標靶治療伴隨診斷市場：策略性洞察與預測（2026-2031 年）

針對標靶治療的伴隨診斷市場預計將以 13.3% 的複合年成長率成長，從 2026 年的 81 億美元成長到 2031 年的 151 億美元。

全球標靶治療伴隨診斷市場被視為精準醫療的關鍵促進者，有助於識別最有可能從特定治療性介入獲益的患者群體。這些診斷在根據個別基因和分子特徵制定治療策略方面發揮著至關重要的作用，尤其是在腫瘤學和複雜性慢性疾病領域。由於標靶治療的日益普及、對個人化醫療的日益關注以及基於生物標記的檢測在臨床工作流程中的整合，該市場正蓬勃發展。隨著製藥公司在藥物和診斷開發方面合作日益密切，伴隨診斷正成為現代藥物開發和商業化策略中不可或缺的組成部分。

市場促進因素

其主要驅動力是癌症和其他慢性疾病的日益普遍，這些疾病需要標靶治療和個性化的治療方法。伴隨診斷能夠精準辨識生物標記物，使臨床醫師能夠選擇改善療效並減少副作用的治療方法。

標靶治療產品線的擴展和核准的增加是另一個關鍵因素。隨著更多精準藥物進入市場，對相應診斷工具的需求也不斷成長，這些工具用於識別合格的患者。這種同步成長推動了對檢驗的生物標記檢測平台的需求。

分子診斷技術的進步正在進一步加速市場擴張。次世代定序、聚合酵素鏈鎖反應(PCR) 和多重檢測技術的創新使得同時、快速、準確地檢測多種生物標記成為可能。這些技術提高了擴充性、診斷準確性和臨床效用。

此外，監管機構對聯合開發模式的支持正在促進製藥公司和診斷試劑生產商之間的合作。伴隨診斷和標靶治療核准流程的簡化提高了行業信心，並推動了該領域投資的增加。

市場限制因素

高昂的研發和檢驗成本仍然是一項重大挑戰。伴隨診斷檢測需要與標靶治療同步進行廣泛的臨床檢驗，這導致研發週期延長和經濟負擔加重。

各地報銷政策的差異也限制了這些技術的普及。診斷測試保險覆蓋範圍的不統一為醫療服務提供者和檢測實驗室帶來了不確定性，影響了市場滲透率。

發展中地區先進分子檢測基礎設施的匱乏進一步限制了其發展。熟練專業人員的短缺和專業檢測能力的不足阻礙了技術的廣泛應用。調查方法的標準化和各實驗室間檢測性能的一致性仍然是亟待解決的挑戰。

對技術和細分市場的洞察

市場細分按產品類型、技術、應用和地區進行。檢測方法、試劑盒和試劑佔據了主要細分市場，因為它們在檢測基因突變和蛋白質表現方面發揮著至關重要的作用，而這些檢測和表達對於選擇標靶治療。

在技​​術方面，次世代定序是主要組成部分，它能夠進行全面的基因組分析並同時檢測多種生物標記。這項技術在精準腫瘤學中尤其重要，因為精準腫瘤學需要準確地辨識複雜的基因變異。

按應用領域分類，腫瘤學領域佔據市場主導地位，這主要得益於生物標記檢測在癌症診斷和治療方法選擇中的廣泛應用。伴隨診斷對於識別基因改變的腫瘤和指導標靶治療至關重要，有助於改善臨床療效。

終端使用者包括醫院、診斷檢測實驗室和研究機構。診斷檢測實驗室憑藉其專業的檢測能力和分子診斷的高處理能力，佔據了較大的市場佔有率。

競爭格局與策略展望

競爭格局的特點是全球診斷和生命科學公司積極進軍，專注於創新和策略聯盟。羅氏診斷、賽默飛世爾科技、Illumina、安捷倫科技和凱傑等主要企業正在投資先進的分子檢測平台，並拓展其生物標記產品組合。

策略性舉措包括製藥公司和診斷公司之間的合作，共同開發治療方法和伴隨診斷。此外，各公司也正在投資次世代定序平台、多重檢測和生物資訊工具，以提高診斷的準確性和擴充性。

新趨勢包括伴隨診斷從腫瘤學擴展到心血管疾病、神經系統疾病和自體免疫疾病，以及將人工智慧融入其中，以改善生物標記的發現和數據解釋。

結論

受精準醫療的擴展、標靶治療療法核准的增加以及分子​​診斷技術的進步的推動，全球標靶治療治療伴隨診斷市場預計將保持穩定成長。儘管高成本、複雜的監管環境和基礎設施的限制仍然是主要挑戰，但持續的創新和協作開發模式將為市場的長期擴張提供支援。

本報告的主要益處

• 深入分析：獲得跨地區、客戶群、政策、社會經濟因素、消費者偏好和產業領域的詳細市場洞察。
• 競爭格局：我們了解主要企業的策略舉措，並確定最佳的市場進入方式。
• 市場促進因素和未來趨勢：我們將評估影響市場的主要成長要素和新興趨勢。
• 實用建議：我們支援制定策略決策以開發新的收入來源。
• 適合各類讀者：非常適合Start-Ups、研究機構、顧問公司、中小企業和大型企業。

我們的報告的使用範例

產業和市場洞察、機會評估、產品需求預測、打入市場策略、區域擴張、資本投資決策、監管分析、新產品開發和競爭情報。

報告範圍

• 2021年至2025年的歷史數據和2026年至2031年的預測數據
• 成長機會、挑戰、供應鏈前景、法律規範與趨勢分析
• 評估競爭對手的市場定位、策略和市場佔有率。
• 細分市場和區域銷售成長及預測評估
• 公司簡介，包括策略、產品、財務狀況和主要發展動態。

目錄

第1章執行摘要

第2章：市場概述

• 市場概覽
• 市場的定義
• 調查範圍
• 市場區隔

第3章：商業環境

• 市場促進因素
• 市場限制因素
• 市場機遇
• 波特五力分析
• 產業價值鏈分析
• 政策與法規
• 策略建議
• 產品平臺分析
• 發病率和盛行率分析
• 專利分析

第4章 技術展望

第5章：標靶治療伴隨診斷市場：依組件分類

• 檢測方法、試劑盒、試劑
• 裝置
• 軟體服務

第6章：標靶治療伴隨診斷市場：依技術分類

• 聚合酵素鏈鎖反應（PCR）
• 次世代定序（NGS）
• 免疫組織化學（IHC）
• 原位雜合反應（ISH）
• 基因表現分析

第7章：標靶治療伴隨診斷市場：依應用領域分類

• 腫瘤學
• 循環系統
• 神經病學
• 感染疾病

第8章：標靶治療伴隨診斷市場：按地區分類

• 北美洲
  • 美國
  • 加拿大
  • 墨西哥
• 南美洲
  • 巴西
  • 阿根廷
  • 其他
• 歐洲
  • 英國
  • 德國
  • 法國
  • 西班牙
  • 其他
• 中東和非洲
  • 沙烏地阿拉伯
  • UAE
  • 其他
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 韓國
  • 印尼
  • 泰國
  • 其他

第9章：競爭環境與分析

• 主要企業及策略分析
• 市佔率分析
• 合併、收購、協議和合作關係
• 競爭環境儀錶板

第10章：公司簡介

• Roche Diagnostics
• Abbott Laboratories
• Thermo Fisher Scientific
• Agilent Technologies
• Qiagen
• Illumina
• Danaher Corporation
• Bio-Rad Laboratories
• Myriad Genetics
• Hologic

第11章附錄

The Companion Diagnostics for Targeted Therapies market is projected to expand at a CAGR of 13.3%, attaining USD 15.1 billion in 2031 from USD 8.1 billion in 2026.

The global companion diagnostics for targeted therapies market is positioned as a critical enabler of precision medicine, supporting the identification of patient populations most likely to benefit from specific therapeutic interventions. These diagnostics play a vital role in aligning treatment strategies with individual genetic and molecular profiles, particularly in oncology and complex chronic diseases. The market is gaining momentum due to the increasing adoption of targeted therapies, rising emphasis on personalized healthcare, and the growing integration of biomarker-based testing into clinical workflows. As pharmaceutical companies increasingly co-develop drugs and diagnostics, companion diagnostics are becoming an integral component of modern drug development and commercialization strategies.

