미국의 바이오 분석 검사 서비스 시장 규모, 점유율, 동향 분석 보고서 : 분자별, 검사별, 워크플로우별, 최종 용도별, 부문별 예측(2025-2030년)

Market Size & Trends:

The U.S. bioanalytical testing services market size was estimated at USD 1.98 billion in 2024 and is expected to grow at a CAGR of 9.33% from 2025 to 2030. 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.

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, Grand View Research 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
  • LC-MS Studies
  • Immunoassays
  • Pharmacokinetics (PK)
  • ADA Assay
  • Other immunoassays
  • Other Large Molecule Tests
• Test Outlook (Revenue, USD Million, 2018 - 2030)
• ADME
  • In-vivo
  • In-vitro
• 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
  • Sample Collection, Handling and Storage
  • Protein Precipitation
  • Liquid-Liquid Extraction
  • Solid Phase Extraction
  • Others
• Method Development and Validation
• Sample Analysis
  • Hyphenated Technique
  • Chromatographic Technique
  • Electrophoresis
  • Ligand Binding Assay
  • Mass Spectrometry
  • Spectroscopic Techniques
  • Nuclear Magnetic Resonance (NMR)
  • Others
  • Genomic and Molecular Techniques
  • Polymerase Chain Reaction (PCR)
  • Next-Generation Sequencing (NGS)
  • Others
• Other Processes
• End Use Outlook (Revenue, USD Million, 2018 - 2030)
• Pharma & BioPharma Companies
• CDMO
• CRO
• Others

Table of Contents

Chapter 1. Research Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Molecule
  • 1.2.2. Test
  • 1.2.3. Workflow
  • 1.2.4. End Use
• 1.3. Research Methodology
• 1.4. Information Procurement
  • 1.4.1. Purchased Database
  • 1.4.2. GVR's Internal Database
  • 1.4.3. Secondary Sources
  • 1.4.4. Primary Research
• 1.5. Information Or Data Analysis
  • 1.5.1. Data Analysis Models
• 1.6. Market Formulation & Validation
• 1.7. Model Details
  • 1.7.1. Commodity Flow Analysis
  • 1.7.2. Parent Market Analysis
• 1.8. List Of Secondary Sources
• 1.9. List Of Abbreviations
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
• 2.3. Competitive Insights

Chapter 3. U.S. Bioanalytical Testing Services Market Variables, Trends & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Related/Ancillary Market Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
    • 3.2.1.1. Technological Advancements & Growing R&D Investments
    • 3.2.1.2. Regulatory Control and Increasing Awareness Regarding Bioanalytical Testing
    • 3.2.1.3. Expansion of Bioanalytical Testing Facilities
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Compliance Issues While Outsourcing
    • 3.2.2.2. Data Security Concerns
• 3.3. Investments & Funding Perspective
• 3.4. Clinical Trials Volume Analysis, (2024)
  • 3.4.1. Total Number Of Clinical Trials By Region (2024)
  • 3.4.2. Total Number Of Clinical Trials, By Phase (2024)
  • 3.4.3. Total Number Of Clinical Trials, By Study Design (2024)
  • 3.4.4. Total Number Of Clinical Trials, By Key Therapeutic Area (2024)
• 3.5. Pricing Model Analysis
• 3.6. Technology Landscape
• 3.7. Regulatory Framework
• 3.8. Market Analysis Tools
  • 3.8.1. Porter's Five Force Analysis
  • 3.8.2. PESTEL by SWOT Analysis
  • 3.8.3. COVID-19 Impact Analysis

Chapter 4. U.S. Bioanalytical Testing Services Market: Molecule Estimates & Trend Analysis

