Optimizing drug development, manufacturing and supply is critical if pharmaceutical companies are to translate innovation into therapeutic and commercial gains that balance health benefits with affordable access and durable revenue streams. Yet the bar for achieving this kind of synergy, in an unpredictable operating environment, keeps getting higher.
Drug development costs continue to rise as deeper understanding of disease pathogenesis and pathways ramps up treatment specificity and complexity, all against a backdrop of more stringent drug regulation and payer scrutiny of product value. Even the lowest estimate for the average cost of bringing a new drug to market is $1.3 billion.
As a result, industry is forever looking for new ways to boost productivity, quality and efficiency in drug development, production and supply, all the way from bench to bedside. Clinical research as well as manufacturing equipment and facilities, are key pressure points. These challenges are amplified by the biotechnology revolution and associated demand for new technologies, capacity and expertise.
Productivity, quality and efficiency are especially important for small and medium-sized companies with limited resources. They must choose between investing in internal capabilities, partnering with larger players, or outsourcing to a contract development and manufacturing organization (CDMO). These companies also need to be future-focused, taking on board lessons learned from the normalization of digital tools and virtual interactions during the COVID-19 pandemic.
For example, COVID-related restrictions have shown that virtual inspections to monitor drug safety and adherence to good manufacturing practices (GMP) are a feasible alternative to in-person oversight. And supply chain disruptions during the pandemic are shaping new attitudes to sourcing of active pharmaceutical ingredients (APIs) and finished products.
Growing complexity and risks in drug development and supply also have implications for outsourcing models. Companies must consider how best they can structure and manage CDMO partnerships to weather a future in which uncertainty and disruption may become increasingly routine.