基因融合檢測市場－全球產業規模、佔有率、趨勢、機會和預測（按類別、按技術、按適應症、按最終用戶、按地區和按競爭分類，2020 年至 2030 年）

2024 年全球基因融合檢測市場價值為 4.7124 億美元，預計到 2030 年將達到 9.4749 億美元，複合年成長率為 12.32%。基因融合，也稱為基因易位或染色體易位，是指來自基因組不同區域的兩個獨立基因異常連接或融合在一起時發生的遺傳事件。這種融合可以產生混合基因，也稱為嵌合基因，它結合了兩個原始基因的部分內容。基因融合事件對生物體的健康有重大影響，特別是當它們發生在人類細胞中並與癌症等疾病有關時。基因融合發生在遺傳物質重新排列時，通常是透過稱為染色體易位的過程。在染色體易位中，一條染色體的一部分斷裂並附著到另一條染色體上，導致這些染色體上的基因融合。

識別特定的基因融合事件對於診斷和治療具有重要意義，尤其是在癌症方面。基因融合測試用於檢測這些事件並指導治療決策。在某些情況下，已經開發出針對性的治療方法來抑制異常嵌合蛋白的功能。癌症治療標靶療法的開發和採用推動了對腫瘤進行精確分子分析的需求，包括檢測基因融合。這些療法通常依賴於識別特定的基因改變作為治療目標。基因組技術的不斷進步，特別是次世代定序（NGS）和高通量分子檢測，使得基因融合檢測更加容易獲得、更具成本效益且更有效率。研究工作不斷發現新的基因融合事件及其與包括癌症在內的各種疾病的相關性。這項研究激發了人們對開發和商業化基因融合測試的興趣。

關鍵市場促進因素

基因組技術的進步

主要市場挑戰

組織可用性

主要市場趨勢

個人化醫療

目錄

第 1 章：產品概述

第2章：研究方法

第3章：執行摘要

第4章：顧客之聲

第5章：全球基因融合檢測市場展望

• 市場規模和預測
  • 按價值
• 市場佔有率和預測
  • 按類別（研究、診斷）
  • 依技術（次世代定序 (NGS)、螢光原位雜合技術 (FISH)、聚合酶鍊式反應 (PCR)、免疫組織化學 (IHC)）
  • 按適應症（實體腫瘤、血液系統惡性腫瘤）
  • 按最終用戶（製藥和生物技術公司、醫院和診斷實驗室、學術和研究中心）
  • 按地區
  • 按公司分類（2024）
• 市場地圖

第6章：亞太地區基因融合檢測市場展望

• 市場規模和預測
• 市場佔有率和預測
• 亞太地區：國家分析
  • 中國
  • 印度
  • 澳洲
  • 日本
  • 韓國

第7章：歐洲基因融合檢測市場展望

• 市場規模和預測
• 市場佔有率和預測
• 歐洲：國家分析
  • 法國
  • 德國
  • 西班牙
  • 義大利
  • 英國

第8章：北美基因融合檢測市場展望

• 市場規模和預測
• 市場佔有率和預測
• 北美：國家分析
  • 美國
  • 墨西哥
  • 加拿大

第9章：南美洲基因融合檢測市場展望

• 市場規模和預測
• 市場佔有率和預測
• 南美洲：國家分析
  • 巴西
  • 阿根廷
  • 哥倫比亞

第10章：中東與非洲基因融合檢測市場展望

• 市場規模和預測
• 市場佔有率和預測
• MEA：國家分析
  • 南非
  • 沙烏地阿拉伯
  • 阿拉伯聯合大公國

第 11 章：市場動態

• 驅動程式
• 挑戰

第 12 章：市場趨勢與發展

• 最新動態
• 產品發布
• 併購

第 13 章：全球基因融合測試市場：SWOT 分析

第 14 章：波特五力分析

• 產業競爭
• 新進入者的潛力
• 供應商的力量
• 顧客的力量
• 替代產品的威脅

第 15 章： 大環境分析

第 16 章：競爭格局

• Amoy Diagnostics Co., Ltd.
• ArcherDX (Integrated 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 NV
• Thermo Fisher Scientific Inc

第 17 章：策略建議

第18章調查會社について,免責事項

Global Gene Fusion Testing Market was valued at USD 471.24 Million in 2024 and is expected to reach USD 947.49 Million in the forecast period with a CAGR of 12.32% through 2030. Gene fusion, also known as gene translocation or chromosomal translocation, is a genetic event that occurs when two separate genes from different regions of the genome become abnormally connected or fused together. This fusion can result in the creation of a hybrid gene, also known as a chimeric gene, which combines portions of both original genes. Gene fusion events can have significant implications for an organism's health, particularly when they occur in human cells and are associated with diseases, such as cancer. Gene fusion occurs when there is a rearrangement of genetic material, often through a process called chromosomal translocation. In chromosomal translocation, a piece of one chromosome breaks off and attaches to another chromosome, leading to the fusion of genes located on these chromosomes.

