In Situ Hybridization Companies

The in situ hybridization (ISH) market is expected to reach USD 2.35 billion in 2030 from USD 1.64 billion in 2025, at a CAGR of 7.4% during the forecast period. The growth of the in situ hybridization (ISH) market is primarily driven by significant advancements in ISH technologies, particularly through automation and multiplexing, which enhance the sensitivity, specificity, and efficiency of ISH-based assays. Furthermore, the increasing integration of ISH methodologies in precision medicine and the development of laboratory-developed tests (LDTs) are facilitating the implementation of personalized treatment approaches via the identification of patient-specific genetic markers. Additionally, there is a burgeoning interest in spatial transcriptomics within the realms of cancer and neuroscience research, which underscores the application of ISH techniques. Researchers are focused on elucidating spatial gene expression patterns that are essential for decoding disease mechanisms and tailoring therapeutic responses.

The global in situ hybridization (ISH) market is highly consolidated, with key players such as F. Hoffmann-La Roche Ltd (Switzerland), Danaher (US), and Abbott (US) leading the field. These companies have employed a range of strategies to enhance their market positions, including new product developments, strategic acquisitions, collaborative agreements, and geographical expansions. A notable development occurred in January 2025 when Roche received 510(k) clearance from the FDA for its VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, marking it as the first FDA-cleared ISH test that can detect the entire spectrum of B-cell lymphoma subtypes with elevated sensitivity. This milestone not only bolsters Roche’s oncology diagnostic offerings but also signifies a pivotal move toward the clinical validation of sophisticated ISH assays, which are anticipated to significantly enhance diagnostic precision and patient stratification within the realm of precision oncology. In a parallel development, Bio-Techne expanded its RNAscope probe portfolio in February 2025, now boasting over 70,000 unique probes across 450+ species. This expansion highlights the company's strategic emphasis on spatial transcriptomics and high-plex tissue analysis, fields that are witnessing increased demand in oncology, neuroscience, and immunology research. Furthermore, the availability of these probes for both manual and automated platforms, including integration with the Lunaphore COMET system, indicates an industry trend towards greater workflow flexibility and scalability, effectively bridging the gap from exploratory research to clinical assay development.

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Recent collaborations illustrate the escalating significance of integrated multiomic platforms in ISH workflows. In April 2025, Leica Biosystems partnered with Bio-Techne (ACD) to automate RNAscope Multiomic LS assays on the BOND RX platform. This innovation allows for the protease-free, simultaneous detection of RNA and protein biomarkers, which is vital for translational research due to its enhanced spatial resolution and multiplexing capabilities that optimize laboratory efficiencies. Additionally, Leica Biosystems’ earlier partnership in January 2025 with Molecular Instruments (MI) has incorporated HCR Pro RNA-ISH technology into both the BOND RX and RXm platforms. This integration enables high-sensitivity, multiplexed detection of RNA and protein with the flexibility of brightfield or fluorescence imaging. Such advancements significantly broaden the application of ISH in complex tissue analyses, especially in oncology, where concurrent evaluation of nucleic acid and protein targets enriches biological understanding. These developments underscore a broader trend towards automation, multiplexing, and spatially resolved molecular profiling; the merging of transcriptomic and proteomic analytics; and the growing regulatory acknowledgment of ISH-based assays in clinical diagnostics, which are pivotal in shaping the future landscape of the in situ hybridization (ISH) market.

F. Hoffmann-La Roche Ltd (Switzerland)

F. Hoffmann-La Roche Ltd stands out as a significant entity in the global in situ hybridization (ISH) market, leveraging its integrated diagnostics-pharmaceutical business model alongside a substantial geographic presence and an unwavering focus on innovation, strategic partnerships, and product enhancements. The company operates through two principal segments: Diagnostics and Pharmaceuticals, with the Diagnostics sector further divided into Core Lab, Molecular Lab, Pathology Lab, Point of Care, and Diabetes Care. Within the Pathology Labs division, Roche offers a range of ISH-based assays designed for both diagnostic and research purposes across various domains, including oncology, cardiology, neurology, infectious diseases, and diabetes. The company emphasizes the development of comprehensive diagnostic solutions, integrating laboratory automation, digital health technologies, and AI-driven clinical decision support systems. According to Roche’s 2024 annual report, in 2023, the Diagnostics division processed over 29 billion tests on more than 100,000 platforms, underscoring the robust global demand for its tests, consumables, and software products like uPath. Roche has recently achieved regulatory approvals for the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, a notable advancement in the in situ hybridization (ISH) market that bolsters its diagnostic offerings in hematopathology and enhances its capability to establish new clinical benchmarks in ISH-based molecular diagnostics. The company’s competitive edge in the ISH space is further fortified by its commitment to automation and workflow optimization, exemplified by the introduction of the BenchMark ULTRA PLUS system in 2022. This sophisticated tissue staining platform improves diagnostic throughput, accuracy, and sustainability, catering to high-throughput pathology environments. The global deployment of this technology illustrates Roche’s proficiency in delivering integrated solutions that complement its ISH product line and fortify its leadership position in providing holistic diagnostic platforms. Such strategic initiatives emphasize Roche’s dedication to developing clinically relevant diagnostic platforms and maintaining its competitive advantage in the rapidly evolving global in situ hybridization (ISH) market.

Abbott (US)

Abbott has established itself as a leading entity in the global in situ hybridization (ISH) market, driven by a robust diagnostic portfolio and extensive global reach, particularly through its VYSIS brand. Within its Molecular Diagnostics segment, Abbott provides an extensive array of ISH probes, probe kits, reagents, and instrumentation tailored for applications in genetic analysis, oncology, and personalized medicine. Key offerings include the UroVysion Bladder Cancer Kit, the VYSIS CLL FISH Probe Kit, and the AneuVysion Multicolor DNA Probe Kit, which are essential tools for cancer diagnostics and chromosomal investigations. Moreover, Abbott supports clinical competence and technical utilization through resources like the VYSIS FISH Knowledge Center, which offers comprehensive protocols and best practices for healthcare professionals. The company’s well-established distribution network spanning North America, Europe, Asia Pacific, and beyond ensures robust market penetration, reinforcing Abbott's reputation as a reliable provider of ISH solutions on a global scale.

Market Ranking

The in situ hybridization (ISH) market is notably consolidated, with five key players collectively commanding approximately 60-65% of the total market share. F. Hoffmann-La Roche Ltd boasts a robust portfolio of ISH instruments and probes, enabling significant contributions to laboratory workflows. Danaher, particularly through its Leica Biosystems division, leverages its expertise in ISH technologies, including a diverse array of probes, kits, and reagents, to maintain a strong market position. Abbott is particularly influential in the ISH probe segment, thanks to its well-established Vysis product line, which is widely utilized in cytogenetics and cancer diagnostics. BIO-TECHNE CORPORATION, through its subsidiary ACD Bio, has carved out a competitive advantage in the RNA-ISH probe space, offering an extensive selection of over 70,000 probes tailored for both research and clinical applications. Thermo Fisher Scientific Inc. has secured a solid foothold in the market through a comprehensive range of ISH instruments and DNA probes, supporting various laboratory workflows. The remaining 35-40% of the market is occupied by regional and niche vendors, which opens avenues for emerging players to capture market share. Competition is intensifying in the ISH arena, driven by the escalating demand for precision medicine applications, advancements in RNA-ISH and multiplex assay technologies, and increasing needs in cancer diagnostics. There's also a growing interest in the application of ISH methodologies within infectious disease research and neuroscience, further stimulating market dynamics.

Related Reports:

In Situ Hybridization Market by Offering (Consumables, Instruments, Software), Technology (FISH (DNA FISH, RNA, PNA), CISH), Application (Cancer Diagnostics, Research, Discovery), End User (Hospitals, Pharma & Biotech, Academia) - Global Forecast to 2030

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