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Continuous Manufacturing and Serialization Drive the Market due to the Need for Personalized Medicines
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The life science industry is on the verge of transformation due to the introduction of new product lines, increasing preference for personalized medicines and localized manufacturing, and high cost pressure. The industry needs the help of digitalization technologies to accelerate the journey of transformation. Increasing focus on improving process flexibility, enhancing operational efficiency, reducing time to market, and minimizing costs have shifted the industry from paper-based solutions to paperless automation systems. Increasing demand for automation solutions helps the industry to facilitate real-time information management across the enterprise throughout the entire value chain. The major trends such as serialization and supply chain optimization are increasing the need for integration of various systems across the value chain. The life science is one of the highly regulated industries; hence, it has various regulatory bodies in global and regional level imposing various regulations. For example, USFDA’s Drug Supply Chain and Security Act (DSCSA) and European Union’s Falsified Medicines Directive (EU FMD), and many other regional regulations in Asia, the Middle East and Africa, and Brazil mandate the serialization, which drives the implementation of automation systems in various levels of supply chain. Along with this, the push for adoption of open standards in process automation drives the automation suppliers to collaborate with IT solution providers to enhance the interoperability of various systems in different levels of automation such as DCS, MES, and ERP. Life science companies, regulatory bodies, government organizations, and academic institutions together collaborated to form a technology roadmap to transform the future of the life science industry. This industry is expected to see a high rise in the number of contract manufacturers as life science companies focus on leveraging their expertise in developing innovative technologies. Automation suppliers need to focus on small manufacturers and contract manufacturers as the leading life science companies have already established partnerships with giant automation providers. Investments in automation and Pharma 4.0 solutions are high in greenfield projects of both big and small life science companies because of the ease of implementation of regulatory compliance. The market for ACS in the life sciences industry is mature in the US due to the stringent regulations imposed by the US Food and Drug Administration (FDA). Europe and Asia are fast growing, mainly due to value chain integration. Activities such as sourcing, development, and final manufacturing are performed in different regions, and final goods are sold in the US and Europe, which needs compliance from regulatory bodies such as USFDA and EMA that drives the rapid growth in ACS in the life sciences industry.
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