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Gene Fusion Testing Market - Global Forecast 2025-2032

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    Report

  • 198 Pages
  • October 2025
  • Region: Global
  • 360iResearch™
  • ID: 5924686
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Senior leaders in healthcare, biotechnology, and diagnostics are rapidly adopting advanced gene fusion testing to enhance clinical precision and drive organizational agility. As the gene fusion testing market continues to evolve, next-generation solutions empower strategic decision-making in an environment that demands speed, accuracy, and resilience. The market’s alignment with precision medicine initiatives further ensures long-term operational viability and competitive differentiation.

Market Snapshot: Gene Fusion Testing Market Overview

The global gene fusion testing market is experiencing strong and sustained growth. Market size is projected to increase from USD 480.95 million in 2024 to USD 541.32 million in 2025, with expectations to reach USD 1.25 billion by 2032. This expansion is underpinned by a robust compound annual growth rate (CAGR) of 12.76%. Momentum stems from greater adoption of next generation sequencing, advanced molecular diagnostics, and regulatory initiatives that facilitate deployment across key healthcare markets. Organizations are responding to the demand for faster, data-driven decisions by investing heavily in digital pathology, bioinformatics, and value-based healthcare models. These shifts enable organizations to seamlessly align laboratory operations with changing clinical and data requirements.

Scope & Segmentation: Global Gene Fusion Testing Market Applications

  • Technology Platforms: Fluorescence in situ hybridization, immunohistochemistry, targeted and whole genome next generation sequencing, transcriptome sequencing, and reverse transcription polymerase chain reaction. Each platform specializes in sensitive and reliable detection for a wide range of clinical needs.
  • Sample Types: Blood-based specimens, such as plasma and serum, as well as tissue samples, including formalin-fixed paraffin-embedded and fresh frozen. These accommodate broad clinical diagnostics and research initiatives.
  • Clinical Applications: Hematology (leukemia, lymphoma), oncology (breast, lung, colorectal, prostate cancers), and rare genetic diseases like developmental and neuromuscular disorders. These address diverse care settings and multidisciplinary teams.
  • End Users: Diagnostic laboratories (both independent and hospital-based), hospitals (across inpatient and outpatient care), pharmaceutical and biotechnology companies, academic institutions, and private research bodies. Each segment presents unique workflow, compliance, and innovation needs.
  • Regional Coverage: Americas (including United States, Canada, Mexico, Brazil, Argentina, Chile, Colombia, Peru), Europe, Middle East and Africa (regions such as United Kingdom, Germany, France, Russia, Italy, Spain, Netherlands, Sweden, Poland, Switzerland, United Arab Emirates, Saudi Arabia, Qatar, Turkey, Israel, South Africa, Nigeria, Egypt, Kenya), and Asia-Pacific (China, India, Japan, Australia, South Korea, Indonesia, Thailand, Malaysia, Singapore, Taiwan). Regional differences in health policy and reimbursement models influence operational success and deployment.
  • Key Companies Analyzed: Thermo Fisher Scientific Inc., Illumina, Inc., F. Hoffmann-La Roche Ltd, Agilent Technologies, Inc., QIAGEN N.V., Bio-Rad Laboratories, Inc., NanoString Technologies, Inc., BGI Genomics Co., Ltd., Foundation Medicine, Inc., Archer DX, Inc. These leaders set benchmarks for innovation and quality in the gene fusion testing landscape.

Gene Fusion Testing Market: Key Takeaways

  • Recent developments in sequencing and multiplexed PCR deliver enhanced analytical sensitivity, strengthening clinical diagnostics and supporting better patient outcomes.
  • Integration of digital pathology and bioinformatics streamlines sample processing and supplies actionable insights, accelerating adoption of precision medicine.
  • Expanding use in hematology, oncology, and rare disease applications is boosting laboratory acceptance and supporting diverse clinical workflows.
  • Collaborations across academia and industry accelerate innovation, ensuring rapid translation of new assays into clinical practice.
  • Regional disparities in policy, reimbursement, and infrastructure require organizations to tailor market entry strategies for sustained success.
  • Major companies differentiate through specialization, ongoing innovation, and active portfolio development, prompting continuous strategic reassessment.

Assessing Tariff Impact on Supply Chains and Pricing

Anticipated changes to United States tariff policy for 2025 could increase costs for key reagents and equipment, creating procurement and supply chain uncertainties. Senior leaders should consider diversifying suppliers, forming dual-source agreements, and evaluating domestic sourcing. Close collaboration with logistics partners can help reduce risks, stabilize pricing, and protect delivery timelines.

Methodology & Data Sources

This report leverages both quantitative and qualitative research, including direct interviews with laboratory executives, market surveys, and analysis of peer-reviewed publications, industry disclosures, and proprietary data. These methods ensure actionable and trustworthy insight for executive planning.

Why This Report Matters

  • Empowers executives to make informed strategic choices with segmented, actionable market intelligence aligned to leadership objectives.
  • Clarifies the implications of regulatory and tariff shifts on supply chain reliability, enabling effective risk mitigation and cost continuity.
  • Supports investment decisions in new technologies, geographic regions, and strategic partnerships to build long-term resilience and growth.

