In-situ Hybridization Market Size - By Product (Consumables, Instruments, Services), Technology (Fluorescent In-Situ Hybridization, Chromogenic In-Situ Hybridization), Application (Cancer, Cytogenetics, Immunology), End-use & Forecast 2024 – 2032

In-situ Hybridization Market Size - By Product (Consumables, Instruments, Services), Technology (Fluorescent In-Situ Hybridization, Chromogenic In-Situ Hybridization), Application (Cancer, Cytogenetics, Immunology), End-use & Forecast 2024 – 2032

In-situ Hybridization Market Size

In-situ Hybridization Market size was valued at USD 1.6 billion in 2023 and is estimated to grow at 8.6% CAGR from 2024 to 2032. In-situ hybridization (ISH) is a powerful molecular biology technique used to visualize and locate specific nucleic acid sequences within cells or tissues. The technique allows researchers to detect and localize the presence of specific DNA or RNA sequences in individual cells, providing valuable information about gene expression, gene editing, chromosomal abnormalities, and the spatial distribution of nucleic acids.

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The increasing technological advancement in the field of in-vitro diagnostics is a significant driving factors for the in-situ hybridization market. For instance, automation of ISH workflows and the availability of digital imaging systems have made the technique more efficient, reducing hands-on time and improving data analysis. This has contributed to the market growth by enhancing workflow productivity and result interpretation.
 

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Furthermore, growing prevalence of chronic diseases, rising R&D investments, rising adoption of genetic testing (market size is estimated to account for USD 43 billion by the end of year 2032), increasing demand for precision medicine, government initiatives and funding, and increasing education & awareness, are the promoting factors fostering the growth of the market.

In-situ Hybridization Market Trends

The growing prevalence of chronic diseases is a significant driver for in-situ hybridization industry. ISH allows for the visualization of specific genetic markers, mutations, and gene expression patterns associated with different types of chronic diseases.

• Cancer is one of the leading causes of morbidity and mortality globally, with a rising incidence in many countries. For instance, according to Wiley, in 2024, there are approximately 2,001,140 new cancer cases and it is the equivalent of about 5480 diagnoses each day in the U.S.
• ISH helps in early detection by cancer biomarkers and identifying genetic abnormalities, such as gene amplifications or translocations, which are critical for early intervention and treatment planning.
• Similarly, neurological disorders such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, and others are becoming more prevalent with aging populations. ISH helps researchers and clinicians understand gene expression changes, protein distribution, and cellular interactions in the brain.
• ISH is also used to study gene expression patterns in heart tissues affected by CVDs, providing insights into disease mechanisms. It helps identify molecular targets for drug development and assesses the efficacy of cardiovascular therapies, thereby escalating the growth of the market.

In-situ Hybridization Market Analysis

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Based on product, the market is divided into consumables, instruments, and services. The instruments segment is estimated to account for USD 1.3 billion by the end of 2032.

• Advances in ISH technologies have led to the development of sophisticated instruments with enhanced capabilities for ISH assays. Modern ISH instruments are often automated, offering improved efficiency, reproducibility, and reduced hands-on time. For instance, automation minimizes manual errors and increases throughput, making it attractive for high-volume testing.
• Instruments are extensively used in academic research institutions and laboratories conducting ISH studies. These instruments facilitate gene expression analysis, chromosomal studies, and biomarker discovery.
• Modern instruments offer high precision and sensitivity, ensuring accurate detection of nucleic acid sequences. This is crucial for reliable clinical findings, cancer diagnostics, and treatment decisions.
• For instance, according to the National Library of Medicine, in 2023, the introduction of DART-FISH, a padlock probe-based technology capable of profiling large numbers of genes in centimeter-sized human tissue sections has increased the sensitivity and resolution of FISH procedures, making it easier to detect specific DNA sequences in various applications, thus contribute to their dominance in the market.

