Melanoma Diagnostics and Therapeutics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product Type (Diagnostics Dermoscopy Devices, Biopsy Devices), By Therapeutics (Chemotherapy, Biological Therapy, Targeted Therapy, Immune Therapy), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 7.66 Billion
CAGR (2026-2031)	10.32%
Fastest Growing Segment	Immune Therapy
Largest Market	North America
Market Size (2031)	USD 13.81 Billion

Market Overview

The Global Melanoma Diagnostics and Therapeutics Market will grow from USD 7.66 Billion in 2025 to USD 13.81 Billion by 2031 at a 10.32% CAGR. The Global Melanoma Diagnostics and Therapeutics Market comprises screening technologies such as dermatoscopy and biopsy as well as pharmacological treatments including immunotherapies and targeted therapies. Market expansion is fundamentally supported by the increasing prevalence of malignant skin cancers and an aging demographic structure globally. Furthermore, expanded public health initiatives regarding skin examination and ultraviolet radiation risks drive the consistent demand for early detection services. According to the American Cancer Society, in 2025, an estimated 104,960 new cases of invasive melanoma will be diagnosed in the United States.

One substantial challenge potentially impeding market growth is the prohibitive cost of newer therapeutic agents. High pricing for biologics and immunotherapies places a considerable strain on healthcare budgets and complicates reimbursement processes in many regions. This financial barrier limits patient access to essential care and restricts market penetration in developing nations where out-of-pocket expenditure remains the primary funding source for medical treatments.

Key Market Drivers

The rising global incidence of melanoma and skin cancers acts as the primary catalyst for the expansion of the diagnostics and therapeutics sector. This escalation in disease prevalence creates a critical need for advanced screening methods and effective pharmacological interventions, fundamentally widening the patient base. As environmental factors and aging demographics contribute to higher case rates, healthcare systems are prioritizing early detection programs to mitigate mortality risks, thereby sustaining demand for diagnostic products. According to the World Health Organization's International Agency for Research on Cancer, February 2024, in the 'Global cancer burden growing' release, approximately 330,000 new cases of melanoma were diagnosed worldwide in 2022. This trend is pronounced in specific high-risk regions; for instance, according to Cancer Research UK, May 2024, in the 'Skin cancer cases reach all-time high' analysis, a record high of 20,800 new melanoma cases were projected to be diagnosed in the United Kingdom in 2024.

Concurrently, the rapid adoption of novel immunotherapies and checkpoint inhibitors is significantly propelling market revenue and reshaping clinical standards. The transition from traditional chemotherapy to precision immuno-oncology agents has improved patient survival rates and encouraged widespread commercial uptake of these biological treatments. Major pharmaceutical developers are witnessing distinct financial growth from these innovations, which incentivizes further research and development into combination therapies. According to Merck, February 2024, in the 'Fourth-Quarter and Full-Year 2023 Financial Results', sales of the immunotherapy Keytruda grew 19% to reach $25.0 billion for the full year 2023, driven largely by sustained demand in metastatic indications including melanoma. This commercial performance underscores the market's heavy reliance on next-generation therapeutic classes to drive future value.

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Key Market Challenges

The prohibitive cost associated with novel therapeutic agents, particularly biologics and immunotherapies, acts as a primary restraint on the Global Melanoma Diagnostics and Therapeutics Market. While these treatments often provide improved clinical outcomes, their elevated pricing structures impose significant financial pressure on healthcare systems and private payers. This economic burden frequently leads to stringent reimbursement criteria and prolonged approval timelines for coverage, effectively delaying the commercial adoption of these drugs in cost-sensitive markets. Consequently, the high financial threshold reduces the potential volume of prescriptions, directly limiting revenue generation for pharmaceutical developers.

This pricing challenge is further exacerbated by the disparity in global healthcare funding, restricting the uptake of advanced therapies in regions relying heavily on out-of-pocket expenditure. According to the American Society of Clinical Oncology, in 2024, the monthly price for certain checkpoint inhibitors when dosed specifically for metastatic melanoma reached approximately $47,538. Such expenditure levels are unsustainable for many patients and smaller insurance schemes, resulting in a substantial gap between the availability of advanced therapeutics and their accessibility to the wider patient population, thereby throttling overall market expansion.

Key Market Trends

The Adoption of Tumor-Infiltrating Lymphocyte (TIL) Cell Therapies represents a pivotal shift towards personalized cellular mechanisms for treating advanced, refractory solid tumors. This trend addresses critical unmet needs in patients who have progressed following standard anti-PD-1 regimens, moving beyond non-specific immune stimulation to highly targeted cellular attacks. The immediate commercial success of the first FDA-approved TIL product highlights the market's readiness for these complex biologics to manage metastatic disease. According to Iovance Biotherapeutics, November 2024, in the 'Third Quarter and Year to Date 2024 Financial Results', the company reported $42.1 million in net product revenue specifically from U.S. sales of Amtagvi during the third quarter of 2024.

