Fluorescent In Situ Hybridization Probe Market - Global Industry Size, Share, Trends, Opportunity & Forecast, Segmented By Technology (Q FISH, FLOW FISH, Others), By Type (DNA, RNA (mRNA, miRNA, Others)), By Application (Cancer Research, Genetic Diseases, Others), By End-Use (Research, Clinical, Companion Diagnostics), By Region, & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 1.11 Billion
CAGR (2026-2031)	7.04%
Fastest Growing Segment	Cancer Research
Largest Market	North America
Market Size (2031)	USD 1.67 Billion

Market Overview

The Global Fluorescent In Situ Hybridization Probe Market will grow from USD 1.11 Billion in 2025 to USD 1.67 Billion by 2031 at a 7.04% CAGR. Fluorescent In Situ Hybridization probes are specialized cytogenetic tools designed to detect and localize specific DNA sequences on chromosomes using fluorescently labeled genetic markers. The primary driver supporting the growth of this market is the escalating global prevalence of target diseases such as cancer and genetic abnormalities which necessitates accurate molecular diagnostic solutions to guide personalized treatment strategies. This rising disease burden directly fuels the demand for cytogenetic testing and advanced genomic analysis. According to the American Cancer Society, in 2025, an estimated 2,041,910 new cancer cases will be diagnosed in the United States, highlighting the substantial need for precise diagnostic interventions.

The market is further supported by the increasing integration of these probes into clinical workflows for hematological malignancies and solid tumor profiling. However, market expansion faces a significant challenge regarding the high operational costs associated with fluorescence microscopy infrastructure and the complex testing procedures. The requirement for highly skilled personnel to interpret results and the substantial capital investment for imaging equipment can limit accessibility in resource-constrained settings and impede the broader adoption of FISH testing compared to lower-cost alternatives.

Key Market Drivers

The accelerated adoption of personalized medicine and companion diagnostics acts as a primary catalyst for the Global Fluorescent In Situ Hybridization Probe Market. As clinicians increasingly prioritize targeted therapies that require specific biomarkers for patient selection, the utilization of FISH probes to identify genetic aberrations such as HER2 amplification or ALK rearrangements has surged. This shift reinforces the role of cytogenetic analysis in oncology, where precise molecular profiling dictates therapeutic efficacy. According to the Personalized Medicine Coalition, in May 2025, in the 'Personalized Medicine at FDA: The Scope & Significance of Progress in 2024' report, the FDA approved 18 new personalized medicines in 2024, accounting for approximately 38% of all newly approved therapeutic molecular entities. This trend underscores the critical dependency of modern pharmacotherapy on robust diagnostic tools to ensure accurate patient stratification.

Technological innovations in multiplexing and automated FISH systems are simultaneously revolutionizing laboratory workflows by addressing the bottlenecks of manual analysis. Manufacturers are developing pre-optimized and automated probe panels that significantly reduce turnaround times and enhance signal-to-noise ratios, thereby improving diagnostic throughput in high-volume pathology centers. According to Empire Genomics, in April 2025, the company announced the launch of the first pre-optimized hematology FISH probe panels for the CellWriter S automated platform to streamline testing procedures. Such advancements are crucial for sustaining market expansion, as evidenced by the financial performance of key industry players. According to Revvity, in February 2025, the company reported its Diagnostics segment revenue for the fiscal year 2024 increased to $1.5 billion, reflecting the enduring commercial demand for advanced diagnostic solutions.

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Key Market Challenges

The market expansion of Global Fluorescent In Situ Hybridization (FISH) Probes is significantly constrained by the high operational costs and the resource-intensive nature of the testing procedures. FISH analysis requires substantial capital investment in advanced fluorescence microscopy infrastructure and relies heavily on complex protocols that demand precision. This financial and technical burden creates a high barrier to entry, effectively limiting the adoption of FISH testing to well-funded reference laboratories and large academic centers. Consequently, smaller community hospitals and resource-constrained healthcare facilities are often unable to justify the return on investment, which directly restricts the potential customer base and slows the broader commercial penetration of these diagnostic tools.

Furthermore, this challenge is exacerbated by a critical shortage of specialized laboratory professionals qualified to interpret intricate genomic data. The scarcity of a skilled workforce creates operational bottlenecks, leading to longer turnaround times and reduced testing capacity. According to the American Society for Clinical Pathology, in 2025, the vacancy rate for anatomic pathology departments was reported at 28.5%, highlighting a severe deficit in the specialized personnel required for solid tumor profiling and complex diagnostics. This workforce gap forces many healthcare providers to rely on alternative, less labor-intensive diagnostic methods, thereby directly hampering the volume growth and revenue potential of the FISH probe market.

Key Market Trends

The rapid expansion of RNA FISH in spatial transcriptomics and single-cell analysis is fundamentally reshaping the market by moving beyond traditional DNA-centric applications to the visualization of gene expression within tissue architecture. This trend is driven by the increasing need to understand the tumor microenvironment and cellular heterogeneity, where RNA-based probes allow researchers to map transcript distribution at subcellular resolution. The commercial impact of this shift is evident in the growing consumption of spatial biology reagents, which are becoming a recurrent revenue stream for probe manufacturers. According to 10x Genomics, January 2025, in the 'Preliminary Select Fourth Quarter and Full Year 2024 Results' report, the company generated spatial consumables revenue of approximately $121.1 million for the fiscal year 2024, highlighting the substantial ongoing utilization of these advanced in situ hybridization platforms in life science research.

