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North America GMP Cell Therapy Consumables Market Forecast to 2028 - COVID-19 Impact and Regional Analysis

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    Report

  • 151 Pages
  • January 2023
  • Region: North America
  • The Insight Partners
  • ID: 5732046
UP TO OFF until Jun 30th 2024
The North America GMP cell therapy consumables market is expected to grow from US$ 6,233.00 million in 2022 to US$ 26,093.86 million by 2028; it is estimated to grow at a CAGR of 27.0% from 2022 to 2028.

Growing Regulatory Approvals for Cell and Gene Therapy (CGT) Product Boosts North America GMP Cell

Therapy Consumables Market

The COVID-19 pandemic accelerated the pace of the ongoing developments in cell and gene therapy (CGT). As per the 2019 U.S. Food and Drug Administration (FDA) report, in the last two years, CGT developers submitted ~500 applications to the FDA to initiate clinical trials. Out of those applications, the FDA predicts that ~10-20 CGT products will be approved annually by 2025. Considering the pace with which the therapies are expected to enter the market, the Alliance for Regenerative Medicine expects this industry's revenues to grow at a CAGR of 40% by 2025.

A few of the FDA-approved CGT developments include:

In 2021, FDA approved Breyanzi. Breyanzi is a cell-based gene therapy to treat patients suffering from certain types of large B-cell lymphoma cancer. Each dose is a customized treatment that uses the patient’s T-cells to fight relapsed or refractory disease.

FDA checks the quality of medication products by carefully monitoring manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations. The regulations comprise minimum requirements for the methods, facilities, and controls to be used during the manufacturing, processing, and packing of a product. The regulations confirm that the product is safe for usage and has the ingredients and strength it claims to have. The approval process for new therapy/drug marketing applications includes a review of the manufacturer's compliance with the CGMPs. FDA evaluators and investigators verify whether the firm has the necessary facilities, equipment, and ability to manufacture the drug it intends to market. Therefore, the outlook of the CGT field is promising due to the increased rate of FDA approvals and patient enthusiasm. In addition, continued advances in CGT following GMP will transform the way diseases are treated and modify healthcare delivery on both the individual and industry levels. Hence, the growing regulatory approvals for cell and gene therapy (CGT) product boosts the North America GMP cell therapy consumables market .

Market Overview

North America is one of the most developed regions in the world. North America accounts for the major share of the GMP cell therapy consumables market over the forecast period. The US is expected to hold the major share in the market owing to the surge in drug discovery, increase in R&D activities, and rise in strategic collaborations among market players. Moreover, rising incidences of cancer, infectious diseases, autoimmune disorders, and neurological disorders have augmented the demand for personalized medicine and regenerative medicine, which, in turn, drive the growth of the GMP cell therapy consumables market. The US holds a significant share of the North America GMP cell therapy consumables market. The market growth is due to rising government health expenditure, increasing developments in the pharmaceutical industry, and growing demand for novel drugs owing to the prevalence of various infectious diseases. According to US Centers for Medicare & Medicaid Services, the national healthcare expenditure in the US increased by 9.7% in 2019 to reach US$ 4.1 trillion in 2020. National health spending is expected to grow at an annual rate of 5.4% from 2019 to 2028, and it is expected to reach US$ 6.2 trillion by 2028. The rising health expenditure is estimated to increase various funding in the research related to the development of drugs, fueling the North America GMP cell therapy consumables market .

