병리학 전망 : 자동화 플랫폼, 디지털 이미징 및 시장 역학( 제3판)

Pathology remains fundamental to modern clinical diagnostics, supplying the cellular, tissue, and organ level insights that guide disease detection, treatment selection, and patient management. As healthcare becomes more data driven and personalized, the value of pathology continues to increase. Advances in imaging, staining, and molecular techniques have improved understanding of how structural changes in tissues relate to disease progression, while rising testing volumes and workforce shortages are prompting laboratories to reassess how they operate. The Future of Pathology: Automated Platforms, Digital Imaging, and Market Dynamics, 3rd Edition by Kalorama Information covers these market trends and more with estimates and forecasts spanning 2025-2030.

A Market Shaped by Technology, Workflows, and Precision Medicine

The field is evolving toward solutions that strengthen diagnostic accuracy, improve reproducibility, and streamline operations. Several forces are driving this shift:

• Growing need for standardized, high volume pathology workflows
• Rising importance of oncology and precision medicine applications
• Expanding use of tissue based biomarker analysis and multiplex assays
• Movement toward quantitative and data rich interpretation of disease
• Increasing integration of pathology findings into broader clinical systems

As a result, digital pathology, automated staining platforms, and artificial intelligence enabled image analytics are gaining traction across laboratories of all sizes. These innovations allow faster turnaround, expanded testing capacity, and more consistent interpretation of complex specimens. They also strengthen the link between anatomic pathology and in vitro diagnostics, enabling deeper incorporation of pathology data into cancer care pathways.

Scope of the Report

This Kalorama Information report provides a comprehensive analysis of the global pathology market across eight major segments:

• Traditional non PAP stains
• PAP tests
• In situ hybridization
• Immunohistochemistry
• HPV testing
• Circulating tumor cells
• Flow cytometry
• Digital pathology

Market estimates are provided at the manufacturer level for 2025 and 2030, including compound annual growth rates. Competitive analysis is included for 2025, along with regional assessments covering North America, Europe, Asia Pacific, and the Rest of the World. Estimates and forecasts were developed through extensive primary and secondary research including interviews with industry experts, company personnel, healthcare providers, and government officials.

A Market Positioned for Significant Growth

Despite its long history, pathology remains a dynamic market with substantial potential. Innovations in multiplexing, automation, and digital analysis are expanding diagnostic capability, improving workflow efficiency, and opening opportunities for deeper clinical integration. With continued technological progress and global expansion, the pathology market is poised for ongoing evolution through 2030 and beyond.

TABLE OF CONTENTS

CHAPTER 1: EXECUTIVE SUMMARY

• ABOUT KALORAMA INFORMATION
• INDUSTRY AT A GLANCE
• SCOPE AND METHODOLOGY
• SIZE AND GROWTH OF THE MARKET
  • Figure 1-1: Global Pathology IVD Market, 2025-2030 ($ million)
• COMPETITIVE OUTLOOK

CHAPTER 2: MARKET OVERVIEW

• OVERVIEW OF IVD PATHOLOGY
  • Histology
  • Cytology
  • Digital Pathology
• PATHOLOGY AND CANCER
• ADVANCED ANALYSIS SOLUTIONS
  • Table 2-1: Selected Advanced Pathology Techniques
• LABORATORY DEVELOPED TESTS
  • Laboratory Developed Tests in Pathology
• AI AND PATHOLOGY

CHAPTER 3: PAP TESTS: MARKET SIZE AND GROWTH

• OVERVIEW
  • Table 3-1: Primary and Secondary Prevention of Cervical Cancer, Screening Responses by Country, 2022
• MARKET SUMMARY
  • Table 3-2: Global PAP Test Market Trend, 2020, 2025, 2030 ($ million)
  • Figure 3-1: Global PAP Test Market Trend, 2020, 2025, 2030 ($ million)
  • Regional Market Overview
    • Table 3-3: Global PAP Test Market, by Region, 2025-2030 ($ million) [Asia Pacific, Europe, North America, ROW]
    • Figure 3-2: Global PAP Test Market, by Region, 2025-2030 ($ million) [Asia Pacific, Europe, North America, RoW]

