The global market for bioanalytical testing services is on a promising trajectory, with a valuation of USD 4.78 billion in 2024 and an expected growth to approximately USD 9.68 billion by 2032. This growth, according to SNS Insider, represents a compound annual growth rate (CAGR) of 9.24% during this period.
Several factors are driving this rapid expansion. The increasing utilization of biologics, coupled with a rise in non-life-threatening diseases and stringent regulatory requirements set by drug regulatory agencies, are significant contributors. Bioanalytical testing is integral to the development process of new drugs, enabling researchers to accurately assess the safety and efficacy of their products.
The shift in the healthcare sector towards personalized medicine has further amplified the reliance on bioanalytical testing services, allowing treatments to be customized to meet individual patient needs. Additionally, the COVID-19 pandemic has underscored the critical role of these services in diagnostic testing and vaccine development.
Technological advancements, particularly in mass spectrometry and artificial intelligence, have improved the accuracy and efficiency of bioanalytical tests. While North America currently dominates this market, nations within the Asia-Pacific region are emerging as the fastest-growing markets.
A comprehensive analysis of key players in the bioanalytical testing services market reveals major companies such as Thermo Fisher Scientific Inc., Charles River Laboratories, ICON Plc, and SGS SA, among others.
In terms of market segmentation, small molecules accounted for the largest share in 2024, with 54.7%. This is primarily due to their widespread application in both generic and branded drug development, requiring less complex analytical procedures compared to large molecules. The segment for large molecules is also growing, driven by the increasing number of biologics and biosimilars in development.
When analyzing test types, pharmacokinetics (PK) testing held a dominant share of 33.2% in 2024, as it is essential for understanding drug disposition. The bioequivalence testing segment is projected to grow the fastest, driven by the rising development of generic drugs that require proof of therapeutic equivalence.
By technological approach, analytical techniques comprised the largest market segment, valued at USD 1.56 billion in 2024, due to their critical function in quantifying drugs and biomarkers. However, genomic and molecular procedures are the fastest-growing segment, largely due to the increasing focus on personalized medicine.
In terms of service type, clinical bioanalytical services led in revenue with a 48.9% share in 2024, attributed to the increasing number of global clinical trials and the outsourcing trend among biopharmaceutical companies. The custom assay development segment is experiencing rapid growth, responding to the need for tailored bioanalytical solutions.
Oncology was the largest application area in 2024, holding 37.6% of the market share, driven by a surge in oncology drug trials and regulatory focus on precision cancer therapies. Neurology is the fastest-growing application area, fueled by a robust pipeline of research and development for neurodegenerative conditions.
Regionally, North America maintained a significant market share of over 48% in 2024, bolstered by a high concentration of pharmaceutical and biopharmaceutical companies, established contract research organizations (CROs), and substantial investments in drug development. The Asia-Pacific region is recognized as the fastest-growing area for bioanalytical testing services, benefiting from lower-cost clinical trials and supportive government policies.
Recent developments in the industry include a June 2024 announcement from PPD, part of Thermo Fisher Scientific, regarding the expansion of its bioanalytical laboratory in Richmond, Virginia. This expansion aims to enhance automation technologies and increase capacity for LC-MS/MS testing to meet the growing demand for biologics and gene therapy evaluations. In March 2024, Syneos Health collaborated with a prominent Asian pharmaceutical company to bolster its bioanalytical testing capabilities in India, with a focus on high-throughput biomarker analyses and cell-based assays for oncology and immunology trials.
This market analysis highlights key trends and projections, offering insights into the evolving field of bioanalytical testing services.
