Hepatocellular Carcinoma - Opportunity Analysis and Forecasts to 2029

Hepatocellular Carcinoma - Opportunity Analysis and Forecasts to 2029

Summary

Hepatocellular carcinoma (HCC) is the most frequent type of primary malignancy of the liver. 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. Until the entry of Roches combination therapy of Avastin + Tecentriq in May 2020, Bayers multikinase inhibitor commanded the largest first-line and second-line patient share in the HCC market. This led to a shift in multikinase inhibitor monotherapy as standard of care (SOC) and initiated a new strategy in the HCC market whereby combinations are now the predominant therapeutic option under development.

The pipeline drugs in development for HCC are mostly already approved for other indications and HCC represents a growth strategy for the brands. There are currently nine pipeline products in Phase III clinical trial; additionally, seven marketed agents are in clinical trials to expand their labels in new lines of therapy and new combinations within HCC. The most common MOAs under investigation for HCC include tyrosine kinase inhibitors (TKI) and immuno-oncology (IO) agents (programmed cell death 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors, and cytotoxic T-lymphocyte associated protein 4 (CTLA-4) inhibitors). In addition to the active late-stage pipeline, there are a large number of ongoing Phase I and II trials.

Key Highlights

- Upon approval of Avastin + Tecentriq by the FDA, in May 2020, the combination replaced the SoC in first-line advanced HCC, shifting Nexavar and Lenvima to second-line treatment options.
- The greatest drivers of growth in the global HCC market include the launch of new pipeline therapies, combinations of therapies with different MOAs, label expansion from other oncology indications to HCC, and label expansion into earlier lines of therapy, in addition to an increase in diagnosed incident cases in many 8MM countries.
- The main barrier to growth in the HCC market is patent expiration of key biologic brands with subsequent biosimilar launch.
- The most important unmet needs in the HCC market are better HCC surveillance and prophylactic treatments, curative therapies in early-stage HCC, improved survival for intermediate-stage HCC, data on sequencing of treatments, prognostic biomarkers, treatments for patients with impaired liver function.

KEY QUESTIONS ANSWERED

- Which unmet needs are limiting the treatment of hepatocellular carcinoma in the 8MM?
- What strategies can the pharmaceutical industry employ to increase treatment rates for hepatocellular carcinoma? How should these strategies differ across different geographical markets?
- What effect will the launch of biosimilars and generics have on the sales of branded agents?
- What are the main R&D trends in the hepatocellular carcinoma market and which companies are leading the way?
- Are there major differences in the mechanisms of action used by therapies in late-stage versus early-stage clinical development?

Scope

- Overview of HCC including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Topline HCC market revenue, annual cost of therapy, and major pipeline product sales in the forecast period.
- Key topics covered include current treatment and pipeline therapies, unmet needs and opportunities, and the drivers and barriers affecting HCC therapeutics sales in the 8MM.
- Pipeline analysis: Comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline 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, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.
- 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 market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing 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 2019-2029.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

1
1.1 List of Tables
1.2 List of Figures
2 Hepatocellular Carcinoma: Executive Summary
2.1 Global HCC Market Expected to Grow at 17.7% CAGR to $5.3B 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/-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

List Of Tables

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

List Of Figures

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

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