The Global In situ Hybridization Market is projected to reach USD 2.8 billion by 2027 from USD 1.5 billion in 2022, at a CAGR of 12.6% during the forecast period. One of the key driving factors of the in situ hybridization market is the increasing awareness of companion diagnostics and the growing incidence of cancer and genetic disorders. Moreover, the growth of the ISH market is largely driven by a rise in government and private funding in life sciences and cancer research, the increasing number of reagent rental agreements, and the application of innovative technologies and methodologies in the fields of tissue and in vitro diagnostics.

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Key drivers of the in situ hybridization market include rising incidence of genetic disorders and cancer, and growing awareness of companion diagnostics. However, a shortage of skilled professionals poses a significant challenge to the growth of this market.

Driver: Rising incidence of genetic disorders and cancer

Over the years, there has been an increase in the incidence of cancer worldwide. Over the last two decades, extensive studies related to human diseases have recognized recurrent genomic abnormalities as potential driving factors for various cancers. Cytogenetic assays such as ISH help integrate IHC and DNA FISH to complete the in situ tool-set for researchers to discover, develop, and implement new-generation diagnostic procedures. Directly imaging gene expression in situ at the RNA level delivers a unique insight into the interplay between cancer cells and the tumor microenvironment while cancer progresses. A similar pattern is also followed for genetic disorders.

Challenge: Shortage of skilled professionals

To conduct an ISH-based test, it is crucial to understand the molecular information of a chromosome or a gene. In addition, the reluctance to move from manual operations to automation is another challenge for market growth. Many providers find it challenging to transition to IT-based approaches from manual or traditional methods or may not prefer to make the shift at all. Thus, the shortage of skilled, well-trained, and technically knowledgeable laboratory technicians to conduct ISH-based diagnosis limits their overall adoption, particularly in emerging markets.

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The consumables accounted for the largest share of the in situ hybridization market.

The market is segmented into consumables, instruments, and software based on product. The ISH consumables segment accounted for the largest share of this market. Robust funding by private and government authorities in cancer research is set to boost the adoption of ISH products. In addition, advent of novel technologies employed in tissue diagnostic protocols and IVD applications is expected to further drive the segment growth through the forecast period.

The DNA FISH technology segment dominated the fluorescent in situ hybridization market.

Based on the technology, the market is FISH (fluorescent in situ hybridization) and CISH (chromogenic in situ hybridization). The FISH segment is further categorized into DNA FISH, RNA FISH, and PNA FISH. The DNA FISH segment dominated the fluorescent in-situ hybridization market with the highest revenue share. DNA FISH utilizes DNA as a probe to detect the nucleic acid sequence during FISH. DNA FISH is often used in cytogenetics and cancer diagnostics and can detect aberrations in genomes, which result in genetic abnormalities. The FISH procedure’s success depends on the genetic material's stability (DNA/RNA). Hence, DNA is preferred over RNA due to the stability acquired from the hydrogen bonds of its double helix structure.

The academic and research institutes have generated the second highest revenue in the in situ hybridization market.

Based on the end user, the market is segmented into hospital & diagnostic laboratories, academic and research institutes, CROs, and pharmaceutical & biotechnology companies. The academic and research institutes generated the second highest revenue in the global market. Academic research laboratories use ISH products for educational purposes, such as understanding the complex processes involved in disease formation. ISH is often used to study different diseases, such as cancer, in which chromosomal abnormalities occur where extra copies of chromosomes are present or a portion of a chromosome is deleted, repeated, or reversed in orientation. Increasing collaborations between pharma, diagnostic companies, and research institutes are expected to drive market growth for this segment.

Key Market Players

The market for in situ hybridization is competitive and highly consolidated, with key players strategizing to capture the market. Prominent players in the ISH market are Abbott (US), Thermo Fisher Scientific (US), Danaher Corporation (US), Merck KGaA (US), F. Hoffmann-La Roche AG (US), BioView (Israel), Agilent Technologies (US), Biocare Medical (US), Bio-Techne Corporation (US), QIAGEN N.V. (Germany), PerkinElmer (US), Enzo Biochem (US), Bio-Rad Laboratories (US), Abnova Corporation (Taiwan), BioGenex Laboratories (US), OpGen US), Bio SB (US), GeneMed Biotechnologies (US), Abcam plc. (UK), Creative Bioarray (US), BioCat GmbH (Spain), ZytoVision (Germany), NeoGenomics Laboratories (US), and Oxford Gene Technology (UK).

 The Asia Pacific region is the fastest-growing region of the in situ hybridization market in 2021.

The Asia Pacific region is estimated to grow at the highest CAGR in the in situ hybridization market during the forecast period. China and India are the key revenue contributors to the Asia Pacific in situ hybridization market. Favorable government support for product approvals and the presence of major players in these countries are anticipated to drive regional market growth.

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Recent Developments:

• In 2022, RNAscope ISH Detection Kit manufactured by Bio-Techne received CE-IVD approval for the BOND-III platform (Leica Biosystems).
• In 2021, Applied Spectral Imaging (ASI) and KromaTiD, Inc. entered a strategic commercial partnership granting ASI worldwide rights to market KromaTiD’s proprietary Pinpoint FISH (PPF) probes and assay services.
• In 2020, Creative Bioarray introduced an advanced FISH probe to detect the 2019 Novel Coronavirus.

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