The U.S. Bioanalytical Testing Services Market was valued at USD 1.98 Billion in 2024, and is projected to reach USD 3.39 Billion by 2030, rising at a CAGR of 9.33%. The growth of the U.S. bioanalytical testing services industry is driven by several factors, such as the rising drug development and approval process, growing demand for biologics, biosimilars, and gene therapies, and rising outsourcing of testing services. In addition, Stringent FDA regulations are driving the need for precise bioanalytical testing. Furthermore, the expansion of bioanalytical testing facilities is another key aspect driving the market growth.
Several industry players and biopharmaceutical companies are investing significantly to upgrade and expand their testing infrastructure to meet the growing demand for advanced bioanalytical services. Moreover, a surge in the number of complex biologics, biosimilars, gene therapies, and personalized medicine development is further creating the need for sophisticated testing platforms to perform complex bioanalyses, such as pharmacokinetics, biomarker discovery, and immunogenicity assessments.
Moreover, several service providers are developing state-of-the-art facilities integrated with high-resolution mass spectrometry (HRMS), NGS, and automation technologies to offer faster, more accurate, and cost-effective bioanalytical testing, further propelling market progression. For instance, in September 2024, Laboratory Corporation of America Holdings announced the completion expansion of its laboratory in Greenfield. The expansion aimed to o support the development and validation of preclinical and clinical molecular bioanalytical testing services for advanced therapies, including cell and gene therapies for rare diseases, oncology, and other therapeutic areas. This expansion offered a competitive advantage to the firm.
Increasing regulatory control and awareness regarding the importance of bioanalytical testing are key factors propelling the growth of the bioanalytical testing service market. The introduction of stringent guidelines on drug development, particularly in pharmacokinetics, pharmacodynamics, and bioequivalence testing by several regulatory agencies, such as the U.S. FDA and EMA, leads to a rising preference for outsourcing. These guidelines highlight the need for precise and reliable bioanalytical methods to enhance the safety and efficacy of new drugs & biosimilars. For instance, the U.S. FDA’s Bioanalytical Method Validation Guidance provides clear standards for method development, validation, and sample analysis, which have driven pharmaceutical companies to seek specialized expertise from contract service providers. Moreover, the market participants assist sponsors in complying with regulatory requirements by offering advanced analytical platforms and standardized protocols, driving market demand.
Likewise, technological advancements and growing R&D investments are key factors driving the U.S. bioanalytical testing service industry growth. The continuous developments of innovative technologies, such as High-Throughput Screening (HTS), Liquid Chromatography-Mass Spectrometry (LC-MS), and Next-generation Sequencing (NGS), have significantly enhanced the precision, speed, and sensitivity of bioanalytical testing. These innovations assist service providers in conducting more complex studies and gaining accurate data on drug efficacy, safety, and pharmacokinetics, among others. Moreover, integrating automation and Artificial Intelligence (AI) into bioanalytical workflows streamlined processes, reduced human error, and improved throughput. Such factors are anticipated to drive the market over the estimated period.
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Several industry players and biopharmaceutical companies are investing significantly to upgrade and expand their testing infrastructure to meet the growing demand for advanced bioanalytical services. Moreover, a surge in the number of complex biologics, biosimilars, gene therapies, and personalized medicine development is further creating the need for sophisticated testing platforms to perform complex bioanalyses, such as pharmacokinetics, biomarker discovery, and immunogenicity assessments.
Moreover, several service providers are developing state-of-the-art facilities integrated with high-resolution mass spectrometry (HRMS), NGS, and automation technologies to offer faster, more accurate, and cost-effective bioanalytical testing, further propelling market progression. For instance, in September 2024, Laboratory Corporation of America Holdings announced the completion expansion of its laboratory in Greenfield. The expansion aimed to o support the development and validation of preclinical and clinical molecular bioanalytical testing services for advanced therapies, including cell and gene therapies for rare diseases, oncology, and other therapeutic areas. This expansion offered a competitive advantage to the firm.
Increasing regulatory control and awareness regarding the importance of bioanalytical testing are key factors propelling the growth of the bioanalytical testing service market. The introduction of stringent guidelines on drug development, particularly in pharmacokinetics, pharmacodynamics, and bioequivalence testing by several regulatory agencies, such as the U.S. FDA and EMA, leads to a rising preference for outsourcing. These guidelines highlight the need for precise and reliable bioanalytical methods to enhance the safety and efficacy of new drugs & biosimilars. For instance, the U.S. FDA’s Bioanalytical Method Validation Guidance provides clear standards for method development, validation, and sample analysis, which have driven pharmaceutical companies to seek specialized expertise from contract service providers. Moreover, the market participants assist sponsors in complying with regulatory requirements by offering advanced analytical platforms and standardized protocols, driving market demand.
Likewise, technological advancements and growing R&D investments are key factors driving the U.S. bioanalytical testing service industry growth. The continuous developments of innovative technologies, such as High-Throughput Screening (HTS), Liquid Chromatography-Mass Spectrometry (LC-MS), and Next-generation Sequencing (NGS), have significantly enhanced the precision, speed, and sensitivity of bioanalytical testing. These innovations assist service providers in conducting more complex studies and gaining accurate data on drug efficacy, safety, and pharmacokinetics, among others. Moreover, integrating automation and Artificial Intelligence (AI) into bioanalytical workflows streamlined processes, reduced human error, and improved throughput. Such factors are anticipated to drive the market over the estimated period.
U.S. Bioanalytical Testing Services Market Report: Segmentation
This report forecasts revenue growth at country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, the analyst has segmented the U.S. bioanalytical testing services market report based on molecule, test, workflow, and end-use:Molecule Outlook (Revenue, USD Million, 2018-2030)
- Small Molecule
- Large Molecule
Test Outlook (Revenue, USD Million, 2018-2030)
- ADME
- Pharmacokinetics (PK)
- Pharmacodynamics (PD)
- Bioavailability
- Bioequivalence
- Biomarker Testing
- Cell-based Assay
- Virology Testing
- Other Tests
Workflow Outlook (Revenue, USD Million, 2018-2030)
- Sample Collection and Preparation
- Method Development and Validation
- Sample Analysis
- Other Processes
End Use Outlook (Revenue, USD Million, 2018-2030)
- Pharma & BioPharma Companies
- CDMO
- CRO
- Others
Why Should You Buy This Report?
- Comprehensive Market Analysis: Gain detailed insights into the market across major regions and segments.
- Competitive Landscape: Explore the market presence of key players.
- Future Trends: Discover the pivotal trends and drivers shaping the future of the market.
- Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.
This report addresses:
- Market intelligence to enable effective decision-making
- Market estimates and forecasts from 2018 to 2030
- Growth opportunities and trend analyses
- Segment and regional revenue forecasts for market assessment
- Competition strategy and market share analysis
- Product innovation listings for you to stay ahead of the curve
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Table of Contents
Chapter 1. Research Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. U.S. Bioanalytical Testing Services Market Variables, Trends & Scope
Chapter 4. U.S. Bioanalytical Testing Services Market: Molecule Estimates & Trend Analysis
Chapter 5. U.S. Bioanalytical Testing Services Market: Test Estimates & Trend Analysis
Chapter 6. U.S. Bioanalytical Testing Services Market: Workflow Estimates & Trend Analysis
Chapter 7. U.S. Bioanalytical Testing Services Market: End Use Estimates & Trend Analysis
Chapter 8. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
The companies profiled in this U.S. Bioanalytical Testing Services market report include:- 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)
Methodology
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Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 150 |
| Published | April 2025 |
| Forecast Period | 2024 - 2030 |
| Estimated Market Value ( USD | $ 1.98 Billion |
| Forecasted Market Value ( USD | $ 3.39 Billion |
| Compound Annual Growth Rate | 9.3% |
| Regions Covered | United States |
| No. of Companies Mentioned | 12 |
