
Global Bioanalytical Testing Services in CRO Market Size Study, By Molecule (Small, Large), By Test (Bioavailability, Bioequivalence, ADME, Biomarker Testing, Cell-based Assay, Virology Testing, Other Tests), By Workflow (Sample Collection & Preparation,
Description
The Global Bioanalytical Testing Services in CRO Market was valued at USD 3.07 billion in 2023 and is expected to expand at a CAGR of 9.02% from 2024 to 2032. The rapid expansion of biopharmaceutical research, the rising complexity of biologics and biosimilars, and stringent regulatory requirements are key drivers of this market. Bioanalytical testing services in Contract Research Organizations (CROs) provide an essential function in the drug development process, ensuring drug safety, efficacy, and regulatory compliance. Increasing pharmaceutical R&D expenditures, coupled with the rising demand for outsourcing bioanalytical services, further strengthen the market growth.
The rising prevalence of chronic diseases and the increasing number of clinical trials have resulted in higher demand for bioanalytical services globally. CROs specializing in bioanalytical testing offer specialized expertise in mass spectrometry, chromatography, ligand binding assays, and genomic analysis, supporting the pharmaceutical industry's need for faster and more cost-efficient drug development. The growing adoption of advanced technologies, such as liquid chromatography-tandem mass spectrometry (LC-MS/MS), immunoassays, and digital laboratory solutions, has also accelerated the market expansion.
The market's growth is further bolstered by the expansion of CROs in emerging markets, particularly in Asia-Pacific and Latin America, where regulatory landscapes are evolving to align with global standards. Major pharmaceutical firms are increasingly partnering with bioanalytical CROs to streamline drug development, optimize costs, and enhance efficiency. Additionally, stringent guidelines from regulatory agencies like the FDA, EMA, PMDA, and ICH have heightened the need for advanced method development, validation, and pharmacokinetic (PK) testing, increasing CRO engagement.
Regionally, North America dominates the market due to its strong presence of pharmaceutical and biotechnology companies, high R&D investments, and well-established CROs offering cutting-edge bioanalytical services. However, Asia-Pacific is expected to witness the fastest CAGR due to low operational costs, increasing outsourcing of clinical trials, and advancements in biosimilar research. The European market is driven by strict regulatory standards and growing collaborations between biotech firms and CROs. Meanwhile, Latin America and the Middle East & Africa are also experiencing steady market expansion due to rising clinical research activities and investments in healthcare infrastructure.
Major Market Players Included in this Report:
• Thermo Fisher Scientific Inc.
• ICON Plc
• Charles River Laboratories International
• Wuxi AppTec
• IQVIA
• Syneos Health
• SGS SA
• Labcorp
• Intertek Group Plc
• Pace Analytical Services LLC
• Medpace
• BioAgilytix Labs
• PPD Inc.
• Frontage Laboratories
• Covance
The Detailed Segments and Sub-segments of the Market are Explained Below:
By Molecule:
• Small Molecule
• Large Molecule
LC-MS Studies
Immunoassays
Pharmacokinetics (PK)
ADA Assay
Others
By Test:
• ADME
• In-Vivo
• In-Vitro
• Pharmacokinetics (PK)
• Pharmacodynamics (PD)
• Bioavailability
• Bioequivalence
• Biomarker Testing
• Cell-based Assay
• Virology Testing
• Other Tests
By Workflow:
• Sample Collection & Preparation
Sample Collection, Handling & Storage
Protein Precipitation
Liquid-Liquid Extraction
Solid Phase Extraction
Others
• Method Development & Validation
• Sample Analysis
Hyphenated Techniques
Chromatographic Techniques
Electrophoresis
Ligand Binding Assay
Mass Spectrometry
Spectroscopic Techniques
Nuclear Magnetic Resonance (NMR)
Others
• Genomic & Molecular Techniques
Polymerase Chain Reaction (PCR)
Next-Generation Sequencing (NGS)
Others
• Other Workflow Processes
By End Use:
• Pharma & Biopharma Companies
• Academic & Research Institutes
• Others
By Region:
North America
• U.S.
• Canada
• Mexico
Europe
• U.K.
• Germany
• France
• Italy
• Spain
• Denmark
• Sweden
• Norway
• Netherlands
• Switzerland
Asia Pacific
• India
• China
• Japan
• South Korea
• Australia
• Thailand
• Indonesia
• Malaysia
• Singapore
• Taiwan
Latin America
• Brazil
• Argentina
• Colombia
Middle East & Africa (MEA)
• South Africa
• Saudi Arabia
• UAE
• Kuwait
• Israel
Years Considered for the Study:
• Historical Year – 2022
• Base Year – 2023
• Forecast Period – 2024 to 2032
Key Takeaways:
• Market Estimates & Forecast for 10 years from 2022 to 2032.
• Annualized revenues and regional-level analysis for each market segment.
• Detailed geographical landscape with country-level market insights.
• Competitive landscape with major player profiles, key strategies, and revenue analysis.
• Analysis of key business strategies and recommendations on future market approach.
• Demand-side and supply-side analysis of the market, identifying growth trends and potential investment opportunities.
Please note:The single user license is non-downloadable and non-printable. Global Site license allows these actions.
The rising prevalence of chronic diseases and the increasing number of clinical trials have resulted in higher demand for bioanalytical services globally. CROs specializing in bioanalytical testing offer specialized expertise in mass spectrometry, chromatography, ligand binding assays, and genomic analysis, supporting the pharmaceutical industry's need for faster and more cost-efficient drug development. The growing adoption of advanced technologies, such as liquid chromatography-tandem mass spectrometry (LC-MS/MS), immunoassays, and digital laboratory solutions, has also accelerated the market expansion.
The market's growth is further bolstered by the expansion of CROs in emerging markets, particularly in Asia-Pacific and Latin America, where regulatory landscapes are evolving to align with global standards. Major pharmaceutical firms are increasingly partnering with bioanalytical CROs to streamline drug development, optimize costs, and enhance efficiency. Additionally, stringent guidelines from regulatory agencies like the FDA, EMA, PMDA, and ICH have heightened the need for advanced method development, validation, and pharmacokinetic (PK) testing, increasing CRO engagement.
Regionally, North America dominates the market due to its strong presence of pharmaceutical and biotechnology companies, high R&D investments, and well-established CROs offering cutting-edge bioanalytical services. However, Asia-Pacific is expected to witness the fastest CAGR due to low operational costs, increasing outsourcing of clinical trials, and advancements in biosimilar research. The European market is driven by strict regulatory standards and growing collaborations between biotech firms and CROs. Meanwhile, Latin America and the Middle East & Africa are also experiencing steady market expansion due to rising clinical research activities and investments in healthcare infrastructure.
Major Market Players Included in this Report:
• Thermo Fisher Scientific Inc.
• ICON Plc
• Charles River Laboratories International
• Wuxi AppTec
• IQVIA
• Syneos Health
• SGS SA
• Labcorp
• Intertek Group Plc
• Pace Analytical Services LLC
• Medpace
• BioAgilytix Labs
• PPD Inc.
• Frontage Laboratories
• Covance
The Detailed Segments and Sub-segments of the Market are Explained Below:
By Molecule:
• Small Molecule
• Large Molecule
LC-MS Studies
Immunoassays
Pharmacokinetics (PK)
ADA Assay
Others
By Test:
• ADME
• In-Vivo
• In-Vitro
• Pharmacokinetics (PK)
• Pharmacodynamics (PD)
• Bioavailability
• Bioequivalence
• Biomarker Testing
• Cell-based Assay
• Virology Testing
• Other Tests
By Workflow:
• Sample Collection & Preparation
Sample Collection, Handling & Storage
Protein Precipitation
Liquid-Liquid Extraction
Solid Phase Extraction
Others
• Method Development & Validation
• Sample Analysis
Hyphenated Techniques
Chromatographic Techniques
Electrophoresis
Ligand Binding Assay
Mass Spectrometry
Spectroscopic Techniques
Nuclear Magnetic Resonance (NMR)
Others
• Genomic & Molecular Techniques
Polymerase Chain Reaction (PCR)
Next-Generation Sequencing (NGS)
Others
• Other Workflow Processes
By End Use:
• Pharma & Biopharma Companies
• Academic & Research Institutes
• Others
By Region:
North America
• U.S.
• Canada
• Mexico
Europe
• U.K.
• Germany
• France
• Italy
• Spain
• Denmark
• Sweden
• Norway
• Netherlands
• Switzerland
Asia Pacific
• India
• China
• Japan
• South Korea
• Australia
• Thailand
• Indonesia
• Malaysia
• Singapore
• Taiwan
Latin America
• Brazil
• Argentina
• Colombia
Middle East & Africa (MEA)
• South Africa
• Saudi Arabia
• UAE
• Kuwait
• Israel
Years Considered for the Study:
• Historical Year – 2022
• Base Year – 2023
• Forecast Period – 2024 to 2032
Key Takeaways:
• Market Estimates & Forecast for 10 years from 2022 to 2032.
• Annualized revenues and regional-level analysis for each market segment.
• Detailed geographical landscape with country-level market insights.
• Competitive landscape with major player profiles, key strategies, and revenue analysis.
• Analysis of key business strategies and recommendations on future market approach.
• Demand-side and supply-side analysis of the market, identifying growth trends and potential investment opportunities.
Please note:The single user license is non-downloadable and non-printable. Global Site license allows these actions.
Table of Contents
285 Pages
- Chapter 1. Global Bioanalytical Testing Services in CRO Market Executive Summary
- 1.1. Global Bioanalytical Testing Services in CRO Market Size & Forecast (2022-2032)
- 1.2. Regional Summary
- 1.3. Segmental Summary
- 1.3.1. By Molecule
- 1.3.2. By Test
- 1.3.3. By Workflow
- 1.3.4. By End Use
- 1.4. Key Market Trends
- 1.5. Recession Impact
- 1.6. Analyst Recommendations & Conclusion
- Chapter 2. Global Bioanalytical Testing Services in CRO Market Definition and Research Assumptions
- 2.1. Research Objective
- 2.2. Market Definition
- 2.3. Research Assumptions
- 2.3.1. Inclusion & Exclusion
- 2.3.2. Limitations
- 2.3.3. Supply Side Analysis
- 2.3.3.1. Availability
- 2.3.3.2. Infrastructure
- 2.3.3.3. Regulatory Environment
- 2.3.3.4. Market Competition
- 2.3.3.5. Economic Viability (Consumer’s Perspective)
- 2.3.4. Demand Side Analysis
- 2.3.4.1. Regulatory Frameworks
- 2.3.4.2. Technological Advancements
- 2.3.4.3. Environmental Considerations
- 2.3.4.4. Consumer Awareness & Acceptance
- 2.4. Estimation Methodology
- 2.5. Years Considered for the Study
- 2.6. Currency Conversion Rates
- Chapter 3. Global Bioanalytical Testing Services in CRO Market Dynamics
- 3.1. Market Drivers
- 3.1.1. Increasing Pharmaceutical & Biopharmaceutical R&D Expenditures
- 3.1.2. Growing Complexity of Biologics & Biosimilars
- 3.1.3. Stringent Regulatory Requirements for Drug Development
- 3.1.4. Technological Advancements in Bioanalytical Testing
- 3.2. Market Challenges
- 3.2.1. High Costs of Bioanalytical Testing
- 3.2.2. Regulatory Compliance & Changing Guidelines
- 3.2.3. Shortage of Skilled Workforce in Bioanalytical Testing
- 3.3. Market Opportunities
- 3.3.1. Expansion of CROs in Emerging Markets
- 3.3.2. Increasing Demand for Personalized Medicine
- 3.3.3. Rising Outsourcing Trend in Bioanalytical Testing
- Chapter 4. Global Bioanalytical Testing Services in CRO Market Industry Analysis
- 4.1. Porter’s Five Forces Model
- 4.1.1. Bargaining Power of Suppliers
- 4.1.2. Bargaining Power of Buyers
- 4.1.3. Threat of New Entrants
- 4.1.4. Threat of Substitutes
- 4.1.5. Competitive Rivalry
- 4.2. PESTEL Analysis
- 4.2.1. Political
- 4.2.2. Economic
- 4.2.3. Social
- 4.2.4. Technological
- 4.2.5. Environmental
- 4.2.6. Legal
- 4.3. Top Investment Opportunities
- 4.4. Top Winning Strategies
- 4.5. Disruptive Trends in the Market
- 4.6. Industry Expert Perspective
