The global bioanalytical testing services in CRO market size is expected to reach USD 5.62 billion by 2030, according to a new report by Grand View Research, Inc. The market is estimated to register a CAGR of 9.02% over the forecast period. The market growth is primarily driven by rising drug development, increased outsourcing, and stringent regulatory requirements. Pharmaceutical and biopharmaceutical companies are increasingly depending on CROs to optimize costs, enhance efficiency, and meet global compliance standards. Further, advancements in bioanalytical technologies, such as high-throughput mass spectrometry and automation, are improving testing accuracy and speed, thereby accelerating market growth potential in near future.
The increasing number of new drug development, particularly for biologics, biosimilars, and gene therapies, is a key driver for the market. Pharmaceutical and biopharmaceutical companies are outsourcing bioanalytical testing to specialized CROs to streamline operations, reduce costs, and accelerate regulatory approvals. The growing complexity of drug molecules necessitates advanced analytical methods, driving demand for high-quality bioanalytical services. Additionally, small and mid-sized pharma firms, lacking in-house expertise, are increasingly relying on CROs for comprehensive testing solutions. This outsourcing trend is further boosted by the need for specialized assays, compliance with stringent global regulations, and faster turnaround times. As R&D investments rise, the dependence on CROs for bioanalytical testing continues to grow, thereby strengthening market expansion in near future.
Furthermore, stringent regulatory guidelines by several authorities such as the FDA, EMA, and ICH implement strict guidelines for bioanalytical testing to enhance drug safety, efficacy, and quality. Growing need for compliance with Good Laboratory Practices (GLP) and evolving bioanalytical method validation requirements will drive demand for specialized CRO services. Moreover, frequent regulatory updates necessitate continuous adaptation, pushing pharmaceutical companies to collaborate with experienced CROs with established compliance frameworks. The increasing scrutiny on pharmacokinetics, bioavailability, and biomarker analysis further accelerates the market growth.
Technological innovations in bioanalytical testing, such as high-throughput mass spectrometry, chromatography, and ligand-binding assays to enhance testing efficiency and accuracy will likely to drive market growth. Moreover, the integration of real-time monitoring and cloud-based platforms to optimize data integrity and regulatory compliance will boost customer preference towards bioanalytical testing services CRO market. The rise of novel therapeutic modalities like cell and gene therapies requires specialized bioanalytical techniques, further expanding CRO service portfolios.
Several key service providers such as ICON Plc., Charles River Laboratories, Syneos Health, SGS SA, LabCorp, etc. operating in the bioanalytical testing services in CRO industry is implementing several strategic initiatives to broaden their service offerings. For instance, in August 2023, Pace Analytical Services announced the acquisition of Alpha Analytical, adding new capabilities such as advanced hydrocarbon analytical support along with expanded sediment & tissue testing. Such acquisitions broadened company’s offerings in the market.
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Based on molecule, small molecule segment dominated the market primarily attributed to large number of small molecules in drug development. Stringent regulatory requirements for pharmacokinetics and bioequivalence studies will drive the segmental demand.
Based on the test, bioavailability test held the largest market share in 2024, regulatory agencies require comprehensive pharmacokinetic data, increasing demand for bioanalytical testing. Innovations in analytical methodologies enhance accuracy, ensuring drug formulations meet safety and performance standards, further strengthening this segment.
Based on workflow, sample analysis segment held the largest market share in 2024due to its critical role in pharmacokinetics, toxicology, and biomarker studies. Advanced analytical techniques, including chromatography and immunoassays, improve detection sensitivity and regulatory compliance. Growing biologics and biosimilars development further bolster demand for precise and high-throughput sample analysis services.
Based on end use, pharma and biopharma companies segment held the largest market share in 2024due to increasing R&D investment in biologics and personalized medicine further drives market demand. Advanced analytical technologies and regulatory expertise enable CROs to support complex testing needs, strengthening their market presence.
Grand View Research has segmented the global bioanalytical testing services in CRO market based on molecule, test, workflow, end use, and region:
Bioanalytical Testing Services In CRO Molecule Outlook (Revenue, USD Billion, 2018 - 2030)
Small Molecule
Large Molecule
LC-MS Studies
Immunoassays
Pharmacokinetics (PK)
ADA Assay
Others
Others
Bioanalytical Testing Services In CRO Test Outlook (Revenue, USD Billion, 2018 - 2030)
ADME
In-Vivo
In-Vitro
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Bioavailability
Bioequivalence
Biomarker Testing
Cell-based Assay
Virology Testing
Other Tests
Bioanalytical Testing Services In CRO Workflow Outlook (Revenue, USD Billion, 2018 - 2030)
Sample Collection & Preparation
Sample Collection, Handling & Storage
Protein Precipitation
Liquid-Liquid Extraction
Solid Phase Extraction
Others
Method Development & Validation
Sample Analysis
Hyphenated technique
Chromatographic technique
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
Bioanalytical Testing Services In CRO End Use Outlook (Revenue, USD Billion, 2018 - 2030)
Pharma & Biopharma Companies
Academic & Research Institutes
Others
Bioanalytical Testing Services In CRO Regional Outlook (Revenue, USD Billion, 2018- 2030)
North America
U.S.
Canada
Mexico
Europe
UK
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 and Africa (MEA)
South Africa
Saudi Arabia
UAE
Kuwait
Israel
List of Key Companies in Bioanalytical Testing Services In CRO Market
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
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