A quick peek into the report
Market Report Coverage
Key Market Players and Competition Synopsis
The gene fusion testing market encompasses the healthcare industry segment focused on developing, producing, and commercializing tests and technologies designed to detect and analyze gene fusions. Gene fusion testing involves the identification of abnormal fusion events where two separate genes join together, leading to the formation of fusion proteins with modified functions. These genetic alterations are commonly associated with various diseases, particularly cancer. In this study, several types of fundamental technologies have been examined that have facilitated these advances, namely, polymerase chain reaction (PCR), next-generation sequencing (NGS), immunohistochemistry (IHC), fluorescence in-situ hybridization (FISH). The global gene fusion testing market is strongly driven by the continuous introduction of advanced technologies as well as increased investments and funding from both the government and private sectors.
Key Companies Profiled:
• Amoy Diagnostics Co., Ltd.
• ArcherDX (Integerated DNA Technologies, Inc.)
• Arima Genomics
• Biocartis
• Biocare Medical, LLC
• F. Hoffmann-La Roche Ltd
• Guardant Health, Inc
• Illumina, Inc.
• Myriad Genetics, Inc.
• Natera, Inc.
• NeoGenomics, Inc.
• OncoDNA
• QIAGEN N.V.
• Quest Diagnostics Incorporated.
• Thermo Fisher Scientific Inc.
Global Gene Fusion Testing Market Industry Overview
Source: BIS Research Analysis
The global gene fusion testing market was valued at $255.3 million in 2022 and is anticipated to reach $897.6 million by 2033, witnessing a CAGR of 12.25% during the forecast period 2023-2033. The global gene fusion testing market is expected to be driven by the rising utilization of gene fusion testing in the development of targeted therapies.
Market Lifecycle Stage
The global gene fusion testing market is in progressing phase. The gene fusion testing market is experiencing rapid growth due to the rising cancer incidence because of gene fusion mutations. The demand for early detection, precise selection of targeted therapies, personalized medicine approaches, and the growing recognition and implementation of gene fusion testing in clinical settings all contribute to the escalating need for these diagnostic tests in cancer care.
Impact
Gene fusion testing is a diagnostic method that involves molecular analysis to detect and examine genetic abnormalities called gene fusions. Gene fusions arise when two distinct genes from different chromosomal locations become abnormally joined, resulting in a hybrid gene formation. This fusion can trigger the synthesis of abnormal proteins or cause changes in gene expression, potentially contributing to the development of diverse diseases, including specific types of cancer. The progression of cancer is influenced by a variety of genetic changes, encompassing mutations, deletions, gene fusions, amplifications, and rearrangements. In addition, the entry of several established players, such as Amoy Diagnostics Co., Ltd., Arima Genomics, Biocartis, Biocare Medical, LLC, Danaher Corporation, F. Hoffmann-La Roche Ltd, Guardant Health, Inc., Illumina, Inc., Myriad Genetics, Inc., and others, is expected to aid the market growth.
Reducing the need for time-consuming and expensive laboratory assays, AI-powered prediction models can help identify patients who should receive further tests for diagnosis first. These models could identify novel, previously undetected gene fusion events, enhancing the comprehension of the genomic environment of malignancies and assisting in the design of targeted therapeutics.
Market Segmentation:
Segmentation 1: by Category
• Research
• Diagnostic
Source: BIS Research Analysis
Research to Continue its Dominance in the by Category Segment
Based on category type, the research segment dominated the global gene fusion testing market in FY2022. The increasing adoption of kits, assays, and accessories contributed to the prominence of the research segment. Research use assays and kits in gene fusion testing are specifically designed and intended for use in research settings rather than for diagnostic purposes. These assays and kits are valuable tools for researchers and scientists who are studying gene fusions and their implications in various diseases, particularly cancer.
Segmentation 2: by Technology
• NGS
• FISH
• PCR
• IHC
Next-Generation Sequencing Segment to Hold Major Share in the Global Gene Fusion Testing Market (by Technology)
Based on technology, the NGS segment dominated the global gene fusion testing market in FY2022. Next-generation sequencing (NGS), plays a significant role in gene fusion testing. It is a powerful and advanced technology used to analyze DNA and RNA sequences with high throughput and accuracy. In the context of gene fusion testing, NGS allows for the comprehensive examination of genes and their rearrangements, enabling the identification of fusion events between different genes.
Segmentation 3: by Indication
• Solid Tumors
• Hematological Malignancies
Solid Tumors Segment to Hold Major Share in the Global Gene Fusion Testing Market (by Indication)
Based on indication, the global gene fusion testing market was dominated by the solid tumors segment in FY2022. In the field of oncology, gene fusion testing in solid tumors holds significant importance within molecular diagnostics. Its primary objective is to pinpoint particular gene fusions arising from chromosomal rearrangements or translocations within tumor cells. These gene fusions can generate abnormal fusion proteins that significantly contribute to the advancement and evolution of solid tumors.
