치료제 모니터링 시장 : 제품, 기술, 약제 클래스별, 최종사용자별 - 세계 예측(2025-2030년)

The Therapeutic Drug Monitoring Market was valued at USD 3.79 billion in 2023, expected to reach USD 4.38 billion in 2024, and is projected to grow at a CAGR of 16.11%, to USD 10.78 billion by 2030.

Therapeutic Drug Monitoring (TDM) involves measuring drug concentrations in the bloodstream to optimize dosage and maximize therapeutic efficacy while minimizing toxicity. The necessity of TDM arises from the need to individualize medication regimens due to patient variability in drug absorption, distribution, metabolism, and excretion. Applications of TDM primarily include drugs with narrow therapeutic ranges, such as anticonvulsants, antibiotics, and immunosuppressants, and are crucial in personalized medicine, ensuring effective treatment while reducing adverse effects. The end-use scope primarily extends to hospitals, laboratories, and clinical settings [pharmacokinetic units], actively engaged in increasing treatment efficacy and safety. The market growth of TDM is influenced by factors such as the rising prevalence of chronic diseases, advancements in pharmacogenomics, and an increased focus on personalized medicine; however, challenges such as the high cost of testing, strict regulatory frameworks, and the need for skilled professionals could hamper growth. Moreover, TDM presents potential opportunities with innovations in point-of-care testing and the integration of AI for predictive monitoring, creating avenues for real-time drug monitoring and improving patient outcomes. To leverage these opportunities, stakeholders should invest in research and development to create cost-effective TDM solutions, fostering strategic partnerships with biotech firms and healthcare facilities to broaden their reach and adaptability. While market limitations include technological limitations and a lack of awareness in undeveloped regions, advancements in non-invasive sampling and rapid diagnostic techniques could significantly surmount these challenges. The most promising areas for innovation encompass developing portable and user-friendly monitoring devices and enhancing data analytics capabilities to deliver more precise and actionable insights. Overall, a strategic focus on innovation, affordability, and patient-centric solutions would be paramount for sustained market growth and capturing emerging opportunities in the dynamic field of Therapeutic Drug Monitoring.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Therapeutic Drug Monitoring Market

The Therapeutic Drug Monitoring Market is undergoing transformative changes driven by a dynamic interplay of supply and demand factors. Understanding these evolving market dynamics prepares business organizations to make informed investment decisions, refine strategic decisions, and seize new opportunities. By gaining a comprehensive view of these trends, business organizations can mitigate various risks across political, geographic, technical, social, and economic domains while also gaining a clearer understanding of consumer behavior and its impact on manufacturing costs and purchasing trends.

• Market Drivers
  • Increased Demand for Personalized Medicine
  • Rising Adoption of Therapeutic Drug Monitoring Across Various Therapeutic Fields
  • Growing Use and Importance in Patients with Solid Organ Transplantation
• Market Restraints
  • Inadequate Reimbursement Policies
  • Need of High Capital Investments
• Market Opportunities
  • Future Perspectives of Therapeutic Drug Monitoring in Developing Nations
  • Developments in Immunoassay and Other Therapeutic Drug Monitoring Technologies
• Market Challenges
  • Clinical Challenges and Limited Availability of Skilled Laboratory Technicians

Porter's Five Forces: A Strategic Tool for Navigating the Therapeutic Drug Monitoring Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Therapeutic Drug Monitoring Market. It offers business organizations with a clear methodology for evaluating their competitive positioning and exploring strategic opportunities. This framework helps businesses assess the power dynamics within the market and determine the profitability of new ventures. With these insights, business organizations can leverage their strengths, address weaknesses, and avoid potential challenges, ensuring a more resilient market positioning.

PESTLE Analysis: Navigating External Influences in the Therapeutic Drug Monitoring Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Therapeutic Drug Monitoring Market. Political, Economic, Social, Technological, Legal, and Environmental factors analysis provides the necessary information to navigate these influences. By examining PESTLE factors, businesses can better understand potential risks and opportunities. This analysis enables business organizations to anticipate changes in regulations, consumer preferences, and economic trends, ensuring they are prepared to make proactive, forward-thinking decisions.

Market Share Analysis: Understanding the Competitive Landscape in the Therapeutic Drug Monitoring Market

A detailed market share analysis in the Therapeutic Drug Monitoring Market provides a comprehensive assessment of vendors' performance. Companies can identify their competitive positioning by comparing key metrics, including revenue, customer base, and growth rates. This analysis highlights market concentration, fragmentation, and trends in consolidation, offering vendors the insights required to make strategic decisions that enhance their position in an increasingly competitive landscape.

FPNV Positioning Matrix: Evaluating Vendors' Performance in the Therapeutic Drug Monitoring Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Therapeutic Drug Monitoring Market. This matrix enables business organizations to make well-informed decisions that align with their goals by assessing vendors based on their business strategy and product satisfaction. The four quadrants provide a clear and precise segmentation of vendors, helping users identify the right partners and solutions that best fit their strategic objectives.

