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Mesenchymal Stem Cells / Medicinal Signaling Cells (MSCs) - Advances & Applications, 2025

Published Apr 01, 2025
Length 381 Pages
SKU # BFM19886921

Description



EXECUTIVE SUMMARY

MSCs are multipotent cells that have been referred to as mesenchymal stem cells, medicinal signaling cells, and mesenchymal stromal cells, reflecting their versatility and diverse applications. MSCs can differentiate into a variety of cell types, such as osteoblasts, chondrocytes, myocytes, and adipocytes. Their unique ability to secrete factors that promote tissue repair and modulate their microenvironment with anti-inflammatory and anti-fibrotic effects makes them essential in regenerative medicine. Furthermore, their immuno-evasive properties make MSCs particularly suitable for allogenic transplantation.

MSCs serve as vital raw materials across numerous industries, including regenerative medicine, cosmeceuticals, and cultured meat production. Key applications include:

Cell-based therapies for musculoskeletal diseases, spinal injuries, and cardiovascular conditions.
Engineered tissues and organs, such as skin, bone, blood vessels, and liver.
Cell-derived products, such as exosomes and growth factors, utilized in cosmetics and skincare.
Cultured meat production, leveraging MSCs' role in muscle development and their ability to differentiate into muscle and fat cells.

Globally, 12 MSC-based therapies have been approved for various indications, with the majority concentrated in South Korea, Japan, and the EU.

Specifically, the Republic of Korea has approved five products: Queencell from Anterogen, Cellgram AMI from Pharmicell, Cupistem from Anterogen, Cartistem from Medipost, and NeuroNataR from Corestem. Japan has approved two products: Temcell HS from JCR Pharmaceuticals and Stemirac from Nipro Corporation. The EMA in Europe has approved two products: Holoclar from Chiesi Farmaceutici and Alofisel from TiGenix/Takeda. India has approved one product: Stempeucel from Stempeutics. Iran has approved one product: MesestroCell developed by Cell Tech Pharmed. Finally, Australia has approved one product: Remestemcel-L from Mesoblast.

Despite this progress, no MSC-based therapeutic have yet received U.S. FDA approval, although the FDA is actively reviewing Mesoblast’s Remestemcel-L.

The cosmeceutical market is also rapidly adopting MSC-derived products, particularly exosomes, to leverage their anti-aging and regenerative properties, with companies like L’Oréal and Johnson & Johnson investing heavily in this space. Similarly, cultured meat companies are utilizing MSCs for producing muscle and fat cells, enhancing taste and texture. Groundbreaking approvals, such as lab-grown chicken by Upside Foods and Good Meat, have paved the way for further growth in this industry.

MSC-based gene editing is expanding, enabling the overexpression of antitumor genes and therapeutic factors. Researchers are also exploring the use of MSCs in 3D printing and engineered organ production, with breakthroughs anticipated in the next decade.

Importantly, companies like Cynata Therapeutics are pioneering iPSC-derived MSC production technologies, enabling large-scale therapeutic development. Today there are at least eight companies who are involved with the development of iPSC-derived MSCs therapeutics (iMSCs), including Cynata Therapeutics, Eterna Therapeutics, Implant Therapeutics, Bone Therapeutics, Brooklyn ImmunoTherapeutics, Fujifilm CDI, Citius Pharmaceuticals, and Kiji Therapeutics.

There are also over 1,670 clinical trials involving MSCs are registered on ClinicalTrials.gov. Nearly 75% (three-quarters) of these clinical studies are using MSCs for the development of regenerative medicine (RM) products. Approximately 14% of the studies are using MSCs for disease modeling. The remaining 11% of the studies are using MSCs for drug discovery and cytotoxicity testing applications.

Challenges in these trials include maintaining MSC phenotype and functionality during expansion. However, ongoing advancements suggest a promising future, with projections for at least 50 globally approved MSC-based products by 2040, averaging 3–4 new approvals annually.

Key Players in MSC Research Products

The demand for MSC-based research products has surged in recent years, with major suppliers expanding their portfolios. Companies like RoosterBio have increased the access to quality MSCs through supply chain industrialization, standardized cell bank product forms, and fit-for-purpose cGMP-compatible cells and media systems.

Other leading MSC research product suppliers include PromoCell, Lonza, Thermo Fisher Scientific, STEMCELL Technologies, Miltenyi Biotec, Bio-Techne (R&D Systems), ScienCell Research Laboratories, and the ATCC.

Challenges and Opportunities

While MSC commercialization faces hurdles—such as scalability and regulatory approval—opportunities abound. The market for MSC-based products is poised for notable growth across the research, therapeutic, cosmetic, and food industries.

Within this rapidly changing landscape, having a thorough understanding of the competition is essential.

This global strategic report presents rates of MSC clinical trials, scientific publications, patents, funding events, and collaborations. It presents the pipeline for MSC-based therapeutics, identifies market opportunities and threats, and explores future directions and emerging applications. It reveals innovative MSC products, services, and technologies offered by 125 leading competitors. Finally, it presents detailed market size figures for the global MSC market, segmented by geography and business segment with future forecasts through 2031.

About the Publisher

With an online readership of nearly one million viewers per year, the publisher is a U.S. market research firm with over 19+ years of experience. As the first and only market research firm to specialize in the stem cell industry, the publisher’s research has been cited by the Wall Street Journal and Vogue Magazine, as well as quoted in Tony Robbin’s best-selling book, Life Force. Founded in 2006 and headquartered in Washington, DC, the publisher is strategically positioned to be near the National Institutes of Health (NIH), the U.S. FDA, the Maryland Biotech Corridor, and policy makers on Capitol Hill. In addition to leveraging an experienced team of analysts, the publisher has unparalleled access to key opinion leaders (KOLs) from across the MSC market.

Table of Contents

381 Pages
    • Statement of the Report
    • Target Demographic
    • Sources for this Report
    • Purpose of the Report
    • Executive Summary
    • Introduction
    • Stabilization of Human MSCs (hMSCs) as a Technology
    • The Impact of MSCs on Regenerative Medicine
    • Timeline of MSC Nomenclature
    • Sources of MSCs
    • Cell Surface Markers in MSCs
    • In vitro Differentiation Potentials of MSCs
    • Soluble Factors Secreted by MSCs
    • Stemness Genes Present in MSCs
    • Types of MSCs and their Biomedical Applications
    • Genes that are Pivotal for MSCs' Properties
    • MSC-Based Clinical Studies by Geography
    • Sources of MSCs used in Current Clinical Trials
    • Share of Autologous & Allogeneic MSCs Clinical Trials
    • MSC-Based Clinical Trials by Disease Indication
    • MSC-Based Clinical Trials by Phase of Study
    • Select MSC-Based Clinical Trials
    • MSC Patent Publications by Jurisdiction
    • MSC Patent Applicants
    • MSC Patent Inventors
    • MSC Patent Owners
    • Legal Status of MSC Patent Applications
    • MSC-Derived Exosome Patents
    • Patents for iPSC-Derived MSCs (iMSCs)
    • MSC Patents by Therapy Type
    • PubMed.gov Published Papers on MSCs in Cell Therapy
    • PubMed.gov Published Papers on MSC-Based Immunotherapies
    • PubMed.gov Published Papers on MSCs in Gene Therapy
    • PubMed.gov Published Papers on MSCs in Tissue Engineering
    • PubMed.gov Published Papers on MSCs in Aesthetics
    • Number of Published Papers on the Applications of MSCs in Major Diseases
    • Published Papers on Modified MSCs
    • Published Papers on MSC-Derived Exosomes
    • Methods of Isolations of MSCs
    • Cell Expansion: Conventional Cultures to Bioreactors
    • Downstream Processing of MSCs
    • Autologous & Allogeneic MSC Manufacturing: A Comparison
    • Large Scale Manufacturing of MSCs
    • Staff Shortage
    • Need for Automation
    • Capacity Constraints
    • CDMO Platforms with Greater Potentials
    • CMOs/CDMOs
    • Geographic Distribution of Manufacturing Facilities
    • Continued Rise of Outsourcing
    • Major CDMOs in the U.S.
    • Major Cell & Gene Therapy CDMOs in Europe
    • UK's Dominance in European Contract Manufacturing
    • Small Molecule Priming of MSCs
    • Particle Engineering of MSCs
    • Genetic Engineering of MSCs
    • Examples of Bioengineered MSCs to Produce Anticancer Therapeutics
    • Engineered MSCs for Neurological Conditions
    • Engineered MSCs for Cardiovascular Diseases
    • Engineered MSCs for Lung Injury
    • Engineered MSCs for Diabetes
    • Bioengineering Approaches to Improve MSC Administration
    • Studies Using MSCs for Autoimmune Diseases
    • Studies using MSCs for Cardiovascular Diseases
    • Studies using MSCs for Neurodegenerative Diseases
    • Studies using MSCs for Bone & Cartilage Diseases
    • Studies using MSCs in GvHD
    • Studies using MSCs in Crohn's Disease
    • Studies using MSCs in Type 1 Diabetes
    • Studies using MSCs in Systemic Lupus Erythematosus (SLE)
    • Studies using MSCs in Parkinson's Disease
    • Studies using MSCs in Alzheimer's Disease
    • Studies using MSCs in Kidney Failure
    • Studies using MSCs in Spinal Cord Injury
    • Studies using MSCs for Wound Healing
    • Collaboration between BioSolution Designs & RoosterBio
    • Collaboration between CytoMed Therapeutics, Ltd. &Sengkang General Hospital
