Bespak®'s Head of Business Development, Richard Turner alongside Simon Gardner, Business Development Director, explore what manufacturers around the world are saying about the transition to next-generation propellants in pressurised Metered Dose Inhalers (pMDIs). What pressures are they facing? What decisions are keeping them up at night? And what are they looking for from their contract development and manufacturing organisation (CDMO) partner?
What India is telling us
Richard's recent visit to India revealed an unusually self-contained market, with its own suppliers of components, propellants and Active Pharmaceutical Ingredients (APIs). It is also not a straightforward early adopter of low Global Warming Potential (GWP) propellants. Several high-volume molecules fall under India's Essential Medicines Act, which caps pricing and makes the economics of transitioning to HFA-152a or HFO-1234ze(E) difficult for the domestic market.
More ambitious Indian generics companies are not delivering for India alone. They are targeting expansion into Europe and the United States and building their strategies on the more complex multi component formulations that fall outside the Essential Medicines Act entirely. These products attract higher prices in Europe and the US, making the economics of investment far more favourable.
What makes India particularly valuable as a market to watch is the pace at which it moves. Go back in six months and the landscape has shifted in ways that the rest of the world takes much longer to replicate.
For companies that have taken their time to commit to a strategy in this changing environment, the urgency now is not just about starting the transition. It is about mapping the full portfolio: which molecules, which propellants, which competitors, which markets and in what order.
The conversation has shifted
The question that used to dominate conversations within the pMDI industry was a binary choice between HFA-152a or HFO-1234ze(E) and watching what major players committed to before deciding.
That choice has not gone away, but behind it is a more complicated decision based on the different values and market demands for the most valuable formulations. The molecules and therapy classes that dominated the generic inhaler market are subject to strong competition and aggressive pricing so the business case for investing in complex formulations can look far more attractive. To complicate things further, these more commercially attractive products are being split across both propellants. Some of the highest-value targets are on HFA-152a, others on HFO-1234ze(E). Generic manufacturers who want a broad portfolio in Europe or the US now need to consider both propellants and the potential need for a dual-propellant strategy when companies would have preferred to just select one.
Embracing both propellants brings complications in investment requirements, manufacturing, development programmes and supply chain. A company targeting both propellants needs a manufacturing strategy that can handle HFA-152a and HFO-1234ze(E) without duplicating infrastructure. It also means the companies that are waiting to see which propellant wins will have a long wait but are in reality running out of time as markets, regulations and their competitors move. Regulatory pathways are becoming clearer and potentially shorter, manufacturing capacity is booking up, and lead times on filling equipment remain too long for a company wanting to delay and then make a quick decision to catch up with their competition. The traditional behaviour of generic manufacturers — to wait, watch and follow — does not work for a transition of this scale and complexity.
Making the right propellant decision means understanding and balancing commercial, technical, quality, operational, commercial, sustainability and strategic factors together and understanding that the balance will shift as markets and device demands evolve. Flexibility and responsiveness are not optional extras; they are what make a dynamic propellant strategy viable for the long term.
What customers are actually asking for
When customers describe what they value most from a CDMO, the answer is not a capability list. It is the removal of risk. They want to see a clear pathway to success. Demonstrated experience has enormous value in reducing risks from what can appear to be a minefield of hidden costs, delays and damage to net present value. Bespak's position is grounded in exactly that track record, including playing a pivotal role in the regulatory approval and commercialisation of the first low carbon pMDI developed by AstraZeneca.
Beyond track record, customers increasingly value end-to-end capabilities. This may not be needed from day one, but knowing the capability exists, and that a single partner can bring in resources without restarting a procurement process and the risks and delays this generates, is a key factor for anyone looking to reduce risks and timelines
That combination of experience, breadth of capabilities and track record makes Bespak a valuable sounding board on tactical and strategic decisions. Which propellant for which market? Which molecules and formulation are worth the development investment given the current landscape? How does a company with a two-year delay in its programme de-risk a path to a 2030 launch? Those conversations happen because Bespak has exposure across products, markets and stages of development simultaneously — a helicopter view of the market, technologies and pipelines that individual manufacturers, focused on their own pipeline, cannot replicate.
Beyond the propellant
The propellant shift and customer requirements are demanding that companies deliver sustainable practices across their entire supply chains, and Bespak is working with customers to get ahead of that. The use of recycled metals and bio-plastics will play a part in new products and devices, and Bespak is actively working independently and with customers to offer leading performance with best-in-class sustainability in its valves, dose counters and devices.
That focus on supply chain sustainability is arriving at the same time as growing interest in supply chain robustness as a key component in overall business resilience. Bespak has work underway to ensure that finished product packing can be coupled directly to its pMDI filling operation to eliminate unnecessary transport impacts and improve supply chain performance. Integrating device components, filling and packing enables reduced environmental impact and not only eliminates unnecessary movements but increases supply chain resilience and responsiveness.
Advanced modelling and simulation is also reducing both the material waste and time built into traditional pMDI development. As the industry looks beyond propellant GWP, that kind of impact across the development process is where the next gains in supply chain sustainability will come from.
What do the companies that navigate this well have in common
Industry experience around the two propellant candidates is maturing, paving the way for clear and dependable product development and regulatory approval pathways. The companies that are now well through the transition and those just starting their programmes have an increasingly clear view of their target pipeline, across markets, propellants and molecules, and are acting to deliver their product lifecycle and growth strategies.
Indecision has costs that don't show up immediately in a financial business case. The costs appear in the marketing and business growth plans when capacity has been committed to others, regulatory slots are taken, and the window to a 2030 launch before competitors get there, has closed. Article 5 countries may have a legislative deadline of 2045, but the practical timeline is closer to 2035, because new low GWP products will be specified by customers and legacy propellant availability will force the changes before legislation requires it.
Bespak has committed to the inhalation industry for the long term, investing in new facilities and capabilities grounded in a clear view of where markets and supply chains are heading. The infrastructure for pMDI development and manufacturing with any propellant is already in place. The question is who has the foresight to secure it.
Richard Turner
Head of Business Development
Simon Gardner
Business Development Director
