A quick peek into the report
Table of Contents
1.1 Inclusion and Exclusion Criteria
2.1 Scope of the Study
2.2 Key Questions Answered in the Report
Research Methodology
4.1 Introduction to Gene Fusion Testing
4.1.1 Different Technologies for Gene Fusion Testing
4.1.2 Advantages and Limitations of Gene Fusion Testing
4.1.3 Current Market Size and Future Growth Potential, $Million, 2022-2033
4.1.3.1 Neurotrophic Tyrosine Receptor Kinase (NTRK) Gene Fusion vs. Other Gene Fusions
4.1.4 Role of Artificial Intelligence (AI) and Machine Learning (ML) in Gene Fusion Testing
4.1.5 Reimbursement Landscape
4.2 Stakeholder’s Survey Response
4.2.1 Awareness of Gene Fusion Testing
4.2.2 Familiarity with the NGS Offerings of the Following Companies
4.2.3 Adoption and Barriers for Gene Fusion Testing
5.1 Regulatory Landscape
5.1.1 Legal Requirements and Frameworks in the U.S.
5.1.1.1 CMS Regulation (Reimbursement Scenario)
5.1.1.2 Marketing Authorization
5.1.2 Legal Requirements and Frameworks in Europe
5.1.3 Legal Requirements and Frameworks in Asia-Pacific
5.1.3.1 Legal Requirements and Framework in China
5.1.3.2 Legal Requirements and Framework in Japan
6.1 Market Drivers
6.1.1 Rising Cancer Incidence due to Gene Fusion Mutations
6.1.2 Increasing Utilization of Gene Fusion Testing in the Development of Targeted Therapies
6.1.3 Global Rise in Research Grants Dedicated to Cancer Screening and Prevention Efforts
6.1.4 Impact Analysis
6.2 Business Restraints
6.2.1 Complexity of Testing Process
6.2.2 Lack of Standardization and Reimbursement Barriers
6.2.3 Impact Analysis
6.3 Business Opportunities
6.3.1 Increasing Demand for Gene Fusion Testing in Clinical Research
6.3.2 Leveraging Artificial Intelligence to Predict Gene Fusion Status in Several Cancer Types
7.1 Overview
7.2 Key Strategies and Developments
7.2.1 Product Approvals and Launches
7.2.2 Partnerships and Collaborations
7.2.3 Mergers and Acquisitions
7.2.4 Other Developments
7.3 Market Share Analysis
7.3.1 By Company
7.4 Growth-Share Analysis
7.4.1 By Company
7.4.2 By Technology
7.4.3 By Indication
7.4.4 By End User
8.1 Overview
8.2 Research
8.3 Diagnostic
9.1 Overview
9.2 Next-Generation Sequencing (NGS)
9.3 Fluorescence In-Situ Hybridization (FISH)
9.4 Polymerase Chain Reaction (PCR)
9.5 Immunohistochemistry (IHC)
10.1 Overview
10.2 Solid Tumors
10.2.1 Lung Cancer
10.2.2 Breast Cancer
10.2.3 Colorectal Cancer
10.2.4 Thyroid Cancer
10.2.5 Others
10.3 Hematological Malignancies
11.1 Overview
11.2 Pharmaceutical and Biotechnology Companies
11.3 Hospitals and Diagnostic Laboratories
11.4 Research and Academic Centers
12.1 Overview
12.2 North America
12.2.1 North America Gene Fusion Testing Market, by Indication
12.2.2 North America Gene Fusion Testing Market (by Country)
12.2.2.1 U.S.
12.2.2.1.1 U.S. Gene Fusion Testing Market (by Indication)
12.2.2.2 Canada
12.2.2.2.1 Canada Gene Fusion Testing Market (by Indication)
12.3 Europe
12.3.1 Europe Gene Fusion Testing Market, by Indication
12.3.2 Europe Gene Fusion Testing Market (by Country)
12.3.2.1 Germany
12.3.2.1.1 Germany Gene Fusion Testing Market (by Indication)
12.3.2.2 France
12.3.2.2.1 France Gene Fusion Testing Market (by Indication)
12.3.2.3 U.K.
12.3.2.3.1 U.K. Gene Fusion Testing Market (by Indication)
12.3.2.4 Italy
12.3.2.4.1 Italy Gene Fusion Testing Market (by Indication)
12.3.2.5 Spain
12.3.2.5.1 Spain Gene Fusion Testing Market (by Indication)
12.3.2.6 Netherlands
12.3.2.6.1 Netherlands Gene Fusion Testing Market (by Indication)
12.3.2.7 Rest-of-Europe
12.3.2.7.1 Rest-of-Europe Gene Fusion Testing Market (by Indication)
12.4 Asia-Pacific
12.4.1 Asia-Pacific Gene Fusion Testing Market, by Indication
12.4.2 Asia-Pacific Gene Fusion Testing Market (by Country)
12.4.2.1 China
