Hepatocellular Carcinoma Market Analysis 2034: Industry Trends, Market Size, and Emerging Therapeutic Developments - DelveInsight

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

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Some of the key facts of the Hepatocellular Carcinoma Market Report:
• The Hepatocellular Carcinoma market size is anticipated to grow with a significant CAGR during the study period (2020-2034).In July 2026, The U.S. FDA issued a Complete Response Letter (CRL) to Elevar Therapeutics for its New Drug Application seeking approval of the rivoceranib and camrelizumab combination as a first-line treatment for patients with unresectable or metastatic hepatocellular carcinoma. The agency's decision was not related to the therapy's clinical efficacy or safety data, which the FDA had previously recognized as sufficient, but instead stemmed from manufacturing deficiencies identified during a current Good Manufacturing Practice (cGMP) inspection at a facility involved in the production of rivoceranib.
• In August 2026, The FDA has issued tentative approval for Omcazio (cabozantinib) capsules, a novel 505(b)(2) alternate-salt formulation of cabozantinib developed by Handa Pharmaceuticals, for multiple oncology indications. Omcazio is approved for use in adults with advanced renal cell carcinoma (RCC) as both a standalone treatment and in combination with nivolumab (Opdivo) as first-line therapy. It is also indicated for adults with hepatocellular carcinoma (HCC) who have previously received sorafenib (Nexavar), as well as for adults and pediatric patients aged 12 years and older with previously treated, unresectable, locally advanced, or metastatic well-differentiated extra-pancreatic neuroendocrine tumors (epNETs).
• In February 2026, The FDA has granted Fast Track designation to irpagratinib for the treatment of previously treated advanced hepatocellular carcinoma (HCC) characterized by FGF19 overexpression. Patients with advanced HCC typically have limited therapeutic options once standard treatments fail. In a press announcement, Abbisko Therapeutics reported that the U.S. Food and Drug Administration awarded Fast Track status to its investigational agent irpagratinib (ABSK-011) for individuals with advanced HCC whose tumors overexpress fibroblast growth factor 19 (FGF19) and who have already been treated with immune checkpoint inhibitors (ICIs) and multi-targeted kinase inhibitors (mTKIs).
• In September 2025, Merck (NYSE: MRK) announced that the U.S. FDA has approved KEYTRUDA QLEXTM, a subcutaneous formulation of pembrolizumab combined with berahyaluronidase alfa, for adult patients across most KEYTRUDA® solid tumor indications. Utilizing Alteogen Inc.'s hyaluronidase technology, KEYTRUDA QLEX is designed for administration by healthcare professionals and is anticipated to be available in the U.S. by late September.
• In September 2025, Lion TCR, a clinical-stage biotech firm, announced that the U.S. FDA has granted Investigational New Drug (IND) clearance to initiate Phase 1b/2 trials of its proprietary TCR-T cell therapy, LioCyx-M004, in patients with chronic hepatitis B (CHB). This IND approval represents the third key regulatory milestone for LioCyx-M004, following its earlier Fast Track and Orphan Drug Designations for treating hepatitis B virus-associated hepatocellular carcinoma (HBV-HCC).
• In July 2025, Zymeworks Inc. revealed that the U.S. FDA has approved the IND application for ZW251, a new antibody-drug conjugate aimed at glypican-3, intended for treating hepatocellular carcinoma (HCC).
• In July 2025, Sirtex Medical reported that the FDA has approved SIR-Spheres® Y-90 resin microspheres for the treatment of unresectable hepatocellular carcinoma (HCC), making it the only radioembolization therapy in the U.S. authorized for both HCC and liver metastases from colorectal cancer.
• In April 2025, Mursla Bio was granted FDA Breakthrough Device Designation for EvoLiverTM, a dynamic biopsy blood test leveraging organ-specific extracellular vesicles (EVs) to monitor hepatocellular carcinoma (HCC) in patients with high-risk cirrhosis.
• In April 2025, The FDA has granted full approval to the combination of nivolumab and ipilimumab as a first-line treatment for adults with unresectable hepatocellular carcinoma. The approval is based on results from the Phase III CheckMate 9DW study (NCT04039607), which showed that the dual immunotherapy regimen delivered a statistically significant and clinically meaningful overall survival benefit compared with physician-selected monotherapy using sorafenib (Nexavar) or lenvatinib (Lenvima).
