In a year defined by volatility and rapid transformation, the latest Horizons Report from CRB Group offers a revealing look at how life sciences organizations are navigating uncertainty while maintaining cautious optimism. Amid evolving trade dynamics, shifting regional investments and growing regulatory pressures, the findings underscore a sector striving to balance resilience with adaptability.
CRB’s Horizons Report series delivers annual insights into emerging trends, challenges and opportunities across the life sciences and food and beverage industries. Drawing on industry surveys and expert analysis, each report provides valuable perspectives to help executives, scientists and professionals make informed strategic decisions and stay ahead in their fields.
In this discussion, CRB’s Peter Walters, fellow of advanced therapies, and Lindsey Stigers, senior director of design operations, share their perspectives on what the data means for leaders interpreting the results within their own organizations – and how strategic decision-making must evolve in an environment where change is the only constant.
Isabel Ely, PhD (IE):
Science Writer
Technology Networks
Isabel holds a BSc in exercise and sport science from the University of Exeter, a MRes in medicine and health and a PhD in medicine from the University of Nottingham. Her doctoral research explored the role of dietary protein and exercise in optimizing muscle health as we age.
Before we dive deeper, what key takeaways should readers keep in mind as they interpret this year’s findings within their own organizations?
Fellow of Advanced Therapies
CRB
Peter Walters is a fellow of advanced therapies at CRB, with over 20 years of experience specializing in pharmaceutical process and facility design. He has a deep technical background in designing processes, equipment and spaces for multi-process facilities predicated on maximum flexibility, logistics optimization and technologies that reduce costs while allowing pipeline expandability and higher-quality therapeutics.
As with all survey results, sample size may not be representative of the entire industry’s experience. I would also emphasize that this is an extraordinary period of change and turmoil for the industry, so things are likely to change and shift between when the report was published and where things stand today for readers.
Science Writer
Technology Networks
Isabel holds a BSc in exercise and sport science from the University of Exeter, a MRes in medicine and health and a PhD in medicine from the University of Nottingham. Her doctoral research explored the role of dietary protein and exercise in optimizing muscle health as we age.
The report paints a nuanced picture – cautious optimism despite volatility. What surprised you most about the data or the sentiment expressed by industry leaders this year?
Senior Director, Design Operations. CRB.
Lindsey Stigers, PE, has more than 24 years of experience in the design and execution of pharmaceutical and biotech projects at CRB. Most recently, she has been the project director for several large, phased expansion projects with operational pharmaceutical facilities. She provides engineering design and project management services for projects around the world.
Stigers is an associate and a business unit manager directing a multidisciplinary team focused on the pharmaceutical marketplace. Her design background includes work with a variety of processes, including active pharmaceutical ingredient manufacturing, formulation, aseptic filling, primary and secondary packaging, lyophilization, potent compounds, cytotoxic drugs, kilo labs, hydrogenation, hazardous powder handling, solvent handling, oligonucleotide synthesis, mammalian cell culture and microbial fermentation. She also has extensive experience with process simulation and data-centric project delivery.
At the time of the survey, I was surprised the most by the lack of large shifts in plans given the level of uncertainty and volatility that was being forecasted. Many major investments that occurred were happening anyway, and had been in process long before 2025. People seemed to be keeping a close eye on developments but not reacting one way or another for the most part. And even more surprising was the increase in activity to beat any possible tariff activity that may occur to get ahead of cost increases from commodity and specialized equipment purchases from overseas.
Fellow of Advanced Therapies
CRB
Peter Walters is a fellow of advanced therapies at CRB, with over 20 years of experience specializing in pharmaceutical process and facility design. He has a deep technical background in designing processes, equipment and spaces for multi-process facilities predicated on maximum flexibility, logistics optimization and technologies that reduce costs while allowing pipeline expandability and higher-quality therapeutics.
There has been a lot of publicity around large US investments and I think that was reflected in the large pharma accelerated investments results, but at a manufacturing site level, we saw investment plans slowing across the board. I think this points to an interesting dynamic that is going on right now, with the announcement of plans for new facilities, but a hesitancy for investments in existing infrastructure. That means slowed funding for existing facilities in terms of improvements and expansions.
