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There are a number of market trends shaping the life sciences industry. Global population and life expectancies are increasing. Globalization of markets, especially the growing pool of middle class consumers in emerging economies, provides an increasing revenue base for large life sciences companies, but also creates the challenge of dealing with multiple global regulatory standards. At the same time, pressures to lower costs have never been greater, with growing competition from generic drug manufacturers, patent cliffs and pressures from bulk buyers.
Globalization continues to affect the Life Sciences industry. While demand for medications is rising in emerging economies, cost pressures from new competitors and healthcare payers in traditional markets are dampening economic prospects of life sciences companies. However, with new, innovative R & D and production processes, an increase of new life sciences products can be expected in the future.
Manufacturers of branded products are operating under tighter margins due to competition from generics, pressure to reduce costs, and higher regulatory burdens. While this is a business challenge, it will also drive capex in automation technology as companies invest in technologies to improve efficiencies, reduce time-to-market, ensure quality, and reduce costs.
Track and trace continues to be an important global driver of investment in the life sciences industry, which is expected to continue over the next few years to address counterfeit prescription drugs, global compliance, and confirmation of end-to-end data integrity. Companies are implementing track and trace solutions to meet increasing regulations, safety concerns and legal challenges.
Digital Transformation and Smart Manufacturing Comes to Life Sciences
The Life Sciences industry’s primary manufacturing concerns include improving productivity and reducing costs, the ability to document and secure everything from raw materials to process changes and software version control, and serialization and track and trace capabilities to meet local regulations while ensuring the highest levels of security. The ability to move from batch processes to continuous processes, particularly for bulk pharmaceuticals, is critical, especially with the use of disposable and modular production increasing. As with all industries in a connected world, cybersecurity continues to be a significant issue and an area that requires further investments.
Smart means real-time performance management solutions that improve efficiency and asset utilization while maintaining product quality. It also means digitalizing quality and production process while providing end-to-end traceability to ensure product integrity. In addition, it means providing energy management that improves energy efficiency for cost effectiveness, sustainability and safety. Finally, it means implementing an automation integration layer that reduces time-to-value and risk through standardizing automation and recipe management across the manufacturing network.
Another benefit of smart manufacturing that is driving today’s digital transformation is the ability to deliver workflow software solutions that, for example, enable a model-driven MES, enforce production rules and manufacturing procedures, enhance knowledge management, and drive collaboration across the workforce. For life sciences, workflow software functionality adds closed-loop work process management, along with escalation and system-of-record capture of processes, procedures and activities.
Line performance can be improved in 3 ways: 1) increase equipment up-time, 2) increase line throughput, and 3) increase product quality. As with all other manufacturing plants, repeatable quality across efficient batch executions is highly desired in the Life Sciences manufacturing industry. Recipe and Batch management solutions work as an “intelligent agent”, allocating equipment, downloading parameters and automating recipe procedures in the most efficient operations possible. The solution abstracts recipes from underlying control systems, which helps to standardize new product introduction processes and procedures enterprise-wide.
In conclusion, Globalization of markets, increasing price and margin pressures, multiple global regulatory compliance challenges, cost pressure and growing competition from generic drug manufacturers are now driving innovation and investment in life sciences manufacturing technologies. Life sciences companies seek solutions to improve product quality and reduce costs. Smart manufacturing enables the implementation of information-enabled operations that offer virtually infinite potential to improve business performance. Life Sciences companies can use data that has long been stranded inside machines and processes to identify production inefficiencies, compare product quality against manufacturing conditions, and pinpoint potential safety, production, or environmental issues. Remote access connectivity and mobile technologies can immediately connect operators with off-site experts to avoid or more quickly troubleshoot and resolve downtime events.