Drawing on the insights of our leadership team, we’ve compiled a global perspective on the state of the bioanalytical industry in 2024. Through thoughtful discussions with our CEO, John Bucksath, and key team members Amy Mize, Mouhssin Oufir, and Brian Wile, KCAS Bio delivers a roadmap for navigating the complexities of this dynamic sector.
As we approach the end of 2024, we spoke with Dr. Amy Mize, Chief Commercial Officer at KCAS Bio, to discuss the changing landscape of bioanalysis and KCAS Bio’s strategic plans for 2025.
Reflecting on 2024: A Year of Adjustments and Strategic Shifts
When asked about the overall trajectory of the bioanalytical market in 2024, Amy described 2024 as a transitional year for the bioanalytical market, particularly in the commercial sector, noting a strong trend toward greater geographical flexibility among our sponsors.
“In 2024, we’ve seen that clients are making strategic decisions based on geography, especially larger pharma companies,” Amy explained. “While they may not need global capabilities for a specific study, we find that they are anticipating future needs, such as Phase II or even Phase III trials, which could require support in or across multiple regions. If a lab doesn’t have the ability to scale across regions like the U.S., Europe, and APAC, it could impact their decision to work with that provider in the first place.”
This shift toward a more global approach is not limited to one service area. While flow cytometry has been a major driver of geographic expansion, the nature of specific sample types, like plasmid and serum, are also contributing to the demand for flexible, cross-border solutions.
However, Amy also recognized that while the year began slower than expected across the industry due to inflation and global economic concerns, she has seen a positive turnaround in the later part of 2024.
“Despite the challenges – particularly in European markets, where the recovery has been slower – there are encouraging signs that the bioanalytical market is picking up speed as we approach 2025,” she said.
Globalization and Expansion at KCAS Bio
In 2024, KCAS Bio expanded its global footprint in flow cytometry, with the addition of the Cytek Aurora platform at the Lyon location, and KCAS Bio’s strategic alliance partner lab Crux Biolabs in Melbourne, Australia, to match the Cytek Aurora instrumentation already in use at Philadelphia.
“Having harmonized instrumentation across all these locations allows us to support global studies with the same high level of consistency and quality. We’ve already seen a significant amount of interest from clients in this capability, which is exciting for us as we move into 2025,” Amy said.
The global spread of these advanced technologies is part of their broader commitment to enhancing its ability to serve multinational studies. This harmonization of platforms enables seamless data transfer between locations, a critical factor for clients looking for cross-border bioanalytical services.
Large Pharma Trends: Seeking Hybrid Solutions and Long-Term Relationships
Amy noted that large pharma companies are seeking expansion opportunities, particularly for complex biologics. Many large pharma organizations have already established their preferred provider relationships, which Amy admits can make it challenging for new vendors. However, there is a growing demand for specialized service offerings that address the unique needs of large molecules space.
“One area of expansion that we’ve seen is in hybrid mass spectrometry,” Amy shared. “For many large molecule projects, clients require both ligand binding assays (LBAs) and mass spectrometry (LC-MS/MS) to get the full picture of their molecular profiles. Being able to offer both technologies under one roof in the form of Hybrid-LC-MS has opened doors for KCAS Bio and has helped us establish deeper relationships with many of our large pharma clients.”
Despite the challenges of navigating long procurement cycles and extensive qualification processes, Amy sees potential for growth. With many large pharma companies expanding their portfolios through acquisitions, the need for bioanalytical services is expected to increase, giving KCAS Bio the opportunity to step in and continue as a trusted provider.
Economic Trends and Implications for 2025
As the market approaches 2025, there is cautious optimism about the potential for greater stability and predictability. The challenges of high inflation and shifting investment strategies in 2023 and 2024 created uncertainty, but as Amy explained, there are now signs of renewed growth and improving conditions.
“We’ve seen a slow but steady recovery within the clinical space, with recruitment and study start times starting to pick up,” Amy observed. “We’re cautiously optimistic as we move into 2025 that demand for services will continue to rise, and we’ll see a more predictable flow of work industry wide. Europe still lags the U.S. in this recovery, but the signs are positive that things will begin to pick up in both regions.”
Recognizing and Adapting to Regional Trends
When discussing KCAS Bio’s approach to regional market differences, Amy emphasized that one size doesn’t fit all. The company tailors its services to meet the specific needs of clients across the U.S., Europe, and APAC.
“There is a lot of regional variation – even within the U.S. itself,” she explained. “What we do in the U.S. may not always align with what’s needed in Europe or the APAC region. It’s about understanding our clients’ goals and drivers and being flexible enough to offer solutions that are tailored to their specific needs – whether it’s for nonclinical or clinical studies.”
Preparing to Meet Demands by Looking Ahead to 2025
KCAS Bio is focused on meeting the growing demand for complex bioanalytical solutions, particularly in large molecules.
“We’ve invested in the technologies and expertise to support a wide range of bioanalytical needs,” Amy said. “Clients continue to look for providers who can offer comprehensive services under one roof, and KCAS Bio is well-positioned to meet that demand. Our company offers a range of services, including flow cytometry, mass spectrometry, and molecular PCR, to address the diverse needs of the evolving global market.”
The 2025 Wild Card: GLP-1 and the Future of Biopharma
With the rise of GLP-1 therapies and their potential to reshape the pharmaceutical industry, many are asking how companies are positioning themselves to address these emerging studies. Amy is optimistic about the company’s ability to support this space, drawing on the team’s extensive experience with complex molecules.
“We have significant experience working with these types of molecules and have supported a variety of studies using different technologies,” Amy noted. “As GLP-1 therapies continue to evolve, we’ll be there to help our clients navigate the scientific challenges, whether it’s through ligand binding assays, mass spectrometry, or other specialized bioanalytical methods.”