In Situ Hybridization Market Size, Share & Trends Analysis Report By Technology, By Probe, By Product, By Application, By End-use, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global in situ hybridization market size was valued at USD 1.44 billion in 2022 and it is expected to expand at a compound annual growth rate (CAGR) of 6.9% from 2023 to 2030. In-situ hybridization has become an important process to identify, localize, and detect the specific DNA sequences in cells with an increasing number of unknown viruses, such as COVID-19.  Growing demand for molecular diagnostic tools is anticipated to boost the adoption of In Situ Hybridization (ISH) technology in the coming years. The rising prevalence of chronic diseases coupled with the increasing need for rapid diagnostic techniques contributes to the increased adoption of ISH.

The increasing number of cancer cases can be attributed to smoking and unhealthy eating. It is a high-impact-rendering driver of the ISH market’s growth. According to the national cancer institute, in 2021, 1,898,160 new cancer cases and 608,570 cancer-related deaths were forecasted in the U.S. As per WHO, by September 2021, 70% of deaths from cancer were reported in low- and middle-income countries. In 2020, cancer was the leading cause of death with approximately 100 million deaths worldwide. While breast cancer remains the most common form of cancer. It led to a new high in cases and death in 2020, with 2.26 million total cases and 685,000 deaths.

The In Situ Hybridization (ISH) industry is predominantly driven by technological advancements in the field of IVD. The advent of 3D FISH technology is one of the major advancements responsible for lucrative growth opportunities. It facilitates visualization and analysis of target cells in 3D aspects, thereby creating the potential for optimal research outcomes.

Various players are indulging in numerous strategic initiatives to synergize their resources for technological advancement. For instance, in June 2022, Quotient Limited entered into a partnership with Theradiag to advance the autoimmune IVDs specialty. Threading will provide autoimmune reagents and quality controls, while the quotient is expected to use its MosaiQ platform.

In addition, research based on the application of FISH technology for the detection of chromosome changes in pathology archives concluded that FISH images were consistent in identifying abnormalities, such as uniparental disomy, and are one of the best alternatives for validation of SNP microarray analysis. Furthermore, it is a fully automated method for prenatal cancer diagnostics that saves time in diagnostic & research applications by offering faster and more consistent results. The above-mentioned factors are anticipated to encourage major In Situ Hybridization (ISH) market players and independent research communities to invest in various research initiatives.

Similarly, increasing investments in R&D pertaining to IVD is another major driver for the In Situ Hybridization (ISH) industry’s growth. The presence of government organizations, for instance, the European Diagnostic Manufacturers Association (EDMA), which focuses on the development and overall growth of the European IVD industry is also contributing to the growth of the ISH market’s growth.

According to the European IVD Market Statistics Report 2021, since 2020, the IVD market has witnessed around 25% growth owing to COVID-19 testing. The EDMA invested approximately EUR 1 billion in the R&D of IVD every year.

Technology Insights

Fluorescence In-Situ Hybridization (FISH) is a type of ISH that uses complementary fluorescent probes that bind to the chromosomes at specific sites. It offers researchers a method to visualize and map the genetic ingredients in an individual cell. Owing to its wide scope of applications, this segment held the largest share of the market based on technology in 2022. This technique is used in cytogenetics for understanding various chromosomal abnormalities and genetic mutations.

FISH has a wide range of applications, such as detecting chromosomal aberrations, aneuploidy, solid tumors, and others. Technological advancements have led to the development of multiplex FISH, which is used to identify several regions or genes simultaneously, using different colors.

However, Chromogenic In Situ Hybridization (CISH) is an emerging field. It is expected to be a cost-effective, practical, and valid substitute for FISH. This technique combines ISH and Immunohistochemistry (IHC). CISH probes are labeled with digoxigenin or biotin and can be detected using a bright-field microscope. As mentioned earlier, CISH is cheaper compared to FISH and it is employed as a bright-field microscope instead of the fluorescence microscope.

