治療藥物監測市場規模、佔有率及成長分析（按產品、技術、藥物類別、檢體、最終用戶和地區）－2025 年至 2032 年產業預測

2023 年全球治療藥物監測市場規模為 21.9 億美元，預計將從 2024 年的 23.7 億美元成長到 2032 年的 45.3 億美元，預測期內（2025-2032 年）的複合年成長率為 8.4%。

由於個人化醫療的興起以及慢性病治療中對加強藥物劑量管理的需求，全球治療藥物監測 (TDM) 市場正在獲得發展動力。這種成長主要是由於癲癇、自體免疫疾病和心血管疾病等慢性疾病的盛行率不斷上升，這些疾病需要對治療指數較窄的藥物進行持續監測。隨著預測醫療和精準醫療的進步，醫療格局正在發生變化，重點是透過人工智慧增強數位技術進行照護現場和即時追蹤，以實現快速、個性化的干涉。特別是慢性病患病率高且監測基礎設施有限的地區具有巨大的成長潛力。然而，該市場面臨的挑戰包括檢測成本高、報銷做法不一致以及不同地區的臨床標準不同，這些可能會阻礙其廣泛應用。

目錄

介紹

• 調查目的
• 研究範圍
• 定義

調查方法

• 資訊採購
• 二次資料和一次資料方法
• 市場規模預測
• 市場假設與限制

執行摘要

• 全球市場展望
• 供需趨勢分析
• 細分機會分析

市場動態與展望

• 市場概覽
• 市場規模
• 市場動態
  • 促進因素和機會
  • 限制與挑戰
• 波特的分析

關鍵市場考察

• 關鍵成功因素
• 競爭程度
• 主要投資機會
• 市場生態系統
• 市場吸引力指數（2024年）
• PESTEL分析
• 總體經濟指標
• 價值鏈分析
• 定價分析
• 技術分析
• 監管分析
• 專利分析
• 案例研究

治療藥物監測市場規模（按產品）

• 市場概覽
• 軟體
• 耗材
  • 免疫檢測測定試劑套件
  • 層析法試劑套件
  • 其他
• 裝置
  • 免疫檢測分析儀
  • 層析法和質譜檢測器
  • 其他

治療藥物監測市場規模（按技術）

• 市場概覽
• 免疫檢測
• 層析法-光譜法
• 其他

治療藥物監測市場規模（依藥物類別）

• 市場概覽
• 抗驚厥藥
• 抗心律不整藥物
• 免疫抑制劑
• 抗生素
• 其他

治療藥物監測市場規模（按檢體）

• 市場概覽
• 血
• 唾液

治療藥物監測市場規模（按最終用戶分類）

• 市場概覽
• 醫院
• 診斷實驗室
• 研究和學術機構

治療藥物監測市場規模

• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 西班牙
  • 法國
  • 英國
  • 義大利
  • 其他歐洲國家地區
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 韓國
  • 其他亞太地區
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲
• 中東和非洲
  • 海灣合作理事會國家
  • 南非
  • 其他中東和非洲地區

競爭資訊

• 前五大公司對比
• 主要企業市場定位（2024年）
• 主要市場參與者所採取的策略
• 近期市場趨勢
• 公司市場佔有率分析（2024年）
• 主要企業簡介
  • 公司詳情
  • 產品系列分析
  • 公司分部佔有率分析
  • 收益與前一年同期比較對比（2022-2024 年）

主要企業簡介

• 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.

結論和建議

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