腫瘤伴隨診斷市場機會、成長動力、產業趨勢分析及 2025 - 2034 年預測

2024 年全球腫瘤伴隨診斷市場規模達 46 億美元，預計 2025 年至 2034 年的複合年成長率為 10.8%。腫瘤伴隨診斷是提供關鍵見解的重要工具，可確保在癌症治療中安全有效地使用相應藥物或生物製品。這些診斷有助於識別患者腫瘤中的特定基因標記、突變和生物標記，使醫療保健提供者能夠確定患者是否可能對標靶治療產生反應。精準醫療的日益普及已將重點從傳統治療方法轉移到根據患者獨特的腫瘤特徵和基因特徵客製化治療的個人化方法。這一趨勢是推動腫瘤伴隨診斷需求的關鍵促進因素。

市場根據產品、技術、疾病類型和最終用途進行細分。根據提供內容，市場分為產品和服務。該產品部門包括儀器、消耗品和軟體，2024 年創造了 30 億美元的收入，預計在預測期內的複合年成長率為 10.6%。聚合酶鍊式反應 (PCR) 系統和次世代定序儀 (NGS) 等儀器在檢測基因突變方面具有很高的靈敏度和準確性。消耗品（包括試劑、檢測試劑盒、引子和探針）可確保結果的準確性。軟體解決方案在分析和解釋複雜的基因組和臨床資料方面發揮關鍵作用，人工智慧 (AI) 和機器學習 (ML) 等先進演算法可以提高預測準確性並實現簡化的資料解釋。

根據技術，市場還分為 PCR、NGS、免疫組織化學 (IHC)、原位雜合技術 (ISH)/螢光原位雜合技術 (FISH) 和其他技術。 PCR 在 2024 年佔據了 34.2% 的市場佔有率，預計到 2034 年將達到 45 億美元。 PCR 系統在檢測微量 DNA 或 RNA 方面具有高靈敏度和效率，可在數小時內快速提供結果，這對於及時的臨床決策至關重要。 PCR 技術的進步，例如數位 PCR (dPCR) 和即時 PCR (qPCR)，使得可以在一次測試中同時檢測多種癌症生物標記物，從而降低成本並節省時間。

依疾病類型，市場分為乳癌、非小細胞肺癌、大腸癌、白血病、黑色素瘤、攝護腺癌等。乳癌領域在 2024 年佔據市場主導地位，佔有 34.7% 的佔有率，這主要是由於疾病的盛行率不斷上升。最終用途細分包括醫院、診斷實驗室、學術和研究機構以及其他最終用戶。 2024 年，醫院佔據了 38.4% 的市場佔有率，這歸功於其管理大量住院和門診癌症患者的能力。伴隨診斷使醫院能夠管理個人化治療，減少副作用並提高存活率。

由於癌症發病率不斷上升以及美國食品藥物管理局（FDA）對伴隨診斷的嚴格標準，美國仍然是一個關鍵市場。這些法規鼓勵開發更安全、更有效的診斷試劑盒和儀器，促進該地區腫瘤伴隨診斷市場的整體成長。

目錄

第1章：方法論與範圍

第2章：執行摘要

第3章：行業洞察

• 產業生態系統分析
• 產業衝擊力
  • 成長動力
    • 癌症發生率上升
    • 基因組技術的進步
    • 標靶治療需求不斷成長
    • 增加研發投入
  • 產業陷阱與挑戰
    • 開發成本高
    • 嚴格的監管要求
• 成長潛力分析
• 監管格局
• 技術格局
• 未來市場趨勢
• 波特的分析
• PESTEL分析

