미국의 악성 흑색종 진단 및 치료제 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the United States melanoma diagnostics and Therapeutics Market size was valued at USD 3.45 billion in 2025 and is estimated to grow from USD 3.75 billion in 2026 to reach USD 5.68 billion by 2031, at a CAGR of 8.66% during the forecast period (2026-2031).

This report is Segmented by Product Type (Diagnostics [Dermatoscopy Devices and More], Therapeutics [Chemotherapy and More]), Stage of Disease (Localized, Regional, Distant), Patient Age Group (18-44 Years, 45-64 Years, 65 Years and Above), and End User (Hospitals and Clinics, Cancer Specialty Centers, and More). The Market Forecasts are Provided in Terms of Value (USD).

United States Melanoma Diagnostics and Therapeutics Market Trends and Insights

Adoption of Immunotherapy and Targeted Therapy

The United States Melanoma Diagnostics and Therapeutics Market is being shaped by deeper use of checkpoint inhibitors and targeted therapy combinations across advanced and adjuvant care settings. The FDA approval of nivolumab and hyaluronidase-nvhy in December 2024 added a subcutaneous option that reduces infusion dependence and supports more outpatient administration. BRAF and MEK inhibitor combinations remain important for mutation-positive patients and continue to support targeted use alongside broader PD-1-based therapy pathways. As survival lengthens, a larger chronic-treatment cohort remains in care longer, which increases repeat prescribing, monitoring, and specialist center activity.

Expansion of Molecular and AI-Assisted Diagnostic Workflows

The United States Melanoma Diagnostics and Therapeutics Market is also advancing because diagnostic workflows are becoming more accurate and more scalable. A 2025 study in Nature Communications found that explainable AI improved dermatologist balanced diagnostic accuracy to 82.7% from 79.9% with standard AI, with performance gains seen across experience levels. A separate 2025 Nature Medicine study reported that the PanDerm model outperformed 12 clinicians in early-stage melanoma detection by 10.2% and identified 77.5% of melanomas at first imaging compared with 32.6% for clinicians without AI support. Molecular monitoring is also improving because tumour-informed ctDNA approaches are showing reliable value in predicting immune checkpoint inhibitor response and spotting relapse earlier in advanced disease. These workflow gains raise confirmed biopsy and staging volumes because more clinically uncertain lesions move into formal diagnostic review before treatment decisions are made.

High Total Cost of Advanced Therapy Courses

The United States Melanoma Diagnostics and Therapeutics Market still faces a clear growth limit from the cost of advanced oncology care. A 2024 JMCP study reported that total direct melanoma care expenditure in the United States reached USD 13.55 billion annually, which shows how large the spending base already is before wider use of newer modalities. The same study found that prescription medicines represented 18.27% of per-patient costs, and that share is likely to rise as biologics and cellular therapies move further into care pathways. Broader U.S. anticancer therapy spending was USD 99 billion in 2023 and is projected to reach USD 180 billion by 2028, which keeps payer pressure high across oncology formularies. The Medicare Part D out-of-pocket cap of USD 2,000 helps patient affordability from 2025 onward, but it does not remove the budget pressure hospitals and payers face when high-cost biologics and cellular therapies scale further.

Other drivers and restraints analyzed in the detailed report include:

1. Regulatory Momentum for Novel Oncology Modalities
2. Rising Melanoma Incidence and Earlier Case Identification
3. Prior Authorization and Reimbursement Friction

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Therapeutics accounted for 75.31% of the United States Melanoma Diagnostics and Therapeutics market size in 2025, which kept this category well ahead of diagnostics in revenue terms. That lead reflects the higher pricing of checkpoint inhibitors and BRAF and MEK combination regimens compared with diagnostic procedures and devices. Immunotherapy remained the largest therapeutic contributor because PD-1 based regimens continue to define standard care across multiple melanoma settings. Targeted therapy also holds an important role because BRAF V600 mutations are present in a large share of advanced cutaneous melanoma cases, which sustains demand for mutation-linked treatment pathways. The therapeutics side of the United States Melanoma Diagnostics and Therapeutics industry is projected to advance at a 9.38% CAGR through 2031 as the treated pool broadens and cell therapy adds another option for advanced disease.

Diagnostics represented the remaining revenue base and are rising with the spread of AI-supported lesion evaluation and more frequent molecular follow-up. Dermoscopy remains the primary front-end tool because it fits routine dermatology workflows and supports early lesion triage before biopsy confirmation. AI-enhanced systems now have stronger clinical backing, with PanDerm and explainable AI studies showing measurable gains in early-stage melanoma detection and balanced diagnostic accuracy. Biopsy devices and liquid biopsy tools are also gaining importance because more suspicious lesions and more advanced-stage patients are moving into formal confirmation, molecular staging, and treatment-response monitoring pathways.

