Gene Fusion Testing Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028, Segmented by Category (Research, Diagnostic), by Technology (Next-Generation Sequencing (NGS), Fluorescence In-Situ Hybridization (FISH), Polymerase Chain Reaction (PCR), Immunohistochemistry (IHC)), by Indication (Solid Tumors, Hematological Malignancies), by End User (Pharmaceutical and Biotec
Published Date: November - 2024 | Publisher: MIR | No of Pages: 320 | Industry: Healthcare | Format: Report available in PDF / Excel Format
View Details Buy Now 2890 Download Sample Ask for Discount Request CustomizationGene Fusion Testing Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028, Segmented by Category (Research, Diagnostic), by Technology (Next-Generation Sequencing (NGS), Fluorescence In-Situ Hybridization (FISH), Polymerase Chain Reaction (PCR), Immunohistochemistry (IHC)), by Indication (Solid Tumors, Hematological Malignancies), by End User (Pharmaceutical and Biotec
| Forecast Period | 2024-2028 |
| Market Size (2022) | 244.30 million |
| CAGR (2023-2028) | 10.51% |
| Fastest Growing Segment | Pharmaceutical & Biotechnology Companies |
| Largest Market | North America |
Market Overview
Global Gene Fusion Testing Market has valued at USD 244.30 million in 2022 and is anticipated to witness a robust growth in the forecast period with a CAGR of 10.51% through 2028
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.
Key Market Drivers
Advancements in Genomic Technologies
Next-Generation Sequencing (NGS) technologies, such as Illumina and Ion Torrent, enable rapid and cost-effective sequencing of DNA and RNA. They have transformed genomics research and clinical diagnostics. NGS has been adapted for single-cell analysis, allowing researchers to study individual cells' genomes, transcriptomes, and epigenomes. This technology has broad applications in understanding cell heterogeneity and disease mechanisms.
Metagenomic sequencing allows for the study of microbial communities and their genetic diversity. This has applications in environmental microbiology, microbiome research, and infectious disease diagnostics.
Increasing Utilization of Gene Fusion Testing in the Development of Targeted Therapies
Gene fusion testing helps identify specific genetic alterations, including fusion events, that drive the development and progression of diseases, especially cancer. These fusion events often create unique and targetable proteins or protein domains. Targeted therapies can be designed to inhibit these proteins, disrupting the disease's underlying mechanisms. Gene fusion testing allows for the stratification of patients based on their genetic profiles. Patients who harbor specific fusion events that are targetable by a particular therapy can be selected for treatment. This personalized approach maximizes the chances of treatment success while minimizing side effects for patients who are unlikely to benefit from the therapy. Pharmaceutical companies use gene fusion testing data to inform the development of targeted therapies. Once a fusion event is identified as a potential drug target, researchers can design and test therapeutic agents, such as small molecule inhibitors or monoclonal antibodies, to specifically target the fusion protein. Gene fusion testing plays a pivotal role in patient selection for clinical trials of targeted therapies. These trials are designed to assess the safety and efficacy of new drugs in specific patient populations. Patients with the relevant fusion event are enrolled, ensuring that the therapy is tested on those most likely to benefit.
In some cases, gene fusion testing is used to develop companion diagnostic tests. These tests are designed to identify patients who are most likely to respond to a specific targeted therapy. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), often require companion diagnostics for certain targeted therapies. Gene fusion testing is also used to monitor a patient's response to targeted therapy. Changes in the fusion event or its associated markers can provide insights into treatment efficacy. If a therapy is not working, adjustments can be made quickly to explore alternative treatment options. Gene fusion testing can help researchers understand mechanisms of drug resistance. As patients may develop resistance to targeted therapies over time, continued testing and analysis of fusion events can guide the development of next-generation therapies that overcome resistance mechanisms. Gene fusion testing can reveal rare or previously undruggable targets. Even in cases where fusion events are relatively rare, they can be highly relevant for the small subset of patients who carry them. Identifying these targets opens new avenues for drug development. Targeted therapies developed through gene fusion testing tend to have fewer side effects compared to traditional chemotherapy because they selectively target cancer cells while sparing healthy ones. By tailoring treatment based on gene fusion testing results, patients have a higher chance of responding positively to therapy, leading to improved clinical outcomes and potentially longer survival rates. This factor will pace up the demand of
Rising Incidence of Cancer
The global population is growing, and as people live longer, the risk of developing cancer increases with age. Aging is a significant risk factor for many types of cancer. Unhealthy lifestyle choices, such as smoking, excessive alcohol consumption, poor diet, lack of physical activity, and exposure to environmental carcinogens, contribute to the development of many cancers. The increasing prevalence of obesity is linked to a higher risk of several cancers, including breast, colorectal, and endometrial cancer. Environmental factors, including air pollution, exposure to hazardous chemicals, and radiation, can contribute to cancer risk. Occupational exposures to carcinogens are also a concern.
