Respiratory trends and challenges for 2023

17 Jan 2023 4min read

What are some of the challenges the industry is currently facing and what might be driving future respiratory drug delivery developments? These were the questions we put to industry experts at the Drug Delivery to the Lungs (DDL) annual conference, as part of an informal poll to get a feel for the latest respiratory trends.

We asked for responses to six questions, ranging from the challenges that companies face in the early and late stages of their developments, to the factors that will most strongly influence future respiratory device development and what people would be willing to sacrifice (if anything) to make their devices more sustainable. The survey had 50 respondents across the three days, including representatives from a number of leading pharmaceutical and respiratory drug delivery organisations. Here are the results.

Which formulation type is the industry most interested in?

Dry powder formulations were of most interest to 32% of respondents, compared with 22% for liquid (solution or suspension). From the others on our list, generic (16%), high payload (12%) and systemic (11%) were also highlighted. In a number of the scientific papers presented, biologics were cited as being the centre of much activity in the industry. In the DDL Annual lecture, Hugh Smyth stated that 50% of commercial pre-clinical inhalation studies were in this category, with gene therapy of particular interest.

What types of formation are of most interest to you

What will most strongly influence future respiratory device development?

Factors which were considered as the strongest influences of future respiratory device development were usability and adherence (24%) and sustainability (23%). The former reflects an ongoing need to find ways to improve how patients interact with devices and the latter is probably at least partly influenced by the impending drive to replace HFC propellants. John Pritchard, co-founder of DDL, presented a podium paper which emphasised the risk that this transition could take place in an uncontrolled way, with serious implications for supply of essential patient medication. Cost (17%)
and high delivery efficiency (16%) were also cited as of interest, while connectivity polled the lowest result at 6%.

What would you sacrifice to make your medical device more sustainable?

Our next question asked what people would be willing to sacrifice to make their device more sustainable, with 41% indicating that it would be connectivity, as opposed to cost (18%) and development time (14%), among others.

It’s worth noting that our poll had a relatively small sample size and that ‘connectivity’ means different things to different people. However, this response does strike us as significant and raises a question on how much of a priority this new area of functionality, which has been greatly discussed in the drug delivery sector over recent years, may turn out to be in future developments. The challenge of improving sustainability, in relation to corporate operations but also to the products that are placed on the market, is definitely becoming more prominent across the Pharma industry and seems to be moving beyond rhetoric. Our fourth question asked what the biggest strategic problem that you are currently facing is, in which sustainability (21%) came second only to the changing regulatory
space (25%).

What would you sacrifice to make your medical device more sustainable?

What challenges do companies face in the early and later stage of device developments?

In the early stages it was a close run between defining the development strategy (24%) and understanding the unmet needs and challenges of customers (25%). These are both areas where Team’s clients are requesting increasing levels of support.

Regulatory approval (35%) was a clear leader for late-stage development challenges. This perhaps reflects the strategic problems related to changes in the regulatory space, leaving companies unclear on what is required of them (e.g. to meet the MDR), but could also be indicative merely of a shortage of resource, within regulatory agencies or of Notified Bodies. The second and third placed challenges – industrialisation and design transfer (22%) and demonstrating equivalence (20%) are also areas where Team frequently finds itself helping clients on the final ‘hard yards’ to product launch. Some of the real subtleties of bringing new respiratory devices to market often only make themselves known during scale-up and commercialisation.

What challenges do companies face in the early and later stage of device developments?

What does 2023 have in store?

So, what does this all mean for 2023 and beyond? From the drug product and therapy area perspective we can expect to see increased attention in vaccination and gene therapy although, to quote a DDL speaker, “there are formidable barriers to overcome”. On the device side it feels as though there will be active innovation in areas such as nebulisers and nasal delivery systems. We can also expect additional generic devices to reach the market – it will be interesting to see the impact that they have.

Finally, I’m personally intrigued to see the path the industry takes between introducing connectivity into devices, with demonstrable improvements in adherence as a likely key driver, and improving their sustainability. Finding a way to do both would be a great New Year resolution.