Simultaneously, the Development of Personalized mRNA-Based Cancer Vaccines is redefining adjuvant care by utilizing neoantigen sequences to reduce recurrence rates. These therapies are engineered to recognize the unique mutational profile of a patient’s specific tumor, thereby generating a potent and tailored T-cell response when paired with established checkpoint inhibitors. This approach significantly enhances long-term survival prospects compared to monotherapy standards in the post-surgical setting. According to Merck, June 2024, in the 'Moderna and Merck Announce New 3-Year Data for mRNA-4157 Combined With Pembrolizumab', the combination of the vaccine mRNA-4157 and Keytruda reduced the risk of recurrence or death by 49% compared to Keytruda alone in high-risk stage III/IV melanoma patients.

Segmental Insights

The Immune Therapy segment represents the fastest-growing category within the Global Melanoma Diagnostics and Therapeutics Market. This rapid expansion is driven by a fundamental shift in clinical practice where checkpoint inhibitors are increasingly preferred over traditional chemotherapy for their superior long-term survival rates. Major regulatory bodies such as the U.S. Food and Drug Administration have supported this trajectory by approving multiple immunotherapeutic agents for advanced stages of the disease. The proven ability of these treatments to deliver durable patient outcomes has solidified their position as a primary standard of care, thereby sustaining high market demand.

Regional Insights

North America commands the largest share of the global melanoma diagnostics and therapeutics market, driven by the rising incidence of skin cancer across the United States and Canada. The region benefits from a dense network of biotechnology firms focused on developing targeted therapies and immunotherapies. Additionally, supportive regulatory frameworks, such as expedited review processes by the U.S. Food and Drug Administration, facilitate the rapid introduction of new treatment options. High healthcare spending and established reimbursement models for molecular diagnostics further ensure patient access to essential care, solidifying North America's market leadership.

Recent Developments

• In November 2024, Castle Biosciences presented new findings from its prospective, multicenter DECIDE study at the European Congress on Dermato-Oncology in Vienna. The research demonstrated that integrating results from the company's DecisionDx-Melanoma gene expression profile test into clinical workflows significantly influenced surgical management decisions. Specifically, the data showed a 25% reduction in unnecessary sentinel lymph node biopsy procedures when the test was used. Furthermore, the study reported that no patients identified as low-risk by the test who opted for the biopsy had a positive sentinel lymph node, validating the test's utility in safely guiding de-escalation of surgical care.
• In June 2024, Merck and Moderna presented positive three-year follow-up data from their collaborative Phase 2b KEYNOTE-942 trial at the American Society of Clinical Oncology (ASCO) Annual Meeting. The study evaluated the investigational individualized neoantigen therapy mRNA-4157 (V940) in combination with Keytruda as an adjuvant treatment for patients with resected high-risk melanoma. The results showed that this combination reduced the risk of recurrence or death by 49% compared to Keytruda alone. Additionally, the combination therapy demonstrated a 62% reduction in the risk of developing distant metastasis or death, highlighting the sustained clinical benefit of this mRNA-based therapeutic approach.
• In February 2024, Iovance Biotherapeutics announced that the U.S. FDA granted accelerated approval for Amtagvi (lifileucel), marking a historic milestone as the first individualized T cell therapy approved for a solid tumor cancer. The therapy is indicated for adult patients with unresectable or metastatic melanoma who have previously been treated with a PD-1 blocking antibody and, if applicable, a BRAF inhibitor. Amtagvi utilizes a proprietary manufacturing process to expand the patient's own tumor-infiltrating lymphocytes to fight the cancer. The approval was based on clinical data demonstrating a deep and durable response, offering a new therapeutic avenue for patients with limited treatment options.
• In January 2024, DermaSensor Inc. announced that it received U.S. FDA clearance for its novel, AI-powered skin cancer evaluation system. This handheld, non-invasive device is the first of its kind designed to assist primary care physicians in the point-of-care detection of all three common skin cancers, including melanoma, basal cell carcinoma, and squamous cell carcinoma. The clearance was supported by a pivotal study led by the Mayo Clinic, which demonstrated that the device achieved a 96% sensitivity rate in detecting melanoma. This development addresses a significant unmet need by equipping non-specialist clinicians with an automated tool to objectively evaluate suspicious skin lesions.

Key Market Players

• Abbott Laboratories Inc.
• Amgen, Inc.
• Bristol-Myers Squibb
• Novartis AG
• F. Hoffmann-La Roche Ltd
• Agilent Technologies Inc.
• AstraZeneca Plc
• Pfizer Inc.
• Eli Lilly & Co.
• GlaxoSmithKline Plc

By Product Type	By Therapeutics	By Region
Diagnostics Dermoscopy Devices Biopsy Devices	Chemotherapy Biological Therapy Targeted Therapy Immune Therapy	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Melanoma Diagnostics and Therapeutics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Melanoma Diagnostics and Therapeutics Market, By Product Type:

• Diagnostics Dermoscopy Devices
• Biopsy Devices

• Melanoma Diagnostics and Therapeutics Market, By Therapeutics:

• Chemotherapy
• Biological Therapy
• Targeted Therapy
• Immune Therapy

• Melanoma Diagnostics and Therapeutics Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE