コンパニオン診断薬市場規模、シェア、成長分析：製品別、技術別、適応症別、サンプルタイプ別、エンドユーザー別、地域別 - 産業予測 2025～2032年

コンパニオン診断薬市場規模は2023年に69億米ドルと評価され、2024年の77億6,000万米ドルから2032年には199億2,000万米ドルに成長し、予測期間（2025-2032年）のCAGRは12.5%で成長する見通しです。

コンパニオン診断市場は、がん罹患率の上昇と精密医療への需要の高まりに牽引され、大きな成長を遂げています。これらの検査は、特にがん領域において、関連する生物学的治療の安全かつ効果的な投与を決定するために不可欠です。ゲノム、プロテオミクス、メタボローム・プロファイリングが進化し続ける中、適切な治療法を特定し、良好な転帰を予測するコンパニオン診断薬のニーズが急増しています。さらに、個別化治療の登場は、個別化治療アプローチにおけるこれらの診断薬の重要な役割を浮き彫りにしています。特にFDAやEMAのような政府のイニシアティブや有利な規制ガイダンスによる支援は、市場の勢いを加速させています。合理化された承認プロセスはコンパニオン診断薬の利用可能性を高め、治療効果の改善とタイムリーな患者ケアを促進します。

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
• 規制分析
• 技術分析
• ケーススタディ
• 顧客と購買基準の分析

コンパニオン診断薬市場規模：製品・サービス別& CAGR（2025-2032）

• 市場概要
• アッセイキット試薬
• 機器とシステム
• ソフトウェアとサービス

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
• インサイチューハイブリダイゼーション
• 次世代シーケンシング
• 免疫組織化学
• その他の技術

コンパニオン診断薬市場規模：適応症別& CAGR（2025-2032）

• 市場概要
• がん
  • 肺がん
  • 乳がん
  • 血液がん
  • 大腸がん
  • その他のがん
• 神経疾患
• 心血管疾患
• 感染症
• その他の適応症

コンパニオン診断薬市場規模：サンプルタイプ別& CAGR（2025-2032）

• 市場概要
• 組織サンプル
• 血液サンプル
• その他のサンプルタイプ

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
• 製薬・バイオテクノロジー企業
• リファレンスラボ
• 契約調査機関
• その他のエンドユーザー

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
• 最近の市場動向
• 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
  • 企業の詳細
  • 製品ポートフォリオ分析
  • 企業の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

• Abbott（United States）
• IDVet（France）
• F. Hoffmann-La Roche Ltd.（Switzerland）
• Agilent Technologies, Inc.（United States）
• AniCell Biotech（United States）
• Illumina, Inc.（United States）
• Guardant Health（United States）
• Thermo Fisher Scientific Inc.（United States）
• BIOMERIEUX（France）
• NEOGEN Corporation（United States）
• Zoetis Inc.（United States）
• Myriad Genetics, Inc.（United States）
• Virbac SA（France）

結論と提言

Companion Diagnostics Market size was valued at USD 6.9 billion in 2023 and is poised to grow from USD 7.76 billion in 2024 to USD 19.92 billion by 2032, growing at a CAGR of 12.5% during the forecast period (2025-2032).

The companion diagnostic market is experiencing significant growth, driven by the rising incidence of cancer and the increasing demand for precision medicine. These tests are critical for determining the safe and effective administration of related biological treatments, particularly in oncology. As genomic, proteomic, and metabolomic profiling continues to evolve, the need for companion diagnostics to identify appropriate therapies and predict positive outcomes is surging. Furthermore, the advent of personalized medication highlights the essential role of these diagnostics in individualized treatment approaches. Support from government initiatives and favorable regulatory guidance, particularly from entities like the FDA and EMA, is accelerating market momentum. Streamlined approval processes enhance the availability of companion diagnostics, promoting improved treatment efficacy and timely patient care.

