Automated Cell Processing System Market: Focus on Apheresis, Expansion, Harvest, Fill / Finish, Cryopreservation, Thawing, 2020-2030
The automated cell processing system market is expected to reach USD 220 million in 2020 and anticipated to grow at a CAGR of 16% during the forecast period 2020-2030.
Advanced Therapy Medicinal Products (ATMPs), such as cell and gene therapies, have entered a transformative phase within the healthcare sector. Over the past two decades, regulatory approval has been granted to more than 30 ATMPs. Presently, there are over 1,050 clinical trials undertaken by more than 1,000 global companies dedicated to evaluating cell and gene therapies, as reported by The Alliance for Regenerative Medicine. However, despite advancements in the automated cell processing system market, several challenges impede their commercial success. The current manufacturing process for cell therapy is laborious, time-consuming, and expensive. Specialized therapeutic products often require manual labor in distinct (open processing) settings, making scalability difficult and posing a high risk of contamination. Another concern is the variability between batches, where even slight alterations in production protocols can impact product quality. Consequently, cell therapies are priced significantly, ranging from USD 300,000 to USD 500,000 per dose.
Experts propose that addressing manufacturing challenges in cell therapy can be accomplished by embracing automated and closed cell processing systems. These solutions efficiently oversee multiple aspects of the manufacturing process while complying with global regulatory standards. Their advantages include reduced contamination risk, optimized utilization of facilities and resources, minimized process variation, and consistent product quality. Additionally, these systems offer substantial reductions in labor costs, estimated between 40% to 90%. The potential for cost savings, combined with the streamlining of complex cell therapy processing, has garnered substantial interest from stakeholders in the automated cell processing system market. With the growing demand for cost-effective personalized medicine and the benefits offered by automated closed systems, it is anticipated that this specialized market will undergo significant growth in the forecasted future.
Report Coverage
Advanced Therapy Medicinal Products (ATMPs), such as cell and gene therapies, have entered a transformative phase within the healthcare sector. Over the past two decades, regulatory approval has been granted to more than 30 ATMPs. Presently, there are over 1,050 clinical trials undertaken by more than 1,000 global companies dedicated to evaluating cell and gene therapies, as reported by The Alliance for Regenerative Medicine. However, despite advancements in the automated cell processing system market, several challenges impede their commercial success. The current manufacturing process for cell therapy is laborious, time-consuming, and expensive. Specialized therapeutic products often require manual labor in distinct (open processing) settings, making scalability difficult and posing a high risk of contamination. Another concern is the variability between batches, where even slight alterations in production protocols can impact product quality. Consequently, cell therapies are priced significantly, ranging from USD 300,000 to USD 500,000 per dose.
Experts propose that addressing manufacturing challenges in cell therapy can be accomplished by embracing automated and closed cell processing systems. These solutions efficiently oversee multiple aspects of the manufacturing process while complying with global regulatory standards. Their advantages include reduced contamination risk, optimized utilization of facilities and resources, minimized process variation, and consistent product quality. Additionally, these systems offer substantial reductions in labor costs, estimated between 40% to 90%. The potential for cost savings, combined with the streamlining of complex cell therapy processing, has garnered substantial interest from stakeholders in the automated cell processing system market. With the growing demand for cost-effective personalized medicine and the benefits offered by automated closed systems, it is anticipated that this specialized market will undergo significant growth in the forecasted future.
Report Coverage
- The report conducts an examination of the automated cell processing system market based on distinct cell processing stages, operational scope, end-user categories, and geographic regions.
- It thoroughly analyzes various factors, including drivers, restraints, opportunities, and challenges, that impact the market's growth trajectory.
- It evaluates potential advantages and impediments within the market, providing insights into the competitive landscape for leading market players.
- The report offers revenue forecasts for market segments across five different regions.
- It conducts an extensive evaluation encompassing more than 60 automated and closed systems currently present in the market. This evaluation is aligned with specific cell therapy processing stages such as apheresis, separation, expansion, harvest, fill/finish, cryopreservation, and thawing. Detailed attributes include essential features like traceability, user-friendliness, configurability, scalability, process monitoring, touch-screen user interface, data management, integration capabilities, and alert systems. Product specifications cover dimensions (length, width, depth, height, and weight), supported cell types (stem cells and immune cells), cell culture types (adherent and suspension), operational scales (pre-clinical, clinical, and commercial), application scopes (research and therapeutic), and end-user categories (hospitals/medical centers/clinics, research institutes/academic institutes, laboratories, commercial organizations), as well as support services offered such as product support, technical assistance, training, installation, validation, maintenance, regulatory compliance, among others.
- A comprehensive assessment is conducted considering supplier power based on developer experience/expertise in the industry, portfolio aspects encompassing the number of systems, supported cells, culture types, operational scales, applications, end-users, support services, regulatory certifications, and key product specifications. Supplier competitiveness is evaluated based on these diverse parameters.
- Detailed profiles of industry participants offering automated and closed cell therapy processing systems are provided, including company overviews, financial details (if available), and comprehensive system descriptions. Each profile incorporates recent developments, highlighting achievements, partnership activities, and future growth strategies envisioned by these entities.
- A thorough review of partnerships in automated and closed cell therapy processing systems since 2016 is presented, considering parameters such as partnership year, adopted models, therapy types, cell processing steps, systems involved, partner focus areas, major contributors (in terms of partnership quantity), and geographical locations of collaborators.
- An exploration is made into recent initiatives undertaken by major pharmaceutical entities in the automated cell processing system market. This assessment evaluates their strategic activities, investments, and engagements within this domain.
- Cytiva
- Pall
- Terumo BCT
- ThermoGenesis
1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Context and Background
3.2. Cell Therapies
3.3. Cell Therapy Manufacturing
3.4. Key Challenges Associated with Manufacturing Cell Therapies
3.5. Overview of Automated and Closed Cell Processing Systems
3.5.1. Need for Automated and Closed Cell Processing in Cell Therapy Manufacturing
3.5.2. Advantages and Affiliated Challenges
3.6. Key Growth Drivers and Roadblocks
3.7. Recent Developments and Upcoming Trends
4. COMPETITIVE LANDSCAPE
4.1. Chapter Overview
4.2. Automated and Closed Cell Therapy Processing Systems: Overall Market Landscape
4.2.1. Analysis by Cell Processing Step
4.2.2. Analysis by Types of Cells
4.2.3. Analysis by Type of Culture
4.2.4. Analysis by Scale of Operation
4.2.5. Analysis by Key Features
4.2.6. Analysis by Application Area
4.2.7. Analysis by Regulatory Certifications / Accreditations
4.2.8. Analysis by End User
4.3. Automated and Closed Cell Therapy Processing Systems: Developer Landscape
4.3.1. Analysis by Year of Establishment
4.3.2. Analysis by Company Size
4.3.3. Analysis by Type of Support Service(s) Offered
4.3.4. Analysis by Location of Headquarters
5. PRODUCT COMPETITIVENESS ANALYSIS
5.1. Chapter Overview
5.2. Assumptions / Key Parameters
5.3. Methodology
5.4. Product Competitiveness Analysis
5.4.1. Automated and Closed Cell Processing Systems for Apheresis
5.4.2. Automated and Closed Cell Processing Systems for Separation
5.4.3. Automated and Closed Cell Processing Systems for Expansion
5.4.4. Automated and Closed Cell Processing Systems for Harvest
5.4.5. Automated and Closed Cell Processing Systems for Fill Finish
5.4.6. Automated and Closed Cell Processing Systems for Cryopreservation
5.4.7. Automated and Closed Cell Processing Systems for Thawing
6. COMPANY PROFILES
6.1 Chapter Overview
6.2 Cytiva
6.2.1. Company Overview
6.2.2. Product Portfolio
6.2.3. Recent Developments and Future Outlook
6.3. Pall
6.3.1. Company Overview
6.3.2. Product Portfolio
6.3.3. Recent Developments and Future Outlook
6.4. Terumo BCT
6.4.1. Company Overview
6.4.2. Product Portfolio
6.4.3. Financial Information
6.4.4. Recent Developments and Future Outlook
6.5 ThermoGenesis
6.5.1. Company Overview
6.5.2. Product Portfolio
6.5.3. Financial Information
6.5.4. Recent Developments and Future Outlook
7. PARTNERSHIPS
7.1 Chapter Overview
7.2. Partnership Models
7.3. Automated and Closed Cell Therapy Processing Systems: Recent Partnerships
