피부 생검 기기 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the skin biopsy devices market size is expected to increase from USD 2.81 billion in 2025 to USD 2.99 billion in 2026 and reach USD 4.10 billion by 2031, growing at a CAGR of 6.52% over 2026-2031.

This report is Segmented by Type (Shave, Punch, Excisional, Incisional, Needle), Device (Punches, Needles, Forceps, Guidance Systems, Biopsy Guns, Accessories), Indication (Skin Cancer, Actinic Keratosis, Dermatitis, Psoriasis, Infection), End User (Hospitals, Dermatology Clinics, Diagnostic Labs, Ascs), and Geography (North America, Europe, Asia-Pacific, and More). Forecasts in Terms of Value (USD).

Global Skin Biopsy Devices Market Trends and Insights

Rising Skin Cancer And Melanoma Burden

Escalating melanoma incidence remains the most durable structural support for the skin biopsy devices market. GLOBOCAN 2024 estimated 337,969 new melanoma cases worldwide and 58,398 deaths, with Europe alone accounting for 150,781 cases, or 44.6% of global incidence. IARC also reported in May 2025 that more than 80% of global melanoma cases were attributable to ultraviolet radiation exposure, which makes future case generation more predictable across aging and outdoor-exposed populations. The WHO Global Status Report on Cancer 2026 said rising case volumes are outpacing diagnostic capacity in many health systems, which strengthens the role of biopsy-based confirmation when imaging alone cannot close the diagnostic gap. This keeps biopsy tools positioned as core clinical instruments rather than optional upgrades within the skin biopsy devices market. It also means that demand is being supported by disease burden itself, not only by technology adoption or procurement cycles.

Shift Toward Minimally Invasive Dermatology Diagnostics

Patient preference and clinic economics are both moving procedures toward smaller-footprint biopsy techniques in the skin biopsy devices market. A 2025 review in Frontiers in Medicine noted that punch and needle methods reduce anesthesia needs, limit wound area, and allow multi-site sampling during a single outpatient visit, which supports higher per-encounter device use. A 2025 study in the Egyptian Journal of Medicine found that 2.5 mm punch biopsies still produced diagnostically sufficient tissue while reducing patient discomfort compared with larger punches. The April 2026 launch of the Harpera microbiopsy punch showed how the design frontier is moving toward sub-millimeter sampling that avoids sutures and shortens recovery time. Smaller instruments also create a recurring demand stream for accessories and consumables, which adds another layer of support to the skin biopsy devices market. A relatively accessible 510(k) pathway for biopsy instruments further helps companies bring iterative design improvements to market faster than they could through a more novel regulatory route.

High Procedure And Post-Procedure Cost Burden

Procedure affordability remains a meaningful constraint on procedure conversion in the skin biopsy devices market. The cost of a single biopsy encounter often exceeds USD 400 once pathology charges are added, and pathology under CPT 88305 averaged USD 182, which means multi-lesion visits can quickly produce several separate charges. A 2024 Journal of the American Academy of Dermatology analysis found reimbursement pressure on pathology costs while patient out-of-pocket burden moved in the opposite direction, which reinforces the strain on cost-sensitive settings. In South America and parts of Southeast Asia, out-of-pocket payment still acts as a direct access barrier, which suppresses actual utilization even when clinical need is present. Capital spending friction adds another layer, because health systems under budget pressure often favor consumable restocking over higher-cost guidance systems or digital pathology platforms. This makes the skin biopsy devices market more volume-sensitive in lower-income settings and more exposed to payer policy changes in developed ones.

Other drivers and restraints analyzed in the detailed report include:

1. AI-Assisted Pathology And Digital Slide Review Adoption
2. Rising Ambulatory Dermatology And Outpatient Biopsy Volumes
3. Limited Specialist Capacity For Biopsy And Histopathology

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

Segment Analysis

Punch biopsy accounted for 34.31% of the skin biopsy devices market size in 2025, which made it the leading procedure type in the skin biopsy devices market. Its position reflects broad clinical use across inflammatory dermatoses, non-melanoma skin cancers, and uncertain lesions that require full-thickness sampling. The technique captures epidermis, dermis, and superficial subcutis in a single pass, which keeps it clinically useful when lesion architecture matters to diagnosis. That practical versatility supports repeat use across both routine dermatology visits and more suspicious lesion workups.

