The biologics market is growing rapidly and is on track to be worth $719.14 bn by 2030, up from $366.6 bn in 2021.¹ This growth is being driven primarily by the rising prevalence of chronic diseases, such as cancer, diabetes, and heart disease, which demand sophisticated diagnostics and therapeutic treatments.²

Many of these life-changing biologics – used to treat conditions such as rheumatoid arthritis, Crohn’s disease, and cancer – are reaching blockbuster status, providing treatment for millions of chronic disease patients around the world. However, many of these therapies were brought to market during the first wave of innovation, and their patents will expire in the coming years. With exclusivity only lasting approximately 20 years, 230 biologics are expected to fall out of patent in the next few years up to 2025.³, ?

After the loss of exclusivity, biopharma companies will be able to develop generic versions of these treatments to compete with the original branded product. This is already reflected in the biosimilar market, which is expected to reach $143.6 bn in 2031, growing at a compound annual growth rate of 24.7% from 2021.? The biosimilar product will be cheaper than the original, leading to the original innovator losing market share. If pharmaceutical companies want to compete with standard generic products, they will have to reformulate their product to extend its life cycle.

Reformulating an existing drug product’s route of administration can extend exclusivity. This, coupled with breakthrough innovation in targeted therapies for chronic and orphan lung diseases, means that companies are shifting towards delivery via the respiratory tract. In this article, Bernhard Müllinger, General Manager and COO, Resyca® and Kris Brosig, Director of Business Development discuss the current challenges of inhaled biologics, exploring how formulation and device innovation may be the answer to overcome them.

The Benefits of Biologic Reformulation

Traditionally, biologics have been administered parenterally, relying on healthcare professionals (HCPs) to deliver these essential medications to patients. Diversifying the delivery route of biologics to self-administered alternatives, such as oral, inhaled, or self-administered injectable drugs, can help reduce the load on HCP resources while improving patient convenience. This is because medication can be taken at home rather than in a clinical setting. In addition, up to 10% of the population suffers from injection anxiety.? Moving away from injectables, coupled with easing treatment access, can help to improve patient adherence, moving towards more patient-centric healthcare.

Choosing a Delivery Method for Biologic Reformulation

There are many options for administering a drug product, and biologic oral solid dose (OSD) formulation is a method that has also gained interest in recent years. As with formulating any drug product, there are challenges that need to be overcome. For orally administered biologics, this stems from the fact that they must travel through the gastrointestinal tract to be absorbed by the body and reach the desired target. Biologics are sensitive materials that undergo degradation under acidic conditions and when exposed to stress. Drug formulations must make the biologic robust enough to survive the stress associated with each route of administration or encapsulate it for protection. Recent advancements in formulation technology have led to breakthroughs in this area, enhancing product stability and bioavailability even for molecules with a larger molecular weight. Nevertheless, oral administration may not be suitable for all biologic drug products, and so other methods of delivery are also being investigated.