North America GMP Cell Therapy Consumables Market Segmentation

The North America GMP cell therapy consumables market is segmented on the basis of product, cell therapy, process, end use, and country.
  • Based on product, the North America GMP cell therapy consumables market is segmented into kits, reagents/molecular biology reagents, growth factors/cytokines and interleukins (including protein and nucleic acid purification buffers), and others. The kits segment held the largest share of the North America GMP cell therapy consumables market in 2022.
  • Based on cell therapy, the North America GMP cell therapy consumables market is segmented into NK cell therapy, stem cell therapy, T-cell therapy, and others. The T-cell therapy segment registered the largest share of the North America GMP cell therapy consumables market in 2022.
  • Based on process, the North America GMP cell therapy consumables market is segmented into cell collection and characterization/sorting and separation, cell culture and expansion/preparation, cryopreservation, cell processing and formulation, cell isolation and activation, cell distribution/handling, process monitoring and control/readministration/quality assurance, and others. The cell collection and characterization/sorting and separation segment held the largest share of the North America GMP cell therapy consumables market in 2022.
  • Based on end use, the North America GMP cell therapy consumables market is segmented into clinical, commercial, and research. The clinical segment held the largest share of the North America GMP cell therapy consumables market in 2022.
  • Based on country, the North America GMP cell therapy consumables market is segmented into the US, Canada, and Mexico. The US dominated the North America GMP cell therapy consumables market in 2022.

Bio-Techne Corp, BPS Bioscience Inc, Corning Inc, FUJIFILM Irvine Scientific Inc, Global Life Sciences Solutions USA LLC, Lonza Group AG, Merck KGaA, Miltenyi Biotec BV & Co KG, Sartorius AG, and Thermo Fisher Scientific Inc are the leading companies operating in the GMP cell therapy consumables market in North America.

Table of Contents

1. Introduction
1.1 Study Scope
1.2 Research Report Guidance
1.3 Market Segmentation
1.3.1 North America GMP Cell Therapy Consumables Market - by Product
1.3.2 North America GMP Cell Therapy Consumables Market - by Cell Therapy
1.3.3 North America GMP Cell Therapy Consumables Market - by End Use
1.3.4 North America GMP Cell Therapy Consumables Market - by End Use
1.3.5 North America GMP Cell Therapy Consumables Market - by Country

2. North America GMP Cell Therapy Consumables Market - Key Takeaways

3. Research Methodology
3.1 Coverage
3.2 Secondary Research
3.3 Primary Research

4. North America GMP Cell Therapy Consumables Market - Market Landscape
4.1 Overview
4.2 North America PEST Analysis
4.3 Experts’ Opinion

5. North America GMP Cell Therapy Consumables Market - Key Market Dynamics
5.1 Market Drivers
5.1.1 Rise in Research & Development and Drug Discovery
5.1.2 Increase in Strategic Collaborations
5.2 Market Restraints
5.2.1 Stringent Regulatory Policies
5.3 Market Opportunities
5.3.1 Growing Regulatory Approvals for Cell and Gene Therapy (CGT) Product
5.4 Future Trends
5.4.1 Increasing Clinical Trials and Rising GMP Demand
5.5 Impact Analysis

6. GMP Cell Therapy Consumables Market - North America Analysis
6.1 North America GMP Cell Therapy Consumables Market Revenue Forecast and Analysis

7. North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 - by Product
7.1 Overview
7.2 North America GMP Cell Therapy Consumables Market Revenue Share, by Product 2021 & 2028 (%)
7.3 Kits
7.3.1 Overview
7.3.2 Kits: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
7.4 Reagents/ Molecular Biology Reagents
7.4.1 Overview
7.4.2 Reagents/ Molecular Biology Reagents: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
7.5 Growth Factors/Cytokines and Interleukins (Including Protein and Nucleic Acid Purification Buffers)
7.5.1 Overview
7.5.2 Growth Factors/Cytokines and Interleukins (Including Protein and Nucleic Acid Purification Buffers): North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
7.6 Others
7.6.1 Overview
7.6.2 Others: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)

8. North America GMP Cell Therapy Consumables Market Analysis and Forecasts to 2028 - by Cell Therapy
8.1 Overview
8.2 North America GMP Cell Therapy Consumables Market, by Cell Therapy 2021 & 2028 (%)
8.3 NK Cell Therapy
8.3.1 Overview
8.3.2 NK Cell Therapy: GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
8.4 Stem Cell Therapy
8.4.1 Overview
8.4.2 Stem Cell Therapy: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
8.5 T-cell Therapy
8.5.1 Overview
8.5.2 T-cell Therapy: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
8.6 Others
8.6.1 Overview
8.6.2 Others: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)

