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Opportunity Analyzer: Hepatocellular Carcinoma - Opportunity Analysis and Forecasts to 2024

Summary

Liver cancer is the second leading cause of cancer related death in the world in men and the sixth leading cause of cancer death in women. Hepatocellular carcinoma (HCC) is the most dominant form of liver cancer, accounting for approximately 85% of liver cancer cases. The prognosis of HCC is dependent on the stage of the disease at diagnosis. However, even with treatments such as surgical resection, liver transplantation, and ablative therapies, which are only suitable for early-stage HCC patients, the majority of patients are likely to progress onto the advanced stages of the disease.

Highlights

Key Questions Answered

- Nexavar, approved in 2007, is the only available targeted treatment option for patients with advanced HCC and has dominated the HCC market in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) since its launch.
- The current late and early stage pipeline is very strong and diverse. Which drug will have the biggest impact on the market? What strategies are developers undertaking to overcome the high risk of clinical trial failure?
- Nexavar will lose patent protection within the forecast period. How will this impact the HCC market and will new market entries be able to stabilize the HCC market?

Key Findings

- The main driver of growth in the HCC market is the expected launch of second-line treatments for patients with advanced HCC. The market growth will be further supported by an increase in HCC incidence numbers due to a growing aging population as well as market-specific increase in risk factors.
- The biggest barrier for HCC is the patent expiry of Nexavar and expected introduction of generic sorafenib in the 7MM. The effect of this will be strongest in the US where it will have the largest impact on the HCC market. Further patent expiries will also have a negative impact on the HCC market.
- The largest unmet needs in HCC are more treatment options for patients with advanced HCC. First line as well as second line and beyond treatments are urgently needed to improve the treatability of these patients.

Scope

- Overview of HCC, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized HCC market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024.
- Key topics covered include market characterization, unmet needs, R&D and clinical trials assessment, late stage clinical trial analysis and implications for the HCC therapeutics market.
- Pipeline analysis: focus on the late-stage pipeline HCC drugs discussing emerging trends as well as overview of earlier phase drugs.
- Analysis of the current and future market competition in the global HCC therapeutics 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. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global HCC therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global HCC therapeutics market in 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.
- Track drug sales in the global HCC therapeutics market from 2014-2024.
- 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