Probe Insights

The DNA probe held the largest share of the In Situ Hybridization (ISH) market based on the type of probe. ISH uses labeled complementary single-stranded DNA as a probe that attaches to a specific sequence on the target DNA. Major benefits associated with DNA probes include the rapid speed of performing assays, which has made this technique one of the pivotal cytogenetic diagnostic procedures. Breast cancer is one of the major contributors responsible for fueling DNA probe adoption for clinical usage. It is the second-largest cause of cancer-related deaths and a major contributor to world mortality rates. The growing penetration of DNA probes in infectious disease testing has expanded the growth prospects for this segment.

ISH also uses labeled complementary single-stranded RNA as probes, also called riboprobes. RNA probes are expected to be more stable than DNA probes. Over the recent past, miRNA ISH has been improving with significant modification, such as the use of Locked Nucleic Acid (LNA) probes. This reduces the background signal and enhances the probe's signal. Early identification and validation of infectious bacteria help healthcare professionals decide the ensuing best course of treatment. Owing to the aforementioned benefits, the RNA probe segment is anticipated to grow lucratively over the forecast period.

Product Insights

Instruments held the largest share of the In Situ Hybridization (ISH) industry in 2022. This segment is expected to grow during the forecast period owing to the rising demand for instruments from diagnostics and research laboratories. Increased demand for better imaging of FISH, CISH, and ISH samples is expected to boost the demand for better microscopes & imaging systems.

Potential benefits, such as higher cost-efficiency, ease of usage, and portability have made these instruments a preferred choice among researchers and pathologists for in situ hybridization techniques. For instance, in April 2022, Thermo Fisher Scientific launched Raman spectroscopic analyzer for monitoring several applications, including biopharmaceutical manufacturing. It is a compact system that uses several patented probes to accelerate results and enable fully automated in situ measurements.

The kits and probes segment is expected to exhibit lucrative growth with a 7.0% CAGR during the forecast period. The rising incidence of target disorders such as cancer is expected to drive the demand for these products. Growing incidence of genetic diseases, such as leU.K.emia, solid tumors, lymphoma, and autism, is predicted to fuel the adoption of the FISH & CISH probe. Rising demand for sensitive, rapid, and accurate diagnostic techniques, extensive R&D for the development of novel probes, and an increase in healthcare expenditure are anticipated to drive market growth in future years.

Application Insights

The cancer segment dominated the In Situ Hybridization (ISH) industry in 2022 with 40.14% of the total revenue share. The increasing incidence of cancer is expected to boost the demand for use of ISH probes in cancer diagnostics. Lung cancer continues to spread rapidly. This upsurge is believed to be a consequence of the adoption of certain lifestyle habits, such as smoking and unhealthy eating. ISH probes act as a better alternative than potentially hazardous and costly radioactive methods that are used for the detection and research of chromosomal alteration in tumor cells. Consequentially, this is expected to propel the inclination of researchers and pathologists toward FISH & CISH probes.

In June 2022, Daiichi Sankyo and AstraZeneca announced positive results of a new breast cancer treatment clinical trial. The data from the phase 3 trial suggested that the product, Enhertu, could reduce the risk of cancer progression or death by 50%. The treatment is intended for patients with HER2-low. HER2 expression is determined by two tests, including ISH, which is employed to identify genetic materials. The companies are expected to generate Enhertu’s sales from HER2-low patients to reach USD 4.6 billion by 2030. The increase in HER2-low treatment rate is proportional to the rising tests conducted for HER-2.

End-use Insights

Hospital & diagnostic laboratories held the largest, 49.18% market share in 2022. Prenatal diagnosis and gene expression are emerging clinical applications of ISH, which are anticipated to broaden the growth potential of this segment. In addition, growing demand for rapid & accurate diagnostic techniques and rising awareness levels among pathologists continues to fuel growth. The clinical urgency to satiate diagnostic needs in developing countries is one of the major factors responsible for expediting the penetration of ISH. The aforementioned factors are cumulatively responsible for the greater share garnered by this segment.

