Mesenchymal Stem Cells / Medicinal Signaling Cells (MSCs)

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'Oreal 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.

1. REPORT OVERVIEW

1.1. Statement of the Report
1.2. Target Demographic
1.3. Sources for this Report
1.4. Purpose of the Report
- 1.4.1. Survey Recent Advancements
- 1.4.2. Provide a Summary of the Global MSC Market
- 1.4.3. Access Opportunities for Commercialization
- 1.4.4. Identify Major Market Players and Evaluate the Competive Environment
- 1.4.5. Identify Existing and Emerging Trends
- 1.4.6. Identify Critical Opportunities and Threats within the MSC Market
1.5. Executive Summary
1.6. Introduction

2. MESENCHYMAL STEM CELLS (MSCs): AN OVERVIEW

2.1. Stabilization of hMSCs as a Technology
2.2. The Impact of MSCs on Regenerative Medicine
2.3. Timeline of MSC Nomenclature
2.4. Sources of MSCs
- 2.4.1. Bone Marrow-Derived MSCs (BM-MSCs)
- 2.4.2. Adipose-Derived MSCs (AD-MSCs)
- 2.4.3. Umbilical Cord-Derived MSCs (UC-MSCs)
2.5. Cell Surface Markers in MSCs
2.6. In vitro Differentiation Potentials of MSCs
2.7. Soluble Factors Secreted by MSCs
2.8. Stemness Genes Present in MSCs
2.9. Types of MSCs and their Biomedical Applications
2.10. Genes that are Pivotal for MSC's Properties

3. MSC-BASED CLINICAL TRIAL LANDSCAPE

3.1. MSC-Based Clinical Studies by Geography
3.2. Sources of MSCs used in Current Clinical Trials
3.3. Share of Autologous & Allogeneic MSCs Clinical Trials
3.4. MSC-Based Clinical Trials by Disease Indication
3.5. MSC-Based Clinical Trials by Phase of Study
3.6. Select MSC-Based Clinical Trials
- 3.6.1. MSC-Based Clinical Trials for Musculoskeletal Disorders
- 3.6.2. MSC-Based Clinical Trials for Neurological Disorders
- 3.6.3. Clinical Trials involving MSC-Drived Exosomes
- 3.6.4. Primed MSCs in Clinical Trials
- 3.6.5. Clinical Trials involving Scaffold-Based MSCs

4. MESENCHYMAL STEM CELLS (MSCS): PATENT LANDSCAPE

4.1. MSC Patent Publications by Jurisdiction
4.2. MSC Patent Applicants
4.3. MSC Patent Inventors
4.4. MSC Patent Owners
4.5. Legal Status of MSC Patent Applications
4.6. MSC-Derived Exosome Patents
- 4.6.1. MSC-Derived Exosome Patents by Jurisdiction
- 4.6.2. MSC-Derived Exosome Patent Applicants
- 4.6.3. MSC-Derived Exosome Patent Inventors
- 4.6.4. MSC-Derived Exosome Patent Owners
- 4.6.5. Legal Status of MSC-Derived Exosome Patents
4.7. Patents for iPSC-Derived MSCs
- 4.7.1. iPSC-Derived MSC Patents by Jurisdiction
- 4.7.2. iPSC-Derived MSC Patent Owners
4.8. MSC Patents by Therapy Type

5. PUBLISHED SCIENTIFIC PAPERS ON MSCS

5.1. PubMed.gov Published Papers on MSCs in Cell Therapy
5.2. PubMed.gov Published Papers on MSC-Based Immunotherapies
5.3. PubMed.gov Published Papers on MSCs in Gene Therapy
5.4. PubMed.gov Published Papers on MSCs in Tissue Engineering
5.5. PubMed.gov Published Papers on MSCs in Aesthetics
5.6. Number of Published Papers on the Applications of MSCs in Major Diseases
5.7. Published Papers on Modified MSCs
5.8. Published Papers on MSC-Derived Exosomes

6. MSC MANUFACTURING PLATFORMS: AN OVERVIEW

6.1. Methods of Isolations of MSCs
6.2. Cell Expansion: Conventional Cultures to Bioreactors
- 6.2.1. Monolayer Culture Systems
- 6.2.2. Bioreactor-Based Cell Expansion
  - 6.2.2.1. Stirred Tank Bioreactor
  - 6.2.2.2. Rocking Bioreactor
  - 6.2.2.3. Hollow Fiber Bioreactors
  - 6.2.2.4. Fixed-Bed Bioreactor
- 6.2.3. Bioreactors in Current Use
  - 6.2.3.1. Automated Platforms
  - 6.2.3.2. Miniaturized Bioreactors
  - 6.2.3.3. Verical-Wheel Bioreactors
- 6.2.4. MSC Expansion Systems: A Snapshot
- 6.2.5. Number of Cells per batch by Technologies
- 6.2.6. Microcarriers used for Cell Expansion
6.3. Downstream Processing of MSCs
- 6.3.1. Cell Detachment and Separation (Harvesting)
- 6.3.2. Cell Washing and Concentration
- 6.3.3. Safety and Potency Assays
- 6.3.4. Surface Markers for Distinguishing MSCs from Fibroblasts
6.4. Autologous & Allogeneic MSC Manufacturing: A Comparison
- 6.4.1. Cost of Manufacturing Allogeneic MSCs
- 6.4.2. Cost of Manufacturing Autologous MSCs
- 6.4.3. Cost of Donor Screening & Testing
- 6.4.4. Cost of Release Testing
- 6.4.5. Cost Breakdown in MSC Manufacturing
  - 6.4.5.1. Strategies for Cost Reduction
- 6.4.6. Cost of Manufacture in Partial Automation
  - 6.4.6.1. CoG Breakdown in Partially Automated MSC Manufacturing
  - 6.4.6.2. CoG Breakdown in Fully Automated MSC Manufacturing
  - 6.4.6.3. Higher Throughput in Partially Automated Facilities
6.5. MSC Manufacturing Economics in Small Scale
- 6.5.1. Small Scale Manufacturing Model
  - 6.5.1.1. Cost of Culture Media in Small Scale Manufacturing
6.6. Large Scale Manufacturing of MSCs
- 6.6.1. The Four Bioprocessing Strategies for Large Scale Manufacturing of MSCs 129
- 6.6.2. Commonly Used Sources of MSCs for Large Scale Expansion
- 6.6.3. Commonly Used Culture Media for Large Scale Expansion of MSCs
- 6.6.4. Expansion Ratios Achieved with Different Culture Media

7. CELL & GENE THERAPY CONTRACT MANUFACTURING

7.1. Staff Shortage
7.2. Need for Automation
7.3. Capacity Constraints
7.4. CDMO Platforms with Greater Potentials
- 7.4.1. Type of CDMOs Used by Sponsors
7.5. CMOs/CDMOs
- 7.5.1. Contract Manufacturing Organizations (CMOs)
  - 7.5.1.1. Major Services Offered by CMOs
- 7.5.2. Contract Development and Manufacturing Organizations (CDMOs)
  - 7.5.2.1. Major CDMOs
  - 7.5.2.2. Major Services offered by CDMOs
7.6. Geographic Distribution of Manufacturing Facilities
7.7. Continued Rise of Outsourcing
- 7.7.1. Specific Areas of Outsourcing
- 7.7.2. Select Services for Outsourcing in 2023
- 7.7.3. Expected Rate of Outsourcing Increase between 2023 and 2025
7.8. Major CDMOs in the U.S.
7.9. Major Cell & Gene Therapy CDMOs in Europe
7.10. U.K.'s Domination in European Contract Manufacturing
- 7.10.1. GMP Manufacturing in U.K.
- 7.10.2. Cleanroom Footprint in UK
- 7.10.3. Cell Therapy Process Capabilities in U.K.
- 7.10.4. Gene Therapy Process Capabilities in U.K.
- 7.10.5. Future Capacity and Expansion in U.K.

8. BIOENGINEERING SOLUTIONS TO BOOST MSC'S FUNCTIONS

8.1. Small Molecule Priming of MSCs
8.2. Particle Engineering of MSCs
- 8.2.1. Materials used in Microparticles (MPs) Fabrication
8.3. Genetic Engineering of MSCs
- 8.3.1. Engineered MSCs as Living Drug Factories
8.4. Examples of Bioengineered MSCs to Produce Anticancer Therapeutics
8.5. Engineered MSCs for Neurological Conditions
8.6. Engineered MSCs for Cardiovascular Diseases
8.6. Engineered MSCs for Lung Injury
8.7. Engineered MSCs for Diabetes
8.8. Bioengineering Approaches to Improve MSC Administration

9. MAJOR DISEASES ADDRESSED BY MSCS

9.1. Studies Using MSCs for Autoimmune Diseases
9.2. Studies using MSCs for Cardiovascular Diseases
9.3. Studies using MSCs for Neurodegenerative Diseases
9.4. Studies using MSCs for Bone & Cartilage Diseases
9.5. Studies using MSCs in GvHD
9.6. Studies using MSCs in Crohn's Disease
9.7. Studies using MSCs in Type 1 Diabetes
9.8. Studies using MSCs in Systemic Lupus Erythematosus (SLE)
9.9. Studies using MSCs in Parkinson's Disease
9.10. Studies using MSCs in Alzheimer's Disease
9.11. Studies using MSCs in Kidney Failure
9.12. Studies using MSCs in Spinal Cord Injury
9.13. Studies using MSCs for Wound Healing

10. RECENT COLLABORATIONS IN MSC SECTOR, 2020-2024

10.1. Collaboration between BioSolution Designs & RoosterBio
10.2. Collaboration between CytoMed Therapeutics, Ltd. & Sengkang General Hospital
10.3. Collaboration between REPROCELL & Histocell
10.4. Collaboration between FUJIFILM Dyosynth & RoosterBio
10.5. RoosterBio's Collaboration with AGC Biologics
10.6. RoosterBio's Partnership with ShiftBio
10.7. RoosterBio's Partnership with Univercells Technologies
10.8. Collaboration between Cynata & Fujifilm
10.9. Collaboration between American CryoStem Corp. & BioTherapeutic Lab Corp.
10.10. RoosterBio's Collaboration with Sartorius
10.11. Collaboration between American CryoStem and CRADA
10.12. RoosterBio's Collaboration with Sartorius Korea Biotech
10.13. Collaboration between Catalent & BrainStorm
10.14. Collaboration between Cipla & Stempeutics
10.15. Aethlon's Collaboration with University of Pittsburgh
10.16. RoosterBio's Collaboration with Senti Biosciences

11. MSC-BASED PRODUCTS IN THE MARKET

11.1. Approved MSC Therapies
- 11.1.1. Queencell
- 11.1.2. Cellgram AMI
- 11.1.3. Cupistem
- 11.1.4. Cartistem
- 11.1.5. NeuroNataR
- 11.1.6. Holoclar
- 11.1.7. Remestemcel-L
- 11.1.8. Temcell HS
- 11.1.9. Stempeucel
- 11.1.10. Alifosel
- 11.1.11. MesestroCell
- 11.1.12. Stemirac
11.2. Marketed Biomaterial Carrier-Based MSCs & MSC Progenitors
- 11.2.1. Osteocel
- 11.2.2. AlloStem
- 11.2.3. Grafix
- 11.2.4. Cellentra VCBM
- 11.2.5. Trinity ELITE
- 11.2.6. Map3
- 11.2.7. BIO4
- 11.2.8. Trinity Evolution
- 11.2.9. Carticel
- 11.2.10. Chondron
- 11.2.11. DeNovo NT
- 11.2.12. Chondrocelect
- 11.2.13. Ossron
- 11.2.14. JACC
- 11.2.15. MACI
- 11.2.16. Ortho-ACI
- 11.2.17. Ossgrow
- 11.2.18. Cartigrow
11.3. Topical Cosmetic Products Containing MSCs/MSC-Derived Exosomes

