U.S. Cell And Gene Therapy Manufacturing Market Size Report by 2033
The U.S. cell and gene therapy manufacturing market size was estimated at USD 4.10 billion in 2023 and is expected to surpass around USD 45.46 billion by 2033 and poised to grow at a compound annual growth rate (CAGR) of 27.2% during the forecast period 2024 to 2033.
Key Takeaways:
U.S. Cell And Gene Therapy Manufacturing Market Growth
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
U.S. Cell And Gene Therapy Manufacturing Market Report Scope
| Report Attribute | Details |
| Market Size in 2024 | USD 5.22 Billion |
| Market Size by 2033 | USD 45.46 Billion |
| Growth Rate From 2024 to 2033 | CAGR of 27.2% |
| Base Year | 2023 |
| Forecast Period | 2024 to 2033 |
| Segments Covered | Therapy type, scale, mode, workflow |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Key Companies Profiled | Lonza; Bluebird Bio; Catalent Inc.; F. Hoffmann-La Roche Ltd.; Samsung Biologics; Boehringer Ingelheim; Cellular Therapeutics; Hitachi Chemical Co., Ltd.; Bluebird Bio Inc.; Takara Bio Inc.; Miltenyi Biotec; Thermo Fisher Scientific; F. Hoffmann-La Roche Ltd; Novartis AG; Merck KGaA; Wuxi Advanced Therapies |
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
Some of the prominent players in the U.S. Cell And Gene Therapy Manufacturing Market include:
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
By Scale
By Mode
By Workflow
Chapter 1 U.S. Cell and gene therapy manufacturing Market: Methodology And Scope
1.1 Research Methodology
1.2 Research Assumptions
1.2.1 Estimates And Forecast Timeline
1.3 Research Methodology
1.4 Information Procurement
1.4.1 Purchased Database
1.4.2 nova one advisor Internal Database
1.4.3 Secondary Sources
1.4.4 Primary Research
1.4.5 Details Of Primary Research
1.5 Information Or Data Analysis
1.5.1 Data Analysis Models
1.6 Market Formulation & Validation
1.7 Model Details
1.7.1 Commodity Flow Analysis
1.7.1.1 Approach 1: Commodity Flow Approach
1.8 Market: CAGR Calculation
1.9 List of Secondary Sources
1.10 Objectives
Chapter 2 U.S. Cell and gene therapy manufacturing Market: Executive Summary
2.1 Competition Milieu
2.2 Segment Outlook
2.3 Market Summary, 2023 (USD Million)
Chapter 3 U.S. Cell and gene therapy manufacturing Market: Variables, Trends, & Scope
3.1 Market Segmentation
3.2 Parent Market Lineage
3.3 Ancillary Market Lineage
3.4 Penetration and Growth Prospect Mapping for Therapy Type, 2023
3.5 Market Dynamics
3.5.1 Market Drivers Analysis
3.5.1.1 Growing Pipeline Of Cell And Gene Therapy
