FUTURE OF CELL & GENE THERAPY 2025 & BEYOND
Mark Sawicki Ph.D., President and CEO, Cryoport Systems
The cell and gene therapy (CGT) industry is seeing accelerating advancements in science, manufacturing and global distribution, all of which are reshaping the advanced therapies landscape. As the market continues to expand, bringing additional regulatory approvals, investment, and innovation, companies will need to navigate both opportunities and challenges to ensure successful commercialization of advanced therapies.
In this Q&A, Mark Sawicki, Ph.D., President and CEO of Cryoport Systems shares his insights on the future of CGT, highlighting the key factors driving growth, the role of standardization, and the critical importance of a resilient, scalable supply chain. From regulatory shifts to technological breakthroughs, Mark provides a forward-looking perspective on what's next for the industry and how stakeholders can work together to accelerate progress.
1. The cell and gene therapy (CGT) market is expected to grow significantly by 2025. What do you think are the key factors driving this growth, and how can stakeholders ensure the industry’s growth trajectory continues?
MARK: The rapid expansion of the CGT market is being driven by several factors, including advancements in genetic engineering, increased investment in clinical development, and a growing number of regulatory approvals, including 7 approvals by the FDA in 2024 alone. The industry is also benefiting from improved manufacturing technologies and the emergence of allogeneic therapies, which promise greater scalability. To sustain this momentum, stakeholders must continue to invest in infrastructure that supports global distribution, enhance regulatory alignment across regions, and prioritise innovations that improve efficiency and COGS optimisation. Collaboration between industry, academia, and regulatory agencies will also be crucial in ensuring continued progress.
2. Scalability is highlighted as the defining challenge in CGT. How do you see the industry addressing this challenge, particularly in the context of maintaining quality while scaling?
MARK: Scaling CGT therapies requires a delicate balance between increasing production capacity and maintaining stringent quality and safety standards. The industry is addressing this through automation, closed-system manufacturing, and the standardization of cryopreservation processes. Standardized cryopreservation solutions like Cryoport Systems’ IntegriCell™ cryopreservation services play a crucial role by preserving cellular viability and consistency, helping to extend manufacturability and overcome common roadblocks associated with manufacturing slot utilisation. This is important for allogenic therapies, where batch-to-batch consistency is essential for scalability, and also for autologous therapies, where the complexity of lining up patient-derived leukopak collection against manufacturing availability is only becoming more complicated as these therapeutics are reaching larger patient populations. Advances in supply chain management, including enhanced tracking and monitoring systems, are also playing a critical role in ensuring product integrity during scale-up.
3. Technological advancements such as genome editing, AI, and automation are expected to fuel the growth of CGT. How are these innovations reshaping the development process and what benefits will they bring to patient care?
MARK: Genome editing tools like CRISPR are enhancing the precision and efficiency of therapeutic development, allowing for more targeted and durable treatments. AI is accelerating drug discovery and optimisation by analysing complex biological data, while automation is streamlining manufacturing processes, reducing human error, and improving consistency. These innovations are not only shortening development timelines but also making therapies more accessible by reducing costs and improving scalability. For patients, this translates to safer, more effective treatments that are able to reach the market faster.
4. As regulatory scrutiny increases, how do you foresee the regulatory landscape evolving in the next few years, and what steps should companies take to navigate this?
MARK: Regulators are adapting to the rapid pace of CGT innovation by refining approval pathways, increasing post-market surveillance, and emphasizing product consistency. We can expect more structured guidance on topics like comparability testing, potency assays, and long-term patient monitoring.
One critical area of focus is standardization in CGT logistics and supply chain management. For example, ISO 21973, the first international standard for the transportation of cells for therapeutic use, was developed with direct input from Cryoport Systems’ experts, who worked closely with regulatory agencies to establish best practices for handling, storage, and transit conditions. As regulatory expectations continue to evolve, aligning with these global standards will be essential for ensuring compliance and maintaining product integrity.
