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DIGITAL PATHOLOGY MARKET ANALYSIS

Digital Pathology Market, by Product Type (Image Analysis Software, Scanner {Bright Field Scanner, Fluorescence Scanner}, Services {Installation & Integration, Maintenance Services, Consulting Services}), by Therapeutic Area (Oncology, Hematology, Autoimmune Disorder, Dermatology and Others), by Technology (Immunohistochemistry, ISH & FISH, Immunofluorescence and others) End User (Pharmaceutical & Biotechnology Companies, Diagnostic Labs, Hospital Laboratories, and Others), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa)

  • Published In : May 2023
  • Code : CMI379
  • Pages :240
  • Formats :
      Excel and PDF
  • Industry : Medical Devices

Global Digital Pathology Market is estimated to be valued at US$ 884.4 million in 2023 and is expected to exhibit a CAGR of 12.2% during the forecast period (2023-2030). Increase in product launches by market players is expected to drive the market words over forecast period. Moreover, increase in number of government initiatives is expected to drive the market growth.

Analysts’ Views on Global Digital Pathology Market :

Increasing number of product launches by market players can boost the market growth over forecast period. For instance, in November 2022, Nucleai, Inc., a software and AI-powered spatial biology solution providing company, launched the new generation of multiplex immunofluorescence (mIF) analysis system. The newly launched multiplex immunofluorescence (mIF) analysis system provides increased levels of speed and accuracy for drug discovery and development.

Figure 1. Global Digital Pathology Market Share (%), By Product Type, 2023

DIGITAL PATHOLOGY MARKET

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Global Digital Pathology Market- Driver

Rising Government Initiatives

Increasing initiatives by government bodies such as loosening restrictions on digital pathology software-hardware approvals and others is expected to offer lucrative growth opportunities. For instance, in April 2020, the U.S. Food and Drug Administration (FDA) issued a waiver permitting pathologists to perform primary readings from their homes and loosening restrictions on software-hardware approvals. This resulted in an increase of digital clinical pathology implementation.

Increasing Technological Advancements in Digital Pathology Systems

Digital pathology offers a better viewing experience, which enhances analysis. This lowers diagnostic error rates. These tools additionally provide service providers immediate access to earlier cases for comparison. These advanced systems store data for use in long-term predictive analysis. Specimens are barcoded to reduce the chance of misidentification. Also, this removes concerns about lost data due to slide breakage. Increasing technological advancements in digital pathology systems is expected to drive the market growth over the forecast period. For instance, according to an article published by Visceral Medicine Journal in 2021, digital pathology has technological advancement from artificial intelligence to label-free imaging. The use of artificial intelligence in digital pathology is growing along with the development of slide scanners, the abundance of data produced, and ever-increasing computing power.

Figure 2. Global Digital Pathology Market Share (%), By Region, 2023

DIGITAL PATHOLOGY MARKET

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Global Digital Pathology Market - Regional Analysis

Among regions, North America is expected to dominate the market over the forecast period. The key drivers that are expected to propel the North America digital pathology market growth include the need for improving efficiency and accuracy of pathological diagnosis alongside the higher demand for remote work. As stated by Margaretta Colangelo, an advisory board member of the AI Precision Health Institute at the University of Hawaiʻi Cancer Center, in May 2022, the number of pathologists in North America is 4X less than what is needed on a global scale.

Europe is expected to hold second position in Global Digital Pathology Market over the forecast period. Europe is among the early adopters of digital pathology. One of the key drivers of its adoption in the region is that digital pathology supports collaborative research. Digital pathology provides access to large datasets & pathological images even from remote locations. This has encouraged several organizations to collaborate for adoption of a common digital platform. For instance, in 2020, the Deutsches Krebsforschungszentrum (DKTK) also known as the German Cancer Consortium, launched a Joint Imaging Platform (JIP) in the radiology and nuclear medicine departments of 10 university hospitals in Germany for feasible and shared analysis of pathological images.

Global Digital Pathology Market- Impact of Coronavirus (COVID-19) Pandemic

According to World Health Organization (WHO), Coronavirus disease 2019 (COVID-19) is a highly contagious infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).  Till January 16, 2023, worldwide 663,640,386 people were affected.