9. North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 - by End Use
9.1 Overview
9.2 North America GMP Cell Therapy Consumables Market Revenue Share, by End User 2021 & 2028 (%)
9.3 Clinical
9.3.1 Overview
9.3.2 Clinical: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
9.4 Commercial
9.4.1 Overview
9.4.2 Commercial: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
9.5 Research
9.5.1 Overview
9.5.2 Research: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)

10. North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 - by Process
10.1 Overview
10.2 North America GMP Cell Therapy Consumables Market Revenue Share, by End User 2021 & 2028 (%)
10.3 Cell Collection and Characterization/Sorting and Separation
10.3.1 Overview
10.3.2 Cell Collection and Characterization/ Sorting and Separation: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
10.4 Cell Culture and Expansion/Preparation
10.4.1 Overview
10.4.2 Cell Culture and Expansion/Preparation: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
10.5 Cryopreservation
10.5.1 Overview
10.5.2 Cryopreservation: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
10.6 Cell Processing and Formulation
10.6.1 Overview
10.6.2 Cell Processing and Formulation: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
10.7 Cell Isolation and Activation
10.7.1 Overview
10.7.2 Cell Isolation and Activation: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
10.8 Cell Distribution/Handling
10.8.1 Overview
10.8.2 Cell Distribution/Handling: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
10.9 Process Monitoring and Control/Readministration/Quality Assurance
10.9.1 Overview
10.9.2 Process Monitoring and Control/Readministration/Quality Assurance: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
10.10 Other
10.10.1 Overview
10.10.2 Other: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)

11. North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 - Country Analysis
11.1 Overview
11.1.1 North America: GMP Cell Therapy Consumables Market, by Country, 2021 & 2028 (%)
11.1.1.1 US: GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ ‘Million)
11.1.1.1.1 Overview
11.1.1.1.2 US: GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ ‘Million)
11.1.1.1.3 US: GMP Cell Therapy Consumables Market, by Product, 2019-2028 (US$ ‘Million)
11.1.1.1.4 US: GMP Cell Therapy Consumables Market, by Cell Therapy, 2019-2028 (US$ ‘Million)
11.1.1.1.5 US: GMP Cell Therapy Consumables Market, by End Use, 2019-2028 (US$ ‘Million)
11.1.1.1.6 US: GMP Cell Therapy Consumables Market, by Process, 2019-2028 (US$ ‘Million)
11.1.1.2 Canada: GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ ‘Million)
11.1.1.2.1 Overview
11.1.1.2.2 Canada: GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ ‘Million)
11.1.1.2.3 Canada: GMP Cell Therapy Consumables Market, by Product, 2019-2028 (US$ ‘Million)
11.1.1.2.4 Canada: GMP Cell Therapy Consumables Market, by Cell Therapy, 2019-2028 (US$ ‘Million)
11.1.1.2.5 Canada: GMP Cell Therapy Consumables Market, by End Use, 2019-2028 (US$ ‘Million)
11.1.1.2.6 Canada: GMP Cell Therapy Consumables Market, by Process, 2019-2028 (US$ ‘Million)
11.1.1.3 Mexico: GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ ‘Million)
11.1.1.3.1 Overview
11.1.1.3.2 Mexico: GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ ‘Million)
11.1.1.3.3 Mexico: GMP Cell Therapy Consumables Market, by Product, 2019-2028 (US$ ‘Million)
11.1.1.3.4 Mexico: GMP Cell Therapy Consumables Market, by Cell Therapy, 2019-2028 (US$ ‘Million)
11.1.1.3.5 Mexico: GMP Cell Therapy Consumables Market, by End Use, 2019-2028 (US$ ‘Million)
11.1.1.3.6 Mexico: GMP Cell Therapy Consumables Market, by Process, 2019-2028 (US$ ‘Million)

