North America Digital Pathology Market Size, Share & Trends Analysis Report By Product (Software, Device), By Application, By End Use (Cancer Hospitals, Diagnostic Labs), By Region, And Segment- Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2023-2032

The North America digital pathology market size was estimated at USD 553.89 million in 2022 and is expected to surpass around USD 1049.54 million by 2032 and poised to grow at a compound annual growth rate (CAGR) of 6.6% during the forecast period 2023 to 2032.

North America Digital Pathology Market Size, 2023 to 2032

Key Takeaways:

  • The device segment dominated the market and accounted for the largest revenue share of 58.0% in 2022.
  • The academic and research institutes segment dominated the North America digital pathology market and held the leading revenue share of 69.0% in 2022.
  • The academic research segment dominated the market and accounted for the largest revenue share of 49.0% in 2022.
  • The disease diagnosis segment accounted for a revenue share of 49.0% in 2022.
  • In North America, the U.S. dominated the market and accounted for the largest revenue share of 85.5% in 2022.

North America Digital Pathology Market Report Scope

Report Attribute Details
Market Size in 2023 USD 590.45 million
Market Size by 2032 USD 1049.54 million
Growth Rate From 2023 to 2032 CAGR of 6.6%
Base Year 2022
Forecast Period 2023 to 2032
Segments Covered Product, Application, End use, Country
Market Analysis (Terms Used) Value (US$ Million/Billion) or (Volume/Units)
Report Coverage Revenue forecast, company ranking, competitive landscape, growth factors, and trends
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

 

The market is predominantly driven by the growing prevalence of chronic diseases such as cancer. As a consequence of the high prevalence of cancer, pathologists require data that facilitate personalizing therapy for patients. Hence, digital pathology is progressively being selected by pathologists as it has various benefits including accelerated diagnosis rate, diagnostic accuracy, and offers therapeutic recommendations to improve patient outcomes.

The growing number of collaborative agreements to develop as well as expedite the adoption of digital pathology in cancer diagnostics serves as a key growth factor contributing to the market. The use of artificial intelligence in digital pathology has gained momentum in the past years. The increasing need for lowering healthcare costs, increasing importance of big data in healthcare, rising adoption of precision medicine, and declining hardware costs are some factors driving the growth. In addition, increasing usage of artificial intelligence-based analytical tools in healthcare and high capital investments in this field are further propelling the market growth.

During the coronavirus outbreak, the exponential need for home-based workstations and safe clinical informatics systems allowing healthcare professionals to read images remotely and enabling virtual collaboration between their multi-disciplinary care teams has increased. Various histopathology departments in the region faced a reducing workforce and increasing workload during the pandemic. Digital pathology considered being the potential solution for some of the challenges faced by the pathologist, there is an increase in the adoption of digital diagnosis of disease during coronavirus outbreak.

In April 2020, Philips announced that the FDA granted a waiver for home use of consumer monitors with the company's IntelliSite Pathology Solution during the emergency. The temporary exemption of restrictions on remote use of the digital pathology helps pathologists to access whole slide images from home and fasten the diagnosis of histology cases. Some pathology labs that have adopted DP in their workflows across different sites pre-COVID-19, reported improved collaboration, and an average productivity gain of 21.0% with operation efficiency increased by 13.0%. These types of initiatives are anticipated to fuel market growth.

Product Insights

The device segment dominated the market and accounted for the largest revenue share of 58.0% in 2022. 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.

End-use Insights

The academic and research institutes segment dominated the North America digital pathology market and held the leading revenue share of 69.0% in 2022. 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.

Application Insights

The academic research segment dominated the market and accounted for the largest revenue share of 49.0% in 2022. The disease diagnosis segment accounted for a revenue share of 49.0% in 2022. 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.

Country Insights

In North America, the U.S. dominated the market and accounted for the largest revenue share of 85.5% in 2022. 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.

Key Companies & Market Share Insights

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:

  • 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.
  • Sectra AB

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2032. For this study, Nova one advisor, Inc. has segmented the North America Digital Pathology market.

By Product 

  • Software
  • Device

By Application 

  • Drug Discovery & Development
  • Academic Research
  • Disease Diagnosis
  • Cancer Cell Detection
  • Others

By End-use 

  • Cancer Hospitals
  • Diagnostic Labs
  • Academic & Research Institutes

By Country 

U.S.

Canada

Frequently Asked Questions

The North America digital pathology market size was estimated at USD 553.89 million in 2022 and is expected to surpass around USD 1049.54 million by 2032

The North America digital pathology market is expected to grow at a compound annual growth rate of 6.6% from 2023 to 2032

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

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.

Chapter 1 Research Methodology & Scope
                   1.1 Market Segmentation & Scope
                       1.1.1 Estimates and Forecast Timeline
                   1.2 Research Methodology
                   1.3 Information Procurement
                       1.3.1 Purchased database:
                       1.3.2 Nova one advisor Internal Database
                       1.3.3 Secondary sources
                       1.3.4 Primary Research:
                       1.3.5 Details of Primary Research
                   1.4 Information or Data Analysis
                       1.4.1 Data Analysis Models
                   1.5 Market Formulation & Validation
                   1.6 Model Details
                       1.6.1 Commodity Workflow Analysis (Model 1)
                   1.7 List of Primary Sources
                   1.8 List of Secondary Sources
                   1.9 List of Abbreviations
                   1.10 Market Definitions
                   1.11 Report Objectives
Chapter 2 Executive Summary
                   2.1 Market Outlook
                       2.1.1 North America North America Digital Pathology Market Outlook, 2020-2032
                   2.2 North America North America Digital Pathology Market Summary, 2023
                   2.3 Segment Outlook
                   2.4 Regional Insights
                       2.4.1 U.S.
                            2.4.1.1 U.S. Digital Pathology market estimates and forecasts, 2020 - 2032
                       2.4.2 Canada
                            2.4.2.1 Canada Digital Pathology market estimates and forecasts, 2020 - 2032
                   2.5 Competitive Insights
Chapter 3 North America Digital Pathology Market: Product Estimates & Trend Analysis
                   3.1 North America Digital Pathology Market: Product Movement Analysis
                   3.2 Software
                       3.2.1 Software market estimates and forecasts, 2020 - 2032
                   3.3 Devices
                       3.3.1 Device market estimates and forecasts, 2020 - 2032
Chapter 4 North America Digital Pathology Market: Application Estimates & Trend Analysis
                   4.1 North America Digital Pathology Market: Application Movement Analysis
                   4.2 Drug Discovery & Development
                       4.2.1 Drug Discovery & Development market estimates and forecasts, 2020 - 2032
                   4.3 Academic Research
                       4.3.1 Academic Research market estimates and forecasts, 2020 - 2032
                   4.4 Disease Diagnosis
                       4.4.1 Disease Diagnosis market estimates and forecasts, 2020 - 2032
                       4.4.2 Cancer cell Detection
                            4.4.2.1 Cancer cell detection market estimates and forecasts, 2020 - 2032
                       4.4.3 Other applications
                            4.4.3.1 Other applications market estimates and forecasts, 2020 - 2032
Chapter 5 North America Digital Pathology Market: End-use Estimates & Trend Analysis
                   5.1 North America Digital Pathology Market: End-use Movement Analysis
                   5.2 Cancer Hospitals
                       5.2.1 Hospitals market estimates and forecasts, 2020 - 2032
                   5.3 Diagnostic Laboratories
                       5.3.1 Diagnostic Laboratories MARKET estimates and forecasts, 2020 - 2032
                       5.3.2 Independent Pathology Labs
                            5.3.2.1 Independent Pathology labs market estimates and forecats, 2020 - 2032
                       5.3.3 Large Pathology Labs
                            5.3.3.1 Large Pathology labs market estimates and forecats, 2020 - 2032
                   5.4 Academic and Research Institutes
                       5.4.1 Academic and Research Institutes market estimates and forecasts, 2020 - 2032
Chapter 6 North America Digital Pathology Market Variables, Trends & Scope
                   6.1 Market Lineage Outlook
                       6.1.1 Parent market outlook
                       6.1.2 Ancillary market outlook
                   6.2 Penetration & Growth Prospect Mapping
                   6.3 North America Digital Pathology Market Dynamics
                       6.3.1 Market Driver Analysis
                            6.3.1.1 Increasing prevalence of chronic diseases
                            6.3.1.2 Higher Cost-Efficiency
                            6.3.1.3 Rapid technological advancement
                       6.3.2 Market restraint analysis
                            6.3.2.1 Lack of reimbursement for digital pathology-enabled services
                       6.3.3 Industry Challenges
                   6.4 North America Digital Pathology Market Analysis Tools: Porters
                   6.5 SWOT Analysis By Factors (Political & Legal, Economic, Social and Technology)
                   6.6 Regulatory Framework
                       6.6.1 List of regulations
                   6.7 Political Landscape, Current & Future Scenario
                       6.7.1 List of regulations
                   6.8 Cost Structure Analysis
                       6.8.1 Price Erosion Analysis
Chapter 7 Potential Buyer Analysis
                   7.1 U.S. Demographic Information and Consumer Market Size
                       7.1.1 Pathology Laboratories
                       7.1.2 Hospitals
                       7.1.3 Academic & Research Institutes
                   7.2 List of Potential Customers
                       7.2.1 List of hospitals in the U.S
                       7.2.2 List of Pathology Laboratoreis in the U.S
                       7.2.3 Penetration of Digital Pathology
                       7.2.4 Estimated Penetration of Digital Pathology In Primary Read Vs Secondary in the U.S.
                            7.2.4.1 Estimated penetration of digital pathology in pathology laboratories
                            7.2.4.2 Estimated penetration of digital pathology in Cancer Hospitals
                   7.3 Future Outlook
                       7.3.1 User Perspective Analysis
                            7.3.1.1 Consumer behaviour analysis
                            7.3.1.2 Market influencer analysis
                                7.3.1.2.1 Consumer preference
                                7.3.1.2.2 Technology trends
                                7.3.1.2.3 Cost of implementation
                       7.3.2 Opportunity Analysis
                            7.3.2.1 Potential growth for digital pathology solutions
                            7.3.2.2 Market Entry Strategies
                            7.3.2.3 Regulatory requirements for new players
                            7.3.2.4 Competitive Strategies
                   7.4 Covid-19 Impact Analysis
                       7.4.1 COVID-19 Outbreak
                       7.4.2 Current Scenario
                       7.4.3 Demand Analysis
Chapter 8 North America Digital Pathology Market Competitive & Vendor Landscape
                   8.1 Participation Categorization
                   8.2 Public Companies
                       8.2.1 Estimated Company Market Share Analysis, 2023
                       8.2.2 Company market position analysis
                   8.3 Private Companies
                       8.3.1 Company market position analysis
                       8.3.2 Regional network map
                       8.3.3 List of emerging companies
                   8.4 Recent Developments & Impact Analysis, By Key Market Participants
                       8.4.1 Strategic Initiatives & Outcome Analysis
                   8.5 Major Deals And Strategic Alliances Analysis
                   8.6 Case Study
                   8.7 Detailed List of Players
                       8.7.1 List Of Distributors
                       8.7.2 List Of Key Companies, by Region
Chapter 9 Company Profiles
                   9.1 Danaher
                       9.1.1 Company overview
                       9.1.2 Financial performance
                       9.1.3 Product benchmarking
                       9.1.4 Strategic initiatives
                   9.2 Hamamatsu Photonics, Inc.
                       9.2.1 Company overview
                       9.2.2 Financial performance
                       9.2.3 Product benchmarking
                       9.2.4 Strategic Initiatives
                   9.3 Koninklijke Philips N.V.
                       9.3.1 Company overview
                       9.3.2 Financial performance
                       9.3.3 Product benchmarking
                       9.3.4 Strategic Initiatives
                   9.4 Olympus Corporation
                       9.4.1 Company overview
                       9.4.2 Financial performance
                       9.4.3 Product benchmarking
                       9.4.4 Strategic Initiatives
                   9.5 F. Hoffmann-La Roche Ltd
                       9.5.1 Company overview
                       9.5.2 Financial performance
                       9.5.3 Product benchmarking
                       9.5.4 Strategic Initiatives
                   9.6 Mikroscan Technologies, Inc.
                       9.6.1 Company overview
                       9.6.2 FINANCIAL PERFORMANCE
                       9.6.3 Product benchmarking
                       9.6.4 Strategic Initiatives
                   9.7 3DHISTECH LTD
                       9.7.1 Company overview
                       9.7.2 FINANCIAL PERFORMANCE
                       9.7.3 Product benchmarking
                       9.7.4 Strategic initiatives
                   9.8 Inspirata, Inc.
                       9.8.1 Company overview
                       9.8.2 Financial performance
                       9.8.3 Product benchmarking
                       9.8.4 Strategic initiatives
                   9.9 Visiopharm A/S
                       9.9.1 Company overview
                       9.9.2 Financial performance
                       9.9.3 Product benchmarking
                       9.9.4 Strategic initiatives
                   9.10 Huron Technologies International, Inc.
                       9.10.1 Company overview
                       9.10.2 Financial performance
                       9.10.3 Product benchmarking
                       9.10.4 Strategic initiatives
Chapter 10 Key Opinion Leader (KOL) Commentary

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