OpportunityAnalyzer: Hodgkin’s Lymphoma (HL) – Global Drug Forecast and Market Analysis to 2024

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Hodgkin's lymphoma (HL), or Hodgkin's disease, is a malignancy which involves the lymph nodes and the lymphatic system. HL is a relatively rare type of cancer, accounting for 12% of all lymphomas and 0.6% of all new cancer cases, but overall prognosis is very good. However, treatment options for those patients who have failed first-line treatment are very few, and a significant unmet medical need remains in those patients. GlobalData estimated the HL market in the 7MM was valued at $316m in 2014. The HL market will increase approximately four-fold over the forecast period, reaching $1.4 billion by 2024 at a CAGR of 16%. This growth will be driven by label extensions for Adcetris (brentuximab vedotin), which is poised to enter earlier lines of HL therapy, as well as the approval and uptake of premium-priced products, such as the immune checkpoint inhibitors, Opdivo (nivolumab) and Keytruda (pembrolizumab). By the end of the forecast period, GlobalData expects Adcetris to retain and extend its lead as the HL market front-runner, with Opdivo and Keytruda making up a significant amount of the market. GlobalData anticipates that pipeline agents will have to show an efficacy advantage over currently used and inexpensive standard of care therapies. The challenge for new entrants in the HL market is to meet the high unmet need of relapsed or refractory (R/R) HL patients, reduce the long-term toxic side effects of current treatments, and improve overall survival.

Scope

Overview of HL, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, disease management, and current treatment options.

Top-line HL therapeutics market revenue from 2014–2024. Average cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, and clinical trial design for the HL 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 HL 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

Over the last forty years, only one targeted therapy has been approved for the treatment of HL — Adcetris. The HL space is now filled with excitement because Adcetris label extensions and approval of the first anti-PD-1 therapies are expected to change the treatment landscape. What will be the impact of these newly approved drugs on HL sales?

With the success of molecular-targeted therapies, including immune checkpoint inhibitors, across the oncology therapy area, what R&D strategies are being leveraged by companies to remain competitive in the HL space?

The survival of R/R HL patients remains poor, especially for those who fail transplant therapies. Therefore, there are considerably high unmet needs within this indication. What are the main unmet needs remaining in this space? Will the drugs under development fulfil the unmet needs of the HL market?

4SC
Acetylon Pharmaceuticals
Actinium Pharmaceuticals
ADC Therapeutics
Affimed Therapeutics
Amgen
Aptose Biosciences
Bayer Schering Pharma
Bellicum Pharmaceuticals
Bristol-Myers Squibb
Cell Medica Limited
Cellular Biomedicine Group
Constellation Pharmaceuticals
Curis
Eddingpharm
Gamida Cell
Incyte Corporation
Johnson & Johnson
Kyowa Hakki Kirin
Linus Oncology
Medarex
Menarini
Merck & Co.
Millennium Pharmaceuticals
Mirati Therapeutics
NantKwest
Novartis
Ono Pharmaceutical
Pfizer
Seattle Genetics
Syndax Pharmaceuticals
Takeda
Teva
TG Therapeutics
Yakult Honsha

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Symptoms

3.3Diagnosis

3.4Clinical Staging and Prognostic Factors

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global Trends

4.3.1Incidence

4.3.2Survival Rates for HL — 7MM

4.4Forecast Methodology

4.4.1Sources Used

4.4.2Sources Not Used

4.4.3Forecast Assumptions and Methods, HL Diagnosed Incident Cases

4.4.4Forecast Assumptions and Methods, HL Five-Year Diagnosed Prevalent Cases

4.4.5Forecast Assumptions and Methods, HL Diagnosed Incident Cases, Clinical Stages at Diagnosis

4.4.6Forecast Assumptions and Methods, HL Diagnosed Incident Cases, Cellular Types

4.5Epidemiological Forecast for HL (2014–2024)