CHAPTER 4: IN SITU HYBRIDIZATION: MARKET SIZE AND GROWTH

• OVERVIEW
  • Figure 4-1: In Situ Hybridization Indication Distribution, 2025 (%) [Oncology, Other]
  • Table 4-1: Selected in Situ Hybridization-based Tests
• MARKET SUMMARY
  • Table 4-2: Global In Situ Hybridization Test Market Trend, 2020, 2025, 2030 ($ million)
  • Figure 4-2: Global In Situ Hybridization Test Market Trend, 2020, 2025, 2030 ($ million)
  • Regional Market Overview
    • Table 4-3: Global In Situ Hybridization IVD Test Market, by Region, 2025-2030 ($ million) [Asia Pacific, Europe, North America, RoW]
    • Figure 4-3: Global In Situ Hybridization IVD Test Market, by Region, 2025-2030 [Asia Pacific, Europe, North America, RoW]

CHAPTER 5: IMMUNOHISTOCHEMISTRY: MARKET SIZE AND GROWTH

• OVERVIEW
  • Figure 5-1: Immunohistochemistry Distribution, by Product Type, 2025 (%) [Equipment & Instruments, Reagents]
  • Table 5-1: Selected IHC Test Innovations
• MARKET SUMMARY
  • Table 5-2: Global Immunohistochemistry Test Market Trend, 2020, 2025, 2030 ($ million)
  • Figure 5-2: Global Immunohistochemistry Test Market Trend, 2020, 2025, 2030 ($ million)
  • Regional Market Overview
    • Table 5-3: Global Immunohistochemistry Test Market, by Region, 2025-2030 ($ million) [Asia Pacific, Europe, North America, RoW]
    • Figure 5-3: Global Immunohistochemistry Test Market, by Region, 2025-2030 ($ million) [Asia Pacific, Europe, North America, RoW]

CHAPTER 6: HUMAN PAPILLOMAVIRUS (HPV): MARKET SIZE AND GROWTH

• OVERVIEW
  • Figure 6-1: HPV Screening Market: HPV DNA/RNA and Pap Test Distribution of Sales, 2025 (%)
  • Table 6-1: Selected HPV Test Innovations
• MARKET SUMMARY
  • Table 6-2: Global HPV (DNA/RNA) Test Market Trend, 2020, 2025, 2030 ($ million)
  • Figure 6-2: Global HPV (DNA/RNA) Test Market Trend, 2020, 2025, 2030 ($ million)
  • Regional Market Overview
    • Table 6-3: Global HPV (DNA/RNA) Test Market, by Region, 2025-2030 ($ million) [Asia Pacific, Europe, North America, RoW]
    • Figure 6-3: Global HPV (DNA/RNA) Test Market, by Region, 2025-2030 ($ million) [Asia Pacific, Europe, North America, RoW]

CHAPTER 7: CIRCULATING TUMOR CELLS (CTCS): MARKET SIZE AND GROWTH

• OVERVIEW
  • Table 7-1: Selected CTC Test Innovations
• MARKET SUMMARY
  • Figure 7-1: Circulating Tumor Cells (CTCs) Distribution, by Product Type, 2025 (%) [Consumables/Reagents, Equipment and Instruments]
  • Table 7-2: Global Circulating Tumor Cells (CTCs) Test Market Trend, 2020, 2025, 2030 ($ million)
  • Figure 7-2: Global Circulating Tumor Cells (CTCs) Test Market Trend, 2020, 2025, 2030 ($ million)
  • Regional Market Overview
    • Table 7-3: Global Circulating Tumor Cells (CTCs) IVD Test Market, by Region, 2025-2030 ($ million) [Asia Pacific, Europe, North America, RoW]
    • Figure 7-3: Global Circulating Tumor Cells (CTCs) Test Market, by Region, 2025-2030 ($ million) [Asia Pacific, Europe, North America, RoW]

