Life Science Leader Magazine

APR 2013

The vision of Life Science Leader is to be an essential business tool for life science executives. Our content is designed to not only inform readers of best practices, but motivate them to implement those best practices in their own businesses.

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BIO INNOVATION NOTES of suppliers interested in investing in challenging assay innovation. This is a curious trend, given that it counts as one of the strongest areas of opportunity we've noted this year. It could be that there is simply more low-hanging fruit in areas such as single-use devices, downstream processing, automation software, simpler sensor technologies, etc. Despite the fact that fewer vendors are investing resources into assays, the demand for solutions will continue to grow. Ultimately, solutions will be found. Whether these come from established industry suppliers or new industry entrants remains to be seen. Figure 1: Selected Key Assays In Development By Vendors (Of ~40 Areas Evaluated) Disposable/single-use monitoring systems Sensors and probes 22.8% 18.1% Testing/assay services: Impurities detection 12.6% Monitoring systems 11.8% Testing/assay services: Biosimilarity testing 8.7% Testing/assay services: Glycan/glycosylation analysis/ characterization 7.9% Survey Methodology: The 2013 Tenth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production is an evaluation by BioPlan Associates, Inc. that yields a composite view of and trend analysis from 300 to 400 responsible individuals at biopharmaceutical manufacturers and CMOs in 29 countries. The respondents also include more than 185 direct suppliers of materials, services, and equipment to this industry. Each year the study covers issues including new product needs, facility budget changes, current capacity, future capacity constraints, expansions, use of disposables, trends and budgets in disposables, trends in downstream purification, quality management and control, hiring, and employment. The quantitative trend analysis provides details and comparisons of production by biotherapeutic developers and CMOs. It also evaluates trends over time and assesses differences in the world's major markets in the U.S. and Europe. If you want to learn more about the report, please go to bioplanassociates.com. 22 LifeScienceLeader.com April 2013

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