United States Bioanalytical Testing Services Market By Molecule (Small Molecule, Large Molecule), By Test (ADME, Pharmacokinetics (PK), Pharmacodynamics (PD), Bioavailability, Bioequivalence, Biomarker Testing, Cell-based Assay, Virology Testing, Others), By Workflow (Sample Collection and Preparation, Method Development and Validation, Sample Analysis, Other Processes), By End User (Pharma & BioPharma Companies, CDMO, CRO, Others), By Region, Competition, Forecast & Opportunities, 2020-2030F
Market Overview
The United States Bioanalytical Testing Services Market was valued at USD 2.03 billion in 2024 and is projected to reach USD 3.49 billion by 2030, expanding at a CAGR of 9.41% during the forecast period. This market is witnessing strong growth due to the expanding pipeline of biologics and biosimilars and the rising number of clinical trials. As pharmaceutical and biotechnology companies increasingly shift from small-molecule drugs to complex biologics, there is heightened demand for specialized testing services, including pharmacokinetics (PK), pharmacodynamics (PD), and bioequivalence studies. Outsourcing bioanalytical services helps streamline development timelines and ensures regulatory compliance, particularly with stringent U.S. FDA requirements. The emergence of personalized medicine and targeted therapies further boosts the need for tailored testing methodologies and advanced analytical technologies. Innovations such as high-resolution mass spectrometry, automated platforms, and LIMS are improving testing precision and scalability. Moreover, the proliferation of GLP and GCLP-compliant labs, combined with real-time analytics and data-driven decision-making, is enhancing efficiency and supporting market expansion.
Key Market Drivers
Increasing Demand for Biologics and Biosimilars
The growing demand for biologics and biosimilars is a significant catalyst in the U.S. bioanalytical testing services market. The development of monoclonal antibodies, vaccines, gene therapies, and cell-based treatments requires robust and highly sensitive analytical methods, including ligand-binding assays and immunogenicity testing. Unlike traditional small-molecule drugs, biologics necessitate extensive PK/PD evaluations and rigorous validation to ensure quality and regulatory compliance. The FDA’s approval of 19 biosimilars in 2024 alone—including those for ustekinumab and denosumab—highlights the accelerating pace of biosimilar integration. With 63 FDA-approved biosimilars across 17 reference products to date, the industry’s focus on therapeutic equivalence, efficacy, and safety continues to drive demand for comprehensive and advanced testing services.
Key Market Challenges
High Operational Costs and Capital Investment Requirements
High operational expenses and capital investment needs pose major challenges to the growth of the U.S. bioanalytical testing services market. Laboratories must invest in advanced instruments like mass spectrometers and chromatographs, which are not only expensive to acquire but also costly to maintain and calibrate. Ensuring compliance with regulatory standards such as those enforced by the FDA and EMA demands further financial commitments for audits, certifications, and documentation. Adhering to GLP and GMP guidelines increases operational complexity and overhead. Small and mid-sized laboratories often struggle with limited access to capital and may lack the infrastructure to compete with larger, established players. These financial barriers can restrict market entry, slow innovation, and hinder expansion efforts, especially for emerging service providers.
Key Market Trends
Rising Emphasis on Biomarker Development and Companion Diagnostics
Biomarker development and companion diagnostics are emerging as pivotal trends in the U.S. bioanalytical testing services market. Biomarkers are essential for diagnosing diseases, predicting treatment responses, and tailoring personalized therapies. Companion diagnostics help identify patients most likely to benefit from specific drugs, thereby aligning treatment strategies with individual genetic profiles. In oncology, tests like FoundationOne Liquid CDx, which detects mutations in solid tumors, exemplify how diagnostics are driving precision medicine. Regulatory backing and funding initiatives from agencies such as the NIH—through programs like PAR-25-024—are promoting biomarker validation and adoption in clinical trials. These efforts underscore the strategic shift toward more personalized and targeted healthcare solutions, increasing demand for specialized bioanalytical services to support drug development pipelines.
Key Market Players
In this report, the United States Bioanalytical Testing Services Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies present in the United States Bioanalytical Testing Services Market.
Available Customizations:
United States Bioanalytical Testing Services Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:
Company Information
The United States Bioanalytical Testing Services Market was valued at USD 2.03 billion in 2024 and is projected to reach USD 3.49 billion by 2030, expanding at a CAGR of 9.41% during the forecast period. This market is witnessing strong growth due to the expanding pipeline of biologics and biosimilars and the rising number of clinical trials. As pharmaceutical and biotechnology companies increasingly shift from small-molecule drugs to complex biologics, there is heightened demand for specialized testing services, including pharmacokinetics (PK), pharmacodynamics (PD), and bioequivalence studies. Outsourcing bioanalytical services helps streamline development timelines and ensures regulatory compliance, particularly with stringent U.S. FDA requirements. The emergence of personalized medicine and targeted therapies further boosts the need for tailored testing methodologies and advanced analytical technologies. Innovations such as high-resolution mass spectrometry, automated platforms, and LIMS are improving testing precision and scalability. Moreover, the proliferation of GLP and GCLP-compliant labs, combined with real-time analytics and data-driven decision-making, is enhancing efficiency and supporting market expansion.
