The North America digital pathology market size was valued at USD 365.8 million in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 6.5% from 2021 to 2028. Digital pathology has been classified under Class II devices by the U.S. FDA for primary diagnosis. The growing number of initiatives to promote the use of digital pathology as a tool for enhanced disease diagnosis and advanced pathology practice is creating potential opportunities for the market across the country. These organizations are striving to promote digital pathology through promoting awareness pertaining to practicalities and strategies adopted for proper implementation and improvement of pathology workflows.
The continual deployment of R&D investments, rising implementation of digital imaging, supportive government initiatives, and the presence of prominent players domiciled in this region are major drivers promoting the dominance of this regional market. The approval of the AI-powered tool designed by AI-based, digital pathology-focused companies to identify invasive breast cancer and skin lesions is another factor boosting the market growth.
Return on investment associated with digital pathology as a result of clinical workflow improvements, greater accuracy, and faster decision-making process, play a critical role in fueling the adoption of digital pathology. The presence of organizations involved in encouraging research in digital pathology is also one of the key factors responsible for the dominant share held by the market in the U.S. For instance, the Centre for Medical Image Science and Visualization (CMIV) aims toward delivering research solutions and develop advanced tools and visualization applications for image analysis.
The device segment dominated the market and accounted for the largest revenue share of 52.0% in 2020. The devices include scanners, clinical-grade computers, and slide management systems. Increasing adoption for academic and research activities and enhanced resolution are the key factors driving the growth of the segment.
Digital pathology also allows the sharing of information for publication and research, diagnostics, and education through the internet. Thus, it reduces the sharing costs. Traditionally, to achieve accurate tumor diagnosis results, multiple tests had to be carried out, which are drastically reduced by a single test performed by a digital pathology system. Increasing the usage rate of the digital imaging systems to facilitate quicker diagnosis, mainly of chronic diseases; the improved uptake of these products serves as the crucial driver for the market.
The academic and research institutes segment dominated the North America digital pathology market and held the leading revenue share of 65.0% in 2020. Digital pathology is predominantly used by research institutes, educational institutes, and veterinary pathologists. Academic medical centers, commercial labs, and large independent pathology labs were initial adopters of digital pathology systems. The high penetration in research institutes is due to the high adoption of digital pathology in oncology clinical trials, preclinical GLP pathology, and drug discovery and development.
Hospitals are implementing digital scanners for rapid diagnosis and better outcomes. As of now, it is anticipated to play a critical role in diagnostics as the FDA approved the digital pathology systems for primary diagnosis, further widening its growth potential. Rising cancer prevalence and high demand for better diagnostic and treatment options are further contributing towards the growth.
The academic research segment dominated the market and accounted for the largest revenue share of 46.0% in 2020. The disease diagnosis segment accounted for a revenue share of 46.0% in 2020. The growth of the academic research segment can be attributed to factors such as an increase in the adoption of digital pathology in various research studies including tumor morphological and biomarker profiling.
The disease diagnosis application segment of digital pathology is anticipated to exhibit the fastest growth. An increasing number of activities by public and private organizations such as the American Society for Clinical Pathology (ASCP) and College of American Pathologists (CAP), which are focused on improving the quality of cancer diagnosis is presenting lucrative growth opportunities. These organizations also aim to achieve ease of consultation through conducting regular training and quality assurance sessions concerning the usage of whole slide images in cancer diagnosis.
Moreover, increasing cancer cases demand a greater number of pathologists and subsequent working hours for cancer diagnosis. As cited in GE healthcare publications, digital pathology allows a pathologist to study approximately 150 slides in a day and, therefore, increases the overall laboratory efficiency by 13.0%. These associated benefits with the use of this technology are anticipated to propel growth in the coming years.
In North America, the U.S. dominated the market and accounted for the largest revenue share of 81.5% in 2020. This growth is attributed to the presence of companies focusing on research activities in digital pathology and the development of advanced tools to improve image analysis in the country.
The industry is expected to remain innovation-led, with frequent acquisitions and strategic alliances. Application development along with competent distribution channels will be key for competitive advantage. Leading companies are focusing on strategies such as collaborations, new product developments, research agreements, and mergers and acquisitions to gain a competitive advantage. For instance, in July 2020, Paige, a computational pathology player, received the U.S. FDA 510(k) clearance for the FullFocus, digital pathology image viewer for primary diagnosis. The clearance allowed in vitro diagnostic (IVD) use of FullFocus in conjugation with Philips Ultra-Fast Scanner.
Moreover, in April 2020, FDA approved Sectra's digital pathology module for primary diagnostics. Before this module is only used for research in the U.S. This module can be used in conjunction with the AT2 DX scanner provided by Leica Biosystem. This will intensify the competition in the market as previously the market is dominated by Philips. Some of the prominent market players in the North America digital pathology market include:
Hamamatsu Photonics, Inc.
Koninklijke Philips N.V.
F. Hoffmann-La Roche Ltd
Huron Technologies International, Inc.
Market size value in 2021
USD 382.3 million
Revenue forecast in 2028
USD 593.9 million
CAGR of 6.5% from 2021 to 2028
Base year for estimation
Actual estimates/Historical data
2016 - 2019
2021 - 2028
Revenue in USD Million and CAGR from 2021 to 2028
Revenue forecast, company share, competitive landscape, growth factors, and trends
Product, application, end use, country
Key companies profiled
Leica Biosystems; Hamamatsu Photonics, Inc.; Koninklijke Philips N.V., F. Hoffmann-La Roche Ltd, Mikroscan Technologies, 3DHISTECH Ltd., Inspirata, Inc. Visiopharm A/S, Huron Technologies International, Inc. and Sectra AB
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This report forecasts revenue growth at regional and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2028. For the purpose of this study, Grand View Research has segmented North America digital pathology market report on the basis of product, application, end-use, and country:
Product Outlook (Revenue, USD Million, 2016 - 2028)
Application Outlook (Revenue, USD Million, 2016 - 2028)
Drug Discovery & Development
Cancer Cell Detection
End-use Outlook (Revenue, USD Million, 2016 - 2028)
Academic & Research Institutes
Country Outlook (Revenue, USD Million, 2016 - 2028)
b. The North America digital pathology market size was estimated at USD 365.8 million in 2020 and is expected to reach USD 382.3 million in 2021.
b. The North America digital pathology market is expected to grow at a compound annual growth rate of 6.5% from 2021 to 2028 to reach USD 593.90 million by 2028.
b. Academic & research institutes held the leading market share of 65.0% as of 2020. Digital pathology is predominantly used by research institutes, educational institutes, and veterinary pathologists. Academic medical centers, commercial labs, and large independent pathology labs were initial adopters of digital pathology systems, thereby contributing to the dominant revenue share.
b. Some key players operating in the North America digital pathology market include Leica Biosystems; Hamamatsu Photonics, Inc.; Koninklijke Philips N.V., F. Hoffmann-La Roche Ltd, Mikroscan Technologies, 3DHISTECH Ltd., Inspirata, Inc. Visiopharm A/S, Huron Technologies International, Inc. and Sectra AB
b. Continual R&D investments, rising implementation of digital imaging, supportive government initiatives, and the presence of prominent players domiciled in this region are major drivers promoting the dominance of this regional market.
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