Gene Fusion Testing Market - A Global and Regional Analysis: Focus on by Category, Technology, Indication, End User, and Region - Analysis and Forecast, 2023-2033

Aug 2023| BIS793A| BIS Research

Report Highlights

Global Gene Fusion Testing Market to Reach $897.6 Million by 2033

Global Gene Fusion Testing Market Industry Overview

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.


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

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.

Report Synopsis

Report Metrics Details
Base year considered 2023
Forecast period considered 2023-2033
Base year market size $282.5 Million in 2023
Market size forecast $897.6 Million by 2033
Growth rate 12.25%
Units considered $ Million
Segments covered By Category, By Technology, By Indication, By End-user, By Region
Industry covered BIS Healthcare
Regions covered North America, Europe, Asia Pacific, Latin America
Countries covered U.S., Canada, Germany, Italy, France, U.K., Spain, Netherlands, Rest-of-Europe, China, Japan, India, South Korea, Australia, Rest-of-Asia-Pacific, Brazil, Mexico, Rest-of-Latin America, Rest-of-the-World
Companies studied
  • Quest Diagnostics Incorporated.
  • Amoy Diagnostics Co., Ltd.
  • Thermo Fisher Scientific Inc.
  • 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

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

How can this report add value to an organization?

Workflow/Innovation Strategy: The gene fusion testing market (by indication) has been segmented into solid tumors and hematological malignancies. Moreover, the study provides the reader with a detailed understanding of the different indication of gene fusion testing in solid tumors.

Growth/Marketing Strategy: 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.

Competitive Strategy: Key players in the global gene fusion testing market have been analyzed and profiled in the study, including manufacturers. Moreover, a detailed competitive benchmarking of the players operating in the global gene fusion testing market has been done to help the reader understand how players stack against each other, presenting a clear market landscape.

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
  • Quest Diagnostics Incorporated.
  • Thermo Fisher Scientific Inc.

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