Summary
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.
Highlights
Key Questions Answered
- 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?
Key Findings
- One of the main drivers in the expansion of the HL market will be the label extensions of Adcetris in earlier lines of HL therapy, which will include the post-transplantation consolidation setting, as well as newly diagnosed advanced stage patients. The premium-priced anti-PD1-therapies, Opdivo and Keytruda, will also launch and be used in the treatment of the R/R HL population. These drugs are poised to partially meet the remaining unmet medical need of these hard-to-treat patients.
- Another driver of market growth will be the few players in the HL space; therefore, there is ample room for new market entrants. A major driver will also be an increase in HL incidence due to a growing population. This will lead to an overall increase of the number of drug-treatable HL patients, and market size.
- Companies are focusing on the development of therapies targeting the R/R HL population, hoping to expedite the route to market for their pipeline products, and improving the complete remission rate and duration of remission of these patients.
- One of the largest unmet needs is that of the newly diagnosed advanced stage HL population. Other unmet needs include the high proportion of patients failing transplant therapies and the toxicity of second-line treatment options.
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.
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 HL market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global HL market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing 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
2.3 Upcoming Related Reports
3 Disease Overview
3.1 Etiology and Pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.2 Symptoms
3.3 Diagnosis
3.4 Clinical Staging and Prognostic Factors
4 Epidemiology
4.1 Disease Background
4.2 Risk Factors and Comorbidities
4.3 Global Trends
4.3.1 Incidence
4.3.2 Survival Rates for HL - 7MM
4.4 Forecast Methodology
4.4.1 Sources Used
4.4.2 Sources Not Used
4.4.3 Forecast Assumptions and Methods, HL Diagnosed Incident Cases
4.4.4 Forecast Assumptions and Methods, HL Five-Year Diagnosed Prevalent Cases
4.4.5 Forecast Assumptions and Methods, HL Diagnosed Incident Cases, Clinical Stages at Diagnosis
4.4.6 Forecast Assumptions and Methods, HL Diagnosed Incident Cases, Cellular Types
4.5 Epidemiological Forecast for HL (2014-2024)
4.5.1 Diagnosed Incident Cases of HL
4.5.2 Age-Specific Diagnosed Incident Cases of HL
4.5.3 Sex-Specific Diagnosed Incident Cases of HL
4.5.4 Age-Standardized Diagnosed Incidence of HL
4.5.5 Diagnosed Incident Cases of HL by Clinical Stage at Diagnosis
4.5.6 Diagnosed Incident Cases of HL by Cellular Types
4.5.7 Five-Year Diagnosed Prevalent Cases of HL
4.6 Discussion
4.6.1 Epidemiological Forecast Insight
4.6.2 Limitations of the Analysis
4.6.3 Strengths of the Analysis
5 Current Treatment Options
5.1 Overview
5.1.1 Treatment of Classical HL
5.1.2 Treatment of NLPHL
5.1.3 Treatment of Children and Pregnant HL Patients
5.1.4 Marketed Agents for the Treatment of HL
5.2 Product Profiles
5.2.1 Adcetris (brentuximab vedotin)
6 Unmet Needs Assessment and Opportunity Analysis
6.1 Unmet Needs Analysis
6.1.1 Overview
6.1.2 Low Cure Rate in Newly Diagnosed Advanced Unfavorable-Stage Patients
6.1.3 Only Half of Relapse/Refractory Patients Are Cured by ASCT
6.1.4 Toxic Second-Line Chemotherapy
6.1.5 Long-Term Toxicity Associated With Radiotherapy
6.1.6 Current Treatment Is Less Effective in Older HL Patients
6.1.7 Underuse of Prognostic Factors for Treatment Planning in the Front-Line and Relapse/Refractory Settings
6.1.8 Prohibitively High Cost of Therapy
6.1.9 Lack of Patients to Participate in Clinical Trials
6.2 Opportunity Analysis
6.2.1 Overview
6.2.2 Less Toxic and More Efficacious Front-Line Therapies Will Increase Acceptance for Premium Price
6.2.3 Therapies and Strategies That Improve Cure Rates in the Relapse/Refractory Setting
6.2.4 New Therapies Adapted for the Treatment of Older HL Patients
6.2.5 Pharmacological Therapies That Can Replace Radiation Therapy
6.2.6 Reducing Treatment Cost to Enhance Overall Treatment Rate and Drug Uptake
7 R&D Strategies
7.1 Overview
7.1.1 Targeting of Relapsed and Refractory Patients
7.1.2 Developing Combination Therapies with Established and Novel Drugs
7.1.3 Seeking Fast Track or Breakthrough Therapy Designation
7.1.4 Including HL as an Indication in Multiple Tumor Type, Early Phase Clinical Trials
7.1.5 Involving Academic Groups in HL Drug Discovery and Clinical Trials
7.2 Clinical Trial Design
7.2.1 Overview
7.2.2 Selection of Primary Efficacy Endpoints to Support Regulatory Approval
7.2.3 Target Patient Population
7.2.4 Number of Patients Enrolled in Clinical Trials
8 Pipeline Assessment
8.1 Overview
8.2 Late-Stage Drugs in Clinical Development
8.2.1 Opdivo (nivolumab)
8.2.2 Keytruda (pembrolizumab)
8.2.3 INCB40093 (+INCB39110)
8.2.4 AFM-13
8.3 Other Drugs That Reached Phase II Clinical Development
8.3.1 JNJ-40346527
8.3.2 Jakafi (ruxolitinib phosphate)
8.3.3 MK-2206
8.3.4 Entinostat
8.3.5 Resminostat
8.4 Innovative Early-Stage Approaches
8.4.1 Overview
8.4.2 Cell-Based Therapies
8.4.3 Molecular-Targeted Therapies
8.4.4 Epigenetic Modulators
9 Pipeline Valuation Analysis
9.1 Clinical Benchmark of Key Pipeline Drugs
9.2 Commercial Benchmark of Key Pipeline Drugs
9.3 Competitive Assessment
9.4 Top-Line Ten-Year Forecast
9.4.1 US
9.4.2 5EU
9.4.3 Japan
10 Appendix
10.1 Bibliography
10.2 Abbreviations
10.3 Methodology
10.4 Forecasting Methodology
10.4.1 General Forecast Assumptions
10.4.2 Drugs Included in Each Line of Treatment
10.4.3 Key Launch Dates
10.4.4 General Pricing Assumptions
10.4.5 Individual Drug Assumptions
10.4.6 Pricing of Pipeline Agents
10.5 Primary Research
10.5.1 Physicians and Specialists Included in this Study
10.5.2 Online Survey of High-Prescribing Physicians
10.6 About the Authors
10.6.1 Author
10.6.2 Epidemiologist
10.6.3 Reviewer
10.6.4 Therapy Area Director
10.6.5 Global Head of Healthcare
10.7 About us
10.8 Disclaimer
1.1 List of Tables
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
1.2 List of 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
1.1 List of Tables
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
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
