Press Release

Global Gene Fusion Testing Market to grow with a CAGR of 10.40%

Increasing healthcare infrastructure and a supportive regulatory environment are the major drivers for the Global Gene Fusion Testing Market.

 

According to TechSci Research report, “Global Gene Fusion Testing Market Industry Size, Share, Trends, Competition, Opportunity and Forecast, 2018-2028”, 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% and will probably reach USD 850.20 million by 2028. This can be due to collaborations and partnerships among leading companies with a diverse approach to merge the expertise of individual companies and to strengthen their position in the market.

The adoption of gene fusion testing as a standard of care is indeed a driver for the Global Gene Fusion Testing Market. Gene fusion testing offers a higher level of diagnostic accuracy, especially in the field of oncology. By identifying specific fusion events associated with cancer, healthcare providers can make more precise diagnoses, reducing the risk of misdiagnosis or under diagnosis. Gene fusion testing plays a pivotal role in tailoring treatment decisions to individual patients. When specific fusion events are detected, clinicians can choose targeted therapies that are more likely to be effective. This approach maximizes treatment efficacy while minimizing side effects, leading to better patient outcomes. Medical societies and organizations are increasingly including gene fusion testing in clinical guidelines and recommendations for specific diseases, particularly in oncology. This formal endorsement encourages healthcare providers to adopt these tests as a standard of care. Gene fusion testing is essential for patient stratification in clinical trials, ensuring that investigational drugs are tested on individuals who are most likely to benefit. The successful outcomes of such trials contribute to the adoption of gene fusion testing in clinical practice.

 

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A diagnostic technique called gene fusion testing uses molecular analysis to look for and analyses the genetic anomalies known as gene fusions. When two distinct genes from different chromosomal sites fuse improperly to generate a hybrid gene, this process is known as gene fusion. This fusion has the potential to lead to the manufacture of aberrant proteins or alter gene expression, which may aid in the emergence of a variety of illnesses, including forms of cancer.

In February 2023, Arima Genomics, Inc., a business that uses 3D genomics to reveal actionable insights to empower researchers and clinicians working to improve human health, and Pierian, a company that is now a part of Velsera and develops precision engines that enable the democratisation of omic data across clinical and research applications, today announced co-marketing and licensing agreements that will improve the ability of clinical labs to detect gene fusions. Arima Genomics' targeted next-generation sequencing (NGS) testing pipelines will be integrated by Velsera into the Pierian Clinical Genomics Workspace (CGW), the premier cloud-based platform that offers clinical labs more streamlined and precise NGS data analysis, interpretation, and reporting. Combining these two approaches will make it simpler for clinical laboratories to use sample-to-answer Arima gene fusion testing, assisting them in detecting gene fusions and other structural variants.

Standardization and validation are significant challenges in the Global Gene Fusion Testing Market. Ensuring the accuracy, reliability, and consistency of gene fusion testing is crucial for its clinical and research applications. Gene fusion events can be highly diverse, involving different fusion partners, breakpoints, and fusion variants. Standardizing tests to detect a wide array of fusion events can be complex. Multiple technologies are used for gene fusion testing, including PCR, FISH, NGS, and RT-PCR. Each technology has its own protocols, chemistries, and limitations, making it challenging to standardize across platforms. Tissue samples used for gene fusion testing can vary in quality, quantity, and composition. Standardized protocols should account for these variations to ensure reliable results. The development of standardized reference materials that mimic clinical samples with known fusion events is essential for validation. However, creating such materials can be difficult due to the diversity of fusion events.

Global Gene Fusion Testing Market segmentation is based on category, Technology, Indication, End User, and Region.

Based on Technology, Global Gene Fusion Testing Market is segmented into Next-Generation Sequencing (NGS), Fluorescence In-Situ Hybridization (FISH), Polymerase Chain Reaction (PCR), Immunohistochemistry (IHC). Fluorescence In-Situ Hybridization (FISH) is a molecular biology technique used to visualize and detect the presence or location of specific DNA sequences or RNA sequences within cells or tissues. It is a powerful tool in genetics and cytogenetics research, as well as in clinical diagnostics. In FISH, specific DNA or RNA sequences are targeted using fluorescently labeled probes. These probes are short, single-stranded pieces of DNA or RNA that are complementary to the sequence of interest. Probes are designed to bind only to the target sequence, ensuring specificity. The key feature of FISH is its use of fluorescent labels. When the probes have successfully hybridized to the target sequences, they emit fluorescent signals, which can be visualized using fluorescence microscopy. Each probe is labeled with a distinct fluorescent dye, allowing for the detection of multiple sequences simultaneously by using different colors.

Based on Region, North America dominated the Global Gene Fusion Testing Market. The United States has a well-established regulatory framework for medical devices and diagnostic tests. The Food and Drug Administration (FDA) plays a pivotal role in the approval and regulation of gene fusion tests, and its decisions often influence the global market. The prevalence of cancer and other genetic diseases in North America drives the demand for advanced diagnostic tools like gene fusion testing. There's a growing emphasis on early and accurate diagnosis, which further fuels the market. The region attracts significant investments in healthcare and biotechnology, which includes funding for research and development of gene fusion testing technologies. Healthcare providers in North America tend to be early adopters of new technologies, including gene fusion testing, when they demonstrate clinical utility and efficacy. Additionally, patients in the region often have access to a wide range of diagnostic options and may request advanced testing.

Asia-pacific region to fastest growth in the Global Gene Fusion Testing Market. The Asia-Pacific region has experienced a notable increase in the incidence of cancer, mirroring global trends. As gene fusion testing is particularly relevant in the field of oncology, the growing burden of cancer in APAC drives the demand for advanced diagnostic tools, including gene fusion tests. APAC is home to a significant portion of the world's population, including countries like China and India with billions of people. This large and diverse population provides a substantial patient pool for gene fusion testing and clinical trials, making it an attractive market for healthcare companies. Many countries in the Asia-Pacific region are experiencing economic growth and increasing healthcare expenditure. As healthcare systems improve and become more accessible, there is greater capacity for advanced diagnostic tests like gene fusion testing.

 

Some of the major companies operating in the Global Gene Fusion Testing Market include:

  • Amoy Diagnostics Co., Ltd.
  • ArcherDX (Integerated 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

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“Certain areas, particularly in North America, are projected to exert significant demand for Gene Fusion Testing. The growth in the competitive landscape and the presence of well-established companies in the market, committed to enhance the overall wellbeing of people each year, are expected to contribute to a remarkable growth of the Global Gene Fusion Testing Market in the forecast period," said Mr. Karan Chechi, Research Director with TechSci Research, a research-based Global management consulting firm.

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 Biotechnology Companies, Hospitals and Diagnostic Laboratories, Academic and Research Centers), by region, and Competition evaluated the future growth potential of Global Gene Fusion Testing Market and provides statistics & information on market size, structure, and future market growth. The report intends to provide innovative market intelligence and help decision makers take sound investment decisions. Besides, the report also identifies and analyzes the emerging trends along with essential drivers, challenges, and opportunities in Global Gene Fusion Testing Market.

 

 

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