Disease Overview
Malignant tumors of the liver are primarily adenocarcinomas, with two major cell types: hepatocellular carcinoma (HCC), and cholangiocarcinoma. Liver cancer is the third-leading cause of cancer-related deaths, and HCC accounts for 85% of all primary liver cancers. It occurs mainly due to hepatitis C infection, and to a lesser extent hepatitis B and alcohol. While surgical resection and liver transplantation are potentially curative therapies for early-stage HCC, the majority of diagnoses take place at a disease stage that is too advanced for these treatments.
Market Snapshot
Malignant tumors of the liver are primarily adenocarcinomas, with two major cell types: hepatocellular carcinoma (HCC), and cholangiocarcinoma. Liver cancer is the third-leading cause of cancer-related deaths, and HCC accounts for 85% of all primary liver cancers. It occurs mainly due to hepatitis C infection, and to a lesser extent hepatitis B and alcohol. While surgical resection and liver transplantation are potentially curative therapies for early-stage HCC, the majority of diagnoses take place at a disease stage that is too advanced for these treatments.
Market Snapshot
- New drug launches in both the first- and second-line settings will expand the previously stagnant HCC market.
- Nexavar dominates the systemic therapy landscape across all treatment settings
- Incident cases of HCC are expected to increase by almost 30% during 2018–38.
- Bayer and Amgen dominate the HCC market with the only approved targeted therapies.
- Targeted therapies for second-line treatment constitute the largest proportion of the HCC pipeline.
Table of Contents
FORECAST: HEPATOCELLULAR CARCINOMA (HCC) (Published on 24 July 2017)
Overview
Executive Summary
Market Overview And Trends
Market Definition And Methodology
Cabometyx (Cabozantinib)
Cyramza (Ramucirumab)
Keytruda (Pembrolizumab)
Lenvima (Lenvatinib)
Nexavar (Sorafenib)
Opdivo (Nivolumab)
Stivarga (Regorafenib)
Primary Research Methodology
Executive Summary
Market Overview And Trends
Market Definition And Methodology
Cabometyx (Cabozantinib)
Cyramza (Ramucirumab)
Keytruda (Pembrolizumab)
Lenvima (Lenvatinib)
Nexavar (Sorafenib)
Opdivo (Nivolumab)
Stivarga (Regorafenib)
Primary Research Methodology
TREATMENT: HEPATOCELLULAR CARCINOMA (HCC) (Published on 20 June 2017)
Overview
Executive Summary
Primary Research Methodology
Disease Definition And Diagnosis
Patient Segmentation
Current Treatment Options
Prescribing Trends
Unmet Needs In Hepatocellular Carcinoma
Future Treatment Trends
Executive Summary
Primary Research Methodology
Disease Definition And Diagnosis
Patient Segmentation
Current Treatment Options
Prescribing Trends
Unmet Needs In Hepatocellular Carcinoma
Future Treatment Trends
EPIDEMIOLOGY: HEPATOCELLULAR CARCINOMA (HCC) (Published on 20 February 2019)
Overview
Disease Background
Methodology
Forecast
Bibliography
Appendix: Additional Sources
Disease Background
Methodology
Forecast
Bibliography
Appendix: Additional Sources
MARKETED DRUGS: HEPATOCELLULAR CARCINOMA (HCC) (Published on 24 July 2017)
Overview
Executive Summary
Product Overview
Product Profile: Nexavar
Product Profile: Stivarga
Executive Summary
Product Overview
Product Profile: Nexavar
Product Profile: Stivarga
PIPELINE: HEPATOCELLULAR CARCINOMA (HCC) (Published on 24 July 2017)
Overview
Executive Summary
Clinical Pipeline Overview
Comparator Therapy
Recently Discontinued Drugs
Additional Pharma Intelligence Pipeline Resources
Product Profile (Late Stage): Adi-Peg 20
Product Profile (Late Stage): Cabometyx
Product Profile (Late Stage): Cyramza
Product Profile (Late Stage): Keytruda
Product Profile (Late Stage): Lenvima
Product Profile (Late Stage): Opdivo
Executive Summary
Clinical Pipeline Overview
Comparator Therapy
Recently Discontinued Drugs
Additional Pharma Intelligence Pipeline Resources
Product Profile (Late Stage): Adi-Peg 20
