Dublin, May 07, 2025 (GLOBE NEWSWIRE) -- The "Gene Fusion Testing Market - A Global and Regional Analysis: Focus on Category, Technology, Indication, End User, and Region - Analysis and Forecast, 2025-2035" report has been added to ResearchAndMarkets.com's offering.
The global gene fusion testing market is a critical component of molecular diagnostics and precision medicine, focused on identifying genetic alterations, specifically gene fusions, that contribute to the development of various diseases, particularly cancer. These tests detect gene rearrangements that may lead to abnormal protein functions, driving cancer progression.
As the demand for advanced diagnostic technologies grows, the global gene fusion testing market has become essential in precision medicine, enabling the development of personalized treatments tailored to the unique genetic profiles of individual patients. This market plays a vital role in transforming cancer care, allowing for more targeted and effective therapies based on genetic findings.
In the global gene fusion testing market, several technologies such as next-generation sequencing (NGS), fluorescence in situ hybridization (FISH), and polymerase chain reaction (PCR) are used to detect gene fusions in various cancers. As advancements continue, the global gene fusion testing market is expected to grow exponentially, offering new opportunities for early diagnosis, precise treatment selection, and improved patient outcomes. The rising demand for personalized medicine further propels the global gene fusion testing market, ensuring that patients receive treatments tailored to their genetic makeup, enhancing the effectiveness of therapies and minimizing side effects.
Market Demand Drivers:
- Growing Prevalence of Cancer Driven by Gene Fusion Mutations
- Expanding Use of Gene Fusion Testing in Targeted Therapy Development
- Global Increase in Research Funding Focused on Cancer Screening and Prevention
Market Restraints:
- Challenges Due to the Complexity of the Testing Process
- Issues with Standardization and Barriers in Reimbursement Policies
Market Opportunities:
- Growing Demand for Gene Fusion Testing in Clinical Research
- Utilizing Artificial Intelligence to Predict Gene Fusion Status Across Various Cancer Types
Market Lifecycle Stage
The global gene fusion testing market is experiencing significant growth, fueled by the rising prevalence of cancer associated with gene fusion mutations. The increasing demand for early detection, precise selection of targeted therapies, and personalized medicine is driving this expansion. Additionally, the growing adoption of gene fusion testing in clinical practice is further accelerating the need for these diagnostic tests in cancer care. As the global gene fusion testing market continues to evolve, it plays a crucial role in enabling more accurate and individualized treatment options for cancer patients, improving overall patient outcomes.
Industrial Impact
Gene fusion testing is a diagnostic method that employs molecular analysis to detect and examine genetic abnormalities known as gene fusions. These occur when two distinct genes from different chromosomal regions become abnormally joined, creating a hybrid gene. This fusion can result in the production of abnormal proteins or changes in gene expression, potentially contributing to the development of various diseases, including certain cancers.
Cancer progression is influenced by multiple genetic alterations, such as mutations, deletions, amplifications, and rearrangements, with gene fusions being a key factor. The involvement of leading industry players, including Amoy Diagnostics Co., Ltd., Biocartis, Biocare Medical, LLC, Danaher Corporation, and F. Hoffmann-La Roche Ltd., is expected to drive further growth in the global gene fusion testing market.
In addition, AI-powered prediction models offer the potential to minimize the need for time-consuming and expensive laboratory assays by identifying patients who may require additional diagnostic testing. These models could also uncover previously undetected gene fusion events, improving the understanding of the genomic landscape of cancers and supporting the development of targeted therapeutic approaches in the global gene fusion testing market.
Market Segmentation
Research to Continue its Dominance in the by Category Segment
In terms of category type, the research segment is anticipated to lead the global gene fusion testing market in FY2024. The increasing adoption of kits, assays, and accessories has greatly contributed to the growth and prominence of this segment. These research-specific assays and kits, primarily designed for use in research settings rather than diagnostic applications, are vital for scientists and researchers studying gene fusions and their involvement in various diseases, especially cancer. As demand for these tools continues to rise, the research segment is set to maintain its dominant position in the global gene fusion testing market.
NGS to Continue its Dominance in the Technology Segment
Based on technology, the NGS (Next-Generation Sequencing) segment is projected to dominate the global gene fusion testing market in FY2024. NGS is an advanced and transformative technology that plays a pivotal role in gene fusion testing, providing high-throughput and accurate analysis of DNA and RNA sequences. In the context of gene fusion testing, NGS facilitates a comprehensive examination of genetic rearrangements, enabling the precise identification of fusion events between different genes with exceptional accuracy. As NGS continues to evolve, it is set to maintain its leading position in the global gene fusion testing market.
Solid Tumors to Continue its Dominance in the Indication Segment
Based on indication, the solid tumors segment is anticipated to lead the global gene fusion testing market in FY2024. In oncology, gene fusion testing for solid tumors is crucial in molecular diagnostics, focusing on identifying specific gene fusions caused by chromosomal rearrangements or translocations within tumor cells. These gene fusions can result in the production of abnormal fusion proteins, which play a significant role in the progression and development of solid tumors. As the demand for precise cancer diagnostics increases, the solid tumors segment is expected to maintain its dominance in the global gene fusion testing market.
Pharmaceutical and Biotechnology Companies to Continue its Dominance in the End User Segment
Based on end user, the pharmaceutical and biotechnology companies segment is expected to hold the largest share of the global gene fusion testing market in FY2024. These companies play a crucial role in the market, utilizing their expertise and resources to drive innovation and promote advancements in this rapidly evolving field. With a keen understanding of the significant potential of gene fusion testing, pharmaceutical and biotechnology companies are leading efforts to revolutionize cancer diagnostics and treatment strategies, ensuring continued growth and development in the global gene fusion testing market.
U.K. to Continue its Dominance as the Leading Country in Europe
Germany is the dominant market in Europe, with the U.K. projected to experience the highest growth rate. The U.K. has adopted a supportive approach towards the development of gene fusion testing technologies. Furthermore, the country is known for its robust academic and research institutions, which play a critical role in advancing genetic testing technologies and driving innovation in the global gene fusion testing market.
Key Market Players and Competition Synopsis
The companies that are profiled have been selected based on inputs gathered from primary experts and analysing company coverage, product portfolio, and market penetration. Some of the prominent companies in this market are:
- Amoy Diagnostics Co., Ltd.
- Biocartis
- Biocare Medical, LLC
- F. Hoffmann-La Roche Ltd.
- Guardant Health, Inc.
- Illumina, Inc.
- Myriad Genetics, Inc.
- Thermo Fisher Scientific Inc.
- QIAGEN N.V.
Companies that are not a part of the aforementioned pool have been well represented across different sections of the report (wherever applicable)
How can this report add value to an organization?
Workflow/Innovation Strategy: The gene fusion testing market, segmented by indication, comprises solid tumors and hematological malignancies. Furthermore, the study provides a thorough analysis of the diverse applications of gene fusion testing in solid tumors, offering readers a comprehensive understanding of its role in identifying gene fusions linked to these specific cancer types.
Growth/Marketing Strategy: Gene fusion testing is a molecular diagnostic technique employed to identify and analyze specific genetic alterations in cancer cells. It occurs when two distinct genes, typically located on different chromosomes, fuse abnormally, creating a hybrid gene that generates a unique protein with modified functions.
Competitive Strategy: Key players in the global gene fusion testing market have been extensively analyzed and profiled in this study, including manufacturers. Furthermore, a detailed competitive benchmarking of these players has been performed to give readers a clear insight into how companies measure up against each other, presenting a comprehensive view of the market landscape.
Key Topics Covered
1. Product Definition
1.1 Inclusion and Exclusion Criteria
2. Market Scope
2.1 Scope of the Study
2.2 Key Questions Answered in the Report
3. Research Methodology
4. Market Overview
4.1 Introduction to Gene Fusion Testing
4.1.1 Different Technologies for Gene Fusion Testing
4.1.2 Advantages and Limitations of Gene Fusion Testing
4.1.3 Current Market Size and Future Growth Potential, $Million, 2023-2035
4.1.4 Role of Artificial Intelligence (AI) and Machine Learning (ML) in Gene Fusion Testing
4.1.5 Reimbursement Landscape
4.2 Stakeholder's Survey Response
4.2.1 Awareness of Gene Fusion Testing
4.2.2 Familiarity with the NGS Offerings of the Following Companies
4.2.3 Adoption and Barriers for Gene Fusion Testing
5. Industry Outlook
5.1 Regulatory Landscape
5.1.1 Legal Requirements and Frameworks in the U.S.
5.1.2 Legal Requirements and Frameworks in Europe
5.1.3 Legal Requirements and Frameworks in Asia-Pacific
5.1.3.1 Legal Requirements and Framework in China
5.1.3.2 Legal Requirements and Framework in Japan
6. Global Gene Fusion Testing Market: Market Dynamics
6.1 Impact Analysis
6.2 Market Drivers
6.3 Market Restraints
6.4 Market Opportunities
7. Global Gene Fusion Testing Market: Competitive Insights
7.1 Overview
7.2 Key Strategies and Developments
7.2.1 Product Approvals and Launches
7.2.2 Partnerships and Collaborations
7.2.3 Mergers and Acquisitions
7.2.4 Other Developments
7.3 Market Share Analysis
7.3.1 By Company
7.4 Growth-Share Analysis
8. Global Gene Fusion Testing Market (by Category), ($Million), 2023-2035
8.1 Overview
8.2 Research
8.3 Diagnostic
9. Global Gene Fusion Testing (by Technology), ($Million), 2023-2035
9.1 Overview
9.2 Next-Generation Sequencing (NGS)
9.3 Fluorescence In-Situ Hybridization (FISH)
9.4 Polymerase Chain Reaction (PCR)
9.5 Immunohistochemistry (IHC)
10. Global Gene Fusion Testing Market (by Indication), ($Million), 2023-2035
10.1 Overview
10.2 Solid Tumors
10.2.1 Lung Cancer
10.2.2 Breast Cancer
10.2.3 Colorectal Cancer
10.2.4 Thyroid Cancer
10.2.5 Others
10.3 Hematological Malignancies
11. Global Gene Fusion Testing Market (by End User), ($Million), 2023-2035
11.1 Overview
11.2 Pharmaceutical and Biotechnology Companies
11.3 Hospitals and Diagnostic Laboratories
11.4 Research and Academic Centers
12. Global Gene Fusion Testing Market (by Region), ($Million), 2023-2035
12.1 Overview
12.2 North America
12.3 Europe
12.4 Asia-Pacific
12.5 Latin America
12.6 Rest-of-the-World
13. Competitive Landscape and Company Profiles
13.1 Competitive Landscape
13.1.1 New Offerings
13.1.2 Mergers and Acquisitions
13.1.3 Partnerships, Alliances, and Business Expansion
13.1.4 Funding Activities
13.1.5 Regulatory Approvals
13.2 Amoy Diagnostics Co., Ltd.
13.3 Arima Genomics
13.4 Biocartis
13.5 Biocare Medical, LLC
13.6 Bio-Rad Laboratories, Inc.
13.7 F. Hoffmann-La Roche Ltd.
13.8 Guardant Health, Inc.
13.9 Illumina, Inc.
13.10 Invitae Corporation
13.11 Myriad Genetics, Inc.
13.12 NeoGenomics, Inc.
13.13 OncoDNA
13.14 PerkinElmer, Inc.
13.15 QIAGEN N.V.
13.16 Thermo Fisher Scientific Inc.
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