- 4.7. Analyst Recommendations & Conclusion
- Chapter 5. Global Bioanalytical Testing Services in CRO Market Size & Forecast by Molecule (2022-2032)
- 5.1. Segment Dashboard
- 5.2. Global Bioanalytical Testing Services in CRO Market by Molecule Revenue Trend Analysis, 2022 & 2032 (USD Billion)
- 5.2.1. Small Molecule
- 5.2.2. Large Molecule
- 5.2.2.1. LC-MS Studies
- 5.2.2.2. Immunoassays
- 5.2.2.3. Pharmacokinetics (PK)
- 5.2.2.4. ADA Assay
- 5.2.2.5. Others
- Chapter 6. Global Bioanalytical Testing Services in CRO Market Size & Forecast by Test (2022-2032)
- 6.1. Segment Dashboard
- 6.2. Global Bioanalytical Testing Services in CRO Market by Test Revenue Trend Analysis, 2022 & 2032 (USD Billion)
- 6.2.1. ADME
- 6.2.2. In-Vivo
- 6.2.3. In-Vitro
- 6.2.4. Pharmacokinetics (PK)
- 6.2.5. Pharmacodynamics (PD)
- 6.2.6. Bioavailability
- 6.2.7. Bioequivalence
- 6.2.8. Biomarker Testing
- 6.2.9. Cell-based Assay
- 6.2.10. Virology Testing
- 6.2.11. Other Tests
- Chapter 7. Global Bioanalytical Testing Services in CRO Market Size & Forecast by Workflow (2022-2032)
- 7.1. Segment Dashboard
- 7.2. Global Bioanalytical Testing Services in CRO Market by Workflow Revenue Trend Analysis, 2022 & 2032 (USD Billion)
- 7.2.1. Sample Collection & Preparation
- 7.2.1.1. Sample Collection, Handling & Storage
- 7.2.1.2. Protein Precipitation
- 7.2.1.3. Liquid-Liquid Extraction
- 7.2.1.4. Solid Phase Extraction
- 7.2.1.5. Others
- 7.2.2. Method Development & Validation
- 7.2.3. Sample Analysis
- 7.2.3.1. Hyphenated Techniques
- 7.2.3.2. Chromatographic Techniques
- 7.2.3.3. Electrophoresis
- 7.2.3.4. Ligand Binding Assay
- 7.2.3.5. Mass Spectrometry
- 7.2.3.6. Spectroscopic Techniques
- 7.2.3.7. Nuclear Magnetic Resonance (NMR)
- 7.2.3.8. Others
- 7.2.4. Genomic & Molecular Techniques
- 7.2.4.1. Polymerase Chain Reaction (PCR)
- 7.2.4.2. Next-Generation Sequencing (NGS)
- 7.2.4.3. Others
- 7.2.5. Other Workflow Processes
- Chapter 8. Global Bioanalytical Testing Services in CRO Market Size & Forecast by End Use (2022-2032)
- 8.1. Segment Dashboard
- 8.2. Global Bioanalytical Testing Services in CRO Market by End Use Revenue Trend Analysis, 2022 & 2032 (USD Billion)
- 8.2.1. Pharma & Biopharma Companies
- 8.2.2. Academic & Research Institutes
- 8.2.3. Others
- Chapter 9. Global Bioanalytical Testing Services in CRO Market Size & Forecast by Region (2022-2032)
- 9.1. North America
- 9.1.1. U.S.
- 9.1.2. Canada
- 9.1.3. Mexico
- 9.2. Europe
- 9.2.1. U.K.
- 9.2.2. Germany
- 9.2.3. France
- 9.2.4. Italy
- 9.2.5. Spain
- 9.2.6. Netherlands
- 9.2.7. Switzerland
- 9.3. Asia-Pacific
- 9.3.1. India
- 9.3.2. China
- 9.3.3. Japan
- 9.3.4. South Korea
- 9.3.5. Australia
- 9.3.6. Thailand
- 9.4. Latin America
- 9.4.1. Brazil
- 9.4.2. Argentina
- 9.4.3. Colombia
- 9.5. Middle East & Africa
- 9.5.1. South Africa
- 9.5.2. Saudi Arabia
- 9.5.3. UAE
- 9.5.4. Israel
- 9.5.5. Kuwait
- Chapter 10. Competitive Intelligence
- 10.1. Key Company SWOT Analysis
- 10.1.1. Thermo Fisher Scientific Inc.
- 10.1.2. ICON Plc
- 10.1.3. Charles River Laboratories International
- 10.2. Market Strategies
- 10.3. Company Profiles
- Chapter 11. Research Process
- 11.1. Research Process
- 11.1.1. Data Mining
- 11.1.2. Analysis
- 11.1.3. Market Estimation
- 11.1.4. Validation
- 11.1.5. Publishing
- 11.2. Research Attributes
- List of Tables
- TABLE 1. Global Bioanalytical Testing Services in CRO Market, Report Scope
- TABLE 2. Global Bioanalytical Testing Services in CRO Market Estimates & Forecasts by Region 2022-2032 (USD Billion)
- TABLE 3. Global Bioanalytical Testing Services in CRO Market Estimates & Forecasts by Molecule 2022-2032 (USD Billion)
- TABLE 4. Global Bioanalytical Testing Services in CRO Market Estimates & Forecasts by Test 2022-2032 (USD Billion)
- TABLE 5. Global Bioanalytical Testing Services in CRO Market Estimates & Forecasts by Workflow 2022-2032 (USD Billion)
- TABLE 6. Global Bioanalytical Testing Services in CRO Market Estimates & Forecasts by End-Use 2022-2032 (USD Billion)
- TABLE 7. North America Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 8. U.S. Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 9. Canada Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 10. Mexico Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 11. Europe Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 12. Germany Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 13. UK Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 14. France Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 15. Italy Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 16. Spain Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 17. Asia Pacific Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 18. China Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 19. India Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 20. Japan Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 21. South Korea Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 22. Latin America Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 23. Brazil Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 24. Argentina Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 25. Middle East & Africa Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 26. Saudi Arabia Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 27. UAE Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 28. South Africa Bioanalytical Testing Services in CRO Market Estimates & Forecasts, 2022-2032 (USD Billion)
- TABLE 29. Key Market Strategies Adopted by Major Players in the Bioanalytical Testing Services in CRO Market
- TABLE 30. SWOT Analysis of Leading Companies in the Bioanalytical Testing Services in CRO Market
- This list is not complete, final report does contain more than 100 tables. The list may be updated in the final deliverable.
- List of Figures
- FIGURE 1. Global Bioanalytical Testing Services in CRO Market, Research Methodology
- FIGURE 2. Global Bioanalytical Testing Services in CRO Market, Market Estimation Techniques
- FIGURE 3. Global Market Size Estimates & Forecast Methods
- FIGURE 4. Global Bioanalytical Testing Services in CRO Market, Key Trends 2023
- FIGURE 5. Global Bioanalytical Testing Services in CRO Market, Growth Prospects 2022-2032
- FIGURE 6. Global Bioanalytical Testing Services in CRO Market, Porter’s Five Forces Analysis
- FIGURE 7. Global Bioanalytical Testing Services in CRO Market, PESTEL Analysis
- FIGURE 8. Global Bioanalytical Testing Services in CRO Market, Value Chain Analysis
- FIGURE 9. Global Bioanalytical Testing Services in CRO Market by Segment, 2022 & 2032 (USD Billion)
- FIGURE 10. Global Bioanalytical Testing Services in CRO Market by Molecule, 2022 & 2032 (USD Billion)
- FIGURE 11. Global Bioanalytical Testing Services in CRO Market by Test, 2022 & 2032 (USD Billion)
- FIGURE 12. Global Bioanalytical Testing Services in CRO Market by Workflow, 2022 & 2032 (USD Billion)
- FIGURE 13. Global Bioanalytical Testing Services in CRO Market by End-Use, 2022 & 2032 (USD Billion)
- FIGURE 14. Global Bioanalytical Testing Services in CRO Market, Regional Snapshot 2022 & 2032
- FIGURE 15. North America Bioanalytical Testing Services in CRO Market 2022 & 2032 (USD Billion)
- FIGURE 16. Europe Bioanalytical Testing Services in CRO Market 2022 & 2032 (USD Billion)
- FIGURE 17. Asia Pacific Bioanalytical Testing Services in CRO Market 2022 & 2032 (USD Billion)
- FIGURE 18. Latin America Bioanalytical Testing Services in CRO Market 2022 & 2032 (USD Billion)
- FIGURE 19. Middle East & Africa Bioanalytical Testing Services in CRO Market 2022 & 2032 (USD Billion)
- FIGURE 20. Global Bioanalytical Testing Services in CRO Market, Company Market Share Analysis (2023)
- FIGURE 21. Key Investment Opportunities in the Bioanalytical Testing Services in CRO Market
- FIGURE 22. Competitive Landscape, Key Strategies Adopted by Leading Market Players
- FIGURE 23. Technological Innovations in Bioanalytical Testing Services
- FIGURE 24. Impact of Regulatory Changes on the Bioanalytical Testing Services in CRO Market
- FIGURE 25. Demand Side vs. Supply Side Analysis of Bioanalytical Testing Services
- This list is not complete, final report does contain more than 50 figures. The list may be updated in the final deliverable.
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