Drug delivery has become a strategic asset
In March 2024, the Food and Drug Administration approved Udenyca OBI, the first biosimilar on-body injector referencing Neulasta Onpro. The approval marked the end of a notable period in biopharma. For almost a decade after pegfilgrastim lost exclusivity, Amgen’s delivery format retained roughly half the U.S. market and protected a segment that Coherus estimated to be worth approximately $1.2 billion.
The molecule itself had become commoditised. The delivery system had not.
The example illustrates an increasingly important reality across biologics and specialty pharmaceuticals. While competitive strategy has traditionally focused on clinical differentiation and intellectual property, delivery systems are becoming an important source of commercial advantage in their own right.
As more therapies migrate from infusion centres to home administration, delivery decisions increasingly influence market access, patient adoption, persistence and competitive durability.
The strategic question is no longer whether delivery can create value. It is whether organisations are making the right delivery decisions early enough to capture that value.
Delivery creates value through multiple mechanisms
Delivery innovation can influence asset performance through several distinct mechanisms.
Launch differentiation is often the most visible. In categories where clinical differentiation between therapies is narrow, the delivery experience can become a primary point of distinction for patients, providers and payers.
Delivery also influences site-of-care access. Devices that enable home administration can expand addressable patient populations, alleviate pressure on infusion infrastructure and alter reimbursement dynamics.
A third mechanism is adherence and persistence. Features that reduce friction during administration can improve real-world treatment continuation and increase lifetime patient value.
Finally, delivery can act as a barrier to entry. Competitors seeking to replicate a differentiated delivery experience must often reproduce both the molecule and the associated delivery system, increasing development complexity and extending the period of commercial advantage.
Together, these mechanisms position delivery as a strategic lever rather than simply a development consideration.
Why many organisations under-exploit delivery
Despite its growing strategic importance, delivery often receives less strategic attention than other sources of competitive advantage.
One reason is timing. Critical decisions regarding device architecture, formulation characteristics and delivery modality are frequently deferred until Phase II or later, when clinical and chemistry, manufacturing and controls constraints have already narrowed the available options.
Delivery decisions influence value creation throughout the asset life cycle, from launch differentiation and site-of-care access through to loss-of-exclusivity planning and franchise defense (see Figure 1). Yet many of the choices that shape these outcomes are made before launch preparation begins.
Ownership is another challenge. Delivery decisions are often led by engineering and development functions, with commercial teams providing input later in the process. The result can be optimisation against technical feasibility rather than the competitive realities the asset will face at launch.
The evidence used to evaluate delivery options can present a similar issue. Delivery options are frequently assessed through patient preference research and human factors testing. While these inputs are important, they do not necessarily answer questions about long-term differentiation, payer value, competitive replicability or franchise durability.