12. MARKET ANALYSIS

12.1. Market Size for MSC Therapies
12.2. Global Demand for Mesenchymal Stem Cells (MSCs)
- 12.2.1. Global Demand for MSCs in Academic and Preclinical Studies
- 12.2.2. Global Demand for MSCs in Clinical Trials
- 12.2.3. Global Demand for MSCs for Developing MSC Therapeutics
- 12.2.4. Global Demand for MSCs to Develop Exosome Products
- 12.2.5. Global Demand for MSCs in Emerging Industries
- 12.2.6. Global Market for Mesenchymal Stem Cells (MSCs)
- 12.2.7. Global MSC Market by Application

13. COMPANY PROFILES

13.1. Advancells
- 13.1.1. MSC-Derived Exosome Therapy
13.2. Aegle Therapeutics
- 13.2.1. Dystrophic Epidermolysis Bullosa
- 13.2.2. Burns/Scarring
- 13.2.3. Additional Indications
13.3. AGC Biologics
- 13.3.1. Cell Therapy Manufacturing
- 13.3.2. Services
13.4. AlloSource, Inc.
- 13.4.1. Allografts with Tissue-Derived MSCs
- 13.4.2. Products
  - 13.4.2.1. AlloConnex
  - 13.4.2.2. AlloFuse & AlloFuse Plus DBM
  - 13.4.2.3. AlloFlex Plus
  - 13.4.2.4. AlloFuse Cervical Grafts
  - 13.4.2.5. AlloFuse Fiber and Fiber Boats
  - 13.4.2.6. AlloFuse Select CM
13.5. Ambulero
- 13.5.1. Supercharged MSCs
- 13.5.2. Ambulero's Pipeline
13.6. American CryoStem Corporation
- 13.6.1. Adult Stem Cell Storage Service
- 13.6.2. Products Offered
  - 13.6.2.1. CELLECT
  - 13.6.2.2. ACSelerateMAX
  - 13.6.2.3. ATCELL
13.7. American Type Culture Collection (ATCC)
- 13.7.1. Stem Cell Products
13.8. Amniotics
- 13.8.1. Technology
- 13.8.2. Product Pipeline
13.9. Andelyn Biosciences
- 13.9.1. Andelyn's Solutions
13.10. Anemocyte S.r.l
- 13.10.1. GMP Capacity
- 13.10.2. Product Types
- 13.10.3. Manufacturing Services
13.11. Anterogen, Co., Ltd.
- 13.11.1. Products
  - 13.11.1.1. Cupistem Injection
  - 13.11.1.2. Queencell
13.12. Avid Bioservices, Inc.
- 13.12.1. Services
13.13. Bacthera
- 13.13.1. Services
13.14. Baylx, Inc.
- 13.14.1. Technology
- 13.14.2. Product Pipeline
  - 13.14.2.1. BX-U001 for Rheumatoid Arthritis
13.15. BioCardia
- 13.15.1. Product Pipeline
13.16. BioCentriq
- 13.16.1. Clinical Manufacturing Serevices
- 13.16.2. Process Development Services
13.17. BioEden, Inc.
13.18. Bioinova s.r.o
- 13.18.1. Products
- 13.18.2. Services
  - 13.18.2.1. Storage & Transportation Solution
  - 13.18.2.2. Cryopreservation
  - 13.18.2.3. Autologous Therapy
  - 13.18.2.4. Allogeneic Therapy
13.19. BioRestorative Therapies
- 13.19.1. BRTX-100
- 13.19.2. ThermoStem
13.20. Bioscience Institute S.p.A
- 13.20.1. Aesthetic Stem Cells
  - 13.20.1.1. LIPOSKILL for Skin Rejuvenation
  - 13.20.1.2. LIPOSKILL PLUS for Face Reshaping
  - 13.20.1.3. LIPOSKILL PLUS for Breast Augmentation
  - 13.20.1.4. LIPOSKILL PLUS for Buttock Enhancement
  - 13.20.1.5. LIPOSKILL PLUS for Reduction of Scars and Stretch Marks
  - 13.20.1.6. HAIRSKILL for Hair Loss Treatment
  - 13.20.1.7. GYNSKILL for Vulvo-Vaginal Rejuvenation
- 13.20.2. Regenerativ Stem Cells
  - 13.20.2.1. ORTHOSKILL for Regenerative Orthopedics
  - 13.20.2.2. OVOSKILL for Early Menopause Treatment
  - 13.20.2.3. ANDROSKILL for Erectile Dysfunction Treatment
  - 13.20.2.4. Anti-Aging IV Therapy
  - 13.20.2.5. XEROSTOMIA Treatment
  - 13.20.2.6. Empty Nose Syndrome (ENS) Treatment
  - 13.20.2.7. Stem Cell Therapy for Body Performance
13.21. Blue Horizon International, LLC
- 13.21.1. BHI's Stem Cell Division
13.22. Boehringer Ingelheim BioXellence
- 13.22.1. Services
13.23. Bonus Biogroup, Ltd.
- 13.23.1. BonoFill
- 13.23.2. MesenCure
13.24. BrainStorm Cell Therapeutics, Inc.
- 13.24.1. NurOwn Technology
- 13.24.2. Manufacturing of NurOwn
- 13.24.3. BrainStorm's Clinical Trials
13.25. Catalent
- 13.25.1. Cell Therapy Process Development
- 13.25.2. Cell Therapy CGMP Manufacturing
13.26. CCRM
13.27. Cell2Cure ApS
- 13.27.1. Product
  - 13.27.1.1. Mode of Action
  - 13.27.1.2. Manufacture
13.28. Cell Care Therapeutics
- 13.28.1. Platform
- 13.28.2. CCT-101
13.29. Cellcolabs
- 13.29.1. Ordering Cells
13.30. CELLeBRAIN
- 13.30.1. Core Technology
- 13.30.2. CELLeBRAIN's Product Pipeline
13.31. Cellipont Bioservices
- 13.31.1. Cellipont's Capabilities
- 13.33.2. Cellipont's Cell Expertise
13.34. Celprogen, Inc.
- 13.34.1. Products
- 13.34.2. Services
13.35. CellProthera
- 13.35.1. ProtheraCytes
- 13.35.2. Technology: StemXpand
13.36. CellResearch Corporation, Pte, Ltd.
- 13.36.1. Umbilical Cord Lining Stem Cells
- 13.36.2. CALECIM
13.37. Cell Surgical Network (CSN)
- 13.37.1. Technology: The Time Machine 3.0 Auto
