This report contains an analysis of developments across the rapidly evolving fields of cell therapy (CT) and tissue engineering (TE), with a focus on competitive dynamics and commercial successes and failures. Cell therapy is the utilization of living cells for the treatment or potential cure of human disease or injury. Tissue engineering (TE) is a field of medicine that is focused on restoring, maintaining, improving, or replacing damaged tissues and organs through the combination of scaffolds, cells, and biologically active molecules. This report highlights important issues across these interrelated fields, including market challenges, economic evaluation, policy improvements, pricing and reimbursement, and rates of global adoption. Because several of the developments in cell therapy and regenerative medicine (RM) are closely related, the report also gives an overview of the regenerative medicine industry.
One of the earliest examples of cell therapy was the transplantation of hematopoietic stem cells (HSCs) in the 1950s from a donor to a recipient to create a bone marrow transplant, which today represents a well-established type of cell therapy practiced worldwide. Newer forms of cell therapy involve the delivery of other cell types to a patients, including CAR-T and CAR-NK cells, mesenchymal stem cells (MSCs), neural stem cells (NSCs), and to a lesser degree, induced pluripotent stem cells (iPSCs), embryonic stem cells (ESCs), directly reprogrammed cells, and other pluripotent and differentiated cell types.
Because tissue engineering (TE) integrates cellular products with scaffolds, it is integral to the field of cell therapy. These scaffolds are often made using naturally occurring proteins or biocompatible synthetic polymers. Some TE products are made using a protein-based extracellular matrix (ECM) obtained from a donor. The ECM is prepared by removing the cells by a process called decellularization. Cells and growth factors are seeded on to the ECM to develop a tissue or organ.
Cell therapy, gene-modified cell therapy, gene therapy, and tissue engineering are the four pillars of regenerative medicine (RM). These therapies have the potential to favorably change the quality of life and improve the health status of patients suffering from cellular defects, genetic diseases, neurodegenerative diseases, tissue malignancies, and other medical conditions. The combined efforts of research and clinical scientists in academic, translational and industry settings have led us to the development of several approved commercial firsts, such as Glybera, Kymriah, Yescarta, Holoclar, and Luxturna.
Today, the healthcare environment is under great pressure to develop therapies capable of reversing or significantly impacting the progression of serious illnesses. The arrival of regenerative medicine (RM) has been propelled by advances across the cell therapy (CT) and tissue (TE) engineering industries. Regenerative medicines have the potential to transform the healthcare landscape by providing transformative, durable and potentially curative outcomes to human injuries, diseases, and genetic disorders.
With the number of regenerative medicine firms expanding exponentially, over a thousand clinical trials ongoing worldwide (>50% in oncology), and key strategic alliances underway among industry and academic partners, the success of regenerative medicine therapies seems to be a certainty. This report reports the market for regenerative medicine (RM) products approved worldwide, including 44 approvals across the U.S., Europe, South Korea, India, China, Japan, Australia and New Zealand. Additionally, the RM sector saw venture capital investment grow from a mere $200 million in 2010 to a massive $14.6 billion in 2018. This massive investment and market growth in the RM space indicates a future with heavy competition.
Thus, the main objectives of this cell therapy (CT) and tissue engineering (TE) report are to provide the reader with the following details:
- Total global financings in cell therapy and gene-modified cell therapy space.
- Corporate partnerships in cell therapy and gene-modified cell therapy space.
- Private placements and venture financings in cell therapy and gene-modified cell therapy space.
- The history of cell therapy from 1944 to present.
- Potential applications of cell therapy.
- FDA-approved cell therapy products made from human HSCs.
- Leading induced pluripotent stem cell (iPSC) companies.
- Potential applications of iPSCs.
- Various sources of mesenchymal stem cells (MSCs).
- Various clinical applications of mesenchymal stem cells (MSCs).
- Various biologically-active substances secreted by mesenchymal stem cells (MSCs).
- The estimated consumption of MSCs in the cell therapy industry (future projections).
- Other cell types with the potential to disrupt MSC’s demand.
- Approved MSC-based cell therapy products in the global market.
- Diseases addressed by neural stem cells in clinical trials.
- Leading companies in neural stem cells space.
- Indications addressed by human embryonic stem cells (hESCs) in clinical trials.
- Leading cell therapy startups.
- Cell therapies with RMAT designation.
- Number of gene-modified cell therapy companies.
- Number of CAR-T cell therapy companies.
- Number of NK cell therapy companies in the world.
- Approved TE products in the global market.
- Number of cell therapy clinical trials.
- Diseases addressed by MSCs in clinical trials.
- Number of clinical trials using MSCs.
- Anticipated clinical events in cell therapy space.
- Number of clinical trials in gene-modified cell therapy space.
- Anticipated developments in cell therapy space in 2019.
- Number of clinical trials in Tissue Engineering (TE) space.
- Approved cell therapy products by geography.
- Approved tissue engineering (TE) products by geography.
- Cell and gene therapy manufacturing capacities in the U.S. and Europe.
- Select CMOs/CDMOs in cell and gene therapy space.
- Projected outsourcing market for the manufacture of cell and gene therapy products.
- Projected growth of cell manufacturing capacity.
- Global market for cell therapy products by geography.
- Global market for tissue-engineered products by geography.
- Profiles of companies that are developing products in cell therapy and tissue engineering spaces.
For companies involved with the commercialization of cell therapy (CT) and tissue engineering (TE) products, this report provides market size determinations, coupled with five-year forecasts and trends. It analyzes emerging market forces, highlights industry partnerships and deal-making, and captures the progression of cell therapy and tissue engineering products across various states of development. With the rapid evolution of this market sector, this global strategic report is your guide to research advances, clinical breakthroughs, and commercialized successes.
