Marketing 360: Contract Research Organizations
Contract research organizations (CROs) and contract manufacturing organizations (CMOs) are now pillars in the drug development pipeline, lending support to biotechnology, pharmaceutical and medical device companies at all scales and phases. They offer the full range of research, development, clinical trial and manufacturing services now required to move complex new entities through FDA approval. And the field is growing fast: Analysts at Industry Standard Research (ISR Reports) predict the compound annual growth for R&D outsourcing expenditure will average 7.4% over the next 4 years, an estimate that would put the CRO market at nearly $34 billion in 2019.
Many benefits are on the table. Contractual arrangements arm vendors with tighter control over their R&D spending. A range of expertise can be tapped into and potential biases within a science company can be removed. Multiple projects, from pharmacokinetics to immunogenicity, can be seeded at once, across many locations. Combined, these factors can fast-track time-to-clinic. Finally, outsourcing can be more cost-effective, as both equipment and labor are used exclusively when needed, with far less upfront capital investment.
Drug developers know what they’re doing, but modern therapies are increasingly complex and require a huge breadth of expertise. Oftentimes, CROs are the only feasible R&D route. A prime example of this evolution is the shift from small molecules to targeted biologics — and it doesn’t stop there. Look forward to a future with cancer immunotherapies (requiring autologous T-cell transfusions) and antibody drug conjugates (ADCs), which comprise three unique parts (read: three times the variables), with a highly toxic component. Regulatory agencies demand deep, quality data to ensure each patient reaction will be beneficial.
Contract research organizations are well positioned to field the influx of complex needs. In recent years, pharma lay-offs have created a pool of tens of thousands of skilled freelancers, some of whom are consolidating in CROs. Through their specialization, these organizations offer a unique opportunity to move beyond the limits of specific vendor resources and increase the likelihood of financial return for potential investors. As always, there is a trade-off. Vendors need to be prudent when choosing an outsourcing partner. But if done correctly – their biopharma programs will thrive.
Looking for CRO support — or offering your own outsourced services? Check out Tools & Services.
This post is part of Chempetitive Group’s Marketing 360 series. These articles offer a high-level analysis of a very specific science marketing area, delivering a smart overview in just 360 words.