Opportunity Analyzer: Hepatocellular Carcinoma - Opportunity Analysis and Forecasts to 2024
1 Table of Contents
1 Table of Contents 9
1.1 List of Tables 14
1.2 List of Figures 18
2 Introduction 20
2.1 Catalyst 20
2.2 Related Reports 21
2.3 Upcoming Reports 21
3 Disease Overview 22
3.1 Etiology and Pathophysiology 23
3.1.1 Etiology 23
3.1.2 HBV Infection 24
3.1.3 HCV Infection 24
3.2 Surveillance of HCC 25
3.3 Alpha-Fetoprotein and other Biomarkers 27
3.4 Pathophysiology 28
3.5 Clinical Staging and Treatment Guidelines 29
3.6 Prognosis and Progression 33
4 Epidemiology 34
4.1 Disease Background 34
4.2 Risk Factors and Comorbidities 35
4.3 Global Trends 37
4.3.1 Incidence 37
4.3.2 Relative Survival 38
4.3.3 Stage at Diagnosis 40
4.4 Forecast Methodology 41
4.4.1 Sources Used 46
4.4.2 Sources Not Used 49
4.4.3 Forecast Assumptions and Methods 50
4.5 Epidemiological Forecast of HCC (2014-2024) 53
4.5.1 Diagnosed Incident Cases of HCC 53
4.5.2 Age-Specific Diagnosed Incident Cases of HCC 55
4.5.3 Sex-Specific Diagnosed Incident Cases of HCC 56
4.5.4 Age-Standardized Diagnosed Incidence of HCC 58
4.5.5 Diagnosed Incident Cases of HCC by BCLC Stages 59
4.5.6 Diagnosed Incident Cases of HCC with HBV and HCV Comorbidities 61
4.5.7 Five-Year Diagnosed Prevalent Cases of HCC 63
4.6 Discussion 65
4.6.1 Epidemiological Forecast Insight 65
4.6.2 Limitations of the Analysis 66
4.6.3 Strengths of the Analysis 67
5 Current Treatment Options 68
5.1 Overview 68
5.2 Product Profiles - Major Brands 70
5.2.1 Nexavar (sorafenib) 70
5.3 Therapy Approaches 75
5.3.1 Early-Stage HCC Treatment 75
5.3.2 Intermediate and Advanced-Stage HCC Treatment 80
5.4 Other Treatments 85
5.4.1 Adjunctive Therapy and Treatment of Underlying Diseases 85
5.4.2 Systemic Chemotherapy 85
5.4.3 Radiation Therapy 86
6 Unmet Needs Assessment and Opportunity Analysis 87
6.1 Overview 87
6.2 Unmet Needs Analysis 87
6.2.1 Improved Treatability of Late-Stage HCC (First and Second Line) 87
6.2.2 Better Prognostic Biomarkers 89
6.2.3 Safe and Efficacious Adjuvant and Neoadjuvant Therapies 91
6.2.4 Better HCC Surveillance and Prophylactic Treatments 94
7 RandD Strategies 97
7.1 Overview 97
7.2 Treatments for Nexavar-Refractory Patients 97
7.3 C-Met as a Molecular Target for HCC as well as a Potential Biomarker 98
7.4 HCC as an Add-on Indication for Marketed Products 98
7.5 Multi-kinase Inhibitors Remain Well Represented in the Early- and Late-Stage Pipeline 98
7.6 Clinical Trial Design 99
7.6.1 Clinical Trial Failures 2007-2015 99
7.6.2 HCC Phase III Clinical Trial Design 2015 101
7.6.3 Clinical Trial Design Cornerstones 103
8 Pipeline Assessment 105
8.1 Overview 105
8.2 Promising Drugs in Clinical Development 106
8.2.1 Multi Kinase Inhibitors 107
8.2.2 Lenvima (lenvatinib) 108
8.2.3 Stivarga (regorafenib) 114
8.2.4 Cometriq (cabozantinib) 119
8.2.5 Tivantinib (ARQ 197) 124
8.2.6 Pexa-Vec (pexastimogene devacirepvec) 132
8.2.7 Cyramza (ramucirumab) 136
8.2.8 Pegargiminase (ADI-PEG 20) 143
8.2.9 Livatag (doxorubicin Transdrug) 147
8.2.10 ThermoDox (Heat-Activated Liposomal Encapsulation of Doxorubicin) 151
8.2.11 Peretinoin (polyprenoic acid) 156
8.3 Innovative Early-Stage Approaches 161
8.3.1 Overview 161
8.3.2 Immunotherapies 163
9 Pipeline Valuation Analysis 167
9.1 Overview 167
9.2 Clinical Benchmark of Key Pipeline Drugs 168
9.2.1 First-Line Therapy for Patients with Advanced HCC 168
9.2.2 Second-Line Therapy for Patients with Advanced HCC 169
9.2.3 Adjunctive Therapy Following Resection/Ablation or RFA 172
9.3 Commercial Benchmark of Key Pipeline Drugs 173
9.3.1 First-Line Therapy for Patients with Advanced HCC 173
9.3.2 Second-Line Therapy for Patients with Advanced HCC 174
9.3.3 Adjunctive Therapy Following Resection/Ablation or RFA 176
9.4 Competitive Assessment 178
9.4.1 First-Line and Second-Line Therapy for Patients with Advanced HCC 178
9.4.2 Adjunctive Therapy Following Resection/Ablation or RFA 180
9.5 Top-Line 10-Year Forecast 182
9.5.1 US 185
9.5.2 5EU 187
9.5.3 Japan 188
10 Appendix 189
10.1 Bibliography 189
10.2 Abbreviations 212
10.3 Methodology 216
10.4 Forecasting Methodology 216
10.4.1 HCC Incidence Patients 216
10.4.2 Progression 217
10.4.3 Percent Drug-Treated Patients 219
10.4.4 Drugs Included in Each Therapeutic Class and Patient Distributions Not Included in HCC Sales 219
10.4.5 Launch and Patent Expiry Dates 221
10.4.6 General Pricing Assumptions 222
10.4.7 Individual Drug and Pipeline Assumptions 223
10.4.8 Generic Erosion 230
10.5 Physicians and Specialists Included in this Study 231
10.5.1 Primary Research - Prescriber Survey 232
10.6 About the Authors 233
10.6.1 Author 233
10.6.2 Reviewer 233
10.6.3 Epidemiologists 234
10.6.4 Global Head of Healthcare 235
10.7 About GlobalData 236
10.8 Disclaimer 236

