EXECUTIVE SUMMARY – Market for Cell Therapy and Tissue Engineering
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 practised 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 favourably 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:
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.
Table of Content
Statement of the Report
Cell Therapy Industry
Tissue Engineering Industry
BRIEF OVERVIEW OF REGENERATIVE MEDICINE (RM) INDUSTRY
Number of RM Companies
Table Number of RM Companies by Geography, 2018
RM Product Approvals in 2017/2018
Table RM Product Approvals in 2017/2018
RM Products Approved Worldwide
Table RM Products with Marketing Approval by Geography/Country
Table Approved RM Products by Therapy Type
Table Approved RM Products by Indication
Approved RM Products in Australia
Table The Lone Cell Therapy Product Approved in Australia
The Two RM Products Approved in Canada
Table The Two RM Products Approved in Canada
RM Product Approved in China
Table RM Product Approved in China
Approved RM Products in Europe
Table Approved RM Products in Europe
Table RM Products with Withdrawn Approvals in Europe
Approved RM Products in India
Table Approved RM Products in India
RM Products Approved in Japan
Table RM Products Approved in Japan
RM Products Approved in New Zealand
Table RM Products Approved in New Zealand
RM Products Approved in South Korea
Table RM Products Approved in South Korea
Approved RM Products in the U.S.
Table Approved RM Products in the U.S.
RM Products with RMAT Designation
Table RM Products with RMAT Designation
Total RM Clinical Trials
Table Total RM Clinical Trials by Phase, 2017/2018
Total RM Clinical Trials by Technology Type
Table Total RM Clinical Trials by Technology Type
Table Select Anticipated RM Industry Clinical Trial Data Readouts: 2019
RM Industry: Total Global Financings, 2018
Table RM Industry: Total Global Financings, 2018
Total Financings to RM Industry by Type and Year, 2016-2018
Table Total Financings to RM Industry by Type and Year, 2016-2018
Corporate Partnerships (Upfront Payments) in RM Industry, 2018
Table Corporate Partnerships (Upfront Payments) in RM Industry, 2018
Private Placements and Venture Fianancings in RM Industry, 2018
Table Private Placements and Venture Financings in RM Industry, 2018
Public Offerings (IPOs & Follow-Ons) in RM Industry, 2018
Table Public Offerings (IPOs & Follow-Ons) in RM Industry, 2018
Total Merger & Acquisition within RM Industry by Year, 2016-2018
Table Total Merger & Acquisition within RM Industry by Year, 2016-2018
Anticipated RM Product Launches
Estimated RM Treated Patients, 2018-2030
Top 20 RM Companies by Pipeline Size
Table Top 20 RM Companies by Pipeline Size, 2018
CELL THERAPY (CT): AN OVERVIEW
Cell Therapy Timeline
Table Timeline of Notable Events in Cell Therapy Sector
Potential Applications of Stem Cells in Personalized Medicine
Types of Stem Cells Used in Cell Therapy
Hematopoietic Stem Cells (HSCs)
Table Common Indications for HSCTs
FDA-Approved Cell Therapies Made from Hematopoietic Stem Cells
Table FDA-Approved Allogeneic HSCs
Induced Pluripotent Stem Cells
Table Leading iPSC Therapy Companies
Potential Applications of iPSCs
Mesenchymal Stem Cells (MSCs)
Clinical Applications of MSCs
Biologically Active Substances Secreted by MSCs
Table Groth Factors Secreted by MSCs
Table Cytokines Secreted by MSCs
Table Chemokines Secreted by MSCs