Furthermore, the Contract Research Organization (CRO) segment is growing at a faster pace, despite the absolute value of revenue being relatively lower than other segments. Numerous organizations outsource their research and clinical trials to CROs and factors such as a specialized workforce, deducing the expenses for companies, and enhancing efficiency can encourage companies and other organizations to outsource their clinical research to CROs.  All the aforementioned factors can be attributed to the lucrative growth of this segment during the forecast period. For instance, Reveal Biosciences is one of the major CROs in ISH, IHC, IF, and histopathology. The organization employs propriety technologies such as NGPc Next-Generation Pathology, Whole-slide imaging, multiplexing, and ImageDx image analysis software. 

Regional Insights

North America held the largest share in 2022 with 44.29%. This can be attributed to the extensive adoption of ISH in R&D across this region. The presence of technologically upgraded infrastructure is also responsible for the increased adoption of ISH, which enables early diagnosis of diseases. Furthermore, the presence of key players in the In Situ Hybridization (ISH) industry, and the launch of innovative products in the region are expected to fuel the In Situ Hybridization (ISH) industry growth in this region.

For instance, in April 2021, the U.S.-based Bio-Techne Corporation launched new DNAscope assays under its RNAscope advanced ISH assay technology. The assay can visualize single-molecule gene expression at a single-cell resolution in intact cells. Such products are expected to broaden the scope of application for ISH and drive its adoption in the U.S.

Asia Pacific is expected to witness lucrative growth during the forecast period. An increase in investments by manufacturers & government, supportive government initiatives in the biotechnology sector, and the presence of untapped opportunities are among the key factors anticipated to propel In Situ Hybridization (ISH) industry growth. In addition, continuous R&D in cancer treatment is also expected to fuel market growth.

Key Companies & Market Share Insights

Market players employ various strategies to increase their production capabilities and promote the reach of their product offerings. The frequency of strategic initiatives in the In Situ Hybridization (ISH) industry is high as it is a highly technology-oriented market, which requires advanced equipment for product development and discovery.

For instance, in July 2021, BioView collaborated with Capio Biosciences to develop a platform for the collection of Circulating Tumor Cells (CTCs) from whole blood. Integrating the technologies of both companies would further advance the CTC Liquid Biopsy downstream analysis. Similarly, in December 2020, the company also collaborated with RUBYnanomed to develop a custom imaging solution to accelerate the implementation of CTC technology in the clinic, which would further improve the diagnosis of cancer. Some of the key players in the global In situ hybridization market include:

• Thermo Fisher Scientific Inc.

• Abbott (Abbott Molecular)

• PerkinElmer, Inc.

• BioView

• Agilent Technologies, Inc.

• Merck KGaA

• Bio-Rad Laboratories, Inc.

• Oxford Gene Technology IP Limited

• Leica Biosystems Nussloch GmbH

• F. Hoffman-La Roche Limited

• NeoGenomics Laboratories, Inc.

• Advanced Cell Diagnostics, Inc. 

In Situ Hybridization Market Report Scope 

Global In-Situ Hybridization Market Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global in situ hybridization market report based on technology, probe, product, application, end-use, and region:

• Technology Outlook (Revenue, USD Million, 2018 - 2030)

  • Fluorescent In Situ Hybridization (FISH)

  • Chromogenic In Situ Hybridization (CISH)

• Probe Outlook (Revenue, USD Million, 2018 - 2030)

  • DNA

  • RNA

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Instruments

  • Kits & Probes

  • Software

  • Services

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Cancer

  • Cytogenetics

  • Developmental Biology

  • Infectious Diseases

  • Others

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Research & Diagnostic Laboratories

  • CROs

  • Academic Institutes

  • Others

• Regional Scope Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait