This report provides an overview of the digital pathology market from 2023 to 2028. 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 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., 33 interviews with digital pathology stakeholders from hospitals, academia, biopharma, and CROs; stakeholder survey with 81 users in the clinical digital pathology space) 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 ~$880M in 2023 and is expected to grow 15% p.a. in the next 5 years, to reach ~$1.75B by 2028.

For each of the subsegments analyzed, we present forecasted data from 2023-2028. In addition, we detail market drivers (e.g., increased adoption in certain customer segments) and moderators (e.g., high cost of instruments and software), market trends (interest in using image analysis and AI tools), a high-level customer breakdown (clinical use (AMC and community hospitals), large pharma, small pharma, CROs), and offer key information on top competitors.

This report features a survey of 81 clinical stakeholders in the U.S., EU, and RoW to understand, at a granular level, the level of adoption, current applications, and future use and spend on scanners, image management systems, image analysis tools, and data storage in routine clinical practice. The survey also captures vendor familiarity and utilization, as well as the expected adoption of new tools over the next 6 months.  

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

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

Companies Profiled in the Report:

• 3DHistech


• Aiforia


• Akoya Biosciences


• DeepBio


• Evident


• Flagship Biosciences


• FujiFilm


• Gestalt


• Hamamatsu


• Ibex


• Imagene


• Indica Labs


• Leica Microsystems


• Lunit


• Mindpeak


• Nucleai


• Owkin


• Paige


• PathAI


• Philips


• PredxBio


• Proscia


• Roche


• Sectra


• Siemens Healthineers


• Tempus


• Tribun Health


• Ultivue


• Visiopharm


• Zeiss