Product Profile (Late Stage): Cabometyx
Product Profile (Late Stage): Cyramza
Product Profile (Late Stage): Keytruda
Product Profile (Late Stage): Lenvima
Product Profile (Late Stage): Opdivo
LIST OF FIGURES
Figure 1: HCC sales across the US, Japan, and five major EU markets, by country, 2016–25
Figure 2: HCC sales across the US, Japan, and five major EU markets, by class, 2016–25
Figure 3: Proportion of total HCC sales attributable to Bayer/Amgen’s products Nexavar and Stivarga across the US, Japan, and five major EU markets, 2016–25
Figure 4: Sales value of drugs in the first-line treatment setting for HCC across the US, Japan, and five major EU markets, 2016–25
Figure 5: Sales of key HCC drugs within the first-line setting across the US, Japan, and five major EU markets, by brand, 2016–25
Figure 6: Sales value of drugs in the second-line treatment setting for HCC across the US, Japan, and five major EU markets, 2016–25
Figure 7: Sales of key HCC drugs within the second-line setting across the US, Japan, and five major EU markets, by brand, 2016–25
Figure 8: Patient-based forecast methodology for HCC
Figure 9: Price sources and calculations, by country
Figure 10: Cabometyx sales for HCC across the US and five major EU markets, by country, 2016–25
Figure 11: Cyramza sales for HCC across the US, Japan, and five major EU markets, by country, 2016–25
Figure 12: Keytruda sales for HCC across the US, Japan, and five major EU markets, by country, 2016–25
Figure 13: Lenvima sales for HCC across the US, Japan, and five major EU markets, by country, 2016–25
Figure 14: Nexavar sales for HCC across the US, Japan, and five major EU markets, by country, 2016–25
Figure 15: Opdivo sales for HCC across the US, Japan, and five major EU markets, by country, 2016–25
Figure 16: Stivarga sales for HCC across the US, Japan, and five major EU markets, by country, 2016–25
Figure 17: BCLC classification tree
Figure 18: Proportion of HCC patients in each BCLC stage, by country
Figure 19: Average percentage of HCC patients who experience disease recurrence, by BCLC disease stage
Figure 20: Proportion of recurrent HCC patients who have intrahepatic versus extrahepatic recurrence, by country
Figure 21: Proportion of recurrent HCC patients who have early versus late recurrence, by country
Figure 22: Proportion of first-line early-stage HCC patients receiving each treatment type, by country
Figure 23: Top three first-line locoregional therapies for early-stage HCC, by country
Figure 24: Proportion of first-line Stage B, C, and D HCC patients receiving each treatment type, by region
Figure 25: Top three first-line systemic therapies for intermediate (Stage B) HCC, by country
Figure 26: Top three first-line systemic therapies for advanced (Stage C) HCC, by country
Figure 27: Top three first-line systemic therapies for end-stage (Stage D) HCC, by country
Figure 28: Top three first-line locoregional therapies for intermediate (Stage B) HCC, by country
Figure 29: Proportion of second-line Stage B, C, and D HCC patients receiving each treatment type, by region
Figure 30: Top three second-line systemic therapies for intermediate (Stage B) HCC, by country
Figure 31: Top three second-line systemic therapies for advanced (Stage C) HCC, by country
Figure 32: Top three second-line systemic therapies for end-stage (Stage D) HCC, by country
Figure 33: Proportion of first- and second-line intrahepatic recurrent HCC patients receiving each treatment type, by region
Figure 34: Top three first-line systemic therapies for intrahepatic recurrent HCC, by country
Figure 35: Top three second-line systemic therapies for intrahepatic recurrent HCC, by country
Figure 36: Top three first-line locoregional therapies for intrahepatic recurrent HCC, by country
Figure 37: Top three second-line locoregional therapies for intrahepatic recurrent HCC, by country