Identifying specific gene fusion events is of great diagnostic and therapeutic relevance, particularly in cancer. Gene fusion testing is used to detect these events and guide treatment decisions. In some cases, targeted therapies have been developed to inhibit the function of abnormal chimeric proteins. The development and adoption of targeted therapies for cancer treatment were driving the need for precise molecular profiling of tumors, including the detection of gene fusions. These therapies often rely on the identification of specific genetic alterations as therapeutic targets. Ongoing advancements in genomic technologies, particularly next-generation sequencing (NGS) and high-throughput molecular assays, were making gene fusion testing more accessible, cost-effective, and efficient. Research efforts were continually uncovering new gene fusion events and their relevance in various diseases, including cancer. This research drove interest in developing and commercializing gene fusion tests.

Key Market Drivers

Advancements in Genomic Technologies

Next-Generation Sequencing (NGS) technologies, such as Illumina and Ion Torrent, have revolutionized genomics research and clinical diagnostics by enabling rapid and cost-effective sequencing of DNA and RNA.

Long-read sequencing technologies, such as those developed by Pacific Biosciences (PacBio) and Oxford Nanopore, provide a more comprehensive view of the genome, particularly useful for detecting structural variants and complex genomic regions. The CRISPR-Cas9 system has transformed genome editing, enabling precise and targeted gene modifications, making it a powerful tool for functional genomics, gene therapy, and genetic engineering. Notably, in December 2023, the U.S. Food and Drug Administration approved Casgevy, the first CRISPR-based treatment for sickle cell disease and beta-thalassemia, marking a significant milestone in gene-editing therapeutics.

Advances in technologies like DNA methylation sequencing (bisulfite sequencing) and chromatin immunoprecipitation sequencing (ChIP-seq) have deepened our understanding of epigenetic modifications and their roles in gene regulation and disease. Techniques such as single-molecule fluorescence in situ hybridization (smFISH) and single-molecule real-time (SMRT) sequencing offer insights into molecular processes at the individual molecule level. Metagenomic sequencing facilitates the study of microbial communities and their genetic diversity, with applications in environmental microbiology, microbiome research, and infectious disease diagnostics.

Key Market Challenges

Tissue Availability

In some cases, obtaining enough tissue for gene fusion testing can be challenging, especially when dealing with small biopsies or fine-needle aspirates. Insufficient tissue can result in inadequate test results. The quality of tissue samples is crucial for accurate gene fusion testing. Factors such as tissue preservation, fixation, and handling can impact the integrity of the genetic material and affect the reliability of test results. Tumors are often heterogeneous, meaning that different regions of the tumor may have distinct genetic profiles, including gene fusion events. Obtaining a single tissue sample may not fully represent the genetic diversity within the tumor. In some cases, tumors may be in anatomically challenging or inaccessible areas, making it difficult to obtain tissue samples for testing. Invasive procedures like biopsies carry inherent risks, including bleeding, infection, and damage to surrounding tissues. These risks can influence the decision to perform a biopsy and impact tissue availability. For rare or uncommon tumor types, obtaining sufficient tissue samples for gene fusion testing can be particularly challenging due to the limited number of cases available for study. Properly preserving and storing tissue samples for future testing is essential. Inadequate preservation or long-term storage conditions can compromise the quality of the samples. Obtaining informed consent for tissue collection is crucial, and ethical considerations may affect the availability of tissue samples, especially in cases involving minors or vulnerable populations.

