U.S. Cell And Gene Therapy Manufacturing Market (2024 - 2030) Size, Share & Trends Analysis Report By Therapy Type (Cell Therapy Manufacturing, Gene therapy manufacturing), By Scale, By Mode, By Workflow, And Segment Forecasts

Table of Contents

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 GVR’s 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, 2018 - 2030 (USD Million)
                      5.2.2 Stem Cell Therapy
                      5.2.3 Cell Therapy Manufacturing Market Estimates And Forecast For Stem Cell Therapy, 2018 - 2030 (USD Million)
                      5.2.4 Non-Stem Cell Therapy
                      5.2.5 Cell Therapy Manufacturing Market Estimates And Forecast For Non-Stem Cell Therapy, 2018 - 2030 (USD Million)
                  5.3 Gene Therapy Manufacturing
                      5.3.1 Gene Therapy Manufacturing Market Estimates And Forecast, 2018 - 2030 (USD Million)
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, 2018 - 2030 (USD Million)
                  6.3 Commercial-Scale Manufacturing
                      6.3.1 U.S. Cell and gene therapy manufacturing Market Estimates And Forecast For Commercial-Scale Manufacturing, 2018 - 2030 (USD Million)
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, 2018 - 2030 (USD Million)
                  7.3 In-House Manufacturing
                      7.3.1 U.S. Cell and gene therapy manufacturing Market For In-House Manufacturing, 2018 - 2030 (USD Million)
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, 2018 - 2030 (USD Million)
                  8.3 Cell Banking
                      8.3.1 U.S. Cell and gene therapy manufacturing Market For Cell Banking, 2018 - 2030 (USD Million)
                  8.4 Process Development
                      8.4.1 U.S. Cell and gene therapy manufacturing Market For Process Development, 2018 - 2030 (USD Million)
                  8.5 Fill And Finish Operations
                      8.5.1 U.S. Cell and gene therapy manufacturing Market For Fill And Finish Operations, 2018 - 2030 (USD Million)
                  8.6 Analytical And Quality Testing
                      8.6.1 U.S. Cell and gene therapy manufacturing Market For Analytical And Quality Testing, 2018 - 2030 (USD Million)
                  8.7 Raw Material Testing
                      8.7.1 U.S. Cell and gene therapy manufacturing Market For Raw Material Testing, 2018 - 2030 (USD Million)
                  8.8 Vector Production
                      8.8.1 U.S. Cell and gene therapy manufacturing Market For Vector Production, 2018 - 2030 (USD Million)
                  8.9 Others
                      8.9.1 U.S. Cell and gene therapy manufacturing Market For Others, 2018 - 2030 (USD Million)
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

List of Tables

Table 1 List of secondary sources
Table 2 CMO Investments in API Biologics - Cell, Gene, Vaccine, and Virus, April - July 2020
Table 3 FDA approved Cellular and Gene Therapy Products as of July 2020
Table 4 Cell and Gene Therapy Products approved in the European Union
Table 5 Summary of risk factors associated with COVID-19 transmission in cell and gene therapy manufacturing
Table 6 Impact Analysis
Table 7 List of cell therapy manufacturers:
Table 8 List of potential end-users
Table 9 List of emerging players
Table 10 List of market differentiators
Table 11 Competitive dashboard analysis
Table 12 Top cell therapy companies of 2023
Table 13 Testing methods
Table 14 Best Practices for the effective control of raw material
Table 15 U.S. cell & gene therapy manufacturing market, by therapy type, 2018 - 2030 (USD Million) (Volume, Number of Doses)
Table 16 U.S. cell therapy manufacturing market, by cell type, 2018 - 2030 (USD Million)
Table 17 U.S. cell & gene therapy manufacturing market, by scale, 2018 - 2030 (USD Million)
Table 18 U.S. cell & gene therapy manufacturing market, by mode, 2018 - 2030 (USD Million) (Volume, Number of Doses)
Table 19 U.S. cell & gene therapy manufacturing market, by workflow, 2018 - 2030 (USD Million)

List of Figures

Fig. 1 Market research process
Fig. 2 Data triangulation techniques
Fig. 3 Primary research pattern
Fig. 4 Market research approaches
Fig. 5 Value-chain-based sizing & forecasting
Fig. 6 QFD modeling for market share assessment
Fig. 7 Market formulation & validation
Fig. 8 Medicines in development, by disease
Fig. 9 Classification of companies
Fig. 10 U.S. Cell and gene therapy manufacturing market snapshot, 2023 (USD Million)
Fig. 11 Cell & gene therapy manufacturing market segmentation
Fig. 12 Market dynamics
Fig. 13 Market driver relevance analysis (Current & future impact)
Fig. 14 Most common therapeutic areas targeted by cell therapies in development
Fig. 15 Gene therapy clinical trials number as of 2021
Fig. 16 Regenerative medicine clinical trials
Fig. 17 Expedited approval pathway designations by technology
Fig. 18 Market restraint relevance analysis (Current & future impact)
Fig. 19 Cell and gene therapy market SWOT analysis
Fig. 20 Cell and gene therapy market Porter’s five forces analysis
Fig. 21 Cell therapy manufacturing collaborations from 2014 to 2018
Fig. 22 Areas of disruption due to COVID-19 reported by respondents
Fig. 23 Breakdown of CoGs per process for cell therapy manufacture
Fig. 24 Comparison of costs estimated by campaign, day rate, and hybrid models
Fig. 25 Campaign model for cell and gene therapies production
Fig. 26 Day rate model for cell and gene production
Fig. 27 Hybrid model for cell and gene therapies production
Fig. 28 The proportion of funds allocation in anti-EBV CTLs and PSCs
Fig. 29 Impact Analysis
Fig. 30 Cell and gene therapy market: Therapy type outlook and key takeaways
Fig. 31 Cell and gene therapy market: therapy type movement analysis
Fig. 32 Cell therapy manufacturing market estimates and forecast, 2018 - 2030 (USD Million) (Volume, Number of Doses)
Fig. 33 Cell therapy manufacturing market estimates and forecast for stem cell therapy, 2018 - 2030 (USD Million) (Volume, Number of Doses)
Fig. 34 Cell therapy manufacturing market estimates and forecast for non-stem cell therapy, 2018 - 2030 (USD Million) (Volume, Number of Doses)
Fig. 35 Gene therapy manufacturing market estimates and forecast, 2018 - 2030 (USD Million) (Volume, Number of Doses)
Fig. 36 U.S. Cell and gene therapy manufacturing market: Scale outlook and key takeaways
Fig. 37 U.S. Cell and gene therapy manufacturing market: Scale movement analysis
Fig. 38 Number of cell therapy clinical trials, by phase, 2020
Fig. 39 Number of CAR-T cell therapy clinical trials, by phase, as of September 2019
Fig. 40 U.S. Cell and gene therapy manufacturing market estimates and forecast for precommercial-scale manufacturing, 2018 - 2030 (USD Million)
Fig. 41 U.S. Cell and gene therapy manufacturing market estimates and forecast for commercial-scale manufacturing, 2018 - 2030 (USD Million)
Fig. 42 U.S. Cell and gene therapy manufacturing market: Mode outlook and key takeaways
Fig. 43 U.S. Cell and gene therapy manufacturing market: Mode movement analysis
Fig. 44 U.S. Cell and gene therapy manufacturing market for contract manufacturing, 2018 - 2030 (USD Million) (Volume, Number of Doses)
Fig. 45 U.S. Cell and gene therapy manufacturing market for in-house manufacturing, 2018 - 2030 (USD Million) (Volume, Number of Doses)
Fig. 46 U.S. Cell and gene therapy manufacturing market: Workflow outlook and key takeaways
Fig. 47 U.S. Cell and gene therapy manufacturing market: Workflow outlook and key takeaways
Fig. 48 U.S. Cell and gene therapy manufacturing market: Workflow movement analysis
Fig. 49 U.S. Cell and gene therapy manufacturing market for cell processing, 2018 - 2030 (USD Million)
Fig. 50 U.S. Cell and gene therapy manufacturing market for cell banking, 2018 - 2030 (USD Million)
Fig. 51 U.S. Cell and gene therapy manufacturing market for process development, 2018 - 2030 (USD Million)
Fig. 52 U.S. Cell and gene therapy manufacturing market for fill and finish operations, 2018 - 2030 (USD Million)
Fig. 53 U.S. Cell and gene therapy manufacturing market for analytical and quality testing, 2018 - 2030 (USD Million)
Fig. 54 U.S. Cell and gene therapy manufacturing market for raw material testing, 2018 - 2030 (USD Million)
Fig. 55 Gene therapy manufacturing facilities: Trends & types
Fig. 56 Gene therapy clinical trials
Fig. 57 Viral vectors used in clinical trials
Fig. 58 U.S. Cell and gene therapy manufacturing market for vector production, 2018 - 2030 (USD Million)
Fig. 59 U.S. Cell and gene therapy manufacturing market for others, 2018 - 2030 (USD Million)
Fig. 60 Strategy framework
Fig. 61 Market participation categorization