Figure 38: Proportion of first- and second-line extrahepatic recurrent HCC patients receiving each treatment type, by region
Figure 39: Top three first-line systemic therapies for extrahepatic recurrent HCC, by country
Figure 40: Top three second-line systemic therapies for extrahepatic recurrent HCC, by country
Figure 41: Proportion of systemic therapy use intended for bridging or downstaging therapy versus standard treatment
Figure 42: Proportion of locoregional therapy use intended for bridging or downstaging therapy versus standard treatment
Figure 43: Proportion of patients receiving standard systemic and locoregional therapy vs systemic and locoregional therapy for bridging or downstaging, by country
Figure 44: Trends in incident cases of HCC in the US, Japan, and five major EU markets, by country, 2018–38
Figure 45: Nexavar for HCC – SWOT analysis
Figure 46: The authors drug assessment summary of Nexavar for HCC
Figure 47: The authors drug assessment summary of Nexavar for HCC
Figure 48: Stivarga for HCC – SWOT analysis
Figure 49: The authors drug assessment summary of Stivarga for HCC
Figure 50: The authors drug assessment summary of Stivarga for HCC
Figure 51: ADI-PEG 20 for HCC – SWOT analysis
Figure 52: The authors drug assessment summary of ADI-PEG 20 for HCC
Figure 53: The authors drug assessment summary of ADI-PEG 20 for HCC
Figure 54: Cabometyx for HCC – SWOT analysis
Figure 55: The authors drug assessment summary of Cabometyx for HCC
Figure 56: The authors drug assessment summary of Cabometyx for HCC
Figure 57: Cyramza for HCC – SWOT analysis
Figure 58: The authors drug assessment summary of Cyramza for hepatocellular carcinoma
Figure 59: The authors drug assessment summary of Cyramza for hepatocellular carcinoma
Figure 60: Keytruda for HCC – SWOT analysis
Figure 61: The authors drug assessment summary of Keytruda for HCC
Figure 62: The authors drug assessment summary of Keytruda for HCC
Figure 63: Lenvima for HCC – SWOT analysis
Figure 64: The authors drug assessment summary of Lenvima for HCC
Figure 65: The authors drug assessment summary of Lenvima for HCC
Figure 66: Opdivo for HCC – SWOT analysis
Figure 67: The authors drug assessment summary of Opdivo for HCC
Figure 68: The authors drug assessment summary of Opdivo for hepatocellular carcinoma
Figure 2: HCC sales across the US, Japan, and five major EU markets, by class, 2016–25
Figure 3: Proportion of total HCC sales attributable to Bayer/Amgen’s products Nexavar and Stivarga across the US, Japan, and five major EU markets, 2016–25
Figure 4: Sales value of drugs in the first-line treatment setting for HCC across the US, Japan, and five major EU markets, 2016–25
Figure 5: Sales of key HCC drugs within the first-line setting across the US, Japan, and five major EU markets, by brand, 2016–25
Figure 6: Sales value of drugs in the second-line treatment setting for HCC across the US, Japan, and five major EU markets, 2016–25
Figure 7: Sales of key HCC drugs within the second-line setting across the US, Japan, and five major EU markets, by brand, 2016–25
Figure 8: Patient-based forecast methodology for HCC
Figure 9: Price sources and calculations, by country
Figure 10: Cabometyx sales for HCC across the US and five major EU markets, by country, 2016–25
Figure 11: Cyramza sales for HCC across the US, Japan, and five major EU markets, by country, 2016–25
Figure 12: Keytruda sales for HCC across the US, Japan, and five major EU markets, by country, 2016–25
Figure 13: Lenvima sales for HCC across the US, Japan, and five major EU markets, by country, 2016–25
Figure 14: Nexavar sales for HCC across the US, Japan, and five major EU markets, by country, 2016–25
Figure 15: Opdivo sales for HCC across the US, Japan, and five major EU markets, by country, 2016–25
Figure 16: Stivarga sales for HCC across the US, Japan, and five major EU markets, by country, 2016–25
Figure 17: BCLC classification tree
Figure 18: Proportion of HCC patients in each BCLC stage, by country
