治疗药物监测市场规模、份额及成长分析（按产品、技术、药物类别、检体、最终用户和地区）－2025 年至 2032 年产业预测

2023 年全球治疗药物监测市场规模为 21.9 亿美元，预计将从 2024 年的 23.7 亿美元成长到 2032 年的 45.3 亿美元，预测期内（2025-2032 年）的复合年增长率为 8.4%。

由于个人化医疗的兴起以及慢性病治疗中对加强药物剂量管理的需求，全球治疗药物监测 (TDM) 市场正在获得发展动力。这种增长主要是由于癫痫、自体免疫疾病和心血管疾病等慢性疾病的盛行率不断上升，这些疾病需要对治疗指数较窄的药物进行持续监测。随着预测医疗和精准医疗的进步，医疗格局正在发生变化，重点是透过人工智慧增强数位技术进行照护现场和即时跟踪，以实现快速、个性化的干预。特别是慢性病患病率高且监测基础设施有限的地区具有巨大的成长潜力。然而，该市场面临的挑战包括检测成本高、报销做法不一致以及不同地区的临床标准不同，这些可能会阻碍其广泛应用。

目录

介绍

• 调查目的
• 研究范围
• 定义

调查方法

• 资讯采购
• 二次资料和一次资料方法
• 市场规模预测
• 市场假设与限制

执行摘要

• 全球市场展望
• 供需趋势分析
• 细分机会分析

市场动态与展望

• 市场概览
• 市场规模
• 市场动态
  • 驱动因素和机会
  • 限制与挑战
• 波特的分析

关键市场考察

• 关键成功因素
• 竞争程度
• 主要投资机会
• 市场生态系统
• 市场吸引力指数（2024年）
• PESTEL分析
• 总体经济指标
• 价值链分析
• 定价分析
• 技术分析
• 监管分析
• 专利分析
• 案例研究

治疗药物监测市场规模（按产品）

• 市场概览
• 软体
• 耗材
  • 免疫检测测定试剂套件
  • 层析法试剂套件
  • 其他的
• 装置
  • 免疫检测分析仪
  • 层析法和质谱检测器
  • 其他的

治疗药物监测市场规模（按技术）

• 市场概览
• 免疫检测
• 层析法-光谱法
• 其他的

治疗药物监测市场规模（依药物类别）

• 市场概览
• 抗惊厥药
• 抗心律不整药物
• 免疫抑制剂
• 抗生素
• 其他的

治疗药物监测市场规模（按检体）

• 市场概览
• 血
• 唾液

治疗药物监测市场规模（按最终用户划分）

• 市场概览
• 医院
• 诊断实验室
• 研究和学术机构

治疗药物监测市场规模

• 北美洲
  • 美国
  • 加拿大
• 欧洲
  • 德国
  • 西班牙
  • 法国
  • 英国
  • 义大利
  • 其他欧洲国家地区
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 韩国
  • 其他亚太地区
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲
• 中东和非洲
  • 海湾合作委员会国家
  • 南非
  • 其他中东和非洲地区

竞争资讯

• 前五大公司对比
• 主要企业市场定位（2024年）
• 主要市场参与者所采取的策略
• 近期市场趋势
• 公司市场占有率分析（2024年）
• 主要企业简介
  • 公司详情
  • 产品系列分析
  • 公司分部份额分析
  • 收益与前一年同期比较对比（2022-2024 年）

主要企业简介

• 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.

结论和建议

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