Uveal Melanoma Market

• Treatment of uveal melanoma, particularly in the metastatic setting, is increasingly focused on complex and personalized therapeutic approaches. Emerging targeted strategies, such as molecularly targeted therapies ─ hold promise for improving outcomes and extending survival in patients with metastatic uveal melanoma.
• KIMMTRAK has emerged as a significant milestone in the treatment of metastatic uveal melanoma, demonstrating a measurable survival advantage compared to traditional therapies. However, its efficacy is confined to patients expressing HLA-A*02:01, which limits its applicability to a specific genetic subset. This highlights a fundamental limitation in current immunotherapeutic strategies and underscores the urgent need to develop alternative, broadly applicable treatments that address the heterogeneous HLA landscape of the uveal melanoma patient population. 
• While uveal melanoma is associated with low rates of primary tumor recurrence following local treatment, the risk of distant metastasis remains high, with up to 50% of patients developing systemic disease.
• Protein engineering has enabled the development of innovative immunotherapies and molecularly targeted treatments for metastatic uveal melanoma, most notably KIMMTRAK, which represents a major step forward in addressing the disease’s therapeutic challenges.
• Approximately half of patients with uveal melanoma develop metastatic disease, most commonly involving the liver, followed by the lungs, skin and soft tissue, and bone.
• Despite significant advancements in the treatment of uveal melanoma over recent decades, a definitive standard of care has yet to be established. The absence of a universally accepted gold standard highlights the ongoing uncertainty surrounding optimal disease management. While novel therapies have emerged, their clinical benefit remains inconclusive, underscoring the need for continued research and refinement of therapeutic strategies.
• The pipeline for uveal melanoma is growing, several key players including Aura Biosciences (belzupacap sarotalocan), IDEAYA Biosciences (darovasertib), Replimune (RP2), Linnaeus Therapeutics (LNS8801), Novartis (DYP688), and others in clinical development. 

DelveInsight’s “Uveal Melanoma – Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of uveal melanoma, historical and forecasted epidemiology as well as uveal melanoma market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The uveal melanoma market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM uveal melanoma market size from 2020 to 2034. The report also covers current uveal melanoma treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Uveal Melanoma: Understanding and Treatment Algorithm

Uveal Melanoma Overview

Uveal melanoma is a rare but aggressive cancer and the most common primary intraocular malignancy in adults, accounting for approximately 83% of all ocular melanomas. It originates from melanocytes within the uveal tract of the eye, which includes the iris, ciliary body, and choroid, with about 90% of cases arising in the choroid. Typically presenting unilaterally between the ages of 50 and 70, uveal melanoma is biologically and clinically distinct from cutaneous melanoma, despite their shared cellular origin. It is not associated with ultraviolet light exposure (except in iris melanoma) and is primarily driven by mutations in GNAQ and GNA11, unlike the BRAF and NRAS mutations common in cutaneous melanoma. Uveal melanoma has a unique molecular landscape, a characteristic pattern of metastasis, and limited therapeutic options in the metastatic setting. 

Uveal Melanoma Diagnosis

The diagnosis of uveal melanoma has significantly advanced with the refinement of imaging modalities and growing expertise among ocular oncologists. Diagnostic confirmation typically involves ocular ultrasound, magnetic resonance imaging, computed tomography, and fluorescein angiography. In select challenging cases, such as when ruling out metastatic disease, fine needle aspiration biopsy may be required, though it carries risks including retinal detachment and vitreous hemorrhage. Smaller choroidal tumors suspected to be benign nevi are often managed through active surveillance, as distinguishing them from early melanomas can be difficult, particularly since transformation occurs in only a small fraction of cases. Prognostication is further informed by molecular and cytogenetic markers, including BAP1 expression loss (often with monosomy 3), gain of chromosome 8q, and epithelioid cell morphology. These biomarkers are strongly associated with increased metastatic potential, immune evasion, and reduced survival. Tumor size and cellular composition also contribute to risk assessment, with larger, thicker tumors and epithelioid histology indicating a more aggressive clinical course. Molecular profiling thus plays a critical role in guiding surveillance strategies and informing treatment decisions following local disease control. 

Further details related to diagnosis are provided in the report…

Uveal Melanoma Treatment

The treatment of uveal melanoma is tailored to tumor size, location, and the patient’s visual potential, with surgery remaining a mainstay of management. Surgical options include local resection, enucleation (removal of the eye and part of the optic nerve), and, in advanced cases, exenteration (removal of the eye along with surrounding tissues). Enucleation is typically reserved for large tumors or when vision cannot be preserved, while exenteration is indicated for extensive local invasion. Radiation therapy is a widely used alternative or adjunct to surgery, employing either external beam radiation (such as charged-particle therapy or Gamma Knife radiosurgery) or internal radiation, most commonly via localized plaque brachytherapy, which delivers targeted radiation using a radioactive plaque placed on the outer eye wall. Less commonly, thermal treatments like photocoagulation and thermotherapy may be used, particularly for small tumors, to destroy cancer cells by disrupting their blood supply or applying heat. In select cases, particularly with small or indeterminate lesions, a watchful waiting approach is employed to monitor tumor progression before initiating treatment, especially when the lesion occurs in the only functioning eye. The choice of therapy balances tumor control with vision preservation and quality of life.