CHAPTER 8: FLOW CYTOMETRY: MARKET SIZE AND GROWTH

• OVERVIEW
  • Table 8-1: Selected Flow Cytometry Innovations
• MARKET OVERVIEW
  • Table 8-2: Global Flow Cytometry Test Market Trend, 2020, 2025, 2030 ($ million)
  • Figure 8-1: Global Flow Cytometry Test Market Trend, 2020, 2025, 2030 ($ million)
  • Regional Market Overview
    • Table 8-3: Global Flow Cytometry Test Market, by Region, 2025-2030 ($ million) [Asia Pacific, Europe, North America, RoW]
    • Figure 8-2: Global Flow Cytometry Test Market, by Region, 2025-2030 ($ million) [Asia Pacific, Europe, North America, RoW]

CHAPTER 9: TRADITIONAL NON-PAP TISSUE STAINS: MARKET SIZE AND GROWTH

• OVERVIEW
  • Table 9-1: Selected Traditional Tissue Stain Test Innovations
  • Table 9-2: Selected Vendors of Traditional Pathology Stains
• MARKET SUMMARY
  • Table 9-3: Global Traditional non-Pap Tissue Stains Test Market Trend, 2020, 2025, 2030 ($ million)
  • Figure 9-1: Global Traditional non-Pap Tissue Stains Test Market Trend, 2020, 2025, 2030 ($ million)
  • Regional Market Overview
    • Table 9-4: Global Traditional non-Pap Tissue Stains Test Market, by Region, 2025-2030 ($ million) [Asia Pacific, Europe, North America, RoW]
    • Figure 9-2: Global Traditional non-Pap Tissue Stains Test Market, by Region, 2025-2030 ($ million) [Asia Pacific, Europe, North America, RoW]

CHAPTER 10: DIGITAL PATHOLOGY: MARKET SIZE AND GROWTH

• OVERVIEW
  • Component Overview
  • Digital Pathology Software
  • Digital Pathology Scanners
  • Brightfield
  • Fluorescence
  • Whole Slide Imaging
  • A. Menarini Diagnostics
  • Huron Digital Pathology
  • PerkinElmer
  • Digital Pathology Communication and Storage
  • Table 10-1: Selected Digital Pathology Innovations
• APPLICATIONS
  • Digital Pathology for Precision Medicine
  • Digital Pathology for Research and Education
  • Digital Pathology for Disease Diagnostics
  • Hospitals
  • Diagnostic Laboratories
  • Post-Pandemic Normalization
  • Outpatient Clinics
  • Other Areas of Digital Pathology (Research Applications)
  • Biotech and Pharmaceutical Applications
  • Education and Research Applications
• MARKET SUMMARY
  • Table 10-2: Digital Pathology Markets, by Component, 2025 ($ million) [Clinical Support Services, Hardware, Software]
  • Figure 10-1: Digital Pathology Markets, by Component, 2025 (%) [Clinical Support Services, Hardware, Software]
  • Table 10-3: Global Digital Pathology Test Market Trend, 2020, 2025, 2030 ($ million)
  • Figure 10-2: Global Digital Pathology Test Market Trend, 2020, 2025, 2030 ($ million)
  • Regional Market Overview
    • Table 10-4: Global Digital Pathology Test Market, by Region, 2025-2030 ($ million) [Asia Pacific, Europe, North America, RoW]
    • Figure 10-3: Global Digital Pathology Test Market, by Region, 2025-2030 ($ million) [Asia Pacific, Europe, North America, RoW]

