Cell Therapy Manufacturing Market Industry Trends and Global Forecasts to 2035 - ResearchAndMarkets.com

The "Cell Therapy Manufacturing Market (6th Edition): Industry Trends and Global Forecasts to 2035 - Distribution by Type of Cell Therapy, Source of Cells, Scale of Operation, Type of Manufacturer and Geography" report has been added to ResearchAndMarkets.com's offering.

The cell therapy manufacturing market is valued at USD 4.90 billion in 2024 growing at a CAGR of 9.90% during the forecast period 2024-2035.

Currently, over 300 cell therapies are in various stages of clinical development, with more than 1,930 clinical studies initiated since 2019 focusing on these candidates. Several of these commercialized cell therapies have emerged as top-selling drugs in the healthcare sector. For example, Gilead Sciences reported that Yescarta achieved sales exceeding USD 1.5 billion, while Tecartus generated sales of USD 370 million in 2023.

Given the substantial evidence supporting the clinical benefits and therapeutic potential of cell therapies, stakeholders are now concentrating on optimizing the manufacturing processes for these therapies. In recent years, numerous advanced automation technologies and platforms have been developed, demonstrating the potential to significantly lower manufacturing costs, thus making these products more affordable. One notable innovation, GMP-In-A Box, offers several advantages, including increased throughput, reduced idle time between batch runs, and decreased manual labor. However, the overall automation process faces challenges due to the complex steps involved in cell therapy manufacturing. Additionally, the lack of specialized infrastructure and trained personnel in this field poses significant obstacles to the growth of this segment.

The report offers market leaders and newcomers valuable insights into revenue estimations for both the overall market and its sub-segments. The report provides stakeholders with a pulse on the Cell Therapy Manufacturing Market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.

Key Market Segments

Type of Cell Therapy

• T Cell Therapies
• NK Cell Therapies
• Dendritic Cell Therapies
• Stem Cell Therapies

Source of Cells

• Autologous
• Allogeneic
• Unspecified

Scale of Operation

• Clinical
• Commercial

Type of Manufacturer

• In-house Manufacturing
• Contract Manufacturing Organization

Research Coverage:

• A general introduction to cell therapies, along with information on the key challenges and factors influencing the cell therapy manufacturing market. It provides details on the automation tools and technologies being utilized for improving manufacturing processes and the future prospects in this domain.
• An overview of the current market landscape with respect to the industry players engaged in the manufacturing of cell-based therapies. It features information on their company size, year of establishment, location of headquarters, location of manufacturing facilities, type of manufacturer, type of cell manufactured, source of cells, scale of operation and additional services offered.
• An overview of the current cell therapy manufacturing market landscape with respect to the non-industry players engaged in the manufacturing of cell-based therapies. It features information on their year of establishment, location of headquarters, location of manufacturing facilities, type of manufacturer, type of cell manufactured, source of cells, scale of operation and additional services offered.
• A discussion on cell therapy manufacturing related regulations across various geographies, featuring an analysis of the diverse certifications / accreditations awarded to the manufacturing facilities by important regulatory bodies across the globe.
• An overview of the several roadmaps published by different agencies across the globe in order to provide strategies to advance cell therapy manufacturing process.
• An elaborate discussion on the role of technology automation in cell therapy manufacturing in order to optimize the current manufacturing practices with the use of closed and single use systems. It features a roadmap that provides information on the steps to develop automation devices, supported by two case studies. It also presents a qualitive analysis on the cost incurred while manufacturing cell-based therapies using manual versus automated manufacturing approaches. In addition, it features a list of organizations that offer automated technologies for manufacturing operations or provide services to therapy developers to automate their cell therapy production process.
• Profiles of industry players involved in cell therapy manufacturing. Each profile features a brief overview of the company, along with details related to its service portfolio, its manufacturing capabilities and facilities, recent developments and an informed future outlook.
• Profiles of non-industry players involved in cell therapy manufacturing, featuring an overview of the organization, along with details related to their service portfolio and manufacturing facilities.
• A discussion on non-profit organizations in cell therapy manufacturing, featuring a list of organizations that are actively involved in the development and production of cell-based therapies, across different geographical locations, along with information on various international / national societies that help in disseminating knowledge about the advancement of these therapies to the general community.
• An analysis of completed, ongoing and planned clinical trial, based on several relevant parameters, such as trial registration year, enrolled patient population, trial status, trial phase, type of sponsor / collaborator, patient segment, study design, most active players and geographical distribution of trials.
• A detailed analysis of the recent partnerships and collaborations inked by players focused on the manufacturing of cell-based therapies, since 2016, based on several relevant parameters, such as the year of partnership, type of partnership, type of cells manufactured, scale of operation, most active players and geographical distribution.
• An analysis of the various expansion initiatives undertaken by service providers engaged in this domain in order to augment their respective cell therapy manufacturing capabilities, during the period 2017-2024, based on several relevant parameters, such as year of expansion, type of expansion, type of cell manufactured, scale of operation, location of expanded manufacturing facility, and most active players.
• An in-depth analysis of the various cell therapy manufacturing focused initiatives undertaken by big pharma players, based on several relevant parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative, scale of operation and type of cell manufactured.
• An estimate of the overall, installed capacity for the manufacturing of cell-based therapies, based on information reported by various industry and non-industry stakeholders in the public domain, highlighting the distribution of the available capacity on the basis of scale of operation and key geographical regions.
• Informed estimates of the annual commercial and clinical demand for cell therapies, based on type of cell therapy and key geographical regions.
• A detailed analysis of various factors that are likely to influence the price of cell-based therapies, featuring different models / approaches adopted by manufacturers in order to determine the price of their proprietary offerings.
• A qualitative analysis that highlights the various factors that need to be taken into consideration by cell therapy developers, while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
• A detailed total cost of ownership analysis based on company size, for cell therapy manufacturing organizations, over a period of 20 years.
• A detailed cell therapy manufacturing market forecast analysis in order to estimate the existing market size and future opportunity over the next decade. Based on multiple parameters, such as number of ongoing / planned clinical studies, cell therapy manufacturing costs, target patient population, and anticipated adoption of such therapies, we have provided informed estimates on the evolution of the market in the short to mid-term and mid to long-term, for the forecast period 2024-2035. The report also features the likely distribution of the current and forecasted opportunity within the market. Further, in order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry's growth.
• Detailed projections of the current and future cell therapy manufacturing market across different types of cell therapy, such as T cell therapies, NK cell therapies, dendritic cell therapies, and stem cell therapies.
• Detailed projections of the current and future cell therapy manufacturing industry across different sources of cell, such as autologous, allogeneic and unspecified.
• Detailed projections of the current and future cell therapy manufacturing market across different scales of operation, such as clinical and commercial.
• Detailed projections of the current and future cell therapy manufacturing revenue across different types of manufacturers, such as in-house manufacturers and contract manufacturing organizations.
• Detailed projections of the current and future cell therapy manufacturing market across various geographies, such as North America, Europe, Asia Pacific, and Rest of the World.
• A discussion on affiliated trends, key drivers and challenges, which are likely to impact the industry's evolution, under an elaborate SWOT framework, along with a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall market dynamics.
• Insights generated in a market-wide survey, featuring inputs solicited from experts who are directly / indirectly involved in the development and / or manufacturing of cell-based therapies.

