Hepatocellular Carcinoma – Opportunity Analysis and Forecasts to 2029

The hepatocellular carcinoma (HCC) market is expected to grow from $1bn in 2019 to $5.3bn in 2029 in the eight major markets (8MM*) at a compound annual growth rate (CAGR) of 17.8%. The significant growth in the therapy market is driven by implementing new strategies such as developing combinations of therapies with different mechanism of actions, label expansion of marketed therapies for HCC into earlier lines of therapy, and label expansion of drugs approved in other indications into HCC.

Mandana Emamzadeh, PhD, Pharma Analyst at GlobalData, comments: “The treatment landscape of HCC is rapidly changing and it is hoped that the numerous clinical trials due to report in the near future will expand treatment options across adjuvant, intermediate, and advanced settings.”

GlobalData’s report highlights nine late-stage pipeline therapies for HCC that will enter the market by 2029. In early- and intermediate-stage HCC, systemic therapies used as adjuvant treatment or as combinations with transcatheter arterial chemoembolization (TACE), respectively, are seeking to introduce new options to the HCC paradigm where currently none exist. Within the advanced setting, the majority of trials are for the first-line setting and a few are in the second line, creating a competitive market.

Emamzadeh explains: “By 2029, first-line advanced HCC, with $2.5bn global sales, is forecast to be the most profitable line of therapy due to the highest number of treated cases, as well as the relatively high cost of treatment in this setting, which decreases in subsequent lines of therapy. With fewer treated cases, sales in the intermediate, second-line advanced, adjuvant, and third-line advanced settings are $1.8bn, $572.1m, $307.7m, and $120.1m, respectively.”

IO agents will be the dominant class in the HCC market contributing $3.8bn, followed by angiogenesis inhibitors and TKI contributing $965.7m and $505.5m to global sales in 2029, respectively.

Emamzadeh concludes: “Between 2019 and 2029, barriers such as patent expiry of key drugs will depreciate the market value with the emergence of generics and biosimilars of the top-selling brands, including Bayer’s Nexavar, Eisai’s Lenvima, and Roche’s Avastin. Despite this, the market is growing at an impressive rate and opportunities exist for developers to further improve the HCC treatment landscape.”

*8MM: US, France, Germany, Italy, Spain, UK, Japan, and China

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.

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?

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.

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.

Companies mentioned

AstraZeneca

Bayer

BMS

Onyx Pharmaceuticals

Eisai

Exelixis

Roche/Genentech

Merck & Co.

Novartis

Ono

ImClone Systems

Suzhou Zelgen Biopharmaceutical

Jiangsu Hengrui Medicine

BeiGene Ltd

CStone Pharmaceuticals Co

Innovent Biologics

Shanghai Junshi Bioscience

Table of Contents

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

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/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

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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