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OpportunityAnalyzer: Hodgkin's Lymphoma (HL) - Opportunity Analysis and Forecasts to 2024

Published: Jan 1, 2016 | Pages: 255 | Publisher: GlobalData | Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)

OpportunityAnalyzer: Hodgkin's Lymphoma (HL) - Opportunity Analysis and Forecasts to 2024

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.
 Table of Contents

1 Table of Contents 12
1.1 List of Tables 17
1.2 List of Figures 21

2 Introduction 22
2.1 Catalyst 22
2.2 Related Reports 23
2.3 Upcoming Related Reports 23

3 Disease Overview 24
3.1 Etiology and Pathophysiology 26
3.1.1 Etiology 26
3.1.2 Pathophysiology 28
3.2 Symptoms 33
3.3 Diagnosis 34
3.4 Clinical Staging and Prognostic Factors 34

4 Epidemiology 37
4.1 Disease Background 37
4.2 Risk Factors and Comorbidities 38
4.3 Global Trends 39
4.3.1 Incidence 39
4.3.2 Survival Rates for HL - 7MM 42
4.4 Forecast Methodology 43
4.4.1 Sources Used 46
4.4.2 Sources Not Used 47
4.4.3 Forecast Assumptions and Methods, HL Diagnosed Incident Cases 48
4.4.4 Forecast Assumptions and Methods, HL Five-Year Diagnosed Prevalent Cases 49
4.4.5 Forecast Assumptions and Methods, HL Diagnosed Incident Cases, Clinical Stages at Diagnosis 49
4.4.6 Forecast Assumptions and Methods, HL Diagnosed Incident Cases, Cellular Types 50
4.5 Epidemiological Forecast for HL (2014-2024) 51
4.5.1 Diagnosed Incident Cases of HL 51
4.5.2 Age-Specific Diagnosed Incident Cases of HL 52
4.5.3 Sex-Specific Diagnosed Incident Cases of HL 54
4.5.4 Age-Standardized Diagnosed Incidence of HL 56
4.5.5 Diagnosed Incident Cases of HL by Clinical Stage at Diagnosis 58
4.5.6 Diagnosed Incident Cases of HL by Cellular Types 59
4.5.7 Five-Year Diagnosed Prevalent Cases of HL 60
4.6 Discussion 61
4.6.1 Epidemiological Forecast Insight 61
4.6.2 Limitations of the Analysis 62
4.6.3 Strengths of the Analysis 62

5 Current Treatment Options 64
5.1 Overview 64
5.1.1 Treatment of Classical HL 65
5.1.2 Treatment of NLPHL 68
5.1.3 Treatment of Children and Pregnant HL Patients 68
5.1.4 Marketed Agents for the Treatment of HL 69
5.2 Product Profiles 70
5.2.1 Adcetris (brentuximab vedotin) 70

6 Unmet Needs Assessment and Opportunity Analysis 89
6.1 Unmet Needs Analysis 89
6.1.1 Overview 89
6.1.2 Low Cure Rate in Newly Diagnosed Advanced Unfavorable-Stage Patients 90
6.1.3 Only Half of Relapse/Refractory Patients Are Cured by ASCT 91
6.1.4 Toxic Second-Line Chemotherapy 92
6.1.5 Long-Term Toxicity Associated With Radiotherapy 93
6.1.6 Current Treatment Is Less Effective in Older HL Patients 94
6.1.7 Underuse of Prognostic Factors for Treatment Planning in the Front-Line and Relapse/Refractory Settings 95
6.1.8 Prohibitively High Cost of Therapy 96
6.1.9 Lack of Patients to Participate in Clinical Trials 97
6.2 Opportunity Analysis 98
6.2.1 Overview 98
6.2.2 Less Toxic and More Efficacious Front-Line Therapies Will Increase Acceptance for Premium Price 98
6.2.3 Therapies and Strategies That Improve Cure Rates in the Relapse/Refractory Setting 100
6.2.4 New Therapies Adapted for the Treatment of Older HL Patients 102
6.2.5 Pharmacological Therapies That Can Replace Radiation Therapy 103
6.2.6 Reducing Treatment Cost to Enhance Overall Treatment Rate and Drug Uptake 104

7 R&D Strategies 106
7.1 Overview 106
7.1.1 Targeting of Relapsed and Refractory Patients 106
7.1.2 Developing Combination Therapies with Established and Novel Drugs 107
7.1.3 Seeking Fast Track or Breakthrough Therapy Designation 109
7.1.4 Including HL as an Indication in Multiple Tumor Type, Early Phase Clinical Trials 111
7.1.5 Involving Academic Groups in HL Drug Discovery and Clinical Trials 112
7.2 Clinical Trial Design 114
7.2.1 Overview 114
7.2.2 Selection of Primary Efficacy Endpoints to Support Regulatory Approval 115
7.2.3 Target Patient Population 117
7.2.4 Number of Patients Enrolled in Clinical Trials 118

