Digital Pathology Market Size, Share & COVID-19 Impact Analysis, By Product (Hardware (Scanners, Tissue Microarrayer, and Others), Software (Pathology Management, Digital Microscopy Viewers, Image Analyzers, and Others), and Storage Systems), By Application (Disease Diagnosis, Drug Discovery, and Others), By End-user (Hospitals & Clinics, Clinical Laboratories, and Others), and Regional Forecast, 2022-2029

The global digital pathology market size was valued at USD 798.8 million in 2021. The market is projected to grow from USD 892.5 million in 2022 to USD 2,045.9 million by 2029, exhibiting a CAGR of 12.6% during the forecast period. The global COVID-19 pandemic has been unprecedented and staggering, with digital pathology experiencing higher-than-anticipated demand across all regions compared to pre-pandemic levels. Based on our analysis, the global market exhibited a rise of 31.2% in 2020 as compared to 2019.

Digital pathology is a field utilizing digital tools to collect, interpret, analyze, and share information. Digital slides are created from either a whole slide scanning device from previously prepared devices or directly with a digital microscope. The digital slide is then further used for analysis through high throughput algorithms, shared Over the Air (OTA), or stored for future use.

The rising prevalence of chronic diseases and increasing hospital admissions for treatment support the surging demand for pathology tests. Furthermore, rising workload is anticipated to drive the adoption of digital tools in the traditional pathology ecosystem. Moreover, the increasing applications of these devices in modern medicine and rising awareness of novel diagnostics are expected to increase the patient pool for diagnosis and supports the digital pathology market growth.

• For instance, according to an article published by Express Healthcare in 2022, the incorporation of digital tools by pathologists resulted in increased productivity and overall efficiency by 15.0% compared to traditional pathology workflows. Moreover, key advantages, such as reduced workload and increased efficiency, are anticipated to augment the market's growth.

Has COVID-19 Pandemic Impacted Digitalization of Pathology Tools? 

The impact of COVID-19 has resulted in considerably high growth in the digitization of pathology during the period of our analysis. This growth is attributable to the significant spike in the adoption of these devices, favorable regulations for emergency use cases, and a decline in in-person visits to pathologists and physicians. The global market witnessed a growth rate of 31.2% in 2020 as compared to 11.6% in 2019. Frequent lockdowns and social distancing rules were enforced to control the spread of the coronavirus, which led to a significant reduction in the number of patient consultations.

For instance, according to a research study published by the Journal of Clinical Pathology in 2021, the transition from traditional methods to digitization coincided with the arrival of the pandemic, accelerating the adoption of this technology in Switzerland. The increased challenges of workload and a declining number of pathologists also expected to bolster the demand for such tools to streamline workflow. Moreover, the decline in patient visits and relaxation of regulations led to a huge uptake of these systems among pathologists.

For instance, in March 2020, the Clinical Laboratory Improvement Amendments authorized by the Centers for Medicare and Medicaid Services (CMS) issued a memo under the Social Security Act stating remote sign-out and viewing of digital workflow, keeping the protection of pathologists and quality of patient care at top priority during the pandemic. Furthermore, initiatives from various private and public organizations to control the spread of the disease have further supported the market growth.

Moreover, virtual education expanded to ensure that physicians can provide care to patients. In March, the Centers for Medicare & Medicaid Services (CMS) announced regulatory changes to make it easier for patients in the U.S. to receive medical care through telepathology services. The huge shift toward virtual care resulted in the transformation of most companies to satisfy the incessant demand for tele services.

However, there was a recovery inpatient volumes similar to the pre-pandemic levels, which impeded the staggering growth of the market during the pandemic. This factor was due to the relaxation of regulations and mandates imposed by various governments globally. In 2021, the patient volume bounced back owing to higher vaccination coverage among the general population. Furthermore, the implementation of strong guidelines and COVID-19 protocols in public places are likely to slow the market’s growth in 2021, estimated to be 7.4% with respect to the year 2020.

How Has Artificial Intelligence Transformed the Digital Pathology Industry?