Localized melanoma accounted for 48.24% of revenue in 2025, and that made it the largest stage segment in the United States Melanoma Diagnostics and Therapeutics Market. This position aligns with SEER data showing that 77% of diagnosed melanoma cases are localized and that the 5-year survival rate for localized disease is 100%. High localized case volumes support steady demand for skin examination, dermoscopy, excision, pathology review, and selected adjuvant management after surgery. Regional-stage disease also contributes meaningful treatment value because adjuvant PD-1 therapy and combination regimens are active in resected higher-risk disease. Published RELATIVITY-098 results further support ongoing use of nivolumab plus relatlimab in the adjuvant setting for resected Stage III and IV melanoma.

Distant-stage disease is projected to grow at a 10.52% CAGR through 2031, which makes it the fastest-rising stage segment in the United States Melanoma Diagnostics and Therapeutics Market. Growth at this stage is being supported by a steady flow of higher-intensity regimens, longer follow-up windows, and the addition of cellular therapy after prior lines of care. The FDA approval of lifileucel in 2024 expanded treatment options for unresectable or metastatic melanoma and added a new revenue stream tied to complex specialist delivery.

Complete Report Scope:

• By Product Type
  • Diagnostics
    • Dermatoscopy Devices
    • Biopsy Devices
    • Other Diagnostics
  • Therapeutics
    • Chemotherapy
    • Targeted Therapy
    • Immunotherapy
    • Other Therapeutics
• By Stage of Disease
  • Localized
  • Regional
  • Distant
• By Patient Age Group
  • 18 to 44 Years
  • 45 to 64 Years
  • 65 Years and Above
• By End User
  • Hospitals and Clinics
  • Cancer Specialty Centers
  • Ambulatory Surgical Centers
  • Other End Users

List of Companies Covered in this Report:

1. Abbvie
2. Amgen
3. AstraZeneca
4. Bristol-Myers Squibb
5. DermTech, Inc.
6. Eli Lilly and Company
7. Roche
8. Genentech
9. GlaxoSmithKline
10. Guardant Health, Inc.
11. Incyte
12. Iovance Biotherapeutics
13. Merck
14. Natera, Inc.
15. Novartis
16. Pfizer
17. Quest Diagnostics
18. Regeneron Pharmaceuticals

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 Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Melanoma Incidence and Earlier Case Identification
  • 4.2.2 Adoption of Immunotherapy and Targeted Therapy
  • 4.2.3 Expansion of Molecular and AI-Assisted Diagnostic Workflows
  • 4.2.4 Regulatory Momentum for Novel Oncology Modalities
  • 4.2.5 Decentralized Biopsy and Laboratory Testing Pathways
• 4.3 Market Restraints
  • 4.3.1 High Total Cost of Advanced Therapy Courses
  • 4.3.2 Prior Authorization and Reimbursement Friction
  • 4.3.3 Toxicity Monitoring and Treatment Discontinuation Risk
• 4.4 Supply Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Bargaining Power of Suppliers
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Threat of New Entrants
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Industry Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product Type
  • 5.1.1 Diagnostics
    • 5.1.1.1 Dermatoscopy Devices
    • 5.1.1.2 Biopsy Devices
    • 5.1.1.3 Other Diagnostics
  • 5.1.2 Therapeutics
    • 5.1.2.1 Chemotherapy
    • 5.1.2.2 Targeted Therapy
    • 5.1.2.3 Immunotherapy
    • 5.1.2.4 Other Therapeutics
• 5.2 By Stage of Disease
  • 5.2.1 Localized
  • 5.2.2 Regional
  • 5.2.3 Distant
• 5.3 By Patient Age Group
  • 5.3.1 18 to 44 Years
  • 5.3.2 45 to 64 Years
  • 5.3.3 65 Years and Above
• 5.4 By End User
  • 5.4.1 Hospitals and Clinics
  • 5.4.2 Cancer Specialty Centers
  • 5.4.3 Ambulatory Surgical Centers
  • 5.4.4 Other End Users

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 AbbVie Inc.
  • 6.3.2 Amgen Inc.
  • 6.3.3 AstraZeneca PLC
  • 6.3.4 Bristol-Myers Squibb Company
  • 6.3.5 DermTech, Inc.
  • 6.3.6 Eli Lilly and Company
  • 6.3.7 F. Hoffmann-La Roche Ltd.
  • 6.3.8 Genentech, Inc.
  • 6.3.9 GSK plc
  • 6.3.10 Guardant Health, Inc.
  • 6.3.11 Incyte Corporation
  • 6.3.12 Iovance Biotherapeutics
  • 6.3.13 Merck & Co., Inc.
  • 6.3.14 Natera, Inc.
  • 6.3.15 Novartis AG
  • 6.3.16 Pfizer Inc.
  • 6.3.17 Quest Diagnostics Incorporated
  • 6.3.18 Regeneron Pharmaceuticals, Inc.

7 Market Opportunities & Future Outlook

• 7.1 White-Space and Unmet-Need Assessment