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Cranfield, UK, 14 August 2024 – “Poor decisions around IT infrastructure can make or break the success of a digital pathology transformation.” – Imogen Fitt, Senior Market Analyst
The digital pathology (DP) market has made tremendous progress over the last four years, with vendors, key opinion leaders and regulatory bodies making significant efforts to educate laboratories on topics like change management, budgetary considerations, and the general DP implementation process.
However, despite this, there does remain a significant area of obscurity within the software domain, with many users asking:
- What is the difference between a digital pathology ‘IMS’ and a viewer?
- What is a ‘pathology PACS’?
- How do users differentiate between different vendor solutions?
Part of the challenge is that many vendors exist today offering DP software products orientated around workflow management, but there is significant differentiation in the terminology each vendor chooses to use.
In the article below, we define product categories currently available, examine how these are specialised between distinct markets, and forecast future development to answer the question: how should digital pathology IT evolve in the future?
1. What is the difference between a Digital Pathology “IMS” and a Viewer?
Although exact definitions vary, the term ‘viewer’ can briefly be described as the IT which facilitates the display/visualisation of DP images and metadata.
These were built when digital pathology first emerged as a discipline and were primarily orientated around single users for image analysis and sharing. As demand started to scale the need for workflow management tools to track and analyse higher slide volumes started to emerge, which would result in the development of Aperio’s ‘Slide Manager’.
Figure 1 showcases the differences in functionalities between viewers and what is traditionally known as an IMS (Information Management System) or digital pathology workflow software. As is shown, workflow software must have a built-in viewer to be used and can be considered an extension of an IMS, the FDA even considers ‘Viewer and Management Software’ under the same product code (QKQ).*
*(It should also be noted that under the FDA-enforced ‘pixel pathway’ digital pathology solutions must be approved as end-to-end solutions. This means that approval for ‘Viewer and Management Software’ vendors will only apply to the specific scanners, AI products and displays the approval was granted for. This limits how quickly new vendors, and most types of innovations, can penetrate the US market and further complicates evolution!)
Figure 1: Features and functionality differences between digital pathology workflow software (an “IMS”) and a viewer. As is shown, a viewer is a component in an IMS designed for singular use, whereas workflow software provides the ability to integrate with multiple other systems and manage digital pathology at scale.
* Please note EHR refers to an Electronic Health Record, EDC an Enterprise Data Capture system, LIS and LIMS to Laboratory Information (Management) Software and VNA to a Vendor Neutral Archive.
Originally the term IMS became popular as it was the brand name used to describe Philips’ digital pathology workflow software, but over the last few years, this has slowly started to fall out of fashion.
Image Management System, digital pathology solution, enterprise pathology platform, clinical trials platform, and pathology PACS are all examples of nomenclature used today on vendor websites to describe what was formerly known as an IMS.
2. How is terminology changing, and why is Pathology PACS becoming more popular?
Digital pathology workflow software can be tailored to many applications, as shown in Figure 2. At a minimum, users in each require a digital pathology viewer, but the ability to provide other functionalities, such as creating exams/tests and performing quality assurance for teaching purposes can greatly enhance a user’s experience, ultimately encouraging greater use.
Figure 2: Distinct use cases for digital pathology images, and relative differences in workflow management required. Some applications, shown in a lighter shade of purple, can be addressed by other markets and don’t necessarily require digital pathology vendors to develop targeted modules.
Typically vendors first emerged providing digital pathology software for one or two of these applications (most commonly clinical, education or research use) but over time vendors have expanded portfolios and these boundaries have blurred. Instead, vendors now use terminology to position a company or product in relation to competing solutions.
Those hoping to target high-volume usage for example, often use the term ‘enterprise’ to denote scale, whereas those focusing on more distinctive research markets emulate terminology already in use like DP ‘clinical trials platform’.
Whilst IMS has by no means disappeared completely, another term that has started to emerge over the last year in clinical settings is ‘Pathology PACS’. This is mostly used by vendors with a radiology background or partnership. The term ‘PACS’ or Picture-Arching and Communications System is well established within healthcare already and whilst traditionally a term used in radiology, it has also spread into other departments, such as nuclear medicine imaging, cardiology, oncology and dermatology.
