Life Cycle Management for Biologics - Out of Thin Air

By Anders Månsson, Senior Advisor at Ventures Accelerated

February 3, 2026

In this editorial, I have chosen to focus on a fascinating area that I have gained more in-depth insight into lately, namely the role that inhaled medicine can play in securing more patient friendly formulations of modern-day biologics and peptides, which are notoriously difficult if not impossible to develop into oral formulations. 

It was quite some time ago since Big Pharma, notably among those what is today AstraZeneca and GSK, produced to the market modern Dry Powder Inhalers for use in the respiratory field, mainly for Asthma and COPD. Since then, however, little has happened in this area, and about a decade ago AstraZeneca even closed its development site in Lund, Sweden, which was the site responsible for the respiratory field. This site currently harbors instead the buzzling Medicon Village Complex, a hub for a vast array of pharma, biotech and med-tech companies in Southern Sweden, closely integrated with the Medicon Valley Alliance of the Greater Copenhagen area.

Now, however, inhaled medicine has a key role to play again. Inhaler-based delivery of biologics and peptides offers a compelling non‑invasive alternative to injections and, as such, it could become a strategic pillar for Big Pharma and Complex Generics companies as many blockbuster biologics face a major patent cliff and oral formulations remain technically constrained. The respiratory airway route combines a biologically favorable absorption surface with differentiated devices, opening room for both lifecycle management of expiring assets and genuinely new product classes. 

By 2030, dozens of high‑value biologics will lose exclusivity, with estimates of around 70 biologic medicines coming off patent globally and creating a multibillion‑euro opportunity for competitors, particularly biosimilar or complex generics players. Analyses of the biopharma pipeline highlight a looming patent cliff where loss of exclusivity on blockbuster biologics will intensify price competition, compress margins, and push originators to seek new differentiation beyond the molecule itself. 

For originator companies, this shift makes delivery and device innovation more strategically important, as they can create new IP around formulations, devices, and usage patterns even when core composition‑of‑matter patents expire. Inhalation platforms tailored to specific biologics or indications can thus form part of a broader defense and offense strategy: defending share on existing mechanisms of action while opening niches that are harder for conventional injectables or oral biosimilars to match. Seen from another angle, for companies seeking to develop “value added generics” through administration form development, the lure of the biologics patent cliff is of course equally attractive.  

Problem and Solution 

Despite decades of effort, oral peptide and protein delivery still suffers from intrinsically low and highly variable bioavailability. Biologic macromolecules are denatured by gastric acidity, degraded by proteolytic enzymes, and face tight epithelial junctions in the intestine, all of which drastically limit systemic absorption. 

To overcome these barriers, oral formulations often require permeation enhancers, enzyme inhibitors, and complex delivery systems, yet even then they typically achieve single‑digit bioavailability with substantial inter‑patient variability. These constraints make it difficult to match the predictable exposure profiles of parenteral routes, especially for large, structurally delicate proteins. As a result, only a narrow subset of peptides with favorable physicochemical properties has made it into viable oral products, leaving a large unmet need for non‑invasive yet reliable systemic delivery options. The lung, however, provides a large absorptive surface (in the order of tens of square meters) with a very thin alveolar epithelium and extensive vascularization, enabling relatively rapid systemic uptake for appropriately engineered molecules and particles. Unlike the gastrointestinal tract, the pulmonary environment also avoids hepatic first‑pass metabolism and many of the enzymatic degradation pathways that limit oral bioavailability of peptides and proteins. 

Dry powder inhalers, nebulizers, and pressurized metered‑dose inhalers have evolved to deliver complex biologics while maintaining structural integrity and functional activity, often through specialized excipients and controlled aerosolization conditions. This is why the concept that an inhaled route can bridge the gap between fully systemic injectables and minimally effective oral options for biologics, is so interesting. 

From a patient perspective, inhalers offer a non‑invasive, self‑administered alternative to repeated subcutaneous or intravenous injections, which can improve adherence and acceptance, particularly for chronic diseases. Injectables are associated with needle phobia, injection‑site reactions, and, in the case of IV infusions, time‑consuming hospital or clinic visits; inhaled regimens can shift some of this burden to convenient at‑home use. 

Strategic role in a post‑cliff landscape 

Inhaler‑based biologics create several layers of differentiation that are attractive in the context of expiring patents. First, developers can generate new IP around formulation, particle engineering, and device‑drug combinations, even when the underlying biologic sequence is no longer protected. Second, by anchoring products to specific inhaler platforms, companies can build device ecosystems, data‑enabled adherence tools, and service models that are harder for biosimilar competitors to copy quickly. 

Conclusions & Outlook 

The convergence of a looming biologics patent cliff, the persistent difficulty of oral biologic delivery, and accelerating technology for inhaled formulations positions pulmonary administration as a strategically important space for innovation. Companies that invest early in robust inhalation platforms, device‑drug IP, and focused clinical programs in respiratory and select systemic indications, may be well placed to defend and extend the value of their biologic portfolios as traditional patents expire. At the same time, Complex Generics companies that utilize generic or soon-to-be-generic APIs and innovate through administration form development, are also likely to find in inhalation medicine a solid platform for difficult-to-copy value adding differentiation.  

As such, more patient friendly formulations of modern blockbuster biologics can be conjured up, I am tempted to say, “out of thin air”, and this seems to be a particularly hot space to watch in the coming years, for Big Pharma and Complex Generics companies alike.  

At Ventures Accelerated, we are keen to provide intelligence and advice on areas and trends that fundamentally change the strategic landscape in modern-day drug development and commercialization strategy.