The COVID-19 had a positive impact on the global digital pathology market, as many pharmaceutical and medical device companies were focusing on developing image analysis software and slide scanners for digital pathologies. Thus, increasing launches of new digital diagnostic system during the pandemic, aided in the growth of global digital pathology market. For instance, in November 2020, 3DHISTECH Ltd., a software company based in the U.K., launched new digital diagnostic system named PANNORAMIC pathology diagnostic system, which aids to fulfill special requirements of routine pathology. The PANNORAMIC pathology diagnostic system is a new integrated digital pathology solution that enables the pathologist to deliver a quick diagnosis.

Digital Pathology Market Report Coverage

Report Coverage Details
Base Year: 2022 Market Size in 2023: US$ 884.4 Mn
Historical Data for: 2017 to 2021 Forecast Period: 2023 to 2030
Forecast Period 2023 to 2030 CAGR: 12.2% 2030 Value Projection: US$ 1,977.9 Mn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC Countries, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Product Type: Image Analysis Software, Scanner (Bright Field Scanner, Fluorescence Scanner), Services (Installation and Integration, Maintenance Services, Consulting Services)
  • By Therapeutic Area: Oncology, Hematology, Autoimmune Disorders, Dermatology, Others  
  • By Technology: Immunohistochemistry, ISH & FISH, Immunofluorescence, Others
  • By End User: Pharmaceutical and Biotechnology Companies, Diagnostic Labs, Hospital Laboratories, Others 
Companies covered:

Leica Biosystems Nussloch GmbH,  Olympus Corporation,  F. Hoffmann-La Roche Ltd.,  Merck KGaA,  GE Healthcare,  Mikroscan Technologies, Inc.,  Koninklijke Philips N.V.,  Sectra AB,  Propath UK Limited,  Inspirata, Inc.,  Hamamatsu Photonics, Inc.,  OracleBio Limited,  MD Biosciences,  Aiforia,  Xybion Digital Inc.,  Nucleai, Inc

Growth Drivers:
  • Increasing product launches and product approval by key players in the market
  • The increasing collaboration, agreements between market players 
Restraints & Challenges:
  • The high cost of digital pathology system 

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Global Digital Pathology Market Segmentation:

The Global Digital Pathology Market report is segmented into Product Type, Therapeutic Area, Technology, End User and Region

Based on Product Type, the market is segmented into, Image Analysis Software, Scanner, Services. Out of which, image analysis software segment is expected to dominate the global digital pathology market during the forecast period and this is attributed due to increasing product launches

Based on Therapeutic Area, the market is segmented into oncology, Hematology, Autoimmune Disorders, Dermatology and others. Out of which, oncology segment is expected to dominate the market over the forecast period and this is attributed due to increasing usage of digital pathology in various cancer/tumor types.

Based on Technology, the market is segmented into Immunohistochemistry, ISH & FISH, Immunofluorescence and Others. Out of which, Immunohistochemistry segment is expected to dominate the market over the forecast period and this is attributed due to increasing research and development activities.

Based on End User, Global Digital Pathology Market is segmented into Pharmaceutical and Biotechnology Companies, Diagnostic Labs, Hospital Laboratories and Others. Pharmaceutical and Biotechnology Companies segment is expected to dominate the market over the forecast period and this is attributed to the increasing product launches by pharmaceutical and biotechnology companies operating in the market.

Based on Region, Global Digital Pathology Market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East and Africa. North America is expected to dominate the market over the forecast period and this is attributed to the increase in number of product approvals from regulatory authorities.

Among all segmentation, product type segment has highest potential due to increasing product launches by market players. For instance, in October 2021, PerkinElmer, Inc., a life-science research, and food, environmental, and industrial testing company, launched the Signals Image Artist software, a next-generation cell image analysis software. Signals image artist software is used in the management platform of drug discovery research.

Global Digital Pathology Market Cross Sectional Analysis:

Among product type segment, Scanner held as a dominant segment in 2023 in North America region due to increasing product launches. For instance, in June 2022, F. Hoffmann-La Roche Ltd, a pharmaceutical company, announced the launch of the next-generation VENTANA DP 600 slide scanner with CE-IVD mark (Conformité Européenne-in vitro diagnostic mark). This newly launched slide scanner produces clear image of stained histology slides from patient tissue samples. It also provides ease-of-use and workflow flexibility to pathology lab workers.

In therapeutic area segment, oncology segment is dominant in North America region due to increasing incidence of cancer. For instance, in December 2022, according to the article published by the National Center for Biotechnology Information, the number of cancer cases in India for the year 2022 were estimated to be 14,61,427 (crude rate:100.4 per 100,000).

