What’s Next for Cell & Gene Therapy: Top 10 Industry Predictions for 2025
The cell and gene therapy (CGT) market is set to reach $25.37 billion in 2025, which is an increase from $18.13 billion in 2023 representing a notable 19% year-over-year growth.1 This accelerating momentum underscores the transformative potential of the CGT market as it tackles industry challenges and advances patient care worldwide. What key trends and developments will drive this trajectory and redefine the future of the field?
To address this question, Cryoport Systems’ CEO, Mark Sawicki, provides a comprehensive analysis into the challenges and growth opportunities shaping the CGT industry. His 10 key predictions highlight how the field will not only realize its projected growth but also lay the groundwork for pioneering advancements in the years to come.
1. Scalability Will Become the Defining Challenge
As more CGT products progress toward commercialization, scaling processes while maintaining quality will be paramount. Robust logistics, cryopreservation services, and integrated supply chain infrastructure will be required to ensure consistent outcomes at scale with companies needing to adopt flexible and efficient models to keep pace with demand. Those organizations that do not prioritize scalability and the requirements of future stages early on risk their preparedness for commercialization down the road.
2. Technological Advancements Will Fuel Industry Growth
The continued refinement of genome editing tools, the application of AI for therapy design and target selection, and greater automation in manufacturing will collectively enhance CGT development.2 Technological advancements in the use of AI for CGT development will result in the ability to improve research and manufacturing efficiency, safety, and accessibility for patients worldwide. Certain CGT organizations are already progressing in the use of AI, such as Cytiva, Nucleus Biologics, and 64x Bio. These companies are investing in the development of AI tools to streamline cell media optimization, increase viral vector productivity, and otherwise improve the developmental process.3
3. Regulatory Scrutiny Will Intensify
As the regulatory environment tightens, compliance will become increasingly critical for CGT developers. With filings for novel therapies expected to increase by about 30% year-over-year to a record 15 filings in 2025, regulatory support and advisory services will become vital to compliantly traverse the changing landscape.4 This support helps organizations navigate global requirements to ensure smoother filings while also reducing overall approval timelines.
4. Allogeneic Therapies Will Gain Momentum
Clinical trials for allogeneic therapies will advance as new data becomes available. The industry can expect a number of recently approved therapies to scale commercially in 2025. Companies focusing on allogeneic therapies like those from Atara, ImmunityBio, and Mesoblast will pave the way for more accessible treatment options and the broader adoption of allogeneic solutions. The increase in these trials will also increase the need for effective donor sourcing and a robust infrastructure from the earliest stages to support scalability.
5. Gene Therapy Adoption Will Foster Global Expansion
The number of patients treated with gene therapies will grow significantly as therapies from leading developers like Sarepta, Crispr/Vertex, and bluebird bio continue to gain global traction. The expansion of these therapies will highlight the importance of robust logistics networks and integrated supply chain management solutions. The timely and secure delivery of treatments will hinge on superior delivery systems that can not only maintain product viability despite delays but actively mitigate risk throughout the transport process. The integration of seamless supply chain support will also become especially vital when moving drug products across global borders.
6. Risk Mitigation Will Be a Strategic Priority
Supply chain disruptions across CGT operations remain a key concern in 2025. This challenge drives the need for comprehensive risk management strategies to actively mitigate disruptions. Effective contingency planning and compliance adherence will be key hurdles to address. Those CGT organizations that increasingly adopt digital tools to predict disruptions and integrate risk management strategies into their daily operations will see success in maintaining lifesaving therapy availability and integrity.
7. Increased Mergers and Acquisitions Will Shape the Landscape
Mergers and acquisitions (M&As) will accelerate as large pharmaceutical and biotech companies address revenue losses due to patent expirations.5 These strategic moves will consolidate resources and drive innovation, which is especially appealing for small to mid-size biotechnology companies looking to establish themselves in the CGT market. Strong partnering relationships with external vendors for critical aspects of supply chain management like biostorage can help to keep capital expenditures low, which is a critical benchmark for companies looking to become attractive acquisition targets.
8. Standardization Will Drive Efficiency
The push for standardized manufacturing and cryopreservation processes will address variability challenges and improve scalability across the industry. This move toward consistency will streamline operations to overall enhance product reliability. The standardization of processes and compliance is particularly important for therapies nearing commercialization as there is little room for fluctuation or error.
9. Collaboration Between Stakeholders Will Deepen
Partnerships among biotech companies, academic institutions, and supply chain providers will strengthen innovation pipelines. These collaborations will foster the exchange of expertise and resources, accelerating the development and delivery of next-generation therapies. The emphasis on collaboration will especially be important to conversations within the industry on evolving CGT business models such as point-of-care.6
10. Early Development Support Will Gain Importance
Early-stage companies will require specialized support to navigate the unique challenges of preclinical and clinical development. Tailored solutions will enable these organizations to optimize their workflows, validate processes, and ensure compliance from the outset, setting the stage for long-term success. This assistance will be especially important for these companies as they learn to navigate compliance and regulatory expectations, making partnering with established supply chain providers essential.
Successfully navigating the complexities of the CGT industry landscape and staying ahead of these 10 crucial trends is paramount to therapeutic success. Partnering with Cryoport Systems provides companies with a platform of connected supply chain services that work cohesively to streamline processes and expertly navigate regulatory requirements throughout all stages and phases of CGT development. Let’s work together to navigate the challenges of 2025 and beyond, ensuring your therapies reach the patients who need them most.
References & Further Reading:
- Cell and Gene Therapy Market Size Report, 2024-2033. (2024, April). Nova 1 Advisor. https://www.novaoneadvisor.com/report/cell-and-gene-therapy-market
- Bhandari, M., Chang, A., Devenyns, T., Devereson, A., Loche, A., & Van Der Veken, L. (2022, November 16). How AI can accelerate R&D for cell and gene therapies. McKinsey & Company. https://www.mckinsey.com/industries/life-sciences/our-insights/how-ai-can-accelerate-r-and-d-for-cell-and-gene-therapies
- Opportunities for AI to assist cell & gene therapy companies. (2023, October 10). Cell&Gene. https://www.cellandgene.com/doc/opportunities-for-ai-to-assist-cell-gene-therapy-companies-0001
- Cryoport reports first quarter 2023 results. (2023, May 4). Cryoport. https://www.sec.gov/Archives/edgar/data/1124524/000110465923056041/tm2314749d1_ex99-1.htm
- Bernauer, T., Kaetzler, R., Parekh, R., & Rudnicki, J. (2024, February 29). Life Sciences M&A shows new signs of life. McKinsey & Company. https://www.mckinsey.com/capabilities/m-and-a/our-insights/life-sciences-m-and-a-shows-new-signs-of-life
- 2025 Outlook for CGT: Focus on non-oncology indications, in vivo gene editing, and POC. (2024, December 4). Cell&Gene. https://www.cellandgene.com/doc/outlook-for-cgt-focus-on-non-oncology-indications-in-vivo-gene-editing-and-poc-0001