The global cell and gene therapy manufacturing market accounted for USD 9.23 billion in 2023 and is expected to reach at USD 124.45 billion by 2034 with a CAGR of 26.68% during the forecast period 2024-2034. Surge in advanced therapies, increased prevalence of cancer & other diseases, growing pharmaceutical research & development spending, increasing partnerships between pharmaceutical companies & Contract Development & Manufacturing Organizations (CDMOs), many companies are expanding their production capabilities for vector production, while strategic initiatives to produce investigational therapies are on the rise, growing number of clinical trials for cellular & gene-modified therapy products, increased research & development activities, government authorities & market players are making significant investments, and a heightened focus on expanding manufacturing facilities among market players are some of the key factors boosting the market growth.
A heightened focus on expanding manufacturing facilities among market players is predicted to boost the market growth during the forecast period. The emergence of cell and gene therapies represents a groundbreaking advancement in medicine, offering promising prospects for curing numerous diseases. This rapidly evolving sector has experienced significant growth in recent years, making substantial contributions to both patient care and advancements in medical research. Among the remarkable milestones within this field is the successful development and commercialization of CAR-T (Chimeric Antigen Receptor T-cell) therapies, which have revolutionized the lives of individuals with specific blood cancers. Through CAR-T therapy, a patient's immune cells are utilized to target and eliminate cancer cells, leading to unprecedented long-term remission rates compared to traditional treatments. For instance, in October 2023, eXmoor Pharma, a comprehensive partner in cell and gene therapy (CGT) manufacturing, has inaugurated its latest Good Manufacturing Practice (GMP) facility, the Cell and Gene Therapy Centre. This facility is dedicated to supporting the production of various therapies for clinical trials.
By therapy type, cell therapy manufacturing was the highest revenue-grossing segment in the global cell and gene therapy manufacturing market in 2023 owing to the marketplace is witnessing a rise in the number of products being introduced, increase in ongoing clinical trials concentrating on CAR-T cell therapies and other cell-based treatments, and surge in investment by key players in the market. For instance, in October 2023, Bayer AG inaugurated a new facility for cell therapy production in Berkeley, California, USA, aiming to deliver cell therapies to patients worldwide. This investment of USD 250 million will facilitate the manufacturing of materials necessary for clinical trials and potential commercial release of BlueRock Therapeutics' bemdaneprocel (BRT-DA01), an experimental cell therapy being assessed for Parkinson's Disease treatment. Additionally, gene therapy is predicted to grow at the fastest CAGR during the forecast period owing to numerous products are presently undergoing clinical trials, with increasing clinical achievements observed across several. Many gene therapy companies are directing their efforts towards manufacturing and commercialization, alongside a notable increase in diverse strategic initiatives undertaken by companies to enhance their footprint in the gene therapy manufacturing sector.
By scale, pre-commercial/R&D scale manufacturing was the highest revenue-grossing segment in the global cell and gene therapy manufacturing market in 2023 owing to the expanding portfolio of gene and cell therapies, surge in investments and growing array of strategic initiatives undertaken by market participants. Additionally, commercial-scale manufacturing is predicted to grow at the fastest CAGR during the forecast period owing to the surge in number of regulatory approvals for gene & cell therapy products, driving up demand for their commercial production, and increase in the introduction of new services. For instance, in February 2022, Thermo Fisher Scientific has introduced the Patheon Commercial Packaging Services specifically tailored for cell and gene therapy, now available in the U.S. and Europe. This comprehensive offering integrates logistics, serialization compliance, and worldwide distribution.
By mode, contract manufacturing was the highest revenue-grossing segment in the global cell and gene therapy manufacturing market in 2023 owing to the increasing need for cell and gene therapies, coupled with a limited manufacturing capacity, and rise in the development of innovative therapies. For instance, in August 2023, NKGen Biotech has initiated the administration of SNK02, an allogeneic NK cell therapy, to the initial participant in a Phase I clinical trial targeting the treatment of solid tumors. Additionally, in-house manufacturing is predicted to grow at the fastest CAGR during the forecast period. Academic institutions offering personalized patient treatment programs, along with numerous entities possessing significant capital advantages over contract manufacturing, are fostering strategic partnerships with contract manufacturers. This trend is further fueled by increasing investments from prominent market players.
