Evaluating Supply and Demand Patterns for Contract Biologics Manufacturing - Pharmaceutical Technology

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Evaluating Supply and Demand Patterns for Contract Biologics Manufacturing
The authors analyze the supply–demand trends for contract biologics manufacturing and the strategies of pharmaceutical and biotechnology companies and their suppliers in the value chain.

Pharmaceutical Technology

Outsourcing mixed: case-by-case decisions. Feedback from biomanufacturing directors also showed that the decision to outsource is made on a case-by-case basis as opposed to an overall strategic leaning toward outsourcing or keeping manufacturing in-house. Select comments are outlined below:

  • "Whether we outsource or not would be driven by our pipeline. Two sources contribute to our pipeline: our in-house R&D and molecules we acquire in early phases of development. We plan to expand our facilities, but we are conservative in our investments in GMP facilities. If we have a big project that requires more capacity than we have in-house, we would consider outsourcing GMP production."
  • "Our strategy is a balanced approach between in-house production and outsourcing. In this way we can minimize our risk, and it gives us maximum flexibility."
  • "Up to now, we have been trying to develop the processes ourselves. Now we have identified a few CMOs that can do process development better than us, and so we are in the process of changing our strategy. We would like to go backwards and let these CMOs do some process development. Our decision to outsource used to be based solely on volume and demand. Now we also include quality, technology, and previous experience with that CMO when we decide to farm something out."
  • "Cost and time are our main drivers in our biomanufacturing strategy. Our philosophy is to keep flexible. We want to bring our products into manufacture as soon as possible, so we shuffle what we do in-house, versus outsourcing based on capacity and time."

Demand for expanded outsourcing services

Table I: Services planned to be outsourced during the next three years (1).
To understand what biopharmaceutical manufacturing directors believe are the most important services to outsource, the survey asked the directors to list the services that they plan to outsource within the next three years (see Table I). Many of the biopharmaceutical manufacturing directors would prefer to have their contract manufacturer offer a complete set of services, rather than dealing with several contractors for individual services. As might be expected, smaller biopharmaceutical companies with fewer employees and resources and less expertise are especially concerned about the burden of coordinating various service providers. In addition, some of the larger biopharmaceutical companies recognize that many of the biopharmaceutical contract manufacturers have areas of expertise that they do not have and are looking to contract manufacturers to provide.

Table II: Select new or planned service offerings of biopharmaceutical contract manufacturers (1) .
The majority of biopharmaceutical contract manufacturers are expanding their service offerings to meet demand for additional service offerings. Table II shows a list of expanded offerings by the biopharmaceutical contract manufacturers. This list includes some of the service offerings that were added during the past two years and those that biopharmaceutical contract manufacturers plan to add in the next two years.


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