In Situ Hybridization Market: Growth, Size, Share, and Trends

The in situ hybridization (ISH) market is growing rapidly with its increasing use in precision medicine and laboratory-developed tests (LDTs). Techniques like RNA-ISH and FISH provide highly accurate molecular insights, helping improve diagnosis in complex diseases. For example, in February 2025, Molecular Instruments launched RNA-ISH tests to better differentiate psoriasis from atopic dermatitis, enabling more personalized treatments. Companies such as Precision for Medicine and Scantox are also expanding FISH-based services for oncology, gene therapy, and preclinical research. Similarly, Plus Therapeutics received USD 5.7 million in February 2025 to advance its CNSide LM diagnostic test, which uses FISH to detect tumor-specific genetic changes in cerebrospinal fluid. These advancements reflect the rising importance of ISH in developing precise and targeted healthcare solutions.

The growth of the ISH market is constrained by its high costs, driven by expensive probe synthesis, capital-intensive instruments, and elevated operational fees. Multiplex assays further increase reagent and imaging expenses, making ISH less affordable for smaller labs and price-sensitive regions, which limits its wider adoption in research and diagnostics.

The ISH market is set for strong growth as it addresses key limitations of traditional IHC. While IHC is fast and affordable, its reliance on specific antibodies restricts its use for novel or rare targets. ISH, by directly detecting nucleic acids, is better suited for gene- and nucleic acid-based therapies where antibodies may not exist. Studies show ISH methods like FISH offer superior accuracy, particularly in cases like HER2 breast cancer testing, where IHC often gives inconclusive results. The growing demand for precise molecular diagnostics in personalized medicine and drug discovery is driving adoption. With advancements in probes, automation, and multiplexing, ISH providers are well-positioned to capture this rising market opportunity.

The ISH market faces significant challenges primarily due to the inherent technical complexities involved in the procedure, which hinder its broader implementation. ISH necessitates meticulous sample preparation, encompassing precise fixation, permeabilization, and denaturation protocols. Any deviation or error during these critical steps can compromise the accuracy. Additionally, fluorescent ISH techniques encounter issues such as signal saturation and photobleaching, which impede the clarity and stability of the emitted signals during imaging. Interpreting ISH results can be challenging and requires expertise to mitigate errors attributable to background fluorescence or non-specific probe binding. There is a notable shortage of skilled professionals adept at executing these demanding protocols, particularly in smaller laboratories, which exacerbates the challenge. Furthermore, certain tissue types can exhibit difficulties in probe penetration and binding, thereby impacting the test's reliability. These technical obstacles, coupled with workforce shortages, significantly impede the widespread adoption of ISH in both clinical and research settings, ultimately constraining market growth.