Acellular Therapy Market market to grow at a significant CAGR. Acellular Therapy Market market report by BIS Research provides deep market insight, industry analysis, trends.

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March 2022
Global Acellular
Therapy Market -
Strategies and
Applications
Focus on Application, Pipeline, and
Competitive Landscape
Table of Content

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BIS Research is a leading market intelligence and technology research company. BIS Research publishes in-
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Table of Content
Executive Summary..........................................................................13
1. Global Acellular Therapy Market: Strategic Overview ................19
1.1 Acellular Therapy: Overview...........................................................................20
1.2 Stem Cell Therapy ...........................................................................................20
1.2.1 Extracellular Vesicles .................................................................................... 22
1.2.2 Cell-Free Therapy with Extracellular Vesicles............................................. 23
1.3 Cell Therapy vs. Cell-Free Therapy................................................................23
1.3.1 Advantages of Cell Therapy and Cell-Free Therapy ................................... 24
1.3.2 Risks and Limitations of Cell Therapy and Cell-Free Therapy .................. 25
1.3.2.1 Challenges and Risks Associated with Stem Cell-Based Therapy in
Regenerative Medicine............................................................................... 25
1.3.2.2 Challenges and Risks Associated with Cell-Free Therapies:..................... 26
1.4 Application of Extracellular Vesicles (EVs) in Regenerative Medicine .......27
1.4.1.1 Cardiology .................................................................................................. 27
1.4.1.2 Hepatology ................................................................................................. 28
1.4.1.3 Neurology................................................................................................... 29
1.4.1.4 Gastroenterology........................................................................................ 29
1.4.1.5 Oncology .................................................................................................... 30
1.5 Acellular Therapy: A Novel Approach for COVID-19 ....................................31
1.5.1 COVID-19 Therapeutic Strategies Involving the MSC Secretome ............. 31
1.5.2 Extracellular Vesicles Used in COVID-19 for Several Reasons ................. 32
1.6 Expert Insights.................................................................................................33
1.7 Clinical Trial Analysis: Acellular Therapy......................................................34
1.7.1 Acellular Therapy Pipeline Analysis............................................................. 35
1.7.2 Acellular Therapy Clinical Trial Design........................................................ 38
1.7.2.1 ExoFlo ........................................................................................................ 38
1.7.2.1.1 Product Profile.......................................................................................................... 38
1.7.2.1.2 ExoFlo Phase II Study Design ................................................................................. 39
1.8 Extracellular Vesicles-Based Therapeutics: Regulatory Aspects...............43
1.8.1 Regulatory Frameworks in the U.S............................................................... 44

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1.8.2 Regulatory Frameworks in Europe............................................................... 45
1.8.3 Regulatory Frameworks in Canada .............................................................. 46
1.8.4 Regulatory Frameworks in Japan................................................................. 46
1.8.5 Regulatory Frameworks in Australia............................................................ 47
1.8.6 Regulatory Frameworks in South Korea...................................................... 47
1.8.7 Challenges Prior to Clinical Translation ...................................................... 48
1.9 Competitive Landscape ..................................................................................48
1.9.1 Clinical Developments................................................................................... 49
1.9.2 Regulatory and Legal Activities.................................................................... 50
1.9.3 Partnerships and Alliances ........................................................................... 51
1.9.4 Funding Activities .......................................................................................... 52
1.9.5 Business Expansions .................................................................................... 53
1.10 Company Profiles ............................................................................................54
1.10.1 Overview ......................................................................................................... 54
1.10.2 Aegle Therapeutics Corp............................................................................... 54
1.10.2.1 Company Overview.................................................................................... 54
1.10.2.2 Role of Aegle Therapeutics Corp in the Acellular Therapy Market ............ 54
1.10.2.3 Business Strategies.................................................................................... 55
1.10.2.4 SWOT Analysis .......................................................................................... 56
1.10.3 ArunA Biomedical .......................................................................................... 57
1.10.3.1 Company Overview.................................................................................... 57
1.10.3.2 Role of ArunA Biomedical in the Acellular Therapy Market........................ 57
1.10.3.3 Business Strategies.................................................................................... 57
1.10.3.4 SWOT Analysis .......................................................................................... 58
1.10.4 Capricor Therapeutics, Inc............................................................................ 59
1.10.4.1 Company Overview.................................................................................... 59
1.10.4.2 Role of Capricor Therapeutics, Inc. in the Acellular Therapy Market ......... 59
1.10.4.3 Business Strategies.................................................................................... 60
1.10.4.4 SWOT Analysis .......................................................................................... 60
1.10.5 Codiak BioSciences, Inc................................................................................ 61
1.10.5.1 Company Overview.................................................................................... 61
1.10.5.2 Role of Codiak BioSciences, Inc. in the Acellular Therapy Market ............ 61

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1.10.5.3 Financials ................................................................................................... 62
1.10.5.4 Key Insights About Financial Health of the Company ................................ 62
1.10.5.5 Business Strategies.................................................................................... 63
1.10.5.6 SWOT Analysis .......................................................................................... 64
1.10.6 Direct Biologics, LLC..................................................................................... 65
1.10.6.1 Company Overview.................................................................................... 65
1.10.6.2 Role of Direct Biologics, LLC in the Acellular Therapy Market................... 65
1.10.6.3 Business Strategies.................................................................................... 65
1.10.6.4 SWOT Analysis .......................................................................................... 66
1.10.7 EV Therapeutics, Inc...................................................................................... 67
1.10.7.1 Company Overview.................................................................................... 67
1.10.7.2 Role of EV Therapeutics in the Acellular Therapy Market.......................... 67
1.10.7.3 SWOT Analysis .......................................................................................... 68
1.10.8 Evox Therapeutics Ltd................................................................................... 69
1.10.8.1 Company Overview.................................................................................... 69
1.10.8.2 Role of Evox Therapeutics Ltd in the Acellular Therapy Market ................ 69
1.10.8.3 Business Strategies.................................................................................... 70
1.10.8.4 SWOT Analysis .......................................................................................... 71
1.10.9 Exogenus Therapeutics................................................................................. 72
1.10.9.1 Company Overview.................................................................................... 72
1.10.9.2 Role of Exogenus Therapeutics in the Acellular Therapy Market .............. 72
1.10.9.3 Business Strategies.................................................................................... 72
1.10.9.4 SWOT Analysis .......................................................................................... 73
1.10.10 Invitrx Therapeutics, Inc................................................................................ 74
1.10.10.1 Company Overview.................................................................................... 74
1.10.10.2 Role of Invitrx Therapeutics, Inc. in the Acellular Therapy Market ............. 74
1.10.10.3 SWOT Analysis .......................................................................................... 75
1.10.11 Organicell Regenerative Medicine, Inc......................................................... 76
1.10.11.1 Company Overview.................................................................................... 76
1.10.11.2 Role of Organicell Regenerative Medicine, Inc. in the Acellular
Therapy Market .......................................................................................... 76
1.10.11.3 Business Strategies.................................................................................... 77
1.10.11.4 SWOT Analysis .......................................................................................... 78

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1.10.12 Rion LLC ......................................................................................................... 79
1.10.12.1 Company Overview.................................................................................... 79
1.10.12.2 Role of Rion LLC in the Acellular Therapy Market ..................................... 79
1.10.12.3 SWOT Analysis .......................................................................................... 80
1.10.13 Stem Cell Medicine Ltd.................................................................................. 81
1.10.13.1 Company Overview.................................................................................... 81
1.10.13.2 Role of Stem Cell Medicine Ltd. in the Acellular Therapy Market .............. 81
1.10.13.3 Business Strategies.................................................................................... 82
1.10.13.4 SWOT Analysis .......................................................................................... 82

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List of Figures
Figure 1: Count of Published Research Papers for Acellular, Cell-Free, and Exosome-Based Therapy
(Since 2015)
Figure 2: Count of Clinical Trial for Cell-Free or Exosome-Based Therapies (as of March 2022)
Figure 3: Global Acellular Therapy Market: Segmentation
Figure 4: Function of Mesenchymal Stem Cells (MSCs)
Figure 5: Hierarchy of Cell-Based and Cell-Free Therapy
Figure 6: Three Major Classes of Extracellular Vesicles (EVs)
Figure 7: Advantages of Cell-Based and Cell-Free Therapy
Figure 8: Risk Factors with Stem Cell Therapy (SCT)
Figure 9: Clinical Risks with Stem Cell Therapy (SCT)
Figure 10: Extracellular Vesicles (EVs): Potential Therapeutic Tool for Several Disease Areas
Figure 11: Properties of Mesenchymal Stem Cells (MSCs) Secretome
Figure 12: Advantages, Challenges, and Clinical Applications of Cell-Based and Cell-Free Therapy
Figure 13: Number of Clinical Trials by Academic Institutions and Biopharmaceutical Companies
Figure 14: Acellular Drugs Clinical Trials (by Phase), 2022
Figure 15: Acellular Drugs Global Clinical Trials (by Indication), 2022
Figure 16: ExoFlo Phase II Clinical Trial Design for COVID-19 Associated Acute Respiratory Distress
Syndrome (ARDS)
Figure 17: ExoFlo Phase II Clinical Trial Arms and Interventions for COVID-19 Associated Acute
Respiratory Distress Syndrome (ARDS)
Figure 18: ExoFlo Phase II Clinical Trial Design for Mild-to-Moderate COVID-19
Figure 19: ExoFlo Phase II Clinical Trial Arms and Interventions for Mild-to-Moderate COVID-19
Figure 20: Three Factors Determine the Regulatory Status of hMSC-Based Products
Figure 21: Challenges Prior to Clinical Translation
Figure 22: Share of Key Developments and Strategies, January 2018-March 2022
Figure 23: Share of Clinical Developments (by Company), January 2018-March 2022
Figure 24: Share of Regulatory and Legal Activities (by Company), January 2018-March 2022
Figure 25: Share of Partnerships and Alliances (by Company), January 2018-March 2022
Figure 26: Share of Funding Activities (by Company), January 2018-March 2022
Figure 27: Share of Business Expansions (by Company), January 2018-March 2022
Figure 28: Aegle Therapeutics Corp: Product Portfolio
Figure 29: Aegle Therapeutics Corp: SWOT Analysis
Figure 30: ArunA Biomedical: Product Portfolio
Figure 31: ArunA Biomedical: SWOT Analysis
Figure 32: Capricor Therapeutics, Inc.: Product Portfolio
Figure 33: Capricor Therapeutics, Inc.: SWOT Analysis
Figure 34: Codiak BioSciences Inc.: Product Portfolio

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Figure 35: Codiak BioSciences, Inc.: Overall Financials/Revenue, $Million, 2019-2021
Figure 36: Codiak BioSciences, Inc.: R&D Expenditure, $Million, 2019-2021
Figure 37: Codiak BioSciences, Inc.: R&D Expenditure (by Product), $Million, 2019-2021
Figure 38: Codiak BioSciences, Inc.: SWOT Analysis
Figure 39: Direct Biologics, LLC: Product Portfolio
Figure 40: Direct Biologics, LLC: SWOT Analysis
Figure 41: EV Therapeutics, Inc.: Product Portfolio
Figure 42: EV Therapeutics, Inc.: SWOT Analysis
Figure 43: Evox Therapeutics Ltd: Product Portfolio
Figure 44: Evox Therapeutics Ltd: SWOT Analysis
Figure 45: Exogenus Therapeutics: Product Portfolio
Figure 46: Exogenus Therapeutics: SWOT Analysis
Figure 47: Invitrx Therapeutics, Inc.: Product Portfolio
Figure 48: Invitrx Therapeutics, Inc.: SWOT Analysis
Figure 49: Organicell Regenerative Medicine, Inc.: Product Portfolio
Figure 50: Organicell Regenerative Medicine, Inc.: SWOT Analysis
Figure 51: Rion LLC: Product Portfolio
Figure 52: Rion LLC: SWOT Analysis
Figure 53: Stem Cell Medicine Ltd.: Product Portfolio
Figure 54: Stem Cell Medicine Ltd.: SWOT Analysis

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List of Tables
Table 1: Cell Therapies Vs. Cell-Free Therapies
Table 2: Emerging Acellular Drugs Pipeline
Table 3: Regulatory Proteins in ExoFlo

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