12. GMP Cell Therapy Consumables Market - Industry Landscape
12.1 Overview
12.2 Growth Strategies in GMP Cell Therapy Consumables Market
12.3 Inorganic Growth Strategies
12.3.1 Overview
12.4 Organic Growth Strategies
12.4.1 Overview

13. Company Profiles
13.1 Sartorius AG
13.1.1 Key Facts
13.1.2 Business Description
13.1.3 Products and Services
13.1.4 Financial Overview
13.1.5 SWOT Analysis
13.1.6 Key Developments
13.2 Thermo Fisher Scientific Inc
13.2.1 Key Facts
13.2.2 Business Description
13.2.3 Products and Services
13.2.4 Financial Overview
13.2.5 SWOT Analysis
13.2.6 Key Developments
13.3 Miltenyi Biotec BV & Co KG
13.3.1 Key Facts
13.3.2 Business Description
13.3.3 Products and Services
13.3.4 Financial Overview
13.3.5 SWOT Analysis
13.3.6 Key Developments
13.4 Bio-Techne Corp
13.4.1 Key Facts
13.4.2 Business Description
13.4.3 Products and Services
13.4.4 Financial Overview
13.4.5 SWOT Analysis
13.4.6 Key Developments
13.5 Corning Inc
13.5.1 Key Facts
13.5.2 Business Description
13.5.3 Products and Services
13.5.4 Financial Overview
13.5.5 SWOT Analysis
13.5.6 Key Developments
13.6 FUJIFILM Irvine Scientific Inc
13.6.1 Key Facts
13.6.2 Business Description
13.6.3 Products and Services
13.6.4 Financial Overview
13.6.5 SWOT Analysis
13.6.6 Key Developments
13.7 Lonza Group AG
13.7.1 Key Facts
13.7.2 Business Description
13.7.3 Products and Services
13.7.4 Financial Overview
13.7.5 SWOT Analysis
13.7.6 Key Developments
13.8 BPS Bioscience Inc
13.8.1 Key Facts
13.8.2 Business Description
13.8.3 Products and Services
13.8.4 Financial Overview
13.8.5 SWOT Analysis
13.8.6 Key Developments
13.9 Merck KGaA
13.9.1 Key Facts
13.9.2 Business Description
13.9.3 Products and Services
13.9.4 Financial Overview
13.9.5 SWOT Analysis
13.9.6 Key Developments
13.10 Global Life Sciences Solutions USA LLC
13.10.1 Key Facts
13.10.2 Business Description
13.10.3 Products and Services
13.10.4 Financial Overview
13.10.5 SWOT Analysis
13.10.6 Key Developments

14. Appendix
14.1 About the Publisher
14.2 Glossary of Terms
Table 1. US: GMP Cell Therapy Consumables Market, by Product - Revenue and Forecast to 2028 (US$ ‘Million)
Table 2. US: GMP Cell Therapy Consumables Market, by Cell Therapy - Revenue and Forecast to 2028 (US$ ‘Million)
Table 3. US: GMP Cell Therapy Consumables Market, by End Use- Revenue and Forecast to 2028 (US$ ‘Million)
Table 4. US: GMP Cell Therapy Consumables Market, by Process - Revenue and Forecast to 2028 (US$ ‘Million)
Table 5. Canada: GMP Cell Therapy Consumables Market, by Product - Revenue and Forecast to 2028 (US$ ‘Million)
Table 6. Canada: GMP Cell Therapy Consumables Market, by Cell Therapy - Revenue and Forecast to 2028 (US$ ‘Million)
Table 7. Canada: GMP Cell Therapy Consumables Market, by End Use- Revenue and Forecast to 2028 (US$ ‘Million)
Table 8. Canada: GMP Cell Therapy Consumables Market, by Process - Revenue and Forecast to 2028 (US$ ‘Million)
Table 9. Mexico: GMP Cell Therapy Consumables Market, by Product - Revenue and Forecast to 2028 (US$ ‘Million)
Table 10. Mexico: GMP Cell Therapy Consumables Market, by Cell Therapy - Revenue and Forecast to 2028 (US$ ‘Million)
Table 11. Mexico: GMP Cell Therapy Consumables Market, by End Use- Revenue and Forecast to 2028 (US$ ‘Million)
Table 12. Mexico: GMP Cell Therapy Consumables Market, by Process - Revenue and Forecast to 2028 (US$ ‘Million)
Table 13. Recent Inorganic Growth Strategies in the GMP Cell Therapy Consumables Market
Table 14. Recent Organic Growth Strategies in GMP Cell Therapy Consumables Market
Table 15. Glossary of Terms


