治療薬モニタリングの市場規模、シェア、成長分析：製品別、技術別、薬剤クラス別、検体別、エンドユーザー別、地域別 - 産業予測 2025～2032年

治療薬モニタリングの世界市場規模は、2023年に21億9,000万米ドルと評価され、2024年の23億7,000万米ドルから2032年には45億3,000万米ドルに成長し、予測期間（2025～2032年）のCAGRは8.4％で成長する見通しです。

治療薬モニタリング（TDM）の世界市場は、個別化医療の普及と慢性疾患治療における薬剤投与量管理強化の必要性により、勢いを増しています。この成長は、てんかん、自己免疫疾患、心血管疾患など、治療指数の低い薬剤の継続的なモニタリングを必要とする慢性疾患の有病率の上昇に大きく後押しされています。予測医療と精密医療の進歩に伴い、迅速で個別化された介入のためのポイントオブケアとAI強化デジタル技術によるリアルタイムの追跡が重視され、状況は変化しています。特に、慢性疾患の罹患率が高く、モニタリングのインフラが限られている地域は、大きな成長の可能性を秘めています。しかし、この市場は、高い検査コスト、一貫性のない償還慣行、地域によって異なる臨床基準などの課題に直面しており、これが幅広い普及を妨げる可能性があります。

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
• 技術分析
• 規制分析
• 特許分析
• ケーススタディ

治療薬モニタリング市場規模：製品別

• 市場概要
• ソフトウェア
• 消耗品
  • 免疫測定ベースのキット
  • クロマトグラフィーベースのキット
  • その他
• 装置
  • 免疫測定分析装置
  • クロマトグラフィーおよび質量分析検出器
  • その他

治療薬モニタリング市場規模：技術別

• 市場概要
• 免疫測定
• クロマトグラフィー-分光分析
• その他

治療薬モニタリング市場規模：薬剤クラス別

• 市場概要
• 抗てんかん薬
• 抗不整脈薬
• 免疫抑制薬
• 抗生物質
• その他

治療薬モニタリング市場規模：検体別

• 市場概要
• 血
• 唾液

治療薬モニタリング市場規模：エンドユーザー別

• 市場概要
• 病院
• 診断ラボ
• 調査・学術機関

治療薬モニタリング市場規模

• 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年）

主要企業プロファイル

• Abbott Laboratories
• Roche Holding AG
• Thermo Fisher Scientific Inc
• Siemens Healthineers
• Bio-Rad Laboratories
• Danaher Corporation
• Chromsystems Instruments & Chemicals GmbH
• SEKISUI CHEMICAL CO., LTD
• Biomerieux SA
• Exagen Inc.

結論と提言

Global Therapeutic Drug Monitoring Market size was valued at USD 2.19 Billion in 2023 and is poised to grow from USD 2.37 Billion in 2024 to USD 4.53 Billion by 2032, growing at a CAGR of 8.4% in the forecast period (2025-2032).

The Global Therapeutic Drug Monitoring (TDM) Market is gaining momentum, driven by the increasing adoption of personalized medicine and the need for enhanced drug dosage management in chronic disease care. This growth is significantly fueled by the rising prevalence of chronic conditions such as epilepsy, autoimmune diseases, and cardiovascular disorders that necessitate the continuous monitoring of narrow therapeutic index drugs. The landscape is transforming with the advancement of predictive and precision medicine, emphasizing real-time tracking via point-of-care and AI-enhanced digital technologies for swift, personalized interventions. Notably, regions with high chronic disease rates and limited monitoring infrastructure represent significant growth potential. However, the market faces challenges, including high testing costs, inconsistent reimbursement practices, and varying clinical standards across geographies, which may impede broader adoption.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Therapeutic Drug Monitoring 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.

Global Therapeutic Drug Monitoring Market Segments Analysis

The global therapeutic drug monitoring market is segmented into product, technology, drug class, specimen, end users and region. By product, the market is software, consumables, and equipment. By technology, the market is segmented into immunoassays, chromatography-spectrometry, and others. By drug class, the market is segmented into antiepileptic drugs, antiarrhythmic drugs, immunosuppressant drugs, antibiotic drugs, and others. By specimen, the market is segmented into blood, and saliva. Based on end user, the market is segmented into hospital, diagnostic labs, and research and academic institutes. By region, the market is analyzed across North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America.

