Bioanalytical Testing Services Market to Grow at 10.2% CAGR from $4.64B in 2022 to $10.11B by 2030

New York, US - December 23, 2025 - Bioanalytical testing services provide the critical quantitative analysis of drugs, metabolites, and biomarkers in biological samples like blood, plasma, and urine, supporting pharmaceutical breakthroughs from early discovery to clinical trials. These services empower companies to bring life-saving therapies to patients faster and safer, touching lives through treatments for cancer, neurological disorders, and beyond.​

Key Growth Drivers

Pharmaceutical firms increasingly outsource bioanalytical testing services to streamline R&D, focusing core teams on innovation while tapping specialized expertise. This shift cuts costs, speeds timelines, and ensures compliance with rigorous standards like GLP and GCP, making drug development more accessible and efficient.​

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The rise of biologics and biosimilars demands precise assays for pharmacokinetics, immunogenicity, and cell-based potency testing, where CROs deliver reliable results without heavy in-house investments. Quality-by-design principles, backed by FDA and EMA guidelines, further integrate these services into robust manufacturing, enhancing product reliability for real-world health impacts.​

Recent Industry Updates

Labcorp expanded its central lab capabilities in Japan through CB Trial Laboratory in May 2023, boosting drug development support in Asia with advanced bioanalytical offerings. KCAS Bioanalytical acquired Active Biomarkers in France in September 2022, strengthening expertise in oncology and cell/gene therapies across Europe.​

Eurofins Scientific acquired WESSLING Hungary in July 2022, enhancing BioPharma testing in Central Europe, while SGS snapped up Proderm for clinical solutions in cosmetics and pharma. Pharmaron's UK Gene Therapy CDMO secured a government grant in March 2023 to scale viral vector facilities, underscoring rising investments in advanced modalities.​

These moves reflect a dynamic landscape where strategic expansions meet surging needs for oncology, infectious disease, and autoimmune testing amid global health challenges.​

Market Size, Share, Trends, Analysis, and Forecast to 2031

• Global bioanalytical testing services market grows from established bases to substantial expansion by 2031 at strong compound rates, driven by outsourcing trends and biologics demand.​
• North America commands the largest share, led by U.S. healthcare investments and high R&D spending on novel drugs for infectious and neurological conditions.​
• Asia Pacific registers the fastest growth through 2031, fueled by China and India as outsourcing hubs with expanding biopharma capabilities.​
• Europe advances steadily via regulatory harmonization and focus on autoimmune and oncology assays, supported by key CRO networks.​
• Trends emphasize cell-based assays for potency and MOA studies, alongside biomarkers for personalized medicine and virology for emerging threats.​
• Analysis highlights services like pharmacokinetics and immunogenicity; oncology leads disease segments, with pharma/biopharma end-users dominating due to GLP alignment.​
• Forecast to 2031 predicts acceleration from gene therapies, biosimilars, and QbD adoption, with CROs/CDMOs bridging early-phase risks to market readiness.​

Global and Regional Analysis

North America dominates, with the U.S. spearheading through rising health expenditures, patent-driven innovations by firms like Pfizer and Amgen, and demand for tests against re-emerging diseases like tuberculosis and influenza. Government initiatives foster outsourcing to compliant facilities.​

Asia Pacific surges as a growth engine, where developing nations like China, India, Japan, and South Korea attract global pharma for cost-effective, high-quality bioanalytical testing services amid biotech booms. Europe benefits from EMA guidelines and hubs in Germany, UK, and France, prioritizing metabolic and respiratory assays.​

South & Central America and Middle East & Africa contribute emerging shares via infectious disease focus and local manufacturing, diversifying the global footprint.​

Segmental Breakdown

Cell-based assays lead services, quantifying drug effects on living cells for cytotoxicity, signaling, and neutralization vital for immunogenicity and biologics validation. Oncology tops disease indications, leveraging ICP-MS for platinum-based chemotherapies like cisplatin.​

Pharma and biopharma companies drive end-user demand, outsourcing for toxicokinetics and dosage analysis to mitigate risks from lab setup to release. CROs like Charles River and Eurofins, plus CDMOs, provide specialized platforms for over 1,000 global operations.​

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Strategic Opportunities Ahead

Bioanalytical testing services unlock efficiencies for early-phase drugs, reducing capital burdens and accelerating therapies for cardiovascular, respiratory, and bone diseases. Innovations in AQbD ensure consistent quality, appealing to startups and giants alike.​

As noncommunicable diseases burden rises neurological, metabolic, and infectious outsourcing empowers faster responses, from HIV to cancer. Providers thrive by expanding in high-growth regions and mastering large-molecule assays.​

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