Gene Fusion Testing Market to Grow with a CAGR of 12.32% through 2030

Advancements in next-generation sequencing (NGS) technologies and growing investments in oncology diagnostics, is expected to drive the Global Gene Fusion Testing Market growth in the forecast period, 2026-2030

According to TechSci Research report, “Gene Fusion Testing Market – Global Industry Size, Share, Trends, Competition Forecast & Opportunities, 2030F”, the Global Gene Fusion Testing Market stood at USD 471.24 Million in 2024 and is expected to reach USD 947.49 Million by 2030 with a CAGR of 12.32% during the forecast period. 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.

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.

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The Global Gene Fusion Testing Market is segmented into category, technology, indication, end user, regional distribution, and company.

Based on the End User, Pharmaceutical and Biotechnology Companies emerged as the fastest growing segment in the Global Gene Fusion Testing Market during the forecast period. This is driven by the rising focus on precision medicine and development of targeted therapies. These companies are increasingly utilizing gene fusion testing to identify novel biomarkers, stratify patient populations, and design more effective clinical trials. The growing pipeline of oncology drugs targeting gene fusions—such as ALK, ROS1, NTRK, RET, and NRG1—has significantly increased the demand for companion diagnostics, making gene fusion testing an essential tool in drug development and regulatory approval processes. Moreover, the integration of next-generation sequencing (NGS) platforms into R&D workflows has enhanced the ability of pharmaceutical firms to conduct large-scale genomic profiling, accelerating the discovery of new therapeutic targets.

Based on the Region, Asia-Pacific emerged as the fastest growing region in the Global Gene Fusion Testing Market during the forecast period. This is due to the increasing presence of local and international diagnostic companies that are expanding their operations and investing in molecular diagnostics across Asia-Pacific. The region’s growing healthcare expenditure, improving laboratory capabilities, and rising affordability of next-generation sequencing (NGS) technologies are enabling wider adoption of gene fusion testing, even in emerging markets. Moreover, regulatory agencies across countries like Singapore, South Korea, and Australia are streamlining approval processes for molecular diagnostic tools and companion diagnostics, which is facilitating quicker market entry and access. Strategic partnerships between pharmaceutical firms and diagnostics providers to co-develop gene fusion-targeted therapies are also accelerating commercialization. Furthermore, the rising participation in global clinical trials and the inclusion of Asian populations in precision oncology studies are expanding the relevance and application of gene fusion tests in regional clinical practice.

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

• 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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“The Global Gene Fusion Testing Market is expanding due to the growing emphasis on biomarker-driven clinical trial designs, which rely on detailed genomic insights to select appropriate patient cohorts for targeted cancer therapies. This shift is transforming the oncology drug development landscape, prompting pharmaceutical and biotechnology companies to integrate gene fusion testing into early-stage research and clinical development. By identifying rare but actionable genetic alterations, such as NTRK, ALK, or RET fusions, these tests enhance trial efficiency, improve response rates, and support regulatory approvals for precision medicines. As a result, the demand for advanced fusion testing technologies continues to rise.,” said Mr. Karan Chechi, Research Director of TechSci Research, a research-based management consulting firm.

“Gene Fusion Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 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, 2020-2030F”, has 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 cutting-edge 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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