1. REPORT OVERVIEW
1.1 Statement of the Report
1.2 Executive Summary
1.3 Cell Therapy Industry: An Overview
1.4 Tissue Engineering Industry: An Overview
2. BRIEF OVERVIEW OF REGENERATIVE MEDICINE (RM) INDUSTRY
2.1 Number of RM Companies
2.2 RM Product Approvals in 2017/2018
2.2.1 RM Products Approved Worldwide
220.127.116.11 Number of RM Products Approved by Geography/Country
18.104.22.168 Approved RM Products by Therapy Type
22.214.171.124 Approved RM Products by Indication
2.2.2 Approved RM Products in Australia
2.2.4 The Two RM Products Approved in Canada
2.2.5 RM Product Approved in China
2.2.6 Approved RM Products in Europe
126.96.36.199 RM Products with Withrawn Approvals in Europe
2.2.7 Approved RM Products in India
2.2.8 RM Products Approved in Japan
2.2.9 RM Products Approved in New Zealand
2.2.10 RM Products Approved in South Korea
2.2.11 Approved RM Products in the U.S.
2.3 RM Products with RMAT Designation
2.4 Total RM Clinical Trials
2.4.1 Total RM Clinical Trials by Technology Type
188.8.131.52 Select Anticipated RM Industry Clinical Trial Data Readouts: 2019
2.5 RM Industry: Total Global Financings, 2018
2.5.1 Total Financings to RM Industry by Type and Year, 2016-2018
2.5.2 Corporate Partnerships (Upront Payments) in RM Industry, 2018
2.5.3 Private Placements and Venture Fianancings in RM Industry, 2018
2.5.4 Public Offerings (IPOs & Follow-Ons) in RM Industry, 2018
2.5.5 Total Merger & Acquisition within RM Industry by Year, 2016-2018
2.6 Anticipated RM Product Launches
2.6.1 Estimated RM Treated Patients, 2018-2030
2.7 Top 20 RM Companies by Pipeline Size
3. CELL THERAPY (CT): AN OVERVIEW
3.1 Cell Therapy Timeline
3.1.1 Potential Applications of Stem Cells in Personalized Medicine
3.1.2 Types of Stem Cells Used in Cell Therapy
3.2 Hematopoietic Stem Cells (HSCs)
3.2.1 FDA-Approved Cell Therapies Made from Hematopoietic Stem Cells
3.3 Induced Pluripotent Stem Cells
3.3.1 Potential Applications of iPSCs
3.4 Mesenchymal Stem Cells (MSCs)
3.4.1 Clinical Applications of MSCs
3.4.2 Biologically Active Substances Secreted by MSCs
184.108.40.206 Growth Factors
220.127.116.11 Forecasted Approved MSC-Based Product Types, 2020-2060
18.104.22.168 MSC Consumption Through 2040
22.214.171.124 Future Decline in MSCs’ Demand
126.96.36.199 MSCs - The Transistors of the Future Commercial RM
3.4.3 Approved MSC-Based Products
3.5 Neural Stem Cells (NSCs)
3.5.1 Diseases Addressed by Neural Stem Cells in Clinical Trials
3.5.2 Leading Players in NSC Clinical Trials
3.5.3 Indications Addressed by NSCs in Clinical Trials
3.6 Embryonic Stem Cells (ESCs)
3.6.1 Indications Addressed by ESCs
3.7 Notable Events in Cell Therapy Space, 2018
3.7.1 Orphan Drug Designation for Pluristem’s PLX-R18
3.7.2 Positive Data from Biocardia’s CardiAMP
3.7.3 Survival Outcome Announced by Mesoblast for its Phase III Remestemcel-L
3.7.4 Topline Results for NeoCart Announced by Histogenics
3.7.5 Fast Track Designation for Nohla’s Dilanubicel (NLA101)
3.7.6 RMAT Designation for Cellerant’s Romyelocel-L
3.8 Top 16 Stem Cell Therapy Startups
3.9 Cell Therapies with RMAT Designation
3.9.1 RMAT Designation for Romyelocel-L
3.9.2 RMAT Designation for CLBS14-RfA
3.9.3 RMAT Designation for CAP-1002
3.9.4 RMAT Designation for MPC Therapy
3.9.5 RMAT Designation for CEVA101
3.9.6 RMAT Designation for Multistem
3.9.7 RMAT Designation for AST-OPC1
3.9.8 RMAT Designation for ATIR101
3.9.9 RMAT Designation for Ixmyelocel-T
3.9.10 RMAT Designation for jCell
3.9.11 RMAT Designation for RVT-802
4. GENE-MODIFIED CELL THERAPY
4.1 Number of Gene-Modified Cell Therapy Companies
4.2 CAR-T Cell Therapy
4.2.1 Global Distribution of CAR-T Cell Therapy Companies
4.3 Select Events in Cell-Based Immuno-Oncology Space, 2018
4.3.1 Leading Cancer Immunotherapy Companies
4.3.2 Major Immunotherapy Startups
4.4 T-Cell Receptor Therapy (TCR Therapy)
4.4.1 Process of TCR-Engineered T Cells Therapy
4.4.2 Promise of TCR Therapy in Solid Tumors
4.4.3 Clinical Progress of TCRs
4.4.4 Venture Activity and Deal Flow for the Development of TCR Therapies
4.5 Natural Killer (NK) Cell Therapies
4.5.1 CAR-Expressing NK Cells
4.6 Tumor Infiltrating Lymphocytes (TILs) Therapy
4.7 Marrow-Infiltrating Lymphocytes (MILs)
4.8 Gamma-Delta T-Cells Therapy
4.8.1 Big Biopharma’s Interest in Gamma-Delta T-Cells Therapy
4.9 Dendritic Cell (DC) Therapy
4.9.1 Cancer Types Targeted by DC Therapy Studies
4.9.2 Ongoing Clinical Trials Testing DC Vaccines
5. TISSUE ENGINEERING
5.1 Smart Biomaterials in Tissue Engineering
5.1.1 Biosynthetic Materials
5.1.2 3D Printable Inks
5.2 Synthetic and Naturally-Derived Scaffolds
5.3 Tissue Substitutes
5.3.1 Cell-Based Tissues
5.4 TWO Key Developments in Tissue Engineering Space in 2018
5.4.1 FDA Approval for RECELL
6. CLINICAL TRIAL LANDSCAPE: REGENERATIVE MEDICINE
6.1 Number of Patient Participation in RM Clinical Trials, 2018
6.2 Number of Clinical Trials by Indications in the RM Sector, 2018
7. CELL THERAPY CLINICAL TRIALS
7.1 Cell Therapy Clinical Trials by Indication, 2018
7.2 Mesenchymal Stem Cells (MSCs) in Clinical Trials
7.2.1 Number of Clinical Trials and Number of Patients Treated using MSCs
7.2.2 MSC Target Indication, Total Trials and Cells used per Patient
7.2.3 Number of Clinical Trials using MSCs
7.2.4 Indications for Which MSCs are Tested in Clinical Trials
7.2.5 Clinical Trials using MSCs by Geography/Country
7.3 Clinical Trials using hESCs
7.4 Anticipated Clinical Events in Cell Therapy Space
7.4.1 BLA Filing for Remestemcel-L
7.4.2 Conditional MA Application for Tab-Cel
7.4.3 MultiStem being Developed for Multiple Diseases
8. CLINICAL TRIALS IN GENE-MODIFIED CELL THERAPIES
8.1 The Most Common Target Antigens for CAR-T Cell Therapies
8.2 Antigens other than CD19 in Clinical Trials Targeted by CAR-T
8.3 Antigens Targeted by CAR-T in Solid Cancers in Clinical Trials
8.4 Anticipated Developments in CAR-T Space
9. CLINICAL TRIALS IN TISSUE ENGINEERING SPACE
9.1 Anticipated Clinical Events in Tissue Engineering Space, 2019/2020
10. APPROVED CELL THERAPY PRODUCTS WORLDWIDE
10.1 Number of Cell Therapies Approved by Geography
10.2 Cell Therapy Products by Therapy Type
10.3 Indications Addressed by the Approved Cell Therapy Products
10.4 Approved Cell Therapy Product in Australia
10.5 Cell Therapy Products Approved in Canada
10.6 Approved Cell Therapies in Europe
10.6.1 Yescarta (Axicabtagene Ciloleucel)
10.6.2 Kymriah (Tisagenlecleucel)
10.7 Approved Cell Therapy Products in India
10.8 Approved Cell Therapy Product in Japan
10.8.1 TEMCELL HS
10.9 Approved Cell Therapy Product in New Zealand
10.10 Approved Cell Therapy Products in South Korea
10.10.6 CureSkin Inj
10.10.8 RMS Ossron
10.10.9 Immuncell LC
10.11 Approved Cell Therapy Products in the U.S
10.11.1 HPC, Cord Blood
10.11.3 HPC, Cord Blood (Bloodworks)
10.11.4 HPC, Cord Blood (LifeSouth Copmmunity Blood Center)
10.11.7 HPC, Cord Blood (Clinimmune Labs)
10.11.9 Laviv (Azficel-T)
10.11.10 Provenge (Sipuleucel-T)
11. APPROVED TISSUE ENGINEERED (TE) PRODUCTS
12. MANUFACTURING OF CELLS FOR CELL THERAPIES
12.1 Cost of Cell Manufacture
12.1.1 Cost of Cell Manufacture in a Partially-Automated Facility
12.1.2 Cost of Manufacture in a Fully-Automated Facility
12.1.3 Net Present Cost (NPC) of the Three Methods
12.2 In-House Gene Therapy Manufacturing Capabilities of Select Big and Mid Pharma
12.3 External Gene Therapy Manufacturing by Big and Mid Pharma
12.4 Cell Manufacturing Capacities in North America
12.5 Cell Manufacturing Capacities in Europe
13. CMOs & CDMOs
13.1 Appropriate Phase for Outsourcing
13.2 Important Points Condirered while Fixing a CMO/CDMO
13.3 In-House vs. Outsourcing
13.4 Number of Cell Gene Therapy CMOs/CDMOs in Europe
13.5 Projected Growth of CMOs and CDMOs
13.6 Projected Growth of Cell Manufacturing Capacity
14. MARKET ANALYSIS
14.1 Global Market for RM Products
14.1.1 Global RM Products Market by Geography
14.2 Global Market for Cell Therapy Products
14.3 Global Market for Gene-Modified Cell Therapy Products
14.3.1 Global Market for CAR-T Therapy by Geography
14.3.2 Global Market for CAR-T Therapy by Country
14.3.3 Global Market for CAR-T Cell Therapy by Targeted Antigens
14.3.4 Competitive Landscape
14.4 Global Market for Tissue-Engineered Products
15. COMPANY PROFILES
15.1 Adaptimmune Therapeutics plc
15.2 Admedus Ltd
15.2.2 CardioCel 3D
15.3 Advanced Bioscience Laboratories, Inc.
15.3.1 Biomanufacturing Services
188.8.131.52 Manufacturing of Virus-Based Products
184.108.40.206 Manufacturing of Protein-Based Products
220.127.116.11 Aseptic Filling Services
18.104.22.168 Immunology and Biomarker Testing
22.214.171.124 Contract Research Assays
126.96.36.199 Clinical Immunology Solutions
188.8.131.52 Preclinical Solutions
184.108.40.206 Product Development Solutions
220.127.116.11 Government Partnering
18.104.22.168 Translational Product Development
15.4 Allogene Therapeutics, Inc
15.5 AlloSource, Inc.
15.6 Ambys Medicines, Inc.
15.7 Anterogen Co., Ltd.
15.7.1 Cupistem Injection
15.8 APAC Biotech Pvt., Ltd.
15.9 apceth Biopharma GmbH
15.10 Asterias Biotherapeutics, Inc
15.11 Atara Biotherapeutics, Inc.
15.12 Athersys, Inc
15.13 ATVIO Biotech Ltd
15.13.1 AT132 for X-Linked Myotubular Myopathy
15.13.2 AT342 for Crigler-Najjar Syndrome
15.13.3 AT982 for Pompe Disease