Needle biopsy is the fastest-growing type, with skin biopsy devices market size for this category projected to expand at a 10.38% CAGR through 2031. Growth is tied to maturing ultrasound guidance that helps clinicians reach deeper skin and subcutaneous lesions without relying on hospital-grade imaging infrastructure. The 2025 IEEE EMBC publication on an automatic punch biopsy device with simultaneous wound closure also showed that procedure automation is moving forward within the skin biopsy devices industry, especially in areas where ease of use and faster turnover matter. Shave biopsy remains useful for superficial lesions, but it faces pressure as clinicians increasingly favor full-thickness sampling for more definitive histopathology. Excisional and incisional biopsy will continue to serve specific roles for small suspicious lesions and larger lesions, and their mix will remain closely linked to melanoma staging and procedural reimbursement.

Biopsy punches and curettes represented 33.44% of 2025 value, which kept them at the core of the skin biopsy devices market because they are familiar, low-cost, and used in large disposable volumes. Their demand base remains durable because they fit routine clinic workflows and do not depend on capital budgets or specialized training in the same way as advanced platforms. This part of the skin biopsy devices market also benefits from regular replenishment cycles, which gives distributors and manufacturers a steady revenue stream. As a result, even when attention shifts to innovation, the underlying unit demand for simple instruments remains firm.

Guidance systems are the fastest-growing device category at a 9.52% CAGR through 2031, reflecting the move toward image-confirmed and operator-supportive procedures in the skin biopsy devices market. High-frequency ultrasound above 20 MHz is increasingly used for skin evaluation, and published work in 2025 reinforced its value in dermatologic surgery and lesion characterization. A 2026 Ultrasonography study described the HUMaN handheld ultrasound system with magnetic needle navigation and sub-millimeter mean accuracy, which points to more point-of-care guidance options as the skin biopsy devices market evolves. Better guidance reduces operator variability and improves specimen adequacy, which matters when clinics want more reliable sampling without adding major workflow complexity. Accessories and consumables linked to specimen handling also remain attractive, because traceability and workflow documentation are becoming more important across the skin biopsy devices industry.

Complete Report Scope:

• By Type
  • Shave Biopsy
  • Punch Biopsy
  • Excisional Biopsy
  • Incisional Biopsy
  • Needle Biopsy
• By Device
  • Biopsy Punches and Curettes
  • Biopsy Needles
  • Biopsy Forceps
  • Guidance Systems
  • Needle-Based Biopsy Guns
  • Biopsy Accessories and Consumables
• By Indication
  • Skin Cancer
  • Actinic Keratosis
  • Dermatitis
  • Psoriasis
  • Skin Infection
  • Other Indications
• By End User
  • Hospitals
  • Dermatology Clinics
  • Diagnostic Laboratories
  • Ambulatory Surgical Centers
  • Other End Users
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 38.61% of the skin biopsy devices market share in 2025, which made it the largest regional contributor to the skin biopsy devices market. The region benefits from established reimbursement structures, a dense ambulatory surgical center network, and a very high burden of skin cancer diagnosis. CMS set the 2026 payment rate for ambulatory surgical center procedures at USD 750.50, which supports continued procedural economics and device procurement in outpatient settings. The U.S. FDA also reclassified optical diagnostic devices for melanoma from Class III to Class II under special controls in April 2026, which opens a more practical 510(k) pathway for adjunctive tools that will still rely on confirmatory biopsy. Canada adds stability through coverage for medically necessary biopsy procedures, while Mexico is expanding the role of private dermatology channels.

Europe remains the second-largest regional block in the skin biopsy devices market and carries the highest share of global melanoma incidence. GLOBOCAN 2024 showed that Europe accounted for 150,781 new melanoma cases, equal to 44.6% of global incidence. This high disease burden supports demand across Germany, the United Kingdom, France, Italy, and Spain, while teledermatology policy support in markets such as Ireland can improve how cases move into biopsy pathways. At the same time, tighter medical device compliance processes favor larger firms with stronger regulatory capacity and make market access harder for smaller specialists.

