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間葉系幹細胞/薬用シグナル細胞（MSC）市場 - 進歩と応用、2025年

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

出版日
発行
BioInformant
ページ情報
英文 387 Pages
納期
即納可能 即納可能とは
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=157.33円
間葉系幹細胞/薬用シグナル細胞（MSC）市場 - 進歩と応用、2025年
出版日: 2024年12月09日
発行: BioInformant
ページ情報: 英文 387 Pages
納期: 即納可能 即納可能とは
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  • 概要
  • 目次
概要

MSCは多能性細胞であり、その多用途性と多様な用途を反映して、間葉系幹細胞、薬用シグナル細胞、間葉系間質細胞などと呼ばれてきました。MSCは、骨芽細胞、軟骨細胞、筋細胞、脂肪細胞など様々な細胞型に分化することができます。組織修復を促進する因子を分泌し、抗炎症作用や抗線維化作用によって微小環境を調節するユニークな能力を持つことから、再生医療において不可欠な存在となっています。さらに、その免疫侵襲性の特性から、MSCは特に同種移植に適しています。

MSCは、再生医療、化粧品、培養食肉生産など、数多くの産業において重要な原材料として役立っています。

世界的には、12のMSCベースの治療法が様々な適応症で承認されており、その大部分は韓国、日本、EUに集中しています。

特に韓国では5つの製品が承認されています。具体的には、韓国ではAnterogenのQueencell、PharmicellのCellgram AMI、Anterogen社のCupistem、MedipostのCartistem、Corestem社のNeuroNataRの5製品が承認されています。日本ではJCRのTemcell HSとニプロのStemiracの2製品が承認されています。インドでは1製品が承認されました。このような進展にもかかわらず、米国FDAの承認を受けたMSCベースの治療薬はまだありません。

化粧品市場もまた、MSC由来の製品、特にエクソソームを急速に採用し、そのアンチエージングおよび再生特性を活用しようとしており、L'OrealやJohnson & Johnsonなどの企業がこの分野に多額の投資を行っています。同様に、培養食肉企業は、筋肉や脂肪細胞の生産にMSCを活用し、味や食感を向上させています。Upside FoodsやGood Meatによるラボグロウン・チキンのような画期的な承認は、この業界のさらなる成長への道を開いた。

MSCに基づく遺伝子編集は拡大しており、抗腫瘍遺伝子や治療因子の過剰発現を可能にしています。研究者たちはまた、3Dプリンティングや人工臓器製造におけるMSCの利用を模索しており、今後10年で飛躍的な発展が見込まれています。

当レポートでは、間葉系幹細胞/薬用シグナル細胞（MSC）市場について調査し、MSCの臨床試験、科学論文、特許、資金調達イベント、共同研究の割合を紹介しています。MSCベースの治療薬のパイプラインを紹介し、市場機会と脅威を特定し、将来の方向性と新たな用途を探ります。また、125の主要な競合企業が提供する革新的なMSC製品、サービス、技術を明らかにしています。最後に、世界のMSC市場の詳細な市場規模を地域別、事業分野別に分類し、2031年までの将来予測を掲載しています。

目次

第1章 報告書の概要

第2章 間葉系幹細胞（MSC）：概要

  • 技術としてのhMSCの安定化
  • MSCが再生医療に与える影響
  • MSC命名法のタイムライン
  • MSCの供給源
  • MSCの細胞表面マーカー
  • MSCのin vitro分化能
  • MSCから分泌される可溶性因子
  • MSCに存在する幹細胞遺伝子
  • MSCの種類とその生物医学的応用
  • MSCの特性に重要な遺伝子

第3章 MSCベースの臨床試験の情勢

第4章 間葉系幹細胞（MSCS）：特許の情勢

第5章 MSCSに関する出版された科学論文

第6章 MSC製造プラットフォーム：概要

  • MSCの分離方法
  • 細胞増殖：従来の培養からバイオリアクターへ
  • MSCの下流処理
  • 自己および同種MSC製造の比較
  • MSC小規模製造の経済性
  • MSCの大規模製造

第7章 細胞・遺伝子治療の受託製造

第8章 MSCの機能を高めるバイオエンジニアリングソリューション

  • MSCの小分子プライミング
  • MSCの粒子工学
  • MSCの遺伝子工学
  • 抗がん治療薬を生産するためのバイオエンジニアリングMSCの例
  • 神経疾患のための人工MSC
  • 心血管疾患のための人工MSC
  • 肺損傷のための人工MSC
  • 糖尿病のための人工MSC
  • MSC管理を改善するためのバイオエンジニアリングアプローチ

第9章 MSCSが取り組む主な疾患

第10章 MSCセクターにおける最近のコラボレーション、2020年～2024年

第11章 市場におけるMSCベースの製品

  • 承認されたMSC療法
  • 市販のバイオマテリアルキャリアベースのMSCおよびMSC前駆細胞
  • MSC/MSC由来エクソソームを含む外用化粧品

第12章 市場分析

  • MSC療法の市場規模
  • 間葉系幹細胞（MSC）の世界の需要

第13章 企業プロファイル

  • 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
  • Charless 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.
  • 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
  • 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.
  • ThermoFisher Scientific
  • Vericel Corporation
  • Wuxi App Tec
  • Xintela AB

図表索引

表の索引

目次

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.

TABLE OF CONTENTS

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