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 concludes, the bioanalytical industry has seen significant changes, particularly in flow cytometry and the evolving pharmaceutical landscape. Brian Wile, PhD, General Manager at KCAS Bio Philadelphia, shared insights on this year’s challenges, opportunities, and key trends shaping the path to 2025.

Reflecting on the Year in Bioanalysis

When asked about the most significant changes he has seen over the past year, Brian noted the bioanalytical market has been shaped by two primary industry-wide events.

“The first was the broad impact of rising interest rates and its specific effects on biotech,” he explained. “Biotech is often a roller coaster, with many companies rising and falling based on the results of their clinical trials. This year was no exception, however, the cost of placing bets on these companies increased, leading to more cautious and conservative decision-making. As a result, many companies refocused their pipelines, prioritizing certain molecules and clinical trials while scaling back on what could be perceived as ‘riskier’ ventures – hit hardest were those in cutting-edge gene therapies and rare disease sectors, for instance.”

The second major trend Brian observed was the growing investment in immunology, particularly in the areas of inflammation and autoimmune diseases.

“This year, the immunology sector has seen a huge surge in investment, even rivaling oncology for the first time in terms of total funding.  This shift has been particularly evident in Philadelphia, where companies have pivoted from oncology-focused therapies to autoimmune disease treatments,” he said.

Brian continued, “Immunology is a big focus for us at KCAS Bio, especially in cell therapy. With local companies making this shift, we’ve been able to support their work with our flow cytometry services.”

KCAS Bio’s Global Strategy and Flow Cytometric Harmonization

In 2024, KCAS Bio expanded its global capabilities in spectral flow cytometry, adding facilities in Philadelphia, Lyon, and through a partnership with Crux Biolabs in Melbourne, to support increasing demand for flow cytometry and immunology research.

According to Brian, “We’ve made significant strides in globalizing our flow cytometry capabilities.  We now have instruments in multiple locations, which allows us to harmonize data across regions, providing our clients with consistent, reliable results no matter where they are based, or where they need to conduct their studies.”

The addition of spectral flow cytometry capabilities has been particularly important, as it became increasingly clear that spectral flow will play a central role in advancing immunology research.

He specifically highlighted KCAS Bio’s efforts to enhance its portfolio of ready-made, off-the-shelf panels designed specifically for immunology applications. “As clients pivot toward immunology, we’ve ensured that we have the tools they need to accelerate their work,” Brian said. “These ‘backbone panels’ are designed to answer common immunology questions quickly and efficiently.”

The Growing Need for Global Presence

As the global market becomes more interconnected, harmonizing bioanalytical services has become essential. “Post-COVID, we have continued to see a shift toward a more unified global approach,” Brian observed. “It’s critical for labs across the world to work together seamlessly, and that’s something we’re seeing more and more with respect to inquiries from our sponsors. They expect harmonization with services like flow cytometry, and we’re committed to meeting those demands.”

This global trend has been facilitated by the growing maturity and widespread adoption of flow cytometry as a core bioanalytical technique.  Brian mentioned several key initiatives – including those from SOULCAP, NIST, and CDISC – which are working to standardize data collection, management, and analysis.

“These initiatives are helping to propel the field forward, and they will have a significant impact on high-dimensional spectral flow cytometry,” he says. “At KCAS Bio, we’re proud to be a part of this transformation. Our team’s participation in these global standardization efforts is shaping the future of flow cytometry.”

Looking Ahead to 2025

As the political landscape evolves, there are growing expectations for changes in regulatory frameworks and market dynamics. While it’s still early to assess the full impact, Brian pointed to several trends he expects to see in the coming year.

“I think we can expect continued interest rate cuts, which could spur more investment in biotech,” he said. “That said, there is continued uncertainty around international trade and supply chains, which may lead to more reliance on domestic manufacturing and services.”

Brian also believes the global shift toward a unified bioanalytical market will continue to accelerate. “The world is becoming one global marketplace, and the demand for harmonized services is only going to grow within the pharma and biotech sectors. For companies like KCAS Bio, this trend presents a huge opportunity to expand our footprint and strengthen our relationships with sponsors.”

Another major shift Brian sees for 2025 is the increasing reliance on artificial intelligence (AI) and bioinformatics in bioanalysis. “AI is already playing a significant role in flow cytometry, particularly when it comes to high-dimensional data analysis,” he said. “As AI tools continue to improve, we’ll likely see even greater integration of these technologies into bioanalytical workflows.”

Flow Cytometry and Large Pharma

As for the large pharmaceutical market, Brian noted that more and more companies are adopting spectral flow cytometry. “It was once limited to a few high-complexity groups, but now we’re seeing broad adoption,” he explained. “The large pharma market is increasingly asking for this capability, and it’s becoming a standard expectation for both internal labs and contract research organizations (CROs).”

“We’re absolutely well-positioned to be the partner of choice in the flow cytometry space,” Brian stated. “Our global footprint, our participation in world-wide harmonization initiatives, and our commitment to providing high-quality, standardized data make us a trusted partner for clients around the world of any size.”

“The bioanalytical landscape is rapidly evolving, and it’s exciting to be part of this transformation. As we enter 2025, we’re confident that KCAS Bio is ready to meet the challenges and opportunities that lie ahead.”