8 Pipeline Assessment 120
8.1 Overview 120
8.2 Late-Stage Drugs in Clinical Development 121
8.2.1 Opdivo (nivolumab) 121
8.2.2 Keytruda (pembrolizumab) 133
8.2.3 INCB40093 (+INCB39110) 142
8.2.4 AFM-13 149
8.3 Other Drugs That Reached Phase II Clinical Development 157
8.3.1 JNJ-40346527 157
8.3.2 Jakafi (ruxolitinib phosphate) 160
8.3.3 MK-2206 163
8.3.4 Entinostat 166
8.3.5 Resminostat 170
8.4 Innovative Early-Stage Approaches 174
8.4.1 Overview 174
8.4.2 Cell-Based Therapies 177
8.4.3 Molecular-Targeted Therapies 179
8.4.4 Epigenetic Modulators 182

9 Pipeline Valuation Analysis 184
9.1 Clinical Benchmark of Key Pipeline Drugs 184
9.2 Commercial Benchmark of Key Pipeline Drugs 186
9.3 Competitive Assessment 188
9.4 Top-Line Ten-Year Forecast 192
9.4.1 US 195
9.4.2 5EU 198
9.4.3 Japan 201

10 Appendix 204
10.1 Bibliography 204
10.2 Abbreviations 228
10.3 Methodology 235
10.4 Forecasting Methodology 235
10.4.1 General Forecast Assumptions 235
10.4.2 Drugs Included in Each Line of Treatment 237
10.4.3 Key Launch Dates 238
10.4.4 General Pricing Assumptions 238
10.4.5 Individual Drug Assumptions 240
10.4.6 Pricing of Pipeline Agents 246
10.5 Primary Research 248
10.5.1 Physicians and Specialists Included in this Study 248
10.5.2 Online Survey of High-Prescribing Physicians 250
10.6 About the Authors 251
10.6.1 Author 251
10.6.2 Epidemiologist 251
10.6.3 Reviewer 252
10.6.4 Therapy Area Director 252
10.6.5 Global Head of Healthcare 253
10.7 About GlobalData 254
10.8 Disclaimer 254
List of Tables

