Source: NextGen Intelligence Stats and Consulting LLP

Cell And Gene Therapy Manufacturing Market Analysis By Therapy Type

By Therapy Type, the market is segmented into Cell Therapy Manufacturing (Stem Cell Therapy, Non-Stem Cell Therapy) and Gene Therapy Manufacturing. The Cell Therapy Manufacturing segment is now the largest in the global Cell and Gene Therapy Manufacturing market, with a significant market share of approximately 60.19% in 2023. This is due to the greater number of cell therapy products that have attained regulatory approval and are more advanced in clinical development than gene therapies. Cell therapies, particularly for oncological uses such as CAR T-cell therapies, have demonstrated a tremendous clinical impact and are being increasingly utilized, prompting the need for specialized manufacturing techniques. The Gene Therapy Manufacturing segment will be the fastest-growing segment in the globally. This strong growth primarily stems from the increasing number of gene therapy candidates entering late-stage clinical trials, as well as the significant role these therapies are expected to play in treating a broad spectrum of genetic diseases and rare disorders. The improvement in viral vector manufacturing and delivery systems, which are important enablers of gene therapy, is a key driver. 

Cell And Gene Therapy Manufacturing Market Analysis By Scale

By Scale, the market has been segmented into Pre-commercial/ R&D Manufacturing and Commercial Scale Manufacturing. The Pre-commercial/ R&D Manufacturing segment accounted for the largest revenue share in the market, holding approximately 73.34% in 2023. This is due to the large pipeline of cell and gene therapies in preclinical and clinical development. The intrinsic complexity and high failure rate of early-stage development result in a huge majority of therapeutic candidates still within R&D, necessitating specialized manufacturing services for small batches, process optimization, and analytical testing. The commercial-scale manufacturing segment is expected to register the highest CAGR over the forecast period. This is spurred by the rising approvals of cell and gene therapy products and their movement from clinical development to commercialization. As a greater number of therapies become available, patient demand for large-scale, low-cost, and highly regulated manufacturing processes increases. 

Cell And Gene Therapy Manufacturing Market Analysis By Mode

By Mode, the market is segmented into Contract Manufacturing and In-house Manufacturing.

The Contract Manufacturing segment acquired largest revenue share in the global Cell and Gene Therapy Manufacturing market, with approximately 67.13% in 2023. This is because, owing to the immense capital input, technical competence, and cutting-edge infrastructure required for the manufacturing of cell and gene therapies, many biotechs and pharmaceutical firms, particularly smaller players, often lack these resources. Contract Manufacturing Organizations (CMOs) outsourcing enables companies to leverage existing capabilities, reduce overhead costs, and accelerate development times. The In-house Manufacturing segment is expected to have the largest CAGR during the forecast period. This is driven by academic centers with tailor-made patient treatment regimes and big pharmaceutical firms with deep pockets. These players continue to invest in developing their own manufacturing processes in an attempt to exert more control over the process, protect proprietary knowledge, and attain long-term cost savings for their high-volume or strategic products. 

Cell And Gene Therapy Manufacturing Market Analysis By Workflow

By Workflow, the market is classified into Cell Processing, Cell Banking, Process Development, Fill & Finish Operations, Analytical And Quality Testing, Raw Material Testing, Vector Production, and Other Workflow. The Process Development segment accounted for approximately 17.57% of the market in 2024. This is attributed to its crucial role in optimizing and scaling up cell and gene therapy manufacturing processes. Successful process development helps ensure product quality, consistency, and manufacturability from the initial stages of research through to commercialization. The Vector Production segment is expected to record the highest CAGR during the forecast period. This is attributed to an increasing numbers of gene therapy candidates progress to the clinic & regulatory approval, demand for high-quality, high-titer viral vectors, including adeno-associated virus (AAV) and lentivirus, has jumped. 

Cell And Gene Therapy Manufacturing Market Analysis By End Use

By End Use, the market is divided into Biopharmaceutical Companies and Contract Development & Manufacturing Organizations (CDMOs). The Biopharmaceutical Companies segment is the largest end-use segment of the market, as biopharmaceutical companies are the initial developers and, ultimately, the commercializers of cell and gene therapies. They undertake extensive R&D, clinical testing, and, upon approval, commercial-scale manufacturing. The Contract Development & Manufacturing Organizations (CDMOs) segment is projected to grow at the highest growth rate in the market. This is driven by the increasing trend of biopharmaceutical companies outsourcing their manufacturing operations. The tremendous complexity, specialized facilities, and substantial upfront capital investment required for cell and gene therapy manufacturing make contract development and manufacturing organizations (CDMOs) the prefered choice, particularly for smaller biotechs and companies seeking to manage fluctuating demand or expedite timelines.