전임상 바이오 분석 시험 시장 규모, 점유율, 동향 분석 : 분자별, 시험별, 워크플로우별, 최종 용도별, 지역별, 부문별 예측(2025-2033년)

Preclinical Bioanalytical Testing Services Market Summary

The global preclinical bioanalytical testing services market size was estimated at USD 1.17 billion in 2024 and is projected to reach USD 2.62 Billion by 2033, growing at a CAGR of 9.76% from 2025 to 2033. The market's growth is driven by the rising demand for new drug development, the increasing prevalence of chronic & rare diseases, and the expansion of biologics and cell & gene therapy development.

Furthermore, stringent regulatory requirements have heightened the need for precise pharmacokinetic and toxicokinetic analyses during preclinical studies, thereby fueling the demand for specialized bioanalytical testing services

Other factors contributing to growth include rising advances in bioanalytical technologies, such as LC-MS/MS and immunoassays, increasing cost efficiency, and the growing adoption of advanced bioanalytical technologies.

The rapid expansion of biologics, biosimilars, monoclonal antibodies, and cell and gene therapies is fueling the requirement for advanced preclinical bioanalytical testing services. The most complex molecules require highly sensitive, specific, and validated analytical methods to assess their pharmacokinetics, immunogenicity, and safety. Besides, the drug pipelines are increasingly shifting towards large-molecule therapeutics, and bioanalytical laboratories must develop innovative assays and platforms to meet regulatory expectations. This expansion drives the need for specialized expertise, validation processes, and technologies in preclinical bioanalysis to support the accurate and efficient development of drugs.

Moreover, advancements in high-sensitivity platforms transform preclinical bioanalytical testing services by enabling precise detection and quantification of low-abundance biomarkers, proteins & drug molecules. In addition, LC-MS/MS, ligand-binding assays, and hybrid technology platforms are enhancing the analytical accuracy, reproducibility, and throughput. These innovations support the characterization of complex biologics and cell or gene therapies with improved sensitivity and lower detection limits. In addition, automated sample preparation, microfluidics & multiplexing further streamline workflows, reduce variability, increase efficiency, and ensure reliable data generation, critical for early-stage drug development and regulatory compliance.

Furthermore, regulatory agencies such as the FDA, EMA, and PMDA enforce stringent guidelines for bioanalytical validation, pharmacokinetic analysis, toxicology profiling, and biomarker quantification to ensure the safety and reliability of drugs before human trials. Pharmaceutical companies rely on certified preclinical bioanalytical testing partners with GLP-compliant infrastructure, validated technologies, and robust reporting capabilities to meet regulatory expectations. This increases outsourcing preferences to minimize compliance risks, avoid delays in trial approvals, and enhance submission accuracy. As adherence to strict validation protocols becomes essential, demand for high-quality, audit-ready bioanalytical services surges, accelerating market expansion.

Global Preclinical Bioanalytical Testing Services Market Report Segmentation

This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. For this report, Grand View Research has segmented the preclinical bioanalytical testing services market report based on molecule, test, workflow, end use, and region:

• Molecule Outlook (Revenue, USD Million, 2021 - 2033)
• Small Molecule
• Large Molecule
• Test Outlook (Revenue, USD Million, 2021 - 2033)
• 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, 2021 - 2033)
• 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
  • Genomic and Molecular Techniques
• Other processes
• End Use Outlook (Revenue, USD Million, 2021 - 2033)
• Pharma & BioPharma Companies
• CDMO
• CRO
• Others
• Regional Outlook (Revenue, USD Million, 2021 - 2033)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Denmark
  • Sweden
  • Norway
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • Thailand
  • South Korea
• Latin America
  • Brazil
  • Argentina
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait
  • Oman
  • Qatar

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Market Definitions
• 1.3. Information Analysis
  • 1.3.1. Market Formulation & Data Visualization
• 1.4. Data Validation & Publishing
• 1.5. Information Procurement
  • 1.5.1. Primary Research
• 1.6. Information or Data Analysis
• 1.7. Market Formulation & Validation
• 1.8. Market Model
• 1.9. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. 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 Trends and Outlook
• 3.3. Market Dynamics
  • 3.3.1. Market Driver Analysis
  • 3.3.2. Market Restraint Analysis
• 3.4. Technology Landscape
• 3.5. Pricing Model Analysis
• 3.6. Industry Analysis Tools
  • 3.6.1. Porter's Five Forces Analysis
  • 3.6.2. PESTEL Analysis
  • 3.6.3. COVID-19 Impact Analysis