Table Forecasted Approved MSC-Based Product Types, 2020-2060
Table Estimated MSC Consumption in 2040
Approved MSC-Based Products
Table MSC-Based Approved Products
Neural Stem Cells (NSCs)
Diseases Addressed by Neural Stem Cells in Clinical Trials
Table Diseases Addressed by Neural Stem Cells in Clinical Trials
Leading Players in NSC Clinical Trials
Table Select List of Companies Active in Clinical Trials using NSCs
Indications Addressed by NSCs in Clinical Trials
Embryonic Stem Cells (ESCs)
Indications Addressed by ESCs
Table Companies involved in hESCs Projects and the Diseases Addressed
Notable Events in Cell Therapy Space, 2018
Table Notable Events in Cell Therapy Space, 2018
Orphan Drug Designation for Pluristem's PLX-R18
Positive Data from Biocardia's CardiAMP
Survival Outcome Announced by Mesoblast for its Phase III Remestemcel-L
Topline Results for NeoCart Announced by Histogenics
Fast Track Designation for Nohla's Dilanubicel (NLA101)
RMAT Designation for Cellerant's Romyelocel-L
Top 16 Stem Cell Therapy Startups
Table Top 16 Stem Cell Therapy Start-Ups
Cell Therapies with RMAT Designation
Table Cell Therapy Product Candidates with RMAT Designation
RMAT Designation for Romyelocel-L
RMAT Designation for CLBS14-RfA
RMAT Designation for CAP-1002
RMAT Designation for MPC Therapy
RMAT Designation for CEVA101
RMAT Designation for Multistem
RMAT Designation for AST-OPC1
RMAT Designation for ATIR101
RMAT Designation for Ixmyelocel-T
RMAT Designation for jCell
RMAT Designation for RVT-802
GENE-MODIFIED CELL THERAPY
Number of Gene-Modified Cell Therapy Companies
Table Number of Gene-Modified Cell Therapy Companies
CAR-T Cell Therapy
Global Distribution of CAR-T Cell Therapy Companies
Table Geographical Distribution of CAR-T Cell Therapy Companies
Select Events in Cell-Based Immuno-Oncology Space, 2018
Table Select Events in Cell-Based Immuno-Oncology Space, 2018
Leading Cancer Immunotherapy Companies
Table Top Ten Cancer Immunotherapy Companies
Major Immunotherapy Startups
Table Major Immunotherapy Startups
T-Cell Receptor Therapy (TCR Therapy)
Process of TCR-Engineered T Cells Therapy
The promise of TCR Therapy in Solid Tumors
Clinical Progress of TCRs
Table Select Ongoing Clinical Trials Involving TCRs
Venture Activity and Deal Flow for the Development of TCR Therapies
Table Venture Activity and Deal Flow for the Development of TCR Therapies, 2018
Natural Killer (NK) Cell Therapies
CAR-Expressing NK Cells
Table CAR-NK Cells in Clinical Trials
Table Select NK Cell Therapies in Clinical and Preclinical Development
tumour-infiltrating Lymphocytes (TILs) Therapy
Table Examples of Clinical Trials using TILs
Marrow-Infiltrating Lymphocytes (MILs)
Gamma-Delta T-Cells Therapy
Big Biopharma's Interest in Gamma-Delta T-Cells Therapy
Table The Two Gamma-Delta T-cell Therapy Companies
Dendritic Cell (DC) Therapy
Cancer Types Targeted by DC Therapy Studies
Ongoing Clinical Trials Testing DC Vaccines
Table Select Ongoing Clinical Trials Testing DC Vaccines
Smart Biomaterials in Tissue Engineering
3D Printable Inks
Synthetic and Naturally-Derived Scaffolds
Table Approved TE Products
TWO Key Developments in Tissue Engineering Space in 2018
Table Select Events in Tissue Engineering Space, 2018
FDA Approval for RECELL
CLINICAL TRIAL LANDSCAPE: REGENERATIVE MEDICINE
Table Number of Clinical Trials in RM Sector, 2017-2018
Number of Patient Participation in RM Clinical Trials, 2018