1.1 List of Tables
Table 1: Diagnostic Tools Utilized for HCC Surveillance in the 7MM 26
Table 2: Risk Factors and Comorbidities for HCC 36
Table 3: 7MM, Most Recent One-Year and Five-Year Relative Liver Cancer Survival in Men and Women 39
Table 4: US and Germany, Relative Survival Temporal Trend 39
Table 5: 7MM, BCLC and Child-Pugh Stage at Diagnosis, Men and Women (%) 41
Table 6: 7MM, Sources Used for Diagnosed Incidence of HCC 42
Table 7: 7MM, Sources of Epidemiological Data Used for Diagnosed Incident Cases Segmented by BCLC Clinical Stages 43
Table 8: 7MM, Sources of Epidemiological Data Used to Forecast Five-Year Diagnosed Prevalent Cases of HCC 44
Table 9: 7MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Incident Cases of HCC with HBV and HCV Comorbidities 45
Table 10: 7MM, Diagnosed Incident Cases of HCC, Both Sexes, Ages ?30 Years, N, 2014-2024 54
Table 11: 7MM, Age-Specific Diagnosed Incident Cases of HCC, Both Sexes, N, 2014 55
Table 12: 7MM, Sex-Specific Diagnosed Incident Cases of HCC, Ages ?30 Years, N (Row %), 2014 57
Table 13: 7MM, Diagnosed Incident Cases of HCC by BCLC Stage, Ages ?30 Years, N (Row %), 2014 60
Table 14: 7MM, Diagnosed Incident Cases of HCC with HBV and HCV, Ages ?30 Years, Both Sexes, N, 2014 (Row %) 62
Table 15: 7MM, Five-Year Diagnosed Prevalent Cases of HCC, Ages ?30 Years, Both Sexes, N, 2014-2024 64
Table 16: Leading Treatments for Hepatocellular Carcinoma 69
Table 17: Product Profile - Nexavar 72
Table 18: Efficacy of Nexavar 73
Table 19: Nexavar SWOT Analysis 75
Table 20: Early-Stage Treatment (BCLC Stage A) Approaches in the 7MM 76
Table 21: Success Rate of Ablation and Resection (BCLC Stage A/B) in the 7MM* 78
Table 22: Ablation Methods Used to Treat HCC 79
Table 23: Transarterial Therapies HCC 80
Table 24: Transarterial Regional Therapies used in BCLC B Patients in the 7MM 82
Table 25: Overall Unmet Needs - Current Level of Attainment 87
Table 26: BCLC Stage at Time of Diagnosis in the 7MM 96
Table 27: Key HCC Clinical Trial Successes and Failures* (2007-2015) 100
Table 28: Design of Current Phase III Trials in HCC 102
Table 29: Suitable Primary and Secondary Endpoints for HCC 104
Table 30: HCC - Late-Stage Pipeline, 2015 106
Table 31: Product Profile - Lenvima 109
Table 32: Efficacy of Lenvima 111
Table 33: Lenvima SWOT Analysis 113
Table 34: Global Sales Forecast ($m) for Lenvima, 2014-2024 114
Table 35: Product Profile - Stivarga 115
Table 36: Efficacy of Stivarga 118
Table 37: Stivarga SWOT Analysis 119
Table 38: Global Sales Forecast ($m) for Stivarga, 2014-2024 119
Table 39: Product Profile - Cometriq 120
Table 40: Efficacy of Cometriq 123
Table 41: Cometriq SWOT Analysis 124
Table 42: Global Sales Forecast ($m) for Cometriq, 2014-2024 124
Table 43: Product Profile - Tivantinib 125
Table 44: Efficacy of Tivantinib 129
Table 45: Efficacy of Tivantinib in Patients with High MET Tumors 129
Table 46: Safety of Tivantinib 130
Table 47: Drug-Related Events Occurring in ?10% of Patients in any Treatment Group 130
Table 48: Tivantinib SWOT Analysis 131
Table 49: Global Sales Forecast ($m) for tivantinib, 2014-2024 131
Table 50: Product Profile - Pexa-Vec 132
Table 51: Efficacy of Pexa-Vec - High Dose vs Low Dose 134
Table 52: Efficacy of Pexa-Vec 135
Table 53: Pexa-Vec SWOT Analysis 136
Table 54: Product Profile - Cyramza 137
Table 55: Efficacy of Cyramza 140
Table 56: Safety of Cyramza (Grade 3 or Greater) 141
Table 57: Cyramza SWOT Analysis 142
Table 58: Global Sales Forecast ($m) for Cyramza, 2014-2024 142
Table 59: Product Profile - Pegargiminase (ADI-PEG 20) 143
Table 60: Efficacy of ADI-PEG 20 145
Table 61: ADI-PEG 20 SWOT Analysis 146
Table 62: Global Sales Forecast ($m) for ADI-Peg 20, 2014-2024 147
Table 63: Product Profile - Livatag 148
Table 64: Efficacy of Livatag 149
Table 65: Livatag SWOT Analysis 150
Table 66: Global Sales Forecast ($m) for Livatag, 2014-2024 151
Table 67: Product Profile - ThermoDox 152
Table 68: Efficacy of ThermoDox (Subgroup Analysis) 154
Table 69: ThermoDox SWOT Analysis 155
Table 70: Global Sales Forecast ($m) for ThermoDox, 2014-2024 155
Table 71: Product Profile - Peretinoin 156
Table 72: Efficacy of Peretinoin 159
Table 73: Safety of Peretinoin 160
Table 74: Peretinoin SWOT Analysis 160
Table 75: Global Sales Forecast ($m) for Peretinoin, 2014-2024 161
Table 76: Key Early-Stage HCC Pipeline 162
Table 77: Clinical Benchmark of Key Pipeline Drugs - First-Line Advanced Treatments 169
Table 78: Clinical Benchmark of Key Pipeline Drugs - Second-Line, Advanced HCC 171
Table 79: Clinical Benchmark of Key Pipeline Drugs - Adjuvant Treatment to Ablation and Resection 172
Table 80: Clinical Benchmark of Key Pipeline Drugs - Adjuvant Treatment to RFA 173
Table 81: Commercial Benchmark of Key Pipeline Drugs - First-Line Advanced HCC Treatments 174
Table 82: Commercial Benchmark of Key Pipeline Drugs - Second-Line, Advanced HCC 176
Table 83: Commercial Benchmark of Key Pipeline Drugs - Adjuvant to Resection/Ablation 177
Table 84: Commercial Benchmark of Key Pipeline Drugs - Adjuvant to RFA 177
Table 85: Top-Line Sales Forecast ($m) for HCC, 2014-2024 183
Table 86: Key Events Impacting Sales for HCC, 2014-2024 185
Table 87: HCC Market - Drivers and Barriers, 2014-2024 185
Table 88: Key Launch Dates 221
Table 89: Key Patent Expiries 222
Table 90: BCLC C Patient Shares Eligible for Second-Line (to Nexavar) Treatment 226
Table 91: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 232