Top-down and bottom-up approaches were used to estimate and validate the size of the Companion Diagnostics 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 Market Segments Analysis

Global Companion Diagnostics Market is segmented by Product, Technology, Indication, Sample Type, End User and region. Based on Product, the market is segmented into Assays, Kits, And Reagents, Instruments & Systems and Software & Services. Based on Technology, the market is segmented into Polymerase Chain Reaction, In Situ Hybridization, Next-Generation Sequencing, Immunohistochemistry and Other Technologies. Based on Indication, the market is segmented into Cancer, Neurological Diseases, Cardiovascular Diseases, Infectious Diseases and Other Indications. Based on Sample Type, the market is segmented into Tissue Samples, Blood Samples and Other Sample Types. Based on End User, the market is segmented into Pharmaceutical & Biotechnology Companies, Reference Laboratories, Contract Research Organizations and Other End Users. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Companion Diagnostics Market

In recent years, there has been a significant rise in cancer cases, which has intensified the demand for effective companion diagnostics (CDx) assays. This increasing incidence heightens the necessity for genetic testing, which equips healthcare professionals with critical insights to tailor treatment plans specifically for their patients' unique cancer profiles. Consequently, the surging prevalence of cancer is driving the market for CDx products, as these assays are essential in delivering precise and personalized therapeutic approaches. Thus, the urgent need for innovative and efficient CDx solutions has become a prominent market driver in the face of escalating cancer diagnoses.

Restraints in the Companion Diagnostics Market

The Companion Diagnostics market faces significant restraints due to the considerable financial investment required for regulatory compliance, validation, and clinical trials. These high expenses can pose a significant challenge for smaller companies, potentially hindering their ability to enter and compete in the market. Furthermore, ambiguous and varied reimbursement policies surrounding companion diagnostics further complicate market expansion. The complexity of navigating these policies can deter new entrants, creating additional barriers for growth and limiting access to advancements in personalized medicine. As a result, these factors collectively contribute to a restrained landscape within the Companion Diagnostics sector.

Market Trends of the Companion Diagnostics Market

The Companion Diagnostics market is poised for significant growth driven by innovations in Next-Generation Sequencing (NGS) technology. NGS enables comprehensive gene profiling in surgically removed tumors, facilitating the identification of cancer-associated genes and enhancing personalized treatment strategies. The transition of NGS from research to clinical applications, as highlighted by a recent CDC report, underscores its increasing importance in precision medicine. As its technological capabilities expand and adoption in clinical settings accelerates, NGS is expected to play a pivotal role in improving patient outcomes, ultimately fueling market growth and solidifying its place in oncological diagnostics and treatment planning.

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
• Regulatory Analysis
• Technology Analysis
• Case Studies
• Customer And Buying Criteria Analysis

Global Companion Diagnostics Market Size by Product & Service & CAGR (2025-2032)

• Market Overview
• Assays, Kits, And Reagents
• Instruments & Systems
• Software & Services

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

• Market Overview
• Polymerase Chain Reaction
• In Situ Hybridization
• Next-Generation Sequencing
• Immunohistochemistry
• Other Technologies

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

• Market Overview
• Cancer
  • Lung Cancer
  • Breast Cancer
  • Blood Cancer
  • Colorectal Cancer
  • Other Cancers
• Neurological Diseases
• Cardiovascular Diseases
• Infectious Diseases
• Other Indications

Global Companion Diagnostics Market Size by Sample Type & CAGR (2025-2032)

• Market Overview
• Tissue Samples
• Blood Samples
• Other Sample Types

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

• Market Overview
• Pharmaceutical & Biotechnology Companies
• Reference Laboratories
• Contract Research Organizations
• Other End Users

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

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

• Abbott (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• IDVet (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• F. Hoffmann-La Roche Ltd. (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Agilent Technologies, Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• AniCell Biotech (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Illumina, Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Guardant Health (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Thermo Fisher Scientific Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• BIOMERIEUX (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• NEOGEN Corporation (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Zoetis Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Myriad Genetics, Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Virbac SA (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations