Store
The Future of Pathology: Automated Platforms, Digital Imaging, and Market Dynamics, 3rd Edition
Publication Date: February 28, 2026
Tags: Cytology, Diagnostics, Histology, Histology and Cytology, HPV, In Vitro Diagnostics (IVD), IVD
Pages: 120
SKU: 26-035KA
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.
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
- 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
Related products
In Vitro Diagnostic (IVD) Procedure Volumes, 2023-2028
October 22, 2023
Gain invaluable insights into the global IVD market with Kalorama Information’s comprehensive report In Vitro Diagnostic (IVD) Procedure Volumes (Chemistry, Immunoassays, Hematology, Microbiology, Histology, Point of Care), 2023-2028. This analysis provides essential data on the number of IVD procedures, offering a gold standard for new entrants and existing marketers in the diagnostic products industry.
…
Price range: $6,000.00 through $9,000.00
Cell and Gene Therapy Funding and Deals Analysis, 2021-2023
December 8, 2023
Explore the dynamic world of cell and gene therapy deal-making with Kalorama Information’s comprehensive report, Cell and Gene Therapy Funding and Deals Analysis: Financings, Partnering, M&A, Tech Transfers, IPOs/SPACs, Other Deals, 2021-2023. This report tracks the deal-making activities in cell and gene therapy since 2021, providing insightful graphs of quarterly trends from 2021-2023 and detailing…
Price range: $5,000.00 through $7,500.00
30-Country IVD Market Atlas, 2024
December 23, 2024
With over two decades of experience in publishing in vitro diagnostic (IVD) market research, Kalorama Information presents the 30 Country In Vitro Diagnostics (IVD) Market Atlas, 2024. This quarterly updated report offers a unique approach focused on country-level research and analysis, providing a detailed analysis of major IVD segments forecasted for five years…
Price range: $5,000.00 through $7,875.00
