The Manufacturing Execution Systems market has always been fragmented by industry and technology. A Magic Quadrant cannot do justice to the nuanced differences, so in conjunction with the release of the Magic Quadrant for Manufacturing Execution Systems, there will be six industry specific context documents. These documents focus on the unique challenges in the industry, and feature MES vendors not found in the Magic Quadrant document. This document covers life sciences manufacturing (pharmaceutical, biotech, medical device, etc.).
The life sciences market is one of the most highly regulated markets in manufacturing. It is composed of both discrete manufacturing (medical device) and process manufacturing (pharmaceutical and biotech) sectors.
Life sciences manufacturing is impacted by trends that are popular in other manufacturing disciplines:
- Mass customization — The drive to provide personalized products at low unit cost is not something that life sciences companies have faced in the past. However, the rise of biotech and personalized medicine, as well as advancements in manufacturing such as additive manufacturing, are creating new challenges in life sciences manufacturing production.
- Contract manufacturing — Life sciences manufacturers are also pursuing increasingly complex and multidisciplined supply chains mixing in-house manufacturing with contract manufacturing to enable them to enter emerging markets more rapidly. This strategy enables moving production closer to the customer. Contract manufacturing adds another layer to the life sciences manufacturing supply chain, with commensurate complication in regulatory compliance tracking.
- Regulatory — This involves the requirements for data integrity, label requirements, compliance requirements, good practice regulations and guidelines (GxP) applicable to life sciences organizations, Good Automated Manufacturing Practice (GAMP 5), and requirements for continuous improvements. One of the biggest differentiators and challenges between life sciences and other industries is represented by the volume of FDA warning letters .
These differentiators present a challenge and an opportunity for MES vendors in the life sciences sector. Learn more here