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Robust Adoption of Artificial Intelligence-based Digital Tools to Foster Industry Progress

Increasing adoption of artificial intelligence-based digital tools by key consumers owing to a higher demand for workflow management is anticipated to augment the market growth. The rising focus of major players involved in patenting innovative technology to offer a customized platform for key digital pathology stakeholders provides the companies a competitive advantage in the market.

Furthermore, key market players now prefer to gain IP5 certifications for their patent registrations. The certification is part of a collaborative program across five major patent offices worldwide such as the U.S. PTO and the European Patent Office (EPO) among others. These certifications help the companies distribute their digital tools among key countries without individually applying for separate patents.

• For instance, in May 2022, OptraSCAN, an end-to-end solution provider, was awarded a U.S. patent for its digital scanner OS-SiA. The patent now provides a competitive advantage to the company equipped with inbuilt Artificial Intelligence (AI) to analyze the scanned tissue and provide predictive analysis in real-time.

Moreover, strategic initiatives to develop and standardize sharing platforms to enable seamless transfer of data across the industry are anticipated to support the adoption of artificial intelligence in pathology and, subsequently, the growth of the market.

• For instance, according to an article published by the MDPI Cancers in 2022, multiple platform developers, such as Leica Biosystems Imaging, Inc., use Convolutional Neural Network (CNN) as a base algorithm to develop a platform based on deep learning.

Key manufacturers involved in developing solutions using machine learning and AI are expected to support the increasing demand for digital type pathology solutions, thereby catering to the market growth.

Has Rising Burden of Chronic Diseases Transformed the Digital Pathology Market?

Subsequently Rising Number of Tests to Drive Market Growth

Higher incidences of chronic diseases and subsequent increase in number of tests are estimated to support the adoption of these systems. Increasing product adoption, along with a rising focus of market players catering to the rising need for diagnostics, is anticipated to drive the growth of the market size. Moreover, increasing applications of these platforms, such as predictive analysis, are expected to augment the market growth.

• For instance, in April 2022, PreciseDx announced the launch of its digital platform, which can accurately diagnose Parkinson's disease (PD) in patients earlier than the onset of severe symptoms. The launch supports the increasing demand for these systems with additive benefits of machine learning.

Moreover, increasing approval for digital tools is expected to support the rising adoption of these devices, thereby augmenting the market growth. Moreover, increasing research programs funded by governments to support innovation in digital tools in pathology is anticipated to drive the market growth.

• For instance, in March 2022, the U.S. Food and Drug Administration (FDA) awarded Inspirata clearance for Dynamyx software for primary diagnosis in place of a traditional glass slide. The clearance improves the distribution of the software in the U.S. and provides an open platform for compatibility with scanners available across the industry.

Rapid Digitization in Pathology to Propel Industry Growth

The increasing demand for digitization in pathology has given rise to competition among key players in the market. Moreover, increasing competition combined with the increasing need for drug discovery through applications of high through-put algorithms in the market has promoted major players to invest in developing novel tools to streamline workload and customization.

• For instance, in March 2022, Nucleai announced that it raised a Series B funding of USD 33 million. The company is a developer of an AI-powered pathology platform aiming to predict a patient's response to treatment. The investment will support the company's continued development of its platform and expand its presence amongst biopharma companies and contract research organizations.

Rising investments by domestic players from industry stakeholders to launch novel tools along with the rising number of product launches to cater to the increasing demand for digitalizing of tools is anticipated to support the growth of the market.

What are the Major Restraining Factors for the Market?

High Upfront Costs for Installation of Devices to Hamper Market Growth

Although incorporating and utilizing these systems in modern medicine has its benefits and applications in pathology, digitization of tools requires a high upfront cost for installation and training in using those systems to regularize workflow. Digital devices have a high cost and subsequently require software to analyze the data, share, and store the data, which may either have individual costs or be part of an end-to-end full system product offering.