    • Collaboration between REPROCELL & Histocell
    • Collaboration between FUJIFILM Diosynth & RoosterBio
    • RoosterBio's Collaboration with AGC Biologics
    • RoosterBio's Partnership with ShiftBio
    • RoosterBio's Partnership with Univercells Technologies
    • Collaboration between Cynata & Fujifilm
    • Collaboration between American CryoStem Corp. &BioTherapeutic Lab Corp.
    • RoosterBio's Collaboration with Sartorius
    • Collaboration between American CryoStem and CRADA
    • RoosterBio's Collaboration with Sartorius Korea Biotech
    • Collaboration between Catalent & BrainStorm
    • Collaboration between Cipla & Stempeutics
    • Aethlon's Collaboration with University of Pittsburgh
    • RoosterBio's Collaboration with Senti Biosciences
    • Approved MSC Therapies
    • Marketed Biomaterial Carrier-Based MSCs & MSC Progenitors
    • Topical Cosmetic Products Containing MSCs/MSC-Derived Exosomes
    • Market Size for MSC Therapies
    • Global Demand for Mesenchymal Stem Cells (MSCs)
    • Advancells
    • Aegle Therapeutics
    • AGC Biologics
    • AlloSource, Inc.
    • Ambulero
    • American CryoStem Corporation
    • American Type Culture Collection (ATCC)
    • Amniotics
    • Andelyn Biosciences
    • Anemocyte S.r.l
    • Anterogen, Co., Ltd.
    • Avid Bioservices, Inc.
    • Bacthera
    • Baylx, Inc.
    • BioCardia
    • BioCentriq
    • BioEden, Inc.
    • Bioinova s.r.o
    • BioRestorative Therapies
    • Bioscience Institute S.p.A
    • Blue Horizon International, LLC
    • Boehringer Ingelheim BioXellence
    • Bonus Biogroup, Ltd.
    • BrainStorm Cell Therapeutics, Inc.
    • Catalent
    • CCRM
    • Cell2Cure ApS
    • Cell Care Therapeutics
    • Cellcolabs
    • CELLeBRAIN
    • Cellipont Bioservices
    • Celprogen, Inc.
    • CellProthera
    • CellResearch Corporation, Pte, Ltd.
    • Cell Surgical Network (CSN)
    • Celltex Therapeutics Corporation
    • CellTherapies
    • Cellular Biomedicine Group
    • Charles River Laboratories
    • CHIESI Farmaceutici S.p.A
    • Citius Pharmaceuticals, Inc.
    • CorestemChemon, Inc.
    • Creative Bioarray
    • Creative Medical Technology Holdings, Inc.
    • Curia Global, Inc.
    • Cynata Therapeutics, Ltd.
    • Cytovance Biologics
    • Defined Bioscience, Inc.
    • Direct Biologics
    • eQcell, Inc.
    • Excellos
    • Exosla Therapeutics
    • EXOSOMEplus
    • Exothera
    • Fujifilm Diosynth Biotechnologies
    • Future Cell Japan, Co., Ltd.
    • Genezen
    • GenScript Biotech Corporation
    • Hope Biosciences, LLC
    • Implant Therapeutics, Inc.
    • INCELL Corporation LLC
    • InGeneron GmbH
    • Invitrx Therapeutics
    • Japan Tissue Engineering, Co., Ltd. (J-TEC)
    • JCR Pharmaceuticals, Co., Ltd.
    • Jointechlabs
    • Kangstem Biotech, Co., Ltd.
    • Kimera Labs
    • LifeCell
    • Longeveron
    • Lonza Group, Ltd.
    • Lorem Cytori USA, Inc.
    • MEDPOST
    • Mesoblast, Ltd.
    • Millipore Sigma
    • NecstGen
    • NextCell
    • NIPRO Corporation
    • Novadip Biosciences
    • Novus Biologicals, LLC
    • NuVasive
    • OCT Therapies & Research Pvt., Ltd.
    • OmniaBio, Inc.
    • Orthocell, Ltd.
    • Orthofix Medical, Inc.
    • Ossium Health
    • Personal Cell Sciences Corporation
    • Personalized Stem Cells, Inc.
    • Pfizer CentreOne
    • Pluri Biotech, Ltd.
    • Porton Advanced
    • Prometheus Life Technologies
    • PromoCell GmbH
    • PuREC, Co., Ltd.
    • Regrow Biosciences
    • Reliance Life Sciences, Pvt., Ltd.
    • Remedy Cell, Ltd.
    • Rentschler Biopharma
    • REPROCELL USA, Inc.
    • Resilence
    • RESTEM, LLC
    • RHEACELL GmbH & Co., KG
    • Richter-HELM
    • RoosterBio, Inc.
    • RTI Surgical
    • RoslinCT
    • Samsung Biologics
    • San Bio, Co., Ltd.
    • Smith & Nephew, Inc.
    • StemBioSys, Inc.
    • STEMCELL Technologies, Inc.
    • Stemedica Cell Technologies, Inc.
    • Stemmatters
    • StemMedical
    • Stempeutics Research Pvt., Ltd.
    • StromaBio AB
    • TaiwanBio Therapeutics, Co., Ltd.
    • Takeda Pharmaceutical, Co., Ltd.
    • Tempo Bioscience
    • ThermoFisher Scientific
    • Vericel Corporation
    • Wuxi App Tec
    • Xintela AB
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