The pipeline is filling up fast. 346 trials registered in 2025 and more than 100 already in 2026, with 127 InhBioX candidates now in Phase II and III. Infectious disease leads, and vaccines dominate. Infectious disease and COPD are the main indications, and 60% of Covid-19 trials are vaccines. Synthetic peptides top the molecule list, followed by recombinant proteins and recombinant vector vaccines. The device gap is the opportunity. Nasal accounts for 57% of the delivery choice opportunity. because of late phase COVID vaccines, and there is not a single portable inhaler candidate in Phase III: this is a huge Terminations of clinical trial are rarely about the science. Of 68 discontinued trials, 33% stopped for recruitment challenges and 19% for business or strategic reasons. Adverse events, lack of efficacy and regulatory issues accounted for just 10% each. Biotechs are the creation engines, while Big Pharma has specialised in filing and commercialisation.
The inhaled biologics field is no longer emerging; it has emerged. A structured interrogation of commercial and clinical trial databases identified 346 inhaled biologic trials commencing in 2025 and over 100 already registered in 2026, with 117 candidates in Phase II and III. Biologics now represent 58% of the inhaled clinical pipeline: biologics lead inhaled pipelines. Three molecule classes lead, commanding 40% of the pipeline between them: i. synthetic peptides (16%), ii. recombinant proteins (14%), and iii. recombinant vector vaccines (10%). The pipeline concentrates on two mechanistic strategies: a. receptor agonism and, b. ionchannel activation.
Infectious diseases dominate the indications, with cystic fibrosis, RSV and idiopathic pulmonary fibrosis, the principal unmet needs. Innovation is, above all, a small-biotech story: 57% of Phase I trials are led by private companies. Analysis of discontinued programmes (N=68) shows that inhaled biologics do not fail on science: recruitment (38%) and regulatory issues (14%) dominate terminations, while adverse events and lack of efficacy together account for only 19%.
Biologic drugs have transformed the treatment of chronic and infectious disease, but their delivery has remained dominated by injection because large molecules do not survive the gastrointestinal tract.1 Two upstream forces are now reshaping this position. First, the science of inhaled biologics, mechanisms, targets and the behaviour of macromolecules in the airway, has been studied intensively. Second, the pace and expertise of biologics manufacturing have accelerated, allowing candidates to be produced at scale. Inhalation and nasal delivery offer a credible alternative route for local delivery to the respiratory epithelium, and for systemic exposure where it is required.
The objective of this work was to quantify the public and searchable inhaled biologics clinical landscape from clinical and commercial databases to establish, on the evidence, what therapies might be coming and when. We looked at volume, molecule classes, targets, indications, sponsors, delivery routes and the specific therapies being advanced.
