United States Skin Cancer Therapeutics Market By Cancer Type (Melanoma, Non-melanoma, Others), By Type (Diagnosis, {Dermatoscopy, Biopsy, Genetic Tests, Others}, Therapeutics {Chemotherapy, Immunotherapy, Targeted Therapy, Others}), By Region, Competition Forecast & Opportunities, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 1.14 Billion
CAGR (2026-2031)	5.14%
Fastest Growing Segment	Melanoma
Largest Market	Midwest
Market Size (2031)	USD 1.54 Billion

Market Overview

The United States Skin Cancer Therapeutics Market will grow from USD 1.14 Billion in 2025 to USD 1.54 Billion by 2031 at a 5.14% CAGR. The United States Skin Cancer Therapeutics Market encompasses pharmaceutical agents and biological therapies, including immunotherapy and targeted therapy, utilized for the treatment of melanoma and non-melanoma malignancies. A primary driver propelling this sector is the escalating incidence of skin cancers which necessitates effective pharmacological interventions. Furthermore, an aging demographic and heightened public awareness regarding ultraviolet radiation exposure significantly support demand by increasing the rate of early diagnosis. According to the American Cancer Society, in 2025, an estimated 104,960 new cases of invasive melanoma will be diagnosed in the United States, highlighting the critical need for therapeutic options.

Despite these growth factors, the market encounters a substantial challenge regarding the high costs associated with novel biologic treatments. These elevated prices often result in strict reimbursement policies and financial toxicity for patients, thereby limiting broad market accessibility. Additionally, complex regulatory requirements for approval can delay the commercialization of new drugs and increase development expenses. Consequently, while the demand for effective treatments persists, economic and regulatory barriers could impede the potential rate of market expansion.

Key Market Drivers

The rising prevalence of melanoma and non-melanoma skin cancers acts as a primary catalyst for the United States Skin Cancer Therapeutics Market, creating a critical necessity for effective pharmaceutical treatments. This expanding disease burden necessitates aggressive therapeutic regimens to manage the associated mortality and morbidity. According to the American Cancer Society, January 2025, in the 'Cancer Facts & Figures 2025' report, it was projected that approximately 8,430 deaths from melanoma would occur in the United States during the year, emphasizing the severe impact of the condition. Furthermore, according to the Skin Cancer Foundation, in 2025, the number of new melanoma cases diagnosed was estimated to increase by 5.9 percent compared to the prior year, a trend that reinforces the urgent and growing need for accessible therapeutic solutions across the country.

The accelerated adoption of advanced immunotherapy and targeted agents is the second significant factor propelling market expansion. Oncologists are increasingly prescribing novel biologics, such as tumor-infiltrating lymphocyte (TIL) therapies and immune checkpoint inhibitors, which provide durable responses for patients with metastatic or unresectable disease. This shift is substantiated by the rapid commercial uptake of recently approved drugs. For instance, according to Iovance Biotherapeutics, November 2025, in the 'Third Quarter 2025 Financial Results', the company reported $58 million in U.S. net product revenue for Amtagvi, a cell therapy for melanoma, within a single quarter. This financial performance illustrates the robust market receptivity to innovative agents that address gaps in current standards of care.

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Key Market Challenges

The growth of the United States Skin Cancer Therapeutics Market is significantly impeded by the prohibitive costs associated with novel biologic treatments. While immunotherapies and targeted therapies offer clinical advancements, their elevated pricing structures create substantial economic barriers that restrict market penetration. Insurance providers and payers frequently implement stringent reimbursement protocols and complex prior authorization requirements to manage these heavy expenditures. These administrative hurdles directly limit broad accessibility to advanced standard-of-care regimens, causing delays in treatment initiation and reducing the overall volume of prescribed therapies, which subsequently dampens the revenue potential for manufacturers.

This economic pressure translates into severe financial toxicity for patients, further hampering market expansion by affecting treatment adherence and adoption rates. High out-of-pocket expenses often force individuals to delay or abandon necessary therapy, effectively shrinking the addressable market for these drugs. According to the American Cancer Society, in 2025, the list price for many prescription medicines is more than $100,000 annually. Such pricing levels create systemic resistance to the widespread commercialization of innovative skin cancer therapeutics, placing a verifiable ceiling on the market's growth trajectory despite the rising disease incidence.

Key Market Trends

The Accelerated Adoption of Neoadjuvant Immunotherapy Regimens is reshaping the standard of care for resectable stage III melanoma by prioritizing pre-surgical systemic treatment to eradicate micrometastatic disease early. This approach contrasts with traditional adjuvant protocols by leveraging the intact tumor microenvironment to generate a stronger immune response, thereby improving patient outcomes. The clinical validity of this shift was solidified by landmark data presenting superior efficacy for pre-surgical interventions. According to the European Society for Medical Oncology, October 2025, in the 'NADINA Trial Update', the combination of neoadjuvant nivolumab and ipilimumab demonstrated a 12-month event-free survival rate of 85.2 percent, significantly outperforming the 61.7 percent observed with adjuvant therapy alone. This compelling evidence is driving oncologists to rapidly integrate neoadjuvant protocols into first-line treatment planning.

Simultaneously, the Integration of Artificial Intelligence for Precision Treatment Selection is gaining momentum as clinicians utilize genomic profiling to personalize management strategies. Advanced diagnostic platforms now employ machine learning algorithms to analyze tumor biology, offering prognostic insights that guide critical decisions regarding sentinel lymph node biopsies and the intensity of follow-up care. This technological uptake is evident in the growing utilization of gene expression profile tests across the country. According to Castle Biosciences, January 2025, in the 'Preliminary Unaudited Fourth Quarter and Full-Year 2024 Results', the company delivered 36,008 DecisionDx-Melanoma test reports in 2024, representing an 8 percent increase in adoption compared to the previous year. This improved risk stratification reduces unnecessary surgical procedures and directs healthcare resources toward high-risk patients who require aggressive intervention.

Segmental Insights

The Melanoma segment is identified as the fastest growing category in the United States Skin Cancer Therapeutics Market, driven by increasing patient incidence rates and substantial progress in drug development. This expansion is largely supported by the authorization of new immunotherapies and targeted therapies by the U.S. Food and Drug Administration, which has significantly broadened the available treatment landscape. As healthcare providers adopt these approved therapeutic options for advanced disease stages, the demand for effective melanoma management continues to rise, prompting sustained investment from pharmaceutical developers within the region.

Regional Insights

The Midwest region holds a leading position in the United States Skin Cancer Therapeutics Market, driven by a marked escalation in melanoma incidence rates across states such as Minnesota and Ohio. This market dominance is sustained by an established network of premier medical research facilities, including institutions like the Mayo Clinic, which accelerates the adoption of approved immunotherapies and targeted drugs. Additionally, the region’s significant agricultural workforce faces high occupational sun exposure, necessitating widespread access to dermatological oncology treatments. These factors collectively ensure the Midwest remains a central focus for therapeutic distribution and market expansion.

Recent Developments

• In October 2025, Regeneron Pharmaceuticals received FDA approval for Libtayo (cemiplimab) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence following surgery and radiation. This approval positioned the PD-1 inhibitor as the first therapeutic option authorized for this specific post-surgical patient population. The regulatory endorsement was based on results from the Phase 3 C-POST trial, which showed that the treatment significantly reduced the risk of disease recurrence or death compared to placebo. This development expands the drug's label and provides a new systemic intervention for high-risk non-melanoma skin cancer patients.
• In January 2025, Replimune Group announced that the U.S. FDA had accepted its Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. The agency granted Priority Review for the application, acknowledging the potential of the therapy to address significant unmet needs in patients who had previously progressed on anti-PD-1 containing regimens. This submission was substantiated by data from the IGNYTE clinical trial, particularly the cohort of patients with anti-PD-1 failed melanoma. This regulatory advancement marks a critical step toward introducing a new oncolytic immunotherapy to the skin cancer therapeutics market.
• In June 2024, Moderna and Merck announced positive three-year follow-up data from the Phase 2b KEYNOTE-942 trial, which evaluated their investigational mRNA cancer vaccine, mRNA-4157 (V940), combined with Keytruda. The study focused on patients with resected high-risk stage III/IV melanoma. The results indicated that the combination therapy reduced the risk of recurrence or death by 49% compared to Keytruda monotherapy. Additionally, the data demonstrated a 62% reduction in the risk of distant metastasis or death, reinforcing the potential of this individualized neoantigen therapy to provide sustained clinical benefits in the adjuvant treatment setting.
• In February 2024, Iovance Biotherapeutics received accelerated approval from the U.S. Food and Drug Administration for Amtagvi (lifileucel), establishing it as the first cellular therapy indicated for a solid tumor. This approval addresses adult patients with unresectable or metastatic melanoma who have previously been treated with a PD-1 blocking antibody and, if BRAF V600 mutation-positive, a BRAF inhibitor. The regulatory decision was supported by efficacy data from the C-144-01 clinical trial, which demonstrated a meaningful objective response rate. This milestone introduces a novel tumor-infiltrating lymphocyte immunotherapy to the market, offering a new treatment avenue for patients with limited therapeutic options.

Key Market Players

• Merck & Co. Inc
• Bristol‑Myers Squibb Company
• Roche Holding AG
• Novartis International AG
• Pfizer Inc
• Amgen Inc
• Eli Lilly and Company
• Regeneron Pharmaceuticals Inc
• Sanofi S.A.
• AstraZeneca PLC

By Cancer Type	By Type	By Region
Melanoma Non-melanoma Others	Diagnosis Therapeutics	Northeast Midwest South West

Report Scope:

In this report, the United States Skin Cancer Therapeutics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• United States Skin Cancer Therapeutics Market, By Cancer Type:

• Melanoma
• Non-melanoma
• Others

• United States Skin Cancer Therapeutics Market, By Type:

• Diagnosis
• Therapeutics

• United States Skin Cancer Therapeutics Market, By Region:

• Northeast
• Midwest
• South
• West