PUBLISHER: Grand View Research | PRODUCT CODE: 1529616
PUBLISHER: Grand View Research | PRODUCT CODE: 1529616
The global chemistry, manufacturing and control services outsourcing market size is anticipated to reach USD 15.16 billion by 2030 and is projected to grow at a CAGR of 6.72% from 2024 to 2030, according to a new report by Grand View Research, Inc. Stringent regulatory requirements, increasing R&D investments, and growing need for cost-efficient manufacturing solutions are key factor driving market growth potential. Moreover, complexity of drug development, technological advancements in biologics and personalized medicine, and biopharmaceutical companies focusing on core competencies are another key factors positively impacting the market growth.
The incorporation of state-of-the-art technologies such as automation, artificial intelligence, continuous manufacturing, and digital analytics serves to enhance precision, reduce costs, and accelerate production capabilities. For instance, AI and machine learning applications in quality control and predictive maintenance are expected to reduce operational costs by 20-30%. AI and machine learning algorithms offers predictive analytics for process optimization, quality control, and troubleshooting, reducing time and cost in drug development. Automation in manufacturing processes, including robotics and continuous manufacturing, improves production efficiency, minimizes human error, and enhance product quality. In addition, advancements in digitalization, such as electronic lab notebooks (ELNs) and laboratory information management systems (LIMS), streamline data management and regulatory compliance, assisting seamless information flow and traceability. These advancements enable CMC service providers to offer enhanced quality and heightened reliability services compliant to complex demands of modern biopharmaceuticals including biologics and personalized medicines. The integration of advanced solutions is expected to further propel the market growth and competitiveness of the market.
Stringent regulatory scenario in several economies is anticipated to boost the global CMC services outsourcing market. Regulatory agencies, such as the U.S. FDA, the EU EMA, and several other national regulatory authorities enforce strict standards to ensure the safety, efficacy, and quality of pharmaceuticals and biologics. These stringent regulations require thorough documentation, comprehensive testing, and robust quality control throughout the drug development and manufacturing process. Pharmaceutical and biotechnology companies often encounter difficulties in keeping abreast of the evolving regulatory landscape and the associated compliance costs resulting in outsourcing of CMC services to specialized service providers. Moreover, market participants offer critical support in areas such as regulatory submissions, stability studies, analytical method validation, GMP compliance and several others, thereby propelling the industry growth potential.