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Market Research Report

Global Market for Cell Therapy & Tissue Engineering 2019

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Global Market for Cell Therapy & Tissue Engineering 2019
Published: May 1, 2019 Content info: 300 Pages
Description

This report contains 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.

Table of Contents

Table of Contents

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
      • 2.2.1.1 Number of RM Products Approved by Geography/Country
      • 2.2.1.2 Approved RM Products by Therapy Type
      • 2.2.1.3 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
    • 2.2.6.1 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
      • 2.4.1.1 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
      • 3.4.2.1 Growth Factors
      • 3.4.2.2 Cytokines
      • 3.4.2.3 Chemokines
      • 3.4.2.4 Forecasted Approved MSC-Based Product Types, 2020-2060
      • 3.4.2.5 MSC Consumption Through 2040
      • 3.4.2.6 Future Decline in MSCs' Demand
      • 3.4.2.7 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
    • 5.3.2 Collagen
  • 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
  • 10.4.1 Ortho-ACI.
  • 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)
    • 10.6.3 Alofisel
    • 10.6.4 Holoclar.
  • 10.7 Approved Cell Therapy Products in India
    • 10.7.1 Cartigrow
    • 10.7.2 Ossgrow
    • 10.7.3 Apceden
    • 10.7.4 Stempeucel
  • 10.8 Approved Cell Therapy Product in Japan
    • 10.8.1 TEMCELL HS
  • 10.9 Approved Cell Therapy Product in New Zealand
    • 10.9.1 Prochymal
  • 10.10 Approved Cell Therapy Products in South Korea
    • 10.10.1 KeraHeal-Allo
    • 10.10.2 Neuronata-R
    • 10.10.3 Cupistem
    • 10.10.4 Cartistem
    • 10.10.5 Cellgram-AMI
    • 10.10.6 CureSkin Inj.
    • 10.10.7 Queencell.
    • 10.10.8 RMS Ossron
    • 10.10.9 Immuncell LC
    • 10.10.10 CreaVax-RCC
    • 10.10.11 KeraHeal
    • 10.10.12 Chondron
  • 10.11 Approved Cell Therapy Products in the U.S.
    • 10.11.1 HPC, Cord Blood
    • 10.11.2 Clevecord.
    • 10.11.3 HPC, Cord Blood (Bloodworks)
    • 10.11.4 HPC, Cord Blood (LifeSouth Copmmunity Blood Center)
    • 10.11.5 Allocord
    • 10.11.6 Ducord
    • 10.11.7 HPC, Cord Blood (Clinimmune Labs)
    • 10.11.8 Hemacord
    • 10.11.9 Laviv (Azficel-T)
    • 10.11.10 Provenge (Sipuleucel-T)

11. APPROVED TISSUE ENGINEERED (TE) PRODUCTS

  • 11.1 Spherox
  • 11.2 HeartSheet
  • 11.3 JACC
  • 11.4 JACE
  • 11.5 Kaloderm
  • 11.6 Holoderm
  • 11.7 MACI
  • 11.8 GINTUIT

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.
    • 15.2.1 CardioCel
    • 15.2.2 CardioCel 3D
    • 15.2.3 VascuCel
  • 15.3 Advanced Bioscience Laboratories, Inc.
    • 15.3.1 Biomanufacturing Services
      • 15.3.1.1 Manufacturing of Virus-Based Products
      • 15.3.1.2 Manufacturing of Protein-Based Products
      • 15.3.1.3 Aseptic Filling Services
      • 15.3.1.4 Immunology and Biomarker Testing
      • 15.3.1.5 Contract Research Assays
      • 15.3.1.6 Clinical Immunology Solutions
      • 15.3.1.7 Preclinical Solutions
      • 15.3.1.8 Product Development Solutions
      • 15.3.1.9 Government Partnering
      • 15.3.1.10 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
    • 15.7.2 Queencell.
  • 15.8 APAC Biotech Pvt., Ltd.
    • 15.8.1 APCEDEN
  • 15.9 apceth Biopharma GmbH
  • 15.10 Asterias Biotherapeutics, Inc.
  • 15.11 Atara Biotherapeutics, Inc.
  • 15.12 Athersys, Inc.
    • 15.12.1 MultiStem
  • 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.
    • 15.14.1 AVXS-101
  • 15.15 Avita Medical Ltd.
    • 15.15.1 RECELL System
    • 15.15.2 ReGenerCell.
    • 15.15.3 ReNovaCell
  • 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
    • 15.25.1 ALLOB
    • 15.25.2 JTA-004
  • 15.26 Brainstorm Cell Therapeutics, Inc.
    • 15.26.1 NurOwn
  • 15.27 Brammer Bio, LLC
    • 15.27.1 Services
    • 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
    • 15.29.1 CNA1003
  • 15.30 CARsgen Therapeutics, Ltd.
  • 15.31 Cell Cure Neurociences Ltd.
    • 15.31.1 OpRegen
  • 15.32 Cellerant Therapeutics, Inc.
  • 15.33 Cell Medica Limited
  • 15.34 Cell Therapy Catapult, Ltd.
    • 15.34.1 Capabilities
  • 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.
    • 15.39.1 Holoclar
  • 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
    • 15.41.1 ACT3D
  • 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.
    • 15.45.1 PROVENGE
  • 15.46 Enzyvant, Inc.
    • 15.46.1 RVT-802
  • 15.47 Eureka Therapeutics, Inc.
    • 15.47.1 ARTEMIS
    • 15.47.2 E-ALPHA
  • 15.48 Fate Therapeautics, Inc.
  • 15.49 Fibrocell Technologies, Inc.
    • 15.49.1 Fibrocell's Pipeline
  • 15.50 FUJIFILM Diosynth Biotechnologies, Inc.
    • 15.50.1 Services
  • 15.51 Gamida Cell Ltd.
  • 15.52 GC Cell
  • 15.53 Genzyme Corporation
    • 15.53.1 Epicel
  • 15.54 Glycostem Therapeutics BV
    • 15.54.1 Technology
    • 15.54.2 oNKord
  • 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.
  • 15.62 J-TEC
  • 15.63 JW CreaGene Co., Ltd.
    • 15.63.1 Products
  • 15.64 Kadimastem Ltd.
    • 15.64.1 AstroRx
    • 15.64.2 Incapsulin
  • 15.65 Kaneka Eurogentec S.A.
  • 15.66 KBI Biopharma, Inc.
  • 15.67 Kiadis Pharma N.V.
    • 15.67.1 ATIR101
  • 15.68 Kite Pharma, Inc.
    • 15.68.1 Yescarta
  • 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
      • 15.71.1.1 Transplant Conditioning
      • 15.71.1.2 Stem Cell Expansion
      • 15.71.1.3 Stem Cell Harvesting
      • 15.71.1.4 Post Transplant Complications
  • 15.72 MaxCyte, Inc.
    • 15.72.1 Products
      • 15.72.1.1 MaxCyte STX
      • 15.72.1.2 MaxCyte VLX
      • 15.72.1.3 MaxCyte GT
  • 15.73 Medigene AG
  • 15.74 MEDIPOST CO., Ltd.
    • 15.74.1 CARTISTEM.
    • 15.74.2 PNEUMOSTEM
    • 15.74.3 NEUROSTEM
  • 15.75 Mesoblast Limited
  • 15.76 Miromatrix Medical, Inc.
    • 15.76.1 MIRODERM
    • 15.76.2 MICROMESH
  • 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.
    • 15.78.1 MB-101
    • 15.78.2 MB-102
    • 15.78.3 MB-103
    • 15.78.4 MB-104
    • 15.78.5 MB-105
    • 15.78.6 MB-106
    • 15.78.7 MB-107
  • 15.79 NantKwest, Inc.
  • 15.80 NexImmune, Inc.
  • 15.81 Neuralstem, Inc.
  • 15.82 Nohla Therapeutics, Inc.
  • 15.83 Novartis AG
    • 15.83.1 Kymriah
  • 15.84 Novasep Holding SAS
    • 15.84.1 Biopharmaceutical Manufacturing Solutions
  • 15.85 NuVasive, Inc.
    • 15.85.1 Osteocel
    • 15.85.2 AttraX Scaffold
  • 15.86 Orgenesis, Inc.
    • 14.86.1 MaSTHerCell
  • 15.87 Orthocell Limited
  • 15.88 Osiris Therapeutics, Inc.
    • 15.88.1 Grafix
    • 15.88.2 Grafix PL PRIME
    • 15.88.3 Cartiform
    • 15.88.4 BIO4
  • 15.89 Orthofix Medical, Inc.
    • 15.89.1 Trinity ELITE.
    • 15.89.2 Trinity EVOLUTION
    • 15.89.3 VersaShield
  • 15.90 Oxford BioMedica plc
    • 15.90.1 Oxford BioMedica's Partnering Activities
  • 15.91 Paragon Bioservices, Inc.
    • 15.91.1 Services
  • 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)
    • 15.97.1 Chondron
    • 15.97.2 Ossron
  • 15.98 ReNeuron Group plc
  • 15.99 Richter-Helm BioLogics GmbH & Co. KG
    • 15.99.1 Process Development
    • 15.99.2 Analytics
    • 15.99.3 Production
  • 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
  • 15.101 RoslinCT
    • 15.101.1 Services
  • 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.
    • 15.106.1 SBI-101
  • 15.107 SQZ Biotechnologies
    • 15.107.1 SQZ Platform.
  • 15.108 Stempeutics Research Pvt., Ltd.
    • 15.108.1 Stempeucel
    • 15.108.2 Stempeucare
    • 15.108.3 Stempeutron
  • 15.109 Takara Bio, Inc.
    • 15.109.1 Services and Support
  • 15.110 Terumo Corporation
    • 15.110.1 HeartSheet
  • 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 Technology
    • 15.113.1 CAR-Treg Transplantation (TX200)
    • 15.113.2 CAR-Treg Dermatology
    • 15.113.3 CAR-Treg Multiple Sclerosis
  • 15.114 Vericel Corporation
    • 15.114.1 MACI
    • 15.114.2 Epicel
  • 15.115 ViaCyte, Inc.
    • 15.115.1 Product Candidates
    • 15.115.1.1 PEC-Direct
    • 15.115.1.2 PEC-Encap
  • 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
    • 15.119.3 genMILs
  • 15.120 Wuxi App Tec, Inc.
    • 15.120.1 Services