7.3.1. Analysis by Year of Partnership
7.3.2. Analysis by Type of Partnership
7.3.3. Analysis by Type of Therapy
7.3.4. Analysis by Cell Processing Step
7.3.5. Analysis by Type of Automated and Closed Cell Processing Systems
7.3.6. Analysis by Partner’s Focus Area
7.3.7. Most Active Players: Analysis by Number of Partnerships
7.3.8. Geographical Analysis
7.3.8.1. Country-Wise Distribution
7.3.8.2. Intercontinental and Intracontinental Agreements
8. BIG PHARMA INITIATIVES IN AUTOMATED AND CLOSED CELL THERAPY PROCESSING SYSTEMS DOMAIN
8.1. Chapter Overview
8.2. Initiatives Undertaken by Big Pharma Players
8.2.1. Initiatives Undertaken by AbbVie
8.2.2. Initiatives Undertaken by Bristol Myers Squibb
8.2.3. Initiatives Undertaken by Gilead Sciences
8.2.4. Initiatives Undertaken by GlaxoSmithKline
8.2.5. Initiatives Undertaken by Johnson & Johnson
8.2.6. Initiatives Undertaken by Novartis
8.2.7. Initiatives Undertaken by Roche
8.2.8. Initiatives Undertaken by Sanofi
8.2.9. Initiatives Undertaken by Takeda Pharmaceutical
8.2.10. Summary of Big Pharma Initiatives
9. LIKELY PARTNER
9.1. Chapter Overview
9.2. Scope and Methodology
9.3. Automated and Closed Cell Therapy Processing Systems: Potential Strategic Partners for Cell Therapy Development
9.3.1. Dendritic Cell Therapy
9.3.2. Stem Cell Therapy
9.3.3. T-cell Therapy
9.3.4. Natural Killer Cell Therapy
9.4. Automated and Closed Cell Therapy Processing Systems: Potential Strategic Partners for Cell Therapy Manufacturing
9.4.1. Dendritic Cell Therapy
9.4.2. Stem Cell Therapy,
9.4.3. T-cell Therapy
9.4.4. Natural Killer Cell Therapy
10. CASE STUDY: COST BENEFIT ANALYSIS USING PARTIALLY AUTOMATED AND FULLY AUTOMATED SYSTEMS
10.1. Chapter Overview
10.2. Comparative Analysis of Manual, Partially Automated and Fully Automated Cell Processing Systems
10.3. Likely Cost Saving Potential for Kymriah®
10.4. Likely Cost Saving Potential for Yescarata®
10.5. Cost Saving Potential of Fully Automated Processing Systems: Regional Trends
10.6. Concluding Remarks
11. MARKET SIZING AND OPPORTUNITY ANALYSIS
11.1. Chapter Overview
11.2. Key Assumptions and Methodology
11.3. Overall Automated and Closed Cell Therapy Processing Systems Market, 2020-2030
11.3.1. Overall Automated and Closed Cell Therapy Processing Systems Market: Distribution by Cell Therapy Processing Step
11.3.1.1. Automated and Closed Cell Therapy Processing Systems Market for Apheresis, 2020-2030
11.3.1.2. Automated and Closed Cell Therapy Processing Systems Market for Separation, 2020-2030
11.3.1.3. Automated and Closed Cell Therapy Processing Systems Market for Expansion, 2020-2030
11.3.1.4. Automated and Closed Cell Therapy Processing Systems Market for Harvest, 2020-2030
11.3.1.5. Automated and Closed Cell Therapy Processing Systems Market for Fill / Finish, 2020-2030
11.3.1.6. Automated and Closed Cell Therapy Processing Systems Market for Cryopreservation, 2020-2030
11.3.1.7. Automated and Closed Cell Therapy Processing Systems Market for Thawing, 2020-2030
11.3.2. Automated and Closed Cell Therapy Processing Systems Market: Distribution by Scale of Operation
11.3.2.1. Automated and Closed Cell Therapy Processing Systems Market for Pre-clinical / Clinical Operations, 2020-2030
11.3.2.2. Automated and Closed Cell Therapy Processing Systems Market for Commercial Operations, 2020-2030
11.3.3. Automated and Closed Cell Therapy Processing Systems Market: Distribution by End User
11.3.3.1. Automated and Closed Cell Therapy Processing Systems Market for Hospitals / Medical Centers / Clinics / Research Institutes / Academic Institutes, 2020-2030
11.3.3.2. Automated and Closed Cell Therapy Processing Systems Market for Cell Therapy Manufacturers / Developers, 2020-2030
11.3.4. Automated and Closed Cell Therapy Processing Systems Market: Distribution by Key Geographic Regions
