Navigating the green revolution: Why next-generation propellants are critical for pMDIs

The imperative to address climate change is reshaping industries worldwide, and pharmaceutical manufacturers are no exception. In respiratory medicine, the spotlight has fallen on pressurized metered-dose inhalers (pMDIs). While crucial for millions of patients, pMDIs harness propellants with a global warming potential (GWP) many times higher than CO2. This significant environmental footprint is a critical concern, especially as global legislation now mandates phasing down these high-GWP propellants.

The drive towards next-generation propellants (NGPs) in pMDIs isn’t just an environmental aspiration; it’s a necessity driven by converging legislative, economic and patient-centric factors. This is about delivering pMDIs that pair precision engineering with sustainable innovation, helping you overcome aerosol challenges, stay ahead of evolving sustainability regulations and reach patients faster with a familiar, accessible format.

Why green propellants are high on the pMDI agenda

The urgency to adopt low-GWP NGPs stems from critical areas:

• Global legislative pressure: International accords like the Kigali Amendment to the Montreal Protocol push for a substantial 70% reduction in high-GWP HFCs by 2030 [1]. The EU F-Gas regulation targets a 95% HFC reduction by 2034, with similar controls emerging in the US and UK [2]. This evolving landscape signifies the impending removal of current pMDI exemptions, compelling industry action.
• Economic imperative: Beyond environmental compliance, there’s a clear financial incentive. HFC supply for pMDIs is tightening, increasing costs. Advocating a mass switch to other delivery routes could incur substantial costs for healthcare systems, patients and insurers. Studies suggest such a shift could cost the UK’s NHS an extra ~$127 million annually [3].
• Patient well-being and choice: pMDIs remain vital for many patients, especially for rescue medications like short-acting beta-agonists (SABAs). A forced, widespread transition away from pMDIs could decrease patient adherence, potentially increasing asthma and chronic obstructive pulmonary disease (COPD) exacerbations and hospitalizations.

Recognizing these drivers, major pharmaceutical players like GSK, AstraZeneca, and Chiesi have committed to launching NGP pMDIs by 2025/2026.

The challenges of transitioning to next-generation propellants

While the need for greener propellants is clear, the path to widespread adoption is complex:

• Significant investment required: Decarbonizing pMDI platforms demands substantial capital investment in new manufacturing infrastructure, equipment and research.
• Complex regulatory environment: Navigating evolving global frameworks for new drug products and propellants is a considerable hurdle. This includes demonstrating equivalence, and it’s crucial to avoid costly surprises with end-to-end analytical testing and regulatory insight.
• Technical challenges in reformulation: Developing stable, effective and patient-friendly pMDI formulations with new propellants requires extensive R&D. Issues like drug solubility, valve performance and patient usability must be carefully addressed. To fine-tune your aerosol strategy, deep expertise is essential.
• Supply chain readiness: Establishing a robust and reliable supply chain for novel propellants and components is crucial, requiring significant coordination.

How Kindeva is leading the transition to a sustainable pMDI future

Despite these challenges, we at Kindeva are committed to accelerating the transition to NGPs, building on our unparalleled pMDI pedigree and deep expertise. As pioneers in the 1990s switch from CFCs to HFAs, we launched the world’s first CFC-free salbutamol pMDI. Today, we apply that same spirit to low-GWP formulations, ensuring exceptional performance with minimal environmental impact.

We bring proven expertise, helping partners overcome aerosol challenges and tap into our deep experience in pMDI formulation and aerosol delivery. Our approach involves simultaneous formulation, component and device optimization, enabling smooth scale-up to market and providing a platform to more. We design stability and shelf life around your formulation’s needs and market realities, ensuring robust products.

We demonstrate green propellant leadership, operating at the forefront of commercial green propellant lines. With registration batches completed in 2024 and full commercial-scale operations planned for 2025, our Loughborough, UK site is central to this effort. We are the first contract development and manufacturing organization (CDMO) to have HFA-152a low-GWP propellant capability, truly creating a future where the propellants are greener. As a leading commercial manufacturer of pMDIs using HFA-152a and HFO-1234ze, we ensure compliance and competitiveness, guiding you through this shift without compromising performance. We partner with you to navigate evolving regulations while protecting your product and reputation.

Our commitment extends beyond manufacturing. Our UK sites are powered by 100% renewable energy, and we hold ISO 14001 and ISO 45001 certifications. This dedication is part of our global $200 million investment to build scalable infrastructure and develop advanced, eco-friendly formulations.

Pioneering a patient-first, sustainable future in respiratory care

The journey towards fully decarbonized pMDIs is a complex yet critical endeavor, essential for both planetary health and patient well-being. At Kindeva, we are not just adapting to this future; we are actively shaping it with a patient-first device design philosophy that delivers real-life results. We believe in empowering your patients with better therapies they can manage at home — devices designed to minimize systemic side effects, maximize lung deposition, and ensure rapid onset of action and ease-of-use. This targeted delivery and dose flexibility expands market reach, ensuring that with every breath you give, patients benefit from pMDIs that truly embody precision engineering with sustainable innovation.

Ready to explore what’s possible for next-generation pMDIs? Ask us how we can support you to manufacture a greener tomorrow.

References

[1] United Nations Environment Programme. “The Kigali Story: How the Kigali Amendment Is Helping Us Fight Climate Change.” UNEP Ozone Secretariat, 2024. https://ozone.unep.org/news/kigali-story

[2] European Commission. “Fluorinated Greenhouse Gases (F-Gas) Legislation.” European Commission, 2025. https://climate.ec.europa.eu/eu-action/fluorinated-greenhouse-gases/f-gas-legislation_en

[3] Costs of switching to low global warming potential inhalers. An economic and carbon footprint analysis of NHS prescription data in England. DOI: 10.1136