After your R&D team has had a "Eureka!" moment, the first order of business is to engage in process development and production
of the product for clinical supply. Perhaps that moment came a few years ago and now you need to ensure that you can supply
enough product to meet commercial demand. Do you choose to build or retrofit your own manufacturing plant or do you buy via outsourcing to a contract manufacturing organization (CMO)? This complex decision shouldn't be made lightly because it
could affect nearly everything about your business, including your company's financial situation, intellectual property position,
and business and product goals.
THE CURRENT MARKET
In 2009, many small- to medium-sized biopharmaceutical companies struggled to raise funds for their product development and
manufacturing projects, while large, financially stable companies reigned in spending and reassessed their pipelines. The
building of new manufacturing facilities decreased, possibly reflecting changes in business philosophies as well as a reduced
ability by the pharmaceutical and biotech companies to progress with construction.1,2 At the same time, the global CMO market declined to approximately $2.6 billion, a reduction from years past.3 In general, CMOs saw a drop in requests for proposal, more sensitivity to pricing from potential clients, and there was
(and continues to be) increased level of competitiveness amongst CMOs. At least one CMO closed its doors (QSV Biologics).
Mergers and acquisitions also changed the landscape of the CMO business, as CMOs of all sizes and capabilities were integrated
into larger pharmaceutical or biotech companies (Watson Pharmaceuticals/Eden Biodesign; Merck/Avecia; Recipharm/Cobra).
Today, the business environment seems to be on the rebound: interest in pipelines including biologics remains strong, and
for companies considering outsourcing, CMO capacity is broadly available (though, perhaps because of the acquisitions of 2009,
capacity may not remain readily available). Process economics continue to improve through leaps in productivity and the acceptance
of new production technologies. There is a wider array of product types requiring cGMP manufacture, including the emergence
of biosimilars as originator product patents expire. But the industry has learned some valuable lessons as a result of the
tumult of 2009. Companies remain cautious when evaluating requirements for risk sharing, product quality compliance, and business
partner compatibility. Cost-containment is still paramount and everyone is looking to manage their project budgets efficiently.