Bioanalytical Testing Services Market to Reach US$10.4 Bn by 2032, Says Persistence Market Research

The global bioanalytical testing services market is positioned for strong growth as drug development becomes increasingly complex. According to Persistence Market Research, the market is projected to expand from US$5.6 billion in 2025 to US$10.4 billion by 2032, reflecting a CAGR of 9.2% during the forecast period. The adoption of advanced testing platforms, strict regulatory frameworks, and the growing demand for biologics and gene therapies are pivotal in shaping this growth trajectory.

Among service categories, bioavailability testing leads with nearly 35.8% share in 2025, owing to its direct role in determining drug absorption and systemic exposure. Geographically, North America dominates the market with about 48.2% share, driven by robust R&D spending and rapid uptake of novel technologies supporting biologics and advanced therapy medicinal products (ATMPs). Europe follows as the fastest-growing market, benefiting from harmonized guidelines and integrated service models.

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Key Highlights from the Report

• Global bioanalytical testing services market to reach US$10.4 Bn by 2032 with a 9.2% CAGR from 2025.
• North America leads with 48.2% market share in 2025 due to adoption of advanced bioanalytical methods.
• Europe emerges as the fastest-growing region supported by ICH M10 harmonization.
• Bioavailability testing dominates with a 35.8% share in 2025.
• Pharma and biopharma companies hold the largest end-user share at 54.8%.
• In 2024, SGS launched new specialized bioanalytical services in North America to expand clinical trial support.

Market Segmentation

The bioanalytical testing services market is segmented by test type, including ADME, pharmacokinetics (PK), pharmacodynamics (PD), bioavailability, bioequivalence, biomarker testing, cell-based assays, and virology testing. Among these, bioavailability testing leads the market with a projected 35.8% share in 2025, as regulators and sponsors rely on it for understanding systemic drug exposure. Bioequivalence testing also plays a vital role, particularly in the approval of generics and complex formulations.

From an end-user perspective, the market is divided into pharmaceutical and biopharmaceutical companies, CDMOs, CROs, and others. Pharma and biopharma companies dominate the space with an estimated 54.8% share in 2025, owing to their growing pipeline of biologics and personalized medicine. CROs, however, are gaining traction as outsourcing partners, providing specialized assays and multi-site regulatory compliance to support global trials.

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Regional Insights

North America holds the largest share of the bioanalytical testing services market, accounting for nearly 48.2% in 2025. Strong regulatory frameworks like the FDA's implementation of ICH M10 guidance and the expansion of cell and gene therapy trials fuel demand for high-complexity bioanalytical services.

Europe is the fastest-growing market, supported by harmonized regulations under ICH M10 and a rising focus on ATMPs. Hybrid lab models that integrate LC-MS, ligand-binding, and molecular assays under a unified quality system are expanding rapidly across the region.

Market Dynamics
Market Drivers

The rise of biologics and gene therapies is one of the most powerful drivers of the bioanalytical testing services market. These therapies require sophisticated assays to measure pharmacokinetics, biodistribution, and immunogenicity. Hybrid assay platforms that combine LC-MS and ligand-binding technologies are becoming essential, while high-sensitivity qPCR and digital PCR are used for viral vector analysis. Personalized medicine also boosts demand, as therapies for rare diseases and small patient populations require precise, validated methods.

Market Restraints

Complex and evolving regulatory requirements pose significant challenges to laboratories. Compliance with ICH M10, GLP, GCP, and local frameworks increases documentation burdens and slows lab efficiency. Smaller labs often struggle to keep pace with stringent licensing, BSL-2/3 requirements, and frequent updates from agencies like the EMA. These factors limit competition and push sponsors toward larger CROs with the scale to absorb compliance costs.

Market Opportunities

Specialized outsourcing firms present new opportunities by providing access to cutting-edge technologies without requiring in-house investments. Companies such as Frontage Laboratories, Syneos Health, and Eurofins are expanding multi-site networks to harmonize global bioanalytical workflows. This trend benefits small and mid-size biotech firms that need high-complexity assays but lack the infrastructure or expertise. Integrated outsourcing solutions also accelerate trial timelines and ensure regulatory compliance across regions.

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Reasons to Buy the Report

• Gain insights into a US$10.4 Bn market projected for 2032.
• Understand evolving regulatory frameworks such as ICH M10 and their impact on testing practices.
• Identify leading segments and regional growth hotspots across North America, Europe, and Asia Pacific.
• Benchmark strategies of top players investing in hybrid assay platforms and integrated workflows.
• Access updates on recent service launches and technological advancements in the industry.

Frequently Asked Questions (FAQs)

• How Big is the Bioanalytical Testing Services Market?
• Who are the Key Players in the Global Market for Bioanalytical Testing Services?
• What is the Projected Growth Rate of the Market from 2025 to 2032?
• What is the Market Forecast for Bioanalytical Testing Services by 2032?
• Which Region is Estimated to Dominate the Industry through the Forecast Period?

Company Insights

The competitive landscape of the global bioanalytical testing services market features leading CROs and service providers with robust global networks. Key players include:

• Thermo Fisher Scientific Inc.
• Charles River Laboratories International
• ICON Plc
• Syneos Health
• IQVIA Inc.
• Pace Analytical Services LLC
• Intertek Group Plc
• SGS SA
• Wuxi AppTec
• Labcorp

Recent Developments

• In June 2025, Avance Biosciences launched its Next-Generation Sequencing (NGS) Center of Excellence, strengthening sequencing capabilities across drug development stages.
• In May 2025, Celerion introduced an upgraded version of Labnotes, its proprietary electronic lab notebook software, designed to enhance data handling and analysis.

Conclusion

The global bioanalytical testing services market is undergoing a rapid transformation, driven by the rise of biologics, gene therapies, and regulatory harmonization across major markets. With a projected CAGR of 9.2% between 2025 and 2032, the industry is set to double in value, offering lucrative opportunities for CROs, outsourcing firms, and technology providers. As pharma and biopharma companies increasingly rely on specialized assays, the role of bioanalytical testing will continue to expand as a cornerstone of modern drug development.

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About Persistence Market Research:

At Persistence Market Research, we specialize in creating research studies that serve as strategic tools for driving business growth. Established as a proprietary firm in 2012, we have evolved into a registered company in England and Wales in 2023 under the name Persistence Research & Consultancy Services Ltd. With a solid foundation, we have completed over 3600 custom and syndicate market research projects, and delivered more than 2700 projects for other leading market research companies' clients.

Our approach combines traditional market research methods with modern tools to offer comprehensive research solutions. With a decade of experience, we pride ourselves on deriving actionable insights from data to help businesses stay ahead of the competition. Our client base spans multinational corporations, leading consulting firms, investment funds, and government departments. A significant portion of our sales comes from repeat clients, a testament to the value and trust we've built over the years.

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