Global Bioanalytical Testing Services in CRO Market Size Study, By Molecule, By Test, By Workflow, By End Use, and Regional Forecasts 2022-2032

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.

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