Certain infectious agents, such as human papillomavirus (HPV), hepatitis B and C viruses, and Helicobacter pylori, can cause cancers. Efforts to prevent these infections can reduce cancer incidence. Inherited genetic mutations can increase the risk of specific cancers. While these mutations are relatively rare, they contribute to some cancer cases. Improved cancer screening and early detection programs have led to the identification of cancers at earlier stages when treatment is more likely to be successful. This can result in higher reported incidence rates. Increased awareness of cancer and better access to healthcare services have led to more people seeking medical attention for symptoms, resulting in earlier cancer diagnoses. Changes in lifestyle and dietary habits, along with increased exposure to carcinogens, have occurred due to globalization and urbanization. Advances in cancer treatment have increased survival rates. However, cancer survivors remain at risk of developing secondary cancers, contributing to overall incidence rates. Although there have been significant efforts to reduce tobacco use, it remains a leading cause of cancer. In regions where tobacco control measures are not as stringent, the incidence of smoking-related cancers remains high. In some regions, improved access to healthcare has resulted in earlier cancer diagnoses, leading to higher reported incidence rates. This factor will accelerate the demand of
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 found at for study.
Complexity of Gene Fusion Events
Gene fusion events can involve a wide range of fusion partner genes, and these partners can vary between individuals and even within the same type of cancer. Identifying all potential fusion partners and designing tests that cover this diversity can be challenging. Some gene fusions are rare or entirely novel, making them difficult to detect using conventional testing methods. Detecting these rare events requires highly sensitive and comprehensive techniques. Gene fusion events can have multiple variants, including different breakpoints and fusion junctions. Each variant may have distinct clinical implications, complicated interpretation, and treatment decisions. Tumors are often heterogeneous, meaning that different regions of a tumor may have different fusion events. This heterogeneity can impact the accuracy of gene fusion testing if only a small portion of the tumor is sampled. Gene fusions may co-occur with other genetic mutations or alterations in the same tumor. Understanding the interplay between different genetic alterations and their combined impact on disease is complex. Some gene fusion events involve complex chromosomal rearrangements, such as translocations or inversions, which can be challenging to detect and characterize. The accuracy and sensitivity of gene fusion detection assays can vary depending on the specific assay used, potentially leading to differences in results between laboratories and platforms. Certain gene fusion events may be specific to tissue types or diseases. Designing tests that cover a broad spectrum of fusion events across different diseases can be complex.
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.
Segmental Insights
Category Insights
In 2022, the Global Gene Fusion Testing Market dominated by research segment and is predicted to continue expanding over the coming years.
Technology Insights
In 2022, the Global Gene Fusion Testing Market dominated by Next-Generation Sequencing (NGS) segment and is predicted to continue expanding over the coming years.
Indication Insights
In 2022, the Global Gene Fusion Testing Market dominated by solid tumours segment and is predicted to continue expanding over the coming years.
End User Insights
In 2022, the Global Gene Fusion Testing Market largest share was held by pharmaceutical and biotechnology companies’ segment in the forecast period and is predicted to continue expanding over the coming years.
Regional Insights
The North America region dominates the Global Gene Fusion Testing Market in 2022. North America, particularly the United States and Canada, boasts advanced healthcare infrastructure and a well-developed healthcare system. This includes access to cutting-edge medical technologies and well-established clinical research capabilities, which are crucial for the development and adoption of advanced diagnostic tests like gene fusion testing.
Recent Developments
- In February2023, Arima Genomics, Inc., a business that uses 3Dgenomics to reveal actionable insights to empower researchers and cliniciansworking to improve human health, and Pierian, a company that is now a part ofVelsera and develops precision engines that enable the democratisation of omicdata across clinical and research applications, today announced co-marketingand licensing agreements that will improve the ability of clinical labs todetect gene fusions. Arima Genomics' targeted next-generation sequencing (NGS)testing pipelines will be integrated by Velsera into the Pierian ClinicalGenomics Workspace (CGW), the premier cloud-based platform that offers clinicallabs more streamlined and precise NGS data analysis, interpretation, andreporting. Combining these two approaches will make it simpler for clinicallaboratories to use sample-to-answer Arima gene fusion testing, assisting themin detecting gene fusions and other structural variants.
- In March 2021, Idylla GeneFusion Assay is a quicklab workflow solution for gene fusion testing, according to moleculardiagnostics company Biocartis. The new test recognizes several gene fusions,which are thought to be important in cancer research, in a single cartridge.Compared to other tests, it delivers the results in around three hours. Theavailability of the test results for Next generation Sequencing (NGS)frequently takes days or even weeks. The Idylla GeneFusion Assay is advertisedas the first FFPE4 RNA5-based assay on the Idylla platform and features ahighly multiplexed panel of biomarkers. Using 1-3 slices of FFPEtissue, it merges the conventional testing methods into a fully automatedprocess and delivers accurate data on ALK, ROS1, RET, NTRK1/2/3 fusions, andMET exon 14 skipping.
- In July 2020, FastTRK for Clinicians, a freeclinical testing program for the diagnosis of neurotrophic tyrosine receptorkinase (NTRK) gene fusions in TRK fusion cancer patients in Canada, is aservice offered by Bayer Inc. Regardless of the test's outcomes, the patient'schoice of therapy, or their insurance coverage, Bayer will pay the entire costof the test.Somemalignancies are brought on by gene modifications, or "genomicalterations." An NTRK gene fusion with an unrelated gene result in TRKfusion cancer. Children and adults with TRK fusion cancer might develop thecondition in any organ or tissue type in the body. Clinicians can use FastTRKto examine all solid tumor types for the presence of an NTRK gene fusion intheir patients' malignancy. If an NTRK gene fusion is discovered, the patientcan qualify for targeted therapy.
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.
- QIAGENN.V.
- ThermoFisher Scientific Inc
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