Bioanalytical Testing Services In CRO Market Size, Share & Trends Analysis Report By Molecule (Small, Large), By Test (Bioavailability, Bioequivalence), By Test, By Workflow, By End-use, By Region, And Segment Forecasts, 2025 - 2030

Market Size & Trends

The global bioanalytical testing services in CRO market size was estimated at USD 3.35 billion in 2024 and is anticipated to grow at a CAGR of 9.02% from 2025 to 2030. Growing demand for outsourcing bioanalytical testing due to cost efficiency, regulatory compliance, and specialized expertise. Rising pharmaceutical and biopharmaceutical R&D activities, along with the growing complexity of biologics and biosimilars, further boost overall market expansion. Stringent regulatory requirements for drug development and approval necessitate advanced bioanalytical testing, prompting companies to rely on CROs. Additionally, technological advancements in mass spectrometry, chromatography, and immunoassays enhance testing capabilities, boosting bioanalytical testing services CRO market demand. Furthermore, the surge in clinical trials, particularly for novel biologics and personalized medicine, also accelerates industry growth in the forthcoming years.

Regulatory control and increasing awareness regarding bioanalytical testing are key drivers in the bioanalytical testing services in CRO industry. Stringent regulatory guidelines from authorities such as the U.S. FDA and EMA, PMDA, mandate rigorous bioanalytical validation to enhance drug safety and efficacy, prompting pharmaceutical and biotech companies to partner with specialized Contract Research Organizations (CROs). Additionally, rising awareness about the critical role of bioanalytical testing in drug development, personalized medicine, and biosimilar approvals further accelerating market demand.

The expansion of bioanalytical testing laboratories in the CRO market is driven by increasing demand for outsourced analytical services, stringent regulatory requirements, and the growing complexity of biopharmaceutical development. Rising investments in biologics, biosimilars, and cell and gene therapies necessitate advanced bioanalytical techniques, prompting CROs to expand their capabilities. Additionally, pharmaceutical companies are seeking cost-effective and efficient testing solutions, further fueling the growth of bioanalytical CROs. Technological advancements, such as high-throughput screening and mass spectrometry, also enhance testing efficiency, supporting market expansion.

Growing investments in pharmaceutical R&D and the rising prevalence of chronic diseases are also key factors driving CROs to expand their bioanalytical testing capabilities. As the growing pipeline of novel therapies, including cell and gene therapies, the demand for specialized bioanalytical services is surging across the globe. Additionally, global regulatory agencies are enforcing stringent guidelines on drug safety and efficacy, propelling CROs to broaden their testing capacity to enhance compliance. These factors contribute to the expansion of bioanalytical testing laboratories in the CRO market.

Technology Landscape

Technological advancements in bioanalytical testing services are significantly enhancing the efficiency, accuracy, and scalability of CROs. The integration of automation, artificial intelligence (AI), and high-throughput screening (HTS) has streamlined sample analysis, reducing turnaround times and human errors. Additionally, advancements in mass spectrometry, next-generation sequencing (NGS), and bioinformatics are improving the sensitivity and specificity of bioanalytical assays. These innovations are critical in supporting complex biologics, gene therapies, and cell-based assays, enabling CROs to meet the evolving demands of pharmaceutical and biotechnology companies.

The growing adoption of digital technologies, such as cloud-based laboratory information management systems (LIMS) and blockchain for secure data sharing, is further driving the bioanalytical testing services in CRO industry. These technologies enhance real-time data tracking, improve collaboration, and traceability, which is crucial for regulatory submissions. Additionally, advancements in bioinformatics and machine learning are enabling predictive analytics for drug efficacy and toxicity assessments, accelerating clinical development timelines. As CROs continue to integrate these innovative technologies, they offer more robust and scalable solutions, strengthening their role in the expanding global biopharmaceutical landscape.

