Hepatocellular Carcinoma – Opportunity Analysis and Forecasts to 2029

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Hepatocellular Carcinoma: Executive Summary

2.1 Global HCC Market Expected to Grow at

14.5% CAGR to $5.5B During 2019–2029

2.2 Competitive Market with New Strategies to Gain Patient Share in the HCC Market

2.3 High Level of Unmet Needs Leaves Room for Further Research

2.4 Opportunity for Pipeline Agents with First-in-Class Approvals

2.5 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology

4.1.1 HBV and HCV Infection

4.1.2 Alcohol

4.1.3 NAFLD

4.2 Pathophysiology

4.2.1 MAPK Pathway

4.2.2 PI3K/Akt Pathway

4.2.3 Wnt/β-catenin Pathway

4.2.4 JAK/STAT Pathway

4.3 Surveillance of HCC

4.4 Biomarkers

4.5 Clinical Staging and Treatment Guidelines

4.6 Prognosis and Progression

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.4 Forecast Methodology

5.4.1 Sources Used

5.4.2 Forecast Assumptions and Methods

5.4.3 Diagnosed Incident Cases of HCC

5.4.4 Diagnosed Incident Cases of HCC by BCLC Stage

5.4.5 Diagnosed Incident Cases of HCC by Child-Pugh Stage

5.4.6 Diagnosed Incident Cases by HCC Risk Factors

5.4.7 Diagnosed Incident Cases of HCC by Cirrhotic Versus Non-cirrhotic HCC

5.4.8 Diagnosed Incident Cases of HCC by Biomarker AFP

5.4.9 Five-Year Diagnosed Prevalent Cases of HCC

5.4.10 All-Time Diagnosed Prevalent Cases of BCLC by Stage

5.5 Epidemiological Forecast for HCC

5.5.1 Diagnosed Incident Cases of HCC

5.5.2 Sex-Specific Diagnosed Incident Cases of HCC

5.5.3 Age-Specific Diagnosed Incident Cases of HCC

5.5.4 Diagnosed Incident Cases of HCC by BCLC Stage

5.5.5 Diagnosed Incident Cases of HCC by Child-Pugh Stage

5.5.6 Diagnosed Incident Cases of HCC by Risk Factors

5.5.7 Diagnosed Incident Cases by Cirrhotic Versus Non-cirrhotic HCC

5.5.8 Diagnosed Incident Cases of HCC by Biomarker AFP

5.5.9 Five-Year Diagnosed Prevalent Cases of HCC

5.5.10 All-Time Diagnosed Prevalent Cases of HCC by BCLC Stage

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 COVID-19 Impact

5.6.3 Limitations of Analysis

5.6.4 Strengths of Analysis

6 Current Treatment Options

6.1 Overview

6.2 Curative Therapy

6.2.1 Surgical Approaches: Transplant and Resection

6.2.2 Local Ablative Therapies

6.3 Non-curative/Palliative Therapy

6.3.1 Transarterial Regional Therapies

6.3.2 Systemic Therapy

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Better HCC Surveillance and Prophylactic Treatments

