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Global Acellular Therapy Market - Strategies and Applications: Focus on Application, Pipeline, and Competitive Landscape

  • Report
  • 85 Pages
  • April 2022
  • Region: Global
  • BIS Research
  • ID: 5575688

This Study Highlights the Acellular Therapy Market: Strategies and Applications

Market Report Coverage - Acellular Therapy

Market Segmentation

  • Acellular Therapy: Overview
  • Stem Cell Therapy
  • Cell Therapy vs. Cell-Free Therapy
  • Application of Extracellular Vesicles (EVs) in Regenerative Medicine
  • Acellular Therapy: A Novel Approach for COVID-19
  • Expert Insights
  • Clinical Trial Analysis: Acellular Therapy
  • Extracellular Vesicles-Based Therapeutics: Regulatory Aspects
  • Competitive Landscape

Key Companies Profiled

Aegle Therapeutics Corp, ArunA Biomedical, Capricor Therapeutics, Inc., Codiak BioSciences, Inc., Direct Biologics, LLC, EV Therapeutics, Inc., Evox Therapeutics Ltd, Exogenus Therapeutics, Invitrx Therapeutics, Inc., Organicell Regenerative Medicine, Inc., Rion LLC, Stem Cell Medicine Ltd.

Key Questions Answered in the Report

  • What is acellular therapy?
  • How has acellular therapy evolved over the years?
  • What are the strategies and methods of implementation in the acellular therapy industry which can affect the future perception of the market?
  • What are the major applications for acellular therapy?
  • How are acellular therapies developed?
  • What are emerging acellular therapies?
  • What does the product pipeline for the acellular therapy market look like?
  • What is the role of acellular therapy in COVID-19 treatment?
  • Which key developmental strategies have been implemented by the major players to sustain in the competitive market?
  • What are the key regulatory implications in developed and developing regions for the acellular therapy market?
  • Who are the leading players with significant offerings to the acellular therapy market, and what is the current market dominance for each of these leading players?
  • Who are the key manufacturers in the acellular therapy market, and what are their contributions?
  • What are the emerging trends in the acellular therapy market, and how are these trends revolutionizing the treatment procedure for multiple disease areas such as cancer, neurological disorders or cardiac diseases?
  • Which regulatory procedures are required to unify the approval process for the emerging acellular therapy market?
  • What are the gaps in regularizing acellular therapy market adoption in regular healthcare routines, and how are these gaps being tackled?

Market Overview

Humans have a finite capacity for regeneration. The goal of regenerative medicine is to help an organism heal. Stem cell research has made remarkable progress, laying a strong foundation for its use in regenerative medicine applications of wounded or diseased tissues. Stem cells (SCs) have been used to transplant into the damaged tissue as SCs live in humans for the remainder of their lives and can help differentiate into new stems and differentiated cells. SC transplantation has become the backbone of regenerative medicine. Intercellular communication between stem and differentiated cells has been a focus of regenerative medicine. However, benefits from some stem cell therapies are related to paracrine actions rather than long-term engraftment and survival of transplanted cells. The benefits of stem cell therapy through paracrine actions have led to the development of a cell-free therapeutic method, also known as acellular therapy. Acellular therapy based on stem cell therapy is expected to be used for promoting regeneration using bioactive chemicals. Intercellular communication between cells is now widely understood to occur through extracellular vesicles (EVs) and not just through soluble bioactive chemicals. Recent research has focused on finding alternatives to cell-based therapy that involves paracrine elements. The utilization of soluble factors (secretome), extracellular vesicles, and mitochondrial transport can all be used to generate stem ""cell-free"" therapies. EVs are now being investigated as possible cell-free therapeutic agents due to their capacity to bypass biological barriers and promote intercellular information transmission of bioactive substances. EVs are a heterogeneous set of lipid membrane-enclosed, double-layered vesicles with distinct biophysical properties and activities in physiology and pathology. Because of their ability to transport nucleic acids (including mRNAs and miRNAs), proteins, and lipids across cells, they are emerging as an important intercellular communication mediator. EVs can communicate with target cells in a variety of ways. The potential use of EVs as therapeutic agents in acellular regenerative medicine has recently received great traction. Additionally, extracellular vesicles are being utilized to treat pathological circumstances and meet the acellular strategy's challenges and operational concerns.

This strategic report provides a multidimensional view of the strategic evolution of the ongoing acellular therapy initiatives. The purpose of the study is to gain a holistic view of the active acellular therapy projects implemented in several countries. The report contains the analysis of variables such as recent trends, technological advancements, and international level initiatives across the globe influencing the adoption of acellular therapy. The scope of this report is centered upon conducting a detailed study of the strategies, best R&D practices across the globe and understanding the focus of eminent stakeholders that are contributing to augmenting the growth of the acellular therapy initiatives.

