State of the Cell and Gene Therapy Industry

State of the Industry: 2023 Predictions with Dr. Mark Sawicki

Cryoport Systems has grown to become a leader in the cell and gene therapy industry since its founding in 1999. Throughout those 20+ years, we’ve seen how both the growth and transformation of the market has continually created new life-saving therapies for patients in need. This innovation is particularly true of the modern advancements seen in the last few years.

As the beginning of 2023 is fast underway, we spoke with Dr. Mark Sawicki, Cryoport Systems’ Chief Executive Officer, on his predictions for what our clients and their patients can expect from the industry this year. His insights into the evolving state of the industry detail both how cell and gene therapy developers are continually striving toward new medical advancements and how Cryoport Systems is an important part of the growth to come within the industry.

What to Expect:

Last year sparked innovation for the cell and gene therapy sector with 9 MAA/BLA filings according to Mark. However, 2023 holds the potential to outshine its predecessor. “Expect up to an additional 22 MAA or BLA submissions for Cryoport-supported therapies in 2023,” Mark stated. “As well as the potential for 11 new therapy approvals and an additional 12 label or geographic expansion approvals.”

This potential jump in Cryoport-supported commercial therapy approvals mirrors national expectations. Vivo Pharma Intelligence reported in January that “as many as 13 new cell or gene therapies could be approved for use in the US, Europe, or both by the end of 2023.” This advancement reflects and validates the FDA’s 2019 prediction for the industry that 10-20 new cell and gene therapies would be approved a year by 2025.

This accelerating growth showcases the increased potential for the number of patients who can be supported by these therapies. Cryoport Systems plays a crucial role in this process as the end-to-end supply chain partner for therapies across the world. Our comprehensive supply chain platform mitigates risk and ensures that the quality of these potential therapies stays consistent from manufacturing to the point of care.

Challenges in the Industry:

While growth in the industry propels new therapies forward, pain points in the ramp up of cell and gene therapies aren’t obsolete. Patient access is an issue across the board for cell and gene therapies. “At the [2023] JP Morgan conference,” Mark stated, “multiple companies including Bristol Myers Squibb and Allogene indicated that they are only accessing approximately 30% of their patient demand.”

The limited number of authorized treatment centers is a large factor in the problem of patient access. A study done by Avalere in 2021 found that many southern states specifically experience the biggest challenge in patient access. States such as Alabama, Kentucky, Mississippi, and Tennessee had the median distance of 46.7 miles required for patients to travel to access an authorized treatment center for CAR-T therapies. This level-of-access burden as referred to in the study prohibits patients from getting the life-saving therapies they need, making Cryoport Systems’ logistics and supply chain solutions an important factor in connecting patients with life-saving therapies.

Areas of Innovation:

Cryoport Systems is entering 2023 with optimism as we launch new products and services. The imminent launch of Cryoport’s leukapheresis supply chain platform aims to establish a standardized, integrated cell collection, cryopreservation, storage and distribution solution for the global Cell & Gene Therapy Market. Over time, the platform will improve the quality of leukapheresis, support on-time delivery of starting material, improve manufacturing slot management, and enhance manufacturing efficiency.

“The platform combines Cryoport’s global leadership in supply chain solutions, including distribution and storage, with Cell Matters’ experience and expertise in cryopreservation,” Mark stated. “In the near future, cell collection capabilities will complete the integrated supply chain platform. The goal is to streamline the complex processes necessary to treat an increasing number of patients with today’s most advanced cell therapies while ensuring the highest quality and safety standards.”

Additionally, the opportunities associated with our new Global BioServices offerings allow us to extend our reach. Our facilities in Texas and New Jersey as well as our recent acquisitions in France and Belgium expands our logistics abilities to include additional services like long-term storage, kit production, and packaging and labeling.

“Cryoport continues to build on its market dominance as the premier supply chain partner for the cell and gene industry,” Mark said. “Our facilities, services, and product launches will allow us to more extensively support our clients and the market…. It’s exciting to see years of planning starting to contribute to the business and markets we serve.”

Questions or comments? We welcome your feedback!