Outsourcing: Biologics Manufacturing: The CMO Advantage - The biologics CMO market—especially in mammalian cell culture—is still relatively undeveloped and represents a significant opportu

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Outsourcing: Biologics Manufacturing: The CMO Advantage
The biologics CMO market—especially in mammalian cell culture—is still relatively undeveloped and represents a significant opportunity.


BioPharm International
Volume 20, Issue 2

Since the late 1990s, the use of CMOs has steadily increased. Our research indicates that complications remain, however, as companies with relatively sophisticated manufacturing capabilities still encounter issues in replicating a facility. Consequently, biologics manufacturing companies should carefully weigh the risks associated with contract manufacturing against the potential benefits before making an outsourcing decision. Our research also indicated, however, that an increased level of knowledge, experience, and skills among contract manufacturers and their deeper understanding of biologics manufacturing are helping to reduce these risks, thereby keeping the outsourcing of manufacturing as a viable option.

DEMAND FOR BIOTECH PRODUCTS ON THE RISE


Figure 1. Estimated number of biotech drugs in the market and their revenues (adapted from reference 2).
Since recombinant insulin was first developed and commercialized in the early 1980s, biotechnology-derived therapeutic products have grown in both number and revenues generated. The growth has accelerated in recent years and is expected to continue in the near future. The worldwide market for biotech drugs in 2010 is estimated to be nearly $70 billion, with an estimated compound annual growth rate of around 10% from 2005 to 2010 (Figure 1).


Figure 2. Number of biotech drugs, including peptides and proteins, in the pipeline (adapted from reference 3).
As shown in Figure 1, the number of biotech drugs is expected to grow from 100 in 2005 to about 150 in 2010. A closer look at the current research and development (R&D) pipeline shows more than 500 protein and 150 peptide drugs in various stages of development, suggesting that this growth will continue (Figure 2). This increasing demand for biotech products will likely require greater manufacturing capacity.


Figure 3. Implied demand for manufacturing capacity for monoclonal antibodies (MAbs). (Adapted from reference 4).
Spare capacity based on planned capacity projections is decreasing from around 57% to 25% for monoclonal antibodies (Figure 3). While it may appear that no additional capacity is required, we believe this is not the case, for two reasons.

First, all capacity is not the same. While certain types of manufacturing capacity, such as those used for fill-and-finish operations, are abundant, industry professionals have indicated that other types of capacity for upstream processes like fermentation and purification are scarce.

Second, both supply and demand in biotech operations can be highly uncertain. Even though biologics manufacturing is more advanced now than before, it is still relatively immature and may lead to significant supply uncertainties. On the demand side, drug development and commercialization risks can lead to large de-mand variations. These uncertainties require a substantial buffer in manufacturing capacity.

We believe these reasons, combined with the significant reduction in spare capacity we expect to see in the near future, indicate that the need to develop more manufacturing capacity is high. However, additional capacity is needed more in some areas than others, as we will discuss below.

MAMMALIAN CELL CULTURE SHOWS HIGH POTENTIAL

There are significant differences in the outsourcing market for the two main types of biotech drug manufacturing, microbial manufacturing and mammalian cell manufacturing.


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