Leading Market Companies

• AGC Biologics
• BioNTech Innovative Manufacturing Services
• Cell and Gene Therapy Catapult
• Cell Therapies
• Center for Cell and Gene Therapy, Baylor College of Medicine
• Centre for Cell Manufacturing Ireland, National University of Ireland
• Charles River Laboratories
• Clinical Cell and Vaccine Production Facility, University of Pennsylvania
• FUJIFILM Cellular Dynamics
• Guy's and St. Thomas' GMP Facility, Guy's Hospital
• KBI Biopharma
• Laboratory for Cell and Gene Medicine, Stanford University
• Lonza
• MEDINET
• Minaris Regenerative Medicine
• Molecular and Cellular Therapeutics, University of Minnesota
• Newcastle Cellular Therapies Facility, Newcastle University
• Nikon CeLL Innovation
• Rayne Cell Therapy Suite, King's College London
• RoslinCT
• Scottish National Blood Transfusion Services Cellular Therapy Facility, Scottish Centre for Regenerative Medicine
• Sydney Cell and Gene Therapy
• Thermo Fisher Scientific
• WuXi AppTec

Key Topics Covered:

1. PREFACE

2. RESEARCH METHODOLOGY

3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS

4. EXECUTIVE SUMMARY

5. INTRODUCTION

• Cell Therapy Manufacturing Models
• Scalability of Cell Therapy Manufacturing Processes
• Types of Cell Therapy Manufacturers
• Key Challenges for Manufacturing Cell Therapies
• Key Factors Influencing Cell Therapy Manufacturing
• Automation of Cell Therapy Manufacturing Processes
• Cell Therapy Manufacturing Supply Chain
• Future Perspectives

6. CELL THERAPY MANUFACTURERS (INDUSTRY PLAYERS): MARKET LANDSCAPE

7. CELL THERAPY MANUFACTURERS (NON-INDUSTRY PLAYERS): MARKET LANDSCAPE

8. REGULATORY LANDSCAPE

• Current Scenario
• Regulatory Authorities for Cell Therapy Manufacturing
• Summary of Guidelines for Early-Stage Manufacturing of Cell Therapies
• Existing Challenges to Early-Stage Manufacturing of Cell Therapies
• Variability in Regulatory Guidelines across Different Geographies

9. ROADMAPS FOR OVERCOMING CHALLENGES

• Roadmap for the US
  • Cell Processing
  • Cell Preservation, Distribution and Handling
  • Process Automation and Data Analytics
  • Process Monitoring and Quality Control
  • Standardization and Regulatory Support
  • Workforce Development
  • Supply Chain and Logistics
• Roadmaps for Other Geographies

10. AUTOMATION TECHNOLOGIES FOR CELL THERAPY MANUFACTURING

• Automation of Cell Therapy Manufacturing Processes
  • Closed Systems
  • Single-use Systems
  • Modular Systems
• Growth Drivers and Roadblocks
• Case Studies
  • Roadmap to Develop an Automated Cell Manufacturing / Processing Device
  • Automating the Cell Therapy Manufacturing Process
• GMP-in-a-Box
• List of Automated and Closed Cell Therapy Processing Systems
• Comparative Analysis of Manual and Automated Processes

11. COMPANY PROFILES: INDUSTRY PLAYERS

Service Providers in North America

• AGC Biologics
• Charles River Laboratories
• FUJIFILM Cellular Dynamics
• KBI Biopharma
• Thermo Fisher Scientific
• WuXi Advanced Therapies

Service Providers in Europe

• BioNTech Innovative Manufacturing Services
• Cell and Gene Therapy Catapult
• Lonza
• RoslinCT

Service Providers in Asia Pacific

• Cell Therapies
• Minaris Regenerative Medicine
• MEDINET
• Nikon CeLL Innovation

12. COMPANY PROFILES: NON-INDUSTRY PLAYERS

• Center for Cell and Gene Therapy, Baylor College of Medicine
• Centre for Cell Manufacturing Ireland, National University of Ireland
• Clinical Cell and Vaccine Production Facility, University of Pennsylvania
• Guy's and St. Thomas' GMP Facility, Guy's Hospital
• Laboratory for Cell and Gene Medicine, Stanford University
• Molecular and Cellular Therapeutics, University of Minnesota
• Newcastle Cellular Therapies Facility, Newcastle University
• Rayne Cell Therapy Suite, King's College London
• Scottish National Blood Transfusion Services Cellular Therapy Facility, Scottish Centre for Regenerative Medicine
• Sydney Cell and Gene Therapy