3.5.1.2 Supportive Regulatory Bodies
3.5.1.3 Increase In Investment By Government And Private Players
3.5.2 Market Restraint Analysis
3.5.2.1 Technological Challenges Associated With Manufacturing
3.5.2.2 High Cost Of Manufacturing
3.5.3 Market Opportunity Analysis
3.5.3.1 Rising Pressure On Drug Developers/Manufacturers To Meet The Growing Market Demand
3.5.3.2 Expansion In Potential Markets Such As Asia Pacific And Latin America
3.5.4 Market Challenge Analysis
3.5.4.1 Lack Of Manufacturing Capacity
3.6 Swot Analysis; By Factor (Political & Legal, Economic, And Technological)
3.7 Porter’s Five Forces Analysis
3.8 Major Deals And Strategic Alliances Analysis
3.8.1 Mergers And Acquisitions
3.8.2 Technological Collaborations
3.8.3 Licensing And Partnerships
3.9 Covid-19 Impact Analysis
3.9.1 Challenge Analysis
3.9.2 Opportunity Analysis
3.9.3 Key Developments And Activities
Chapter 4 Focus On Manufacturers
4.1 Cell And Gene Therapy Manufacturing
4.1.1 Facility Expansion For Cell And Gene Therapies
4.1.2 Major Deals And Strategic Alliances Analysis
4.1.3 Mergers And Acquisitions
4.1.4 Technological Collaborations And Partnerships
4.1.5 Product Approvals And Launch
4.2 Cost Of Goods Analysis In Cell And Gene Therapy Manufacturing
4.2.1 Overall Cost Of Goods Analysis
4.2.2 Raw Material
4.2.3 Labor Costs
4.2.4 Process Costs
4.2.5 Cost Models
4.2.6 Campaign Model
4.2.7 Day Rate Model
4.2.8 Hybrid Model
4.2.9 Cost Of Goods Analysis, By Technique
4.2.10 Materials
4.2.11 Equipment
4.2.12 Personnel
4.2.13 Facility
Chapter 5 Therapy Type Business Analysis
5.1 U.S. Cell and gene therapy manufacturing Market: Therapy Type Movement Analysis
5.2 Cell Therapy Manufacturing
5.2.1 Cell Therapy Manufacturing Market Estimates And Forecast, 2020 - 2033
5.2.2 Stem Cell Therapy
5.2.3 Cell Therapy Manufacturing Market Estimates And Forecast For Stem Cell Therapy, 2020 - 2033
5.2.4 Non-Stem Cell Therapy
5.2.5 Cell Therapy Manufacturing Market Estimates And Forecast For Non-Stem Cell Therapy, 2020 - 2033
5.3 Gene Therapy Manufacturing
5.3.1 Gene Therapy Manufacturing Market Estimates And Forecast, 2020 - 2033
Chapter 6 Manufacturing Scale Business Analysis
6.1 U.S. Cell and gene therapy manufacturing Market: Scale Movement Analysis
6.2 Precommercial/R&D Scale Manufacturing
6.2.1 U.S. Cell and gene therapy manufacturing Market Estimates And Forecast For Precommercial/R&D Scale Manufacturing, 2020 - 2033
6.3 Commercial-Scale Manufacturing
6.3.1 U.S. Cell and gene therapy manufacturing Market Estimates And Forecast For Commercial-Scale Manufacturing, 2020 - 2033
