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.
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