第4章：競爭格局

• 介紹
• 公司市佔率分析
• 公司矩陣分析
• 主要市場參與者的競爭分析
• 競爭定位矩陣
• 策略儀表板

第5章：市場估計與預測：依供應量，2021 年至 2034 年

• 主要趨勢
• 產品
  • 樂器
  • 耗材
  • 軟體
• 服務

第6章：市場估計與預測：按技術，2021 年至 2034 年

• 主要趨勢
• 聚合酶鍊式反應（PCR）
• 下一代定序（NGS）
• 免疫組織化學（IHC）
• 原位雜合技術（ISH）/螢光原位雜合技術（FISH）
• 其他技術

第7章：市場估計與預測：依疾病類型，2021 年至 2034 年

• 主要趨勢
• 乳癌
• 非小細胞肺癌
• 大腸直腸癌
• 白血病
• 黑色素瘤
• 攝護腺癌
• 其他疾病類型

第8章：市場估計與預測：依最終用途，2021 年至 2034 年

• 主要趨勢
• 醫院
• 診斷實驗室
• 學術和研究機構
• 其他最終用途

第9章：市場估計與預測：按地區，2021 年至 2034 年

• 主要趨勢
• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 英國
  • 法國
  • 西班牙
  • 義大利
  • 荷蘭
• 亞太地區
  • 中國
  • 日本
  • 印度
  • 澳洲
  • 韓國
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
• 中東和非洲
  • 南非
  • 沙烏地阿拉伯
  • 阿拉伯聯合大公國

第10章：公司簡介

• Abbott Laboratories
• Agilent Technologies
• BioMérieux
• Biocartis
• Bio-Rad Laboratories
• EntroGen
• F. Hoffmann-La Roche
• Foundation Medicine
• Guardant Health
• Illumina
• Leica Biosystems
• Myriad Genetics
• QIAGEN
• Sysmex Corporation
• Thermo Fisher Scientific

The Global Oncology Companion Diagnostic Market reached USD 4.6 billion in 2024 and is expected to grow at a CAGR of 10.8% from 2025 to 2034. Oncology companion diagnostics are essential tools that provide critical insights into the safe and effective use of corresponding drugs or biological products in cancer treatment. These diagnostics help identify specific genetic markers, mutations, and biomarkers in a patient's tumor, enabling healthcare providers to determine whether a patient is likely to respond to a targeted therapy. The increasing adoption of precision medicine has shifted the focus from traditional treatment methods to personalized approaches that tailor therapies based on a patient's unique tumor characteristics and genetic profile. This trend is a key driver fueling the demand for oncology companion diagnostics.

The market is segmented by offering, technology, disease type, and end-use. By offering, the market is divided into products and services. The product segment, which includes instruments, consumables, and software, generated USD 3 billion in revenue in 2024 and is projected to grow at a CAGR of 10.6% during the forecast period. Instruments such as polymerase chain reaction (PCR) systems and next-generation sequencers (NGS) offer high sensitivity and accuracy in detecting genetic mutations. Consumables, including reagents, assay kits, primers, and probes, ensure accurate results. Software solutions play a pivotal role in analyzing and interpreting complex genomic and clinical data, with advanced algorithms such as artificial intelligence (AI) and machine learning (ML) improving predictive accuracy and enabling streamlined data interpretation.

The market is also categorized by technology into PCR, NGS, immunohistochemistry (IHC), in situ hybridization (ISH)/fluorescence in situ hybridization (FISH), and other technologies. PCR held a 34.2% market share in 2024 and is expected to reach USD 4.5 billion by 2034. PCR systems provide high sensitivity and efficiency in detecting minimal amounts of DNA or RNA, delivering quick results within hours, which is essential for timely clinical decision-making. Advancements in PCR technologies, such as digital PCR (dPCR) and real-time PCR (qPCR), allow for the simultaneous detection of multiple cancer biomarkers in a single test, reducing costs and saving time.

