The cell therapy manufacturing market is projected to grow at an annualized rate of >16.5%, till 2030
Roots Analysis has done a detailedstudy on Cell Therapy Manufacturing Market (3rdEdition), 2019 - 2030, covering various important aspects of theindustry and identifying key future growth opportunities.
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Key Market Insights
§ More than 100industry players and over 60 non-industry players currently claim tomanufacture different types of cell therapies, either for in-house requirementsor on contract basis
§ The market isfragmented, featuring both established players and new entrants, which claim tooperate at various scales and manufacture a diverse range of cell therapies
§ In order to cater tothe growing needs of clients / sponsors, companies have established presenceacross different regions; presently, the US, the UK and China are the key hubsfor cell therapy manufacturing
§ In recent years, asignificant increase in partnership activity has been observed in this domain;in fact, therapy developers have already inked manufacturing deals with bothindigenous and international experts
§ In order to enhancecore competencies related to the domain, both drug developers and CMOs areactively investing in expanding their existing infrastructure and capabilities
§ Cell therapymanufacturers are also gradually opting to automate various operations in thesupply chain; the primary objective is to achieve favorable bench-to-clinictimelines and cut down on production related losses
§ Currently, theinstalled global capacity for cell therapy manufacturing is estimated to bespread across 1.2+ million square feet of dedicated cleanroom area distributed acrossvarious scales of operation
§ More than 70,000patients were estimated to have been enrolled in cell therapy related clinicaltrials; the demand for cell therapies is anticipated to grow significantly overthe next decade
§ Revenues frommanufacturing operations of T-cell therapies are anticipated to capture highermarket share; the benefit will be realized by both autologous and allogeneictherapies across different regions the world
§ Clinical scalemanufacturing operations are likely to drive the future market size, takinginto consideration both in-house and contract service requirements
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Table of Contents
1. PREFACE
1.1. Scope ofthe Report
1.2. ResearchMethodology
1.3. ChapterOutlines
2. EXECUTIVESUMMARY
3. INTRODUCTION
3.1. Context andBackground
3.2. Introductionto Cell Therapies
3.2.1. Comparisonof Cell Therapies and Other Biotechnology Products
3.2.2. Classificationof Advanced Therapy Medicinal Products (ATMPs)
3.2.3. CurrentMarket Landscape of ATMPs
3.3. Overview ofCell Therapy Manufacturing
3.4. CellTherapy Manufacturing Models
3.4.1. CentralizedManufacturing
3.4.2. DecentralizedManufacturing
3.5. Scalabilityof Cell Therapy Manufacturing
3.5.1. Scale-up
3.5.2. Scale-out
3.6. Types ofCell Therapy Manufacturers
3.7. KeyManufacturing-related Challenges
3.8. FactorsInfluencing Cell Therapy Manufacturing
3.9. AutomatingCell Therapy Manufacturing
3.10. Cell TherapyManufacturing Supply Chain
3.11. FuturePerspectives
4. MARKETOVERVIEW
4.1. ChapterOverview
4.2. CellTherapy Manufacturers (Industry Players): Overall Market Landscape
4.2.1. Analysis byLocation of Headquarters
4.2.2. Analysis byLocation of Manufacturing Facility
4.2.3. Analysis byType of Cells Manufactured
4.2.4. Analysis bySource of Cells
4.2.5. Analysis byScale of Operation
4.2.6. Analysis byType of Cell Culture
4.2.7. Analysis byPurpose of Production
4.2.8. Analysis byManufacturing Capabilities / Services