• According to an article published by the Journal of Pathology Informatics in 2021, digitization of pathology requires imaging hardware, information technology infrastructure, and trained scanning technicians. Imaging hardware, such as whole slide scanners, may range from USD 100,000 to USD 400,000. Software bought on a subscription-based model may cost up to USD 15,000 in annual costs. Moreover, value-added software services and customized tools may add the cost further. The high cost of integration may hamper the adoption of this technology and further hamper the market's growth.

In recent years, an increasing number of pathologists retiring as compared to the number of pathologists joining the workforce has been observed. This factor has directly affected the market due to an astute shortage of pathologists. This factor has further affected the potential consumer base adopting and training for these systems, affecting the market adversely.

• For instance, according to an article published by Vachette Pathology in 2022, the total net deficit of pathologists per 100,000 populations was found to be 5,700. Moreover, the total number of pathologists is expected to grow by 8.1% to suffice the rising need for pathologists among the patient population. The reduced number of pathologists is anticipated to affect the market adversely.

SEGMENTATION

By Product Analysis

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Hardware Segment to Hold a Dominant Share Owing to Strong Demand for Time-Efficient Pathology Outcomes

Based on product, the market is segmented into hardware, software, and storage systems. The hardware segment accounted for the largest share of the global market. The rise in the number of laboratories performing in-vitro tests and the increasing need for time-efficient outcomes are responsible for the growing demand for hardware products, which is anticipated to drive the segment’s growth. The hardware segment is further sub-segmented into scanners, tissue microarrayers, and others. The growing demand for digital databases for storage of specimens across the globe is anticipated to grow the segment during the forecast period. The scanner segment is expected to register the fastest growth during the forecast period.

The software segment is anticipated to grow during the forecast period due to increasing demand for Artificial Intelligence (AI)-based algorithms in the industry, owing to increasing applications in pathology data processing and assisted analysis. The software segment is further sub-segmented into pathology management, digital microscopy viewers, image analyzers, and others. The increasing prevalence of infectious outbreaks has led to rising demand for in-vitro diagnostic tests, resulting in a higher workload for pathologists. Software, such as microscopy viewers, image analyzers, and others, assist pathologists in disease diagnosis reduce workload and enhance diagnosis. These are some of the key reasons for improving the adoption of the pathology software, thereby augmenting the segment's growth.

The storage systems segment is anticipated to grow through the forecast period due to high demand for storage of key data to share, analyze, and store for future use as well as remotely access the data instantly. Furthermore, the introduction of novel digital tools by leading players is fueling the growth in the global market.

By Application Analysis

Drug Discovery Segment to Hold a Dominant Share Due to Strong Demand for Potential Pipeline Drugs

The market is segmented into disease diagnosis, drug discovery, and others based on application. The drug discovery segment is anticipated to grow during the forecast period owing to increasing demand for potential pipeline drugs for treating of life-threatening diseases along with emerging applications of pathology tools in drug discovery such as high-throughput screening.

The disease diagnosis segment is expected to grow during the forecast period owing to increasing burden of pathological tests among the patient population and rising awareness towards early diagnosis to anticipate the risk of disease and take evasive action.

• For instance, in December 2021, F. Hoffmann-La Roche Ltd. announced the launch of three novel artificial intelligence-based deep learning algorithms to detect breast cancer biomarkers. The increasing initiatives of key companies in providing pathology solutions to cater to the demand for disease diagnostics are anticipated to drive segmental growth.

Therefore, the rising applications of digital tools in drug discovery and disease diagnosis, such as high throughput screening, deep learning, and cancer diagnostics, among others, are anticipated to drive the growth of the applications segment.

By End-user Analysis

Increasing Adoption of Digital Pathology Services in Hospitals & Clinics to Augment the Segmental Share during 2022-2029

The global market is segmented into hospitals & clinics, clinical laboratories, and others based on end-user.

The hospitals & clinics segment held the largest share in the global market in 2021. The dominance of the segment is attributed to the increasing number of hospital admissions and pathology services offered through major hospitals. Moreover, strategic collaborations to introduce advanced products through partnerships with key hospitals and higher adoption of digital tools owing to higher footfalls are anticipated to drive the segment's growth. Leading hospitals in the U.S., the U.K. and other developed countries have installed pathology tools and systems to enhance the workflow, which has been pivotal in attracting a large patient pool.