Key Market Drivers
Increasing Demand for Biologics and Biosimilars
The growing demand for biologics and biosimilars is a significant catalyst in the U.S. bioanalytical testing services market. The development of monoclonal antibodies, vaccines, gene therapies, and cell-based treatments requires robust and highly sensitive analytical methods, including ligand-binding assays and immunogenicity testing. Unlike traditional small-molecule drugs, biologics necessitate extensive PK/PD evaluations and rigorous validation to ensure quality and regulatory compliance. The FDA’s approval of 19 biosimilars in 2024 alone—including those for ustekinumab and denosumab—highlights the accelerating pace of biosimilar integration. With 63 FDA-approved biosimilars across 17 reference products to date, the industry’s focus on therapeutic equivalence, efficacy, and safety continues to drive demand for comprehensive and advanced testing services.
Key Market Challenges
High Operational Costs and Capital Investment Requirements
High operational expenses and capital investment needs pose major challenges to the growth of the U.S. bioanalytical testing services market. Laboratories must invest in advanced instruments like mass spectrometers and chromatographs, which are not only expensive to acquire but also costly to maintain and calibrate. Ensuring compliance with regulatory standards such as those enforced by the FDA and EMA demands further financial commitments for audits, certifications, and documentation. Adhering to GLP and GMP guidelines increases operational complexity and overhead. Small and mid-sized laboratories often struggle with limited access to capital and may lack the infrastructure to compete with larger, established players. These financial barriers can restrict market entry, slow innovation, and hinder expansion efforts, especially for emerging service providers.
Key Market Trends
Rising Emphasis on Biomarker Development and Companion Diagnostics
Biomarker development and companion diagnostics are emerging as pivotal trends in the U.S. bioanalytical testing services market. Biomarkers are essential for diagnosing diseases, predicting treatment responses, and tailoring personalized therapies. Companion diagnostics help identify patients most likely to benefit from specific drugs, thereby aligning treatment strategies with individual genetic profiles. In oncology, tests like FoundationOne Liquid CDx, which detects mutations in solid tumors, exemplify how diagnostics are driving precision medicine. Regulatory backing and funding initiatives from agencies such as the NIH—through programs like PAR-25-024—are promoting biomarker validation and adoption in clinical trials. These efforts underscore the strategic shift toward more personalized and targeted healthcare solutions, increasing demand for specialized bioanalytical services to support drug development pipelines.
Key Market 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.
In this report, the United States Bioanalytical Testing Services Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
- United States Bioanalytical Testing Services Market, By Molecule:
- Small Molecule
- Large Molecule
- United States Bioanalytical Testing Services Market, By Test:
- ADME
- Pharmacokinetics (PK)
- Pharmacodynamics (PD)
- Bioavailability
- Bioequivalence
- Biomarker Testing
- Cell-based Assay
- Virology Testing
- Others
- United States Bioanalytical Testing Services Market, By Workflow:
- Sample Collection and Preparation
- Method Development and Validation
- Sample Analysis
- Other Processes
- United States Bioanalytical Testing Services Market, By End User:
- Pharma & BioPharma Companies
- CDMO
- CRO
- Others
- United States Bioanalytical Testing Services Market, By Region:
- North-East
- Mid-West
- West
- South
Company Profiles: Detailed analysis of the major companies present in the United States Bioanalytical Testing Services Market.
Available Customizations:
United States Bioanalytical Testing Services Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:
Company Information
- Detailed analysis and profiling of additional market players (up to five).
1. PRODUCT OVERVIEW
1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations
2. RESEARCH METHODOLOGY
2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations
3. EXECUTIVE SUMMARY
3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, Trends
4. VOICE OF CUSTOMER
5. UNITED STATES BIOANALYTICAL TESTING SERVICES MARKET OUTLOOK
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Molecule (Small Molecule, Large Molecule)
5.2.2. By Test (ADME, Pharmacokinetics (PK), Pharmacodynamics (PD), Bioavailability, Bioequivalence, Biomarker Testing, Cell-based Assay, Virology Testing, Others)
5.2.3. By Workflow (Sample Collection and Preparation, Method Development and Validation, Sample Analysis, Other Processes)