Table Number of Patient Participation in RM Clinical Trials, 2018
Number of Clinical Trials by Indications in the RM Sector, 2018
Table Number of Clinical Trials by Indications in the RM Sector, 2018
CELL THERAPY CLINICAL TRIALS
Table Number of Cell Therapy Clinical Trials, 2018
Cell Therapy Clinical Trials by Indication, 2018
Mesenchymal Stem Cells (MSCs) in Clinical Trials
Table Number of Clinical Trials using MSCs
Number of Clinical Trials and Number of Patients Treated using MSCs
Table Number of Clinical Trials and Number of Patients Treated using MSCs
MSC Target Indication, Total Trials and Cells used per Patient
Table MSC Target Indication, Total Trials and Cells used per Patient
Number of Clinical Trials using MSCs
Indications for Which MSCs are Tested in Clinical Trials
Clinical Trials using MSCs by Geography/Country
Clinical Trials using hESCs
Table The 29 Clinical Trials using hESCs
Anticipated Clinical Events in Cell Therapy Space
BLA Filing for Remestemcel-L
Conditional MA Application for Tab-Cel
MultiStem being Developed for Multiple Diseases
Table Select Anticipated Clinical Data and Events in Cell Therapy Space
CLINICAL TRIALS IN GENE-MODIFIED CELL THERAPIES
Table Numbers of Gene Modified Cell Therapy Clinical Trials, 2017-2018
The Most Common Target Antigens for CAR-T Cell Therapies
Antigens other than CD19 in Clinical Trials Targeted by CAR-T
Table Antigens other than CD19 in Clinical Trials Targeted by CAR-T
Antigens Targeted by CAR-T in Solid Cancers in Clinical Trials
Anticipated Developments in CAR-T Space
Table Anticipated Developments in CAR-T Space
CLINICAL TRIALS IN TISSUE ENGINEERING SPACE
Table Number of Clinical Trials in TE Space, 2017-2018
Anticipated Clinical Events in Tissue Engineering Space, 2019/2020
Table Anticipated Clinical Events in Tissue Engineering Space, 2019/2020
APPROVED CELL THERAPY PRODUCTS WORLDWIDE
Number of Cell Therapies Approved by Geography
Table No. of Approved Cell Therapy & Gene-Modified Cell Products by Region/Country
Cell Therapy Products by Therapy Type
Table Cell Therapy Products by Therapy Type
Indications Addressed by the Approved Cell Therapy Products
Table Indications Addressed by the Approved Cell Therapy Products
Approved Cell Therapy Product in Australia
Table Approved Cell Therapy Product in Australia
Cell Therapy Products Approved in Canada
Table Cell Therapy Products Approved in Canada
Approved Cell Therapies in Europe
Table Approved Cell Therapy and Gene-Modified Cell Therapies in Europe
Yescarta (Axicabtagene ciloleucel)
Approved Cell Therapy Products in India
Table Approved Cell Therapy Products in India
Approved Cell Therapy Product in Japan
Table Approved Cell Therapy Product in Japan
Approved Cell Therapy Product in New Zealand
Table Approved Cell Therapy Product in New Zealand
Approved Cell Therapy Products in South Korea
Table Approved Cell Therapy Products in South Korea
Approved Cell Therapy Products in the U.S.
Table Approved Cell Therapy Products in the U.S.
HPC, Cord Blood
HPC, Cord Blood (Bloodworks)
HPC, Cord Blood (LifeSouth Copmmunity Blood Center)
HPC, Cord Blood (Clinimmune Labs)
APPROVED TISSUE ENGINEERED (TE) PRODUCTS
Table Approved TE Products in Europe
Table Approved TE Products in Japan
Table Approved TE Products in South Korea
Table Approved TE Products in the U.S.
Table Addressable Cartilage Repair Patient Population in the U.S.
