PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1901499
PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1901499
Preclinical Bioanalytical Testing Services Market size was valued at US$ 1,234.56 Million in 2024, expanding at a CAGR of 9.5% from 2025 to 2032.
The Preclinical Bioanalytical Testing Services Market is a contract research and laboratory services segment that supports drug development by analyzing drug candidates' pharmacokinetics (PK), toxicology, biomarkers, and bioavailability prior to clinical trials. These services provide a reliable, compliant, and data-driven assessment of a molecule's safety and efficacy. The increasing number of biologics and complex modalities that require advanced analytical platforms is driving market growth. An important trend is the growing use of high-sensitivity LC-MS/MS and automation to improve throughput and data accuracy. However, the market faces constraints such as high operational costs and stringent regulatory expectations, which lengthen testing timelines. Despite these challenges, the expansion of outsourcing by pharmaceutical and biotechnology companies, particularly for specialty assays and method development, represents a significant opportunity, making preclinical bioanalytical services an essential component of modern drug discovery pipelines.
Preclinical Bioanalytical Testing Services Market- Market Dynamics
Increasing Prevalence of Chronic Diseases Propel Growth In The Market
The rising prevalence of chronic diseases is expected to drive future growth in the preclinical bioanalytical testing services market. Chronic disease is a type of illness that lasts three months or longer and can deteriorate over time. Bioanalytical testing services assist in identifying and measuring specific biomarkers associated with chronic diseases, as well as therapeutic drug monitoring, ensuring that drug levels in the patient's body remain within the therapeutic range. For instance, according to the National Library of Medicine, a US-based agency, the number of people in the US aged 50 and older who have at least one chronic condition will rise by 99.5%, or 142.66 million, by 2050. Furthermore, the World Health Organization (WHO) 2022 Highlights, a Switzerland-based intergovernmental health organization, reported 41 million deaths in September 2022, accounting for 74% of all deaths caused by noncommunicable diseases (NCDs) or chronic diseases worldwide. As a result, the rising prevalence of chronic diseases fuels the expansion of the Preclinical bioanalytical testing services industry.
The Global Preclinical Bioanalytical Testing Services Market is segmented by Workflow, Molecule, Test, End Use and Region.
According to the test, the bioavailability test segment will be the most important in the market for bioanalytical testing services. Bioavailability is critical in determining the efficacy of a new drug's pharmacokinetic profile after administration in clinical trials. Furthermore, there has been an increase in the number of active clinical trials. As a result, incorporating bioavailability testing into these trials is critical to ensuring consistency and stability among formulations used, ultimately improving patient outcomes. For instance, according to a report published in February 2023 by the WHO International Clinical Trials Registry Platform (ICTRP), clinical trial registrations in the Western Pacific region increased significantly in 2022. This increase is primarily due to the large number of clinical trial registrations in China and Japan, which rank first and second in the region, respectively.
By Workflow, the Sample Collection and Preparation segment takes over the market due to its selectivity, convenience, speed, and extraction phase configurations. Technology-driven sample preparations are being developed to meet the growing demand for automation, reduced solvent usage, and miniaturization, resulting in on-site, in situ, and in vivo applications. For example, in November 2023, Thermo Fisher Scientific introduced automated sample preparation solutions for laboratories certified for in vitro diagnostics (IVD) and in vitro diagnostic regulation (IVD-R). The new solutions will help to improve and automate respiratory diagnostic testing.
Preclinical Bioanalytical Testing Services Market- Geographical Insights
North America stands out in the preclinical bioanalytical testing services market due to its innovative spirit and robust infrastructure. The region boasts well-established and developed facilities. The United States, in particular, has a high demand for bioanalytical testing services due to its large pharmaceutical and biotechnology industries. Furthermore, strict FDA regulations in the region ensure that pharmaceutical companies maintain high-quality testing standards, necessitating bioanalytical testing services. As a result, major companies are expanding their testing service portfolios to meet rising demand. In August 2024, SGS Societe Generale de Surveillance SA launched its new bioanalytical testing services in North America with the help of Agilex Biolabs Pty Ltd. This expansion expands testing solutions and boosts market growth by offering comprehensive support for clinical trials and drug development.
United States Preclinical Bioanalytical Testing Services Market- Country Insights
The US market is rapidly expanding, owing to increased demand for precision medicine and an expanding pipeline of biologics and biosimilars. According to industry reports, the United States had 64 approved biosimilars as of December 2024, demonstrating the country's leadership in biologics innovation and the resulting demand for bioanalytical validation. The growing importance of pharmacokinetic and pharmacodynamic studies in drug development has increased the demand for specialized analytical methods. Furthermore, increased funding for life sciences research and a strong emphasis on regulatory compliance have prompted the outsourcing of bioanalytical testing to ensure consistent data quality. The application of cutting-edge technologies in analytical workflows, such as high-throughput screening and LC-MS/MS, improves result accuracy and turnaround time.
The preclinical bioanalytical testing services market has a competitive landscape that includes a large number of players, ranging from established companies to emerging startups. The market is highly fragmented, with key players prioritizing strategic collaborations, mergers and acquisitions, and technological advancements to strengthen their market positions. The growing demand for specialized bioanalytical services, fueled by advances in pharmaceutical and biotechnology research, has increased competition, prompting businesses to broaden their service offerings and geographic reach. The emphasis on quality, dependability, and regulatory compliance remains a critical differentiator in this competitive environment. Major companies in the bioanalytical testing services market include Thermo Fisher Scientific Inc (PPD, Inc.), Parexel International, Pharmaron, and BioAgilytix Labs. These companies have established themselves as industry leaders, providing a wide range of bioanalytical services to pharmaceutical and biotechnology companies.
In June 2024, Lebanon, a New Jersey laboratory facility in Curia, was acquired by Pace Analytical Services. The acquisition will offer support to drug development partners that are new in the market by providing rapid and highly expert development and analytical laboratory services on a commercial basis across the biopharma sector.
In November of 2024, Altasciences stated that it has expanded its bioanalytical service portfolio by providing flexible, high-quality analytical solutions for preclinical and clinical studies, reinforcing its 30-year commitment to accelerating global drug development and client success.