CHAPTER 11: TOTAL IVD PATHOLOGY MARKET

• Table 11-1: Total IVD Pathology Market, Sales and Market Share by Segment, ($ million) (%) 2025-20230 [Circulating Tumor Cells (CTCs), Digital Pathology, Flow Cytometry, HPV-DNA, Immunohistochemistry, in situ Hybridization, Pap Tests, Traditional non-Pap Stains]
• Figure 11-1: Total Global IVD Pathology Market, 2020-2030 ($ million)
• TOTAL IVD PATHOLOGY MARKET BY SEGMENT
  • Figure 11-2: Global IVD Pathology Market, by Segment Distribution, 2025 (%) [Circulating Tumor Cells (CTCs), Digital Pathology, Flow Cytometry, HPV-DNA, Immunohistochemistry, in situ Hybridization, Pap Tests, Traditional non-Pap Stains]
  • Figure 11-3: Total IVD Pathology Annual Growth, by Segment, 2020-2030 (%) [Circulating Tumor Cells (CTCs), Digital Pathology, Flow Cytometry, HPV-DNA, Immunohistochemistry, in situ Hybridization, Pap Tests, Traditional non-Pap Stains]
• IVD PATHOLOGY MARKET BY REGION
  • Table 11-2: Global Pathology Market, by Region, 2025-2030 ($ million) [Asia Pacific, Europe, North America, RoW]
  • Figure 11-4: Global Pathology Market, by Region, 2025-2030 ($ million) [Asia Pacific, Europe, North America, RoW]
  • Table 11-3: Global Pathology Sales Distribution, by Region, 2025-2030 (%)
• [Asia Pacific, Europe, North America, RoW]
  • North America
    • Table 11-4: North America Pathology Market, by Segment, 2025-2030 ($ million) [Circulating Tumor Cells (CTCs), Digital Pathology, Flow Cytometry, HPV-DNA, Immunohistochemistry, in situ Hybridization, Pap Tests, Traditional non-Pap Stains]
  • Europe
    • Table 11-5: Europe Pathology Market, by Segment, 2025-2030 ($ million) [Circulating Tumor Cells (CTCs), Digital Pathology, Flow Cytometry, HPV-DNA, Immunohistochemistry, in situ Hybridization, Pap Tests, Traditional non-Pap Stains]
  • Asia Pacific
    • Table 11-6: Asia Pacific Pathology Market, by Segment, 2025-2030 ($ million) [Circulating Tumor Cells (CTCs), Digital Pathology, Flow Cytometry, HPV-DNA, Immunohistochemistry, in situ Hybridization, Pap Tests, Traditional non-Pap Stains]
  • Rest of World
    • Table 11-7: Rest of World Pathology Market, by Segment, 2025-2030 ($ million) [Circulating Tumor Cells (CTCs), Digital Pathology, Flow Cytometry, HPV-DNA, Immunohistochemistry, in situ Hybridization, Pap Tests, Traditional non-Pap Stains]
• COUNTRY DISTRIBUTION
  • Figure 11-5: Total Global IVD Pathology Market Share, by Country, 2025 (%) [Australia, Canada, China, France, Germany, Italy, Japan, Spain, United Kingdom, United States, RoW]
• IVD PATHOLOGY COVID-19 IMPACT 2018-2030
  • Historical
  • The COVID-19 Era
  • Post-COVID-19 IVD Pathology
  • Future IVD Pathology
    • Figure 11-6: COVID-19 Pandemic Impact on the IVD Pathology Market, 2018-2030 (%)
• COMPETITIVE ANALYSIS
  • Table 11-8: Revenues of the Major Pathology Companies, 2020-2025 ($ million)
  • Figure 11-7: Global IVD Pathology Competitive Summary, 2025 (%)
  • Top Four IVD Pathology Competitors
  • Roche
    • Table 11-9: Pathology Launches by Roche
  • Beckton Dickinson (BD)
  • Agilent
  • Danaher
• THE COMMERCIAL OUTLOOK FOR IVD PATHOLOGY