13. NON-PROFIT ORGANIZATIONS IN CELL THERAPY MANUFACTURING

• Cell Therapy Manufacturing: Non-Profit Organizations
  • CellCAN
  • Cell Therapy Manufacturing Cooperative Research Center
  • National Cell Manufacturing Consortium (NCMC)
  • California Institute of Regenerative Medicine (CIRM)
• Cell Therapy Manufacturing: International Societies

14. CLINICAL TRIAL ANALYSIS

15. PARTNERSHIPS AND COLLABORATIONS

• Partnership Models
• Cell Therapy Manufacturing: List of Partnerships
• Analysis by Type of Cells
• Analysis by Scale of Operation
• Analysis by Region
• Most Active Players: Analysis by Number of Partnerships
• Cell Therapy Manufacturing: List of Mergers and Acquisitions

16. RECENT EXPANSIONS

17. BIG PHARMA INITIATIVES

• List of Cell Therapy Manufacturing Focused Initiatives of Big Pharma Players
• Competitive Benchmarking of Big Pharmaceutical Players

18. CAPACITY ANALYSIS

19. DEMAND ANALYSIS

• Global Demand for Cell Therapy Manufacturing
• Global Clinical Demand for Cell Therapy Manufacturing
• Global Commercial Demand for Cell Therapy Manufacturing

20. COST PRICE ANALYSIS

• Factors Contributing to the High Price of Cell Therapies
• Pricing Models for Cell Therapies
• Cell Therapy Cost Optimization
• Role of Cell Therapy Contract Manufacturing Organizations
• Reimbursement-related Considerations for Cell Therapies
  • Case Study: The National Institute for Health and Care Excellence's (NICE) Appraisal of CAR-T Therapies

21. MAKE VERSUS BUY DECISION MAKING FRAMEWORK

22. TOTAL COST OF OWNERSHIP FOR CELL THERAPY MANUFACTURING ORGANIZATIONS

• Sample Dataset for the Estimation of Total Cost of Ownership
• Total Cost of Ownership for Mid-sized Cell Therapy Manufacturing Organizations, Y0-Y20
• Total Cost of Ownership for Mid-sized Cell Therapy Manufacturing Organizations: Analysis by CAPEX and OPEX, Y0 and Y20

23. GLOBAL CELL THERAPY MANUFACTURING MARKET

• Global Cell Therapy Manufacturing Market, Historical Trends (2022-2023) and Forecasted Estimates (2024-2035)

24. CELL THERAPY MANUFACTURING MARKET, BY TYPE OF CELL THERAPY

• Cell Therapy Manufacturing Market: Distribution by Type of Cell Therapy, 2022, 2024 and 2035

25. CELL THERAPY MANUFACTURING MARKET, BY SOURCE OF CELLS

• Cell Therapy Manufacturing Market: Distribution by Source of Cells, 2022, 2024 and 2035

26. CELL THERAPY MANUFACTURING MARKET, BY SCALE OF OPERATION

• Cell Therapy Manufacturing Market: Distribution by Scale of Operation, 2022, 2024 And 2035
• Clinical Cell Therapy Manufacturing Market, by Type of Therapy
• Commercial Cell Therapy Manufacturing Market, by Type of Cell Therapy

27. CELL THERAPY MANUFACTURING MARKET, BY TYPE OF MANUFACTURER

• Cell Therapy Manufacturing Market: Distribution by Type of Manufacturer, 2022, 2024 And 2035

28. CELL THERAPY MANUFACTURING MARKET, BY GEOGRAPHY

29. SWOT ANALYSIS

30. SURVEY ANALYSIS

31. CONCLUDING REMARKS

For more information about this report visit https://www.researchandmarkets.com/r/40ji5u

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