Simultaneously, the convergence of FISH assays with Next-Generation Sequencing (NGS) platforms represents a critical evolution in diagnostic workflows, establishing a comprehensive approach to genomic profiling. While NGS offers high-throughput sequence analysis, FISH remains indispensable for validating structural variations and detecting translocations that sequencing may miss, leading laboratories to increasingly adopt integrated testing models. This dual-modality approach ensures robust detection of clinically relevant biomarkers, sustaining the demand for cytogenetic testing services alongside molecular sequencing. According to NeoGenomics, February 2025, in the 'Fourth Quarter and Full Year 2024 Results' report, the company announced a full-year 2024 revenue of $661 million, a performance attributed to the strong volume growth of its comprehensive oncology testing menu which leverages both cytogenetic and advanced molecular modalities.

Segmental Insights

The cancer research segment is the fastest-growing area in the global Fluorescent In Situ Hybridization probe market, driven by the critical need for precise genetic analysis in oncology. This growth occurs because these probes effectively identify chromosomal abnormalities used to guide personalized treatment plans. Furthermore, regulatory bodies like the United States Food and Drug Administration have approved FISH-based companion diagnostics, validating their use in drug development and clinical trials. As the focus shifts toward targeted therapies, laboratories increasingly rely on these tools to support accurate genomic profiling and therapeutic research.

Regional Insights

North America holds the leading share of the Global Fluorescent In Situ Hybridization Probe Market, driven by a well-developed healthcare system and a high incidence of targeted genetic conditions. The region benefits significantly from the concentrated presence of key industry manufacturers, ensuring steady supply and development. Additionally, the U.S. Food and Drug Administration facilitates market growth by establishing rigorous yet clear approval frameworks for diagnostic devices, thereby enhancing clinical confidence. This regulatory clarity, combined with comprehensive reimbursement structures for genetic testing, solidifies North America’s status as the primary revenue generator in this sector.

Recent Developments

• In September 2025, Oxford Gene Technology received authorization from the U.S. Food and Drug Administration (FDA) for its CytoCell KMT2A Breakapart FISH Probe Kit PDx as a companion diagnostic. This approval allowed the kit to be used for detecting clinically relevant rearrangements in the KMT2A gene, which are associated with acute leukemia. The authorization marked a significant regulatory milestone for the company, positioning the test as a robust and accessible solution for aiding in the management of patients with KMT2A-rearranged acute leukemia. The development highlighted the company's commitment to expanding its portfolio of compliant diagnostic tools in the global market.
• In April 2025, Empire Genomics formed a strategic partnership with BioDot to introduce a new line of hematology-focused FISH probe panels and controls. This collaboration involved the launch of the BDot Probe Line, which was pre-optimized and validated for use on the BioDot CellWriter S platform. The new product line was designed to streamline the workflow for detecting hematologic malignancies, such as leukemia and multiple myeloma, by eliminating the need for manual probe optimization. The partnership aimed to accelerate time-to-results and enhance the efficiency of FISH testing in clinical cytogenetics and molecular pathology laboratories.
• In January 2025, Molecular Instruments announced the launch of its new HCR Gold and HCR Pro product lines, which were developed to advance the capabilities of RNA fluorescence in situ hybridization (RNA-FISH). These new offerings utilized the company's proprietary Hybridization Chain Reaction imaging platform to enable multiplexed, quantitative, and high-resolution analysis even in thick or autofluorescent samples. The launch aimed to expand the diagnostic relevance of the technology by facilitating its integration with other genomic platforms, such as Next-Generation Sequencing (NGS) and PCR, thus supporting broader adoption of these advanced probes in research and clinical diagnostics.
• In January 2024, Barco and Applied Spectral Imaging entered a commercial partnership to integrate their respective technologies for digital pathology. The collaboration aimed to combine Barco's visualization solutions with Applied Spectral Imaging's advanced imaging and analysis capabilities, particularly for Fluorescent In Situ Hybridization (FISH). This alliance was designed to offer pathology laboratories a comprehensive workflow that effectively bridges brightfield and FISH imaging, thereby improving operational efficiency and diagnostic precision. The partnership focused on delivering best-in-class digital solutions to meet the complex requirements of modern pathology and cytogenetics departments, ensuring seamless connectivity and superior image quality for clinical professionals.

Key Market Players

• Thermo Fisher Scientific Inc.
• PerkinElmer Health Sciences Inc
• Biodot Inc
• New Horizons Diagnostic Corp
• Merck KGaA
• Agilent Technologies, Inc.
• Abnova Corp.
• Genemed Biotechnologies Inc
• F. Hoffmann-La Roche Ltd
• Oxford Gene Technology Ltd

By Technology	By Type	By Application	By End-Use	By Region
Q FISH FLOW FISH Others	DNA RNA	Cancer Research Genetic Diseases Others	Research Clinical Companion Diagnostics	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Fluorescent In Situ Hybridization Probe Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Fluorescent In Situ Hybridization Probe Market, By Technology:

• Q FISH
• FLOW FISH
• Others

• Fluorescent In Situ Hybridization Probe Market, By Type:

• DNA
• RNA

• Fluorescent In Situ Hybridization Probe Market, By Application:

• Cancer Research
• Genetic Diseases
• Others

• Fluorescent In Situ Hybridization Probe Market, By End-Use:

• Research
• Clinical
• Companion Diagnostics

• Fluorescent In Situ Hybridization Probe Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE