Anatomic Pathology Track & Trace Solution Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Application (Slides Tracking, Specimen Tracking, Tissue Cassettes & Blocks Tracking), By End User (Hospital Laboratories, Independent & Reference Laboratories, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 673.93 MIllion
CAGR (2026-2031)	7.48%
Fastest Growing Segment	Hospital Laboratories
Largest Market	North America
Market Size (2031)	USD 1038.92 MIllion

Market Overview

The Global Anatomic Pathology Track & Trace Solution Market will grow from USD 673.93 MIllion in 2025 to USD 1038.92 MIllion by 2031 at a 7.48% CAGR. Anatomic pathology track and trace solutions consist of integrated hardware and software systems designed to monitor biological specimens throughout the laboratory workflow to ensure accurate identification and chain of custody. The market is primarily propelled by the escalating global prevalence of chronic diseases requiring tissue diagnostics and the critical necessity to eliminate pre-analytical errors that compromise patient safety. Furthermore, stringent regulatory mandates regarding laboratory accreditation enforce the adoption of these automated identification technologies to mitigate liability risks and improve operational efficiency.

Despite these drivers, the substantial capital investment required for implementation and the complexity of interfacing these systems with legacy laboratory information infrastructure present significant barriers to broad adoption. This challenge is intensified by the growing burden on diagnostic resources which necessitates efficiency yet strains financial budgets. According to the American Cancer Society, in 2024, approximately 2,001,140 new cancer cases were projected to occur in the United States. This surging volume of diagnostic demand underscores the urgent need for robust tracking capabilities despite the economic impediments to their acquisition.

Key Market Drivers

The escalating global prevalence of cancer and chronic diseases acts as a primary catalyst for the adoption of anatomic pathology track and trace solutions, fundamentally necessitating higher throughput and precision in tissue diagnostics. As the burden of oncological conditions intensifies, laboratories face unprecedented pressure to process increasing volumes of biopsy specimens without compromising speed or accuracy. This surge in diagnostic demand directly correlates with the need for automated tracking systems to manage complex workflows and ensure specimen integrity from collection to archiving. According to the American Cancer Society, January 2025, in the 'Cancer Facts & Figures 2025' report, an estimated 2,041,910 new cancer cases are projected to be diagnosed in the United States alone, underscoring the critical requirement for scalable laboratory infrastructures capable of handling this growing workload.

Concurrently, the critical need to minimize diagnostic errors and misidentification serves as a forceful driver, compelling laboratories to implement robust chain-of-custody technologies to safeguard patient safety. Manual labeling and specimen handling processes are increasingly viewed as untenable sources of risk, prompting a shift toward barcode and RFID-enabled tracking to mitigate liability and adhere to strict quality standards. This focus on error reduction is highlighted by industry safety watchdogs; according to ECRI, March 2025, in the 'Top 10 Patient Safety Concerns 2025' report, diagnostic errors regarding cancers, major vascular events, and infections were identified as the seventh most critical safety challenge facing healthcare organizations. Furthermore, regulatory compliance reinforces this trend, as evidenced by the growing number of facilities seeking rigorous quality stamps. According to the College of American Pathologists, March 2025, in the '2024 Annual Report', a record 657 laboratories achieved initial accreditation, reflecting the expanding market commitment to standardized, error-free diagnostic operations.

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Key Market Challenges

The substantial capital investment required to implement anatomic pathology track and trace solutions acts as a significant barrier to market expansion. Laboratories face high upfront costs for necessary hardware and software, which are further complicated by the expenses associated with interfacing these new tools with legacy laboratory information systems. This financial burden is particularly difficult for smaller, independent facilities that operate on rigid budgets and cannot easily absorb the costs of upgrading infrastructure or retraining staff to manage complex integrated networks.

These economic pressures are compounded by external financial constraints that limit the discretionary funds available for technological improvements. When laboratories experience reduced revenue streams, they are often forced to prioritize immediate operational expenses over capital equipment purchases. According to the College of American Pathologists, in 2024, the final Medicare Physician Fee Schedule resulted in an overall payment reduction of approximately 2 percent for pathology services. This contraction in financial reimbursement directly impedes the ability of pathology groups to secure the budget necessary for automated tracking systems, stalling their adoption despite the clear operational benefits.

Key Market Trends

The integration of track and trace systems with digital pathology workflows is rapidly emerging as a transformative trend, fundamentally shifting the market from simple physical tracking to holistic diagnostic data management. This convergence addresses the growing necessity to link physical specimens directly with their digital counterparts, such as whole slide images (WSI), ensuring that the chain of custody extends into the virtual diagnostic space. As laboratories increasingly adopt remote sign-out and telepathology, the ability to maintain synchronized identification between the glass slide and its digital twin becomes a prerequisite for operational continuity. This shift toward digitization is substantial; according to Labcorp, February 2024, in the '2024 Lab Leader Report', approximately 33% of surveyed laboratory decision-makers had either started or planned to implement digital pathology workflows, creating a parallel demand for tracking solutions capable of bridging the physical-digital divide.