• For instance, in May 2022, Sectra announced an agreement with UniHA, a cooperative of French public hospitals. The agreement will enable hospitals associated with UniHA to procure Sectra's solution on pre-decided terms and conditions. The partnership allows the hospital network to manage its workflow, supporting the segment's growth.

On the other hand, the clinical laboratories segment is anticipated to grow during the study period owing to the increasing number of clinical laboratories developing databases through digitizing slides is anticipated to support the adoption of digital tools through clinical laboratories. Moreover, key solution providers are collaborating to expand their product portfolio by offering customized solutions along with increasing demand for digitization is estimated to foster the growth of the segment.

• For instance, in March 2022, F. Hoffmann-La Roche Ltd. announced a collaboration with Bristol Myers Squibb to support the advancement and deployment of two new pathology algorithms. The two assay methods developed are for use in clinical trials. The collaboration aims to create an AI-based image analysis algorithm to aid pathologists in interpreting VENTANA PD-L1 (SP142) Assay. Such collaborations focused on providing key solutions to cater to the increasing demand among clinical laboratories is anticipated to drive the segment's growth.

Furthermore, higher adoption of telepathology during the pandemic for remote diagnostics has provided an upper hand to clinical laboratories for improving awareness among key consumers.

How is the Market Segmented on the Basis of Region?

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The North American region dominated the global market with a contribution of USD 280.6 million in the global market in 2021. The growing incidence of chronic diseases such as cardio-diabetic disorders among the patient population and the increasing geriatric population at a higher risk of developing such disorders are expected to increase the demand for pathology tests. The growing burden of tests coupled with rising demand for streamlining workload is anticipated to improve the adoption of digital tools among pathologists.

• According to an article published by the Journal of the American Medical Association Network in 2021, the total number of adults suffering from diabetes in the U.S. were estimated to be 13.0% and 34.5% of people met the criteria of pre-diabetes. The prevalence of pre-diabetes and diabetes was found to be higher in older adults. The increasing prevalence and risk of chronic diseases among the aging population are anticipated to support the demand for routine tests and drive the market growth.

Moreover, the emphasis of market players on inorganic growth strategies, such as partnerships and collaborations, to launch innovative digital tools to manage workflow to cater to the rising demand for customized solutions are the major factors responsible for driving the growth of the North American market.

• For instance, in January 2022, Vital Signs Solutions Ltd. announced the launch of the PocDoc test, a smartphone-based at-home test for cardiovascular disease. The test covers a full five marker lipid panel, established as the gold standard in cardiovascular assessment under six minutes.

Moreover, the strategic presence of major market players, such as Thermo Fisher Scientific Inc., Apollo Enterprise Imaging Corp, and Huron Technologies International Inc., in the region and growing adoption of digital tools are anticipated to support the growth of the North American market.

Europe accounted for the second-largest market share in the global market. Upsurge in the patient population preferring digital tools over traditional pathology, alongside strategic developments such patenting proprietary technology by key industry players in the region, is boosting the market growth. Moreover, the growing adoption of technologically advanced products in the region and regulatory approvals for these products are expected to augment the segment's growth.

• For instance, in September 2021, Visiopharm announced that it had been granted the European patent for a novel method developed for labeling histopathological images and training deep learning models. The patent now provides the company a proprietary advantage in the pathology industry and is expected to drive the market’s growth in Europe.

On the other hand, the Asia Pacific market is expected to register the highest growth rate during the forecast period. Rising number of healthcare chains partnering with key companies to manage the increasing burden of tests among diagnostic laboratories is estimated to augment industry growth. Moreover, increasing investments by private and public institutions along with developing healthcare infrastructure is responsible for increasing the adoption of digital tools and solutions among key stakeholders. Moreover, the increasing patient population is driving the market growth in Asian countries.

