Bioanalytical Testing Services Market to Reach USD 8.02 Billion by 2030, Supported by Booming Biologics Pipelines and AI Integration

Mordor Intelligence has published a new report on the Bioanalytical Testing Services Market, offering a comprehensive analysis of trends, growth drivers, and future projections.

The bioanalytical testing services market is forecast to expand from around USD 4.29 billion in 2025 to approximately USD 6.65 billion by 2030, representing a compound annual growth rate (CAGR) of about 9.19% during 2025-2030.
This steady upward trajectory is driven by growing demand for biologic drug development, rising complexity in therapeutics, increasing outsourcing of analytical work, and incorporation of advanced testing platforms. Pharmaceutical and biotech companies are leaning heavily on external testing partners to navigate pharmacokinetics (PK), immunogenicity, biomarker profiling, and ADME/PD aspects essential for drug discovery and regulatory filing.

Report Overview: https://www.mordorintelligence.com/industry-reports/bioanalytical-testing-services-market?utm_source=openpr

Key Trends

Broader Adoption of Complex Therapeutics
The development of monoclonal antibodies, biosimilars, gene and cell therapies has raised demand for specialized analytical testing. This includes ligand-binding assays, high-resolution mass spectrometry, and immunogenicity profiling to meet stringent regulatory standards.

Greater Focus on Oncology and Rare Diseases
Oncology continues to account for the largest portion of testing service demand, backed by immune-oncology trials and biomarker-heavy protocols. At the same time, rare disease testing programs offer the fastest growth within therapeutic areas due to increased research and niche clinical pipelines.

Outsourcing Push to Asia-Pacific
While North America remains the largest regional market, Asia-Pacific is the fastest-growing region, driven by lower-cost testing capacity, WHO‐cGMP‐compliant facilities, and expanding CRO and CDMO networks across India, China, and Southeast Asia.

Automation and AI-Powered Bioassay Platforms
Leading providers are investing in lab automation and AI-driven workflows to support high-throughput mass spectrometry and ligand binding assays. These technologies reduce turnaround time and support data integrity for regulatory submissions.

Tighter Regulatory and Data-Guidance Requirements
Regulatory frameworks like FDA's focus on immunogenicity testing, ICH M10 guidance on data integrity, and global sourcing oversight are pushing sponsors to seek certified bioanalytical partners with compliant data systems.

Market Segmentation

By Molecule Type

Small Molecules

Large Molecules

By Test Type

Bioavailability & Bioequivalence

Pharmacokinetics

Pharmacodynamics

Absorption-Distribution-Metabolism-Excretion

Immunogenicity & Neutralizing-Antibody Assays

Biomarker & Omics-Based Assays

Other Tests

By End User

Pharmaceutical Companies

Biopharmaceutical & Biotech Firms

Contract Development & Manufacturing Organizations

Academic & Government Institutes

By Region:

North America

Europe

Asia‐Pacific

South America

Middle East & Africa

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Key Players

Although Mordor Intelligence lists many major players in the related large molecule testing segment, representative global providers include:

SGS SA

Syneos Health

Charles River Laboratories

Labcorp Drug Development (Covance)

ICON plc

These organizations operate multi-modal testing networks covering PK, immunogenicity, biomarker, and cell therapy assays. Investment in digital lab systems, audit-ready analytics, and end-to-end phase capability help these leaders address the increasing complexity and volume of outsourced bioanalyses.

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Conclusion

The global bioanalytical testing services market is set to grow from around USD 4.29 billion in 2024 to USD 6.65 billion by 2030, at a 9.19% CAGR. Demand reflects the rising complexity of modern drug pipelines-especially biologics, immuno-oncology, and gene therapies-and an increasing preference for outsourcing precision testing to accredited laboratories. Oncology remains the top therapeutic domain in terms of testing volume, while rare disease analytics are rising at the fastest pace.

North America continues as the primary market, offering robust cGMP-compliant lab capacity and early access to complex trial phases. Asia-Pacific offers rapid expansion opportunity, supported by competitive costs, favorable regulations, and growing local CRO infrastructure. Providers that align with regulatory demands, deliver faster turnaround through automation, and offer globally compliant systems are well-positioned to lead as sponsors increasingly rely on external bioanalytical testing to support regulatory filings, biosimilar programs, and pipeline expansion.

Industry Related Reports

Large Molecule Bioanalytical Testing Services Market: The Large Molecule Bioanalytical Services Market Report is Segmented by Phase (Preclinical and Clinical), Molecule Type (Monoclonal Antibodies, and More), Service (ADME, Pharmacokinetics, and More), Therapeutic Area (Oncology, and More), End User (SMEs, Large Firms, and More), and Geography (North America, Europe, Asia-Pacific, and More).

Get More Insights: https://www.mordorintelligence.com/industry-reports/large-molecule-bioanalytical-testing-services-market?utm_source=openpr

Healthcare Analytical Testing Services Market: The Healthcare Analytical Testing Services Market is Segmented by Service Type (Bioanalytical Testing, Stability Testing, and More), Molecule (Small-Molecul, and More), Development Phase (Pre-Clinical, Phase I-III, and More), End User (Pharmaceutical Companies, Biopharmaceutical Companies, and More), and Geography (North America, Europe, Asia Pacific, and More).

Get More Insights: https://www.mordorintelligence.com/industry-reports/healthcare-analytical-testing-services-market?utm_source=openpr

Pharmaceutical Analytical Testing Outsourcing Market: Pharmaceutical Analytical Testing Outsourcing Market Report is Segmented by Services (Bioanalytical Testing [Clinical and More] and More), Test Type (Chemistry Testing and More), Phase (Phase I and More), Technology Platform (Chromatography-Based and More), Outsourcing Model (Full-Service CRO, and More), End-User (Virtual / Small Biotech and More), and Geography.
Get More Insights: https://www.mordorintelligence.com/industry-reports/pharmaceutical-analytical-testing-outsourcing-market?utm_source=openpr

About Mordor Intelligence:

Mordor Intelligence is a trusted partner for businesses seeking comprehensive and actionable market intelligence. Our global reach, expert team, and tailored solutions empower organizations and individuals to make informed decisions, navigate complex markets, and achieve their strategic goals.

With a team of over 550 domain experts and on-ground specialists spanning 150+ countries, Mordor Intelligence possesses a unique understanding of the global business landscape. This expertise translates into comprehensive syndicated and custom research reports covering a wide spectrum of industries, including aerospace & defense, agriculture, animal nutrition and wellness, automation, automotive, chemicals & materials, consumer goods & services, electronics, energy & power, financial services, food & beverages, healthcare, hospitality & tourism, information & communications technology, investment opportunities, and logistics.

For any inquiries or to access the full report, please contact:

media@mordorintelligence.com
https://www.mordorintelligence.com/

Mordor Intelligence, 11th Floor, Rajapushpa Summit, Nanakramguda Rd, Financial District, Gachibowli, Hyderabad, Telangana - 500032, India

Mordor Intelligence is a trusted partner for businesses seeking comprehensive and actionable market intelligence. Our global reach, expert team, and tailored solutions empower organizations and individuals to make informed decisions, navigate complex markets, and achieve their strategic goals.

With a team of over 550 domain experts and on-ground specialists spanning 150+ countries, Mordor Intelligence possesses a unique understanding of the global business landscape. This expertise translates into comprehensive syndicated and custom research reports covering a wide spectrum of industries, including aerospace & defense, agriculture, animal nutrition and wellness, automation, automotive, chemicals & materials, consumer goods & services, electronics, energy & power, financial services, food & beverages, healthcare, hospitality & tourism, information & communications technology, investment opportunities, and logistics.

For any inquiries or to access the full report, please contact:

media@mordorintelligence.com
https://www.mordorintelligence.com/

This release was published on openPR.