4.3. CellTherapy Manufacturers (Non-Industry Players): Overall Market Landscape
4.3.1. Analysis byLocation of Headquarters
4.3.2. Analysis byLocation of Manufacturing Facility
4.3.3. Analysis byType of Cells Manufactured
4.3.4. Analysis bySource of Cells
4.3.5. Analysis byScale of Operation
4.3.6. Analysis byType of Cell Culture
4.3.7. Analysis byPurpose of Production
4.3.8. Analysis by ManufacturingCapabilities / Services
4.4. CellTherapy Manufacturing: Role of Logistics Service Providers
5. REGULATORYLANDSCAPE
5.1. ChapterOverview
5.2. CurrentScenario
5.2.1. RegulatoryGuidelines in the US
5.2.2. RegulatoryGuidelines in Europe
5.2.3. RegulatoryGuidelines in Japan
5.2.4. ConditionalApprovals
5.3. RegulatoryAccreditations for Cell Therapy Manufacturing
5.3.1. FacilitiesApproved by Regulators to Manufacture Cell Therapies
5.4. Summary ofGuidelines for Clinical-Stage Manufacturing of Cell Therapies
5.5. ExistingChallenges to Clinical-Stage Manufacturing
5.5.1. Variabilityin Regulatory Guidelines across Different Geographies
5.6. Conclusion
6. ROADMAPSFOR OVERCOMING EXISTING CHALLENGES
6.1. ChapterOverview
6.2. Roadmap forthe US
6.2.1. CellProcessing
6.2.2. CellPreservation, Distribution and Handling
6.2.3. ProcessAutomation and Data Analytics
6.2.4. ProcessMonitoring and Quality Control
6.2.5. Standardizationand Regulatory Support
6.2.6. Workforce Development
6.2.7. Supply Chainand Logistics
6.3. Roadmapsfor Other Geographies
6.3.1. Europe
6.3.2. Asia Pacific
7. AUTOMATIONTECHNOLOGIES FOR CELL THERAPY MANUFACTURING
7.1. ChapterOverview
7.2. Automationof Cell Therapy Manufacturing Processes
7.2.1. ClosedSystems
7.2.2. Single-useSystems
7.2.3. ModularSystems
7.3. CaseStudies
7.3.1. Roadmap toDeveloping an Automated Cell Manufacturing / Processing Device
7.3.2. AutomatingCell Therapy Manufacturing
7.4. GMP-in-a-Box
7.5. List ofAutomation Service Providers
7.6. ComparativeAnalysis of Manual and Automated Processes
7.7. ConcludingRemarks
8. PROFILES:INDUSTRY PLAYERS
8.1. ChapterOverview
8.2. ServiceProviders in the US
8.2.1 CognateBioServices
8.2.1.1. CompanyOverview
8.2.1.2. ServicePortfolio
8.2.1.3. ManufacturingCapabilities
8.2.1.4. Partnerships
8.2.1.5. FutureOutlook
8.2.2. FUJIFILMCellular Dynamics
8.2.2.1. CompanyOverview
8.2.2.2. ServicePortfolio
8.2.2.3. ManufacturingCapabilities
8.2.2.4. Partnerships
8.2.2.5. FutureOutlook
8.2.3. KBIBiopharma
8.2.3.1. CompanyOverview
8.2.3.2. ServicePortfolio
8.2.3.3. ManufacturingCapabilities
8.2.3.4. Partnerships
8.2.3.5. FutureOutlook
8.2.4. HitachiChemical Advanced Therapeutics Solutions
8.2.4.1. Company Overview
8.2.4.2. ServicePortfolio
8.2.4.3. ManufacturingCapabilities
8.2.4.4. Partnerships
8.2.4.5. FutureOutlook
8.2.5. WaismanBiomanufacturing
8.2.5.1. CompanyOverview
8.2.5.2. ServicePortfolio
8.2.5.3. ManufacturingCapabilities
8.2.5.4. Partnerships
8.2.5.5. FutureOutlook
8.3. ServiceProviders in Europe
8.3.1. BioNTechInnovative Manufacturing Services
8.3.1.1. CompanyOverview
8.3.1.2. ServicePortfolio
8.3.1.3. ManufacturingCapabilities
8.3.1.4. Partnerships
8.3.1.5. FutureOutlook
8.3.2. Cell andGene Therapy Catapult
8.3.2.1. CompanyOverview
8.3.2.2. ServicePortfolio
8.3.2.3. ManufacturingCapabilities
8.3.2.4. Partnerships
8.3.2.5. FutureOutlook
8.3.3. Lonza
8.3.3.1. CompanyOverview
8.3.3.2. ServicePortfolio
8.3.3.3. ManufacturingCapabilities
8.3.3.4. Partnerships
8.3.3.5. FutureOutlook
8.3.4. MaSTherCell
8.3.4.1. CompanyOverview
8.3.4.2. ServicePortfolio
8.3.4.3. ManufacturingCapabilities
8.3.4.4. Partnerships
8.3.4.5. FutureOutlook
8.3.5. Roslin Cell Therapies
8.3.5.1. CompanyOverview
8.3.5.2. ServicePortfolio
8.3.5.3. ManufacturingCapabilities