Figure 1. North America GMP Cell Therapy Consumables Market Segmentation
Figure 2. North America GMP Cell Therapy Consumables Market, by Country
Figure 3. North America GMP Cell Therapy Consumables Market Overview
Figure 4. Kits Segment Held the Largest Share of Product Segment in North America GMP Cell Therapy Consumables Market
Figure 5. US Expected to Show Remarkable Growth During Forecast Period
Figure 6. North America: PEST Analysis
Figure 7. Experts’ Opinion
Figure 8. North America GMP Cell Therapy Consumables Market: Impact Analysis of Drivers and Restraints
Figure 9. North America GMP Cell Therapy Consumables Market - Revenue Forecast and Analysis - 2019-2028
Figure 10. North America GMP Cell Therapy Consumables Market Revenue Share, by Product 2021 & 2028 (%)
Figure 11. Kits: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
Figure 12. Reagents/ Molecular Biology Reagents: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
Figure 13. Growth Factors/Cytokines and Interleukins (Including Protein and Nucleic Acid Purification Buffers): North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
Figure 14. Others: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
Figure 15. North America GMP Cell Therapy Consumables Market, by Cell Therapy 2021 & 2028 (%)
Figure 16. NK Cell Therapy: GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
Figure 17. Stem Cell Therapy: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
Figure 18. T-cell Therapy: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
Figure 19. Other Applications: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
Figure 20. North America GMP Cell Therapy Consumables Market Revenue Share, by End User 2021 & 2028 (%)
Figure 21. Clinical: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
Figure 22. Commercial: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
Figure 23. Research: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
Figure 24. North America GMP Cell Therapy Consumables Market Revenue Share, by End User 2021 & 2028 (%)
Figure 25. Cell Collection and Characterization/Sorting and Separation: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
Figure 26. Cell Culture and Expansion/Preparation: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
Figure 27. Cryopreservation: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
Figure 28. Cell Processing and Formulation: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
Figure 29. Cell Isolation and Activation: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
Figure 30. Cell Distribution/Handling: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
Figure 31. Process Monitoring and Control/Readministration/Quality Assurance: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
Figure 32. Other: North America GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ Million)
Figure 33. North America: GMP Cell Therapy Consumables Market, by Key Country - Revenue (2021) (US$ ‘Million)
Figure 34. North America: GMP Cell Therapy Consumables Market, by Country, 2021 & 2028 (%)
Figure 35. US: GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ ‘Million)
Figure 36. Canada: GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ ‘Million)
Figure 37. Mexico: GMP Cell Therapy Consumables Market - Revenue and Forecast to 2028 (US$ ‘Million)
Figure 38. Growth Strategies in GMP Cell Therapy Consumables Market

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Bio-Techne Corp
  • BPS Bioscience Inc
  • Corning Inc
  • FUJIFILM Irvine Scientific Inc
  • Global Life Sciences Solutions USA LLC
  • Lonza Group AG
  • Merck KGaA
  • Miltenyi Biotec BV & Co KG
  • Sartorius AG
  • Thermo Fisher Scientific Inc

Table Information