‘Pathology PACS’ is now more frequently appearing in existing tenders and RFPs across Western Europe, and for vendors, it comes with the advantage of being able to more easily communicate with and appeal to hospital IT departments.
Like the different image standards that are still widespread in the market today, however, multiple terms will likely continue to persist and be used interchangeably for some time, a confusing pain point for customers.
3. How will Pathology IT Evolve in the Future?
Pathology Imaging Will Consolidate
Digitisation in pathology has traditionally focused on anatomic/histopathology departments whilst cytology, gross and frozen section analyses have faded into the background. Consequently, vendors focusing on these underserved sub-segments have emerged, and whilst related business makes up a small proportion of revenue for the worldwide market today; cytology for example, is now growing quickly.
As this happens, cytology and anatomic software markets are coalescing, evidenced by tenders requesting scanners that can visualise anatomic and Z-stack images, and by vendor development. Techcyte (traditionally focused on cytology) for example partnered with the Mayo Clinic in January 2024 to develop an anatomic digital pathology platform, whilst Paige recently updated its workflow software to be able to visualise Z-stack images.
Beyond this, there are also gross images which can be reviewed and workflows for these and other procedures are currently not included in most DP workflow software. Signify Research expects that as the market starts to mature and customers seek to consolidate their budgets, these three separate DP imaging domains will continue to merge and eventually form a single solution, alike to how radiology PACS evolved from separate MRI, CT and X-ray IMS systems.
As this trend continues*, domains outside of traditional pathology are also more likely to influence DP.
* This is likelier to impact clinical settings rather than research, which still operates on a project-by-project basis in most instances.
Increasing Influence of LIS, Genomics and Radiology in Clinical Settings
Molecular diagnostics is already closely linked with pathology diagnosis, and as clinical use of genomics sequencing starts to increase digital pathology will play a more important role in revealing molecular insights using predictive image analysis software, flagging patients for further genomic testing and ultimately supporting the personalisation of treatment pathways.
In some markets, like the Netherlands, pathologists and oncologists are working more and more closely to help diagnose and determine treatment pathways for patients, with the digital pathology system seen as a ‘cockpit’ of relevant genomic, DP and other multimodal information. This will inevitably lead to adaptions in IT in the form of additional modules or integrations. Philips and Sectra are two examples of vendors already well along this strategic positioning and product development pathway.
Alternatively, some vendors, like ZayaAI and 3DHISTECH, are now offering their own Laboratory Information System (LIS) software. The integration between digital pathology Image Management Systems (IMS) and LIS is becoming a significant challenge as DP use increases in clinical settings. Many labs worldwide are still using outdated software that is difficult to interface with; although numerous LIS vendors are slowly releasing modern cloud-based modular products, the digital pathology industry must often wait for these updates to penetrate ageing LIS legacy systems in related markets. As the DP market evolves, vendors will likely start to cannibalise more and more of the LIS workflow, with some already offering reporting with their solutions.
The third market which will increasingly influence clinical DP implementations in the future will come as no surprise. Recent pathology-radiology announcements have garnered much attention, and Signify Research expects that these larger radiology vendor influences will help to promote the use of the DP DICOM standard, whilst also facilitating short-term storage of images via integration with vendor-neutral archives (VNAs).
For those unfamiliar, the VNA is a storage product offered by many radiology vendors which was originally intended to house multiple proprietary formats from radiology PACS software and support ingestion and management of non-DICOM based imaging outside of radiology. (Note the similarity in mistakes and relevance of lessons learned!) Pathology partnerships that vendors like Corista, Tribun Healthcare, Proscia and Indica Labs have established are now focusing on being able to integrate workflow software with VNAs, to provide short-term storage archives; many today do not yet offer the ability to view DP images within VNAs, but vendors do have a roadmap towards achieving this. As requests for VNAs in DP increase, in a few years, these archives will form a core part of the DP infrastructure.
AI Management & Orchestration Platforms
Whilst Signify Research has commented on this topic before, it’s worth revisiting the challenge that lies ahead for workflow software and the integration of AI into both research and clinical settings.
As Figure 3 shows, DP workflow software is expected to evolve to provide a leading role in the management of AI across workflows.
