01 AI-Powered Digital Pathology Expands IHC Interpretation The immunohistochemistry market is increasingly integrating artificial intelligence and digital pathology into tissue-analysis workflows. AI-assisted image analysis can quantify biomarker expression and support more consistent interpretation than manual scoring alone. The combination of IHC staining with computational pathology is particularly relevant in oncology, where biomarker results can influence treatment selection. These developments are supporting immunohistochemistry market growth as laboratories adopt technologies that improve the efficiency and consistency of tissue-based diagnosis.In April 2025, Roche received FDA Breakthrough Device Designation for its VENTANA TROP2 (EPR20043) RxDx Device, an IHC assay combined with a digital pathology algorithm for evaluating TROP2 expression in non-small cell lung cancer tissue.
02 Companion Diagnostics Strengthen Biomarker-Based Oncology IHC is increasingly being incorporated into companion diagnostics that identify patients who may benefit from specific targeted therapies. These assays connect tissue biomarker assessment with therapeutic decision-making and are expanding the clinical role of IHC beyond conventional tumor classification. In June 2026, the FDA approved the VENTANA PTEN (SP218) RxDx Assay as a companion diagnostic for identifying prostate cancer patients who may be eligible for TRUQAP in combination with abiraterone. The qualitative IHC assay assesses PTEN protein in prostate tumor tissue.
01 Growing Use of Biomarker Testing for Treatment Selection The increasing use of biomarker-guided cancer therapies is strengthening demand for IHC assays that identify clinically relevant protein expression in tumor tissue. As targeted therapies expand, pathology laboratories require validated assays that can provide treatment-relevant information, supporting immunohistochemistry market demand.In May 2025, the FDA approved Roche's VENTANA MET (SP44) RxDx Assay for assessing MET protein expression in non-squamous non-small cell lung cancer tissue. The IHC assay was authorized as a companion diagnostic to help identify patients eligible for treatment with EMRELIS.
01 Standardization Requirements Increase Testing Complexity IHC testing requires controlled tissue preparation, staining procedures, antibody selection, quality control, and interpretation to achieve reliable results. Differences in laboratory procedures and scoring approaches can affect reproducibility, while validation and quality-assurance requirements add operational work. These factors can increase the resources required to introduce new IHC assays and maintain consistent testing performance across laboratories.In January 2026, the FDA approved manufacturing-process changes for the VENTANA anti-MSH6 (SP93) Antibody, illustrating the ongoing need for controlled manufacturing and quality processes for clinically used IHC reagents.
01 Expansion of IHC Into New Biomarker and Companion-Diagnostic Applications The growing number of therapies linked to tissue biomarkers is creating opportunities for IHC manufacturers to develop assays for additional cancer types and molecular targets. New companion diagnostics can extend established staining platforms into treatment-selection pathways while creating demand for validated antibodies, detection systems, and laboratory workflows. This expansion is creating new immunohistochemistry market opportunities as precision oncology increases the number of clinically actionable tissue biomarkers.In June 2026, the FDA added the VENTANA PTEN (SP218) RxDx Assay to its list of authorized companion diagnostic devices. The assay identifies PTEN protein loss in prostate cancer tissue and is linked to treatment eligibility for TRUQAP in combination with abiraterone.
01 Maintaining Reproducibility Across IHC Testing and Interpretation IHC results can be affected by pre-analytical conditions, staining procedures, antibody performance, instrument settings, and interpretation methods. Maintaining reproducibility becomes particularly important when biomarker results determine eligibility for targeted treatment. Laboratories therefore need appropriate validation, controls, standardized procedures, and qualified interpretation to ensure that results remain clinically reliable.In February 2024, the College of American Pathologists published an updated evidence-based guideline for analytical validation of IHC assays. The recommendations addressed predictive and nonpredictive IHC assays and included considerations for verification and revalidation, highlighting the continuing importance of analytical consistency in clinical IHC testing.
June 2026 Agilent Technologies completed the acquisition of Biocare Medical, expanding its immunohistochemistry portfolio with antibodies, detection systems, and automated tissue diagnostics solutions.
March 2026 Thermo Fisher Scientific completed the acquisition of Clario, strengthening its pathology, biomarker, and clinical research capabilities supporting immunohistochemistry-based diagnostics.
June 2025 Roche received U.S. FDA approval for the VENTANA MET (SP44) RxDx Assay, expanding its immunohistochemistry companion diagnostic portfolio for non-small cell lung cancer.
May 2025 Agilent Technologies launched the PD-L1 IHC 22C3 pharmDx assay on the Agilent Dako Omnis platform, expanding its companion diagnostics portfolio for precision oncology.