• For instance, in February 2022, Siriraj Hospital of Mahidol University, based in Thailand, announced its extended partnership with DB Results, an Australian digital business consultant. The agreement involves the utilization of DB's Outsystems for building its digital applications, such as the Pathology App. Such initiatives, and the rising demand for pathology services, which are anticipated to drive the market's growth.

Latin America and the Middle East & Africa are developing in the global market. The increasing number of patients owing to growing medical tourism and the rising adoption of digitization in these regions are expected to drive the growth during the forecast period. Moreover, factors such as increasing healthcare spending by patient population along with increasing applications of digital tools, such as remote review of cases, virtual education, decreased response time, and improved workflow, are some key reasons expected to enhance the market growth of these regions.

Who are the Key Players Operating in this Market?

The global market is dominated with key players such as F. Hoffmann-La Roche Ltd, Koninklijke Philips N.V., Leica Biosystems Nussloch GmbH, and 3DHISTECH Ltd. The dominance of these players is attributed to the product portfolio of digital tools along with strong research and development investments to launch technologically advanced tools. Moreover, strategic collaborations with key service providers and a well-established distribution channel are key factors driving the market. The key companies operating in the market are focused on introducing technologically advanced products to gain a competitive advantage over other market players.

• For instance, in January 2022, Aiforia announced its collaboration with the Mayo Clinic to establish an AI-powered pathology research architecture at the Mayo Clinic. The collaboration is focused on leveraging Aiforia’s expertise in digital platforms and deep learning, aiming to enable faster results and scalable studies in translational research. This development further strengthens the digital pathology market share of the company in the competitive landscape.

Moreover, the emergence of several domestic market players focusing on the development of customized software and providing competitive pricing is further estimated to cater to the increasing demand among developing markets across the globe.

LIST OF KEY COMPANIES PROFILED:

• Thermo Fisher Scientific Inc. (U.S.)


• Hoffmann-La Roche Ltd. (Switzerland)


• Hamamatsu Photonics K.K. (Japan)


• 3DHISTECH Ltd. (Hungary)


• Koninklijke Philips N.V. (Netherland)


• Apollo Enterprise Imaging Corp (U.S.)


• Sectra AB (Sweden)


• Huron Technologies International Inc. (Canada)

What are the Key Industry Developments of this Market?

• April 2022 – 3DHISTECH Ltd. announced an agreement with the Catalan Health Institute (ICS) to deploy digital tools for pathology within a network of 8 hospitals, over 168 pathologists, and over 1 million slides each year as part of its DigiPatICS project. The development promotes the company's brand image in the industry with a key focus on establishing its market presence.

• March 2022 – Thermo Fisher Scientific, Inc. launched CE-IVD marked Ion Torrent Genexus Dx Integrated Sequencer, an automated, next-generation sequencing (NGS) platform for use in clinical laboratories and to perform both diagnostic and clinical research.


• January 2022 - Leica Biosystems Nussloch GmbH announced its partnership with Leap Therapeutics, a biotechnology company, to develop a companion diagnostic to detect Dickkopfrelated protein 1 (DKK1). The assay development is aimed at the clinical development of Leap Therapeutics’ anti-DKK1 cancer therapy, DKN-01, currently being studied in clinical trials.


• October 2021 - F. Hoffmann-La Roche Ltd., collaborated with PathAI, a global leader in AI-powered technology, with an aim to develop AI-based applications for improved patient care.


• September 2021 - Koninklijke Philips N.V. announced its partnership with Healius Pathology, an Australian provider of laboratory and pathology services, to install multisite digital solutions for automating workflow. The development aims to cater to Healius Pathology's clinicians to make timely decisions about patient care.

REPORT COVERAGE

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The digital pathology market research report provides a detailed analysis of the market. It focuses on key aspects such as leading companies, products, applications, and end-user. Besides this, it offers insights into the digital pathology market trends in the global market and highlights key industry developments. In addition to the abovementioned factors, the report encompasses several factors that have contributed to the market's growth in recent years.

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