15.13.4 AT307 for CASQ2-CPVT
15.14 AveXis, Inc.
15.15 Avita Medical Ltd
15.15.1 RECELL System
15.16 Batavia Bioscience B.V.
15.16.1 Research Services
15.16.2 Development Services
15.16.3 Characterization Services
15.16.4 Manufacturing Services
15.16.5 Consultancy Services
15.17 Bellicum Pharmaceuticals, Inc.
15.18 Betalin Therapeutics
15.18.1 Engineered Micro-Pancreas (EMP)
15.19 BioCardia, Inc
15.20 BioReliance Corporation
15.21 Biosolution Co., Ltd.
15.22 Biostage, Inc
15.22.1 Cellspan Esophageal Implants
15.22.2 Cellspan Bronchial Implants
15.22.3 Cellspan Tracheal Implants
15.23 Biovian Oy
15.24 BlueRock Therapeutics
15.24.1 BlueRock’s Pipeline
15.25 Bone Therapeutics SA
15.26 Brainstorm Cell Therapeutics, Inc
15.27 Brammer Bio, LLC
15.27.2 Process Development
15.27.3 Gene Therapy Manufacturing
15.27.4 Viral Vectors
15.28 Caladrius Biosciences, Inc
15.29 Carina Biotech
15.30 CARsgen Therapeutics, Ltd
15.31 Cell Cure Neurociences Ltd
15.32 Cellerant Therapeutics, Inc.
15.33 Cell Medica Limited
15.34 Cell Therapy Catapult, Ltd
15.35 Cellular Biomedicine Group, Inc
15.36 Cellular Dynamics International, Inc
15.37 Celonic AG
15.38 Celyad SA
15.39 Farmaceutici S.p.A
15.40 Cobra Biologics Ltd.
15.40.1 DNA Platform Process, Development and Scale Up
15.40.2 Viral Vector Platform Process
15.41 co-don AG
15.42 Corestem, Inc.
15.42.1 NEURONATA-R inj.
15.43 Cynata Therapeutics, Ltd
15.44 Cytori Therapeutics, Inc
15.45 Dendreon Pharmaceuticals, Inc.
15.46 Enzyvant, Inc.
15.47 Eureka Therapeutics, Inc
15.48 Fate Therapeautics, Inc
15.49 Fibrocell Technologies, Inc.
15.49.1 Fibrocell’s Pipeline
15.50 FUJIFILM Diosynth Biotechnologies, Inc.
15.51 Gamida Cell Ltd.
15.52 GC Cell
15.53 Genzyme Corporation
15.54 Glycostem Therapeutics BV
15.55 Hemostemix, Inc
15.56 Histogenics Corporation
15.57 Humacyte, Inc
15.58 Immusoft Corporation
15.58.1 ISP Technology
15.59 Innovative Cellular Therapeutics Co., Ltd
15.60 Iovance Biotherapeutics, Inc.
15.61 JCR Pharmaceuticals Co., Ltd.
15.61.1 TEMCELL HS Inj.
15.63 JW CreaGene Co., Ltd
15.64 Kadimastem Ltd.
15.65 Kaneka Eurogentec S.A.
15.66 KBI Biopharma, Inc.
15.67 Kiadis Pharma N.V
15.68 Kite Pharma, Inc
15.69 Lion TCR Pte. Ltd.
15.70 Lonza Group Ltd
15.70.1 Custom Development and Manufacturing
15.71 Magenta Therapeutics, Inc.
15.71.1 Magenta’s Programs
22.214.171.124 Transplant Conditioning
126.96.36.199 Stem Cell Expansion
188.8.131.52 Stem Cell Harvesting
184.108.40.206 Post Transplant Complications
15.72 MaxCyte, Inc
220.127.116.11 MaxCyte STX
18.104.22.168 MaxCyte VLX
22.214.171.124 MaxCyte GT
15.73 Medigene AG
15.74 MEDIPOST CO., Ltd.
15.75 Mesoblast Limited
15.76 Miromatrix Medical, Inc.
15.77 MolMed S.p.A
15.77.1 MolMed’s Clinical Trial Programs
15.77.2 MolMed’s GMP Solutions
15.78 Mustang Bio, Inc
15.79 NantKwest, Inc.
15.80 NexImmune, Inc.
15.81 Neuralstem, Inc
15.82 Nohla Therapeutics, Inc
15.83 Novartis AG
15.84 Novasep Holding SAS
15.84.1 Biopharmaceutical Manufacturing Solutions
15.85 NuVasive, Inc.
15.85.2 AttraX Scaffold
15.86 Orgenesis, Inc
15.87 Orthocell Limited
15.88 Osiris Therapeutics, Inc
15.88.2 Grafix PL PRIME
15.89 Orthofix Medical, Inc.
15.89.1 Trinity ELITE
15.89.2 Trinity EVOLUTION
15.90 Oxford BioMedica plc
15.90.1 Oxford BioMedica’s Partnering Activities
15.91 Paragon Bioservices, Inc
15.92 Pharmicell Co., Ltd
15.92.1 Cellgram AMI
15.93 Pluristem Therapeutics, Inc
15.94 Posedia Therapeutics, Inc
15.95 PROMETHERA Biosciences S.A
15.96 Recipharm AB
15.97 Regenerative Medical System (RMS)
15.98 ReNeuron Group plc
15.99 Richter-Helm BioLogics GmbH & Co. KG
15.99.1 Process Development
15.100 RoosterBio, Inc
15.100.1 MSCs in different Formats
15.100.2 Bioprocess Media
15.100.3 Plug & Play Systems
15.100.4 CliniControl Products
15.102 Rubius Therapeutics, Inc.
15.103 Sangamo Therapeutics, Inc
15.104 SCM Lifesciences Co., Ltd.
15.105 Semma Therapeutics Inc
15.105.1 SCbeta Cells
15.106 Sentien Biotechnologies, Inc
15.107 SQZ Biotechnologies
15.107.1 SQZ Platform
15.108 Stempeutics Research Pvt., Ltd
15.109 Takara Bio, Inc.
15.109.1 Services and Support
15.110 Terumo Corporation
15.111 The Cell and Gene Therapy Catapult
15.111.1 Catapult’s Industrialization Team
15.111.2 Catapult’s Manufacturing Center at Stevenage
15.111.3 Catapult’s Regulatory Team
15.112 Triumvira Immunologics USA, Inc.
15.113 TxCell S.A
15.113.1 CAR-Treg Transplantation (TX200)
15.113.2 CAR-Treg Dermatology
15.113.3 CAR-Treg Multiple Sclerosis
15.114 Vericel Corporation
15.115 ViaCyte, Inc
15.115.1 Product Candidates
15.116 Vibalogics GmbH
15.117 Voyager Therapeutics, Inc
15.118 Waisman Biomanufacturing
15.118.1 Services and Products
15.119 WindMIL Therapeutics, Inc.
15.119.1 Unmodified MILs
15.119.2 MIL CARs
15.120 Wuxi App Tec, Inc.
List of Figures
Figure 2.1: Number of RM Companies by Geography, 2018
Figure 2.2: RM Products with Marketing Approval by Geography/Country
Figure 2.3: Approved RM Products by Therapy Type
Figure 2.4: Approved RM Products by Indication
Figure 2.5: Total RM Clinical Trials by Phase, 2017/2018
Figure 2.6: Total RM Clinical Trials by Technology Type
Figure 2.7: RM Industry: Total Global Financings, 2018
Figure 2.8: Total Financings to RM Industry by Type and Year, 2016-2018
Figure 2.9: Total Merger & Acquisition within RM Industry by Year, 2016-2018
Figure 2.10: Anticipated RM Product Launches, 2018-2030
Figure 2.11: Estimated RM Treated Patients, 2018-2030
Figure 3.1: Potential Applications of Stem Cells in Personalized Medicine
Figure 3.2: Potential Applications of iPSCs
Figure 3.3: Sources of MSCs
Figure 3.4: Clinical Applications of MSCs
Figure 3.5: Forecasted Approved MSC-Based Product Types, 2020-2060
Figure 3.6: Rise and Fall of MSCs, 2020-2060
Figure 3.7: MSCs - “The Transistors of the Future Commercial RM”
Figure 3.8: Types of Diseases Targeted by Neural Stem Cells in Clinical Trials
Figure 4.1: Geographical Distribution of CAR-T Cell Therapy Companies
Figure 4.2: Process of TCR-Engineered T Cells Therapy
Figure 4.3: Cancer Types Targeted by DC Therapy Studies
Figure 6.1: Number of Clinical Trials in RM Sector, 2017-2018
Figure 6.2: Number of Patient Participation in RM Clinical Trials, 2018
Figure 7.1: Number of Cell Therapy Clinical Trials, 2018
Figure 7.2: Cell Therapy Clinical Trials by Indication, 2018
Figure 7.3: Clinical Trials using MSCs by Indication
Figure 7.4: Number of Clinical Trials and Number of Patients Treated using MSCs
Figure 7.5: Number of Clinical Trials using MSCs by Phase of Development
Figure 7.6: Diseases Targeted by MSCs in Clinical Trials
Figure 7.7: Clinical Trials using MSCs by Geography/Country
Figure 8.1: Numbert of Gene Modified Cell Therapy Clinical Trials, 2017-2018
Figure 8.2: The Most Common Target Antigens for CAR-T Cell Therapies
Figure 8.3: Antigens other than CD19 in Clinical Trials Targeted by CAR-T
Figure 8.4: Antigens Targeted by CAR-T in Solid Cancers in Clinical Trials
Figure 9.1: Number of Clinical Trials in TE Space, 2017-2018
Figure 10.1: No. of Approved Cell Therapy & Gene-Modified Cell Products by Region/Country
Figure 10.2: Cell Therapy Products by Therapy Type
Figure 10.3: Indications Addressed by the Approved Cell Therapy Products
Figure 11.1: Annual U.S. Revenue for MACI
Figure 12.1: Expenditure Categories in Cell Manufacturing
Figure 12.2: The Impact of Head Count on Labor Cost
Figure 12.3: Cost of Manufacture in a Partially-Automated Facility
Figure 12.4: Cost of Manufacture in a Fully-Automated Facility
Figure 12.5: NPC of Manual, Partially-Automated and Fully-Automated Processes
Figure 13.1: The Appropriate Phase for Outsourcing a Cell or Gene Therapy Project
Figure 13.2: Important Points Considered while Fixing a CDMO
Figure 13.3: Share of In-House and CDMO Manufacture of Cell and Gene Therapies
Figure 13.4: Number of Cell Gene Therapy CMOs/CDMOs in Europe
Figure 13.5: Projected Growth of Outsourcing Market, 2018-2025
Figure 13.6: Projected Growth of Cell Manufacturing Capacity, 2018-2025
Figure 14.1: Global Market for Regenerative Medicinal Products, 2018-2025
Figure 14.2: Global Market for RM Products by Geography, 2018-2025
Figure 14.3: Global Market for Approved Cell Therapy Products, 2018-2025
Figure 14.4: Global Market for CAR-T Cell Therapies, 2018-2023
Figure 14.5: Global Market for CAR-T Therapy by Geography, 2024
Figure 14.6: Global Market for CAR-T Therapy by Country, 2024
Figure 14.7: Global Market for CAR-T Cell Therapies by Targeted Antigen, 2018
Figure 14.8: Global Market for Tissue-Engineered Products, 2018-2025
List of Tables
Table 2.1: Number of RM Companies by Geography, 2018
Table 2.2: RM Product Approvals in 2017/2018
Table 2.3: RM Products with Marketing Approval by Geography/Country
Table 2.4: Approved RM Products by Therapy Type
Table 2.5: Approved RM Products by Indication
Table 2.6: The Lone Cell Therapy Product Approved in Australia
Table 2.7: The Two RM Products Approved in Canada
Table 2.8: RM Product Approved in China
Table 2.9: Approved RM Products in Europe
Table 2.10: RM Products with Withrawn Approvals in Europe
Table 2.11: Approved RM Products in India
Table 2.12: RM Products Approved in Japan
Table 2.13: RM Products Approved in New Zealand
Table 2.14: RM Products Approved in South Korea
Table 2.15: Approved RM Products in the U.S.
Table 2.16: RM Products with RMAT Designation
Table 2.17: Total RM Clinical Trials by Phase, 2017/2018
Table 2.18: Total RM Clinical Trials by Technology Type
Table 2.19: Select Anticipated RM Industry Clinical Trial Data Readouts: 2019
Table 2.20: RM Industry: Total Global Financings, 2018
Table 2.21: Total Financings to RM Industry by Type and Year, 2016-2018
Table 2.22: Corporate Partnerships (Upront Payments) in RM Industry, 2018
Table 2.23: Private Placements and Venture Fianancings in RM Industry, 2018
Table 2.24: Public Offerings (IPOs & Follow-Ons) in RM Industry, 2018
Table 2.25: Total Merger & Acquisition within RM Industry by Year, 2016-2018
Table 2.26: Top 20 RM Companies by Pipeline Size, 2018
Table 3.1: Timeline of Notable Events in Cell Therapy Sector
Table 3.2: Common Indications for HSCTs
Table 3.3: FDA-Approved Allogeneic HSCs
Table 3.4: Leading iPSC Therapy Companies
Table 3.5: Groth Factors Secreted by MSCs
Table 3.6: Cytokines Secreted by MSCs
Table 3.7: Chemokines Secreted by MSCs
Table 3.8: Forecasted Approved MSC-Based Product Types, 2020-2060
Table 3.9: Estimated MSC Consumption in 2040
Table 3.10: MSC-Based Approved Products
Table 3.11: Diseases Addressed by Neural Stem Cells in Clinical Trials
Table 3.12: Select List of Companies Active in Clinical Trials using NSCs
Table 3.13: Companies involved in hESCs Projects and the Diseases Addressed
Table 3.14: Notable Events in Cell Therapy Space, 2018
Table 3.15: Top 16 Stem Cell Therapy Start Ups
Table 3.16: Cell Therapy Product Candidates with RMAT Designation
Table 4.1: Number of Gene-Modified Cell Therapy Companies
Table 4.2: Geographical Distribution of CAR-T Cell Therapy Companies
Table 4.3: Select Events in Cell-Based Immuno-Oncology Space, 2018
Table 4.4: Top Ten Cancer Immunotherapy Companies
Table 4.5: Major Immunotherapy Startups
Table 4.6: Select Ongoing Clinical Trials Involving TCRs
Table 4.7: Venture Activity and Deal Flow for the Development of TCR Therapies, 2018
Table 4.8: CAR-NK Cells in Clinical Trials
Table 4.9: Select NK Cell Therapies in Clinical and Preclinical Development
Table 4.10: Examples of Clinical Trials using TILs
Table 4.11: The Two Gamma-Delta T-cell Therapy Companies
Table 4.12: Select Ongoing Clinical Trials Testing DC Vaccines
Table 5.1: Approved TE Products
Table 5.2: Select Events in Tissue Engineering Space, 2018
Table 6.1: Number of Clinical Trials in RM Sector, 2017-2018
Table 6.2: Number of Patient Participation in RM Clinical Trials, 2018
Table 6.3: Number of Clinical Trials by Indications in the RM Sector, 2018
Table 7.1: Number of Cell Therapy Clinical Trials, 2018
Table 7.2: Number of Clinical Trials using MSCs
Table 7.3: Number of Clinical Trials and Number of Patients Treated using MSCs
Table 7.4: MSC Target Indication, Total Trials and Cells used per Patient
Table 7.5: The 29 Clinical Trials using hESCs
Table 7.6: Select Anticipated Clinical Data and Events in Cell Therapy Space
Table 8.1: Numbert of Gene Modified Cell Therapy Clinical Trials, 2017-2018
Table 8.2: Antigens other than CD19 in Clinical Trials Targeted by CAR-T
Table 8.3: Anticipated Developments in CAR-T Space
Table 9.1: Number of Clinical Trials in TE Space, 2017-2018
Table 9.2: Anticipated Clinical Events in Tissue Engineering Space, 2019/2020
Table 10.1: No. of Approved Cell Therapy & Gene-Modified Cell Products by Region/Country
Table 10.2: Cell Therapy Products by Therapy Type
Table 10.3: Indications Addressed by the Approved Cell Therapy Products
Table 10.4: Approved Cell Therapy Product in Australia
Table 10.5: Cell Therapy Products Approved in Canada
Table 10.6: Approved Cell Therapy and Gene-Modified Cell Therapies in Europe
Table 10.7: Approved Cell Therapy Products in India
Table 10.8: Approved Cell Therapy Product in Japan
Table 10.9: Approved Cell Therapy Product in New Zealand
Table 10.10: Approved Cell Therapy Products in South Korea
Table 10.11: Approved Cell Therapy Products in the U.S.
Table 11.1: Approved TE Products in Europe
Table 11.2: Approved TE Products in Japan
Table 11.3: Approved TE Products in South Korea
Table 11.4: Approved TE Products in the U.S
Table 11.5: Addressable Cartilage Repair Patient Population in the U.S.