Market Concentration & Characteristics

The bioanalytical testing services in CRO industry showcase moderate innovation, driven by advancements in analytical technologies, biomarker discovery, and automation. Continuous improvements in mass spectrometry, chromatography, and high-throughput screening enhance service capabilities. AI and digital solutions are emerging trends, optimizing data analysis and compliance. However, innovation remains constrained by stringent regulatory requirements and high validation costs, slowing rapid adoption of novel techniques.

The industry experiences moderately high M&A activity, as larger CROs acquire niche service providers to expand capabilities and geographic reach. Strategic consolidations enhance end-to-end service offerings, regulatory expertise, and efficiency. Further, private equity investments boost market consolidation, thereby intensifying competition.

The impact of Regulations is expected to be significant and enhancing data integrity, Good Laboratory Practices (GLP), and evolving bioanalytical guidelines. Several agencies such as the FDA and EMA mandate rigorous validation protocols, ensuring assay reliability. Compliance requirements increase operational costs and extend project timelines, impacting service pricing. Frequent regulatory updates necessitate continuous adaptation, driving demand for specialized expertise in regulatory consulting and compliance-driven bioanalytical testing services.

CROs are diversifying service portfolios to address growing demand for specialized bioanalytical testing, including cell and gene therapy assays, biomarker analysis, and pharmacokinetics. Integration of bioinformatics, digital platforms, and real-time data analytics enhances value-added services. Expansion into niche areas, such as biosimilar and biologic testing, strengthens market positioning.

The market is expanding globally, with CROs increasing their footprint in emerging markets such as Asia-Pacific and Latin America. Cost advantages, skilled workforce availability, and supportive regulatory reforms are key aspects driving market expansion. North America and Europe remain dominant, but demand for localized bioanalytical services in developing regions boosts enormous investments.

Molecule Insights

The small molecule segment accounted for a largest revenue share of 55.13% in 2024. The segment growth is owing to the high demand for pharmacokinetic, bioavailability, and bioequivalence studies. Extensive utilization of bioanalytical testing services in generic and innovator drug development will drive market growth. Growing adoption of advanced techniques such liquid chromatography-mass spectrometry (LC-MS) for precise analysis will likely drive segmental demand. Stringent regulatory requirements for drug validation further boost outsourcing to specialized CROs. Increasing R&D investments and the rise of complex formulations continue to offer lucrative segment growth opportunities in the market.

On the other hand, large molecule segment is expected to register the highest CAGR over the analysis period. Increasing demand for large molecule biotherapeutics is propelling the demand for MS in peptide bioanalysis. In addition, CROs offer other technologies, such as flow cytometry, quantitative Polymerase Chain Reaction (qPCR), and Enzyme-Linked Immunosorbent Spot (ELISpot) assays for enhancing preclinical & clinical studies. Hence, the growing use of large molecule bioanalytical testing for clinical studies is expected to improve segment growth over the forecast period.

Test Insights

On the basis of tests, the bioavailability segment accounted for a highest share in the global market in 2024. These tests are crucial for assessing drug absorption, distribution, and overall therapeutic efficacy. Advanced analytical techniques, including LC-MS/MS and chromatography, enhance accuracy and compliance. Growing biologics and generic drug development further strengthens this segment. The increasing focus on optimizing drug formulations broadened market dominance for bioavailability testing.

The ADME tests segment is expected to grow at the highest CAGR over the estimated timeline in the bioanalytical testing services CRO market. These tests assess drug absorption, distribution, metabolism, and excretion, enhancing safety and efficacy. Rising demand for biologics, personalized medicine, and AI-driven drug discovery accelerates market expansion. Moreover, regulatory emphasis on early-stage ADME profiling drives outsourcing to CROs. Advancements in high-throughput screening and in vitro models further enhance predictive accuracy, boosting the rapid growth of this segment.

Workflow Insights

Based on workflow, the sample analysis segment dominated the market and accounted for the largest revenue share in 2024. The segment growth is due to its critical role in drug development. It ensures accurate quantification of analytes in biological matrices, supporting pharmacokinetics, toxicokinetics, and biomarker studies. Advanced techniques such as LC-MS/MS and immunoassays enhance precision and compliance with regulatory standards. Increasing demand for biologics and biosimilars drives the need for robust sample analysis, making it the largest workflow segment. Continuous innovation in automation and high-throughput screening further strengthens its market demand.

