
Published On: Apr 2025
Published On: Apr 2025
At 26.4% CAGR, North America Cell and Gene Therapy Market is Projected to be Worth US$ 14,049.06 Million by 2031, says Business Market Insights
According to Business Market Insights' research, the North America Cell and Gene Therapy market was valued at US$ 2,159.08 million in 2023 and is projected to reach US$ 14,049.06 million by 2031, registering a CAGR of 26.4% from 2023 to 2031. Automation of cell and gene therapy manufacturing service and increase in number of approvals of cell and gene therapies are among the critical factors attributed to drive the North America cell and gene therapy market growth.
Incorporating automation in cell and gene therapy manufacturing can lead to a reduced risk of contamination, improved consistency, and decreased cost of production. Lonza Cocoon and the CliniMACS Prodigy system from Miltenyi are a few of the devices designed to boost the automation of most sequential unit operations for a CAR-T process within a single system. With the rise in demand for cell and gene therapies, the production of cell and gene therapy products has shifted from a small-volume process to a large-volume process worldwide. In addition to the increasing research activities, the evolution of cell and gene therapy from an academic and clinical setting to commercialization has propelled the demand for automation in commercial manufacturing. In May 2024, Ori Biotech launched IRO platform, an automated manufacturing platform. It's a piece of manufacturing tech designed to be space- and cost-efficient. The company says its tech is flexible enough to transition between projects at various stages of development. Further, government agencies are adopting automation in the manufacturing of cell therapies to increase national production capabilities. Thus, automation of cell and gene therapy manufacturing services is expected to bring new trends in the North America cell and gene therapy market in the coming years.
On the contrastingly, high cost of cell and gene therapy manufacturing hampers the growth of North America cell and gene therapy market.
Based on type, the North America cell and gene therapy market is bifurcated into cell therapy and gene therapy. The cell therapy segment held 64.8% market share in 2023, amassing US$ 1,399.42 million. It is projected to garner US$ 9,986.54 million by 2031 to register 27.8% CAGR during 2023-2031. Furthermore, the cell therapy segment is subcategorized into allogeneic, autologous, viral vectors. Additionally, the gene therapy segment is bifurcated into non-viral vectors and viral vectors.
In terms of services, the North America cell and gene therapy market is segmented into process development, cGMP manufacturing, regulatory services, and bioassay services. The process development segment held 46.8% share of North America cell and gene therapy market in 2023, amassing US$ 1,011.20 million. It is anticipated to garner US$ 7,662.76 million by 2031 to expand at 28.8% CAGR during 2023-2031.
By scale, the North America cell and gene therapy market is divided into commercial/ R and D manufacturing and commercial scale manufacturing. The commercial/ R and D manufacturing segment held 64.8% share of North America Cell and Gene Therapy market in 2023, amassing US$ 1,399.60 million. It is projected to garner US$ 9,472.43 million by 2031 to expand at 27.0% CAGR from 2023 to 2031.
By end user, the North America cell and gene therapy market is segmented into contract research organizations, pharmaceutical and biopharmaceutical companies, and academic and research institutes. The contract research organizations segment held 46.1% share of North America Cell and Gene Therapy market in 2023, amassing US$ 996.17 million. It is estimated to garner US$ 6,849.50 million by 2031 to expand at 27.3% CAGR during 2023-2031.
Based on country, the North America cell and gene therapy market is categorized into the US, Canada, and Mexico. Our regional analysis states that the US captured 92.0% share of North America cell and gene therapy market in 2023. It was assessed at US$ 1,986.35 million in 2023 and is likely to hit US$ 13,108.35 million by 2031, registering a CAGR of 26.6% during 2023-2031.
Key players operating in the North America Cell and Gene Therapy market are Catalent Inc., Charles River Laboratories International Inc., F. Hoffmann-La Roche Ltd, FUJIFILM Holdings Corp, Lonza Group AG, Lotte Corp, Merck KGaA, Takara Bio Inc, Thermo Fisher Scientific Inc., and WuXi AppTec Co Ltd, among others.
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