Market Drivers

A primary driver is the increasing prevalence of cancer and other chronic diseases, which require targeted and personalized treatment approaches. Companion diagnostics enable precise biomarker identification, allowing clinicians to select therapies that improve treatment outcomes and reduce adverse effects.

The growing pipeline and approval of targeted therapies is another significant factor. As more precision drugs enter the market, the need for corresponding diagnostic tools to identify eligible patients continues to rise. This parallel growth is strengthening demand for validated biomarker testing platforms.

Technological advancements in molecular diagnostics are further accelerating market expansion. Innovations in next-generation sequencing, polymerase chain reaction, and multiplex assays enable rapid and accurate detection of multiple biomarkers simultaneously. These technologies enhance scalability, diagnostic accuracy, and clinical utility.

Additionally, regulatory support for co-development models is encouraging collaboration between pharmaceutical and diagnostics companies. Streamlined approval pathways for companion diagnostics and targeted therapies are increasing industry confidence and investment in this segment.

Market Restraints

High development and validation costs remain a significant challenge. Companion diagnostic assays require extensive clinical validation alongside targeted therapies, leading to increased development timelines and financial burden.

Variability in reimbursement policies across regions also limits adoption. Inconsistent coverage for diagnostic tests creates uncertainty for healthcare providers and laboratories, affecting market penetration.

Limited access to advanced molecular testing infrastructure in developing regions further constrains growth. The lack of skilled professionals and specialized laboratory capabilities restricts widespread implementation. Standardization of testing methodologies and consistent assay performance across laboratories also remain ongoing challenges.

Technology and Segment Insights

The market is segmented by product type, technology, application, and geography. Assays, kits, and reagents represent a dominant segment due to their essential role in detecting genetic mutations and protein expressions used in targeted therapy selection.

By technology, next-generation sequencing is a key segment, enabling comprehensive genomic profiling and simultaneous analysis of multiple biomarkers. This capability is particularly important in precision oncology, where complex genetic variations must be identified accurately.

In terms of application, oncology dominates the market, driven by the widespread use of biomarker-based testing in cancer diagnosis and treatment selection. Companion diagnostics are critical in identifying genetically altered tumors and guiding targeted therapies, improving clinical outcomes.

End-users include hospitals, diagnostic laboratories, and research institutions. Diagnostic laboratories hold a significant share due to their specialized testing capabilities and high throughput of molecular diagnostics.

Competitive and Strategic Outlook

The competitive landscape is characterized by strong participation from global diagnostics and life sciences companies focusing on innovation and strategic collaborations. Key players such as Roche Diagnostics, Thermo Fisher Scientific, Illumina, Agilent Technologies, and QIAGEN are investing in advanced molecular testing platforms and expanding their biomarker portfolios.

Strategic initiatives include partnerships between pharmaceutical and diagnostics companies for co-development of therapies and companion tests. Companies are also investing in next-generation sequencing platforms, multiplex assays, and bioinformatics tools to enhance diagnostic accuracy and scalability.

Emerging trends include the expansion of companion diagnostics beyond oncology into cardiovascular, neurological, and autoimmune diseases, as well as the integration of artificial intelligence to improve biomarker discovery and data interpretation.

Conclusion

The global companion diagnostics for targeted therapies market is expected to witness steady growth, driven by the expansion of precision medicine, increasing targeted therapy approvals, and advancements in molecular diagnostics. While high costs, regulatory complexities, and infrastructure limitations remain key challenges, ongoing innovation and collaborative development models will support long-term market expansion.

Key Benefits of this Report

• Insightful Analysis: Gain detailed market insights across regions, customer segments, policies, socio-economic factors, consumer preferences, and industry verticals.
• Competitive Landscape: Understand strategic moves by key players to identify optimal market entry approaches.
• Market Drivers and Future Trends: Assess major growth forces and emerging developments shaping the market.
• Actionable Recommendations: Support strategic decisions to unlock new revenue streams.
• Caters to a Wide Audience: Suitable for startups, research institutions, consultants, SMEs, and large enterprises.

