Global Perspectives on the 2024 Bioanalytical Market: An Interview with Mouhssin Oufir

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 2024 draws to a close, the bioanalytical market has seen some intriguing shifts – especially within Europe. We spoke with Dr. Mouhssin Oufir, General Manager of KCAS Bio SAS in Lyon, France, to gain his insights on the trends that he has watched shape the industry over this past year and what he believes we can expect as we all look ahead to 2025.

Oligonucleotides and ADCs: Key Trends in Bioanalysis

Mouhssin began by highlighting two key trends that have emerged across new drug modalities in 2024: the increasing focus on oligonucleotides (OGN) (single-stranded DNA/RNA or DNA/RNA analogs) and the rise of Antibody-Drug Conjugates (ADCs) and Peptide-Drug Conjugates (PDCs).

“Oligonucleotides are becoming a major focus for many bioanalytical projects,” he says. “Antisense oligonucleotides (ASOs), aptamers, RNA interference (RNAi) including siRNA and miRNA, as well as common RNA-modulating chemical drugs are in high demand since the success of COVID-19 vaccines that has accelerated the clinical development of new mRNA vaccines.”

Analyzing these requires specialized technologies depending on needed sensitivity, precision and accuracy like quantitative PCR (qPCR), Droplet Digital™ PCR (ddPCR™), digital PCR (dPCR), Hybridization immunoassays (h-ELISA), and MS-based technologies (LC-MS/MS or LC-HRMS in negative mode). Having access to all these technologies under the same roof gives companies a competitive edge, and we are seeing more projects that require this customizable integrated approach to attract sponsors.

Alongside oligonucleotides, the market for ADCs/ PDCs—complex molecules that link antibodies/peptides to cytotoxic drugs—is also growing. “For ADCs/PDCs, specialized methods are needed to quantify both the antibody/peptide and the payload (the cytotoxic compound),” Mouhssin explains. “LC-MS/MS is generally used for quantifying the small molecule payload, while immunoassays like standard ELISA and ECLIA (Meso Scale Discovery MSD) are critical for total antibody quantification. Moreover, client requests for hybrid LC-MSMS approach for the antibody quantitation is rising as well. The ability to provide both technologies/approaches under one roof is a significant advantage especially when the sample volume (mouse studies) is limited.”

However, not all trends have followed the expected trajectory. “In contrast, demand for cell and gene therapy projects has unexpectedly declined in 2024,” Mouhssin notes. “There was a surge of interest in late 2022 and throughout 2023, likely driven by the COVID-19 pandemic, but now things are slowing down. That said, this sector tends to be cyclical, so it will likely pick up again.”

How Large Pharma is Shaping the Bioanalytical Landscape

Turning to the broader pharmaceutical landscape, Mouhssin explains that large pharmaceutical companies are undergoing significant changes, especially in terms of their R&D strategies. He recently attended the European Bioanalytical Forum (EBF) Open Symposium 2024 and had discussions with C-suite industry leaders. The trend, he notes, is that many large pharmaceutical companies are further scaling back their R&D departments.

“This shift has already happened in the U.S., and we expect the trend to follow in Europe in the coming months. As large pharma increasingly reduces their in-house R&D teams, they will likely rely more on outsourcing studies to CROs. This presents a huge opportunity for mid-sized and larger CROs to step in and take on that additional work.”

But there’s a catch. “While small CROs may anticipate a benefit from this shift, many aren’t equipped to handle the large-scale demands large pharma requires,” Mouhssin points out. “To compete, they need to have the right digital tools – such as LIMS (Laboratory Information Management Systems) and ELN (Electronic Lab Notebooks) systems. Mid-sized and large CROs with the necessary infrastructure are in the best position to attract this growing opportunity.”

The Investment Landscape in Europe: What’s Next?

Investment trends have also been a key topic of conversation within the industry. After a dip in biotech funding in early 2023, largely driven by inflation and the rising cost of capital, the tone seems to be shifting.

Mouhssin notes that while the European market typically lags the U.S. by six to nine months, the signs of recovery are already starting to present themselves. “By the end of 2023, we saw biotech companies struggling to secure funding, especially for their earlier-phase projects. But big pharma is increasingly looking to acquire promising assets from biotech companies. As long as biotech can get through Phase I trials and prove their value, there is still a chance for them to be bought out by larger players.”

However, uncertainty remains in Europe, where political instability and shifting regulations continue to make investors cautious. “In France, for example, there’s a lot of uncertainty about tax policies, tax-refund changes (CIR Credit Impot Recherche) which makes people somewhat hesitant to invest,” he says. “Germany is dealing with its own issues, and UK is still navigating the impact of Brexit. These individualized local challenges can slow things down, but I expect that by Q1 2025, we will have more clarity on the situation.”

Looking Ahead to 2025 for the Bioanalytical Market in Europe

As we look ahead to 2025, Mouhssin acknowledged that Europe’s bioanalytical market will be shaped by political and economic factors – particularly the upcoming changes in U.S. leadership and the shifting dynamics within large pharmaceutical companies. But there is a lot of optimism, especially as more CROs and biotech companies pivot to address the evolving needs of the industry.

“At KCAS Bio, the company has already positioned itself for these coming changes.” He says, ” The strategy we’ve taken around globally harmonized flow cytometry, in particular, has set us apart and gives us a strong differentiator in the market.”

Looking to the future, KCAS Bio will continue expanding its capabilities to meet the demands of the market. “The goal is to bring together all the right technologies under one brand,” he explains. “This will give us a significant edge in attracting more customers and supporting the growing demand for bioanalytical and biomarker services.”

As we approach 2025, it’s clear that the bioanalytical market in Europe – and beyond – will continue to evolve, driven by technological advancements (Artificial Intelligence AI is already part of such changes), shifting pharma strategies, and changing investment climates. While there is still some uncertainty, the overall outlook remains positive, and KCAS Bio is preparing to meet these challenges head-on.

Flexibility, rapidity and technological innovations will be key to success in an increasingly competitive landscape.