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United States and Canada Skin Cancer Dermatology Tests - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)

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    Report

  • 180 Pages
  • June 2026
  • Region: Canada, United States
  • Mordor Intelligence
  • ID: 6254594
The united states and canada skin cancer dermatology tests market size was valued at USD 3.58 billion in 2025 and is estimated to grow from USD 3.77 billion in 2026 to reach USD 4.86 billion by 2031, at a CAGR of 5.25% during the forecast period (2026-2031). This report is Segmented by Cancer Type (Melanoma, Non-Melanoma), Test Type (Dermatoscopy, Skin Biopsy, Lymph Node Biopsy, Imaging Tests, Genetic and Molecular Tests), End Use (Hospitals and Clinics, Diagnostic Laboratories, Dermatology Clinics, Ambulatory Surgical Centers), and Country (United States, Canada). The Market Forecasts are Provided in Terms of Value (USD).

United States and Canada Skin Cancer Dermatology Tests Market Trends and Insights

Rising Melanoma Screening Intensity in High-Risk Populations

Melanoma incidence in the United States has been rising at an average of 1.1% per year over 2014-2023, with age-adjusted new case rates near 22.3 per 100,000 and 112,000 new invasive cases projected in 2026, which keeps referral volumes elevated across the United States and Canada skin cancer dermatology tests market. This sustained rise is translating into stronger demand for risk stratification, lesion assessment, and confirmatory testing among people aged 50 and older, outdoor workers, and other groups with high cumulative UV exposure. Another layer of demand is coming from melanoma-in-situ, which reached an estimated 107,240 cases in 2025 and requires differentiation from benign lesions even when it does not follow the same downstream procedural path as invasive disease. In Canada, melanoma accounts for 1 in 24 new cancer diagnoses, and Nova Scotia and Prince Edward Island report incidence levels above the national average, which points to localized areas where screening expansion can lift testing demand faster than the national averageG. The result is a structural increase in specialist referrals that supports multi-year growth in the United States and Canada skin cancer dermatology tests market even before any single platform change is considered.

Faster Adoption of AI-Assisted Dermoscopy and Spectroscopy

The January 2024 FDA clearance of DermaSensor expanded the diagnostic setting for the United States and Canada skin cancer dermatology tests market because the device was cleared for use by primary care physicians to help detect melanoma, basal cell carcinoma, and squamous cell carcinoma. The company’s pivotal study later published in 2025 reported 95.5% sensitivity across skin cancer types and showed that physician cancer prediction accuracy improved by 12.5%, which strengthens the clinical case for front-end triage use. In practice, AI spectroscopy does not remove downstream testing from the skin cancer dermatology tests market because lesions flagged as suspicious still move into biopsy or specialist review, which means the tool can add an upstream triage layer without replacing confirmatory testing. The FDA’s March 2026 reclassification of OYD and ONV device classes from Class III to Class II further changes the economics by replacing the premarket approval route with a 510(k) pathway for eligible products. That policy reset should accelerate launches, widen competition, and reinforce the strong outlook for imaging within the United States and Canada skin cancer dermatology tests market.

High Out-of-Pocket Sensitivity for Advanced Diagnostic Workups

High cost sharing remains a real constraint on the market because complex workups can combine dermoscopy, molecular testing, and confirmatory biopsy for a single suspicious lesion. The American Cancer Society reported that cancer-related out-of-pocket costs in the United States reached USD 16.2 billion in 2025, while total time and financial costs to patients were estimated at USD 21.1 billion, which shows the broader affordability pressure around cancer care decisions. In the United States and Canada skin cancer dermatology tests market, that pressure can cause patients to delay a biopsy even after a suspicious triage result, which directly reduces realized test volumes and slows treatment initiation. The problem is sharper for advanced molecular assays because patient cost sharing can become substantial even when the clinical need is high. This creates a gap between clinical value and completed utilization, especially in older and lower-income patient groups that already carry elevated disease risk.

Other drivers and restraints analyzed in the detailed report include:
  • Expansion of Teledermatology Triage Into Diagnostic Pathways
  • Reimbursement Support for Medically Necessary Diagnostic Workups
  • Limited Reimbursement Clarity for Novel Adjunctive Tests

Segment Analysis

Non-melanoma skin cancer accounted for 71.31% of revenue in 2025 and remained the largest disease segment in the United States and Canada skin cancer dermatology tests market because of the very large annual volume of basal cell carcinoma and squamous cell carcinoma cases. The Skin Cancer Foundation reports 3.6 million annual U.S. basal cell carcinoma diagnoses and 1.8 million squamous cell carcinoma diagnoses, which supports a steady flow of biopsies and histopathology work in dermatology clinics and diagnostic laboratories. This gives non-melanoma disease a stable volume base because the pathway from lesion review to biopsy and pathology remains familiar, repeatable, and widely used across care settings. At the same time, CMS non-coverage for molecular biomarker testing in cutaneous SCC limits how much the non-melanoma segment can lift value per patient despite its dominant role in testing volumes.

