Therapeutic drug monitoring (TDM) is a medical practice that involves the measurement and evaluation of drug levels in the blood to ensure that a patient is receiving the optimal dose of a drug for their individual needs. TDM is used to measure the levels of drugs in the blood to adjust drug dosages and minimize the risk of adverse reactions. It is also used for monitoring the drug levels of drugs that have a narrow therapeutic window, meaning the difference between a therapeutic dose and a toxic dose is small. TDM is a valuable tool for optimizing drug therapy and can be used to ensure that the patient is receiving the correct dose of the drug.

Currently, therapeutic drug monitoring market is projected to reach USD  2.9 billion by 2027 from USD  1.8 billion in 2022, at a CAGR of 9.6% during the forecast period. The growth of this market is majorly driven by the rising number of organ transplant procedures, the use of TDM across various therapeutic fields. However, the need for high capital investments may restrain the growth of this market.

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Market Growth Driver:

Precision medicine is an evolving approach for disease treatment and prevention that considers individual variability in genes, environments, and lifestyles. Precision medicine involves selecting drugs wholly tailored to a patient based on disease condition and history. Although this practice is expanding into all disease areas, oncology has seen the most progress.

Market Growth Opportunity:

Anti-TNF-alpha biologics are an effective treatment for autoimmune diseases, such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). With the increasing healthcare costs and patent expiries, the number of RD activities focusing on the development of biosimilars has increased over the last few years.

Market Challenge:

Clinical laboratories across major markets are still evolving. As a result, technicians face operational challenges in ensuring effective sample procurement, storage, and transportation, especially while adopting novel technologies such as chemiluminescence immunoassays, HPLC, and multiplex flow immunoassays (MFI).

The prominent players operating in the therapeutic drug monitoring market are Abbott (US), Thermo Fisher Scientific (US), F. Hoffmann-La Roche Ltd. (Switzerland), Siemens Healthineers AG (Germany), Danaher Corporation (US), Bio-Rad Laboratories (US), bioMérieux SA (France), Theradiag SA (France), Grifols S.A. (Spain), Exagen Inc. (US), R-Biopharm AG (Germany), ARK Diagnostics, Inc. (US), apDia Group (Belgium), Immundiagnostik AG (Germany), and Sekisui Medical Co. Ltd. (Japan).

Abbott

Abbott accounted for the largest share of 15–17% of the TDM market in 2021. Abbott is a well-established and prominent player in the TDM market. It offers a wide range of products in the market and has a strong global presence, mainly due to its excellent distribution channel. The company also has a well-developed supply chain and distribution networks. Extensive RD activity and clinical trials for newly developed medicines are expected to drive its market share in the coming years. The company has a strong RD expenditure and portfolio of FDA-approved and CE Mark-certified products, which has helped enhance its presence in the TDM market. In 2021, it invested USD 2.7 billion in RD.

Siemens Healthineers AG

Siemens accounted for the largest share of 11–13% of the TDM market in 2021. Siemens Healthineers is one of the leading players in the TDM market. Its broad portfolio of TDM systems (including immunoassay, integrated chemistry, clinical chemistry, and drug testing), along with its vast geographic reach, accounts for its strong presence in the market. Siemens Healthineers also focuses on RD to develop innovative and advanced products in the immunoassays and TDM market. For instance, the company invested USD 1,731.45 million in its RD in 2022. It has a strong network of RD sites globally that help the company cater to the needs of local markets.

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Thermo Fisher Scientific

Thermo Fisher Scientific accounted for 10–12% of the TDM market in 2021. It is one of the leading players in the TDM market. The company has an extensive product portfolio based on various technologies. It has a strong presence in more than 150 countries across North America, Europe, Asia, and Latin America and has a substantial direct and indirect distribution network across the globe. The company invested USD 1.4 billion in RD activities in 2021 (4% of the total revenue). Thermo Fisher’s extensive RD enables the company to enhance its technology, software, and services capabilities. A significant focus on RD activities also helps the company provide innovative products and maintain and improve its competitive position.

Recent Developments:

·         In 2021, Thermo Fisher Scientific (US) partnered with Mindray on Clinical Chemistry Analyzers for use with Drugs of Abuse Immunoassays.

·         In 2020, F. Hoffmann-La Roche (Switzerland) announced that, New diagnostics will be built featuring of labs, biotech production and office workspace in of South Africa To strengthen its offerings in its diagnostics segment

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