• 4.1. U.S. Bioanalytical Testing Services Market, By Molecule: Segment Dashboard
• 4.2. U.S. Bioanalytical Testing Services Market, By Molecule: Movement Analysis
• 4.3. U.S. Bioanalytical Testing Services Market Estimates & Forecasts, By Molecule, 2018 - 2030 (USD Million)
• 4.4. Small Molecule
  • 4.4.1. Small Molecule Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.5. Large Molecule
  • 4.5.1. Large Molecule Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.5.2. LC-MS Studies
    • 4.5.2.1. LC-MS Studies Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.5.3. Immunoassays
    • 4.5.3.1. Immunoassays Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 4.5.3.2. Pharmacokinetics (PK)
      • 4.5.3.2.1. Pharmacokinetics (PK) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 4.5.3.3. ADA Assay
      • 4.5.3.3.1. ADA Assay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 4.5.3.4. Other
      • 4.5.3.4.1. Other Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.5.4. Other Large Molecule Tests
    • 4.5.4.1. Other Large Molecule Tests Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 5. U.S. Bioanalytical Testing Services Market: Test Estimates & Trend Analysis

• 5.1. U.S. Bioanalytical Testing Services Market, By Test: Segment Dashboard
• 5.2. U.S. Bioanalytical Testing Services Market, By Test: Movement Analysis
• 5.3. U.S. Bioanalytical Testing Services Market Estimates & Forecasts, By Test, 2018 - 2030 (USD Million)
• 5.4. ADME
  • 5.4.1. ADME Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 5.4.2. In-vivo
    • 5.4.2.1. In-vivo Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 5.4.3. In-vitro
    • 5.4.3.1. In-vitro Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.5. Pharmacokinetics (PK)
  • 5.5.1. Pharmacokinetics (PK) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.6. Pharmacodynamics (PD)
  • 5.6.1. Pharmacodynamics (PD) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.7. Bioavailability
  • 5.7.1. Bioavailability Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.8. Bioequivalence
  • 5.8.1. Bioequivalence Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.9. Biomarker Testing
  • 5.9.1. Biomarker Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.10. Cell-based Assay
  • 5.10.1. Cell-based Assay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.11. Virology Testing
  • 5.11.1. Virology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.12. Other Tests
  • 5.12.1. Other Tests Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 6. U.S. Bioanalytical Testing Services Market: Workflow Estimates & Trend Analysis

• 6.1. U.S. Bioanalytical Testing Services Market, By Workflow: Segment Dashboard
• 6.2. U.S. Bioanalytical Testing Services Market, By Workflow Movement Analysis
• 6.3. U.S. Bioanalytical Testing Services Market Estimates & Forecasts, By Workflow, 2018 - 2030 (USD Million)
• 6.4. Sample Collection and Preparation
  • 6.4.1. Sample Collection and Preparation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.4.2. Sample Collection, Handling and Storage
    • 6.4.2.1. Sample Collection, Handling and Storage Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.4.3. Protein Precipitation
    • 6.4.3.1. Protein Precipitation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.4.4. Liquid-Liquid Extraction
    • 6.4.4.1. Liquid-Liquid Extraction Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.4.5. Solid Phase Extraction
    • 6.4.5.1. Solid Phase Extraction Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.4.6. Others
    • 6.4.6.1. Others Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.5. Method Development and Validation
  • 6.5.1. Method Development and Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.6. Sample Analysis
  • 6.6.1. Sample Analysis Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.2. Hyphenated Technique
    • 6.6.2.1. Hyphenated Technique Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.3. Chromatographic technique
    • 6.6.3.1. Chromatographic Technique Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.4. Electrophoresis
    • 6.6.4.1. Electrophoresis Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.5. Ligand Binding Assay
    • 6.6.5.1. Ligand Binding Assay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.6. Mass Spectrometry
    • 6.6.6.1. Mass Spectrometry Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.7. Spectroscopic Techniques
    • 6.6.7.1. Spectroscopic Techniques Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.6.7.2. Nuclear Magnetic Resonance (NMR)
      • 6.6.7.2.1. Nuclear Magnetic Resonance (NMR) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.6.7.3. Others
      • 6.6.7.3.1. Others Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.8. Genomic and Molecular Techniques
    • 6.6.8.1. Genomic and Molecular Techniques Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.6.8.2. Polymerase Chain Reaction (PCR)
      • 6.6.8.2.1. Polymerase Chain Reaction (PCR) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.6.8.3. Next-Generation Sequencing (NGS)
      • 6.6.8.3.1. Next-Generation Sequencing (NGS) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.6.8.4. Others
      • 6.6.8.4.1. Others Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.7. Other Processes
  • 6.7.1. Other Processes Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 7. U.S. Bioanalytical Testing Services Market: End Use Estimates & Trend Analysis

