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PUBLISHER: TechSci Research | PRODUCT CODE: 1703265

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PUBLISHER: TechSci Research | PRODUCT CODE: 1703265

Gene Fusion Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Category, By Technology, By Indication, By End User, By Region and Competition, 2020-2030F

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Description

Table of Contents

Global Gene Fusion Testing Market was valued at USD 471.24 Million in 2024 and is expected to reach USD 947.49 Million in the forecast period with a CAGR of 12.32% through 2030. Gene fusion, also known as gene translocation or chromosomal translocation, is a genetic event that occurs when two separate genes from different regions of the genome become abnormally connected or fused together. This fusion can result in the creation of a hybrid gene, also known as a chimeric gene, which combines portions of both original genes. Gene fusion events can have significant implications for an organism's health, particularly when they occur in human cells and are associated with diseases, such as cancer. Gene fusion occurs when there is a rearrangement of genetic material, often through a process called chromosomal translocation. In chromosomal translocation, a piece of one chromosome breaks off and attaches to another chromosome, leading to the fusion of genes located on these chromosomes.

Market Overview
Forecast Period2026-2030
Market Size 2024USD 471.24 Million
Market Size 2030USD 947.49 Million
CAGR 2025-203012.32%
Fastest Growing SegmentPharmaceutical and Biotechnology Companies
Largest MarketNorth America

Identifying specific gene fusion events is of great diagnostic and therapeutic relevance, particularly in cancer. Gene fusion testing is used to detect these events and guide treatment decisions. In some cases, targeted therapies have been developed to inhibit the function of abnormal chimeric proteins. The development and adoption of targeted therapies for cancer treatment were driving the need for precise molecular profiling of tumors, including the detection of gene fusions. These therapies often rely on the identification of specific genetic alterations as therapeutic targets. Ongoing advancements in genomic technologies, particularly next-generation sequencing (NGS) and high-throughput molecular assays, were making gene fusion testing more accessible, cost-effective, and efficient. Research efforts were continually uncovering new gene fusion events and their relevance in various diseases, including cancer. This research drove interest in developing and commercializing gene fusion tests.

Key Market Drivers

Advancements in Genomic Technologies

Next-Generation Sequencing (NGS) technologies, such as Illumina and Ion Torrent, have revolutionized genomics research and clinical diagnostics by enabling rapid and cost-effective sequencing of DNA and RNA.

Long-read sequencing technologies, such as those developed by Pacific Biosciences (PacBio) and Oxford Nanopore, provide a more comprehensive view of the genome, particularly useful for detecting structural variants and complex genomic regions. The CRISPR-Cas9 system has transformed genome editing, enabling precise and targeted gene modifications, making it a powerful tool for functional genomics, gene therapy, and genetic engineering. Notably, in December 2023, the U.S. Food and Drug Administration approved Casgevy, the first CRISPR-based treatment for sickle cell disease and beta-thalassemia, marking a significant milestone in gene-editing therapeutics.

Advances in technologies like DNA methylation sequencing (bisulfite sequencing) and chromatin immunoprecipitation sequencing (ChIP-seq) have deepened our understanding of epigenetic modifications and their roles in gene regulation and disease. Techniques such as single-molecule fluorescence in situ hybridization (smFISH) and single-molecule real-time (SMRT) sequencing offer insights into molecular processes at the individual molecule level. Metagenomic sequencing facilitates the study of microbial communities and their genetic diversity, with applications in environmental microbiology, microbiome research, and infectious disease diagnostics.

Key Market Challenges

Tissue Availability

In some cases, obtaining enough tissue for gene fusion testing can be challenging, especially when dealing with small biopsies or fine-needle aspirates. Insufficient tissue can result in inadequate test results. The quality of tissue samples is crucial for accurate gene fusion testing. Factors such as tissue preservation, fixation, and handling can impact the integrity of the genetic material and affect the reliability of test results. Tumors are often heterogeneous, meaning that different regions of the tumor may have distinct genetic profiles, including gene fusion events. Obtaining a single tissue sample may not fully represent the genetic diversity within the tumor. In some cases, tumors may be in anatomically challenging or inaccessible areas, making it difficult to obtain tissue samples for testing. Invasive procedures like biopsies carry inherent risks, including bleeding, infection, and damage to surrounding tissues. These risks can influence the decision to perform a biopsy and impact tissue availability. For rare or uncommon tumor types, obtaining sufficient tissue samples for gene fusion testing can be particularly challenging due to the limited number of cases available for study. Properly preserving and storing tissue samples for future testing is essential. Inadequate preservation or long-term storage conditions can compromise the quality of the samples. Obtaining informed consent for tissue collection is crucial, and ethical considerations may affect the availability of tissue samples, especially in cases involving minors or vulnerable populations.