Key Company Profiles

The report delves into recent significant developments in the Therapeutic Drug Monitoring Market, highlighting leading vendors and their innovative profiles. These include apDia Group, Cambridge Life Sciences Limited, Danaher Corporation, ARK Diagnostics, Inc., Assay Genie, DiaSorin SpA, Merck KGaA, Grifols, S.A., Siemens Healthineers AG, Cardinal Health, Inc., Pfizer Inc., DiaSystem Scandinavia AB, R-Biopharm AG, Bio-Rad Laboratories, Inc., Krishgen Biosystems, H.U. Group Holdings, Inc., Buhlmann Laboratories AG, Myriad Genetics, Inc., Theradiag SA, Randox Laboratories, Ltd., Thermo Fisher Scientific, Inc., Tecan Trading AG, OneCare Media, LLC, Chromsystems Instruments & Chemicals GmbH, Agilent Technologies, Inc., Eagle Biosciences, Inc., Svar Life Science AB, Sekisui Chemical Co Ltd., Neoteryx, LLC by Trajan Group, Veolia Group, bioMerieux SA, ARUP Laboratories, Abbott Laboratories, F. Hoffmann-La Roche AG, and Exagen Inc..

Market Segmentation & Coverage

This research report categorizes the Therapeutic Drug Monitoring Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Based on Product, market is studied across Consumables, Data Management Services, and Equipment. The Equipment is further studied across Chromatography & MS Detectors, Clinical Chemistry Analyzers, and Immunoassay Analyzers.
• Based on Technology, market is studied across Chromatography-MS, Immunoassays, and Proteomic Technologies. The Chromatography-MS is further studied across GC-MS and LC-MS. The Immunoassays is further studied across Chemiluminescence Immunoassays, Colorimetric Immunoassays, Fluorescence Immunoassays, and Radioimmunoassays.
• Based on Drug Class, market is studied across Antiarrhythmic Drugs, Antibiotic Drugs, Antiepileptic Drugs, Bronchodilator Drugs, Immunosuppressant Drugs, and Psychoactive Drugs.
• Based on End-User, market is studied across Hospital Labs and Private Labs.
• Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

The report offers a comprehensive analysis of the market, covering key focus areas:

1. Market Penetration: A detailed review of the current market environment, including extensive data from top industry players, evaluating their market reach and overall influence.

2. Market Development: Identifies growth opportunities in emerging markets and assesses expansion potential in established sectors, providing a strategic roadmap for future growth.

3. Market Diversification: Analyzes recent product launches, untapped geographic regions, major industry advancements, and strategic investments reshaping the market.

4. Competitive Assessment & Intelligence: Provides a thorough analysis of the competitive landscape, examining market share, business strategies, product portfolios, certifications, regulatory approvals, patent trends, and technological advancements of key players.

5. Product Development & Innovation: Highlights cutting-edge technologies, R&D activities, and product innovations expected to drive future market growth.

The report also answers critical questions to aid stakeholders in making informed decisions:

1. What is the current market size, and what is the forecasted growth?

2. Which products, segments, and regions offer the best investment opportunities?

3. What are the key technology trends and regulatory influences shaping the market?

4. How do leading vendors rank in terms of market share and competitive positioning?

5. What revenue sources and strategic opportunities drive vendors' market entry or exit strategies?

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

• 2.1. Define: Research Objective
• 2.2. Determine: Research Design
• 2.3. Prepare: Research Instrument
• 2.4. Collect: Data Source
• 2.5. Analyze: Data Interpretation
• 2.6. Formulate: Data Verification
• 2.7. Publish: Research Report
• 2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Market Dynamics
  • 5.1.1. Drivers
    • 5.1.1.1. Increased Demand for Personalized Medicine
    • 5.1.1.2. Rising Adoption of Therapeutic Drug Monitoring Across Various Therapeutic Fields
    • 5.1.1.3. Growing Use and Importance in Patients with Solid Organ Transplantation
  • 5.1.2. Restraints
    • 5.1.2.1. Inadequate Reimbursement Policies
    • 5.1.2.2. Need of High Capital Investments
  • 5.1.3. Opportunities
    • 5.1.3.1. Future Perspectives of Therapeutic Drug Monitoring in Developing Nations
    • 5.1.3.2. Developments in Immunoassay and Other Therapeutic Drug Monitoring Technologies
  • 5.1.4. Challenges
    • 5.1.4.1. Clinical Challenges and Limited Availability of Skilled Laboratory Technicians
• 5.2. Market Segmentation Analysis
  • 5.2.1. Product: Rising demand for data management services for efficient drug management
  • 5.2.2. End-User: Increasing demand from hospitals where accurate drug management is essential
• 5.3. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental
• 5.5. Client Customization

6. Therapeutic Drug Monitoring Market, by Product

• 6.1. Introduction
• 6.2. Consumables
• 6.3. Data Management Services
• 6.4. Equipment
  • 6.4.1. Chromatography & MS Detectors
  • 6.4.2. Clinical Chemistry Analyzers
  • 6.4.3. Immunoassay Analyzers

