遺伝子融合検査市場- 世界の産業規模、シェア、動向、機会、予測、カテゴリー別、技術別、適応症別、エンドユーザー別、地域別、競争別、2020-2030F

世界の遺伝子融合検査市場は、2024年に4億7,124万米ドルと評価され、予測期間には9億4,749万米ドルに達すると予測され、2030年までのCAGRは12.32%です。

遺伝子融合は、遺伝子転座または染色体転座としても知られ、ゲノムの異なる領域にある2つの別々の遺伝子が異常に結合または融合することで起こる遺伝的事象です。この融合は、キメラ遺伝子としても知られる、両方の元の遺伝子の一部が組み合わさったハイブリッド遺伝子の生成をもたらすことがあります。遺伝子融合現象は、特にヒト細胞で起こり、がんなどの疾患と関連する場合、生物の健康に重大な影響を及ぼす可能性があります。遺伝子融合は、多くの場合、染色体転座と呼ばれる過程を経て、遺伝物質の再配列が起こったときに起こる。染色体転座では、ある染色体の一部が切断されて別の染色体に結合し、これらの染色体上に位置する遺伝子の融合につながります。

特定の遺伝子融合事象を特定することは、特にがんにおいて、診断および治療に大きく関連します。遺伝子融合検査は、このような事象を検出し、治療方針を決定するために使用されます。場合によっては、異常なキメラタンパク質の機能を阻害する標的療法が開発されています。がん治療のための標的療法の開発と採用は、遺伝子融合の検出を含む腫瘍の精密な分子プロファイリングの必要性を促しています。これらの治療法はしばしば、治療標的としての特定の遺伝子変化の同定に依存しています。ゲノム技術、特に次世代シークエンシング（NGS）と高スループット分子アッセイの継続的な進歩は、遺伝子融合検査をより利用しやすく、費用対効果が高く、効率的なものにしていました。研究努力は、がんを含む様々な疾患における新しい遺伝子融合事象とその関連性を絶えず明らかにしていました。この調査は、遺伝子融合検査の開発と商業化への関心を高めました。

主な市場促進要因

ゲノム技術の進歩

主な市場課題

組織の入手可能性

主要市場動向

個別化医療

目次

第1章 概要

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 顧客の声

第5章 世界の遺伝子融合検査市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • カテゴリー別（調査、診断）
  • 技術別（次世代シーケンシング（NGS）、蛍光in-situハイブリダイゼーション（FISH）、ポリメラーゼ連鎖反応（PCR）、免疫組織化学（IHC））
  • 適応症別（固形腫瘍、造血悪性腫瘍）
  • エンドユーザー別（製薬・バイオテクノロジー企業、病院・診断研究所、学術研究センター）
  • 地域別
  • 企業別（2024）
• 市場マップ

第6章 アジア太平洋地域の遺伝子融合検査市場展望

• 市場規模・予測
• 市場シェア・予測
• アジア太平洋地域：国別分析
  • 中国
  • インド
  • オーストラリア
  • 日本
  • 韓国

第7章 欧州の遺伝子融合検査市場展望

• 市場規模・予測
• 市場シェア・予測
• 欧州：国別分析
  • フランス
  • ドイツ
  • スペイン
  • イタリア
  • 英国

第8章 北米の遺伝子融合検査市場展望

• 市場規模・予測
• 市場シェア・予測
• 北米：国別分析
  • 米国
  • メキシコ
  • カナダ

第9章 南米の遺伝子融合検査市場展望

• 市場規模・予測
• 市場シェア・予測
• 南米：国別分析
  • ブラジル
  • アルゼンチン
  • コロンビア

第10章 中東・アフリカの遺伝子融合検査市場展望

• 市場規模・予測
• 市場シェア・予測
• 中東・アフリカ：国別分析
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦

第11章 市場力学

• 促進要因
• 課題

第12章 市場動向と発展

• 最近の動向
• 製品上市
• 合併と買収

第13章 世界の遺伝子融合検査市場：SWOT分析

第14章 ポーターのファイブフォース分析

• 業界内の競合
• 新規参入の可能性
• サプライヤーの力
• 顧客の力
• 代替品の脅威

第15章 PESTEL分析

第16章 競合情勢

• 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

第17章 戦略的提言

第18章 調査会社について・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