Table of Contents

1 Global Acellular Therapy Market: Strategic Overview
1.1 Acellular Therapy: Overview
1.2 Stem Cell Therapy
1.2.1 Extracellular Vesicles
1.2.2 Cell-Free Therapy with Extracellular Vesicles
1.3 Cell Therapy vs. Cell-Free Therapy
1.3.1 Advantages of Cell Therapy and Cell-Free Therapy
1.3.2 Risks and Limitations of Cell Therapy and Cell-Free Therapy
1.3.2.1 Challenges and Risks Associated with Stem Cell-Based Therapy in Regenerative Medicine
1.3.2.2 Challenges and Risks Associated with Cell-Free Therapies:
1.4 Application of Extracellular Vesicles (EVs) in Regenerative Medicine
1.4.1.1 Cardiology
1.4.1.2 Hepatology
1.4.1.3 Neurology
1.4.1.4 Gastroenterology
1.4.1.5 Oncology
1.5 Acellular Therapy: A Novel Approach for COVID-19
1.5.1 COVID-19 Therapeutic Strategies Involving the MSC Secretome
1.5.2 Extracellular Vesicles Used in COVID-19 for Several Reasons
1.6 Expert Insights
1.7 Clinical Trial Analysis: Acellular Therapy
1.7.1 Acellular Therapy Pipeline Analysis
1.7.2 Acellular Therapy Clinical Trial Design
1.7.2.1 ExoFlo
1.7.2.1.1 Product Profile
1.7.2.1.2 ExoFlo Phase II Study Design
1.8 Extracellular Vesicles-Based Therapeutics: Regulatory Aspects
1.8.1 Regulatory Frameworks in the U.S.
1.8.2 Regulatory Frameworks in Europe
1.8.3 Regulatory Frameworks in Canada
1.8.4 Regulatory Frameworks in Japan
1.8.5 Regulatory Frameworks in Australia
1.8.6 Regulatory Frameworks in South Korea
1.8.7 Challenges Prior to Clinical Translation
1.9 Competitive Landscape
1.9.1 Clinical Developments
1.9.2 Regulatory and Legal Activities
1.9.3 Partnerships and Alliances
1.9.4 Funding Activities
1.9.5 Business Expansions
1.1 Company Profiles
1.10.1 Overview
1.10.2 Aegle Therapeutics Corp
1.10.2.1 Company Overview
1.10.2.2 Role of Aegle Therapeutics Corp in the Acellular Therapy Market
1.10.2.3 Business Strategies
1.10.2.4 SWOT Analysis
1.10.3 ArunA Biomedical
1.10.3.1 Company Overview
1.10.3.2 Role of ArunA Biomedical in the Acellular Therapy Market
1.10.3.3 Business Strategies
1.10.3.4 SWOT Analysis
1.10.4 Capricor Therapeutics, Inc.
1.10.4.1 Company Overview
1.10.4.2 Role of Capricor Therapeutics, Inc. in the Acellular Therapy Market
1.10.4.3 Business Strategies
1.10.4.4 SWOT Analysis
1.10.5 Codiak BioSciences, Inc.
1.10.5.1 Company Overview
1.10.5.2 Role of Codiak BioSciences, Inc. in the Acellular Therapy Market
1.10.5.3 Financials
1.10.5.4 Key Insights About Financial Health of the Company
1.10.5.5 Business Strategies
1.10.5.6 SWOT Analysis
1.10.6 Direct Biologics, LLC
1.10.6.1 Company Overview
1.10.6.2 Role of Direct Biologics, LLC in the Acellular Therapy Market
1.10.6.3 Business Strategies
1.10.6.4 SWOT Analysis
1.10.7 EV Therapeutics, Inc.
1.10.7.1 Company Overview
1.10.7.2 Role of EV Therapeutics in the Acellular Therapy Market
1.10.7.3 SWOT Analysis
1.10.8 Evox Therapeutics Ltd
1.10.8.1 Company Overview
1.10.8.2 Role of Evox Therapeutics Ltd in the Acellular Therapy Market
1.10.8.3 Business Strategies
1.10.8.4 SWOT Analysis
1.10.9 Exogenus Therapeutics
1.10.9.1 Company Overview
1.10.9.2 Role of Exogenus Therapeutics in the Acellular Therapy Market
1.10.9.3 Business Strategies
1.10.9.4 SWOT Analysis
1.10.10 Invitrx Therapeutics, Inc.
1.10.10.1 Company Overview
1.10.10.2 Role of Invitrx Therapeutics, Inc. in the Acellular Therapy Market
1.10.10.3 SWOT Analysis
1.10.11 Organicell Regenerative Medicine, Inc.
1.10.11.1 Company Overview
1.10.11.2 Role of Organicell Regenerative Medicine, Inc. in the Acellular Therapy Market
1.10.11.3 Business Strategies
1.10.11.4 SWOT Analysis
1.10.12 Rion LLC
1.10.12.1 Company Overview
1.10.12.2 Role of Rion LLC in the Acellular Therapy Market
1.10.12.3 SWOT Analysis
1.10.13 Stem Cell Medicine Ltd.
1.10.13.1 Company Overview
1.10.13.2 Role of Stem Cell Medicine Ltd. in the Acellular Therapy Market
1.10.13.3 Business Strategies
1.10.13.4 SWOT Analysis

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
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

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

Companies Mentioned

  • Aegle Therapeutics Corp
  • ArunA Biomedical
  • Capricor Therapeutics, Inc.
  • Codiak BioSciences, Inc.
  • Direct Biologics, LLC
  • EV Therapeutics, Inc.
  • Evox Therapeutics Ltd
  • Exogenus Therapeutics
  • Invitrx Therapeutics, Inc.
  • Organicell Regenerative Medicine, Inc.
  • Rion LLC
  • Stem Cell Medicine Ltd.