Sustainability in pharma R&D: water, pollution and circularity

Regulatory pressure accelerates sustainability in pharma R&D

Regulatory signals are already shifting R&D timelines. The European Medicines Agency’s updated guidance on environmental risk assessment (ERA) makes ERA submission mandatory at marketing authorization and tightens expectations regarding environmental fate and ecotoxicology data¹Environmental risk assessment of medicinal products for human use – Scientific guideline. (2024b, September 12). European Medicines Agency (EMA). https://www.ema.europa.eu/en/environmental-risk-assessment-medicinal-products-human-use-scientific-guideline. This means that data on how a compound behaves in the environment and its toxicity to aquatic organisms must be generated at an earlier stage of the development process. In addition, the European Commission’s Product Environmental Footprint (PEF) methodology provides standardized guidance for assessing the environmental impacts of products across their entire lifecycle, including pharmaceuticals²Environmental Footprint. (n.d.). European Platform on Life Cycle Assessment (EPLCA). https://eplca.jrc.ec.europa.eu/EnvironmentalFootprint.html. Globally, the World Health Organization’s ‘Greener Pharmaceuticals Regulatory Highway’ initiative encourages regulatory authorities to adopt and implement digital and policy innovations that support the lower-impact manufacture, distribution, and use of medical products³Greener Pharmaceuticals’ regulatory Highway. (n.d.). https://www.who.int/publications/m/item/greener-pharmaceuticals-regulatory-highway. This signals that regulators may incentivize or require product-level sustainability information. National initiatives are following this trend: France has published a methodology for assessing the carbon footprint of medicines and is piloting sectoral approaches that make product environmental metrics relevant for procurement and market entry, as discussed in Part II of this series⁴Carbon Footprint of Medicines: Assessment Methodology. (2025). In Direction Générale des Entreprises (DGE). https://www.entreprises.gouv.fr/files/files/Publications/2025/Guide/eng-bro-a4-methodo-dge-0128.pdf. These developments mean that environmental performance must be considered during the research and development stages, rather than being added on afterwards.

Integrating environmental considerations in early-stage molecule design

In practice, R&D can address environmental impact in several ways, not just in terms of carbon footprint. During the discovery and lead optimization phases, for example, the chemical structure of a candidate compound can influence its persistence and potential for bioaccumulation. Incorporating in silico and bench screens for biodegradability and basic aquatic toxicity enables high-risk chemotypes to be identified at an early stage, thus avoiding the need for costly redesign later on⁵Hemmerich, J., & Ecker, G. F. (2020). In silico toxicology : From structure–activity relationships towards deep learning and adverse outcome pathways. Wiley Interdisciplinary Reviews Computational Molecular Science, 10(4), e1475. https://doi.org/10.1002/wcms.1475.

During synthetic-route scouting, several tools and approaches enable meaningful comparisons between routes in terms of both environmental impact and economic efficiency⁶Crawford, S. E., Hartung, T., Hollert, H., Mathes, B., Van Ravenzwaay, B., Steger-Hartmann, T., Studer, C., & Krug, H. F. (2017). Green Toxicology : a strategy for sustainable chemical and material development. Environmental Sciences Europe, 29(1), 16. https://doi.org/10.1186/s12302-017-0115-z:

Tools:

• Process Mass Intensity (PMI): This measures the total mass of all materials used to make a unit of product. A lower PMI indicates a more efficient use of resources, resulting in less waste and a smaller environmental footprint.
• Solvent acceptability matrices: Rank solvents based on environmental hazards, safety and regulatory concerns. Opting for eco-friendly solvents can minimize toxic emissions, enhance laboratory safety, and reduce waste treatment requirements.
• Environmental factor (E-factor): This calculates the mass of waste produced per unit of product. A lower E-factor means less waste is generated, minimizing the need for disposal and reducing pollution.

Approaches:

• Telescoped reactions: Combining multiple reaction steps without isolating intermediates reduces solvent use, energy consumption and waste generation.
• Continuous flow processes: Conduct reactions in a steady, controlled stream rather than in batches to improve energy efficiency, reduce chemical waste and often enhance product quality.
• Enzymatic steps: Use biological catalysts instead of harsh chemical reagents to lower the use of hazardous substances and reduce harmful by-products.

Managing water and materials with circularity in mind

Environmental considerations vary by modality. For example, for small molecules, the primary concerns are typically solvent use, chemical hazards, and energy consumption, whereas for biologics, the main concerns are water consumption, effluent management and single-use plastics and solid waste. Processes such as fermentation, buffer preparation, chromatography and cleaning-in-place generate large volumes of water for injection and aqueous waste. Although single-use technologies, including disposable bioreactors and tubing, can reduce the demand for water, chemicals, and energy for cleaning, they also generate more plastic waste, highlighting the trade-offs that must be considered when designing sustainable biological processes.⁷Chen, Z., Lian, J. Z., Zhu, H., Zhang, J., Zhang, Y., Xiang, X., Huang, D., Tjokro, K., Barbarossa, V., Cucurachi, S., & Dong, B. (2024). Application of life cycle assessment in the pharmaceutical industry: A critical review. Journal of Cleaner Production, 459, 142550. https://doi.org/10.1016/j.jclepro.2024.142550⁸Argoud, S., Budzinski, K., D’Aquila, D., Madabhushi, S. R., & Smith, P. (2022). Green metrics for biologics. Current Opinion in Green and Sustainable Chemistry, 35, 100614. https://doi.org/10.1016/j.cogsc.2022.100614.

To reduce the environmental impact of pharmaceutical R&D, downstream and upstream approaches should complement each other. In terms of wastewater management, the removal of active pharmaceutical ingredients (APIs) can be improved by handling API-rich streams separately and using targeted treatment strategies. This may involve combining conventional biological treatment with additional steps, such as activated carbon adsorption or advanced oxidation processes to break down pollutants⁹Hübner, U., Spahr, S., Lutze, H., Wieland, A., Rüting, S., Gernjak, W., & Wenk, J. (2024). Advanced oxidation processes for water and wastewater treatment – Guidance for systematic future research. Heliyon, 10(9), e30402. https://doi.org/10.1016/j.heliyon.2024.e30402. While these technologies are effective, they entail operating costs and can generate transformation by-products that require careful monitoring. Boehringer Ingelheim’s “Clean Water” initiative, launched in 2011 as part of its Be Green program, demonstrates how comprehensive wastewater management can keep traces of pharmaceuticals well below effective thresholds, thereby protecting local water sources while supporting sustainable production and community health [  ].

Applying circularity principles is equally critical for single-use clinical kits and packaging. Strategies such as minimizing primary packaging, validating donation or reuse pathways where clinically and regulatorily appropriate, and designing for recyclability can substantially reduce environmental impact across the product lifecycle without compromising patient safety. Supplier engagement is also essential: R&D teams should obtain information on manufacturing impacts early on, including PMI, solvent inventories, water balances and waste treatment practices.

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From commitment to measurable impact

R&D teams do not need to invent tools from scratch to assess their environmental impact. Established ways to compare options objectively include green-chemistry metrics such as PMI and E-factor, solvent-acceptability matrices, product life-cycle assessment (LCA) methods and green-chemistry scorecards¹⁰Rose, H. B., Kosjek, B., Armstrong, B. M., & Robaire, S. A. (2022). Green and sustainable metrics: Charting the course for green-by-design small molecule API synthesis. Current Research in Green and Sustainable Chemistry, 5, 100324. https://doi.org/10.1016/j.crgsc.2022.100324. For example, Sanofi has used the LCA methodology to incorporate eco-design² principles into its R&D processes. The company aims to apply these principles to the design of all new medicines and vaccines by 2025, and to extend them to its top 20 best-selling products by 2030¹¹Sanofi. (2023, June 5). We’re Eco‑designing, from R&D to commercialization. Sanofi Magazine. Retrieved from https://www.sanofi.com/en/magazine/sustainability/we-re-eco-designing-from-rd-to-commercialization. Similarly, AstraZeneca’s Green Labs Programme demonstrates how engaging colleagues from R&D and manufacturing can help to scale up sustainability initiatives, reducing energy use, minimizing waste, and innovating laboratory processes. This approach lowers environmental impact and fosters a culture of responsibility and efficiency within research environments¹²AstraZeneca. (2025, March 13). Green labs: Creating a culture of sustainable science. Retrieved from https://www.astrazeneca.com/what-science-can-do/topics/sustainability/creating-culture-sustainability-across-labs.html. These initiatives among global pharmaceutical companies show how sustainability tools and collaborative programs can turn ambitious eco-design ideas into practical R&D activities.

Pharmaceutical companies can turn CSR commitments into measurable outcomes by embedding environmental considerations into every stage of R&D. This includes not only the pharmaceutical product itself, but also associated materials, devices, and routes of administration, from early-stage compound screening and route selection to clinical operations and resource management. Tools such as green chemistry metrics, targeted wastewater treatment and life-cycle assessments allow teams to make informed decisions that reduce environmental impact while maintaining scientific rigor and market competitiveness. As regulatory requirements and societal expectations increase, integrating sustainability into the discovery and development process is no longer optional, but a strategic necessity. Companies that embrace this approach will not only safeguard the environment, but also strengthen their reputation, enhance operational efficiency and deliver innovative medicines that combine scientific excellence with responsible sustainable management. Alcimed supports R&D teams in translating these sustainability strategies into practical, measurable actions that create a lasting impact. Don’t hesitate to contact our team!

¹ Route scouting refers to the early-stage evaluation of different synthetic pathways to produce a compound, with the aim of identifying the most efficient, cost-effective and sustainable manufacturing process.

² Eco-design refers to the practice of designing products and processes with environmental considerations in mind from the outset, with the aim of minimizing resource use, energy consumption and waste generation throughout the product’s lifecycle.

About the authors, 

Haiko, Senior Consultant in Alcimed’s Life Sciences team in Germany
Elisabeth, Business Unit Director in Alcimed’s Life Sciences team in Germany