1.2 List of Figures
Figure 1: Breakdown of Liver Cancer into Different Categories 22
Figure 2: Barcelona Clinic Liver Cancer Staging System for Hepatocellular Carcinoma 31
Figure 3: Surveillance and Diagnostic Algorithm for Hepatocellular Carcinoma in Japan 32
Figure 4: 7MM, Diagnosed Incidence Rate of HCC (Cases per 100,000 Population), Ages ?30 Years, Both Sexes, 2004-2013 38
Figure 5: 7MM, Diagnosed Incident Cases of HCC, Ages ?30 Years, Both Sexes, N, 2014-2024 54
Figure 6: 7MM, Age-Specific Diagnosed Incident Cases of HCC, Both Sexes, N, 2014 56
Figure 7: 7MM, Diagnosed Incident Cases of HCC, Ages ?30 Years, N, 2014 58
Figure 8: 7MM, Age-Standardized Diagnosed Incidence Cases of HCC, Ages ?30 Years, N, 2014 59
Figure 9: 7MM, Diagnosed Incident Cases of HCC by BCLC Stage, Ages ?30 Years, Both Sexes N, 2014 61
Figure 10: 7MM, Diagnosed Incident Cases of HCC with HCV, Ages ?30 Years, N, 2014 63
Figure 11: 7MM, Five-Year Diagnosed Prevalent Cases of HCC, Ages ?30 Years, Both Sexes, N, 2014-2024 65
Figure 12: HCC Treatment Regimen by BCLC Stage 69
Figure 13: Principle of Transarterial Chemoembolization (TACE) 81
Figure 14: Loco Regional HCC Treatment Regimen Proposal 83
Figure 15: Clinical Positioning Overview of Late-Stage HCC Pipeline 107
Figure 16: Lenvima - Clinical Trial Overview 111
Figure 17: Stivarga - Clinical Trial Overview 117
Figure 18: Cometriq - Clinical Trial Overview 121
Figure 19: Cometriq -Study Design 122
Figure 20: Tivantinib - Clinical Trial Overview 127
Figure 21: Pexa-Vec - Clinical Trial Overview 134
Figure 22: Cyramza - Clinical Trial Overview 139
Figure 23: ADI-PEG 20 - Clinical Trial Overview 145
Figure 24: Livatag - Clinical Trial Overview 149
Figure 25: ThermoDox - Clinical Trial Overview 153
Figure 26: Peretinoin - Clinical Trial Overview 157
Figure 27: Competitive Assessment of Late-Stage Pipeline Agents in HCC - Advanced HCC, 2014-2024 180
Figure 28: Competitive Assessment of Late-Stage Pipeline Agents in HCC-Adjuvant Setting, 2014-2024 181
Figure 29: Global Sales for HCC by Region, 2014 and 2024 184
Figure 30: Recurrence-Free Survival as Basis for Assumed Progression from BCLC Stage A to B 217
Figure 31: Survival Probabilities as Basis for Assumed Progression from BCLC Stage B to C 218
Figure 32: Survival Probabilities as Basis for Assumed Progression from BCLC Stage C to D 219

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