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

• 4.1. Segment Dashboard
• 4.2. Preclinical Bioanalytical Testing Services Market: Molecule Movement Analysis
• 4.3. Preclinical Bioanalytical Testing Services Size & Trend Analysis, by Molecule, 2021 to 2033 (USD Million)
• 4.4. Small Molecule
  • 4.4.1. Small molecule market estimates and forecasts 2021 to 2033 (USD Million)
• 4.5. Large Molecule
  • 4.5.1. Large molecule market estimates and forecasts 2021 to 2033 (USD Million)

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

• 5.1. Segment Dashboard
• 5.2. Preclinical Bioanalytical Testing Services Market: Test Movement Analysis
• 5.3. Preclinical Bioanalytical Testing Services Size & Trend Analysis, by Test, 2021 to 2033 (USD Million)
• 5.4. ADME
  • 5.4.1. ADME market estimates and forecasts 2021 to 2033 (USD Million)
  • 5.4.2. In-vivo
    • 5.4.2.1. In-vivo market estimates and forecasts 2021 to 2033 (USD Million)
  • 5.4.3. In-vitro
    • 5.4.3.1. In-vitro market estimates and forecasts 2021 to 2033 (USD Million)
• 5.5. Pharmacokinetics (PK)
  • 5.5.1. Pharmacokinetics (PK) market estimates and forecasts 2021 to 2033 (USD Million)
• 5.6. Pharmacodynamics (PD)
  • 5.6.1. Pharmacodynamics (PD) market estimates and forecasts 2021 to 2033 (USD Million)
• 5.7. Bioavailability
  • 5.7.1. Bioavailability market estimates and forecasts 2021 to 2033 (USD Million)
• 5.8. Bioequivalence
  • 5.8.1. Bioequivalence market estimates and forecasts 2021 to 2033 (USD Million)
• 5.9. Biomarker Testing
  • 5.9.1. Biomarker testing market estimates and forecasts 2021 to 2033 (USD Million)
• 5.10. Cell-based Assay
  • 5.10.1. Cell-based assay market estimates and forecasts 2021 to 2033 (USD Million)
• 5.11. Virology Testing
  • 5.11.1. Virology testing market estimates and forecasts 2021 to 2033 (USD Million)
• 5.12. Other Tests
  • 5.12.1. Other tests market estimates and forecasts 2021 to 2033 (USD Million)

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

• 6.1. Segment Dashboard
• 6.2. Preclinical Bioanalytical Testing Services Market: Workflow Movement Analysis
• 6.3. Preclinical Bioanalytical Testing Services Size & Trend Analysis, by Workflow, 2021 to 2033 (USD Million)
• 6.4. Sample Collection and Preparation
  • 6.4.1. Sample collection and preparation market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.4.2. Sample Collection, Handling and Storage
    • 6.4.2.1. Sample collection, handling and storage market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.4.3. Protein Precipitation
    • 6.4.3.1. Protein precipitation market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.4.4. Liquid-Liquid Extraction
    • 6.4.4.1. Liquid-Liquid extraction market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.4.5. Solid Phase Extraction
    • 6.4.5.1. Solid phase extraction market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.4.6. Others
    • 6.4.6.1. Others market estimates and forecasts 2021 to 2033 (USD Million)
• 6.5. Method Development and Validation
  • 6.5.1. Method Development and Validation market estimates and forecasts 2021 to 2033 (USD Million)
• 6.6. Sample Analysis
  • 6.6.1. Sample Analysis market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.6.2. Hyphenated technique
    • 6.6.2.1. Hyphenated technique market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.6.3. Chromatographic technique
    • 6.6.3.1. Chromatographic technique market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.6.4. Electrophoresis
    • 6.6.4.1. Electrophoresis market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.6.5. Ligand Binding Assay
    • 6.6.5.1. Ligand binding assay market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.6.6. Mass Spectrometry
    • 6.6.6.1. Mass spectrometry market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.6.7. Spectroscopic Techniques
    • 6.6.7.1. Spectroscopic techniques market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.6.8. Genomic and Molecular Techniques
    • 6.6.8.1. Genomic and molecular techniques market estimates and forecasts 2021 to 2033 (USD Million)
• 6.7. Other processes
  • 6.7.1. Other processes market estimates and forecasts 2021 to 2033 (USD Million)

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

• 7.1. Segment Dashboard
• 7.2. Preclinical Bioanalytical Testing Services Market; End Use Movement Analysis
• 7.3. Preclinical Bioanalytical Testing Services Size & Trend Analysis, by End Use, 2021 to 2033 (USD Million)
• 7.4. Pharma & BioPharma Companies
  • 7.4.1. Pharma & BioPharma Companies market estimates and forecasts 2021 to 2033 (USD Million)
• 7.5. CDMO
  • 7.5.1. CDMO market estimates and forecasts 2021 to 2033 (USD Million)
• 7.6. CRO
  • 7.6.1. CRO market estimates and forecasts 2021 to 2033 (USD Million)
• 7.7. Others
  • 7.7.1. Others market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 8. Preclinical Bioanalytical Testing Services Market: Regional Business Analysis

• 8.1. Regional Dashboard
• 8.2. Market Size & Forecasts and Trend Analysis, 2021 to 2033
• 8.3. North America
  • 8.3.1. North America preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.3.2. U.S.
    • 8.3.2.1. Key Country Dynamics
    • 8.3.2.2. Competitive Scenario
    • 8.3.2.3. Regulatory Framework
    • 8.3.2.4. U.S. preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.3.3. Canada
    • 8.3.3.1. Key Country Dynamics
    • 8.3.3.2. Competitive Scenario
    • 8.3.3.3. Regulatory Framework
    • 8.3.3.4. Canada preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.3.4. Mexico
    • 8.3.4.1. Key Country Dynamics
    • 8.3.4.2. Competitive Scenario
    • 8.3.4.3. Regulatory Framework
    • 8.3.4.4. Mexico preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
• 8.4. Europe
  • 8.4.1. Europe preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.4.2. Germany
    • 8.4.2.1. Key Country Dynamics
    • 8.4.2.2. Competitive Scenario
    • 8.4.2.3. Regulatory Framework
    • 8.4.2.4. Germany preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.4.3. UK
    • 8.4.3.1. Key Country Dynamics
    • 8.4.3.2. Competitive Scenario
    • 8.4.3.3. Regulatory Framework
    • 8.4.3.4. UK preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.4.4. France
    • 8.4.4.1. Key Country Dynamics
    • 8.4.4.2. Competitive Scenario
    • 8.4.4.3. Regulatory Framework
    • 8.4.4.4. France preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.4.5. Italy
    • 8.4.5.1. Key Country Dynamics
    • 8.4.5.2. Competitive Scenario
    • 8.4.5.3. Regulatory Framework
    • 8.4.5.4. Italy preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.4.6. Spain
    • 8.4.6.1. Key Country Dynamics
    • 8.4.6.2. Competitive Scenario
    • 8.4.6.3. Regulatory Framework
    • 8.4.6.4. Spain preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.4.7. Denmark
    • 8.4.7.1. Key Country Dynamics
    • 8.4.7.2. Competitive Scenario
    • 8.4.7.3. Regulatory Framework
    • 8.4.7.4. Denmark preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.4.8. Sweden
    • 8.4.8.1. Key Country Dynamics
    • 8.4.8.2. Competitive Scenario
    • 8.4.8.3. Regulatory Framework
    • 8.4.8.4. Sweden preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.4.9. Norway
    • 8.4.9.1. Key Country Dynamics
    • 8.4.9.2. Competitive Scenario
    • 8.4.9.3. Regulatory Framework
    • 8.4.9.4. Norway preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
• 8.5. Asia Pacific
  • 8.5.1. Asia Pacific preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.5.2. Japan
    • 8.5.2.1. Key Country Dynamics
    • 8.5.2.2. Competitive Scenario
    • 8.5.2.3. Regulatory Framework
    • 8.5.2.4. Japan preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.5.3. China
    • 8.5.3.1. Key Country Dynamics
    • 8.5.3.2. Competitive Scenario
    • 8.5.3.3. Regulatory Framework
    • 8.5.3.4. China preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.5.4. India
    • 8.5.4.1. Key Country Dynamics
    • 8.5.4.2. Competitive Scenario
    • 8.5.4.3. Regulatory Framework
    • 8.5.4.4. India preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.5.5. South Korea
    • 8.5.5.1. Key Country Dynamics
    • 8.5.5.2. Competitive Scenario
    • 8.5.5.3. Regulatory Framework
    • 8.5.5.4. South Korea preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.5.6. Australia
    • 8.5.6.1. Key Country Dynamics
    • 8.5.6.2. Competitive Scenario
    • 8.5.6.3. Regulatory Framework
    • 8.5.6.4. Australia preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.5.7. Thailand
    • 8.5.7.1. Key Country Dynamics
    • 8.5.7.2. Competitive Scenario
    • 8.5.7.3. Regulatory Framework
    • 8.5.7.4. Thailand preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
• 8.6. Latin America
  • 8.6.1. Latin America preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.6.2. Brazil
    • 8.6.2.1. Key Country Dynamics
    • 8.6.2.2. Competitive Scenario
    • 8.6.2.3. Regulatory Framework
    • 8.6.2.4. Brazil preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.6.3. Argentina
    • 8.6.3.1. Key Country Dynamics
    • 8.6.3.2. Competitive Scenario
    • 8.6.3.3. Regulatory Framework
    • 8.6.3.4. Argentina preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
• 8.7. MEA
  • 8.7.1. MEA preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.7.2. South Africa
    • 8.7.2.1. Key Country Dynamics
    • 8.7.2.2. Competitive Scenario
    • 8.7.2.3. Regulatory Framework
    • 8.7.2.4. South Africa preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.7.3. Saudi Arabia
    • 8.7.3.1. Key Country Dynamics
    • 8.7.3.2. Competitive Scenario
    • 8.7.3.3. Regulatory Framework
    • 8.7.3.4. Saudi Arabia preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.7.4. UAE
    • 8.7.4.1. Key Country Dynamics
    • 8.7.4.2. Competitive Scenario
    • 8.7.4.3. Regulatory Framework
    • 8.7.4.4. UAE preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.7.5. Kuwait
    • 8.7.5.1. Key Country Dynamics
    • 8.7.5.2. Competitive Scenario
    • 8.7.5.3. Regulatory Framework
    • 8.7.5.4. Kuwait preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.7.6. Oman
    • 8.7.6.1. Key Country Dynamics
    • 8.7.6.2. Competitive Scenario
    • 8.7.6.3. Regulatory Framework
    • 8.7.6.4. Oman preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)
  • 8.7.7. Qatar
    • 8.7.7.1. Key Country Dynamics
    • 8.7.7.2. Competitive Scenario
    • 8.7.7.3. Regulatory Framework
    • 8.7.7.4. Qatar preclinical bioanalytical testing services market, 2021 - 2033 (USD Million)

Chapter 9. Competitive Landscape

• 9.1. Company Categorization
• 9.2. Company Market Position Analysis, 2024
• 9.3. Company Profiles
  • 9.3.1. Labcorp
    • 9.3.1.1. Company overview
    • 9.3.1.2. Financial performance
    • 9.3.1.3. Service benchmarking
    • 9.3.1.4. Strategic initiatives
  • 9.3.2. Eurofins Scientific SE
    • 9.3.2.1. Company overview
    • 9.3.2.2. Financial performance
    • 9.3.2.3. Service benchmarking
    • 9.3.2.4. Strategic initiatives
  • 9.3.3. SGS SA
    • 9.3.3.1. Company overview
    • 9.3.3.2. Financial performance
    • 9.3.3.3. Service benchmarking
    • 9.3.3.4. Strategic initiatives
  • 9.3.4. Charles River Laboratories International
    • 9.3.4.1. Company overview
    • 9.3.4.2. Financial performance
    • 9.3.4.3. Service benchmarking
    • 9.3.4.4. Strategic initiatives
  • 9.3.5. Syneos Health
    • 9.3.5.1. Company overview
    • 9.3.5.2. Financial performance
    • 9.3.5.3. Service benchmarking
    • 9.3.5.4. Strategic initiatives
  • 9.3.6. KCAS Bio
    • 9.3.6.1. Company overview
    • 9.3.6.2. Financial performance
    • 9.3.6.3. Service benchmarking
    • 9.3.6.4. Strategic initiatives
  • 9.3.7. ICON plc
    • 9.3.7.1. Company overview
    • 9.3.7.2. Financial performance
    • 9.3.7.3. Service benchmarking
    • 9.3.7.4. Strategic initiatives
  • 9.3.8. WuXi AppTec
    • 9.3.8.1. Company overview
    • 9.3.8.2. Financial performance
    • 9.3.8.3. Service benchmarking
    • 9.3.8.4. Strategic initiatives
  • 9.3.9. Thermo Fisher Scientific Inc (PPD, Inc.)
    • 9.3.9.1. Company overview
    • 9.3.9.2. Financial performance
    • 9.3.9.3. Service benchmarking
    • 9.3.9.4. Strategic initiatives
  • 9.3.10. Parexel International
    • 9.3.10.1. Company overview
    • 9.3.10.2. Financial performance
    • 9.3.10.3. Service benchmarking
    • 9.3.10.4. Strategic initiatives
  • 9.3.11. Pharmaron
    • 9.3.11.1. Company overview
    • 9.3.11.2. Financial performance
    • 9.3.11.3. Service benchmarking
    • 9.3.11.4. Strategic initiatives
  • 9.3.12. BioAgilytix Labs
    • 9.3.12.1. Company overview
    • 9.3.12.2. Financial performance
    • 9.3.12.3. Service benchmarking
    • 9.3.12.4. Strategic initiatives
  • 9.3.13. QPS Holdings
    • 9.3.13.1. Company overview
    • 9.3.13.2. Financial performance
    • 9.3.13.3. Service benchmarking
    • 9.3.13.4. Strategic initiatives
  • 9.3.14. Altasciences
    • 9.3.14.1. Company overview
    • 9.3.14.2. Financial performance
    • 9.3.14.3. Service benchmarking
    • 9.3.14.4. Strategic initiatives