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 Roche's combination therapy of Avastin + Tecentriq in May 2020, Bayer's 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
KEY QUESTIONS ANSWERED
Scope
Reasons to Buy
The report will enable you to -
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.
Table of Contents
1 Table of Contents
2 Hepatocellular Carcinoma: Executive Summary
3 Introduction
4 Disease Overview
5 Epidemiology
6 Current Treatment Options
7 Unmet Needs and Opportunity Assessment
8 R&D Strategies
9 Pipeline Assessment
10 Pipeline Valuation Analysis
List of Tables
List of Figures
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- 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