Global Pharmacokinetics Services Market Size, Segmentation, Trends and Growth Analysis Forecast by 2031

Pharmacokinetics Services Market Overview and Analysis:

In 2022, the global market size for pharmacokinetics services reached USD 992.2 million, and it is projected to exhibit a robust compound annual growth rate (CAGR) of 7.2% from 2023 to 2031.

Pharmacokinetics services refer to specialized offerings provided by organizations, typically in the pharmaceutical and biotechnology sectors, to study and analyze the pharmacokinetic properties of drugs or therapeutic compounds. Pharmacokinetics is the branch of pharmacology that deals with the absorption, distribution, metabolism, and excretion (ADME) of substances within an organism, often focusing on how these factors influence the concentration of drugs in the body over time.

Elevated drug attrition rates, largely attributable to suboptimal pharmacokinetics (PK) of therapeutic agents, have emerged as a significant concern within the pharmaceutical industry. To mitigate this challenge, researchers are increasingly adopting a proactive approach by integrating PK investigation into the evaluation of novel drug candidates at each stage of development. The trend of implementing predictive preclinical pharmacokinetics/pharmacodynamics (PK/PD) models throughout various clinical trial phases is gaining traction as a promising strategy to address major bottlenecks in the pharmaceutical development process. This strategic incorporation of PK studies serves as a valuable tool in the early identification of potential challenges, enabling timely modifications and the formulation of effective development strategies to mitigate obstacles in drug development.

By proactively assessing the pharmacokinetic profile of novel therapeutic moieties at each developmental stage, researchers aim to minimize concerns surrounding high drug attrition rates. Through predictive preclinical PK/PD models, pharmaceutical companies can anticipate and address issues related to drug absorption, distribution, metabolism, and excretion, offering insights that guide necessary modifications and optimize development strategies. Thus, the proactive integration of PK studies not only aids in the early identification of potential challenges but also facilitates informed decision-making, allowing for necessary adjustments and refinements in drug development processes. This strategic use of pharmacokinetics services emerges as a crucial element in the pharmaceutical industry's efforts to enhance success rates and streamline the overall drug development pipeline.

Market Segmentation: Pharmacokinetics Services Market is Segmented By Drug Type (Small Molecules and Large Molecules), Application (SMEs and Large Enterprises) End-use (Biotechnology & Pharmaceutical Companies, Academic & Government Research Institutes and Other End-Users) and Geography (Asia-Pacific, North America, Europe, and Middle-East & Africa). The Market Sizes and Forecasts for the UV-Curable Adhesives Market are Provided based on Value (USD Million) for all The Above Segments.

Pharmacokinetics Services Market Trends:

The pharmaceutical industry's increasing reliance on real-world evidence to complement traditional clinical trial data may impact pharmacokinetic services. Post-market pharmacokinetic studies could gain significance in assessing drug performance in real-world scenarios. Also, systems pharmacology, integrating pharmacokinetic and pharmacodynamic data with computational models, may become more prevalent. This holistic approach allows for a deeper understanding of drug interactions within biological systems.

Market Drivers:

Rising Importance of Personalized Medicine

The shift towards personalized medicine, where treatments are customized based on individual patient attributes, is likely to contribute to an increased demand for pharmacokinetic studies. These studies are essential in comprehending the variability in drug responses observed across diverse patient populations. In the context of personalized medicine, understanding how drugs are absorbed, distributed, metabolized, and excreted in different individuals becomes crucial. Pharmacokinetic studies help elucidate the factors contributing to variations in drug metabolism and response, providing valuable insights into tailoring treatments to meet the specific needs and characteristics of individual patients.

By conducting comprehensive pharmacokinetic assessments, healthcare professionals and researchers can gain a deeper understanding of how a drug behaves in the body, considering factors such as genetics, lifestyle, and other individualized variables. This knowledge is instrumental in optimizing drug dosages, minimizing adverse effects, and ensuring that therapeutic interventions are not only effective but also well-tailored to the unique physiological profiles of patients. Thus, as the paradigm of personalized medicine gains prominence, the role of pharmacokinetic studies becomes increasingly pivotal. These studies offer a pathway to unravel the complexities of individual drug responses, paving the way for more precise and patient-centric therapeutic approaches in the realm of healthcare.

