Digital & Computational Pathology Market Report – Second Edition: 2024 - 2029

This report provides an overview of the digital and computational pathology market (referred to within this report as the digital pathology market) from 2024 to 2029. The digital pathology market, as defined in this report, is comprised of revenue from instruments and software sold to clinical, academic, biopharma, and CRO customers, along with algorithm development services and other service revenues generated by CROs and reference labs.* This market is highly fragmented today, with top vendors providing multiple tools relevant for different aspects of the digital pathology workflow (i.e., slide scanning, slide viewing, image analysis, report generation, and image storage) and many other mid-sized and smaller-sized players that provide tools for individual aspects of the digital pathology workflow (i.e., only AI tools). Many players have formed partnerships with other DP providers, which will likely impact growth for some of the small to mid-sized players as consolidation occurs.

For this report, we leverage a combination of secondary research (e.g., analysis of quarterly and annual reports, earnings call transcripts, clinical trials, congress abstracts, company websites, etc.) and primary research (e.g., 35 interviews with digital pathology stakeholders from hospitals, academia, biopharma, and CROs, 100 clinical pathology lab survey respondents, 40 biopharma survey respondents) to assess the current and expected future adoption and utilization of digital pathology tools and technologies, and to characterize the key market dynamics. From our research and analysis, we estimate that the digital pathology market is ~$990M in 2024 and is expected to grow at 14% p.a. in the next 5years, to reach ~$1.94B by 2029.

For each of the subsegments analyzed, we present forecasted data from 2024-2029. In addition, we detail market drivers (e.g., shifting sentiment towards adoption) and moderators (e.g., limited reimbursement), market trends (growing importance of a one-stop-shop for image analysis tools), a high-level customer breakdown (clinical use (AMC & community hospitals), large pharma, small pharma, CROs), and offer key information on top competitors. All analyses are based on publicly reported data and DeciBio research and analysis.**

*Reagents and wet-lab materials used for tissue analysis are excluded from the scope of this report, as they are captured in our Spatial Biology Market Report. The scope of the report also excludes digital cytology platforms and technologies.

** Disclaimer: Some of the companies listed in this report may be DeciBio Consulting clients and customers

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Technologies and Revenues Included:

• Digital pathology / image analysis in which automated image analysis, algorithms, or pathologist-supported software is used to perform image analysis of any sort from an image of a scanned slide
• 3rd Party Image Analysis performed by a standalone image analysis company or spatial image analysis performed by a standalone image analysis company
• Technology classes which are designed to profile and analyze biomarkers including IF, IHC, H&E, digital-spatial profiling, and ISH
• Instrument and software revenues associated with the purchase of digital pathology platforms (e.g., slide scanners) or software used to run the assays and analyze the data, and service revenues associated with the processing or analysis of slides (e.g., by CROs / Reference Labs) or CDx development
• Global sales of products and services to academic, clinical, biotech / pharmaceutical companies, and CRO customers

Technologies and Revenues Excluded:

• Instrumentation, assays, and reagents upstream of slide digitization (e.g., autostainers, dyes, and antibodies), including spatial biology instrument and reagent revenues
• Spend downstream of image analysis (e.g., data storage and compute is assessed qualitatively but not included in the model)
• Spatial analysis conducted on-platform or offered by instrument manufacturers (e.g., analytics tools provided by Nanostring, 10x)
• Digital cytology platforms and technologies
• Service revenues passed to CROs / reference labs for slide staining
• Service revenue related to CDx development

Updated Content

• Incorporated the latest trends in the Digital & Computational Pathology market, based on interviews (N = 35) with experts, a clinically-focused survey (N =100), a biopharma-focused survey (N = 40), and extensive secondary research
• Updated our database of Digital & Computational Pathology companies and their offerings, highlighting key recent activity and product updates
• Updated market sizing, segmentation, and forecast based on primary research findings and publicly-available information
• Evaluated emerging, high-growth applications in depth, elucidating both quantitative and qualitative market drivers, moderators, and trends, including a new deep-dive on the computational pathology market landscape
• Included primary vendor feedback on perceived strengths and weaknesses, as well as stakeholder familiarity and satisfaction scores as part of the Global Report License

Updated Numbers

• Updated a bottom-up market model (based on number of customers by type and annual spend), informed by primary and secondary research (e.g., public filings)
• Assessed market sizes for each of the market segments analyzed, including by customer, products / services, technology, application, therapeutic area, and geography
• Projected revenues for each market segment from the current year (2024) through 2029

Table of Contents

• Introduction & Methodology
• Executive Summary
• Market Analysis
• Computational Pathology Market Landscape
• Partnership Landscape
• Primary Market Reseach (data from 100-respondent clinical survey)
• Primary Vendor Feedback (Global License)
• Competitive Analysis

Segmentations Covered in Market Analysis:

Customer:

• AMC Clinical
• Community Hospital
• Large Biopharma
• Small Biopharma
• CRO / Reference Labs

Products / Services:

• Scanners / Image acquisition
• Image Management Software
• Image Analysis / AI Algorithms
• Custom Image Analysis Development Services
• Other Services

Histological Method:

• IHC
• H&E
• Immunofluorescence
• In-situ Hybridization
• Spatial

Application:

• Basic & Translational Research
• Clinical Research & Trials
• Routine Clinical
• Training & Slide Archiving

Therapeutic Area:

• Oncology
• Liver Disease
• Infectious Disease
• Neurology
• Other

Geography:

• United States
• Europe
• Rest of World

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Clinical Respondent Survey (N=100)

The focus of this survey was to characterize the use of digital pathology within the clinical lab setting. Though respondents were asked specifically about use of DP within clinical practice, some vendor familiarity may be skewed by research activities. In order to ensure ample feedback on tool utilization, respondents were enriched for DP users and as a result, survey data tends to skew higher than market averages.

Survey participants were asked about:

• Slide scanners (including use of different vendors, the number of scanners in their lab, utility of scanners, reasons for slide scanning)
• Image management software (including use of different vendors, use cases of IMS, interoperability of IMS with LIS / LIMS)
• IA/ AI algorithms (including use of different vendors, utility of IA / AI tools, reasons for using IA / AI tools, use of Dx / Px / quantification algorithms)
• Data storage (including use of different vendors, storage solutions utilized, length of storage)

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Biopharma Respondent Survey (N=40)

The focus of this survey was to characterize the current use of digital and computational pathology in biopharma. Respondents were asked about use of digital pathology and image analysis tools within research and clinical trials, as well as expectations for potential future use

Survey participants were asked about:

• Digital pathology infrastructure and capabilities (e.g., in-house scanners, image analysis)
• Volume of slides digitized annually and projected increase
• Familiarity with vendors across scanners, IMS, and IA tools
• Digital pathology usage across research phases and therapeutic areas
• Preferred IA / AI algorithm tools
• Cost model and annual spend on AI algorithms
• Perceived impact of digital pathology
• Adoption of new DP technology in next 6 months and expected barriers to adoption

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