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Market Overview

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The global market for hepatocellular carcinoma (HCC) treatment is forecasted to reach USD 7.3 billion by 2027, growing at a compound annual growth rate (CAGR) of 17.39% from 2022 to 2027. HCC is the most common type of liver cancer, accounting for approximately 90% of cases. It is an aggressive form of cancer with a low five-year survival rate of less than 5%, making it a significant public health concern worldwide. The development of HCC is influenced by factors such as hepatitis B and C infections, aflatoxin exposure, liver cirrhosis, hemochromatosis in Asia and Africa, while developed countries see a higher prevalence due to diabetes, obesity, and non-alcoholic steatohepatitis (NASH). Liver cancer is a leading cause of cancer-related deaths globally, with over 800,000 deaths and 900,000 new cases reported annually.

The research estimates that China, followed by the United States and Japan, will have a high prevalence of HCC in 2020, driving the growth of the HCC treatment market. The number of people affected by HCC is projected to exceed 1 million per year by 2025.

The global portfolio of HCC treatment includes more than 155 assets at various stages of development. Most drugs sponsored by the industry in active clinical development for HCC are currently in Phase II trials. Monoclonal antibodies targeting PD-1 and PD-L1 are dominant in the HCC drug pipeline.

The clinical trial portfolio for HCC treatment comprises over 220 trials at different stages of development. The majority of industry-sponsored drugs in active clinical development for HCC are in Phase II trials. The distribution of clinical trials across phases I to IV indicates that the majority of trials for HCC are in the early and mid-stages of development, with 55-60% in Phase I and II, and only 40% in Phase III and IV. The United States has a significant lead in the number of HCC clinical trials globally.

Biological therapies, particularly immune-targeted therapies (immunotherapies), are widely used in the treatment of HCC. With the approval of Nivolumab for HCC in 2017, there is a growing demand for therapies with novel mechanisms of action (MOAs). Several new classes of therapies are expected to enter the global HCC treatment market in the coming years. Biologics targeting programmed cell death 1 (PD-1) and programmed cell death ligand 1 (PD-L1) have gained traction in the HCC market due to their favorable clinical profiles.

The recent introduction of biologic products for the treatment of HCC is expected to create profitable opportunities for market growth. Despite the availability of various therapies for HCC patients, there is still room for improvement in the treatment landscape. The research predicts the launch of five new agents in the eight major markets (8MM), including three PD-1 inhibitors (Camrelizumab, Tislelizumab, and Cemiplimab), one PD-L1 inhibitor (Durvalumab), and one Lymphocyte-activation gene (LAG-3) inhibitor (Relatlimab). The introduction of these late-stage drugs will drive market growth.

Therapeutic agents targeting PD-1 and PD-L1 have shown effectiveness in HCC, with some already in use and others in development. Over the next five years, the research expects an increase in innovation from the research and development pipeline, as well as technological advancements that will enhance the evidence base for interventions and improve outcomes.

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Market Segmentation

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The market is segmented based on various factors, including drug class, gender type, age group, and geography.

Segmentation by Drug Class
Chemotherapy
Targeted Therapy

Segmentation by Gender Type
Men
Women

Segmentation by Age Group
Below 29 years
30-49 years
50+ years

Segmentation by Geography
North America – US
Europe – Germany, France, UK, Italy, Spain
APAC – China, Japan

Chemotherapeutic drugs are projected to maintain their dominance in the global HCC therapeutics market within the drug class. However, targeted therapies are expected to exhibit the highest growth rate during the forecast period. The recent approval of biologics such as Tecentriq (Atezolizumab) is anticipated to drive the global hepatocellular carcinoma treatment market between 2022 and 2027. Traditionally, the HCC industry has relied on chemotherapies that have been available for over a decade. However, ongoing advancements have prompted research into novel mechanisms of action (MOAs) to address the issue of treatment non-response, which affects a significant number of patients. With the anticipated launch of new drugs, primarily targeting the moderate-to-severe patient population between 2023 and 2026, the hepatocellular carcinoma treatment market is poised for substantial growth. Biologics such as anti-PD-1 and PD-L1 inhibitors are gaining traction in the HCC market due to their favorable clinical profile.

In terms of gender type, men are expected to account for a significant share of the global hepatocellular carcinoma treatment market. This can be attributed to the higher prevalence of HCC among men compared to women.

Based on age group, the global hepatocellular carcinoma treatment market is primarily dominated by the 50 years and above age group segment. While HCC can occur at any age, it is most commonly diagnosed in individuals between 50 and 65 years old.

Geographically, the United States holds a dominant position in the global hepatocellular carcinoma treatment market. This can be attributed to factors such as healthcare affordability, knowledge and awareness among the population, and technological advancements in the region. However, China is expected to experience faster growth with a high compound annual growth rate (CAGR) in the HCC drug market. This is due to improved access to and quality of healthcare, increased awareness about disease management, and rising healthcare expenditure in the region. Among the eight major markets (8MM), the United States accounts for a significant market share of 48.07% with a CAGR of 19.33% in the hepatocellular carcinoma treatment market.

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Competitive Landscape

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The global market for hepatocellular carcinoma (HCC) treatment is characterized by the presence of numerous companies offering both generic and patented drugs. In 2017, the U.S. Food and Drug Administration (FDA) approved Nivolumab (Opdivo), an anti PD-1 monoclonal antibody, for the treatment of HCC. Subsequently, the FDA approved Keytruda (pembrolizumab) in 2018 and Tecentriq (atezolizumab) in 2020 for the same indication. While generic products continue to hold a significant share in the HCC treatment market, the introduction of biologics and targeted therapies represents a shift in the therapeutic landscape.