Melanoma is the fastest-growing cancer type segment and is projected to advance at a 6.38% CAGR through 2031, which makes it the value-intensive growth engine inside the market size by disease category. The segment is benefiting from broader use of gene expression profiling, stronger policy support for medically necessary melanoma assays, and rising detection of melanoma-in-situ lesions that need better pre-biopsy discrimination from benign lesions. Coverage of melanoma risk stratification testing and the Pigmented Lesion Assay also supports a broader diagnostic mix, since testing can now inform biopsy decisions and downstream management rather than serving only as a post-biopsy add-on. That mix shift explains why melanoma remains smaller in volume but stronger in revenue intensity within the skin cancer dermatology tests market.

Complete Report Scope:

  • By Cancer Type
    • Melanoma
    • Non-Melanoma
  • By Test Type
    • Dermatoscopy
    • Skin Biopsy
    • Lymph Node Biopsy
    • Imaging Tests
    • Genetic and Molecular Tests
  • By End Use
    • Hospitals and Clinics
    • Diagnostic Laboratories
    • Dermatology Clinics
    • Ambulatory Surgical Centers
  • Country
    • United States
    • Canada

List of Companies Covered in this Report:

  • 3Gen
  • Agilent Technologies
  • Canfield Scientific
  • Castle Biosciences, Inc.
  • DermaSensor, Inc.
  • DermTech, Inc.
  • Roche
  • FotoFinder Systems
  • Foundation Medicine, Inc.
  • GE HealthCare Technologies Inc.
  • LabCorp
  • MetaOptima Technology Inc.
  • NeoGenomics Laboratories
  • Quest Diagnostics
  • Siemens Healthineers
  • SkinIO
  • SkinVision B.V.
  • Speclipse, Inc.

Additional Benefits:

  • The market estimate (ME) sheet in Excel format
  • 3 months of analyst support

Table of Contents

1 Introduction
1.1 Study Assumptions & Market Definition
1.2 Scope of the Study
2 Research Methodology3 Executive Summary
4 Market Landscape
4.1 Market Overview
4.2 Market Drivers
4.2.1 Rising Melanoma Screening Intensity in High-Risk Populations
4.2.2 Faster Adoption of AI-Assisted Dermoscopy and Spectroscopy
4.2.3 Expansion of Teledermatology Triage Into Diagnostic Pathways
4.2.4 Reimbursement Support for Medically Necessary Diagnostic Workups
4.2.5 Increased Use of Non-Invasive Pre-Biopsy Assessment Tools
4.2.6 Employer and Payer Focus on Earlier Stage Detection Economics
4.3 Market Restraints
4.3.1 High Out-of-Pocket Sensitivity for Advanced Diagnostic Workups
4.3.2 Variable Clinical Adoption Across Non-Specialist Settings
4.3.3 Limited Reimbursement Clarity for Novel Adjunctive Tests
4.3.4 Workflow Friction From Confirmatory Biopsy Capacity Constraints
4.4 Value Chain Analysis
4.5 Regulatory Landscape
4.6 Technological Outlook
4.7 Porter's Five Forces Analysis
4.7.1 Threat of New Entrants
4.7.2 Bargaining Power of Suppliers
4.7.3 Bargaining Power of Buyers
4.7.4 Threat of Substitutes
4.7.5 Intensity of Competitive Rivalry
5 Market Size & Growth Forecasts (Value, USD)
5.1 By Cancer Type
5.1.1 Melanoma
5.1.2 Non-Melanoma
5.2 By Test Type
5.2.1 Dermatoscopy
5.2.2 Skin Biopsy
5.2.3 Lymph Node Biopsy
5.2.4 Imaging Tests
5.2.5 Genetic and Molecular Tests
5.3 By End Use
5.3.1 Hospitals and Clinics
5.3.2 Diagnostic Laboratories
5.3.3 Dermatology Clinics
5.3.4 Ambulatory Surgical Centers
5.4 Country
5.4.1 United States
5.4.2 Canada
6 Competitive Landscape
6.1 Market Concentration
6.2 Market Share Analysis
6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
6.3.1 3Gen
6.3.2 Agilent Technologies, Inc.
6.3.3 Canfield Scientific, Inc.
6.3.4 Castle Biosciences, Inc.
6.3.5 DermaSensor, Inc.
6.3.6 DermTech, Inc.
6.3.7 F. Hoffmann-La Roche Ltd
6.3.8 FotoFinder Systems GmbH
6.3.9 Foundation Medicine, Inc.
6.3.10 GE HealthCare Technologies Inc.
6.3.11 Laboratory Corporation of America Holdings
6.3.12 MetaOptima Technology Inc.
6.3.13 NeoGenomics Laboratories, Inc.
6.3.14 Quest Diagnostics Incorporated
6.3.15 Siemens Healthineers AG
6.3.16 SkinIO
6.3.17 SkinVision B.V.
6.3.18 Speclipse, Inc.
7 Market Opportunities & Future Outlook
7.1 White-space & unmet-need assessment

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • 3Gen
  • Agilent Technologies, Inc.
  • Canfield Scientific, Inc.
  • Castle Biosciences, Inc.
  • DermaSensor, Inc.
  • DermTech, Inc.
  • F. Hoffmann-La Roche Ltd
  • FotoFinder Systems GmbH
  • Foundation Medicine, Inc.
  • GE HealthCare Technologies Inc.
  • Laboratory Corporation of America Holdings
  • MetaOptima Technology Inc.
  • NeoGenomics Laboratories, Inc.
  • Quest Diagnostics Incorporated
  • Siemens Healthineers AG
  • SkinIO
  • SkinVision B.V.
  • Speclipse, Inc.