MANUFACTURING OF CELLS FOR CELL THERAPIES
Table Expenditure Categories in Cell Manufacturing
Cost of Cell Manufacture
Table The Impact of Head Count on Labor Cost
Cost of Cell Manufacture in a Partially-Automated Facility
Table Cost of Manufacture in a Partially-Automated Facility
Cost of Manufacture in a Fully-Automated Facility
Table Cost of Manufacture in a Fully-Automated Facility
Net Present Cost (NPC) of the Three Methods
In-House Gene Therapy Manufacturing Capabilities of Select Big and Mid Pharma
Table In-House Gene Therapy Manufacturing Capabilities of Select Big and Mid Pharma
External Gene Therapy Manufacturing by Big and Mid Pharma
Table External Gene Therapy Manufacturing by Big and Mid Pharma
Cell Manufacturing Capacities in North America
Table Cell and Gene Therapy Manufacturing Capacities in North America
Cell Manufacturing Capacities in Europe
Table Cell and Gene Therapy Manufacturing Capacities in Europe
CMOs & CDMOs
Table Select CDMOs in Cell and Gene Therapy Space
Appropriate Phase for Outsourcing
Table The Appropriate Phase for Outsourcing a Cell or Gene Therapy Project
Important Points Condirered while Fixing a CMO/CDMO
Table Important Points Considered While Fixing a CDMO
In-House vs. Outsourcing
Table Share of In-House and CDMO Manufacture of Cell and Gene Therapies
Number of Cell Gene Therapy CMOs/CDMOs in Europe
Projected Growth of CMOs and CDMOs
Projected Growth of Cell Manufacturing Capacity
Global Market for RM Products
Table Global Market for RM Products by Therapy Type, 2018-2025
Global RM Products Market by Geography
Table Global Market for RM Products by Geography, 2018-2025
Global Market for Cell Therapy Products
Table Global Market for Approved Cell Therapy Products, 2018-2025
Global Market for Gene-Modified Cell Therapy Products
Table Global Market for CAR-T Cell Therapy Products, 2018-2025
Global Market for CAR-T Therapy by Geography
Global Market for CAR-T Therapy by Country
Global Market for CAR-T Cell Therapy by Targeted Antigens
Table CAR-T Cell Therapy – Competitive Landscape
Global Market for Tissue-Engineered Products
Table Global Market for Tissue-Engineered Products, 2018-2025
Adaptimmune Therapeutics plc
Table Adaptimmune's Pipeline Programs
Advanced Bioscience Laboratories, Inc.
Allogene Therapeutics, Inc.
Table Allogene Therapeutics' Pipeline of Allogeneic T-Cell Product Candidates
Ambys Medicines, Inc.
Anterogen Co., Ltd.
APAC Biotech Pvt., Ltd.
apceth Biopharma GmbH
Table apceth's Pipeline Overview
Asterias Biotherapeutics, Inc.
Table Asterias' Pipeline Programs
Atara Biotherapeutics, Inc.
Table Atara's Pipeline of T-Cell Immunotherapy and CAR-T Product Candidates
Table Athersys' Clinical Programs using MultiStem
ATVIO Biotech Ltd.
AT132 for X-Linked Myotubular Myopathy
AT342 for Crigler-Najjar Syndrome
AT982 for Pompe Disease
AT307 for CASQ2-CPVT
Table Audentes' Product Candidates
Avita Medical Ltd.
Batavia Bioscience B.V.
Bellicum Pharmaceuticals, Inc.
Table Bellicum Pharmaceuticals' Product Candidates
Engineered Micro-Pancreas (EMP)
Table BioCardia's Advanced Pipeline
Biosolution Co., Ltd.
Table Biosolution's Products and Product Candidates
Cellspan Esophageal Implants
Cellspan Bronchial Implants
Cellspan Tracheal Implants
Bone Therapeutics SA
Brainstorm Cell Therapeutics, Inc.
Table Brainstorm's Clinical Programs
Brammer Bio, LLC
Gene Therapy Manufacturing
Caladrius Biosciences, Inc.
Table Caladrius' Proprietary Technology Platforms and Pipeline Programs
CARsgen Therapeutics, Ltd.
Table CARsgen Therapeutics' Product Candidates
Cell Cure Neurociences Ltd.
Cellerant Therapeutics, Inc.
Table Cellerant's Program Pipeline for Blood Disorders
Cell Medica Limited
Table Cell Medica's Product Pipeline
Cell Therapy Catapult, Ltd.
Cellular Biomedicine Group, Inc.
Table CBG's Immuno-Oncology Stem Cell Therapy Pipeline
Cellular Dynamics International, Inc.
Table Celyad's Programs' Status at a Glance
Cobra Biologics Ltd.
DNA Platform Process, Development and Scale Up
Viral Vector Platform Process
Table Corestem's Key Clinical Pharmaceutical Development
Cynata Therapeutics, Ltd.
Cytori Therapeutics, Inc.
Table Cytori's Cell Therapy Development Pipeline
Dendreon Pharmaceuticals, Inc.
