Hepatocellular Carcinoma Market

Key Highlights

• According to Surveillance, Epidemiology, and End Results (SEER), in the US, the incidence rate of Hepatocellular Carcinoma and Intrahepatic bile duct cancer was 9.0 per 100,000 which is estimated to be around 42,230 new diagnosed cases in 2021 and the mortality rate was 6.6 per 100,000 per year and the 5-year survival rate was 20.3%. Of them, the stage wise incident cases of Hepatocellular Carcinoma and intrahepatic bile duct cancer was Localized (45%), Regional (26%), Distant (18%), and Unknown (11%). 
• Hepatocellular Carcinoma epidemiology is segmented as Total Incident Cases of Hepatocellular Carcinoma, Stage-wise Patients of Hepatocellular Carcinoma, and Total Treated Cases of Hepatocellular Carcinoma] in the Hepatocellular Carcinoma market report.

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DelveInsight's "Hepatocellular Carcinoma Market Insights, Epidemiology, and Market Forecast — 2034" report delivers an in-depth understanding of the Hepatocellular Carcinoma, historical and forecasted epidemiology as well as the Hepatocellular Carcinoma (HCC) market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The Hepatocellular Carcinoma market report provides current treatment practices, emerging drugs, Hepatocellular Carcinoma market share of the individual therapies, current and forecasted Hepatocellular Carcinoma market Size from 2020 to 2034, segmented by seven major markets. The Report also covers current Hepatocellular Carcinoma treatment practice/algorithm, and unmet medical needs to curate best of the opportunities and assesses the underlying potential of the market.

Hepatocellular Carcinoma Market Disease: Understanding and Treatment Algorithm

The DelveInsight’s Hepatocellular Carcinoma market report gives a thorough understanding of Hepatocellular Carcinoma by including details such as disease definition, symptoms, causes, pathophysiology, diagnosis, and treatment. Hepatocellular Carcinoma (HCC) defined as a liver tumor not eligible for local therapies given the extent of disease or liver tumors that recurred after local therapies. Patients with advanced Hepatocellular Carcinoma (HCC) usually have significant underlying liver disease which is associated with poor tolerability to systemic chemotherapy.

The cancer may have spread to nearby lymph nodes and/or to distant sites within the body. Hepatocellular Carcinoma doesn't often metastasize, but when it does, it's most likely to spread to the lungs and bones. These cancers are widespread, they cannot be removed with surgery. 

Signs and symptoms are not always directly related to the stage of the cancer, the effects of disease is highly individualized for each person and following are some of the symptoms occurred in individuals Gynecomastia, Erythrocytosis, High cholesterol, Hypercalcemia, Hypoglycemia.

Hepatocellular Carcinoma Diagnosis

Tests and procedures used to diagnose Hepatocellular Carcinoma (HCC) include blood tests and liver tissue biopsy. Some of the tests and procedures used to diagnose Hepatocellular Carcinoma, such as CT scan and MRI, are also used in the staging process. A positron emission tomography (PET) scan may also be used: PET scan, which is a procedure used to find malignant tumor cells in the body.

Hepatocellular Carcinoma Treatment

Treatment decisions depend on the size of the cancer and whether it has spread. It also depends on the health of your liver tissue that is not affected by the cancer, for example if you have liver cirrhosis.  Hepatocellular Carcinoma can now be treated with immunotherapy, some of the drugs, or treatment with a single drug include: atezolizumab and bevacizumab, lenvatinib, sorafenib.

TECENTRIQ is a drug that can increase the ability of the body's own immune system to target the cancer. It might be used along with another drug, Avastin, which is a monoclonal antibody. These medications are given by infusion (intravenously) on a schedule that can be anywhere from two to four weeks. The use of high-energy particles is another potential treatment for stage 4 Hepatocellular Carcinoma. Two types that might be used are external beam radiation therapy (EBRT) and stereotactic body radiation therapy (SBRT).

Hepatocellular Carcinoma Epidemiology 

The Hepatocellular Carcinoma epidemiology section provides insights about historical and current Hepatocellular Carcinoma patient pool and forecasted trends for individual seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Key Findings

• According to Surveillance, Epidemiology, and End Results (SEER), in the US, the incidence rate of Hepatocellular Carcinoma and Intrahepatic bile duct cancer was 9.0 per 100,000 which is estimated to be around 42,230 new diagnosed cases in 2021 and the mortality rate was 6.6 per 100,000 per year and the 5-year survival rate was 20.3%. Of them, the stage wise incident cases of Hepatocellular Carcinoma and intrahepatic bile duct cancer was Localized (45%), Regional (26%), Distant (18%), and Unknown (11%). 

• The disease epidemiology covered in the report provides historical as well as forecasted Hepatocellular Carcinoma epidemiology [segmented as Total Incident Cases of Hepatocellular Carcinoma, Stage-wise Patients of Hepatocellular Carcinoma, and Total Treated Cases of Hepatocellular Carcinoma] in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2020 to 2034.

