According to nova one advisor to the U.S. cell and gene therapy manufacturing market size was valued at USD 4.10 billion in 2023 and is projected to reach USD 45.46 billion by 2033, growing at a CAGR of 27.2% from 2024 to 2033.
According to nova one advisor to the U.S. cell and gene therapy manufacturing market size was valued at USD 4.10 billion in 2023 and is projected to reach USD 45.46 billion by 2033, growing at a CAGR of 27.2% from 2024 to 2033.
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Advanced therapies have significantly impacted the treatment of numerous rare and life-threatening diseases and revolutionized the biopharmaceutical sector. The accelerated development of the advanced therapy industry is a crucial driving force for the market’s growth. The market is witnessing substantial growth owing to key market players, including CDMOs offering GMP manufacturing services and adopting highly innovative manufacturing technologies for production. Major players are undertaking various strategic initiatives to boost their market presence, leading to market growth in the country. For instance, in January 2021, Fujifilm invested USD 40 million to develop a new manufacturing facility for viral vectors and innovative therapy products.
The National Cell Manufacturing Consortium (NCMC) has been established through collaboration between 15 academic institutes, more than 25 companies, and government agencies to enable cost-effective, large-scale manufacturing of cell therapies. This consortium is focused on developing, maturing, and implementing innovative technologies for cell therapy manufacturing. With the presence of a high number of contract manufacturers and research organizations, the market space is highly competitive. In addition, the entry of new players and facility expansion by existing players has intensified the competition in the U.S. market.
In 2023, the U.S. cell & gene therapy manufacturing market accounted for a revenue share of over 38% in the global cell & gene therapy manufacturing market. This market’s Major players include Thermo Fisher Scientific, Inc.; Fujifilm Diosynth Biotechnologies; Lonza; Merck; and Catalent, Inc. These companies undertake various strategies to strengthen their market presence. For instance, in March 2022, FUJIFILM Corporation announced the acquisition of Shenandoah Biotechnology, Inc. to strengthen its presence in cell culture solutions for cell & gene therapy manufacturing. Thus, such initiatives undertaken by key players are anticipated to impact market growth in the upcoming years positively.
What are the Importance of U.S. Cell And Gene Therapy Manufacturing Market?
Revolutionizing Medicine: Cell and gene therapies represent cutting-edge medical advancements, offering potential cures or treatments for previously incurable diseases. Manufacturing facilities in the U.S. are at the forefront of this revolution, driving innovation and progress in healthcare.
Economic Growth: The cell and gene therapy manufacturing sector contributes to economic growth by creating jobs, attracting investment, and fostering the growth of related industries such as biotechnology, pharmaceuticals, and medical devices. This sector’s expansion boosts the overall economy and enhances competitiveness on a global scale.
Improving Healthcare Access: By establishing robust manufacturing capabilities within the U.S., the accessibility of cell and gene therapies can be improved for patients nationwide. Local manufacturing reduces logistical challenges associated with transporting sensitive biological materials and ensures timely access to treatments.
Regulatory Leadership: The U.S. has established itself as a leader in regulatory frameworks for cell and gene therapies, ensuring safety, efficacy, and quality standards. Strong manufacturing capabilities within the country facilitate compliance with these regulations, fostering trust among patients, healthcare providers, and regulatory agencies.
Research and Development Hub: Investment in cell and gene therapy manufacturing facilities fosters a collaborative environment that attracts top talent and encourages research and development initiatives. This concentration of expertise accelerates scientific discoveries and facilitates the translation of research findings into tangible therapies.
Global Leadership: A robust cell and gene therapy manufacturing market in the U.S. enhances the country’s position as a global leader in biotechnology and healthcare innovation. It strengthens international collaborations, attracts foreign investment, and enables the export of high-value therapeutic products to global markets.
Overall, the importance of the U.S. cell and gene therapy manufacturing market lies in its ability to drive medical progress, stimulate economic growth, improve healthcare access, uphold regulatory standards, foster innovation, and solidify the country’s position as a leader in the global biotechnology landscape.
Key Takeaways:
- The cell therapy manufacturing segment dominated the market with a revenue share of 56.12% in 2023.
- The gene therapy segment is expected to grow significantly during the forecast period.
- Pre-commercial/ R&D scale manufacturing captured a significant revenue share of 72.4% in 2023.
- Commercial scale manufacturing segment is projected to garner the fastest CAGR during the forecast period.
- The contract manufacturing segment held the highest revenue share of 65.11% in 2023.
- The in-house manufacturing segment is projected to exhibit the fastest CAGR during the forecast period.
- The process development segment had a significant revenue share of 16.9% in 2023.
- The vector production segment is estimated to register the fastest CAGR during the forecast period.
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Segments Insights:
Therapy Type Insights
The cell therapy manufacturing segment dominated the market with a revenue share of 56.12% in 2023. With the growing number of ongoing clinical trials and products entering the market, cell therapy is gradually gaining importance in immuno-oncology. Only a few CAR T-cell therapies have been approved by the U.S. FDA. Over 250+ clinical trials studying CAR T-cell and other cell therapies indicate that potential indications are broadening to include solid & liquid tumours. Thus, the demand for advanced cell manufacturing services will increase in the coming years. As many cell therapy products are allogeneic and expected to have large market sizes, there is a growing need for commercial-scale production.
The gene therapy segment is expected to grow significantly during the forecast period. With many products in clinical trials, production process improvement is a major need for the gene therapy manufacturing sector. With increased investments from players and the clinical success of more products, several gene therapy companies are focusing on manufacturing & commercialization. Evaluating the existing process & its scalability and deciding on in-house or outsourced manufacturing are some of the major factors to be considered while designing the manufacturing process for gene therapy products.
Scale Insights
Pre-commercial/ R&D scale manufacturing captured a significant revenue share of 72.4% in 2023. The rapidly changing market environment for cell and gene therapies is the main contributing factor for innovation in R&D about gene & cell therapy. The pre-commercial manufacturing segment is anticipated to grow as the market witnesses more positive data from ongoing clinical trials. More than 400 companies in North America were actively developing cell and gene therapy products for various diseases.
Commercial scale manufacturing segment is projected to garner the fastest CAGR during the forecast period. Large biopharmaceutical companies, such as Bristol-Myers Squibb (BMS), Novartis AG, and Merck KGaA, are investing significant money in cell & gene therapy programs and manufacturing facilities. These companies have capabilities, resources, and skilled professionals, enabling quicker entry into clinical trials and shorter time to market. Such companies are expected to propel the market for commercial-scale manufacturing by the increasing number of products entering the market.
Mode Insights
The contract manufacturing segment held the highest revenue share of 65.11% in 2023. With the increasing demand for cell & gene therapies, the challenges with adequate manufacturing capacity have created opportunities for contract manufacturing service providers. With the rapid transformation in the industry, outsourcing services is projected to deliver a competitive edge to market participants in terms of expertise and experience.
The in-house manufacturing segment is projected to exhibit the fastest CAGR during the forecast period. Building a small in-house manufacturing facility can be a suitable option for gene therapy companies having difficulty finding contract manufacturing service partners or securing production time slots in the required time frame. However, the capital associated with building a manufacturing facility for a single cell or gene therapy product can be challenging for emerging & small pharmaceutical or biotechnology firms.
Workflow Insights
The process development segment had a significant revenue share of 16.9% in 2023. The surge in therapies transiting from clinical trials to receiving regulatory approvals is significantly driving the segment growth. The development of robust and organized methods for cell therapy production has become crucial. Process development strategies deliver efficiency while enhancing candidate programs’ safety and quality profiles.
The vector production segment is estimated to register the fastest CAGR during the forecast period. Viral vectors are being increasingly adopted for treating multiple health conditions, including metabolic, muscular, infectious, cardiovascular, hematologic, and ophthalmologic, as well as various types of cancer. The most widely deployed viral vectors are adenoviral, lentiviral, AAV, retroviral, and herpes simplex virus. Viral vectors are manufactured using different cell lines with unique growth and transfection characteristics.
Recent Developments
- In April 2022, Novartis expanded its manufacturing capacity for its gene therapy product Zolgensma. The company has been granted commercial licensure approval by the U.S. FDA multi-product gene therapy manufacturing facility in Durham, NC. This marked the second manufacturing facility for the company.
- In February 2022, Thermo Fisher Scientific, Inc. launched a new service for cell and gene therapy manufacturing, named Patheon Commercial Packaging Services. The service offers end-to-end solutions for cryogenic packaging and global distribution, accelerating the commercial launch of therapies in the U.S. & Europe. The initiative strengthened the company’s offerings in this domain.
- In January 2022, Thermo Fisher announced the acquisition PeproTech, a key manufacturer of recombinant proteins including cytokines. The deal value was worth over USD 1.85 billion.
Cell & Gene Therapy Research and Manufacturing Solutions
The global cell and gene therapy manufacturing market size was estimated at USD 9.95 billion in 2023 and is projected to hit around USD 106.03 billion by 2033, growing at a CAGR of 26.7% during the forecast period from 2024 to 2033.
Cell and gene therapies are set to become the new standard of healthcare, but nevertheless remain variable, complex, and difficult to manufacture with consistency.
As an industry, we are building collective knowledge and experience that will help to accelerate development, approval, and delivery of therapies, but we still have some bottlenecks to solve while attempting to bring cost of goods down:
- What’s the best way to minimize variability in your process?
- Can you seamlessly transition from RUO to GMP?
- How can you scale-up manufacturing from bench-top to clinic to large-scale?
To overcome these challenges and set yourself up for regulatory approval, you need high-quality raw materials, cutting-edge manufacturing solutions, and precision analytics that empower you to accelerate development and standardize processes.
Immune Cell Therapy
Demonstrating comparability and reproducibility is essential for the advancement of your immune cell therapy. Understanding your therapy’s mechanism of action and quantifying CQAs are complex and can be the source of costly clinical and regulatory setbacks.
Our high-quality, GMP-grade raw materials coupled with precision analytics technology enable you to provide robust, reliable data to determine proof of concept, ensure regulatory approval and accelerate time to patient.
These scalable, flexible solutions can help you adapt to an ever-changing regulatory landscape. We’re also here to help to embed flexibility into your process, so that you can easily adapt your process to meet changing requirements.
These scalable, flexible solutions enable you to seamless move from the lab to the clinic and adapt to an ever-changing regulatory landscape:
- Animal-free RUO and GMP proteins
- Non-viral gene delivery systems
- Immune cell culture solutions
- Automated analytical instruments
Regenerative Medicine
Minimizing variability is the keystone to success when developing regenerative therapies. With consistent, scalable solutions coupled with a reliable supply of high-quality raw materials, we can help you to forge a pathway towards safe, life-changing therapies.
We recognize the challenges you face to scale-up production - that’s why all our regenerative medicine solutions are made with scalability at their core.
We provide tailored solutions to help you throughout the regenerative medicine development workflow, including:
- Animal-free RUO and GMP proteins
- Non-viral gene delivery systems
- Stem cell and organoid culture solutions
- RUO and GMP small molecules
- Spatial biology platforms
- Automated analytical instruments
Gene Therapy
Achieving safe and effective transgene delivery is among the greatest challenges faced by gene therapy developers. The inherent complexity of viral vectors makes them difficult to characterize with consistency throughout development and manufacturing stages.
That’s why we provide precision analytical tools for critical quality attribute analysis to ensure safe, high quality, consistent, and efficacious therapies.
These customizable, flexible, and fast assay and analytics systems provide the high-specificity, automation, and reliable results you need throughout the gene therapy development workflow:
- Spatial biology platforms for in vivo monitoring
- Automated vector analysis and characterization solutions
- Immunoassays
Some of the prominent players in the U.S. Cell And Gene Therapy Manufacturing Market include:
- Lonza
- Bluebird Bio Inc.
- Catalent Inc.
- F. Hoffmann-La Roche Ltd
- Samsung Biologics
- Boehringer Ingelheim
- Cellular Therapeutics
- Hitachi Chemical Co., Ltd.
- Takara Bio Inc.
- Miltenyi Biotec
- Thermo Fisher Scientific
- Novartis AG
- Merck KGaA
- Wuxi Advanced Therapies
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. Cell And Gene Therapy Manufacturing market.
By Therapy Type
- Cell therapy manufacturing
- Stem cell therapy
- Non-stem cell therapy
- Gene therapy manufacturing
By Scale
- Pre-commercial/ R&D scale manufacturing
- Commercial scale manufacturing
By Mode
- Contract manufacturing
- In-house manufacturing
By Workflow
- Cell processing
- Cell banking
- Process development
- Fill & finish operations
- Analytical and quality testing
- Raw material testing
- Vector production
- Others
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