Therapeutic Drug Monitoring Market Analysis and Forecast till 2031: By Product (Consumables, Equipment, Data Management Services), By Technology (Immunoassays, Proteomic Technologies), By Drug Class (Anti-epileptics, Antibiotics, Immunosuppressants, Anti-

Therapeutic Drug Monitoring Market Analysis and Forecast till 2031: By Product (Consumables, Equipment, Data Management Services), By Technology (Immunoassays, Proteomic Technologies), By Drug Class (Anti-epileptics, Antibiotics, Immunosuppressants, Anti-arrhythmics), By End-use (Hospital Labs, Private Labs), and Region

The global therapeutic drug monitoring market was valued at USD 1.4 Billion in 2021 and it is anticipated to grow up to USD 4.5 Billion by 2031, at a CAGR of 12.3% during the forecast period.

Therapeutic Drug Monitoring is a medical practice which is used for determining the concentration of particular drug in the bloodstream of the patient at different time interval. It is used in sustaining constant volume drug in the bloodstream without any toxic effect. Therapeutic drug monitoring is not used in majority of drugs but only the drugs which have narrow therapeutic window. It is also used in drugs with marked pharmacokinetic variability.

Market Trends and Drivers

Rising preference for precision medicine will boost the overall market growth. 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. Recently, cancer patients are being provided treatment through combination drugs, based on studies conducted on the patient’s parameters such as systems biology, analysis of the tumor, and gene expression data in the absence and presence of pharmacological perturbation. This approach, which is currently being tested in various settings, aims to revolutionize pharmacotherapy in oncology and other disease areas. TDM can be of immense value to advance this novel way of treating patients.

Market Restraints and Challenges

Operational barriers faced in conducting TDM tests may hampers the market growth. 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). Laboratory space also needs to be reconfigured to meet the requirements of conducting specific immunoassay tests for pathogen detection to avoid cross-contamination and ensure efficient time management. The need to maintain and operate advanced immunoassay instruments, particularly those capable of handling a single sample type, is highly expensive. Due to the rapid mutation of microbes and the increasing outbreak of epidemics, clinical laboratories need to adopt innovative technologies capable of rapid sample diagnosis. However, a shortage of skilled laboratory technicians to operate advanced immunoassay diagnostic products limits their overall adoption, particularly in emerging markets. Also, the reluctance to move from manual operations toward automation is another major challenge for market growth. This is because many providers find it difficult to transition to IT-based approaches from manual or traditional approaches and may not prefer to make the shift at all.

Global Therapeutic Drug Monitoring Market Segmental Overview

The report analyses the Global vascular closure devices market based on product, technology, drug class, end-use, and region.

Global Therapeutic Drug Monitoring Market by Product

Based on product, it is segmented into therapeutic drug monitoring market is segmented into consumables, equipment, and data management services. The consumables segment is projected to grow at the significant CAGR during the forecast period. The major factors contributing to the growth of this market are the requirement of repeat purchase of kits and reagents, coupled with the increasing number of immunoassay tests being performed across the globe. Furthermore, rising demand for new technology-based, cost-effective kits and the extensive use of these reagents in the RD area are some of the factors responsible for its lucrative growth.

Global Therapeutic Drug Monitoring Market by Technology

Based on technology, it is segmented into immunoassays and proteomic technologies. The immunoassay segment dominated the market in 2021 owing to the availability of highly specific and reliable immunoassays, the rising adoption rate of the advanced techniques, and the requirement of minimal training to handle the equipment. Immunoassays is a bioanalytical methods that use the specificity of an antigen-antibody reaction to detect and quantify target molecules in biological samples. These methods are frequently used in clinical diagnostics, drug discovery, drug monitoring, and food testing.

Global Therapeutic Drug Monitoring Market by Drug Class

Based on drug class, it is segmented into anti-epileptics, antibiotics, immunosuppressants and anti-arrhythmics. The anti-epileptics segment held the largest market share in 2021. This is attributed to the increasing prevalence of epilepsy and seizures and the resultant explosive growth in the number of Anti-epileptic drugs. It has been observed that the immunosuppressants segment has witnessed a higher penetration; the small margin for the therapeutic index of these drugs and the inter-individual differences observed in the blood concentrations of the immunosuppressants necessitate TDM for these drugs.

Global Therapeutic Drug Monitoring Market by End-use

Based on end-use, it is segmented into hospitals labs and private labs. The hospital labs segment is likely to dominate the market during the forecast period. Around 50% of the therapeutic drug monitoring is carried out in hospitals due to the availability of accurate patient information, such as age, metabolism, ethnicity, and drug performance history. The need for accurate patient history required to devise effective treatment plans has led many hospitals to design request forms for drug metabolite monitoring; the increasing use of computerized entry of patient history and information records is expected to further improve the TDS service in the hospitals

Geographical Analysis of Global Therapeutic Drug Monitoring Market

Region-wise, it is studied across North America, Europe, Asia Pacific, and the Rest of the World. North America is expected to garner the largest share of the ultrasound market in 2020. Factors such as a High rate of organ transplantation coupled with the high acceptance and gradual adoption of these metabolite measuring procedures is one of the major drivers for the large market share. Furthermore, presence of unmet needs and the continuous efforts of the government to provide low-cost services with the aim of promoting individualized dosage patterns for organ transplantation cases as well as to support personalized medicine initiatives. are driving the growth of the North America ultrasound market.

Major Players in the Global Therapeutic Drug Monitoring MarketCOVID-19 Impact

A worldwide emergency has been caused by the COVID-19 pandemic. Data from the Scottish Biologic Therapeutic Drug Monitoring (TDM) service shows a drop in TDM testing since pandemic onset. For instance, in April 2020, a 75.6% reduction in adalimumab testing and a 36.2% reduction in infliximab testing was noticed, mainly due to a large number of cancellations of outpatient. Likewise, it is also believed that disruption to normal patterns of care and disease monitoring of patients on biologics could increase the threat of disease and adverse clinical reactions. Research associations and other medical bodies are making various attempts to conduct clinical trials to develop a suitable anti-COVID drug, which is anticipated to fuel the growth of the TDM market. Moreover, the Pharmacology group - AC43 of the National Agency for Research on AIDS and Viral Hepatitis and the Therapeutic Drug Monitoring Group of the French Society of Pharmacology and Therapeutics proposed, at the end of March 2020, that a TDM evaluation be performed 48 hours after the start of treatment to check the early attainment of an adequate residual concentration.

Recent Developments

• In July 2022, Bio-Rad extended range of anti-idiotypic antibodies for bioanalysis, drug monitoring.
• 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.
• In February 2019, LabCorp, announced a new assay in its therapeutic drug monitoring (TDM) DoseASSURE portfolio. The new Certolizumab Concentration and Anti-Certolizumab Antibody DoseASSURE CTZ assay, helps physicians monitor individual drug response for patients who are on Certolizumab, a biologic drug used to treat certain inflammatory diseases, such as rheumatoid arthritis and Crohn’s disease

Frequently Asked Questions

Q1. How big is the ultrasound probe disinfection market?Ans. The global therapeutic drug monitoring market size was USD 1.4 Billion in 2021 and is anticipated to reach USD 4.5 Billion in 2031, growing at a rate of 12.3% from 2022 to 2031.Q2. What is the therapeutic drug monitoring market growth rate?Ans. The growth rate of the therapeutic drug monitoring market is 12.3%.Q3. Which region holds a major market share for the therapeutic drug monitoring market?Ans. North America holds a major market share of the therapeutic drug monitoring market in 2021.Q4. Which segment accounted for the largest therapeutic drug monitoring market share?Ans. By end user, the hospitals segment accounted for the largest therapeutic drug monitoring market share.Q5. Who are the key players in the therapeutic drug monitoring market?Q6. What are the factors driving the therapeutic drug monitoring market growth?Ans. The major factors driving the growth of the market are the increasing demand for therapeutic drug for disease management across the globe.Q7. What are the key growth strategies of therapeutic drug monitoring market players?Ans. The key growth strategies of therapeutic drug monitoring market players are product launch and product approval.Q8. Which region will provide more business opportunities for the therapeutic drug monitoring market during the forecast period?Ans. The North America region will provide more business opportunities for the therapeutic drug monitoring market during the forecast period.

The global therapeutic drug monitoring market was valued at USD 1.4 Billion in 2021 and it is anticipated to grow up to USD 4.5 Billion by 2031, at a CAGR of 12.3% during the forecast period.

Therapeutic Drug Monitoring is a medical practice which is used for determining the concentration of particular drug in the bloodstream of the patient at different time interval. It is used in sustaining constant volume drug in the bloodstream without any toxic effect. Therapeutic drug monitoring is not used in majority of drugs but only the drugs which have narrow therapeutic window. It is also used in drugs with marked pharmacokinetic variability.

Global Therapeutic Drug Monitoring Market Scope and Report StructureMarket Trends and Drivers

Rising preference for precision medicine will boost the overall market growth. 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. Recently, cancer patients are being provided treatment through combination drugs, based on studies conducted on the patient’s parameters such as systems biology, analysis of the tumor, and gene expression data in the absence and presence of pharmacological perturbation. This approach, which is currently being tested in various settings, aims to revolutionize pharmacotherapy in oncology and other disease areas. TDM can be of immense value to advance this novel way of treating patients.

Market Restraints and Challenges

Operational barriers faced in conducting TDM tests may hampers the market growth. 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). Laboratory space also needs to be reconfigured to meet the requirements of conducting specific immunoassay tests for pathogen detection to avoid cross-contamination and ensure efficient time management. The need to maintain and operate advanced immunoassay instruments, particularly those capable of handling a single sample type, is highly expensive. Due to the rapid mutation of microbes and the increasing outbreak of epidemics, clinical laboratories need to adopt innovative technologies capable of rapid sample diagnosis. However, a shortage of skilled laboratory technicians to operate advanced immunoassay diagnostic products limits their overall adoption, particularly in emerging markets. Also, the reluctance to move from manual operations toward automation is another major challenge for market growth. This is because many providers find it difficult to transition to IT-based approaches from manual or traditional approaches and may not prefer to make the shift at all.

Global Therapeutic Drug Monitoring Market Segmental Overview

The report analyses the Global vascular closure devices market based on product, technology, drug class, end-use, and region.

Global Therapeutic Drug Monitoring Market by Product

Based on product, it is segmented into therapeutic drug monitoring market is segmented into consumables, equipment, and data management services. The consumables segment is projected to grow at the significant CAGR during the forecast period. The major factors contributing to the growth of this market are the requirement of repeat purchase of kits and reagents, coupled with the increasing number of immunoassay tests being performed across the globe. Furthermore, rising demand for new technology-based, cost-effective kits and the extensive use of these reagents in the RD area are some of the factors responsible for its lucrative growth.

Global Therapeutic Drug Monitoring Market by Technology

Based on technology, it is segmented into immunoassays and proteomic technologies. The immunoassay segment dominated the market in 2021 owing to the availability of highly specific and reliable immunoassays, the rising adoption rate of the advanced techniques, and the requirement of minimal training to handle the equipment. Immunoassays is a bioanalytical methods that use the specificity of an antigen-antibody reaction to detect and quantify target molecules in biological samples. These methods are frequently used in clinical diagnostics, drug discovery, drug monitoring, and food testing.

Global Therapeutic Drug Monitoring Market by Drug Class

Based on drug class, it is segmented into anti-epileptics, antibiotics, immunosuppressants and anti-arrhythmics. The anti-epileptics segment held the largest market share in 2021. This is attributed to the increasing prevalence of epilepsy and seizures and the resultant explosive growth in the number of Anti-epileptic drugs. It has been observed that the immunosuppressants segment has witnessed a higher penetration; the small margin for the therapeutic index of these drugs and the inter-individual differences observed in the blood concentrations of the immunosuppressants necessitate TDM for these drugs.

Global Therapeutic Drug Monitoring Market by End-use

Based on end-use, it is segmented into hospitals labs and private labs. The hospital labs segment is likely to dominate the market during the forecast period. Around 50% of the therapeutic drug monitoring is carried out in hospitals due to the availability of accurate patient information, such as age, metabolism, ethnicity, and drug performance history. The need for accurate patient history required to devise effective treatment plans has led many hospitals to design request forms for drug metabolite monitoring; the increasing use of computerized entry of patient history and information records is expected to further improve the TDS service in the hospitals

Geographical Analysis of Global Therapeutic Drug Monitoring Market

Region-wise, it is studied across North America, Europe, Asia Pacific, and the Rest of the World. North America is expected to garner the largest share of the ultrasound market in 2020. Factors such as a High rate of organ transplantation coupled with the high acceptance and gradual adoption of these metabolite measuring procedures is one of the major drivers for the large market share. Furthermore, presence of unmet needs and the continuous efforts of the government to provide low-cost services with the aim of promoting individualized dosage patterns for organ transplantation cases as well as to support personalized medicine initiatives. are driving the growth of the North America ultrasound market.

Major Players in the Global Therapeutic Drug Monitoring MarketCOVID-19 Impact

A worldwide emergency has been caused by the COVID-19 pandemic. Data from the Scottish Biologic Therapeutic Drug Monitoring (TDM) service shows a drop in TDM testing since pandemic onset. For instance, in April 2020, a 75.6% reduction in adalimumab testing and a 36.2% reduction in infliximab testing was noticed, mainly due to a large number of cancellations of outpatient. Likewise, it is also believed that disruption to normal patterns of care and disease monitoring of patients on biologics could increase the threat of disease and adverse clinical reactions. Research associations and other medical bodies are making various attempts to conduct clinical trials to develop a suitable anti-COVID drug, which is anticipated to fuel the growth of the TDM market. Moreover, the Pharmacology group - AC43 of the National Agency for Research on AIDS and Viral Hepatitis and the Therapeutic Drug Monitoring Group of the French Society of Pharmacology and Therapeutics proposed, at the end of March 2020, that a TDM evaluation be performed 48 hours after the start of treatment to check the early attainment of an adequate residual concentration.

Recent Developments

• In July 2022, Bio-Rad extended range of anti-idiotypic antibodies for bioanalysis, drug monitoring.
• 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.
• In February 2019, LabCorp, announced a new assay in its therapeutic drug monitoring (TDM) DoseASSURE portfolio. The new Certolizumab Concentration and Anti-Certolizumab Antibody DoseASSURE CTZ assay, helps physicians monitor individual drug response for patients who are on Certolizumab, a biologic drug used to treat certain inflammatory diseases, such as rheumatoid arthritis and Crohn’s disease

Frequently Asked Questions

Q1. How big is the ultrasound probe disinfection market?Ans. The global therapeutic drug monitoring market size was USD 1.4 Billion in 2021 and is anticipated to reach USD 4.5 Billion in 2031, growing at a rate of 12.3% from 2022 to 2031.Q2. What is the therapeutic drug monitoring market growth rate?Ans. The growth rate of the therapeutic drug monitoring market is 12.3%.Q3. Which region holds a major market share for the therapeutic drug monitoring market?Ans. North America holds a major market share of the therapeutic drug monitoring market in 2021.Q4. Which segment accounted for the largest therapeutic drug monitoring market share?Ans. By end user, the hospitals segment accounted for the largest therapeutic drug monitoring market share.Q5. Who are the key players in the therapeutic drug monitoring market?Q6. What are the factors driving the therapeutic drug monitoring market growth?Ans. The major factors driving the growth of the market are the increasing demand for therapeutic drug for disease management across the globe.Q7. What are the key growth strategies of therapeutic drug monitoring market players?Ans. The key growth strategies of therapeutic drug monitoring market players are product launch and product approval.Q8. Which region will provide more business opportunities for the therapeutic drug monitoring market during the forecast period?Ans. The North America region will provide more business opportunities for the therapeutic drug monitoring market during the forecast period.

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