Access TOC
Download Brochure
January 2025
The cell and gene therapy manufacturing market size is estimated to be USD 5.08 billion in 2024 to reach an estimate of USD 22.88 billion by 2034, at a 16.25% CAGR between 2025 to 2034. The burgeoning biotechnology sector, growing cell and gene therapy research, and increasing investments drive the market.
Unlock Infinite Advantages: Subscribe to Annual Membership
Cell and gene therapy manufacturing is a specialized process that produces cell and gene therapy (CGT) products on a large scale. It requires advanced facilities, equipment, and expertise. Cell therapy involves transplanting cells into a patient to replace or repair damaged tissue, and gene therapy involves inserting, deleting, or modifying genes in a patient’s cells to treat or prevent disease. Both cell and gene therapy products undergo different manufacturing processes. Steps involved in cell therapy manufacturing are sourcing and isolation of cells, activation, and genetic modification, and expansion and culture. The steps involved in gene therapy manufacturing are viral vector expression, cell growth, harvest of viral vector, and filtration & purification.
Considering its potential to treat cancer, cell and gene therapy has sparked a lot of interest. With a complicated and expanding sector, a Contract Development and Manufacturing Company (CDMO) may assist customers in smoothing commercial cell and gene therapy manufacturing needs.
In August 2022, Cytiva, a subsidiary of Danaher Corporation, and Forecyte Bio, a provider of CDMO service designed for cell gene therapy, collaborated to accelerate the development and manufacturing of cell and gene therapies in China and the U.S. Forecyte Bio will use Cytiva’s Flex Factory platform to launch its contract development and manufacturing organization (CDMO) business.
Artificial intelligence (AI) plays a vital role in the manufacturing of CGT products. AI introduces automation in the manufacturing process, overcoming the challenges faced during conventional processes. AI can aid in the large-scale manufacturing of CGT. Automation enhances efficiency and reproducibility, reducing the time and cost of manufacturing. The use of AI and robots is still in its infancy. However, it is favorable for large-scale and homogenous production, reducing variability. Moreover, AI and machine learning (ML) algorithms can be used in R&D to develop novel CGTs. AI and ML can be used to rapidly screen more candidates and select designs that fulfill the desired criteria. AI and ML can also aid in streamlining the supply chain of CGTs, resulting in timely delivery to large consumers.
A recent survey on the cell and gene therapy (CGT) industry reveals that while CGT innovators and healthcare providers have had a positive view of the sector over the past 12–18 months (86% and 83%, respectively), contract development and manufacturing organizations (CDMOs) were less optimistic (66%). Looking forward, optimism increases across all groups for the next 12–18 months, with CGT innovators (93%), healthcare providers (86%), and CDMOs (83%) expecting positive developments. Gene therapies are anticipated to have a more favorable outlook compared to autologous and allogeneic cell therapies.
Burgeoning Biotech Sector
The rapidly expanding biotechnology sector promotes cell and gene therapy manufacturing owing to its growing demand. The increasing number of biotechnology companies is accelerating research and development activities and manufacturing of CGT products. The increasing investment and expanding manufacturing facilities play a major role in expanding the biotech sector. Several institutions and organizations regularly conduct seminars, workshops, and conferences to increase awareness about biotech products and aid in the training of researchers. The increasing number of biotech startups globally also augments market growth. This also leads to the growing research and development activities to develop novel CGTs. The increasing number of FDA-approved therapies fuel the growth of CGT manufacturing.
Growing Demand for Precision Medicine
The growing demand for precision medicine presents future growth opportunities for the cell and gene therapy manufacturing market due to rapidly changing demographics and increasing population. Several government organizations release guidelines and initiatives to support precision medicine development. The government and private organizations also provide funding for precision medicine research. CGT products are the most personalized forms of medicine. Autologous cell therapies and CRISPR-directed gene therapy enable a new era of precision medicine. Moreover, technological advancements in CGT manufacturing facilitate the development of precision medicine.
Hurdles Faced During Market Growth
One of the most significant issues is the high cost of cell treatments, which has financial consequences for patients, payers, and providers. As a result, firms must lower their pricing in order to increase the acceptance of these medicines, which is projected to hamper market growth throughout the forecast period.
The allogeneic cell therapy segment is estimated to be valued at US$ 1,198.2 Mn in 2022 and is expected to reach US$ 3,129.6 Mn by 2030 at a CAGR of 12.8%.
By therapy, the allogeneic cell therapy segment held a dominant presence in the cell and gene therapy manufacturing market in 2023. Allogeneic cell therapy is a process in which the donor’s healthy blood-forming cells (stem cells) are introduced into a patient’s body. Allogeneic stem cells are used to treat one or more patients. They are predominantly used in medical emergencies. They also offer superior advantages over autologous stem cells. Cells from healthy, young donors are derived to reduce the risk of co-morbidities associated with disease states. The latest innovations in the effective storage and availability of these cells in healthcare settings augment the segment’s growth.
The somatic cell technology segment is estimated to be valued at US$ 823.2 Mn in 2022 and is expected to reach US$ 2,345.6 Mn by 2030 at a CAGR of 14.0%.
By technology, the somatic cell technology segment led the global cell and gene therapy manufacturing market in 2023. Somatic cell technology is a technique by which the nucleus of a differentiated cell is introduced into an oocyte from which its genetic material has already been removed. This technique allows the development of near-identical genetic copies of valuable animals with known and desirable traits to be reproduced. Stem cells derived from somatic cells can help cure degenerative diseases. The rising incidences of degenerative diseases and advancements in technology promote the segment’s growth.
IPSC’s (Induced pluripotent stem cell) segment is estimated to be valued at US$ 1,092.5 Mn in 2022 and is expected to reach US$ 4,092.3 Mn by 2030 at a CAGR of 17.9%.
By source, the induced pluripotent stem cells segment registered its dominance over the global cell and gene therapy manufacturing market in 2023. Induced pluripotent stem cells (iPSCs) are immature cells derived from adult cells that have the ability to differentiate into any cell type in the body. They are used to model human development and diseases and perform high-throughput drug screening. The rising incidences of neurological and other chronic disorders, increasing investments & collaborations, and technological advancements potentiate the segment’s growth.
The musculoskeletal segment is estimated to be valued at US$ 807.3 Mn in 2022 and is expected to reach US$ 2,740.2 Mn by 2030 at a CAGR of 16.5%.
By application, the musculoskeletal segment held the largest share of the cell and gene therapy manufacturing market in 2023. The rising incidences and prevalence of musculoskeletal disorders and growing research and development activities boost the segment’s growth. According to the World Health Organization, approximately 1.71 billion globally suffer from musculoskeletal disorders. The growing demand for CGT to treat musculoskeletal disorders also propels the segment’s growth.
North America dominated the cell and gene therapy manufacturing market in 2023. The presence of key players, technological advancements, and favorable government policies drive the market. The U.S. Department of Health and Human Services will launch the Cell and Gene Therapy Access Model in January 2025, inviting drug manufacturers to provide access to CGT products at lower prices. The rising investments in North America also show positive growth in the market. The Government of Canada invested around $2.2 billion from 2020 to 2024 to strengthen domestic biomanufacturing and life sciences capabilities.
The increasing number of FDA-approved CGT products potentiates market growth. As of December 2024, 41 CGT products have been approved by the U.S. FDA. In 2022, the U.S. FDA approved 12 CGTs, while in 2023, it approved 7 CGT products for different purposes.
Asia-Pacific is anticipated to grow at the fastest rate in the cell and gene therapy manufacturing market during the forecast period. The rising incidences and prevalence of chronic disorders, expanding manufacturing ecosystem, and rising foreign direct investment drive the market. The Chinese government permits foreign investment in CGT and wholly foreign-owned hospitals in selected cities of China. It has also pledged to encourage more research in CGT at the country’s biotech hub in the eastern Chinese city of Suzhou. The Indian Government also supports CGT manufacturing with the growing biotech sector and encourages collaboration to boost market growth.
Josh Ludwig, Global Director of Global Operations for ScaleReady, commented that, in the future, the focus will shift from autologous to allogeneic approaches with durable responses and eliminate the use of viruses, lentivirus, and retrovirus in favor of nonviral gene editing techniques. This has the potential to reduce costs by providing off-the-shelf varieties of CAR-T therapies.
By Therapy
By Technology
By Source
By Application
By Region
January 2025
January 2025
January 2025
January 2025
Annual Access, Limitless Research! Unlock all market research reports with our annual subscription. Stay on top of market trends and crucial insights year-round!
2500+
Client Queries in 20235000+
Insights Published60+
Consulting Projects Per Year40+
Analysts