Science Writer
Technology Networks
Isabel holds a BSc in exercise and sport science from the University of Exeter, a MRes in medicine and health and a PhD in medicine from the University of Nottingham. Her doctoral research explored the role of dietary protein and exercise in optimizing muscle health as we age.
The report mentions regional shifts in R&D and manufacturing (e.g., greater activity in Asia and Europe, even as US investment accelerates). How should a global company evaluate location risk vs reward under this changed landscape, and what are the implications for site capital allocation decisions?
Senior Director, Design Operations. CRB.
Lindsey Stigers, PE, has more than 24 years of experience in the design and execution of pharmaceutical and biotech projects at CRB. Most recently, she has been the project director for several large, phased expansion projects with operational pharmaceutical facilities. She provides engineering design and project management services for projects around the world.
Stigers is an associate and a business unit manager directing a multidisciplinary team focused on the pharmaceutical marketplace. Her design background includes work with a variety of processes, including active pharmaceutical ingredient manufacturing, formulation, aseptic filling, primary and secondary packaging, lyophilization, potent compounds, cytotoxic drugs, kilo labs, hydrogenation, hazardous powder handling, solvent handling, oligonucleotide synthesis, mammalian cell culture and microbial fermentation. She also has extensive experience with process simulation and data-centric project delivery.
There are certainly many factors that drive a global company to determine location for investment, including patient population, marketplace, skilled labor presence, labor market trends and more recently, we are seeing replicability come into play as well. Can designs be easily copied in a way that accelerates schedules? What locations facilitate that type of leveraging? Getting products to market in the near term to achieve desired return on investment, balanced with long-term sustainability, local jurisdictional cooperation and enthusiasm, is a balance and individual companies assign value to those elements in different ways. All other things being weighted equally, schedule advantages appear to be paramount, with capital cost investment never being far behind.
One of the identified headwinds is regulatory change – particularly potential staffing cuts at agencies such as the US Food and Drug Administration (FDA). How significant is the risk that regulatory resource constraints will delay drug approvals or infrastructure investments, and how should engineering and capital-project teams plan around such regulatory uncertainty?
Fellow of Advanced Therapies
CRB
Peter Walters is a fellow of advanced therapies at CRB, with over 20 years of experience specializing in pharmaceutical process and facility design. He has a deep technical background in designing processes, equipment and spaces for multi-process facilities predicated on maximum flexibility, logistics optimization and technologies that reduce costs while allowing pipeline expandability and higher-quality therapeutics.
I think if you look closely at the news, we have already seen companies experience delays and push-backs for application review results. For some companies, having your approval date pushed out can be incredibly hard as it signifies a major shift in marketing and potential revenue returns, and typically involves teams of people to prepare and plan for. I think in terms of capital-project teams, the FDA cutbacks will be felt at a pre-submission level, and coordination such as Type-C [meetings] and early engagement meetings will become harder to get access to, which will mean completing your capital investments with less regulatory involvement and direction.
Science Writer
Technology Networks
Isabel holds a BSc in exercise and sport science from the University of Exeter, a MRes in medicine and health and a PhD in medicine from the University of Nottingham. Her doctoral research explored the role of dietary protein and exercise in optimizing muscle health as we age.
Finally, what single piece of advice would you offer executives planning capital projects in this unpredictable environment?
Fellow of Advanced Therapies
CRB
Peter Walters is a fellow of advanced therapies at CRB, with over 20 years of experience specializing in pharmaceutical process and facility design. He has a deep technical background in designing processes, equipment and spaces for multi-process facilities predicated on maximum flexibility, logistics optimization and technologies that reduce costs while allowing pipeline expandability and higher-quality therapeutics.
Construction of a new facility is no trivial matter. Through the course of design, site selection, construction and start up, they can take years to go from pencil to operational. I think we will continue to see tariffs, taxes and pricing plans change over the next couple of years and I would advise against trying to dramatically change your company’s expansion strategy as a result of those. A rushed investment executed poorly will haunt your company long after market rates change.
