Immunochemistry: Empowering Precision Medicine
The Role of IHC in Precision Oncology
Immunohistochemistry (IHC) enables visualisation and quantification of protein biomarkers within tissue samples, providing actionable insights into tumour classification, therapy response, and prognosis.
By using highly specific antibodies, IHC identifies critical molecular signatures, such as HER2, PD-L1, and Ki-67, which enable patient stratification for targeted therapies and immuno-oncology regimens.
Combined with multiplex staining and digital pathology platforms, IHC allows clinicians to assess tumour heterogeneity, immune cell infiltration, and therapy response with unprecedented clarity.
Beyond solid tumours, IHC is increasingly being adopted in cell and gene therapy (CGT) biomarker validation and in women’s healthcare with FemTech applications, such as hormone receptor profiling in endometrial and ovarian cancers, expanding its relevance across emerging clinical frontiers.
As oncology becomes more data-driven and personalised, IHC serves as a foundational bridge between histopathology and molecular medicine, powering more accurate, evidence-based care.
Digital Pathology and AI: Enabling Scalable Diagnostics
IHC is transforming digital pathology from static tissue analysis to dynamic, data-rich diagnostics.
By combining IHC-stained slides with high-resolution digital scanners and AI-powered image analysis platforms, pathologists can quantify protein expression, assess spatial biomarker co-localisation (e.g. PD-L1 and Ki-67), and reduce interpretive variability.
Digital IHC delivers:
- Faster turnaround through remote slide review
- Greater precision with automated quantification
- Multiplexed visualisation of biomarkers in situ
This synergy supports decentralised diagnostics, cross-site collaboration, and personalised treatment planning, making digital IHC a cornerstone of modern precision medicine.
Visiongain Analyst Insight: As regulatory requirements tighten and multiplex diagnostics move toward platform consolidation, IVD and pathology companies with vertically integrated digital + assay ecosystems will dominate procurement contracts and hospital adoption.
IHC in Multi-Omics Integration
IHC is becoming a critical enabler of spatial multi-omics linking proteomic, transcriptomic, genomic, and metabolomic data within intact tissue architecture.
Advanced platforms, such as MALDI HiPLEX-IHC, merge IHC with mass spectrometry imaging to visualise intact proteins, lipids, and small molecules on a single tissue section, offering single-cell clarity and enabling the visualisation of co-localised biomarkers, like CD20, PTEN, and PanCK, within a spatial context.
This approach enables:
- Detailed profiling of tumour microenvironments and immune landscapes
- Real-time metabolic mapping and therapeutic response prediction
- Integration of spatial protein signatures with genomic and transcriptomic data
By embedding IHC into AI-powered multi-omic workflows, pathologists can uncover novel drug resistance mechanisms, stratify patients with greater precision, and accelerate personalised treatment strategies across oncology and immune-mediated diseases.
Visiongain Analyst Insight: As spatial biology matures, the winners in IHC will be those who move beyond single-marker analysis to develop scalable, multiplex-compatible diagnostics that can be validated across diverse tissue types and trial settings.
Key Players Making Headlines
Roche: In 2024, Roche expanded its navify® Digital Pathology platform with over 20 AI algorithms developed in collaboration with global partners. This marks a major milestone in transforming IHC from manual interpretation to a data-driven, precision diagnostic engine, especially vital in oncology, CGTs, and FemTech.
BioCare Medical: In March 2025, BioCare launched NeoPATH Pro™, developed by Vitro and distributed exclusively in the U.S. The platform debuted at the USCAP Annual Meeting, bringing multiplex staining and digital integration to the forefront of IHC.
Thermo Fisher / Epredia : The Lab Vision™ PT Module available via Epredia and Thermo Fisher automates antigen retrieval and dewaxing, streamlining critical pre-treatment steps in IHC workflows.
Danaher / Abcam: Danaher completed its acquisition of Abcam in December 2023. The move enhances Danaher’s precision pathology strategy by integrating Abcam’s validated antibodies, multiplex kits, and dual-domain (research and clinical) expertise in IHC.
