해부 병리학 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the anatomic pathology market size is expected to grow from USD 38.34 billion in 2025 to USD 41.27 billion in 2026 and is forecast to reach USD 59.63 billion by 2031 at 7.65% CAGR over 2026-2031.

This report is Segmented by Product & Services (Instruments, Consumables, and Services), Application (Disease Diagnosis, Drug Discovery & Development, and Other Applications), End User (Hospitals, Diagnostic Laboratories, and More), Geography (North America, Europe, Asia-Pacific, The Middle East and Africa, and South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Anatomic Pathology Market Trends and Insights

Rising Burden of Cancer and Chronic Diseases

Global cancer cases reached 20 million in 2022, with lung cancer alone contributing 2.5 million diagnoses. The American Cancer Society forecasts more than 2 million new US diagnoses and 618,000 deaths in 2025, keeping specimen volumes on an upward curve. Aging populations in developed economies and lifestyle shifts in emerging regions add parallel growth, while screening programs highlight the economic payoff of early detection. These trends drive sustained demand across histology, cytology, and molecular sub-specialties, cementing the anatomic pathology market as an indispensable pillar of oncology care.

Growing Adoption of Precision and Personalized Medicine

Companion diagnostics now sit at the core of many oncology drug launches. In April 2025, Roche received breakthrough device designation for its AI-enabled TROP2 test that guides treatment of non-small-cell lung cancer and unites immunohistochemistry with digital algorithms. The Human Proteome Project confirms identification of 93% of predicted human proteins, broadening the biomarker pool for future assays. Liquid biopsy platforms, including circulating DNA fragmentomics, add non-invasive options with detection limits below 0.32 copies/µL for HPV-driven cancers. Laboratories therefore invest in multiplex staining, next-generation sequencing, and image analysis software to secure this medicine-first revenue stream.

Stringent Regulatory and Accreditation Requirements

The FDA final rule on laboratory-developed tests, effective July 2024, ends decades of enforcement discretion and forces thousands of assays into the medical-device pathway with design control, adverse event reporting, and premarket review obligations. Quality System Regulation revisions harmonize with ISO 13485, requiring broad documentation updates and audits. In Europe, digital pathology guidance from professional societies demands standardized validation and sustainability, adding compliance expense while improving cross-border consistency. US payers simultaneously narrow networks and reduce reimbursement, compounding pressure on smaller labs.

Other drivers and restraints analyzed in the detailed report include:

1. Continuous Technological Advancements in Pathology Instruments and Automation
2. Increasing Integration of Digital Pathology and Artificial Intelligence
3. Shortage of Skilled Pathologists and Histotechnologists

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

Segment Analysis

Consumables held 46.54% revenue in 2025 because every tissue block requires reagents, stains, and slides. Rising test complexity boosts premium antibody and molecular kit demand, supporting steady incremental growth. Services post the fastest 10.25% CAGR to 2031 as outsourcing gains traction and specialized molecular assays exceed in-house bandwidth. Instruments move in step with lab expansions, with digital scanners and automated stainers mitigating staff gaps and lifting standardization. Quest Diagnostics notes that upfront digital readouts prevent diagnostic delay and improve inter-pathologist collaboration, highlighting efficiency gains.

The anatomic pathology market size for consumables is projected to reach USD 27.59 billion in 2031, equal to 46.27% of total value. In contrast, services are anticipated to account for 34.20% of the anatomic pathology market size at the end of the forecast horizon due to sustained double-digit growth. Consumable suppliers therefore pursue reagent-lease models, guaranteeing recurring revenue while easing customer capital strain.

Geography Analysis

North America commanded 41.12% revenue in 2025 owing to high cancer screening rates, established reimbursement, and early digital adoption. US healthcare spending surpasses USD 4 trillion, and pathology influences two-thirds of clinical decisions, solidifying service demand. Workforce programs from the American Society for Clinical Pathology focus on scholarship funding and reimbursement advocacy, though vacancies remain in double digits.

Asia-Pacific delivers the fastest 9.31% CAGR through 2031. China's healthcare outlays reached 8.53 trillion yuan in 2022 and may pass 20 trillion yuan by 2030, boosting laboratory build-outs across provincial centers. Japan embeds AI imaging within routine pathology workflows to cut manual fatigue, and India's diagnostic chains expand into tier-4 towns to capture preventive testing demand. Telepathology pilots link remote hospitals to central labs, improving access without duplicating infrastructure.