Key Market Trends

Personalized Medicine

Gene fusion testing plays a crucial role in identifying specific genetic alterations that drive diseases, particularly in cancer. With the advent of personalized medicine, oncologists and other healthcare providers can use the results of gene fusion tests to select targeted therapies that are most likely to be effective for individual patients. This approach maximizes treatment efficacy while minimizing side effects. Gene fusion testing is used to stratify patients into different subgroups based on their genetic profiles. Patients with similar gene fusion events may respond differently to treatments. Personalized medicine enables the selection of the most appropriate treatment regimen for each patient based on their specific genetic alterations. Gene fusion tests are often developed alongside targeted therapies as companion diagnostics. These tests help identify patients who are most likely to benefit from a particular drug. Regulatory agencies like the U.S. Food and Drug Administration (FDA) often require companion diagnostics as part of the drug approval process. Personalized medicine extends beyond initial treatment selection. It also involves ongoing monitoring of a patient's response to therapy. Gene fusion testing can be used to assess whether a targeted therapy is effectively suppressing the fusion event and whether treatment adjustments are needed.

Key Market Players

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

Report Scope:

In this report, the Global Gene Fusion Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Gene Fusion Testing Market, By Category:

• Research
• Diagnostic

Gene Fusion Testing Market, By Technology:

• Next-Generation Sequencing (NGS)
• Fluorescence In-Situ Hybridization (FISH)
• Polymerase Chain Reaction (PCR)
• Immunohistochemistry (IHC)

Gene Fusion Testing Market, By Indication:

• Solid Tumors
• Hematological Malignancies

Gene Fusion Testing Market, By End User:

• Pharmaceutical and Biotechnology Companies
• Hospitals and Diagnostic Laboratories
• Academic and Research Centers

Global Gene Fusion Testing Market, By region:

• North America
  • United States
  • Canada
  • Mexico
• Asia-Pacific
  • China
  • India
  • South Korea
  • Australia
  • Japan
• Europe
  • Germany
  • France
  • United Kingdom
  • Spain
  • Italy
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Gene Fusion Testing Market.

Available Customizations:

Global Gene Fusion Testing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Gene Fusion Testing Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Category (Research, Diagnostic)
  • 5.2.2. By Technology (Next-Generation Sequencing (NGS), Fluorescence In-Situ Hybridization (FISH), Polymerase Chain Reaction (PCR), Immunohistochemistry (IHC))
  • 5.2.3. By Indication (Solid Tumors, Hematological Malignancies)
  • 5.2.4. By End User (Pharmaceutical and Biotechnology Companies, Hospitals and Diagnostic Laboratories, Academic and Research Centers)
  • 5.2.5. By Region
  • 5.2.6. By Company (2024)
• 5.3. Market Map

6. Asia Pacific Gene Fusion Testing Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Category
  • 6.2.2. By Technology
  • 6.2.3. By Indication
  • 6.2.4. By End User
  • 6.2.5. By Country
• 6.3. Asia Pacific: Country Analysis
  • 6.3.1. China Gene Fusion Testing Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Category
      • 6.3.1.2.2. By Technology
      • 6.3.1.2.3. By Indication
      • 6.3.1.2.4. By End User
  • 6.3.2. India Gene Fusion Testing Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Category
      • 6.3.2.2.2. By Technology
      • 6.3.2.2.3. By Indication
      • 6.3.2.2.4. By End User
  • 6.3.3. Australia Gene Fusion Testing Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Category
      • 6.3.3.2.2. By Technology
      • 6.3.3.2.3. By Indication
      • 6.3.3.2.4. By End User
  • 6.3.4. Japan Gene Fusion Testing Market Outlook
    • 6.3.4.1. Market Size & Forecast
      • 6.3.4.1.1. By Value
    • 6.3.4.2. Market Share & Forecast
      • 6.3.4.2.1. By Category
      • 6.3.4.2.2. By Technology
      • 6.3.4.2.3. By Indication
      • 6.3.4.2.4. By End User
  • 6.3.5. South Korea Gene Fusion Testing Market Outlook
    • 6.3.5.1. Market Size & Forecast
      • 6.3.5.1.1. By Value
    • 6.3.5.2. Market Share & Forecast
      • 6.3.5.2.1. By Category
      • 6.3.5.2.2. By Technology
      • 6.3.5.2.3. By Indication
      • 6.3.5.2.4. By End User