Key Market Trends

Personalized Medicine

Gene fusion testing plays a crucial role in identifying specific genetic alterations that drive diseases, particularly in cancer. With the advent of personalized medicine, oncologists and other healthcare providers can use the results of gene fusion tests to select targeted therapies that are most likely to be effective for individual patients. This approach maximizes treatment efficacy while minimizing side effects. Gene fusion testing is used to stratify patients into different subgroups based on their genetic profiles. Patients with similar gene fusion events may respond differently to treatments. Personalized medicine enables the selection of the most appropriate treatment regimen for each patient based on their specific genetic alterations. Gene fusion tests are often developed alongside targeted therapies as companion diagnostics. These tests help identify patients who are most likely to benefit from a particular drug. Regulatory agencies like the U.S. Food and Drug Administration (FDA) often require companion diagnostics as part of the drug approval process. Personalized medicine extends beyond initial treatment selection. It also involves ongoing monitoring of a patient's response to therapy. Gene fusion testing can be used to assess whether a targeted therapy is effectively suppressing the fusion event and whether treatment adjustments are needed.

Key Market Players

  • Amoy Diagnostics Co., Ltd.
  • ArcherDX (Integrated DNA Technologies, Inc.)
  • Biocartis
  • Biocare Medical, LLC
  • F. Hoffmann-La Roche Ltd.
  • Guardant Health, Inc
  • Illumina, Inc.
  • Myriad Genetics, Inc.
  • Natera, Inc.
  • NeoGenomics, Inc.
  • QIAGEN N.V.
  • Thermo Fisher Scientific Inc

Report Scope:

In this report, the Global Gene Fusion Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Gene Fusion Testing Market, By Category:

  • Research
  • Diagnostic

Gene Fusion Testing Market, By Technology:

  • Next-Generation Sequencing (NGS)
  • Fluorescence In-Situ Hybridization (FISH)
  • Polymerase Chain Reaction (PCR)
  • Immunohistochemistry (IHC)

Gene Fusion Testing Market, By Indication:

  • Solid Tumors
  • Hematological Malignancies

Gene Fusion Testing Market, By End User:

  • Pharmaceutical and Biotechnology Companies
  • Hospitals and Diagnostic Laboratories
  • Academic and Research Centers

Global Gene Fusion Testing Market, By region:

  • North America
    • United States
    • Canada
    • Mexico
  • Asia-Pacific
    • China
    • India
    • South Korea
    • Australia
    • Japan
  • Europe
    • Germany
    • France
    • United Kingdom
    • Spain
    • Italy
  • South America
    • Brazil
    • Argentina
    • Colombia
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Gene Fusion Testing Market.

Available Customizations:

Global Gene Fusion Testing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).
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Product Code: 16768

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Gene Fusion Testing Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Category (Research, Diagnostic)
    • 5.2.2. By Technology (Next-Generation Sequencing (NGS), Fluorescence In-Situ Hybridization (FISH), Polymerase Chain Reaction (PCR), Immunohistochemistry (IHC))
    • 5.2.3. By Indication (Solid Tumors, Hematological Malignancies)
    • 5.2.4. By End User (Pharmaceutical and Biotechnology Companies, Hospitals and Diagnostic Laboratories, Academic and Research Centers)
    • 5.2.5. By Region
    • 5.2.6. By Company (2024)
  • 5.3. Market Map

6. Asia Pacific Gene Fusion Testing Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Category
    • 6.2.2. By Technology
    • 6.2.3. By Indication
    • 6.2.4. By End User
    • 6.2.5. By Country
  • 6.3. Asia Pacific: Country Analysis
    • 6.3.1. China Gene Fusion Testing Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Category
        • 6.3.1.2.2. By Technology
        • 6.3.1.2.3. By Indication
        • 6.3.1.2.4. By End User
    • 6.3.2. India Gene Fusion Testing Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Category
        • 6.3.2.2.2. By Technology
        • 6.3.2.2.3. By Indication
        • 6.3.2.2.4. By End User
    • 6.3.3. Australia Gene Fusion Testing Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Category
        • 6.3.3.2.2. By Technology
        • 6.3.3.2.3. By Indication
        • 6.3.3.2.4. By End User
    • 6.3.4. Japan Gene Fusion Testing Market Outlook
      • 6.3.4.1. Market Size & Forecast
        • 6.3.4.1.1. By Value
      • 6.3.4.2. Market Share & Forecast
        • 6.3.4.2.1. By Category
        • 6.3.4.2.2. By Technology
        • 6.3.4.2.3. By Indication
        • 6.3.4.2.4. By End User
    • 6.3.5. South Korea Gene Fusion Testing Market Outlook
      • 6.3.5.1. Market Size & Forecast
        • 6.3.5.1.1. By Value
      • 6.3.5.2. Market Share & Forecast
        • 6.3.5.2.1. By Category
        • 6.3.5.2.2. By Technology
        • 6.3.5.2.3. By Indication
        • 6.3.5.2.4. By End User

7. Europe Gene Fusion Testing Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Category
    • 7.2.2. By Technology
    • 7.2.3. By Indication
    • 7.2.4. By End User
    • 7.2.5. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. France Gene Fusion Testing Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Category
        • 7.3.1.2.2. By Technology
        • 7.3.1.2.3. By Indication
        • 7.3.1.2.4. By End User
    • 7.3.2. Germany Gene Fusion Testing Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Category
        • 7.3.2.2.2. By Technology
        • 7.3.2.2.3. By Indication
        • 7.3.2.2.4. By End User
    • 7.3.3. Spain Gene Fusion Testing Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Category
        • 7.3.3.2.2. By Technology
        • 7.3.3.2.3. By Indication
        • 7.3.3.2.4. By End User
    • 7.3.4. Italy Gene Fusion Testing Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Category
        • 7.3.4.2.2. By Technology
        • 7.3.4.2.3. By Indication
        • 7.3.4.2.4. By End User
    • 7.3.5. United Kingdom Gene Fusion Testing Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Category
        • 7.3.5.2.2. By Technology
        • 7.3.5.2.3. By Indication
        • 7.3.5.2.4. By End User

8. North America Gene Fusion Testing Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Category
    • 8.2.2. By Technology
    • 8.2.3. By Indication
    • 8.2.4. By End User
    • 8.2.5. By Country
  • 8.3. North America: Country Analysis
    • 8.3.1. United States Gene Fusion Testing Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Category
        • 8.3.1.2.2. By Technology
        • 8.3.1.2.3. By Indication
        • 8.3.1.2.4. By End User
    • 8.3.2. Mexico Gene Fusion Testing Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Category
        • 8.3.2.2.2. By Technology
        • 8.3.2.2.3. By Indication
        • 8.3.2.2.4. By End User
    • 8.3.3. Canada Gene Fusion Testing Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Category
        • 8.3.3.2.2. By Technology
        • 8.3.3.2.3. By Indication
        • 8.3.3.2.4. By End User

9. South America Gene Fusion Testing Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Category
    • 9.2.2. By Technology
    • 9.2.3. By Indication
    • 9.2.4. By End User
    • 9.2.5. By Country
  • 9.3. South America: Country Analysis
    • 9.3.1. Brazil Gene Fusion Testing Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Category
        • 9.3.1.2.2. By Technology
        • 9.3.1.2.3. By Indication
        • 9.3.1.2.4. By End User
    • 9.3.2. Argentina Gene Fusion Testing Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Category
        • 9.3.2.2.2. By Technology
        • 9.3.2.2.3. By Indication
        • 9.3.2.2.4. By End User
    • 9.3.3. Colombia Gene Fusion Testing Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Category
        • 9.3.3.2.2. By Technology
        • 9.3.3.2.3. By Indication
        • 9.3.3.2.4. By End User

10. Middle East and Africa Gene Fusion Testing Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Category
    • 10.2.2. By Technology
    • 10.2.3. By Indication
    • 10.2.4. By End User
    • 10.2.5. By Country
  • 10.3. MEA: Country Analysis
    • 10.3.1. South Africa Gene Fusion Testing Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Category
        • 10.3.1.2.2. By Technology
        • 10.3.1.2.3. By Indication
        • 10.3.1.2.4. By End User
    • 10.3.2. Saudi Arabia Gene Fusion Testing Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Category
        • 10.3.2.2.2. By Technology
        • 10.3.2.2.3. By Indication
        • 10.3.2.2.4. By End User
    • 10.3.3. UAE Gene Fusion Testing Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Category
        • 10.3.3.2.2. By Technology
        • 10.3.3.2.3. By Indication
        • 10.3.3.2.4. By End User

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Recent Developments
  • 12.2. Product Launches
  • 12.3. Mergers & Acquisitions

13. Global Gene Fusion Testing Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Product

15. PESTLE Analysis

16. Competitive Landscape

  • 16.1. Amoy Diagnostics Co., Ltd.
    • 16.1.1. Business Overview
    • 16.1.2. Company Snapshot
    • 16.1.3. Products & Services
    • 16.1.4. Financials (In case of listed companies)
    • 16.1.5. Recent Developments
    • 16.1.6. SWOT Analysis
  • 16.2. ArcherDX (Integrated DNA Technologies, Inc.)
  • 16.3. Biocartis
  • 16.4. Biocare Medical, LLC
  • 16.5. F. Hoffmann-La Roche Ltd.
  • 16.6. Guardant Health, Inc
  • 16.7. Illumina, Inc.
  • 16.8. Myriad Genetics, Inc.
  • 16.9. Natera, Inc.
  • 16.10. NeoGenomics, Inc.
  • 16.11. QIAGEN N.V.
  • 16.12. Thermo Fisher Scientific Inc

17. Strategic Recommendations

18. About Us & Disclaimer

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