Table 1: Characteristics of the Five Histologic Subtypes of HL 25
Table 2: Notable Somatic Alterations Identified in RS and L and H cells of HL 30
Table 3: Symptoms of HL 33
Table 4: The Lugano Staging Classification of HL 35
Table 5: Prognostic Risk Factors of HL 36
Table 6: Cotswold Modification of the Ann Arbor Staging Classification for HL 38
Table 7: Risk Factors and Comorbidities for HL 39
Table 8: Trends in the Age-Standardized Incidence of HL in the US, All Ages, 1998-2007 40
Table 9: Trends in the Age-Standardized Incidence of HL in the 5EU, All Ages, 1998-2007 41
Table 10: Trends in the Age-standardized Incidence of HL in Japan, All Ages, 1998-2007 42
Table 11: Trends in the Five-Year Relative Survival (%) of HL in the 7MM, Both Sexes, 1995-2007 42
Table 12: 7MM, Sources of Epidemiological Data Used for the Forecast of HL Diagnosed Incident Cases 44
Table 13: 7MM, Sources of Epidemiological Data Used for the Forecast of HL Diagnosed Five-Year Prevalent Cases 44
Table 14: 7MM, Sources of Epidemiological Data Used for the Segmentation of HL Diagnosed Incident Cases by Clinical Stage at Diagnosis 45
Table 15: 7MM, Sources of Epidemiological Data Used for the Segmentation of HL Diagnosed Incident Cases by Cellular Type 45
Table 16: 7MM, Diagnosed Incident Cases of HL, Both Sexes, All Ages, N, 2014-2024 51
Table 17: 7MM, Age-Specific Diagnosed Incident Cases of HL, Both Sexes, N (Row %), 2014 53
Table 18: 7MM, Sex-Specific Diagnosed Incident Cases of HL, All Ages, N (Row %), 2014 55
Table 19: 7MM, Five-Year Diagnosed Prevalent Cases of HL, Both Sexes, All Ages, N, 2014-2024 60
Table 20: Treatment Guidelines for HL 64
Table 21: Leading Pharmacological Treatments for HL 69
Table 22: Product Profile - Adcetris (brentuximab vedotin) 71
Table 23: Efficacy of Adcetris in R/R HL patients 82
Table 24: Efficacy of Adcetris in the Post-ASCT HL Setting 83
Table 25: Safety of Adcetris in R/R HL patients 85
Table 26: Safety of Adcetris in the Post-ASCT HL setting 86
Table 27: Adcetris SWOT Analysis, 2015 87
Table 28: Global Sales Forecast ($m) for Adcetris, 2014-2024 88
Table 29: Overall Unmet Needs - Current Level of Attainment 90
Table 30: Design of Current Phase II and III Trials in HL 115
Table 31: Key Pipeline of HL Therapies in Clinical Development, 2015 120
Table 32: Product Profile - Opdivo (nivolumab) 122
Table 33: Efficacy of Opdivo in Patients with R/R HL 129
Table 34: Safety of Opdivo 130
Table 35: Opdivo SWOT Analysis, 2015 131
Table 36: Global Sales Forecast ($m) for Opdivo, 2014-2024 132
Table 37: Product Profile - Keytruda (pembrolizumab) 134
Table 38: Efficacy of Keytruda in Patients with R/R HL 139
Table 39: Safety of Keytruda 140
Table 40: Keytruda SWOT Analysis, 2015 141
Table 41: Global Sales Forecast ($m) for Keytruda, 2014-2024 142
Table 42: Product Profile - INCB40093 (+INCB39110) 143
Table 43: Efficacy of INCB40093 (+INCB39110) in Patients with R/R HL 147
Table 44: Safety of INCB40093 (+INCB39110) 148
Table 45: INCB40093 (+INCB39110) SWOT Analysis, 2015 148
Table 46: Global Sales Forecast ($m) for INCB40093 (+INCB39110), 2014-2024 149
Table 47: Product Profile - AFM-13 150
Table 48: Efficacy of AFM-13 Patients with R/R HL 155
Table 49: AFM-13 SWOT Analysis, 2015 156
Table 50: Global Sales Forecast ($m) for AFM-13, 2014-2024 157
Table 51: Product Profile - JNJ-40346527 158
Table 52: Product Profile - Jakafi (ruxolitinib phosphate) 161
Table 53: Product Profile - MK-2206 164
Table 54: Safety of MK-2206 166
Table 55: Product Profile - Entinostat 167
Table 56: Efficacy of Entinostat in Patients with R/R HL 169
Table 57: Safety of Entinostat 170
Table 58: Product Profile - Resminostat 171
Table 59: Efficacy of Resminostat in Patients with R/R HL 173
Table 60: Safety of Entinostat 174
Table 61: Early-Stage Pipeline Products in HL 176
Table 62: Clinical Benchmarking of Marketed Drugs for Newly Diagnosed and R/R HL 185
Table 63: Clinical Benchmarking of Key Pipeline Drugs for R/R HL 186
Table 64: Commercial Benchmarking of Marketed Drugs for Newly Diagnosed and R/R HL 187
Table 65: Commercial Benchmarking of Key Pipeline Drugs for R/R HL 188
Table 66: Top-Line Global Sales Forecasts ($m) for HL, 2014-2024 193
Table 67: Global HL Market - Drivers and Barriers, 2014-2024 195
Table 68: Key Events Impacting Sales of the US HL Market, 2014-2024 196
Table 69: Key Events Impacting Sales of the 5EU HL Market, 2014-2024 199
Table 70: Key Events Impacting Sales of the Japanese HL Market, 2014-2024 202
Table 71: Key Launch Dates 238
Table 72: Average Body Weight, Height and Surface Area Across the 7MM 240
Table 73: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 250 


List of Figures

Figure 1: 7MM, Diagnosed Incident Cases of HL, Both Sexes, All Ages, N, 2014-2024 52
Figure 2: 7MM, Age-Specific Diagnosed Incident Cases of HL, Both Sexes, N, 2014 54
Figure 3: 7MM, Sex-Specific Diagnosed Incident Cases of HL, All Ages, N, 2014 56
Figure 4: 7MM, Age-Standardized Diagnosed Incidence of HL (Cases per 100,000 Population), All Ages, by Sex, 2014 57
Figure 5: 7MM, Diagnosed Incident Cases of HL by Clinical Stage at Diagnosis, All Ages, Both Sexes, N, 2014 58
Figure 6: 7MM, Diagnosed Incident Cases of HL by Cellular Types, All Ages, Both Sexes, N, 2014 59
Figure 7: 7MM, Five-Year Diagnosed Prevalent Cases of HL, Both Sexes, All Ages, N, 2014-2024 61
Figure 8: Treatment Overview for Adult HL 65
Figure 9: Adcetris - Phase II and III trials 81
Figure 10: Opdivo - Phase I and II Trials 127
Figure 11: Keytruda - Phase I and II Trials 137
Figure 12: INCB40093 (+INCB39110) - Phase I and II Trials 146
Figure 13: AFM-13 - Phase I and II Trials 154
Figure 14: JNJ-40346527 - Phase I and II trials 159
Figure 15: Entinostat (SNDX-275) - Phase II Trial 169
Figure 16: Resminostat - Phase II Trial 172
Figure 17: Competitive Assessment of Marketed and Pipeline HL Agents, 2014-2024 191
Figure 18: Sales from HL Therapeutic Agents by Region, 2014 and 2024 194
Figure 19: US Sales for HL Therapeutic Agents, 2014 and 2024 197
Figure 20: 5EU Sales for HL Therapeutic Agents, 2014 and 2024 200
Figure 21: Japan Sales for HL Therapeutic Agents, 2014 and 2024 203

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