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

The global bioanalytical testing services market is experiencing robust expansion, projected to grow from US$5.6 billion in 2025 to US$10.4 billion by 2032, at a compound annual growth rate (CAGR) of 9.2%. This strong growth is underpinned by the increasing complexity of therapeutic modalities such as biologics, biosimilars, and gene therapies, coupled with the stringent regulatory landscape that governs their development.

Market leaders are actively investing in integrated hybrid assay platforms that combine LC-MS, ligand-binding assays, and molecular techniques under a unified Quality Management System (QMS). These systems enable streamlined workflows across biologics, gene therapies, and Advanced Therapy Medicinal Products (ATMPs).

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The global trend toward outsourcing bioanalytical testing is accelerating as pharmaceutical and biopharmaceutical companies seek to enhance flexibility, regulatory compliance, and cost-efficiency. As a result, contract research organizations (CROs) and specialized bioanalytical firms are becoming indispensable strategic partners across all phases of drug development.

Key Industry Highlights

Leading Region: North America holds approximately 48.2% of the global market share in 2025, driven by advanced bioanalytical infrastructure and strong adoption of emerging assay technologies.

Fastest-Growing Region: Europe, supported by the implementation of ICH M10 guidelines and increasing demand for harmonized validation processes across the EU and U.K.

Dominant Test Type: Bioavailability testing, commanding 35.8% of the market in 2025 due to its central role in determining systemic drug exposure.

Top End-User Segment: Pharma and biopharma companies, contributing around 54.8% of total demand in 2025, as they rely heavily on regulated bioanalytical data for clinical and regulatory decision-making.

Recent Service Expansion: In August 2024, SGS SA introduced new specialized bioanalytical testing services in North America to support discovery, preclinical, and clinical programs.

Market Dynamics

Driver - Increasing Demand for Biologics and Gene Therapies

The rapid evolution of biologics and gene therapies is the primary driver for bioanalytical testing services. These therapies require specialized analytical methods to evaluate pharmacokinetics (PK), immunogenicity, and biodistribution.
High-sensitivity technologies such as quantitative PCR (qPCR), digital PCR (dPCR), and hybrid LC-MS/ligand-binding platforms are being adopted to assess viral vector shedding and monitor immune responses. The growing emphasis on personalized medicine further strengthens the need for ultra-precise and validated bioanalytical assays tailored for small patient populations and rare diseases.

Restraint - Complex Regulatory and Compliance Requirements

The evolving global regulatory framework poses challenges for bioanalytical laboratories. Adherence to ICH M10, GLP, GCP, and local regulatory standards demands significant documentation, frequent audits, and robust data integrity systems.
Smaller labs face scalability issues and may struggle with operational costs linked to BSL-2/BSL-3 containment requirements for viral vector testing. Regular updates from regulatory agencies such as the FDA and EMA necessitate costly method revalidations, reducing operational efficiency and delaying study timelines.

Opportunity - Expansion of Specialized Outsourcing Firms

The emergence of specialized outsourcing firms presents new growth opportunities. These firms offer advanced technologies such as high-resolution mass spectrometry, automated sample processing, and AI-driven data analytics, helping pharmaceutical clients meet regulatory standards efficiently.
Companies like Frontage Laboratories, Eurofins Scientific, and Syneos Health are expanding their global footprints and integrating multi-site networks to deliver harmonized and compliant bioanalytical workflows. This enables small and mid-sized biotech firms to access cutting-edge analytical capabilities without heavy capital investment.

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Category-Wise Analysis

By Test Type

The market is segmented into ADME, pharmacokinetics (PK), pharmacodynamics (PD), bioavailability, bioequivalence, biomarker testing, cell-based assays, and virology testing.

Bioavailability testing leads with 35.8% market share in 2025, owing to its critical role in determining drug absorption and systemic exposure.

Bioequivalence testing continues to expand steadily, supported by the growing need to validate generic formulations and complex modified-release drugs.

Biomarker and cell-based assays are increasingly used in clinical trials for immunogenicity assessments, response monitoring, and efficacy validation, reflecting a shift toward precision medicine.

By End-User

Based on end-user segmentation, the market is divided into pharma and biopharma companies, CROs, CDMOs, and others.

Pharma and biopharma companies dominate with a 54.8% share in 2025, driven by their reliance on validated bioanalytical data for R&D and regulatory filings.

CROs play a pivotal role by providing high-complexity, multi-modal assays across global clinical trials. Their regulatory readiness and operational scalability make them preferred partners for large pharmaceutical sponsors.

Regional Insights
North America

North America leads the global bioanalytical testing services market, accounting for 48.2% of global revenue in 2025.
The U.S. Food and Drug Administration's (FDA) adoption of the ICH M10 guidance in 2024 has standardized validation expectations across chromatographic and ligand-binding assays. The increasing number of cell and gene therapy trials in the U.S. has further intensified the need for integrated biodistribution and immunogenicity testing.

Europe

Europe is the fastest-growing market, benefiting from unified regulatory frameworks under ICH M10 and progressive updates to EMA's ATMP guidelines. Hybrid laboratory models that integrate LC-MS, ligand-binding, and molecular workflows under one QMS are becoming increasingly prevalent.
Key hubs such as Germany, Switzerland, and the U.K. are witnessing substantial investment in inspection-ready bioanalytical facilities capable of supporting complex therapeutic modalities.

Asia Pacific

Asia Pacific is emerging as a dynamic region characterized by a mix of regulatory maturity and cost competitiveness.
Countries such as China and Japan are advancing regulatory alignment with Western standards, while India, Korea, and Singapore focus on clinical trial execution and logistics excellence. Regional CROs are investing in hybrid analytical platforms, micro-volume testing, and cold-chain infrastructure to support multi-country trial operations.

Competitive Landscape

The global market is moderately consolidated, with a handful of multinational CROs and analytical service providers holding significant market shares.

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Key Players:

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

Leading companies are focusing on expanding hybrid testing capabilities, digital lab management, and integrated data systems. Mid-tier firms are differentiating through agility, customized testing services, and faster turnaround times to attract small and mid-size pharmaceutical clients.

Market Segmentation

By Molecule

Small Molecule
Large Molecule

By Test

ADME
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Bioavailability
Bioequivalence
Biomarker Testing
Cell-based Assay
Virology Testing
Other Tests

By Workflow

Sample Collection and Preparation
Method Development and Validation
Sample Analysis
Other Processes

By End-user

Pharma and Biopharma Companies
CDMO
CRO
Others

By Region

North America
Europe
East Asia
South Asia & Oceania
Latin America
Middle East & Africa

Recent Developments

June 2025: Avance Biosciences inaugurated its Next-Generation Sequencing (NGS) Center of Excellence, designed to unify and enhance sequencing capabilities for drug development.

May 2025: Celerion launched an upgraded version of its Labnotes Electronic Laboratory Notebook (ELN) platform, improving assay data integrity and analysis efficiency.

August 2024: SGS SA expanded its bioanalytical testing services in North America to cover preclinical and clinical phases, offering comprehensive assay support.

Future Outlook

The future of the bioanalytical testing services market is set for substantial transformation. The convergence of artificial intelligence (AI), automation, and digital lab ecosystems will redefine analytical workflows and enhance data integrity. Hybrid assay systems combining LC-MS, ligand-binding, and molecular assays are expected to become the industry standard by 2032.

With global regulatory harmonization under ICH M10 and the continued rise of biologics and gene therapies, outsourcing partnerships between CROs and pharmaceutical firms will deepen. As a result, the global market is forecasted to surpass US$10.4 billion by 2032, emphasizing an industry increasingly driven by innovation, integration, and compliance excellence.

In summary, the bioanalytical testing services market stands at a pivotal juncture, transitioning from traditional analytical approaches toward fully integrated, automated, and globally harmonized systems. These advancements will be instrumental in shaping the future of drug development, ensuring speed, safety, and efficacy in the biopharmaceutical landscape.

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This release was published on openPR.