Jim Miller
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Several formerly contract-only CMOs have converted, after recent acquisitions, to a more mixed model that combines contract
manufacturing with proprietary products. The most prominent examples include Patheon's late 2012 acquisition of Banner Pharmacaps,
a softgel manufacturer with its own lines of over-the-counter (OTC) and nutritional softgel products.
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The trend was further highlighted in 2012 with the acquisition of Metrics by Mayne Pharma, an Australian generic pharmaceutical
company. Metrics has been known primarily for its analytical, formulation, and clinical manufacturing services, but the acquisition
revealed that more than half of its $52 million in revenues came from sales of proprietary products it had developed internally.
Conversations with other CDMOs indicate that a number of CDMOs have quietly pursued similar strategies in recent years.
The effort to build a proprietary revenue stream is not limited to dose CMOs. Contract manufacturers of APIs have also been
pursuing these opportunities. For instance, the development of proprietary generic APIs has been a major initiative for DSM
Pharmaceutical Products in the business strategy it rolled out in 2012; up to that point the company had focused primarily
on custom manufacturing.
Companies that manufacture both their own products and client products have long been part of the CMO landscape. Most manufacturers
of generic APIs have long offered custom manufacturing of advanced intermediates and proprietary APIs.
Many bio/pharmaceutical companies have been offering contract manufacturing as a means of boosting manufacturing-capacity
utilization. Although most companies are satisfied to pick up the odd product, some share manufacturing capacity between proprietary
products and a strategically important contract manufacturing business that has a substantial sales and project management
infrastructure. This shared capacity model is especially common in the injectables segment of the CMO market.
There are other variants of the mixed proprietary–plus–contract model as well. Private-label manufacturers develop and manufacture products under their own application but package
the product under the name of a contract client, usually a retailer. In a variation of that model, a generics drug company
will out-license its products to other pharmaceutical companies and supply the manufactured product. A further variation of
the model is a drug-delivery company that develops a product for a client using its proprietary drug-delivery technologies
or know-how, and then manufactures the product for commercial supply.
Clear rationale
For CMOs entering the proprietary products game for the first time, the rationale seems rather clear:
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Better margins. Proprietary products typically promise better profitability than contract manufacturing. CMOs can capture the higher unit
price of the finished product and the 40+% gross margin that drug companies can command.
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Better utilization. Proprietary products can absorb some of the unutilized capacity in CMO facilities. This utilization is especially valuable
for solid-dose CMOs, among which there is significant excess capacity.
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Greater control and predictability. In the contract-only CMO model, manufacturers are totally at the mercy of their clients' marketing prowess and product success.
With proprietary products, CDMOs can gain some predictability over revenues and utilization.
A move into proprietary products can be particularly attractive to smaller CDMOs that cannot gain traction in the contract
manufacturing business and need an extra boost to drive growth. Global bio/pharma vendor-consolidation strategies favor larger
CMOs with broader capabilities, which could leave smaller CMOs out of the mix and searching for new growth avenues.