7. Europe Gene Fusion Testing Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Category
  • 7.2.2. By Technology
  • 7.2.3. By Indication
  • 7.2.4. By End User
  • 7.2.5. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. France Gene Fusion Testing Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Category
      • 7.3.1.2.2. By Technology
      • 7.3.1.2.3. By Indication
      • 7.3.1.2.4. By End User
  • 7.3.2. Germany Gene Fusion Testing Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Category
      • 7.3.2.2.2. By Technology
      • 7.3.2.2.3. By Indication
      • 7.3.2.2.4. By End User
  • 7.3.3. Spain Gene Fusion Testing Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Category
      • 7.3.3.2.2. By Technology
      • 7.3.3.2.3. By Indication
      • 7.3.3.2.4. By End User
  • 7.3.4. Italy Gene Fusion Testing Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Category
      • 7.3.4.2.2. By Technology
      • 7.3.4.2.3. By Indication
      • 7.3.4.2.4. By End User
  • 7.3.5. United Kingdom Gene Fusion Testing Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Category
      • 7.3.5.2.2. By Technology
      • 7.3.5.2.3. By Indication
      • 7.3.5.2.4. By End User

8. North America Gene Fusion Testing Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Category
  • 8.2.2. By Technology
  • 8.2.3. By Indication
  • 8.2.4. By End User
  • 8.2.5. By Country
• 8.3. North America: Country Analysis
  • 8.3.1. United States Gene Fusion Testing Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Category
      • 8.3.1.2.2. By Technology
      • 8.3.1.2.3. By Indication
      • 8.3.1.2.4. By End User
  • 8.3.2. Mexico Gene Fusion Testing Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Category
      • 8.3.2.2.2. By Technology
      • 8.3.2.2.3. By Indication
      • 8.3.2.2.4. By End User
  • 8.3.3. Canada Gene Fusion Testing Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Category
      • 8.3.3.2.2. By Technology
      • 8.3.3.2.3. By Indication
      • 8.3.3.2.4. By End User

9. South America Gene Fusion Testing Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Category
  • 9.2.2. By Technology
  • 9.2.3. By Indication
  • 9.2.4. By End User
  • 9.2.5. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Gene Fusion Testing Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Category
      • 9.3.1.2.2. By Technology
      • 9.3.1.2.3. By Indication
      • 9.3.1.2.4. By End User
  • 9.3.2. Argentina Gene Fusion Testing Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Category
      • 9.3.2.2.2. By Technology
      • 9.3.2.2.3. By Indication
      • 9.3.2.2.4. By End User
  • 9.3.3. Colombia Gene Fusion Testing Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Category
      • 9.3.3.2.2. By Technology
      • 9.3.3.2.3. By Indication
      • 9.3.3.2.4. By End User

10. Middle East and Africa Gene Fusion Testing Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Category
  • 10.2.2. By Technology
  • 10.2.3. By Indication
  • 10.2.4. By End User
  • 10.2.5. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Gene Fusion Testing Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Category
      • 10.3.1.2.2. By Technology
      • 10.3.1.2.3. By Indication
      • 10.3.1.2.4. By End User
  • 10.3.2. Saudi Arabia Gene Fusion Testing Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Category
      • 10.3.2.2.2. By Technology
      • 10.3.2.2.3. By Indication
      • 10.3.2.2.4. By End User
  • 10.3.3. UAE Gene Fusion Testing Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Category
      • 10.3.3.2.2. By Technology
      • 10.3.3.2.3. By Indication
      • 10.3.3.2.4. By End User

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Recent Developments
• 12.2. Product Launches
• 12.3. Mergers & Acquisitions

13. Global Gene Fusion Testing Market: SWOT Analysis

14. Porter's Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Product

15. PESTLE Analysis

16. Competitive Landscape

• 16.1. Amoy Diagnostics Co., Ltd.
  • 16.1.1. Business Overview
  • 16.1.2. Company Snapshot
  • 16.1.3. Products & Services
  • 16.1.4. Financials (In case of listed companies)
  • 16.1.5. Recent Developments
  • 16.1.6. SWOT Analysis
• 16.2. ArcherDX (Integrated DNA Technologies, Inc.)
• 16.3. Biocartis
• 16.4. Biocare Medical, LLC
• 16.5. F. Hoffmann-La Roche Ltd.
• 16.6. Guardant Health, Inc
• 16.7. Illumina, Inc.
• 16.8. Myriad Genetics, Inc.
• 16.9. Natera, Inc.
• 16.10. NeoGenomics, Inc.
• 16.11. QIAGEN N.V.
• 16.12. Thermo Fisher Scientific Inc

17. Strategic Recommendations

18. About Us & Disclaimer