4.5.1Diagnosed Incident Cases of HL

4.5.2Age-Specific Diagnosed Incident Cases of HL

4.5.3Sex-Specific Diagnosed Incident Cases of HL

4.5.4Age-Standardized Diagnosed Incidence of HL

4.5.5Diagnosed Incident Cases of HL by Clinical Stage at Diagnosis

4.5.6Diagnosed Incident Cases of HL by Cellular Types

4.5.7Five-Year Diagnosed Prevalent Cases of HL

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Current Treatment Options

5.1Overview

5.1.1Treatment of Classical HL

5.1.2Treatment of NLPHL

5.1.3Treatment of Children and Pregnant HL Patients

5.1.4Marketed Agents for the Treatment of HL

5.2Product Profiles

5.2.1Adcetris (brentuximab vedotin)

6Unmet Needs Assessment and Opportunity Analysis

6.1Unmet Needs Analysis

6.1.1Overview

6.1.2Low Cure Rate in Newly Diagnosed Advanced Unfavorable-Stage Patients

6.1.3Only Half of Relapse/Refractory Patients Are Cured by ASCT

6.1.4Toxic Second-Line Chemotherapy

6.1.5Long-Term Toxicity Associated With Radiotherapy

6.1.6Current Treatment Is Less Effective in Older HL Patients

6.1.7Underuse of Prognostic Factors for Treatment Planning in the Front-Line and Relapse/Refractory Settings

6.1.8Prohibitively High Cost of Therapy

6.1.9Lack of Patients to Participate in Clinical Trials

6.2Opportunity Analysis

6.2.1Overview

6.2.2Less Toxic and More Efficacious Front-Line Therapies Will Increase Acceptance for Premium Price

6.2.3Therapies and Strategies That Improve Cure Rates in the Relapse/Refractory Setting

6.2.4New Therapies Adapted for the Treatment of Older HL Patients

6.2.5Pharmacological Therapies That Can Replace Radiation Therapy

6.2.6Reducing Treatment Cost to Enhance Overall Treatment Rate and Drug Uptake

7R&D Strategies

7.1Overview

7.1.1Targeting of Relapsed and Refractory Patients

7.1.2Developing Combination Therapies with Established and Novel Drugs

7.1.3Seeking Fast Track or Breakthrough Therapy Designation

7.1.4Including HL as an Indication in Multiple Tumor Type, Early Phase Clinical Trials

7.1.5Involving Academic Groups in HL Drug Discovery and Clinical Trials

7.2Clinical Trial Design

7.2.1Overview

7.2.2Selection of Primary Efficacy Endpoints to Support Regulatory Approval

7.2.3Target Patient Population

7.2.4Number of Patients Enrolled in Clinical Trials

8Pipeline Assessment

8.1Overview

8.2Late-Stage Drugs in Clinical Development

8.2.1Opdivo (nivolumab)

8.2.2Keytruda (pembrolizumab)

8.2.3INCB40093 (+INCB39110)

8.2.4AFM-13

8.3Other Drugs That Reached Phase II Clinical Development

8.3.1JNJ-40346527

8.3.2Jakafi (ruxolitinib phosphate)