- 13.37.2. Time Machine Process
13.38. Celltex Therapeutics Corporation
- 13.38.1. Therapy Services
13.39. CellTherapies
- 13.39.1. Services
- 13.39.2. Contract Manufacturing
- 13.39.3. Apheresis Management
- 13.39.4. Clinical Trial Support
13.40. Cellular Biomedicine Group
13.41. Charless River Laboratories
- 13.41.1. Cell Therapy Manufacturing Services
13.42. CHIESI Farmaceutici S.p.A
- 13.42.1. Holoclar
13.43. Citius Pharmaceuticals, Inc.
- 13.43.1. Stem Cell Platform
13.44. CorestemChemon, Inc.
- 13.44.1. Neuronata-R inj.
13.45. Creative Bioarray
- 13.45.1. MSC Services
- 13.45.2. MSC Isolation and Expanson Services
- 13.45.3. MSC Characterization Services
- 13.45.4. MSC Differentiation Services
13.46. Creative Medical Technology Holdings, Inc.
- 13.46.1. Rapid Autologous Therapies
- 13.46.2. Creative Medical's Preclinical and Clinical Pipeline
13.47. Curia Global, Inc
- 13.47.1. Services
13.48. Cynata Therapeutics, Ltd.
- 13.48.1. Cymerus Platform
  - 13.48.1.1. CYP-001
  - 13.48.1.2. CYP-004
  - 13.48.1.3. Cymerus MSCs for ARDS
  - 13.48.1.4. CYP-006TK
13.49. Cytovance Biologics
- 13.49.1. GMP Manufacturing
13.50. Defined Bioscience, Inc.
- 13.50.1. Products
  - 13.50.1.1. Applications in Stem Cells
  - 13.50.1.2. Applications in Cultivated Meat
13.51. Direct Biologics
- 13.51.1. ExoFlo
13.52. eQcell, Inc.
- 13.52.1. Innovation
13.53. Excellos
13.54. Exosla Therapeutics
13.55. EXOSOMEplus
13.56. Exothera
- 13.56.1. Exoscan Process Analysis Services
- 13.56.2. Process Design & Development Services
- 13.56.3. GMP Manufacturing Services
13.57. Fujifilm Diosynth Biotechnologies
- 13.57.1. Cell & Gene Therapy Services
13.58. Future Cell Japan, Co., Ltd.
- 13.58.1. Conditioned Media from UC-MSCs
13.59. Genezen
- 13.59.1. Genezen's Capabilities
13.60. GenScript Biotech Corporation
- 13.60.1. Cell Therapy Product Solutions
  - 13.60.1.1. CytoSinct Nanobeads
  - 13.60.1.2. CytoSinct Manual Separator System
  - 13.60.1.3. CytoSinct 1000
13.61. Hope Biosciences, LLC
- 13.61.1. Adult Stem Cell Banking
- 13.61.2. Newborn Stem Cell Banking
- 13.61.3. Sponsored Clinical Trials
13.62. Implant Therapeutics, Inc.
- 13.62.1. Services
13.63. INCELL Corporation LLC
- 13.63.1. Product Line
- 13.63.2. Cell & Tissue Products
- 13.63.3. Tissue Collections & Kit Products
- 13.63.4. Storage of Cell & Tissue Products
13.64. InGeneron GmbH
- 13.64.1. Transpose RT Process
- 13.64.2. Adipose-Derived Regenerative Cells (ADRCs)
13.65. Invitrx Therapeutics
- 13.65.1. Reluma
13.66. Japan Tissue Engineering, Co., Ltd. (J-TEC)
- 13.66.1. JACC
13.67. JCR Pharmaceuticals, Co., Ltd.
- 13.67.1. TEMCELL HS Inj.
13.68. Jointechlabs
- 13.68.1. Products
  - 13.68.1.1. MiniTC
  - 13.68.1.2. Mini-Stem
- 13.68.2. Jointech's Products in Pipeline
  - 13.68.2.1. JTL-T-01 (Osteoarthritis Clinical Therapy)
  - 13.68.2.2. JTL-T-02 (Wounds Clinical Therapy)
13.69. Kangstem Biotech, Co., Ltd.
- 13.69.1. Stem Cell Therapeutics
- 13.69.2. Stem Cell Therapy
13.70. Kimera Labs
- 13.70.1. Vive
- 13.70.2. Luxir
13.71. LifeCell
- 13.71.1. Large-Scale Manufacturing of MSCs
13.72. Longeveron
- 13.72.1. Lomecel-B
- 13.72.2. Clinical Pipeline
13.73. Longeveron
- 13.73.1. Lomecel-B
  - 13.73.1.1. Manufacturing Method
- 13.73.2. Focused Therapeutic Areas
  - 13.73.2.1. Hypoplastic Left Heart Syndrome (HLHS) Research Program
  - 13.73.2.2. Alzheimer's Disease (AD) Research Program
  - 13.73.2.3. Aging Frailty Research Program
13.74. Lonza Group, Ltd
- 13.74.1. Sell& Gene Technologies Segment
- 13.74.2. Bioscience Segment
- 13.74.3. Personalized Medicines Segment
13.75. Lorem Cytori USA, Inc.
- 13.75.1. Celution System
- 13.75.2. Cytori Cell Therapy
13.76. MEDPOST
- 13.76.1. Products
  - 13.76.1.1. CARTISTEM
  - 13.76.1.2. PNEUMOSTEM
  - 13.76.1.3. SMUP-IA-01
  - 13.76.1.4. SMUP-IV-01
13.77. Mesoblast, Ltd.
- 13.77.1. Technology Platform
- 13.77.2. Intellectual Property Estate
- 13.77.3. Product Candidates
  - 13.77.3.1. Revascor
  - 13.77.3.2. MPC-06-ID
  - 13.77.3.3. Remestemcel-L
  - 13.77.3.4. MPC-300-IV
13.78. Millipore Sigma
- 13.78.1. Cell Culture & Analysis Products
13.79. NecstGen
- 13.79.1. Cell Therapy Development & Manufacturing
- 13.79.2. Viral Vector Development & Manufacturing
- 13.79.3. Cleanroom Rental
13.80. NextCell
- 13.80.1. ProTrans
- 13.80.2. Cellaviva
- 13.80.3. NextCell's Products in Pipeline
13.81. NIPRO Corporation
- 13.81.1. Stemirac
13.82. Novadip Biosciences