Asia-Pacific is the fastest-growing regional cluster, with skin biopsy devices market size projected to expand at a 10.65% CAGR through 2031. The region is being driven by China, India, Australia, Japan, and South Korea, although each country is scaling dermatology capacity through a different mix of public hospitals, private care, and specialty services. Australia's high melanoma exposure profile supports consistent biopsy demand, while China is seeing a broader set of specimen collection points beyond traditional public hospitals. The Middle East and Africa remain smaller in absolute size, but GCC healthcare expansion is steadily adding outpatient dermatology capacity. South America is being led by Brazil and Argentina, where delayed diagnosis still leaves room for stronger early detection and tissue confirmation pathways.

1. AccuTec, Inc.
2. Beckton Dickinson
3. Boston Scientific
4. Cardinal Health
5. Conmed
6. Cook Group
7. Danaher
8. DTR Medical Ltd
9. Gallini Srl
10. Innovia Medical
11. Integra LifeSciences
12. KAI Group
13. Danaher
14. Medline Industries
15. Merit Medical Systems
16. Olympus
17. Sklar Instruments

Additional Benefits:

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

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions and 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 Skin Cancer and Melanoma Burden
  • 4.2.2 Shift Toward Minimally Invasive Dermatology Diagnostics
  • 4.2.3 AI-Assisted Pathology and Digital Slide Review Adoption
  • 4.2.4 Rising Ambulatory Dermatology and Outpatient Biopsy Volumes
  • 4.2.5 Teledermatology-Enabled Biopsy Triage and Referral Capture
• 4.3 Market Restraints
  • 4.3.1 High Procedure and Post-Procedure Cost Burden
  • 4.3.2 Limited Specialist Capacity for Biopsy and Histopathology
  • 4.3.3 Variable Reimbursement and Device Procurement Friction
• 4.4 Supply 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 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Type
  • 5.1.1 Shave Biopsy
  • 5.1.2 Punch Biopsy
  • 5.1.3 Excisional Biopsy
  • 5.1.4 Incisional Biopsy
  • 5.1.5 Needle Biopsy
• 5.2 By Device
  • 5.2.1 Biopsy Punches and Curettes
  • 5.2.2 Biopsy Needles
  • 5.2.3 Biopsy Forceps
  • 5.2.4 Guidance Systems
  • 5.2.5 Needle-Based Biopsy Guns
  • 5.2.6 Biopsy Accessories and Consumables
• 5.3 By Indication
  • 5.3.1 Skin Cancer
  • 5.3.2 Actinic Keratosis
  • 5.3.3 Dermatitis
  • 5.3.4 Psoriasis
  • 5.3.5 Skin Infection
  • 5.3.6 Other Indications
• 5.4 By End User
  • 5.4.1 Hospitals
  • 5.4.2 Dermatology Clinics
  • 5.4.3 Diagnostic Laboratories
  • 5.4.4 Ambulatory Surgical Centers
  • 5.4.5 Other End Users
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

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 AccuTec, Inc.
  • 6.3.2 Becton, Dickinson and Company
  • 6.3.3 Boston Scientific Corporation
  • 6.3.4 Cardinal Health, Inc.
  • 6.3.5 ConMed Corporation
  • 6.3.6 Cook Medical LLC
  • 6.3.7 Danaher Corporation
  • 6.3.8 DTR Medical Ltd
  • 6.3.9 Gallini Srl
  • 6.3.10 Innovia Medical
  • 6.3.11 Integra LifeSciences Holdings Corporation
  • 6.3.12 KAI Group
  • 6.3.13 Leica Biosystems Nussloch GmbH
  • 6.3.14 Medline Industries, LP
  • 6.3.15 Merit Medical Systems, Inc.
  • 6.3.16 Olympus Corporation
  • 6.3.17 Sklar Instruments

7 Market Opportunities and Future Outlook

• 7.1 White-Space and Unmet-Need Assessment