8.3.3MK-2206

8.3.4Entinostat

8.3.5Resminostat

8.4Innovative Early-Stage Approaches

8.4.1Overview

8.4.2Cell-Based Therapies

8.4.3Molecular-Targeted Therapies

8.4.4Epigenetic Modulators

9Pipeline Valuation Analysis

9.1Clinical Benchmark of Key Pipeline Drugs

9.2Commercial Benchmark of Key Pipeline Drugs

9.3Competitive Assessment

9.4Top-Line Ten-Year Forecast

9.4.1US

9.4.25EU

9.4.3Japan

10Appendix

10.1Bibliography

10.2Abbreviations

10.3Methodology

10.4Forecasting Methodology

10.4.1General Forecast Assumptions

10.4.2Drugs Included in Each Line of Treatment

10.4.3Key Launch Dates

10.4.4General Pricing Assumptions

10.4.5Individual Drug Assumptions

10.4.6Pricing of Pipeline Agents

10.5Primary Research

10.5.1Physicians and Specialists Included in this Study

10.5.2Online Survey of High-Prescribing Physicians

10.6About the Authors

10.6.1Author

10.6.2Epidemiologist

10.6.3Reviewer

10.6.4Therapy Area Director

10.6.5Global Head of Healthcare

10.7About GlobalData

10.8Disclaimer

Table

Table 1: Characteristics of the Five Histologic Subtypes of HL

Table 2: Notable Somatic Alterations Identified in RS and L and H cells of HL

Table 3: Symptoms of HL

Table 4: The Lugano Staging Classification of HL

Table 5: Prognostic Risk Factors of HL

Table 6: Cotswold Modification of the Ann Arbor Staging Classification for HL

Table 7: Risk Factors and Comorbidities for HL

Table 8: Trends in the Age-Standardized Incidence of HL in the US, All Ages, 1998–2007

Table 9: Trends in the Age-Standardized Incidence of HL in the 5EU, All Ages, 1998–2007

Table 10: Trends in the Age-standardized Incidence of HL in Japan, All Ages, 1998–2007

Table 11: Trends in the Five-Year Relative Survival (%) of HL in the 7MM, Both Sexes, 1995–2007

Table 12: 7MM, Sources of Epidemiological Data Used for the Forecast of HL Diagnosed Incident Cases

Table 13: 7MM, Sources of Epidemiological Data Used for the Forecast of HL Diagnosed Five-Year Prevalent Cases

Table 14: 7MM, Sources of Epidemiological Data Used for the Segmentation of HL Diagnosed Incident Cases by Clinical Stage at Diagnosis

Table 15: 7MM, Sources of Epidemiological Data Used for the Segmentation of HL Diagnosed Incident Cases by Cellular Type

Table 16: 7MM, Diagnosed Incident Cases of HL, Both Sexes, All Ages, N, 2014–2024

Table 17: 7MM, Age-Specific Diagnosed Incident Cases of HL, Both Sexes, N (Row %), 2014

Table 18: 7MM, Sex-Specific Diagnosed Incident Cases of HL, All Ages, N (Row %), 2014

Table 19: 7MM, Five-Year Diagnosed Prevalent Cases of HL, Both Sexes, All Ages, N, 2014–2024

Table 20: Treatment Guidelines for HL

Table 21: Leading Pharmacological Treatments for HL

Table 22: Product Profile – Adcetris (brentuximab vedotin)

Table 23: Efficacy of Adcetris in R/R HL patients

Table 24: Efficacy of Adcetris in the Post-ASCT HL Setting

Table 25: Safety of Adcetris in R/R HL patients

Table 26: Safety of Adcetris in the Post-ASCT HL setting

Table 27: Adcetris SWOT Analysis, 2015

Table 28: Global Sales Forecast ($m) for Adcetris, 2014–2024

Table 29: Overall Unmet Needs – Current Level of Attainment

Table 30: Design of Current Phase II and III Trials in HL

Table 31: Key Pipeline of HL Therapies in Clinical Development, 2015

Table 32: Product Profile – Opdivo (nivolumab)

Table 33: Efficacy of Opdivo in Patients with R/R HL

Table 34: Safety of Opdivo

Table 35: Opdivo SWOT Analysis, 2015

Table 36: Global Sales Forecast ($m) for Opdivo, 2014–2024

Table 37: Product Profile – Keytruda (pembrolizumab)

Table 38: Efficacy of Keytruda in Patients with R/R HL

Table 39: Safety of Keytruda

Table 40: Keytruda SWOT Analysis, 2015

Table 41: Global Sales Forecast ($m) for Keytruda, 2014–2024

Table 42: Product Profile – INCB40093 (+INCB39110)