- 13.82.1. The 3M3 Platform
- 13.82.2. Products
13.82.2.1 3MAUTO
13.82.2.2 3MALLO
13.82.2.3 3MEXO
13.83. Novus Biologicals, LLC
13.84. NuVasive
- 13.84.1. Osteocel Portfolio
  - 13.84.1.1. Osteocel Plus
  - 13.84.1.2. Osteocel Pro
13.85. OCT Therapies & Research Pvt., Ltd
13.86. OmniaBio, Inc.
- 13.86.1. Services
  - 13.86.1.1. Process Development
  - 13.86.1.2. GMP Manufacturing
  - 13.86.1.3. Analytical Development
  - 13.86.1.4. Regulatory Guidance
13.87. Orthocell, Ltd.
- 13.87.1. OrthoACI
13.88. Orthofix Medical, Inc.
- 13.88.1. Trinity Elite
- 13.88.2. Trinity Evolution
13.89. Ossium Health
- 13.89.1. Platform
- 13.89.2. Applications
  - 13.89.2.1. Hematologic Diseases
  - 13.89.2.2. Organ Transplant Rejection
  - 13.89.2.3. Musculoskeletal Defects
- 13.89.3. Products
  - 13.89.3.1. OssiGraft Prime
  - 13.89.3.2. OssiGraft
  - 13.89.3.3. GMP Human Mesenchymal Stem Cells
  - 13.89.3.4. GMP Human Selected CD34+ Cells
  - 13.89.3.5. RUO Mesenchymal Stem Cells
  - 13.89.3.6. RUO Human Selected CD34+ Cells
13.90. Personal Cell Sciences Corporation
- 13.90.1. Autokine CM
- 13.90.2. Products
13.91. Personalized Stem Cells, Inc.
- 13.91.1. Personalized Stem Cells for Knee Osteoarthritis
13.92. Pfizer CentreOne
- 13.92.1. Manufacturing
13.93. Pluri Biotech, Ltd.
- 13.93.1. PLX Products
13.94. Porton Advanced
- 13.94.1. Cell Therapy Services
- 13.94.2. LVV Services
- 13.94.3. PLX-PAD
- 13.94.4. PLX-R18
- 13.94.5. PLX-Immune
13.95. Prometheus Life Technologies
- 13.95.1. Organoids
13.96. PromoCell GmbH
- 13.96.1. Products
13.97. PuREC, Co., Ltd.
- 13.97.1. PuREC Solution for Hypophosphatasia
- 13.97.2. PuREC Solution for Spinal Canal Stenosis
13.97. Regrow Biosciences
- 13.97.1. Ossgrow
- 13.97.2. Cartigrow
13.98. Reliance Life Sciences, Pvt., Ltd.
- 13.98.1. Regenerative Medicine Products
13.99. Remedy Cell, Ltd.
- 13.99.1. Proprietary Platform
- 13.99.2. Drug Candidate: RC-0315
13.100. Rentschler Biopharma
- 13.100.1. Services
13.101. REPROCELL USA, Inc.
- 13.101.1. Services
- 13.101.2. Products
13.102. Resilence
- 13.102.1. Resilience's Capabilities
13.103. RESTEM, LLC
- 13.103.1. Umbilical Cord Lining Stem Cells (ULSCs)
- 13.103.2. Muscular Dystrophy - Clinical Trial
- 13.103.3. Dermatomyositis & Polymyositis - Clinical Trial
- 13.103.3. Heart Failure - Clinical Trial
13.104. RHEACELL GmbH & Co., KG
- 13.104.1. Technology
- 13.104.2. ABCB5+MSCs
13.105. Richter-HELM
- 13.105.1. Services
13.106. RoosterBio, Inc.
- 13.106.1. Technology
- 13.106.2. Products
  - 13.106.2.1. Human Mesenchymal Stem Cells (hMSCs)
- 13.106.3. Genetic Engineering Tools
  - 13.106.3.1. Genetic Engineering Media
- 13.106.4. Cell Culture Media & Supplements
- 13.106.5. Cell & Media Kits
- 13.106.6. MSC-Derived Exosomes
- 13.106.7. cGMP CliniControl Products
- 13.106.8. Process Development Services
- 13.106.9. hMSC Analytical Services
13.107. RTI Surgical
- 13.107.1. Map3
13.108. RoslinCT
- 13.108.1. Services
  - 13.108.1.1. Process Development
  - 13.108.1.2. GMP Manufacturing
  - 13.108.1.3. Quality Control
  - 13.108.1.4. Quality & Regulations
  - 13.108.1.5. Product Storage & Logistics
- 13.108.2. RoslinCT-Lykan Bioscience Combine
13.109. Samsung Biologics
- 13.109.1. Contract Manufacturing Capabilities
13.110. San Bio, Co., Ltd.
- 13.110.1. SB623
13.111. Smith & Nephew, Inc.
- 13.111.1. Grafix
13.112. StemBioSys, Inc.
- 13.112.1. CELLvo Matrix Technology
- 13.112.2. CELLVO hAD-MSCs
- 13.112.3. CELLvo hBM-MSCs
- 13.112.4. CELLvo hWJ-MSCs
- 13.112.5. CELLvo Amniotic Membrane MSCs
13.113. STEMCELL Technologies, Inc.
- 13.113.1. Products
  - 13.113.1.1. MSC & MSC Progenitor Cell Research Products
13.114. Stemedica Cell Technologies, Inc.
- 13.114.1. BioSmart Technology
- 13.114.2. Research & Development
13.115. Stemmatters
13.116. StemMedical
- 13.116.1. Stemform Procedure
- 13.116.2. Therapeutics Development
13.117. Stempeutics Research Pvt., Ltd.
- 13.117.1. Stempeucel
13.118. StromaBio AB
- 13.118.1. MSC Platform
13.119. TaiwanBio Therapeutics, Co., Ltd.
13.120. Takeda Pharmaceutical, Co., Ltd.
- 13.120.1. Alofisel
13.121. Tempo Bioscience
- 13.121.1. Tempo iMSCs
13.122. ThermoFisher Scientific
- 13.122.1. CDMO Services for Cell Therapy
13.123. Vericel Corporation
- 13.123.1. MACI
13.124. Wuxi App Tec
- 13.124.1. CTDMO Services
13.125. Xintela AB
- 13.125.1. Technology Platform
- 13.125.2. Stem Cell Products
  - 13.125.2.1. XSTEM
  - 13.125.2.2. EQSTEM
  - 13.125.2.3. Cancer Therapy

