Fluorescent In Situ Hybridization (FISH) Probe Market Size, Share & Trend Report

Fluorescent In Situ Hybridization (FISH) Probe Market Size, Share & Trend Analysis Report By Application (Cancer Diagnostics, Genetic Diseases), By Type of RNA, By End-use, And Segment Forecasts, 2012 - 2022

  • Published Date: Feb, 2018
  • Base Year for Estimate: 2015
  • Report ID: 978-1-68038-596-0
  • Format: Electronic (PDF)
  • Historical Data: 2012 - 2015
  • Number of Pages: 100

Industry Insights

The global fluorescent in situ hybridization (FISH) probe market size was estimated at USD 543.1 million in 2016 and is anticipated to grow at a CAGR of 6.8% over the forecast period.

Increasing demand for In Vitro Diagnostics (IVD) testing in the diagnosis of various chronic diseases is expected to drive the demand in coming years. Growing demand for IVD is attributed towards the high levels of reliability, rapidity, and sensitivity and is expected to propel FISH probe market growth.

U.S. FISH probe market

DNA probe-based diagnostics is gaining popularity in medical diagnostics for the determination of suspected diseases caused by pathogen or bacteria.  In addition, identification of new areas for diagnostic markets, increased automation of diagnostic tests, investments in pharmacogenomics and pharmaceutical research are major growth propellers for this industry.

Rising prevalence of diseases having the cytogenetic base such as genetic abnormalities and cancer coupled with the demand for rapid, sensitive & accurate prognosis techniques for disease validation. This is anticipated to boost the adoption of these techniques and thereby fueling the growth over the forecast period.

Furthermore, increasing R&D initiatives by various key players for development of novel disease-specific biomarkers and pipeline products awaiting regulatory approval are attributing towards the industry growth. Growing awareness levels among people coupled with an increase in healthcare expenditure and development of novel probes are expected to drive the market further.

Type of RNA Insights

mRNA segment held the largest revenue share in 2016 owing to growing demand for molecular profiling by healthcare professionals. Technologically advanced in molecular pathology tools that help in disease prognosis and stratification for appropriate treatment are further contributing toward the increased demand.

RNA probes are majorly used for cancer analysis and are helpful in differentiating between cancer subtypes. Novel probes targeting disease-specific RNA are being developed by companies such as RNAscope series by Advanced Cell Diagnostics for cancer and infectious diseases and Stellaris RNA probe by BioSearch technologies. Recently approved fluorescent hybridization kits for companion diagnostic use include INFORM HER 2/ NEU probe developed by Ventana Medical Systems, PATHYVISION HER- 2 by Abbott Molecular and HER2 FISH PharmDx by Dako Denmark.

Industry players are providing tailor-made, accurate probe development services according to client specifications. Synthesis of RNA probes is costly owing to cost-intensive nature of reagents, difficult RNA tagging process and more complicated procedure.

However, RNA probes are more preferred, because RNA- RNA hybrids are known to be more stable than DNA RNA hybrids making the labeling reaction more efficient. Ventana ALK CDx assay by Ventana Medical systems and RG7422 PI3K Inh by Roche Molecular are waiting for approval and are expected to be commercialized over the forecast period.

Application Insights

Fluorescent in situ hybridization probes is most commonly used in research for genetic diseases and cancer diagnostics. Increasing cancer incidence across the globe and demand for sensitive, rapid, and accurate molecular diagnostic tests are factors anticipating boosting the overall market growth in coming years. According to the estimates of the WHO, the average prevalence rate of hospital-acquired infections in Europe and the U.S. was valued at 7.1% and 4.5%, respectively. In cancer diagnostics, these probes are widely used for the diagnosis of breast and lung cancer.

Depending on the current level of implementation and future growth prospects, genetic disease segment is expected to witness faster demand than cancer and other segments. For instance, the market penetration of this probe application in cancer diagnostics is highest in the current scenario and, hence, the segment accounted for a larger share of the market.

On the other hand, penetration of these probe for other medical applications is relatively less, thereby accounting for a comparatively smaller share. However, increasing R&D pertaining to the application of these probes in genetic diseases and other infectious diseases testing is expected to provide a lucrative platform in near future. In case of genetic disease, the market penetration is less at present scenario but is expected to grow at a significant rate due to high R&D activities pertaining to the detection of chromosomal aberrations.

End-use Insights

Fluorescence in situ hybridization is the most important technique used for the detection of genetic abnormalities. They are commonly used in clinical procedures, companion diagnostics, and research studies. Clinical segment held the largest market share as of 2016 due to wide applications in the detection of genetic disorders, cancer, and infectious diseases.

Global FISH probe market

The specificity & high sensitivity of this technology and the rapid assays performing speed have made this technique an important cytogenetic test that offers significant benefits in research and diagnostic studies of hematological malignancies and solid tumor.