Further details related to treatment are provided in the report…

Uveal Melanoma Epidemiology

The uveal melanoma epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incident cases of uveal melanoma, site-specific incident cases of uveal melanoma, stage-specific incident cases of uveal melanoma, mutation-specific incident cases of uveal melanoma and total treated cases of uveal melanoma in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034. 

• Uveal melanoma is a rare cancer with an age-adjusted incidence of approximately 5 per million, affecting around 2,500 individuals annually in the US. Despite its low incidence, it is clinically significant due to its high risk of metastasis and limited treatment options in advanced stages.
• In the UK, uveal melanoma is considered a rare malignancy, with an estimated annual incidence of 500 to 600 newly diagnosed cases.
• Uveal melanoma accounts for only 5% of all melanomas, it is the most common primary intraocular malignancy in adults.
• Up to 50% of individuals with uveal melanoma eventually develop metastatic disease. Metastases typically emerge within a median of three to five years following treatment of the primary tumor, and treatment at this stage is generally given with palliative intent.

Uveal Melanoma Drug Chapters

The drug chapter segment of the uveal melanoma report encloses a detailed analysis of uveal melanoma marketed drugs. It also deep dives into uveal melanoma pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations. 

Marketed Drugs

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. KIMMTRAK specifically 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. In 2024, KIMMTRAK was launched in 14 additional countries (including Australia, Spain, Poland, and the United Kingdom, excluding Scotland) for a total of 24 countries launched at the end of 2024.

Immunocore is focusing on three key growth areas for KIMMTRAK: global expansion in metastatic uveal melanoma, potential expansion into 2L+ advanced cutaneous melanoma, and adjuvant uveal melanoma.

• In December 2024, Immunocore announced that KIMMTRAK has been recommended for funding through the National Health Service (NHS) in England by the National Institute for Health and Care Excellence (NICE). NICE recommended KIMMTRAK within its marketing authorization for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma. The recommendation overturns the initial negative decision by NICE in May 2023, which the Company successfully appealed in December 2023.
• In December 2024, Immunocore announced first patient was enrolled in a Phase III ATOM trial and was randomly assigned to receive treatment for non-metastatic uveal melanoma.

HEPZATO KIT (melphalan): Delcath Systems

HEPZATO KIT is a combination product that administers HEPZATO (melphalan), a well-known and long-approved chemotherapeutic agent, directly to the liver through Delcath's novel device delivery system, the Hepatic Delivery System (HDS), which permits higher drug exposure in target tissues while limiting systemic toxicity. The use of the HDS allows a healthcare provider team to surgically isolate the liver while the hepatic venous blood is filtered during melphalan infusion and subsequent washout during a Percutaneous Hepatic Perfusion (PHP) procedure. PHP, which can only be performed with Delcath's HDS, results in loco-regional delivery of a relatively high melphalan dose. HEPZATO KIT is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the HEPZATO KIT REMS.

• In April 2025, Delcath Systems announced publication of comparative analysis from randomized portion of Phase III FOCUS study in Annals of Surgical Oncology. 
• In February 2025, the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology to recommend HEPZATO KIT as a Category 2A treatment option for patients with hepatic-dominant metastatic uveal melanoma.

Note: Detailed list will be provided in the final report.

Emerging Drugs

Darovasertib: IDEAYA Biosciences

Darovasertib is a potent and selective protein kinase C (PKC) inhibitor being developed to broadly address primary and metastatic uveal melanoma. Darovasertib has received US FDA Breakthrough Therapy Designation (BTD) as neoadjuvant therapy in enucleation recommended primary uveal melanoma and Fast Track designation for darovasertib in combination with crizotinib in adult patients with metastatic uveal melanoma, where a Phase II/III registration-enabling trial of the darovasertib and crizotinib combination in 1L HLA-A2-negative metastatic uveal melanoma is ongoing.  Darovasertib has also been designated as an Orphan Drug by the US FDA in uveal melanoma, including in metastatic uveal melanoma.

• In April 2025, IDEAYA Biosciences announced a successful FDA Type D meeting on the Phase III registrational trial design that will assess the safety and efficacy of darovasertib for potential regulatory approval as neoadjuvant therapy for primary uveal melanoma. IDEAYA is targeting to initiate the Phase III randomized clinical trial evaluating neoadjuvant darovasertib in primary uveal melanoma in the first half of 2025.
• In March 2025, IDEAYA Biosciences announced that the FDA has granted darovasertib, a potential first-in-class PKC inhibitor, BTD for the potential treatment of adult patients with primary uveal melanoma for whom enucleation has been recommended.

