Bioanalytical Testing Services In CRO Market To Reach $5.62 Billion By 2030

Bioanalytical Testing Services In CRO Market Growth & Trends

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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Bioanalytical Testing Services In CRO Market Report Highlights

• 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.

Bioanalytical Testing Services In CRO Market Segmentation

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