8.3.5.4. Partnerships
8.3.5.5. FutureOutlook
8.4. ServiceProviders in Asia Pacific
8.4.1. CellTherapies
8.4.1.1. CompanyOverview
8.4.1.2. ServicePortfolio
8.4.1.3. ManufacturingCapabilities
8.4.1.4. Partnerships
8.4.1.5. FutureOutlook
8.4.2. Japan TissueEngineering (J-TEC)
8.4.2.1. CompanyOverview
8.4.2.2. ServicePortfolio
8.4.2.3. ManufacturingCapabilities
8.4.2.4. Partnerships
8.4.2.5. Future Outlook
8.4.3. MEDINET
8.4.3.1. CompanyOverview
8.4.3.2. ServicePortfolio
8.4.3.3. ManufacturingCapabilities
8.4.3.4. Partnerships
8.4.3.5. FutureOutlook
8.4.4. Nikon CeLLinnovation
8.4.4.1. CompanyOverview
8.4.4.2. ServicePortfolio
8.4.4.3. ManufacturingCapabilities
8.4.4.4. Partnerships
8.4.4.5. FutureOutlook
8.4.5. WuXiAdvanced Therapies
8.4.5.1. CompanyOverview
8.4.5.2. ServicePortfolio
8.4.5.3. ManufacturingCapabilities
8.4.5.4. Partnerships
8.4.5.5. FutureOutlook
9. PROFILES:NON-INDUSTRY PLAYERS
9.1. ChapterOverview
9.2. Center forCell and Gene Therapy, Baylor College of Medicine
9.2.1. Overview
9.2.2. OperatingSegments
9.2.3. ServicePortfolio
9.2.4. ManufacturingFacilities and Capabilities
9.3. Centre for CellManufacturing Ireland, National University of Ireland
9.3.1. Overview
9.3.2. ServicePortfolio
9.3.3. ManufacturingFacilities and Capabilities
9.4. ClinicalCell and Vaccine Production Facility, University of Pennsylvania
9.4.1. Overview
9.4.2. ServicePortfolio
9.4.3. ManufacturingFacilities and Capabilities
9.5. Guy’s andSt. Thomas’ GMP Facility, Guy’s Hospital
9.5.1. Overview
9.5.2. ServicePortfolio
9.5.3. ManufacturingFacilities and Capabilities
9.6. Laboratoryfor Cell and Gene Medicine, Stanford University
9.6.1. Overview
9.6.2. ServicePortfolio
9.6.3. ManufacturingFacilities and Capabilities
9.7. Molecularand Cellular Therapeutics, University of Minnesota
9.7.1. Overview
9.7.2. ServicePortfolio
9.7.3. ManufacturingFacilities and Capabilities
9.8. NewcastleCellular Therapies Facility, Newcastle University
9.8.1. Overview
9.8.2. ServicePortfolio
9.8.3. ManufacturingFacilities and Capabilities
9.9. Rayne CellTherapy Suite, King’s College London
9.9.1. Overview
9.9.2. ManufacturingFacilities and Capabilities
9.10. ScottishNational Blood Transfusion Services Cellular Therapy Facility, Scottish Centrefor Regenerative Medicine
9.10.1. Overview
9.10.2. ManufacturingFacilities and Capabilities
9.11. Sydney Celland Gene Therapy
9.11.1. Overview
9.11.2. ManufacturingFacilities and Capabilities
10. ROLE OFNON-PROFIT ORGANIZATIONS
10.1. ChapterOverview
10.2. Cell TherapyManufacturing Service Providers: Non-Profit Organizations
10.2.1. CellCAN
10.2.2. Cell TherapyManufacturing Cooperative Research Center (CTM CRC)
10.2.3. National CellManufacturing Consortium (NCMC)
10.2.4. CaliforniaInstitute of Regenerative Medicine (CIRM)
10.3. Cell TherapyManufacturing: Affiliated International Societies
11. PARTNERSHIPS
11.1. ChapterOverview
11.2. PartnershipModels
11.3. Cell TherapyManufacturing: List of Partnerships
11.3.1. Analysis byYear of Partnership
11.3.2. Analysis byType of Partnership Model
11.3.3. Analysis byYear and Type of Partnership Model
11.4. Analysis byType of Cells
11.5. Analysis byScale of Operation
11.6. GeographicalAnalysis
11.6.1. Continent-wiseDistribution
11.6.2. Country-wiseDistribution
11.7. Most ActivePlayers: Analysis by Number of Partnerships
11.8. Cell TherapyManufacturing: List of Acquisitions
11.8.1. Analysis byYear and Type of Cells
11.8.2. GeographicalAnalysis
11.8.3. OwnershipChange Matrix
12. FACILITYEXPANSIONS
12.1. ChapterOverview
12.2. Cell TherapyManufacturing: List of Expansions
12.2.1. CumulativeYear-wise Distribution
12.2.2. Analysis byType of Cells
