Gene Fusion Testing Market - A Global and Regional Analysis: Focus on Category, Technology, Indication, End User, and Region - Analysis and Forecast, 2025-2035

Global Gene Fusion Testing Market Industry Overview

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 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.

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:

Segmentation 1: by Category

• Research
• Diagnostic

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.

Segmentation 2: by Technology

• NGS
• FISH
• PCR
• IHC

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.

Segmentation 3: by Indication

• Solid Tumors
• Hematological Malignancies

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.

Segmentation 4: by End User

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

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.

Segmentation 5: by Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Rest-of-the-World

U.K. to Continue its Dominance as the Leading Country in Europe Region

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.

Demand - Drivers and Limitations

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

The gene fusion testing market is a crucial segment within the healthcare industry, dedicated to the development, production, and commercialization of tests and technologies aimed at detecting and analyzing gene fusions. This testing identifies abnormal fusion events where two distinct genes merge to form fusion proteins with modified functions, often linked to various diseases, particularly cancer. This study explores several core technologies that have driven advancements in gene fusion testing, including polymerase chain reaction (PCR), next-generation sequencing (NGS), immunohistochemistry (IHC), and fluorescence in-situ hybridization (FISH). The expansion of the global gene fusion testing market is fueled by the ongoing introduction of innovative technologies and increasing investments and funding from both government and private sectors.

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.

Methodology

Key Considerations and Assumptions in Market Engineering and Validation

• Detailed secondary research to ensure maximum coverage of manufacturers/suppliers operational in a country.
• Exact revenue information, up to a certain extent, will be extracted for each company from secondary sources and databases. Revenues specific to product/service/technology will then be estimated for each market player based on fact-based proxy indicators as well as primary inputs.
• The currency conversion rate has been taken from the historical exchange rate of Oanda and/or other relevant websites.
• Any economic downturn in the future has not been taken into consideration for the market estimation and forecast.
• The base currency considered for the market analysis is US$. Currencies other than the US$ have been converted to the US$ for all statistical calculations, considering the average conversion rate for that particular year.
• The term "product" in this document may refer to "service" or "technology" as and where relevant.
• The term "manufacturers/suppliers" may refer to "service providers" or "technology providers" as and where relevant.

Primary Research

The key data points taken from the primary sources include:

• Validation and triangulation of all the numbers and graphs
• Validation of the report's segmentation and key qualitative findings
• Understanding of the numbers of the various markets for market type
• Percentage split of individual markets for regional analysis

Secondary Research

Open Sources

• Food and Drug Administration (FDA), European Medical Agency (EMA), National Medical Product Administration (NMPA), Ministry of Health, Labor, and Welfare (MHLW), Pharmaceutical and Medical Devices Association (PMDA), Frontiers, and World Intellectual Property Organization (WIPO)
• Annual reports, SEC filings, and investor presentations of the leading market players
• Company websites and detailed study of their portfolio
• Gold standard magazines, journals, whitepapers, press releases, and news articles
• Databases

The key data points taken from the secondary sources include:

• Segmentations, split-ups, and percentage shares
• Data for market value
• Key industry trends of the top players in the market
• Qualitative insights into various aspects of the market, key trends, and emerging areas of innovation
• Quantitative data for mathematical and statistical calculations

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).