PUBLISHER: Grand View Research | PRODUCT CODE: 1751217
PUBLISHER: Grand View Research | PRODUCT CODE: 1751217
The global pharmaceutical analytical testing services in CRO market size was estimated at USD 7.52 billion in 2024 and is projected to grow at a CAGR of 8.61% from 2025 to 2030. This growth is primarily attributed to factors such as the growing prevalence of chronic diseases, demand for outsourcing analytical testing services, investments in pharmaceutical R&D, and a shift toward cost-efficient drug development processes across the globe.
In addition, pharmaceuticals are increasingly outsourced to CROs to utilize specialized expertise, minimize their capital investment in the infrastructure, and streamline the timelines for the drug approval process and regulatory requirements. These tests are essential throughout development, from raw materials analysis and method validation to stability studies and impurity profiling.
As CROs offer advanced analytical technologies such as mass spectrometry, NGS, Raman spectroscopy, and automation/AI for rapid and accurate testing are expected to enhance the demand for pharmaceutical analytical testing services in CROs for developing personalized and precision medicine.
Moreover, factors such as an increasing pipeline of biologics, biosimilars, advanced therapies, and rising stringent quality control to enhance pharmaceutical products' safety, efficacy, and consistency are contributing to market growth. Besides, the expanding adoption of automation, artificial intelligence, and digital data management systems like Laboratory Information Management Systems (LIMS) in CROs is anticipated to boost the efficiency and reliability of analytical testing processes. This led pharmaceutical companies to expand their partnerships with CROs for cost-saving strategies and strategic collaborations that boost innovation, reduce risk, and improve time-to-market.
Furthermore, stringent regulatory frameworks worldwide are another major driver for the pharmaceutical analytical testing services in CRO market. Regulatory authorities such as the U.S. FDA, EMA, PMDA, and WHO require comprehensive analytical validation, method development, and stability testing to enhance drug safety, efficacy, and quality. These regulations are becoming increasingly stringent, particularly for complex biologics, biosimilars, and advanced therapies, mandating in-depth characterization and impurity profiling. The implementation of ICH guidelines (Q2, Q3, Q6) and GMP/GLP standards has intensified the demand for compliant analytical methodologies. Frequent audits and regulatory inspections further influence pharmaceutical companies to engage with specialized CROs possessing global regulatory knowledge, validated infrastructure, and quality management systems, allowing risk mitigation, faster approvals, and sustained market access across geographies.
Further, the adoption of Quality by Design (QbD) principles, which emphasize a systematic approach to product development, highlights the importance of early-stage analytical characterization. Under the QbD framework, pharmaceutical companies must define Critical Quality Attributes (CQAs) and ensure that variations in raw materials or manufacturing processes do not compromise product performance. The FDA's Process Analytical Technology (PAT) initiative promotes real-time monitoring of manufacturing parameters to maintain product consistency. This regulatory push, combined with the industry's transition toward more sophisticated drug formulations, is expanding the role of CROs in pharmaceutical analytical testing. Such aforementioned factors are expected to drive the overall market demand in the near future.
Global Pharmaceutical Analytical Testing Services In CRO Market Report Segmentation
This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global pharmaceutical analytical testing services in CRO market report based on service, end use and region.