INDEX 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

INDEX 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 2.9: (CONTINUED)
  • 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 2.14: (CONTINUED)
  • TABLE 2.14: (CONTINUED)
  • TABLE 2.15: Approved RM Products in the U.S.
  • TABLE 2.15: (CONTINUED)
  • TABLE 2.15: (CONTINUED)
  • TABLE 2.15: (CONTINUED)
  • TABLE 2.16: RM Products with RMAT Designation
  • TABLE 2.16: (CONTINUED)
  • TABLE 2.16: (CONTINUED)
  • TABLE 2.16: (CONTINUED)
  • 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 2.19: (CONTINUED)
  • TABLE 2.19: (CONTINUED)
  • 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 3.10: (CONTINUED)
  • 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 3.16: (CONTINUED)
  • TABLE 3.16: (CONTINUED)
  • 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 5.1: (CONTINUED)
  • 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 7.6: (CONTINUED)
  • TABLE 7.6: (CONTINUED)
  • TABLE 7.6: (CONTINUED)
  • TABLE 7.6: (CONTINUED)
  • TABLE 7.6: (CONTINUED)
  • 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 8.3: (CONTINUED)
  • 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 10.10: (CONTINUED)
  • TABLE 10.11: Approved Cell Therapy Products in the U.S.
  • TABLE 10.11: (CONTINUED)
  • TABLE 10.11: (CONTINUED)
  • 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 12.8: (CONTINUED)
  • TABLE 12.8: (CONTINUED)
  • 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 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
  • TABLE 14.5: CAR-T Cell Therapy - Competitive Landscape
  • TABLE 14.6: Global Market for Tissue-Engineered Products, 2018-2025.
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