Product Code: GVR-4-68038-289-1
Cell And Gene Therapy Manufacturing Market Growth & Trends:
The global cell and gene therapy manufacturing market size is expected to reach USD 47.1 billion by 2030, according to a new report by Grand View Research, Inc. The market is expected to register a CAGR of 26.6% from 2023 to 2030 owing to the exponential progress of the clinical pipeline, coupled with a rising number of regulatory approvals for advanced therapies, which has majorly driven the growth of the market.
Significant investments by government authorities and key market players are other factors fueling the growth of cell and gene therapy manufacturing. Around USD 2.3 billion was invested in gene therapies by companies over the last decade. Major service providers, including CDMOs/CMOs and in-house manufacturers, consider these therapies as an active area of investment. For instance, in May 2020, Thermo Fisher Scientific also invested USD 180 million to scale up its viral vector manufacturing capacity twofold. These players are investing significant amounts either in building and/or expanding manufacturing capabilities or forming strategic alliances with competitors to boost their market presence. Thus, these factors are anticipated to act as primary driving factors for this market.
The number of cell and gene therapies entering clinical trials and later gaining marketing authorization from regulatory bodies is increasing every year. By the end of 2019, 17 cell and gene therapy products were approved by the U.S. FDA for commercial use. The U.S. FDA is expecting to receive over 200 gene and cell treatment INDs annually from the beginning of 2020. The regulatory body is also planning to approve up to 20 products per year from 2025. Such supportive government initiatives are expected to increase the demand for cell and gene therapy manufacturing services in the near future.
Following an article published in March 2020, in the U.S., the number of cell and gene therapies in the pipeline (phase III trials) was 289 at the beginning of 2019, which reached 362 in early 2020. The number is expected to increase twofold if the preclinical pipeline is considered. This growing number indicates the high demand for manufacturing services for cell and gene therapies. According to a report by America's Biopharmaceutical Companies, gene and cell therapies range from early to late stages of clinical development with a focus on a wide spectrum of diseases, including neurologic conditions, genetic disorders, and cancer.
Cell And Gene Therapy Manufacturing Market Report Highlights:
- The cell therapy manufacturing segment dominated the 2022 market in terms of revenue. A growing number of ongoing clinical trials and increasing research in this space has resulted in the segment dominance
- A high number of candidate molecules in the pre-commercial scale stage has contributed to the largest revenue share for the pre-commercial scale manufacturing market segment in 2022
- With an increasing number of regulatory approvals for gene and cell therapy products, the demand for commercial production of these therapies is increasing rapidly, thereby increasing the share of the commercial-scale manufacturing segment
- The contract manufacturing segment is expected to witness lucrative growth during the forecast period, as a substantial number of biomanufacturers are turning to CMOs for efficient and rapid product development
- Moreover, the constantly growing clinical pipeline is another contributing factor expected to accelerate contract manufacturing segment growth
- North America dominated the global market in terms of revenue owing to advancements in research and development pertaining to gene therapy and the increasing number of investments by the regional governments
- The Asia Pacific region is anticipated to grow at the fastest rate throughout the forecast period
- This can be attributed to the establishment of accelerated approval pathways, growing private and government investments, and increasing healthcare needs
Table of Content
Chapter 1 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
- 1.7.1.2 Approach 2: Country-wise market estimation using bottom-up approach
- 1.8 Market: CAGR Calculation
- 1.9 List of Secondary Sources
- 1.10 Objectives
- 1.10.1 Objective 1
- 1.10.2 Objective 2
Chapter 2 Executive Summary
- 2.1 Competition Milieu
- 2.2 Segment Outlook