Seamless interoperability with Laboratory Information Systems (LIS) and Electronic Health Records (EHR) has concurrently become a dominant market requirement, moving beyond basic connectivity to demand deep, bi-directional data integration. Laboratories are actively phasing out standalone tracking solutions that create data silos, favoring systems that can automatically populate accession data and update case status in real-time across the enterprise IT architecture. This trend is driven by the operational imperative to eliminate redundant data entry and ensure that specimen location data is instantly accessible to clinicians and pathologists within their primary diagnostic interfaces. The urgency of this requirement is evident in current industry challenges; according to Medical Laboratory Observer, April 2024, in the '2024 State of the Industry Survey', 51% of laboratory professionals identified interoperability and data integration issues with other systems as a significant stumbling block, directly influencing the market preference for open-architecture tracking platforms.

Segmental Insights

Hospital laboratories represent the fastest-growing segment in the Global Anatomic Pathology Track & Trace Solution Market due to the increasing volume of diagnostic tests and the critical need for patient safety. These facilities are prioritizing the adoption of tracking systems to minimize specimen identification errors and improve workflow efficiency. The growth is further propelled by strict adherence to accreditation standards set by organizations such as the College of American Pathologists, which mandate rigorous sample management protocols. Consequently, hospitals are actively integrating these solutions to ensure accuracy and compliance in their diagnostic processes.

Regional Insights

North America maintains a leading position in the global anatomic pathology track and trace solution market, driven by stringent regulatory requirements and a strong focus on patient safety. The region exhibits high adoption rates of automated tracking systems to mitigate specimen labeling errors and improve workflow efficiency. Compliance with rigorous quality control standards enforced by the U.S. Food and Drug Administration compels laboratories to implement robust identification technologies. Furthermore, the established healthcare infrastructure and continuous investment in diagnostic precision support the sustained expansion of this regional market.

Recent Developments

• In January 2025, Leica Biosystems announced a significant strategic investment in Indica Labs to co-develop a comprehensive digital pathology solution. The companies planned to launch a platform that combines Leica’s Aperio scanning hardware with a customized version of Indica’s HALO AP image management software. This integrated system was designed to allow clinical laboratories to manage digital workflows effectively, enabling both onsite and remote primary diagnosis while supporting open interfaces for various artificial intelligence applications. The collaboration aimed to streamline the tracking and management of digital slides, thereby enhancing the scalability and precision of anatomic pathology operations.
• In August 2024, Sakura Finetek USA formed a strategic partnership with KUBTEC to distribute advanced specimen imaging systems to pathology laboratories across the United States. This collaboration involved the commercialization of KUBTEC’s digital x-ray and optical imaging products, which are utilized during the grossing phase of the pathology workflow to verify specimen integrity and surgical margins. By integrating these imaging technologies, the companies aimed to improve the accuracy of tissue processing and documentation. The alliance was designed to enhance laboratory grossing efficiency and provide pathologists with critical visual data required for accurate case tracking and diagnosis.
• In February 2024, Roche entered into a collaboration agreement with PathAI to develop artificial intelligence algorithms specifically for its companion diagnostics business. Under this arrangement, the partner company agreed to work exclusively with Roche Tissue Diagnostics for a specified period to create AI-powered solutions that integrate seamlessly into the navify Digital Pathology platform. This initiative aimed to accelerate the adoption of digital workflows by embedding advanced diagnostic tools directly into the laboratory's case management systems. The partnership focused on enhancing precision medicine capabilities and improving the efficiency of specimen analysis and data tracking for patient diagnosis.
• In January 2024, Epredia announced the launch of sales for its SlideMate Laser printer in the United States, a solution designed to enhance sample traceability in anatomic pathology laboratories. This technology enables high-resolution laser printing directly onto microscope slides, allowing for the embedding of significantly more characters in a barcode compared to traditional methods. By facilitating the inclusion of detailed identifying information on slide tabs, the system aims to reduce potential errors and improve patient sample tracking throughout the cancer diagnostics workflow. The product was developed to support laboratories of various sizes in maintaining robust chain-of-custody and optimizing operational efficiency.

Key Market Players

• Leica Biosystems Nussloch GmbH
• Thermo Fisher Scientific Inc
• Zebra Technologies Corp.
• Agilent Technologies Inc
• CompuGroup Medical
• LigoLab Information Systems
• General Data Healthcare Inc.
• Psychē Systems Corporation
• Siemens Healthineers AG
• Indica Labs, LLC

By Application	By End User	By Region
Slides Tracking Specimen Tracking Tissue Cassettes & Blocks Tracking	Hospital Laboratories Independent & Reference Laboratories Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Anatomic Pathology Track & Trace Solution Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Anatomic Pathology Track & Trace Solution Market, By Application:

• Slides Tracking
• Specimen Tracking
• Tissue Cassettes & Blocks Tracking

• Anatomic Pathology Track & Trace Solution Market, By End User:

• Hospital Laboratories
• Independent & Reference Laboratories
• Others

• Anatomic Pathology Track & Trace Solution Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE