patients

11.3.3 Percent Drug-Treated Patients

11.3.4 Drugs Included in Each Therapeutic Class

11.3.5 Launch and Patent Expiry Dates

11.3.6 General Pricing Assumptions

11.3.7 Individual Drug Assumptions

11.3.8 Generic Erosion

11.3.9 Pricing of Pipeline Agents

11.4 Primary Research – KOLs Interviewed for This Report

11.5 Primary Research – Prescriber Survey

11.6 About the Authors

11.6.1 Analyst

11.6.2 Therapy Area Directors

11.6.3 Epidemiologist

11.6.4 Managing Epidemiologist

11.6.5 Global Director of Therapy Analysis and Epidemiology

11.6.6 Global Head and EVP of Healthcare Operations and Strategy

11.7 About GlobalData

11.8 Contact Us

11.9 Disclaimer

List of Tables

Table 1: B-Cell NHL: Key Metrics in the 7MM

Table 2: Molecular Characteristics of NHL (2008 WHO Classification)

Table 3: The Ann Arbor Staging System ...

Table 1: B-Cell NHL: Key Metrics in the 7MM

Table 2: Molecular Characteristics of NHL (2008 WHO Classification)

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

Table 4: B-Cell NHL Cancer Stages

Table 5: Risk Factors and Comorbidities for NHL

Table 6: Treatment Guidelines for B-Cell NHL

Table 7: Leading Treatments for B-Cell NHL

Table 8: Ongoing Phase III/Pivotal Phase II Trials in B-cell NHL of Pipeline Drugs

Table 9: Ongoing Phase III Trials in B-cell NHL of Marketed Drugs

Table 10: Comparison of Therapeutic Classes in Development for NHL, 2018–2027

Table 11: Clinical Benchmark of Key Pipeline and Marketed Drugs – iNHL

Table 12: Clinical Benchmark of Key Pipeline and Marketed Drugs – DLBCL

Table 13: Clinical Benchmark of Key Pipeline and Marketed Drugs – MCL

Table 14: Commercial Benchmark of Key Pipeline and Marketed Drugs – iNHL

Table 15: Commercial Benchmark of Key Pipeline and Marketed Drugs – DLBCL

Table 16: Commercial Benchmark of Key Pipeline and Marketed Drugs – MCL

Table 17: Key Events Impacting Sales for B-cell NHL, 2017–2027

Table 18: B-cell NHL Market – Global Drivers and Barriers, 2017-2027

Table 19: Key Historical and Projected Launch Dates for B-cell NHL

Table 20: Key Historical and Projected Patent Expiry Dates for B-cell NHL

Table 21: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Global Sales Forecast by Region for B-Cell NHL in 2017 and 2027

Figure 2: Competitive Assessment of the Marketed and Pipeline Drugs for ...

Figure 1: Global Sales Forecast by Region for B-Cell NHL in 2017 and 2027

Figure 2: Competitive Assessment of the Marketed and Pipeline Drugs for iNHL (FL and MZL) Benchmarked Against the SOC, Rituxan (+/- chemotherapy)

Figure 3: Competitive Assessment of the Marketed and Pipeline Drugs for DLBCL Benchmarked Against the SOC, Rituxan (+/- chemotherapy)

Figure 4: Competitive Assessment of the Marketed and Pipeline Drugs for MCL Benchmarked Against the SOC, Rituxan (+/- chemotherapy)

Figure 5: 7MM, Age-Standardized Diagnosed Incidence of B-Cell NHL, Ages ≥18 Years, 2017

Figure 6: 7MM, Age-Standardized Diagnosed Prevalence of B-Cell NHL, Ages ≥18 Years, 2017

Figure 7: Sources Used for Diagnosed Incident Cases of B-Cell NHL

Figure 8: Sources Used for Diagnosed Incident Cases of DLBCL, FL, MZL, and MCL

Figure 9: Sources Used for Diagnosed Incident Cases of DLBCL, FL, MZL, and MCL by Cancer Staging

Figure 10: Sources Used for Diagnosed Incident Cases of FL by Grade

Figure 11: Sources Used for Diagnosed Prevalent Cases of B-Cell NHL

Figure 12: Sources Used for Diagnosed Prevalent Cases of DLBCL, FL, MZL, and MCL

Figure 13: 7MM, Diagnosed Incident Cases of B-Cell NHL, Men and Women, Ages ≥18 Years, 2017

Figure 14: 7MM, Age-Specific Diagnosed Incident Cases of B-Cell NHL, Men and Women, 2017

Figure 15: 7MM, Sex-Specific Diagnosed Incident Cases of B-Cell NHL, Men and Women, Ages ≥18 Years, 2017

Figure 16: 7MM, Diagnosed Incident Cases of DLBCL, FL, MZL, and MCL, Men and Women, Ages ≥18 Years, 2017

Figure 17: 7MM, Diagnosed Incident Cases of DLBCL by Cancer Stage, Men and Women, Ages ≥18 Years, 2017

Figure 18: 7MM, Diagnosed Incident Cases of FL by Cancer Stage, Men and Women, Ages ≥18 Years, 2017

Figure 19: 7MM, Diagnosed Incident Cases of MZL by Cancer Stage, Men and Women, Ages ≥18 Years, 2017

Figure 20: 7MM, Diagnosed Incident Cases of MCL by Cancer Stage, Men and Women, Ages ≥18 Years, 2017

Figure 21: 7MM, Diagnosed Incident Cases of FL by Grade, Men and Women, Ages ≥18 Years, 2017

Figure 22: 7MM, Diagnosed Prevalent Cases of B-Cell NHL, Men and Women, ≥18 Years, 2017

Figure 23: 7MM, Diagnosed Prevalent Cases of DLBCL, FL, MZL, and MCL, Men and Women, Ages ≥18 Years, 2017

Figure 24: Unmet Needs and Opportunities in B-cell NHL

Figure 25: Overview of the Development Pipeline in iNHL (FL and MZL)

Figure 26: Overview of the Development Pipeline in DLBCL

Figure 27: Overview of the Development Pipeline in MCL

Figure 28: Key Phase II/III Trials for the Pipeline Agents in the 7MM During the Forecast Period

Figure 29: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC, iNHL

Figure 30: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC, Indolent DLBCL

Figure 31: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC, Indolent MCL

Figure 32: Global (7MM) Sales Forecast by Region for B-cell NHL in 2017 and 2027

Figure 33: Global (7MM) Sales Forecast by Class for Disease B-cell NHL in 2017 and 2027

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