- 2.3 Market Summary, 2022 (USD Million)
Chapter 3 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, 2022
- 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 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) (Volume, Number Of Doses)
- 5.2.2 Stem Cell Therapy
- 5.2.3 Cell Therapy Manufacturing Market Estimates And Forecast For Stem Cell Therapy, 2018 - 2030 (USD Million) (Volume, Number Of Doses)
- 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) (Volume, Number Of Doses)
- 5.3 Gene Therapy Manufacturing
- 5.3.1 Gene Therapy Manufacturing Market Estimates And Forecast, 2018 - 2030 (USD Million) (Volume, Number Of Doses)
Chapter 6 Manufacturing Scale Business Analysis
- 6.1 Cell And Gene Therapy Manufacturing Market: Scale Movement Analysis
- 6.2 Precommercial/R&D Scale Manufacturing
- 6.2.1 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 Cell And Gene Therapy Manufacturing Market Estimates And Forecast For Commercial-Scale Manufacturing, 2018 - 2030 (USD Million)
Chapter 7 Mode Business Analysis
- 7.1 Cell And Gene Therapy Manufacturing Market: Mode Movement Analysis
- 7.2 Contract Manufacturing
- 7.2.1 Cell And Gene Therapy Manufacturing Market For Contract Manufacturing, 2018 - 2030 (USD Million) (Volume, Number Of Doses)
- 7.3 In-House Manufacturing
- 7.3.1 Cell And Gene Therapy Manufacturing Market For In-House Manufacturing, 2018 - 2030 (USD Million) (Volume, Number Of Doses)
Chapter 8 Workflow Business Analysis
- 8.1 Cell And Gene Therapy Manufacturing Market: Workflow Movement Analysis
- 8.2 Cell Processing
- 8.2.1 Cell And Gene Therapy Manufacturing Market For Cell Processing, 2018 - 2030 (USD Million)
- 8.3 Cell Banking
- 8.3.1 Cell And Gene Therapy Manufacturing Market For Cell Banking, 2018 - 2030 (USD Million)
- 8.4 Process Development
- 8.4.1 Cell And Gene Therapy Manufacturing Market For Process Development, 2018 - 2030 (USD Million)
- 8.5 Fill And Finish Operations
- 8.5.1 Cell And Gene Therapy Manufacturing Market For Fill And Finish Operations, 2018 - 2030 (USD Million)
- 8.6 Analytical And Quality Testing
- 8.6.1 Cell And Gene Therapy Manufacturing Market For Analytical And Quality Testing, 2018 - 2030 (USD Million)
- 8.7 Raw Material Testing
- 8.7.1 Cell And Gene Therapy Manufacturing Market For Raw Material Testing, 2018 - 2030 (USD Million)
- 8.8 Vector Production
- 8.8.1 Cell And Gene Therapy Manufacturing Market For Vector Production, 2018 - 2030 (USD Million)
- 8.9 Others
- 8.9.1 Cell And Gene Therapy Manufacturing Market For Others, 2018 - 2030 (USD Million)
Chapter 9 Regional Business Analysis
- 9.1 North America
- 9.1.1 Swot Analysis
- 9.1.1.1 North America Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.1.2 U.S.
- 9.1.2.1 Key Country Dynamics
- 9.1.2.2 Target Disease Prevalence
- 9.1.2.3 Competitive Scenario
- 9.1.2.4 Regulatory Framework
- 9.1.2.5 Reimbursement Scenario
- 9.1.2.6 U.S. Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.1.3 Canada
- 9.1.3.1 Key Country Dynamics
- 9.1.3.2 Target Disease Prevalence
- 9.1.3.3 Competitive Scenario
- 9.1.3.4 Regulatory Framework
- 9.1.3.5 Reimbursement Scenario
- 9.1.3.6 Canada Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.2 Europe
- 9.2.1 Swot Analysis
- 9.2.1.1 Europe Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.2.2 Germany
- 9.2.2.1 Key Country Dynamics
- 9.2.2.2 Target Disease Prevalence
- 9.2.2.3 Competitive Scenario
- 9.2.2.4 Regulatory Framework
- 9.2.2.5 Reimbursement Scenario
- 9.2.2.6 Germany Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.2.3 U.K.
- 9.2.3.1 Key Country Dynamics
- 9.2.3.2 Target Disease Prevalence
- 9.2.3.3 Competitive Scenario
- 9.2.3.4 Regulatory Framework
- 9.2.3.5 Reimbursement Scenario
- 9.2.3.6 UK Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.2.4 France
- 9.2.4.1 Key Country Dynamics
- 9.2.4.2 Target Disease Prevalence
- 9.2.4.3 Competitive Scenario
- 9.2.4.4 Regulatory Framework
- 9.2.4.5 Reimbursement Scenario
- 9.2.4.6 France Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.2.5 Italy
- 9.2.5.1 Key Country Dynamics
- 9.2.5.2 Target Disease Prevalence
- 9.2.5.3 Competitive Scenario
- 9.2.5.4 Regulatory Framework
- 9.2.5.5 Reimbursement Scenario
- 9.2.5.6 Italy Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.2.6 Spain
- 9.2.6.1 Key Country Dynamics
- 9.2.6.2 Target Disease Prevalence
- 9.2.6.3 Competitive Scenario
- 9.2.6.4 Regulatory Framework
- 9.2.6.5 Reimbursement Scenario
- 9.2.6.6 Spain Cell & Gene Therapy Market Estimates And Forecasts, 2018 - 2030 (USD Million)
- 9.2.7 Denmark
- 9.2.7.1 Key Country Dynamics
- 9.2.7.2 Target Disease Prevalence
- 9.2.7.3 Competitive Scenario
- 9.2.7.4 Regulatory Framework
- 9.2.7.5 Reimbursement Scenario
- 9.2.7.6 Denmark Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.2.8 Sweden
- 9.2.8.1 Key Country Dynamics
- 9.2.8.2 Target Disease Prevalence
- 9.2.8.3 Competitive Scenario
- 9.2.8.4 Regulatory Framework
- 9.2.8.5 Reimbursement Scenario
- 9.2.8.6 Sweden Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.2.9 Norway
- 9.2.9.1 Key Country Dynamics
- 9.2.9.2 Target Disease Prevalence
- 9.2.9.3 Competitive Scenario
- 9.2.9.4 Regulatory Framework
- 9.2.9.5 Reimbursement Scenario
- 9.2.9.6 Norway Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.3 Asia Pacific
- 9.3.1 SWOT Analysis
- 9.3.1.1 Key Region Dynamics
- 9.3.1.2 Asia Pacific Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.3.2 Japan
- 9.3.2.1 Target Disease Prevalence
- 9.3.2.2 Competitive Scenario
- 9.3.2.3 Regulatory Framework
- 9.3.2.4 Reimbursement Scenario
- 9.3.2.5 Japan Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.3.3 China
- 9.3.3.1 Target Disease Prevalence
- 9.3.3.2 Competitive Scenario
- 9.3.3.3 Regulatory Framework
- 9.3.3.4 Reimbursement Scenario
- 9.3.3.5 China Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.3.4 India
- 9.3.4.1 Target Disease Prevalence
- 9.3.4.2 Competitive Scenario
- 9.3.4.3 Regulatory Framework
- 9.3.4.4 Reimbursement Scenario
- 9.3.4.5 India Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.3.5 South Korea
- 9.3.5.1 Target Disease Prevalence
- 9.3.5.2 Competitive Scenario
- 9.3.5.3 Regulatory Framework
- 9.3.5.4 Reimbursement Scenario
- 9.3.5.5 South Korea Cell & Gene Therapy Market Estimates And Forecasts, 2018 - 2030 (USD Million)
- 9.3.6 Australia
- 9.3.6.1 Target Disease Prevalence
- 9.3.6.2 Competitive Scenario
- 9.3.6.3 Regulatory Framework
- 9.3.6.4 Reimbursement Scenario
- 9.3.6.5 Australia Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.3.7 Thailand
- 9.3.7.1 Target Disease Prevalence
- 9.3.7.2 Competitive Scenario
- 9.3.7.3 Regulatory Framework
- 9.3.7.4 Reimbursement Scenario
- 9.3.7.5 Thailand Cell & Gene Therapy Market Estimates And Forecasts, 2018 - 2030 (USD Million)
- 9.4 Latin America
- 9.4.1 Swot Analysis:
- 9.4.2 Key Regional Dynamics
- 9.4.2.1 Latin America Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.4.3 Brazil
- 9.4.3.1 Target Disease Prevalence
- 9.4.3.2 Competitive Scenario
- 9.4.3.3 Regulatory Framework
- 9.4.3.4 Reimbursement Scenario
- 9.4.3.5 Brazil Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.4.4 Mexico
- 9.4.4.1 Target Disease Prevalence
- 9.4.4.2 Competitive Scenario
- 9.4.4.3 Regulatory Framework
- 9.4.4.4 Reimbursement Scenario
- 9.4.4.5 Mexico Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.4.5 Argentina
- 9.4.5.1 Target Disease Prevalence
- 9.4.5.2 Competitive Scenario
- 9.4.5.3 Regulatory Framework
- 9.4.5.4 Reimbursement Scenario
- 9.4.5.5 Argentina Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.5 Middle East & Africa (MEA)
- 9.5.1 Swot Analysis
- 9.5.2 Key Regional Dynamics
- 9.5.2.1 Middle East & Africa Cell & Gene Therapy Market Estimates And Forecasts, 2018 - 2030 (USD Million)
- 9.5.3 South Africa
- 9.5.3.1 Target Disease Prevalence
- 9.5.3.2 Competitive Scenario
- 9.5.3.3 Regulatory Framework
- 9.5.3.4 Reimbursement Scenario
- 9.5.3.5 South Africa Cell & Gene Therapy Market Estimates And Forecasts, 2018 - 2030 (USD Million)
- 9.5.4 Saudi Arabia
- 9.5.4.1 Target Disease Prevalence
- 9.5.4.2 Competitive Scenario
- 9.5.4.3 Regulatory Framework
- 9.5.4.4 Reimbursement Scenario
- 9.5.4.5 Saudi Arabia Cell & Gene Therapy Market Estimates And Forecasts, 2018 - 2030 (USD Million)
- 9.5.5 UAE
- 9.5.5.1 Target Disease Prevalence
- 9.5.5.2 Competitive Scenario
- 9.5.5.3 Regulatory Framework
- 9.5.5.4 Reimbursement Scenario
- 9.5.5.5 UAE Cell & Gene Therapy Market Estimates And Forecasts, 2018 - 2030 (USD Million)
- 9.5.6 Kuwait
- 9.5.6.1 Target Disease Prevalence
- 9.5.6.2 Competitive Scenario
- 9.5.6.3 Regulatory Framework
- 9.5.6.4 Reimbursement Scenario
- 9.5.6.5 Kuwait Cell & Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 10 Competitive Landscape
- 10.1 Strategy Framework
- 10.2 Market Participation Categorization
- 10.3 Company Profiles
- 10.3.1 Thermo Fisher Scientific, Inc.
- 10.3.1.1 Company Overview
- 10.3.1.2 Financial Performance
- 10.3.1.3 Product Benchmarking
- 10.3.1.4 Strategic Initiatives
- 10.3.2 Merck Kgaa
- 10.3.2.1 Company Overview
- 10.3.2.1.1 Milliporesigma
- 10.3.2.2 Financial Performance
- 10.3.2.3 Product Benchmarking
- 10.3.2.4 Strategic Initiatives
- 10.3.3 Lonza
- 10.3.3.1 Company Overview
- 10.3.3.2 Financial Performace
- 10.3.3.3 Product Benchmarking
- 10.3.3.4 Strategic Initiatives
- 10.3.4 Catalent, Inc.
- 10.3.4.1 Company Overview
- 10.3.4.2 Financial Performance
- 10.3.4.3 Product Benchmarking
- 10.3.4.4 Strategic Initiatives
- 10.3.5 Takara Bio, Inc.
- 10.3.5.1 Company Overview
- 10.3.5.2 Financial Performance
- 10.3.5.3 Product Benchmarking
- 10.3.5.4 Strategic Initiatives
- 10.3.6 F. Hoffmann-La Roche Ltd.
- 10.3.6.1 Company Overview
- 10.3.6.2 Financial Performance
- 10.3.6.3 Product Benchmarking
- 10.3.6.4 Strategic Initiatives
- 10.3.7 Wuxi Advanced Therapies
- 10.3.7.1 Company Overview
- 10.3.7.2 Financial Performance
- 10.3.7.3 Product Benchmarking
- 10.3.7.4 Strategic Initiatives
- 10.3.8 Samsung
- 10.3.8.1 Company Overview
- 10.3.8.1.1 Samsung Biologics
- 10.3.8.2 Company Overview
- 10.3.8.3 Financial Performance
- 10.3.8.4 Product Benchmarking
- 10.3.8.5 Strategic Initiatives
- 10.3.9 Boehringer Ingelheim International Gmbh
- 10.3.9.1 Company Overview
- 10.3.9.2 Financial Performance
- 10.3.9.3 Product Benchmarking
- 10.3.9.4 Strategic Initiatives
- 10.3.10 Novartis Ag
- 10.3.10.1 Company Overview
- 10.3.10.2 Financial Performance
- 10.3.10.3 Product Benchmarking
- 10.3.10.4 Strategic Initiatives
- 10.3.11 Hitachi Chemical Co., Ltd. (Showa Denko Materials Co Ltd)
- 10.3.10.1 Company Overview
- 10.3.10.1.1 Apceth Biopharma
- 10.3.10.2 Company Overview
- 10.3.10.3 Financial Performance
- 10.3.10.4 Product Benchmarking
- 10.3.10.5 Strategic Initiatives
- 10.3.12 Cellular Therapeutics
- 10.3.12.1 Company Overview
- 10.3.12.2 Product Benchmarking
- 10.3.13 Miltenyi Biotech
- 10.3.13.1 Company Overview
- 10.3.13.2 Financial Performance
- 10.3.13.3 Product Benchmarking
- 10.3.13.4 Strategic Initiatives
- 10.3.14 Bluebird Bio Inc.
- 10.3.14.1 Company Overview
- 10.3.14.2 Financial Performance
- 10.3.14.3 Product Benchmarking
- 10.3.14.4 Strategic Initiatives
- 10.4 Recent Developments And Impact Analysis By Key Market Participants
- 10.5 Company Mapping
- 10.6 Vendor Landscape
- 10.6.1 List Of Key Distributors And Channel Partners
- 10.6.2 Key Company Market Share Analysis, 2022
- 10.7 Public Companies
- 10.7.1 Company Market Position Analysis
- 10.7.2 Competitive Dashboard Analysis
- 10.8 Private Companies
- 10.8.1 List Of Key Emerging Companies
- 10.8.2 Regional Network Map
- 10.8.3 Company Market Position Analysis