Sample Collection and Preparation segment is expected to register highest CAGR over the forecast period. This growth is driven by innovations in automated sample processing, microsampling techniques, and advanced storage solutions to enhance efficiency. Regulatory emphasis on standardized procedures further accelerates demand. As clinical trials expand globally, the need for streamlined, high-quality sample management continues to bolster market growth.

End Use Insights

On the basis of end use, the pharma & biopharma companies segment accounted for the largest revenue share in 2024. The segment growth is owing to increasing drug development activities, particularly for biologics and biosimilars. Stringent regulatory requirements for pharmacokinetics, bioavailability, and ADME studies further boost reliance on CROs. Advanced analytical technologies improve efficiency and compliance, supporting market dominance. Growing investments in precision medicine and novel therapeutics fortify sustained demand for specialized bioanalytical testing services from pharmaceutical and biopharmaceutical companies.

The academic & research institutes segment is expected to witness significant growth over the forecast period. Increasing collaborations with CROs for preclinical and translational research drive demand. Rising government funding and investments in drug discovery and biomarker research further support growth. Advancements in analytical technologies enhance study accuracy, fostering innovation. Expanding focus on personalized medicine and novel therapies continues to strengthen the role of academic institutions in bioanalytical testing services.

Regional Insights

North America dominated the market, accounting for a revenue share of 43.07% in 2024. The high regional growth is owing to growing investment in R&D of new drugs by the pharmaceutical and biotechnology industries. As this activity increases, the demand for bioanalytical testing services also grows. The growth of pharmaceutical industries in the U.S. and Canada is a contributing factor. In addition, the substantial presence of key market players and ongoing clinical trials are anticipated to drive market growth. The expansion of the market in the region can be attributed to the existence of technologically advanced CROs & CDMOs and an upsurge in the allocation of grants. The increasing prevalence of diverse diseases led to additional investments in clinical research throughout the projected period.

U.S. Bioanalytical Testing Services in CRO Market Trends

The bioanalytical testing services in CRO industry in the U.S. held the largest share in North America in 2024. Increased R&D investments and a rising need for biopharmaceutical products are key drivers for the market's expansion. The demand for specific tests, including electrophoresis, electrochemical & titrimetric assays, and immunoassays, has seen a notable upswing due to the development of combination molecules, biosimilars, and other innovative medicines. Along with this, rapid growth in emerging areas of medicine, such as personalized medicines, orphan drugs, and biosimilars, is expected to propel the bioanalytical testing services market in the U.S.

Europe Bioanalytical Testing Services in CRO Market Trends

The bioanalytical testing services in CRO market in Europe is expected to grow at a significant CAGR during the forecast period, owing to the presence of reputable biopharmaceutical companies in this region. Europe has a robust pharmaceutical & biotechnology sector with numerous drug discovery, development, and manufacturing companies. The growing number of pharmaceutical and biotech activities necessitates extensive bioanalytical testing to ensure drug safety, efficacy, & compliance. The surge in demand for sophisticated medicines encourages these industries to seek support from CROs.

The Germany bioanalytical testing services in CRO market held the largest share in Europe in 2024. The growth can be attributed to a rising demand for outsourcing services from major companies such as Novartis, Sanofi, Roche, GlaxoSmithKline, and AstraZeneca. The country's increased requirement for improved product designs, consulting, product maintenance, and related services is expected to be a crucial factor driving market growth in the coming years. Advancements in technology & quality clinical resources are some of the primary factors expected to propel this market over the forecast period.

The bioanalytical testing services in CRO market in the UK is anticipated to grow at a significant CAGR over the forecast period. Growth in the country can be attributed to extensive R&D initiatives and clinical trials being undertaken to address the challenges posed by various infectious diseases. These companies often require bioanalytical testing services to assess their pharmaceutical products' safety, efficacy, and quality, contributing to market growth. Furthermore, the country's dominance in the European bioanalytical testing services market can primarily be attributed to the increased focus on healthcare R&D.

Asia Pacific Bioanalytical Testing Services in CRO Market Trends

The bioanalytical testing services in CRO market in Asia Pacific is expected to grow at the fastest CAGR over the forecast period. owing to increasing pharmaceutical & biotechnology activities, rising healthcare expenditure, increasing investments by companies from developed economies in enhancing regional healthcare, and amendments made by regulatory bodies for changing clinical trial evaluation standards to align with the global standards. Furthermore, key companies are establishing new facilities and forming alliances to increase the reach of their offerings to various locations in the region. For instance, in July 2023, Labcorp announced the opening of a new kit production facility and the completed expansion of its immunology & immunotoxicology lab in China as part of its global growth and investment strategy. These new & expanded operations will help harness China’s drug development capabilities to advance a pipeline of innovative therapies.

The China bioanalytical testing services in CRO market held the largest share in Asia Pacific in 2024. The market growth is owing to its large population, diverse patient demographics, and cost-effectiveness. As a result, both domestic and international pharmaceutical companies outsource their clinical trials and associated functional services such as analytical testing to CROs in China, driving the demand for bioanalytical testing services.

The bioanalytical testing services in CRO market in India is expected to grow at the fastest CAGR over the forecast period, to low costs, the availability of industry experts, and the presence of WHO-cGMP-compliant facilities. India has become one of the most preferred sites for clinical trials due to its largest patient pool, developing healthcare sector, educated physicians, and cost competitiveness. Moreover, growing investment from overseas firms for research and development is expected to support market growth over the projected period.

Key Bioanalytical Testing Services In CRO Company Insights

The prominent market players operating across the global market focus on implementing numerous strategic initiatives such as acquisitions, mergers, service launches, partnerships, expansions, and collaborations, among others, to broaden the geographical reach and gain a competitive edge in the overall market. For instance, in March 2023, SGS launched a new SGS China bioanalysis center in Shanghai. The new laboratory is equipped with instruments such as MSD, Microplate Reader, MESO Sector S600, ciex Triple Quad 6500 LC-MS/MS, Bio-Rad bio-Plex 3D & Molecular device SpectraMax M5, a WinNonlin software, and Watson LIMS system for pharmacokinetics. In addition, the center analyzes biological samples, designs testing schemes, and offer complete data analysis reports. Such integrations broadened the service offerings of the company in the significant market.

Recent Developments

• In September 2023, Syneos Health, Inc. acquired by a consortium of private investment firm affiliates composed of Patient Square Capital, Elliott Investment Management L.P., and Veritas Capital.

• 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.

• In May 2023, Wheeler Bio, Inc. and Charles River Laboratories International, Inc. announced an agreement to implement RightSource, a flexible biologics testing lab at Wheeler Bio’s current good manufacturing practice biologics manufacturing facility in Oklahoma City. RightSource will make fast, reliable quality control more accessible to a broader range of companies.

Bioanalytical Testing Services In CRO Market Report Scope

Global Bioanalytical Testing Services In CRO Market Report Segmentation

This report forecasts revenue growth and provides an analysis on the latest trends in each of the sub-segments from 2018 to 2030. For the purpose of this report, Grand View Research has segmented the global bioanalytical testing services in CRO market based on molecule, test, workflow, end use, and region:

• Molecule Outlook (Revenue, USD Billion, 2018 - 2030)

  • Small Molecule

  • Large Molecule 

    • LC-MS Studies

    • Immunoassays

      • Pharmacokinetics (PK)

      • ADA Assay

      • Others

    • Others

• 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

• 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

• End Use Outlook (Revenue, USD Billion, 2018 - 2030)

  • Pharma & Biopharma Companies

  • Academic & Research Institutes

  • Others

• RegionalOutlook (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