By disease type, the market is divided into breast cancer, non-small cell lung cancer, colorectal cancer, leukemia, melanoma, prostate cancer, and others. The breast cancer segment dominated the market with a 34.7% share in 2024, primarily due to the rising prevalence of the disease. End use segmentation includes hospitals, diagnostic laboratories, academic and research institutions, and other end users. Hospitals accounted for 38.4% of the market share in 2024, attributed to their capacity to manage high volumes of cancer patients, both inpatient and outpatient. Companion diagnostics empower hospitals to manage personalized treatments, reducing side effects and improving survival rates.

The United States remains a key market due to the increasing incidence of cancer and the stringent standards established by the U.S. Food and Drug Administration (FDA) for companion diagnostics. These regulations have encouraged the development of safer, more effective diagnostic kits and instruments, enhancing the overall growth of the oncology companion diagnostic market in the region.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates and calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360° synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Rising prevalence of cancer
    • 3.2.1.2 Advancements in genomic technologies
    • 3.2.1.3 Rising demand for targeted therapies
    • 3.2.1.4 Increased investment in research and development
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 High development costs
    • 3.2.2.2 Stringent regulatory requirements
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
• 3.5 Technological landscape
• 3.6 Future market trends
• 3.7 Porter's analysis
• 3.8 PESTEL analysis

Chapter 4 Competitive Landscape, 2024

• 4.1 Introduction
• 4.2 Company market share analysis
• 4.3 Company matrix analysis
• 4.4 Competitive analysis of major market players
• 4.5 Competitive positioning matrix
• 4.6 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Offering, 2021 – 2034 ($ Mn)

• 5.1 Key trends
• 5.2 Product
  • 5.2.1 Instrument
  • 5.2.2 Consumables
  • 5.2.3 Software
• 5.3 Services

Chapter 6 Market Estimates and Forecast, By Technology, 2021 – 2034 ($ Mn)

• 6.1 Key trends
• 6.2 Polymerase chain reaction (PCR)
• 6.3 Next-generation sequencing (NGS)
• 6.4 Immunohistochemistry (IHC)
• 6.5 In situ hybridization (ISH)/fluorescence in situ hybridization (FISH)
• 6.6 Other technologies

Chapter 7 Market Estimates and Forecast, By Disease Type, 2021 – 2034 ($ Mn)

• 7.1 Key trends
• 7.2 Breast cancer
• 7.3 Non-small cell lung cancer
• 7.4 Colorectal cancer
• 7.5 Leukemia
• 7.6 Melanoma
• 7.7 Prostate cancer
• 7.8 Other disease types

Chapter 8 Market Estimates and Forecast, By End Use, 2021 – 2034 ($ Mn)

• 8.1 Key trends
• 8.2 Hospitals
• 8.3 Diagnostic laboratories
• 8.4 Academic and research institutions
• 8.5 Other end use

Chapter 9 Market Estimates and Forecast, By Region, 2021 – 2034 ($ Mn)

• 9.1 Key trends
• 9.2 North America
  • 9.2.1 U.S.
  • 9.2.2 Canada
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 France
  • 9.3.4 Spain
  • 9.3.5 Italy
  • 9.3.6 Netherlands
• 9.4 Asia Pacific
  • 9.4.1 China
  • 9.4.2 Japan
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 South Korea
• 9.5 Latin America
  • 9.5.1 Brazil
  • 9.5.2 Mexico
  • 9.5.3 Argentina
• 9.6 Middle East and Africa
  • 9.6.1 South Africa
  • 9.6.2 Saudi Arabia
  • 9.6.3 UAE

Chapter 10 Company Profiles

• 10.1 Abbott Laboratories
• 10.2 Agilent Technologies
• 10.3 BioMérieux
• 10.4 Biocartis
• 10.5 Bio-Rad Laboratories
• 10.6 EntroGen
• 10.7 F. Hoffmann-La Roche
• 10.8 Foundation Medicine
• 10.9 Guardant Health
• 10.10 Illumina
• 10.11 Leica Biosystems
• 10.12 Myriad Genetics
• 10.13 QIAGEN
• 10.14 Sysmex Corporation
• 10.15 Thermo Fisher Scientific