INDEX OF FIGURES

FIGURE 2.1: Mesenchymal Stem Cells and its Derivatives
FIGURE 3.1: Increase in the Number of Registered MSC-Based Clinical Trials, 1995-2024
FIGURE 3.2: MSC-Based Clinical Trials by Region
FIGURE 3.3: MSC-Based Clinical Trials by Cell Source, 2024
FIGURE 3.4: Share of Autologous & Allogeneic MSCs in Clinical Trials
FIGURE 3.5: MSC-Based Clinical Trials by Indication
FIGURE 3.6: Percent Share of MSC-Based Clinical Trials by Phase of Study
FIGURE 4.1: MSC Patent Publications Over Time, 2000-Aug 2024
FIGURE 4.2: MSC-Derived Exosome Patent Publications over Time
FIGURE 4.3: iPSC-Derived MSCs Patent Publications over Time
FIGURE 5.1: Published Papers in PubMed.gov on Mesenchymal Stem Cells (MSCs)
FIGURE 5.2: PubMed.gov Published Papers on MSCs in Cell Therapy
FIGURE 5.3: PubMed.gov Published Papers on MSC-Based Immunotherapies
FIGURE 5.4: PubMed.gov Published Papers on MSCs in Gene Therapy
FIGURE 5.5: PubMed.gov Published Papers on MSCs in Tissue Engineering
FIGURE 5.6: PubMed.gov Published Papers on MSCs in Aesthetics
FIGURE 5.7: PubMed Published Papers on Major Ten Diseases addressed by MSCs
FIGURE 5.8: Number of Published Papers on Modified MSCs
FIGURE 5.9: Number of Published Papers on MSC-Derived Exosomes
FIGURE 6.1: Advantages and Disadvantages of Autologous & Allogeneic MSCs
FIGURE 6.1: Monolayer Culture Systems
FIGURE 6.2: Stirred Tank Bioreactor
FIGURE 6.3: Rocking Bioreactor or Wave Bioreactor
FIGURE 6.4: Hollow Fiber Bioreactor
FIGURE 6.5: Fixed-Bed Reactor
FIGURE 6.6: CompacT SelecT System from Sartorius
FIGURE 6.7: DASbox Mini Bioreactor Systerm
FIGURE 6.8: PBS-80 Vertical-Wheel Bioreactor
FIGURE 6.9: Number of Cells per batch by Technologies
FIGURE 6.10: Single-Use Harvestainer for Small Scale Application
FIGURE 6.11: Single-Use Harvestainer for Large Scale Application
FIGURE 6.12: Cost of Goods (CoG) in MSC Manufacturing
FIGURE 6.13: Impact of Headcount on Overall CoG per Batch
FIGURE 6.14: CoG Breakdown in Partially-Automated MSC Manufacturing
FIGURE 6.15: CoG Breakdown in Fully Automated MSC Manufacturing
FIGURE 6.16: Higher Throughput in Partially Automated Facilities
FIGURE 6.17: Model of a Clean Room in a Small Scale Manufacturing Facility
FIGURE 6.18: The Four Bioprocessing Strategies for Large Scale Manufacturing of MSCs
FIGURE 6.19: Commonly Used Sources of MSCs for Large Scale Expansion
FIGURE 6.20: Commonly Used Culture Media for Large Scale Expansion of MSCs
FIGURE 7.1: CDMO Platforms with Greater Potentials
FIGURE 7.2: Type of CDMOs Used by Sponsors
FIGURE 7.3: Major Services Offered by CMOs
FIGURE 7.4: Major Services used by Sponsors from CDMOs
FIGURE 7.5: Geographic Distribution of Manufacturing Facilities, 2017-2027
FIGURE 7.6: Percent Share of Outsourcing
FIGURE 7.7: Select Services for Outsourcing in 2023
FIGURE 7.8: Changing Priorities in Outsorcing Services between 2023 and 2025
FIGURE 7.9: Cleanroom Footprint in UK, 2018-2023
FIGURE 7.10: Cell Therapy Process Capabilities in U.K.
FIGURE 7.11: Gene Therapy Process Capabilities in U.K.
FIGURE 8.1: Bioengineering Solutions to Boost the Innate Functions of MSCs
FIGURE 8.2: Bioengineering Approaches to MSC Administration
FIGURE 9.1: Major Diseases Addresses by MSCs in Clinical Trials
FIGURE 9.2: Percent Share of Autoimmune Diseases using MSCs in Clinical Trials
FIGURE 9.3: Percent Share of MSCs by Source in Trials for Cardiovascular Diseases
FIGURE 9.4: Percent Shares of Neurological Diseases in Clinical Trials using MSCs
FIGURE 9.5: Percent Shares of MSC-Based Musculoskeletal Studies by Source
FIGURE 12.1: Global Market for MSC-Based Therapeutics, 2023-2031
FIGURE 12.2: Global Market for Mesenchymal Stem Cells (MSCs)
FIGURE 12.3: Market Share of MSCs by Application
FIGURE 13.1: CELLeBRAIN's Core Technology
FIGURE 13.2: CALECIM
FIGURE 13.3: Schematic Diagram of CytoSinct Nanobeads
FIGURE 13.4: CytoSinct 1000
FIGURE 13.5: Why-iPSC Derived MSCs (iMSCs)
FIGURE 13.6: MiniTC
FIGURE 13.7: Mini-Stem