Expanded Application in Biologics and Biosimilars

The expanding market for biologics and biosimilars is anticipated to generate a heightened demand for pharmacokinetic services specifically designed to accommodate the distinctive attributes of these intricate therapeutic entities. As the landscape of biologics and biosimilars evolves, there is a growing recognition of the need for specialized pharmacokinetic studies that can comprehensively address the complex behaviour, interactions, and dynamics inherent in these advanced therapeutic modalities. Biologics, which include a diverse range of therapeutic proteins, monoclonal antibodies, and other complex molecules, present unique challenges in terms of pharmacokinetics due to their intricate structures and mechanisms of action. Similarly, biosimilars, designed to mimic the properties of existing biologics, necessitate thorough pharmacokinetic assessments to ensure their equivalence in terms of absorption, distribution, metabolism, and excretion.

Market Restraints

High Cost of Pharmacokinetic Studies

Conducting comprehensive pharmacokinetic studies involves sophisticated methodologies, advanced technologies, and specialized expertise, leading to high overall costs. The financial burden associated with these studies may limit the accessibility of pharmacokinetics services for some pharmaceutical companies, particularly smaller ones with budget constraints. Thus, this may slow down the growth of the studied marker over the forecast period.

COVID-19 Impact on Pharmacokinetics Services Market

The COVID-19 pandemic has led to disruptions in clinical trials worldwide, including those related to pharmacokinetics studies. Site closures, restrictions on patient visits, and prioritization of COVID-19 research may have affected the progression and timelines of ongoing studies. The pandemic prompted a shift in research priorities, with a significant focus on COVID-19-related studies and vaccine development. This shift could have impacted funding allocations and resources available for non-COVID-19-related research, including pharmacokinetic studies. The overall impact of the pandemic on pharmaceutical companies' drug development pipelines may indirectly influence the demand for pharmacokinetic services. Delays or reprioritization of drug development programs could affect the need for related services.

Segmental Analysis:

Small Molecule Segment is Expected to Witness Significant Growth Over the Forecast Period

Small molecules are organic compounds with relatively low molecular weight, typically below 900 daltons. They form the basis of many pharmaceutical drugs and are extensively studied in the field of pharmacokinetics. Pharmacokinetics refers to the study of how the body absorbs, distributes, metabolizes, and excretes drugs, including small molecules. Small molecules are characterized by their low molecular weight, allowing them to be easily absorbed through cell membranes. Also, small molecules are often formulated into specific dosage forms (tablets, capsules, injections) to optimize their delivery and absorption profiles. Thus, the pharmacokinetics of small molecules is fundamental to drug development, ensuring safe and efficacious use.

Small and Medium Enterprise Segment is Expected to Witness Significant Growth Over the Forecast Period

Small and Medium Enterprises (SMEs) play a vital role in various industries, including the healthcare and pharmaceutical sectors. When it comes to pharmacokinetics services, SMEs contribute in unique ways to the development and optimization of drug therapies. Small and Medium Enterprises specializing in pharmacokinetics services often offer niche expertise, focusing on specific aspects of drug development and analysis. Some SMEs engage in educational and training initiatives, offering workshops, webinars, and training programs to professionals in the pharmacokinetics field. This knowledge-sharing contributes to the continuous development of expertise in the industry. Thus, small and medium enterprises in the pharmacokinetics services sector play a crucial role in contributing specialized expertise, fostering innovation, and providing flexible and cost-effective solutions. Their collaboration with larger pharmaceutical entities enhances the overall efficiency of drug development processes, contributing to advancements in healthcare and the pharmaceutical industry.

Biotechnology & Pharmaceutical Companies Segment is Expected to Witness Significant Growth Over the Forecast Period

Biotechnology and pharmaceutical companies are major stakeholders in the healthcare industry, driving advancements in drug development and therapeutic interventions. Pharmacokinetics services play a pivotal role in their research and development endeavours, contributing to the safety, efficacy, and regulatory approval of novel drug candidates. Biotechnology and pharmaceutical companies engage in the entire drug development lifecycle, from early-stage research to clinical trials and eventual market approval. Pharmacokinetics services are integral at every stage, providing critical data on how drugs interact with the body.

Moreover, Pharmacokinetics services support Therapeutic Drug Monitoring (TDM), allowing companies to monitor drug concentrations in patients to ensure therapeutic efficacy while avoiding toxicity. Thus, the segment is expected to witness significant growth over the forecast period.