Global Digital Pathology Market: Key Developments

In September 2022, Scopio Labs, a company advancing digital microscopy, launched the Full-Field Bone Marrow Aspirate (FF-BMA) application platform. This platform is the first to allow a complete digital workflow for bone marrow aspirate scanning and analysis. The highresolution full-field imaging and AI-driven decision support system from Scopio bring hematopathology one step closer to the much-needed digital transformation.

On October 18, 2022, GE Healthcare, a manufacturing company, and Tribun Health, a software company, announced a partnership with the goal of delivering departmental digital pathology solutions that give healthcare professionals a more comprehensive understanding of patient records. The alliance intends to bring a data management solution by interfacing Tribun’s Health Suite data into GE Healthcare’s solution, such as GE Healthcare’s vendor neutral archive, Edison Datalogue.

In April 2022, Scopio Labs, a company advancing digital microscopy, announced the launch and CE Mark (Conformité Européenne) approval of X100 Full Field Peripheral Blood Smear (Full Field PBS) all-digital morphology analysis platform, which is the first digital microscope that allows remote consultation and includes a computer-vision based decision support system, advancing manual microscopy into the digital age.

In May 2022, OptraSCAN India Private Limited, a company that provides the digital pathology solutions, announced that its digital pathology scanner OS-SiA had been granted U.S. patent-No 2020/0334814 A1 by the United States Patent and Trademark Office. With its built-in intelligence, OS-SiA can simultaneously scan, index, and analyze abnormal samples. The end user will benefit from being able to overlay the results of the analysis over the entire slide image that has been scanned.

Global Digital Pathology Market: Restraint

High cost of digital pathology system  

The use of digital pathology for routine diagnoses is rapidly expanding, but its widespread application is difficult from a financial standpoint. According to an article published in July 2022 by the National Center for Biotechnology Information, significant financial investments are needed for digital pathology, which may be affordable for high-income nations but are prohibitively expensive for many low- and middle-income nations. Despite the wide range of mentioned pricing for each device, a single high-throughput scanner will cost between US$ 100,000 and US$ 400,000. Additional expenses come from hardware (high-resolution displays and powerful computers), additional software, IT infrastructure, and staff.

Global Digital Pathology Market: Key Players

Major players operating in the global digital pathology market include Leica Biosystems Nussloch GmbH,  Olympus Corporation,  F. Hoffmann-La Roche Ltd.,  Merck KGaA,  GE Healthcare,  Mikroscan Technologies, Inc.,  Koninklijke Philips N.V.,  Sectra AB,  Propath UK Limited,  Inspirata, Inc.,  Hamamatsu Photonics, Inc.,  OracleBio Limited,  MD Biosciences,  Aiforia,  Xybion Digital Inc., Nucleai, Inc.

*Definition: Digital pathology is a branch of pathology that focuses on data management using data generated from digitized specimen slides. Digital pathology employs virtual microscopy through the use of computer-based technology.

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About Author

Manisha Vibhute is a consultant with over 5 years of experience in market research and consulting. With a strong understanding of market dynamics, Manisha assists clients in developing effective market access strategies. She helps medical device companies navigate pricing, reimbursement, and regulatory pathways to ensure successful product launches.

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Frequently Asked Questions

The global Digital Pathology Market size was valued at USD 884.4 million in 2023 and is expected to reach USD 1,977.9 million in 2030.

Global Digital Pathology Market is estimated to be valued at US$ 884.4 million in 2023 and is expected to exhibit a CAGR of 12.2% between 2023 and 2030.

Increasing product launches by market players, increasing government initiatives, and product approval by regulatory authorities in the market are expected to drive the Market growth

Image analysis software is the leading imaging technology segment in the market

The major factor that can hamper growth of the market include the high cost of digital pathology equipment

Major players operating in the market include Leica Biosystems Nussloch GmbH,  Olympus Corporation,  F. Hoffmann-La Roche Ltd.,  Merck KGaA,  GE Healthcare,  Mikroscan Technologies, Inc.,  Koninklijke Philips N.V.,  Sectra AB,  Propath UK Limited,  Inspirata, Inc.,  Hamamatsu Photonics, Inc.,  OracleBio Limited,  MD Biosciences,  Aiforia,  Xybion Digital Inc., Nucleai, Inc.
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