Visiongain Analyst Insight: As consolidation accelerates, diagnostic platforms that combine proprietary antibodies, digital pathology, and regulatory-grade multiplexing will lead the next wave of market differentiation and M&A interest.
CRO Partnerships: Strategic Integration Moves
Strategic alliances between IHC leaders and CROs are emerging as key differentiators enabling companies to accelerate assay validation, expand multiplex capabilities, and gain a competitive edge in biomarker-driven clinical trials.
Visiongain Intelligence Centre, 2025
These partnerships demonstrate how IHC leaders are aligning with CROs to facilitate faster trial execution, image analytics, and biomarker development.
Visiongain Analyst Insight: For emerging IHC platforms, strategic CRO alliances are not optional; they are a prerequisite for clinical scalability, payer engagement, and biomarker-driven asset positioning.
Market Drivers Reshaping the IHC Landscape
- Precision Medicine and Companion Diagnostics: IHC remains essential for determining eligibility for HER2-, PD-L1-, and EGFR-targeted therapies. In November 2024, the FDA granted accelerated approval to Ziihera (zanidatamab-hrii, Jazz Pharmaceuticals), a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive biliary tract cancer. The approval was supported by Roche’s VENTANA PATHWAY anti-HER-2/neu (4B5) antibody as a companion diagnostic.
- Technological Innovation: Multiplex IHC and spatial imaging platforms like Akoya’s Phenoptics and Agilent’s DAKO Omnis are enabling deeper biomarker profiling. AI-powered image analysis is also enhancing speed, consistency, and accuracy.
- Digital Pathology Maturity: Cloud-enabled ecosystems, such as Roche’s navify®, are transforming IHC into scalable, collaborative diagnostics platforms, supporting decentralised care and faster turnaround.
- Cancer Incidence and Demand for Personalisation: Global cancer prevalence continues to drive demand for biomarker-rich diagnostics, particularly across breast, lung, and colorectal cancers. IHC remains a first-line tool for tumour classification and therapy guidance.
- Regulatory Pressure and Device Reclassification: The FDA’s reclassification of IHC assays as medical devices increases validation requirements, favouring vendors with high-compliance platforms and verified antibody performance.
- Healthcare Infrastructure Investment: Ageing populations and the rising burden of chronic disease are accelerating IHC adoption across hospitals and diagnostic labs worldwide.
Market Outlook: IHC at a Turning Point
The IHC market is transitioning from legacy stain-based workflows to fully integrated, AI-enabled diagnostics ecosystems. Platforms that support spatial analysis, multiplexing, and regulatory compliance will see increased uptake across oncology, CGTs, and autoimmune diseases.
At the same time, reimbursement models, FDA reclassification, and CRO-aligned trial infrastructure are raising the bar for clinical validation and scalability.
Visiongain forecasts sustained growth in IHC, driven by:
- Adoption in multi-omics and AI workflows
- Platform consolidation and M&A
- Demand for decentralised, image-based diagnostics
- Growth in CDx use across solid tumour indications
Strategic agility, not just assay accuracy, will define leadership in the next phase of market expansion.
Strategic Questions for Executives
- Platform Competitiveness: Is your IHC technology differentiated for integration with digital pathology, AI, and multi-omics workflows?
- Development Strategy: Are your CRO partnerships and assay pipelines aligned for multiplex validation, clinical deployment, and regulatory scalability?
- Regulatory & Innovation Readiness: How are you preparing for evolving FDA classifications, global compliance standards, and the shift toward recombinant antibody development?
What’s Next from Visiongain
At Visiongain, we track the strategic forces reshaping diagnostics from the evolution of immunohistochemistry (IHC) and spatial biology to AI integration and regulatory change.
Our market intelligence is built for decision-makers: data-driven, analyst-curated, and commercially focused. Whether you’re assessing IHC market dynamics, exploring digital pathology platforms, or evaluating CRO alignment and assay development strategy, our reports provide the clarity and foresight to lead.
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