The U.S. bioanalytical testing services market size is anticipated to reach USD 3.39 billion by 2030 and is expected to expand at a CAGR of 9.33% during the forecast period, according to a new report by Grand View Research, Inc. The market is driven by a surge in drug development and the increasing complexity of therapeutic modalities.

As pharmaceutical and biopharmaceutical companies race to bring new treatments to market, especially biologics, biosimilars, and gene therapies, the demand for precise and reliable bioanalytical testing has intensified. This is further amplified by stringent FDA regulations that mandate rigorous pharmacokinetic, pharmacodynamic, and bioequivalence assessments, prompting companies to seek specialized testing services that meet regulatory standards.

Outsourcing has become a strategic imperative for many sponsors, allowing them to streamline operations and access advanced technologies without the overhead of maintaining in-house labs. Contract research organizations (CROs) and CDMOs are stepping up with state-of-the-art facilities equipped with high-resolution mass spectrometry (HRMS), next-generation sequencing (NGS), and automation platforms that deliver faster, more accurate results. These innovations enhance testing capabilities and reduce turnaround times and operational costs, making them highly attractive to industry players.

Moreover, the rise of personalized medicine and complex biologics is reshaping the landscape, requiring more sophisticated assays and biomarker analyses. This shift is encouraging long-term partnerships between sponsors and service providers and significant investments in infrastructure expansion.

Further key findings from the report suggest:

  • Based on molecule, the market is classified into small molecule, and large molecule. 
  • Based on test, the bioavailability segment accounted for the largest market share in 2024.
  • By workflow, the sample analysis segment accounted for the largest revenue share in 2024.
  • Based on end use, the market is segregated into pharma & biopharma companies, CDMO, CRO, and others. The pharma & biopharma companies segment dominated in 2024 and is expected to grow at the fastest CAGR during the forecast period.
  • In March 2025, NAMSA announced the acquisition of WuXi AppTec's U.S. medical device testing operations. This acquisition will unite two companies specializing in biological safety testing for medical devices, benefiting over 4,000 manufacturers worldwide.

List of Key Players in the U.S. Bioanalytical Testing Services Market

  • 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)

Order a free sample PDF of the U.S. Bioanalytical Testing Services Market Intelligence Study, published by Grand View Research.