• 7.1. U.S. Bioanalytical Testing Services Market, By End Use: Segment Dashboard
• 7.2. U.S. Bioanalytical Testing Services Market, By End Use: Movement Analysis
• 7.3. U.S. Bioanalytical Testing Services Market Estimates & Forecasts, By End Use, 2018 - 2030 (USD Million)
• 7.4. Pharma & BioPharma Companies
  • 7.4.1. Pharma & BioPharma Companies Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.5. CDMO
  • 7.5.1. CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.6. CRO
  • 7.6.1. CRO Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.7. Others
  • 7.7.1. Others Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Market Participant Categorization
• 8.2. Company Market Share/Assessment Analysis, 2024
• 8.3. Company Profiles
  • 8.3.1. Thermo Fisher Scientific, Inc.
    • 8.3.1.1. Company Overview
    • 8.3.1.2. Financial Performance
    • 8.3.1.3. Service Benchmarking
    • 8.3.1.4. Strategic Initiatives
  • 8.3.2. ICON plc
    • 8.3.2.1. Company Overview
    • 8.3.2.2. Financial Performance
    • 8.3.2.3. Service Benchmarking
    • 8.3.2.4. Strategic Initiatives
  • 8.3.3. Charles River Laboratories International, Inc.
    • 8.3.3.1. Company Overview
    • 8.3.3.2. Financial Performance
    • 8.3.3.3. Service Benchmarking
    • 8.3.3.4. Strategic Initiatives
  • 8.3.4. Laboratory Corporation of America Holdings.
    • 8.3.4.1. Company Overview
    • 8.3.4.2. Financial Performance
    • 8.3.4.3. Service Benchmarking
    • 8.3.4.4. Strategic Initiatives
  • 8.3.5. IQVIA Inc.
    • 8.3.5.1. Company Overview
    • 8.3.5.2. Financial Performance
    • 8.3.5.3. Service Benchmarking
    • 8.3.5.4. Strategic Initiatives
  • 8.3.6. Syneos Health
    • 8.3.6.1. Company Overview
    • 8.3.6.2. Financial Performance
    • 8.3.6.3. Service Benchmarking
    • 8.3.6.4. Strategic Initiatives
  • 8.3.7. SGS SA
    • 8.3.7.1. Company Overview
    • 8.3.7.2. Financial Performance
    • 8.3.7.3. Service Benchmarking
    • 8.3.7.4. Strategic Initiatives
  • 8.3.8. Intertek Group Plc
    • 8.3.8.1. Company Overview
    • 8.3.8.2. Financial Performance
    • 8.3.8.3. Service Benchmarking
    • 8.3.8.4. Strategic Initiatives
  • 8.3.9. Pace Analytical Services, LLC
    • 8.3.9.1. Company Overview
    • 8.3.9.2. Financial Performance
    • 8.3.9.3. Service Benchmarking
    • 8.3.9.4. Strategic Initiatives
  • 8.3.10. Medpace Holdings, Inc.
    • 8.3.10.1. Company Overview
    • 8.3.10.2. Financial Performance
    • 8.3.10.3. Service Benchmarking
    • 8.3.10.4. Strategic Initiatives
  • 8.3.11. North America Science Associates Inc. (NAMSA)
    • 8.3.11.1. Company Overview
    • 8.3.11.2. Financial Performance
    • 8.3.11.3. Service Benchmarking
    • 8.3.11.4. Strategic Initiatives