The final frontier of drug development: Biotechnology and pharmaceutical innovation in low earth orbit

A quiet revolution is unfolding approximately 250 miles above the Earth's surface. In the microgravity environment of low Earth orbit (LEO), pharmaceutical companies, biotech startups and government-funded researchers are conducting experiments that may fundamentally alter how we discover, develop and manufacture drugs. For practitioners at the intersection of space law, life sciences regulation and intellectual property, this nascent sector presents a complex and rapidly evolving set of legal questions, many of which existing frameworks are ill-equipped to answer.

The science: Why microgravity matters

The International Space Station (ISS) has hosted hundreds of biotechnology experiments spanning disease categories from neurodegenerative disorders and cardiovascular disease to cancer, musculoskeletal conditions and infectious diseases. Research aboard the ISS has demonstrated that microgravity enables protein crystallization with superior structural resolution, three-dimensional tissue engineering unconstrained by gravitational sedimentation and accelerated stem cell expansion, each offering tangible advantages over terrestrial laboratory conditions. For example, Merck has conducted multiple investigations crystallizing monoclonal antibodies in microgravity, yielding crystal structures that informed improved subcutaneous drug formulations. Bristol Myers Squibb has grown crystals of small-molecule antiviral drugs targeting HIV aboard the ISS Pharmaceutical In-space Laboratory. Redwire's BioFabrication Facility has printed cardiac tissue samples in orbit, and multiple investigations have modeled tumor organoids in LEO to study cancer biology in environments that more closely replicate in vivo conditions than standard two-dimensional cell cultures on Earth.

The research scope is broad: NASA's Space Station Research Explorer catalogs experiments in drug discovery, vaccine development, protein crystallization, nanotechnology, tissue regeneration and organ manufacturing, among dozens of other categories. DARPA-funded programs, such as those conducted by Rhodium Scientific, have characterized the effects of variable gravity on biomanufacturing of therapeutics and nutraceuticals from bacteria and yeast--a potential pathway toward in-space pharmaceutical production at scale.

The economics: Plummeting launch costs and a growing market

The commercial viability of space-based pharmaceutical work has been fundamentally reshaped by the dramatic decline in launch costs. From approximately $100,000 per kilogram in the Space Shuttle era to under $1,000 per kilogram with SpaceX's Falcon 9, and projected costs below $100 per kilogram by 2030 with the advent of Starship, the economic calculus is shifting rapidly. McKinsey has projected significant revenue growth for industries that collaborate with space companies and the broader space economy is forecast to reach $2 trillion by 2040. Private market equity investment in the space economy totaled $10.7 billion in the first half of 2024 alone, across 235 rounds, with growth-stage and late-stage funding both showing strong momentum.

Yet the dedicated space biotechnology sector remains small--fewer than ten pure-play space biotech companies have secured significant venture funding, a stark contrast to the $65 billion invested annually in terrestrial biotechnology. This disparity reflects both the sector's early-stage maturity and the magnitude of the opportunity for first movers and the advisors who serve them.

The legal landscape: Uncharted territory

The legal challenges confronting space-based pharmaceutical development are as novel as the science itself. Several areas demand immediate attention from regulators and the legal community.

Regulatory approval pathways present perhaps the most immediate hurdle. The U.S. Food and Drug Administration (FDA) has no established guidelines for drugs or biologics researched, developed or manufactured in space. Questions abound: Does a drug crystallized in microgravity and returned to Earth for formulation and distribution follow the same approval pathway as a conventionally manufactured product? What Good Manufacturing Practice (GMP) standards apply to an orbital laboratory or an autonomous free-flying capsule? How should the FDA evaluate the reproducibility of processes conducted in an environment that cannot be precisely replicated on the ground? These are not hypothetical concerns--companies like Varda Space Industries are already conducting pharmaceutical processing experiments in orbit aboard free-flying capsules and returning products to Earth for analysis.

Intellectual property (IP) protection in LEO presents equally thorny questions. Under the 1967 Outer Space Treaty, outer space is not subject to national appropriation, yet the practical enforcement of patent rights requires territorial jurisdiction. The ISS Intergovernmental Agreement allocates jurisdiction over ISS modules to their respective sponsoring nations, providing a partial framework, but commercial space stations--such as those under development by Axiom Space, targeting initial operational capability around 2028--will operate under different and as-yet-undefined governance structures. Practitioners must consider which nation's patent laws govern an invention conceived and reduced to practice aboard a privately owned orbital platform, how trade secret protections apply in a shared-infrastructure environment, and whether existing international treaties provide adequate enforcement mechanisms.

The ISS itself faces a critical transition. NASA plans to deorbit the station around 2030, creating a potential gap before commercial successors are fully operational. This transition period raises questions about continuity of research programs, preservation of institutional knowledge, and the regulatory status of experiments in progress during the handoff from a government-managed to a commercially-managed orbital research environment.

Export control and technology transfer regulations add further complexity. The International Traffic in Arms Regulations (ITAR) and Export Administration Regulations (EAR) impose strict controls on space-related technologies, while pharmaceutical research inherently involves dual-use technologies and biological materials that may trigger additional scrutiny. Companies operating in both domains must navigate overlapping and sometimes conflicting regulatory regimes.

Liability and insurance frameworks for space-based pharmaceutical operations remain largely untested. The Outer Space Treaty establishes state responsibility for national space activities, including those of private entities, but the allocation of liability for a defective drug manufactured in orbit--whether between the drug developer, the launch provider, the platform operator and the nation of registry--has no clear precedent. Product liability attorneys would be wise to begin considering how terrestrial frameworks like strict liability and failure-to-warn doctrines translate to products with an orbital manufacturing component.

Extraterrestrial applications: Beyond Earth markets

While near-term commercial activity focuses on producing space-manufactured products for terrestrial use, the longer trajectory includes pharmaceutical applications for space itself. As human presence in LEO expands through commercial stations, and as NASA and international partners pursue lunar and eventually Martian missions, the demand for in-space medical countermeasures will grow. Research already underway on the ISS--including studies on space radiation effects on human cells, immune system dysfunction in microgravity, and accelerated bone and muscle loss--directly informs the development of therapeutics for long-duration spaceflight. The legal frameworks governing the manufacture and administration of pharmaceuticals beyond Earth's atmosphere will need to evolve in parallel with the technology.

Conclusion

The convergence of dramatically reduced launch costs, demonstrated scientific advantages of microgravity and growing private investment are transforming space-based biotechnology from a research curiosity into a commercially viable sector. For the legal profession, this transformation demands proactive engagement. Regulatory agencies need input from practitioners who understand both pharmaceutical development and space operations. Companies entering this sector need counsel who can navigate overlapping domestic and international legal regimes. And the broader legal community needs to develop the frameworks that will govern a pharmaceutical supply chain extending from orbital platforms to patients on Earth--and eventually, to patients beyond it.

References

NASA, Space Station Research Explorer, https://www.nasa.gov/mission/station/research-explorer/ (last visited Oct. 2, 2024).

Bruno Venditti, The Cost of Space Flight Before and After SpaceX, Visual Capitalist (Jan. 27, 2022), https://www.visualcapitalist.com/the-cost-of-space-flight/.

FutureTimeline.net, Launch Costs to Low Earth Orbit, 1980-2100, https://futuretimeline.net/data-trends/6.htm (Sept. 1, 2018).

Carsten Hirschberg et al., The Potential of Microgravity: How Companies Across Sectors Can Venture into Space, McKinsey & Co. (Jun. 13, 2022), https://www.mckinsey.com/industries/aerospace-and-defense/our-insights/the-potential-of-microgravity-how-companies-across-sectors-can-venture-into-space.

SpaceIQ, Space Investment Quarterly, Q2 2024.

Treaty on Principles Governing the Activities of States in the Exploration and Use of Outer Space, Including the Moon and Other Celestial Bodies, Jan. 27, 1967, 18 U.S.T. 2410, 610 U.N.T.S. 205 (Outer Space Treaty).

Agreement Among the Government of Canada, Governments of Member States of the European Space Agency, the Government of Japan, the Government of the Russian Federation, and the Government of the United States of America Concerning Cooperation on the Civil International Space Station, Jan. 29, 1998 (ISS IGA).