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Based on technology, the in-situ hybridization market is bifurcated into fluorescent in-situ hybridization and chromogenic in-situ hybridization The fluorescent in-situ hybridization segment accounted for USD 888.8 million in 2023.

• FISH is extensively used in basic and translational research for gene mapping, chromosome analysis, gene expression analysis, and studying genomic variations. In clinical settings, FISH is vital for cancer diagnostics, detecting chromosomal aberrations, identifying infectious agents, and diagnosing genetic disorders.
• It utilizes fluorescently labeled probes allowing for easy visualization and imaging of DNA or RNA targets under a fluorescence microscope. Multiple fluorescent labels can be used simultaneously, enabling researchers to detect and distinguish multiple targets within a single sample.
• For instance, in 2023, Sysmex introduced the DNA fluorescence in-situ hybridization probe exhibiting remarkable specificity for direct in-situ detection of genetic changes across various sample types. These DNA FISH probes are high quality, reliable, and easy-to-use, provided in ready-to-use premixed and directly labeled formats to ensure batch-to-batch consistency and minimize scoring times and retest rates.
• Further, FISH allows for quantitative analysis of gene copy number variations (CNVs), gene amplifications, and deletions. It enables researchers to measure gene expression levels within individual cells, providing valuable insights into cellular functions and disease mechanisms.
• Thus, such aforementioned factors are expected to augment the segmental growth.

Based on application, the in-situ hybridization market is segmented into cancer, cytogenetics, developmental biology, infectious diseases, neuroscience, immunology, and other applications. The cancer segment held a market share of 24.5% in the year 2023.

• Cancer is characterized by genetic mutations, amplifications, deletions, translocations, and other genomic aberrations. Different types of cancer exhibit unique genetic signatures and biomarkers, making molecular analysis essential for accurate diagnosis and treatment decisions.
• ISH is crucial for identifying specific genetic markers and gene expression patterns that help classify tumors into subtypes with distinct prognoses and treatment responses. Similarly, in breast cancer, ISH-based tests for HER2 gene amplification status guide treatment decisions with HER2-targeted therapies. Thus, the growing number of breast cancer increases the adoption of these techniques.
• For instance, according to the World Health Organization (WHO) in 2023, an estimated 2.3 million women were diagnosed with breast cancer worldwide. Further, it caused 670,000 deaths globally in 2022.
• Further, ISH enables the identification of specific genetic targets for targeted therapies which are more effective and have fewer side effects than traditional chemotherapy. By matching patients to the most appropriate treatments based on their genetic profiles, ISH contributes to the advancement of precision medicine in cancer care, thereby expanding the growth of the market.

Based on end-use, the in-situ hybridization market is classified into hospitals and diagnostic laboratories, academic and research institutes, contract research organizations, pharmaceuticals and biotechnology companies, and other end-users. The hospitals and diagnostic laboratories segment held a market size of USD 636.2 million in the year 2023.

• Hospitals and labs use ISH for diagnosing genetic disorders by detecting specific genetic abnormalities, such as deletions, duplications, and translocations. Further, ISH is valuable in paediatric settings for diagnosing genetic conditions early in life.
• These settings have in-house ISH testing capabilities providing quicker turnaround times for results. Performing ISH tests in-house reduces the need to outsource testing to external laboratories.
• In these settings ISH-based tests are used for routine cancer screening especially in high-risk populations. Consequently, it helps monitor treatment response and disease progression over time, guiding adjustments to treatment plans.
• The technology is used in the hospitals and laboratories to detect and localize viral RNA or DNA in infected tissues aiding in the diagnosis of viral infections. It can also identify specific bacterial species in infected tissues helping in the diagnosis of bacterial infections. Thus, such factors are expected to escalate the growth of the market.

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The U.S. in-situ hybridization market is anticipated to grow at CAGR of 8.2% during the analysis timeframe.

