The global economic uncertainties, increasing healthcare costs and expiring patents are putting pharma companies in a state of turmoil. However, on the brighter side, the rapid development of the emerging markets, progress in drug research, the rise in generics production, the availability of high-potency drugs, and innovations in manufacturing trends will sustainably modify the global pharmaceutical landscape. Moreover, the increasing prevalence of chronic diseases and the growing demand for medications, high market growth, new medicines, and therapy forms, changing regulations, and progressing digitization are going to give birth to new manufacturing trends to meet the growing demand.
Manufacturing trends in the pharma industry
Process analytical technology
This initiative sets a legal framework in the USA aiming to motivate pharma companies to improve the production process and achieve consistent quality while reducing waste and costs. In order to comply with this regulation and the changing manufacturing trends, pharma companies need to have systems in place that ensure detailed monitoring of their continuous and batch processes. Process analytical technology is one of the vital manufacturing trends that enables and drives continuous manufacturing. It was identified as one of the most important manufacturing trends in pharma companies along with integrated manufacturing business and automation processes.
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Digitization and labeling information
Effective tracking, tracing, and labeling is a mandatory proof of authenticity and prevention of drug counterfeiting. Digitization of labeling information has resulted in greater emphasis being placed on collecting, securing, and processing digital data about pharma products.
There are several issues relating to introducing new drugs in the market. This includes manufacturing issues as well, so a review of manufacturing trends in approvals of new molecular entities (NMEs) can provide insight into manufacturing activity. A key trend in NME approvals is the increased share of orphan drugs approved as NMEs. Orphan drugs are defined as drugs that treat diseases which are known to affect 200,000 or fewer people, as defined by the US Food and Drug Administration (FDA). The FDA provides incentives, including market-exclusivity benefits, for developing orphan drugs. Due to a smaller patient population, these drugs are typically produced in lower volumes when compared to primary care drugs.
Risk-based manufacturing inspections
The FDA is continuing its plan to use a risk-based selection model for manufacturing inspections in the pharma industry. This forms a part of its strategy to allocate resources more effectively and gain greater parity between inspections of domestic and foreign drug-manufacturing facilities. In September 2018), the FDA published an internal policy that outlines the agency’s risk-based, site-selection model for inspecting foreign drug-manufacturing facilities. The FDA prioritizes inspections of sites regardless of their location with the help of a risk-based site-selection model. This is one of the critical manufacturing trends that pharma companies must watch out for.
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