Table 12.1: Expenditure Categories in Cell Manufacturing
Table 12.2: The Impact of Head Count on Labor Cost
Table 12.3: Cost of Manufacture in a Partially-Automated Facility
Table 12.4: Cost of Manufacture in a Fully-Automated Facility
Table 12.5: In-House Gene Therapy Manufacturing Capabilities of Select Big and Mid Pharma
Table 12.6: External Gene Therapy Manufacturing by Big and Mid Pharma
Table 12.7: Cell and Gene Therapy Manufacturing Capacities in North America
Table 12.8: Cell and Gene Therapy Manufacturing Capacities in Europe
Table:13.1: Select CDMOs in Cell and Gene Therapy Space
Table 13.2: The Appropriate Phase for Outsourcing a Cell or Gene Therapy Project
Table 13.3: Important Points Considered While Fixing a CDMO
Table 13.4: Share of In-House and CDMO Manufacture of Cell and Gene Therapies
Table 14.1: Global Market for RM Products by Therapy Type, 2018-2025
Table 14.2: Global Market for RM Products by Geography, 2018-2025
Table 14.3: Global Market for Approved Cell Therapy Products, 2018-2025
Table 14.4: Global Market for CAR-T Cell Therapy Products, 2018-2024
Table 14.5: CAR-T Cell Therapy - Competitive Landscape
Table 14.6: Global Market for Tissue-Engineered Products, 2018-2025
Table 15.1: Adaptimmune’s Pipeline Programs
Table 15.2: Allogene Therapeutics’ Pipeline of Allogeneic T-Cell Product Candidates
Table 15.3: apceth’s Pipeline Overview
Table 15.4: Asterias’ Pipeline Programs
Table 15.5: Atara’s Pipeline of T-Cell Immunotherapy and CAR-T Product Candidates
Table 15.6: Athersys’ Clinical Programs using MultiStem
Table 15.7: Audentes’ Product Candidates
Table 15.8: Bellicum Pharmaceuticals’ Product Candidates
Table 15.9: BioCardia’s Advanced Pipeline
Table 15.10: Biosolution’s Products and Product Candidates
Table 15.11: Brainstorm’s Clinical Programs
Table 15.12: Caladrius’ Proprietary Technology Platforms and Pipeline Programs
Table 15.13: CARsgen Therapeutics’ Product Candidates
Table 15.14: Cellerant’s Program Pipeline for Blood Disorders
Table 15.15: Cell Medica’s Product Pipeline
Table 15.16: CBG’s Immuno-Oncology Stem Cell Therapy Pipeline
Table 15.17: Celyad’s Programs’ Status at a Glance
Table 15.18: Corestem’s Key Clinical Pharmaceutical Development
Table 15.19: Cytori’s Cell Therapy Development Pipeline
Table 15.20: Eureka’s Development Pipeline
Table 15.21: Fate Therapeutics’ Cell Therapy Product Candidates Pipeline
Table 15.22: Fibrocell’s Personalized Biologics Pipeline
Table 15.23: Gamida Cell’s Pipeline Programs
Table 15.24: Current Status of GC Cell’s Clinical Activities
Table 15.25: Hemostemix’s Clinical Pipeline
Table 15.26: ICT’s Pipeline Programs
Table 15.27: Iovance’s Clinical Pipeline
Table 15.28: JCR’s RM Products in Development
Table 15.29: Kite’s CAR-T Pipeline
Table 15.30: Lion TCR’s Product Candidates
Table 15.31: Magenta’s Product Candidates
Table 15.32: Medigene’s Immunotherapy Pipeline Projects
Table 15.33: Mesoblast’s Advanced Product Candidates
Table 15.34: MolMed’s Product Candidates
Table 15.35: Mustang Bio’s Product Pipeline
Table 15.36: NantKwest’s Clinical Trials using Cryopreserved haNK Cells
Table 15.37: NexImmune’s Adoptive Cellular Therapy (ACT) Programs
Table 15.38: Neuralstem’s Cell Therapy Programs
Table 15.39: Nohla’s Donor Cell Therapy Programs
Table 15.40: Oxford BioMedica’s Proprietary Product Pipeline
Table 15.41: Oxford BioMedica’s Partnered Products
Table 15.42: Oxford BioMedica’s IP Enabled and Royalty Bearing Products
Table 15.43: Pharmicell’s Clinical Trials for Commercialization
Table 15.44: Posedia’s Product Pipeline
Table 15.45: PROMETHERA’s Product Pipeline
Table 15.46: ReNeuron’s Program Pipeline
Table 15.47: Rubius’ Pipeline Programs
Table 15.48: Sangamo’s Proprietary Programs
Table 15.49: Sangamo’s Proprietary Programs
Table 15.50: SCM Lifesciences’ Product Pipeline
Table 15.51: Sentien’s SBI-101 Clinical Programs
Table 15.52: Triumvira’s Product Pipeline
Table 15.53: ViaCyte’s Product Pipeline
Table 15.54: Voyager’s Pipeline Programs
- Adaptimmune Therapeutics plc
- Admedus Ltd
- Advanced Bioscience Laboratories, Inc.
- Allogene Therapeutics, Inc
- AlloSource, Inc.
- Ambys Medicines, Inc.
- Anterogen Co., Ltd.
- APAC Biotech Pvt., Ltd.
- apceth Biopharma GmbH
- Asterias Biotherapeutics, Inc
- Atara Biotherapeutics, Inc.
- Athersys, Inc
- ATVIO Biotech Ltd
- AveXis, Inc.
- Avita Medical Ltd
- Batavia Bioscience B.V.
- Bellicum Pharmaceuticals, Inc.
- Betalin Therapeutics
- BioCardia, Inc
- BioReliance Corporation
- Biosolution Co., Ltd.
- Biostage, Inc
- Biovian Oy
- BlueRock Therapeutics
- Bone Therapeutics SA
- Brainstorm Cell Therapeutics, Inc
- Brammer Bio, LLC
- Caladrius Biosciences, Inc
- Carina Biotech
- CARsgen Therapeutics, Ltd
- Cell Cure Neurociences Ltd
- Cell Medica Limited
- Cell Therapy Catapult, Ltd
- Cellerant Therapeutics, Inc.
