Mapping the Future: Q&A with Mark Sawicki, Ph.D., on 2025 Trends in Cell and Gene Therapy
The cell and gene therapy (CGT) industry achieved remarkable innovation in 2024 with trial diversification and clinical research breakthroughs reshaping the field.1 As the CGT industry enters a pivotal phase of commercial growth and therapy expansion, Cryoport Systems’ CEO, Mark Sawicki, Ph.D., shares his perspectives on where the market is headed. His insights shine a light on the industry as a whole, his key predictions for 2025, and how Cryoport Systems is uniquely positioned to support its continued evolution.
Q: Dr. Sawicki, how would you describe the current state of the CGT industry as we move into 2025?
Dr. Sawicki: “The CGT industry is undergoing a period of transformative growth. We’re seeing unprecedented advancements in therapeutic development with new gene-editing technologies, automation, and AI reshaping what’s possible. At the same time, the industry is grappling with challenges like scalability, regulatory complexities, and ensuring equitable patient access. These dynamics make it a truly exciting and critical time to be part of this field.”
Q: Your top 10 predictions for 2025 highlight major shifts in the industry. Which do you believe will have the most immediate impact on therapeutic developers?
Dr. Sawicki: “I think the need for scalability and the intensifying regulatory landscape will have the most immediate and profound impact. As therapies progress from clinical trials to commercialization, the ability to scale operations efficiently while maintaining product quality is essential. Similarly, the increase in regulatory filings, particularly in the U.S. and Europe, underscores the need for strategic regulatory planning and support to navigate this complex environment.”
Q: Technological advancements play a significant role in your predictions. Can you elaborate on how these innovations are shaping the CGT space?
Dr. Sawicki: “Absolutely. Technologies like AI are optimizing therapy design and target selection, enabling developers to achieve greater precision and efficiency. Automation has the potential to streamline manufacturing processes, reduce costs, and minimize human error. These innovations can not only accelerate timelines but may also improve the overall quality and accessibility of therapies, which is critical as the industry scales.”
Q: You also mentioned the rising trend of increased global adoption of gene therapies. What does this mean for patients and the industry as a whole?
Dr. Sawicki: “Greater adoption means that more patients worldwide will have access to these potentially life-saving treatments. This expansion requires a robust global infrastructure to manage the logistics of transporting these sensitive materials safely and efficiently. It also calls for collaboration between regulatory agencies, developers, and supply chain partners to ensure therapies reach patients without delay.”
Q: With mergers and acquisitions on the rise, how do you see this trend influencing the CGT landscape?
Dr. Sawicki: “Most often, mergers and acquisitions bring much needed resources and expertise to the table. They help smaller companies overcome challenges like limited manufacturing capacity and funding constraints, enabling them to bring therapies to market faster. However, these consolidations also require careful integration of operations to ensure continuity and efficiency.”
Q: What role does Cryoport Systems play in addressing the scalability challenges you’ve identified?
Dr. Sawicki: “Cryoport Systems is committed to providing end-to-end supply chain solutions that support the scalability of CGT operations. From our integrated cryopreservation services to our global logistics network, we ensure that therapies can be transported and stored with the highest levels of quality and reliability. Our ability to adapt and scale alongside our clients makes us a trusted partner in their growth journeys.”
Q: Risk mitigation is another key theme in your predictions. How can the industry better prepare for potential disruptions?
Dr. Sawicki: “Risk mitigation starts with a comprehensive strategy that addresses quality, safety, and reliability at every step. Cryoport Systems leads the way in this area by integrating advanced, risk-mitigating protocols into our temperature-controlled supply chain solutions. For example, our proprietary Veri-Clean® system ensures that all shipping containers meet the highest decontamination standards while our Chain of Compliance® provides end-to-end adherence to ISO 21973 standards. With near real-time monitoring and data retention through the Cryoportal®, we empower our clients with the tools they need to anticipate and mitigate risks effectively.”
Q: How can stakeholders across the industry collaborate to drive progress?
Dr. Sawicki: “Collaboration is essential. Developers, manufacturers, regulators, logistics providers, and technology innovators must work together to create an ecosystem that supports the efficient development and delivery of cell and gene therapies. By fostering partnerships and leveraging each other’s expertise, we can overcome challenges and unlock the full prospect of these potentially life-saving therapies.”
Q: How does Cryoport Systems’ integrated approach support early-stage therapeutic developers?
Dr. Sawicki: “Early-stage developers face unique challenges, such as process validation and regulatory compliance adherence. Our integrated approach provides tailored solutions for each stage of development from preclinical to commercialization. By offering expert advisory services, scalable cryopreservation services, integrated BioServices and biostorage, and end-to-end supply chain management, we help these companies overcome barriers and accelerate their timelines.”
Q: Looking ahead, what excites you most about the future of the CGT industry?
Dr. Sawicki: “The potential to revolutionize healthcare is what excites me most. Cell and gene therapies are not just incremental improvements; they’re breakthroughs that can cure or limit diseases once thought untreatable. The prospect of playing a role in making these therapies accessible to patients worldwide is incredibly rewarding. At the same time, these advanced therapies are often irreplaceable materials, and we take our responsibility to ensure the safety of these treatments while in our care very seriously. This is at the heart of everything we do and is why our industry-leading processes are as advanced and robust as they are.”
Our sincere thanks to Dr. Sawicki for sharing his insights with us. The cell and gene therapy industry is poised for tremendous growth and innovation in 2025. At Cryoport Systems, we’re honored to be part of this journey, working alongside our partners to enable these groundbreaking advancements. By focusing on collaboration, scalability, and risk mitigation, we can help ensure that these life-changing therapies reach the patients who need them most. The future is incredibly bright, and we’re excited to see what we can achieve together. Join us in shaping the future of medicine. Explore how our integrated services can support your mission to bring transformative therapies to market.