Figure 19: Average percentage of HCC patients who experience disease recurrence, by BCLC disease stage
Figure 20: Proportion of recurrent HCC patients who have intrahepatic versus extrahepatic recurrence, by country
Figure 21: Proportion of recurrent HCC patients who have early versus late recurrence, by country
Figure 22: Proportion of first-line early-stage HCC patients receiving each treatment type, by country
Figure 23: Top three first-line locoregional therapies for early-stage HCC, by country
Figure 24: Proportion of first-line Stage B, C, and D HCC patients receiving each treatment type, by region
Figure 25: Top three first-line systemic therapies for intermediate (Stage B) HCC, by country
Figure 26: Top three first-line systemic therapies for advanced (Stage C) HCC, by country
Figure 27: Top three first-line systemic therapies for end-stage (Stage D) HCC, by country
Figure 28: Top three first-line locoregional therapies for intermediate (Stage B) HCC, by country
Figure 29: Proportion of second-line Stage B, C, and D HCC patients receiving each treatment type, by region
Figure 30: Top three second-line systemic therapies for intermediate (Stage B) HCC, by country
Figure 31: Top three second-line systemic therapies for advanced (Stage C) HCC, by country
Figure 32: Top three second-line systemic therapies for end-stage (Stage D) HCC, by country
Figure 33: Proportion of first- and second-line intrahepatic recurrent HCC patients receiving each treatment type, by region
Figure 34: Top three first-line systemic therapies for intrahepatic recurrent HCC, by country
Figure 35: Top three second-line systemic therapies for intrahepatic recurrent HCC, by country
Figure 36: Top three first-line locoregional therapies for intrahepatic recurrent HCC, by country
Figure 37: Top three second-line locoregional therapies for intrahepatic recurrent HCC, by country
Figure 38: Proportion of first- and second-line extrahepatic recurrent HCC patients receiving each treatment type, by region
Figure 39: Top three first-line systemic therapies for extrahepatic recurrent HCC, by country
Figure 40: Top three second-line systemic therapies for extrahepatic recurrent HCC, by country
Figure 41: Proportion of systemic therapy use intended for bridging or downstaging therapy versus standard treatment
Figure 42: Proportion of locoregional therapy use intended for bridging or downstaging therapy versus standard treatment
Figure 43: Proportion of patients receiving standard systemic and locoregional therapy vs systemic and locoregional therapy for bridging or downstaging, by country
Figure 44: Trends in incident cases of HCC in the US, Japan, and five major EU markets, by country, 2018–38
Figure 45: Nexavar for HCC – SWOT analysis
Figure 46: The authors drug assessment summary of Nexavar for HCC
Figure 47: The authors drug assessment summary of Nexavar for HCC
Figure 48: Stivarga for HCC – SWOT analysis
Figure 49: The authors drug assessment summary of Stivarga for HCC
Figure 50: The authors drug assessment summary of Stivarga for HCC
Figure 51: ADI-PEG 20 for HCC – SWOT analysis
Figure 52: The authors drug assessment summary of ADI-PEG 20 for HCC
Figure 53: The authors drug assessment summary of ADI-PEG 20 for HCC
Figure 54: Cabometyx for HCC – SWOT analysis
Figure 55: The authors drug assessment summary of Cabometyx for HCC
Figure 56: The authors drug assessment summary of Cabometyx for HCC
Figure 57: Cyramza for HCC – SWOT analysis
Figure 58: The authors drug assessment summary of Cyramza for hepatocellular carcinoma
Figure 59: The authors drug assessment summary of Cyramza for hepatocellular carcinoma
Figure 60: Keytruda for HCC – SWOT analysis
Figure 61: The authors drug assessment summary of Keytruda for HCC
Figure 62: The authors drug assessment summary of Keytruda for HCC
Figure 63: Lenvima for HCC – SWOT analysis
Figure 64: The authors drug assessment summary of Lenvima for HCC