7. Therapeutic Drug Monitoring Market, by Technology

• 7.1. Introduction
• 7.2. Chromatography-MS
  • 7.2.1. GC-MS
  • 7.2.2. LC-MS
• 7.3. Immunoassays
  • 7.3.1. Chemiluminescence Immunoassays
  • 7.3.2. Colorimetric Immunoassays
  • 7.3.3. Fluorescence Immunoassays
  • 7.3.4. Radioimmunoassays
• 7.4. Proteomic Technologies

8. Therapeutic Drug Monitoring Market, by Drug Class

• 8.1. Introduction
• 8.2. Antiarrhythmic Drugs
• 8.3. Antibiotic Drugs
• 8.4. Antiepileptic Drugs
• 8.5. Bronchodilator Drugs
• 8.6. Immunosuppressant Drugs
• 8.7. Psychoactive Drugs

9. Therapeutic Drug Monitoring Market, by End-User

• 9.1. Introduction
• 9.2. Hospital Labs
• 9.3. Private Labs

10. Americas Therapeutic Drug Monitoring Market

• 10.1. Introduction
• 10.2. Argentina
• 10.3. Brazil
• 10.4. Canada
• 10.5. Mexico
• 10.6. United States

11. Asia-Pacific Therapeutic Drug Monitoring Market

• 11.1. Introduction
• 11.2. Australia
• 11.3. China
• 11.4. India
• 11.5. Indonesia
• 11.6. Japan
• 11.7. Malaysia
• 11.8. Philippines
• 11.9. Singapore
• 11.10. South Korea
• 11.11. Taiwan
• 11.12. Thailand
• 11.13. Vietnam

12. Europe, Middle East & Africa Therapeutic Drug Monitoring Market

• 12.1. Introduction
• 12.2. Denmark
• 12.3. Egypt
• 12.4. Finland
• 12.5. France
• 12.6. Germany
• 12.7. Israel
• 12.8. Italy
• 12.9. Netherlands
• 12.10. Nigeria
• 12.11. Norway
• 12.12. Poland
• 12.13. Qatar
• 12.14. Russia
• 12.15. Saudi Arabia
• 12.16. South Africa
• 12.17. Spain
• 12.18. Sweden
• 12.19. Switzerland
• 12.20. Turkey
• 12.21. United Arab Emirates
• 12.22. United Kingdom

13. Competitive Landscape

• 13.1. Market Share Analysis, 2023
• 13.2. FPNV Positioning Matrix, 2023
• 13.3. Competitive Scenario Analysis
  • 13.3.1. Capitainer announces collaboration with AstraZeneca.
  • 13.3.2. Novo Holdings invests in proteomics technology company, Evosep.
  • 13.3.3. AegirBio AB enters into an agreement with Atlas Special Opportunities, LLC regarding convertible bonds of SEK 55 million with attached warrants to intensify investments in i.a. TDM and saliva sampling.
  • 13.3.4. Clinical LC-MS methods for therapeutic drug monitoring analysis.
  • 13.3.5. Boditech Med has obtained the export license of four TDM products.
  • 13.3.6. Pace Obtains EPA Approval on Method for Detecting Dioxins and Dibenzofurans Through GC-MS/MS Technology.
  • 13.3.7. Bio-Rad Extends Range of Anti-Idiotypic Antibodies for Bioanalysis and Drug Monitoring.
  • 13.3.8. Beckman Coulter and Saladax Biomedical Team Up on Antipsychotic Therapeutic Drug Monitoring.
  • 13.3.9. Ampersand Capital Partners Invests in Syft Technologies, Leading SIFT-MS Solutions Provider.

Companies Mentioned

• 1. apDia Group
• 2. Cambridge Life Sciences Limited
• 3. Danaher Corporation
• 4. ARK Diagnostics, Inc.
• 5. Assay Genie
• 6. DiaSorin SpA
• 7. Merck KGaA
• 8. Grifols, S.A.
• 9. Siemens Healthineers AG
• 10. Cardinal Health, Inc.
• 11. Pfizer Inc.
• 12. DiaSystem Scandinavia AB
• 13. R-Biopharm AG
• 14. Bio-Rad Laboratories, Inc.
• 15. Krishgen Biosystems
• 16. H.U. Group Holdings, Inc.
• 17. Buhlmann Laboratories AG
• 18. Myriad Genetics, Inc.
• 19. Theradiag SA
• 20. Randox Laboratories, Ltd.
• 21. Thermo Fisher Scientific, Inc.
• 22. Tecan Trading AG
• 23. OneCare Media, LLC
• 24. Chromsystems Instruments & Chemicals GmbH
• 25. Agilent Technologies, Inc.
• 26. Eagle Biosciences, Inc.
• 27. Svar Life Science AB
• 28. Sekisui Chemical Co Ltd.
• 29. Neoteryx, LLC by Trajan Group
• 30. Veolia Group
• 31. bioMerieux SA
• 32. ARUP Laboratories
• 33. Abbott Laboratories
• 34. F. Hoffmann-La Roche AG
• 35. Exagen Inc.