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 accounted for the largest share of the global gene fusion testing market in FY2022. Pharmaceutical and biotechnology companies hold an important position in the gene fusion testing market, utilizing their expertise and resources to drive innovation and propel advancements in this rapidly evolving field. They are aware of the immense potential of gene fusion testing in revolutionizing cancer diagnostics and treatment approaches.
Segmentation 5: by Region
• North America
• Europe
• Asia-Pacific
• Latin America
• Rest-of-the-World
North America held the largest share of 49.64% in 2022 in the global gene fusion testing market, owing to the presence of most key players and rising funding in the region.
Demand - Drivers and Limitations
Market Demand Drivers:
• Rising Cancer Incidence Due to Gene Fusion Mutations
• Increasing Utilization of Gene Fusion Testing in the Development of Targeted Therapies
• Global Rise in Research Grants Dedicated to Cancer Screening and Prevention Efforts
Market Restraints:
• Complexity of Testing Process
• Lack of Standardization and Reimbursement Barriers
Market Opportunities:
• Increasing Demand of Gene Fusion Testing in Clinical Research
• Leveraging Artificial Intelligence to Predict Gene Fusion Status in Several Cancer Type
Analyst View
According to Akash Mhaskar, Principal Analyst, BIS Research, “The global gene fusion testing market is experiencing rapid growth due to the increasing utilization of Utilization of gene fusion testing in the development of targeted therapies. Targeted therapies present multiple advantages compared to conventional treatments, including higher efficacy, less side effects, and enhanced patient outcomes. By using gene fusion testing, healthcare providers are more active to revolutionize disease management by offering more personalized and superior therapeutic interventions. The global gene fusion testing market has witnessed a steady growth in the number of new entrants and investments in genetic testing, thereby driving a surge in demand for the products and services required in the testing of gene fusion. This trend is also expected to continue over the forecast period. Therefore, the impact of the aforementioned factors is expected to drive the global gene fusion testing market in the near future.”
Gene Fusion Testing Market - A Global and Regional Analysis
Focus on by Category, Technology, Indication, End User, and Region - Analysis and Forecast, 2023-2033
Frequently Asked Questions
Gene fusion testing is a molecular diagnostic method employed to identify and analyze distinct genetic alterations in cancer cells. It arises when two distinct genes, typically from different chromosomes, abnormally join together, giving rise to a hybrid gene that generates a unique protein with modified functions. Gene fusion testing typically involves analyzing the genetic material (DNA or RNA) from a patient's tumor sample. It has proven valuable in managing various cancer indications, with NTRK gene fusion being a prevalent fusion event observed across several cancer types. Techniques such as polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), immunohistochemistry (IHC), and next-generation sequencing (NGS) are commonly used to detect and characterize gene fusions.
New technologies and methods are rapidly emerging to enhance the testing of genetic alterations in chromosomes, which is driving the market for gene fusion testing. Here are some prevalent patterns in the industry:
Increasing utilization of gene fusion testing in the development of targeted therapies: Gene fusion testing plays an important role in identifying the appropriate patients for targeted therapies. By utilizing gene fusion testing, healthcare providers can accurately identify patients whose diseases are driven by specific genetic alterations. This enables the customization of treatment approaches to effectively address these specific genetic abnormalities. As the knowledge of gene fusions and their implications advances, the potential for targeted therapies guided by gene fusion testing expands, offering prospects for precision medicine and enhancing the overall quality of patient care.
Leveraging artificial intelligence to predict gene fusion status in several cancer type: Artificial intelligence (AI) techniques have opened up possibilities for utilizing sophisticated computational algorithms to predict the status of gene fusions in diverse cancer types. Through the utilization of extensive datasets containing genomic and clinical information, AI models can be trained to recognize patterns and correlations that may indicate the occurrence of gene fusion events. By examining genomic data, including DNA or RNA sequencing data, alongside clinical characteristics, AI algorithms can pinpoint predictive markers that indicate the presence or absence of particular gene fusions.
These are only a few illustrations of the major developments in the industry for genetic testing. Emerging innovations and technologies are anticipated to emerge as the area develops further, helping to influence the industry's future.
A new entrant can focus on various gene fusion testing product offerings by established players. The market is fragmented with established market leaders such as Danaher Corporation, F. Hoffmann-La Roche Ltd, Illumina, Inc., and Thermo Fisher Scientific Inc.,, who have had their presence in the market for the past many years. The new entrants can focus on their strategy of product launches and global expansions for gene fusion testing.
• Detailed segmentation is delivered.
• Region and country-level data based on market segmentation by indication is provided.
• Market share analysis (by company) is provided.
• Growth share analysis (by company, technology, indication, and end user) is provided.
• Companies that manufacture and commercialize consumables required in the testing of genetic abnormal alterations in chromosomes
• Any new entrant that wants to know where the opportunities lie in the gene fusion testing market
• Any established player that wants to expand its product portfolio or business in new geographies