MSC는 다능성 세포로, 그 다용도성과 다양한 용도를 반영하여 간엽줄기세포, 약용신호세포, 간엽간질세포 등으로 불리며, 골아세포, 연골세포, 근육세포, 지방세포 등 다양한 세포형으로 분화할 수 있습니다. 조직 회복을 촉진하는 인자를 분비하고, 항염증 작용과 항섬유화 작용을 통해 미세환경을 조절하는 독특한 능력을 가지고 있으며, 재생의료에 있으며, 필수적인 존재가 되고 있습니다. 또한 MSC는 면역침습성 특성으로 인해 동종 이식에 특히 적합합니다.
MSC는 재생의료, 화장품, 배양육 생산 등 다양한 산업에서 중요한 원료로 활용되고 있습니다.
전 세계에서 12개의 MSC 기반 치료제가 다양한 적응증으로 승인되었으며, 대부분 한국, 일본, EU에 집중되어 있습니다.
특히 한국에서는 5개 제품이 승인되고 있습니다. 구체적으로 한국에서는 Anterogen의 Queencell, Pharmicell의 Cellgram AMI, Anterogen의 Cupistem, Medipost의 Cartistem, Corestem의 NeuroNataR 등 5개 제품이 승인되고 있습니다. 일본에서는 JCR의 Temcell HS와 Nipro Corporation의 Stemirac 등 2개 제품이 승인되고 있습니다. 인도에서는 1개 제품이 승인되었습니다. 이러한 진전에도 불구하고 미국 FDA의 승인을 받은 MSC 기반 치료제는 아직 없습니다.
화장품 시장도 MSC 유래 제품, 특히 엑소좀을 빠르게 채택하여 노화 방지 및 재생 특성을 활용하고 있으며, L'Oreal 및 Johnson & Johnson과 같은 회사는 이 분야에 많은 투자를 하고 있습니다. 마찬가지로 배양육 기업은 MSC를 근육과 지방 세포 생산에 활용하여 맛과 질감을 개선하기 위해 MSC를 활용하고 있으며, 업사이드 푸드(Upside Foods)와 굿미트(Good Meat)의 랩그로운 치킨과 같은 획기적인 승인은 이 산업이 더욱 성장할 수 있는 길을 열었습니다.
MSC를 기반으로 한 유전자 편집이 확대되고 있으며, 항종양 유전자 및 치료 인자의 과발현을 가능하게 하고 있습니다. 연구자들은 또한 3D 프린팅과 인공장기 제조에 MSC를 활용하는 방안을 모색하고 있으며, 향후 10년 내에 비약적인 발전이 예상됩니다.
중간엽줄기세포/약용 시그널 세포(MSC) 시장에 대해 조사했으며, MSC 임상시험, 과학논문, 특허, 자금조달 이벤트, 공동 연구의 비율을 소개하고 있습니다. MSC 기반 치료제 파이프라인을 소개하고, 시장 기회와 위협을 식별하고, 향후 방향성과 새로운 용도를 모색합니다. 또한 125개의 주요 경쟁사가 제공하는 혁신적인 MSC 제품, 서비스, 기술을 소개하고 있습니다. 마지막으로 세계 MSC 시장의 상세한 시장 규모를 지역별, 사업 분야별로 분류하고, 2031년까지의 예측을 게재하고 있습니다.
목차
제1장 보고서 개요
제2장 중간엽줄기세포(MSC) : 개요
기술로서 hMSC의 안정화
MSC가 재생의료에 미치는 영향
MSC 명명법의 타임라인
MSC의 공급원
MSC의 세포 표면 마커
MSC의 in vitro 분화능
MSC로부터 분비되는 가용성 요인
MSC에 존재하는 줄기세포 유전자
MSC의 유형과 생물의학적 응용
MSC의 특성에 중요한 유전자
제3장 MSC 기반 임상시험의 상황
제4장 중간엽줄기세포(MSCS) : 특허 상황
제5장 MSCS에 관한 출판된 과학논문
제6장 MSC 제조 플랫폼 : 개요
MSC 분리 방법
세포 증식 : 기존 배양으로부터 바이오리액터로
MSC의 다운스트림 처리
자기 및 동종 MSC 제조의 비교
MSC 소규모 제조의 경제성
MSC의 대규모 제조
제7장 세포·유전자 치료 수탁제조
제8장 MSC의 기능을 높이는 바이오엔지니어링 솔루션
MSC의 소분자 프라임
MSC의 입자 공학
MSC의 유전자 공학
항암 치료제를 생산하기 위한 바이오엔지니어링 MSC의 예
신경질환을 위한 인공 MSC
심혈관질환을 위한 인공 MSC
폐손상을 위한 인공 MSC
당뇨병을 위한 인공 MSC
MSC 관리를 개선하기 위한 바이오엔지니어링 어프로치
제9장 MSCS가 대처하는 주요 질환
제10장 MSC 부문에서의 최근 협업, 2020-2024년
제11장 시장의 MSC 기반 제품
승인된 MSC 요법
시판 바이오소재 캐리어 기반 MSC 및 MSC 전구세포
MSC/MSC 유래 엑소좀을 포함한 외용 화장품
제12장 시장 분석
MSC 요법의 시장 규모
중간엽줄기세포(MSC)의 세계 수요
제13장 기업 개요
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
도표 색인
표 색인
KSA
영문 목차
영문목차
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
