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Transforming the Biologics Product Lifecycle with Inhalation Innovation

In recent years, the biopharmaceuticals landscape has witnessed a revolutionary shift with the emergence of new nasal inhalation technologies. Among these, soft mist nasal sprays have emerged as a promising avenue, particularly for the delivery of biologic drug products. Such nasal drug delivery innovations hold promise in transforming the way biologic drug products are administered and managed throughout their lifecycle.

In this article, Nicolas Buchmann, CTO, and Frank Verhoeven, Business Developer at Resyca (a joint venture between Bespak and Medspray), delve into the potential transformative impact of inhalation innovations on the biopharmaceutical product lifecycle.

A Dynamic and Growing Inhalation Market

The global market for inhalation drug delivery devices is experiencing rapid expansion, poised to reach a value of $20.7 billion by 2031, growing at a compound annual growth rate (CAGR) of 4.4%.1 This growth trajectory is propelled by several key drivers, notably the escalating prevalence of chronic lung conditions worldwide and the need for more efficient and patient-friendly drug delivery methods.

Chronic respiratory ailments such as asthma, cystic fibrosis, pulmonary arterial hypertension (PAH) and chronic obstructive pulmonary disease (COPD) have increasingly been diagnosed globally. In 2019, 262 million individuals were living with asthma worldwide, with approximately 1,000 asthma-related fatalities occurring daily, many of which are preventable.2 Additionally, PAH affects up to 70 million individuals globally, accounting for nearly 1% of the global population, a figure expected to rise as the population grows older and larger.3 Cystic fibrosis, affecting 162,428 people globally, further underscores the demand for effective treatment modalities.4

Given the nature of these conditions, inhalation emerges as the preferred route for drug delivery, enabling targeted therapy directly to the affected sites within the respiratory system.

The burgeoning biologics market is exerting an unexpected influence on the inhalation landscape. Projected to be valued at approximately $854.86 billion by 2032, with a remarkable CAGR of 7.9% from 2023 to 2032,5 the global biologics market is driving innovation in drug delivery methodologies.

Traditional approaches to drug delivery often present obstacles in achieving optimal therapeutic outcomes and patient compliance, particularly with biologic drugs. Given the sensitive nature of biopharmaceutical formulations, parenteral delivery routes are often required to bypass the gastrointestinal tract. However, this approach causes discomfort for patients and puts constraints on drug administration confined to clinical settings, creating inconveniences for patients and strain on healthcare provider (HCP) resources.

Innovations in inhalation delivery technologies, particularly in nasal inhalation such as soft mist nasal sprays, have opened avenues for novel drug delivery strategies. Nasal delivery now presents a viable alternative for administering a wide array of biologic formulations, offering improved patient experiences and expanding treatment accessibility beyond clinical settings.6

Large Molecule Innovation: Opportunities and Challenges for Developers

These developments in biopharmaceutical drug delivery present both opportunities and challenges for developers of large-molecule drugs. As the biologics segment grows, competition within the biopharma industry will also intensify. Notably, major industry drugs, such as Humira, Keytruda, Revlimid and Eliquis, are set to lose their exclusivity in the coming years.7 The resultant industry changes, partly fueled by patent expiries, are catalysing the expansion of the biosimilars market, projected to expand at a CAGR of 18.32% until 2029, reaching an estimated $82.27 billion within the next decade.8