Inhaled biologics are revolutionizing the way therapies reach patients by offering targeted, effective, and often less invasive drug delivery options. By delivering proteins, peptides, RNA-based therapeutics, and vaccines directly to the lungs, these treatments can produce quick results, decrease systemic side effects, and bypass first-pass metabolism.

Once limited mainly to respiratory diseases like asthma and COPD, inhaled biologics are now gaining popularity across various therapeutic areas. This growth is opening exciting new opportunities for innovators, contract development and manufacturing organizations (CDMOs), and device manufacturers alike. CDMOs with proven expertise in dry powder inhalation, such as Experic, are uniquely positioned to help innovators navigate this transition and prepare for the next generation of inhaled biologic therapies.

As global demand for new delivery options grows, advances in science, market needs, and manufacturing capabilities are accelerating progress. At the same time, many sponsors are advancing small-molecule inhalation programs today while evaluating how and when to incorporate large-molecule strategies in the future.

Market Drivers for Inhaled Biologics

Patient-Centric Care
Patients are increasingly drawn to needle-free, self-administered options that reduce discomfort and improve adherence. Inhaled delivery lessens the anxiety and inconvenience of injections while offering greater independence for patients managing chronic conditions at home.

Therapeutic Diversification

While still in the early stages, interest in inhaled biologics is expanding beyond asthma and COPD into areas such as oncology, infectious diseases, and rare genetic disorders. These early investigations signal opportunities for developers, though regulatory and technical pathways remain complex. 

Global Health Preparedness
Recent pandemics have accelerated exploration of inhaled vaccines and prophylactic treatments. Pulmonary delivery may provide both systemic and mucosal immunity, making it a promising option for improving global readiness against infectious diseases.

Technology Convergence
Advances in device engineering, particle formulation, and analytics are converging to enable more candidates for pulmonary and systemic delivery. This progress supports more precise dosing, consistent performance, and scalable development.

Emerging Trends in Inhaled Biologics Development

1. Advancements in Dry Powder Inhalation (DPI) Technologies

Modern DPI technologies enable the precise delivery of complex biologics. Particle engineering approaches—such as spray drying, lyophilization, and more advanced methods like PRINT™—are driving improvements in uniformity, stability, and aerodynamic performance. These techniques help ensure that sensitive biologic compounds remain viable throughout manufacturing, storage, and delivery.

 

On the device side, next-generation inhalers emphasize intuitive use with features such as dose counters, feedback cues, and airflow optimization, helping ensure consistent delivery across patient groups. At the same time, it may require larger payload capacities to accommodate the higher doses and total powder often associated with biologics.

 

2. Expansion Beyond Pulmonary Indications

While inhaled biologics remain the most established treatment for respiratory diseases, their potential for systemic delivery is gaining attention. The lungs’ large surface area and rich blood supply enable rapid absorption into the bloodstream, creating opportunities to deliver therapies that are typically administered by injection. Developers are now exploring inhaled formulations for:

  • Cancer immunotherapies targeting metastatic lung lesions
  • Rapid-acting options, such as inhaled insulin, for glycemic control
  • Gene and RNA-based treatments that may benefit from local uptake in pulmonary tissue

Several inhaled biologic therapies are already available, including insulin formulations for diabetes, inhaled vaccines for respiratory diseases, and interferon-based treatments for viral infections. These early successes show that pulmonary delivery of biologics is not just theoretical. It is an active and growing field that is expected to continue expanding in the coming years.

 

3. Analytical and Formulation Innovation

As inhaled biologics become more complex, so do their development and testing processes. Quality-by-Design (QbD) and risk-based methods are becoming increasingly standard, enabling teams to identify and improve critical quality attributes (CQAs) throughout the entire development process, from early development to commercialization.

Advanced analytical capabilities now include:

  • Particle size distribution analysis to ensure optimal lung deposition.
  • Aerodynamic performance testing for consistent delivery to the lower airways.
  • Stability studies simulating storage and transport conditions.

These tools not only enhance product performance but also lower the risk of expensive reformulation late in development.

Future Outlook

The inhaled biologics field is set for strong growth as technology advances and market demand grows. Expect increased investment in systemic uses beyond traditional respiratory treatments, ongoing integration of digital health features (such as adherence-tracking “smart” inhalers), and advancements in spray drying, encapsulation, and device engineering to expand formulation options.

Even as that future develops, many teams will initially concentrate on small-molecule inhalation to reach near-term milestones, while keeping options open for large-molecule pathways as evidence and capabilities improve. 

CDMOs with extensive expertise in dry powder inhalation, like Experic, play a crucial role in this transition by helping innovators meet today’s goals while establishing the technical and operational foundation for future biologic programs.

Conclusion

Inhaled biologics are transitioning from a niche to mainstream use, driven by expanding indications, technological advancements, and growing patient demand for less invasive treatments. For innovators ready to enter this field, opportunities are plentiful, but so are the challenges.

Experic specializes in dry powder inhalation, precision capsule filling, and handling of challenging powders. With its scientific knowledge, technical expertise, and flexible, purpose-built facility, Experic offers the bridge from today’s inhalation strategies to tomorrow’s biologic breakthroughs.

The future of biologics delivery could very well be in the air, and those investing in inhaled biologics today will shape patient care in the future.