- Cellular Biomedicine Group, Inc
- Cellular Dynamics International, Inc
- Celonic AG
- Celyad SA
- co-don AG
- Cobra Biologics Ltd.
- Corestem, Inc.
- Cynata Therapeutics, Ltd
- Cytori Therapeutics, Inc
- Dendreon Pharmaceuticals, Inc.
- Enzyvant, Inc.
- Eureka Therapeutics, Inc
- Farmaceutici S.p.A
- Fate Therapeautics, Inc
- Fibrocell Technologies, Inc.
- FUJIFILM Diosynth Biotechnologies, Inc.
- Gamida Cell Ltd.
- GC Cell
- Genzyme Corporation
- Glycostem Therapeutics BV
- Hemostemix, Inc
- Histogenics Corporation
- Humacyte, Inc
- Immusoft Corporation
- Innovative Cellular Therapeutics Co., Ltd
- Iovance Biotherapeutics, Inc.
- JCR Pharmaceuticals Co., Ltd.
- JW CreaGene Co., Ltd
- Kadimastem Ltd.
- Kaneka Eurogentec S.A.
- KBI Biopharma, Inc.
- Kiadis Pharma N.V
- Kite Pharma, Inc
- Lion TCR Pte. Ltd.
- Lonza Group Ltd
- Magenta Therapeutics, Inc.
- MaxCyte, Inc
- Medigene AG
- MEDIPOST CO., Ltd.
- Mesoblast Limited
- Miromatrix Medical, Inc.
- MolMed S.p.A
- Mustang Bio, Inc
- NantKwest, Inc.
- Neuralstem, Inc
- NexImmune, Inc.
- Nohla Therapeutics, Inc
- Novartis AG
- Novasep Holding SAS
- NuVasive, Inc.
- Orgenesis, Inc
- Orthocell Limited
- Orthofix Medical, Inc.
- Osiris Therapeutics, Inc
- Oxford BioMedica plc
- Paragon Bioservices, Inc
- Pharmicell Co., Ltd
- Pluristem Therapeutics, Inc
- Posedia Therapeutics, Inc
- PROMETHERA Biosciences S.A
- Recipharm AB
- Regenerative Medical System (RMS)
- ReNeuron Group plc
- Richter-Helm BioLogics GmbH & Co. KG
- RoosterBio, Inc
- Rubius Therapeutics, Inc.
- Sangamo Therapeutics, Inc
- SCM Lifesciences Co., Ltd.
- Semma Therapeutics Inc
- Sentien Biotechnologies, Inc
- SQZ Biotechnologies
- Stempeutics Research Pvt., Ltd
- Takara Bio, Inc.
- Terumo Corporation
- The Cell and Gene Therapy Catapult
- Triumvira Immunologics USA, Inc.
- TxCell S.A
- Vericel Corporation
- ViaCyte, Inc
- Vibalogics GmbH
- Voyager Therapeutics, Inc
- Waisman Biomanufacturing
- WindMIL Therapeutics, Inc.
- Wuxi App Tec, Inc.
The content and statistics contained within the publisher's reports are compiled using a broad range of sources, as described below.
- Clinical Trial Databases (ClinicalTrials.gov, International Clinical Trials Registry Platform, European Union Clinical Trials Register, Chinese Clinical Trial Registry, Others)
- Scientific Publication Databases (PubMed, Highwire Press, Google Scholar)
- Patent Databases (United States Patent and Trade Office, World Intellectual Property Organization, Google Patent Search)
- Grant Funding Databases (RePORT Database, CIRM, MRC, Wellcome Trust - UK, Others)
- Product Launch Announcements (Trade Journals, Google News)
- Industry Events (Google News, Google Alerts, Press Releases)
- Company News (SEC Filings, Investor Publications, Historical Performance)
- Social Analytics (Google Adwords, Google Trends, Twitter, Topsy.com, Hashtagify.me, BuzzSumo.com)
- Interviews with Stem Cell Industry Leaders
Research & Analysis Methodologies
The publisher employs the following techniques for deriving its market research:
- Historical Databases: As the first and only market research firm to specialize in the stem cell industry, the publisher has 13+ years of historical data on each segment of the stem cell the industry. This provides an extremely rare and robust database for establishing market size determinations, as well as making future market predictions.
- Prolific Interviews with Industry Leaders: As the global leader in stem cell industry data, the publisher has interviewed hundreds of leaders from across the stem cell industry, including the CEO of FUJIFILM CDI, FUJIFILM Irvine Scientific, Pluristem Therapies, Celularity, and many others.
- Industry Relationships: The research team and its President/Founder, Cade Hildreth, Chair and present at a wide range of stem cell industry events, including Phacilitate's Advanced Therapies Week, World Stem Cell Summit (WSCS), Perinatal Stem Cell Society Congress, AABB's International Cord Blood Symposium (ICBS), and other events hosted within the U.S. and worldwide.
- Global Integrated Feedback: Because the publisher maintains the world's largest stem cell industry news site that is read by nearly a million unique readers per year and the company has large social media audiences (25.7K+ followers on Linked, 21.2K+ followers on Twitter, and 4.3K+ followers on Facebook), the publisher is able to publish content relevant to the industry and receive immediate feedback/input from a global community of readers. In short, the publisher's data is crowd-sourced from market participants worldwide, including those in diverse geographic regions.
- Preliminary Research: In addition to the interviews described above, the publisher conducts market surveys, executes social media polls, and aggregates market data from stem cell industry announcements, press releases, and corporate filings/presentations.
- Secondary Research: The publisher summarizes, collects and synthesizes existing market research that is relevant to the market area of interest.
- Future Projections: Using the resources described above, the publisher is uniquely positioned to make future projections about market size, market growth by segment, market trends, technology evolution, funding activities (financing rounds, M&A, and IPOs), and importantly, market leadership (market share by company).