Melanoma Market

Key Highlights

• Among the 7MM, the US accounted for the highest share in the market size of melanoma in 2023, which is expected to grow during the forecast period.
• The current available diverse range of treatments for melanoma includes surgeries (hysterectomy), chemotherapy, radiation therapy, and drug therapies targeting PD-1 and LAG-3.
• In ASCO 2024, Moderna presented data of pembrolizumab with V940 (mRNA-4157) versus pembrolizumab with placebo for adjuvant treatment of high-risk stage II-IV melanoma and mRNA-4157 (V940) plus pembrolizumab in resected melanoma: 3-year update from the mRNA-4157-P201 (KEYNOTE-942) trial.
• After FDA approval AMTAGVI became the first FDA-approved T-cell therapy for a solid tumor cancer and the first treatment option for advanced melanoma after anti-PD-1 and targeted therapy.
• OPDUALAG was approved by the FDA for unresectable or metastatic melanoma in 2022. It is currently being evaluated for many other segments of melanoma.
• In 2023, the FDA granted an Orphan Drug Designation for Linnaeus Therapeutics’s LNS8801 for treating patients with metastatic cutaneous melanoma.
• Quantitatively melanoma pipeline seems to be quite strong. Several key players are IO Biotech, Regeneron Pharmaceuticals, Iovance Biotherapeutics, Highlight Therapeutics, Linnaeus Therapeutics, Ultimovacs, BioNTech, and others.
• In a nutshell, it is estimated that the melanoma treatment space will experience significant growth during the forecast period of 2024–2034. The future is brighter for patients with melanoma. Targeted agents and biomarker-driven therapies hold promise for improved outcomes both as single agents and combinations.

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

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

Melanoma Disease Understanding 

Melanoma is a common skin cancer that arises from the melanin cells within the upper layer of the skin (epidermis) or from similar cells that may be found in moles (nevi). This type of skin cancer may send down roots into deeper layers of the skin, and some of these microscopic roots may spread (metastasize), causing new tumor growths in vital organs of the body. It typically falls into one of three general categories, i.e., cutaneous, mucosal, and ocular. The exact cause of malignant melanoma is unknown. Excessive exposure to the sun, particularly before puberty, and living in areas that are closer to the sun (i.e., tropical climates) increases the risk of developing skin cancer. A defective gene known as CDK4 has been identified and may be associated with an increased risk for familial malignant melanoma. Cutaneous melanoma is the most common of these categories, and is traditionally classified into primary and metastatic; primary melanoma is further divided into a) melanoma in situ when the atypical melanocytes are limited to the epidermis; b) invasive melanoma if it conquers the dermis. Invasive melanoma is historically classified according to clinical and histopathological characteristics into four major histological subtypes: superficial spreading melanoma, lentigo melanoma, nodular, and acral melanoma.

Melanoma Diagnosis

Early detection and recognition of skin cancer are essential. Recognizing the early warning signs of melanoma and doing regular self-examinations of the skin can help find melanoma early when the disease is more curable. Doctors use many tests to find or diagnose cancer. Initial evaluation includes a physical exam and biopsy. Depending on the results of the assessment, imaging tests are performed tests to learn if cancer has spread to another part of the body from where it started including ultrasound, computed tomography (CT or CAT) scan, magnetic resonance imaging (MRI), and positron emission tomography (PET) or PET-CT scan.

Further details related to country-based variations in diagnosis are provided in the report…

Melanoma Treatment

The treatment of melanoma depends on its thickness, whether the cancer has spread, the stage, whether there are specific genetic changes in melanoma cells, the rate of Metastatic melanoma growth, and the person’s overall health. 

Over the past years, several therapies have been approved by the US FDA. Depending on the features of the tumor (location, stage, and genetic profile), the therapeutic options may be surgical resection, chemotherapy, radiotherapy, photodynamic therapy (PDT), immunotherapy, or targeted therapy. Yet, for individuals at Stages I–III, the most common treatment choice is surgical resection, and for solitary metastatic melanoma, metastasectomy remains the primary intervention.