Eureka Therapeutics, Inc.
Table Eureka's Development Pipeline
Fate Therapeautics, Inc.
Table Fate Therapeutics' Cell Therapy Product Candidates Pipeline
Fibrocell Technologies, Inc.
Table Fibrocell's Personalized Biologics Pipeline
FUJIFILM Diosynth Biotechnologies, Inc.
Gamida Cell Ltd.
Table Gamida Cell's Pipeline Programs
Table Current Status of GC Cell's Clinical Activities
Glycostem Therapeutics BV
Table Hemostemix's Clinical Pipeline
Innovative Cellular Therapeutics Co., Ltd.
Table ICT's Pipeline Programs
Iovance Biotherapeutics, Inc.
Table Iovance's Clinical Pipeline
JCR Pharmaceuticals Co., Ltd.
TEMCELL HS Inj.
Table JCR's RM Products in Development
JW CreaGene Co., Ltd.
Kaneka Eurogentec S.A.
KBI Biopharma, Inc.
Kiadis Pharma N.V.
Kite Pharma, Inc.
Table Kite's CAR-T Pipeline
Lion TCR Pte. Ltd.
Table Lion TCR's Product Candidates
Lonza Group Ltd.
Custom Development and Manufacturing
Magenta Therapeutics, Inc.
Table Magenta's Product Candidates
Table Medigene's Immunotherapy Pipeline Projects
MEDIPOST CO., Ltd.
Table Mesoblast's Advanced Product Candidates
Miromatrix Medical, Inc.
MolMed's Clinical Trial Programs
MolMed's GMP Solutions
Table MolMed's Product Candidates
Mustang Bio, Inc.
Table Mustang Bio's Product Pipeline
Table NantKwest's Clinical Trials using Cryopreserved haNK Cells
Table NexImmune's Adoptive Cellular Therapy (ACT) Programs
Table Neuralstem's Cell Therapy Programs
Nohla Therapeutics, Inc.
Table Nohla's Donor Cell Therapy Programs
Novasep Holding SAS
Biopharmaceutical Manufacturing Solutions
Osiris Therapeutics, Inc.
Grafix PL PRIME
Orthofix Medical, Inc.
Oxford BioMedica plc
Oxford BioMedica's Partnering Activities
Table Oxford BioMedica's Proprietary Product Pipeline
Table Oxford BioMedica's Partnered Products
Table Oxford BioMedica's IP Enabled and Royalty Bearing Products
Paragon Bioservices, Inc.
Pharmicell Co., Ltd.
Table Pharmicell's Clinical Trials for Commercialization
Pluristem Therapeutics, Inc.
Posedia Therapeutics, Inc.
Table Posedia's Product Pipeline
PROMETHERA Biosciences S.A.
Table PROMETHERA's Product Pipeline
Regenerative Medical System (RMS)
ReNeuron Group plc
Table ReNeuron's Program Pipeline
Richter-Helm BioLogics GmbH & Co. KG.
MSCs in different Formats
Plug & Play Systems
Rubius Therapeutics, Inc.
Table Rubius' Pipeline Programs
Sangamo Therapeutics, Inc.
Table Sangamo's Proprietary Programs
Table Sangamo's Proprietary Programs
SCM Lifesciences Co., Ltd.
Table SCM Lifesciences' Product Pipeline
Semma Therapeutics Inc.
Sentien Biotechnologies, Inc.
Table Sentien's SBI-101 Clinical Programs
Stempeutics Research Pvt., Ltd.
Takara Bio, Inc.
Services and Support
The Cell and Gene Therapy Catapult
Catapult's Industrialization Team
Catapult's Manufacturing Center at Stevenage
Catapult's Regulatory Team
Triumvira Immunologics USA, Inc.
Table Triumvira's Product Pipeline
CAR-Treg Transplantation (TX200)
CAR-Treg Multiple Sclerosis
Table ViaCyte's Product Pipeline
Voyager Therapeutics, Inc.
Table Voyager's Pipeline Programs
Services and Products
WindMIL Therapeutics, Inc.
Wuxi App Tec, Inc.
Make an enquiry before buying this Report
Please fill the enquiry form below.