INDEX OF TABLES

TABLE 2.1: Timeline of MSC Nomenclature
TABLE 2.2: Sources of MSCs
TABLE 2.3: Advantages & Disadvantages of BM-MSCs
TABLE 2.4: Advantages & Disadvantages of AD-MSCs
TABLE 2.5: Advantages & Disadvantages of UC-MSCs
TABLE 2.6: Positive & Negative Markers in MSCs from Different Sources
TABLE 2.7: in vitro Differentiation Potentials of MSCs
TABLE 2.8: Soluble Factors Secreted by MSCs
TABLE 2.9: Some Typical "Stemness" Genes of MSCs
TABLE 2.10: Types of MSCs and their Biomedical Applications
TABLE 2.11: Genes that are Pivotal for MSC's Properties
TABLE 3.1: MSC-Based Clinical Trials by Cell Source
TABLE 3.2: Select MSC-Based Clinical Trials
TABLE 3.3: Select MSC-Based Clinical Trials for Musculoskeletal Disorders
TABLE 3.4: Select MSC-Based Clinical Trials for Neurological Disorders
TABLE 3.5: Select Clinical Trials involving MSC-Drived Exosomes
TABLE 3.6: Primed MSCs in Clinical Trials
TABLE 3.7: Clinical Trials involving Scaffold-Based MSCs
TABLE 4.1: MSC Patent Records by Jurisdiction, Aug-2024
TABLE 4.2: MSC Patent Applicants, Aug-2024
TABLE 4.3: MSC Patent Inventors
TABLE 4.4: MSC Patent Owners
TABLE 4.5: Legal Status of MSC Patent Applications
TABLE 4.6: MSC-Derived Exosome Patents Jurisdiction
TABLE 4.7: MSC-Derived Exosome Patent Applicants
TABLE 4.8: MSC-Derived Exosome Patent Inventors
TABLE 4.9: MSC-Derived Exosome Patent Owners
TABLE 4.10: Legal Status of MSC-Derived Exosome Patents
TABLE 4.11: iPSC-Derived MSC Patent Applications by Jurisdiction, August 2024
TABLE 4.12: iPSC-Derived MSC Patent Owners
TABLE 4.13: MSC Patents by Applications
TABLE 5.1: PubMed Published Papers on Major Ten Diseases addressed by MSCs
TABLE 5.2: Number of Published Papers on Modified MSCs
TABLE 5.3: Number of Published Papers on MSC-Derived Exosomes
TABLE 6.1: Methods of Isolations of MSCs
TABLE 6.2: A Snapshot of Commercially Availabe Culture Systems
TABLE 6.3: Microcarriers used for Cell Expansion
TABLE 6.4: Basic Assays for MSCs
TABLE 6.5: Cell Surface Markers on MSCs & Fibroblasts: A Comparison
TABLE 6.6: Cost of Manufacturing Allogeneic MSCs
TABLE 6.7: Cost of Manufacturing Autologous MSCs
TABLE 6.8: Cost of Goods (CoG) in MSC Manufacturing
TABLE 6.9: CoG Breakdown in Partially-Automated MSC Manufacturing
TABLE 6.10: CoG Breakdown in Fully Automated MSC Manufacturing
TABLE 6.11: Higher Throughput in Partially Automated Facilities
TABLE 6.12: Key Processes and Cost Assumptions
TABLE 6.13: Quality Control Panels and Cost Assumptions
TABLE 6.14: Additional Supporting Labor Cost Assessments
TABLE 6.15: Additional Supporting Facility and Cost Assumptions
TABLE 6.16: Large Scale Expansions of MSCs by Method, Cell Source and Media
TABLE 6.17: Expansion Ratios Achieved with Different Culture Media
TABLE 7.1: Top Ten Companies in 2003 & 2027
TABLE 7.2: GMP Capacities of U.S.-Based CDMOs
TABLE 7.3: GMP Capacities of European CDMOs
TABLE 7.4: MHRA-Licensed Manufacturing Facilities as of 2023
TABLE 7.5: Cleanroom Footprint in UK, 2019-2023
TABLE 8.1: Examples of Priming Strategies in Animal Models
TABLE 8.2: Materials used in Microparticles (MPs) Fabrication
TABLE 8.3: Genetic Engineering Method used in MSCs
TABLE 8.4: Examples of Bioengineered MSCs as Living Drug Factories
TABLE 8.5: Examples of Oncolology Indications being Studied using Engineered MSCs
TABLE 8.6: Effects of Engineered MSCs in Neurological Indications
TABLE 9.1: Select MSC-Based Clinical Trials for Autoimmune Diseases