By workflow, process development was the highest revenue-grossing segment in the global cell and gene therapy manufacturing market in 2023 owing to the transition of numerous therapies from clinical trials to regulatory approval is on the rise, facilitated by the establishment of reliable and comprehensive methods for cell therapy production, and increase in collaborations among key market players. Process development strategies enhance efficiency while enhancing the quality and safety of candidate programs. These strategies encompass various aspects such as cell characterization, isolation, optimizing cell culture media, eliminating impurities, and scaling up production. For instance, in February 2024, Thermo Fisher Scientific has partnered with Multiply Labs to automate its instrument systems for cell therapy manufacturing. This collaboration aims to bolster large-scale production capabilities, lower manufacturing costs, and expedite the production timelines for cell therapies. Additionally, vector development is predicted to grow at the fastest CAGR during the forecast period owing to the manufacturing services have seen widespread adoption, driven by the expanding market for gene therapies. There's a rising demand for viral vectors, which have been utilized in treating a spectrum of disorders including metabolic, cardiovascular, muscular, infectious, hematologic, ophthalmologic, and cancer-related conditions. Among the commonly employed viral vectors are adenoviral, retroviral, AAV, lentiviral, and herpes simplex virus.
North America region is anticipated for the highest revenue share during the forecast period owing to the increase in the involvement of organizations in gene & cell therapy research & product development, a significant presence of contract development organizations, expanding manufacturing facilities by domestic companies, and rise in collaborations among industry leaders. For instance, in June 2023, Quell Therapeutics has formed a licensing agreement with AstraZeneca to collaborate on the development, manufacturing, and commercialization of engineered Treg cell therapies targeting autoimmune disorders. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the introduction of expedited approval pathways, escalating healthcare demands, heightened investments from both private & governmental sectors, and increasing emphasis on expansion efforts among various companies. For instance, in February 2024, Miltenyi Biotec, a German company specializing in products and services for biomedical research and advanced cellular therapy, has announced the commencement of its operations in India, marking the establishment of its first office in the country. Additionally, the company plans to establish a Center of Excellence (CoE).
This comprehensive research report focuses on the global and regional market size and forecasts from 2023 to 2034.
A heightened focus on expanding manufacturing facilities among market players is predicted to boost the market growth during the forecast period. The emergence of cell and gene therapies represents a groundbreaking advancement in medicine, offering promising prospects for curing numerous diseases. This rapidly evolving sector has experienced significant growth in recent years, making substantial contributions to both patient care and advancements in medical research. Among the remarkable milestones within this field is the successful development and commercialization of CAR-T (Chimeric Antigen Receptor T-cell) therapies, which have revolutionized the lives of individuals with specific blood cancers. Through CAR-T therapy, a patient's immune cells are utilized to target and eliminate cancer cells, leading to unprecedented long-term remission rates compared to traditional treatments. For instance, in October 2023, eXmoor Pharma, a comprehensive partner in cell and gene therapy (CGT) manufacturing, has inaugurated its latest Good Manufacturing Practice (GMP) facility, the Cell and Gene Therapy Centre. This facility is dedicated to supporting the production of various therapies for clinical trials.