5.2.4. By End User (Pharma & BioPharma Companies, CDMO, CRO, Others)
5.2.5. By Region
5.2.6. By Company (2024)
5.3. Market Map
6. NORTH-EAST BIOANALYTICAL TESTING SERVICES MARKET OUTLOOK
6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Molecule
6.2.2. By Test
6.2.3. By Workflow
6.2.4. By End User
7. MID-WEST BIOANALYTICAL TESTING SERVICES MARKET OUTLOOK
7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Molecule
7.2.2. By Test
7.2.3. By Workflow
7.2.4. By End User
8. WEST BIOANALYTICAL TESTING SERVICES MARKET OUTLOOK
8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Molecule
8.2.2. By Test
8.2.3. By Workflow
8.2.4. By End User
9. SOUTH BIOANALYTICAL TESTING SERVICES MARKET OUTLOOK
9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Molecule
9.2.2. By Test
9.2.3. By Workflow
9.2.4. By End User
10. MARKET DYNAMICS
10.1. Drivers
10.2. Challenges
11. MARKET TRENDS & DEVELOPMENTS
11.1. Merger & Acquisition (If Any)
11.2. Product Launches (If Any)
11.3. Recent Developments
12. POLICY & REGULATORY LANDSCAPE
13. UNITED STATES ECONOMIC PROFILE
14. UNITED STATES BIOANALYTICAL TESTING SERVICES MARKET: SWOT ANALYSIS
15. PORTER’S FIVE FORCES ANALYSIS
15.1. Competition in the Industry
15.2. Potential of New Entrants
15.3. Power of Suppliers
15.4. Power of Customers
15.5. Threat of Substitute Products
16. COMPETITIVE LANDSCAPE
16.1. Thermo Fisher Scientific, Inc.
16.1.1. Business Overview
16.1.2. Company Snapshot
16.1.3. Products & Services
16.1.4. Financials (As Reported)
16.1.5. Recent Developments
16.1.6. Key Personnel Details
16.1.7. SWOT Analysis
16.2. ICON plc
16.3. Charles River Laboratories International, Inc.
16.4. Laboratory Corporation of America Holdings.
16.5. IQVIA Inc.
16.6. Syneos Health
16.7. SGS SA
16.8. Intertek Group Plc
16.9. Pace Analytical Services, LLC
16.10. Medpace Holdings, Inc.
17. STRATEGIC RECOMMENDATIONS
18. ABOUT US & DISCLAIMER
1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations
2. RESEARCH METHODOLOGY
2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations
3. EXECUTIVE SUMMARY
3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, Trends
4. VOICE OF CUSTOMER
5. UNITED STATES BIOANALYTICAL TESTING SERVICES MARKET OUTLOOK
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Molecule (Small Molecule, Large Molecule)
5.2.2. By Test (ADME, Pharmacokinetics (PK), Pharmacodynamics (PD), Bioavailability, Bioequivalence, Biomarker Testing, Cell-based Assay, Virology Testing, Others)
5.2.3. By Workflow (Sample Collection and Preparation, Method Development and Validation, Sample Analysis, Other Processes)
5.2.4. By End User (Pharma & BioPharma Companies, CDMO, CRO, Others)
5.2.5. By Region
5.2.6. By Company (2024)
5.3. Market Map
6. NORTH-EAST BIOANALYTICAL TESTING SERVICES MARKET OUTLOOK
6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Molecule
6.2.2. By Test
6.2.3. By Workflow
6.2.4. By End User
7. MID-WEST BIOANALYTICAL TESTING SERVICES MARKET OUTLOOK
7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Molecule
7.2.2. By Test
7.2.3. By Workflow
7.2.4. By End User
8. WEST BIOANALYTICAL TESTING SERVICES MARKET OUTLOOK
8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Molecule
8.2.2. By Test
8.2.3. By Workflow
8.2.4. By End User
9. SOUTH BIOANALYTICAL TESTING SERVICES MARKET OUTLOOK
9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Molecule
9.2.2. By Test
9.2.3. By Workflow
9.2.4. By End User
10. MARKET DYNAMICS
10.1. Drivers
10.2. Challenges
11. MARKET TRENDS & DEVELOPMENTS
11.1. Merger & Acquisition (If Any)
11.2. Product Launches (If Any)
11.3. Recent Developments
12. POLICY & REGULATORY LANDSCAPE
13. UNITED STATES ECONOMIC PROFILE
14. UNITED STATES BIOANALYTICAL TESTING SERVICES MARKET: SWOT ANALYSIS
15. PORTER’S FIVE FORCES ANALYSIS
15.1. Competition in the Industry
15.2. Potential of New Entrants
15.3. Power of Suppliers
15.4. Power of Customers
15.5. Threat of Substitute Products
16. COMPETITIVE LANDSCAPE
16.1. Thermo Fisher Scientific, Inc.
16.1.1. Business Overview
16.1.2. Company Snapshot
16.1.3. Products & Services
16.1.4. Financials (As Reported)
16.1.5. Recent Developments
16.1.6. Key Personnel Details
16.1.7. SWOT Analysis
16.2. ICON plc
16.3. Charles River Laboratories International, Inc.
16.4. Laboratory Corporation of America Holdings.
16.5. IQVIA Inc.
16.6. Syneos Health
16.7. SGS SA
16.8. Intertek Group Plc
16.9. Pace Analytical Services, LLC
16.10. Medpace Holdings, Inc.
17. STRATEGIC RECOMMENDATIONS
18. ABOUT US & DISCLAIMER