• The country is at the forefront of technological advancements in in-situ hybridization. The countries invest heavily in research and development, leading to the introduction of cutting-edge modalities and techniques.
• It has a significant prevalence of chronic diseases such as cancer, cardiovascular diseases, and neurological disorders. The accurate diagnosis and treatment of these conditions require extensive use of FISH and other technologies. As a result, there is a substantial demand for in-situ hybridization in the region.
• For instance, according to the National Library of Medicine, 1,958,310 new cancer cases and 609,820 cancer deaths occurred in the U.S. in 2023.

UK is anticipated to witness robust growth in the global in-situ hybridization market.

• Similar to many developed countries, the UK has a high prevalence of cancer, including breast, lung, prostate, and colorectal cancers.
• The country also faces a significant burden of genetic disorders, necessitating molecular diagnostics such as ISH, further fueling market expansion.

South Korea in-situ hybridization market is expected to grow significantly over the years.

• South Korea has advanced healthcare facilities with modern hospitals, diagnostic laboratories, and research centers. Hospitals and labs in South Korea have access to state-of-the-art ISH instruments, reagents, and technologies.

Additionally, the country has implemented national cancer control programs focusing on prevention, screening, and treatment. The government invests in healthcare infrastructure and technology to improve cancer care and diagnostics.

In-situ Hybridization Market Share

The in-situ hybridization industry is highly competitive, marked by several players striving for market dominance. Providers offer comprehensive in-situ hybridization for biomarker discovery target therapy, and accurate diagnostics. This includes innovations such as automated ISH platforms and robotic systems for workflow efficiency, reducing hands-on time, and reproducibility. Competition is driven by factors such as the quality and reliability of these technologies, integration capabilities with existing platforms, and compliance with regulatory standards. Strategic partnerships with companies and healthcare networks play a crucial role in market positioning.

In-situ Hybridization Market Companies

Some of the eminent market participants operating in the in-situ hybridization industry include

• Agilent Technologies, Inc.
• Bio-Techne Corporation
• Bio-Rad Laboratories, Inc.
• Bio View Ltd.
• Danaher Corporation
• Merck KGaA
• Neogenomics, Inc.
• PerkinElmer, Inc.
• Sysmex Corporation
• Thermo Fisher Scientific Inc.

In-situ Hybridization Industry News

• In March 2023, Sysmex Corporation introduced the first-to-market IVDR-compliant FISH probes, designed by scientists for scientists, exhibiting remarkable specificity for direct in-situ detection of genetic changes across various sample types. These DNA FISH probes were high quality, reliable, and easy-to-use, provided in ready-to-use premixed and directly labeled formats and ensured batch-to-batch consistency and minimized scoring times and retest rates. Thus, it expanded the product portfolio and generated sales of the company.
• In January 2023, Bio-Techne Corporation announced the expansion of its Advanced Cell Diagnostics (ACD)-branded RNAscope in situ hybridization (ISH) portfolio with the release of the RNAscope Plus smRNA-RNA detection assay. The RNAscope Plus smRNA-RNA assay enables the simultaneous fluorescent detection of a small regulatory RNA together with 3 target RNAs or RNA biomarkers in the same tissue section at single-cell and subcellular resolution. Thus, it increased the technological landscape of the company and enhanced the revenue.

The in-situ hybridization market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 – 2032 for the following segments

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Market, By Product

• Consumables
  • Probes
  • Kits and reagents        
  • Accessories      
• Instruments
• Services

Market, By Technology

• Fluorescent in-situ hybridization
  • DNA fluorescent in-situ hybridization                                        
  • RNA fluorescence in-situ hybridization                                     
  • PNA fluorescent in-situ hybridization                                         
• Chromogenic in-situ hybridization

Market, By Application

• Cancer
• Cytogenetics
• Developmental biology
• Infectious diseases
• Neuroscience
• Immunology
• Other applications

Market, By End-use

• Hospitals and diagnostic laboratories
• Academic and research institutes
• Contract research organizations
• Pharmaceuticals and biotechnology companies
• Other end-users

The above information is provided for the following regions and countries

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of Middle East and Africa