• In February 2025, The FDA granted fast track designation to RZ-001, an RNA substitution enzyme-based cancer gene therapy, for the treatment of patients with hepatocellular carcinoma (HCC), according to an announcement from Rznomics Inc. Additionally, RZ-001 has received investigational new drug approval for glioblastoma (GBM) from both the FDA and South Korea's Ministry of Food and Drug Safety, and it has been approved for compassionate use under the FDA's expanded access program for this condition.
• In January 2025, Tempest Therapeutics announced that the US Food and Drug Administration has granted Orphan Drug Designation to amezalpat (TPST-1120), an oral, small molecule, selective PPAR⍺ antagonist for the treatment of patients with hepatocellular carcinoma.
• In November 2024, Carisma Therapeutics announced the presentation of new pre-clinical data on its antiGPC3 in vivo chimeric antigen receptor macrophage and monocyte (together, "CAR-M") therapy for the treatment of hepatocellular carcinoma, developed in collaboration with Moderna, Inc. (Nasdaq: MRNA).
• In October 2024, NAYA Biosciences (NASDAQ: NAYA), a life sciences company focused on developing innovative treatments for oncology, autoimmune diseases, and fertility, announced updates on its clinical trial plans. In July 2024, the company received regulatory approval from the Israeli Ministry of Health and institutional review board clearance to begin enrolling patients across up to seven academic centers. The trial will assess the safety and efficacy of NY-303, a GPC3-targeting NK Engager bispecific antibody, as a monotherapy for treating hepatocellular carcinoma in patients who have not responded to first-line immunotherapy.
• In September 2024, Myeloid Therapeutics administered the first dose of MT-303 in a Phase I clinical trial targeting hepatocellular carcinoma (HCC). This open-label, dose-escalation study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, and preliminary efficacy of MT-303 in adults with advanced or metastatic HCC that overexpresses GPC3. Additionally, the trial will establish the recommended Phase II dose (RP2D) for MT-303.
• In February 2024, Immune-Onc Therapeutics initiated a clinical trial collaboration with Roche to conduct a Phase Ib/II clinical trial aimed at treating hepatocellular carcinoma (HCC), the most prevalent form of liver cancer. This trial will evaluate the efficacy of IO-108, an antibody directed towards LILRB2 developed by Immune-Onc, in combination with Roche's cancer immunotherapy regimen consisting of atezolizumab and bevacizumab.
• Iterion Therapeutics, a biopharmaceutical company with a focus on oncology, is currently enrolling participants for a Phase 1b/2a clinical trial involving their lead compound, tegavivint. This trial is targeting patients with advanced hepatocellular carcinoma (HCC) who have experienced treatment failure with at least one line of systemic therapy. Tegavivint is a small molecule inhibitor of Transducin beta-like protein 1 (TBL1), which is a downstream target in the Wnt/beta-catenin signaling pathway.
• According to the Global Cancer Observatory, in the 7MM the ASR incident rate of liver cancer is 7.4/100,000 which is estimated to be around 135,533 new cases in 2020
• According to the Global cancer observatory, in the Japan the ASR incident rate of liver cancer is 10.4/100,000 which is estimated to be around 45,663 new cases diagnosed in 2020 and the ASR mortality rate of liver cancer is 4.8/100,000 which is estimated to be around 28,155 number of deaths in 2020
• According to the Global cancer observatory in the United kingdom the ASR incident rate of liver cancer is 5.3/100,000 which is estimated to be around 8,156 new cases diagnosed in 2020 and the ASR mortality rate of liver cancer is 4.1/100,000 which is estimated to be around 7,061 number of deaths in 2020
• Key Hepatocellular Carcinoma Companies: Saronic Biotechnology, HiFiBiO Therapeutics, Sirnaomics, Exelixis, Tvardi Therapeutics, Portage Biotech Inc., MoAMiNA Therapeutics Limited, SOTIO Biotech Inc., Surface Oncology, Virogin Biotech Ltd., Innovent Biologics, Beijing ShenogenPharmaceutical Technology Co., Ltd, Can-Fite, CStone Pharmaceuticals, H 3 Biomedicine Inc, Genoscience Pharma, Kymab Limited, Exelixis, and others
• Key Hepatocellular Carcinoma Therapies: SBI 1997, HFB-301001, STP 705, XL092, TTI-101, PORT-7, MTL-CEBPA, SOT101, SRF388, VG161, IBI310, Icaritin, Namodenoson(CF102), CS1003, H3B-6527, GNS561, KY1044, Cabozantinib, amd others
• Of the emerging therapies, and combination therapies one of the most anticipated product to get launched is cabozantinib in combination with atezolizumab. Apart from this, several othermolecules are in mid to late stage such as DKN-01, Cabozantinib S-malate with Pembrolizumab,H3B-6527, and others.
• The Hepatocellular Carcinoma market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Hepatocellular Carcinoma pipeline products will significantly revolutionize the Hepatocellular Carcinoma market dynamics.

