US & EU Melanoma Therapeutics Market - 2025-2033

The US & EU Melanoma Therapeutics market reached US$ 3.89 billion in 2024 and is expected to reach US$ 8.99 billion by 2033, growing at a CAGR of 9.8% during the forecast period 2025-2033.

Melanoma is a type of skin cancer that originates in melanocytes, the cells responsible for producing melanin, the pigment that gives skin, hair and eyes their color. While melanoma primarily affects the skin, it can also occur in other areas of the body where melanocytes are present, including the eyes (ocular melanoma) and mucous membranes (mucosal melanoma). Melanoma therapeutics are the medical treatments and interventions used to treat melanoma, especially in advanced stages where it may have spread beyond the skin. Over the years, melanoma therapies have evolved significantly, with the development of more targeted and immunotherapies offering improved outcomes for patients.

Market Dynamics: Drivers & Restraints

Rising Prevalence of Melanoma in the United States and Europe

The rising prevalence of melanoma in the United States and Europe is significantly driving the growth of the US & EU melanoma therapeutics market and is expected to drive the market over the forecast period. In the United States, melanoma is the 5th most common cancer and the deadliest skin cancer. As more people are diagnosed with melanoma, there is an increased need for therapeutic options, boosting the demand for immunotherapy, targeted therapies, and early-stage detection tools.

For instance, according to the American Cancer Society (ACS) estimates, in the United States in 2025, about 104,960 new melanomas will be diagnosed (about 60,550 in men and 44,410 in women) and about 8,430 people are expected to die of melanoma (about 5,470 men and 2,960 women).

The EU also experiences a growing melanoma burden. For instance, in 2022, approximately 25,000 individuals were newly diagnosed with cutaneous melanoma in Germany, there are around 17,500 new melanoma skin cancer cases in the UK every year, and in France, the number is around 15,000. Melanoma rates are particularly high in countries with high sun exposure, such as Australia, Spain and Italy. Northern European countries, such as Sweden, also show rising cases, primarily due to increased awareness and detection.

With more people being diagnosed and a rising demand for advanced, targeted and immunotherapies, the market is witnessing substantial expansion. The availability of combination therapies, checkpoint inhibitors and targeted therapies has revolutionized the treatment landscape, offering improved survival outcomes and driving market growth. Additionally, the growing focus on early detection and prevention continues to play a key role in the overall market dynamics, ensuring sustained growth in the years ahead.

Adverse Effects Associated with Melanoma Therapeutics

The adverse effects associated with melanoma therapeutics, especially immunotherapies, targeted therapies and chemotherapy, are significantly impacting the growth of the melanoma therapeutics market in both the United States and the European Union. While these treatments have proven effective in increasing survival rates for melanoma patients, their side effects can lead to complications that hinder patient adherence, reduce treatment efficacy and increase overall healthcare costs.

Immunotherapy, particularly checkpoint inhibitors such as PD-1 inhibitors (Pembrolizumab, Nivolumab) and CTLA-4 inhibitors (Ipilimumab), has revolutionized melanoma treatment. However, these therapies can induce significant immune-related adverse events (irAEs), which can affect the skin, liver, intestines and other organs. Targeted therapies, such as BRAF inhibitors (Vemurafenib, Dabrafenib) and MEK inhibitors (Trametinib), have been effective for patients with BRAF-mutant melanoma, but they also come with a set of adverse effects that can hinder treatment progress.

Segment Analysis

The US & EU melanoma therapeutics market is segmented based on type and therapy.

Therapy:

The immunotherapy from therapy segment is expected to dominate the US & EU Melanoma Therapeutics market.

The introduction of checkpoint inhibitors such as Pembrolizumab (Keytruda), Nivolumab (Opdivo) and Ipilimumab (Yervoy) has transformed melanoma treatment. These drugs work by blocking inhibitory signals that prevent the immune system from attacking melanoma cells, effectively enhancing the body's natural immune response. Immunotherapy has not only improved patient outcomes but also driven substantial market growth, positioning it as the leading segment in both the US and EU melanoma therapeutics markets.

The US FDA and the European Medicines Agency (EMA) have granted accelerated approvals for various immunotherapies, expanding their use in first-line, adjuvant and advanced melanoma settings. These approvals have fueled market penetration, with pembrolizumab, nivolumab, and ipilimumab leading the market.

For instance, in February 2024, the FDA granted accelerated approval to lifileucel (Amtagvi), a tumor-derived autologous T-cell immunotherapy, for the treatment of adults with unresectable or metastatic melanoma that was previously treated with a PD-1 blocking antibody and a BRAF inhibitor with or without a MEK inhibitor if the patient's disease is BRAF V600 positive.

Competitive Landscape

The major US & EU players in the melanoma therapeutics market include Merck & Co., Inc., Bristol-Myers Squibb Company., Amgen, Inc., IOVANCE Biotherapeutics, Inc., Novartis AG, F. Hoffmann-La Roche Ltd, Pfizer Inc., Immunocore Holdings plc., Eisai Co., Ltd., Delcath Systems, Inc. and among others.

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
• Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
• Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
• Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The US & EU Melanoma Therapeutics market report delivers a detailed analysis with 36 key tables, 26 visually impactful figures and 149 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

• Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
• Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
• Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
• Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
• Supply Chain: Distribution and Supply Chain Managers.
• Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
• Academic & Research: Academic Institutions.