12.4.2.1.1 China Gene Fusion Testing Market (by Indication)
12.4.2.2 Japan
12.4.2.2.1 Japan Gene Fusion Testing Market (by Indication)
12.4.2.3 India
12.4.2.3.1 India Gene Fusion Testing Market (by Indication)
12.4.2.4 Australia
12.4.2.4.1 Australia Gene Fusion Testing Market (by Indication)
12.4.2.5 South Korea
12.4.2.5.1 South Korea Gene Fusion Testing Market (by Indication)
12.4.2.6 Rest-of-Asia-Pacific
12.4.2.6.1 Rest-of-Asia-Pacific Gene Fusion Testing Market (by Indication)
12.5 Latin America
12.5.1 Latin America Gene Fusion Testing Market, by Indication
12.5.2 Latin America Gene Fusion Testing Market (by Country)
12.5.2.1 Brazil
12.5.2.1.1 Brazil Gene Fusion Testing Market (by Indication)
12.5.2.2 Mexico
12.5.2.2.1 Mexico Gene Fusion Testing Market (by Indication)
12.5.2.3 Rest-of-Latin America
12.5.2.3.1 Rest-of-Latin America Gene Fusion Testing Market (by Indication)
12.6 Rest-of-the-World
12.6.1 Rest-of-the-World Gene Fusion Testing Market (by Indication)
13.1 Overview
13.2 Amoy Diagnostics Co., Ltd.
13.2.1 Company Overview
13.2.2 Role of Amoy Diagnostics Co., Ltd. in the Global Gene Fusion Testing Market
13.2.3 Key Competitors
13.2.4 Recent Developments
13.2.5 Analyst Perspective
13.3 ArcherDX (Integerated DNA Technologies, Inc.)
13.3.1 Company Overview
13.3.2 Role of ArcherDX (Integerated DNA Technologies, Inc.) in the Global Gene Fusion Testing Market
13.3.3 Key Competitors
13.3.4 Recent Developments
13.3.5 Analyst Perspective
13.4 Arima Genomics
13.4.1 Company Overview
13.4.2 Role of Arima Genomics in the Global Gene Fusion Testing Market
13.4.3 Key Competitors
13.4.4 Recent Developments
13.4.5 Analyst Perspective
13.5 Biocartis
13.5.1 Company Overview
13.5.2 Role of Biocartis in the Global Gene Fusion Testing Market
13.5.3 Key Competitors
13.5.4 Recent Developments
13.5.5 Financials
13.5.6 Key Insights about the Financial Health of the Company
13.5.7 Analyst Perspective
13.6 Biocare Medical, LLC
13.6.1 Company Overview
13.6.2 Role of Biocare Medical, LLC in the Gene Fusion Testing Market
13.6.3 Key Competitors
13.6.4 Recent Developments
13.6.5 Analyst Perspective
13.7 F. Hoffmann-La Roche Ltd
13.7.1 Company Overview
13.7.2 Role of F. Hoffmann-La Roche Ltd in the Global Gene Fusion Testing Market
13.7.3 Key Competitors
13.7.4 Recent Developments
13.7.5 Financials
13.7.6 Key Insights about the Financial Health of the Company
13.7.7 Analyst Perspective
13.8 Guardant Health, Inc
13.8.1 Company Overview
13.8.2 Role of Guardant Health, Inc in the Global Gene Fusion Testing Market
13.8.3 Key Competitors
13.8.4 Financials
13.8.5 Key Insights about the Financial Health of the Company
13.8.6 Analyst Perspective
13.9 Illumina, Inc.
13.9.1 Company Overview
13.9.2 Role of Illumina, Inc. in the Global Gene Fusion Testing Market
13.9.3 Key Competitors
13.9.4 Recent Developments
13.9.5 Financials
13.9.6 Key Insights about the Financial Health of the Company
13.9.7 Analyst Perspective
13.10 Myriad Genetics, Inc.
13.10.1 Company Overview
13.10.2 Role of Myriad Genetics, Inc. in the Global Gene Fusion Testing Market
13.10.3 Key Competitors
13.10.4 Recent Developments
13.10.5 Financials
13.10.6 Key Insights about the Financial Health of the Company
13.10.7 Analyst Perspective
13.11 Natera, Inc.
13.11.1 Company Overview
13.11.2 Role of Natera, Inc. in the Global Gene Fusion Testing Market
13.11.3 Key Competitors
13.11.4 Financials
13.11.5 Key Insights about the Financial Health of the Company
13.11.6 Analyst Perspective
13.12 NeoGenomics, Inc.
13.12.1 Company Overview
13.12.2 Role of NeoGenomics, Inc. in the Global Gene Fusion Testing Market
13.12.3 Key Competitors
13.12.4 Recent Developments
13.12.5 Financials
13.12.6 Key Insights about the Financial Health of the Company
13.12.7 Analyst Perspective
13.13 OncoDNA
13.13.1 Company Overview
13.13.2 Role of OncoDNA in the Gene Fusion Testing Market
13.13.3 Key Competitors
13.13.4 Recent Developments
13.13.5 Analyst Perspective
13.14 QIAGEN N.V.
13.14.1 Company Overview
13.14.2 Role of QIAGEN N.V. in the Global Gene Fusion Testing Market
13.14.3 Key Competitors
13.14.4 Recent Developments
13.14.5 Financials
13.14.6 Key Insights about the Financial Health of the Company
13.14.7 Analyst Perspective
13.15 Quest Diagnostics Incorporated.
13.15.1 Company Overview
13.15.2 Role of Quest Diagnostics Incorporated. in the Global Gene Fusion Testing Market
13.15.3 Key Competitors
13.15.4 Financials
13.15.5 Analyst Perspective
13.16 Thermo Fisher Scientific Inc.
13.16.1 Company Overview
13.16.2 Role of Thermo Fisher Scientific Inc. in the Global Gene Fusion Testing Market
13.16.3 Key Competitors
13.16.4 Recent Developments
13.16.5 Financials
13.16.6 Key Insights about the Financial Health of the Company
13.16.7 Analyst Perspective
Table 1: Global Gene Fusion Testing Market, Impact Analysis
Table 2: Key Questions Answered in the Report
Table 3: Advantages of Gene Fusion Testing
Table 4: Limitations of Gene Fusion Testing
Table 5: NTRK Gene Fusion in Different Types of Cancer
Table 6: Different Types of Gene Fusion
Table 7: Gene Fusion Testing Market: Global Regulatory Scenario
Table 8: Gene Fusion Mutations in Cancer
Table 9: Tissue-Agnostic Targeted Therapies Approved by FDA
Table 10: Global Grants for Cancer Screening
Table 11: Impact Analysis: Business Drivers
Table 12: Gene Fusion Testing Methods: Challenges
Table 13: Impact Analysis: Business Restraints
Table 14: Artificial Intelligence in the Field of Gene Fusion Testing
Table 15: Companies Offering Research Use Products
Table 16: Companies Offering Diagnostic Products
Table 17: NTRK Test Rate Across Several Europen Countries
Figure 1: Global Gene Fusion Testing Market, $Million, 2022-2033
Figure 2: Global Gene Fusion Testing Market: Drivers, Restraints, and Opportunities
Figure 3: Global Gene Fusion Testing Market (by Category), $Million, 2022-2033
Figure 4: Global Gene Fusion Testing Market (by Technology), $Million, 2022-2033
Figure 5: Global Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 6: Global Gene Fusion Testing Market (by Region), $Million, 2022 and 2033
Figure 7: Global Gene Fusion Testing Market Segmentation
Figure 8: Global Gene Fusion Testing Market: Research Methodology
Figure 9: Primary Research Methodology
Figure 10: Bottom-Up Approach (Segment-Wise Analysis)
Figure 11: Top-Down Approach (Segment-Wise Analysis)
Figure 12: Different Approaches to Study Gene Fusion
Figure 13: Different Techniques Used in Gene Fusion Testing
Figure 14: Global Gene Fusion Testing Market, $Million, 2022-2033
Figure 15: Artificial Intelligence and Machine Learning in Gene Fusion Testing
Figure 16: SOPHiA DDM RNAtarget Technology Workflow
Figure 17: Awareness to the Concept of Gene Fusion Testing
Figure 18: Familarity with NGS Offerings by Key Market Players for Gene Fusion Testing
Figure 19: Perceived Importance of Key Drivers to Improve Gene Fusion Testing Adoption
Figure 20: Agreement Level with Key Barriers to Gene Fusion Testing Adoption
Figure 21: Steps Involved in FDA Regulation
Figure 22: FDA Guidelines for CDx Approval
Figure 23: Criteria for CMS Coverage/Reimbursement
Figure 24: Steps for Obtaining Marketing Authorization
Figure 25: Europe In Vitro Diagnostic Devices Regulation Regulatory Process
Figure 26: Workflow for Medical Device Regulations
Figure 27: Estimated Number of New Cancer Cases, 2020 and 2030
Figure 28: Clinical Trials Based on Gene Fusion Testing
Figure 29: Share of Key Developments, January 2020-July 2023
Figure 30: Number of Product Approvals and Launches (by Company), January 2020 to July 2023
Figure 31: Partnerships and Collaborations, January 2020-July 2023
Figure 32: Mergers and Acquisitions, January 2020-July 2023
Figure 33: Other Developments, January 2020-July 2023
Figure 34: Global Fusion Testing Market, Company Share Analysis, % Share, 2022
Figure 35: Growth-Share Analysis for Global Gene Fusion Testing Market (by Company), 2021-2022
Figure 36: Growth-Share Analysis for Global Gene Fusion Testing Market (by Technology), 2022-2033
Figure 37: Growth-Share Analysis for Global Gene Fusion Testing Market (by Indication), 2022-2033
Figure 38: Growth-Share Analysis for Global Gene Fusion Testing Market (by End User), 2022-2033
Figure 39: Global Gene Fusion Testing Market (by Category)
Figure 40: Share of Global Gene Fusion Testing Market (by Category), $Million, 2022 and 2033
Figure 41: Global Gene Fusion Testing Market (Research), $Million, 2022-2033
Figure 42: Global Gene Fusion Testing Market (Diagnostic), $Million, 2022-2033
Figure 43: Global Gene Fusion Testing Market (by Technology)
Figure 44: Share of Global Gene Fusion Testing Market (by Technology), $Million, 2022 and 2033
Figure 45: Global Gene Fusion Testing Market (Next-Generation Sequencing), $Million, 2022-2033
Figure 46: Global Gene Fusion Testing Market (Fluorescence In-Situ Hybridization), $Million, 2022-2033
Figure 47: Global Gene Fusion Testing Market (Polymerase Chain Reaction), $Million, 2022-2033
Figure 48: Global Gene Fusion Testing Market (Immunohistochemistry), $Million, 2022-2033
Figure 49: Global Gene Fusion Testing Market (by Indication)
Figure 50: Share of Global Gene Fusion Testing Market (by Indication), $Million, 2022 and 2033
Figure 51: Global Gene Fusion Testing Market (by Solid Tumors), $Million, 2022 and 2033
Figure 52: Global Gene Fusion Testing Market (Solid Tumors), $Million, 2022-2033
Figure 53: Global Gene Fusion Testing Market (Lung Cancer), $Million, 2022-2033
Figure 54: Global Gene Fusion Testing Market (Breast Cancer), $Million, 2022-2033
Figure 55: Global Gene Fusion Testing Market (Colorectal Cancer), $Million, 2022-2033
Figure 56: Global Gene Fusion Testing Market (Thyroid Cancer), $Million, 2022-2033
Figure 57: Global Gene Fusion Testing Market (Others), $Million, 2022-2033
Figure 58: Global Gene Fusion Testing Market (Hematological Malignancies), $Million, 2022-2033
Figure 59: Global Gene Fusion Testing Market (by End User)
Figure 60: Share of Global Gene Fusion Testing Market (by End User), $Million, 2022 and 2033
Figure 61: Global Gene Fusion Testing Market (Pharmaceutical and Biotechnology Companies), $Million, 2022-2033
Figure 62: Global Gene Fusion Testing Market (Hospitals and Diagnostic Laboratories), $Million, 2022-2033
Figure 63: Global Gene Fusion Testing Market (Research and Academic Centers), $Million, 2022-2033
Figure 64: Global Gene Fusion Testing Market (by Region), $Million, 2022 and 2033
Figure 65: North America Gene Fusion Testing Market, $Million, 2023-2033
Figure 66: North America: Market Dynamics
Figure 67: North America Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 68: North America Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 69: U.S. Gene Fusion Testing Market, $Million, 2022-2033
Figure 70: U.S. Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 71: U.S. Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 72: Canada Gene Fusion Testing Market, $Million, 2022-2033
Figure 73: Canada Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 74: Canada Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 75: Europe Gene Fusion Testing Market, $Million, 2022-2033
Figure 76: Europe: Market Dynamics
Figure 77: Europe Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 78: Europe Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 79: Germany Gene Fusion Testing Market, $Million, 2022-2033