Driver of the Global Therapeutic Drug Monitoring Market

The Global Therapeutic Drug Monitoring (TDM) market is experiencing significant growth due to the rising emphasis on personalized medicine and pharmacogenomics. As healthcare systems transition from universal treatment strategies to tailored approaches, TDM becomes essential in optimizing drug efficacy while minimizing adverse effects. It plays a crucial role in achieving therapeutic drug levels, especially for medications with narrow therapeutic indices like immunosuppressants, antiepileptics, and oncology treatments. Additionally, the growing incidence of chronic and complex diseases, including cancer, cardiovascular conditions, and autoimmune disorders, necessitates individualized therapeutic plans, further integrating TDM into standard clinical practice.

Restraints in the Global Therapeutic Drug Monitoring Market

The Therapeutic Drug Monitoring (TDM) market faces significant challenges due to the absence of standardized test protocols and assay procedures. This lack of standardization leads to variability in drug concentration assays, which ultimately results in inconsistent clinical interpretations. Differences in calibration standards, assay platforms, sample processing methods, and laboratory practices contribute to non-uniform data that compromises the accuracy of therapeutic assessments. Additionally, the absence of universally accepted therapeutic ranges and regulatory harmonization creates distrust among clinicians and complicates international acceptance. Such discrepancies hinder data interoperability, limit integration with electronic health systems, and reduce physician confidence, ultimately impeding the broader utilization and scalability of TDM across healthcare settings.

Market Trends of the Global Therapeutic Drug Monitoring Market

The global Therapeutic Drug Monitoring (TDM) market is experiencing a robust trend characterized by a surge in investments and mergers & acquisitions (M&A) that reshape its competitive landscape. Established diagnostics and pharmaceutical companies are actively acquiring specialty TDM firms to tap into advanced monitoring technologies and broaden their therapeutic portfolios. This wave of strategic collaborations enhances research and development, particularly in bioanalytical platforms and assay creation. Furthermore, venture capital is rapidly flowing into precision diagnostics, catalyzing the advent of innovative, AI-powered TDM solutions. This investment rush is driven by an increasing clinical demand for personalized drug dosing and outcomes-focused therapies, positioning TDM as a critical component in modern healthcare.

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
• Technology Analysis
• Regulatory Analysis
• Patent Analysis
• Case Studies

Global Therapeutic Drug Monitoring Market Size by Product & CAGR (2025-2032)

• Market Overview
• Software
• Consumables
  • Immunoassay-based kits
  • Chromatography-based kits
  • Others
• Equipment
  • Immunoassay Analyzers
  • Chromatography & MS Detectors
  • Others

Global Therapeutic Drug Monitoring Market Size by Technology & CAGR (2025-2032)

• Market Overview
• Immunoassays
• Chromatography-Spectrometry
• Others

Global Therapeutic Drug Monitoring Market Size by Drug Class & CAGR (2025-2032)

• Market Overview
• Antiepileptic Drugs
• Antiarrhythmic Drugs
• Immunosuppressant Drugs
• Antibiotic Drugs
• Others

Global Therapeutic Drug Monitoring Market Size by Specimen & CAGR (2025-2032)

• Market Overview
• Blood
• Saliva

Global Therapeutic Drug Monitoring Market Size by End Users & CAGR (2025-2032)

• Market Overview
• Hospital
• Diagnostic labs
• Research and Academic Institutes

Global Therapeutic Drug Monitoring Market Size & CAGR (2025-2032)

• North America (Product, Technology, Drug Class, Specimen, End Users)
  • US
  • Canada
• Europe (Product, Technology, Drug Class, Specimen, End Users)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Product, Technology, Drug Class, Specimen, End Users)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Product, Technology, Drug Class, Specimen, End Users)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Product, Technology, Drug Class, Specimen, End Users)
  • 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 Laboratories
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Roche Holding AG
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Thermo Fisher Scientific Inc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Siemens Healthineers
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Bio-Rad Laboratories
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Danaher Corporation
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Chromsystems Instruments & Chemicals GmbH
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• SEKISUI CHEMICAL CO., LTD
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Biomerieux SA
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Exagen Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations