Small Molecule Segment to Hold Significant Share of Pharmacokinetics Services Market During 2023-2031

According to our latest study on "Pharmacokinetics Services Market Forecast to 2031 - Global Analysis - Drug Type, Service Type, Therapeutic Application, and End User," the market value is expected to reach US$ 1,579.87 million by 2031 from US$ 874.96 million in 2023; the market is estimated to record a CAGR of 7.6% during 2023-2031. The report highlights the key factors driving the pharmacokinetics services market growth and prominent players with their developments in the market.

The pharmacokinetics services market has been segmented on the basis of drug type, service type, therapeutic application, and end user. By drug type, the market is segmented into small molecules, large molecules, and vaccines. The small molecule segment held the largest market share in 2023. Pharmacokinetics service companies provide comprehensive PK/PD (i.e., pharmacokinetics and pharmacodynamics) services to evaluate the fundamental physicochemical properties and structural motifs that are responsible for the efficacy and safety profile of small molecules. These services include PK bioanalysis; PD biomarker analysis; high-throughput absorption, distribution, metabolism, and excretion (HT-ADME) profiling; in vitro ADME assays; drug transporter assays; and non-radiolabeled and radiolabeled in vivo ADME studies. In vitro ADME studies are crucial in gaining insights into metabolism and potential drug interactions. Companies also offer drug interaction screening services, including in vitro ADME assays, data interpretation systems, and expert study designs, to determine the ADME properties of small molecules.

By service type, the pharmacokinetics services market is segmented into preclinical ADME and human studies, PK/PD analysis and reporting, dosing simulations, risk analysis, and others. The preclinical ADME and human studies segment held the largest market share in 2023. The segment is further anticipated to register the highest CAGR during the forecast period. Drug development is a costly process for pharmaceutical and biotechnology manufacturers, and a drug's inability to meet safety profiles often leads to failure in the final stages of clinical studies. ADME toxicology testing is meant to address this issue in the early stages of drug development, i.e., during preclinical trials. Toxicology testing is a crucial step before introducing a new drug to the market to ensure its safety. This testing aids in the better understanding of drug levels and kinetics after its exposure to the human body, reducing the time and costs of drug discovery. Preclinical ADME toxicology testing is an important aspect of drug discovery for venture capital (VC) firms, as study outcomes help them make informed financial decisions. In January 2024, CN Bio and Altis Biosystems agreed to work together to develop a next-generation human gut/liver in vitro model for advanced ADME studies. Such inorganic growth strategies adopted by market players are contributing to the pharmacokinetics market growth for the preclinical ADME and human studies segment.

The pharmacokinetics services market, by therapeutic application, is categorized into oncology, infectious diseases, neurological disorders, autoimmune diseases, gynecological disorders, cardiovascular diseases, respiratory disorders, and others. The oncology segment held the largest market share in 2023. Further, the infectious diseases segment is anticipated to register the highest CAGR during the forecast period. Human immunodeficiency virus (HIV) is a major public health issue across the world. As per the World Health Organization (WHO), nearly 58 million individuals across the world have chronic hepatitis C virus infection, and ~1.5 million new infections occur every year. Critically ill patients who suffer from severe infections are at a high risk of receiving antimicrobial drugs in suboptimal doses. PK/PD modeling is a technique used to describe and measure the relationship between drug dose, concentration, and effect. Laboratories that specialize in the treatment of patients with serious infections, such as HIV, fungal infections, and tuberculosis, focus on providing therapeutic drug monitoring using liquid chromatography-mass spectrometry (LC-MS). Therapeutic drug monitoring (TDM) is a well-established clinical tool that allows clinicians to perform ADME and clearance studies. It also helps clinicians determine the necessary doses of drugs for each patient while taking into account the complex drug-drug interactions. The Infectious Disease Pharmacokinetics Laboratory at the University of Florida (IDPL) offers drug assays that most other clinical labs do not provide.

The pharmacokinetics services market, by end user, is categorized into pharmaceutical and biotechnology companies, contract research organizations, and others. The contract research organization segment held the largest market share in 2023. It is further anticipated to register the highest CAGR during the forecast period. Contract research organizations provide services to support the pharmaceutical, biotechnology, and medical device industries. These services usually include in vivo PD and Pharmacokinetics services, PK/PD modeling, DMPK analysis, and PK mouse and rat models. PK/PD studies play a crucial role in the drug discovery process. They generate high-quality data on the pharmacokinetic (PK) and pharmacodynamic (PD) properties of drug candidates.

Charles River Laboratories International Inc., Eurofins Scientific SE, Evotec SE, Certara Inc., Parexel International Corp, Thermo Fisher Scientific Inc., Allucent, PACIFIC BIOLABS, SGS SA, and Shanghai Medicilon Inc. are among the leading companies operating in the global Pharmacokinetics Services market.

Companies operating in the Pharmacokinetics Services market adopt various organic and inorganic strategies. Organic strategies mainly include product launches and product approvals. Acquisitions, collaborations, and partnerships are among the inorganic growth strategies witnessed in the Pharmacokinetics Services market. These growth strategies allow the market players to expand their businesses and enhance their geographic presence, thereby contributing to the overall Pharmacokinetics Services market growth. Further, acquisition and partnership strategies help them strengthen their customer base and expand their product portfolios.

A few of the significant developments by key market players are listed below.

- Thermo Fisher Scientific expanded its clinical research operations with the opening of a state-of-the-art bioanalytical lab in Richmond, Virginia. The new unit will support the burgeoning demand generated in the biopharmaceutical ecosystem for consistent, high-quality laboratory services to accelerate drug development. The Richmond Bioanalytical Lab, whose entities have been operating since 1985, provides services for all phases of small molecule drug, biologics, vaccine, and biomarker development. Drug testing services include drug PK/PD, and immunogenicity and biomarker quantitation to support drug efficacy and safety. (Source: Thermo Fisher Scientific, Press Release, October 2022)

- Charles River Laboratories International, Inc., partnered with Kibur Medical to offer exclusive access to its implantable microdevice (IMD) for in vivo preclinical oncology studies. Kibur's microdevice technology can hold up to 20 different compounds for local administration, which allows it to dose therapies directly into disease tissue, allowing for investigative studies of early-stage compounds where pharmacokinetic properties are poorly understood. (Source: Charles River Laboratories International, Inc., Newsletter, February 2021).






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