Figure 80: Germany Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 81: Germany Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 82: France Gene Fusion Testing Market, $Million, 2022-2033
Figure 83: France Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 84: France Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 85: U.K. Gene Fusion Testing Market, $Million, 2022-2033
Figure 86: U.K. Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 87: U.K. Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 88: Italy Gene Fusion Testing Market, $Million, 2022-2033
Figure 89: Italy Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 90: Italy Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 91: Spain Gene Fusion Testing Market, $Million, 2022-2033
Figure 92: Spain Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 93: Spain Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 94: Netherlands Gene Fusion Testing Market, $Million, 2022-2033
Figure 95: Netherlands Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 96: Netherlands Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 97: Rest-of-Europe Gene Fusion Testing Market, $Million, 2022-2033
Figure 98: Rest-of-Europe Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 99: Rest-of-Europe Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 100: Asia-Pacific Gene Fusion Testing Market, $Million, 2022-2033
Figure 101: Asia-Pacific: Market Dynamics
Figure 102: Asia-Pacific Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 103: Asia-Pacific Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 104: China Gene Fusion Testing Market, $Million, 2022-2033
Figure 105: China Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 106: China Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 107: Japan Gene Fusion Testing Market, $Million, 2022-2033
Figure 108: Japan Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 109: Japan Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 110: India Gene Fusion Testing Market, $Million, 2022-2033
Figure 111: India Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 112: India Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 113: Australia Gene Fusion Testing Market, $Million, 2022-2033
Figure 114: Australia Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 115: Australia Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 116: South Korea Gene Fusion Testing Market, $Million, 2022-2033
Figure 117: South Korea Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 118: South Korea Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 119: Rest-of-Asia-Pacific Gene Fusion Testing Market, $Million, 2022-2033
Figure 120: Rest-of-Asia-Pacific Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 121: Rest-of-Asia-Pacific Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 122: Latin America Gene Fusion Testing Market, $Million, 2023-2033
Figure 123: Latin America: Market Dynamics
Figure 124: Latin America Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 125: Latin America Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 126: Brazil Gene Fusion Testing Market, $Million, 2022-2033
Figure 127: Brazil Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 128: Brazil Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 129: Mexico Gene Fusion Testing Market, $Million, 2022-2033
Figure 130: Mexico Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 131: Mexico Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 132: Rest-of-Latin America Gene Fusion Testing Market, $Million, 2022-2033
Figure 133: Rest-of-Latin America Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 134: Rest-of-Latin America Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 135: Rest-of-the-World Gene Fusion Testing Market, $Million, 2022-2033