These probes are used in research studies for gene mapping, genetic aberrations, and identification of novel oncogenes in cancer detection and treatment. It also used in molecular-based testing for gene mapping and identification of novel oncogenes. Extensive studies on genetic abbreviation associated with diseases and increasing prevalence of genomic abnormalities & cancers are attributing toward the segment growth.

Regional Insights

North America accounted for largest revenue share as of 2016. Presence of high incidence rate of genetic disorders leading to birth defects, developmental disabilities, and other metabolic syndromes are some of the factors attributing toward the growth. According to CDC, around 3-4% of newborns in the U.S. are born with genetic abnormalities. Approximately 10% of adults and 30% of children in the U.S. are hospitalized owing to genetic disorder base. Fluorescent ISH is estimated to provide 98% accuracy in detection of chromosomal aberrations leading to such disorders.

In addition, usage of these assays in various disease areas such as cancer and genetic disorders is increasing in this region and is further expected to drive the demand. Rising levels of awareness among people with an early diagnosis of genetic disorders, increasing amount of disposable income, and highly established R&D infrastructure are key factors attributing to this market growth. Favorable healthcare reimbursement policies and government reforms are anticipated to push the industry further.

Asia Pacific is anticipated to show lucrative growth in coming years. The industry is growing in terms of revenue generation from cytogenetics and molecular diagnostic sectors in this region. Presence of supportive government initiatives pertaining to the increasing investments by manufacturers and government in the biotechnology sector and high untapped opportunities are the important factors anticipating the growth.

In addition, continuous R&D activities for cancer treatment facilitate the demand for cancer Research are expected to fuel the demand in coming years. Growing adoption of new techniques for molecular-based cytogenetics, increasing outsourcing activities, and demand for early diagnosis & detection of diseases are anticipated to propel the growth in this region.

FISH Market Share Insights

Some of the key players operating in this industry are Oxford Gene Technologies, Life Science Technologies, PerkinElmer Inc., Abnova Corporation, Biosearch Technologies Inc, Genemed Biotechnologies, Inc., and F. Hoffmann-La Roche AG. The market is competitive in nature with some of the companies including Abbott Laboratories and Agilent Technologies holding major market share owing to the extensive product portfolio, for instance, Vysis EGR1 FISH Probe Kit by Abbott.

Companies are adopting competitive strategies such as new product development, strategic collaborations and regional expansions to gain an advantage. For instance, in 2016, Oxford Gene Technology expanded its portfolio of Cytocell Aquarius FISH probes in the field of pathology. In addition, in 2016, the company introduced a new range of non-human fluorescent in situ hybridization probes for pig, chicken, and mouse.

CytoCell dominates the market for multiple myeloma FISH probes with its extensive product portfolio, strong geographic presence, and marketing channels. For instance, CytoCell introduced products for multiple myeloma FISH probe, some of them include BCL2 Breakapart, 57 BCL6 Breakapart, 58 CCND1 Breakapart, 58 IGH Breakapart, 59 IGH/BCL2 Translocation, Dual Fusion, and 60 IGH/CCND1 Translocation, Dual Fusion.

Report Scope

Attribute

Details

Base year for estimation

2015

Actual estimates/Historical data

2012 - 2015

Forecast period

2016 - 2022

Market representation

Revenue in USD Million and CAGR from 2016 to 2022

Regional scope

North America, Europe, Asia Pacific, Latin America, Middle East & Africa

Country scope

U.S., Canada, Germany, UK, Japan, China, India, Brazil, Mexico, South Africa

Report coverage

Revenue forecast, company share, competitive landscape, growth factors, and trends

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Segments covered in the report

This report forecasts revenue growth at global, regional, & country levels, and provides an analysis of the industry trends in each of the sub-segments from 2012 to 2022. For the purpose of this study, Grand View Research has segmented the global FISH probes market report on the basis of technology, RNA type, application, end-use, and region:

  • RNA Outlook (Revenue, USD Million, 2012 – 2022)

    • mRNA

    • miRNA

    • Other

  • Application Outlook (Revenue, USD Million, 2012 – 2022)

    • Cancer research

      • Lung

      • Breast

      • Other

    • Genetic diseases

    • Other

  • End-use Outlook (Revenue, USD Million, 2012 – 2022)

    • Research

    • Clinical

    • Companion diagnostics

  • Regional Outlook (Revenue, USD Million, 2012 – 2022)

    • North America

      • U.S.

      • Canada

    • Europe

      • UK

      • Germany

    • Asia Pacific

      • Japan

      • China

      • India

    • Latin America

      • Brazil

      • Mexico

    • Middle East & Africa

      • South Africa

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