Table 43: Efficacy of INCB40093 (+INCB39110) in Patients with R/R HL

Table 44: Safety of INCB40093 (+INCB39110)

Table 45: INCB40093 (+INCB39110) SWOT Analysis, 2015

Table 46: Global Sales Forecast ($m) for INCB40093 (+INCB39110), 2014–2024

Table 47: Product Profile – AFM-13

Table 48: Efficacy of AFM-13 Patients with R/R HL

Table 49: AFM-13 SWOT Analysis, 2015

Table 50: Global Sales Forecast ($m) for AFM-13, 2014–2024

Table 51: Product Profile – JNJ-40346527

Table 52: Product Profile – Jakafi (ruxolitinib phosphate)

Table 53: Product Profile – MK-2206

Table 54: Safety of MK-2206

Table 55: Product Profile – Entinostat

Table 56: Efficacy of Entinostat in Patients with R/R HL

Table 57: Safety of Entinostat

Table 58: Product Profile – Resminostat

Table 59: Efficacy of Resminostat in Patients with R/R HL

Table 60: Safety of Entinostat

Table 61: Early-Stage Pipeline Products in HL

Table 62: Clinical Benchmarking of Marketed Drugs for Newly Diagnosed and R/R HL

Table 63: Clinical Benchmarking of Key Pipeline Drugs for R/R HL

Table 64: Commercial Benchmarking of Marketed Drugs for Newly Diagnosed and R/R HL

Table 65: Commercial Benchmarking of Key Pipeline Drugs for R/R HL

Table 66: Top-Line Global Sales Forecasts ($m) for HL, 2014–2024

Table 67: Global HL Market – Drivers and Barriers, 2014–2024

Table 68: Key Events Impacting Sales of the US HL Market, 2014–2024

Table 69: Key Events Impacting Sales of the 5EU HL Market, 2014–2024

Table 70: Key Events Impacting Sales of the Japanese HL Market, 2014–2024

Table 71: Key Launch Dates

Table 72: Average Body Weight, Height and Surface Area Across the 7MM

Table 73: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country

Figures

Figure 1: 7MM, Diagnosed Incident Cases of HL, Both Sexes, All Ages, N, 2014–2024

Figure 2: 7MM, Age-Specific Diagnosed Incident Cases of HL, Both Sexes, N, 2014

Figure 3: 7MM, Sex-Specific Diagnosed Incident Cases of HL, All Ages, N, 2014

Figure 4: 7MM, Age-Standardized Diagnosed Incidence of HL (Cases per 100,000 Population), All Ages, by Sex, 2014

Figure 5: 7MM, Diagnosed Incident Cases of HL by Clinical Stage at Diagnosis, All Ages, Both Sexes, N, 2014

Figure 6: 7MM, Diagnosed Incident Cases of HL by Cellular Types, All Ages, Both Sexes, N, 2014

Figure 7: 7MM, Five-Year Diagnosed Prevalent Cases of HL, Both Sexes, All Ages, N, 2014–2024

Figure 8: Treatment Overview for Adult HL

Figure 9: Adcetris – Phase II and III trials

Figure 10: Opdivo – Phase I and II Trials

Figure 11: Keytruda – Phase I and II Trials

Figure 12: INCB40093 (+INCB39110) – Phase I and II Trials

Figure 13: AFM-13 – Phase I and II Trials

Figure 14: JNJ-40346527 – Phase I and II trials

Figure 15: Entinostat (SNDX-275) – Phase II Trial

Figure 16: Resminostat – Phase II Trial

Figure 17: Competitive Assessment of Marketed and Pipeline HL Agents, 2014–2024

Figure 18: Sales from HL Therapeutic Agents by Region, 2014 and 2024

Figure 19: US Sales for HL Therapeutic Agents, 2014 and 2024

Figure 20: 5EU Sales for HL Therapeutic Agents, 2014 and 2024

Figure 21: Japan Sales for HL Therapeutic Agents, 2014 and 2024

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