12.2.3. Analysis byScale of Operation
12.2.3. Analysis byPurpose of Expansion
12.2.4. Analysis byLocation of Manufacturing Facility
12.2.5. Analysis byRegion and Purpose of Expansion
13. CAPACITYANALYSIS
13.1. ChapterOverview
13.2. KeyAssumptions and Methodology (Industry Players)
13.2.1 Cell TherapyManufacturing: Installed Global Capacity (Number of Cleanrooms)
13.2.1.1. Analysis by Size of Manufacturer
13.2.1.2. Analysis by Scale of Operation
13.2.1.3. Analysis by Location of Manufacturing Facility
13.2.2. Cell TherapyManufacturing: Installed Global Capacity (Cleanroom Area)
13.2.2.1. Analysis by Size of Manufacturer
13.2.2.2. Analysis by Scale of Operation
13.2.2.3. Analysis by Location of Manufacturing Facility
13.3. KeyAssumptions and Methodology (Non-Industry Players)
13.3.1. Cell TherapyManufacturing: Installed Global Capacity (Number of Cleanrooms)
13.3.1.1. Analysis by Scale of Operation
13.3.1.2. Analysis by Location of Manufacturing Facility
13.3.2. Cell TherapyManufacturing: Installed Global Capacity (Cleanroom Area)
13.3.2.1. Analysis by Scale of Operation
13.3.2.2. Analysis by Location of Manufacturing Facility
13.4 ConcludingRemarks
14. DEMANDANALYSIS
14.1 ChapterOverview
14.2 KeyAssumptions and Methodology
14.3 Cell TherapyManufacturing: Overall Annual Demand
14.3.1. Analysis byType of Cells
14.3.2. Analysis byScale of Operations
14.3.3. Analysis byGeography
15. COST PRICEANALYSIS
15.1. Chapter Overview
15.2. FactorsContributing to the High Price of Cell Therapies
15.3. PricingModels for Cell Therapies
15.3.1. Based onAssociated Costs for T-cell Therapies
15.3.2. Based onAssociated Costs for Stem Cell Therapies
15.3.3. Based on Availabilityof Competing Products
15.3.4. Based onTarget Patient Segment
15.3.5. Based onOpinions of Industry Experts
15.4. Cell TherapyCost Optimization
15.4.1. Role of Costof Goods Sold
15.4.2. Role ofAutomation
15.4.3. Role of CellTherapy Contract Manufacturing Organizations
15.5. Reimbursement-relatedConsiderations for Cell Therapies
15.5.1. Case Study:The National Institute for Health and Care Excellence’s (NICE) Appraisal ofCAR-T Therapies
16. MAKE VERSUSBUY DECISION MAKING FRAMEWORK
16.1. ChapterOverview
16.2. Make versusBuy Decision Making: Analytical Output
17. MARKETSIZING AND OPPORTUNITY ANALYSIS
17.1. ChapterOverview
17.2. Scope of theForecast
17.3. ForecastMethodology
17.4. Input Tablesand Key Assumptions
17.5. Overall CellTherapy Manufacturing Market, 2019-2030
17.5.1. Cell TherapyManufacturing Market, 2019-2030: Distribution by Type of Cell Therapy
17.5.2. Cell TherapyManufacturing Market, 2019-2030: Distribution by Source of Cells
17.5.3. Cell Therapy ManufacturingMarket, 2019-2030: Distribution by Scale of Operation
17.5.4. Cell TherapyManufacturing Market, 2019-2030: Distribution by Purpose of
Production
17.5.5. Cell TherapyManufacturing Market, 2019-2030: Geographical Distribution
17.6. MarketOpportunity in Commercial Scale Manufacturing of Cell-based Therapies
17.6.1. OverallCommercial Scale Manufacturing Market for T-cell Therapies, 2019-2030
17.6.1.1. Distribution by Type of Therapy (CAR-T Therapy,TCR Therapy, and TIL Therapy)
17.6.1.2. Distribution by Source of Cells
17.6.1.3. Geographical Distribution
17.6.2. OverallCommercial Scale Manufacturing Market for Dendritic Cell and Tumor CellTherapies, 2019-2030
17.6.2.1. Distribution by Type of Therapy (Dendritic CellTherapy, and Tumor Cell Therapy)
17.6.2.2. Distribution by Source of Cells
17.6.2.3. Geographical Distribution
17.6.3. OverallCommercial Scale Manufacturing Market for NK Cell Therapies, 2019-2030
17.6.3.1. Distribution by Source of Cells
17.6.3.2. Geographical Distribution
17.6.4. OverallCommercial Scale Manufacturing Market for Stem Cell Therapies, 2019-2030
17.6.4.1. Distribution by Source of Cells
17.6.4.2. Geographical Distribution
17.7. MarketOpportunity in Clinical Scale Manufacturing of Cell-based Therapies
17.7.1. OverallClinical Scale Manufacturing Market for T-cell Therapies, 2019-2030
17.7.1.1. Distribution by Type of Therapy (CAR-T Therapy,TCR Therapy and TIL Therapy)
17.7.1.2. Distribution by Source of Cells
17.7.1.3. Geographical Distribution
17.7.2. OverallClinical Scale Manufacturing Market for Dendritic Cell and Tumor CellTherapies, 2019-2030
17.7.2.1. Distribution by Type of Therapy (Dendritic CellTherapy, Tumor Cell Therapy)
17.7.2.2. Distribution by Source of Cells
17.7.2.3. Geographical Distribution
17.7.3. OverallClinical Scale Manufacturing Market for NK Cell Therapies, 2019-2030
17.7.3.1. Distribution by Source of Cells
17.7.3.2. Geographical Distribution
17.7.4. OverallClinical Scale Manufacturing Market for Stem Cell Therapies, 2019-2030
17.7.4.1. Distribution by Source of Cells
17.7.4.2. Geographical Distribution
18. KEYINSIGHTS
18.1. ChapterOverview
18.2. Cell TherapyManufacturers: Grid Analysis
18.3. Cell TherapyManufacturers: Logo Landscape by Type of Cell Therapy
18.3.1. LogoLandscape: Immune Cell Manufacturers
18.3.2. LogoLandscape: Stem Cell Manufacturers
18.4. Cell TherapyManufacturers: World Map Representation of Location of Manufacturing Facility
18.4.1. IndustryPlayers
18.4.2. Non-IndustryPlayers
19. SWOTANALYSIS
19.1. ChapterOverview
19.2. Strengths
19.3. Weaknesses
19.4. Opportunities
19.5. Threats
19.6. Comparisonof SWOT Factors
19.6.1. ConcludingRemarks
20. CONCLUSION
20.1. ChapterOverview
20.2. KeyTakeaways
21. SURVEYANALYSIS
21.1. ChapterOverview
21.2. SeniorityLevel of Respondents
21.3. Type of CellTherapy
21.4. Scale ofOperation
21.5. Source ofCells
21.6. Type of CellCulture System
22.7. Availabilityof Fill / Finish Services
22. INTERVIEWTRANSCRIPTS
22.1. ChapterOverview
22.2. Lion TCR
22.2.1. CompanyOverview
22.2.2. InterviewTranscript: Victor Lietao Li, Co-Founder and Chief Executive Officer
22.3. CellTherapies
22.3.1. CompanyOverview
22.3.2. InterviewTranscript: Tim Oldham, Chief Executive Officer
22.4. CiMaas
22.4.1. CompanyOverview
22.4.2. InterviewTranscript: Gerard MJ Bos, Chief Executive Officer
22.5. GracellBiotechnologies
22.5.1. CompanyOverview
22.5.2. InterviewTranscript: Wei (William) Cao, ChiefExecutive Officer
22.6. GlycostemTherapeutics
22.6.1. CompanyOverview
22.6.2. InterviewTranscript: Troels Jordansen, Chief Executive Officer
22.7. Kadimastem
22.7.1. CompanyOverview
22.7.2. InterviewTranscript: Arik Hasson, Executive VP Research and Development
22.8. Bio Elpida
22.8.1. CompanyOverview
22.8.2. InterviewTranscript: Gilles Devillers, General Manager
22.9. Center forCommercialization of Cancer Immunotherapy / C3i
22.9.1. CompanyOverview
22.9.2. InterviewTranscript: Arnaud Deladeriere, Manager, Business Development &Operations-cGMP Manufacturing Unit
22.10. WaismanBiomanufacturing
22.10.1. Company Overview
22.10.2. Interview Transcript: Brian Dattilo, Manager of BusinessDevelopment
22.11. RoslinCT
22.11.1. Company Overview
22.11.2. Interview Transcript: Fiona Bellot, BusinessDevelopment Manager
22.12. Yposkesi
22.12.1. Company Overview
22.12.2. Interview Transcript: Mathilde Girard, Leader,Cell Therapy Innovation and Development
22.13. University ofMinnesota
22.13.1. Organization Overview
22.13.2. Interview Transcript: David Mckenna, Professor andAmerican Red in Transfusion Medicine
23. APPENDIX 1:TABULATED DATA
24. APPENDIX 2:LIST OF COMPANIES AND ORGANIZATIONS
Contact Details
Gaurav Chaudhary
+1 (415) 800 3415