Figure 3: The evolution of the AI Orchestration platform. Most vendors today offer basic integrations dictated by customer requests, but increasingly digital pathology software vendors will become a single repository of contact for labs wishing to integrate multiple solutions.
Whilst most of the market today offer what essentially amounts to integration lists, some vendors have begun to take a leading role in guiding labs to implement solutions. Gestalt digital pathology, with its ‘AI Algorithm Evaluator’, offers customers the chance to compare outputs from different models with their datasets, whilst Paige is facilitating the purchase of third-party algorithms through its software.
Integration within DP, however, is no simple task. Truly embedding an algorithm seamlessly into a workflow can take years as evidenced by Roche and Ibex Medical Analytics’ partnership which began in 2021 and was launched commercially in 2023. Multiply that by the number of vendors active in the market today and the hundreds of AI applications coming to market or in development, and it’s no wonder that this progress is slow and deliberate.
Time and costs associated with development are already high in an unforgiving investment climate, and, likely, vendors are just as concerned their AI partners may not survive the next round of consolidation as prospective customers are.
The Ultimate Goal: Integrating Research & Clinical Environments to Enable Precision Medicine
Whilst in the short-term vendors have expanded their market focus into other domains to pursue more customers and thus ensure revenue growth, there is an underlying trend impacting wider healthcare that many vendors are considering.
As it digitises, pathology is being heralded as the next pillar of precision medicine, and with the vast amount of physiological data that is set to become captured digitally as use increases, it’s with good reason.
These images contain a wealth of information on molecular, histologic, or physiologic characteristics, known as biomarkers. Many researchers, life sciences companies and DP AI vendors are using already existing expertise and access to imaging data to discover quantitative imaging biomarkers that can be used to support research and drug development. This first helps to identify patterns in populations but can be developed further to support biomarker-driven patient selection for clinical trials.
Some software will also have the potential to be developed into digital companion diagnostic products (CDx) for use in clinical practice on patients who could benefit from certain treatments.
Precision medicine, however, will not come about without an appropriate conduit to deploy any subsequent CDx products. Digital pathology workflow software, which can be utilised by both research and clinical users, offers an intermediate point to facilitate both exchanges as shown in Figure 4.
For DP vendors, these potential partnerships have the potential to be quite lucrative, as life sciences companies famously have no shortage of funds. Simple integration and data referral fees could provide another stream of revenue for workflow vendors, so it’s no wonder many are contemplating this opportunity.
Figure 4: Showcasing the role of digital pathology workflow software in the future as an intersection between clinical and preclinical settings. Vendors have a unique chance to support the dissemination of pathology data as real-world data to research settings, and in turn act as a platform to deploy digital companion diagnostics.
For this to be achieved fully, however, more will be required than singular modules.
Figure 5 below showcases the competency model which will eventually emerge to support precision medicine in DP.
Figure 5: Competency model showcasing the evolution of digital pathology workflow software. The industry has matured from using viewer systems to image and sometimes lab management systems.
Most digital pathology implementations today sit somewhere between the viewer and lab management stages. But to maximise value and growth in the market, workflow software needs to move beyond image management, towards precision medicine enablement.
This also relies on the use of DP scaling clinically over the next few years. Laboratory funding has continued to decline recently, and whilst reimbursement remains tantalisingly close, the case for Return on Investment (ROI) on behalf of labs is still quite poor. To help mitigate this, vendors have made a notable shift towards ergonomics and business-minded solutions.
Precision medicine again, however, offers another solution to the dilemma around ROI, by allowing labs to commercialise access to de-identified DP datasets. For vendors, facilitating this transfer poses both a challenge and promises the potential for higher returns.
This is being pursued already in different domains, such as in radiology where vendors such as OneMedNet, Medexprim and Medicom Technologies are already facilitating the exchange of de-identified and encrypted patient data to life science companies through software platforms, while some more generalist “health data brokers” have existed for some time.
The challenge of curating, standardising, de-identifying and securely transfer medical data is not to be scoffed at however, but with the recent advent of generative AI and tokenisation technologies it has over the last few years become much more feasible. Some DP vendors already offer fledgling services in these areas, like Philips Healthcare with its DP de-identification tools designed for academic studies, and Proscia with its Real-World Data Network.