7.3 More Effective Treatments

7.3.1 Curative Therapies in Early-Stage HCC

7.3.2 Improved Survival for Intermediate-Stage HCC

7.4 Data on Sequencing of Treatments

7.5 Prognostic Biomarkers

7.6 Treatments for Patients with Impaired Liver Function

8 R&D Strategies

8.1 Overview

8.1.1 Combination Therapies with Different MOAs

8.1.2 Label Expansion from Other Oncology Indications to HCC as Part of Lifecycle Management

8.1.3 Label Expansion into Earlier Lines of Therapy

8.2 Clinical Trials Design

8.2.1 Clinical Trial Design Flaws

8.2.2 Appropriate Active Comparator in HCC Clinical Trials

9 Pipeline Assessment

9.1 Overview

9.1.1 Adjuvant Treatment

9.1.2 Intermediate HCC

9.1.3 Advanced HCC

9.2 Innovative Early-Stage Approaches

9.3 Other Drugs in Development

10 Pipeline Valuation Analysis

10.1 Clinical Benchmark of Key Pipeline Drugs

10.1.1 Adjuvant Treatment

10.1.2 Intermediate HCC

10.1.3 Advanced HCC

10.2 Commercial Benchmark of Key Pipeline Drugs

10.2.1 Adjuvant Treatment

10.2.2 Intermediate HCC

10.2.3 Advanced HCC

10.3 Competitive Assessment

10.3.1 Adjuvant Treatment

10.3.2 Intermediate HCC

10.3.3 Advanced HCC

10.4 Top-Line 10-Year Forecast

10.4.1 US

10.4.2 5EU

10.4.3 Japan

10.4.4 China

11 Appendix

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

11.3.1 Forecasting Methodology

11.3.2 Diagnosed Patients

11.3.3 Percent Drug-Treated Patients

11.3.4 Drugs Included in Each Therapeutic Class

11.3.5 Launch and Patent Expiry Dates

11.3.6 Individual Drug Assumptions

11.3.7 General Pricing Assumptions

11.3.8 Generic and Biosimilar Erosion

11.3.9 Pricing of Pipeline Agents

11.4 Primary Research – KOLs Interviewed for This Report

11.4.1 KOLs

11.4.2 Payers

11.5 Primary Research – Prescriber Survey

11.6 About the Authors

11.6.1 Analyst

11.6.2 Therapy Area Director

11.6.3 Epidemiologist

11.6.4 Managing Epidemiologist

11.6.5 Global Director of Therapy Analysis and Epidemiology

11.6.6 Global Head and EVP of Healthcare Operations and Strategy

11.7 About GlobalData

11.8 Contact Us

11.9 Disclaimer

Table 1: HCC: Key Metrics in the 8MM

Table 2: Difference Between HCC in CL and NCL

Table 3: Risk Factors and Comorbidities for HCC

Table 4: Treatment Guidelines for HCC across the 8MM

Table 5: Ablation Methods Used to Treat HCC

Table 6: Transarterial Regional Therapies in HCC

Table 7: Leading Treatments for Hepatocellular Carcinoma, 2021

Table 8: Combination Therapies in Phase III Clinical Development for HCC, 8MM

Table 9: Monotherapies in Phase III Clinical Development for HCC

Table 10: HCC Pipeline Products in Phase III Borrowed from Other Oncology Indications, 8MM

Table 11: Innovative Early-Stage Approaches for HCC, 2021

Table 12: Drugs in Development for HCC, 2021

Table 13: Clinical Benchmarking of Key Marketed and Pipeline Products for Adjuvant Therapy

Table 14: Clinical Benchmarking of Key Marketed and Pipeline Products for Intermediate HCC

Table 15: Clinical Benchmark of Key Marketed Drugs for Advanced HCC

Table 16: Clinical Benchmark of Key Pipeline Drugs for Advanced HCC

Table 17: Clinical Benchmark of Key Pipeline Drugs for Advanced HCC

Table 18: Commercial Benchmarking of Key Marketed and Pipeline Products for Adjuvant Therapy

Table 19: Commercial Benchmarking of Key Marketed and Pipeline Products for Intermediate HCC

Table 20: Commercial Benchmark of Key Marketed Drugs for Advanced HCC

Table 21: Commercial Benchmark of Key Pipeline Drugs for Advanced HCC

Table 22: Commercial Benchmark of Key Pipeline Drugs for Advanced HCC

Table 23: HCC Market – Global Drivers and Barriers, 2019–2029

Table 24: Key Events Impacting Sales for HCC in the US, 2019–2029

Table 25: Key Events Impacting Sales for HCC in the 5EU, 2019–2029

Table 26: Key Events Impacting Sales for HCC in Japan, 2019–2029

Table 27: Key Events Impacting Sales for HCC in China, 2019–2029

Table 28: Key Historical and Projected Launch Dates for HCC

Table 29: Key Historical and Projected Patent Expiry Dates for HCC

Table 30: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

Figure 1: Global Sales Forecast by Country for HCC in 2019 and 2029

Figure 2: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC in Advanced HCC

Figure 3: AASLD Surveillance Algorithm

Figure 4: Barcelona Clinic Liver Cancer Staging System for Hepatocellular Carcinoma

Figure 5: Surveillance and Diagnostic Algorithm for Hepatocellular Carcinoma in Japan

Figure 6: Hong Kong Liver Cancer Staging System

Figure 7: 8MM, Diagnosed Incidence of HCC (Cases per 100,000 Population), Men, Ages ≥18 Years, 2009–2029

