In Situ Hybridization Market Size, Share & Trends Analysis Report By Technology (FISH, CISH), By Type (DNA, RNA) By Product (Instruments, Probes & Kits), By Application, By End Use, And Segment Forecasts, 2018 - 2025

Industry Insights

The global In Situ Hybridization (ISH) market size was estimated at USD 977.3 million in 2016 and is anticipated to expand at a CAGR of 7.3% over the forecast period. Growing demand for molecular diagnostic tools is anticipated to boost the adoption of ISH technology in the coming years. Increase in incidence of chronic diseases, coupled with need for rapid diagnostic techniques, is contributing to the increase in adoption of ISH.

Increasing cancer prevalence is a high impact rendering driver for this industry. According to National Cancer Institute, in 2016, 1,685,210 new cases of cancer were expected to be diagnosed and 595,690 cancer deaths were anticipated to occur in U.S. alone. This has raised the clinical urgency to adopt technologically advanced diagnostic procedures such as ISH for early detection of cancer. High incidence of cancer has also urged government authorities to develop and invest in advanced diagnostic alternatives. The National Cancer Institute estimated that the national expenditure for cancer care in U.S. was approximately USD 125 billion in 2010 and is predicted to reach USD 156 billion in 2020.

Introduction of advanced probe-based technologies are also among key contributors to industry growth. For example, Silver ISH (SISH) assay technology, a type of Chromogenic In Situ Hybridization (CISH), is one of the emerging technologies in the market. Ventana Medical System introduced the “INFORM HER2 SISH DNA Probe Assay” exclusively in U.S. to detect the HER2 gene in breast cancer patients. SISH is a fully automated method for diagnosis of prenatal cancer, which saves time by offering faster and consistent results during clinical trials. This is likely to improve the scope of funding for various research initiatives undertaken for this technology by major market players and independent research communities.

Furthermore, there has been an increase in usage of DNA probe-based diagnostics for detection of diseases suspected to be caused by pathogen or bacteria. Increasing incidence of genetic disorders, solid tumors, leukemia, autism, and other syndromes is anticipated to fuel the market over the forecast period.

Technology Insights

Fluorescence In Situ Hybridization (FISH) held the dominant share as of 2016. The market is predominantly driven by availability of technologically advanced In Vitro Diagnostics (IVD). Advent of 3D DNA FISH technology is considered one of the major advancements owing to which the market is likely to exhibit a strong CAGR. This technology facilitates visualization and analysis of target cells in three-dimensional aspects, thereby creating the potential for positive research outcomes.

FISH has become an indispensable technology for direct and rapid identification of single-cell microbes. Recently introduced technological advancements in FISH are web-based technologies for probe design and optimization in experiments, signal amplification strategies that are easy to implement, innovative approaches for multiplexing, and combination of extracellular staining techniques or transmission electron microscopy. These advancements are anticipated to fuel the adoption of this technology over the forecast period.

CISH is expected to witness steady growth in the coming years. Technological advancements in CISH probes have several advantages over existing technologies for diagnostics and research purposes. These benefits include limited risk of contamination as in case of Polymerase Chain Reaction (PCR), greater reagent stability, cost-efficiency, ability to test archival specimens, and simultaneous observation of tissue morphology.

Other benefits include greater storage time for samples analyzed in a research activity or diagnostic studies, which requires a longer period. In addition, advent of CISH probes has helped overcome practical limitations associated with traditional technologies. These are some of the factors contributing to the growth potential of this segment in the coming years.

Probe Type Insights

Major benefits associated with DNA probes include rapid speed of performing assays, which has made this technique a pivotal cytogenetic diagnostic procedure. Breast cancer is one of the major factors responsible for fueling the adoption of DNA probes for clinical usage. It is the second-largest cause of cancer-related deaths and a major contributor to world mortality rates.

