U.S. Bioanalytical Testing Services Market Summary

The U.S. bioanalytical testing services market size was estimated at USD 1.98 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 9.33% from 2025 to 2030. This robust growth trajectory is influenced by several key factors, including the increasing pace of drug development and regulatory approvals, the surging demand for biologics, biosimilars, and gene therapies, and the rising trend of outsourcing bioanalytical testing services to third-party laboratories. Additionally, stringent regulations by the U.S. Food and Drug Administration (FDA) require precise and validated testing procedures, further reinforcing the need for high-quality bioanalytical testing.

The expansion of testing infrastructure is another major driver of market growth, as numerous industry stakeholders and biopharmaceutical companies are making substantial investments to upgrade laboratory capabilities and expand service portfolios. These expansions aim to support the growing demand for complex bioanalytical assessments. Moreover, the increasing development of complex biologics, biosimilars, gene-based therapies, and personalized medicines has amplified the need for advanced analytical methods, including pharmacokinetics (PK), biomarker identification, and immunogenicity testing, to ensure product safety and efficacy.

Key Market Trends & Insights

  • Based on the type of molecule analyzed, the market is divided into small molecules and large molecules. The large molecule segment is further categorized into liquid chromatography-mass spectrometry (LC-MS) studies, immunoassays, and others. Within immunoassays, subcategories include pharmacokinetics (PK), anti-drug antibody (ADA) assays, and more. However, small molecules held the largest market share in 2024, largely due to their broad application in traditional pharmaceutical development and the relatively established testing protocols available for these compounds.
  • On the basis of test types, the market is segmented into ADME (absorption, distribution, metabolism, and excretion), pharmacokinetics (PK), pharmacodynamics (PD), bioavailability, bioequivalence, biomarker testing, cell-based assays, virology testing, and others. The ADME testing segment is further broken down into in-vivo and in-vitro testing methods, offering comprehensive insights into drug behavior and metabolism at various stages of development.
  • When analyzed by workflow, the market includes stages such as sample collection and preparation, method development and validation, sample analysis, and other associated processes. Among these, sample analysis represented the largest revenue share in 2024. The dominance of this segment is attributed to its critical role in evaluating test results, ensuring regulatory compliance, and guiding decision-making in the clinical development process.
  • Based on end-use, the market is categorized into pharmaceutical and biopharmaceutical companies, contract development and manufacturing organizations (CDMOs), contract research organizations (CROs), and others. The pharmaceutical and biopharmaceutical companies segment held the largest share in 2024 and is anticipated to expand at the fastest CAGR during the forecast period. This is due to the increasing reliance of these companies on external testing services to reduce operational burdens and accelerate the time-to-market for their therapeutics.

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Market Size & Forecast

  • 2024 Market Size: USD 1.98 billion
  • 2033 Projected Market Size: USD 3.39 billion
  • CAGR (2025 - 2033): 9.33%

Key Companies & Market Share Insights

Market players are undertaking various strategic initiatives, such as the launch of new product partnerships, collaborations, and mergers & acquisitions, to strengthen their service portfolio and provide a competitive advantage. For instance, in July 2024, Charles River Laboratories International, Inc. entered into a collaboration agreement with the FOXG1 Research Foundation (FRF) to accelerate drug development through the clinical phase for FOXG1 syndrome. Such innovations are expected to drive the market over the estimated time period.

Key Players

  • Thermo Fisher Scientific, Inc.
  • ICON plc
  • Charles River Laboratories International, Inc.
  • Laboratory Corporation of America Holdings.
  • IQVIA Inc.
  • Syneos Health
  • SGS SA
  • Intertek Group Plc
  • Pace Analytical Services, LLC
  • Medpace Holdings, Inc.
  • North America Science Associates Inc. (NAMSA)

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Conclusion

The U.S. bioanalytical testing services market is expanding rapidly, driven by innovation in biologics and gene therapies, as well as regulatory demands for precision. The growing preference for outsourcing, alongside investments in testing infrastructure, supports increased demand for high-quality services. Small molecules remain dominant, while advanced tests like ADME, PK, and immunoassays are crucial for complex therapeutics. Sample analysis leads workflow demand, and pharma and biopharma companies represent the largest and fastest-growing end users. As drug development becomes more sophisticated, the role of bioanalytical testing in ensuring safety, efficacy, and regulatory compliance will be more critical than ever.