Advances in microgravity research are opening up new possibilities for discovering and manufacturing medicines in space. With the pharmaceutical industry investing around $300 billion globally in research and development each year, even small improvements in the efficiency, speed or success rate of R&D could deliver significant economic benefits whilst accelerating the development of new medicines.
Credit: British Embassy BerneRealising this opportunity now depends on more than scientific advances alone. It requires stronger evidence of value, greater confidence across the pharmaceutical sector, and clear regulatory pathways that enable companies to develop and commercialise new products.
Those opportunities and challenges were the focus of the inaugural UK-Swiss Microgravity Biopharma Dialogue, where the UK Space Agency joined senior representatives from pharmaceutical companies, regulators, government, academia, investors and the space sector at the British Embassy in Berne.
Bringing together two countries with globally significant life sciences sectors, the dialogue explored demand signals and how government, industry, regulators and investors can work together to address the barriers preventing the wider adoption of microgravity enabled research and manufacturing by the pharmaceutical industry.
Convening healthcare providers, regulators and industry helps ensure that innovation is driven by genuine user needs and underpinned by the evidence needed to support adoption at scale, leading to safe, commercially viable products and services that ultimately improve patient outcomes. This end-user first lens aligns with the UK’s drive to grow the space sector beyond traditional players and broaden access to new customer markets.
Rather than revisiting the scientific potential of microgravity, discussions focused on what is needed to inform investment decisions across the sector. Participants identified and explored applications driven by genuine pharmaceutical demand, sought to understand the barriers preventing wider adoption, and agreed the practical steps needed to enable it.
Four themes consistently emerged throughout the dialogue:
Evidence of value: a stronger and broader body of repeatable evidence from microgravity research and manufacturing is needed to consistently demonstrate where it delivers clear advantages over equivalent processes on Earth. Standards: common approaches to generating, documenting and sharing evidence from microgravity research and manufacturing will help build a stronger shared evidence base for industry, regulators and investors. Regulatory clarity: greater clarity on how existing regulatory pathways apply to in-orbit pharmaceutical manufacturing will help build confidence across industry and among investors. Sector awareness: greater understanding across the pharmaceutical industry of the opportunities, quantifiable benefits and practical limitations of microgravity research and manufacturing will support more informed decision-making. Enabling innovation through regulatory clarityDuring the day, the UK Space Agency chaired a focused session exploring the role of governance and regulation in enabling this emerging market. Discussions highlighted that regulatory clarity is considered critical to unlocking commercialisation of in-orbit pharmaceutical manufacturing, so that stakeholders across the value chain have confidence that what is manufactured in space can be safely used on Earth.
Through our Unlocking Space Portfolio, we have been working closely with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and wider government partners to help provide greater confidence in the regulatory pathway for in-orbit pharmaceutical manufacturing. This has included publishing a joint statement with the MHRA, Civil Aviation Authority and Regulatory Innovation Office, confirming that existing UK regulatory frameworks provide a credible foundation for in-orbit pharmaceutical manufacturing, and setting out the work underway to develop a practical roadmap that will help industry navigate those frameworks with confidence.
UKSA has also funded the BioOrbit PHARM feasibility study, which explored an end-to-end mission for manufacturing pharmaceuticals in microgravity. The project undertook an initial assessment of how existing regulatory processes could support future in-orbit manufacturing activities.
Together, these activities are helping to build confidence across the value chain. They help pharmaceutical companies understand how medicines manufactured in orbit can comply with existing regulatory requirements, while giving investors greater confidence that space-enabled pharmaceutical manufacturing has a credible route to market.
What happens nextWith In-Orbit Servicing, Assembly and Manufacturing (ISAM) one of the UK's four Ministerial priorities for growing the space economy, the UK Space Agency and MHRA are continuing to develop a joint regulatory roadmap to support the adoption and commercialisation of in-orbit pharmaceutical manufacturing. Due to be published in Autumn 2026, the roadmap will map each stage of the manufacturing lifecycle against existing UK regulatory frameworks, providing industry with greater clarity and confidence to develop and commercialise new products and services.
This collaborative approach reflects the wider work being delivered through our Unlocking Space Portfolio to accelerate the adoption of space-enabled innovation across health and care. Alongside supporting the emerging market for in-orbit pharmaceutical manufacturing, we are working with NHS organisations to explore how satellite technologies can help address operational challenges, from improving connectivity for remote care to creating more resilient healthcare estates.
The dialogue in Berne reinforced the value of this approach. Bringing together end users, technology providers, regulators, investors and international partners helps shape emerging markets, build confidence and address the barriers that prevent innovation reaching real-world use. The UK Space Agency will contribute to the forthcoming white paper arising from the dialogue, helping to strengthen the shared evidence base and identify practical actions that support the responsible growth of this emerging sector.
To learn more about the collaborative work between the MHRA and the UK Space Agency, or to engage with ongoing discussions around the regulatory pathway, contact UnlockingSpace@dsit.gov.uk.
seen at 09:44, 23 July in UK Space Agency blog.