Country Wise- Hepatocellular Carcinoma Epidemiology

This section provides glimpse of the Hepatocellular Carcinoma epidemiology in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

Learn more about the evolving epidemiology trends and key developments: Hepatocellular Carcinoma Epidemiology Forecast

​​​​​​Hepatocellular Carcinoma Recent Developments

• In September 2025, Merck (NYSE: MRK) announced U.S. FDA approval of KEYTRUDA QLEX™—a subcutaneous formulation of pembrolizumab combined with berahyaluronidase alfa—for use in adults across most solid tumor indications for KEYTRUDA®. Developed with Alteogen Inc.'s hyaluronidase technology, KEYTRUDA QLEX must be administered by a healthcare provider and is expected to be available in the U.S. by late September.
• In September 2025, Lion TCR, a clinical-stage biotechnology company, announced that it received Investigational New Drug (IND) clearance from the U.S. FDA to begin Phase 1b/2 clinical trials for its proprietary TCR-T cell therapy, LioCyx-M004, in patients with chronic hepatitis B (CHB). This approval marks the third major regulatory milestone for LioCyx-M004, which previously received Fast Track and Orphan Drug Designations for treating hepatitis B virus-related hepatocellular carcinoma (HBV-HCC).
• In July 2025, Zymeworks Inc. announced that the U.S. FDA cleared the IND application for ZW251, a novel antibody-drug conjugate targeting glypican-3 for the treatment of hepatocellular carcinoma (HCC).
• In July 2025, Sirtex Medical announced FDA approval of SIR-Spheres® Y-90 resin microspheres for treating unresectable hepatocellular carcinoma (HCC). This makes SIR-Spheres® the only radioembolization therapy in the U.S. approved for both HCC and metastatic colorectal cancer of the liver. 
• In April 2025, Mursla Bio received FDA Breakthrough Device Designation for EvoLiver™, a Dynamic Biopsy-based blood test that uses organ-specific extracellular vesicles (EVs) for the surveillance of hepatocellular carcinoma (HCC) in high-risk cirrhotic patients.
• In February 2025, the FDA granted Fast Track designation to amezalpat (TPST-1120), an oral, small molecule, selective PPAR⍺ antagonist, as a potential treatment for patients with hepatocellular carcinoma (HCC). This follows the orphan drug designation granted to amezalpat for HCC in January.
• In February 2025, RZ-001, an RNA substitution enzyme-based cancer gene therapy, received FDA fast track designation for hepatocellular carcinoma (HCC), according to Rznomics Inc.
• In January 2025, Tempest Therapeutics, Inc. announced that the FDA has granted Orphan Drug Designation (ODD) to amezalpat (TPST-1120), an oral, small molecule, selective PPAR⍺ antagonist, for the treatment of hepatocellular carcinoma (HCC).
• In November 2024, ABK Biomedical, Inc. received FDA approval to advance its Investigational Drug Exemption (IDE) study into Stage 2 of its Route90 pivotal study. This follows the review of interim safety outcomes from the first 16 patients treated in Stage 1. The approval paves the way for the next phase of the study of ABK's advanced imageable embolic medical devices.

Hepatocellular Carcinoma Drug Chapters

The drug chapter segment of the Hepatocellular Carcinoma report encloses the detailed analysis of Hepatocellular Carcinoma marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Hepatocellular Carcinoma clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Hepatocellular Carcinoma Marketed Drugs

CYRAMZA (ramucirumabis): Eli Lilly

It is a VEGFR2 antagonist that specifically binds VEGFR2 and blocks binding of VEGFR ligands, VEGF-A, VEGF-C, and VEGF-D. As a result, ramucirumab inhibits ligand-stimulated activation of VEGFR2, thereby inhibiting ligand-induced proliferation, and migration of human endothelial cells.

KEYTRUDA (pembrolizumab): Merck

It is a checkpoint inhibitor that targets the PD-1/PD-L1 pathway; approved for subsets of patients with advanced Hepatocellular Carcinoma, including those with high microsatellite instability (MSI-H), DNA mismatch repair deficiency (dMMR), or high tumor mutational burden (TMB-H).

TECENTRIQ (atezolizumab): Genetech

It is a checkpoint inhibitor that targets the PD-L1 pathway; approved, in combination with bevacizumab, as a first-line treatment for subsets of patients with advanced Hepatocellular Carcinoma.

JEMPERLI (dostarlimab): GlaxoSmithKline

It is a checkpoint inhibitor that targets the PD-1/PD-L1 pathway; approved for subsets of patients with Hepatocellular Carcinomathat has DNA mismatch repair deficiency (dMMR).