Figure 136: Rest-of-the-World Gene Fusion Testing Market (by Indication), $Million, 2022-2033
Figure 137: Rest-of-the-World Gene Fusion Testing Market (by Solid Tumors), $Million, 2022-2033
Figure 138: Global Gene Fusion Testing Market (by Total Number of Companies Profiled)
Figure 139: Amoy Diagnostics Co., Ltd.: Product Portfolio
Figure 140: ArcherDX (Integerated DNA Technologies, Inc.): Product Portfolio
Figure 141: Arima Genomics: Product Portfolio
Figure 142: Biocartis: Product Portfolio
Figure 143: Biocartis: Overall Financials, $Million, 2020-2022
Figure 144: Biocartis: Revenue (by Segment), $Million, 2020-2022
Figure 145: Biocartis: Revenue (by Region), $Million, 2020-2022
Figure 146: Biocartis: R&D Expenditure, $Million, 2020-2022
Figure 147: Biocare Medical, LLC: Product Portfolio
Figure 148: Empire Genomics, Inc.: Product Portfolio
Figure 149: F. Hoffmann-La Roche Ltd: Product Portfolio
Figure 150: F. Hoffmann-La Roche Ltd: Product Portfolio
Figure 151: F. Hoffmann-La Roche Ltd: Overall Financials, 2020-2022
Figure 152: F. Hoffmann-La Roche Ltd: Revenue (by Segment), 2020-2022
Figure 153: F. Hoffmann-La Roche Ltd: R&D Expenditure, 2020-2022
Figure 154: Guardant Health, Inc: Product Portfolio
Figure 155: Guardant Health, Inc: Overall Financials, $Million, 2020-2022
Figure 156: Guardant Health, Inc: Revenue (by Segment), $Million, 2020-2022
Figure 157: Guardant Health, Inc: Revenue (by Region), $Million, 2020-2022
Figure 158: Guardant Health, Inc: R&D Expenditure, $Million, 2020-2022
Figure 159: Illumina, Inc.: Overall Product Portfolio
Figure 160: Illumina, Inc.: Overall Financials, $Million, 2020-2022
Figure 161: Illumina, Inc.: Revenue (by Segment), $Million, 2020-2022
Figure 162: Illumina, Inc.: Revenue (by Region), $Million, 2020-2022
Figure 163: Illumina, Inc.: R&D Expenditure, $Million, 2020-2022
Figure 164: Myriad Genetics, Inc.: Product Portfolio
Figure 165: Myriad Genetics, Inc.: Overall Financials, $Million, 2020-2022
Figure 166: Myriad Genetics, Inc.: Revenue (by Segment), $Million, 2020-2022
Figure 167: Myriad Genetics, Inc.: R&D Expenditure, $Million, 2020-2022
Figure 168: Natera, Inc.: Product Portfolio
Figure 169: Natera, Inc. Overall Financials, $Million, 2020-2022
Figure 170: Natera, Inc.: Revenue (by Segment), $Million, 2020-2022
Figure 171: Natera, Inc.: Revenue (by Region), $Million, 2020-2022
Figure 172: Natera, Inc.: R&D Expenditure, $Million, 2020-2022
Figure 173: NeoGenomics, Inc.: Product Portfolio
Figure 174: NeoGenomics, Inc.: Overall Financials, $Million, 2020-2022
Figure 175: NeoGenomics, Inc.: Revenue (by Segment), $Million, 2020-2022
Figure 176: NeoGenomics, Inc.: R&D Expenditure, $Million, 2020-2022
Figure 177: OncoDNA: Product Portfolio
Figure 178: QIAGEN N.V.: Product Portfolio
Figure 179: QIAGEN N.V.: Overall Financials, $Million, 2020-2022
Figure 180: QIAGEN N.V.: Revenue (by Segment), $Million, 2020-2022
Figure 181: QIAGEN N.V.: Revenue (by Region), $Million, 2020-2022
Figure 182: QIAGEN N.V.: R&D Expenditure, $Million, 2020-2022
Figure 183: Quest Diagnostics Incorporated.: Product Portfolio
Figure 184: Quest Diagnostics Incorporated.: Overall Financials, $Million, 2020-2022
Figure 185: Quest Diagnostics Incorporated.: Revenue (by Segment), $Million, 2020-2022
Figure 186: Thermo Fisher Scientific Inc.: Product Portfolio
Figure 187: Thermo Fisher Scientific Inc.: Overall Financials, $Million, 2020-2022
Figure 188: Thermo Fisher Scientific Inc.: Revenue (by Segment), $Million, 2020-2022
Figure 189: Thermo Fisher Scientific Inc.: Revenue (by Region), $Million, 2020-2022
Figure 190: Thermo Fisher Scientific Inc.: R&D Expenditure, $Million, 2020-2022
Market Report Coverage
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
• QIAGEN N.V.