North America Segment is Expected to Witness Significant Growth Over the Forecast Period

North America emerged as the dominant force in the market, due to the prominence attributed to the significant concentration of leading pharmaceutical companies operating within North America. The region has witnessed numerous strategic alliances, particularly between major U.S.-based drug manufacturers and Contract Research Organizations (CROs) providing Pharmacokinetics (PK) investigation services. These collaborations underscore the region's commitment to leveraging specialized expertise in advancing drug development.

A noteworthy contributor to North America's dominance is the well-established and effective regulatory framework governing various stages of drug development, encompassing Pharmacokinetics-Pharmacodynamics (PKPD) and toxicology studies. This robust regulatory structure ensures adherence to high-quality standards and fosters an environment conducive to innovation and research. As a result, North America stands out as a powerhouse in the field of pharmacokinetics services, driven by a synergistic network of pharmaceutical enterprises, research collaborations, and regulatory support.

The prevalence of strategic partnerships between pharmaceutical entities and CROs specializing in PK investigation services further amplifies the region's leadership. These collaborations facilitate the efficient outsourcing of critical pharmacokinetic studies, enabling pharmaceutical companies to optimize resources and focus on core aspects of drug development. Thus, North America's dominance in the pharmacokinetics services market can be attributed to its rich ecosystem of pharmaceutical innovation, coupled with a regulatory infrastructure that facilitates and ensures the highest standards in drug development processes. The region's strategic alliances and collaborative initiatives underscore its commitment to advancing pharmacokinetics research and fostering a thriving landscape for pharmaceutical innovation.

Pharmacokinetics Services Market Competitive Landscape:

The shift towards personalized medicine, where treatments are customized based on individual patient attributes, is likely to contribute to an increased demand for pharmacokinetic studies. These studies are essential in comprehending the variability in drug responses observed across diverse patient populations. In the context of personalized medicine, understanding how drugs are absorbed, distributed, metabolized, and excreted in different individuals becomes crucial. Pharmacokinetic studies help elucidate the factors contributing to variations in drug metabolism and response, providing valuable insights into tailoring treatments to meet the specific needs and characteristics of individual patients. By conducting comprehensive pharmacokinetic assessments, healthcare professionals and researchers can gain a deeper understanding of how a drug behaves in the body, considering factors such as genetics, lifestyle, and other individualized variables. This knowledge is instrumental in optimizing drug dosages, minimizing adverse effects, and ensuring that therapeutic interventions are not only effective but also well-tailored to the unique physiological profiles of patients. Some of the players in the global pharmacokinetics services market are:

• Evotec AG
• Certara, L.P.
• Pacific BioLabs
• GVK Biosciences Private Limited
• Shanghai Medicilon Inc.
• Pharmaceutical Product Development, LLC
• Charles River Laboratories International, Inc.
• PAREXEL International Corporation
• Eurofins Scientific, Inc
• Frontage Labs
• SGS SA
• LGC Limited
• Creative Bioarray

Recent Developments:

1) In August 2023, Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company, is dedicated to the development of innovative inhaled therapies targeting serious pulmonary and central nervous system diseases, leveraging its patented iSPERSE™ technology. Among its key developments, PUR1900, an orally inhaled dry powder formulation of the antifungal itraconazole, utilizes iSPERSE technology and is specifically designed for treating Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with asthma. In a recent announcement, Pulmatrix communicated the publication of a research paper titled "Evaluation of the Potential for Drug-Drug Interactions with Inhaled Itraconazole Using Physiologically Based Pharmacokinetic Modelling, Based on Phase 1 Clinical Data." This publication, featured in the peer-reviewed American Association of Pharmaceutical Scientists (AAPS) Journal, explores the assessment of potential drug-drug interactions associated with inhaled itraconazole, utilizing physiologically based pharmacokinetic modelling grounded in Phase 1 clinical data.

2) In May 2022, Evotec SE disclosed a strategic equity investment in Tubulis GmbH, a German company poised for the expansion of its platform technologies aimed at addressing solid tumours through precision-targeted therapeutics.

Frequently Asked Questions (FAQ) :

Q1. What was the Pharmacokinetics Services Market size in 2022?

Q2. What is the Growth Rate of the Pharmacokinetics Services Market ?

Q3. What are the Growth Drivers of the Pharmacokinetics Services Market?

Q4. What segments are covered in the Pharmacokinetics Services Market Report?