Growing penetration of DNA probes in infectious disease testing is boosting the growth prospects for this segment. This can be attributed to associated benefits such as high-volume testing and presence of automated devices equipped to facilitate tests with greater speed and accuracy. Increasing incidence of diseases with chromosomal aberrations such as genetic abnormalities and cancer as well as unmet diagnostic and clinical needs are expected to be high growth rendering drivers for this segment.

Product Insights

Instruments held the largest share in the market in 2016 owing to increase in demand from diagnostic and research laboratories. Potential benefits such as higher cost-efficiency, ease of usage, and portability have made these instruments a preferred choice for ISH among researchers and pathologists.

In addition, increase in number of collaborations among emerging players to expand their product portfolio and establish a competitive position in the market is anticipated to boost market growth. For instance, in April 2016, Agilent Technologies, Inc. and Applied Spectral Imaging announced a comarketing agreement to market Agilent’s FISH imaging systems. Major companies in the market include PerkinElmer, Inc.; Leica Biosystems Nussloch GmbH; and Thermo Fisher Scientific.

The kits and probes segment is expected to exhibit a lucrative CAGR over the forecast period. Rising incidence of target disorders such as cancer is expected to drive demand for these products. Kits and probes are an indispensable part of ISH. Owing to extensive usage in research and clinical laboratories, this segment is anticipated to exhibit strong growth in the coming years. Rising demand for sensitive, rapid, and accurate diagnostic techniques, coupled with extensive R&D for development of novel probes and increase in healthcare expenditure, is anticipated to drive the market through 2025.

The services segment is also expected to exhibit exponential growth. Increasing outsourcing to ensure high adherence to quality standards and improve operational functionalities is contributing toward the lucrative nature of this segment.

Application Insights

By application, the In Situ Hybridization (ISH) market is categorized into cancer, cytogenetics, developmental biology, infectious diseases, and others. Application of ISH technology in cancer accounted for the largest revenue share in 2016. This can be attributed to growing prevalence of cancer and increase in research in this sector. ISH probes act as a better alternative to potentially hazardous and costly radioactive methods used for detection and research of chromosomal alteration in tumor cells. Hence, they have attracted the attention of an increasing number of researchers and pathologists.

This technology facilitates real-time analysis and monitors the progression of chromosomal aberrations. Technological advancements, such as advent of fluorescent molecules that work in conjunction with DNA probes to enhance overall efficiency of diagnostic procedures, are boosting the growth prospects of this segment.

ISH is being increasingly used in cytogenetics to detect chromosomal abnormalities, identify chromosomes, or to determine the location of specific sequences in chromosomes. FISH plays an important role in a variety of research areas, including gene amplification, cytogenetics, and gene mapping.

This technique has further facilitated screening of the complete genome through multicolor chromosome probe techniques, including spectral karyotyping or multiplex FISH and CISH. FISH is used to identify genetic abnormalities including aneuploidy, gene fusions, translocation, deletion, and to monitor the progression of aberrations, which provides genetic disease prognosis and diagnosis.

End-use Insights

Research and diagnostic laboratories accounted for the largest share by end use in 2016 owing to increase in applications of molecular cytogenetics in diagnostics. Increasing number of research initiatives for cell research is expected to fuel the adoption of this technology in R&D labs over the forecast period. Technological advancements in the field of molecular cytology and genomics are also expected to boost the adoption as they are used for diagnosis of diseases and research. Major advantages of these tools, such as high speed of performing assays, are expected to propel the adoption of ISH in labs. Advancements in the field of molecular pathology based on ISH is also expected to propel this segment.

The Contract Research Organizations (CROs) segment is anticipated to witness lucrative growth in the coming years. Increasing trend of outsourcing molecular biology services such as flow cytometry, cytogenetics, anatomic pathology, and ISH for testing in Phase I, II, and III of clinical trials is contributing to the lucrative CAGR of CROs during the forecast period.