Hepatocellular Carcinoma Overview
Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer, typically developing in individuals with chronic liver diseases such as cirrhosis, hepatitis B or C, or fatty liver disease. It occurs when healthy liver cells undergo abnormal growth and form tumors. Symptoms may include weight loss, abdominal pain, jaundice, and fatigue. HCC is often diagnosed through imaging tests and biopsy. Treatment options vary depending on the stage of cancer and may include surgery, liver transplant, chemotherapy, or targeted therapies. Early detection and treatment improve the chances of successful management.

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Hepatocellular Carcinoma Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Hepatocellular Carcinoma Epidemiology Segmentation:
The Hepatocellular Carcinoma market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:
• Total Prevalence of Hepatocellular Carcinoma
• Prevalent Cases of Hepatocellular Carcinoma by severity
• Gender-specific Prevalence of Hepatocellular Carcinoma
• Diagnosed Cases of Episodic and Chronic Hepatocellular Carcinoma

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Hepatocellular Carcinoma Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Hepatocellular Carcinoma market or expected to get launched during the study period. The analysis covers Hepatocellular Carcinoma market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Hepatocellular Carcinoma Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Hepatocellular Carcinoma Therapies and Key Companies
• SBI 1997: Saronic Biotechnology
• HFB-301001: HiFiBiO Therapeutics
• STP 705: Sirnaomics
• XL092: Exelixis
• TTI-101: Tvardi Therapeutics
• PORT-7: Portage Biotech Inc.
• MTL-CEBPA: MoAMiNA Therapeutics Limited
• SOT101: SOTIO Biotech Inc.
• SRF388: Surface Oncology
• VG161: Virogin Biotech Ltd.
• IBI310: Innovent Biologics
• Icaritin: Beijing ShenogenPharmaceutical Technology Co., Ltd
• Namodenoson(CF102): Can-Fite
• CS1003: CStone Pharmaceuticals
• H 3 Biomedicine Inc: H3B-6527
• Genoscience Pharma: GNS561
• Kymab Limited: KY1044
• Exelixis : Cabozantinib

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Hepatocellular Carcinoma Market Drivers
• Rising Disease Burden: Increasing prevalence of chronic liver diseases, hepatitis B and C infections, nonalcoholic steatohepatitis (NASH), and cirrhosis is driving the incidence of hepatocellular carcinoma (HCC).
• Advancements in Targeted and Immunotherapies: The growing adoption of immune checkpoint inhibitors, targeted therapies, and combination regimens is expanding treatment options and improving patient outcomes.
• Strong Clinical Pipeline: A robust pipeline of novel therapeutics, including next-generation immunotherapies, antibody-drug conjugates (ADCs), and precision medicines, is fueling market growth.
• Improved Early Detection: Advances in imaging technologies, biomarker-based diagnostics, and surveillance programs are enabling earlier diagnosis and increasing the eligible treatment population.
• Supportive Regulatory Initiatives: Fast-track approvals, breakthrough therapy designations, and orphan drug incentives are encouraging innovation and accelerating the development of new HCC therapies.

Hepatocellular Carcinoma Market Barriers
• Late-Stage Diagnosis: Many HCC patients are diagnosed at advanced stages, limiting the effectiveness of curative treatments such as surgery or liver transplantation.
• High Treatment Costs: Immunotherapies, targeted therapies, and combination treatments are expensive, creating affordability and reimbursement challenges in many healthcare systems.
• Complex Disease Biology: Tumor heterogeneity, underlying liver dysfunction, and resistance to therapy make treatment challenging and contribute to variable patient outcomes.
• Stringent Clinical Development: Demonstrating meaningful survival benefits while managing liver-related complications increases the complexity, cost, and duration of clinical trials.
• Limited Access to Advanced Care: In several low- and middle-income regions, inadequate screening programs, delayed diagnosis, and restricted access to innovative therapies hinder market growth.

Scope of the Hepatocellular Carcinoma Market Report
• Study Period: 2020-2034
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Hepatocellular Carcinoma Companies: Saronic Biotechnology, HiFiBiO Therapeutics, Sirnaomics, Exelixis, Tvardi Therapeutics, Portage Biotech Inc., MoAMiNA Therapeutics Limited, SOTIO Biotech Inc., Surface Oncology, Virogin Biotech Ltd., Innovent Biologics, Beijing ShenogenPharmaceutical Technology Co., Ltd, Can-Fite, CStone Pharmaceuticals, H 3 Biomedicine Inc, Genoscience Pharma, Kymab Limited, Exelixis, and others
• Key Hepatocellular Carcinoma Therapies: SBI 1997, HFB-301001, STP 705, XL092, TTI-101, PORT-7, MTL-CEBPA, SOT101, SRF388, VG161, IBI310, Icaritin, Namodenoson(CF102), CS1003, H3B-6527, GNS561, KY1044, Cabozantinib, and others
• Hepatocellular Carcinoma Therapeutic Assessment: Hepatocellular Carcinoma current marketed and Hepatocellular Carcinoma emerging therapies
• Hepatocellular Carcinoma Market Dynamics: Hepatocellular Carcinoma market drivers and Hepatocellular Carcinoma market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Hepatocellular Carcinoma Unmet Needs, KOL's views, Analyst's views, Hepatocellular Carcinoma Market Access and Reimbursement

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