4. How Should Vendors Respond?
The DP market is undergoing immense change whilst businesses are growing quickly. This article has listed many ways that workflow software can be augmented, but no one vendor will be able to achieve it all – despite what internal marketing departments may say!
As vendors evolve, Signify Research expects the following specialisms to emerge:
- End-to-End Solutions: these vendors will often have a scanner and wider portfolio to combine their software sales with. Cost-conscious pricing will be a hallmark.
- Clinical drivers: primarily looking to push clinical DP volumes higher. These vendors will focus on developing ergonomic and intuitive workflows that interface well with existing healthcare infrastructures.
- AI-augmented vendors: often these vendors employ an AI-first strategy that sees them focus on closely embedding AI into their platforms and offering customers as much choice as possible when selecting AI.
- Precision medicine partners: these vendors will focus on developing partnerships with life sciences vendors to share DP RWD and/or develop CDx solutions, providing the workflow software to install it in clinical settings.
Today’s DP industry is somewhat clouded by the prolific use of marketing jargon, whilst lacking case studies to support some claims definitively.
With so many metaphorical plates spinning, it can be difficult to prioritise investment and determine how best to approach the market’s needs today. Figure 6 below offers some food for thought in this domain, to both vendors and prospective buyers.
Figure 6: Market requirements for digital pathology software to support in the short to long-term with questions for pathologists and vendors.
For labs, there will be both immediate priorities and long-term considerations when selecting a software partner. Vendors must carefully weigh their internal R&D strategies and position themselves to take advantage of market forces. As the COVID-19 pandemic showcased, there will always be short-term pivots that require immediate attention, but these can only be met with flexibility and speed in leadership.
Ultimately, digital pathology has come a long way since the first scanners were commercialised decades ago, but looking to the future, the industry has a wealth of potential to both grow and contribute positively to patient care.
Related Research
Signify Research’s digital pathology market intelligence service provides rolling 12-month coverage of the digital pathology ecosystem.
Digital Pathology Market Intelligence Service – World – 2024
Signify Research’s Market Intelligence Service provides a rolling 12-month coverage of the global Digital Pathology market. The service is composed of five deliverables, as shown below.
The service is designed to enable you to:
- Inform product investment and business strategy
- Evaluate the ever-changing competitive landscape to assess the impact of associations and select potential partners
- Acquire a holistic view of the nuances between different pathology research and clinical markets
- Understand adjacent markets such as enterprise imaging laboratory information systems and the influence these will have on Digital Pathology.
For further questions or samples of the service contents, please contact Imogen Fitt, the report author.
About The Author
Imogen joined Signify in 2018 as part of the Healthcare IT team. She holds a 1st class Biomedical Sciences degree from the University of Warwick where her studies included molecular biology and pharmacology. Since joining the team Imogen has studied the medical imaging software and hardware markets and is now expanding Signify Research’s Diagnostics and Lifesciences coverage.
About the Diagnostics and Lifesciences Team
The Diagnostics and Lifesciences team provides market intelligence and detailed insights on the multiple healthcare technology markets where the clinical world intersects with the preclinical. Our areas of coverage include digital pathology, laboratory information systems, clinical Real-World Data (cRWD) platforms, oncology information systems, tumour board software, oncology decision support software and radiotherapy IT. Each report provides a data-centric and global outlook of its markets with granular country-level insights. Our research process blends primary data collected from in-depth interviews with healthcare professionals and technology vendors, to provide a balanced and objective view of the market.
About Signify Research
Signify Research provides healthtech market intelligence powered by data that you can trust. We blend insights collected from in-depth interviews with technology vendors and healthcare professionals with sales data reported to us by leading vendors to provide a complete and balanced view of the market trends. Our coverage areas are Medical Imaging, Clinical Care, Digital Health, Diagnostic and Lifesciences and Healthcare IT.
Clients worldwide rely on direct access to our expert Analysts for their opinions on the latest market trends and developments. Our market analysis reports and subscriptions provide data-driven insights which business leaders use to guide strategic decisions. We also offer custom research services for clients who need information that can’t be obtained from our off-the-shelf research products or who require market intelligence tailored to their specific needs.
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