Figure 65: The authors drug assessment summary of Lenvima for HCC
Figure 66: Opdivo for HCC – SWOT analysis
Figure 67: The authors drug assessment summary of Opdivo for HCC
Figure 68: The authors drug assessment summary of Opdivo for hepatocellular carcinoma
LIST OF TABLES
Table 1: HCC sales across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 2: HCC sales across the US, Japan, and five major EU markets, by class ($m), 2016–25
Table 3: Sales of key HCC drugs within the first-line setting across the US, Japan, and five major EU markets, by brand ($m), 2016–25
Table 4: Sales of key HCC drugs within the second-line setting across the US, Japan, and five major EU markets, by brand ($m), 2016–25
Table 5: Summary of drug classes and molecules included in The authors HCC patient-based forecast
Table 6: Exchange rates used for calculating prices
Table 7: Patent expiry dates for key marketed brands in HCC across the US, Japan, and five major EU markets, by country, 2016–25
Table 8: Estimated launch dates for key late-stage HCC pipeline candidates in the US, Japan, and five major EU markets, by country, 2016–25
Table 9: Cabometyx sales for HCC across the US and five major EU markets, by country ($m), 2016–25
Table 10: Cyramza sales for HCC across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 11: Keytruda sales for HCC across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 12: Lenvima sales for HCC across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 13: Nexavar sales for HCC across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 14: Opdivo sales for HCC across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 15: Stivarga sales for HCC across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 16: Oncologists, gastroenterologists, and hepatologists surveyed for the HCC primary research study, 2016
Table 17: Oncologists, gastroenterologists, and hepatologists surveyed for the HCC primary research study, 2016
Table 18: Liver and intrahepatic bile duct cancer five-year survival rates, by TNM stage at diagnosis, 2006–12
Table 19: Marketed treatments available for HCC across the US, Japan, and five major EU markets
Table 20: Genericized treatments commonly used in HCC across the US, Japan, and five major EU markets
Table 21: Off-label treatments used in HCC across the US, Japan, and five major EU markets
Table 22: Locoregional therapies for HCC across the US, Japan, and five major EU markets
Table 23: Cancer registry databases used as a source of HCC incidence data, by country
Table 24: Forecasting methodology for HCC incidence, by country, age group, and gender
Table 25: Sources of survival data used to estimate HCC prevalence, by country
Table 26: Validation of forecast estimates against benchmark estimates
Table 27: Incident cases of HCC in the US, Japan, and five major EU markets, by country, 2018–38
Table 28: Key marketed drugs for HCC
Table 29: Nexavar drug profile
Table 30: Nexavar pivotal trial data in HCC
Table 31: Nexavar late-phase trial data in HCC
Table 32: Stivarga drug profile
Table 33: Stivarga pivotal trial data in HCC
Table 34: Stivarga Phase II data in HCC
Table 35: Phase III pipeline products in development for HCC
Table 36: Nexavar drug profile
Table 37: Nexavar pivotal trial data in hepatocellular carcinoma
Table 38: Late-stage compounds that were recently discontinued for HCC
Table 39: ADI-PEG 20 drug profile
Table 40: ADI-PEG 20 Phase III data in HCC
Table 41: ADI-PEG 20 Phase II data in HCC
Table 42: Cabometyx drug profile
Table 43: Cabometyx Phase III trial in HCC
Table 44: Cabometyx Phase II data in HCC
Table 45: Cyramza drug profile
Table 46: Cyramza Phase III data in HCC
Table 47: Cyramza Phase III trial in HCC
Table 48: Cyramza Phase II data in HCC
Table 49: Keytruda drug profile
Table 50: Keytruda Phase II and Phase III trials in HCC
Table 51: Lenvima drug profile