Europe shows steady uptake as digital slide standards and quality frameworks gain momentum under the European Society of Pathology. Only 3% of UK departments report full staffing, creating urgency for automated coverslippers and AI triage tools. Middle East & Africa and South America lag on large instrument investment, yet mobile slide scanners and cloud portals are spreading, enabling gradual participation in the anatomic pathology market.

1. Roche
2. Danaher (Leica Biosystems)
3. Thermo Fisher Scientific
4. Agilent Technologies
5. Sakura Finetek
6. Quest Diagnostics
7. LabCorp
8. NeoGenomics
9. Cardinal Health
10. BioGenex
11. Bio SB
12. 3DHISTECH
13. Koninklijke Philips
14. Ventana Medical Systems
15. Indica Labs
16. Hologic (Biocare)
17. Sysmex
18. PerkinElmer
19. OptraSCAN
20. Hamamatsu Photonics
21. Microsoft (GigaPath)

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 Burden of Cancer and Chronic Diseases
  • 4.2.2 Growing Adoption of Precision and Personalized Medicine
  • 4.2.3 Continuous Technological Advancements in Pathology Instruments And Automation
  • 4.2.4 Increasing Integration of Digital Pathology and Artificial Intelligence
  • 4.2.5 Expansion of Molecular and Spatial Omics in Routine Histopathology
  • 4.2.6 Emergence of Telepathology Networks in Resource-Limited Settings
• 4.3 Market Restraints
  • 4.3.1 Stringent Regulatory and Accreditation Requirements
  • 4.3.2 Shortage of Skilled Pathologists and Histotechnologists
  • 4.3.3 High Capital and Operating Costs of Advanced Systems
  • 4.3.4 Lack of Standardized Data Formats and Interoperability
• 4.4 Regulatory Landscape
• 4.5 Porter's Five Forces
  • 4.5.1 Threat Of New Entrants
  • 4.5.2 Bargaining Power Of Buyers
  • 4.5.3 Bargaining Power Of Suppliers
  • 4.5.4 Threat Of Substitute Products
  • 4.5.5 Intensity Of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product & Services
  • 5.1.1 Instruments
  • 5.1.2 Consumables
  • 5.1.3 Services
• 5.2 By Application
  • 5.2.1 Disease Diagnosis
    • 5.2.1.1 Cancer
    • 5.2.1.2 Infectious Diseases
    • 5.2.1.3 Other Conditions
  • 5.2.2 Drug Discovery & Development
    • 5.2.2.1 Pre-Clinical Toxicology
    • 5.2.2.2 Companion Diagnostics
    • 5.2.2.3 Biomarker Validation
  • 5.2.3 Other Applications
• 5.3 By End User
  • 5.3.1 Hospitals
  • 5.3.2 Diagnostic Laboratories
  • 5.3.3 Research Laboratories
  • 5.3.4 Other End Users
• 5.4 Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East & Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East & Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 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 Business Segments, Financials, Headcount, Key Information, Market Rank, Market Share, Products and Services, and analysis of Recent Developments)
  • 6.3.1 F. Hoffmann-La Roche
  • 6.3.2 Danaher (Leica Biosystems)
  • 6.3.3 Thermo Fisher Scientific, Inc.
  • 6.3.4 Agilent Technologies, Inc.
  • 6.3.5 Sakura Finetek
  • 6.3.6 Quest Diagnostics Incorporated
  • 6.3.7 Laboratory Corporation of America Holdings
  • 6.3.8 NeoGenomics
  • 6.3.9 Cardinal Health
  • 6.3.10 BioGenex
  • 6.3.11 Bio SB
  • 6.3.12 3DHISTECH
  • 6.3.13 Philips Healthcare
  • 6.3.14 Ventana Medical Systems
  • 6.3.15 Indica Labs
  • 6.3.16 Hologic (Biocare)
  • 6.3.17 Sysmex
  • 6.3.18 PerkinElmer
  • 6.3.19 OptraSCAN
  • 6.3.20 Hamamatsu Photonics
  • 6.3.21 Microsoft (GigaPath)

7 Market Opportunities & Future Outlook

• 7.1 White-Space & Unmet-Need Assessment