Molecular FISH Testing Market Valuations is Skyrocketing and is Poised to Reach Over US$ 1,367.4 Million By 2032 | Astute Analytica

The FISH testing market is booming, driven by its expanding role in diagnosing genetic disorders, personalizing cancer treatments, and enhancing agricultural biotechnology. Its integration across diverse fields makes it a key player in advancing precision medicine and sustainable practices.


New Delhi, Oct. 22, 2024 (GLOBE NEWSWIRE) -- The global molecular FISH testing market is projected to hit the market valuation of US$ 1,367.4 million by 2032 from US$ 731.4 million in 2023 at a CAGR of 7.2% during the forecast period 2024–2032.

The FISH (Fluorescence in situ Hybridization) testing market is poised for significant growth as the demand for precise and comprehensive diagnostic tools continues to rise across various sectors. One of the most promising opportunities is its expanding application in the early detection and monitoring of genetic disorders. In 2023, there were over 6,000 known genetic disorders globally, and FISH testing was instrumental in diagnosing approximately 1,000 of these conditions. With an estimated 350 million individuals affected by rare diseases worldwide, the need for effective diagnostic tools like FISH is more critical than ever. The development of new FISH probes for emerging genetic markers is forecasted to increase, providing enhanced accuracy in diagnosing these complex conditions.

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Another substantial opportunity lies in the integration of FISH testing into personalized medicine, particularly in oncology. In 2023, about 2 million new cancer cases were reported, with FISH testing playing a crucial role in identifying specific genetic mutations in approximately 300,000 of these cases. This integration allows for more targeted therapies and improved patient outcomes. The global market for FISH in cancer diagnostics is anticipated to reach $2.5 billion by 2025, driven by advancements in multiplex FISH assays that enable simultaneous detection of multiple genetic aberrations. With over 1,500 ongoing clinical trials incorporating FISH testing to assess treatment efficacy, the potential for this technology to transform cancer treatment is substantial.

Furthermore, the adoption of FISH testing in agricultural biotechnology presents a unique opportunity for market growth. By 2023, the agricultural biotechnology sector had identified over 500 new genetic markers in crops, with FISH testing facilitating the precise mapping of these markers in around 100 cases. This application is crucial for developing genetically modified crops that are more resilient to climate change and disease. The global market for FISH testing in agricultural applications is projected to grow, driven by the increasing demand for sustainable agricultural practices. With over 200 research institutions investing in the development of FISH-based techniques for crop improvement, the technology is set to play a pivotal role in ensuring food security and sustainability in the future.

Key Findings in Molecular Fish Testing Market

Market Forecast (2032)US$ 1,367.4 million
CAGR7.2%
Largest Region (2023)North America (44.0%)
By TechnologyCryo FISH (28.16%)
By ApplicationCancer Research (51.46%)
By Cellular Stains Type  DAPI (57.47%)
By Probe TypeWhole Chromosome (46.11%)
By End UserClinical (41.98%)
Top Drivers
  • Increasing demand for personalized medicine through genomic analysis in rare cancer cases.
  • Rising adoption of FISH in prenatal diagnostics for chromosomal abnormalities detection.
  • Technological advancements in multiplex FISH assays for complex genetic rearrangements identification.
Top Trends
  • Integration of artificial intelligence in FISH image analysis for enhanced accuracy.
  • Growing use of FISH in liquid biopsy applications for non-invasive testing.
  • Expansion of FISH into veterinary diagnostics for animal genetic disorder studies.
Top Challenges
  • Complexities in interpreting FISH results for polyploidy in plant genomics.
  • Inconsistent signal quality in FISH due to probe hybridization variability issues.
  • Limited probe availability for novel genetic markers in rare diseases.

Centromeric Repeats Probes Projected to Grow at the Highest CAGR of 7.7%

Centromeric Repeats probe types are projected to exhibit the highest CAGR in the molecular FISH testing market, driven by their specialized function in detecting numerical chromosomal abnormalities. These probes target the centromeric regions of chromosomes, enabling precise enumeration and identification of aneuploidies, which are crucial in prenatal diagnostics and oncology. In prenatal testing, centromeric probes are vital for early detection of conditions like Down syndrome (trisomy 21), significantly impacting clinical decisions and patient care.

The strong growth momentum of centromeric repeats probes in the molecular FISH testing market is fueled by several market dynamics. There is a rising demand for non-invasive and accurate prenatal diagnostic techniques as awareness of genetic disorders increases. In oncology, the significance of chromosomal gains or losses in prognosis and treatment planning has heightened the use of centromeric probes for cancers such as leukemias and lymphomas. Technological innovations have enhanced the efficiency and clarity of these probes, improving diagnostic turnaround times and accuracy. The cost-effectiveness of centromeric probes makes them accessible to a wide range of clinical laboratories, promoting widespread adoption. Market expansion is also supported by increased funding and investment in genetic research, encouraging the development of new centromeric probe products with expanded capabilities. While specific statistics for 2023 are not available, these factors collectively contribute to the robust growth and increasing prominence of centromeric repeats probes.

Growth Momentum of Cancer Research Application in Molecular FISH Testing Market to Keep Expanding Rapidly and to Take Up More than 51.46% Market Share

The cancer research application segment within the molecular FISH testing market is experiencing robust growth, with a compound annual growth rate (CAGR) of 7.7% projected through 2023. This strong momentum is fueled by escalating global cancer incidence; the World Health Organization (WHO) estimated 10 million cancer-related deaths in 2023, highlighting a pressing need for advanced diagnostics. Personalized medicine advancements have increased the reliance on FISH testing; as of 2023, over 70 targeted cancer therapies approved by the FDA require companion diagnostics involving FISH assays. In China, the number of hospitals offering FISH testing for cancer patients grew to more than 500 by 2023, effectively doubling over the past five years. The year 2023 alone saw the introduction of over 15 novel FISH probes for cancer research, expanding the technology’s diagnostic scope.