Companies should engage with regulators early, adopt robust management systems, and proactively incorporate validated processes, such as those outlined in ISO 21973, to streamline approvals and mitigate risks. Transparency and data-driven decision-making will be key in navigating this evolving landscape.
5. The focus on allogeneic therapies is intensifying. What are the key hurdles in advancing these therapies, and how can companies address these challenges to make them more accessible?
MARK: Allogeneic therapies offer the promise of off-the-shelf treatments, but they face significant challenges, including durable efficacy, immune rejection, manufacturing scalability, and regulatory complexity. Companies are addressing these hurdles by developing novel immune-evasion strategies, refining cell expansion techniques, and optimising bioprocesses to drive efficiency and consistency at scale.
One of the most pressing considerations is how to ensure the long-term viability and availability of allogeneic cell banks, which is a challenge that extends beyond manufacturing and into cryopreservation and biostorage infrastructure. As these therapies move closer to commercialization, it will be critical to establish standardized, scalable cryopreservation processes that preserve cellular function while supporting global distribution. Additionally, the ability to securely store and retrieve allogeneic cell lines without significant capital investment will require a shift toward strategic biostorage solutions that balance flexibility, compliance, and sustainability.
Ultimately, overcoming these logistical and biological challenges will determine the success of allogenic therapies in delivering broad patient access while maintaining product quality and regulatory alignment.
6. Gene therapy adoption is expected to foster global expansion. What are some of the logistical challenges that companies will face as these therapies scale globally, and how can they be mitigated?
MARK: The global distribution of gene therapies presents challenges related to temperature-controlled supply chains, customs regulations, and regional variations in regulatory requirements. Companies must establish harmonised, risk-mitigating supply chain strategies that account for these complexities, including validated cryopreservation methods, realtime shipment tracking and monitoring, and strict adherence to the industry’s most stringent standards like ISO 21973.
Ensuring compliance with ISO 21973 guidelines – which define best practices for the transportation of cells for therapeutic use – helps reduce variability, enhance product integrity, and mitigate risks associated with transportation. Another critical factor is maintaining ultra-cold temperatures during transit for high-value viral vectors and gene therapies, which are highly sensitive to temperature fluctuations. Advanced solutions like the Cryoport Elite® Ultra Cold Shipping System were specifically developed to address this challenge, offering the same robust functionality of cryogenic shipping systems designed for cell therapies, engineered specifically to meet the needs of gene therapies that are transported at -80°C.
As gene therapy scales globally, mitigating risk in the temperature-controlled supply chain will require a combination of regulatory foresight, advanced coldchain solutions, and strategic partnerships to ensure these life-changing therapies reach patients safely and efficiently.
7. With supply chain disruptions remaining a key concern, what risk management strategies will be crucial for CGT companies to adopt in the coming years?
MARK: Resilience in the temperature-controlled supply chain, especially when it comes to sensitive and oftentimes irreplaceable materials, will require diversification of manufacturing, distribution and biostorage sites, investment in redundancy planning and risk mitigation, and increased visibility through digital tracking systems.
Companies should also develop strategic partnerships with CDMOs, suppliers, and supply chain providers to ensure continuity during disruptions. Implementing predictive analytics to anticipate risks and proactively manage inventory will be another critical component of risk mitigation.
8. The growing trend of mergers and acquisitions (M&As) is expected to impact the CGT market. How do you think M&As will influence innovation and competition within the industry?
MARK: M&As are reshaping the CGT landscape by consolidating expertise, expanding manufacturing capacity, and accelerating commercialization efforts. While this trend fosters efficiency and resource sharing, it also raises concerns about market concentration and reduced competition. To maintain balance, regulators will need to ensure that consolidation does not stifle innovation or limit patient access. Smaller biotechs, often drivers of breakthrough innovations, will need to carefully navigate partnerships to retain agility while benefiting from larger infrastructure support.
9. Standardization in manufacturing and cryopreservation processes is becoming more critical. How do you see the drive for standardization impacting scalability and reliability in CGT?
MARK: Standardization is essential for achieving consistent, high-quality therapies at scale. Efforts to harmonise cryopreservation protocols and establish common quality benchmarks will improve reproducibility across clinical sites. This will not only facilitate regulatory approvals but also enhance patient safety and supply chain efficiency. Companies that invest in robust, validated processes (or who contract with outsourced partners who do) will be best positioned to scale effectively.
10. Collaboration among various stakeholders is key to the future of CGT. What role will partnerships between biotech companies, academic institutions, and other players play in accelerating the development of nextgeneration therapies?
MARK: Collaboration is at the heart of CGT innovation. Academic institutions drive fundamental research, biotech companies translate discoveries into therapies, and logistics and supply chain management partners ensure their safe and efficient delivery. Strategic partnerships enable knowledge-sharing, reduce development costs, and accelerate time-to-market. The most successful companies will be those that actively engage with a diverse network of stakeholders to overcome industry-wide challenges.
11. Early development support is becoming increasingly important for CGT companies. What type of support will be crucial for startups and emerging companies during the early stages of development?
MARK: Startups need access to specialised expertise in regulatory strategy, manufacturing, and clinical trial design. Early partnerships with experienced CDMOs and end-to-end supply chain providers can help bridge critical knowledge gaps. Additionally, funding mechanisms like venture capital and government grants will continue to play a key role in supporting early-stage research and de-risking development programs.
12. With the rapid advancements in CGT, how important will it be for companies to stay agile in order to adapt to evolving technologies and market needs?
MARK: Agility will be a defining factor for success. Companies that embrace continuous process improvement, integrate new technologies, and adapt to shifting regulatory landscapes will be best positioned for long-term success. This requires a culture of innovation, data-driven decision-making, and the flexibility to pivot when needed.
13. As more companies enter the CGT space, how can they differentiate themselves and overcome the challenges associated with commercialization?
MARK: Differentiation will come from technological innovation, manufacturing excellence, and strong regulatory execution. Companies that can demonstrate superior efficacy, efficiency, safety, and supply chain reliability will gain a competitive edge. Building strategic partnerships and establishing a clear commercialization strategy early in development will be key to success.
14. What do you think will be the major obstacles to scaling CGT therapies by 2025, and what steps can the industry take to overcome them?
MARK: CGT scaling will be driven by a number of factors over the next few years. Firstly, community care accessibility is critical to enable the delivery of these therapies in a comprehensive way, secondly, manufacturing capacity continues to hamper availability of a number of the higher volume approved therapies, and lastly, reimbursement and cost optimisation must continue to be a focus of the industry to improve affordability of these groundbreaking therapies to those in need.
15. Looking ahead, which emerging trends or innovations do you think will have the most significant impact on the CGT industry by 2025 and beyond?
MARK: Advances in gene editing and the resulting gene therapies, AI-driven drug discovery, and nextgeneration cryopreservation approaches will all play a major role. The shift toward decentralised manufacturing and real-time patient monitoring will also reshape the industry. Companies that anticipate and adapt to these changes will lead the next phase of CGT innovation.
With the continued growth of the CGT industry, success will be defined by the ability to scale effectively, maintain quality, and adapt to evolving regulatory and technological landscapes. Standardization, strategic collaborations, and robust supply chain solutions will be pivotal in ensuring that these therapies reach patients safely and efficiently on a global scale.
With a deep commitment to innovation and industry leadership, Cryoport Systems remains at the forefront of enabling this progress. By developing nextgeneration solutions for the temperature-controlled supply chain, we are helping to remove critical barriers to commercialization and paving the way for a future where CGT can reach its full potential.
Author Bio
Mark Sawicki Ph.D., has over 20 years’ executive and sales management experience. He has served in senior business development roles at Alcami, AGC Biologics and Curia, increasing revenue at rates far outpacing industry standards.
He holds a Ph.D. in biochemistry from the State University of New York at Buffalo and graduate training at the Hauptman Woodard Medical Research Institute.