DYP688: Novartis

DYP688 is an antibody-drug conjugate (ADC), a biologic drug where an anticancer drug is attached to an antibody. The antibody that is part of DYP688 is designed to bind the protein PMEL17 that is present on GNAQ/11 mutant cancer cells. After binding to PMEL17 on cancer cells, DYP688 is then able to deliver the anticancer drug.

• In May 2025, Novartis announced presentation of results from first-in-human study of DYP688, in patients with metastatic uveal melanoma and other GNAQ/11 mutant melanomas.

RP2: Replimune

RP2 is a derivative of RP1, Replimune’s lead product candidate that is based on a proprietary new strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R) and GM-CSF to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP-R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity

Note: Detailed list will be provided in the final report.

Drug Class Insights 

The drug classes include Tumor cell necrosis after light activation, immune-mediated tumor cell killing, Selective agonist of GPER, PKC inhibitor, and others.

PKC inhibitor 

PKC inhibitors are drugs that block the activity of protein kinase C enzymes, which play a key role in cell signaling pathways related to cancer growth and survival. Darovasertib is a potent, selective oral pan-PKC inhibitor developed for uveal melanoma, especially in tumors with GNAQ or GNA11 mutations that activate PKC signaling. By inhibiting multiple PKC isoforms, darovasertib disrupts downstream pathways essential for tumor cell proliferation and survival, making it a promising targeted therapy for this aggressive cancer.

Note: Detailed insights will be provided in the final report.

Uveal Melanoma Market Outlook

The uveal melanoma market remains niche but strategically significant, shaped by high unmet need, limited treatment options, and emerging innovation. Historically dominated by local therapies, surgery and radiation, effective systemic treatments for metastatic disease have been lacking. Recent approvals, such as KIMMTRAK and HEPZATO KIT, mark progress, but broader therapeutic advancement remains limited. Targeted and immune-based therapies are gaining traction, particularly those addressing GNAQ/GNA11 mutations and immune resistance, though clinical outcomes in advanced disease remain modest. Improved prognostication using combined histopathologic, molecular, and patient-specific markers is helping refine risk assessment, but no gold standard exists. Research continues to focus on predictive biomarkers, treatment resistance, and trial optimization. 

Uveal Melanoma Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020–2034. The landscape of uveal melanoma treatment has experienced a profound transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians, oncology professionals, and the entire healthcare community in their tireless pursuit of advancing cancer care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience. 

Further detailed analysis of emerging therapies drug uptake in the report…

Uveal Melanoma Pipeline Development Activities

The report provides insights into therapeutic candidates in Phase III, Phase II, and Phase I/II. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for uveal melanoma emerging therapy.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on uveal melanoma evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including oncologists, radiation oncologists, surgical oncologists, and others.

Delveinsight’s analysts connected with 15+ KOLs to gather insights; however, interviews were conducted with 7+ KOLs in the 7MM. Centers such as - Melanoma Center at the UPMC Hillman Cancer Center, MD Anderson Cancer Center, Thomas Jefferson University Columbia University Irving Medical Center, UT Southwestern Medical Center, Institut Curie, University of Liverpool, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or uveal melanoma market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in event- free survival, one of the most crucial primary outcome measures is event-free survival and overall survival.

Further, the therapies’ safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed, and this clearly explains the drugs side effects in the trials. In addition, the scoring is also based on the probability of success and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Further detailed analysis of emerging therapies drug uptake in the report…

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of uveal melanoma, explaining its causes, signs, symptoms, pathogenesis, and currently used therapies.
• Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
• Additionally, an all-inclusive account of the emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the uveal melanoma market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM uveal melanoma market.

Uveal Melanoma Report Insights

• Patient Population
• Therapeutic Approaches
• Uveal Melanoma Pipeline Analysis
• Uveal Melanoma Market Size and Trends
• Existing and Future Market Opportunity 

Uveal Melanoma Report Key Strengths

• 10 Years Forecast
• The 7MM Coverage 
• Uveal Melanoma Epidemiology Segmentation
• Key Cross Competition 
• Drugs Uptake and Key Market Forecast Assumptions

Uveal Melanoma Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT Analysis and Conjoint Analysis)

FAQs

• What was the uveal melanoma market size, the market size by therapies, market share (%) distribution in 2024, and what would it look like by 2034? What are the contributing factors for this growth?
• What are the pricing variations among different geographies for approved therapies?
• What can be the future treatment paradigm of uveal melanoma?
• What are the disease risks, burdens, and unmet needs of uveal melanoma? What will be the growth opportunities across the 7MM concerning the patient population with uveal melanoma?

• What are the current options for the treatment of uveal melanoma? What are the current guidelines for treating uveal melanoma in the US, Europe, and Japan?

• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitations of existing therapies? 

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the uveal melanoma market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the analyst view section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of current therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.