Technological advancements have significantly enhanced FISH testing efficiency; in 2023, the turnaround time was reduced to less than 24 hours due to automation and improved probe designs. The cost of FISH testing became more accessible by 2023, reaching levels suitable for routine clinical use. Globally, over 200 biotechnology companies in the molecular FISH testing market were dedicated to developing FISH-based diagnostics and therapeutics in 2023, reflecting strong industry confidence and investment. Government initiatives, such as the U.S. Cancer Moonshot program, allocated continued funding in 2023, emphasizing the importance of molecular diagnostics including FISH. The European Union’s Horizon Europe program dedicated over 500 million euros in 2023 to cancer research projects utilizing molecular diagnostics. These combined factors—technological innovations, increased accessibility, substantial industry investment, and supportive government funding—are propelling the strong growth momentum of FISH testing in cancer research applications, establishing it as the fastest-growing segment in the molecular FISH testing market.

DAPI Cellular Stains to keep Leading the Market by Generating More than 57.47% Market Share

DAPI is projected to grow at a robust CAGR of 6.9% in the molecular FISH testing market, driven by several key factors. The increasing prevalence of genetic disorders and the corresponding demand for precise diagnostic tools are primary catalysts for this growth. As of 2023, it is estimated that around 25% of the global population is affected by genetic diseases, necessitating advanced testing methodologies such as FISH. The expanded application of DAPI in research fields, including oncology and prenatal diagnostics, with approximately 70% of studies using FISH techniques, contributes significantly to this momentum. Furthermore, the rise in government initiatives aimed at enhancing genomic research funding, surpassing $1.5 billion in the last year, has positively impacted the growth trajectory of DAPI in molecular tests.

Additionally, technological advancements in fluorescence microscopy have improved the sensitivity and accuracy of molecular FISH testing, thus promoting DAPI's uptake. Innovations enabling higher resolution imaging and multi-color FISH approaches have attracted more laboratories to adopt DAPI as a primary stain. Over 40% of new laboratory setups in 2023 have integrated DAPI-based FISH methods into their standard operating procedures. This growing trend is further supported by the increasing prevalence of cancer, with the World Health Organization reporting that cancer cases are projected to reach 27 million by 2030, intensifying the need for effective diagnostic solutions. Moreover, the ongoing development of user-friendly kits and reagents that incorporate DAPI is streamlining workflows, resulting in a reported 50% reduction in testing time. These factors collectively underscore DAPI's solid growth momentum, positioning it as an indispensable component of the molecular FISH testing market.

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Highly Consolidated Market: Thermo Fisher, Abbott Laboratories, Agilent Control More than 68% Market Share

The molecular Fluorescence In Situ Hybridization (FISH) testing market is characterized by a high level of consolidation, with the top three players—Thermo Fisher Scientific, Abbott Laboratories, and Agilent Technologies—collectively holding over 68% of the market share. This consolidation indicates a competitive landscape where a few major companies dominate, driving innovation and setting industry standards. The market's competitiveness is fueled by the growing demand for rapid and accurate diagnostic techniques in genetic disorders and cancer detection, compelling these leading companies to continuously invest in research and development.

Abbott Laboratories stands at the forefront of molecular FISH testing market, commanding a leading position with over 32% market share. The company's dominance can be attributed to its expansive product portfolio, innovative technologies, and strategic global presence. Abbott has consistently invested in expanding its production capacity and enhancing its manufacturing facilities to meet the growing demand for molecular FISH testing. With multiple state-of-the-art plants and research sites worldwide, Abbott ensures a robust supply chain and accessibility of its diagnostic solutions across various regions.

In addition to its strong production capabilities, Abbott Laboratories has been proactive in undertaking strategic developments to maintain its market leadership. The company has made significant investments in research and development, leading to the launch of innovative products that address unmet clinical needs. For instance, Abbott has introduced advanced FISH assays that offer higher sensitivity and specificity in detecting genetic anomalies. Moreover, the company has engaged in strategic mergers and acquisitions to broaden its technological expertise and market reach. These initiatives not only reinforce Abbott's dominant position but also contribute to the advancement of the molecular FISH testing market as a whole.

Global Molecular FISH Testing Market Key Players:

  • Oxford Gene Technologies
  • Life Science Technologies
  • PerkinElmer Inc.
  • Abnova Corporation
  • Biosearch Technologies Inc.
  • Genemed Biotechnologies, Inc.
  • F. Hoffmann-La Roche AG.
  • NeoGenomics Laboratories
  • Intertek Group plc
  • Abbott Laboratories
  • Creative Biolabs, Inc.
  • ARUP Laboratories
  • Cepheid
  • MedGenome
  • GeneDx
  • Gene Technologies
  • Other Prominent Players

Key Segmentation:

By Technology:

  • Flow FISH
  • Q FISH
  • Immuno FISH
  • Cryo FISH
  • Other FISH

By Probe Type:

  • Locus specific
  • Centromeric repeats
  • Whole chromosome

By Cellular Stains:

  • DAPI (4,6-diamidino-2-phenylindole)
  • Acridine Orange
  • Others

By Application:

  • Cancer Research
    • Lung
    • Breast
    • Bladder
    • Haematological
    • Gastric
    • Prostrate
    • Cervical
    • Other
  • Genetic Diseases
  • Other

By End User:

  • Research
  • Clinical
  • Companion diagnostics

By Region:

  • North America
  • Europe
  • Asia Pacific 
  • Middle East & Africa
  • South America

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