SECTION TITLE CMOs


to add more services to their equipment and consumable offerings. Moreover, the growth of the biopharmaceutical industry in emerging markets, the increasing need for validation services, and the continued development of new products will continue to provide service providers with opportunities.


Suppliers will need to ensure that the quality of those services remains high. Currently, biomanufacturers surveyed for our study indicate that that vendor change notifications and change control issues are a bigger issue than poor service quality. Still, they are more apt to complain of poor service quality than of poor product quality, suggesting that as suppliers integrate more services with their products, they will need to make the necessary efforts to keep them of comparable quality.


It will be interesting to see what – if any – impact is felt by traditional contract manufacturing organizations as equipment-anchored comp- anies begin to offer process development and related services traditionally only offered by CMOs. These equipment-anchored sup- pliers envision process design and other services as complementing and increasing their mainstream equipment and supplies sales, with the services obviously favoring process development and scale-up using their own products. While this enables larger sales of more bundled products and services – maximizing sales for the vendor as well as convenience and potential cost-savings for clients, it further increases reliance by customers on their selected vendors and means that bioprocessing CMOs and equipment/reagent suppliers will be competing to sell similar services to the same base of clients. This has the potential to see them butting heads in the marketplace.


References


1. 13th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, April 2016, Rockville, MD www.bioplanassociates.com/12th


Eric S. Langer is president and managing partner at BioPlan Associates, Inc., a biotechnology and life sciences marketing research and publishing firm established in Rockville, MD in 1989. He is editor of numerous studies, including “Biopharmaceutical Technology in China,” “Advances in Large-scale Biopharmaceutical


Manufacturing”, and many other industry reports. elanger@bioplanassociates. com 301-921-5979. www.bioplanassociates.com


Survey Methodology: The 2016 Thirteenth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production yields a composite view and trend analysis from over 200 responsible individuals at biopharmaceutical manufacturers and contract manufacturing organizations (CMOs) in 30 countries. The methodology also included over 150 direct suppliers of materials, services and equipment to this industry. This year's study covers such issues as: 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 issues, 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.


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