Ocular Melanoma Market Size (7MM) is going to be ~USD 416 million in 2025, and expected to grow with a CAGR of 18.4% by 2034, estimates DelveInsight

DelveInsight's "Ocular Melanoma Market Insights, Epidemiology and Market Forecast - 2034" report delivers an in-depth understanding of the Ocular Melanoma, historical and forecasted epidemiology and the Ocular Melanoma therapeutics market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

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Key Takeaways from the Ocular Melanoma Market Report
• In December 2025, Iovance Biotherapeutics Inc. announced a study is the first-in-human (FIH) study of IOV-3001. IOV-3001 is an antibody interleukin-2 (IL-2) fusion protein in which a modified form of aldesleukin is incorporated into the antibody palivizumab.
• In December 2025, H. Lee Moffitt Cancer Center and Research Institute conducted a Phase 2 study evaluates the efficacy and safety of sequential treatment with percutaneous hepatic perfusion (PHP) using melphalan/HDS followed by tebentafusp in patients with metastatic uveal melanoma (mUM) with isolated liver metastases. The rationale is that PHP enhances antigen release and immunomodulation, potentially sensitizing tumors to tebentafusp in HLA-A*02:01-positive patients.
• In December 2025, Replimune Inc. initiated a Phase 2/3, Open-Label Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab Versus Ipilimumab in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma.
• Among the 7MM, the United States accounted for the highest number of diagnosed incident cases of ocular melanoma, which is 49.0% of the diagnosed incident cases of ocular melanoma in 2023.
• In the US, out of all diagnosed incident cases of uveal melanoma, choroidal cases were highest, followed by ciliary body and iris melanoma in 2023.
• Among the EU4 and the UK, the United Kingdom accounted for the highest number of ocular melanoma cases, followed by France, whereas Spain accounted for the lowest number of diagnosed incident cases of ocular melanoma.
• In Japan, the highest mutation type-specific cases of ocular melanoma were for GNA11, followed by GNAQ, BAP1, and SF3B1 mutation in 2023.
• The leading Ocular melanoma Companies such as Bristol Myers Squibb, Merck & Co., Inc., Novartis AG, Roche Holding AG, Pfizer Inc., AstraZeneca PLC, Eli Lilly and Company, Bayer AG, GlaxoSmithKline PLC, Amgen Inc., among others.
• Promising Ocular melanoma Therapies such as Melphalan, AU-011 (bezupacap sarotalocan), SEA-CD40, IDE 196 (darovasertib), APG-115, and others

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Ocular melanoma Epidemiology Segmentation in the 7MM
• Total Ocular melanoma Prevalence Cases
• Ocular melanoma Prevalent Cases by severity
• Ocular melanoma Gender-specific Prevalence
• Ocular melanoma Diagnosed Cases of Episodic and Chronic Ocular melanoma

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Marketed Ocular Melanoma Therapies
• KIMMTRAK (tebentafusp-tebn): Immunocore
KIMMTRAK is a novel bispecific protein comprised of a soluble T-cell receptor fused to an anti-CD3 immune-effector function. The drug explicitly targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore's ImmTAC technology platform designed to redirect and activate T cells to recognize and kill tumor cells. KIMMTRAK is indicated for treating adult patients with unresectable or metastatic uveal melanoma. Immunocore is planning to expand access to KIMMTRAK to more patients in the United States, Europe, and globally as it continues to establish the therapy as the standard of care for the first-line treatment for metastatic uveal melanoma in countries where it is launched.

• HEPZATO KIT (melphalan for Injection/Hepatic Delivery System): Delcath Systems
HEPZATO KIT (melphalan for injection/hepatic delivery system) is a combination drug/device product that administers HEPZATO (melphalan) directly to the liver through the HDS, which permits higher drug exposure in target tissues while limiting systemic toxicity. Melphalan is an alkylating drug of the bischloroethylamine type. As a result, its cytotoxicity appears to be related to the extent of its interstrand cross-linking with DNA, probably by binding at the N7 position of guanine. It is ctive against both resting and rapidly dividing tumor cells. In August 2023, the FDA approved HEPZATO KIT (melphalan for injection/hepatic delivery system) containing melphalan as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Efficacy was evaluated in the FOCUS study (NCT02678572), a single-arm, multicenter, open-label trial in 91 patients with uveal melanoma with unresectable hepatic metastases.