11.3.4.1. Automated and Closed Cell Therapy Processing Systems Market in North America, 2020-2030
11.3.4.2. Automated and Closed Cell Therapy Processing Systems Market in Europe, 2020-2030
11.3.4.3. Automated and Closed Cell Therapy Processing Systems Market in Asia-Pacific, 2020-2030
11.3.4.4. Automated and Closed Cell Therapy Processing Systems Market in Latin America (LATAM), 2020-2030
11.3.4.5. Automated and Closed Cell Therapy Processing Systems Market in Middle East North America (MENA), 2020-2030
12. CONCLUSION
12.1. Chapter Overview
12.2. Key Takeaways
13. INTERVIEW / SURVEY TRANSCRIPT(S)
14. APPENDIX 1: TABULATED DATA
15. APPENDIX 2: LIST OF COMPANIES AND ORGANISTIONS
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Context and Background
3.2. Cell Therapies
3.3. Cell Therapy Manufacturing
3.4. Key Challenges Associated with Manufacturing Cell Therapies
3.5. Overview of Automated and Closed Cell Processing Systems
3.5.1. Need for Automated and Closed Cell Processing in Cell Therapy Manufacturing
3.5.2. Advantages and Affiliated Challenges
3.6. Key Growth Drivers and Roadblocks
3.7. Recent Developments and Upcoming Trends
4. COMPETITIVE LANDSCAPE
4.1. Chapter Overview
4.2. Automated and Closed Cell Therapy Processing Systems: Overall Market Landscape
4.2.1. Analysis by Cell Processing Step
4.2.2. Analysis by Types of Cells
4.2.3. Analysis by Type of Culture
4.2.4. Analysis by Scale of Operation
4.2.5. Analysis by Key Features
4.2.6. Analysis by Application Area
4.2.7. Analysis by Regulatory Certifications / Accreditations
4.2.8. Analysis by End User
4.3. Automated and Closed Cell Therapy Processing Systems: Developer Landscape
4.3.1. Analysis by Year of Establishment
4.3.2. Analysis by Company Size
4.3.3. Analysis by Type of Support Service(s) Offered
4.3.4. Analysis by Location of Headquarters
5. PRODUCT COMPETITIVENESS ANALYSIS
5.1. Chapter Overview
5.2. Assumptions / Key Parameters
5.3. Methodology
5.4. Product Competitiveness Analysis
5.4.1. Automated and Closed Cell Processing Systems for Apheresis
5.4.2. Automated and Closed Cell Processing Systems for Separation
5.4.3. Automated and Closed Cell Processing Systems for Expansion
5.4.4. Automated and Closed Cell Processing Systems for Harvest
5.4.5. Automated and Closed Cell Processing Systems for Fill Finish
5.4.6. Automated and Closed Cell Processing Systems for Cryopreservation
5.4.7. Automated and Closed Cell Processing Systems for Thawing
6. COMPANY PROFILES
6.1 Chapter Overview
6.2 Cytiva
6.2.1. Company Overview
6.2.2. Product Portfolio
6.2.3. Recent Developments and Future Outlook
6.3. Pall
6.3.1. Company Overview
6.3.2. Product Portfolio
6.3.3. Recent Developments and Future Outlook
6.4. Terumo BCT
6.4.1. Company Overview
6.4.2. Product Portfolio
6.4.3. Financial Information
6.4.4. Recent Developments and Future Outlook
6.5 ThermoGenesis
6.5.1. Company Overview
6.5.2. Product Portfolio
6.5.3. Financial Information
6.5.4. Recent Developments and Future Outlook
7. PARTNERSHIPS
7.1 Chapter Overview
7.2. Partnership Models
7.3. Automated and Closed Cell Therapy Processing Systems: Recent Partnerships
7.3.1. Analysis by Year of Partnership
7.3.2. Analysis by Type of Partnership
7.3.3. Analysis by Type of Therapy
7.3.4. Analysis by Cell Processing Step
7.3.5. Analysis by Type of Automated and Closed Cell Processing Systems
7.3.6. Analysis by Partner’s Focus Area
7.3.7. Most Active Players: Analysis by Number of Partnerships
7.3.8. Geographical Analysis
7.3.8.1. Country-Wise Distribution
7.3.8.2. Intercontinental and Intracontinental Agreements
8. BIG PHARMA INITIATIVES IN AUTOMATED AND CLOSED CELL THERAPY PROCESSING SYSTEMS DOMAIN
8.1. Chapter Overview
8.2. Initiatives Undertaken by Big Pharma Players
8.2.1. Initiatives Undertaken by AbbVie
8.2.2. Initiatives Undertaken by Bristol Myers Squibb