Chapter 7 Mode Business Analysis
7.1 U.S. Cell and gene therapy manufacturing Market: Mode Movement Analysis
7.2 Contract Manufacturing
7.2.1 U.S. Cell and gene therapy manufacturing Market For Contract Manufacturing, 2020 - 2033
7.3 In-House Manufacturing
7.3.1 U.S. Cell and gene therapy manufacturing Market For In-House Manufacturing, 2020 - 2033
Chapter 8 Workflow Business Analysis
8.1 U.S. Cell and gene therapy manufacturing Market: Workflow Movement Analysis
8.2 Cell Processing
8.2.1 U.S. Cell and gene therapy manufacturing Market For Cell Processing, 2020 - 2033
8.3 Cell Banking
8.3.1 U.S. Cell and gene therapy manufacturing Market For Cell Banking, 2020 - 2033
8.4 Process Development
8.4.1 U.S. Cell and gene therapy manufacturing Market For Process Development, 2020 - 2033
8.5 Fill And Finish Operations
8.5.1 U.S. Cell and gene therapy manufacturing Market For Fill And Finish Operations, 2020 - 2033
8.6 Analytical And Quality Testing
8.6.1 U.S. Cell and gene therapy manufacturing Market For Analytical And Quality Testing, 2020 - 2033
8.7 Raw Material Testing
8.7.1 U.S. Cell and gene therapy manufacturing Market For Raw Material Testing, 2020 - 2033
8.8 Vector Production
8.8.1 U.S. Cell and gene therapy manufacturing Market For Vector Production, 2020 - 2033
8.9 Others
8.9.1 U.S. Cell and gene therapy manufacturing Market For Others, 2020 - 2033
Chapter 9 Competitive Landscape
9.1 Strategy Framework
9.2 Market Participation Categorization
9.3 Company Profiles
9.3.1 Thermo Fisher Scientific, Inc.
9.3.1.1 Company Overview
9.3.1.2 Financial Performance
9.3.1.3 Product Benchmarking
9.3.1.4 Strategic Initiatives
9.3.2 Merck Kgaa
9.3.2.1 Company Overview
9.3.2.1.1 Milliporesigma
9.3.2.2 Financial Performance
9.3.2.3 Product Benchmarking
9.3.2.4 Strategic Initiatives
9.3.3 Lonza
9.3.3.1 Company Overview
9.3.3.2 Financial Performace
9.3.3.3 Product Benchmarking
9.3.3.4 Strategic Initiatives
9.3.4 Catalent, Inc.
9.3.4.1 Company Overview
9.3.4.2 Financial Performance
9.3.4.3 Product Benchmarking
9.3.4.4 Strategic Initiatives
9.3.5 Takara Bio, Inc.
9.3.5.1 Company Overview
9.3.5.2 Financial Performance
9.3.5.3 Product Benchmarking
9.3.5.4 Strategic Initiatives
9.3.6 F. Hoffmann-La Roche Ltd.
9.3.6.1 Company Overview
9.3.6.2 Financial Performance
9.3.6.3 Product Benchmarking
9.3.6.4 Strategic Initiatives
9.3.7 Wuxi Advanced Therapies
9.3.7.1 Company Overview
9.3.7.2 Financial Performance
9.3.7.3 Product Benchmarking
9.3.7.4 Strategic Initiatives
9.3.8 Samsung
9.3.8.1 Company Overview
9.3.8.1.1 Samsung Biologics
9.3.8.2 Company Overview
9.3.8.3 Financial Performance
9.3.8.4 Product Benchmarking
9.3.8.5 Strategic Initiatives
9.3.9 Boehringer Ingelheim International Gmbh
9.3.9.1 Company Overview
9.3.9.2 Financial Performance
9.3.9.3 Product Benchmarking
9.3.9.4 Strategic Initiatives
9.3.10 Novartis Ag
9.3.10.1 Company Overview
9.3.10.2 Financial Performance
9.3.10.3 Product Benchmarking
9.3.10.4 Strategic Initiatives
9.3.11 Hitachi Chemical Co., Ltd. (Showa Denko Materials Co Ltd)
9.3.9.1 Company Overview
9.3.9.1.1 Apceth Biopharma
9.3.9.2 Company Overview
9.3.9.3 Financial Performance
9.3.9.4 Product Benchmarking
9.3.9.5 Strategic Initiatives
9.3.12 Cellular Therapeutics
9.3.12.1 Company Overview
9.3.12.2 Product Benchmarking
9.3.13 Miltenyi Biotech
9.3.13.1 Company Overview
9.3.13.2 Financial Performance
9.3.13.3 Product Benchmarking
9.3.13.4 Strategic Initiatives
9.3.14 Bluebird Bio Inc.
9.3.14.1 Company Overview
9.3.14.2 Financial Performance
9.3.14.3 Product Benchmarking
9.3.14.4 Strategic Initiatives
9.4 Recent Developments And Impact Analysis By Key Market Participants
9.5 Company Mapping
9.6 Vendor Landscape
9.6.1 List Of Key Distributors And Channel Partners
9.6.2 Key Company Market Share Analysis, 2023
9.7 Public Companies
9.7.1 Company Market Position Analysis
9.7.2 Competitive Dashboard Analysis
9.8 Private Companies
9.8.1 List Of Key Emerging Companies
9.8.2 Company Market Position Analysis
Cross-segment Market Size and Analysis for
Mentioned Segments
Additional Company Profiles (Upto 5 With No Cost)
Additional Countries (Apart From Mentioned Countries)
Country/Region-specific Report
Go To Market Strategy
Region Specific Market DynamicsRegion Level Market Share Import Export AnalysisProduction AnalysisOthers