By therapy type, cell therapy manufacturing was the highest revenue-grossing segment in the global cell and gene therapy manufacturing market in 2023 owing to the marketplace is witnessing a rise in the number of products being introduced, increase in ongoing clinical trials concentrating on CAR-T cell therapies and other cell-based treatments, and surge in investment by key players in the market. For instance, in October 2023, Bayer AG inaugurated a new facility for cell therapy production in Berkeley, California, USA, aiming to deliver cell therapies to patients worldwide. This investment of USD 250 million will facilitate the manufacturing of materials necessary for clinical trials and potential commercial release of BlueRock Therapeutics' bemdaneprocel (BRT-DA01), an experimental cell therapy being assessed for Parkinson's Disease treatment. Additionally, gene therapy is predicted to grow at the fastest CAGR during the forecast period owing to numerous products are presently undergoing clinical trials, with increasing clinical achievements observed across several. Many gene therapy companies are directing their efforts towards manufacturing and commercialization, alongside a notable increase in diverse strategic initiatives undertaken by companies to enhance their footprint in the gene therapy manufacturing sector.
By scale, pre-commercial/R&D scale manufacturing was the highest revenue-grossing segment in the global cell and gene therapy manufacturing market in 2023 owing to the expanding portfolio of gene and cell therapies, surge in investments and growing array of strategic initiatives undertaken by market participants. Additionally, commercial-scale manufacturing is predicted to grow at the fastest CAGR during the forecast period owing to the surge in number of regulatory approvals for gene & cell therapy products, driving up demand for their commercial production, and increase in the introduction of new services. For instance, in February 2022, Thermo Fisher Scientific has introduced the Patheon Commercial Packaging Services specifically tailored for cell and gene therapy, now available in the U.S. and Europe. This comprehensive offering integrates logistics, serialization compliance, and worldwide distribution.
By mode, contract manufacturing was the highest revenue-grossing segment in the global cell and gene therapy manufacturing market in 2023 owing to the increasing need for cell and gene therapies, coupled with a limited manufacturing capacity, and rise in the development of innovative therapies. For instance, in August 2023, NKGen Biotech has initiated the administration of SNK02, an allogeneic NK cell therapy, to the initial participant in a Phase I clinical trial targeting the treatment of solid tumors. Additionally, in-house manufacturing is predicted to grow at the fastest CAGR during the forecast period. Academic institutions offering personalized patient treatment programs, along with numerous entities possessing significant capital advantages over contract manufacturing, are fostering strategic partnerships with contract manufacturers. This trend is further fueled by increasing investments from prominent market players.
By workflow, process development was the highest revenue-grossing segment in the global cell and gene therapy manufacturing market in 2023 owing to the transition of numerous therapies from clinical trials to regulatory approval is on the rise, facilitated by the establishment of reliable and comprehensive methods for cell therapy production, and increase in collaborations among key market players. Process development strategies enhance efficiency while enhancing the quality and safety of candidate programs. These strategies encompass various aspects such as cell characterization, isolation, optimizing cell culture media, eliminating impurities, and scaling up production. For instance, in February 2024, Thermo Fisher Scientific has partnered with Multiply Labs to automate its instrument systems for cell therapy manufacturing. This collaboration aims to bolster large-scale production capabilities, lower manufacturing costs, and expedite the production timelines for cell therapies. Additionally, vector development is predicted to grow at the fastest CAGR during the forecast period owing to the manufacturing services have seen widespread adoption, driven by the expanding market for gene therapies. There's a rising demand for viral vectors, which have been utilized in treating a spectrum of disorders including metabolic, cardiovascular, muscular, infectious, hematologic, ophthalmologic, and cancer-related conditions. Among the commonly employed viral vectors are adenoviral, retroviral, AAV, lentiviral, and herpes simplex virus.
North America region is anticipated for the highest revenue share during the forecast period owing to the increase in the involvement of organizations in gene & cell therapy research & product development, a significant presence of contract development organizations, expanding manufacturing facilities by domestic companies, and rise in collaborations among industry leaders. For instance, in June 2023, Quell Therapeutics has formed a licensing agreement with AstraZeneca to collaborate on the development, manufacturing, and commercialization of engineered Treg cell therapies targeting autoimmune disorders. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the introduction of expedited approval pathways, escalating healthcare demands, heightened investments from both private & governmental sectors, and increasing emphasis on expansion efforts among various companies. For instance, in February 2024, Miltenyi Biotec, a German company specializing in products and services for biomedical research and advanced cellular therapy, has announced the commencement of its operations in India, marking the establishment of its first office in the country. Additionally, the company plans to establish a Center of Excellence (CoE).
This comprehensive research report focuses on the global and regional market size and forecasts from 2023 to 2034.
Report Scope:
- Base Year: 2023
- Forecast Period: 2024-2034
- Study Coverage
- Market Forecast by Therapy Type, Scale, Mode, and Workflow
- Market Forecast for 5 Regions and 17+ Countries
- North America (U.S. and Canada)
- Europe (Germany, France, UK, Spain, Italy, Russia, Rest of Europe)
- Asia Pacific (China, Japan, India, Australia, South Korea, Rest of APAC)
- Latin America (Brazil, Mexico, Argentina, Rest of LATAM)
- MEA (South Africa, GCC, Rest of MEA)
- Exhaustive Company Profiles of Top 10+ Major Market Players
Segmentation: Cell And Gene Therapy Manufacturing Market Report 2023 - 2034
Cell And Gene Therapy Manufacturing Market Analysis & Forecast by Therapy Type 2023 - 2034 (Revenue USD Bn)
- Gene Therapy Manufacturing
- Cell Therapy Manufacturing
- Non-Stem Cell Therapy
- Stem Cell Therapy
Cell And Gene Therapy Manufacturing Market Analysis & Forecast by Scale 2023 - 2034 (Revenue USD Bn)
- Commercial Scale Manufacturing
- Pre-Commercial/ R&D Scale Manufacturing
Cell And Gene Therapy Manufacturing Market Analysis & Forecast by Mode 2023 - 2034 (Revenue USD Bn)
- Contract Manufacturing
- In-House Manufacturing
Cell And Gene Therapy Manufacturing Market Analysis & Forecast by Workflow 2023 - 2034 (Revenue USD Bn)
- Analytical And Quality Testing
- Fill & Finish Operations
- Process Development
- Raw Material Testing
- Vector Production
- Cell Processing
- Cell Banking
- Others
Cell And Gene Therapy Manufacturing Market Analysis & Forecast by Region 2023 - 2034 (Revenue USD Bn)
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- UK
- Spain
- Italy
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of APAC
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of LATAM
- Middle East & Africa
- South Africa
- GCC
- Rest of MEA
Table of Contents
1. Research Methodology
2. Introduction
4. Market Environment Analysis
5. Market Dynamics
7. Cell And Gene Therapy Manufacturing Market: Therapy Type Estimates & Trend Analysis
8. Cell And Gene Therapy Manufacturing Market: Scale Estimates & Trend Analysis
9. Cell And Gene Therapy Manufacturing Market: Mode Estimates & Trend Analysis
10. Cell And Gene Therapy Manufacturing Market: Workflow Estimates & Trend Analysis
11. Regional Market Analysis
12. North America Cell And Gene Therapy Manufacturing Market
13. Europe Global Cell And Gene Therapy Manufacturing Market
14. Asia Pacific Global Cell And Gene Therapy Manufacturing Market
15. Latin America Global Cell And Gene Therapy Manufacturing Market
16. MEA Global Cell And Gene Therapy Manufacturing Market
17. Competitor Analysis
18. Company Profiles
Companies Mentioned
- F. Hoffmann-La Roche Ltd.
- Hitachi Chemical Co. Ltd.
- Thermo Fisher Scientific
- F. Hoffmann-La Roche Ltd
- Wuxi Advanced Therapies
- Samsung Biologics
- Cellular Therapeutics
- Boehringer Ingelheim
- Bluebird Bio Inc.
- Bluebird Bio Inc.
- Miltenyi Biotec
- Takara Bio Inc.
- Catalent Inc.
- Merck KGaA
- Novartis AG
- Lonza