• Quest Diagnostics Incorporated.
• Thermo Fisher Scientific Inc.
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.
Global Gene Fusion Testing Market Industry Overview
Source: BIS Research Analysis
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.
Impact
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
Source: BIS Research Analysis
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.
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
Analyst View
According to Akash Mhaskar, Principal Analyst, BIS Research, “The global gene fusion testing market is experiencing rapid growth due to the increasing utilization of Utilization of gene fusion testing in the development of targeted therapies. Targeted therapies present multiple advantages compared to conventional treatments, including higher efficacy, less side effects, and enhanced patient outcomes. By using gene fusion testing, healthcare providers are more active to revolutionize disease management by offering more personalized and superior therapeutic interventions. The global gene fusion testing market has witnessed a steady growth in the number of new entrants and investments in genetic testing, thereby driving a surge in demand for the products and services required in the testing of gene fusion. This trend is also expected to continue over the forecast period. Therefore, the impact of the aforementioned factors is expected to drive the global gene fusion testing market in the near future.”
Gene Fusion Testing Market - A Global and Regional Analysis
Focus on by Category, Technology, Indication, End User, and Region - Analysis and Forecast, 2023-2033
Frequently Asked Questions
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. Gene fusion testing typically involves analyzing the genetic material (DNA or RNA) from a patient's tumor sample. It has proven valuable in managing various cancer indications, with NTRK gene fusion being a prevalent fusion event observed across several cancer types. Techniques such as polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), immunohistochemistry (IHC), and next-generation sequencing (NGS) are commonly used to detect and characterize gene fusions.
New technologies and methods are rapidly emerging to enhance the testing of genetic alterations in chromosomes, which is driving the market for gene fusion testing. Here are some prevalent patterns in the industry:
Increasing utilization of gene fusion testing in the development of targeted therapies: Gene fusion testing plays an important role in identifying the appropriate patients for targeted therapies. By utilizing gene fusion testing, healthcare providers can accurately identify patients whose diseases are driven by specific genetic alterations. This enables the customization of treatment approaches to effectively address these specific genetic abnormalities. As the knowledge of gene fusions and their implications advances, the potential for targeted therapies guided by gene fusion testing expands, offering prospects for precision medicine and enhancing the overall quality of patient care.
Leveraging artificial intelligence to predict gene fusion status in several cancer type: Artificial intelligence (AI) techniques have opened up possibilities for utilizing sophisticated computational algorithms to predict the status of gene fusions in diverse cancer types. Through the utilization of extensive datasets containing genomic and clinical information, AI models can be trained to recognize patterns and correlations that may indicate the occurrence of gene fusion events. By examining genomic data, including DNA or RNA sequencing data, alongside clinical characteristics, AI algorithms can pinpoint predictive markers that indicate the presence or absence of particular gene fusions.
These are only a few illustrations of the major developments in the industry for genetic testing. Emerging innovations and technologies are anticipated to emerge as the area develops further, helping to influence the industry's future.
A new entrant can focus on various gene fusion testing product offerings by established players. The market is fragmented with established market leaders such as Danaher Corporation, F. Hoffmann-La Roche Ltd, Illumina, Inc., and Thermo Fisher Scientific Inc.,, who have had their presence in the market for the past many years. The new entrants can focus on their strategy of product launches and global expansions for gene fusion testing.
• Detailed segmentation is delivered.
• Region and country-level data based on market segmentation by indication is provided.
• Market share analysis (by company) is provided.
• Growth share analysis (by company, technology, indication, and end user) is provided.
• Companies that manufacture and commercialize consumables required in the testing of genetic abnormal alterations in chromosomes
• Any new entrant that wants to know where the opportunities lie in the gene fusion testing market
• Any established player that wants to expand its product portfolio or business in new geographies