Note: Further Details are provided in the final report

Melanoma Epidemiology

As the market is derived using a patient-based model, the melanoma epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by incident Cases of melanoma,  type-specific incident cases of melanoma, stage-specific incident cases of melanoma, mutation-specific (BRAF, MEK) incident cases of melanoma, age-specific incident cases of melanoma, and treatable cases of melanoma in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034. 

• Among the 7MM, the highest cases of invasive melanoma were observed in the US, which were approximately 100,000 in 2023.
• Melanoma is slightly more common in men than women with approximately 60% of cases in men in the US.
• The incidence of melanoma has shown an increasing trend in EU4 and the UK. Among the EU4 countries, Germany accounted for the highest number of incident cases of melanoma, followed by France and then Italy.
• Melanoma of the skin represents Melanoma es in the US, with the rate of new cases of melanoma of the skin was 22.7 per 100,000 per year.
• Melanoma is the 5th most common cancer in the UK, accounting for 4% of all new cancer cases

Melanoma Recent Developments

• In August 2025, Regeneron Pharmaceuticals highlighted its PD-1 inhibitor Libtayo as the standard of care for advanced cutaneous squamous cell carcinoma (CSCC), with ongoing research in melanoma and multiple myeloma.
• In February 2025, Bristol Myers Squibb announced that the phase 3 RELATIVITY-098 trial of Opdualag (nivolumab and relatlimab-rmbw) for adjuvant treatment of completely resected stage III-IV melanoma did not meet its primary endpoint of recurrence-free survival (RFS). The safety profile of Opdualag was consistent with the known profiles of nivolumab and relatlimab.

Melanoma Drug Chapters

The drug chapter segment of the melanoma report encloses a detailed analysis of approved and emerging drugs or late-stage (Phase III and Phase II) Melanoma pipeline drugs. It also deep dives into melanoma pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations. 

Melanoma Marketed Drugs

AMTAGVI (lifileucel): Iovance Biotherapeutics

AMTAGVI is a prescription medicine that is incorporated intravenously. It is used to treat adults with a type of skin cancer that cannot be removed surgically or has spread to other parts of the body called unresectable or metastatic melanoma. It is approved for patients that have been previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. It is the first cancer treatment that uses immune cells called tumor-infiltrating lymphocytes, or TILs. In February 2024, the FDA approved AMTAGVI for advanced melanoma based on the TILVANCE-301 trial.

OPDIVO (nivolumab): Bristol-Myers Squibb

OPDIVO is a prescription medicine that is incorporated intravenously. It is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with BRAF V600 wild-type and mutation-positive unresectable or metastatic melanoma, as a single agent. In 2016, it received its approval in combination with YERVOY for unresectable or metastatic melanoma. In October 2023, the FDA approved OPDIVO, as a monotherapy, for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB or IIC melanoma.

Note: Detailed Marketed therapies assessment will be provided in the final report.

Melanoma Emerging Drugs

Fianlimab + Cemiplimab: Regeneron Pharmaceuticals

It is a monoclonal antibody directed against the inhibitory receptor lymphocyte activation gene-3 protein (LAG-3; LAG3; CD223), with potential immune checkpoint inhibitory and antineoplastic activities. It is being evaluated in a Phase III trial in combination with cemiplimab (PD-1 inhibitor). The investigation determines whether concurrent blockade of LAG-3 and PD-1 can help overcome this resistance and release the brakes on T cell activation.

Fianlimab plus cemiplimab produced high and consistent tumor responses and a comparable toxicity profile to that of anti–PD-L1 monotherapies in patients with advanced melanoma who were PD-L1 inhibitor–naïve in the advanced setting, according to data from a phase I study.

IO102-IO103 + KEYTRUDA: IO Biotech

It is a novel immune-modulating cancer vaccine that stimulates the activation of T cells targeting indoleamine-2,3-dioxygenase 1 (IDO1) and PDL1-positive cells, resulting in potentially increased susceptibility to anti-PD-1 blockade. It is being evaluated in multiple trials. In the highest trial Phase III, it is being investigated in combination with KEYTRUDA (pembrolizumab) as first-line treatment for patients with previously untreated unresectable or metastatic (advanced) melanoma.

In November 2023, IO Biotech announced that it had completed the enrollment of 380 patients in a Phase III clinical trial of its investigational immune-modulating therapeutic cancer vaccine in advanced melanoma.