Conclusion

This analysis equips senior leaders to anticipate ongoing change, drive technology adoption, and secure a resilient position in the dynamic gene fusion testing market.

 

Additional Product Information:

  • Purchase of this report includes 1 year online access with quarterly updates.
  • This report can be updated on request. Please contact our Customer Experience team using the Ask a Question widget on our website.

Table of Contents

1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Adoption of multiplex next-generation sequencing assays for simultaneous gene fusion detection in oncology patients
5.2. Integration of liquid biopsy platforms for noninvasive detection of gene fusions in cancer screening programs
5.3. Expansion of targeted therapies driving demand for precise gene fusion profiling in personalized medicine
5.4. Development of AI-enabled bioinformatics pipelines to improve gene fusion identification accuracy in clinical diagnostics
5.5. Growth of lab-developed tests offering rapid gene fusion analysis for point-of-care oncology decision support
5.6. Rising collaborations between diagnostic companies and pharmaceutical firms to co-develop fusion-driven therapeutic biomarkers
5.7. Regulatory approvals for novel gene fusion detection kits accelerating market entry across emerging geographies
5.8. Increasing utilization of RNA-based multiplex PCR assays for comprehensive detection of rare fusion transcripts in solid tumors
5.9. Emergence of automated sample-to-report platforms reducing turnaround time for gene fusion analysis in clinical labs
5.10. Investment trends fueling expansion of decentralized testing networks for gene fusion assays in community hospitals
6. Cumulative Impact of United States Tariffs 2025
7. Cumulative Impact of Artificial Intelligence 2025
8. Gene Fusion Testing Market, by Technology
8.1. Fluorescence In Situ Hybridization
8.2. Immunohistochemistry
8.3. Next Generation Sequencing
8.3.1. Targeted Next Generation Sequencing
8.3.2. Transcriptome Sequencing
8.3.3. Whole Genome Sequencing
8.4. Reverse Transcription Polymerase Chain Reaction
9. Gene Fusion Testing Market, by Sample Type
9.1. Blood
9.1.1. Plasma
9.1.2. Serum
9.2. Tissue
9.2.1. Formalin Fixed Paraffin Embedded
9.2.2. Fresh Frozen Tissue
10. Gene Fusion Testing Market, by Application
10.1. Hematology
10.1.1. Leukemia
10.1.2. Lymphoma
10.2. Oncology
10.2.1. Breast Cancer
10.2.2. Colorectal Cancer
10.2.3. Lung Cancer
10.2.4. Prostate Cancer
10.3. Rare Diseases
10.3.1. Developmental Disorders
10.3.2. Neuromuscular Disorders
11. Gene Fusion Testing Market, by End User
11.1. Diagnostic Laboratories
11.1.1. Hospital Based Laboratories
11.1.2. Independent Laboratories
11.2. Hospitals
11.2.1. Inpatient Facilities
11.2.2. Outpatient Clinics
11.3. Pharmaceutical Companies
11.3.1. Biotechnology Companies
11.3.2. Pharma Giants
11.4. Research Institutions
11.4.1. Academic Centers
11.4.2. Private Research Laboratories
12. Gene Fusion Testing Market, by Region
12.1. Americas
12.1.1. North America
12.1.2. Latin America
12.2. Europe, Middle East & Africa
12.2.1. Europe
12.2.2. Middle East
12.2.3. Africa
12.3. Asia-Pacific
13. Gene Fusion Testing Market, by Group
13.1. ASEAN
13.2. GCC
13.3. European Union
13.4. BRICS
13.5. G7
13.6. NATO
14. Gene Fusion Testing Market, by Country
14.1. United States
14.2. Canada
14.3. Mexico
14.4. Brazil
14.5. United Kingdom
14.6. Germany
14.7. France
14.8. Russia
14.9. Italy
14.10. Spain
14.11. China
14.12. India
14.13. Japan
14.14. Australia
14.15. South Korea
15. Competitive Landscape
15.1. Market Share Analysis, 2024
15.2. FPNV Positioning Matrix, 2024
15.3. Competitive Analysis
15.3.1. Thermo Fisher Scientific Inc.
15.3.2. Illumina, Inc.
15.3.3. F. Hoffmann-La Roche Ltd
15.3.4. Agilent Technologies, Inc.
15.3.5. QIAGEN N.V.
15.3.6. Bio-Rad Laboratories, Inc.
15.3.7. NanoString Technologies, Inc.
15.3.8. BGI Genomics Co., Ltd.
15.3.9. Foundation Medicine, Inc.
15.3.10. Archer DX, Inc.

Samples

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Companies Mentioned

The key companies profiled in this Gene Fusion Testing market report include:
  • Thermo Fisher Scientific Inc.
  • Illumina, Inc.
  • F. Hoffmann-La Roche Ltd
  • Agilent Technologies, Inc.
  • QIAGEN N.V.
  • Bio-Rad Laboratories, Inc.
  • NanoString Technologies, Inc.
  • BGI Genomics Co., Ltd.
  • Foundation Medicine, Inc.
  • Archer DX, Inc.

Table Information