Regional Insights

North America held the dominant share in the ISH market as of 2016. This can be attributed to availability of research funds and government initiatives for development of novel diagnostic tools. Europe followed North America in terms of revenue share owing to presence of government organizations such as European Diagnostic Manufacturers Association (EDMA), which that focus on development and overall growth of the IVD industry in Europe.

EDMA invests approximately EUR 1 billion every year in R&D pertaining to IVD in Europe. Moreover, MedTech Europe, which represents the medical technology industry in Europe, has received funds from National Institute for Health Research (NIHR) and National Health Services to boost the IVD industry. For instance, NIHR provided funding to four Diagnostic Evidence Cooperatives to improve IVD and aid in overall cost-effectiveness of diagnostic procedures. These initiatives were also undertaken to improve diagnosis of diseases, patient care, and efficiency. All these factors have propelled the usage of DNA, FISH, and CISH probes to improve patient diagnosis, thereby boosting the market.

The Asia Pacific market is anticipated to exhibit lucrative CAGR in the coming years. This can be attributed to rise in awareness among researchers about benefits of ISH technology in diagnostics. In addition, increase in R&D investments by governments to promote research in the field of molecular biology in this region is contributing to overall market growth. 

For instance, in June 2017, Global Health Innovative Technology Fund (GHIT) provided USD 200 million to the Japanese government for R&D in the healthcare industry. GHIT will aim to strengthen its collaboration with Japanese health organizations, such as Japan Agency for Medical Research and Development, Japan’s Pharmaceutical and Medical Devices Agency, Japan International Cooperation Agency, and other major healthcare companies such as Fujifilm for the introduction of innovations in IVD. This is expected to boost the ISH market during the forecast period.

In Situ Hybridization (ISH) Market Share Insights

Some of the key players operating in the ISH market are Thermo Fisher Scientific; Leica BiosystemsNussloch GmbH; BIOVIEW; Agilent Technologies; Merck KGaA; PerkinElmer, Inc.; Bio-Rad Laboratories, Inc.; NeoGenomics Laboratories, Inc.; Advanced Cell Diagnostics, Inc.; and Oxford Gene Technology.

The market is competitive in nature and some of the key players accounted for the largest market share owing to their extensive product portfolios and geographic presence across the world. Major players are adopting strategies such as distribution channel enhancement, operational restructuring, and opting for direct contracts with distributors to reduce their operational expenditure and increase profit margins.

Other companies are adopting strategies such as distribution agreements, mergers and acquisitions, development of new products, geographical expansion, and partnerships to sustain the competition. For example, in May 2017, Thermo Fisher Scientific announced plans to acquire Patheon, a contract development and manufacturing organization, with a view to enhance its capabilities and unique value proposition. Initiatives such as these are anticipated to keep competition at a high during the forecast period.

Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels, and provides an analysis of latest industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the global In Situ Hybridization (ISH) market report on the basis of technology, probe type, product, application, end use, and region:

• Technology Outlook (Revenue, USD Million, 2014 - 2025)

  • Fluorescent In Situ Hybridization (FISH)

  • Chromogenic In Situ Hybridization (CISH)

• Probe type Outlook (Revenue, USD Million, 2014 - 2025)

  • DNA

  • RNA

• Product Outlook (Revenue, USD Million, 2014 - 2025)

  • Instruments

  • Kits & Probes

  • Software

  • Services

• Application Outlook (Revenue, USD Million, 2014 - 2025)

  • Cancer

  • Cytogenetics

  • Developmental Biology

  • Infectious Diseases

  • Others

• End-use Outlook (Revenue, USD Million, 2014 - 2025)

  • Research & Diagnostic Laboratories

  • CROs

  • Academic Institutes

  • Others

• Regional Outlook (Revenue, USD Million, 2014 - 2025)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

  • Asia Pacific

    • Japan

    • China

    • India

  • Latin America

    • Brazil

    • Mexico

  • Middle East & Africa

    • South Africa