OPDIVO (nivolumab): Bristol-Myers Squibb

It is a checkpoint inhibitor that targets the PD-1/PD-L1 pathway; approved for subsets of patients with advanced Hepatocellular Carcinoma, including in combination with ipilimumab.

YERVOY (ipilimumab): Bristol-Myers Squibb

It is a checkpoint inhibitor that targets the CTLA-4 pathway; approved, in combination with nivolumab, for patients with advanced, previously treated Hepatocellular Carcinoma.

Note: Detailed Current therapies assessment will be provided in the full report of Hepatocellular Carcinoma

Hepatocellular Carcinoma Emerging Drugs

H3B-6527, being developed by H3 Biomedicine, is a selective, orally bioavailable, and potent inhibitor of fibroblast growth factor receptor 4 (FGFR4) that is being investigated for the treatment of advanced hepatocellular carcinoma (HCC).  The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for rare diseases or conditions that affect fewer than 200,000 people in the U.S. The orphan drug designation provides H3 Biomedicine with certain benefits, including market exclusivity upon regulatory approval is received, exemption of FDA application fees, and tax credits for qualified clinical trials.

GNS561, being developed by Genoscience Pharma. is a first-in-class, orally bioavailable, small molecule that blocks cancer cell proliferation by inhibiting late-stage autophagy and dose-dependent build-up of enlarged lysosomes by interacting with the palmitoyl-protein thioesterase 1 (PPT1).

SAR445256 (known also as Alomfilimab, and formerly as KY1044) is a human monoclonal IgG1 that selectively binds to Inducible T cell CO-stimulator (ICOS), a protein expressed at high levels on immunosuppressive regulatory T cells and at lower levels on effector T cells. Being developed by Kymab in collaboration with Sanofi, it is designed to exert anti-tumour activity through preferential depletion of intra-tumoral regulatory T cells and stimulation (agonism) of ICOS-positive effector T cells.

Cabozantinib, being developed by Exelixis, is a targeted agent that inhibits the activity of receptor tyrosine kinases including MET, AXL, VEGF receptors and RET. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and resistance to multiple therapies, including immune checkpoint inhibitors (ICIs).

Note: Detailed emerging therapies assessment will be provided in the full report of Hepatocellular Carcinoma

Hepatocellular Carcinoma Market Outlook

There are currently six FDA-approved immunotherapy options for Hepatocellular Carcinoma. Several other immunotherapies are currently being tested in Hepatocellular Carcinoma clinical trial, including oncolytic viruses and adoptive cell therapy. Hence, the therapy market also include AVASTIN (bevacizumab) a targeted antibody that targets the VEGF-A pathway; approved, in combination with atezolizumab, as a first-line treatment for subsets of patients with advanced Hepatocellular Carcinoma.

Among patients who have successful surgeries, the rate of recurrence can be 50% or higher. In the current study, the researchers found that the five patients who underwent surgery and had their tumors shrink significantly have remained disease free for more than 230 days so far. Around 60% patients who did not have a significant tumor response developed disease progression between 56 and 155 days after the end of treatment.

The dynamics of Hepatocellular Carcinoma market is anticipated to change in the coming years owing to increased Research and Development activities and increased patient pool. Key players such as H3 Biomedicine, Genoscience Pharma, Kymab, Sanofi, Exelixis and various others are involved in developing therapies for Hepatocellular Carcinoma.

According to DelveInsight, Hepatocellular Carcinoma market in 7MM is expected to witness a major change in the study period 2020-2034.

Analyst Commentary

• The pipeline of Hepatocellular Carcinoma is very robust, many potential therapies are being investigated for the treatment of Hepatocellular Carcinoma, and it is safe to predict that the treatment space will experience a significant impact on the market during the forecast period.

• The expected introduction of emerging therapies with improved efficacy, more awareness initiatives programs, and further improvement in the diagnosis rate, are likely to boost the growth of the Hepatocellular Carcinoma market in the 7MM. Aside from that, the market size of Hepatocellular Carcinoma may flourish due to increased research and development, label-expansion of approved therapies into other epilepsy in this field.

• The market growth of Hepatocellular Carcinoma may offset by failures and/or discontinuation of the emerging therapies, unaffordable pricing, market access and reimbursement issues, and a scarcity of healthcare specialists.

Hepatocellular Carcinoma Drugs Uptake

This section focusses on the rate of uptake of the potential hepatocellular carcinoma drugs recently launched in the Hepatocellular Carcinoma market or expected to get launched in the market during the study period 2020-2034. The analysis covers Hepatocellular Carcinoma market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions. 

Note: Detailed emerging therapies assessment will be provided in full report of Hepatocellular Carcinoma.

Hepatocellular Carcinoma Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase II and Phase III stage. It also analyses Hepatocellular Carcinoma key players involved in developing targeted therapeutics.

