Pharmacokinetics Services Market - Forecast(2024 - 2030)

Pharmacokinetics Services Market Overview

The Pharmacokinetics Services Market size is estimated to reach $1.7 billion by 2027. Furthermore, it is poised to grow at a CAGR of 8.3% over the forecast period of 2022-2027. The study of drug movement across the body is referred to as pharmacokinetics. Pharmacokinetics (PK) is a branch of pharmacology concerned with determining the destiny of medications given to living organisms. It shows how the body's metabolic changes of compounds in the body, as well as the route of excretion of the drug's metabolites, influence any given chemical after delivery. Pharmacokinetics is the study of how an organism affects a medicine. The mode of administration and the dose of an administered medicine alters the chemical property of pharmacokinetics, which can affect the absorption rate. Glucuronosyltransferasecatalyzes allow the transfer of the glucuronic acid component of UDP-glucuronic acid to a small hydrophobic molecule. This is a glucuronidation reaction. The technique provides a quantitative or measurable foundation for evaluating the effects and time course of pharmaceuticals in the body, allowing measurement of the four essential processes related to drug exposure: absorption, distribution, metabolism, and excretion. For example, the acid dissociation constant allows quantifying the measure of the strength of an acid in solution. When medicines are prescribed, these pharmacokinetic processes determine the drug's concentration in the body. The proper creation of a treatment regimen for patients requires a thorough grasp of these processes. Every medicine's development and approval hinges on a thorough grasp of these factors, as well as facts about the body's biological response to the treatment.

Additionally, the Regulatory criteria for clinical pharmacokinetic data have been gradually evolving in recent years in order to resolve the drug candidate's safety implications, this factor has had a significant impact on the market's reshaping. Furthermore, increased government spending in the healthcare and life sciences sectors is driving up demand for pharmacokinetics services around the world. Socio-economic factors such as increasing global healthcare expenditures and a large increase in the global population of geriatrics are also favorable to the market. However, the high costs associated with systems and technologies, along with the lack of innovation in technology for electrophoresis and electrochemiluminescence equipment are predicted to pose a threat to the market's growth during the forecast period of 2022-2027.

Pharmacokinetics Services Market Report Coverage

The report: “Pharmacokinetics Services Market Forecast (2022-2027)", by Industry ARC covers an in-depth analysis of the following segments of the Pharmacokinetics Services Market.

By Type- Small Molecules Pharmacokinetics Services, and Large Molecules Pharmacokinetics Services.
By End User- Biotechnology & Pharmaceutical Companies, Academic and Government Research Institutes and Others. 
By Geography- North America (U.S., Canada, Mexico), Europe (Germany, United Kingdom (U.K.), France, Italy, Spain, Russia, and Rest of Europe), Asia Pacific (China, Japan India, South Korea, Australia, and New Zealand, and Rest of Asia Pacific), South America (Brazil, Argentina, Chile, Colombia and Rest of South America), and Rest of the World (the Middle East, and Africa).

Key Takeaways

• Geographically, in 2021 North America held a dominant market share. It is owing to the increasing number of pharmaceutical companies in the U.S. and significant investment in drug production made by many pharmaceutical and biopharmaceutical companies giving rise to the demand for pharmacokinetics services. Moreover, in February 2022, The US Food and Drug Administration (FDA) finalized guidance on population pharmacokinetics. Population PK analyses can quantify the impact of intrinsic and extrinsic patient factors on the exposure to a drug. In conjunction with supporting exposure-response data, population PK data can be used to identify patient factors that result in a clinically significant change in drug exposure and inform the proper use of drugs. 
• The increasing number of pharmacokinetics services in the clinical trial and the growing demand for pharmacokinetics services for the drug development process are some of the factors driving the Pharmacokinetics Services Market. However, the high costs of pharmacokinetics studies are one of the factors impeding the market growth.
• A detailed analysis of strengths, weaknesses, opportunities, and threats will be provided in the Pharmacokinetics Services Market Report. 

Pharmacokinetics Services Market Segmentation Analysis- By Type

The Pharmacokinetics Services market based on type can be further segmented into Small Molecules Pharmacokinetics Services, and Large Molecules Pharmacokinetics Services. Small-molecule pharmacokinetic services focus on studying molecules of smaller atomic weight and drug metabolism and the number of drug compounds in urine, blood, saliva, and tissue, using chromatographic techniques in combination with spectroscopic assays. In small molecule drug discovery research, pharmacokinetics describes the disposition of a drug in the body, should be a primary consideration in the selection of a drug candidate, ultimately contributing to its eventual clinical success or failure.

However, Large molecules pharmacokinetics services are estimated to be the fastest-growing, with a CAGR of 9.1% over the forecast period of 2022-2027. Large-molecule pharmacokinetic techniques such as protein measurement, peptide interactions, and mostly greater weight molecules, such as IgE antibodies. They also include immunogenicity assays, Electrochemiluminescence (ECL) assays, and vaccine potency support as well as various other assays like ELISA. Pharmacokinetics of large molecule drugs like monoclonal antibodies, proteins, peptides, and antisense oligonucleotides is essential to support the development of therapeutic biologics.

Pharmacokinetics Services Market Segmentation Analysis- By End User

The Pharmacokinetics Services market based on the End User can be further segmented into Biotechnology & Pharmaceutical Companies, Academic and Government Research Institutes, and Others. Academic and Government Research Institutes held a dominant market share in the year 2021. This segment's dominance can be attributed in large part to government policies that encourage study across academic and research institutes. Additionally, a variety of conferences and courses are being held by government agencies and research institutes around the world to increase understanding of various paradigms associated with pharmacokinetics application in clinical and preclinical drug production, which is further predicted to accelerate the growth of the pharmacokinetics services sector. Academic and government research institute of pharmacokinetics helps to support clinical studies, preclinical studies, lead optimization, and bioanalysis.

However, biotechnology & pharmaceutical companies are estimated to be the fastest-growing, with a CAGR of 9.7% over the forecast period of 2022-2027. The dominance is owing to the increasing usage of these services in various stages of clinical trials in order to identify a prominent drug candidate for diseases such as cancer, cardiovascular, and infectious disease. Population pharmacokinetic analysis is a relatively new approach that can be used to obtain important pharmacokinetic and pharmacodynamic information from sparse data sets routinely obtained in phase II and III clinical trials. Today many pharmaceutical companies use this approach routinely, to differing extents, during their drug development process.

Pharmacokinetics Services Market Segmentation Analysis- By Geography

The Pharmacokinetics Services market based on Geography can be further segmented into North America, Europe, Asia-Pacific, South America, and the Rest of the World. In 2021, North America held a dominant market share of 39% as compared to its other counterparts. It is owing to the increasing number of pharmaceutical companies in the U.S. and significant investment in drug production made by many pharmaceutical and biopharmaceutical companies giving rise to the demand for pharmacokinetics services. According to the Pharmaceutical Manufacturing Industry in the U.S., about 8% of pharmaceutical companies increases in 2021. Furthermore, the US Food and Drug Administration (FDA) issued final recommendations on population pharmacokinetics in February 2022. The impact of intrinsic and extrinsic patient variables on drug exposure can be quantified using population PK (pharmacokinetics) analysis. Population PK (pharmacokinetics) data, when combined with supporting exposure-response data, can be utilized to identify patient factors that cause a clinically meaningful change in drug exposure and instruct correct medication use.

Pharmacokinetics Services Market Drivers

The Rising Number of Pharmacokinetics Services in Clinical Trials have Readily Aided the Market Growth

Pharmacokinetics Services in clinical and preclinical research applications are being exploited in ongoing experiments and clinical trials. In almost all the pharmaceutical and biotechnology drugs clinical trials, an increasing number of research studies prove that Pharmacokinetics studies are useful to better understand a molecule's properties, ADME process as well as how a specific drug would behave once inside the body, such information’s is set to propel the market growth. According to the U.S. National Library of Medicine, about 300,000 clinical trials were registered in 2020, and thus the demand for pharmacokinetics services roses. The primary driver behind the positive development of the worldwide pharmacokinetic services market in recent years has been regulatory demands put on the healthcare research sector pertaining to necessary investigations that must be done before tests are pushed ahead to human clinical trials. Before undertaking human clinical trials, agencies such as the FDA and the European Medications Agency propose that studies be undertaken to assess the safety of medicines in people by studying the influence of treatment on the respiratory, central neurological, and cardiovascular systems in animal models. Some of the most important pharmacokinetic properties to understand during pre-clinical testing include distribution, absorption, metabolism, and excretion. PK/PD analysis has helped in progressing drug development from preclinical studies to rapid and efficient in-man studies. The use of human in vivo as well as in vitro models for studying pharmacokinetics variability in the clinical development phase has been demonstrated for various pharmaceuticals.

Growing Demand for Pharmacokinetics Services for the Drug Development Process Gives Rise to the Demand for Pharmacokinetics Services Market

The role of pharmacokinetics (PK) in drug discovery is to support the optimization of the absorption, distribution, metabolism, and excretion (ADME) properties of lead compounds with the ultimate goal to attain a clinical candidate which achieves a concentration-time profile in the body that is adequate for the desired efficacy and safety profile. In the development of the drug delivery system, PK-PD modeling could guide the formulation design and dosing regimen selection based on the preclinical and clinical data. This technique connects the drug dose to the physiological response, related to the properties of the drug delivery system and physiological system. Without Pharmacokinetics investigation of a drug, regulatory agencies would not approve its use. Thus, pharmacokinetics, in combination with FDA-approved standards, play a crucial role in drug discovery and determining the success or failure of drug approval. According to the National Institute of Health, the number of new drugs approved for sale increased by 60% in 2020, thus, the approval of drugs surges the demand for pharmacokinetics services.

Pharmacokinetics Services Market Challenges

The High Cost of Pharmacokinetics Studies is impeding the market growth

According to the National Cancer Institute, pharmacokinetic studies include method development, in-vitro drug plasma stability studies, protein binding studies and the cost of total pharmacokinetics studies include $1,50,000 to $2,35,000 for each which is too expensive. The cost of pharmacokinetics depends on many factors but, in general, as complexity increases then so do cost. The complexity of pharmacokinetics depends on actual data collected and the manner in which data are collected during the conduct of nonclinical and clinical studies. Pharmacokinetics samples collected can be very complex and require a significant amount of time to properly analyze. Hence, pharmacokinetic studies are critical for characterizing any intrinsic or extrinsic factors that could affect drug exposure. 

Pharmacokinetics Services Industry Outlook

Product launches, mergers and acquisitions, joint ventures, and geographical expansions are key strategies adopted by players in the Pharmacokinetics Services Market. The top 10- Pharmacokinetics Services Market companies are-

1. Eurofins Scientific
2. Genesis Therapeutics
3. Bayer AG
4. Evotec SE
5. Charles River Laboratories
6. GVK Biosciences Private Limited
7. Parexel International Corporation
8. SGS SA
9. Biologics Consulting Group Inc.
10. ICON Plc.

Recent Developments

• In April 2022, Beckley Psytech announced the dosing of the first healthy volunteer in Phase-1 of its clinical trial for assessing the safety and pharmacokinetics of the second innovative formulation of 4-MeO-DMT. BPL-003 is Beckley Psytech’s innovative dry powder intranasal formulation of 5-MeO-DMT using FDA-approved intranasal delivery devices. Data from Phase 1 will be used to select lead compounds for upcoming Phase 2 in treatment-resistant depression (TRD).
• In March 2022, Silo Pharma announced an agreement with CRO firm, Frontage Laboratories for Investigational New Drug- enabling Pharmacokinetics Study. Silo merges traditional therapeutics with psychedelic research to relieve patients suffering from PTSD, Alzheimer’s, Parkinson’s, and other rare neurological disorders. Frontage will study Silo’s Central Nervous System Peptide, SPU-16, “a potential new treatment for multiple sclerosis and other conditions,” and their Joint Homing Peptide, SPU-21, used for treating arthritogenic processes.
• In November 2020, Genesis Therapeutics entered AI-driven, multi-target drug discovery partnership with Genentech. The collaboration leverages Genesis’ graph machine learning and drug discovery expertise to identify innovative drug candidates for therapeutic targets in multiple disease areas.

Relevant Titles

Drug Discovery Services Market- Forecast (2022-2027)

Report Code- HCR 56780

Pharmaceutical Contract Manufacturing Market- Forecast (2022-2027)

Report Code- HCR 0308

Drug Delivery Market- Forecast (2022-2027)

Report Code-HCR 0064

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