TABLE 9.3: Select MSC-Based Clinical Studies for Neurological Diseases
TABLE 9.4: Select MSC-Based Studies for Musculoskeletal Disorders
TABLE 9.5: Select Ongoing Studies using MSCs for GvHD
TABLE 9.6: Studies using MSCs in Crohn's Diseases
TABLE 9.7: Select Studies using MSCs in Type 1 Diabetes
TABLE 9.8: Select Studies using MSCs in Systemic Lupus Erythematosus (SLE)
TABLE 9.9: Select Studies using MSCs in Parkinson's Disease
TABLE 9.10: Select Ongoing Studies using MSCs in Alzheimer's Disease
TABLE 9.11: Select Ongoing Studies using MSCs in Kidney Failure
TABLE 9.12: Select Studies using MSCs in Spinal Cord Injury
TABLE 9.13: Select Studies using MSCs for Wound Healing
TABLE 11.1: Currently Available MSC Therapies
TABLE 11.2: Queencell - Product Information
TABLE 11.3: Cellgram AMI - Product Information
TABLE 11.4: Cupistem - Product Information
TABLE 11.5: Cartistem - Product Information
TABLE 11.6: NeuroNataR - Product Information
TABLE 11.7: Holoclar - Product Information
TABLE 11.8: Remestemcel-L - Product Information
TABLE 11.9: Temcell HS - Product Information
TABLE 11.10: Stempeucel - Product Information
TABLE 11.11: Alifosel - Product Information
TABLE 11.12: MesestroCell - Product Information
TABLE 11.13: Stemirac - Product Information
TABLE 11.14: Previous/Currently Marketed Biomaterial-Based MSCs & MSC Progenitors
TABLE 11.15: Osteocel - Product Information
TABLE 11.16: AlloStem - Product Information
TABLE 11.17: Grafix - Product Information
TABLE 11.18: Cellentra VCBM - Product Information
TABLE 11.19: Trinity ELITE - Product Information
TABLE 11.20: Map3 - Product Information
TABLE 11.21: Bio4 - Product Information
TABLE 11.22: Trinity Evolution - Product Information
TABLE 11.23: Carticel - Product Information
TABLE 11.24: Chondron - Product Information
TABLE 11.25: DeNovo NT - Product Information
TABLE 11.26: Chondrocelect - Product Information
TABLE 11.27: Ossron - Product Information
TABLE 11.28: JACC - Product Information
TABLE 11.29: MACI - Product Information
TABLE 11.30: Ortho-ACI - Product Information
TABLE 11.31: Ossgrow - Product Information
TABLE 11.32: Cartigrow - Product Information
TABLE 11.33: Commercially Available Skincare Cosmetics with MSC-Derived Exosomes
TABLE 12.1: Global Market for MSC-Based Therapeutics, 2023-2031
TABLE 12.2: Global Market for Mesenchymal Stem Cells (MSCs)
TABLE 13.1: Aegle's Product Pipeline
TABLE 13.2: Ambulero's Product Pipeline
TABLE 13.3: Amniotgics' Product Pipeline
TABLE 13.4: Baylx's Product Pipeline
TABLE 13.5: BioCardia's Product Pipeline
TABLE 13.6: Bonus Biogroup's Product Pipeline
TABLE 13.7: BrainStorm's Clinical Trials
TABLE 13.8: CELLeBRAIN's Product Pipeline
TABLE 13.9: CellProthera's Preclinical and Clinical Pipeline
TABLE 13.10: Celltex's Clinical Trials
TABLE 13.11: Corestem's Product Pipeline
TABLE 13.12: Creative Medical's Preclinical and Clinical Pipeline
TABLE 13.13: Regulatory Proteins found in ExoFlo
TABLE 13.14: Hopes Clinical Trial Pipeline using HB-adMSC
TABLE 13.15: Kangstem's Sponsor Initiated Clinical Trials
TABLE 13.16: Longeveron's Clinical Pipeline
TABLE 13.17: NextCell's Products in Pipeline
TABLE 13.18: Novadip's Product Pipeline
TABLE 13.19: RHEACELL's Products in Pipeline
TABLE 13.20: San Bio's Product Pipeline
TABLE 13.21: Stemedica's Product Pipeline
TABLE 13.22: Stempeutics' Product Development Status
TABLE 13.23: Xintela's Product Pipeline

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