The overall portfolio of HCC treatments comprises more than 155 assets in various stages of development. Promising emerging therapeutics under development for HCC include Camrelizumab, Tislelizumab, Cemiplimab, CS-1003, Relatlimab, and others. The introduction of these novel drugs is expected to bring about a significant change in the treatment approach for HCC. With a large number of molecules currently in development, it is anticipated that new market entrants will offer innovative mechanisms of action and improved safety and efficacy profiles compared to existing patented commercial drugs.

Key players in the global HCC treatment market include Roche, Bayer, Merck & Co., Bristol-Myers Squibb, Exelixis Inc, Eli Lilly and Company, Innovent Biologics, AstraZeneca, BeiGene, Jiangsu HenGrui Medicine, and several others. These companies are actively engaged in research and development activities to develop technologically advanced and innovative drugs for HCC. Additionally, they are entering into collaborations to maintain their market position. Strategies such as collaborations, acquisitions, expansion into new geographic markets, research and development investments, and the manufacture of novel drugs are being adopted by these companies to compete in the global HCC therapeutics market.

Key companies profiled in this report include Merck & Co., Bayer, Roche, Eli Lilly and Company, Bristol-Myers Squibb, Exelixis Inc (Exelixis), Innovent Biologics Inc, Akeso, Inc, Jiangsu Hengrui Medicine Co Ltd, AstraZeneca Plc, BeiGene, Sanofi SA, Shenzhou Cell, Yiviva, Surface Oncology, Advenchen Laboratories, LLC, Abbisko Therapeutics, Shanghai Henlius Biotech, Novra Technologies Inc, TaiRx, Inc., Zelgen Biopharmaceuticals, Pfizer, Virogin Biotech, Genoscience.

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Recent Industry Developments

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In November 2018, Merck & Co., Inc. made an announcement regarding the accelerated approval granted by the Food and Drug Administration for pembrolizumab (Keytruda) to treat patients with hepatocellular carcinoma (HCC) who had previously received sorafenib treatment. The approval was based on the results of the KEYNOTE 224 (NCT02702414) trial, a multicenter study that enrolled 104 patients with hepatocellular carcinoma.

In May 2020, Roche announced that atezolizumab in combination with bevacizumab (Tecentriq) received approval from the Food and Drug Administration for the treatment of unresectable or metastatic hepatocellular carcinoma in patients who have not undergone prior systemic therapy. The approval was based on findings from the IMbrave150 (NCT03434379) trial, a randomized, open-label study conducted internationally involving patients with locally advanced unresectable or metastatic hepatocellular carcinoma who had not received prior systemic therapy.

In May 2019, Eli Lilly and Company announced that ramucirumab (Cyramza) was approved by the Food and Drug Administration as a standalone treatment for hepatocellular carcinoma (HCC) in patients with an alpha-fetoprotein (AFP) level of ≥ 400 ng/mL who had previously been treated with sorafenib. The approval was based on data from the REACH-2 (NCT02435433) study, a double-blind, placebo-controlled, multinational trial conducted in 292 patients with advanced HCC and AFP levels ≥ 400 ng/mL who had experienced disease progression on or after sorafenib treatment or were intolerant to it.

In June 2018, Blueprint Medicines Corporation and CStone Pharmaceuticals announced an exclusive collaboration and license agreement for the development and commercialization of avapritinib, BLU-554, and BLU-667 in Mainland China, Hong Kong, Macau, and Taiwan. These therapies may be used as monotherapies or in combination with other treatments.

In December 2016, Exelixis Inc. and Ipsen amended their exclusive collaboration and licensing agreement for the commercialization and ongoing development of cabozantinib. This amendment included commercialization rights in Canada. As per the terms of the amendment, Exelixis received an upfront payment of USD 10 million. Additionally, Exelixis is eligible to receive regulatory milestone payments for the approvals of cabozantinib in Canada for the treatment of advanced renal cell carcinoma (RCC) after prior treatment, first-line RCC, advanced hepatocellular carcinoma (HCC), and potentially other indications.

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Key Questions Answered

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What is the size of the market for treating hepatocellular carcinoma?

The anticipated value of the global market for hepatocellular carcinoma treatment is projected to reach USD 7.3 billion by 2027.

What is the growth rate of the market for treating hepatocellular carcinoma?

The market for hepatocellular carcinoma treatment is experiencing a compound annual growth rate (CAGR) of 17.39% from 2022 to 2027.

Who are the key players in the global market for hepatocellular carcinoma treatment?

The key players in the global market for hepatocellular carcinoma treatment include Merck & Co., Bayer, Roche, Eli Lilly and Company, Bristol-Myers Squibb, Exelixis Inc (Exelixis), Innovent Biologics Inc, Akeso, Inc, Jiangsu Hengrui Medicine Co Ltd, AstraZeneca Plc, BeiGene, and Sanofi SA.

Which region dominates the global market share for hepatocellular carcinoma treatment?

The United States holds the largest market share for hepatocellular carcinoma treatment. However, China is expected to exhibit the highest growth rate during the forecast period.

What are the latest trends in the market for hepatocellular carcinoma treatment?

The latest trends in the market for hepatocellular carcinoma treatment include significant investments in research and development, as well as a focus on T-cell therapies.