がん領域のコンパニオン診断薬の市場規模、シェア、成長分析：コンポーネント別、適応症別、技術別、エンドユーザー別、地域別 - 産業予測、2025年～2032年

がん領域のコンパニオン診断薬の市場規模は、2023年に35億米ドルで、2024年の39億6,000万米ドルから2032年には105億2,000万米ドルに拡大し、予測期間（2025-2032年）のCAGRは13%で成長する見通しです。

コンパニオン診断薬市場は、がん患者の個々の遺伝子プロファイルに基づいて治療を調整する個別化医療の人気の高まりにより、大きな成長が見込まれています。医学研究への投資の増加と様々ながんの罹患率の増加は、これらの診断薬への需要を高め、がん分野の企業に新たな機会を提供します。さらに、精密医療技術の進歩が需要をさらに押し上げると考えられます。しかし、複雑な規制の枠組み、高い導入コスト、分子データの管理の難しさなどの課題が市場開拓の妨げになる可能性があります。全体として、がん領域のコンパニオン診断薬分野は、技術革新と治療ニーズの高まりの両方によって拡大する態勢が整っています。

目次

イントロダクション

• 調査の目的
• 調査範囲
• 定義

調査手法

• 情報調達
• 二次データと一次データの方法
• 市場規模予測
• 市場の前提条件と制限

エグゼクティブサマリー

• 世界市場の見通し
• 供給と需要の動向分析
• セグメント別機会分析

市場力学と見通し

• 市場概要
• 市場規模
• 市場力学
  • 促進要因と機会
  • 抑制要因と課題
• ポーターの分析

主な市場の考察

• 重要成功要因
• 競合の程度
• 主な投資機会
• 市場エコシステム
• 市場の魅力指数（2024年）
• PESTEL分析
• マクロ経済指標
• バリューチェーン分析
• 価格分析

がん領域のコンパニオン診断薬市場規模：コンポーネント別& CAGR（2025-2032）

• 市場概要
• 製品
• サービス

がん領域のコンパニオン診断薬市場規模：エンドユーザー別& CAGR（2025-2032）

• 市場概要
• 病院
• 病理学/診断検査室
• 学術医療センター

がん領域のコンパニオン診断薬市場規模：適応症別& CAGR（2025-2032）

• 市場概要
• 乳がん
• 非小細胞肺がん
• 大腸がん
• 白血病黒色腫
• 前立腺がん
• その他

がん領域のコンパニオン診断薬市場規模：技術別& CAGR（2025-2032）

• 市場概要
• ポリメラーゼ連鎖反応（PCR）
• 次世代シーケンシング（NGS）
• 免疫組織化学（IHC）
• インサイチューハイブリダイゼーション（ISH）/蛍光インサイチューハイブリダイゼーション（FISH）
• その他の技術

がん領域のコンパニオン診断薬市場規模：地域別& CAGR（2025-2032）

• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • スペイン
  • フランス
  • 英国
  • イタリア
  • その他欧州地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• ラテンアメリカ
  • ブラジル
  • その他ラテンアメリカ地域
• 中東・アフリカ
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ

競合情報

• 上位5社の比較
• 主要企業の市場ポジショニング（2024年）
• 主な市場企業が採用した戦略
• 市場の最近の動向
• 企業の市場シェア分析（2024年）
• 主要企業の企業プロファイル
  • 会社概要
  • 製品ポートフォリオ分析
  • セグメント別シェア分析
  • 収益の前年比比較（2022-2024）

主要企業プロファイル

• Roche Holding AG（Switzerland）
• Thermo Fisher Scientific Inc.（USA）
• Agilent Technologies, Inc.（USA）
• Abbott Laboratories（USA）
• BioMerieux S.A.（France）
• Siemens Healthineers AG（Germany）
• Danaher Corporation（USA）
• Foundation Medicine, Inc.（USA）
• Myriad Genetics, Inc.（USA）
• Guardant Health, Inc.（USA）
• Exact Sciences Corporation（USA）
• Illumina, Inc.（USA）
• Becton, Dickinson and Company（BD）（USA）
• Bio-Rad Laboratories, Inc.（USA）
• Leica Biosystems（Germany）
• Sysmex Corporation（Japan）
• Horiba, Ltd.（Japan）
• Invitae Corporation（USA）
• NeoGenomics, Inc.（USA）

結論と推奨事項

Companion Diagnostics for Oncology Market size was valued at USD 3.5 Billion in 2023 and is poised to grow from USD 3.96 Billion in 2024 to USD 10.52 Billion by 2032, growing at a CAGR of 13% during the forecast period (2025-2032).

The companion diagnostics market is expected to see significant growth due to the increasing popularity of personalized medicine, which tailors treatment based on individual genetic profiles in cancer patients. Rising investments in medical research, coupled with the growing incidence of various cancers, will enhance demand for these diagnostics, presenting new opportunities for companies in the oncology sector. Additionally, advancements in precision medicine technology are likely to drive further demand. However, challenges such as complex regulatory frameworks, high implementation costs, and difficulties in managing molecular data may impede market development. Overall, the companion diagnostics for oncology sector is poised for expansion, driven by both technological innovations and increasing treatment needs.

Top-down and bottom-up approaches were used to estimate and validate the size of the Companion Diagnostics For Oncology market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Companion Diagnostics For Oncology Market Segmental Analysis

The global companion diagnostics for oncology market is segmented based on component, technology, end user, indication, and region. In terms of component, the market is segmented into products and services. In terms of end user, the market is segmented into hospitals, pathology/diagnostic laboratories, and academic medical centers. Based on indication, the market is bifurcated into breast cancer, non-small cell lung cancer, colorectal cancer, leukemia, melanoma, prostate cancer, and others. In terms of technology, the market is segmented into polymerase chain reaction (PCR), next-generation sequencing (NGS), immunohistochemistry (IHC), in situ hybridization (ISH)/fluorescence in situ hybridization (FISH), and other technologies. Based on region, the market is segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa.

Driver of the Companion Diagnostics For Oncology Market

The Companion Diagnostics for Oncology market is significantly driven by the advancement of precision medicine. As technologies in this field evolve rapidly, they are accompanied by substantial investments in medical research and development. This surge in investment is largely fueled by the increasing demand for personalized cancer therapies, which aim to reduce side effects and enhance treatment effectiveness. Consequently, this growing emphasis on tailored treatment approaches is expected to contribute to a heightened demand for companion diagnostics, positioning them as essential tools in the management and treatment of oncology patients moving forward.

Restraints in the Companion Diagnostics For Oncology Market

One significant restraint impacting the Companion Diagnostics for Oncology market is the regulatory challenges posed by governmental bodies and authorities. The stringent guidelines and mandates governing the development of new companion diagnostics can complicate the approval process, resulting in delays. This rigorous compliance framework may hinder innovation and slow the progression of the market. As regulatory hurdles become more pronounced, they could impede the timely introduction of novel diagnostics, ultimately affecting the growth potential of the companion diagnostics sector in the oncology field. Therefore, navigating these regulatory landscapes is crucial for advancing market development.

Market Trends of the Companion Diagnostics For Oncology Market

The Companion Diagnostics for Oncology market is witnessing a notable trend toward biomarker discovery as companies aim to enhance their business scope and maximize revenue generation. By employing advanced genomic and proteomic technologies, organizations are not only identifying new biomarkers but also facilitating personalized treatment approaches that align with the evolving landscape of precision medicine. This strategic focus on biomarker innovation promises to drive market growth significantly, catering to the increasing demand for targeted therapies and improving patient outcomes. As the market continues to expand, investment in biomarker research will be crucial to staying competitive and capitalizing on emerging opportunities.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis

Global Companion Diagnostics for Oncology Market Size by Component & CAGR (2025-2032)

• Market Overview
• Products
• Services

Global Companion Diagnostics for Oncology Market Size by End User & CAGR (2025-2032)

• Market Overview
• Hospitals
• Pathology/Diagnostic Laboratories
• Academic Medical Centers

Global Companion Diagnostics for Oncology Market Size by Indication & CAGR (2025-2032)

• Market Overview
• Breast Cancer
• Non-Small Cell Lung Cancer
• Colorectal Cancer
• Leukemia, Melanoma
• Prostate Cancer
• Others

Global Companion Diagnostics for Oncology Market Size by Technology & CAGR (2025-2032)

• Market Overview
• Polymerase Chain Reaction (PCR)
• Next-Generation Sequencing (NGS)
• Immunohistochemistry (IHC)
• In situ hybridization (ISH)/Fluorescence in situ hybridization (FISH)
• Other Technologies

Global Companion Diagnostics for Oncology Market Size & CAGR (2025-2032)

• North America (Component, End User, Indication, Technology)
  • US
  • Canada
• Europe (Component, End User, Indication, Technology)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Component, End User, Indication, Technology)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Component, End User, Indication, Technology)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Component, End User, Indication, Technology)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

• Roche Holding AG (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Thermo Fisher Scientific Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Agilent Technologies, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Abbott Laboratories (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• BioMerieux S.A. (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Siemens Healthineers AG (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Danaher Corporation (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Foundation Medicine, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Myriad Genetics, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Guardant Health, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Exact Sciences Corporation (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Illumina, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Becton, Dickinson and Company (BD) (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Bio-Rad Laboratories, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Leica Biosystems (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sysmex Corporation (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Horiba, Ltd. (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Invitae Corporation (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• NeoGenomics, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations