Tissue Diagnostics Market

The tissue diagnostics market is valued at an estimated USD 6.74 billion in 2025 and is projected to reach USD 10.86 billion by 2030, at a CAGR of 10.0%. The tissue diagnostics market is growing steadily, driven by the rising global incidence of cancer and the increasing need for accurate, early detection tools. The shift toward digital pathology is transforming traditional workflows through improved efficiency and remote analysis. Expanding healthcare expenditure, especially in emerging economies, is also supporting greater adoption of advanced diagnostic technologies. Moreover, the growing availability of reimbursements and the establishment of private diagnostic centers are further boosting access to tissue-based testing and strengthening market growth.  

In April 2025, F. Hoffmann-La Roche Ltd. (Switzerland)  received FDA Breakthrough Device Designation for the VENTANA TROP2 (EPR20043) RxDx Device, the first AI-driven companion diagnostic for non-small cell lung cancer (NSCLC). The device integrates the TROP2 algorithm, Navify Digital Pathology platform, Roche DP 200/600 scanners, and the VENTANA TROP2 assay stained on the BenchMark ULTRA system using the OptiView DAB Detection Kit.

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In March 2025, Epredia (US) received US FDA 510(k) clearance for its E1000 Dx Digital Pathology Solution, developed to enhance laboratory workflows in cancer diagnostics.

The top players in this market are F. Hoffmann-La Roche Ltd. (Switzerland), Agilent Technologies (US), PHC Holdings Corporation (Japan), and Danaher Corporation (US). These players hold leading positions in the market owing to their broad product offerings in the tissue diagnostics market. These players have undertaken various organic and inorganic growth strategies, such as product launches and approvals, collaborations, acquisitions, and agreements, to retain their position in the market.

F. Hoffmann-La Roche Ltd. (Switzerland) holds a leading position in the tissue diagnostics market. It is known for its comprehensive portfolio of instruments, reagents, and software solutions that enable accurate and standardized tissue-based testing. The company’s VENTANA and BenchMark systems are widely adopted across pathology laboratories for immunohistochemistry (IHC) and in situ hybridization (ISH) applications, ensuring reproducibility and workflow efficiency. Roche’s focus on automation, quality, and integration has positioned it as a key enabler of advanced diagnostic practices, supporting faster turnaround times and improved clinical decision-making. With strong R&D capabilities and a global distribution network, Roche continues to innovate in digital pathology and advanced staining systems to enhance diagnostic precision. Its commitment to delivering end-to-end solutions, from tissue preparation to visualization, along with a customer-centric service model, reinforces its leadership and reliability in the global tissue diagnostics landscape.

Danaher Corporation (US) is a major player in the tissue diagnostics market, primarily through its subsidiary Leica Biosystems, which offers a broad range of instruments, consumables, and workflow solutions for anatomic pathology laboratories. The company’s portfolio includes advanced microtomes, tissue processors, automated stainers, and digital pathology systems that streamline and standardize the histopathology workflow. Danaher’s strength lies in its strong operational excellence, focus on quality, and integration of scalable technologies that support both routine diagnostics and research applications. Its Leica Biosystems brand is recognized for its precision-engineered systems, comprehensive reagent kits, and robust digital solutions that facilitate high-quality, reproducible results. By aligning its technologies with evolving laboratory needs and investing in advanced diagnostic capabilities, Danaher continues to strengthen its leadership and expand its global footprint in the tissue diagnostics market.

PHC Holdings Corporation (Japan), through its subsidiaries such as Epredia, plays a vital role in the global tissue diagnostics market with a broad range of histology and cytology solutions. The company’s portfolio spans tissue processors, microtomes, embedding systems, and staining instruments designed to improve accuracy, efficiency, and reproducibility in tissue preparation and analysis. Epredia, in particular, brings decades of expertise in anatomic pathology, enabling PHC Holdings to offer dependable, high-quality products that meet the evolving demands of diagnostic laboratories. Its strong manufacturing capabilities, global service reach, and technical collaborations contribute to maintaining consistent performance across diverse laboratory environments. With increasing attention toward automation, quality assurance, and traceability in pathology workflows, the company remains well-positioned to support the shift toward more streamlined and reproducible tissue diagnostic practices.

Market Ranking

The top five players in the tissue diagnostics market are F. Hoffmann-La Roche Ltd. (Switzerland), Danaher Corporation (US), Agilent Technologies, Inc. (US), PHC Holdings Corporation (Japan), and  Merck KGaA (Germany), each driving market growth through advanced testing solutions, global reach, and comprehensive product portfolios.

Related Reports:

Tissue Diagnostics Market by Product (Consumables [Antibodies, Kits, Reagents, Probes], Instruments [Systems, Scanner], Software, Services), Technology (ISH, IHC, Slide Staining), Disease Type (Breast Cancer, Lymphoma, Prostate Cancer) - Forecast to 2030

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