8.2.3. Initiatives Undertaken by Gilead Sciences
8.2.4. Initiatives Undertaken by GlaxoSmithKline
8.2.5. Initiatives Undertaken by Johnson & Johnson
8.2.6. Initiatives Undertaken by Novartis
8.2.7. Initiatives Undertaken by Roche
8.2.8. Initiatives Undertaken by Sanofi
8.2.9. Initiatives Undertaken by Takeda Pharmaceutical
8.2.10. Summary of Big Pharma Initiatives
9. LIKELY PARTNER
9.1. Chapter Overview
9.2. Scope and Methodology
9.3. Automated and Closed Cell Therapy Processing Systems: Potential Strategic Partners for Cell Therapy Development
9.3.1. Dendritic Cell Therapy
9.3.2. Stem Cell Therapy
9.3.3. T-cell Therapy
9.3.4. Natural Killer Cell Therapy
9.4. Automated and Closed Cell Therapy Processing Systems: Potential Strategic Partners for Cell Therapy Manufacturing
9.4.1. Dendritic Cell Therapy
9.4.2. Stem Cell Therapy,
9.4.3. T-cell Therapy
9.4.4. Natural Killer Cell Therapy
10. CASE STUDY: COST BENEFIT ANALYSIS USING PARTIALLY AUTOMATED AND FULLY AUTOMATED SYSTEMS
10.1. Chapter Overview
10.2. Comparative Analysis of Manual, Partially Automated and Fully Automated Cell Processing Systems
10.3. Likely Cost Saving Potential for Kymriah®
10.4. Likely Cost Saving Potential for Yescarata®
10.5. Cost Saving Potential of Fully Automated Processing Systems: Regional Trends
10.6. Concluding Remarks
11. MARKET SIZING AND OPPORTUNITY ANALYSIS
11.1. Chapter Overview
11.2. Key Assumptions and Methodology
11.3. Overall Automated and Closed Cell Therapy Processing Systems Market, 2020-2030
11.3.1. Overall Automated and Closed Cell Therapy Processing Systems Market: Distribution by Cell Therapy Processing Step
11.3.1.1. Automated and Closed Cell Therapy Processing Systems Market for Apheresis, 2020-2030
11.3.1.2. Automated and Closed Cell Therapy Processing Systems Market for Separation, 2020-2030
11.3.1.3. Automated and Closed Cell Therapy Processing Systems Market for Expansion, 2020-2030
11.3.1.4. Automated and Closed Cell Therapy Processing Systems Market for Harvest, 2020-2030
11.3.1.5. Automated and Closed Cell Therapy Processing Systems Market for Fill / Finish, 2020-2030
11.3.1.6. Automated and Closed Cell Therapy Processing Systems Market for Cryopreservation, 2020-2030
11.3.1.7. Automated and Closed Cell Therapy Processing Systems Market for Thawing, 2020-2030
11.3.2. Automated and Closed Cell Therapy Processing Systems Market: Distribution by Scale of Operation
11.3.2.1. Automated and Closed Cell Therapy Processing Systems Market for Pre-clinical / Clinical Operations, 2020-2030
11.3.2.2. Automated and Closed Cell Therapy Processing Systems Market for Commercial Operations, 2020-2030
11.3.3. Automated and Closed Cell Therapy Processing Systems Market: Distribution by End User
11.3.3.1. Automated and Closed Cell Therapy Processing Systems Market for Hospitals / Medical Centers / Clinics / Research Institutes / Academic Institutes, 2020-2030
11.3.3.2. Automated and Closed Cell Therapy Processing Systems Market for Cell Therapy Manufacturers / Developers, 2020-2030
11.3.4. Automated and Closed Cell Therapy Processing Systems Market: Distribution by Key Geographic Regions
11.3.4.1. Automated and Closed Cell Therapy Processing Systems Market in North America, 2020-2030
11.3.4.2. Automated and Closed Cell Therapy Processing Systems Market in Europe, 2020-2030
11.3.4.3. Automated and Closed Cell Therapy Processing Systems Market in Asia-Pacific, 2020-2030
11.3.4.4. Automated and Closed Cell Therapy Processing Systems Market in Latin America (LATAM), 2020-2030
11.3.4.5. Automated and Closed Cell Therapy Processing Systems Market in Middle East North America (MENA), 2020-2030
12. CONCLUSION
12.1. Chapter Overview
12.2. Key Takeaways
13. INTERVIEW / SURVEY TRANSCRIPT(S)
14. APPENDIX 1: TABULATED DATA
15. APPENDIX 2: LIST OF COMPANIES AND ORGANISTIONS