Figure 8: 8MM, Diagnosed Incidence of HCC (Cases per 100,000 Population), Women, Ages ≥18 Years, 2009–2029

Figure 9: 8MM, Sources Used and Not Used to Forecast the Diagnosed Incident Cases of HCC

Figure 10: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of HCC by BCLC Stage

Figure 11: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of HCC by Child-Pugh Stage

Figure 12: 8MM, Sources Used to Forecast the Diagnosed Incident Cases by HCC Risk Factors (HBV and HCV)

Figure 13: 8MM, Sources Used to Forecast the Diagnosed Incident Cases by HCC Risk Factors (NASH/NAFLD)

Figure 14: 8MM, Sources Used to Forecast the Diagnosed Incident Cases by HCC Risk Factors (Alcohol Use)

Figure 15: 8MM, Sources Used to Forecast the Diagnosed Incident Cases by Cirrhotic versus Non-Cirrhotic HCC

Figure 16: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of HCC by Biomarker AFP

Figure 17: 8MM, Sources Used to Forecast the Five-Year Diagnosed Prevalent Cases of HCC

Figure 18: 8MM, Sources Used to Forecast the All-Time Diagnosed Prevalent Cases of HCC by BCLC Stage

Figure 19: 8MM, Diagnosed Incident Cases of HCC, Both Sexes, Ages ≥18 Years, N, 2019

Figure 20: 8MM, Diagnosed Incident Cases of HCC, by Sex, Ages ≥18 Years, N, 2019

Figure 21: 8MM, Diagnosed Incident Cases of HCC by Age, Both Sexes, N, 2019

Figure 22: 8MM, Diagnosed Incident Cases of HCC by BCLC Stage, Both Sexes, Ages ≥18 Years, N, 2019

Figure 23: 8MM, Diagnosed Incident Cases of HCC by Child-Pugh Stage, Both Sexes, Ages ≥18 Years, N, 2019

Figure 24: 8MM, Diagnosed Incident Cases by HCC by HCC Risk Factors, Both Sexes, Ages ≥18 Years, N, 2019

Figure 25: 8MM, Diagnosed Incident Cases by Cirrhotic versus Non-Cirrhotic HCC, Both Sexes, Ages ≥18 Years, N, 2019

Figure 26: 8MM, Diagnosed Incident Cases of HCC by Biomarker AFP, Both Sexes, Ages ≥18 Years, N, 2019

Figure 27: 8MM, Five-Year Diagnosed Prevalent Cases of HCC, Both Sexes, Ages ≥18 Years, N, 2019

Figure 28: 8MM, All-Time Diagnosed Prevalent Cases of HCC by BCLC Stage, Both Sexes, Ages ≥18 Years, N, 2019

Figure 29: HCC Treatment Regimen by BCLC Stage

Figure 30: Unmet Needs and Opportunities in Hepatocellular Carcinoma

Figure 31: Overview of the HCC Development Pipeline

Figure 32: Key Phase II/III Trials for the Promising Pipeline Agents in Adjuvant Setting that GlobalData Expects to Be Licensed for HCC in the 8MM During the Forecast Period

Figure 33: Key Phase II/III Trials for the Promising Pipeline Agents in Intermediate Setting that GlobalData Expects to Be Licensed for HCC in the 8MM During the Forecast Period

Figure 34: Key Phase II/III Trials for the Promising Pipeline Agents in Advanced Setting that GlobalData Expects to Be Licensed for HCC in the 8MM During the Forecast Period

Figure 35: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked in the Adjuvant Setting for HCC

Figure 36: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC for Intermediate Stage

Figure 37: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC for Advanced Stage

Figure 38: Global (8MM) Sales Forecast by Country for HCC in 2019 and 2029

Figure 39: Global (8MM) Sales Forecast by Class for HCC in 2019 and 2029

Figure 40: Sales Forecast by Class for HCC in the US in 2019 and 2029

Figure 41: Sales Forecast by Class for HCC in the 5EU in 2019 and 2029

Figure 42: Sales Forecast by Class for HCC in Japan in 2019 and 2029

Figure 43: Sales Forecast by Class for HCC in China in 2019 and 2029