Emerging Ocular Melanoma Therapies
• Darovasertib (IDE196): IDEAYA Biosciences
Darovasertib is a potent, orally available selective small molecule inhibitor of PKC that is being developed for genetically defined cancers having GNAQ or GNA11 gene mutations. PKC is a protein kinase that functions downstream of the GTPases GNAQ and GNA11. The company is evaluating darovasertib in a Phase II/III trial as a combination therapy with Pfizer's investigational cMET inhibitor, crizotinib, in patients with metastatic uveal melanoma, a population in which >90% of patients have tumors harboring GNAQ or GNA11 mutations, and separately as a single-agent in Phase II clinical trial as neoadjuvant and adjuvant therapy in patients having primary uveal melanoma.

• Belzupacap Sarotalocan (AU-011): Aura Biosciences
Belzupacap Sarotalocan (Bel-sar) is a novel VDC that consists of an HPV-derived VLP conjugated to hundreds of infrared laser-activated molecules. VDCs are a novel class of drugs with a dual mechanism of action that promotes cancer cell death by both the delivery of the cytotoxic payload to generate acute necrosis and by activating a secondary immune-mediated response. A simple suprachoroidal injection delivers the drug and has the potential to be the first approved therapy in primary choroidal melanoma. Belzupacap sarotalocan has received ODD for the treatment of uveal melanoma from the US FDA and the EMA. The drug has also received FTD from the US FDA for the treatment of choroidal melanoma (Aura Biosciences, 2023c).

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Ocular Melanoma Market Outlook
The treatment scenario for ocular melanoma includes a variety of treatments, depending on the size and location of the tumor, whether it has spread, and the patient's general health. The purposes of uveal melanoma treatment are to avoid metastatic dissemination and to preserve the eye with useful vision. Treatment options for primary lesions include radiation (brachytherapy or proton beam therapy) or surgical enucleation. Approximately half of the patients will develop metastatic disease, and patients remain at lifelong risk of relapse. Most commonly, relapse occurs in the liver (~90%) with less common sites for metastatic spread, including the lung, bone, and skin (Howlett et al., 2023).

Ocular melanoma Drugs and Companies
• Melphalan: Delcath System
• AU-011 (bezupacap sarotalocan): Aura Biosciences
• SEA-CD40: Seagen
• IDE 196 (darovasertib): IDEAYA
• APG-115: Ascentage Pharma

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Scope of the Ocular melanoma Market Report
• Study Period: 2020-2034
• Coverage: 7MM
• Ocular melanoma Companies: Bristol Myers Squibb, Merck & Co., Inc., Novartis AG, Roche Holding AG, Pfizer Inc., AstraZeneca PLC, Eli Lilly and Company, Bayer AG, GlaxoSmithKline PLC, Amgen Inc., among others.
• Ocular melanoma Therapies: Melphalan, AU-011 (bezupacap sarotalocan), SEA-CD40, IDE 196 (darovasertib), APG-115, and others
• Ocular melanoma Therapeutic Assessment: Ocular melanoma current marketed and Ocular melanoma emerging therapies
• Ocular melanoma Market Dynamics: Ocular melanoma market drivers and Ocular melanoma market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Ocular melanoma Unmet Needs, KOL's views, Analyst's views, Ocular melanoma Market Access and Reimbursement

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Table of Contents
1. Ocular melanoma Market Report Introduction
2. Executive Summary for Ocular melanoma
3. SWOT analysis of Ocular melanoma
4. Ocular melanoma Patient Share (%) Overview at a Glance
5. Ocular melanoma Market Overview at a Glance
6. Ocular melanoma Disease Background and Overview
7. Ocular melanoma Epidemiology and Patient Population
8. Country-Specific Patient Population of Ocular melanoma
9. Ocular melanoma Current Treatment and Medical Practices
10. Ocular melanoma Unmet Needs
11. Ocular melanoma Emerging Therapies
12. Ocular melanoma Market Outlook
13. Country-Wise Ocular melanoma Market Analysis
14. Ocular melanoma Market Access and Reimbursement of Therapies
15. Ocular melanoma Market Drivers
16. Ocular melanoma Market Barriers
17. Ocular melanoma Appendix
18. Ocular melanoma Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

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