The uveal melanoma market is small but strategically important, driven by significant unmet medical needs, few available treatments, and growing innovation. Targeted therapies and immunotherapies, especially those focused on GNAQ/GNA11 mutations and overcoming immune resistance, are seeing increased interest, although outcomes in advanced stages remain limited. Advances in prognostic tools that integrate histopathologic, molecular, and patient-specific markers are enhancing risk stratification, but a universally accepted standard is still lacking.
DelveInsight’s Uveal Melanoma Market Insights report includes a comprehensive understanding of current treatment practices, uveal melanoma emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
Key Takeaways from the Uveal Melanoma Market Report
- According to DelveInsight’s analysis, the market size for uveal melanoma in the 7MM is expected to grow significantly by 2034.
- The United States accounted for the highest uveal melanoma treatment market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- 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.
- 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.
- Leading uveal melanoma companies developing emerging therapies, such as Aura Biosciences, IDEAYA Biosciences, Replimune, Linnaeus Therapeutics, Novartis, TriSalus Life Sciences, and others, are developing new uveal melanoma treatment drugs that can be available in the uveal melanoma market in the coming years.
- The promising uveal melanoma therapies in the pipeline include Belzupacap sarotalocan, Darovasertib, RP2, LNS8801, DYP688, Nelitolimod, and others.
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Uveal Melanoma Market Dynamics
The uveal melanoma market dynamics are expected to change in the coming years. With the increasing incidence and high unmet need in uveal melanoma, particularly in metastatic settings where complex and personalized therapies are gaining focus, the limited treatment options create a strong opportunity for new therapies to enter and boost the market, supported further by active efforts from organizations to raise awareness and provide a clinical trial patient pool.
As potential therapies are being investigated for the treatment of uveal melanoma, it is safe to predict that the treatment space will significantly impact the uveal melanoma market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the uveal melanoma market in the 7MM.
However, several factors may impede the growth of the uveal melanoma market. To date, there is no efficient therapeutic algorithm for controlling metastatic uveal melanoma, which is responsible for a rapid fatal outcome in nearly 50% of patients; while immunotherapy agents such as immune checkpoint inhibitors, effective in cutaneous melanoma, have shown limited efficacy in uveal melanoma due to its distinct genetics, unique disease progression, and complex immune interactions, the currently approved therapies not only impose a significant cost burden on patients but also remain under post-marketing surveillance, with the risk of regulatory withdrawal if unforeseen adverse outcomes emerge in real-world use.
Moreover, uveal melanoma treatment poses a significant economic burden and disrupts patients’ overall well-being and QOL. Furthermore, the uveal melanoma market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the uveal melanoma market growth.
Uveal Melanoma Treatment Market
The management of uveal melanoma is individualized based on factors such as tumor size, location, and the patient’s potential for preserving vision, with surgery continuing to play a central role. Surgical approaches include local tumor resection, enucleation, and, in more advanced cases, exenteration. Enucleation is generally performed for large tumors or when there is no possibility of saving vision, while exenteration is reserved for cases with significant local invasion.
Radiation therapy is commonly used either as an alternative or in conjunction with surgery. This may involve external beam techniques, such as charged-particle therapy or Gamma Knife radiosurgery, or internal approaches, most often plaque brachytherapy, which delivers focused radiation through a radioactive disc placed on the eye’s outer surface.
Less frequently, thermal methods like photocoagulation and thermotherapy are used, especially for smaller tumors, to damage cancer cells by cutting off their blood supply or applying heat. In certain scenarios, particularly with small or uncertain lesions, clinicians may opt for active surveillance, especially when the tumor affects the patient’s only seeing eye. Treatment decisions aim to strike a balance between controlling the tumor, preserving vision, and maintaining quality of life.
KIMMTRAK represents a notable advancement in treating metastatic uveal melanoma, offering a proven survival benefit over traditional options. However, its effectiveness is restricted to patients with the HLA-A*02:01 genotype, limiting its use to a specific genetic group. This limitation highlights a key challenge in current immunotherapies and emphasizes the pressing need for broader treatment strategies that can address the genetic diversity of the uveal melanoma population.
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Uveal Melanoma Pipeline Therapies and Key Companies
The pipeline for uveal melanoma is growing, with several key players, including Aura Biosciences (belzupacap sarotalocan), IDEAYA Biosciences (darovasertib), Replimune (RP2), Linnaeus Therapeutics (LNS8801), Novartis (DYP688), and others in clinical development.
Darovasertib is a highly selective and potent inhibitor of protein kinase C (PKC) currently in development for the treatment of both primary and metastatic uveal melanoma. It has been granted Breakthrough Therapy Designation (BTD) by the US FDA for use as a neoadjuvant therapy in patients with primary uveal melanoma for whom enucleation is advised. Additionally, it has received Fast Track designation for use in combination with crizotinib in adults with metastatic uveal melanoma. A Phase II/III registration-enabling trial evaluating this combination as a first-line treatment for HLA-A2-negative metastatic uveal melanoma is ongoing. Darovasertib also holds Orphan Drug Designation from the FDA for uveal melanoma, including its metastatic form.
In April 2025, IDEAYA Biosciences reported a successful FDA Type D meeting regarding the Phase III registrational trial for darovasertib as a neoadjuvant therapy in primary uveal melanoma, paving the way for potential regulatory approval. The company plans to launch this randomized Phase III trial in the first half of 2025.
In March 2025, the FDA granted BTD to darovasertib as a potential first-in-class PKC inhibitor for adults with primary uveal melanoma where enucleation is recommended.
DYP688 is an antibody-drug conjugate (ADC), consisting of an antibody linked to a cytotoxic agent. The antibody targets PMEL17, a protein found on GNAQ/11-mutated melanoma cells. Upon binding to PMEL17, DYP688 facilitates the delivery of the anticancer drug to the tumor cells.
In May 2025, Novartis presented early clinical data from the first-in-human study of DYP688 in patients with metastatic uveal melanoma and other GNAQ/11-mutant melanomas.
RP2, developed by Replimune, is an advanced oncolytic virus therapy based on RP1, their lead candidate derived from a novel strain of herpes simplex virus. RP2 is engineered to express GM-CSF and a fusogenic protein (GALV-GP-R) to enhance tumor cell destruction and stimulate systemic anti-tumor immunity. In addition to these components, RP2 also expresses a molecule resembling an anti-CTLA-4 antibody. This design enables focused delivery of these immunomodulatory proteins to tumors and nearby lymph nodes, aiming to boost immune response at the tumor site while minimizing systemic toxicity.
The anticipated launch of these emerging therapies are poised to transform the uveal melanoma market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the uveal melanoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
Discover more about uveal melanoma marketed and pipeline drugs @ Uveal Melanoma Clinical Trials
Recent Developments in the Uveal Melanoma Market
- In May 2025, Novartis announced presentation of results from the first-in-human study of DYP688 in patients with metastatic uveal melanoma and other GNAQ/11 mutant melanomas.
- 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.