Table 52: Lenvima Phase III data in HCC
Table 53: Lenvima Phase I/II data in HCC
Table 54: Opdivo drug profile
Table 55: Opdivo Phase III trial in HCC
Table 56: Opdivo Phase I/II data in HCC
Table 2: HCC sales across the US, Japan, and five major EU markets, by class ($m), 2016–25
Table 3: Sales of key HCC drugs within the first-line setting across the US, Japan, and five major EU markets, by brand ($m), 2016–25
Table 4: Sales of key HCC drugs within the second-line setting across the US, Japan, and five major EU markets, by brand ($m), 2016–25
Table 5: Summary of drug classes and molecules included in The authors HCC patient-based forecast
Table 6: Exchange rates used for calculating prices
Table 7: Patent expiry dates for key marketed brands in HCC across the US, Japan, and five major EU markets, by country, 2016–25
Table 8: Estimated launch dates for key late-stage HCC pipeline candidates in the US, Japan, and five major EU markets, by country, 2016–25
Table 9: Cabometyx sales for HCC across the US and five major EU markets, by country ($m), 2016–25
Table 10: Cyramza sales for HCC across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 11: Keytruda sales for HCC across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 12: Lenvima sales for HCC across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 13: Nexavar sales for HCC across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 14: Opdivo sales for HCC across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 15: Stivarga sales for HCC across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 16: Oncologists, gastroenterologists, and hepatologists surveyed for the HCC primary research study, 2016
Table 17: Oncologists, gastroenterologists, and hepatologists surveyed for the HCC primary research study, 2016
Table 18: Liver and intrahepatic bile duct cancer five-year survival rates, by TNM stage at diagnosis, 2006–12
Table 19: Marketed treatments available for HCC across the US, Japan, and five major EU markets
Table 20: Genericized treatments commonly used in HCC across the US, Japan, and five major EU markets
Table 21: Off-label treatments used in HCC across the US, Japan, and five major EU markets
Table 22: Locoregional therapies for HCC across the US, Japan, and five major EU markets
Table 23: Cancer registry databases used as a source of HCC incidence data, by country
Table 24: Forecasting methodology for HCC incidence, by country, age group, and gender
Table 25: Sources of survival data used to estimate HCC prevalence, by country
Table 26: Validation of forecast estimates against benchmark estimates
Table 27: Incident cases of HCC in the US, Japan, and five major EU markets, by country, 2018–38
Table 28: Key marketed drugs for HCC
Table 29: Nexavar drug profile
Table 30: Nexavar pivotal trial data in HCC
Table 31: Nexavar late-phase trial data in HCC
Table 32: Stivarga drug profile
Table 33: Stivarga pivotal trial data in HCC
Table 34: Stivarga Phase II data in HCC
Table 35: Phase III pipeline products in development for HCC
Table 36: Nexavar drug profile
Table 37: Nexavar pivotal trial data in hepatocellular carcinoma
Table 38: Late-stage compounds that were recently discontinued for HCC
Table 39: ADI-PEG 20 drug profile
Table 40: ADI-PEG 20 Phase III data in HCC
Table 41: ADI-PEG 20 Phase II data in HCC
Table 42: Cabometyx drug profile
Table 43: Cabometyx Phase III trial in HCC
Table 44: Cabometyx Phase II data in HCC
Table 45: Cyramza drug profile
Table 46: Cyramza Phase III data in HCC
Table 47: Cyramza Phase III trial in HCC
Table 48: Cyramza Phase II data in HCC
Table 49: Keytruda drug profile
Table 50: Keytruda Phase II and Phase III trials in HCC
Table 51: Lenvima drug profile
Table 52: Lenvima Phase III data in HCC
Table 53: Lenvima Phase I/II data in HCC
Table 54: Opdivo drug profile
Table 55: Opdivo Phase III trial in HCC
Table 56: Opdivo Phase I/II data in HCC