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Industry and market insights, opportunity assessment, product demand forecasting, market entry strategy, geographical expansion, capital investment decisions, regulatory analysis, new product development, and competitive intelligence.

Report Coverage

• Historical data from 2021 to 2025 and forecast data from 2026 to 2031
• Growth opportunities, challenges, supply chain outlook, regulatory framework, and trend analysis
• Competitive positioning, strategies, and market share evaluation
• Revenue growth and forecast assessment across segments and regions
• Company profiling including strategies, products, financials, and key developments

TABLE OF CONTENTS

1. EXECUTIVE SUMMARY

2. MARKET SNAPSHOT

• 2.1. Market Overview
• 2.2. Market Definition
• 2.3. Scope of the Study
• 2.4. Market Segmentation

3. BUSINESS LANDSCAPE

• 3.1. Market Drivers
• 3.2. Market Restraints
• 3.3. Market Opportunities
• 3.4. Porter's Five Forces Analysis
• 3.5. Industry Value Chain Analysis
• 3.6. Policies and Regulations
• 3.7. Strategic Recommendations
• 3.8. Product Pipeline Analysis
• 3.9. Incidence and Prevalence Analysis
• 3.10. Patent Analysis

4. TECHNOLOGICAL OUTLOOK

5. COMPANION DIAGNOSTICS FOR TARGETED THERAPIES MARKET BY COMPONENT

• 5.1. Introduction
• 5.2. Assays, Kits & Reagents
• 5.3 Instruments
• 5.4 Software & Services

6. COMPANION DIAGNOSTICS FOR TARGETED THERAPIES MARKET BY TECHNOLOGY

• 6.1. Introduction
• 6.2. Polymerase Chain Reaction (PCR)
• 6.3. Next-Generation Sequencing (NGS)
• 6.4. Immunohistochemistry (IHC)
• 6.5. In Situ Hybridization (ISH)
• 6.6. Gene Expression Profiling

7. COMPANION DIAGNOSTICS FOR TARGETED THERAPIES MARKET BY APPLICATION

• 7.1. Introduction
• 7.2. Oncology
• 7.3. Cardiology
• 7.4. Neurology
• 7.5. Infectious Diseases

8. COMPANION DIAGNOSTICS FOR TARGETED THERAPIES MARKET BY GEOGRAPHY

• 8.1. Introduction
• 8.2. North America
  • 8.2.1. USA
  • 8.2.2. Canada
  • 8.2.3. Mexico
• 8.3. South America
  • 8.3.1. Brazil
  • 8.3.2. Argentina
  • 8.3.3. Others
• 8.4. Europe
  • 8.4.1. United Kingdom
  • 8.4.2. Germany
  • 8.4.3. France
  • 8.4.4. Spain
  • 8.4.5. Others
• 8.5. Middle East and Africa
  • 8.5.1. Saudi Arabia
  • 8.5.2. UAE
  • 8.5.3. Others
• 8.6. Asia Pacific
  • 8.6.1. China
  • 8.6.2. India
  • 8.6.3. Japan
  • 8.6.4. South Korea
  • 8.6.5. Indonesia
  • 8.6.6. Thailand
  • 8.6.7. Others

9. COMPETITIVE ENVIRONMENT AND ANALYSIS

• 8.1. Major Players and Strategy Analysis
• 8.2. Market Share Analysis
• 8.3. Mergers, Acquisitions, Agreements, and Collaborations
• 8.4. Competitive Dashboard

10. COMPANY PROFILES

• 10.1. Roche Diagnostics
• 10.2. Abbott Laboratories
• 10.3. Thermo Fisher Scientific
• 10.4. Agilent Technologies
• 10.5. Qiagen
• 10.6. Illumina
• 10.7. Danaher Corporation
• 10.8. Bio-Rad Laboratories
• 10.9. Myriad Genetics
• 10.10. Hologic

11. APPENDIX

• 11.1. Currency
• 11.2. Assumptions
• 11.3. Base and Forecast Years Timeline
• 11.4. Key benefits for the stakeholders
• 11.5. Research Methodology
• 11.6. Abbreviations