Hepatocellular Carcinoma Clinical Trial Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing, patent details and other information for Hepatocellular Carcinoma emerging therapies.

Learn more about the emerging therapies and key companies active in the therapeutics segment: Hepatocellular Carcinoma Pipeline Insight

Reimbursement Scenario in Hepatocellular Carcinoma

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In a report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

KOL- Views

To keep up with current market trends, we take KOLs and SMEs ' opinions working in the Hepatocellular Carcinoma domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Hepatocellular Carcinoma market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform Competitive and Market Intelligence analysis of the Hepatocellular Carcinoma Market by using various Competitive Intelligence tools that include - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Hepatocellular Carcinoma Market Report

• The report covers the descriptive overview of Hepatocellular Carcinoma, explaining its causes, signs and symptoms, pathophysiology, diagnosis, and currently available therapies
• Comprehensive insight has been provided into the Hepatocellular Carcinoma epidemiology and treatment in the 7MM
• Additionally, an all-inclusive account of both the current and emerging therapies for Hepatocellular Carcinoma are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
• A detailed review of the Hepatocellular Carcinoma market; historical and forecasted is included in the report, covering drug outreach in the 7MM
• Detailed Patient Based Market Forecasting determines the trends shaping and driving the Global Hepatocellular Carcinoma market

Hepatocellular Carcinoma Market Report Highlights

• In the coming years, the Hepatocellular Carcinoma market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
• The companies and academics are working to assess challenges and seek opportunities that could influence Hepatocellular Carcinoma R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition      
• Major players are involved in developing therapies for Hepatocellular Carcinoma. The launch of emerging therapies will significantly impact the Hepatocellular Carcinoma market
• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Hepatocellular Carcinoma
• Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed Hepatocellular Carcinoma clinical trial profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities

Hepatocellular Carcinoma Report Insights

• Patient Based Market Forecasting
• Therapeutic Approaches
• Hepatocellular Carcinoma Pipeline Analysis
• Hepatocellular Carcinoma Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Hepatocellular Carcinoma Report Key Strengths

• 11 Years Forecast
• 7MM Coverage
• Hepatocellular Carcinoma Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Hepatocellular Carcinoma Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness

Key Questions

Market Insights:

• What was the Hepatocellular Carcinoma drug class share (%) distribution in 2025 and how it would look like in 2034?
• What would be the Hepatocellular Carcinoma total market size as well as market size by therapies across the 7MM during the forecast period (2025-2034)?
• What are the key findings of the market across 7MM and which country will have the largest Hepatocellular Carcinoma market size during the forecast period (2025-2034)?
• At what CAGR, the Hepatocellular Carcinoma market is expected to grow by 7MM during the forecast period (2025-2034)?
• What would be the Hepatocellular Carcinoma market outlook across the 7MM during the forecast period (2025-2034)?
• What would be the Hepatocellular Carcinoma market growth till 2034, and what will be the resultant market Size in the year 2034?
• How would the unmet needs affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What are the disease risk, burden, and regional/ethnic differences of Hepatocellular Carcinoma?
• What are the key factors driving the epidemiology trend for seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What is the historical Hepatocellular Carcinoma patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What would be the forecasted patient pool of Hepatocellular Carcinoma in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• Where will be the growth opportunities in the 7MM concerning the patient population about Hepatocellular Carcinoma?
• Out of all 7MM countries, which country would have the highest incident population of Hepatocellular Carcinoma during the forecast period (2025-2034)?
• At what CAGR the patient population is expected to grow by 7MM during the forecast period (2025-2034)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the Hepatocellular Carcinoma treatment in addition to the approved therapies?
• What are the current treatment guidelines for the treatment of Hepatocellular Carcinoma in the USA, Europe, and Japan?
• What are the Hepatocellular Carcinoma marketed drugs and their respective MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, efficacy, etc.?
• How many companies are developing therapies for the treatment of Hepatocellular Carcinoma?
• How many therapies are in-development by each company for Hepatocellular Carcinoma treatment?
• How many are emerging therapies in mid-stage, and late stage of development for Hepatocellular Carcinoma treatment?
• What are the key collaborations (Industry - Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Hepatocellular Carcinoma therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Hepatocellular Carcinoma and its status?
• What are the current challenges faced in drug development?
• What are the key designations that have been granted for the emerging therapies for Hepatocellular Carcinoma?
• What are the global historical and forecasted markets of Hepatocellular Carcinoma?

Reasons to buy

• The Patient Based Market Forecasting analysis will help in developing business strategies by understanding trends shaping and driving the Hepatocellular Carcinoma market
• Organize sales and marketing efforts by identifying the best opportunities for Hepatocellular Carcinoma in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors
• Organize sales and marketing efforts by identifying the best opportunities for the Hepatocellular Carcinoma market
• To understand the future market competition in the Hepatocellular Carcinoma market